Kevin Schulman

All Publications

• Addressing Surprise Medical Bills and Out-of-Network Prices. JAMA internal medicine Schulman, K. A., Richman, B. 2024

  View details for DOI 10.1001/jamainternmed.2024.4270

  View details for PubMedID 39432299

• India's evolving digital health strategy. NPJ digital medicine Narayan, A., Bhushan, I., Schulman, K. 2024; 7 (1): 284

  View details for DOI 10.1038/s41746-024-01279-2

  View details for PubMedID 39414924

  View details for PubMedCentralID 3093249

• A Comparative Analysis of International Drug Price Negotiation Frameworks: An Interview Study of Key Stakeholders. The Milbank quarterly Syversen, I. D., Schulman, K., Kesselheim, A. S., Feldman, W. B. 2024

  Abstract

  Policy Points Health care systems around the world rely on a range of methods to ensure the affordability of prescription drugs, including negotiating prices soon after drug approval and relying on formal clinical assessments that compare newly approved therapies with existing alternatives. The negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks explored in this study. Adding elements from these frameworks could lead to more effective price negotiation in the United States.CONTEXT: In 2022, Congress passed the Inflation Reduction Act, which allowed Medicare, for the first time, to begin negotiating the prices for certain high-cost brand-name prescription drugs. Many other industrialized countries negotiate drug prices, and we sought to compare and contrast key features of the negotiation process across several health systems. We focused, in particular, on the criteria for selecting drugs for price negotiation, procedures for negotiation, factors that influence negotiated prices, and how prices are implemented.METHODS: We included four G7 countries in our analysis (Canada, France, Germany, and the United Kingdom [England]), two Benelux countries (Belgium and the Netherlands), and one Scandinavian country (Norway) with long-established frameworks for drug price negotiation. We also analyzed the Veterans Affairs Health System in the United States. For each system, we gathered relevant legislation, government publications, and guidelines to understand negotiation frameworks, and we reached out to key drug price negotiators in each system to conduct semistructured interviews. All interviews were recorded, transcribed, and coded, and data were analyzed based on an internal assessment tool that we developed.FINDINGS: All eight systems negotiate the prices of brand-name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems in our study differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness-to-pay thresholds are employed, and how specific approaches for priority disease areas are taken.CONCLUSIONS: High-income countries around the world adopt different approaches to conducting price negotiations on brand-name drugs but coalesce around a set of practices that will largely be absent from the current Medicare negotiation framework. US policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.

  View details for DOI 10.1111/1468-0009.12714

  View details for PubMedID 39289915

• Hospital Consolidation and Physician Unionization. The New England journal of medicine Schulman, K., Richman, B. 2024; 390 (16): 1445-1447

  View details for DOI 10.1056/NEJMp2400463

  View details for PubMedID 38647098

• INPATIENT HEART FAILURE PRICING IN THE US Wei, C., Paranjpe, I., Song, N., Sharma, P., Schulman, K., Heidenreich, P. A., Sandhu, A. ELSEVIER SCIENCE INC. 2024: 719

  View details for Web of Science ID 001291434300720

• INPATIENT HEART FAILURE PRICING IN THE US Wei, C., Paranjpe, I., Song, N., Sharma, P., Schulman, K., Heidenreich, P. A., Sandhu, A. ELSEVIER SCIENCE INC. 2024: 719

  View details for Web of Science ID 001324901500720

• PRICE VARIABILITY OF HEART TRANSPLANT AND VENTRICULAR ASSIST PROCEDURES ACROSS THE UNITED STATES Paranjpe, I., Wei, C., Sharma, P., Juthani, P., Lan, R., Sahu, M., Heidenreich, P. A., Dieleman, J., Schulman, K., Sandhu, A. ELSEVIER SCIENCE INC. 2024: 282

  View details for Web of Science ID 001291434300283

• Safety vs price in the generic drug market: metformin. The American journal of managed care Teasdale, B., Hudspeth, A., Kucera, K., Light, D., Nailor, J., Williams, S., Milstein, A., Schulman, K. A. 2024; 30 (4): 161-168

  Abstract

  Generic medications represent 90% of prescriptions in the US market and provide a tremendous financial benefit for patients. Recently, multiple generic drugs have been recalled due to the presence of carcinogens, predominantly N-nitrosodimethylamine (NDMA), including an extensive recall of extended-release (ER) metformin products in 2020.Primary pharmaceutical quality testing and database analysis.We tested marketed metformin immediate-release (IR) and ER tablets from a wide sample of generic manufacturers for the presence of carcinogenic impurities NDMA and N,N-dimethylformamide (DMF). We examined the association of level of impurity with drug price and the impact of the 2020 FDA recalls on unit price and prescription fill rate.Postrecall NDMA levels were significantly lower in metformin ER samples (standardized mean difference = -2.0; P = .01); however, we found continued presence of carcinogens above the FDA threshold in 2 of 30 IR samples (6.67%). Overall, the presence of contaminant levels was not significantly associated with price for either IR (NDMA: R2 = 0.142; P = .981; DMF: R2 = 0.382; P = .436) or ER (NDMA: R2 = 0.124; P = .142; DMF: R2 = 0.199; P = .073) samples. Despite recalls, metformin ER prescription fills increased by 8.9% while unit price decreased by 19.61% (P < .05).Recalls of metformin ER medications were effective in lowering NDMA levels below the FDA threshold; however, some samples of generic metformin still contained carcinogens even after FDA-announced recalls. The absence of any correlation with price indicates that potentially safer products are available on the market for the same price as poorer-quality products.

  View details for DOI 10.37765/ajmc.2024.89450

  View details for PubMedID 38603530

• Assessment of Price Variation in Coronary Artery Bypass Surgery at US Hospitals. Journal of the American Heart Association Wei, C., Paranjpe, I., Sharma, P., Milligan, M., Lam, M., Heidenreich, P. A., Kalwani, N., Schulman, K., Sandhu, A. 2024: e031982

  Abstract

  Little is known about hospital pricing for coronary artery bypass grafting (CABG). Using new price transparency data, we assessed variation in CABG prices across US hospitals and the association between higher prices and hospital characteristics, including quality of care.Prices for diagnosis related group code 236 were obtained from the Turquoise database and linked by Medicare Facility ID to publicly available hospital characteristics. Univariate and multivariable analyses were performed to assess factors predictive of higher prices. Across 544 hospitals, median commercial and self-pay rates were 2.01 and 2.64 times the Medicare rate ($57 240 and $75 047, respectively, versus $28 398). Within hospitals, the 90th percentile insurer-negotiated price was 1.83 times the 10th percentile price. Across hospitals, the 90th percentile commercial rate was 2.91 times the 10th percentile hospital rate. Regional median hospital prices ranged from $35 624 in the East South Central to $84 080 in the Pacific. In univariate analysis, higher inpatient revenue, greater annual discharges, and major teaching status were significantly associated with higher prices. In multivariable analysis, major teaching and investor-owned status were associated with significantly higher prices (+$8653 and +$12 200, respectively). CABG prices were not related to death, readmissions, patient ratings, or overall Centers for Medicare and Medicaid Services hospital rating.There is significant variation in CABG pricing, with certain characteristics associated with higher rates, including major teaching status and investor ownership. Notably, higher CABG prices were not associated with better-quality care, suggesting a need for further investigation into drivers of pricing variation and the implications for health care spending and access.

  View details for DOI 10.1161/JAHA.123.031982

  View details for PubMedID 38362880

• Place of Death Before and During the COVID-19 Pandemic. JAMA network open Teasdale, B., Narayan, A., Harman, S., Schulman, K. A. 2024; 7 (1): e2350821

  View details for DOI 10.1001/jamanetworkopen.2023.50821

  View details for PubMedID 38190187

• Use of Voice-Based Conversational Artificial Intelligence for Basal Insulin Prescription Management Among Patients With Type 2 Diabetes: A Randomized Clinical Trial. JAMA network open Nayak, A., Vakili, S., Nayak, K., Nikolov, M., Chiu, M., Sosseinheimer, P., Talamantes, S., Testa, S., Palanisamy, S., Giri, V., Schulman, K. 2023; 6 (12): e2340232

  Abstract

  Optimizing insulin therapy for patients with type 2 diabetes can be challenging given the need for frequent dose adjustments. Most patients receive suboptimal doses and do not achieve glycemic control.To examine whether a voice-based conversational artificial intelligence (AI) application can help patients with type 2 diabetes titrate basal insulin at home to achieve rapid glycemic control.In this randomized clinical trial conducted at 4 primary care clinics at an academic medical center from March 1, 2021, to December 31, 2022, 32 adults with type 2 diabetes requiring initiation or adjustment of once-daily basal insulin were followed up for 8 weeks. Statistical analysis was performed from January to February 2023.Participants were randomized in a 1:1 ratio to receive basal insulin management with a voice-based conversational AI application or standard of care.Primary outcomes were time to optimal insulin dose (number of days needed to achieve glycemic control), insulin adherence, and change in composite survey scores measuring diabetes-related emotional distress and attitudes toward health technology and medication adherence. Secondary outcomes were glycemic control and glycemic improvement. Analysis was performed on an intent-to-treat basis.The study population included 32 patients (mean [SD] age, 55.1 [12.7] years; 19 women [59.4%]). Participants in the voice-based conversational AI group more quickly achieved optimal insulin dosing compared with the standard of care group (median, 15 days [IQR, 6-27 days] vs >56 days [IQR, >29.5 to >56 days]; a significant difference in time-to-event curves; P = .006) and had better insulin adherence (mean [SD], 82.9% [20.6%] vs 50.2% [43.0%]; difference, 32.7% [95% CI, 8.0%-57.4%]; P = .01). Participants in the voice-based conversational AI group were also more likely than those in the standard of care group to achieve glycemic control (13 of 16 [81.3%; 95% CI, 53.7%-95.0%] vs 4 of 16 [25.0%; 95% CI, 8.3%-52.6%]; difference, 56.3% [95% CI, 21.4%-91.1%]; P = .005) and glycemic improvement, as measured by change in mean (SD) fasting blood glucose level (-45.9 [45.9] mg/dL [95% CI, -70.4 to -21.5 mg/dL] vs 23.0 [54.7] mg/dL [95% CI, -8.6 to 54.6 mg/dL]; difference, -68.9 mg/dL [95% CI, -107.1 to -30.7 mg/dL]; P = .001). There was a significant difference between the voice-based conversational AI group and the standard of care group in change in composite survey scores measuring diabetes-related emotional distress (-1.9 points vs 1.7 points; difference, -3.6 points [95% CI, -6.8 to -0.4 points]; P = .03).In this randomized clinical trial of a voice-based conversational AI application that provided autonomous basal insulin management for adults with type 2 diabetes, participants in the AI group had significantly improved time to optimal insulin dose, insulin adherence, glycemic control, and diabetes-related emotional distress compared with those in the standard of care group. These findings suggest that voice-based digital health solutions can be useful for medication titration.ClinicalTrials.gov Identifier: NCT05081011.

  View details for DOI 10.1001/jamanetworkopen.2023.40232

  View details for PubMedID 38039007

• AI Alone Will Not Reduce the Administrative Burden of Health Care. JAMA Schulman, K. A., Nielsen, P. K., Patel, K. 2023

  View details for DOI 10.1001/jama.2023.23809

  View details for PubMedID 37971721

• Revealed versus potential spatial accessibility of healthcare and changing patterns during the COVID-19 pandemic. Communications medicine Gligorić, K., Kamath, C., Weiss, D. J., Bavadekar, S., Liu, Y., Shekel, T., Schulman, K., Gabrilovich, E. 2023; 3 (1): 157

  Abstract

  Timely access to healthcare is essential but measuring access is challenging. Prior research focused on analyzing potential travel times to healthcare under optimal mobility scenarios that do not incorporate direct observations of human mobility, potentially underestimating the barriers to receiving care for many populations.We introduce an approach for measuring accessibility by utilizing travel times to healthcare facilities from aggregated and anonymized smartphone Location History data. We measure these revealed travel times to healthcare facilities in over 100 countries and juxtapose our findings with potential (optimal) travel times estimated using Google Maps directions. We then quantify changes in revealed accessibility associated with the COVID-19 pandemic.We find that revealed travel time differs substantially from potential travel time; in all but 4 countries this difference exceeds 30 minutes, and in 49 countries it exceeds 60 minutes. Substantial variation in revealed healthcare accessibility is observed and correlates with life expectancy (⍴=-0.70) and infant mortality (⍴=0.59), with this association remaining significant after adjusting for potential accessibility and wealth. The COVID-19 pandemic altered the patterns of healthcare access, especially for populations dependent on public transportation.Our metrics based on empirical data indicate that revealed travel times exceed potential travel times in many regions. During COVID-19, inequitable accessibility was exacerbated. In conjunction with other relevant data, these findings provide a resource to help public health policymakers identify underserved populations and promote health equity by formulating policies and directing resources towards areas and populations most in need.

  View details for DOI 10.1038/s43856-023-00384-9

  View details for PubMedID 37923904

  View details for PubMedCentralID PMC10624905

• Pre-pandemic assessment: a decade of progress in electronic health record adoption among U.S. hospitals. Health affairs scholar Jiang, J. X., Qi, K., Bai, G., Schulman, K. 2023; 1 (5): qxad056

  Abstract

  As the COVID-19 pandemic loomed, the adoption of electronic health records (EHRs) in US hospitals became a pivotal concern. This study provides a pre-pandemic assessment, highlighting a decade of progress in EHR adoption from 2009 to 2019, with the last available survey conducted from January to June of 2020. It delves into the current EHR adoption rates, variations across different hospital categories, the influence of major vendors, and the challenges in implementing these systems. The study found that basic EHR adoption surged from 6.6% to 81.2%, while comprehensive systems increased from 3.6% to 63.2%. Despite this growth, the findings point to enduring disparities among hospitals, a concentrated market share by 6 vendors (90%), and significant concerns regarding maintenance costs. These insights provide an invaluable snapshot of the state of EHR adoption at the brink of the pandemic, serving as a benchmark to assess hospitals' readiness to utilize digital infrastructure in health care. The conclusions underscore the necessity for strategic policy interventions to encourage a competitive landscape and guarantee equitable access, ultimately strengthening the health care system's responsiveness to global health crises such as COVID-19.

  View details for DOI 10.1093/haschl/qxad056

  View details for PubMedID 38756982

  View details for PubMedCentralID PMC10986221

• Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies. JAMA health forum Sexton, Z. A., Perl, J. R., Saul, H. R., Trotsyuk, A. A., Pietzsch, J. B., Ruggles, S. W., Nikolov, M. C., Schulman, K. A., Makower, J. 2023; 4 (8): e232260

  Abstract

  A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies.To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway.In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022.Time from FDA authorization to the first coverage milestone.Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40).In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

  View details for DOI 10.1001/jamahealthforum.2023.2260

  View details for PubMedID 37540524

• Comparison of History of Present Illness Summaries Generated by a Chatbot and Senior Internal Medicine Residents. JAMA internal medicine Nayak, A., Alkaitis, M. S., Nayak, K., Nikolov, M., Weinfurt, K. P., Schulman, K. 2023

  View details for DOI 10.1001/jamainternmed.2023.2561

  View details for PubMedID 37459091

• Engaging Medicare Beneficiaries in Coverage Choices. JAMA Richman, B. D., Schulman, K. A. 2023

  View details for DOI 10.1001/jama.2023.6371

  View details for PubMedID 37140895

• Challenges to Forming Physician Unions-Reply. JAMA Richman, B. D., Schulman, K. A. 2023; 329 (17): 1519-1520

  View details for DOI 10.1001/jama.2023.3884

  View details for PubMedID 37129656

• Effect of low-concentration atropine eyedrops vs placebo onmyopia incidence in children: the LAMP2 randomized clinical trial (vol 329, pg 472, 2023) JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Richman, B. D., Schulman, K. A. 2023; 329 (13): 1123

  View details for DOI 10.1001/jama.2023.3989

  View details for Web of Science ID 000985112000030

• Do Patient Satisfaction Instruments Harm Patients and Physicians?-Reply. JAMA Richman, B. D., Schulman, K. A. 2023; 329 (13): 1122-1123

  View details for DOI 10.1001/jama.2023.1460

  View details for PubMedID 37014340

• Effect of direct transportation to thrombectomy-capable center vs local stroke center on neurological outcomes in patients with suspected large-vessel occlusion stroke in nonurban areas: the RACECAT randomized clinical trial (vol 327, pg 1782, 2022) JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Richman, B. D., Schulman, K. A. 2023; 329 (13): 1123

  View details for DOI 10.1001/jama.2023.3946

  View details for Web of Science ID 000985112000031

• Employer-Based Health Insurance and Employee Compensation. JAMA health forum Schulman, K., Narayan, A. 2023; 4 (3): e225486

  Abstract

  This Viewpoint expounds on how the cost of health insurance is consuming an ever-greater share of total compensation for employers and employees, stagnating real incomes and calling into question its real value.

  View details for DOI 10.1001/jamahealthforum.2022.5486

  View details for PubMedID 36897580

• A data-driven quality-score system for rating drug products and its implications for the health care industry JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION Dabestani, A., Grossman, S., Nathan, J. P., Bazil, C. W., Costantino, R. C., Fox, E. R., Graedon, J., V. Gray, J., Lever, H. M., Light, D. Y., Makuch, R., Schulman, K. A., White, C., Yu, K. 2023; 63 (2): 501-506

  Abstract

  The quality of drug products in the United States has been a matter of growing concern. Buyers and payers of pharmaceuticals have limited insight into measures of drug-product quality. Therefore, a quality-score system driven by data collection is proposed to differentiate between the qualities of drug products produced by different manufacturers. The quality scores derived using this proposed system would be based upon public regulatory data and independently-derived chemical data. A workflow for integrating the system into procurement decisions within health care organizations is also suggested. The implementation of such a quality-score system would benefit health care organizations by including the consideration of the quality of products while also considering price as a part of the drug procurement process. Such a system would also benefit the U.S. health care industry by bringing accountability and transparency into the drug supply chain and incentivizing manufacturers to place an increased emphasis on the quality and safety of their drug products.

  View details for DOI 10.1016/j.japh.2022.10.001

  View details for Web of Science ID 000992903300001

  View details for PubMedID 36336583

• Maintaining Health Care Innovations After the Pandemic. JAMA health forum Herzlinger, R., Richman, B. D., Schulman, K. A. 2023; 4 (2): e225404

  Abstract

  This Viewpoint discusses evaluating and perhaps extending the record of successful innovation arising from the COVID-19 pandemic.

  View details for DOI 10.1001/jamahealthforum.2022.5404

  View details for PubMedID 36763367

• Medicare Overpayment for Outpatient Medication - A Supreme Court Ruling in Context. The New England journal of medicine Kumar, W., Schulman, K. 2023

  View details for DOI 10.1056/NEJMp2212972

  View details for PubMedID 36648085

• Restoring Physician Authority in an Era of Hospital Dominance. JAMA Richman, B. D., Schulman, K. A. 2022; 328 (24): 2400-2401

  View details for DOI 10.1001/jama.2022.23610

  View details for PubMedID 36573992

• Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared DecisionMaking Pathway Wang, P. J., Lu, Y., Mahaffey, K. W., Lin, A., Morin, D. P., Sears, S. F., Chung, M. K., Russo, A. M., Lin, B., Piccini, J. P., Hills, M. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Shah, R., Newswanger, P., DeSutter, K., Nunes, J., Albert, M. A., Schulman, K., Heidenreich, P. A., Bunch, T. J., Sanders, L., Turakhia, M., Stafford, R. S. LIPPINCOTT WILLIAMS & WILKINS. 2022: E582-E583

  View details for Web of Science ID 000928164500042

• Are Patient Satisfaction Instruments Harming Both Patients and Physicians? JAMA Richman, B. D., Schulman, K. A. 2022

  Abstract

  In this Viewpoint, Richman and Schulman argue that patient satisfaction surveys may not actually reflect clinical performance or assist efforts to improve patient experience and are not useful tools to measure physician performance.

  View details for DOI 10.1001/jama.2022.21677

  View details for PubMedID 36394908

• A model to design financially sustainable algorithm-enabled remote patient monitoring for pediatric type 1 diabetes care. Frontiers in endocrinology Dupenloup, P., Pei, R. L., Chang, A., Gao, M. Z., Prahalad, P., Johari, R., Schulman, K., Addala, A., Zaharieva, D. P., Maahs, D. M., Scheinker, D. 2022; 13: 1021982

  Abstract

  Population-level algorithm-enabled remote patient monitoring (RPM) based on continuous glucose monitor (CGM) data review has been shown to improve clinical outcomes in diabetes patients, especially children. However, existing reimbursement models are geared towards the direct provision of clinic care, not population health management. We developed a financial model to assist pediatric type 1 diabetes (T1D) clinics design financially sustainable RPM programs based on algorithm-enabled review of CGM data.Data were gathered from a weekly RPM program for 302 pediatric patients with T1D at Lucile Packard Children's Hospital. We created a customizable financial model to calculate the yearly marginal costs and revenues of providing diabetes education. We consider a baseline or status quo scenario and compare it to two different care delivery scenarios, in which routine appointments are supplemented with algorithm-enabled, flexible, message-based contacts delivered according to patient need. We use the model to estimate the minimum reimbursement rate needed for telemedicine contacts to maintain revenue-neutrality and not suffer an adverse impact to the bottom line.The financial model estimates that in both scenarios, an average reimbursement rate of roughly $10.00 USD per telehealth interaction would be sufficient to maintain revenue-neutrality. Algorithm-enabled RPM could potentially be billed for using existing RPM CPT codes and lead to margin expansion.We designed a model which evaluates the financial impact of adopting algorithm-enabled RPM in a pediatric endocrinology clinic serving T1D patients. This model establishes a clear threshold reimbursement value for maintaining revenue-neutrality, as well as an estimate of potential RPM reimbursement revenue which could be billed for. It may serve as a useful financial-planning tool for a pediatric T1D clinic seeking to leverage algorithm-enabled RPM to provide flexible, more timely interventions to its patients.

  View details for DOI 10.3389/fendo.2022.1021982

  View details for PubMedID 36440201

  View details for PubMedCentralID PMC9691757

• A Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. Journal of the American Heart Association Wang, P. J., Lu, Y., Mahaffey, K. W., Lin, A., Morin, D. P., Sears, S. F., Chung, M. K., Russo, A. M., Lin, B., Piccini, J., Hills, M. T., Berube, C., Pundi, K., Baykaner, T., Garay, G., Lhamo, K., Rice, E., Pourshams, I. A., Shah, R., Newswanger, P., DeSutter, K., Nunes, J. C., Albert, M. A., Schulman, K. A., Heidenreich, P. A., Bunch, T. J., Sanders, L. M., Turakhia, M., Verghese, A., Stafford, R. S. 2022: e8009

  Abstract

  Background Oral anticoagulation (OAC) reduces stroke and disability in atrial fibrillation (AF) but is underutilized. We evaluated the effects of a novel patient-clinician shared decision-making (SDM) tool in reducing OAC patient's decisional conflict as compared to usual care. Methods and Results We designed and evaluated a new digital decision aid in a multicenter, randomized, comparative effectiveness trial, ENHANCE-AF (Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AF Stroke Prevention). The digital AF SDM Toolkit was developed using patient-centered design with clear health communication principles (e.g. meaningful images, limited text). Available in English and Spanish, the toolkit included the following: 1) a brief animated video; 2) interactive questions with answers; 3) a quiz to check on understanding; 4) a worksheet to be used by the patient during the encounter; and 5) an online guide for clinicians. The study population included English or Spanish speakers with non-valvular AF and a CHA2DS2-VASc stroke score ≥1 for men or ≥2 for women. Participants were randomized in a 1:1 ratio to either Usual Care (UC) or the SDM Toolkit. The primary endpoint was the validated 16-item Decisional Conflict Scale (DCS) at 1 month. Secondary outcomes included DCS at 6 months and the 10-item Decision Regret Scale (DRS) at 1 and 6 months as well as a weighted average of Mann-Whitney U-statistics for both DCS and DRS. A total of 1001 participants were enrolled and followed at 5 different sites in the United States between 12/18/19 and 8/17/22. The mean patient age was 69 ±10years (40% females, 16.9% Black, 4.5% Hispanic, 3.6% Asian), and 50% of participants had CHA2DS2-VASc scores ≥3 (M) or ≥4 (F). The primary endpoint at 1 month showed a clinically meaningful reduction in decisional conflict: a 7-point difference in median scores between the two arms (16.4 v 9.4; Mann-Whitney U-statistics=0.550; p-value=0.007). For the secondary endpoint of 1-month DRS, the difference in median scores between arms was 5 points in the direction of less decisional regret (p-value of 0.078). The treatment effects lessened over time: at 6 months the difference in medians was 4.7 points for DCS (p-value=0.060) and 0 points for DRS (p-value=0.35). Conclusions Implementation of a novel, Shared Decision-Making Toolkit (afibguide.com; afibguide.com/clinician) achieved significantly lower decisional conflict compared to usual care in patients with AF.

  View details for DOI 10.1161/JAHA.122.028562

  View details for PubMedID 36342828

• Informed Consent as a Means of Acknowledging and Avoiding Financial Toxicity as Iatrogenic Harm. AMA journal of ethics Schulman, K., Richman, B. 2022; 24 (11): E1063-1068

  Abstract

  Negative health consequences stemming from the financial burden of care on patients and their loved ones are documented as financial toxicity in the literature, and these consequences should be included in informed consent discussions during patient-clinician interactions. However, codes of medical ethics have yet to require obtaining consent to financial costs, even as the No Surprises Act, effective on January 1, 2022, requires some clinicians to facilitate informed financial consent prior to an out-of-network elective service as a means of avoiding arbitration. This article discusses how this requirement can be more broadly applied to informed consent for any intervention.

  View details for DOI 10.1001/amajethics.2022.1063

  View details for PubMedID 36342489

• An Intergenerational Evaluation of Medicare. The American journal of medicine Kumar, W., Schulman, K. 2022

  View details for DOI 10.1016/j.amjmed.2022.09.032

  View details for PubMedID 36252714

• Commentary on 'The Impact Of Healthcare Strikes On Patient Mortality: A Systematic Review And Meta-Analysis Of Observational Studies.' Health services research Bowling, D. S., Richman, B. D., Schulman, K. A. 2022

  View details for DOI 10.1111/1475-6773.14077

  View details for PubMedID 36181453

• The impact of expanded telehealth availability on primary care utilization. NPJ digital medicine Dixit, R. A., Ratwani, R. M., Bishop, J. A., Schulman, K., Sharp, C., Palakanis, K., Booker, E. 2022; 5 (1): 141

  Abstract

  The expanded availability of telehealth due to the COVID-19 pandemic presents a concern that telehealth may result in an unnecessary increase in utilization. We analyzed 4,114,651 primary care encounters (939,134 unique patients) from three healthcare systems between 2019 and 2021 and found little change in utilization as telehealth became widely available. Results suggest telehealth availability is not resulting in additional primary care visits and federal policies should support telehealth use.

  View details for DOI 10.1038/s41746-022-00685-8

  View details for PubMedID 36085158

• Billing And Insurance-Related Administrative Costs: A Cross-National Analysis. Health affairs (Project Hope) Richman, B. D., Kaplan, R. S., Kohli, J., Purcell, D., Shah, M., Bonfrer, I., Golden, B., Hannam, R., Mitchell, W., Cehic, D., Crispin, G., Schulman, K. A. 2022; 41 (8): 1098-1106

  Abstract

  Billing and insurance-related costs are a significant source of wasteful health care spending in Organization for Economic Cooperation and Development nations, but these administrative burdens vary across national systems. We executed a microlevel accounting of these costs in different national settings at six provider locations in five nations (Australia, Canada, Germany, the Netherlands, and Singapore) that supplements our prior study measuring the costs in the US. We found that billing and insurance-related costs for inpatient bills range from a low of $6 in Canada to a high of $215 in the US for an inpatient surgical bill (purchasing power parity adjusted). We created a taxonomy of billing and insurance-related activities (eligibility, coding, submission, and rework) that was applied to data from the six sites and allows cross-national comparisons. Higher costs in the US and Australia are attributed to high coding costs. Much of the savings achieved in some nations is attributable to assigning tasks to people in lower-skill job categories, although most of the savings are due to more efficient billing and insurance-related processes. Some nations also reduce these costs by offering financial counseling to patients before treatment. Our microlevel approach can identify specific cost drivers and reveal national billing features that reduce coding costs. It illustrates a valuable pathway for future research in understanding and mitigating administrative costs in health care.

  View details for DOI 10.1377/hlthaff.2022.00241

  View details for PubMedID 35914203

• The Rise and Potential of Physician Unions. JAMA Bowling, D., Richman, B. D., Schulman, K. A. 2022

  View details for DOI 10.1001/jama.2022.12835

  View details for PubMedID 35900755

• State-level differences in duties permitted to be performed by medical assistants in the delivery of eye care Reeves, M., Xue, J., Milstein, A., Tabin, G., Goldberg, J. L., Schulman, K. ASSOC RESEARCH VISION OPHTHALMOLOGY INC. 2022

  View details for Web of Science ID 000844437002140

• Price and Quality in the Generic Pharmaceutical Market. Circulation Teasdale, B., Light, D., Schulman, K. A. 2022; 145 (16): 1185-1187

  View details for DOI 10.1161/CIRCULATIONAHA.121.057727

  View details for PubMedID 35436136

• Detailed characterization of hospitalized patients infected with the Omicron variant of SARS-CoV-2. Journal of internal medicine Ozdalga, E., Ahuja, N., Sehgal, N., Hom, J., Weng, Y., Pinsky, B., Schulman, K. A., Collins, W. 2022

  View details for DOI 10.1111/joim.13501

  View details for PubMedID 35417053

• Association between state-level malpractice environment and clinician electronic health record (EHR) time. Journal of the American Medical Informatics Association : JAMIA Holmgren, A. J., Rotenstein, L., Downing, N. L., Bates, D. W., Schulman, K. 2022

  Abstract

  OBJECTIVE: Clinicians spend significant time working in the electronic health record (EHR). The US is an outlier in EHR time, suggesting that EHR-related work may be driven in part by the legal environment and threat of malpractice. To assess this, we evaluate the association between state-level malpractice climate and clinician time spent in the EHR.MATERIALS AND METHODS: We use EHR metadata from 351 ambulatory care health systems in the United States using Epic from January-August 2019 combined with state-level data on malpractice incidence and payouts. We used descriptive statistics to measure variation in clinician EHR time, including total EHR time, documentation time per day, and after-hours EHR time per day. Multi-variable regression evaluated the association between clinicians in high malpractice states and EHR use.RESULTS: We found no association between location in a state in the top-quartile of malpractice payouts and time spent in the EHR per day, time spent in the EHR outside of scheduled hours, or time spent documenting per day, except for a subgroup of the clinicians in the highest malpractice specialties, where there was a small increase in EHR time per day (B=6.08 min, P<0.001) and time spent documenting notes (B=2.77 min, P<0.001).DISCUSSION: State-level differences in malpractice incidence are unlikely to be a significant driver of EHR work for most clinicians.CONCLUSION: Policymakers seeking to address EHR documentation burden should examine burden driven by other socio-technical demands on clinician time, such as billing or quality measurement.

  View details for DOI 10.1093/jamia/ocac034

  View details for PubMedID 35271723

• Trends and Determinants of Retail Prescription Drug Costs. Health services research Teasdale, B., Nguyen, A., van Meijgaard, J., Schulman, K. A. 2022

  Abstract

  OBJECTIVE: To characterize price trends and variation for U.S. generic and branded drugs at the retail level as they relate to pharmacy acquisition costs and local market factors.DATA SOURCES: Drug pricing data consisting of US pharmacy claims from 2014 to 2019 collected and licensed by GoodRx, an online tool for comparing drug prices.STUDY DESIGN: Time trends of median drug prices and coefficients of variation were measured for generic and branded drugs, including subgroups based on clinical condition (i.e. diabetes and cancer). Pharmacy competition was measured using the Herfindahl-Hirschman Index (HHI) at the zip-code level. Multivariable linear regression analysis assessed the impact of local market-level factors on drug prices and variation.DATA COLLECTION: U.S. drug pricing data consisting of claims filled through a mix of public and private insurance at 58,332 chain and independent pharmacies across 14,421 zip codes in all 50 states.PRINCIPAL FINDINGS: From 2014 to 2019, pharmacy retail markets trended towards greater competition: average HHI by zip code decreased by 15.0% (p,0.001). Median cash price increased significantly for both generic (6.58%, p<0.001) and branded (84.10%, p<0.001) drugs. When normalized to acquisition costs, cash prices for generic drugs rose 22.03% (p<0.001) while those of branded drugs decreased by 2.31% (p<0.001). Diabetes drugs showed higher baseline overall markup of cash prices relative to acquisition costs (10.54 IQR, 3.28 - 18.43) than cancer drugs (1.88, IQR 1.36 - 3.08). Neither local pharmacy competition nor median income significantly predicted drug price or variation.CONCLUSION: Measures of generic drug price and price variation are high despite decreased costs earlier in the pharmaceutical supply chain, defying expectations of what would happen in a competitive market. Efforts to bypass the pharmacy benefit model for generic drugs may offer consumers an opportunity for substantial savings.

  View details for DOI 10.1111/1475-6773.13961

  View details for PubMedID 35211965

• HSR Invited Commentary Racial Disparities in Healthcare and Health. Health services research Chandran, M., Schulman, K. A. 2022

  View details for DOI 10.1111/1475-6773.13957

  View details for PubMedID 35184275

• Identifying solutions to meet unmet needs of family caregivers using human-centered design. BMC geriatrics Termglinchan, V., Daswani, S., Duangtaweesub, P., Assavapokee, T., Milstein, A., Schulman, K. 1800; 22 (1): 94

  Abstract

  BACKGROUND: Given the rapidly aging society, shrinking workforce, and reducing dependency ratio, there is an increasing challenge for family members to provide care for older adults. While a broad understanding of caregiver burden and its consequences have been studied across various contexts, there is a need to better understand this challenge among family caregivers in Asian societies.METHODS: This study is a cross-sectional observational study. A total of 20 dyads of community-based older adults, who required assistance with at least one activities of daily living, and family caregivers in Thailand participated in the study. We used the first three stages out of five stages of human-centered design: empathize, define, and ideate.RESULTS: On average caregivers were 59.2years old, with 43% still employed. Of the older adult participants, 10 were interviewed, the others had moderate-to-severe cognitive impairment. Based on the analysis, six caregiver personas (i.e. semi-fictional characters) are identified. Caregiver personas of "The 2-Jober" and "My Life Purpose" has the highest caregiver burden score whereas "The Spouse" has the lowest. Based on the specific needs of the caregiver persona "My Life Purpose", the team brainstormed more than 80 potential solutions which were classified into three categories of solutions that satisfied the metrics of desirability, feasibility and viability: distributed medical care system, technology-charged care network, and community gathering for rest and recuperation.CONCLUSIONS: These solutions are culturally sensitive given that they are built around established behavioral patterns. This is an illustration of a method of innovation that can be applied to bring a culturally specific understanding, and to develop products and services to enable further independent aging.

  View details for DOI 10.1186/s12877-022-02790-5

  View details for PubMedID 35109822

• The Dysfunctional Health Benefits Market and Implications for US Employers and Employees. JAMA Scheinker, D., Milstein, A., Schulman, K. 1800

  View details for DOI 10.1001/jama.2021.23258

  View details for PubMedID 34994781

• Digital Health COVID-19 Impact Assessment: Lessons Learned and Compelling Needs. NAM perspectives Lee, P., Abernethy, A., Shaywitz, D., Gundlapalli, A. V., Weinstein, J., Doraiswamy, P. M., Schulman, K., Madhavan, S. 2022; 2022

  View details for DOI 10.31478/202201c

  View details for PubMedID 35402858

• Building a Learning Health System: Creating an Analytical Workflow for Evidence Generation to Inform Institutional Clinical Care Guidelines. Applied clinical informatics Dash, D., Gokhale, A., Patel, B. S., Callahan, A., Posada, J., Krishnan, G., Collins, W., Li, R., Schulman, K., Ren, L., Shah, N. H. 2022; 13 (1): 315-321

  Abstract

  BACKGROUND: One key aspect of a learning health system (LHS) is utilizing data generated during care delivery to inform clinical care. However, institutional guidelines that utilize observational data are rare and require months to create, making current processes impractical for more urgent scenarios such as those posed by the COVID-19 pandemic. There exists a need to rapidly analyze institutional data to drive guideline creation where evidence from randomized control trials are unavailable.OBJECTIVES: This article provides a background on the current state of observational data generation in institutional guideline creation and details our institution's experience in creating a novel workflow to (1) demonstrate the value of such a workflow, (2) demonstrate a real-world example, and (3) discuss difficulties encountered and future directions.METHODS: Utilizing a multidisciplinary team of database specialists, clinicians, and informaticists, we created a workflow for identifying and translating a clinical need into a queryable format in our clinical data warehouse, creating data summaries and feeding this information back into clinical guideline creation.RESULTS: Clinical questions posed by the hospital medicine division were answered in a rapid time frame and informed creation of institutional guidelines for the care of patients with COVID-19. The cost of setting up a workflow, answering the questions, and producing data summaries required around 300hours of effort and $300,000 USD.CONCLUSION: A key component of an LHS is the ability to learn from data generated during care delivery. There are rare examples in the literature and we demonstrate one such example along with proposed thoughts of ideal multidisciplinary team formation and deployment.

  View details for DOI 10.1055/s-0042-1743241

  View details for PubMedID 35235994

• New Medicare Technology Add-On Payment Could Be Used As A Market Support Mechanism To Accelerate Antibiotic Innovation. Health affairs (Project Hope) Gandhi, N., Schulman, K. A. 2021; 40 (12): 1926-1934

  Abstract

  Despite growing antibiotic resistance, the clinical drug development pipeline for antibiotics has been sparse largely because of an unsustainable business model. We illustrate three models to accelerate antibiotic development, using Medicare new technology add-on payments as a market support mechanism. The first two models subsidize drug development for Medicare beneficiaries, and the third model applies a payment for every patient with a resistant infection to essentially create a funding pool. We found that the reimbursement required to sustain research and development would range from $637 to $121,365, depending on the payment model and the incidence of the resistant infection in question. With a $300million public research subsidy, the payment for an antibiotic would drop to between $273 and $10,396 per course. Our market support model could increase the likelihood of attracting private investment for antibiotic development.

  View details for DOI 10.1377/hlthaff.2021.00062

  View details for PubMedID 34871069

• Novel strategies to support global promotion of COVID-19 vaccination. BMJ global health Wood, S., Pate, M. A., Schulman, K. 2021; 6 (10)

  Abstract

  In 2021, many countries have begun distribution of COVID-19 vaccines but are hampered by significant levels of vaccine hesitancy or apathy. Experts recommend that standard health communication campaigns be expanded to include a more holistic approach of behaviourally oriented strategies. We constructed a large-scale Delphi panel of marketing and behavioural science university faculty to assess 12 previously reported US vaccination promotion strategies, asking respondents to assess applicability of the strategy in their country, how efficacy might compare to the USA and recommendations for local adaptations necessary to successful implementation. Separately, we sought to determine whether strategies based on cognitive mechanisms (eg, 'nudges') are more readily generalisable than strategies based on social identity. Ninety-two marketing and behavioural science faculty from universities worldwide participated. Globally, all 12 behavioural strategies were validated; a majority of respondents reported that they would or could work well in their country. While all strategies were strongly validated at a global level, specific need for regional adaptation was identified. Also, open-ended responses suggested the addition of three emergent strategies to a global effort. Finally, we see that strategies based on some types of cognitive mechanisms are more readily generalisable across regions than mechanisms based on social identity, however, this is not always true of 'nudge' strategies. All 12 strategies are robust to global use and consensus exists on adaptation for optimal efficacy in different regions; specific strategy recommendations are posited. Use of these strategies can accelerate individual country efforts to achieve desired vaccination rates to protect global public health.

  View details for DOI 10.1136/bmjgh-2021-006066

  View details for PubMedID 34649869

• The No Surprises Act and Informed Financial Consent. The New England journal of medicine Richman, B., Hall, M., Schulman, K. 2021

  View details for DOI 10.1056/NEJMp2109971

  View details for PubMedID 34551226

• Exploring Workplace Testing with Real-Time Polymerase Chain Reaction SARS-CoV-2 Testing. Journal of the American Board of Family Medicine : JABFM Fuentes, L., Shah, N., Kelly, S., Harnett, G., Schulman, K. A. 2021; 35 (1): 96-101

  Abstract

  Molecular tests (ie, real-time polymerase chain reaction [RT-PCR]) and antigen tests are used to detect SARS-CoV-2. RT-PCR tests are generally considered to be the standard for clinical diagnosis of SARS-CoV-2 due to accuracy and reliability but can take longer to return results than antigen tests. Our aim was to examine if point-of-care (POC) testing for SARS-CoV-2 infection would provide a flexible resource to help achieve workplace safety. We compared test results and time-to-test results between a POC RT-PCR test and a send-out PCR test in a program implemented in summer 2020.POC testing shortened the time to results to 110 minutes in the POC setting from the 754 minutes for send-out tests. The specificity of POC RT-PCR single POC testing was 98.7% compared with send-out RT-PCR testing and was confirmed at 99.8% in a validation analysis. The sensitivity of the POC testing was 100% compared with send-out RT-PCR, although in a validation analysis, sensitivity appeared as 0% because only the 12 positive or indeterminate samples on the first analysis were retested and the majority were false-positives that were correctly ruled out.POC testing for SARS-CoV-2 with RT-PCR technology is possible at reduced time compared with send-out PCR testing.

  View details for DOI 10.3122/jabfm.2022.01.210284

  View details for PubMedID 35039415

• Early Convalescent Plasma for High-Risk Outpatients with Covid-19. The New England journal of medicine Korley, F. K., Durkalski-Mauldin, V., Yeatts, S. D., Schulman, K., Davenport, R. D., Dumont, L. J., El Kassar, N., Foster, L. D., Hah, J. M., Jaiswal, S., Kaplan, A., Lowell, E., McDyer, J. F., Quinn, J., Triulzi, D. J., Van Huysen, C., Stevenson, V. L., Yadav, K., Jones, C. W., Kea, B., Burnett, A., Reynolds, J. C., Greineder, C. F., Haas, N. L., Beiser, D. G., Silbergleit, R., Barsan, W., Callaway, C. W., SIREN-C3PO Investigators 2021

  Abstract

  BACKGROUND: Early administration of convalescent plasma obtained from blood donors who have recovered from coronavirus disease 2019 (Covid-19) may prevent disease progression in acutely ill, high-risk patients with Covid-19.METHODS: In this randomized, multicenter, single-blind trial, we assigned patients who were being treated in an emergency department for Covid-19 symptoms to receive either one unit of convalescent plasma with a high titer of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or placebo. All the patients were either 50 years of age or older or had one or more risk factors for disease progression. In addition, all the patients presented to the emergency department within 7 days after symptom onset and were in stable condition for outpatient management. The primary outcome was disease progression within 15 days after randomization, which was a composite of hospital admission for any reason, seeking emergency or urgent care, or death without hospitalization. Secondary outcomes included the worst severity of illness on an 8-category ordinal scale, hospital-free days within 30 days after randomization, and death from any cause.RESULTS: A total of 511 patients were enrolled in the trial (257 in the convalescent-plasma group and 254 in the placebo group). The median age of the patients was 54 years; the median symptom duration was 4 days. In the donor plasma samples, the median titer of SARS-CoV-2 neutralizing antibodies was 1:641. Disease progression occurred in 77 patients (30.0%) in the convalescent-plasma group and in 81 patients (31.9%) in the placebo group (risk difference, 1.9 percentage points; 95% credible interval, -6.0 to 9.8; posterior probability of superiority of convalescent plasma, 0.68). Five patients in the plasma group and 1 patient in the placebo group died. Outcomes regarding worst illness severity and hospital-free days were similar in the two groups.CONCLUSIONS: The administration of Covid-19 convalescent plasma to high-risk outpatients within 1 week after the onset of symptoms of Covid-19 did not prevent disease progression. (SIREN-C3PO ClinicalTrials.gov number, NCT04355767.).

  View details for DOI 10.1056/NEJMoa2103784

  View details for PubMedID 34407339

• Will CMS Find Aducanumab Reasonable and Necessary for Alzheimer Disease After FDA Approval? JAMA Schulman, K. A., Greicius, M. D., Richman, B. 2021

  View details for DOI 10.1001/jama.2021.11768

  View details for PubMedID 34279572

• When Vaccine Apathy, Not Hesitancy, Drives Vaccine Disinterest. JAMA Wood, S., Schulman, K. 2021

  View details for DOI 10.1001/jama.2021.7707

  View details for PubMedID 34076690

• Reducing administrative costs in US health care: Assessing single payer and its alternatives. Health services research Scheinker, D., Richman, B. D., Milstein, A., Schulman, K. A. 2021

  Abstract

  OBJECTIVE: Excess administrative costs in the US health care system are routinely referenced as a justification for comprehensive reform. While there is agreement that these costs are too high, there is little understanding of what generates administrative costs and what policy options might mitigate them.DATA SOURCES: Literature review and national utilization and expenditure data.STUDY DESIGN: We developed a simulation model of physician billing and insurance-related (BIR) costs to estimate how certain policy reforms would generate savings. Our model is based on structural elements of the payment process in the United States and considers each provider's number of health plan contracts, the number of features in each health plan, the clinical and nonclinical processes required to submit a bill for payment, and the compliance costs associated with medical billing.DATA EXTRACTION: For several types of visits, we estimated fixed and variable costs of the billing process. We used the model to estimate the BIR costs at a national level under a variety of policy scenarios, including variations of a single payer "Medicare-for-All" model that extends fee-for-service Medicare to the entire population and policy efforts to reduce administrative costs in a multi-payer model. We conducted sensitivity analyses of a wide variety of model parameters.PRINCIPAL FINDINGS: Our model estimates that national BIR costs are reduced between 33% and 53% in Medicare-for-All style single-payer models and between 27% and 63% in various multi-payer models. Under a wide range of assumptions and sensitivity analyses, standardizing contracts generates larger savings with less variance than savings from single-payer strategies.CONCLUSION: Although moving toward a single-payer system will reduce BIR costs, certain reforms to payer-provider contracts could generate at least as many administrative cost savings without radically reforming the entire health system. BIR costs can be meaningfully reduced without abandoning a multi-payer system.

  View details for DOI 10.1111/1475-6773.13649

  View details for PubMedID 33788283

• The COVID-19 Pandemic-An Opportune Time to Update Medical Licensing. JAMA internal medicine Mullangi, S., Agrawal, M., Schulman, K. 2021

  View details for DOI 10.1001/jamainternmed.2020.8710

  View details for PubMedID 33439224

• Beyond Politics - Promoting Covid-19 Vaccination in the United States. The New England journal of medicine Wood, S., Schulman, K. 2021

  View details for DOI 10.1056/NEJMms2033790

  View details for PubMedID 33406324

• Quantifying Parkinson's disease motor severity under uncertainty using MDS-UPDRS videos. Medical image analysis Lu, M., Zhao, Q., Poston, K. L., Sullivan, E. V., Pfefferbaum, A., Shahid, M., Katz, M., Kouhsari, L. M., Schulman, K., Milstein, A., Niebles, J. C., Henderson, V. W., Fei-Fei, L., Pohl, K. M., Adeli, E. 2021; 73: 102179

  Abstract

  Parkinson's disease (PD) is a brain disorder that primarily affects motor function, leading to slow movement, tremor, and stiffness, as well as postural instability and difficulty with walking/balance. The severity of PD motor impairments is clinically assessed by part III of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), a universally-accepted rating scale. However, experts often disagree on the exact scoring of individuals. In the presence of label noise, training a machine learning model using only scores from a single rater may introduce bias, while training models with multiple noisy ratings is a challenging task due to the inter-rater variabilities. In this paper, we introduce an ordinal focal neural network to estimate the MDS-UPDRS scores from input videos, to leverage the ordinal nature of MDS-UPDRS scores and combat class imbalance. To handle multiple noisy labels per exam, the training of the network is regularized via rater confusion estimation (RCE), which encodes the rating habits and skills of raters via a confusion matrix. We apply our pipeline to estimate MDS-UPDRS test scores from their video recordings including gait (with multiple Raters, R=3) and finger tapping scores (single rater). On a sizable clinical dataset for the gait test (N=55), we obtained a classification accuracy of 72% with majority vote as ground-truth, and an accuracy of ∼84% of our model predicting at least one of the raters' scores. Our work demonstrates how computer-assisted technologies can be used to track patients and their motor impairments, even when there is uncertainty in the clinical ratings. The latest version of the code will be available at https://github.com/mlu355/PD-Motor-Severity-Estimation.

  View details for DOI 10.1016/j.media.2021.102179

  View details for PubMedID 34340101

• Estimating health care delivery system value for each US state and testing key associations. Health services research Dieleman, J. L., Kaldjian, A. S., Sahu, M., Chen, C., Liu, A., Chapin, A., Scott, K. W., Aravkin, S., Zheng, P., Mokdad, A., Murray, C. J., Schulman, K., Milstein, A. 2021

  Abstract

  To estimate health care systems' value in treating major illnesses for each US state and identify system characteristics associated with value.Annual condition-specific death and incidence estimates for each US state from the Global Burden Disease 2019 Study and annual health care spending per person for each state from the National Health Expenditure Accounts.Using non-linear meta-stochastic frontier analysis, mortality incidence ratios for 136 major treatable illnesses were regressed separately on per capita health care spending and key covariates such as age, obesity, smoking, and educational attainment. State- and year-specific inefficiency estimates were extracted for each health condition and combined to create a single estimate of health care delivery system value for each US state for each year, 1991-2014. The association between changes in health care value and changes in 23 key health care system characteristics and state policies was measured.Not applicable.US state with relatively high spending per person or relatively poor health-outcomes were shown to have low health care delivery system value. New Jersey, Maryland, Florida, Arizona, and New York attained the highest value scores in 2014 (81 [95% uncertainty interval 72-88], 80 [72-87], 80 [71-86], 77 [69-84], and 77 [66-85], respectively), after controlling for health care spending, age, obesity, smoking, physical activity, race, and educational attainment. Greater market concentration of hospitals and of insurers were associated with worse health care value (p-value ranging from <0.01 to 0.02). Higher hospital geographic density and use were also associated with worse health care value (p-value ranging from 0.03 to 0.05). Enrollment in Medicare Advantage HMOs was associated with better value, as was more generous Medicaid income eligibility (p-value 0.04 and 0.01).Substantial variation in the value of health care exists across states. Key health system characteristics such as market concentration and provider density were associated with value.

  View details for DOI 10.1111/1475-6773.13676

  View details for PubMedID 34028028

• Ethical issues in using ambient intelligence in health-care settings. The Lancet. Digital health Martinez-Martin, N., Luo, Z., Kaushal, A., Adeli, E., Haque, A., Kelly, S. S., Wieten, S., Cho, M. K., Magnus, D., Fei-Fei, L., Schulman, K., Milstein, A. 2020

  Abstract

  Ambient intelligence is increasingly finding applications in health-care settings, such as helping to ensure clinician and patient safety by monitoring staff compliance with clinical best practices or relieving staff of burdensome documentation tasks. Ambient intelligence involves using contactless sensors and contact-based wearable devices embedded in health-care settings to collect data (eg, imaging data of physical spaces, audio data, or body temperature), coupled with machine learning algorithms to efficiently and effectively interpret these data. Despite the promise of ambient intelligence to improve quality of care, the continuous collection of large amounts of sensor data in health-care settings presents ethical challenges, particularly in terms of privacy, data management, bias and fairness, and informed consent. Navigating these ethical issues is crucial not only for the success of individual uses, but for acceptance of the field as a whole.

  View details for DOI 10.1016/S2589-7500(20)30275-2

  View details for PubMedID 33358138

• Assessment of Electronic Health Record Use Between US and Non-US Health Systems. JAMA internal medicine Holmgren, A. J., Downing, N. L., Bates, D. W., Shanafelt, T. D., Milstein, A., Sharp, C. D., Cutler, D. M., Huckman, R. S., Schulman, K. A. 2020

  Abstract

  Importance: Understanding how the electronic health record (EHR) system changes clinician work, productivity, and well-being is critical. Little is known regarding global variation in patterns of use.Objective: To provide insights into which EHR activities clinicians spend their time doing, the EHR tools they use, the system messages they receive, and the amount of time they spend using the EHR after hours.Design, Setting, and Participants: This cross-sectional study analyzed the deidentified metadata of ambulatory care health systems in the US, Canada, Northern Europe, Western Europe, the Middle East, and Oceania from January 1, 2019, to August 31, 2019. All of these organizations used the EHR software from Epic Systems and represented most of Epic Systems's ambulatory customer base. The sample included all clinicians with scheduled patient appointments, such as physicians and advanced practice practitioners.Exposures: Clinician EHR use was tracked by deidentified and aggregated metadata across a variety of clinical activities.Main Outcomes and Measures: Descriptive statistics for clinician EHR use included time spent on clinical activities, note documentation (as measured by the percentage of characters in the note generated by automated or manual data entry source), messages received, and time spent after hours.Results: A total of 371 health systems were included in the sample, of which 348 (93.8%) were located in the US and 23 (6.2%) were located in other countries. US clinicians spent more time per day actively using the EHR compared with non-US clinicians (mean time, 90.2 minutes vs 59.1 minutes; P<.001). In addition, US clinicians vs non-US clinicians spent significantly more time performing 4 clinical activities: notes (40.7 minutes vs 30.7 minutes; P<.001), orders (19.5 minutes vs 8.75 minutes; P<.001), in-basket messages (12.5 minutes vs 4.80 minutes; P<.001), and clinical review (17.6 minutes vs 14.8 minutes; P=.01). Clinicians in the US composed more automated note text than their non-US counterparts (77.5% vs 60.8% of note text; P<.001) and received statistically significantly more messages per day (33.8 vs 12.8; P<.001). Furthermore, US clinicians used the EHR for a longer time after hours, logging in 26.5 minutes per day vs 19.5 minutes per day for non-US clinicians (P=.01). The median US clinician spent as much time actively using the EHR per day (90.1 minutes) as a non-US clinician in the 99th percentile of active EHR use time per day (90.7 minutes) in the sample. These results persisted after controlling for organizational characteristics, including structure, type, size, and daily patient volume.Conclusions and Relevance: This study found that US clinicians compared with their non-US counterparts spent substantially more time actively using the EHR for a wide range of clinical activities or tasks. This finding suggests that US clinicians have a greater EHR burden that may be associated with nontechnical factors, which policy makers and health system leaders should consider when addressing clinician wellness.

  View details for DOI 10.1001/jamainternmed.2020.7071

  View details for PubMedID 33315048

• A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department JOURNAL OF PATIENT SAFETY Glickman, S. W., Mehrotra, A., Shea, C. M., Mayer, C., Strickler, J., Pabers, S., Larson, J., Goldstein, B., Mandelkehr, L., Cairns, C. B., Pines, J. M., Schulman, K. A. 2020; 16 (3): 211–15

  View details for DOI 10.1097/PTS.0000000000000287

  View details for Web of Science ID 000568895200025

• Exploring payments in the US pharmaceutical market from 2011 to 2019: Update on pharmacy benefit manager impact AMERICAN HEART JOURNAL Weinstein, E. P., Schulman, K. 2020; 227: 107–10

  View details for Web of Science ID 000564476000014

• Benchmarking the Cost-Effectiveness of Interventions Delaying Diabetes: A Simulation Study Based on NAVIGATOR Data. Diabetes care Leal, J., Reed, S. D., Patel, R., Rivero-Arias, O., Li, Y., Schulman, K. A., Califf, R. M., Holman, R. R., Gray, A. M. 2020

  Abstract

  OBJECTIVE: To estimate using the UK Prospective Diabetes Study Outcomes Model Version 2 (UKPDS-OM2) the impact of delaying type 2 diabetes onset on costs and quality-adjusted life expectancy using trial participants who developed diabetes in the NAVIGATOR (Nateglinide And Valsartan in Impaired Glucose Tolerance Outcomes Research) study.RESEARCH DESIGN AND METHODS: We simulated the impact of delaying diabetes onset by 1-9 years, utilizing data from the 3,058 of 9,306 NAVIGATOR trial participants who developed type 2 diabetes. Costs and utility weights associated with diabetes and diabetes-related complications were obtained for the U.S. and U.K. settings, with costs expressed in 2017 values. We estimated discounted lifetime costs and quality-adjusted life years (QALYs) with 95% CIs.RESULTS: Gains in QALYs increased from 0.02 (U.S. setting, 95% CI 0.01, 0.03) to 0.15 (U.S. setting, 95% CI 0.10, 0.21) as the imposed time to diabetes onset was increased from 1 to 9 years, respectively. Savings in complication costs increased from $1,388 (95% CI $1,092, $1,669) for a 1-year delay to $8,437 (95% CI $6,611, $10,197) for a delay of 9 years. Interventions costing up to $567-$2,680 and 201-947 per year would be cost-effective at $100,000 per QALY and 20,000 per QALY thresholds in the U.S. and U.K., respectively, as the modeled delay in diabetes onset was increased from 1 to 9 years.CONCLUSIONS: Simulating a hypothetical diabetes-delaying intervention provides guidance concerning the maximum cost and minimum delay in diabetes onset needed to be cost-effective. These results can inform the ongoing debate about diabetes prevention strategies and the design of future intervention studies.

  View details for DOI 10.2337/dc20-0717

  View details for PubMedID 32796009

• Are U.S. Hospitals Still "Recession-proof"? The New England journal of medicine Teasdale, B., Schulman, K. A. 2020

  View details for DOI 10.1056/NEJMp2018846

  View details for PubMedID 32610005

• Examining Pharmaceutical Benefits in the United States-A Framework. JAMA health forum Chan, A., Schulman, K. 2020; 1 (3): e200291

  View details for DOI 10.1001/jamahealthforum.2020.0291

  View details for PubMedID 36218593

• The unintended consequences of the 340B safety-net drug discount program. Health services research Thomas, S., Schulman, K. 2020

  View details for DOI 10.1111/1475-6773.13281

  View details for PubMedID 32114714

• Exploring payments in the US pharmaceutical market from 2011 to 2019: Update on pharmacy benefit manager impact. American heart journal Weinstein, E. P., Schulman, K. n. 2020; 227: 107–10

  Abstract

  We extended an earlier analysis of the gross revenue, payments, and net revenues of pharmaceutical manufacturers to include data from 2017 through 2019. In the period of 2017 to 2019, we found that gross revenue increased by 6.8% per annum, and payments from manufacturers increased by 13.5% annually, whereas net revenues for the same manufacturers increased by only 2.9% annually. By 2019, these same firms made payments of 67.4% of net revenue, or $141.4 billion, to generate $209.9 billion in net sales. We observed that list price increases and payments have been growing disproportionally to manufacturer net income despite widespread public concern about rising outpatient prescription drug prices.

  View details for DOI 10.1016/j.ahj.2020.06.017

  View details for PubMedID 32730906

• Pharmacoeconomics: The Economics of Pharmaceuticals PHARMACOEPIDEMIOLOGY, 6TH EDITION Schulman, K. A., Strom, B. L., Kimmel, S. E., Hennessy, S. 2020: 837-866

  View details for Web of Science ID 000632014800035

• Examining Pharmaceutical Benefits in the United States—A Framework Chan, A., Schulman, K. A. JAMA Health Forum. 2020
• Challenges In Ensuring The Quality Of Generic Medicines. Health affairs (Project Hope) Schulman, K. A. 2020; 39 (9): 1643–46

  Abstract

  A refill of a generic attention deficit hyperactivity disorder prescription leads to new side effects and raises questions about the quality of generic drugs.

  View details for DOI 10.1377/hlthaff.2020.00321

  View details for PubMedID 32897777

• Covid-19 and Health Care's Digital Revolution. The New England journal of medicine Keesara, S. n., Jonas, A. n., Schulman, K. n. 2020

  View details for DOI 10.1056/NEJMp2005835

  View details for PubMedID 32240581

• Co-Management by Hospitalists: Why it makes clinical and fiscal sense. The American journal of medicine Rohatgi, N., Schulman, K., Ahuja, N. 2019

  View details for DOI 10.1016/j.amjmed.2019.07.053

  View details for PubMedID 31449770

• The Implications of "Medicare for All" for US Hospitals JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Schulman, K. A., Milstein, A. 2019; 321 (17): 1661–62

  View details for DOI 10.1001/jama.2019.3134

  View details for Web of Science ID 000467314800008

• Workforce Cost Model for Expanding Congenital and Rheumatic Heart Disease Services in Kenya WORLD JOURNAL FOR PEDIATRIC AND CONGENITAL HEART SURGERY Kontchou, N. T., McCrary, A. W., Schulman, K. A. 2019; 10 (3): 321–27

  View details for DOI 10.1177/2150135119837201

  View details for Web of Science ID 000470668700011

• Workforce Cost Model for Expanding Congenital and Rheumatic Heart Disease Services in Kenya. World journal for pediatric & congenital heart surgery Kontchou, N. T., McCrary, A. W., Schulman, K. A. 2019; 10 (3): 321–27

  Abstract

  BACKGROUND: Cardiovascular disease is the number one global killer, with over three quarters of these deaths arising from the populations of low- and middle-income countries (LMICs). Addressing the burden of cardiovascular disease in LMICs must include medical and surgical services for these patients. In this article, we model the needs and costs to scale up the cardiac provider workforce in Kenya, which can be adapted to other LMICs based on country-specific workforce hours and workforce salaries.METHODS: Using published epidemiological reports from sub-Saharan Africa, we structured the model based on the expected disease burden of congenital and rheumatic disease in a simulated 1,000-person population. Services modeled include clinic visits, echocardiograms, diagnostic cardiac catheterizations, interventional catheterizations, and heart surgery. Costs were modeled based on Kenyan public sector salaries. After scaling the model, we created a sensitivity analysis of change in service duration and salaries.RESULTS: Based on a 1,000-person Kenyan population, we estimate that 2.5 heart surgeries will be needed every year, with a corresponding annual workforce cost of US$526. Including accompanying services of clinic visits, echocardiograms, and both diagnostic and interventional cardiac catheterizations, the total annual workforce cost is US$899. Based on estimated productive hours for public sector workforce, 196 full-time equivalent cardiac surgeons will be needed for the entire population of Kenya (2017 figure).CONCLUSIONS: We present a model for appropriate cardiovascular service staffing based on disease burden and workforce costs. This model can be scaled up as needed to plan for local capacity building.

  View details for PubMedID 31084310

• The Implications of "Medicare for All" for US Hospitals. JAMA Schulman, K. A., Milstein, A. 2019

  View details for PubMedID 30946429

• Evaluating the quality of antihypertensive drugs in Lagos State, Nigeria PLOS ONE Ndichu, E., Ohiri, K., Sekoni, O., Makinde, O., Schulman, K. 2019; 14 (2)

  View details for DOI 10.1371/journal.pone.0211567

  View details for Web of Science ID 000458761300051

• Toward an Effective Innovation Agenda. The New England journal of medicine Schulman, K. A., Richman, B. D. 2019

  View details for PubMedID 30673357

• Evaluating the quality of antihypertensive drugs in Lagos State, Nigeria. PloS one Ndichu, E. T., Ohiri, K., Sekoni, O., Makinde, O., Schulman, K. 2019; 14 (2): e0211567

  Abstract

  BACKGROUND: As the burden of noncommunicable diseases grows, access to safe medical therapy is increasing in importance. The aim of this study was to develop a method for evaluating the quality of antihypertensive drugs and to examine whether this prevalence varies by socioeconomic variables.METHODS: We conducted a cross-sectional survey of registered pharmacies in 6 local government areas (LGAs) in Lagos State, Nigeria. In each LGA, we sampled 17 pharmacies from a list of all registered pharmacies derived from the Pharmacists Council of Nigeria. We assessed drug quality based on (1) the level of active pharmaceutical ingredients (APIs), which identified falsely labeled drug samples; and (2) the amount of impurities, which revealed substandard drug samples in accordance with the international pharmacopoeia guidelines. Good-quality drugs met specifications for both API and impurity.RESULTS: Of the 102 drug samples collected, 30 (29.3%) were falsely labeled, 76 (74.5%) were substandard,78 (76.5%) were of poor quality and 24 (23.5%) were of good quality.Among the falsely labeled drugs, 2 samples met standards set for purity while 28 did not. Among the 76 substandard drug samples, 28 were also falsely labeled. Of the falsely labeled drugs, 17 (56.7%) came from LGAs with low socioeconomic status, and 40 (52.6%) of the substandard drug samples came from LGAs with high socioeconomic status. Most of the good-quality drug samples, 14 (58.3%), were from LGAs with low socioeconomic status. Eighteen (60%) of the falsely labeled samples, 37 (48.7%) of the substandard samples, and 15 (62.5%) of the good-quality drug samples were from manufacturers based in Asia. The average price was 375.67 Nigerian naira (NGN) for falsely labeled drugs, 383.33 NGN for substandard drugs, and 375.67 NGN for good-quality drugs. The prevalence of falsely labeled and substandard drug samples did not differ by LGA-level socioeconomic status (P = .39) or region of manufacturer (P = .24); however, there was a trend for a difference by price (P = .06).CONCLUSION: The prevalence of falsely labeled and substandard drug samples was high in Lagos. Treatment of noncommunicable diseases in this setting will require efforts to monitor and assure drug quality.

  View details for PubMedID 30759124

• Stop outrageous air ambulance bills by disclosing the transport price Schulman, K. A., Richman, B. D., Milstein, A. STAT News. 2019
• 'Medicare for all’ won’t fix soaring healthcare costs Schulman, K. A. Los Angeles Times. 2019
• Amazon Alexa and Patient Engagement Schulman, K. A., Wood, S. Stanford Graduate School of Business. 2019
• Apple Health Records Schulman, K. A., Rosenmoller, M. IESE Business School . 2019
• Resolving Surprise Medical Bills Schulman, K. A., Milstein, A., Richman, B. D. Health Affairs. 2019
• Decomposing the Value of Health Insurance Ogbechie-Godec, O. A., Wiske, C. P., Schulman, K. A. Health Management Policy and Innovation. 2019
• The Doctor-of-the-Future Is In: Patient Responses to Disruptive Health-Care Innovations Journal of the Association for Consumer Research Wood, S., Schulman, K. A. 2019; 4 (3)

  View details for DOI 10.1086/704106

• Are Air Ambulances Truly Flying Out Of Reach? Surprise-Billing Policy And The Airline Deregulation Act Chhabra, K., Schulman, K. A., Richman, B. D. Health Affairs. 2019
• A Roadmap To Welcoming Health Care Innovation Mullangi, S., Ibrahim, S. A., Shah, N. H., Schulman, K. A. Health Affairs. 2019
• A Transparent, Mathematical Model to Evaluate Proposals for Healthcare Reform Knight, G. M., Schulman, K. A., Milstein, A., Rea, S., Malloy, G., Khaliq, U., Scheinker, D. Health Management Policy and Innovation. 2019
• Private and Public Incentives for Hospitals to Improve the Quality and Reduce the Cost of Care Liu, X., Schulman, K. A., Scheinker, D. Health Management Policy and Innovation. 2019
• Pharmacoeconomics: the economics of pharmaceuticals Pharmacoepidemiology Schulman, K. A. John Wiley & Sons. 2019; 6th ed.
• The relationship between pharmacy benefit managers (PBMs) and the cost of therapies in the US pharmaceutical market: A policy primer for clinicians. American heart journal Schulman, K. A., Dabora, M. 2018; 206: 113–22

  Abstract

  Pharmaceutical benefit managers (PBMs) are playing an increasingly important role in establishing access to pharmaceutical products for patients. PBMs set retail prices for pharmaceutical products, negotiate "rebates" from manufacturers based on total sales volume of products, and achieve several types of postsale price concessions and payments from pharmacies. All of these activities describe a complex flow of funds that has not been transparent to clinicians or to patients. In this article, we describe these terms and processes to better understand how pharmaceutical products are financed in the United States. In 2016, US pharmaceutical manufacturers reported gross pharmaceutical sales of $462 billion and net pharmaceutical sales of $318 billion. The difference between gross and net sales is largely due to the different "payments" from manufacturers to PBMs and other intermediaries in the marketplace. We examine the flow of funds through the US pharmaceutical distribution system over time using data from the annual reports of 13 major pharmaceutical manufacturers for the period 2011-2016. Overall, we find that net revenues for our sample of firms grew by an average of 2.7% annually between 2011 and 2016, whereas rebates and other payments increased by 15% annually over the same period. Our examination of the pharmaceutical market reveals the enormous scale of payments from pharmaceutical manufacturers to intermediaries. We observed that these payments have been growing disproportionally to manufacturer net income over the past 5 years. We also found a lack of transparency regarding the flow of funds through intermediaries. This entire marketplace is now the subject of intense public debate.

  View details for PubMedID 30447542

• The Evolving Pharmaceutical Benefits Market. JAMA Schulman, K. A., Richman, B. D. 2018; 319 (22): 2269–70

  View details for PubMedID 29625496

• Developing new health technologies for neglected diseases: a pipeline portfolio review and cost model. Gates open research Young, R., Bekele, T., Gunn, A., Chapman, N., Chowdhary, V., Corrigan, K., Dahora, L., Martinez, S., Permar, S., Persson, J., Rodriguez, B., Schaferhoff, M., Schulman, K., Singh, T., Terry, R. F., Yamey, G. 2018; 2: 23

  Abstract

  Background: Funding for product development for neglected diseases fell from 2009-2015, other than a short-term injection of Ebola funding. One impediment to mobilizing resources is a lack of information on product candidates, the estimated costs to move them through the pipeline, and the likelihood of specific launches. This study aimed to help fill these information gaps. Methods: We conducted a pipeline portfolio review to identify current candidates for 35 neglected diseases. Using an adapted version of the Portfolio to Impact (P2I) financial modelling tool, we estimated the costs to move these candidates through the pipeline over the next decade and the likely launches. Since the current pipeline is unlikely to yield several critical products, we estimated the costs to develop a set of priority "missing" products. Results: We found 685 product candidates for neglected diseases as of August 31, 2017; 538 candidates met inclusion criteria for input into the model. It would cost about $16.3 billion (range $13.4-19.8B) to move these candidates through the pipeline, with three-quarters of the costs incurred in the first 5 years, resulting in about 128 (89-160) expected product launches. Based on the current pipeline, there would be very few launches of complex new chemical entities; launches of highly efficacious vaccines for HIV, tuberculosis, or malaria would be unlikely. Estimated additional costs to launch one of each of 18 key missing products range from $13.6B-$21.8B, depending on product complexity. Over the next 5 years, total estimated costs to move current candidates through the pipeline and develop these 18 missing products would be around $4.5-5.8B/year. Conclusions: Since current annual global spending on product development is about $3B, this study suggests the annual funding gap over the next 5 years is at least $1.5-2.8B, which is probably an underestimate. The current portfolio is not balanced across health needs.

  View details for PubMedID 30234193

• Administrative Costs Associated With Physician Billing and Insurance-Related Activities at an Academic Health Care System JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Tseng, P., Kaplan, R. S., Richman, B. D., Shah, M. A., Schulman, K. A. 2018; 319 (7): 691–97

  Abstract

  Administrative costs in the US health care system are an important component of total health care spending, and a substantial proportion of these costs are attributable to billing and insurance-related activities.To examine and estimate the administrative costs associated with physician billing activities in a large academic health care system with a certified electronic health record system.This study used time-driven activity-based costing. Interviews were conducted with 27 health system administrators and 34 physicians in 2016 and 2017 to construct a process map charting the path of an insurance claim through the revenue cycle management process. These data were used to calculate the cost for each major billing and insurance-related activity and were aggregated to estimate the health system's total cost of processing an insurance claim.Estimated time required to perform billing and insurance-related activities, based on interviews with management personnel and physicians.Estimated billing and insurance-related costs for 5 types of patient encounters: primary care visits, discharged emergency department visits, general medicine inpatient stays, ambulatory surgical procedures, and inpatient surgical procedures.Estimated processing time and total costs for billing and insurance-related activities were 13 minutes and $20.49 for a primary care visit, 32 minutes and $61.54 for a discharged emergency department visit, 73 minutes and $124.26 for a general inpatient stay, 75 minutes and $170.40 for an ambulatory surgical procedure, and 100 minutes and $215.10 for an inpatient surgical procedure. Of these totals, time and costs for activities carried out by physicians were estimated at a median of 3 minutes or $6.36 for a primary care visit, 3 minutes or $10.97 for an emergency department visit, 5 minutes or $13.29 for a general inpatient stay, 15 minutes or $51.20 for an ambulatory surgical procedure, and 15 minutes or $51.20 for an inpatient surgical procedure. Of professional revenue, professional billing costs were estimated to represent 14.5% for primary care visits, 25.2% for emergency department visits, 8.0% for general medicine inpatient stays, 13.4% for ambulatory surgical procedures, and 3.1% for inpatient surgical procedures.In a time-driven activity-based costing study in a large academic health care system with a certified electronic health record system, the estimated costs of billing and insurance-related activities ranged from $20 for a primary care visit to $215 for an inpatient surgical procedure. Knowledge of how specific billing and insurance-related activities contribute to administrative costs may help inform policy solutions to reduce these expenses.

  View details for PubMedID 29466590

  View details for PubMedCentralID PMC5839285

• Understanding Frequent Emergency Department Use Among Primary Care Patients POPULATION HEALTH MANAGEMENT Hardy, M., Cho, A., Stavig, A., Bratcher, M., Dillard, J., Greenblatt, L., Schulman, K. 2018; 21 (1): 24–31

  Abstract

  Patients with high emergency department (ED) utilization are an important focus in population health management. This retrospective cohort study analyzed patterns of frequent ED use for 4087 patients enrolled at an academically-affiliated primary care clinic. For all ED visits (n = 4776), the chief complaints, admission rates, number of complaints per patient, and median time between return visits were assessed. Chart reviews were conducted for the 10 highest utilizers from each of the 3 leading complaints to help explain repeated ED use for the same complaints. Results showed that chief complaints for high utilizers were statistically similar to other patients. Nearly half (49.8%) of all ED visits among high utilizers were repeat visits for the same complaint. However, most high utilizers (85%) had 4 or more separate complaints. Their visits clustered temporally, with 55% occurring less than 30 days apart. Visits for psychiatric symptoms demonstrated the shortest time to repeat visit (median 17.5 days, interquartile range: 39.5). Abdominal pain, chest pain, and shortness of breath were the leading complaints and the leading sources of hospital admissions and repeat visits. Chart review revealed that these 3 chief complaints often were associated with a wide range of ongoing chronic conditions, confounded by substance abuse, anxiety, and treatment nonadherence. This study demonstrates an integrative method for examining patterns of ED use among high utilizers. It also highlights the complex nature of high utilization and the inherent difficulty in predicting and addressing the needs of high-utilizer patients.

  View details for PubMedID 28609191

• Mergers between health insurers and pharmacy benefit managers could be bad for your health Richman, B. D., Schulman, K. A. STAT News. 2018
• Committing To Transformation: Chief Innovation Officers And The Role Of Organizational Redesign Jain, S. S., Schulman, K. A. Health Affairs. 2018
• Identifying and Solving the Problem of Poor-Quality Drugs Ndichu, E., Schulman, K. A. Health Management Policy and Innovation. 2018
• The Supply-Side Effects of Moral Hazard on Drug Prices Schulman, K. A. Health Management Policy and Innovation. 2018
• Modeling the Potential Economic Impact of the Medicare Comprehensive Care for Joint Replacement Episode-Based Payment Model JOURNAL OF ARTHROPLASTY Maniya, O. Z., Mather, R. C., Attarian, D. E., Mistry, B., Chopra, A., Strickland, M., Schulman, K. A. 2017; 32 (11): 3268-+

  Abstract

  The Medicare program has initiated Comprehensive Care for Joint Replacement (CJR), a bundled payment mandate for lower extremity joint replacements. We sought to determine the degree to which hospitals will invest in care redesign in response to CJR, and to project its economic impacts.We defined 4 potential hospital management strategies to address CJR: no action, light care management, heavy care management, and heavy care management with contracting. For each of 798 hospitals included in CJR, we used hospital-specific volume, cost, and quality data to determine the hospital's economically dominant strategy. We aggregated data to assess the percentage of hospitals pursuing each strategy; savings to the health care system; and costs and percentages of CJR-derived revenues gained or lost for Medicare, hospitals, and postacute care facilities.In the model, 83.1% of hospitals (range 55.0%-100.0%) were expected to take no action in response to CJR, and 16.1% of hospitals (range 0.0%-45.0%) were expected to pursue heavy care management with contracting. Overall, CJR is projected to reduce health care expenditures by 0.5% (range 0.0%-4.1%) or $14 million (range $0-$119 million). Medicare is expected to save 2.2% (range 2.2%-2.2%), hospitals are projected to lose 3.7% (range 4.7% loss to 3.8% gain), and postacute care facilities are expected to lose 6.5% (range 0.0%-12.8%). Hospital administrative costs are projected to increase by $63 million (range $0-$148 million).CJR is projected to have a negligible impact on total health care expenditures for lower extremity joint replacements. Further research will be required to assess the actual care management strategies adopted by CJR hospitals.

  View details for PubMedID 28669568

• Trends in Hospital-Physician Integration in Medical Oncology AMERICAN JOURNAL OF MANAGED CARE Clough, J. D., Dinan, M. A., Schulman, K. A. 2017; 23 (10): 624–27

  Abstract

  Hospitals have rapidly acquired medical oncology practices in recent years. Experts disagree as to whether these trends are related to oncology-specific market factors or reflect a general trend of hospital-physician integration. The objective of this study was to compare the prevalence, geographic variation, and trends in physicians billing from hospital outpatient departments in medical oncology with other specialties.Retrospective analysis of Medicare claims data for 2012 and 2013.We calculated the proportion of physicians and practitioners in the 15 highest-volume specialties who billed the majority of evaluation and management visits from hospital outpatient departments in each year, nationally and by state.We included 338,998 and 352,321 providers in 2012 and 2013, respectively, of whom 9715 and 9969 were medical oncologists. Among the 15 specialties examined, medical oncology had the highest proportion of hospital outpatient department billing in 2012 and 2013 (35.0% and 38.3%, respectively). Medical oncology also experienced the greatest absolute change (3.3%) between the years, followed by thoracic surgery (2.4%) and cardiology (2.0%). There was marked state-level variation, with the proportion of medical oncologists based in hospital outpatient departments ranging from 0% in Nevada to 100% in Idaho.Hospital-physician integration has been more pronounced in medical oncology than in other high-volume specialties and is increasing at a faster rate. Policy makers should take these findings into consideration, particularly with respect to recent proposals that may continue to fuel these trends.

  View details for Web of Science ID 000413945000010

  View details for PubMedID 29087634

• PCSK9 Inhibitors and the Choice Between Innovation, Efficiency, and Affordability JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mark, D. B., Schulman, K. A. 2017; 318 (8): 711–12

  View details for PubMedID 28829851

• Financing and Distribution of Pharmaceuticals in the United States JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dabora, M. C., Turaga, N., Schulman, K. 2017; 318 (1): 21–22

  View details for PubMedID 28505252

• The economics of PCSK-9 inhibitors. American heart journal Schulman, K. A., Reed, S. D. 2017; 189: 200–201

  View details for PubMedID 28625378

• Battling the Chargemaster: A Simple Remedy to Balance Billing for Unavoidable Out-of-Network Care AMERICAN JOURNAL OF MANAGED CARE Richman, B. D., Kitzman, N., Milstein, A., Schulman, K. A. 2017; 23 (4): E100-+

  Abstract

  To develop an effective legal mechanism to combat chargemaster abuses and to facilitate price transparency.Applying legal doctrines to out-of-network (OON) billing disputes.We reviewed rudimentary contract law and examined the law's handling of contracts where prices have not been specified in advance. These cases are the controlling authority to guide courts, handling of surprise and OON billing problems. We then compared legal remedies that correct OON billing abuses to prevailing legislative and regulatory approaches.Our analysis suggests that providers have no legal authority to collect chargemaster rates from surprise and OON billing abuses. A proper application of contract law can end such abuses and would facilitate superior pricing incentives to other strategies designed to end balance billing disputes.Chargemaster rates on uninsured and OON patients impose significant financial burdens on the vulnerable, distort medical prices, and inflate healthcare costs. Applying rudimentary contract law to these practices offers a solution that is simpler and more effective than other administrative and legislative schemes recently adopted in several states. It will prevent providers from hiding behind a convoluted hospital pricing system, encourage the development of attractive narrow-network insurance products, and shield urgently sick individuals from the dread of medical predation. Patients and payers should know that they are under no obligation to pay surprise bills containing chargemaster rates, and state attorneys general can use the law to prevent providers from pursuing chargemaster-related collection efforts against patients.

  View details for PubMedID 28554214

• Does the Implantable Cardioverter-Defibrillator Benefit Vary With the Estimated Proportional Risk of Sudden Death in Heart Failure Patients? JACC. Clinical electrophysiology Levy, W. C., Li, Y., Reed, S. D., Zile, M. R., Shadman, R., Dardas, T., Whellan, D. J., Schulman, K. A., Ellis, S. J., Neilson, M., O'Connor, C. M. 2017; 3 (3): 291-298

  Abstract

  Prediction of which heart failure patients are most likely to die of sudden death vs. non-sudden death is an important factor in determining who will benefit the most from an ICD.We developed the Seattle Proportional Risk Model (SPRM) to estimate the proportion of total mortality due to sudden death. We prospectively validated the model in HF-ACTION and tested whether the ICD benefit varied with the SPRM.Among 2331 patients enrolled, 1947 patients were retained for analysis over a median follow-up of 2.5 years. The SPRM was calculated using age, gender, diabetes, BMI, SBP, EF, NYHA, sodium, creatinine, and digoxin use.ICD use (ICD or CRT-D) was present prior to death in 1204 patients (62%). SPRM was predictive of sudden death vs. non-sudden death in those without an ICD (P=0.002). The hazard ratio representing ICD versus no ICD was 0.63 for all-cause mortality (P=0.0002). The ICD benefit varied with the SPRM for all-cause mortality (P=0.001), with a greater benefit in those with a higher conditional probability of sudden death.In an ambulatory NYHA II-IV HF population and EF ≤35%, the SPRM was predictive of the proportional risk of sudden vs. non-sudden death. ICDs were associated with a decreased risk of all-cause mortality by 37% and the ICD benefit varied with the SPRM. The SPRM may have utility in risk stratifying patients for a primary prevention ICD.

  View details for DOI 10.1016/j.jacep.2016.09.006

  View details for PubMedID 28553663

  View details for PubMedCentralID PMC5441395

• Barriers to Achieving Economies of Scale in Analysis of EHR Data A Cautionary Tale APPLIED CLINICAL INFORMATICS Sendak, M. P., Balu, S., Schulman, K. A. 2017; 8 (3): 826–31

  Abstract

  Signed in 2009, the Health Information Technology for Economic and Clinical Health Act infused $28 billion of federal funds to accelerate adoption of electronic health records (EHRs). Yet, EHRs have produced mixed results and have even raised concern that the current technology ecosystem stifles innovation. We describe the development process and report initial outcomes of a chronic kidney disease analytics application that identifies high-risk patients for nephrology referral. The cost to validate and integrate the analytics application into clinical workflow was $217,138. Despite the success of the program, redundant development and validation efforts will require $38.8 million to scale the application across all multihospital systems in the nation. We address the shortcomings of current technology investments and distill insights from the technology industry. To yield a return on technology investments, we propose policy changes that address the underlying issues now being imposed on the system by an ineffective technology business model.

  View details for DOI 10.4338/ACI-2017-03-CR-0046

  View details for Web of Science ID 000413010400005

  View details for PubMedID 28837212

• Rapid flurry of new drug pricing leaves no room for public debate Schulman, K. A. The Hill. 2017
• From mHealth Hackathon to Reality: Diabetes Care Schulman, K. A., Cheek, C. Harvard Business School. 2017
• PharmAccess and the M-TIBA Platform: Leveraging Digital Technology in the Developing World Schulman, K. A., Moodley, S., Vasudevan, A. Harvard Business School. 2017
• Shisong Cardiac Center: Kumbo, Cameroon Schulman, K. A., Kontchou, N. Harvard Business School. 2017
• Kada Orthopedics: A Bone of Contention Schulman, K. A., Strickland, M. Harvard Business School. 2017
• China Hospitals Inc.: The Growth of Private Hospitals in China Schulman, K. A., Yu, X., Hwang, A. Harvard Business School. 2017
• Pharmaceutical M&A Activity: Effects on Prices, Innovation, and Competition Richman, B. D., Mitchell, W., Vidal, E., Schulman, K. A. Loyola University Chicago Law Journal. 2017
• A Novel Look At Antitrust Analysis In Health Insurance Markets Richman, B. D., Schulman, K. A. Competition Policy International. 2017
• What U.S. Hospitals Can Still Learn from India’s Private Heart Hospitals Richman, B. D., Schulman, K. A. NEJM Catalyst; Innovations in Care Delivery. 2017
• Obesity Management at Kaiser Permanente: A New Mindset for Healthcare Delivery? Schulman, K. A., Leya, G., Beveridge, C. Harvard Business School. 2017
• Strengthening the Private Health Sector in Africa: The PharmAccess Solution Moodley, S., Vasudevan, A., Schulman, K. A. Health Management Policy and Innovation. 2017
• Extreme Home Makeover - The Role of Intensive Home Health Care NEW ENGLAND JOURNAL OF MEDICINE Ticona, L., Schulman, K. A. 2016; 375 (18): 1707–9

  View details for PubMedID 27806216

• A Patient Reported Approach to Identify Medical Errors and Improve Patient Safety in the Emergency Department. Journal of patient safety Glickman, S. W., Mehrotra, A., Shea, C. M., Mayer, C., Strickler, J., Pabers, S., Larson, J., Goldstein, B., Mandelkehr, L., Cairns, C. B., Pines, J. M., Schulman, K. A. 2016

  Abstract

  OBJECTIVE: Medical errors in the emergency department (ED) occur frequently. Yet, common adverse event detection methods, such as voluntary reporting, miss 90% of adverse events. Our objective was to demonstrate the use of patient-reported data in the ED to assess patient safety, including medical errors.METHODS: Analysis of patient-reported survey data collected over a 1-year period in a large, academic emergency department. All patients who provided a valid e-mail or cell phone number received a brief electronic survey within 24 hours of their ED encounter by e-mail or text message with Web link. Patients were asked about ED safety-related processes.RESULTS: From Aug 2012 to July 2013, we sent 52,693 surveys and received 7103 responses (e-mail response rate 25.8%), including 2836 free-text comments (44% of respondents). Approximately 242 (8.5%) of 2836 comments were classified as potential safety issues, including 12 adverse events, 40 near-misses, 23 errors with minimal risk of harm, and 167 general safety issues (eg, gaps in care transitions). Of the 40 near misses, 35 (75.0%) of 40 were preventable. Of the 52 adverse events or near misses, 5 (9.6%) were also identified via an existing patient occurrence reporting system.CONCLUSIONS: A patient-reported approach to assess ED-patient safety yields important, complementary, and potentially actionable safety information.

  View details for PubMedID 27811598

• Reassessing ACOs and Health Care Reform JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Schulman, K. A., Richman, B. D. 2016; 316 (7): 707–8

  View details for PubMedID 27533151

• Patient Preferences for Features of Health Care Delivery Systems: A Discrete Choice Experiment HEALTH SERVICES RESEARCH Muehlbacher, A. C., Bethge, S., Reed, S. D., Schulman, K. A. 2016; 51 (2): 704–27

  Abstract

  To estimate the relative importance of organizational-, procedural-, and interpersonal-level features of health care delivery systems from the patient perspective.We designed four discrete choice experiments (DCEs) to measure patient preferences for 21 health system attributes. Participants were recruited through the online patient portal of a large health system. We analyzed the DCE data using random effects logit models.DCEs were performed in which respondents were provided with descriptions of alternative scenarios and asked to indicate which scenario they prefer. Respondents were randomly assigned to one of the three possible health scenarios (current health, new lung cancer diagnosis, or diabetes) and asked to complete 15 choice tasks. Each choice task included an annual out-of-pocket cost attribute.A total of 3,900 respondents completed the survey. The out-of-pocket cost attribute was considered the most important across the four different DCEs. Following the cost attribute, trust and respect, multidisciplinary care, and shared decision making were judged as most important. The relative importance of out-of-pocket cost was consistently lower in the hypothetical context of a new lung cancer diagnosis compared with diabetes or the patient's current health.This study demonstrates the complexity of patient decision making processes regarding features of health care delivery systems. Our findings suggest the importance of these features may change as a function of an individual's medical conditions.

  View details for PubMedID 26255998

  View details for PubMedCentralID PMC4799904

• Health Care Tax Inversions - Robbing Both Peter and Paul NEW ENGLAND JOURNAL OF MEDICINE Warraich, H., Schulman, K. A. 2016; 374 (11): 1005–7

  View details for PubMedID 26981932

• https://hbr.org/2016/12/we-interviewed-health-care-leaders-about-their-industry-and-theyre-worried Poku, M., Schulman, K. A. https://hbr.org/2016/12/we-interviewed-health-care-leaders-about-their-industry-and-theyre-worried. 2016
• Alnylam: Building a Biotechnology Powerhouse Schulman, K. A. Harvard Business School. 2016
• Nutrition Science Initiative: Are All Calories Created Equal? Schulman, K., Dabora, M. Harvard Business School. 2016
• Blue D Pharmaceuticals Schulman, K. A., Rasiel, E., Balu, S. Harvard Business School. 2016
• Health Systems in the Developing World Schulman, K., Pate, M., Carbell, G. Harvard Business School. 2016
• Product Portfolio Management at Genentech Schulman, K. A., Gresh, J. https://www.hbs.edu/faculty/Pages/item.aspx?num=50912. 2016
• Health Catalyst Schulman, K. A., Balu, S. Harvard Business School. 2016
• Aggressive Growth Plans For Zimmer Spine Schulman, K. A., Shaw, M. N. Harvard Business School. 2016
• Diffusion of Global Innovations in Health Care: How to Make It Happen Herzlinger, R. E., Schulman, K. A. Health Management Policy and Innovation. 2016
• AbbVie Schulman, K. A., Little, L., Mullangi, S., Schleicher, S. Harvard Business School. 2016
• Savannah Informatics Schulman, K. A. https://www.hbs.edu/faculty/Pages/item.aspx?num=50381. 2016
• The Economics of Precision Medicine Insights and Innovation in Neuromuscular Medicine Schulman, K. A. AANEM. 2016
• Options to Promote Competitive Generics Markets in the United States JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Wiske, C. P., Ogbechie, O. A., Schulman, K. A. 2015; 314 (20): 2129–30

  View details for PubMedID 26513309

• Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model: A Web-based program designed to evaluate the cost-effectiveness of disease management programs in heart failure AMERICAN HEART JOURNAL Reed, S. D., Neilson, M. P., Gardner, M., Li, Y., Briggs, A. H., Polsky, D. E., Graham, F. L., Bowers, M. T., Paul, S. C., Granger, B. B., Schulman, K. A., Whellan, D. J., Riegel, B., Levy, W. C. 2015; 170 (5): 951–60

  Abstract

  Heart failure disease management programs can influence medical resource use and quality-adjusted survival. Because projecting long-term costs and survival is challenging, a consistent and valid approach to extrapolating short-term outcomes would be valuable.We developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model, a Web-based simulation tool designed to integrate data on demographic, clinical, and laboratory characteristics; use of evidence-based medications; and costs to generate predicted outcomes. Survival projections are based on a modified Seattle Heart Failure Model. Projections of resource use and quality of life are modeled using relationships with time-varying Seattle Heart Failure Model scores. The model can be used to evaluate parallel-group and single-cohort study designs and hypothetical programs. Simulations consist of 10,000 pairs of virtual cohorts used to generate estimates of resource use, costs, survival, and incremental cost-effectiveness ratios from user inputs.The model demonstrated acceptable internal and external validity in replicating resource use, costs, and survival estimates from 3 clinical trials. Simulations to evaluate the cost-effectiveness of heart failure disease management programs across 3 scenarios demonstrate how the model can be used to design a program in which short-term improvements in functioning and use of evidence-based treatments are sufficient to demonstrate good long-term value to the health care system.The Tools for Economic Analysis of Patient Management Interventions in Heart Failure Cost-Effectiveness Model provides researchers and providers with a tool for conducting long-term cost-effectiveness analyses of disease management programs in heart failure.

  View details for PubMedID 26542504

  View details for PubMedCentralID PMC4638158

• Specialty Pharmaceuticals for Hyperlipidemia - Impact on Insurance Premiums NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Balu, S., Reed, S. D. 2015; 373 (17): 1591–93

  View details for PubMedID 26444460

• Organizational Characteristics and Patient Experiences With Hospital Care: A Survey Study of Hospital Chief Patient Experience Officers AMERICAN JOURNAL OF MEDICAL QUALITY Manary, M., Staelin, R., Kosel, K., Schulman, K. A., Glickman, S. W. 2015; 30 (5): 432–40

  Abstract

  Beginning in fiscal year 2013, scores based on the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) constitute 30% of incentive-based payments from Medicare's Value-Based Purchasing (VBP) initiative. Yet there is little empirical work to understand hospital approaches to improving the patient experience. In this study, chief patient experience officers at 416 VHA hospitals were surveyed to assess the relationship between organizational characteristics and publicly reported HCAHPS scores. Of 416 institutions, 143 (34.4%) participated. Respondents reported that boards (68%) and chief executive officers (81%) viewed the patient experience as extremely important. In contrast, they reported that in only 15% and 34% of hospitals, respectively, physicians and nurses were supportive of efforts to improve the patient experience. Hospitals with collaborative cultures and higher physician engagement had higher VBP total HCAHPS scores (6.9 points and 8.2 points higher, respectively; both P < .05). These areas should be addressed to improve the patient experience in provider organizations.

  View details for PubMedID 24951105

• Incremental and independent value of cardiopulmonary exercise test measures and the Seattle Heart Failure Model for prediction of risk in patients with heart failure JOURNAL OF HEART AND LUNG TRANSPLANTATION Dardas, T., Li, Y., Reed, S. D., O'Connor, C. M., Whellan, D. J., Ellis, S. J., Schulman, K. A., Kraus, W. E., Forman, D. E., Levy, W. C. 2015; 34 (8): 1017–23

  Abstract

  Multivariable risk scores and exercise measures are well-validated risk prediction methods. Combining information from a functional evaluation and a risk model may improve accuracy of risk predictions. We analyzed whether adding exercise measures to the Seattle Heart Failure Model (SHFM) improves risk prediction accuracy in systolic heart failure.We used a sample of patients from the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) study (http://www.clinicaltrials.gov; unique identifier: NCT00047437) to examine the addition of peak oxygen consumption, expired volume per unit time/volume of carbon dioxide slope, 6-minute walk distance, or cardiopulmonary exercise duration to the SHFM. Multivariable Cox proportional hazards models were used to test the association between the combined end point (death, left ventricular assist device, or cardiac transplantation) and the addition of exercise variables to the SHFM.The sample included 2,152 patients. The SHFM and all exercise measures were associated with events (all p < 0.0001) in proportional hazards models. There was statistically significant improvement in risk estimation when exercise measures were added to the SHFM. However, the improvement in the C index for the addition of peak volume of oxygen consumption (+0.01), expired volume per unit time/volume of carbon dioxide slope (+0.02), 6-minute walk distance (-0.001), and cardiopulmonary exercise duration (+0.001) to the SHFM was small or slightly worse than the SHFM alone. Changes in risk assignment with the addition of exercise variables were minimal for patients above or below a 15% 1-year mortality.Exercise performance measures and the SHFM are independently useful for predicting risk in systolic heart failure. Adding cardiopulmonary exercise testing measures and 6MWD to the SHFM offers only minimal improvement in risk reassignment at clinically meaningful cut points.

  View details for DOI 10.1016/j.healun.2015.03.017

  View details for Web of Science ID 000358183600003

  View details for PubMedID 25940075

  View details for PubMedCentralID PMC4795804

• Enhancing the Value of Statewide Hospital Discharge Data: Improving Clinical Content and Race-Ethnicity Data. Health services research Andrews, R. M., Schulman, K. A. 2015; 50 Suppl 1: 1265-72

  View details for DOI 10.1111/1475-6773.12342

  View details for PubMedID 26205563

  View details for PubMedCentralID PMC4545331

• Market-Based Solutions to Antitrust Threats - The Rejection of the Partners Settlement NEW ENGLAND JOURNAL OF MEDICINE Herzlinger, R. E., Richman, B. D., Schulman, K. A. 2015; 372 (14): 1287–89

  View details for PubMedID 25738542

• Innovation In Health Care Education: A Call To Action Herzlinger, R., Kumar, V., Schulman, K. A., Staman, K. Health Affairs. 2015
• MedCath Corporation (C) Herzlinger, R. E., Schulman, K. A., Upke, F. F. Harvard Business School Supplement. 2015
• Review: In adult outpatients, nurse-managed protocols improve hemoglobin A(1c) levels and blood pressure Commentary ANNALS OF INTERNAL MEDICINE Schulman, K. A. 2014; 161 (12): JC6

  View details for DOI 10.7326/0003-4819-161-12-201412160-02006

  View details for Web of Science ID 000347248400012

  View details for PubMedID 25506878

• Exploring Variation in Care: Alternative Conceptual Models ANNALS OF INTERNAL MEDICINE Dinan, M. A., Schulman, K. A. 2014; 161 (11): 835–U130

  View details for DOI 10.7326/M14-2382

  View details for Web of Science ID 000347247200016

  View details for PubMedID 25437412

• Predicting Nursing Home Placement Among Home- and Community-Based Services Program Participants AMERICAN JOURNAL OF MANAGED CARE Greiner, M. A., Qualls, L. G., Iwata, I., White, H. K., Molony, S. L., Sullivan, M., Burke, B., Schulman, K. A., Setoguchi, S. 2014; 20 (12): E535-+

  Abstract

  Several states offer publicly funded-care management programs to prevent long-term care placement of high-risk Medicaid beneficiaries. Understanding participant risk factors and services that may prevent long-term care placement can facilitate efficient allocation of program resources.To develop a practical prediction model to identify participants in a home- and community-based services program who are at highest risk for long-term nursing home placement, and to examine participant-level and program-level predictors of nursing home placement.In a retrospective observational study, we used deidentified data for participants in the Connecticut Home Care Program for Elders who completed an annual assessment survey between 2005 and 2010.We analyzed data on patient characteristics, use of program services, and short-term facility admissions in the previous year. We used logistic regression models with random effects to predict nursing home placement. The main outcome measures were long-term nursing home placement within 180 days or 1 year of assessment.Among 10,975 study participants, 1249 (11.4%) had nursing home placement within 1 year of annual assessment. Risk factors included Alzheimer's disease (odds ratio [OR], 1.30; 95% CI, 1.18-1.43), money management dependency (OR, 1.33; 95% CI, 1.18-1.51), living alone (OR, 1.53; 95% CI, 1.31-1.80), and number of prior short-term skilled nursing facility stays (OR, 1.46; 95% CI, 1.31-1.62). Use of a personal care assistance service was associated with 46% lower odds of nursing home placement. The model C statistic was 0.76 in the validation cohort.A model using information from a home- and community-based service program had strong discrimination to predict risk of long-term nursing home placement and can be used to identify high-risk participants for targeted interventions.

  View details for Web of Science ID 000351005400001

  View details for PubMedID 25741870

• The Partners HealthCare Settlement and the Future of Health Care Organizations ECONOMISTS VOICE Richman, B. D., Schulman, K. A. 2014; 11 (1)

  View details for DOI 10.1515/ev-2014-0005

  View details for Web of Science ID 000438400900004

• The Impact Of Specialty Pharmaceuticals As Drivers Of Health Care Costs HEALTH AFFAIRS Hirsch, B. R., Balu, S., Schulman, K. A. 2014; 33 (10): 1714–20

  Abstract

  The pharmaceutical industry is shifting its focus from blockbuster small molecules to specialty pharmaceuticals. Specialty pharmaceuticals are novel drugs and biologic agents that require special handling and ongoing monitoring, are administered by injection or infusion, and are sold in the marketplace by a small number of distributors. They are frequently identified by having a cost to payers and patients of $600 or more per treatment. The total costs of the new agents are likely to have a substantial impact on overall health care costs and on patients during the next decade, unless steps are taken to align competing interests. We examine the economic and policy issues related to specialty pharmaceuticals, taking care to consider the impact on patients. We assess the role of cost-sharing provisions, legislation that is promoting realignment within the market, the role of biosimilars in price competition, and the potential for novel drug development paradigms to help bend the cost curve. The economic aspects of this analysis highlight the need for a far-reaching discussion of potential novel approaches to innovation pathways in our quest for both affordability and new technology.

  View details for PubMedID 25288414

• Triggering management for quality improvement. Health services research Scales, C. D., Schulman, K. A. 2014; 49 (5): 1401-6

  View details for DOI 10.1111/1475-6773.12224

  View details for PubMedID 25255819

  View details for PubMedCentralID PMC4213041

• Associations Between Seattle Heart Failure Model Scores and Medical Resource Use and Costs: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Li, Y., Levy, W. C., Neilson, M. P., Ellis, S. J., Whellan, D. J., Schulman, K. A., O'Connor, C. M., Reed, S. D. 2014; 20 (8): 541–47

  Abstract

  Prognostic models, such as the Seattle Heart Failure Model (SHFM), have been developed to predict patient survival. The extent to which they predict medical resource use and costs has not been explored. In this study, we evaluated relationships between baseline SHFM scores and 1-year resource use and costs using data from a clinical trial.We applied generalized linear models to examine the relative impact of a 1-unit increase in SHFM scores on counts of medical resource use and direct medical costs at 1 year of follow-up. Of 2331 randomized patients, 2288 (98%) had a rounded integer SHFM score between -1 and 2, consistent with predicted 1-year survival of 98% and 74%, respectively. At baseline, median age was 59 years, 28% of patients were women, and nearly two-thirds of the cohort had New York Heart Association class II heart failure and one-third had class III heart failure. Higher SHFM scores were associated with more hospitalizations (rate ratio per 1-unit increase, 1.86; P < .001), more inpatient days (2.30; P < .001), and higher inpatient costs (2.28; P < .001), outpatient costs (1.54; P < .001), and total medical costs (2.13; P < .001).Although developed to predict all-cause mortality, SHFM scores also predict medical resource use and costs.

  View details for PubMedID 24887579

  View details for PubMedCentralID PMC4138128

• Can Team-Based Care Improve Patient Satisfaction? A Systematic Review of Randomized Controlled Trials PLOS ONE Wen, J., Schulman, K. A. 2014; 9 (7): e100603

  Abstract

  Team-based approaches to patient care are a relatively recent innovation in health care delivery. The effectiveness of these approaches on patient outcomes has not been well documented. This paper reports a systematic review of the relationship between team-based care and patient satisfaction.We searched MEDLINE, EMBASE, Cochrane Library, CINAHL, and PSYCHOINFO for eligible studies dating from inception to October 8, 2012. Eligible studies reported (1) a randomized controlled trial, (2) interventions including both team-based care and non-team-based care (or usual care), and (3) outcomes including an assessment of patient satisfaction. Articles with different settings between intervention and control were excluded, as were trial protocols. The reference lists of retrieved papers were also evaluated for inclusion.The literature search yielded 319 citations, of which 77 were screened for further full-text evaluation. Of these, 27 articles were included in the systematic review. The 26 trials with a total of 15,526 participants were included in this systematic review. The pooling result of dichotomous data (number of studies: 10) showed that team-based care had a positive effect on patient satisfaction compared with usual care (odds ratio, 2.09; 95% confidence interval, 1.54 to 2.84); however, combined continuous data (number of studies: 7) demonstrated that there was no significant difference in patient satisfaction between team-based care and usual care (standardized mean difference, -0.02; 95% confidence interval, -0.40 to 0.36).Some evidence showed that team-based care is better than usual care in improving patient satisfaction. However, considering the pooling result of continuous data, along with the suboptimal quality of included trials, further large-scale and high-quality randomized controlled trials comparing team-based care and usual care are needed.

  View details for PubMedID 25014674

• Shifting toward Defined Contributions - Predicting the Effects NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Richman, B. D., Herzlinger, R. E. 2014; 370 (26): 2462–65

  View details for PubMedID 24963565

• Removing a Constraint on Hospital Utilization: A Natural Experiment in Maryland AMERICAN JOURNAL OF MANAGED CARE Kalman, N. S., Hammill, B. G., Murray, R. B., Schulman, K. A. 2014; 20 (6): E191–E199

  Abstract

  To limit growth in hospital utilization in the 1990s, Maryland required payers to reimburse excess hospital volume at lower case rates. In 2001, this policy changed and excess volume was paid at full case rates. We investigated the impact of this policy change on hospital utilization and finances.We conducted interrupted time-series analyses of hospital-level annual inpatient admissions, outpatient equivalent volume, equivalent admissions, operating revenue, operating costs, and operating profit.We analyzed each time series for 45 acute care hospitals in Maryland using a segmented regression model, allowing for changes in level and slope of the trend in 2001, when the payment policy was changed. To incorporate trends for all hospitals, we fit these models as hierarchical generalized linear models.We observed significant changes in inpatient admissions, outpatient equivalent volume, and operating costs. Following the policy change, trends in inpatient admissions and outpatient equivalent volume had significant 1-year increases of 7.7% and 17.1%, respectively. The annual growth rate for inpatient admissions increased significantly, from 0.8% to 2.4%. The growth rate for outpatient equivalent volume increased from 3.2% to 4.7%, but this change was not statistically significant. Trends in operating costs had significant 1-year increases of 7.6% and an annual growth rate that increased significantly from 4.8% to 8.4%, exceeding the annual growth rate for utilization.Hospitals responded to changes in payment by accelerating the increase in service volume. The observed increase in utilization coincided with substantial inflation in operating costs that cannot be easily eliminated.

  View details for Web of Science ID 000342973500008

  View details for PubMedID 25180502

• Health City Cayman Islands and the globalization of health services delivery AMERICAN HEART JOURNAL Shah, B. R., Narayan, M., Seth, A., Schulman, K. A. 2014; 167 (5): 770–74

  Abstract

  We describe a new health care campus under development in the Cayman Islands, Health City, based on the low-cost "focused factory" model. The construction of a multispecialty hospital opening in February 2014 less than a 4-hour flight away from the United States and convenient to both Central and South America for patients who already travel to the United States for clinical care could reshape the US health care marketplace and enhance access to affordable specialty health care in the region.

  View details for PubMedID 24766989

• Redistribution of Health Care Costs after the Adoption of Positron Emission Tomography among Medicare Beneficiaries with Non-Small-Cell Lung Cancer, 1998-2005 JOURNAL OF THORACIC ONCOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2014; 9 (4): 512–18

  Abstract

  Treatment patterns and cost implications of increased positron emission tomography imaging use since Medicare approval in 1998 are not well understood. We examined rates of surgery, radiotherapy, and chemotherapy and inpatient and total health care costs between 1998 and 2005 among Medicare beneficiaries with non-small-cell lung cancer.Patients in this retrospective cohort study were 51,374 Medicare beneficiaries diagnosed with non-small-cell lung cancer between 1996 and 2005. The main outcome measures were receipt of surgical resection, radiotherapy, and chemotherapy and inpatient and total health care costs within 1 year of diagnosis.Between 1996-1997 and 2004-2005, the proportion of patients undergoing surgical resection decreased from 29% to 25%, the proportion receiving radiation therapy decreased from 49% to 43%, and inpatient costs decreased from $28,900 to $26,900. The proportion of patients receiving chemotherapy increased from 25% to 40% and total costs increased from $47,300 to $52,200 (p < 0.001 for all comparisons). Changes in use and costs remained after adjustment for shifting demographic characteristics during the study period.Adoption of positron emission tomography between 1998 and 2005 was accompanied by decreases in rates of surgery and radiotherapy and in short-term inpatient costs among Medicare beneficiaries with non-small-cell lung cancer, although there was an increase in chemotherapy and overall costs.

  View details for PubMedID 24736074

• An Evaluation of Mobile Health Application Tools JMIR MHEALTH AND UHEALTH Sama, P. R., Eapen, Z. J., Weinfurt, K. P., Shah, B. R., Schulman, K. A. 2014; 2 (2): e19

  Abstract

  The rapid growth in the number of mobile health applications could have profound significance in the prevention of disease or in the treatment of patients with chronic disease such as diabetes.The objective of this study was to describe the characteristics of the most common mobile health care applications available in the Apple iTunes marketplace.We undertook a descriptive analysis of a sample of applications in the "health and wellness" category of the Apple iTunes Store. We characterized each application in terms of its health factor and primary method of user engagement. The main outcome measures of the analysis were price, health factors, and methods of user engagement.Among the 400 applications that met the inclusion criteria, the mean price of the most frequently downloaded paid applications was US $2.24 (SD $1.30), and the mean price of the most currently available paid applications was US $2.27 (SD $1.60). Fitness/training applications were the most popular (43.5%, 174/400). The next two most common categories were health resource (15.0%, 60/400) and diet/caloric intake (14.3%, 57/400). Applications in the health resource category constituted 5.5% (22/400) of the applications reviewed. Self-monitoring was the most common primary user engagement method (74.8%, 299/400). A total of 20.8% (83/400) of the applications used two or more user engagement approaches, with self-monitoring and progress tracking being the most frequent.Most of the popular mobile health applications focus on fitness and self-monitoring. The approaches to user engagement utilized by these applications are limited and present an opportunity to improve the effectiveness of the technology.

  View details for PubMedID 25099179

• Impact of Cardiovascular Events on Change in Quality of Life and Utilities in Patients After Myocardial Infarction A VALIANT Study (Valsartan In Acute Myocardial Infarction) JACC-HEART FAILURE Lewis, E. F., Li, Y., Pfeffer, M. A., Solomon, S. D., Weinfurt, K. P., Velazquez, E. J., Califf, R. M., Rouleau, J., Kober, L., White, H. D., Schulman, K. A., Reed, S. D. 2014; 2 (2): 159–65

  Abstract

  The objective of this study was to determine the impact of nonfatal cardiovascular (CV) events on changes in health-related quality of life (HRQL).There is limited understanding of the impact of nonfatal CV events on long-term changes in HRQL in survivors of myocardial infarction (MI).The VALIANT (Valsartan In Acute Myocardial Infarction) trial enrolled 14,703 patients post-MI complicated by Killip class II or higher (scale measuring heart failure severity post-MI ranging from class I to IV) and/or reduced ejection fraction. The HRQL substudy included 2,556 (17.4%) patients who completed the EQ-5D with 5 questions, with responses mapped to utility weight on a scale of 0 to 1 and a visual analog scale (VAS) ranging from 0 (worst) to 100 (best) imaginable health state. EQ-5D was administered at baseline and 6, 12, 20, and 24 months. The trajectory of EQ-5D scores was developed by using linear mixed effects regression models with calculation of deviation from this trajectory after nonfatal CV events. Patients who died before the next EQ-5D assessment were excluded.Over a 2-year period, 597 patients experienced a nonfatal CV event and survived to have another EQ-5D assessment. Their baseline EQ-5D scores were lower than patients without a subsequent nonfatal CV event (VAS 61.0 ± 19 vs 68.2 ± 18 [p < 0.001] and US-based utility score 0.76 ± 0.22 vs 0.83 ± 0.17 [p < 0.001]). These patients with CV events experienced a trajectory-adjusted 6.6 point decrease (p < 0.001) in VAS scores and a 0.07 decrease (p < 0.001) in utility score after the nonfatal CV event.MI survivors suffering a CV event experienced significantly worse HRQL than their previous trajectory, suggesting that generic instruments can be responsive to nonfatal events. Reduction in nonfatal CV events may affect longitudinal changes in HRQL.

  View details for PubMedID 24720924

• Bridging Health Care’s Innovation-Education Gap Herzlinger, R., Ramaswamy, V. K., Schulman, K. A. Harvard Business Review. 2014
• Improving Melanoma Screening: MELA Sciences Herzlinger, R. E., Schulman, K. A., Dijols, F. Harvard Business School. 2014
• Could Accountable Care Organizations Stifle Physician Learning and Innovation Huesch, M. D., Schulman, K. A. Health Management Policy and Innovation. 2014
• Hemoglobin, Exercise Training, and Health Status in Patients With Chronic Heart Failure (from the HF-ACTION Randomized Controlled Trial) AMERICAN JOURNAL OF CARDIOLOGY Pina, I. L., Lin, L., Weinfurt, K. P., Isitt, J. J., Whellan, D. J., Schulman, K. A., Flynn, K. E., HF-ACTION Investigators 2013; 112 (7): 971–76

  Abstract

  Anemia is common in patients with chronic heart failure (HF), with a prevalence ranging from 10% to 56%, and may be a risk factor for poor outcomes. Anemia in HF remains poorly understood, with significant gaps in its impact on health-related quality of life (HRQoL), with most studies in HF being retrospective or from registries. The purpose of this study was to explore the relation of hemoglobin (Hgb) with HRQoL and training-induced changes in HRQoL in a cohort of patients in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION). Using data from HF-ACTION, a randomized controlled trial of exercise training in patients with HF and low left ventricular ejection fractions, HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 3 and 12 months, and annually up to 4 years. Treatment group effects on HRQoL were estimated using linear mixed models according to the intention-to-treat principle. It was hypothesized that baseline Hgb would be correlated with baseline KCCQ scales and that Hgb would moderate the beneficial effect of exercise training on HRQoL. Hgb level was not significantly correlated with baseline HRQoL. Baseline Hgb did not moderate the beneficial effect of exercise training on KCCQ overall or subscales relative to usual care. In conclusion, in the HF-ACTION cohort, there was no correlation with baseline Hgb and baseline HRQoL as measured by the KCCQ. In addition, the beneficial effects of HRQoL from exercise training were not modulated by baseline Hgb.

  View details for DOI 10.1016/j.amjcard.2013.05.033

  View details for Web of Science ID 000325384500012

  View details for PubMedID 23809621

• Who Enrolls in the Medicare Part D Prescription Drug Benefit Program? Medication Use Among Patients With Heart Failure JOURNAL OF THE AMERICAN HEART ASSOCIATION Eapen, Z. J., Hammill, B. G., Setoguchi, S., Schulman, K. A., Peterson, E. D., Hernandez, A. F., Curtis, L. H. 2013; 2 (5): e000242

  Abstract

  Dispensing data from Medicare Part D standalone prescription drug plans are now available, but characteristics of enrollees with heart failure have not been well described.We identified 81 874 patients with prevalent heart failure as of January 1, 2010, in a nationally representative 5% sample of Medicare beneficiaries. We classified patients according to enrollment in a Medicare Part D plan as of January 1, 2010. Demographic characteristics, comorbid conditions, and prescriptions were compared by enrollment status. A total of 49 252 (60.2%) were enrolled in a Medicare Part D plan as of January 1. Enrollees were more often women, black, and of lower socioeconomic status. Enrollees with heart failure more often filled prescriptions for loop diuretics than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, β-blockers, or aldosterone antagonists. During the first 4 months of 2010, 5444 (12.3%) reached the coverage gap, and 566 (1.3%) required catastrophic coverage beyond the gap.Medicare beneficiaries with heart failure differ significantly according to enrollment in Part D prescription drug plans and represent a population underrepresented in clinical efficacy trials. Many face the coverage gap, and few select Medicare Part D plans that provide coverage during the gap. Linking Medicare Part D event data with clinical registries could help to determine whether eligible enrollees are undertreated for heart failure.

  View details for PubMedID 24025363

• The Mis-Measure of Physician Performance AMERICAN JOURNAL OF MANAGED CARE Glickman, S. W., Schulman, K. A. 2013; 19 (10): 782–85

  Abstract

  The Affordable Care Act directs the Secretary of Health and Human Services to compare individual physicians using patient experience measures. This policy initiative will utilize the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) survey program. It will impact over 700,000 eligible physicians and will be tied to reimbursement and the Centers for Medicare and Medicaid Services' Physician Compare reporting feature starting in 2015. We believe that the relevance of this framework to today's clinical environment is a critical issue to address before implementing this regulatory mandate. In this article we discuss our concerns about tying individual physician performance to CG-CAHPS scores, including: 1) intrinsic versus extrinsic approaches to assessing the patient experience, 2) measurement issues, and 3) unintended consequences. We also suggest an alternative pathway and opt-out mechanism to facilitate more rapid translation of service excellence into clinical practice.

  View details for Web of Science ID 000326420300002

  View details for PubMedID 24304157

• Financial Incentives in Primary Care Practice The Struggle to Achieve Population Health Goals JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dolor, R. J., Schulman, K. A. 2013; 310 (10): 1031–32

  View details for DOI 10.1001/jama.2013.277575

  View details for Web of Science ID 000324133400019

  View details for PubMedID 24026597

• Medical Resource Use, Costs, and Quality of Life in Patients With Acute Decompensated Heart Failure: Findings From ASCEND-HF JOURNAL OF CARDIAC FAILURE Reed, S. D., Kaul, P., Li, Y., Eapen, Z. J., Davidson-Ray, L., Schulman, K. A., Massie, B. M., Armstrong, P. W., Starling, R. C., O'Connor, C. M., Hernandez, A. F., Califf, R. M. 2013; 19 (9): 611–20

  Abstract

  The Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) randomly assigned 7,141 participants to nesiritide or placebo. Dyspnea improvement was more often reported in the nesiritide group, but there were no differences in 30-day all-cause mortality or heart failure readmission rates. We compared medical resource use, costs, and health utilities between the treatment groups.There were no significant differences in inpatient days, procedures, and emergency department visits reported for the first 30 days or for readmissions to day 180. EQ-5D health utilities and visual analog scale ratings were similar at 24 hours, discharge, and 30 days. Billing data and regression models were used to generate inpatient costs. Mean length of stay from randomization to discharge was 8.5 days in the nesiritide group and 8.6 days in the placebo group (P = .33). Cumulative mean costs at 30 days were $16,922 (SD $16,191) for nesiritide and $16,063 (SD $15,572) for placebo (P = .03). At 180 days, cumulative costs were $25,590 (SD $30,344) for nesiritide and $25,339 (SD $29,613) for placebo (P = .58).The addition of nesiritide contributed to higher short-term costs and did not significantly influence medical resource use or health utilities compared with standard care alone.

  View details for PubMedID 24054337

• Characteristics of Oncology Clinical Trials Insights From a Systematic Analysis of ClinicalTrials.gov JAMA INTERNAL MEDICINE Hirsch, B. R., Califf, R. M., Cheng, S. K., Tasneem, A., Horton, J., Chiswell, K., Schulman, K. A., Dilts, D. M., Abernethy, A. P. 2013; 173 (11): 972–79

  Abstract

  Clinical trials are essential to cancer care, and data about the current state of research in oncology are needed to develop benchmarks and set the stage for improvement.To perform a comprehensive analysis of the national oncology clinical research portfolio.All interventional clinical studies registered on ClinicalTrials.gov between October 2007 and September 2010 were identified using Medical Subject Heading terms and submitted conditions. They were reviewed to validate classification, subcategorized by cancer type, and stratified by design characteristics to facilitate comparison across cancer types and with other specialties.Of 40 970 interventional studies registered between October 2007 and September 2010, a total of 8942 (21.8%) focused on oncology. Compared with other specialties, oncology trials were more likely to be single arm (62.3% vs 23.8%; P < .001), open label (87.8% vs 47.3%; P < .001), and nonrandomized (63.9% vs 22.7%; P < .001). There was moderate but significant correlation between number of trials conducted by cancer type and associated incidence and mortality (Spearman rank correlation coefficient, 0.56 [P = .04] and 0.77 [P = .001], respectively). More than one-third of all oncology trials were conducted solely outside North America.There are significant variations between clinical trials in oncology and other diseases, as well as among trials within oncology. The differences must be better understood to improve both the impact of cancer research on clinical practice and the use of constrained resources.

  View details for DOI 10.1001/jamainternmed.2013.627

  View details for Web of Science ID 000320050200008

  View details for PubMedID 23699837

• Variations in Use of PET among Medicare Beneficiaries with Non-Small Cell Lung Cancer, 1998-2007 RADIOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2013; 267 (3): 807–17

  Abstract

  To explore demographic and regional factors associated with the use of positron emission tomography (PET) in patients with non-small cell lung cancer (NSCLC) and to determine whether their associations with PET use has changed over time.The Office of Human Research Ethics at the University of North Carolina and the institutional review board of the Duke University Health System approved (with waiver of informed consent) this retrospective analysis of Surveillance Epidemiology and End Results Medicare data for Medicare beneficiaries given a diagnosis of NSCLC between 1998 and 2007. The primary outcome was change in the number of PET examinations 2 months before to 4 months after diagnosis, examined according to year and sociodemographic subgroup. PET use was compared between demographic and geographic subgroups and between early (1998-2000) and late (2005-2007) cohorts by using χ(2) tests. Factors associated with use of PET during the study period were further examined by using logit and linear probability multivariable regression analyses.The final cohort included 46 544 patients with 46 935 cases of NSCLC. By 2005, more than half of patients underwent one or more PET examinations, regardless of demographic subgroup. In multivariable logistic regression analysis, patients who underwent PET were more likely to be married, nonblack, and younger than 80 years and to live in census tracts with higher education levels or in the Northeast (P < .001 for all). Living within 40 miles of a PET facility was initially associated with undergoing PET (P < .001), but this association disappeared by 2007. Imaging rates increased more rapidly in patients who were nonblack (P ≤ .01), patients who were younger than 81 years (P < .001), and patients who lived in the Northeast and South (P < .001).PET imaging among Medicare beneficiaries with NSCLC was initially concentrated among nonblack patients younger than 81 years. Despite widespread adoption among all subgroups, differences within demographic subgroups remained.

  View details for DOI 10.1148/radiol.12120174

  View details for Web of Science ID 000319445400017

  View details for PubMedID 23418003

• Associations Between Seattle Heart Failure Model Scores and Health Utilities: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Li, Y., Neilson, M. P., Whellan, D. J., Schulman, K. A., Levy, W. C., Reed, S. D. 2013; 19 (5): 311–16

  Abstract

  The Seattle Heart Failure Model (SHFM) is a well validated prediction model of all-cause mortality in patients with heart failure, but its relationship with generic health status measures has not been evaluated. We sought to investigate relationships between SHFM scores and health utility weights, which are necessary to estimate quality-adjusted life-years in cost-effectiveness analyses.We applied mixed linear regression to examine relationships between baseline SHFM scores and EQ-5D-derived health utilities collected longitudinally in a large clinical trial. A 1-unit increase in SHFM score (higher predicted mortality) was associated with a 0.030 decrease in utility (P < .001) and an additional 0.006 decrease per year (P < .001). With SHFM score modeled as a categorical variable, EQ-5D utilities for patients with rounded SHFM scores of 1 or 2 were significantly lower (-0.041 and -0.053, respectively; both P < .001) and declined more rapidly over time (-0.011 and -0.020, respectively; both P ≤ .004) than for patients with scores of -1.Patients with higher SHFM-predicted mortality had significantly lower health utilities at baseline and greater rates of decline over time, compared with patients with lower SHFM-predicted mortality. These relationships can be applied when examining the cost-effectiveness of heart failure interventions.

  View details for PubMedID 23663813

  View details for PubMedCentralID PMC3709866

• A Web-based communication aid for patients with cancer CANCER Meropol, N. J., Egleston, B. L., Buzaglo, J. S., Balshem, A., Benson, A. B., Cegala, D. J., Cohen, R. B., Collins, M., Diefenbach, M. A., Miller, S. M., Fleisher, L., Millard, J. L., Ross, E. A., Schulman, K. A., Silver, A., Slater, E., Solarino, N., Sulmasy, D. P., Trinastic, J., Weinfurt, K. P. 2013; 119 (7): 1437–45

  Abstract

  Cancer patients and their oncologists often report differing perceptions of consultation discussions and discordant expectations regarding treatment outcomes. CONNECT, a computer-based communication aid, was developed to improve communication between patients and oncologists.CONNECT includes assessment of patient values, goals, and communication preferences; patient communication skills training; and a preconsultation physician summary report. CONNECT was tested in a 3-arm, prospective, randomized clinical trial. Prior to the initial medical oncology consultation, adult patients with advanced cancer were randomized to the following arms: 1) control; 2) CONNECT with physician summary; or 3) CONNECT without physician summary. Outcomes were assessed with postconsultation surveys.Of 743 patients randomized, 629 completed postconsultation surveys. Patients in the intervention arms (versus control) felt that the CONNECT program made treatment decisions easier to reach (P = .003) and helped them to be more satisfied with these decisions (P < .001). In addition, patients in the intervention arms reported higher levels of satisfaction with physician communication format (P = .026) and discussion regarding support services (P = .029) and quality of life concerns (P = .042). The physician summary did not impact outcomes. Patients with higher levels of education and poorer physical functioning experienced greater benefit from CONNECT.This prospective randomized clinical trial demonstrates that computer-based communication skills training can positively affect patient satisfaction with communication and decision-making. Measurable patient characteristics may be used to identify subgroups most likely to benefit from an intervention such as CONNECT.

  View details for DOI 10.1002/cncr.27874

  View details for Web of Science ID 000316811900021

  View details for PubMedID 23335150

  View details for PubMedCentralID PMC3604078

• COSTS OF NEWLY DIAGNOSED NEOVASCULAR AGE-RELATED MACULAR DEGENERATION AMONG MEDICARE BENEFICIARIES, 2004-2008 RETINA-THE JOURNAL OF RETINAL AND VITREOUS DISEASES Qualls, L. G., Hammill, B. G., Wang, F., Lad, E. M., Schulman, K. A., Cousins, S. W., Curtis, L. H. 2013; 33 (4): 854–61

  Abstract

  To examine associations between newly diagnosed neovascular age-related macular degeneration and direct medical costs.This retrospective observational study matched 23,133 Medicare beneficiaries diagnosed with neovascular age-related macular degeneration between 2004 and 2008 with a control group of 92,532 beneficiaries on the basis of age, sex, and race. The index date for each case-control set corresponded to the first diagnosis for the case. Main outcome measures were total costs per patient and age-related macular degeneration-related costs per case 1 year before and after the index date.Mean cost per case in the year after diagnosis was $12,422, $4,884 higher than the year before diagnosis. Postindex costs were 41% higher for cases than controls after adjustment for preindex costs and comorbid conditions. Age-related macular degeneration-related costs represented 27% of total costs among cases in the postindex period and were 50% higher for patients diagnosed in 2008 than in 2004. This increase was attributable primarily to the introduction of intravitreous injections of vascular endothelial growth factor antagonists. Intravitreous injections averaged $203 for patients diagnosed in 2004 and $2,749 for patients diagnosed in 2008.Newly diagnosed neovascular age-related macular degeneration was associated with a substantial increase in total medical costs. Costs increased over time, reflecting growing use of anti-vascular endothelial growth factor therapies.

  View details for PubMedID 23296047

• Cost-effectiveness of the 21-gene recurrence score assay in the context of multifactorial decision making to guide chemotherapy for early-stage breast cancer GENETICS IN MEDICINE Reed, S. D., Dinan, M. A., Schulman, K. A., Lyman, G. H. 2013; 15 (3): 203–11

  Abstract

  New evidence is available regarding the utility of the 21-gene recurrence score assay in guiding chemotherapy use for node-negative, estrogen receptor-positive breast cancer. We applied this evidence in a decision-analytic model to re-evaluate the cost-effectiveness of the assay.We cross-classified patients by clinicopathologic characteristics from the Adjuvant! risk index and by recurrence score risk group. For non-recurrence score-guided treatment, we assumed patients receiving hormonal therapy alone had low-risk characteristics and patients receiving chemotherapy and hormonal therapy had higher-risk characteristics. For recurrence score-guided treatment, we assigned chemotherapy probabilities conditional on recurrence score risk group and clinicopathologic characteristics.An estimated 40.4% of patients in the recurrence score-guided strategy and 47.3% in the non-recurrence score-guided strategy were expected to receive chemotherapy. The incremental gain in quality-adjusted life-years was 0.16 (95% confidence interval, 0.08-0.28) with the recurrence score-guided strategy. Lifetime medical costs to the health system were $2,692 ($1,546-$3,821) higher with the recurrence score-guided strategy, for an incremental cost-effectiveness ratio of $16,677/quality-adjusted life-year ($7,613-$37,219). From a societal perspective, the incremental cost-effectiveness was $10,788/quality-adjusted life-year ($6,840-$30,265).The findings provide supportive evidence for the economic value of the 21-gene recurrence score assay in node-negative, estrogen receptor-positive breast cancer.

  View details for PubMedID 22975761

• Let's Get SEERious: More Accurate Staging With Consequent High Management Impact Is Not Just Stage Migration Reply JOURNAL OF CLINICAL ONCOLOGY Dinan, M. A., Carpenter, W. R., Patz, E. F., Abernethy, A. P., Biddle, A. K., Schulman, K. A., Curtis, L. H. 2013; 31 (6): 820

  View details for DOI 10.1200/JCO.2012.46.7373

  View details for Web of Science ID 000315086400039

  View details for PubMedID 23544205

• Patient Time Costs Associated with Sensor-Augmented Insulin Pump Therapy for Type 1 Diabetes: Results from the STAR 3 Randomized Trial MEDICAL DECISION MAKING Kamble, S., Weinfurt, K. P., Schulman, K. A., Reed, S. D. 2013; 33 (2): 215–24

  Abstract

  Sensor-augmented pump therapy (SAPT) leads to lower glycated hemoglobin levels than multiple daily injections of insulin (MDI) in patients with type 1 diabetes. Patient time and costs associated with SAPT are not known.We compared time spent on diabetes-related care, changes in time, and associated patient time costs between patients randomly assigned to SAPT or MDI. DESIGN, SETTING, AND PARTICIPANTS. During a 52-week clinical trial, participants aged 7 to 70 years (n = 483) reported total time per week spent on diabetes-related care.Patient time, including comparisons during pump initiation, 52-week patient time costs, and changes in weekly time estimates after pump initiation.At baseline, patients in the MDI group reported spending an average of 4.0 hours per week on diabetes-related care. During the pump initiation period (weeks 1-7), SAPT patients spent 1.9 hours more per week than MDI patients (95% confidence interval [CI], 1.2-2.6). After the initiation period (weeks 8-52), SAPT patients spent 1 hour more per week (95% CI, 0.4-1.7) than MDI patients (i.e., 4.4 v. 3.4 hours); patients in both groups spent progressively less time on diabetes-related care by 1.2 minutes per week (95% CI, -1.7 to -0.7). Overall, mean time costs per person were $4600 with the SAPT group and $3523 with the MDI group (difference, $1077; 95% CI, $491-$1638).Time spent on specific activities was not collected, and the estimates do not explicitly account for caregiver time associated with diabetes care activities.Patients receiving SAPT v. MDI spent approximately 2 hours more per week on diabetes-related care during pump initiation and 1 hour more per week thereafter, resulting in higher patient time costs.

  View details for PubMedID 23128579

• Comparative Effectiveness of Nonbiologic versus Biologic Disease-modifying Antirheumatic Drugs for Rheumatoid Arthritis JOURNAL OF RHEUMATOLOGY DeWitt, E., Li, Y., Curtis, J. R., Glick, H. A., Greenberg, J. D., Anstrom, K. J., Kremer, J. M., Reed, G., Schulman, K. A., Reed, S. D. 2013; 40 (2): 127–36

  Abstract

  To evaluate the comparative effectiveness of nonbiologic disease-modifying antirheumatic drugs (DMARD) versus biologic DMARD (bDMARD) for treatment of rheumatoid arthritis (RA), using 2 common analytic approaches.We analyzed change in Clinical Disease Activity Index (CDAI) scores in patients with RA enrolled in a US-based observational registry from 2001 to 2008 using multivariable (MV) regression and propensity score (PS) matching. Among patients who initiated treatment with a nonbiologic DMARD (n = 1729), we compared patients who switched to, or added, another nonbiologic (n = 182) or a bDMARD (n = 342) at 5, 9, and 24 months after treatment change.Both analytic approaches showed that patients switching to or adding another nonbiologic DMARD demonstrated improvement across 9 and 24 months (both p < 0.001). Both approaches also demonstrated greater improvement in CDAI among recipients of bDMARD relative to a second nonbiologic DMARD at 5 months (p < 0.02). The MV regression approach upheld these results at 9 and 24 months (p < 0.03). In contrast, the PS-matching approach did not show a sustained advantage with bDMARD at these later timepoints, possibly because of lower statistical power and/or lower baseline disease activity in the PS-matched cohort.Patients in both treatment groups generally experienced lower CDAI scores across time. Patients switching to bDMARD demonstrated greater improvement than patients switching to nonbiologic DMARD with both analytic approaches at 5 months. Relative advantages with bDMARD were observed at 9 and 24 months only with MV regression. These analyses provide a practical example of how findings in comparative effectiveness research can diverge with different methodological approaches.

  View details for DOI 10.3899/jrheum.120400

  View details for Web of Science ID 000314619500004

  View details for PubMedID 23322461

• The economics of new drugs: can we afford to make progress in a common disease? American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Meeting Hirsch, B. R., Schulman, K. A. 2013

  Abstract

  The concept of personalized medicine is beginning to come to fruition, but the cost of drug development is untenable today. To identify new initiatives that would support a more sustainable business model, the economics of drug development are analyzed, including the cost of drug development, cost of capital, target market size, returns to innovators at the product and firm levels, and, finally, product pricing. We argue that a quick fix is not available. Instead, a rethinking of the entire pharmaceutical development process is needed from the way that clinical trials are conducted, to the role of biomarkers in segmenting markets, to the use of grant support, and conditional approval to decrease the cost of capital. In aggregate, the opportunities abound.

  View details for DOI 10.1200/EdBook_AM.2013.33.e126

  View details for PubMedID 23714477

• Ethics of clinical research: an overview and emerging issues Understanding Clinical Research Wong, Y. W., Schulman, K. A. McGraw-Hill Education. 2013
• Organizational Innovation in Health Care Richman, B. D., Mitchell, W., Schulman, K. A. Health Management Policy and Innovation. 2013
• Patient-Centered Health Care Delivery Systems: A Framework Muehlbacher, A. C., Bethge, S., Schulman, K. A. IGITUR, UTRECHT PUBLISHING & ARCHIVING SERVICES. 2013

  View details for Web of Science ID 000326096100062

• Urinary Diversion in Patients With Spinal Cord Injury in the United States UROLOGY Peterson, A. C., Curtis, L. H., Shea, A. M., Borawski, K. M., Schulman, K. A., Scales, C. D. 2012; 80 (6): 1247–51

  Abstract

  To describe the patterns in the use of bladder augmentation and urinary diversion to manage urologic sequelae among patients with spinal cord injury in the United States.Discharge estimates were derived from the Nationwide Inpatient Sample. All patients underwent bladder augmentation or ileal conduit diversion from 1998 to 2005 and had a diagnosis of spinal cord injury.Ileal loop diversion was performed in an estimated 1919 patients and bladder augmentation in 1132 patients with spinal cord injury from 1998 to 2005. Patients undergoing urinary diversion tended to be older (mean age 46 vs 34 years; P <.001) and to have Medicare as the primary payer (55.0% vs 30.8%; P <.001). Patients who underwent urinary diversion appeared to use more healthcare resources, with a longer length of stay (15 vs 9 days), higher hospital charges ($58,626 vs $37,222), and a greater use of home healthcare services after discharge (all P <.001). Patients at teaching institutions were more likely to undergo bladder augmentation (42%) than those at nonteaching institutions (23%; P <.001).Bladder augmentation is used in approximately one-third of cases to manage the urologic complications of spinal cord injury. These patients likely constitute a clinically distinct population that uses fewer healthcare resources. The lower augmentation rates at nonteaching institutions may indicate an opportunity for quality improvement.

  View details for PubMedID 23206770

• A model for the adoption of ICT by health workers in Africa INTERNATIONAL JOURNAL OF MEDICAL INFORMATICS Jimoh, L., Pate, M. A., Lin, L., Schulman, K. A. 2012; 81 (11): 773–81

  Abstract

  To investigate the potential of information and communication technology (ICT) adoption among maternal and child health workers in rural Nigeria.A prospective, quantitative survey design was used to collect data from quasi-randomly selected clusters of 25 rural health facilities in 5 of the 36 states in Nigeria over a 2-month period from June to July 2010. A total of 200 maternal and child health workers were included in the survey, and the data were analyzed using a modified theory of acceptance model (TAM).There was no significant difference between ICT knowledge and attitude scores across states. There were significant differences in perceived ease of use (P<.001) and perceived usefulness scores (P=.001) across states. Midwives reported higher scores on all the constructs but a lower score on endemic barriers (which is a more positive outcome). However, the differences were only statistically significant for perceived usefulness (P=.05) and endemic barriers (P<.001). Regression analysis revealed that there was no interaction between worker group and age. Older workers were likely to have lower scores on knowledge and attitude but higher scores on perceived ease of use and perceived usefulness. Lastly, we found that worker preference for ICT application in health varied across worker groups and conflicted with government/employer priorities.Although the objective of this study was exploratory, the results provide insight into the intricacies involved in the deployment of ICT in low-resource settings. Use of an expanded TAM should be considered as a mandatory part of any pre-implementation study of ICT among health workers in sub-Saharan Africa.

  View details for PubMedID 22986218

• Proposed 'Grant-And-Access' Program With Price Caps Could Stimulate Development Of Drugs For Very Rare Diseases HEALTH AFFAIRS Valverde, A. M., Reed, S. D., Schulman, K. A. 2012; 31 (11): 2528–35

  Abstract

  The 1983 Orphan Drug Act created incentives for the development of orphan drugs. Despite its successes, including a substantial increase in new drugs, approved orphan drugs still treat fewer than 5 percent of registered rare diseases. In addition, concerns have arisen about the high prices of many of these therapies, which can cost hundreds of thousands of dollars per patient each year. In this article, we propose a new "grant-and-access pathway," in which drug developers could opt to compete for federal grants to subsidize the costs of clinical testing. In return for the grant funding, companies would no longer claim orphan drug tax credits and would agree to price caps for marketed products based on the duration and costs associated with drug development, expected market size, and target rate of return. We identify scenarios in which such a policy could provide a net benefit to society.

  View details for PubMedID 23129684

• In-Hospital Resource Use and Medical Costs in the Last Year of Life by Mode of Death (from the HF-ACTION Randomized Controlled Trial) AMERICAN JOURNAL OF CARDIOLOGY Reed, S. D., Li, Y., Dunlap, M. E., Kraus, W. E., Samsa, G. P., Schulman, K. A., Zile, M. R., Whellan, D. J. 2012; 110 (8): 1150–55

  Abstract

  Patterns of medical resource use near the end of life may differ across modes of death. The aim of this study was to characterize patterns of inpatient resource use and direct costs for patients with heart failure (HF) who died of sudden cardiac death (SCD), HF, other cardiovascular causes, or noncardiovascular causes during the last year of life. Data were from a randomized trial of exercise training in patients with HF. Mode of death was adjudicated by an end point committee. Generalized estimating equations were used to compare hospitalizations, inpatient days, and inpatient costs incurred during the final year of life in patients who died of different causes, adjusting for clinical and treatment characteristics. Of 2,331 patients enrolled in the trial, 231 died after ≥1 year of follow-up with an adjudicated mode of death, including 72 of SCD, 80 of HF, 34 of other cardiovascular causes, and 45 of noncardiovascular causes. Patients who died of SCD were younger, had less severe HF, and incurred fewer hospitalizations, fewer inpatient days, and lower inpatient costs than patients who died of other causes. After adjustment for patient characteristics, inpatient resource use varied by 2 to 4 times across modes of death, suggesting that cost-effectiveness analyses of interventions that reduce mortality from SCD compared to other causes should incorporate mode-specific end-of-life costs. In conclusion, resource use and associated medical costs in the last year of life differed markedly in patients with HF who experienced SCD and patients who died of other causes.

  View details for PubMedID 22762718

• Associations Between Hemoglobin Level, Resource Use, and Medical Costs in Patients With Heart Failure: Findings From HF-ACTION JOURNAL OF CARDIAC FAILURE Reed, S. D., Li, Y., Ellis, S. J., Isitt, J. J., Cheng, S., Schulman, K. A., Whellan, D. J. 2012; 18 (10): 784–91

  Abstract

  Reports that patients with heart failure and anemia incur greater costs and medical resource use have relied largely on data with limited clinical detail.HF-ACTION, a large trial of exercise training in heart failure, recorded hemoglobin at baseline. Medical resource use and hospital bills for inpatient and emergency department visits were collected throughout the study. We analyzed hemoglobin as a continuous variable to evaluate relationships with medical resource use and costs over 1 year.Among 1,763 patients with baseline hemoglobin levels, those with lower hemoglobin levels tended to be older, African American, and women and to have more severe heart failure. Lower hemoglobin was significantly associated with more hospital admissions, inpatient days, outpatient visits, and urgent care or emergency department visits (all P < .005, unadjusted). Although cost outliers influenced estimates, these observations were distributed across hemoglobin levels. Mean 1-year costs across hemoglobin levels defined as ≤ 11, >11-12, >12-13, >13-14, >14-15, and >15 g/dL were $21,106, $20,189, $16,249, $17,989, $13,216, and $12,492, respectively (P < .001, unadjusted). Significant associations remained after multivariable adjustment.Patients with lower baseline hemoglobin levels experienced progressively greater resource use and higher costs.

  View details for PubMedID 23040114

• Cost-Effectiveness of Truncated Therapy for Hepatitis C Based on Rapid Virologic Response VALUE IN HEALTH Gellad, Z. F., Muir, A. J., McHutchison, J. G., Sievert, W., Sharara, A. I., Brown, K. A., Flisiak, R., Jacobson, I. M., Kershenobich, D., Manns, M. P., Schulman, K. A., Reed, S. D. 2012; 15 (6): 876–86

  Abstract

  Shortened courses of treatment with pegylated interferon alfa and ribavirin for patients with hepatitis C virus infection who experience rapid virologic response can be effective in appropriately selected patients. The cost-effectiveness of truncated therapy is not known.To assess the cost-effectiveness of response-guided therapy versus standard-duration therapy on the basis of best available evidence.We developed a decision model for chronic hepatitis C virus infection representing two treatment strategies: 1) standard-duration therapy with pegylated interferon alfa and ribavirin for 48 weeks in patients with genotype 1 or 4 and for 24 weeks in patients with genotype 2 or 3 and 2) truncated therapy (i.e., 50% decrease in treatment duration) in patients with rapid virologic response. Patients for whom truncated therapy failed began standard-duration therapy guided by genotype. We used a Markov model to estimate lifetime costs and quality-adjusted life-years.In the base-case analysis, mean lifetime costs were $46,623 ± $2,483 with standard-duration therapy and $42,354 ± $2,489 with truncated therapy. Mean lifetime quality-adjusted life-years were similar between the groups (17.1 ± 0.7 with standard therapy; 17.2 ± 0.7 with truncated therapy). Across model simulations, the probability of truncated therapy being economically dominant (i.e., both cost saving and more effective) was 78.6%. The results were consistent when we stratified the data by genotype. In one-way sensitivity analyses, the results were sensitive only to changes in treatment efficacy.Truncated therapy based on rapid virologic response is likely to be cost saving for treatment-naive patients with chronic hepatitis C virus infection. Cost-effectiveness varied with small changes in relative treatment efficacy.

  View details for PubMedID 22999138

• Overbilling and Informed Financial Consent - A Contractual Solution NEW ENGLAND JOURNAL OF MEDICINE Richman, B. D., Hall, M. A., Schulman, K. A. 2012; 367 (5): 396–97

  View details for PubMedID 22853013

• Can the Seattle Proportional Risk Model Identify Patients With a Greater ICD Benefit in HF-ACTION? Levy, W. C., Li, Y., Zile, M., Shadman, R., Dardas, T., Whellan, D., Schulman, K., Ellis, S., Neilson, M., O'Connor, C. M., Reed, S. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2012: S50

  View details for DOI 10.1016/j.cardfail.2012.06.170

  View details for Web of Science ID 000307679700160

• Stage Migration, Selection Bias, and Survival Associated With the Adoption of Positron Emission Tomography Among Medicare Beneficiaries With Non-Small-Cell Lung Cancer, 1998-2003 JOURNAL OF CLINICAL ONCOLOGY Dinan, M. A., Curtis, L. H., Carpenter, W. R., Biddle, A. K., Abernethy, A. P., Patz, E. F., Schulman, K. A., Weinberger, M. 2012; 30 (22): 2725–30

  Abstract

  Previous studies have linked the use of positron emission tomography (PET) with improved outcomes among patients with non-small-cell lung cancer (NSCLC). However, this association may be confounded by PET-induced stage migration and selection bias. We examined the association between PET use and overall survival among Medicare beneficiaries with NSCLC.Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER) -Medicare data was used to characterize changes in overall survival, stage-specific survival, and stage distribution among Medicare beneficiaries with NSCLC between 1998 and 2003.A total of 97,007 patients with NSCLC diagnosed between 1998 and 2003 met the study criteria. Two-year and 4-year survival remained unchanged, despite widespread adoption of PET. The proportion of patients staged with advanced disease increased from 44% to 50%. Upstaging of disease was accompanied by stage-specific improved survival, with 2-year survival of stage IV disease increasing from 8% to 11% between 1998 and 2003. PET was more likely to be administered to patients with less advanced disease (stages I through IIIA) and greater overall survival.Overall survival among Medicare beneficiaries with NSCLC was unchanged between 1998 and 2003, despite widespread adoption of PET. The association between PET use and increased survival likely reflects an artifact of selection bias and consequent stage migration.

  View details for DOI 10.1200/JCO.2011.40.4392

  View details for Web of Science ID 000306952100009

  View details for PubMedID 22753917

• Seattle Heart Failure Model Scores are Significantly Predictive of Health Utilities and Their Change Over Time Li, Y., Neilson, M., Whellan, D. J., Schulman, K. A., Levy, W. C., Reed, S. D. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2012: S81

  View details for DOI 10.1016/j.cardfail.2012.06.499

  View details for Web of Science ID 000307679700262

• Cost-Effectiveness of Sensor-Augmented Pump Therapy in Adults with Type 1 Diabetes in the United States VALUE IN HEALTH Kamble, S., Schulman, K. A., Reed, S. D. 2012; 15 (5): 632–38

  Abstract

  A recent randomized trial demonstrated significant reductions in hemoglobin A(1c) levels with sensor-augmented pump therapy (SAPT) compared with multiple daily injections of insulin (MDI) in type 1 diabetes. We analyzed resource use in the trial and estimated the long-term cost-effectiveness of SAPT from the perspective of the US health care system.We undertook a cost-effectiveness analysis combining estimates from the trial and the literature to populate the previously validated Center for Outcomes Research (CORE) Diabetes Model. Results represent the use of 3-day sensors, as in the trial, and 6-day sensors, approved in most markets but not yet approved in the United States.Within-trial hospital days, emergency department visits, and outpatient visits did not differ significantly between the treatment groups. Assuming 65% use of 3-day sensors, treatment-related costs in year 1 were an estimated $10,760 for SAPT and $5072 for MDI. Discounted lifetime estimates were $253,493 in direct medical costs and 10.794 quality-adjusted life-years (QALYs) for SAPT and $167,170 in direct medical costs and 10.418 QALYs for MDI. For 3-day and 6-day sensors, the incremental cost-effectiveness ratios were $229,675 per QALY (95% confidence interval $139,071-$720,865) and $168,104 per QALY (95% confidence interval $102,819-$523,161), respectively. The ratios ranged from $69,837 to $211,113 per QALY with different strategies for incorporating utility benefits resulting from less fear of hypoglycemia with SAPT.Despite superior clinical benefits of SAPT compared with MDI, SAPT does not appear to be economically attractive in the United States for adults with type 1 diabetes in its current state of development. However, further clinical developments reducing disposable costs of the system could significantly improve its economic attractiveness.

  View details for PubMedID 22867771

• Systemic and Ocular Risks Associated With Therapies for Macular Degeneration: Clarification vs Confusion reply ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2012; 130 (6): 807

  View details for Web of Science ID 000305145600035

• Systemic and Ocular Risks Associated With Therapies for Macular Degeneration: Clarification vs Confusion-Reply. Archives of ophthalmology (Chicago, Ill. : 1960) Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2012; 130 (6): 806-7

  View details for DOI 10.1001/archophthalmol.2012.100

  View details for PubMedID 23753704

• Treatment Patterns for Neovascular Age-Related Macular Degeneration: Analysis of 284 380 Medicare Beneficiaries AMERICAN JOURNAL OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Qualls, L. G., Dimartino, L. D., Wang, F., Schulman, K. A., Cousins, S. W. 2012; 153 (6): 1116–24

  Abstract

  To examine trends in the treatment of newly diagnosed neovascular age-related macular degeneration (AMD).Retrospective cohort study.Among 284 380 Medicare beneficiaries with a new diagnosis between 2006 and 2008, we used the cumulative incidence function to estimate procedure rates and the mean frequency function to estimate the cumulative mean number of intravitreous injections. We used Cox log-binomial regression to estimate predictors of the use of vascular endothelial growth factor (VEGF) antagonists within 1 year after diagnosis. Discontinuation of anti-VEGF therapy was defined by absence of treatment for 12 months. Discontinuation rates were calculated using the Kaplan-Meier method.The proportion of patients receiving anti-VEGF therapy increased from 60.3% to 72.7%, photodynamic therapy decreased from 12.8% to 5.3%, and thermal laser treatment decreased from 5.5% to 3.2%. Black patients (hazard ratio, 0.77; 95% confidence interval, 0.75-0.79) and patients of other/unknown race (0.83; 0.81-0.84) were less likely than white patients to receive anti-VEGF therapy. Patients with dementia were less likely to receive anti-VEGF therapy (0.88; 0.88-0.89). Among patients who received anti-VEGF therapy, the mean number of injections within 1 year of the first injection was 4.3 per treated eye. Anti-VEGF therapy was discontinued in 53.6% of eyes within 1 year, and in 61.7% of eyes within 18 months.Treatment of new neovascular AMD changed significantly between 2006 and 2008, most notably in the increasing use of anti-VEGF therapies. However, few patients treated with anti-VEGF medications received monthly injections, and discontinuation rates were high.

  View details for PubMedID 22321802

• Improving the impact of clinical research: A systematic analysis of kidney cancer trials. Hirsch, B., Mitchell, A., Cheng, S., Tasneem, A., Schulman, K. A., Dilts, D. M., Abernethy, A. AMER SOC CLINICAL ONCOLOGY. 2012

  View details for Web of Science ID 000318009803077

• Cost-effectiveness of the 21-gene recurrence score assay in the setting of multifactorial decision making for chemotherapy in early-stage breast cancer Reed, S. D., Dinan, M. A., Schulman, K. A., Lyman, G. H. AMER SOC CLINICAL ONCOLOGY. 2012

  View details for Web of Science ID 000318009801058

• Geographic and network analysis of oncology trials: Portfolio assessment of ClinicalTrials.gov. Cheng, S., Hirsch, B., Califf, R. M., Tasneem, A., Schulman, K. A., Abernethy, A., Dilts, D. M. AMER SOC CLINICAL ONCOLOGY. 2012

  View details for Web of Science ID 000318009800161

• Drug development risk and the cost of capital NATURE REVIEWS DRUG DISCOVERY Baras, A. I., Baras, A. S., Schulman, K. A. 2012; 11 (5): 347–48

  View details for DOI 10.1038/nrd3722

  View details for Web of Science ID 000303460000009

  View details for PubMedID 22498751

• Can We Begin With the End in Mind? End-of-Life Care Preferences Before Long-term Dialysis ARCHIVES OF INTERNAL MEDICINE Patel, U. D., Schulman, K. A. 2012; 172 (8): 663–64

  View details for Web of Science ID 000303128700016

  View details for PubMedID 23446995

• Changes in Initial Treatment for Prostate Cancer Among Medicare Beneficiaries, 1999-2007 INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS Dinan, M. A., Robinson, T. J., Zagar, T. M., Scales, C. D., Curtis, L. H., Reed, S. D., Lee, W., Schulman, K. A. 2012; 82 (5): E781–E786

  Abstract

  In the absence of evidence from large clinical trials, optimal therapy for localized prostate cancer remains unclear; however, treatment patterns continue to change. We examined changes in the management of patients with prostate cancer in the Medicare population.We conducted a retrospective claims-based analysis of the use of radiation therapy, surgery, and androgen deprivation therapy in the 12 months after diagnosis of prostate cancer in a nationally representative 5% sample of Medicare claims. Patients were Medicare beneficiaries 67 years or older with incident prostate cancer diagnosed between 1999 and 2007.There were 20,918 incident cases of prostate cancer between 1999 and 2007. The proportion of patients receiving androgen deprivation therapy decreased from 55% to 36%, and the proportion of patients receiving no active therapy increased from 16% to 23%. Intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the most common method of radiation therapy, accounting for 77% of external beam radiotherapy by 2007. Minimally invasive radical prostatectomy began to replace open surgical approaches, being used in 49% of radical prostatectomies by 2007.Between 2002 and 2007, the use of androgen deprivation therapy decreased, open surgical approaches were largely replaced by minimally invasive radical prostatectomy, and intensity-modulated radiation therapy replaced three-dimensional conformal radiation therapy as the predominant method of radiation therapy in the Medicare population. The aging of the population and the increasing use of newer, higher-cost technologies in the treatment of patients with prostate cancer may have important implications for nationwide health care costs.

  View details for PubMedID 22331001

• Resource Use, Costs, and Utility Estimates for Patients with Cystic Fibrosis with Mild Impairment in Lung Function: Analysis of Data Collected Alongside a 48-Week Multicenter Clinical Trial VALUE IN HEALTH DeWitt, E., Grussemeyer, C. A., Friedman, J. Y., Dinan, M. A., Lin, L., Schulman, K. A., Reed, S. D. 2012; 15 (2): 277–83

  Abstract

  Transport of ions to generate epithelial rehydration (TIGER)-1 was a randomized trial conducted to evaluate the safety and efficacy of denufosol versus placebo in patients with cystic fibrosis with mild impairment in lung function. The trial met its primary end point at 24 weeks, but a subsequent trial did not show a sustained effect of denufosol at 48 weeks. By using the 48-week data, we characterized resource use, direct medical costs, indirect costs, and utility estimates.Data on medications, outpatient and emergency visits, hospital admissions, tests, procedures, and home nursing were captured on study case report forms. Sources for unit costs included the Medicare Physician Fee Schedule, the Nationwide Inpatient Sample, and the Red Book. Health utilities were derived from the Health Utilities Index Mark 2/3. We used multivariable regression to evaluate the impact of baseline covariates on costs.Characteristics of the 352 participants at enrollment included mean age of 14.6 years, history of Pseudomonas aeruginosa colonization in 45.2%, use of dornase alfa in 77.0%, and long-term use of inhaled antibiotics in 37.2%. Over 48 weeks, 22.4% of participants were hospitalized and, on average, participants missed 7.4 days of school or work. Mean total costs (excluding denufosol) were $39,673 (SD $26,842), of which 85% were attributable to medications. Female sex and P. aeruginosa colonization were independently associated with higher costs.Prospective economic data collection alongside a clinical trial allows for robust estimates of cost of illness. The mean annual cost of care for patients with cystic fibrosis with mild impairment in lung function exceeds $43,000 and is driven by medication costs.

  View details for DOI 10.1016/j.jval.2011.11.027

  View details for Web of Science ID 000301930600009

  View details for PubMedID 22433759

• THE POTENTIAL INFLUENCE OF INTERNET-BASED SOCIAL NETWORKING ON THE CONDUCT OF CLINICAL RESEARCH STUDIES JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS Glickman, S. W., Galhenage, S., McNair, L., Barber, Z., Patel, K., Schulman, K. A., McHutchison, J. G. 2012; 7 (1): 71–80

  Abstract

  The rapid growth of internet usage has led to an explosion of social networking sites for discussion of health issues. This provides a forum for subjects to communicate with one another during the course of the studies. Previous studies have raised concerns about the quality of health information on social networking sites, although none have evaluated content related to ongoing clinical trials. We reviewed material posted in virtual communities by self-identified clinical trial participants. We identified material posted in online health forums that could introduce bias into clinical research studies; we believe that this issue warrants further study and discussion. Physicians and others who conduct clinical trials should be aware of this issue. Study investigators and research teams should also talk to their study subjects about where and how they are obtaining information in order to prevent behaviors and correct misinformation that could put a subject's safety or the study objectives at risk. Given the rapid increase in Internet use for health care, a broader evaluation of both the benefits and potential risks of social networking among research participants during the course of a clinical trial appears warranted.

  View details for DOI 10.1525/jer.2012.7.1.71

  View details for Web of Science ID 000301209000008

  View details for PubMedID 22378136

• Introduction of the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Costing Tool A User-Friendly Spreadsheet Program to Estimate Costs of Providing Patient-Centered Interventions CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Reed, S. D., Li, Y., Kamble, S., Polsky, D., Graham, F. L., Bowers, M. T., Samsa, G. P., Paul, S., Schulman, K. A., Whellan, D. J., Riegel, B. J. 2012; 5 (1): 113–19

  Abstract

  Patient-centered health care interventions, such as heart failure disease management programs, are under increasing pressure to demonstrate good value. Variability in costing methods and assumptions in economic evaluations of such interventions limit the comparability of cost estimates across studies. Valid cost estimation is critical to conducting economic evaluations and for program budgeting and reimbursement negotiations.Using sound economic principles, we developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure (TEAM-HF) Costing Tool, a spreadsheet program that can be used by researchers and health care managers to systematically generate cost estimates for economic evaluations and to inform budgetary decisions. The tool guides users on data collection and cost assignment for associated personnel, facilities, equipment, supplies, patient incentives, miscellaneous items, and start-up activities. The tool generates estimates of total program costs, cost per patient, and cost per week and presents results using both standardized and customized unit costs for side-by-side comparisons. Results from pilot testing indicated that the tool was well-formatted, easy to use, and followed a logical order. Cost estimates of a 12-week exercise training program in patients with heart failure were generated with the costing tool and were found to be consistent with estimates published in a recent study.The TEAM-HF Costing Tool could prove to be a valuable resource for researchers and health care managers to generate comprehensive cost estimates of patient-centered interventions in heart failure or other conditions for conducting high-quality economic evaluations and making well-informed health care management decisions.

  View details for PubMedID 22147884

• Pharmacoeconomics: economic evaluation of pharmaceuticals Pharmacoepidemiology Schulman, K. A., Glick, H. A., Polsky, D., Reed, S. D. John Wiley & Sons. 2012; 5th ed.: 678–708
• Creation of the Business School Alliance for Health Management Schulman, K. A. Health Management Policy and Innovation. 2012
• Risks of Adverse Events With Therapies for Age-Related Macular Degeneration: A Response ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2012; 130 (1): 125–26

  View details for Web of Science ID 000298957900022

• Medical Resource Use, Costs and Quality of Life are Similar Between Patients with Acute Decompensated Heart Failure Treated with Nesiritide Versus Placebo Reed, S. D., Kaul, P., Hernandez, A. F., Li, Y., Eapen, Z. J., Schulman, K. A., Whellan, D. J., Westerhout, C. M., Massie, B., Howlett, J. G., Armstrong, P. W., Starling, R., O'Connor, C. M., Califf, R. M. LIPPINCOTT WILLIAMS & WILKINS. 2011

  View details for Web of Science ID 000299738702129

• End Point Selection in Acute Decompensated Heart Failure Clinical Trials: Economic End Points HEART FAILURE CLINICS Reed, S. D., Eapen, Z. J., Schulman, K. A. 2011; 7 (4): 529-+

  Abstract

  The selection of economic end points in acute decompensated heart failure (ADHF) clinical trials requires prospectively planned evaluations that are developed in tandem with clinical end points. Integrating economic end points with concrete clinical outcomes postdischarge will provide meaningful data to evaluate a treatment's incremental value in the setting of ADHF.

  View details for PubMedID 21925436

• THE COST-EFFECTIVENESS OF A TELAPREVIR-INCLUSIVE REGIMEN AS INITIAL THERAPY FOR GENOTYPE 1 HEPATITIS C INFECTION IN INDIVIDUALS WITH THE CC IL-28B POLYMORPHISM Gellad, Z. F., Naggie, S., Reed, S. D., Clark, P. J., Thompson, A. J., Schulman, K. A., Muir, A. J. WILEY-BLACKWELL. 2011: 417A–418A

  View details for Web of Science ID 000295578002118

• Delivering affordable cancer care in high-income countries LANCET ONCOLOGY Sullivan, R., Peppercorn, J., Sikora, K., Zalcberg, J., Meropol, N. J., Amir, E., Khayat, D., Boyle, P., Autier, P., Tannock, I. F., Fojo, T., Siderov, J., Williamson, S., Camporesi, S., McVie, J. G., Purushotham, A. D., Naredi, P., Eggermont, A., Brennan, M. F., Steinberg, M. L., De Ridder, M., McCloskey, S. A., Verellen, D., Roberts, T., Storme, G., Hicks, R. J., Ell, P. J., Hirsch, B. R., Carbone, D. P., Schulman, K. A., Catchpole, P., Taylor, D., Geissler, J., Brinker, N. G., Meltzer, D., Kerr, D., Aapro, M. 2011; 12 (10): 933-980

  Abstract

  The burden of cancer is growing, and the disease is becoming a major economic expenditure for all developed countries. In 2008, the worldwide cost of cancer due to premature death and disability (not including direct medical costs) was estimated to be US$895 billion. This is not simply due to an increase in absolute numbers, but also the rate of increase of expenditure on cancer. What are the drivers and solutions to the so-called cancer-cost curve in developed countries? How are we going to afford to deliver high quality and equitable care? Here, expert opinion from health-care professionals, policy makers, and cancer survivors has been gathered to address the barriers and solutions to delivering affordable cancer care. Although many of the drivers and themes are specific to a particular field-eg, the huge development costs for cancer medicines-there is strong concordance running through each contribution. Several drivers of cost, such as over-use, rapid expansion, and shortening life cycles of cancer technologies (such as medicines and imaging modalities), and the lack of suitable clinical research and integrated health economic studies, have converged with more defensive medical practice, a less informed regulatory system, a lack of evidence-based sociopolitical debate, and a declining degree of fairness for all patients with cancer. Urgent solutions range from re-engineering of the macroeconomic basis of cancer costs (eg, value-based approaches to bend the cost curve and allow cost-saving technologies), greater education of policy makers, and an informed and transparent regulatory system. A radical shift in cancer policy is also required. Political toleration of unfairness in access to affordable cancer treatment is unacceptable. The cancer profession and industry should take responsibility and not accept a substandard evidence base and an ethos of very small benefit at whatever cost; rather, we need delivery of fair prices and real value from new technologies.

  View details for Web of Science ID 000295787900008

  View details for PubMedID 21958503

• Seattle Heart Failure Model Scores Significantly Predict Medical Resource Use and Costs in HF-ACTION Reed, S. D., Li, Y., Ellis, S. J., Whellan, D. J., Schulman, K. A., O'Connor, C. M., Levy, W. C. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2011: S80

  View details for DOI 10.1016/j.cardfail.2011.06.272

  View details for Web of Science ID 000293938700258

• Resource Use and Medical Costs by Cause of Death in HF-ACTION Li, Y., Whellan, D. J., Dunlap, M. E., Kraus, W. E., Samsa, G., Schulman, K. A., Zile, M., Reed, S. D. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2011: S78

  View details for DOI 10.1016/j.cardfail.2011.06.263

  View details for Web of Science ID 000293938700249

• Our failure to advance new treatments for glioma to market JOURNAL OF NEUROSURGERY Sampson, J. H., Kaminski, T. J., Schulman, K. A. 2011; 115 (2): 245–47

  View details for DOI 10.3171/2010.11.JNS101436

  View details for Web of Science ID 000293145100012

  View details for PubMedID 21568655

• Implications of Definitions of Simultaneous and Staged Bilateral Total Knee Replacement (TKR) in Device Epidemiology for Medicare Beneficiaries Setoguchi, S., Greiner, M. A., Pietrobon, R., Attarian, D., Kelley, S., Wellman, S., Schulman, K. A., Bolognesi, M. WILEY-BLACKWELL. 2011: S234–S235

  View details for Web of Science ID 000294946600520

• Bladder Augmentation Versus Urinary Diversion in Patients With Spina Bifida in the United States JOURNAL OF UROLOGY Wiener, J. S., Antonelli, J., Shea, A. M., Curtis, L. H., Schulman, K. A., Krupski, T. L., Scales, C. D. 2011; 186 (1): 161–65

  Abstract

  Augmentation cystoplasty has replaced urinary diversion as the cornerstone of surgical management of refractory neurogenic bladder in patients with spina bifida. Other than single institution series little is known about practice patterns of bladder augmentation vs diversion. Therefore, we characterized the use of bladder augmentation and urinary diversion in patients with spina bifida in a nationally representative, all payer, all ages data set.Discharge estimates were derived from the Nationwide Inpatient Sample. All patients who underwent bladder augmentation or ileal conduit diversion between 1998 and 2005 with a diagnosis consistent with spina bifida were included in the study.Bladder augmentation was performed in an estimated 3,403 patients and ileal loop diversion in 772 with spina bifida between 1998 and 2005. Patients fell into 2 clinically distinct populations. Those patients undergoing bladder augmentation tended to be younger (mean age 16 vs 36 years, p <0.001) and male (52% of bladder augmentations vs 43% of urinary diversions, p = 0.02), and to have private insurance (46% vs 29%, p <0.001) compared to those undergoing urinary diversion. Furthermore, patients undergoing urinary diversion required more health care resources, with significantly longer hospital stays, higher total charges and more use of home health care after discharge home.Augmentation cystoplasty is widely used in the surgical management of neurogenic bladder in patients with spina bifida, although ileal loop diversion is still performed in a substantial proportion with clinically distinct characteristics.

  View details for PubMedID 21575969

• Training the Next Generation of Physician-Executives: An Innovative Residency Pathway in Management and Leadership ACADEMIC MEDICINE Ackerly, D. C., Sangvai, D. G., Udayakumar, K., Shah, B. R., Kalman, N. S., Cho, A. H., Schulman, K. A., Fulkerson, W. J., Dzau, V. J. 2011; 86 (5): 575-579

  Abstract

  The rapidly changing field of medicine demands that future physician-leaders excel not only in clinical medicine but also in the management of complex health care enterprises. However, many physicians have become leaders "by accident," and the active cultivation of future leaders is required. Addressing this need will require multiple approaches, targeting trainees at various stages of their careers, such as degree-granting programs, residency and fellowship training, and career and leadership development programs. Here, the authors describe a first-of-its-kind graduate medical education pathway at Duke Medicine, the Management and Leadership Pathway for Residents (MLPR). This program was developed for residents with both a medical degree and management training. Created in 2009, with its first cohort enrolled in the summer of 2010, the MLPR is intended to help catalyze the emergence of a new generation of physician-leaders. The program will provide physicians-in-training with rigorous clinical exposure along with mentorship and rotational opportunities in management to accelerate the development of critical leadership and management skills in all facets of medicine, including care delivery, research, and education. To achieve this, the MLPR includes 15 to 18 months of project-based rotations under the guidance of senior leaders in many disciplines including finance, patient safety, health system operations, strategy, and others. Developing both clinical and management skill sets during graduate medical education holds the promise of engaging future leaders of health care at an early career stage, keeping more MD-MBA graduates within health care, and creating a bench of talented future physician-executives.

  View details for DOI 10.1097/ACM.0b013e318212e51b

  View details for Web of Science ID 000289971300016

  View details for PubMedID 21436663

• PATIENT TIME AND INDIRECT COSTS ASSOCIATED WITH SENSOR-AUGMENTED INSULIN PUMP THERAPY IN TYPE 1 DIABETES Kamble, S., Weinfurt, K. P., Perry, B. M., Schulman, K. A., Reed, S. D. ELSEVIER SCIENCE INC. 2011: A84

  View details for DOI 10.1016/j.jval.2011.02.468

  View details for Web of Science ID 000299105000438

• Use of Patient-Reported Outcomes in Randomized, Double-Blind, Placebo-Controlled Clinical Trials MEDICAL CARE Dinan, M. A., Compton, K. L., Dhillon, J. K., Hammill, B. G., DeWitt, E., Weinfurt, K. P., Schulman, K. A. 2011; 49 (4): 415–19

  Abstract

  To optimize the use of patient-reported outcomes (PROs) in clinical research, it is first necessary to review the current use of these outcomes in clinical trials to determine under what circumstances they are most useful, and to reveal current limitations.To investigate current patterns of use of PROs in clinical trials.We conducted a systematic literature review of all double-blind, placebo-controlled, randomized clinical trials using one or more PROs as a study outcome from 2004 to 2006. Data were abstracted and analyzed with descriptive statistics and logistic regression to characterize the use of PROs in clinical trials.The 180 clinical trials that met the study inclusion criteria used 173 unique instruments to measure a total of 466 PROs. Most PRO measurements were obtained using relatively few PRO instruments, with one-third of PRO instruments applied in more than 1 trial. In multivariable analysis, tests of statistical significance were more often reported for PROs used as primary trial outcomes. Statistically significant PRO outcomes (P<0.05) were more likely among disease-specific PROs compared with general PROs, PROs with a discussion of minimally important difference, and larger trials.PRO instruments may be improved through efforts to provide centralized electronic administration, cross-validation, and standardized interpretation of clinically relevant outcomes. The majority of PROs used in current clinical trials come from relatively few, commonly used disease-specific PRO instruments within major therapeutic areas.

  View details for PubMedID 21368680

• Effects of Family History and Genetic Polymorphism on the Cost-Effectiveness of Chemoprevention With Finasteride for Prostate Cancer JOURNAL OF UROLOGY Reed, S. D., Scales, C. D., Stewart, S. B., Sun, J., Moul, J. W., Schulman, K. A., Xu, J. 2011; 185 (3): 841–47

  Abstract

  Improvement in the cost-effectiveness of chemoprevention for prostate cancer could be realized through the identification of patients at higher risk. We estimated the cost-effectiveness of prostate cancer chemoprevention across risk groups defined by family history and number of risk alleles, and the cost-effectiveness of targeting chemoprevention to higher risk groups.We developed a probabilistic Markov model to estimate costs, survival and quality adjusted survival across risk groups for patients receiving or not receiving chemoprevention with finasteride. The model uses data from national cancer registries, online sources and the medical literature.The incremental cost-effectiveness of 25 years of chemoprevention with finasteride in patients 50 years old was an estimated $89,300 per quality adjusted life-year (95% CI $58,800-$149,800), assuming finasteride decreased all grades of prostate cancer by 24.8%. Among patients with a positive family history (without genetic testing) chemoprevention provided 1 additional quality adjusted life-year at a cost of $64,200. Among patients with a negative family history at $400 per person tested, the cost-effectiveness of genetically targeted chemoprevention ranged from $98,100 per quality adjusted life-year when limiting finasteride to individuals with 14 or more risk alleles, to $103,200 per quality adjusted life-year when including those with 8 or more risk alleles.Although there are small differences in the cost-effectiveness of genetically targeted chemoprevention strategies in patients with a negative family history, genetic testing could reduce total expenditures if used to target chemoprevention for higher risk groups.

  View details for PubMedID 21239023

• When experiments travel: Clinical trials and the global search for human subjects (Book Review) JOURNAL OF BIOETHICAL INQUIRY Book Review Authored by: Schulman, K. A. 2011; 8 (1): 95–96

  View details for DOI 10.1007/s11673-010-9266-y

  View details for Web of Science ID 000291246900013

• Perspective: The Case for Research Justice: Inclusion of Patients With Limited English Proficiency in Clinical Research ACADEMIC MEDICINE Glickman, S. W., Ndubuizu, A., Weinfurt, K. P., Hamilton, C. D., Glickman, L. T., Schulman, K. A., Cairns, C. B. 2011; 86 (3): 389–93

  Abstract

  Persons with limited English proficiency (LEP) constitute a growing portion of the U.S. population, yet they are underrepresented in clinical research. This inherently limits the societal benefits of the research and its generalizability to ethnic populations living in the United States. To illustrate the complexity associated with including LEP participants in clinical research, the authors critically evaluated LEP consent requirements posted on the Web sites of 134 academic health centers in March 2008. They found wide variability with regard to consent policies and striking interinstitutional differences in posted IRB policies and attitudes toward consent of LEP patients in research. The authors argue this variation highlights competing concerns between autonomy and justice. Outcomes-based justice requires inclusion of LEP patients in the research, yet the consent process is often resource-intensive and complex. The authors suggest that more uniform and specific guidance from federal agencies for enrollment of LEP patients in clinical research be established and that this guidance explicitly recalibrate the current balance between autonomy and justice. Investigators and institutional review boards should also develop streamlined best practices to reduce unnecessary effort and expense associated with recruitment of LEP individuals. LEP individuals should have fair access to clinical research in order to fully realize individual and societal benefits of their participation and to ensure the generalizability of scientific discovery.

  View details for DOI 10.1097/ACM.0b013e318208289a

  View details for Web of Science ID 000287690700031

  View details for PubMedID 21248607

• Resource Use in the Last 6 Months of Life Among Medicare Beneficiaries With Heart Failure, 2000-2007 ARCHIVES OF INTERNAL MEDICINE Unroe, K. T., Greiner, M. A., Hernandez, A. F., Whellan, D. J., Kaul, P., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2011; 171 (3): 196–203

  Abstract

  Heart failure is a common cause of death among Medicare beneficiaries, but little is known about health care resource use at the end of life.In a retrospective cohort study of 229,543 Medicare beneficiaries with heart failure who died between January 1, 2000, and December 31, 2007, we examined resource use in the last 180 days of life, including all-cause hospitalizations, intensive care unit days, skilled nursing facility stays, home health, hospice, durable medical equipment, outpatient physician visits, and cardiac procedures. We calculated overall costs to Medicare and predictors of costs.Approximately 80% of patients were hospitalized in the last 6 months of life; days in intensive care increased from 3.5 to 4.6 (P<.001). Use of hospice increased from 19% to nearly 40% of patients (P<.001). Unadjusted mean costs to Medicare per patient rose 26% from $28,766 to $36,216 (P<.001). After adjustment for age, sex, race, comorbid conditions, and geographic region, costs increased by 11% (cost ratio, 1.11; 95% confidence interval, 1.10-1.13). Increasing age was strongly and independently associated with lower costs. Renal disease, chronic obstructive pulmonary disease, and black race were independent predictors of higher costs.Among Medicare beneficiaries with heart failure, health care resource use at the end of life increased over time with higher rates of intensive care and higher costs. However, the use of hospice services also increased markedly, representing a shift in patterns of care at the end of life.

  View details for DOI 10.1001/archinternmed.2010.371

  View details for Web of Science ID 000287328700003

  View details for PubMedID 20937916

• A Cautious Path Forward on Accountable Care Organizations JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Richman, B. D., Schulman, K. A. 2011; 305 (6): 602–3

  View details for PubMedID 21304085

• Relationship Between Patient Satisfaction With Inpatient Care and Hospital Readmission Within 30 Days AMERICAN JOURNAL OF MANAGED CARE Boulding, W., Glickman, S. W., Manary, M. P., Schulman, K. A., Staelin, R. 2011; 17 (1): 41–48

  Abstract

  To determine whether hospitals where patients report higher overall satisfaction with their interactions among the hospital and staff and specifically their experience with the discharge process are more likely to have lower 30-day readmission rates after adjustment for hospital clinical performance.Among patients 18 years or older, an observational analysis was conducted using Hospital Compare data on clinical performance, patient satisfaction, and 30-day risk-standardized readmission rates for acute myocardial infarction, heart failure, and pneumonia for the period July 2005 through June 2008.A hospital-level multivariable logistic regression analysis was performed for each of 3 clinical conditions to determine the relationship between patient-reported measures of their satisfaction with the hospital stay and staff and the discharge process and 30-day readmission rates, while controlling for clinical performance.In samples ranging from 1798 hospitals for acute myocardial infarction to 2562 hospitals for pneumonia, higher hospital-level patient satisfaction scores (overall and for discharge planning) were independently associated with lower 30-day readmission rates for acute myocardial infarction (odds ratio [OR] for readmission per interquartile improvement in hospital score, 0.97; 95% confidence interval [CI], 0.94-0.99), heart failure (OR, 0.96; 95% CI, 0.95-0.97), and pneumonia (OR, 0.97; 95% CI, 0.96-0.99). These improvements were between 1.6 and 4.9 times higher than those for the 3 clinical performance measures.Higher overall patient satisfaction and satisfaction with discharge planning are associated with lower 30-day risk-standardized hospital readmission rates after adjusting for clinical quality. This finding suggests that patient-centered information can have an important role in the evaluation and management of hospital performance.

  View details for PubMedID 21348567

• Usability evaluation of a personal health record. AMIA ... Annual Symposium proceedings. AMIA Symposium Segall, N., Saville, J. G., L'Engle, P., Carlson, B., Wright, M. C., Schulman, K., Tcheng, J. E. 2011; 2011: 1233–42

  Abstract

  The electronic personal health record (PHR) has been championed as a mediator of patient-centered care, yet its usability and utility to patients, key predictors of success, have received little attention. Human-centered design (HCD) offers validated methods for studying systems effects on users and their cognitive tasks. In HCD, user-centered activities allow potential users to shape the design of the end product and enhance its usability. We sought to evaluate the usability and functionality of HealthView, the PHR of the Duke University Health System, using HCD methods. Study participants were asked to think aloud as they carried out tasks in HealthView. They then completed surveys and interviews eliciting their reactions to the web portal. Findings were analyzed to generate redesign recommendations, which will be incorporated in a future release of HealthView.

  View details for PubMedID 22195184

• Assessment of Left Ventricular Function in Older Medicare Beneficiaries With Newly Diagnosed Heart Failure CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Curtis, L. H., Greiner, M. A., Shea, A. M., Whellan, D. J., Hammill, B. G., Schulman, K. A., Douglas, P. S. 2011; 4 (1): 85–91

  Abstract

  Assessment of left ventricular function is a recommended performance measure for the care of patients with newly diagnosed heart failure. Little is known about the extent to which left ventricular function is assessed in real-world settings.We analyzed a 5% national sample of data from the Centers for Medicare and Medicaid Services from 1991 through 2008. Patients were 65 years or older, with incident heart failure in 1995, 1999, 2003, or 2007. We searched for evidence of tests of left ventricular function from 30 days before through 60 days after an incident heart failure diagnosis. We used logistic regression to identify patient characteristics associated with assessment of left ventricular function. There were 45 005 patients with incident heart failure in 1995, 38 425 in 1999, 39 529 in 2003, and 32 629 in 2007. Assessment of left ventricular function increased from 46% to 60%, with rest echocardiography being the predominant mode. Patients diagnosed with heart failure during a hospitalization had the highest assessment rates (58% in 1995, 64% in 1999, 69% in 2003, and 73% in 2007). After adjustment for other patient characteristics, odds of assessment were 4 times higher among patients diagnosed in inpatient settings.Nearly 40% of Medicare beneficiaries do not undergo assessment of left ventricular function when newly diagnosed with heart failure. Quality-improvement strategies are needed to optimize the care of these patients, especially in outpatient settings.

  View details for PubMedID 21098783

• A policy approach to the development of molecular diagnostic tests NATURE BIOTECHNOLOGY Schulman, K. A., Tunis, S. R. 2010; 28 (11): 1157–59

  Abstract

  Efficiently generating evidence of clinical utility is a major challenge for ensuring clinical adoption of valuable diagnostics. A new approach to reimbursement in the United States offers a balance between evidence and incentives for molecular diagnostic tests.

  View details for PubMedID 21057480

• Geographic Variation and Trends in Carotid Imaging Among Medicare Beneficiaries, 2001 to 2006 CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Curtis, L. H., Greiner, M. A., Patel, M. R., Duncan, P. W., Schulman, K. A., Matchar, D. B. 2010; 3 (6): 599–606

  Abstract

  Diagnostic imaging among Medicare beneficiaries is an important contributor to rising health care costs. We examined temporal trends and geographic variation in the use of carotid ultrasound, carotid magnetic resonance angiography (MRA), and carotid x-ray angiography.Analysis of a 5% national sample of claims from the Centers for Medicare and Medicaid Services for 1999 through 2006. Patients were 65 years or older and underwent carotid ultrasound, carotid MRA, carotid x-ray angiography, or a carotid intervention. The main outcome measures were annual age-adjusted rates of carotid imaging and interventions and factors associated with the use of carotid imaging. Rates of imaging increased by 27%, from 98.2 per 1000 person-years in 2001 to 124.3 per 1000 in 2006. Rates of carotid ultrasound increased by 23%, and rates of MRA increased by 66%. Carotid intervention rates decreased from 3.6 per 1000 person-years in 2001 to 3.1 per 1000 person-years in 2006. In 2006, rates of carotid ultrasound were lowest in the New England, Mountain, and West North Central regions and highest in the Middle Atlantic and South Atlantic regions. Regional differences persisted after adjustment for patient demographic characteristics, history of vascular disease and other comorbid conditions, and study year.From 2001 through 2006, there was substantial growth and variation in the use of carotid imaging, including a marked increase in the use of MRA, and a decrease in the overall rate of carotid intervention.

  View details for PubMedID 20940248

• Risks of Mortality, Myocardial Infarction, Bleeding, and Stroke Associated With Therapies for Age-Related Macular Degeneration ARCHIVES OF OPHTHALMOLOGY Curtis, L. H., Hammill, B. G., Schulman, K. A., Cousins, S. W. 2010; 128 (10): 1273–79

  Abstract

  To examine associations between therapies for age-related macular degeneration and risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.We conducted a retrospective cohort study of 146,942 Medicare beneficiaries 65 years or older with a claim for age-related macular degeneration between January 1, 2005, and December 31, 2006. On the basis of claims for the initial treatment, we assigned beneficiaries to 1 of 4 groups. The active control group included patients who received photodynamic therapy. The other groups included patients who received intravitreous pegaptanib octasodium, bevacizumab, or ranibizumab. We censored data from patients when they received a therapy different from the initial therapy. The main outcome measures were associations between photodynamic, pegaptanib, bevacizumab, and ranibizumab therapies and the risks of all-cause mortality, incident myocardial infarction, bleeding, and incident stroke.After adjustment for baseline characteristics and comorbid conditions, we found significant differences in the rates of mortality and myocardial infarction by treatment group. Specifically, the hazard of mortality was significantly lower with ranibizumab therapy than with photodynamic therapy (hazard ratio, 0.85; 99% confidence interval, 0.75-0.95) or pegaptanib use (0.84; 0.74-0.95), and the hazard of myocardial infarction was significantly lower with ranibizumab use than with photodynamic therapy (0.73; 0.58-0.92). There were no significant differences in the hazard of mortality or myocardial infarction between bevacizumab use and the other therapies. We found no statistically significant relationship between treatment group and bleeding events or stroke.Bevacizumab and ranibizumab use was not associated with increased risks of mortality, myocardial infarction, bleeding, or stroke compared with photodynamic therapy or pegaptanib use.

  View details for PubMedID 20937996

• Moving forward with clinical IT on multiple fronts. An interview with Asif Ahmad and Kevin Schulman, M.D., Duke University Health System/Duke University. Interview by Mark Hagland. Healthcare informatics : the business magazine for information and communication systems Ahmad, A., Schulman, K. 2010; 27 (10): 45-7

  View details for PubMedID 21049721

• Commentary: Per Capita Payments in Clinical Trials: Reasonable Costs Versus Bounty Hunting ACADEMIC MEDICINE Hall, M. A., Friedman, J. Y., King, N. P., Weinfurt, K. P., Schulman, K. A., Sugarman, J. 2010; 85 (10): 1554–56

  Abstract

  Paying more for clinical research than the cost of doing the work may create a conflict of interest that could lead to overzealous recruitment, putting participants and scientific integrity at risk. Thus, although various policies prohibit "finder's fees" simply for recruiting patients, paying the actual costs for research is permissible. Whereas industry-sponsored research routinely pays for the costs of each patient enrolled, the line between reasonable and excessive costs merits more attention. In academic medical centers (AMCs), institutional review boards and conflict of interest committees usually are not involved in reviewing research budgets to determine whether per capita payments are excessive. Also, the costs for clinical services in research are not standardized. Instead, budgets are negotiated both internally, among departments within research institutions, and externally, between researchers and sponsors. Sometimes, rates paid by sponsors exceed what researchers usually receive or are actually paid for particular services, generating a surplus. Nevertheless, the authors see only limited cause for concern because, at the AMCs with which the authors are familiar, any monetary surplus generally remains within the research enterprise to cover unanticipated budget shortfalls or to support research staff in the future during lean times. In addition, the surplus from research budgets is not shared directly with individual investigators. However, further investigation is needed to determine whether practices outside AMCs pose greater concerns.

  View details for DOI 10.1097/ACM.0b013e3181ef9cc6

  View details for Web of Science ID 000282365000007

  View details for PubMedID 20881671

• Animal, Vegetable, or ... Clinical Trial? ANNALS OF INTERNAL MEDICINE Yancy, W. S., Maciejewski, M. L., Schulman, K. A. 2010; 153 (5): 337–U93

  View details for DOI 10.7326/0003-4819-153-5-201009070-00009

  View details for Web of Science ID 000281605500008

  View details for PubMedID 20820043

• Costs of Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage NEUROSURGERY Chou, C., Reed, S. D., Allsbrook, J. S., Steele, J. L., Schulman, K. A., Alexander, M. J. 2010; 67 (2): 345–51

  Abstract

  To assess the impact of vasospasm on costs, length of stay, and mortality among inpatients with aneurysmal subarachnoid hemorrhage.We combined hospital accounting and physician billing data for a consecutive cohort of 198 patients who underwent surgical clipping or endovascular coiling for subarachnoid hemorrhage repair. We considered patients with transcranial Doppler (TCD) velocity of 120 cm/s or greater in the middle cerebral artery to have TCD-defined vasospasm and patients with delayed ischemic neurological deficit to have symptomatic vasospasm. We compared outcomes of patients with TCD-defined vasospasm (n = 116) and those without (n = 73) and patients with symptomatic vasospasm (n = 62) and those without (n = 127), adjusting for demographic and clinical characteristics.In adjusted analyses, the incremental cost attributable to TCD-defined vasospasm was 1.20 times higher (95% confidence interval, 1.06-1.36; P = .004) than for patients without TCD-defined vasospasm. Length of stay was an estimated 1.22 times longer for patients with TCD-defined vasospasm (95% CI, 1.07-1.39; P < .01). For symptomatic vasospasm, adjusted costs were 1.27 times higher (95% CI, 1.12-1.43; P < .001) and length of stay was an estimated 1.24 times longer (95% CI, 1.09-1.40; P < .01) for patients with vasospasm than for those without. There was no significant relationship between either type of vasospasm and in-hospital mortality.Patients with subarachnoid hemorrhage and TCD-defined or symptomatic vasospasm incur higher inpatient costs and longer hospital stays than those without vasospasm.

  View details for PubMedID 20644420

• Geographic Variation in Carotid Revascularization Among Medicare Beneficiaries, 2003-2006 ARCHIVES OF INTERNAL MEDICINE Patel, M. R., Greiner, M. A., DiMartino, L. D., Schulman, K. A., Duncan, P. W., Matchar, D. B., Curtis, L. H. 2010; 170 (14): 1218–25

  Abstract

  Little is known about patterns in the use of carotid revascularization since a 2004 Medicare national coverage decision supporting carotid artery stenting. We examined geographic variation in and predictors of carotid endarterectomy and carotid stenting.Analysis of claims from the Centers for Medicare & Medicaid Services from January 1, 2003, through December 31, 2006. Patients were 65 years or older and had undergone carotid endarterectomy or carotid stenting. The main outcome measures were annual age-adjusted rates of carotid endarterectomy and carotid stenting, factors associated with the use of carotid revascularization, and mortality rate at 30 days and 1 year.The rate of endarterectomy decreased from 3.2 per 1000 person-years in 2003 to 2.6 per 1000 person-years in 2006. After adjustment for demographic and clinical characteristics, there was significant geographic variation in the odds of carotid revascularization, with the East North Central region having the greatest odds of endarterectomy (odds ratio, 1.60; 95% confidence interval, 1.55-1.65) and stenting (1.61; 1.46-1.78) compared with New England. Prior endarterectomy (odds ratio, 3.06; 95% confidence interval, 2.65-3.53) and coronary artery disease (2.12; 2.03-2.21) were strong predictors of carotid stenting. In 2005, mortality was 1.2% at 30 days and 6.8% at 1 year for endarterectomy and 2.3% at 30 days and 10.3% at 1 year for stenting.Significant geographic variation exists for carotid endarterectomy and carotid stenting. Prior endarterectomy and coronary disease were associated with greater odds of carotid stenting.

  View details for Web of Science ID 000280347400006

  View details for PubMedID 20660840

• Economic Evaluation of the HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) Randomized Controlled Trial An Exercise Training Study of Patients With Chronic Heart Failure CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Reed, S. D., Whellan, D. J., Li, Y., Friedman, J. Y., Ellis, S. J., Pina, I. L., Settles, S. J., Davidson-Ray, L., Johnson, J. L., Cooper, L. S., O'Connor, C. M., Schulman, K. A., HF-ACTIOn Investigators 2010; 3 (4): 374–81

  Abstract

  Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) assigned 2331 outpatients with medically stable heart failure to exercise training or usual care. We compared medical resource use and costs incurred by these patients during follow-up.Extensive data on medical resource use and hospital bills were collected throughout the trial for estimates of direct medical costs. Intervention costs were estimated using patient-level trial data, administrative records, and published unit costs. Mean follow-up was 2.5 years. There were 2297 hospitalizations in the exercise group and 2332 in the usual care group (P=0.92). The mean number of inpatient days was 13.6 (standard deviation [SD], 27.0) in the exercise group and 15.0 (SD, 31.4) in the usual care group (P=0.23). Other measures of resource use were similar between groups, except for trends indicating that fewer patients in the exercise group underwent high-cost inpatient procedures. Total direct medical costs per participant were an estimated $50,857 (SD, $81,488) in the exercise group and $56,177 (SD, $92,749) in the usual care group (95% confidence interval for the difference, $-12,755 to $1547; P=0.10). The direct cost of exercise training was an estimated $1006 (SD, $337). Patient time costs were an estimated $5018 (SD, $4600).The cost of exercise training was relatively low for the health care system, but patients incurred significant time costs. In this economic evaluation, there was little systematic benefit in terms of overall medical resource use with this intervention.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047437.

  View details for PubMedID 20551371

• Oversight of Financial Conflicts of Interest in Commercially Sponsored Research in Academic and Nonacademic Settings Weinfurt, K. P., Hall, M. A., Hardy, N., Friedman, J. Y., Schulman, K. A., Sugarman, J. SPRINGER. 2010: 460–64

  Abstract

  Studies of conflicts of interest in clinical research have focused on academic centers, but most clinical research takes place in nonacademic settings.To compare oversight and management of investigators' financial relationships in academic and nonacademic research settings.Survey of officials at 199 sites that contributed participants to commercially sponsored phase 3 clinical trials published in JAMA or the New England Journal of Medicine in 2006 and 2007.Response rates were 66% for academic medical centers, 37% for nonacademic medical centers (inpatient), and 27% for outpatient nonacademic sites. Almost all academic medical centers (97%) and most nonacademic medical centers (87%) followed written conflict-of-interest policies, whereas 44% of outpatient nonacademic sites had written policies (P < 0.001). Academic and nonacademic medical centers relied mainly on internal institutional review boards (69% and 71%, respectively); outpatient nonacademic sites relied primarily on independent institutional review boards (59%; P < 0.001).Nonacademic sites have substantially different approaches to the oversight and management of financial relationships in commercially sponsored clinical research than academic medical centers. These differences warrant more attention to how financial relationships are monitored in community research settings.

  View details for PubMedID 20186498

• Can We Close The Income And Wealth Gap Between Specialists And Primary Care Physicians? HEALTH AFFAIRS Vaughn, B. T., DeVrieze, S. R., Reed, S. D., Schulman, K. A. 2010; 29 (5): 933–40

  Abstract

  Over their lifetimes, primary care physicians earn lower incomes--and accumulate considerably less wealth--than their specialist counterparts. This gap influences medical students, who are choosing careers in primary care in declining numbers. We estimated career wealth accumulation across specialists, primary care physicians, physician assistants, business school graduates, and college graduates. We then compared specialists, represented by cardiologists, to primary care physicians in four scenarios. The wealth gap is substantial; narrowing it would require substantial reductions in specialists' practice income or increases in primary care physicians' practice income, or both, of more than $100,000 a year. Current proposals for increasing primary care physician supply would do little to lessen these differences.

  View details for PubMedID 20439883

• Changes in the Use and Costs of Diagnostic Imaging Among Medicare Beneficiaries With Cancer, 1999-2006 JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Dinan, M. A., Curtis, L. H., Hammill, B. G., Patz, E. F., Abernethy, A. P., Shea, A. M., Schulman, K. A. 2010; 303 (16): 1625–31

  Abstract

  Emerging technologies, changing diagnostic and treatment patterns, and changes in Medicare reimbursement are contributing to increasing use of imaging in cancer. Imaging is the fastest growing expense for Medicare but has not been examined among beneficiaries with cancer.To examine changes in the use of imaging and how those changes contribute to the overall cost of cancer care.Analysis of a nationally representative 5% sample of claims from the US Centers for Medicare & Medicaid Services from 1999 through 2008. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, or prostate cancer.Use and cost of imaging by modality, year, and cancer type.There were 100,954 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, non-Hodgkin lymphoma, and prostate cancer from 1999 through 2006. Significant mean annual increases in imaging use occurred among all cancer types for positron emission tomography (35.9%-53.6%), bone density studies (6.3%-20.0%), echocardiograms (5.0%-7.8%), magnetic resonance imaging (4.4%-11.5%), and ultrasound (0.7%-7.4%). Conventional radiograph rates decreased or stayed the same. As of 2006, beneficiaries with lung cancer and beneficiaries with lymphoma incurred the largest overall imaging costs, exceeding a mean of $3000 per beneficiary within 2 years of diagnosis. By 2005, one-third of beneficiaries with breast cancer underwent bone scans and half of beneficiaries with lung cancer or lymphoma underwent positron emission tomography scans. Mean 2-year imaging costs per beneficiary increased at a rate greater than the increase in mean total costs per beneficiary for all cancer types.Imaging costs among Medicare beneficiaries with cancer increased from 1999 through 2006, outpacing the rate of increase in total costs among Medicare beneficiaries with cancer.

  View details for DOI 10.1001/jama.2010.460

  View details for Web of Science ID 000277085200026

  View details for PubMedID 20424253

• STAR 3 Randomized Controlled Trial to Compare Sensor-Augmented Insulin Pump Therapy with Multiple Daily Injections in the Treatment of Type 1 Diabetes: Research Design, Methods, and Baseline Characteristics of Enrolled Subjects DIABETES TECHNOLOGY & THERAPEUTICS Davis, S. N., Horton, E. S., Battelino, T., Rubin, R. R., Schulman, K. A., Tamborlane, W. V. 2010; 12 (4): 249–55

  Abstract

  Sensor-augmented pump therapy (SAPT) integrates real-time continuous glucose monitoring (RT-CGM) with continuous subcutaneous insulin infusion (CSII) and offers an alternative to multiple daily injections (MDI). Previous studies provide evidence that SAPT may improve clinical outcomes among people with type 1 diabetes. Sensor-Augmented Pump Therapy for A1c Reduction (STAR) 3 is a multicenter randomized controlled trial comparing the efficacy of SAPT to that of MDI in subjects with type 1 diabetes.Subjects were randomized to either continue with MDI or transition to SAPT for 1 year. Subjects in the MDI cohort were allowed to transition to SAPT for 6 months after completion of the study. SAPT subjects who completed the study were also allowed to continue for 6 months. The primary end point was the difference between treatment groups in change in hemoglobin A1c (HbA1c) percentage from baseline to 1 year of treatment. Secondary end points included percentage of subjects with HbA1c < or =7% and without severe hypoglycemia, as well as area under the curve of time spent in normal glycemic ranges. Tertiary end points include percentage of subjects with HbA1c < or =7%, key safety end points, user satisfaction, and responses on standardized assessments.A total of 495 subjects were enrolled, and the baseline characteristics similar between the SAPT and MDI groups. Study completion is anticipated in June 2010.Results of this randomized controlled trial should help establish whether an integrated RT-CGM and CSII system benefits patients with type 1 diabetes more than MDI.

  View details for DOI 10.1089/dia.2009.0145

  View details for Web of Science ID 000275301700001

  View details for PubMedID 20210562

  View details for PubMedCentralID PMC2883476

• Patient Satisfaction and Its Relationship With Clinical Quality and Inpatient Mortality in Acute Myocardial Infarction CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Glickman, S. W., Boulding, W., Manary, M., Staelin, R., Roe, M. T., Wolosin, R. J., Ohman, E., Peterson, E. D., Schulman, K. A. 2010; 3 (2): 188–95

  Abstract

  Hospitals use patient satisfaction surveys to assess their quality of care. A key question is whether these data provide valid information about the medically related quality of hospital care. The objective of this study was to determine whether patient satisfaction is associated with adherence to practice guidelines and outcomes for acute myocardial infarction and to identify the key drivers of patient satisfaction.We examined clinical data on 6467 patients with acute myocardial infarction treated at 25 US hospitals participating in the CRUSADE initiative from 2001 to 2006. Press Ganey patient satisfaction surveys for cardiac admissions were also available from 3562 patients treated at these same 25 centers over this period. Patient satisfaction was positively correlated with 13 of 14 acute myocardial infarction performance measures. After controlling for a hospital's overall guideline adherence score, higher patient satisfaction scores were associated with lower risk-adjusted inpatient mortality (P=0.025). One-quartile changes in both patient satisfaction and guideline adherence scores produced similar changes in predicted survival. For example, a 1-quartile change (75th to 100th) in either the patient satisfaction score or the guideline adherence score yielded the same change in predicted survival (odds ratio, 1.24; 95% CI, 1.02 to 1.49; and odds ratio, 1.24; 95% CI, 1.08 to 1.41, respectively). Satisfaction with nursing care was the most important determinant of overall patient satisfaction (P<0.001).Higher patient satisfaction is associated with improved guideline adherence and lower inpatient mortality rates, suggesting that patients are good discriminators of the type of care they receive. Thus, patients' satisfaction with their care provides important incremental information on the quality of acute myocardial infarction care.

  View details for PubMedID 20179265

• Process of Care Performance Measures and Long-Term Outcomes in Patients Hospitalized With Heart Failure MEDICAL CARE Patterson, M. E., Hernandez, A. F., Hammill, B. G., Fonarow, G. C., Peterson, E. D., Schulman, K. A., Curtis, L. H. 2010; 48 (3): 210–16

  Abstract

  Recent efforts to improve care for patients hospitalized with heart failure have focused on process-based performance measures. Data supporting the link between current process measures and patient outcomes are sparse.To examine the relationship between adherence to hospital-level process measures and long-term patient-level mortality and readmission.Analysis of data from a national clinical registry linked to outcome data from the Centers for Medicare and Medicaid Services (CMS).A total of 22,750 Medicare fee-for-service beneficiaries enrolled in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure between March 2003 and December 2004.Mortality at 1 year; cardiovascular readmission at 1 year; and adherence to hospital-level process measures, including discharge instructions, assessment of left ventricular function, prescription of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker at discharge, prescription of beta-blockers at discharge, and smoking cessation counseling for eligible patients.Hospital conformity rates ranged from 52% to 86% across the 5 process measures. Unadjusted overall 1-year mortality and cardiovascular readmission rates were 33% and 40%, respectively. In covariate-adjusted analyses, the CMS composite score was not associated with 1-year mortality (hazard ratio, 1.00; 95% confidence interval, 0.98-1.03; P = 0.91) or readmission (hazard ratio, 1.01; 95% confidence interval, 0.99-1.04; P = 0.37). Current CMS process measures were not independently associated with mortality, though prescription of beta-blockers at discharge was independently associated with lower mortality (hazard ratio, 0.94; 95% confidence interval, 0.90-098; P = 0.004).Hospital process performance for heart failure as judged by current CMS measures is not associated with patient outcomes within 1 year of discharge, calling into question whether existing CMS metrics can accurately discriminate hospital quality of care for heart failure.

  View details for PubMedID 20125043

• Clopidogrel use and clinical events after drug-eluting stent implantation: Findings from the HealthCore Integrated Research Database AMERICAN HEART JOURNAL Petersen, J. L., Barron, J. J., Hammill, B. G., Cziraky, M. J., Anstrom, K. J., Wahl, P. M., Eisenstein, E. L., Krucoff, M. W., Califf, R. M., Schulman, K. A., Curtis, L. H. 2010; 159 (3): 462–U167

  Abstract

  Relationships between long-term use and level of dual antiplatelet therapy and outcomes after drug-eluting stent implantation are not well established.This is a retrospective cohort study of 9,256 patients receiving drug-eluting stents between January 2003 and August 2006. We classified patients according to tertiles of clopidogrel use during the 12 months after stent implantation. We used inverse probability weighting to account for differential selection into levels of clopidogrel use and logistic regression to estimate propensity scores for levels of clopidogrel use. We used Cox proportional hazards models to estimate effects of level of clopidogrel use on risk of bleeding events, death, and death or nonfatal myocardial infarction.There were 3,102 patients in the high-use group, 3,069 in the medium-use group, and 3,085 in the low-use group. Compared with the high-use group, risk of death or nonfatal myocardial infarction was greater in the medium-use group (hazard ratio [HR] 1.46, 95% CI 1.09-1.99, P = .01) and the low-use group (HR 1.59, 95% CI 1.18-2.14, P = .002). The risk of bleeding events was lower in the medium-use group (HR 0.84, 95% CI 0.71-0.98, P = .03) and the low-use group (HR 0.77, 95% CI 0.65-0.90, P = .002).Higher clopidogrel use 12 months after drug-eluting stent implantation was associated with a greater risk of subsequent bleeding events. Lower use was associated with a greater risk of death or nonfatal myocardial infarction.

  View details for PubMedID 20211310

• Patient Reactions to Confidentiality, Liability, and Financial Aspects of Informed Consent in Cardiology Research CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Fortune-Greeley, A. K., Hardy, N., Lin, L., Friedman, J. Y., Lawlor, J. S., Muhlbaier, L. H., Hall, M. A., Schulman, K. A., Sugarman, J., Weinfurt, K. P. 2010; 3 (2): 151–U90

  Abstract

  Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial.We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001).Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

  View details for PubMedID 20233979

• Relationships between emerging measures of heart failure processes of care and clinical outcomes AMERICAN HEART JOURNAL Hernandez, A. F., Hammill, B. G., Peterson, E. D., Yancy, C. W., Schulman, K. A., Curtis, L. H., Fonarow, G. C. 2010; 159 (3): 406–13

  Abstract

  Previous studies have not confirmed associations between some current performance measures for inpatient heart failure processes of care and postdischarge outcomes. It is unknown if alternative measures are associated with outcomes.Using data for 20,441 Medicare beneficiaries in OPTIMIZE-HF from March 2003 through December 2004, which we linked to Medicare claims data, we examined associations between hospital-level processes of care and patient outcomes. Performance measures included any beta-blocker for patients with left ventricular systolic dysfunction (LVSD); evidence-based beta-blocker for patients with LVSD; warfarin for patients with atrial fibrillation; aldosterone antagonist for patients with LVSD; implantable cardioverter-defibrillator for patients with ejection fraction < or =35%; and referral to disease management. Outcome measures were unadjusted and adjusted associations of each process measure with 60-day and 1-year mortality and cardiovascular readmission at the hospital level.Adjusted hazard ratios for 1-year mortality with a 10% increase in hospital- level adherence were 0.94 for any beta-blocker (95% CI, 0.90-0.98; P = .004), 0.95 for evidence-based beta-blocker (95% CI, 0.92-0.98; P = .004); 0.97 for warfarin (95% CI, 0.92-1.03; P = .33); 0.94 for aldosterone antagonists (95% CI, 0.91-0.98; P = .006); 0.92 for implantable cardioverter-defibrillator (95% CI, 0.87-0.98; P = .007); and 1.01 for referral to disease management (95% CI, 0.99-1.03; P = .21).Several evidence-based processes of care are associated with improved outcomes, can discriminate hospital-level quality of care, and could be considered as clinical performance measures.

  View details for PubMedID 20211302

• Increased rate of central venous catheterization procedures in community EDs AMERICAN JOURNAL OF EMERGENCY MEDICINE Glickman, S. W., Krubert, C., Koppenhaver, J., Glickman, L. T., Schulman, K. A., Cairns, C. B. 2010; 28 (2): 208–12

  Abstract

  Central venous catheterization (CVC) is integral to the emergency department (ED) treatment of critically ill patients, such as those receiving early goal-directed therapy for severe sepsis. No previous studies have described the overall use of CVC in community EDs. The objective of this study was to estimate the overall frequency and temporal trends in CVC use in a sample of patients visiting community EDs.This was a retrospective observational study of 2.97 million patient visits at 28 community EDs (range of annual visits, 10 837-110 136) from January 2004 to February 2008. Data were obtained from a community-based research consortium. Central venous catheterization procedures were aggregated at the hospital level for each study year. Trends in CVC use were evaluated using linear regression.Three thousand four hundred eighty-nine patient visits (0.12% of all ED patient visits) had a CVC procedure performed in the ED. The overall rate of CVC procedures per 1000 ED patient visits increased from 0.87 (95% confidence interval [CI(95%)], 0.80-0.95) in 2004 to 1.62 (CI(95%), 1.38-1.91) procedures in 2008 (P value for trend = .003). There was wide variability in the frequency of CVC procedures performed among EDs, ranging from a low of 0.27 (CI(95%), 0.18-0.42) to a high of 7.58 (CI(95%), 6.27-9.17) procedures per 1000 ED visits. The CVC procedure rates were lower in the 8 rural EDs (0.99 CVCs per 1000 ED patient visits [CI(95%), 0.91-1.07] compared with the 20 urban EDs (1.22 CVCs [CI(95%), 1.18-1.27]; P < .001). An increasing rate of CVC procedures during the study period was observed in urban EDs (0.84-1.94 CVCs per 1000 ED patient visits; P value for trend = .005) but not in rural EDs (1.1-0.93; P value for trend = .41) during the study period.The overall rate of CVC increased from 2004 to 2008. However, there was a wide variation among Eds, and the CVC rate was lower in rural compared with urban EDs. The increase in CVC use in urban EDs may reflect more intensive therapy in the management of ED patients with acute illness or injury. Future efforts are needed to optimize best practices for the use of CVC in community ED practices and to characterize factors responsible for urban rural differences in the rate of CVC procedures.

  View details for PubMedID 20159392

• Relationship Between Cardiac Rehabilitation and Long-Term Risks of Death and Myocardial Infarction Among Elderly Medicare Beneficiaries CIRCULATION Hammill, B. G., Curtis, L. H., Schulman, K. A., Whellan, D. J. 2010; 121 (1): 63–70

  Abstract

  For patients with coronary heart disease, exercise-based cardiac rehabilitation improves survival rate and has beneficial effects on risk factors for coronary artery disease. The relationship between the number of sessions attended and long-term outcomes is unknown.In a national 5% sample of Medicare beneficiaries, we identified 30 161 elderly patients who attended at least 1 cardiac rehabilitation session between January 1, 2000, and December 31, 2005. We used a Cox proportional hazards model to estimate the relationship between the number of sessions attended and death and myocardial infarction (MI) at 4 years. The cumulative number of sessions was a time-dependent covariate. After adjustment for demographic characteristics, comorbid conditions, and subsequent hospitalization, patients who attended 36 sessions had a 14% lower risk of death (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.77 to 0.97) and a 12% lower risk of MI (HR, 0.88; 95% CI, 0.83 to 0.93) than those who attended 24 sessions; a 22% lower risk of death (HR, 0.78; 95% CI, 0.71 to 0.87) and a 23% lower risk of MI (HR, 0.77; 95% CI, 0.69 to 0.87) than those who attended 12 sessions; and a 47% lower risk of death (HR, 0.53; 95% CI, 0.48 to 0.59) and a 31% lower risk of MI (HR, 0.69; 95% CI, 0.58 to 0.81) than those who attended 1 session.Among Medicare beneficiaries, a strong dose-response relationship existed between the number of cardiac rehabilitation sessions and long-term outcomes. Attending all 36 sessions reimbursed by Medicare was associated with lower risks of death and MI at 4 years compared with attending fewer sessions.

  View details for DOI 10.1161/CIRCULATIONAHA.109.876383

  View details for Web of Science ID 000273267700010

  View details for PubMedID 20026778

  View details for PubMedCentralID PMC2829871

• Clinical Effectiveness of Implantable Cardioverter-Defibrillators Among Medicare Beneficiaries With Heart Failure CIRCULATION-HEART FAILURE Hernandez, A. F., Fonarow, G. C., Hammill, B. G., Al-Khatib, S. M., Yancy, C. W., O'Connor, C. M., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2010; 3 (1): 7–13

  Abstract

  The clinical effectiveness of implantable cardioverter-defibrillators (ICDs) in older patients with heart failure has not been established, and older patients have been underrepresented in previous studies.We identified patients with heart failure who were aged 65 years or older and were eligible for an ICD, had left ventricular ejection fraction of 35% or less, and were discharged alive from hospitals participating in the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure and the Get With the Guidelines-Heart Failure quality-improvement programs during the period January 1, 2003, through December 31, 2006. We matched the patients to Medicare claims to examine long-term outcomes. The main outcome measure was all-cause mortality over 3 years. The study population included 4685 patients who were discharged alive and were eligible for an ICD. Mean age was 75.2 years, 60% of the patients were women, mean ejection fraction was 25%, and 376 (8.0%) patients received an ICD before discharge. Mortality was significantly lower among patients who received an ICD compared with those who did not (19.8% versus 27.6% at 1 year, 30.9% versus 41.9% at 2 years, and 38.1% versus 52.3% at 3 years; P<0.001 for all comparisons). The inverse probability-weighted adjusted hazard of mortality at 3 years for patients receiving an ICD was 0.71 (95% CI, 0.56 to 0.91).Medicare beneficiaries hospitalized with heart failure and left ventricular ejection fraction of 35% or less who were selected for ICD therapy had lower risk-adjusted long-term mortality compared with those who did not receive an ICD. Clinical Trial Registration- clinicaltrials.gov. Identifier: NCT00344513.

  View details for PubMedID 20009044

• Property, privacy and the pursuit of integrated medical records The Fragmentation of U.S. Health Care: Causes and Solutions. Hall, M. A., Schulman, K. A. Oxford University Press. 2010
• Costs of Inpatient Care Among Medicare Beneficiaries With Heart Failure, 2001 to 2004 CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Whellan, D. J., Greiner, M. A., Schulman, K. A., Curtis, L. H. 2010; 3 (1): 33–40

  Abstract

  Inpatient care is the primary driver of costs for patients with heart failure. It is unclear whether recent advances in heart failure care have reduced the costs to Medicare for the care of inpatients with heart failure.In a retrospective cohort study of 1 363 977 elderly Medicare beneficiaries hospitalized with heart failure between January 1, 2001, and December 31, 2004, we examined costs to Medicare for all inpatient care, inpatient cardiovascular care, and inpatient heart failure care and the adjusted relationships between patient characteristics and costs. Among 1 363 977 Medicare beneficiaries with an index heart failure hospitalization, 901 885 (66%) had a subsequent inpatient claim during the following year. Noncardiovascular costs accounted for 57% of total inpatient costs, and costs associated with heart failure hospitalizations accounted for 15% of total inpatient costs. No significant changes occurred in total, cardiovascular, and heart failure inpatient costs over time.The costs of inpatient care for patients with heart failure are high, but most subsequent inpatient costs are attributable to noncardiovascular and non-heart failure admissions. Further research is needed to identify predictors of costs, so that patients can be stratified according to risk, and to evaluate strategies that target primary cost drivers for patients with heart failure.

  View details for PubMedID 20123669

• Addressing the systems-based practice requirement with health policy content and educational technology MEDICAL TEACHER Nagler, A., Andolsek, K., Dossary, K., Schlueter, J., Schulman, K. 2010; 32 (12): E559–E565

  Abstract

  Duke University Hospital Office of Graduate Medical Education and Duke University's Fuqua School of Business collaborated to offer a Health Policy lecture series to residents and fellows across the institution, addressing the "Systems-based Practice" competency.During the first year, content was offered in two formats: live lecture and web/podcast. Participants could elect the modality which was most convenient for them. In Year Two, the format was changed so that all content was web/podcast and a quarterly live panel discussion was led by module presenters or content experts. Lecture evaluations, qualitative focus group feedback, and post-test data were analyzed.A total of 77 residents and fellows from 8 (of 12) Duke Graduate Medical Education departments participated. In the first year, post-test results were the same for those who attended the live lectures and those who participated via web/podcast. A greater number of individuals participated in Year Two. Participants from both years expressed the need for health policy content in their training programs. Participants in both years valued a hybrid format for content delivery, recognizing a desire for live interaction with the convenience of accessing web/podcasts at times and locations convenient for them. A positive unintended consequence of the project was participant networking with residents and fellows from other specialties.

  View details for PubMedID 21090944

• Economic Content in Medical Journal Advertisements for Medical Devices and Prescription Drugs PHARMACOECONOMICS Ackerly, D., Glickman, S. W., Schulman, K. A. 2010; 28 (5): 429–38

  Abstract

  Previous studies of economic content in medical journal advertisements have not examined all types of economic content and have not included advertisements for medical devices. To examine trends in the economic content of medical device and pharmaceutical advertisements in medical journals. Three reviewers examined pharmaceutical and medical device advertisements in six leading medical journals from 1997 through 2006. Product characteristics, economic claims and evidence to support those claims were evaluated. Economic content appeared in 23.5% (561/2389) of pharmaceutical and device advertisements; 11.9% made market share claims and 12.7% made other economic claims. From 1997 through 2006, the percentage of medical device advertisements containing economic content declined from 26.7% to 6.7% (p = 0.02), whereas the percentage of pharmaceutical advertisements containing economic content remained stable (21.6-22.0%; p = 0.99). For pharmaceuticals, price claims declined significantly (15.7-4.2%; p < 0.01) and market share claims increased (2.8-11.5%; p = 0.09), and both consistently presented evidence (83% and 98%, respectively) while other types did not (e.g. 13.5% of formulary claims). Medical device economic claims differed from pharmaceutical economic claims; they made fewer market share claims (1.1% vs 12.8%) but more cost-effectiveness (6.5% vs 0.6%) and reimbursement (4.9% vs 0.8%) claims. Fewer than 2% of device advertisements with economic claims provided supporting evidence. The prevalence and type of economic content in pharmaceutical and device advertisements changed between 1997 and 2006, which may reflect evolving market dynamics, such as changes in reimbursement systems. Furthermore, the lack of supporting evidence in medical device advertisements and pharmaceutical formulary claims are potential areas of concern that require additional scrutiny by regulators and journal editors.

  View details for PubMedID 20402543

• Resource use and costs of branch and central retinal vein occlusion in the elderly CURRENT MEDICAL RESEARCH AND OPINION Fekrat, S., Shea, A. M., Hammill, B. G., Nguyen, H., Kowalski, J. W., Schulman, K. A., Curtis, L. H. 2010; 26 (1): 223–30

  Abstract

  To examine the incidence, prevalence, resource use, and costs associated with branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) in elderly patients.In a retrospective cohort study of a nationally representative sample of Medicare beneficiaries from 2001 through 2006, the authors identified patients with BRVO (n = 10,682) and CRVO (n = 6236) and controls with hypertension (n = 49,524) and glaucoma (n = 49,569) but no retinal vein occlusion. Incident cases were those with no claims listing a diagnosis for the same type of retinal vein occlusion in the previous 12 months. Prevalence was defined as the number of beneficiaries with a diagnosis of BRVO or CRVO. The authors summed Medicare reimbursements for all claims and used generalized linear models to estimate the effects of BRVO and CRVO on 1-year and 3-year costs compared with hypertension and glaucoma control groups. The authors also examined trends in the use of diagnostic and treatment modalities.Resource use (fluorescein angiography, optical coherence tomography, intravitreal injection, laser photocoagulation, and vitrectomy) and direct medical costs (total Medicare reimbursement amounts as recorded on each inpatient, outpatient, home health, skilled nursing, hospice, durable medical equipment, and professional service claim) at 1 year and 3 years.After adjustment for baseline characteristics, BRVO was associated with 16% higher 1-year costs and 12% higher 3-year costs compared with hypertension and 18% higher 1-year costs and 13% higher 3-year costs compared with glaucoma. CRVO was associated with 22% higher 1-year costs and 15% higher 3-year costs compared with hypertension and 24% higher 1-year costs and 16% higher 3-year costs compared with glaucoma. Use of fluorescein angiography and optical coherence tomography increased during the study. Use of intravitreal injections increased from less than 1% of patients overall to greater than 13% for BRVO and 16% for CRVO. The incidence of BRVO declined slightly during the study period, whereas the incidence of CRVO remained relatively flat. Prevalence increased in both groups.The results may not be generalizable to younger patients or managed-care beneficiaries. The study included only direct costs to Medicare, not nonmedical expenditures or outpatient prescription medications. Diagnosis and procedure codes may not have been complete. The study could not account for clinical variables, such as the amount of vision loss. It was not feasible to adjust for whether one or both eyes were affected or treated.Although not common in the Medicare population, BRVO and CRVO are important independent predictors of total medical costs. Diagnostic and treatment modalities have changed over time.

  View details for PubMedID 19921963

• Resource use and costs of treatment with anticoagulation and antiplatelet agents: results of the WATCH trial economic evaluation. Journal of cardiac failure Patterson, M. E., Grant, W. C., Glickman, S. W., Massie, B. M., Ammon, S. E., Armstrong, P. W., Cleland, J. G., Collins, J. F., Teo, K. K., Schulman, K. A., Reed, S. D. 2009; 15 (10): 819–27

  Abstract

  BACKGROUND: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial revealed no significant differences among 1587 symptomatic heart failure patients randomized to warfarin, clopidogrel, or aspirin in time to all-cause death, nonfatal myocardial infarction, or nonfatal stroke. We compared within-trial medical resource use and costs between treatments.METHODS AND RESULTS: We assigned country-specific costs to medical resources incurred during follow-up. Annualized rates of hospitalizations, inpatient and outpatient procedures, and emergency department visits did not differ significantly between groups. Annualized total costs averaged $5901 (95% confidence interval [CI], $4776-$7520) for the aspirin group, $5646 (95% CI, $4903-$6584) for the clopidogrel group, and $5830 (95% CI, $4838-$7400) for the warfarin group.CONCLUSIONS: Consistent with clinical findings, our analyses did not identify significant cost differences between treatments.

  View details for PubMedID 19944357

• Response to Letter Regarding Article, "Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure: The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial" CIRCULATION Massie, B. M., Ammon, S. E., Collins, J. F., Krol, W. F., Armstrong, P. W., Cleland, J. F., Ezekowitz, M., Jafri, S. M., O'Connor, C. M., Schulman, K. A., Teo, K., Warren, S. 2009; 120 (20): E165

  View details for DOI 10.1161/CIRCULATIONAHA.109.884650

  View details for Web of Science ID 000271860500016

• Outcomes of inpatients with and without sickle cell disease after high-volume surgical procedures AMERICAN JOURNAL OF HEMATOLOGY Dinan, M. A., Chou, C., Hammill, B. G., Graham, F. L., Schulman, K. A., Telen, M. J., Reed, S. D. 2009; 84 (11): 703–9

  Abstract

  In this study, we examined differences in inpatient costs, length of stay, and in-hospital mortality between hospitalizations for patients with and without sickle cell disease (SCD) undergoing high-volume surgical procedures. We used Clinical Classification Software (CCS) codes to identify discharges in the 2002-2005 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project for patients who had undergone either cholecystectomy or hip replacement. We limited the non-SCD cohort to hospitals where patients with SCD had undergone the same procedure. We compared inpatient outcomes using summary statistics and generalized linear regression analysis to adjust for patient, hospital, and procedural characteristics. Overall, the median age of surgical patients with SCD was more than three decades less than the median age of patients without SCD undergoing the same procedure. In recognition of the age disparity, we limited the analyses to patients aged 18 to 64 years. Nonetheless, patients with SCD undergoing cholecystectomy or hip replacement were 12.1 and 14.4 years younger, had inpatient stays that were 73% and 82% longer, and incurred costs that were 46% and 40% higher per discharge than patients without SCD, respectively. Inpatient mortality for these procedures was low, approximately 0.6% for cholecystectomy and 0.2% for hip replacement and did not differ significantly between patients with and without SCD. Multivariable regression analyses revealed that higher inpatient costs among patients with SCD were primarily attributable to longer hospital stays. Patients with SCD who underwent cholecystectomy or hip replacement required more health care resources than patients without SCD. Am. J. Hematol. 2009. (c) 2009 Wiley-Liss, Inc.

  View details for PubMedID 19787790

• Understanding heart failure through the HF-ACTION baseline characteristics AMERICAN HEART JOURNAL O'Connor, C. M., Whellan, D. J., HF-ACTION Investigators 2009; 158 (4): S1–S5

  View details for DOI 10.1016/j.ahj.2009.07.013

  View details for Web of Science ID 000270705800001

  View details for PubMedID 19782783

• New York Heart Association functional class predicts exercise parameters in the current era AMERICAN HEART JOURNAL Russell, S. D., Saval, M. A., Robbins, J. L., Ellestad, M. H., Gottlieb, S. S., Handberg, E. M., Zhou, Y., Chandler, B., HF-ACTION Investigators 2009; 158 (4): S24–S30

  Abstract

  The New York Heart Association (NYHA) functional class is a subjective estimate of a patient's functional ability based on symptoms that do not always correlate with the objective estimate of functional capacity, peak oxygen consumption (peak V(O2)). In addition, relationships between these 2 measurements have not been examined in the current medical era when patients are using beta-blockers, aldosterone antagonists, and cardiac resynchronization therapy (CRT). Using baseline data from the HF-ACTION (Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing) study, we examined this relationship.One thousand seven hundred fifty-eight patients underwent a symptom-limited metabolic stress test and stopped exercise due to dyspnea or fatigue. The relationship between NYHA functional class and peak V(O2) was examined. In addition, the effects of beta-blockers, aldosterone antagonists, and CRT therapy on these relationships were compared.The NYHA II patients have a significantly higher peak Vo(2) (16.1 +/- 4.6 vs 13.0 +/- 4.2 mL/kg per minute), a lower ventilation (Ve)/V(CO2) slope (32.8 +/- 7.7 vs 36.8 +/- 10.4), and a longer duration of exercise (11.0 +/- 3.9 vs 8.0 +/- 3.4 minutes) than NYHA III/IV patients. Within each functional class, there was no difference in any of the exercise parameters between patients on or off of beta-blockers, aldosterone antagonists, or CRT therapy. Finally, with increasing age, a significant difference in peak Vo(2), Ve/V(CO2) slope, and exercise time was found.For patients being treated with current medical therapy, there still is a difference in true functional capacity between NYHA functional class II and III/IV patients. However, within each NYHA functional class, the presence or absence or contemporary heart failure therapies does not alter exercise parameters.

  View details for DOI 10.1016/j.ahj.2009.07.017

  View details for Web of Science ID 000270705800004

  View details for PubMedID 19782785

  View details for PubMedCentralID PMC2762947

• Alternative Pay-for-Performance Scoring Methods Implications for Quality Improvement and Patient Outcomes MEDICAL CARE Glickman, S. W., Boulding, W., Roos, J. T., Staelin, R., Peterson, E. D., Schulman, K. A. 2009; 47 (10): 1062–68

  Abstract

  Pay-for-performance programs typically rate hospitals using a composite summary score in which process measures are weighted by the total number of treatment opportunities. Alternative methods that weight process measures according to how hospitals organize care and the range for possible improvement may be more closely related to patient outcomes.To develop a hospital-level summary process measure adherence score that reflects how hospitals organize cardiac care and the range for possible improvement; and to compare associations of hospital adherence to this score and adherence to a composite score based on the Centers for Medicare and Medicaid Services scoring system with inpatient mortality.Hospital-level analysis of 7 process measures for acute myocardial infarction (AMI) and 4 process measures for heart failure at 4226 hospitals, and inpatient mortality after AMI at 1351 hospitals in the United States. Data are from the Hospital Compare and Joint Commission Core Measures databases for October 2004 through September 2006.Associations between composite scores based on Centers for Medicare and Medicaid Services methodology and alternative adherence scores with inpatient survival after AMI.In principal components analysis, hospital cardiac care varied between hospitals largely along the lines of "clinical" (ie, pharmacologic interventions) and "administrative" (ie, patient instructions or counseling) activities. A scoring system reflecting this organization was strongly associated with inpatient survival and fit the mortality data better than the composite score. Higher administrative activities scores, holding the clinical activities score fixed, were associated with lower survival.In-hospital cardiac care is organized by clinical and administrative processes of care. Pay-for-performance schemes that incentivize hospitals to focus on administrative process measures may be associated with decreased adherence to clinical processes. A pay-for-performance scheme that acknowledges these factors may be associated with improved inpatient mortality.

  View details for PubMedID 19648833

• Myocardial perfusion, function, and dyssynchrony in patients with heart failure: Baseline results from the single-photon emission computed tomography imaging ancillary study of the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) Trial AMERICAN HEART JOURNAL Atchley, A. E., Kitzman, D. W., Whellan, D. J., Iskandrian, A. E., Ellis, S. J., Pagnanelli, R. A., Kao, A., Abdul-Nour, K., O'Connor, C. M., Ewald, G., Kraus, W. E., Borges-Neto, S., HF-ACTION Investigators 2009; 158 (4): S53–S63

  Abstract

  There are currently limited data on the relationships between resting perfusion abnormalities, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class, and exercise capacity as defined by peak VO(2) and 6-minute walk test in patients with heart failure (HF) and reduced LVEF. Furthermore, the association between resting perfusion abnormalities and left ventricular dyssynchrony is currently unknown. This article addresses the Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION) gated SPECT imaging (gSPECT) substudy baseline results.HF-ACTION was a multicenter, randomized controlled trial of aerobic exercise training versus usual care in 2,331 stable patients with LVEF of < or = 35% and NYHA class II to IV HF symptoms treated with optimal medical therapy. Subjects enrolled in the HF-ACTION substudy underwent resting Tc-99m tetrofosmin gSPECT at baseline (n = 240). Images were evaluated for extent and severity of perfusion abnormalities using a 17-segment and a 5-degree gradation severity score (summed rest score [SRS]). Left ventricular function and dyssynchrony were assessed using validated available commercial software.The average age of patients enrolled was 59, 69% were male, 63% were white, and 33% were African American. Of the 240 participants, 129 (54%) were ischemic and 111 (46%) were nonischemic in etiology. The median LVEF by gSPECT for the entire cohort was 26%. Among the nuclear variables, there was a modest correlation between LVEF and SRS (r = -0.31, P < .0001) and there were stronger correlations between phase SD and SRS (r = 0.66, P < .0001) as well as phase SD and LVEF (r = -0.50, P < .0001). Patients with NYHA class III symptoms had more severe and significant degrees of dyssynchrony (median phase SD 54 degrees ) than those with NYHA class II symptoms (median phase SD 39 degrees, P = .001). Patients with an ischemic etiology had a higher SRS (P < .0001) and significantly more dyssynchrony (P < .0001) than those who were nonischemic. However, there was no difference in LVEF or objective measures of exercise capacity between these groups. With respect to peak VO(2), there was a weak correlation with LVEF (r = 0.18, P = .006) and no correlation with SRS (r = -0.04, P = 0.59) or with dyssynchrony (r = -0.13, P = .09). A weak but statistically significant correlation between SRS and 6-minute walk was observed (r = -0.15, P = .047).Gated SPECT imaging can provide important information in patients with HF due to severe LV dysfunction including quantitative measures of global systolic function, perfusion, and dyssynchrony. These measurements are modestly but significantly related to symptom severity and objective measures of exercise capacity.

  View details for DOI 10.1016/j.ahj.2009.07.009

  View details for Web of Science ID 000270705800008

  View details for PubMedID 19782789

  View details for PubMedCentralID PMC2908486

• N-terminal pro-brain natriuretic peptide and exercise capacity in chronic heart failure: Data from the Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) study AMERICAN HEART JOURNAL Felker, G., Whellan, D., Kraus, W. E., Clare, R., Zannad, F., Donahue, M., Adams, K., McKelvie, R., Pina, I. L., O'Connor, C. M., HF-ACTION Investigators 2009; 158 (4): S37–S44

  Abstract

  To examine the relationship between N-terminal pro-brain natriuretic peptide (NT-proBNP) and exercise capacity in a large contemporary cohort of patients with chronic heart failure.Natriuretic peptides such as NT-proBNP are important biomarkers in heart failure. The relationship between NT-proBNP and exercise capacity has not been well studied.We analyzed the relationship between baseline NT-proBNP and peak oxygen uptake (peak VO(2)) or distance in the 6-minute walk test in 1383 subjects enrolled in the HF-ACTION study. Linear regression models were used to analyze the relationship between NT-proBNP and peak Vo(2) or distance in the 6-minute walk test in the context of other clinical variables. Receiver operator curve analysis was used to evaluate the ability of NT-proBNP to accurately predict a peak VO(2) <12 mL/kg per minute.NT-proBNP was the most powerful predictor of peak VO(2) (partial R(2) = 0.13, P < .0001) of 35 candidate variables. Although NT-proBNP was also a predictor of distance in the 6-minute walk test, this relationship was weaker than that for peak VO(2) (partial R(2) = 0.02, P < .0001). For both peak VO(2) and distance in the 6-minute walk test, much of the variability in exercise capacity remained unexplained by the variables tested. Receiver operator curve analysis suggested NT-proBNP had moderate ability to identify patients with peak VO(2) <12 mL/kg per minute (c-index, 0.69).In this analysis of baseline data from HF-ACTION, NT-proBNP was the strongest predictor of peak VO(2) and a significant predictor of distance in the 6-minute walk test. Despite these associations, NT-proBNP demonstrated only modest performance in identifying patients with a low peak VO(2) who might be considered for cardiac transplantation. These data suggest that, although hemodynamic factors are important determinants of exercise capacity, much of the variability in exercise performance in heart failure remains unexplained by traditional clinical and demographic variables.

  View details for DOI 10.1016/j.ahj.2009.07.011

  View details for Web of Science ID 000270705800006

  View details for PubMedID 19782787

  View details for PubMedCentralID PMC3748954

• Relationship of Doppler-Echocardiographic left ventricular diastolic function to exercise performance in systolic heart failure: The HF-ACTION study AMERICAN HEART JOURNAL Gardin, J. M., Leifer, E. S., Fleg, J. L., Whellan, D., Kokkinos, P., LeBlanc, M., Wolfel, E., Kitzman, D. W., HF-ACTION Investigators 2009; 158 (4): S45–S52

  Abstract

  Patients with systolic heart failure often have concomitant left ventricular (LV) diastolic dysfunction. Although in animal models diastolic dysfunction is associated with worsening exercise capacity and prognosis, information regarding these relationships in patients with established systolic heart failure (HF) is sparse.HF-ACTION was a large, multicenter National Institutes of Health-funded trial of exercise training in systolic HF (LV ejection fraction [LVEF] < or = 35%) and included detailed Doppler-echocardiographic (echo) and cardiopulmonary exercise testing at baseline. We tested the hypothesis that echo measures of LV diastolic function predict key cardiopulmonary exercise outcomes, including aerobic exercise capacity (peak exercise oxygen consumption, VO(2)), distance in the 6-minute walk test (6MWD), and ventilatory efficiency (VE/VCO(2) slope) in patients with systolic HF.Overall, 2,331 patients (28% women, median age 59 years, median LVEF 25%) were enrolled. There were significant bivariate correlations between echo diastolic function variables and peak VO(2) (inverse) and VE/VCO(2) slope (direct) that were strongest for ratio of early diastolic peak transmitral (MV) to myocardial tissue velocity (E/E'), peak MV early-to-late diastolic velocity ratio (E/A), and left atrial dimension (range of absolute r = 0.16-0.28). Both MV E/A and E/E' were more strongly related to all 3 exercise variables than was LVEF. The relationships of E/A and E/E' with 6MWD were weaker than with peak VO(2) or VE/VCO(2) slope. A multivariable model with peak VO(2) as the dependent variable, which included MV E/A and 9 demographic predictors including age, sex, race, body mass index, and New York Heart Association class, explained 40% of the variation in peak VO(2), with MV E/A explaining 6% of the variation. Including LVEF in the model explained less than an additional 1% of the variance in peak VO(2). In a multivariable model for VE/VCO(2) slope, MV E/A was the strongest independent echo predictor, explaining 10% of the variance. The relationship of LV diastolic function variables with 6MWD was weaker than with peak VO(2) or VE/VCO(2) slope.In patients with systolic HF, LV early diastolic function is a modest independent predictor of aerobic exercise capacity and appears to be a better predictor than LVEF.

  View details for DOI 10.1016/j.ahj.2009.07.015

  View details for Web of Science ID 000270705800007

  View details for PubMedID 19782788

  View details for PubMedCentralID PMC2950162

• Outcomes, health policy, and managed care: Relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure AMERICAN HEART JOURNAL Flynn, K. E., Lin, L., Ellis, S. J., Russell, S. D., Spertus, J. A., Whellan, D. J., Pina, I. L., Fine, L. J., Schulman, K. A., Weinfurt, K. P., HF-ACTION Investigators 2009; 158 (4): S64–S71

  Abstract

  Patient-reported outcomes are increasingly used to assess the efficacy of new treatments. Understanding relationships between these and clinical measures can facilitate their interpretation. We examined associations between patient-reported measures of health-related quality of life and clinical indicators of disease severity in a large, heterogeneous sample of patients with heart failure.Patient-reported measures, including the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the EuroQol Visual Analog Scale (VAS), and clinical measures, including peak VO(2), 6-minute walk distance, and New York Heart Association (NYHA) class, were assessed at baseline in 2331 patients with heart failure. We used general linear models to regress patient-reported measures on each clinical measure. Final models included for significant sociodemographic variables and 2-way interactions.The KCCQ was correlated with peak VO(2) (r = .21) and 6-minute walk distance (r = .27). The VAS was correlated with peak VO(2) (r = .09) and 6-minute walk distance (r = .11). Using the KCCQ as the response variable, a 1-SD difference in peak Vo(2) (4.7 mL/kg/min) was associated with a 2.86-point difference in the VAS (95% CI, 1.98-3.74) and a 4.75-point difference in the KCCQ (95% CI, 3.78-5.72). A 1-SD difference in 6-minute walk distance (105 m) was associated with a 2.78-point difference in the VAS (95% CI, 1.92-3.64) and a 5.92-point difference in the KCCQ (95% CI, 4.98-6.87); NYHA class III was associated with an 8.26-point lower VAS (95% CI, 6.59-9.93) and a 12.73-point lower KCCQ (95% CI, 10.92-14.53) than NYHA class II.These data may inform deliberations about how to best measure benefits of heart failure interventions, and they generally support the practice of considering a 5-point difference on the KCCQ and a 3-point difference on the VAS to be clinically meaningful.

  View details for PubMedID 19782791

  View details for PubMedCentralID PMC2805910

• Baseline differences in the HF-ACTION trial by sex AMERICAN HEART JOURNAL Pina, I. L., Kokkinos, P., Kao, A., Bittner, V., Saval, M., Clare, B., Goldberg, L., Johnson, M., Swank, A., Ventura, H., Moe, G., Fitz-Gerald, M., Ellis, S. J., Vest, M., Cooper, L., Whellan, D., HF-ACTION Investigators 2009; 158 (4): S16–S23

  Abstract

  In patients with heart failure (HF), assessment of functional capacity plays an important prognostic role. Both 6-minute walk and cardiopulmonary exercise testing have been used to determine physical function and to determine prognosis and even listing for transplantation. However, as in HF trials, the number of women reported has been small, and the cutoffs for transplantation have been representative of male populations and extrapolated to women. It is also well known that peak VO(2) as a determinant of fitness is inherently lower in women than in men and potentially much lower in the presence of HF. Values for a female population from which to draw for this important determination are lacking.The HF-ACTION trial randomized 2,331 patients (28% women) with New York Heart Association class II-IV HF due to systolic dysfunction to either a formal exercise program in addition to optimal medical therapy or to optimal medical therapy alone without any formal exercise training. To characterize differences between men and women in the interpretation of final cardiopulmonary exercise testing models, the interaction of individual covariates with sex was investigated in the models of (1) VE/VCO(2), (2) VO(2) at ventilatory threshold (VT), (3) distance on the 6-minute walk, and (4) peak VO(2).The women were younger than the men and more likely to have a nonischemic etiology and a higher ejection fraction. Dose of angiotensin converting enzyme inhibitor (ACEI) was lower in the women, on average. The lower ACEI dose may reflect the higher use of angiotensin II receptor blocker (ARB) in women. Both the peak VO(2) and the 6-minute walk distance were significantly lower in the women than in the men. Perhaps the most significant finding in this dataset of baseline characteristics is that the peak VO(2) for women was significantly lower than that for men with similar ventricular function and health status.Therefore, in a well-medicated, stable, class II-IV HF cohort of patients who are able to exercise, women have statistically significantly lower peak VO(2) and 6-minute walk distance than men with similar health status and ventricular function. These data should prompt careful thought when considering prognostic markers for women and listing for cardiac transplant.

  View details for DOI 10.1016/j.ahj.2009.07.012

  View details for Web of Science ID 000270705800003

  View details for PubMedID 19782784

  View details for PubMedCentralID PMC3748941

• Relationship of age and exercise performance in patients with heart failure: The HF-ACTION study AMERICAN HEART JOURNAL Forman, D. E., Clare, R., Kitzman, D. W., Ellis, S. J., Fleg, J. L., Chiara, T., Fletcher, G., Kraus, W. E., HF-ACTION Investigators 2009; 158 (4): S6–S15

  Abstract

  More than three fourths of patients with heart failure (HF) are 65 years and older, and older age is associated with worse symptoms and prognoses than is younger age. Reduced exercise capacity is a chief HF complaint and indicates poorer prognosis, especially among elderly persons, but the mechanisms underlying functional decline in older patients with HF are largely unknown.Baseline cardiopulmonary exercise testing data from the HF-ACTION trial were assessed to clarify age effects on peak oxygen consumption (VO(2)) and ventilation-carbon dioxide production (VE/VCO(2)) slope.Among 2,331 New York Heart Association class II-IV patients with HF, increased age corresponded to decreased peak VO(2) (-0.14 mL kg(-1) min(-1) per year >40 years; P < .0001) and increased VE/VCO(2) slope (0.30 U/y >70 years; P < .0001). In a multivariable model with 34 other potential determinants, age was the strongest independent predictor of peak VO(2) (partial R(2) 0.130, total R(2) 0.392; P < .001) and a significant but relatively weaker predictor of VE/VCO(2) slope (partial R(2) 0.037, total R(2) 0.199; P < .001). Blunted peak heart rate was also a strong predictor of peak VO(2). Although peak heart rate and age were strongly correlated, both were significant independent predictors of peak VO(2) when analyzed simultaneously in a model. Aggregate comorbidity increased significantly with age but did not account for age effects on peak VO(2).Age is the strongest predictor of peak VO(2) and a significant predictor of VE/VCO(2) slope in the HF-ACTION population. Age-dependent comorbidities do not explain changes in peak VO(2). Age-related changes in cardiovascular physiology, potentially magnified by the HF disease state, should be considered a contributor to the pathophysiology and a target for more effective therapy in older patients with HF.

  View details for DOI 10.1016/j.ahj.2009.07.018

  View details for Web of Science ID 000270705800002

  View details for PubMedID 19782790

  View details for PubMedCentralID PMC2762946

• Safety of symptom-limited cardiopulmonary exercise testing in patients with chronic heart failure due to severe left ventricular systolic dysfunction AMERICAN HEART JOURNAL Keteyian, S. J., Isaac, D., Thadani, U., Roy, B. A., Bensimhon, D. R., McKelvie, R., Russell, S. D., Hellkamp, A. S., Kraus, W. E., HF-ACTION Investigators 2009; 158 (4): S72–S77

  Abstract

  To assess the safety of symptom-limited exercise testing in patients with New York Heart Association class II-IV heart failure symptoms due to left ventricular systolic dysfunction, we investigated the frequency of all-cause fatal and nonfatal major cardiovascular (CV) events among subjects enrolled in a prospective clinical trial (HF-ACTION). We hypothesized that exercise testing would be safe, as defined by a rate for all-cause death of <0.1 per 1,000 tests and a rate of nonfatal CV events <1.0 per 1,000 tests.Before enrollment and at 3, 12, and 24 months after randomization, subjects were scheduled to complete a symptom-limited graded exercise test with open-circuit spirometry for analysis of expired gases. To ensure the accurate reporting of exercise test-related events, we report deaths and nonfatal major CV events per 1,000 tests at months 3, 12, or 24 after randomization.A total of 2,331 subjects were randomized into HF-ACTION. After randomization, 2,037 subjects completed 4,411 exercise tests. There were no test-related deaths, exacerbation of heart failure or angina requiring hospitalization, myocardial infarctions, strokes, or transient ischemic attacks. There was one episode each of ventricular fibrillation and sustained ventricular tachycardia. There were no exercise test-related implantable cardioverter defibrillator discharges requiring hospitalization. These findings correspond to zero deaths per 1,000 exercise tests and 0.45 nonfatal major CV events per 1,000 exercise tests (95% CI 0.11-1.81).In New York Heart Association class II-IV patients with severe left ventricular systolic dysfunction, we observed that symptom-limited exercise testing is safe based on no deaths and a rate of nonfatal major CV events that is <0.5 per 1,000 tests.

  View details for DOI 10.1016/j.ahj.2009.07.014

  View details for Web of Science ID 000270705800010

  View details for PubMedID 19782792

  View details for PubMedCentralID PMC2762951

• Disclosure of Financial Relationships to Participants in Clinical Research. NEW ENGLAND JOURNAL OF MEDICINE Weinfurt, K. P., Hall, M. A., King, N. P., Friedman, J. Y., Schulman, K. A., Sugarman, J. 2009; 361 (9): 916–21

  View details for PubMedID 19710491

• Effect of Cardiac Rehabilitation Visits on Mortality among Elderly Medicare Beneficiaries with Heart Failure Whellan, D. J., Hammill, B. G., Schulman, K. A., Curtis, L. H. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2009: S99

  View details for DOI 10.1016/j.cardfail.2009.06.115

  View details for Web of Science ID 000268897500328

• Personalized medicine and disruptive innovation: Implications for technology assessment GENETICS IN MEDICINE Schulman, K. A., Vidal, A., Ackerly, D. 2009; 11 (8): 577–81

  View details for DOI 10.1097/GIM.0b013e3181ae0935

  View details for Web of Science ID 000269273900005

  View details for PubMedID 19606052

• External Validity of the Cardiovascular Health Study A Comparison With the Medicare Population MEDICAL CARE DiMartino, L. D., Hammill, B. G., Curtis, L. H., Gottdiener, J. S., Manolio, T. A., Powe, N. R., Schulman, K. A. 2009; 47 (8): 916–23

  Abstract

  The Cardiovascular Health Study (CHS), a population-based prospective cohort study, has been used to identify major risk factors associated with cardiovascular disease and stroke in the elderly.To assess the external validity of the CHS.Comparison of the CHS cohort to a national cohort of Medicare beneficiaries and to Medicare beneficiaries residing in the CHS geographic regions.CHS participants and a 5% sample of Medicare beneficiaries.Demographic and administrative characteristics, comorbid conditions, resource use, and mortality.Compared with both Medicare cohorts, the CHS cohort was older and included more men and African American participants. CHS participants were more likely to be enrolled in Medicare managed care than beneficiaries in the national Medicare cohort. Compared with the Medicare cohorts, mortality in the CHS was more than 40% lower at 1 year, approximately 25% lower at 5 years, and approximately 15% lower at 10 years. There were minimal differences in comorbid conditions and health care resource use.The CHS cohort is comparable with the Medicare population, particularly with regard to comorbid conditions and resource use, but had lower mortality. The difference in mortality may reflect the CHS recruitment strategy or volunteer bias. These findings suggest it may not be appropriate to project absolute rates of disease and outcomes based on CHS data to the entire Medicare population. However, there is no reason to expect that the relative risks associated with physiologic processes identified by CHS data would differ for nonparticipants.

  View details for PubMedID 19597373

• Pattern and Predictors of the Initiation of Biologic Agents for the Treatment of Rheumatoid Arthritis in the United States: An Analysis Using a Large Observational Data Bank CLINICAL THERAPEUTICS DeWitt, E., Lin, L., Glick, H. A., Anstrom, K. J., Schulman, K. A., Reed, S. D. 2009; 31 (8): 1871–80

  Abstract

  The aim of this study was to identify factors associated with the initiation of biologic agents for the treatment of rheumatoid arthritis (RA) in a large US observational cohort.Semiannual patient-reported data in the ARAMIS (Arthritis, Rheumatism and Aging Medical Information System) data bank from January 1998 to January 2006 were analyzed retrospectively using pooled logistic regression (with adjustment for center-level and temporal effects) to identify patient-, disease-, and treatment-related characteristics associated with the initiation of biologics for the treatment of RA.The analysis included 1545 patients from 7 US centers. By 2006, 41.4% of 679 patients remaining in the sample had received biologics. Initiation of biologics was significantly associated with greater disability in the previous 6-month period (per 1-unit increase in Health Assessment Questionnaire score: odds ratio [OR] = 1.45; 95% CI, 1.22-1.72; P < 0.01) and treatment in the previous period with steroids (OR = 2.24; 95% CI, 1.76-2.85; P < 0.01) or nonbiologic disease-modifying antirheumatic drugs (OR = 2.43; 95% CI, 1.71-3.46; P < 0.01). Two sociodemographic factors were significant predictors of decreased use of biologics: older age (per 10 years: OR = 0.74; 95% CI, 0.660.82; P < 0.01) and lower annual income (per $10,000 reduction: OR = 0.95; 95% CI, 0.91-1.00; P = 0.04). There were no significant differences with respect to sex, race, employment status, comorbidity, previous NSAID use, or treatment center.Disease- and treatment-related factors were significant predictors of the initiation of biologics for RA. Independent of these factors, however, biologics were less often used in patients who were older and those with lower incomes. Use of biologics increased steadily over the period studied.

  View details for PubMedID 19808146

  View details for PubMedCentralID PMC3518838

• Cost of Exercise Training and Its Impact on Medical Resource Use and Costs: Results of HF-ACTION Reed, S. D., Whellan, D. J., Li, Y., Friedman, J. Y., Pina, I. L., Settles, S. J., Davidson-Ray, L., Johnson, J., Cooper, L. S., O'Connor, C. M., Schulman, K. A. CHURCHILL LIVINGSTONE INC MEDICAL PUBLISHERS. 2009: S93

  View details for DOI 10.1016/j.cardfail.2009.06.092

  View details for Web of Science ID 000268897500305

• Cost Utility of Sequential Adjuvant Trastuzumab for HER2/Neu-Positive Breast Cancer VALUE IN HEALTH Reed, S. D., Schulman, K. A. 2009; 12 (5): 637–40

  View details for PubMedID 19473336

• Ethical and Scientific Implications of the Globalization of Clinical Research REPLY NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., Cairns, C. B., Schulman, K. A. 2009; 360 (26): 2793

  View details for Web of Science ID 000267286600031

• Linking inpatient clinical registry data to Medicare claims data using indirect identifiers AMERICAN HEART JOURNAL Hammill, B. G., Hernandez, A. F., Peterson, E. D., Fonarow, G. C., Schulman, K. A., Curtis, L. H. 2009; 157 (6): 995–1000

  Abstract

  Inpatient clinical registries generally have limited ability to provide a longitudinal perspective on care beyond the acute episode. We present a method to link hospitalization records from registries with Medicare inpatient claims data, without using direct identifiers, to create a unique data source that pairs rich clinical data with long-term outcome data.The method takes advantage of the hospital clustering observed in each database by demonstrating that different combinations of indirect identifiers within hospitals yield a large proportion of unique patient records. This high level of uniqueness also allows linking without advance knowledge of the Medicare provider number of each registry hospital. We applied this method to 2 inpatient databases and were able to identify 81% of 39,178 records in a large clinical registry of patients with heart failure and 91% of 6,581 heart failure records from a hospital inpatient database. The quality of the link is high, and reasons for incomplete linkage are explored. Finally, we discuss the unique opportunities afforded by combining claims and clinical data for specific analyses.In the absence of direct identifiers, it is possible to create a high-quality link between inpatient clinical registry data and Medicare claims data. The method will allow researchers to use existing data to create a linked claims-clinical database that capitalizes on the strengths of both types of data sources.

  View details for PubMedID 19464409

• Cost Effectiveness of Ixabepilone Plus Capecitabine for Metastatic Breast Cancer Progressing After Anthracycline and Taxane Treatment JOURNAL OF CLINICAL ONCOLOGY Reed, S. D., Li, Y., Anstrom, K. J., Schulman, K. A. 2009; 27 (13): 2185–91

  Abstract

  Using data from a recent randomized trial, we evaluated the cost effectiveness of ixabepilone plus capecitabine versus capecitabine alone in patients with predominantly metastatic breast cancer considered to be taxane-resistant and previously treated with or resistant to an anthracycline.We developed a stochastic decision-analytic model to represent data collected in the trial on medical resource use, health-related quality of life, and clinical outcomes. Estimates of overall survival were conditional on level of tumor response. We assigned monthly costs and utility weights according to periods defined by the duration of study treatment, time from discontinuation of the study drug until disease progression, and from progression until death and were specific to the level of response and receipt of subsequent therapy. Medical resources were valued in 2008 US dollars. We performed Monte Carlo simulations and sensitivity analyses to evaluate model uncertainty.Overall survival was significantly associated with level of tumor response (P < .001). Total costs were estimated at $60,900 for patients receiving ixabepilone plus capecitabine and $30,000 for patients receiving capecitabine alone. The estimated gain in life expectancy with ixabepilone was 1.96 months (95% CI, 1.36 to 2.64 months); the estimated gain in quality-adjusted survival was 1.06 months (95% CI, 0.09 to 2.03 months). The resulting incremental cost-effectiveness ratio was $359,000 per quality-adjusted life-year (95% CI, $183,000 to $4,030,000). In sensitivity analyses, the results were robust to changes in numerous inputs and assumptions.Addition of ixabepilone to capecitabine adds approximately $31,000 to overall medical costs and affords approximately 1 additional month of quality-adjusted survival.

  View details for DOI 10.1200/JCO.2008.19.6352

  View details for Web of Science ID 000266195000014

  View details for PubMedID 19332722

• Efficacy and Safety of Exercise Training in Patients With Chronic Heart Failure HF-ACTION Randomized Controlled Trial 81st Annual Scientific Session of the American-Heart-Association O'Connor, C. M., Whellan, D. J., Lee, K. L., Keteyian, S. J., Cooper, L. S., Ellis, S. J., Leifer, E. S., Kraus, W. E., Kitzman, D. W., Blumenthal, J. A., Rendall, D. S., Miller, N. H., Fleg, J. L., Schulman, K. A., McKelvie, R. S., Zannad, F., Pina, I. L. AMER MEDICAL ASSOC. 2009: 1439–50

  Abstract

  Guidelines recommend that exercise training be considered for medically stable outpatients with heart failure. Previous studies have not had adequate statistical power to measure the effects of exercise training on clinical outcomes.To test the efficacy and safety of exercise training among patients with heart failure.Multicenter, randomized controlled trial of 2331 medically stable outpatients with heart failure and reduced ejection fraction. Participants in Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION) were randomized from April 2003 through February 2007 at 82 centers within the United States, Canada, and France; median follow-up was 30 months.Usual care plus aerobic exercise training, consisting of 36 supervised sessions followed by home-based training, or usual care alone.Composite primary end point of all-cause mortality or hospitalization and prespecified secondary end points of all-cause mortality, cardiovascular mortality or cardiovascular hospitalization, and cardiovascular mortality or heart failure hospitalization.The median age was 59 years, 28% were women, and 37% had New York Heart Association class III or IV symptoms. Heart failure etiology was ischemic in 51%, and median left ventricular ejection fraction was 25%. Exercise adherence decreased from a median of 95 minutes per week during months 4 through 6 of follow-up to 74 minutes per week during months 10 through 12. A total of 759 patients (65%) in the exercise training group died or were hospitalized compared with 796 patients (68%) in the usual care group (hazard ratio [HR], 0.93 [95% confidence interval {CI}, 0.84-1.02]; P = .13). There were nonsignificant reductions in the exercise training group for mortality (189 patients [16%] in the exercise training group vs 198 patients [17%] in the usual care group; HR, 0.96 [95% CI, 0.79-1.17]; P = .70), cardiovascular mortality or cardiovascular hospitalization (632 [55%] in the exercise training group vs 677 [58%] in the usual care group; HR, 0.92 [95% CI, 0.83-1.03]; P = .14), and cardiovascular mortality or heart failure hospitalization (344 [30%] in the exercise training group vs 393 [34%] in the usual care group; HR, 0.87 [95% CI, 0.75-1.00]; P = .06). In prespecified supplementary analyses adjusting for highly prognostic baseline characteristics, the HRs were 0.89 (95% CI, 0.81-0.99; P = .03) for all-cause mortality or hospitalization, 0.91 (95% CI, 0.82-1.01; P = .09) for cardiovascular mortality or cardiovascular hospitalization, and 0.85 (95% CI, 0.74-0.99; P = .03) for cardiovascular mortality or heart failure hospitalization. Other adverse events were similar between the groups.In the protocol-specified primary analysis, exercise training resulted in nonsignificant reductions in the primary end point of all-cause mortality or hospitalization and in key secondary clinical end points. After adjustment for highly prognostic predictors of the primary end point, exercise training was associated with modest significant reductions for both all-cause mortality or hospitalization and cardiovascular mortality or heart failure hospitalization.clinicaltrials.gov Identifier: NCT00047437.

  View details for Web of Science ID 000264924900024

  View details for PubMedID 19351941

• Effects of Exercise Training on Health Status in Patients With Chronic Heart Failure HF-ACTION Randomized Controlled Trial 81st Annual Scientific Session of the American-Heart-Association Flynn, K. E., Pina, I. L., Whellan, D. J., Lin, L., Blumenthal, J. A., Ellis, S. J., Fine, L. J., Howlett, J. G., Keteyian, S. J., Kitzman, D. W., Kraus, W. E., Miller, N. H., Schulman, K. A., Spertus, J. A., O'Connor, C. M., Weinfurt, K. P. AMER MEDICAL ASSOC. 2009: 1451–59

  Abstract

  Findings from previous studies of the effects of exercise training on patient-reported health status have been inconsistent.To test the effects of exercise training on health status among patients with heart failure.Multicenter, randomized controlled trial among 2331 medically stable outpatients with heart failure with left ventricular ejection fraction of 35% or less. Patients were randomized from April 2003 through February 2007.Usual care plus aerobic exercise training (n = 1172), consisting of 36 supervised sessions followed by home-based training, vs usual care alone (n = 1159). Randomization was stratified by heart failure etiology, which was a covariate in all models.Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary scale and key subscales at baseline, every 3 months for 12 months, and annually thereafter for up to 4 years. The KCCQ is scored from 0 to 100 with higher scores corresponding to better health status. Treatment group effects were estimated using linear mixed models according to the intention-to-treat principle.Median follow-up was 2.5 years. At 3 months, usual care plus exercise training led to greater improvement in the KCCQ overall summary score (mean, 5.21; 95% confidence interval, 4.42 to 6.00) compared with usual care alone (3.28; 95% confidence interval, 2.48 to 4.09). The additional 1.93-point increase (95% confidence interval, 0.84 to 3.01) in the exercise training group was statistically significant (P < .001). After 3 months, there were no further significant changes in KCCQ score for either group (P = .85 for the difference between slopes), resulting in a sustained, greater improvement overall for the exercise group (P < .001). Results were similar on the KCCQ subscales, and no subgroup interactions were detected.Exercise training conferred modest but statistically significant improvements in self-reported health status compared with usual care without training. Improvements occurred early and persisted over time.clinicaltrials.gov Identifier: NCT00047437.

  View details for Web of Science ID 000264924900025

  View details for PubMedID 19351942

• Randomized Trial of Warfarin, Aspirin, and Clopidogrel in Patients With Chronic Heart Failure The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) Trial CIRCULATION Massie, B. M., Collins, J. F., Ammon, S. E., Armstrong, P. W., Cleland, J. F., Ezekowitz, M., Jafri, S. M., Krol, W. F., O'Connor, C. M., Schulman, K. A., Teo, K., Warren, S. R., WATCH Trial Investigators 2009; 119 (12): 1616–24

  Abstract

  Chronic heart failure remains a major cause of mortality and morbidity. The role of antithrombotic therapy in patients with chronic heart failure has long been debated. The objective of this study was to determine the optimal antithrombotic agent for heart failure patients with reduced ejection fractions who are in sinus rhythm.This prospective, randomized clinical trial of open-label warfarin (target international normalized ratio of 2.5 to 3.0) and double-blind treatment with either aspirin (162 mg once daily) or clopidogrel (75 mg once daily) had a 30-month enrollment period and a minimum of 12 months of treatment. We enrolled 1587 men and women >/=18 years of age with symptomatic heart failure for at least 3 months who were in sinus rhythm and had left ventricular ejection fraction of

  View details for DOI 10.1161/CIRCULATIONAHA.108.801753

  View details for Web of Science ID 000264709400009

  View details for PubMedID 19289640

• Ownership of Medical Information JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Hall, M. A., Schulman, K. A. 2009; 301 (12): 1282–84

  View details for DOI 10.1001/jama.2009.389

  View details for Web of Science ID 000264492800030

  View details for PubMedID 19318657

• Clopidogrel Use and Clinical Events After Drug-Eluting Stent Implantation: Findings From the HealthCore Integrated Research Database Petersen, J. L., Barron, J. D., Hammill, B. G., Cziraky, M. J., Anstrom, K. J., Wahl, P. M., Eisenstein, E. J., Krucoff, M. W., Califf, R. M., Schulman, K. A., Curtis, L. H. ELSEVIER SCIENCE INC. 2009: A11–A12

  View details for Web of Science ID 000263864200045

• Community hospital oversight of clinical investigators' financial relationships. IRB Hall, M. A., Weinfurt, K. P., Lawlor, J. S., Friedman, J. Y., Schulman, K. A., Sugarman, J. 2009; 31 (1): 7-13

  View details for PubMedID 19241734

  View details for PubMedCentralID PMC2662335

• Ethical and Scientific Implications of the Globalization of Clinical Research NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., McHutchison, J. G., Peterson, E. D., Cairns, C. B., Harrington, R. A., Califf, R. M., Schulman, K. A. 2009; 360 (8): 816–23

  View details for PubMedID 19228627

• Outcomes of Staphylococcus aureus Infection in Hemodialysis-Dependent Patients CLINICAL JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Li, Y., Friedman, J. Y., O'Neal, B. F., Hohenboken, M. J., Griffiths, R. I., Stryjewski, M. E., Middleton, J. P., Schulman, K. A., Inrig, J. K., Fowler, V. G., Reed, S. D. 2009; 4 (2): 428–34

  Abstract

  Staphylococcus aureus is a leading cause of infection in patients with ESRD. Clinical and economic outcomes associated with S. aureus bacteremia and other S. aureus infections in patients with ESRD were examined.Laboratory, clinical, and hospital billing data from a randomized trial of 3359 hemodialysis-dependent patients hospitalized with S. aureus infection in the United States whose vascular access type was fistula or graft and who were hospitalized with S. aureus infection to evaluate inpatient costs, hospital days, and mortality over 12 wk were used. Generalized linear regression was used to identify independent predictors of 12-wk costs, inpatient days, and mortality.Of the 279 patients (8.3%) who developed S. aureus infection during approximately 1 yr of follow-up, 25.4% were treated as outpatients. Among patients for whom billing data were available, 89 patients hospitalized with S. aureus bacteremia incurred mean 12-wk inpatient costs of $19,454 and 11.9 inpatient days. Among the 70 patients hospitalized with non-bloodstream S. aureus infections, mean inpatient costs were $19,222 and the mean number of inpatient days was 11.3. Twelve-week mortality was 20.2 and 15.7% for patients with S. aureus bloodstream and non-bloodstream infections, respectively. Older age was independently associated with higher risk of death among patients with S. aureus bacteremia and with higher inpatient costs and more hospital days among patients with non-bloodstream infections.Hemodialysis-dependent patients with fistula or graft access incur high costs and long inpatient stays when hospitalized for S. aureus infection.

  View details for PubMedID 19118117

  View details for PubMedCentralID PMC2637588

• Decision making and quality of life in the treatment of cancer: a review SUPPORTIVE CARE IN CANCER Zafar, S., Alexander, S. C., Weinfurt, K. P., Schulman, K. A., Abernethy, A. P. 2009; 17 (2): 117–27

  Abstract

  Complexity in decision making for cancer treatment arises from many factors. When considering how to treat patients, physicians prioritize factors such as stage of disease, patient age, and comorbid illnesses. However, physicians must balance these priorities with the patient's preferences, quality of life, social responsibilities, and fear of uncertainty. Although these factors are important, physicians are often unable to effectively judge their patients' preferences. Patients are often unable to fully understand their prognoses and the treatment intent.These differences influence how patients and physicians make treatment-related decisions. Partially due to these differences, patients are initially more likely than their physicians to accept greater risk for lesser benefit from treatment. As time progresses and as they experience treatment, a patient's preference changes, yet little is known about this process since few studies have examined it in a prospective longitudinal manner. We present an overview of the literature related to patient and physician decision making and quality of life in patients with advanced cancer, and we propose approaches to future decision-making models in cancer treatment.

  View details for PubMedID 18802727

• Clinical Effectiveness of Beta-Blockers in Heart Failure Findings From the OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) Registry JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Hernandez, A. F., Hammill, B. G., O'Connor, C. M., Schulman, K. A., Curtis, L. H., Fonarow, G. C. 2009; 53 (2): 184–92

  Abstract

  We sought to examine associations between initiation of beta-blocker therapy and outcomes among elderly patients hospitalized for heart failure.Beta-blockers are guideline-recommended therapy for heart failure, but their clinical effectiveness is not well understood, especially in elderly patients.We merged Medicare claims data with OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients With Heart Failure) records to examine long-term outcomes of eligible patients newly initiated on beta-blocker therapy. We used inverse probability-weighted Cox proportional hazards models to determine the relationships among treatment and mortality, rehospitalization, and a combined mortality-rehospitalization end point.Observed 1-year mortality was 33%, and all-cause rehospitalization was 64%. Among 7,154 patients hospitalized with heart failure and eligible for beta-blockers, 3,421 (49%) were newly initiated on beta-blocker therapy. Among patients with left ventricular systolic dysfunction (LVSD) (n = 3,001), beta-blockers were associated with adjusted hazard ratios of 0.77 (95% confidence interval [CI]: 0.68 to 0.87) for mortality, 0.89 (95% CI: 0.80 to 0.99) for rehospitalization, and 0.87 (95% CI: 0.79 to 0.96) for mortality-rehospitalization. Among patients with preserved systolic function (n = 4,153), beta-blockers were associated with adjusted hazard ratios of 0.94 (95% CI: 0.84 to 1.07) for mortality, 0.98 (95% CI: 0.90 to 1.06) for rehospitalization, and 0.98 (95% CI: 0.91 to 1.06) for mortality-rehospitalization.In elderly patients hospitalized with heart failure and LVSD, incident beta-blocker use was clinically effective and independently associated with lower risks of death and rehospitalization. Patients with preserved systolic function had poor outcomes, and beta-blockers did not significantly influence the mortality and rehospitalization risks for these patients.

  View details for DOI 10.1016/j.jacc.2008.09.031

  View details for Web of Science ID 000262418500006

  View details for PubMedID 19130987

  View details for PubMedCentralID PMC3513266

• Fueling Innovation In Medical Devices (And Beyond): Venture Capital In Health Care HEALTH AFFAIRS Ackerly, D., Valverde, A. M., Diener, L. W., Dossary, K. L., Schulman, K. A. 2009; 28 (1): W68–W75

  Abstract

  Innovation in health care requires new ideas and the capital to develop and commercialize those ideas into products or services. The necessary capital is often "venture capital," but the link between public policy and the venture capital industry has not been well examined. In this paper we explore the link between venture capital and innovation in health care, and we present new descriptive data from a survey of health care venture capital fund managers. Respondents generally viewed policy levers (for example, reimbursement and regulations) as important risks to venture capital investments, potentially affecting their ability to raise capital for early-stage investment funds.

  View details for PubMedID 19049999

• Searching for industry modernization. Richman, B. D., Mitchell, W., Schulman, K. A. Modern Healthcare. 2009
• A Health Services Research Agenda for Cellular, Molecular and Genomic Technologies in Cancer Care PUBLIC HEALTH GENOMICS Wideroff, L., Phillips, K. A., Randhawa, G., Ambs, A., Armstrong, K., Bennett, C. L., Brown, M. L., Donaldson, M. S., Follen, M., Goldie, S. J., Hiatt, R. A., Khoury, M. J., Lewis, G., McLeod, H. L., Piper, M., Powell, I., Schrag, D., Schulman, K. A., Scott, J. 2009; 12 (4): 233–44

  Abstract

  In recent decades, extensive resources have been invested to develop cellular, molecular and genomic technologies with clinical applications that span the continuum of cancer care.In December 2006, the National Cancer Institute sponsored the first workshop to uniquely examine the state of health services research on cancer-related cellular, molecular and genomic technologies and identify challenges and priorities for expanding the evidence base on their effectiveness in routine care.This article summarizes the workshop outcomes, which included development of a comprehensive research agenda that incorporates health and safety endpoints, utilization patterns, patient and provider preferences, quality of care and access, disparities, economics and decision modeling, trends in cancer outcomes, and health-related quality of life among target populations.Ultimately, the successful adoption of useful technologies will depend on understanding and influencing the patient, provider, health care system and societal factors that contribute to their uptake and effectiveness in 'real-world' settings.

  View details for DOI 10.1159/000203779

  View details for Web of Science ID 000265136600004

  View details for PubMedID 19367091

  View details for PubMedCentralID PMC2844634

• Cancer Patient Preferences for Quality and Length of Life CANCER Meropol, N. J., Egleston, B. L., Buzaglo, J. S., Benson, A. B., Cegala, D. J., Diefenbach, M. A., Fleisher, L., Miller, S. M., Sulmasy, D. R., Weinfurt, K. P., CONNECT Study Res Grp 2008; 113 (12): 3459–66

  Abstract

  Optimal patient decision making requires integration of patient values, goals, and preferences with information received from the physician. In the case of a life-threatening illness such as cancer, the weights placed on quality of life (QOL) and length of life (LOL) represent critical values. The objective of the current study was to describe cancer patient values regarding QOL and LOL and explore associations with communication preferences.Patients with advanced cancer completed a computer-based survey before the initial consultation with a medical oncologist. Assessments included sociodemographics, physical and mental health state, values regarding quality and length of life, communication preferences, and cancer-related distress.Among 459 patients with advanced cancer, 55% placed equal valued on QOL and LOL, 27% preferred QOL, and 18% preferred LOL. Patients with a QOL preference had lower levels of cancer-related distress (P < .001). A QOL preference was also associated with older age (P = .001), male sex (P = .003), and higher educational level (P = .062). Patients who preferred LOL over QOL desired a more supportive and less pessimistic communication style from their oncologists.These data indicate that a values preference for LOL versus QOL may be simply measured, and is associated with wishes regarding the nature of oncologist communication. Awareness of these values during the clinical encounter could improve decision making by influencing the style and content of the communication between oncologists and their patients.

  View details for DOI 10.1002/cncr.23968

  View details for Web of Science ID 000261665100022

  View details for PubMedID 18988231

  View details for PubMedCentralID PMC2606934

• Early and Long-term Outcomes of Heart Failure in Elderly Persons, 2001-2005 ARCHIVES OF INTERNAL MEDICINE Curtis, L. H., Greiner, M. A., Hammill, B. G., Kramer, J. M., Whellan, D. J., Schulman, K. A., Hernandez, A. F. 2008; 168 (22): 2481–88

  Abstract

  The treatment of chronic heart failure has improved during the past 2 decades, but little is known about whether the improvements are reflected in trends in early and long-term mortality and hospital readmission.In a retrospective cohort study of 2 540 838 elderly Medicare beneficiaries hospitalized with heart failure between January 1, 2001, and December 31, 2005, we examined early and long-term all-cause mortality and hospital readmission and patient- and hospital-level predictors of these outcomes.Unadjusted in-hospital mortality declined from 5.1% to 4.2% during the study (P < .001), but 30-day, 180-day, and 1-year all-cause mortality remained fairly constant at 11%, 26%, and 37%, respectively. Nearly 1 in 4 patients were readmitted within 30 days of the index hospitalization, and two-thirds were readmitted within 1 year. Controlling for patient- and hospital-level covariates, the hazard of all-cause mortality at 1 year was slightly lower in 2005 than in 2001 (hazard ratio, 0.98; 95% confidence interval, 0.97-0.99). The hazard of readmission did not decline significantly from 2001 to 2005 (hazard ratio, 0.99; 95% confidence interval, 0.98-1.00).Early and long-term all-cause mortality and hospital readmission rates remain high and have improved little with time. The need to identify optimal management strategies for these clinically complex patients is urgent.

  View details for DOI 10.1001/archinte.168.22.2481

  View details for Web of Science ID 000261486600015

  View details for PubMedID 19064833

  View details for PubMedCentralID PMC2629051

• Resource Use and Costs Associated With Diabetic Macular Edema in Elderly Persons ARCHIVES OF OPHTHALMOLOGY Shea, A. M., Curtis, L. H., Hammill, B. G., Kowalski, J. W., Ravelo, A., Lee, P. P., Sloan, F. A., Schulman, K. A. 2008; 126 (12): 1748–54

  Abstract

  To examine trends in resource use and the effect of incident diabetic macular edema (DME) on 1- and 3-year total direct medical costs in elderly patients.We used a nationally representative 5% sample of Medicare beneficiaries from 2000 through 2004 to identify patients with incident DME and a control cohort of patients with diabetes mellitus but no history of retinal disease. We summed Medicare reimbursement amounts for all claims and applied generalized linear models to estimate the effect of DME on 1- and 3-year costs. We also examined the use of select imaging techniques and treatments.After adjusting for demographic characteristics and baseline comorbid conditions, DME was associated with 31% higher 1-year costs and 29% higher 3-year costs. There were significant shifts in the use of testing and treatment modalities. From 2000 to 2004, use of intravitreal injection increased from 1% to 13% of patients; use of optical coherence tomography increased from 2.5% to more than 40%. Use of laser photocoagulation decreased over time.After adjusting for demographic variables and baseline comorbid conditions, new-onset DME was a significant independent predictor of total medical costs after 1 and 3 years. Diagnostic and treatment modalities used for DME have changed significantly.

  View details for DOI 10.1001/archopht.126.12.1748

  View details for Web of Science ID 000261481700019

  View details for PubMedID 19064859

  View details for PubMedCentralID PMC2630411

• Long-term Outcomes and Costs of Ventricular Assist Devices Among Medicare Beneficiaries JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Hernandez, A. F., Shea, A. M., Milano, C. A., Rogers, J. G., Hammill, B. G., O'Connor, C. M., Schulman, K. A., Peterson, E. D., Curtis, L. H. 2008; 300 (20): 2398–2406

  Abstract

  In 2003, Medicare expanded coverage of ventricular assist devices as destination, or permanent, therapy for end-stage heart failure. Little is known about the long-term outcomes and costs associated with these devices.To examine the acute and long-term outcomes of Medicare beneficiaries receiving ventricular assist devices alone or after open-heart surgery.Analysis of inpatient claims from the Centers for Medicare & Medicaid Services for the period 2000 through 2006. Patients were Medicare fee-for-service beneficiaries who received a ventricular assist device between February 2000 and June 2006 alone as primary therapy (primary device group; n = 1476) or after cardiotomy in the previous 30 days (postcardiotomy group; n = 1467).Cumulative incidence of device replacement, device removal, heart transplantation, readmission, and death, accounting for censoring and competing risks. Patients were followed up for at least 6 months and factors independently associated with long-term survival were identified. Medicare payments were used to calculate total inpatient costs and costs per day outside the hospital.Overall 1-year survival was 51.6% (n = 669) in the primary device group and 30.8% (n = 424) in the postcardiotomy group. Among primary device patients, 815 (55.2%) were discharged alive with a device. Of those, 450 (55.6%) were readmitted within 6 months and 504 (73.2%) were alive at 1 year. Of the 493 (33.6%) postcardiotomy patients discharged alive with a device, 237 (48.3%) were readmitted within 6 months and 355 (76.6%) were alive at 1 year. Mean 1-year Medicare payments for inpatient care for patients in the 2000-2005 cohorts were $178,714 (SD, $142,549) in the primary device group and $111,769 (SD, $95,413) in the postcardiotomy group.Among Medicare beneficiaries receiving a ventricular assist device, early mortality, morbidity, and costs remain high. Improving patient selection and reducing perioperative mortality are critical for improving overall outcomes.

  View details for DOI 10.1001/jama.2008.716

  View details for Web of Science ID 000261150800022

  View details for PubMedID 19033590

  View details for PubMedCentralID PMC2629048

• Physician-Industry Cooperation In The Medical Device Industry HEALTH AFFAIRS Chatterji, A. K., Fabrizio, K. R., Mitchell, W., Schulman, K. A. 2008; 27 (6): 1532–43

  Abstract

  Anecdotal evidence suggests that innovative medical devices often arise from physicians' inventive activity, but no studies have documented the extent of such physician-engaged innovation. This paper uses patent data and the American Medical Association Physician Masterfile to provide evidence that physicians contribute to medical device innovation, accounting for almost 20 percent of approximately 26,000 medical device patents filed in the United States during 1990-1996. Moreover, two measures indicate that physician patents had more influence on subsequent inventive activity than nonphysician patents. This finding supports the maintenance of an open environment for physician-industry collaboration in the medical device discovery process.

  View details for PubMedID 18997209

• Considerations of net present value in policy making regarding diagnostic and therapeutic technologies AMERICAN HEART JOURNAL Califf, R. M., Rasiel, E. B., Schuhnan, K. A. 2008; 156 (5): 879–85

  Abstract

  The pharmaceutical and medical device industries function in a business environment in which shareholders expect companies to optimize profit within legal and ethical standards. A fundamental tool used to optimize decision making is the net present value calculation, which estimates the current value of cash flows relating to an investment.We examined 3 prototypical research investment decisions that have been the source of public scrutiny to illustrate how policy decisions can be better understood when their impact on societally desirable investments by industry are viewed from the standpoint of their impact on net present value.In the case of direct, comparative clinical trials, a simple net present value calculation provides insight into why companies eschew such investments. In the case of pediatric clinical trials, the Pediatric Extension Rule changed the net present value calculation from unattractive to potentially very attractive by allowing patent extensions; thus, the dramatic increase in pediatric clinical trials can be explained by the financial return on investment. In the case of products for small markets, the fixed costs of development make this option financially unattractive.Policy decisions can be better understood when their impact on societally desirable investments by the pharmaceutical and medical device industries are viewed from the standpoint of their impact on net present value.

  View details for PubMedID 19061701

• Long-term Outcomes and Costs of Ventricular Assist Devices among United States Medicare Beneficiaries Hernandez, A. F., Shea, A., Milano, C. A., Rogers, J. G., Hammill, B. G., Schulman, K. A., Peterson, E. D., Curtis, L. H. LIPPINCOTT WILLIAMS & WILKINS. 2008: S1016–S1017

  View details for Web of Science ID 000262104504040

• Cost of Inpatient Care for Medicare Heart Failure Patients, 2001-2004:More Than Just Heart Failure Whellan, D. J., Greiner, M. A., Schulman, K. A., Curtis, L. H. LIPPINCOTT WILLIAMS & WILKINS. 2008: S713

  View details for Web of Science ID 000262104502325

• Factors influencing the participation of gastroenterologists and hepatologists in clinical research BMC HEALTH SERVICES RESEARCH Dev, A. T., Kauf, T. L., Zekry, A., Patel, K., Heller, K., Schulman, K. A., McHutchison, J. G. 2008; 8: 1–11

  Abstract

  Although clinical research is integral to the advancement of medical knowledge, physicians face a variety of obstacles to their participation as investigators in clinical trials. We examined factors that influence the participation of gastroenterologists and hepatologists in clinical research.We surveyed 1050 members of the American Association for the Study of Liver Diseases regarding their participation in clinical research. We compared the survey responses by specialty and level of clinical trial experience.A majority of the respondents (71.6%) reported involvement in research activities. Factors most influential in clinical trial participation included funding and compensation (88.3%) and intellectual pursuit (87.8%). Barriers to participation were similar between gastroenterologists (n = 160) and hepatologists (n = 189) and between highly experienced (n = 62) and less experienced (n = 159) clinical researchers. These barriers included uncompensated research costs and lack of specialized support. Industry marketing was a greater influence among respondents with less trial experience, compared to those with extensive experience (15.7% vs 1.6%; P < .01). Hepatologists and respondents with extensive clinical trial experience tended to be more interested in phase 1 and 2 studies, whereas gastroenterologists and less experienced investigators were more interested in phase 4 studies.This study suggests that the greatest barrier to participation in clinical research is lack of adequate resources. Respondents also favored industry-sponsored research with less complex trial protocols and studies of relatively short duration.

  View details for DOI 10.1186/1472-6963-8-208

  View details for Web of Science ID 000260681400001

  View details for PubMedID 18842135

  View details for PubMedCentralID PMC2572062

• Patient and Implanting Physician Factors Associated With Mortality and Complications After Implantable Cardioverter-Defibrillator Implantation, 2002-2005 CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Al-Khatib, S. M., Greiner, M. A., Peterson, E. D., Hernandez, A. F., Schulman, K. A., Curtis, L. H. 2008; 1 (4): 240–49

  Abstract

  Little is known about factors that influence survival and complications after implantable cardioverter-defibrillator (ICD) implantation in routine clinical practice. We examined patient and implanting physician factors associated with outcomes of ICD therapy in Medicare beneficiaries from 2002 through 2005.We limited this analysis to patients aged >or=65 with Medicare fee-for-service coverage who received an ICD between January 2002 and September 2005. The main outcome measures are time to postprocedural complications within 90 days and 1-year mortality. During the study period, 8581 patients had an ICD implanted by 1959 physicians. The number of procedures increased from 1644 in 2002 to 2374 in the first 3 quarters of 2005. The overall complication rate declined from 18.8% in 2002 to 14.2% in 2005 (P<0.001). Factors independently associated with an increased hazard of complications include chronic lung disease, dementia, renal disease, implantation by a thoracic surgeon, and implantation with removal/replacement. History of congestive heart failure, outpatient implantation, and more recent years of ICD implantation were associated with a lower risk of complications (P<0.05 for all factors). From 2002 to 2005, we observed a decline in 1-year mortality (P<0.001).We observed an appreciable increase in the number of ICD implants, which was associated with a significant decrease in the rate of complications and 1-year mortality. We identified factors associated with an increased risk of mortality and postprocedural complications that may support more nuanced treatment decisions than are currently possible.

  View details for PubMedID 19169382

• Effects of disclosing financial interests on participation in medical research: A randomized vignette trial AMERICAN HEART JOURNAL Weinfurt, K. P., Hall, M. A., Friedman, J. Y., Hardy, N., Fortune-Greeley, A. K., Lawlor, J. S., Allsbrook, J. S., Lin, L., Schulman, K. A., Sugarman, J. 2008; 156 (4): 689–97

  Abstract

  Little is known about the effects of investigators' financial disclosures on potential research participants.We conducted a vignette trial in which 470 participants in a telephone survey were randomly assigned to receive a simulated informed consent document that contained 1 of 2 financial disclosures (per capita payments to the research institution or equity ownership by the investigator) or no disclosure. The main outcome measures were trust in medical research and willingness to participate in a hypothetical clinical trial.Participants in the equity group reported less willingness to participate than participants in the per capita payments group (P = .01) and the no disclosure group (P = .03). Trust in the investigator was highest in the per capita payments group and lowest in the equity group (P < .001). Trust among participants who received no disclosure was also greater than trust among participants in the equity group (P = .04) but did not differ significantly from trust among participants in the per capita payments group (P = .15). Participants in the equity group made 3 times as many negative comments as participants in the per capita payments group; and 10 participants in the equity group spontaneously said they would not participate in the hypothetical trial because of the financial interest, compared with only 1 such participant from the other groups.Although investigators' financial disclosures in research do not substantially affect willingness to participate, potential research participants are more troubled by equity interests than by per capita payments.

  View details for PubMedID 18946893

• Prostate-specific antigen screening among young men in the United States CANCER Scales, C. D., Antonelli, J., Curtis, L. H., Schulman, K. A., Moul, J. W. 2008; 113 (6): 1315–23

  Abstract

  Disagreement exists on the use of prostate-specific antigen (PSA) tests for cancer-risk stratification in young men in the United States. Little is known about the use of PSA testing in these men. To understand policy implications of risk stratification, the authors sought to characterize PSA use among young men.The authors used the 2002 Behavioral Risk Factor Surveillance System to study prostate-cancer screening in a representative sample of men aged 40 years and older (n = 58,511). The primary outcome was self-report of a PSA test in the previous year.Among men aged 40 to 49 years, 22.5% (95% confidence interval [CI], 21.5-23.5) reported having had a PSA test in the previous year, compared with 53.7% (95% CI, 52.8-54.7; P < .001) of men aged >or=50 years. When sociodemographic characteristics were statistically controlled, young, black, non-Hispanic men were more likely than young, white, non-Hispanic men to report having had a PSA test in the previous year (odds ratio [OR], 2.42; 95% CI, 1.95-3.01; P < .001). In young men, annual household income >or=USD 35,000 (OR, 1.50; 95% CI, 1.26-1.78; P < .001) and an ongoing relationship with a physician (OR, 2.52; 95% CI, 2.06-3.07; P < .001) were associated with PSA testing.One-fifth of young men reported having had a PSA test within the previous year. Young, black, non-Hispanic men are more likely than young, white, non-Hispanic men to report having had a PSA test, although screening in this high-risk group remains suboptimal.

  View details for PubMedID 18696715

• Use Of Larger Versus Smaller Drug-Safety Databases Before Regulatory Approval: The Trade-Offs HEALTH AFFAIRS Reed, S. D., Anstrom, K. J., Seils, D. M., Califf, R. M., Schulman, K. A. 2008; 27 (5): W360–W370

  Abstract

  Although efforts to revamp the drug-safety system have been directed at strengthening postmarketing surveillance, strategies for the preapproval stage may be useful. One strategy would be to require larger sample sizes in preapproval safety databases. To evaluate the potential benefits and costs of this approach, we developed a hypothetical model to estimate the expected incremental number of adverse drug events that could be avoided in a postapproval population. We found that the potential to limit adverse events can be an important consideration in sample-size determinations for preapproval trials. Requiring larger preapproval databases could be a cost-effective means of reducing adverse events in postapproval populations.

  View details for PubMedID 18682441

• DECISIONAL CONFLICT AMONG PATIENTS WHO ACCEPT OR DECLINE PARTICIPATION IN PHASE I ONCOLOGY STUDIES JOURNAL OF EMPIRICAL RESEARCH ON HUMAN RESEARCH ETHICS Flynn, K. E., Weinfurt, K. P., Seils, D. M., Lin, L., Burnett, C. B., Schulman, K. A., Meropol, N. J. 2008; 3 (3): 69–77

  Abstract

  WE COMPARED DECISIONAL CONFLICT among adults with advanced cancer who had accepted or declined participation in phase I cancer clinical trials. Respondents completed a 121-item questionnaire that included the Decisional Conflict Scale (DCS), which was designed to measure uncertainty in making health decisions. We used standardized effect sizes to compare the DCS scores of accepters (n = 250) and decliners (n = 65). Accepters had lower decisional conflict than decliners overall (d = 0.42; 95% confidence interval, 0.17--0.68) and on all subscales. Whether greater decisional conflict among decliners represents suboptimal decision-making and is reason for bioethical concern depends on how the results are interpreted. We offer three scenarios to explain the differences and describe opportunities for future empirical work.

  View details for PubMedID 19122780

• Lessons From India In Organizational Innovation: A Tale Of Two Heart Hospitals HEALTH AFFAIRS Richman, B. D., Udayakumar, K., Mitchell, W., Schulman, K. A. 2008; 27 (5): 1260–70

  Abstract

  Recent discussions in health reform circles have pinned great hopes on the prospect of innovation as the solution to the high-cost, inadequate-quality U.S. health system. But U.S. health care institutions-insurers, providers, and specialists-have ceded leadership in innovation to Indian hospitals such as Care Hospital in Hyderabad and the Fortis Hospitals around New Delhi, which have U.S.-trained doctors and can perform open heart surgery for $6,000 (compared to $100,000 in the United States). The Indian success is a window into America's stalemate with inflating costs and stagnant innovation.

  View details for PubMedID 18780909

• Does reimportation reduce price differences for prescription drugs? Lessons from the European Union HEALTH SERVICES RESEARCH Kyle, M. K., Allsbrook, J. S., Schulman, K. A. 2008; 43 (4): 1308–24

  Abstract

  To examine the effect of parallel trade on patterns of price dispersion for prescription drugs in the European Union.Longitudinal data from an IMS Midas database of prices and units sold for drugs in 36 categories in 30 countries from 1993 through 2004.The main outcome measures were mean price differentials and other measures of price dispersion within European Union countries compared with within non-European Union countries.We identified drugs subject to parallel trade using information provided by IMS and by checking membership lists of parallel import trade associations and lists of approved parallel imports.Parallel trade was not associated with substantial reductions in price dispersion in European Union countries. In descriptive and regression analyses, about half of the price differentials exceeded 50 percent in both European Union and non-European Union countries over time, and price distributions among European Union countries did not show a dramatic change concurrent with the adoption of parallel trade. In regression analysis, we found that although price differentials decreased after 1995 in most countries, they decreased less in the European Union than elsewhere.Parallel trade for prescription drugs does not automatically reduce international price differences. Future research should explore how other regulatory schemes might lead to different results elsewhere.

  View details for PubMedID 18355258

• Cost-effectiveness of the oral adsorbent AST-120 versus placebo for chronic kidney disease NEPHROLOGY Takahashi, T., Reed, S. D., Schulman, K. A. 2008; 13 (5): 419–27

  Abstract

  This study was designed to evaluate the cost-effectiveness of AST-120, an oral adsorbent that attenuates the progression of chronic kidney disease.We developed a Markov model with six health states, including four levels of serum creatinine, haemodialysis and death, using data from a randomized clinical trial conducted in Japan. Direct costs relevant to chronic kidney disease were calculated from a Japanese reimbursement perspective. Projected quality-adjusted life years (QALY) and costs were compared between the AST-120 and placebo groups. The target population was nondiabetic patients with serum creatinine levels from 5.0 to 8.0 mg/dL (442-707 micromol/L) at baseline. Probabilistic sensitivity analysis was performed to evaluate the stability of the results.At 3 years, mean total costs per patient were estimated at 6.67 million yen (US$56,982) in the AST-120 group and 9.38 million yen (US$80,196) in the placebo group. Mean total costs were 2.72 million yen (US$23,205) lower among patients receiving AST-120. QALY per patient were 0.295 (approximately 3.5 months) greater for patients receiving AST-120 than for those receiving placebo over 3 years. The finding that treatment with AST-120 dominated placebo (i.e. was less costly and resulted in more QALY) was upheld in sensitivity analyses.The use of AST-120 in patients with advanced chronic kidney disease may help to slow the rate of growth in expenditures for kidney disease.

  View details for PubMedID 18518936

• Association between the medicare Modernization Act of 2003 and patient wait times and travel distance for chemotherapy JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Shea, A. M., Curtis, L. H., Hammill, B. G., DiMartino, L. D., Abernethy, A. P., Schulman, K. A. 2008; 300 (2): 189–96

  Abstract

  The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) altered reimbursements for outpatient chemotherapy drugs and drug administration services. Anecdotal reports suggest that these adjustments may have negatively affected access to chemotherapy for Medicare beneficiaries.To compare patient wait times and travel distances for chemotherapy before and after the enactment of the MMA.Analysis of a nationally representative 5% sample of claims from the Centers for Medicare & Medicaid Services for the period 2003 through 2006. Patients were Medicare beneficiaries with incident breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma who received chemotherapy in inpatient hospital, institutional outpatient, or physician office settings.Days from incident diagnosis to first chemotherapy visit and distance traveled for treatment, controlling for age, sex, race/ethnicity, cancer type, geographic region, comorbid conditions, and year of diagnosis and treatment.There were 5082 incident cases of breast cancer, colorectal cancer, leukemia, lung cancer, or lymphoma in 2003; 5379 cases in 2004; 5116 cases in 2005; and 5288 cases in 2006. Approximately 70% of patients received treatment in physician office settings in each year. Although the distribution of treatment settings in 2004 and 2005 was not significantly different from 2003 (P = .24 and P = .72, respectively), there was a small but significant change from 2003 to 2006 (P = .02). The proportion of patients receiving chemotherapy in inpatient settings decreased from 10.2% in 2003 to 8.8% in 2006 (P = .03), and the proportion in institutional outpatient settings increased from 21.1% to 22.5% (P = .004). The proportion in physician offices remained at 68.7% (P = .29). The median time from diagnosis to initial chemotherapy visit was 28 days in 2003, 27 days in 2004, 29 days in 2005, and 28 days in 2006. In multivariate analyses, average wait times for chemotherapy were 1.96 days longer in 2005 than in 2003 (95% confidence interval [CI], 0.11-3.80 days; P = .04) but not significantly different in 2006 (0.88 days; 95% CI, -0.96 to 2.71 days; P = .35). Median travel distance was 7 miles (11.2 km) in 2003 and 8 miles (12.8 km) in 2004 through 2006. After adjustment, average travel distance remained slightly longer in 2004 (1.47 miles [2.35 km]; 95% CI, 0.87-2.07 miles [1.39-3.31 km]; P < .001), 2005 (1.19 miles [1.90 km]; 95% CI, 0.58-1.80 miles [0.93-2.88 km]; P < .001), and 2006 (1.30 miles [2.08 km]; 95% CI, 0.69-1.90 miles [1.10-3.04 km]; P < .001) compared with 2003.There have not been major changes in travel distance and patient wait times for chemotherapy in the Medicare population since 2003, the year before MMA-related changes in reimbursement.

  View details for DOI 10.1001/jama.300.2.189

  View details for Web of Science ID 000257435500023

  View details for PubMedID 18612116

• Expectations of benefit in early-phase clinical trials: Implications for assessing the adequacy of informed consent MEDICAL DECISION MAKING Weinfurt, K. P., Seils, D. M., Tzeng, J. P., Compton, K. L., Sulmasy, D. P., Astrow, A. B., Solarino, N. A., Schulman, K. A., Meropol, N. J. 2008; 28 (4): 575–81

  Abstract

  Participants in early-phase clinical trials have reported high expectations of benefit from their participation. There is concern that participants misunderstand the trials to which they have consented, which is based on assumptions about what patients mean when responding to questions about likelihood of benefit.Participants were 27 women and 18 men in early-phase oncology trials at 2 academic medical centers in the United States. To determine whether expectations of benefit differ depending on how patients are queried, the authors randomly assigned participants to 1 of 3 interviews corresponding to 3 questions about likelihood of benefit: frequency type, belief type, and vague. In semistructured interviews, participants were queried about how they understood and answered the question. Participants then answered and discussed 1 of the other questions.Expectations of benefit in response to the belief-type question were significantly greater than expectations in response to the frequency-type and vague questions (P=0:02). The most common justifications involved positive attitude (n=27 [60%]) and references to physical health (n=23 [51%]). References to positive attitude were most common among participants with higher (> 70%) expectations (n = 11 [85%]) and least common among those with lower ( < 50%) expectations (n = 3 [27%]).The wording of questions about likelihood of benefit shapes the expectations that patients express. Patients who express high expectations may not do so to communicate understanding but rather to register optimism. Ongoing research will clarify the meaning of high expectations and examine methods for assessing understanding.

  View details for DOI 10.1177/0272989X08315242

  View details for Web of Science ID 000257836200013

  View details for PubMedID 18378940

  View details for PubMedCentralID PMC2630499

• Identification of patients with diabetic macular edema from claims data - A validation study ARCHIVES OF OPHTHALMOLOGY Bearelly, S., Mruthyunjaya, P., Tzeng, J. P., Suner, I. J., Shea, A. M., Lee, J. T., Kowalski, J. W., Curtis, L. H., Schulman, K. A., Lee, P. P. 2008; 126 (7): 986-989

  Abstract

  To assess the validity of an algorithm for identifying patients with diabetic macular edema (DME) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes in administrative billing data from a convenience sample of physician offices.A convenience sample of 12 general ophthalmologists and 10 retina specialists applied prespecified algorithms based on ICD-9-CM diagnosis codes to the billing claims of their practices and selected the associated medical records. Four ophthalmologists abstracted data from the medical records, which were then compared with the coded diagnoses. Main outcome measures were sensitivity, specificity, and the kappa statistic for the DME algorithm (a combination of codes 250.xx and 362.53), treating medical record documentation of DME as the standard criterion.The DME algorithm had a sensitivity of 0.88 and a specificity of 0.96 for identifying DME. Excellent agreement was noted between the algorithm and the medical records (kappa = 0.84). The algorithm performed less well in identifying patients with a diagnosis of clinically significant DME (sensitivity, 0.86; specificity, 0.84; kappa = 0.64).The results of this pilot study suggest that patients with DME can be identified accurately in claims data using ICD-9-CM diagnosis codes. Application of this algorithm could improve investigations of disease prevalence and disease burden and provide an efficient means of assessing care and interventions.

  View details for Web of Science ID 000257511300016

  View details for PubMedID 18625948

• Challenges in enrollment of minority, pediatric, and geriatric patients in emergency and acute care clinical research ANNALS OF EMERGENCY MEDICINE Glickman, S. W., Anstrom, K. J., Lin, L., Chandra, A., Laskowitz, D. T., Woods, C. W., Freeman, D. H., Kraft, M., Beskow, L. M., Weinfurt, K. P., Schulman, K. A., Cairns, C. B. 2008; 51 (6): 775–80

  Abstract

  Emergency department (ED) -based clinical research has the potential to include patient populations that are typically underrepresented in clinical research. The objective of this study is to assess how emergency clinical care and research processes, informed consent, and patient demographic factors (age, sex, and ethnicity/race) affect enrollment and consent in clinical research in the ED.This was an analysis of prospectively collected data of all patients (aged 2 to 101 years) eligible for one of 7 clinical research studies from February 2005 to April 2007 in an academic ED. We measured rates of enrollment and consent in the clinical studies.One thousand two hundred two of the 4418 patients screened for participation in 7 clinical studies were clinically eligible for enrollment. Of the 868 patients who were able to provide a voluntary decision regarding consent, 639 (73.6%) agreed to participate; an overall enrollment rate of 53.2%. The mean age of patients enrolled was 51.8 years (range 3 to 98 years). Black patients (49.2% enrollment) and Latino patients (18.4% enrollment) were less likely to be enrolled in comparison with white patients (58.3% enrollment) (adjusted odds ratio [OR] of enrollment for blacks=0.64; 95% confidence interval [CI] 0.50 to 0.82; adjusted OR of enrollment for Latinos=0.16; 95% CI 0.08 to 0.33). Enrollment rates were lower among pediatric (40.0%) and geriatric patients (49.1%) in comparison with adult patients ages 18 to 64 years (55.5%) (adjusted OR of enrollment for pediatric patients=0.70, 95% CI 0.34 to 1.43; adjusted OR of enrollment for geriatric patients=0.69, 95% CI 0.53 to 0.90). Unique issues contributing to underenrollment included challenges in consent among pediatric and elderly patients, language issues in Latino patients, reduced voluntary consent rates among black patients, and perhaps underuse of minimal risk waivers.In a large academic ED, minority, pediatric, and geriatric patients were less likely to be enrolled in acute care clinical research studies than middle-aged whites. Enrollment and consent strategies designed to enhance research participation in these important patient populations may be necessary to address disparities in the development and application of evidence-based emergency and acute care.

  View details for PubMedID 18191297

• Using health communication best practices to develop a web-based provider-patient communication aid: The CONNECT (TM) study Fleisher, L., Buzaglo, J., Collins, M., Millard, J., Miller, S. M., Egleston, B. L., Solarino, N., Trinastic, J., Cegala, D. J., Benson, A. B., Schulma, K. A., Weinfurt, K. P., Sulmasy, D., Diefenbach, M. A., Meropol, N. J. ELSEVIER IRELAND LTD. 2008: 378–87

  Abstract

  Although there is broad consensus that careful content vetting and user testing is important in the development of technology-based educational interventions, often these steps are overlooked. This paper highlights the development of a theory-guided, web-based communication aid (CONNECT), designed to facilitate treatment decision-making among patients with advanced cancer.The communication aid included an on-line survey, patient skills training module and an automated physician report. Development steps included: (1) evidence-based content development; (2) usability testing; (3) pilot testing; and (4) patient utilization and satisfaction.Usability testing identified some confusing directions and navigation for the on-line survey and validated the relevance of the "patient testimonials" in the skills module. Preliminary satisfaction from the implementation of the communication aid showed that 66% found the survey length reasonable and 70% found it helpful in talking with the physician. Seventy percent reported the skills module helpful and about half found it affected the consultation.Designing patient education interventions for translation into practice requires the integration of health communication best practice including user feedback along the developmental process.This developmental process can be translated to a broad array of community-based patient and provider educational interventions.

  View details for DOI 10.1016/j.pec.2008.02.017

  View details for Web of Science ID 000256846100010

  View details for PubMedID 18417312

  View details for PubMedCentralID PMC2509582

• The relationship between care patterns and receipt of ICDs among medicare beneficiaries Curtis, L. H., Greiner, M. A., Hernandez, A. F., Schulman, K. A. LIPPINCOTT WILLIAMS & WILKINS. 2008: E429

  View details for Web of Science ID 000256160700107

• Effect of cardiac rehabilitation visits on survival among medicare beneficiaries Hammill, B. G., Curtis, L. H., Schulman, K. A., Whellan, D. LIPPINCOTT WILLIAMS & WILKINS. 2008: E417

  View details for Web of Science ID 000256160700056

• Consistency of Financial Interest Disclosures in the Biomedical Literature: The Case of Coronary Stents PLOS ONE Weinfurt, K. P., Seils, D. M., Tzeng, J. P., Lin, L., Schulman, K. A., Califf, R. M. 2008; 3 (5): e2128

  Abstract

  Disclosure of authors' financial interests has been proposed as a strategy for protecting the integrity of the biomedical literature. We examined whether authors' financial interests were disclosed consistently in articles on coronary stents published in 2006.We searched PubMed for English-language articles published in 2006 that provided evidence or guidance regarding the use of coronary artery stents. We recorded article characteristics, including information about authors' financial disclosures. The main outcome measures were the prevalence, nature, and consistency of financial disclosures. There were 746 articles, 2985 authors, and 135 journals in the database. Eighty-three percent of the articles did not contain disclosure statements for any author (including declarations of no interests). Only 6% of authors had an article with a disclosure statement. In comparisons between articles by the same author, the types of disagreement were as follows: no disclosure statements vs declarations of no interests (64%); specific disclosures vs no disclosure statements (34%); and specific disclosures vs declarations of no interests (2%). Among the 75 authors who disclosed at least 1 relationship with an organization, there were 2 cases (3%) in which the organization was disclosed in every article the author wrote.In the rare instances when financial interests were disclosed, they were not disclosed consistently, suggesting that there are problems with transparency in an area of the literature that has important implications for patient care. Our findings suggest that the inconsistencies we observed are due to both the policies of journals and the behavior of some authors.

  View details for PubMedID 18461146

• Evidence-based perspectives on pay for performance and quality of patient care and outcomes in emergency medicine ANNALS OF EMERGENCY MEDICINE Glickman, S. W., Schulman, K. A., Peterson, E. D., Hocker, M. B., Cairns, C. B. 2008; 51 (5): 622–31

  Abstract

  Pay for performance is gaining momentum as a means to improve the quality of clinical care. Recently, the Centers for Medicare & Medicaid Services has expanded pay for performance initiatives to incorporate 9 emergency care metrics, including indicators for cardiac, pneumonia, and stroke care. The American College of Cardiology and American Heart Association (ACC/AHA) have published methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care. The purpose of this study is to grade each of the 9 Physician Quality Reporting Initiative emergency medicine process measures according to the ACC/AHA criteria related to clinical evidence (yes, no, indeterminate). Five of the 9 recently selected metrics in emergency medicine do not appear to meet all of the ACC/AHA criteria for measurement selection. Several of the metrics, including aspirin for acute myocardial infarction (mean hospital adherence 94.7%; SD 6.7%) and pulse oximetry for community-acquired pneumonia (mean 99.4%; SD 2.0%), already have high levels of performance nationally, which raises uncertainty about the overall cost-effectiveness of quality improvement interventions for these measures. Formal methodology needs to be established for future selection of performance measures for quality improvement programs in emergency care. These performance measures should focus on unique aspects of emergency and acute care, including recognition and treatment of time-sensitive life-threatening conditions, assessment of patients with undifferentiated signs and symptoms, and care of all-inclusive geographically based patient populations. In key emergency therapeutic areas, the evidence linking treatment and improved patient outcomes will require additional study before inclusion in pay for performance programs. New research initiatives are needed to assess the effect of timely administration of emergency department interventions on patient outcomes.

  View details for DOI 10.1016/j.annemergmed.2008.01.010

  View details for Web of Science ID 000255487200010

  View details for PubMedID 18358566

• Primary PCI in ST-segment elevation myocardial infarction NEW ENGLAND JOURNAL OF MEDICINE Glickman, S. W., Schulman, K. A., Cairns, C. B. 2008; 358 (16): 1751–52

  View details for Web of Science ID 000254966600020

  View details for PubMedID 18426001

• Medical costs of abnormal serum sodium levels JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY Shea, A. M., Hammill, B. G., Curtis, L. H., Szczech, L. A., Schulman, K. A. 2008; 19 (4): 764–70

  Abstract

  An abnormal serum sodium level is the most common electrolyte disorder in the United States and can have a significant impact on morbidity and mortality. The direct medical costs of abnormal serum sodium levels are not well understood. The impact of hyponatremia and hypernatremia on 6-mo and 1-yr direct medical costs was examined by analyzing data from the Integrated HealthCare Information Services National Managed Care Benchmark Database. During the period analyzed, there were 1274 patients (0.8%) with hyponatremia (serum sodium <135 mmol/L), 162,829 (97.3%) with normal serum sodium levels, and 3196 (1.9%) with hypernatremia (>145 mmol/L). Controlling for age, sex, region, and comorbidities, hyponatremia was a significant independent predictor of costs at 6 mo (41.2% increase in costs; 95% confidence interval, 30.3% to 53.0%) and at 1 yr (45.7% increase; 95% confidence interval, 34.2% to 58.2%). Costs associated with hypernatremia were not significantly different from those incurred by patients with normal serum sodium. In conclusion, hyponatremia is a significant independent predictor of 6-mo and 1-yr direct medical costs.

  View details for DOI 10.1681/ASN.2007070752

  View details for Web of Science ID 000254659100019

  View details for PubMedID 18216314

  View details for PubMedCentralID PMC2390974

• Impact of heart failure on patients undergoing major noncardiac surgery ANESTHESIOLOGY Hammill, B. G., Curtis, L. H., Bennett-Guerrero, E., O'Connor, C. M., Jollis, J. G., Schulman, K. A., Hernandez, A. F. 2008; 108 (4): 559–67

  Abstract

  Changes in the demographics and epidemiology of patients with cardiovascular comorbidities who undergo major noncardiac surgery require an updated assessment of which patients are at greater risk of mortality or readmission. The authors evaluated short-term outcomes among patients with heart failure, coronary artery disease (CAD), or neither who underwent major noncardiac surgery.Patients were aged 65 and older, had Medicare fee-for-service coverage, and underwent 1 of 13 major noncardiac procedures from 2000 through 2004, excluding patients with end-stage renal disease and patients who did not have at least 1 yr of Medicare fee-for-service eligibility before surgery. Main outcome measures were operative mortality and 30-day all-cause readmission.Of 159,327 procedures, 18% were performed in patients with heart failure and 34% were performed in patients with CAD. Adjusted hazard ratios of mortality and readmission for patients with heart failure, compared with patients with neither heart failure nor CAD, were 1.63 (95% confidence interval, 1.52-1.74) and 1.51 (95% confidence interval, 1.45-1.58), respectively. Adjusted hazard ratios of mortality and readmission for patients with CAD, compared with patients with neither heart failure nor CAD, were 1.08 (95% confidence interval, 1.01-1.16) and 1.16 (95% confidence interval, 1.12-1.20), respectively. These effects were statistically significant. Patients with heart failure were at significantly higher risk for both outcomes compared with patients with CAD.Elderly patients with heart failure who undergo major surgical procedures have substantially higher risks of operative mortality and hospital readmission than other patients, including those with coronary disease, admitted for the same procedures. Improvements in perioperative care are needed for the growing population of patients with heart failure undergoing major noncardiac surgery.

  View details for DOI 10.1097/ALN.0b013e31816725ef

  View details for Web of Science ID 000254467500005

  View details for PubMedID 18362586

• Outcomes of second revascularization procedures after stent implantation JOURNAL OF MEDICAL SYSTEMS Konstance, R. P., Eisenstein, E. L., Anstrom, K. J., Shaw, L. K., Califf, R. M., Harrington, R. A., Matchar, D. B., Schulman, K. A., Kong, D. F. 2008; 32 (2): 177–86

  Abstract

  Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease. Between January 2000 and July 2005, 4,666 consecutive patients underwent initial coronary stent implantation (DES or BMS). From this population we identified 569 patients undergoing a second target vessel revascularization (DES, BMS, PTCA or CABG). Outcomes were assessed at 6, 12, and 24 months after the second procedure, with follow-up through September 2006. Adjusted cumulative incidence rates were calculated using inverse probability weighted estimators. We found that at 24 months, there were no significant differences in death or myocardial infarction for PTCA, BMS, DES, and CABG (17.7%, 14.9%, 7.5%, and 10.2%, p = 0.26[3dfl]). DES patients had lower rates of death or myocardial infarction or third target vessel procedures than patients receiving PTCA (14.6% vs. 30.0%, p = 0.01) and BMS (14.6% vs. 42.2%, p < 0.01), but rates similar to CABG patients (14.6% vs. 14.6%, p = 0.99). For patients undergoing a second revascularization procedure, PTCA, BMS, DES, and CABG are associated with a similar risk of death or nonfatal myocardial infarction. DES and CABG are associated with lower rates of third revascularization procedures compared to PTCA and BMS. Further studies are needed to determine the optimum application for CABG vs. DES as a second or third revascularization procedure.

  View details for PubMedID 18461821

• Underuse of left ventricular function assessment in patients with newly diagnosed heart failure Curtis, L. H., Shea, A. M., Hammill, B. G., Schulman, K. A., Douglas, P. S. ELSEVIER SCIENCE INC. 2008: A238–A239

  View details for Web of Science ID 000253997101472

• Relationships among the Kansas City cardiomyopathy questionnaire and clinical measures in patients with heart failure Flynn, K. E., Lin, L., Ellis, S., Fine, L., Pina, I., Roll, S., Russell, S., Schulman, K., Spertus, J., Whelan, D., Weinfurt, K. ELSEVIER SCIENCE INC. 2008: A269

  View details for Web of Science ID 000253997102065

• Racial/ethnic variation in perceptions of medical information sources in Durham County, North Carolina. North Carolina medical journal Williams, J. E., Anstrom, K. J., Friedman, J. Y., Schulman, K. A. 2008; 68 (6): 391-8

  Abstract

  Concerns about health and health care disparities have led some groups to promote better communication of medical information as a potential means of empowering patients to overcome barriers to health care and to practice healthy behaviors. We examined the independent effect of race/ethnicity on perceptions of the usefulness of different sources of health information.We analyzed data from a cross-sectional telephone survey of black, Latino, and white adults (n = 515) in Durham County North Carolina, in 2002. Respondents rated the usefulness of medical information sources, nonmedical information sources, and media. We used logistic regression to determine the effect of race/ethnicity on ratings of information sources, adjusting for demographic, socioeconomic, and health status factors.Compared to white respondents, Latinos and black respondents were more likely to perceive as useful the local health department, ministers/churches, community centers, television, and radio. Latinos were less likely than white and black respondents to report the pharmacy as a useful source of medical information.Some findings may be particular to Durham County, especially those based on the Latino subgroup. Also, the response rate (43%) suggests that nonresponse bias may have affected our results. Finally perceived usefulness may affect one's intent to act on information but may not correlate with the benefit gained from a particular source.There are substantial racial/ethnic differences in perceptions of certain medical information sources. Medical information designed for minority populations may be more effective if disseminated through particular sources.

  View details for PubMedID 18236855

• Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin GENETICS IN MEDICINE Flockhart, D. A., O'Kane, D., Williams, M. S., Watson, M. S., Flockhart, D. A., Gage, B., Gandolfi, R., King, R., Lyon, E., Nussbaum, R., O'Kane, D., Schulman, K., Veenstra, D., Williams, M. S., Watson, M. S., ACMG Working Grp Pharmacogenet 2008; 10 (2): 139–50

  Abstract

  American College of Medical Genetics statements and guidelines are designed primarily as an educational resource for medical geneticists and other health care professionals to help them provide quality medical genetic services. Adherence to these standards and guidelines does not necessarily ensure a successful medical outcome. These statements and guidelines should not be considered inclusive of all proper procedures and tests or exclusive of other procedures and tests that are reasonably directed to obtaining the same results. In determining the propriety of any specific procedure or test, the health care professional should apply his or her own professional judgment to the specific clinical circumstances presented by the individual patient or specimen. It may be prudent, however, to document in the patient's record the rationale for any significant deviation from these standards and guidelines. Warfarin (Coumadin) is a potent drug that when used judiciously and monitored closely, leads to substantial reductions in morbidity and mortality from thromboembolic events. However, even with careful monitoring, initiation of warfarin dosing is associated with highly variable responses between individuals and challenges achieving and maintaining levels within the narrow therapeutic range that can lead to adverse drug events. Variants of two genes, CYP2C9 and VKORC1, account for 30-50% of the variability in dosing of warfarin; thus, many believe that testing of these genes will aid in warfarin dosing recommendations. Evidence about this test is evolving rapidly, as is its translation into clinical practice. In an effort to address this situation, a multidisciplinary expert group was organized in November 2006 to evaluate the role of CYP2C9 and VKORC1 testing in altering warfarin-related therapeutic goals and reduction of adverse drug events. A recently completed Rapid-ACCE (Analytical, Clinical Validity, Clinical Utility, and Ethical, Legal, and Social Implications) Review, commissioned to inform this work group, was the foundation for this analysis. From this effort, specific recommendations for the appropriate use of CYP2C9 and VKORC1 testing were developed and are presented here. The group determined that the analytical validity of these tests has been met, and there is strong evidence to support association between these genetic variants and therapeutic dose of warfarin. However, there is insufficient evidence, at this time, to recommend for or against routine CYP2C9 and VKORC1 testing in warfarin-naive patients. Prospective clinical trials are needed that provide direct evidence of the benefits, disadvantages, and costs associated with this testing in the setting of initial warfarin dosing. Although the routine use of warfarin genotyping is not endorsed by this work group at this time, in certain situations, CYP2C9 and VKORC1 testing may be useful, and warranted, in determining the cause of unusual therapeutic responses to warfarin therapy.

  View details for DOI 10.1097/G1M.0b013e318163c35f

  View details for Web of Science ID 000253277400010

  View details for PubMedID 18281922

• Incidence and prevalence of heart failure in elderly persons, 1994-2003 ARCHIVES OF INTERNAL MEDICINE Curtis, L. H., Whellan, D. J., Hammill, B. G., Hernandez, A. F., Anstrom, K. J., Shea, A. M., Schulman, K. A. 2008; 168 (4): 418–24

  Abstract

  Recent analyses have presented conflicting evidence regarding the incidence and prevalence of heart failure in the United States. We sought to estimate the annual incidence and prevalence of heart failure and associated survival in elderly persons from January 1, 1994, through December 31, 2003.We conducted a retrospective cohort study of 622,789 Medicare beneficiaries 65 years or older who were diagnosed as having heart failure between 1994 and 2003. The main outcome measures were incidence and prevalence of heart failure and survival following a heart failure diagnosis.The incidence of heart failure declined from 32 per 1000 person-years in 1994 to 29 per 1000 person-years in 2003 (P < .01). Incidence declined most sharply among beneficiaries aged 80 to 84 years (from 57.5 to 48.4 per 1000 person-years, P < .01) and increased slightly among beneficiaries aged 65 to 69 years (from 17.5 to 19.3 per 1000 person-years, P < .01). Although risk-adjusted mortality declined slightly from 1994 to 2003, the prognosis for patients diagnosed as having heart failure remains poor. In 2002, risk-adjusted 1-year mortality was 27.5%, more than 3 times higher than for age- and sex-matched patients.Although the incidence of heart failure has declined somewhat during the past decade, modest survival gains have resulted in an increase in the number of patients living with heart failure. Identifying optimal strategies for the treatment and management of heart failure will become increasingly important as the size of the Medicare population grows.

  View details for DOI 10.1001/archinternmed.2007.80

  View details for Web of Science ID 000253374600013

  View details for PubMedID 18299498

• Sensitivity of International Classification of Diseases codes for hyponatremia among commercially insured outpatients in the United States BMC NEPHROLOGY Shea, A. M., Curtis, L. H., Szczech, L. A., Schulman, K. A. 2008; 9: 5

  Abstract

  Administrative claims are a rich source of information for epidemiological and health services research; however, the ability to accurately capture specific diseases or complications using claims data has been debated. In this study, the authors examined the validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes for the identification of hyponatremia in an outpatient managed care population.We analyzed outpatient laboratory and professional claims for patients aged 18 years and older in the National Managed Care Benchmark Database from Integrated Healthcare Information Services. We obtained all claims for outpatient serum sodium laboratory tests performed in 2004 and 2005, and all outpatient professional claims with a primary or secondary ICD-9-CM diagnosis code of hyponatremia (276.1).A total of 40,668 outpatient serum sodium laboratory results were identified as hyponatremic (serum sodium < 136 mmol/L). The sensitivity of ICD-9-CM codes for hyponatremia in outpatient professional claims within 15 days before or after the laboratory date was 3.5%. Even for severe cases (serum sodium < or = 125 mmol/L), sensitivity was < 30%. Specificity was > 99% for all cutoff points.ICD-9-CM codes in administrative data are insufficient to identify hyponatremia in an outpatient population.

  View details for DOI 10.1186/1471-2369-9-5

  View details for Web of Science ID 000207664700005

  View details for PubMedID 18564417

  View details for PubMedCentralID PMC2447828

• Understanding types of innovation and implications for policy Diffusion and Use of Genomic Innovations in Health and Medicine: Workshop Summary Schulman, K. A. National Academies Press. 2008
• Pancreatic beta-cell function as a predictor of cardiovascular outcomes and costs: findings from the Cardiovascular Health Study CURRENT MEDICAL RESEARCH AND OPINION Curtis, L. H., Hammill, B. G., Bethel, M., Anstrom, K. J., Liao, L., Gottdiener, J. S., Schulman, K. A. 2008; 24 (1): 41–50

  Abstract

  To explore relationships between beta-cell function and incident cardiovascular events, death, and medical costs among elderly individuals.In a prospective, population-based cohort of 4555 elderly individuals, we examined the effect of beta-cell function on incident cardiovascular events and mortality. We also examined costs for 3715 of these individuals. We used the computer-based homeostasis model assessment (HOMA) to calculate indices of beta-cell function (HOMA-%B) and insulin sensitivity (HOMA-%S) using baseline fasting glucose and insulin levels. All subjects were followed from 1992/1993 for 6 years or until death.Discrete-time survival model of the effects of beta-cell function on incident cardiovascular events and all-cause mortality; and semiparametric estimators for calculations of mean 6-year costs.Controlling for HOMA-%S, a 20% decrease in HOMA-%B was associated with increased odds of incident cardiovascular events (odds ratio [OR], 1.09; 95% confidence interval [CI], 1.05-1.14) and death (OR, 1.10; 95% CI, 1.07-1.14). The relationships persisted after controlling for clinical and sociodemographic confounders. A 20% decrease in HOMA-%B was also associated with increased costs (cost ratio, 1.03; 95% CI, 1.01-1.05). The significant association did not persist after controlling for confounders.The sample comprises relatively healthy elderly individuals and is based on data from 1992 through 1999, which may not reflect current experience. The measure of beta-cell function is an estimate generated from single measures of glucose and insulin.Beta-cell function as measured by HOMA-%B is a significant predictor of incident cardiovascular events and mortality but not of costs, controlling for HOMA-%S and sociodemographic and clinical confounders.

  View details for PubMedID 18021490

• Using Medicare Administrative Data to Conduct Postmarketing Surveillance of Follow-On Biologics: Issues and Opportunities FOOD AND DRUG LAW JOURNAL Di Martino, L. D., Curtis, L. H., Williams, R. L., Abernethy, D. R., Schulman, K. A. 2008; 63 (4): 891–900

  View details for PubMedID 19601387

• Economic implications of potential changes to regulatory and reimbursement policies for medical devices Reed, S. D., Shea, A. M., Schulman, K. A. SPRINGER. 2008: 50–56

  Abstract

  To evaluate the impact of regulatory scenarios on the financial viability of medical device companies.We developed a model to calculate the expected net present value of a hypothetical product throughout preclinical development, clinical testing, regulatory approval, and postmarketing. We tested 3 scenarios: (1) the current regulatory environment; (2) a scenario in which medical devices are subject to the same evidence standards required for pharmaceuticals; and (3) a scenario consistent with the Coverage with Evidence Development: Coverage with Study Participation (CSP) policy proposed by the Centers for Medicare and Medicaid Services, whereby Medicare will pay for beneficiaries to receive new devices that are not currently determined to be "reasonable and necessary" if the patients participate in clinical studies or registries.When applying assumptions consistent with the implantable cardioverter-defibrillator market, the net present value at the start of development was an estimated $553 million in the current regulatory environment, $322 million in the pharmaceutical scenario, and $403 million in the CSP scenario. Sensitivity analyses showed that the device industry would likely be profitable in all 3 scenarios over a range of assumptions.The environment in which the medical device industry operates is financially attractive. Furthermore, when compared with the alternative of applying the same evidence standards for pharmaceuticals to medical devices, the CSP policy offers improved financial incentives for medical device companies.

  View details for DOI 10.1007/s1106-007-0246-9

  View details for Web of Science ID 000252212300011

  View details for PubMedID 18095045

  View details for PubMedCentralID PMC2150632

• Economic Evaluation of Pharmaceuticals and Clinical Practice DRUG BENEFITS AND RISKS: INTERNATIONAL TEXTBOOK OF CLINICAL PHARMACOLOGY Schulman, K. A., Glick, H. A., Polsky, D., John, K. R., VanBoxtel, C. J., Santoso, B., Edwards, I. R. 2008: 37–55

  View details for Web of Science ID 000271870700009

• Using item banks to construct measures of patient reported outcomes in clinical trials: investigator perceptions CLINICAL TRIALS Flynn, K. E., Dombeck, C. B., DeWitt, E., Schulman, K. A., Weinfurt, K. P. 2008; 5 (6): 575–86

  Abstract

  Item response theory (IRT) promises more sensitive and efficient measurement of patient-reported outcomes (PROs) than traditional approaches; however, the selection and use of PRO measures from IRT-based item banks differ from current methods of using PRO measures.To anticipate barriers to the adoption of IRT item banks into clinical trials.We conducted semistructured telephone or in-person interviews with 42 clinical researchers who published results from clinical trials in the Journal of the American Medical Association, the New England Journal of Medicine, or other leading clinical journals from July 2005 through May 2006. Interviews included a brief tutorial on IRT item banks.After the tutorial, 39 of 42 participants understood the novel products available from an IRT item bank, namely customized short forms and computerized adaptive testing. Most participants (38/42) thought that item banks could be useful in their clinical trials, but they mentioned several potential barriers to adoption, including economic and logistical constraints, concerns about whether item banks are better than current PRO measures, concerns about how to convince study personnel or statisticians to use item banks, concerns about FDA or sponsor acceptance, and the lack of availability of item banks validated in specific disease populations.Selection bias might have led to more positive responses to the concept of item banks in clinical trials.Clinical investigators are open to a new method of PRO measurement offered in IRT item banks, but bank developers must address investigator and stakeholder concerns before widespread adoption can be expected.

  View details for PubMedID 19029206

• Updated estimates of survival and cost effectiveness for imatinib versus interferon-alpha plus low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukaemia PHARMACOECONOMICS Reed, S. D., Anstrom, K. J., Li, Y., Schulman, K. A. 2008; 26 (5): 435–46

  Abstract

  For trials in which participants are followed beyond the main study period to assess long-term outcomes, economic evaluations conducted using short-term data should be systematically updated to reflect new information.We used 60-month survival data from the IRIS (International Randomized study of Interferon vs STI571) trial to update previously published cost-effectiveness estimates, based on 19 months of follow-up, of imatinib versus interferon (IFN)-alpha plus low-dose cytarabine in patients with chronic-phase chronic myeloid leukaemia. For patients treated with imatinib, we used the 60-month data to calibrate the survival curves generated from the original cost-effectiveness model. We used historical data to model survival for patients randomized to IFNalpha. We updated costs for medical resources using 2006 Medicare reimbursement rates and applied average wholesale prices (AWPs) and wholesale acquisition costs (WACs) to study medications.Five-year survival for patients randomized to imatinib was better than predicted in the original model (89.4% vs 83.2%). We estimated remaining life expectancy with first-line imatinib to be 19.1 life-years (3.8 life-years over the original model) and 15.2 QALYs (3.1 QALYs over the original estimate). Estimates for IFNalpha remained at 9.1 life-years and 6.3 QALYs. When we applied AWPs to study medications, incremental cost-effectiveness ratios (ICERs) were $US 51,800-57,500 per QALY. When we applied WACs, ICERs were $US 42,000-46,200 per QALY.Although the analysis revealed that the original survival estimates were conservative, the updated cost-effectiveness ratios were consistent with, or slightly higher than, the original estimates, depending on the method for assigning costs to study medications.

  View details for PubMedID 18429659

• Characteristics of nontraumatic subarachnoid hemorrhage in the United States in 2003. Neurosurgery Shea, A. M., Reed, S. D., Curtis, L. H., Alexander, M. J., Villani, J. J., Schulman, K. A. 2007; 61 (6): 1131-7; discussion 1137-8

  Abstract

  Substantial progress has been made in the diagnosis and treatment of subarachnoid hemorrhage (SAH). However, studies of SAH in the United States do not include information more recent than 2001, precluding analysis of shifts in treatment methods. We examined the epidemiology and in-hospital outcomes of nontraumatic SAH in the United States.We analyzed nationally representative data from the 2003 Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project to determine demographic and hospital characteristics, treatments, and in-hospital outcomes of patients with nontraumatic SAH.In 2003, there were an estimated 31,476 discharges for nontraumatic SAH among patients aged 17 years or older, or 14.5 discharges per 100,000 adults. The in-hospital mortality rate was 25.3%. Microvascular clipping was performed in 7513 discharges, or 23.9% of inpatients with nontraumatic SAH; endovascular coiling was performed in 2849 discharges (9.1%). Adjusted odds of treatment with either procedure were significantly higher in urban teaching hospitals compared with urban nonteaching hospitals (odds ratio, 1.62; 95% confidence interval, 1.00-2.62) or rural hospitals (odds ratio, 3.08; 95% confidence interval, 1.93-4.91).The in-hospital mortality rate associated with nontraumatic SAH continues to exceed 25%. Although it is unclear how many patients with nontraumatic SAH were actually diagnosed with a cerebral aneurysm, this study suggests that less than one-third of patients hospitalized for SAH receive surgical or endovascular treatment. Prospective studies are needed to elucidate either what systematic coding error is occurring in the national database or why patients may not receive treatment to secure a ruptured aneurysm.

  View details for DOI 10.1227/01.neu.0000306090.30517.ae

  View details for PubMedID 18162891

• Promoting quality: the health-care organization from a management perspective. International journal for quality in health care : journal of the International Society for Quality in Health Care Glickman, S. W., Baggett, K. A., Krubert, C. G., Peterson, E. D., Schulman, K. A. 2007; 19 (6): 341-8

  Abstract

  Although agreement about the need for quality improvement in health care is almost universal, the means of achieving effective improvement in overall care is not well understood. Avedis Donabedian developed the structure-process-outcome framework in which to think about quality-improvement efforts.There is now a robust evidence-base in the quality-improvement literature on process and outcomes, but structure has received considerably less attention. The health-care field would benefit from expanding the current interpretation of structure to include broader perspectives on organizational attributes as primary determinants of process change and quality improvement.We highlight and discuss the following key elements of organizational attributes from a management perspective: (i) executive management, including senior leadership and board responsibilities (ii) culture, (iii) organizational design, (iv) incentive structures and (v) information management and technology. We discuss the relevant contributions from the business and medical literature for each element, and provide this framework as a roadmap for future research in an effort to develop the optimal definition of 'structure' for transforming quality-improvement initiatives.

  View details for DOI 10.1093/intqhc/mzm047

  View details for PubMedID 17947386

• A framework for quality improvement: an analysis of factors responsible for improvement at hospitals participating in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) quality improvement initiative. American heart journal Glickman, S. W., Boulding, W., Staelin, R., Mulgund, J., Roe, M. T., Lytle, B. L., Rumsfeld, J. S., Gibler, W. B., Ohman, E. M., Schulman, K. A., Peterson, E. D. 2007; 154 (6): 1206-20

  Abstract

  Hospitals are under increasing pressure to improve their quality of care. However, a key question remains: how can hospitals best design and implement successful quality improvement (QI) programs? Hospitals currently employ a variety of QI initiatives but have little empirical evidence on which to base their quality efforts.We designed and applied a hospital cross-sectional survey to 212 hospitals participating in CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the American College of Cardiology/American Heart Association Guidelines), a voluntary QI initiative of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS). We factor analysis and an ordinary least squares regression model to determine the key hospital factors most associated with unexpected improvements in institutional QI in the treatment of NSTE ACS.From 2002 to 2004, the following factors had a significant association with unexpected increases in the 2004 QI in NSTE ACS treatment: the use of CRUSADE QI tools, clinical commitment to quality by a cardiology coadvocate, institutional financial commitment to quality, and barriers to QI related to resource availability and cultural resistance to change (all P < .10). Of these factors, optimal use of CRUSADE QI tools was associated with the highest absolute improvement in process adherence score relative to other factors.We identified several institutional factors associated with improved quality of care in the treatment of high-risk NSTE ACS. We hope that this evidence-based framework will help guide the development and implementation of future QI programs in order to improve the institutional quality of care for NSTE ACS.

  View details for DOI 10.1016/j.ahj.2007.08.001

  View details for PubMedID 18035096

• The medicare modernization act and reimbursement for outpatient chemotherapy - Do patients perceive changes in access to care? CANCER Friedman, J. Y., Curtis, L. H., Hammill, B. G., Dhillon, J. K., Weaver, C. H., Biswas, S., Abernethy, A. P., Schulman, K. A. 2007; 110 (10): 2304–12

  Abstract

  The primary objectives were to measure and compare time to initiation of chemotherapy for patients undergoing treatment either before or after the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), and to measure and compare the location of care for patients undergoing chemotherapy either before or after the enactment of the MMA.A Web-based survey was conducted of a convenience sample of patients with cancer.A total of 1421 respondents completed the survey, 684 in the pre-MMA group and 737 in the post-MMA group. Respondents aged >or=65 years in both the pre-MMA and post-MMA groups had a median waiting time to chemotherapy of 3.0 weeks (P = .74). Most respondents aged >or=65 years received chemotherapy in outpatient hospital infusion centers or centers affiliated with private practices (73% in the pre-MMA group vs 62% in the post-MMA group; P = .02). However, in multivariate analysis there was no statistically significant difference in treatment location between the pre-MMA and post-MMA cohorts.Overall, the findings do not support generalizations from anecdotal reports that patients have been affected by the change in reimbursement to oncologists for chemotherapy as a result of the MMA. The analysis may be confounded by payments to physicians in the concurrent Centers for Medicare and Medicaid Services cancer demonstration project because these payments may have delayed changes in care. Moreover, research is needed to examine the effects of the legislation on vulnerable populations.

  View details for DOI 10.1002/cncr.23042

  View details for Web of Science ID 000250911000021

  View details for PubMedID 17924373

• The impact of for-profit hospital status an the care and outcomes of patients with non-ST-Segment elevation myocardial infarction JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Shah, B. R., Glickman, S. W., Liang, L., Gibler, W. B., Ohman, E. M., Pollack, C. V., Roe, M. T., Peterson, E. D. 2007; 50 (15): 1462-1468

  Abstract

  We sought to determine whether for-profit status influenced hospitals' care or outcomes among non-ST-segment elevation myocardial infarction (NSTEMI) patients.While for-profit hospitals potentially have financial incentives to selectively care for younger, healthier patients, perform highly reimbursed procedures, reduce costs by limiting access to expensive medications, and encourage shorter in-patient length of stay, there are limited data available to investigate these issues objectively.Using data from the CRUSADE (Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the American College of Cardiology/American Heart Association guidelines) Initiative, we investigated whether for-profit status influenced hospitals' patient case mix, care, or outcomes among 145,357 patients with NSTEMI treated between January 1, 2001, and December 31, 2005, at 532 U.S. hospitals. Impact of for-profit status on care and outcomes was analyzed overall and after adjustment for clinical and facility factors using regression modeling.Patients (n = 11,658) treated at 58 for-profit hospitals were of similar age and gender, but were more likely to be nonwhite (black, Asian, Hispanic, and other) and have health maintenance organization/private insurance, diabetes mellitus, congestive heart failure, hypertension, and renal insufficiency compared with 133,699 patients treated at 474 nonprofit hospitals. For-profit hospitals were less likely to use discharge beta-blockers, but all other treatments were similar including the use of interventional procedures (cardiac catheterization and revascularization procedures) compared with nonprofit centers. In-hospital length of stay and mortality were also similar by hospital type.We found no evidence that for-profit hospitals selectively treat less sick patients, provide less evidence-based care, limit in-hospital stays, or have patients with worse acute outcomes than nonprofit centers.

  View details for DOI 10.1016/j.jacc.2007.07.012

  View details for Web of Science ID 000250115700005

  View details for PubMedID 17919566

• Sex differences in the use of implantable cardioverter-defibrillators for primary and secondary prevention of sudden cardiac death. JAMA Curtis, L. H., Al-Khatib, S. M., Shea, A. M., Hammill, B. G., Hernandez, A. F., Schulman, K. A. 2007; 298 (13): 1517-24

  Abstract

  Previous studies of sex differences in the use of implantable cardioverter-defibrillators (ICDs) predate recent expansions in Medicare coverage and did not provide patient follow-up over multiple years.To examine sex differences in ICD use for primary and secondary prevention of sudden cardiac death.Analysis of a 5% national sample of research-identifiable files obtained from the US Centers for Medicare & Medicaid Services for the period 1991 through 2005. Patients were those aged 65 years or older with Medicare fee-for-service coverage and diagnosed with acute myocardial infarction and either heart failure or cardiomyopathy but no prior cardiac arrest or ventricular tachycardia (ie, the primary prevention cohort [n = 65,917 men and 70,504 women]), or with cardiac arrest or ventricular tachycardia (ie, the secondary prevention cohort [n = 52,252 men and 47,411 women]), from 1999 through 2005.Receipt of ICD therapy and all-cause mortality at 1 year.In the 2005 primary prevention cohort, 32.3 per 1000 men and 8.6 per 1000 women received ICD therapy within 1 year of cohort entry. In multivariate analyses, men were more likely than women to receive ICD therapy (hazard ratio [HR], 3.15; 95% confidence interval [CI], 2.86-3.47). Among men and women alive at 180 days after cohort entry, the hazard of mortality in the subsequent year was not significantly lower among those who received ICD therapy (HR, 1.01; 95% CI, 0.82-1.23). In the 2005 secondary prevention cohort, 102.2 per 1000 men and 38.4 per 1000 women received ICD therapy. Controlling for demographic variables and comorbid conditions, men were more likely than women to receive ICD therapy (HR, 2.44; 95% CI, 2.30-2.59). Among men and women alive at 30 days after cohort entry, the hazard of mortality in the subsequent year was significantly lower among those who received ICD therapy (HR, 0.65; 95% CI, 0.60-0.71).In the Medicare population, women are significantly less likely than men to receive ICD therapy for primary or secondary prevention of sudden cardiac death.

  View details for DOI 10.1001/jama.298.13.1517

  View details for PubMedID 17911496

• Costs of the metabolic syndrome in elderly individuals DIABETES CARE Curtis, L. H., Hammill, B. G., Bethel, M., Anstrom, K. J., Gottdiener, J. S., Schulman, K. A. 2007; 30 (10): 2553–58

  Abstract

  The cardiovascular consequences of the metabolic syndrome and its component risk factors have been documented in elderly individuals. Little is known about how the metabolic syndrome and its individual components translate into long-term medical costs.We used log-linear regression models to assess the independent contributions of the metabolic syndrome and its individual components to 10-year medical costs among 3,789 individuals aged > or = 65 years in the Cardiovascular Health Study.As defined by the National Cholesterol Education Program Third Adult Treatment Panel report, the metabolic syndrome was present in 47% of the sample. Total costs to Medicare were 20% higher among participants with the metabolic syndrome ($40,873 vs. $33,010; P < 0.001). Controlling for age, sex, race/ethnicity, and other covariates, we found that abdominal obesity, low HDL cholesterol, and elevated blood pressure were associated with 15% (95% CI 4.3-26.7), 16% (1.7-31.8), and 20% (10.1-31.7) higher costs, respectively. When added to the model, the metabolic syndrome composite variable did not contribute significantly (P = 0.32).Abdominal obesity, low HDL cholesterol, and hypertension but not the metabolic syndrome per se are important predictors of long-term costs in the Medicare population.

  View details for DOI 10.2337/dc07-0460

  View details for Web of Science ID 000250223400026

  View details for PubMedID 17623825

• Comparison of conflict of interest policies and reported practices in academic medical centers in the United States. Accountability in research Dinan, M. A., Weinfurt, K. P., Friedman, J. Y., Allsbrook, J. S., Gottlieb, J., Schulman, K. A., Hall, M. A., Dhillon, J. K., Sugarman, J. 2007; 13 (4): 325-42

  Abstract

  The authors reviewed the conflict of interest policies of 9 academic medical centers in the United States and interviewed members of the Institutional Review Boards (IRBs) and Conflict of Interest Committees (COICs) at those institutions. They found that many institutions used processes for reporting and managing conflicts of interest that were more decentralized than the processes described in their policies. Also, most institutions had no clear and comprehensive policy to guide investigators regarding disclosure of conflicts of interest to potential research participants. Considerable differences in understanding of conflict of interest policies were observed between IRB and COIC officials.

  View details for DOI 10.1080/08989620601003414

  View details for PubMedID 17849643

  View details for PubMedCentralID PMC2474571

• Entry and Competition in Generic Biologics MANAGERIAL AND DECISION ECONOMICS Grabowski, H. G., Ridley, D. B., Schulman, K. A. 2007; 28 (4-5): 439–51

  View details for DOI 10.1002/mde.1352

  View details for Web of Science ID 000213317500016

• Effects of skeletal morbidities on longitudinal patient-reported outcomes and survival in patients with metastatic prostate cancer. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer DePuy, V., Anstrom, K. J., Castel, L. D., Schulman, K. A., Weinfurt, K. P., Saad, F. 2007; 15 (7): 869-76

  Abstract

  Patients with prostate cancer metastasized to bone frequently experience skeletal morbidities as a result of their disease. We sought to quantify the longitudinal effects on patient-reported outcomes of skeletal-related events (SREs) and to ascertain the declines in health-related quality of life (HRQOL) and pain experienced by patients who experienced SREs.Data are from a clinical trial for the treatment of SREs associated with advanced prostate cancer metastatic to bone. Outcome measures included the Functional Assessment of Cancer Therapy-General (FACT-G) and the Brief Pain Inventory. Among patients who survived 6 months after randomization, patients with no SREs in the initial 6 months after randomization were matched via propensity scores with those experiencing one or more SREs. Similarly, patients with one SRE were matched with a subset of patients with two or more SREs.Patients with SREs in the initial period had significantly worse survival and HRQOL than those with no SREs. Significant differences were found between the pain differences, FACT-G total scores, and FACT-G physical, emotional, and functional subscales. Comparisons of patients with single vs multiple SREs showed similar patterns.The presence of SREs is significantly associated with worse survival and poorer HRQOL in this patient population. Increasing SRE intensity shows a pattern of increasingly decreased survival and poorer HRQOL.

  View details for DOI 10.1007/s00520-006-0203-x

  View details for PubMedID 17262196

• Pay for performance, quality of care, and outcomes in acute myocardial infarction. JAMA Glickman, S. W., Ou, F. S., DeLong, E. R., Roe, M. T., Lytle, B. L., Mulgund, J., Rumsfeld, J. S., Gibler, W. B., Ohman, E. M., Schulman, K. A., Peterson, E. D. 2007; 297 (21): 2373-80

  Abstract

  Pay for performance has been promoted as a tool for improving quality of care. In 2003, the Centers for Medicare & Medicaid Services (CMS) launched the largest pay-for-performance pilot project to date in the United States, including indicators for acute myocardial infarction.To determine if pay for performance was associated with either improved processes of care and outcomes or unintended consequences for acute myocardial infarction at hospitals participating in the CMS pilot project.An observational, patient-level analysis of 105,383 patients with acute non-ST-segment elevation myocardial infarction enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the American College of Cardiology/American Heart Association (ACC/AHA) Guidelines (CRUSADE) national quality-improvement initiative. Patients were treated between July 1, 2003, and June 30, 2006, at 54 hospitals in the CMS program and 446 control hospitals.The differences in the use of ACC/AHA class I guideline recommended therapies and in-hospital mortality between pay for performance and control hospitals.Among treatments subject to financial incentives, there was a slightly higher rate of improvement for 2 of 6 targeted therapies at pay-for-performance vs control hospitals (odds ratio [OR] comparing adherence scores from 2003 through 2006 at half-year intervals for aspirin at discharge, 1.31; 95% confidence interval [CI], 1.18-1.46 vs OR, 1.17; 95% CI, 1.12-1.21; P = .04) and for smoking cessation counseling (OR, 1.50; 95% CI, 1.29-1.73 vs OR, 1.28; 95% CI, 1.22-1.35; P = .05). There was no significant difference in a composite measure of the 6 CMS rewarded therapies between the 2 hospital groups (change in odds per half-year period of receiving CMS therapies: OR, 1.23; 95% CI, 1.15-1.30 vs OR, 1.17; 95% CI, 1.14-1.20; P = .16). For composite measures of acute myocardial infarction treatments not subject to incentives, rates of improvement were not significantly different (OR, 1.09; 95% CI, 1.05-1.14 vs OR, 1.08; 95% CI, 1.06-1.09; P = .49). Overall, there was no evidence that improvements in in-hospital mortality were incrementally greater at pay-for-performance sites (change in odds of in-hospital death per half-year period, 0.91; 95% CI, 0.84-0.99 vs 0.97; 95% CI, 0.94-0.99; P = .21).Among hospitals participating in a voluntary quality-improvement initiative, the pay-for-performance program was not associated with a significant incremental improvement in quality of care or outcomes for acute myocardial infarction. Conversely, we did not find evidence that pay for performance had an adverse association with improvement in processes of care that were not subject to financial incentives. Additional studies of pay for performance are needed to determine its optimal role in quality-improvement initiatives.

  View details for DOI 10.1001/jama.297.21.2373

  View details for PubMedID 17551130

• Does the market value racial and ethnic concordance in physician-patient relationships? HEALTH SERVICES RESEARCH Brown, T. T., Scheffler, R. M., Tom, S. E., Schulman, K. A. 2007; 42 (2): 706–26

  Abstract

  To determine if the market-determined earnings per hour of physicians is sensitive to the degree of area-level racial/ethnic concordance (ALREC) in the local physician labor market.1998-1999 and 2000-2001 Community Tracking Study Physician Surveys and Household Surveys, 2000 U.S. Census, and the Area Resource File.Population-averaged regression models with area-level fixed effects were used to estimate the determinants of log earnings per hour for physicians in a two-period panel (N=12,886). ALREC for a given racial/ethnic group is measured as the percentage of physicians who are of a given race/ethnicity less the percentage of the population who are of the corresponding race/ethnicity. Relevant control variables were included.Average earnings per hour for Hispanic and Asian physicians varies with the degree of ALREC that corresponds to a physician's race/ethnicity. Both Hispanic and Asian physicians earn more per hour in areas where corresponding ALREC is negative, other things equal. ALREC varies from negative to positive for all groups. ALREC for Hispanics is negative, on average, due to the small percentage of the physician workforce that is Hispanic. This results in an average 5.6 percent earnings-per-hour premium for Hispanic physicians. However, ALREC for Asians is positive, on average, due to the large percentage of the physician workforce that is Asian. This results in an average 4.0 percent earnings-per-hour discount for Asian physicians. No similar statistically significant results were found for black physicians.The market-determined earnings per hour of Hispanic and Asian physicians are sensitive to the degree of ALREC in the local labor market. Larger sample sizes may be needed to find statistically significant results for black physicians.

  View details for DOI 10.1111/j.1475-6773.2006.00634.x

  View details for Web of Science ID 000244795700007

  View details for PubMedID 17362214

  View details for PubMedCentralID PMC1955351

• Publication or presentation of results from multicenter clinical trials: Evidence from an academic medical center AMERICAN HEART JOURNAL Turer, A. T., Mahaffey, K. W., Compton, K. L., Califf, R. M., Schulman, K. A. 2007; 153 (4): 674-680

  Abstract

  Nonpublication of research results threatens the integrity of clinical research, but the extent of nonpublication and factors associated with publication remain poorly documented. We sought to examine rates of publication or presentation of research findings from multicenter clinical trials and determine what factors are associated with dissemination of results.We conducted a follow-up study of 217 prospective, multicenter clinical trials of treatment approved in 1998 by the institutional review board of a large academic medical center, of which 197 had enrolled participants and were not known to be ongoing. Follow-up included searches of the literature and the Internet and telephone and e-mail inquiries to investigators and research sponsors. The main outcome measures were manuscript publication or other presentation of research results.Results of 110 (56%) out of 197 multicenter clinical trials have been published in the peer-reviewed literature. Results of 87 (44%) studies have not been published, and results of 52 (26%) studies have not been disseminated in any form. The rate of dissemination of trial results was highest for studies that were phase 3 (81%), lowest risk (86%), and investigational (76%). The dissemination rate was lowest for studies that were supported by internal funds (50%). However, none of these associations were statistically significant.Results of almost half of the multicenter clinical trials conducted in part at a large academic medical center have never been published. Mechanisms to ensure public dissemination of clinical trial results are needed.

  View details for DOI 10.1016/j.ahj.2007.01.005

  View details for Web of Science ID 000245784200035

  View details for PubMedID 17383311

• Developing model language for disclosing financial interests to potential clinical research participants. IRB Weinfurt, K. P., Allsbrook, J. S., Friedman, J. Y., Dinan, M. A., Hall, M. A., Schulman, K. A., Sugarman, J. 2007; 29 (1): 1-5

  View details for PubMedID 17364012

  View details for PubMedCentralID PMC1825040

• Changing gender prevalence of stone disease. The Journal of urology Scales, C. D., Curtis, L. H., Norris, R. D., Springhart, W. P., Sur, R. L., Schulman, K. A., Preminger, G. M. 2007; 177 (3): 979-82

  Abstract

  Recent studies suggest that the incidence of renal stone formation has been increasing and the male predominance of nephrolithiasis is decreasing, which may be due to changes in diet and lifestyle. We examined changes in the prevalence by gender of inpatient hospital discharges for urinary stone disease.The Nationwide Inpatient Sample was used for analysis. Discharges with an International Classification of Diseases, 9th revision, Clinical Modification principal diagnosis of 592.0 (calculus of kidney) or 592.1 (calculus of ureter) from 1997 to 2002 were included in the investigation.An estimated mean+/-SE 1,013,621+/-19,310 discharges for stone disease occurred from 1997 to 2002. Discharges for renal calculus increased by 18.9% during the study period (p<0.001), while discharges for ureteral calculus remained relatively constant. After adjusting for population changes discharges for renal calculi increased by 14.2% (p=0.002). In females discharges for renal calculi increased by 21.0% and discharges for ureteral calculi increased by 19.2% (each p<0.001). After adjusting for population changes renal calculus and ureteral calculus discharges in females increased by 22.0% (p=0.001) and 14.5% (p=0.005), respectively.In this nationally representative sample the population adjusted rate of discharges for stone disease in females dramatically increased from 1997 to 2002. This alteration represents a change in the prevalence by gender of treated stone disease from a 1.7:1 to 1.3:1 male-to-female ratio. It may reflect variations in the underlying prevalence by gender of stone disease. We speculate that the increasing incidence of nephrolithiasis might be due to lifestyle associated risk factors, such as obesity.

  View details for DOI 10.1016/j.juro.2006.10.069

  View details for PubMedID 17296391

• Developing drugs for tuberculosis - Response SCIENCE Glickman, S. W., Rasiel, E. B., Hamilton, C., Schulman, K. A. 2007; 315 (5815): 1076–77

  View details for Web of Science ID 000244387600013

• Economic return of clinical trials performed under the pediatric exclusivity program. JAMA Li, J. S., Eisenstein, E. L., Grabowski, H. G., Reid, E. D., Mangum, B., Schulman, K. A., Goldsmith, J. V., Murphy, M. D., Califf, R. M., Benjamin, D. K. 2007; 297 (5): 480-8

  Abstract

  In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007.To quantify the economic return to industry for completing pediatric exclusivity trials.A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated.Net economic return and net return-to-cost ratio.The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63).The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.

  View details for PubMedID 17284698

  View details for PubMedCentralID PMC2773665

• Trends in operator and hospital procedure volume and outcomes for percutaneous transluminal coronary angioplasty, 1996 to 2001 AMERICAN JOURNAL OF CARDIOLOGY Kansagra, S. M., Curtis, L. H., Anstrom, K. J., Schulman, K. A. 2007; 99 (3): 339–43

  Abstract

  Although the volume/outcome relation for percutaneous transluminal coronary angioplasty (PTCA) is well established, it is unclear how the relation has changed over time. To examine trends in hospital and operator volume and outcomes for PTCA, we conducted a retrospective cohort study of discharge records of patients who underwent PTCA at nonfederal hospitals in Florida and New York from 1996 to 2001. Hospital/operator pairs were divided into 4 classes using American College of Cardiology/American Heart Association volume classifications. Outcome measurements were operator and hospital procedure volume and a combined end point of inpatient mortality and emergency coronary artery bypass graft surgery. Of 452,404 patients, the number of patients who underwent PTCA from 1996 to 2001 increased from 58,180 to 92,277, with a mean annual increase of 9.1%. The risk-adjusted end point of mortality and emergency coronary artery bypass grafting decreased over time, occurring in 2.8% of admissions in 1996 and in 1.6% of admissions in 2001. Class 1 hospital/operator pairs, which were operators performing >or=75 procedures at hospitals performing >400 procedures, had the lowest occurrence of the end point overall and in each year. The risk-adjusted end point difference between classes narrowed over time. In conclusion, outcomes were best for patients receiving care from class 1 hospital/operator pairs, and an increasing proportion of patients received care from class 1 pairs. There were outcome differences within subpopulations of operators in classes 2 and 4, which suggest possibilities for alternative volume classification guidelines.

  View details for DOI 10.1016/j.amjcard.2006.08.037

  View details for Web of Science ID 000243947900010

  View details for PubMedID 17261394

• Relationship between body mass index and prostate cancer screening in the United States. The Journal of urology Scales, C. D., Curtis, L. H., Norris, R. D., Schulman, K. A., Dahm, P., Moul, J. W. 2007; 177 (2): 493-8

  Abstract

  Obesity is associated with more advanced disease and worse outcomes in men with prostate cancer. To our knowledge the relationship between obesity and prostate cancer screening behavior in men 40 or older is unknown. Thus, we examined associations between body mass index and prostate cancer screening behavior.We used the 2002 Behavioral Risk Factor Surveillance System to study prostate cancer screening in a representative sample of 57,827 men 40 years or older. Primary outcomes were the proportion of men ever screened and the proportion screened in the last year for prostate cancer.Obese men were more likely than normal weight men to have had a prostate specific antigen test (62.1% vs 56.1%, p <0.001) and to have had a prostate specific antigen test in the last year (44.2% vs 38.2%, p <0.001). After controlling for sociodemographic characteristics obese men remained more likely than normal weight men to have had a prostate specific antigen test (OR 1.46, 95% CI 1.33-1.61) and to have had a prostate specific antigen test in the last year (OR 1.42, 95% CI 1.30-1.55). Respondents reporting an ongoing relationship with a physician (OR 2.88, 95% CI 2.57-3.22) and black nonHispanic men vs white men (OR 1.58, 95% CI 1.38-1.81) were also more likely to have had a prostate specific antigen test in the last year.Obese men are more likely than normal weight men to be screened for prostate cancer. Associations between advanced stage, worse outcomes and obesity may not be explained by disparities in the screening of obese men for prostate cancer.

  View details for DOI 10.1016/j.juro.2006.09.059

  View details for PubMedID 17222617

• Heart failure and a controlled trial investigating outcomes of exercise TraiNing (HF-ACTION): Design and rationale AMERICAN HEART JOURNAL Whellan, D. J., O'Connor, C. M., Lee, K. L., Keteyian, S. J., Cooper, L. S., Ellis, S. J., Leifer, E. S., Kraus, W. E., Kitzman, D. W., Blumenthal, J. A., Rendall, D. S., Houston-Miller, N., Fleg, J. L., Schulman, K. A., Pina, I. L. 2007; 153 (2): 201-211

  Abstract

  Although there are limited clinical data to support the use of exercise training as a means to reduce mortality and morbidity in patients with heart failure, current guidelines state that exercise is beneficial.The objective of this trial is to determine whether exercise training reduces all-cause mortality or all-cause hospitalization for patients with left ventricular systolic dysfunction and heart failure symptoms. After undergoing baseline assessments to determine whether they can safely exercise, patients are randomized to either usual care or exercise training. Patients in the exercise training arm attend 36 supervised facility-based exercise training sessions. Exercise modalities are cycling or walking. After completing 18 sessions, patients initiate home-based exercise and then transition to solely home-based exercise after completing all 36 sessions. Patients return for facility-based training every 3 months to reinforce their exercise training program. Patients are followed for up to 4 years. Physiologic, quality-of-life, and economic end points that characterize the effect of exercise training in this patient population will be measured at baseline and at intervals throughout the trial. Blood samples will be collected to examine biomarkers such as brain natriuretic peptide, tumor necrosis factor, and C-reactive protein.Because of its relatively low cost, high availability, and ease of use, exercise training is an intervention that could be accessible to most patients with heart failure. The HF-ACTION trial is designed to definitively assess the effect of exercise training on the clinically relevant end points of mortality, hospitalization, and quality of life in patients with heart failure.

  View details for DOI 10.1016/j.ahj.2006.11.007

  View details for Web of Science ID 000244047600008

  View details for PubMedID 17239677

• Long-term costs and resource use in elderly participants with congestive heart failure in the Cardiovascular Health Study AMERICAN HEART JOURNAL Liao, L., Anstrom, K. J., Gottdiener, J. S., Pappas, P. A., Whellan, D. J., Kitzman, D. W., Aurigemma, G. P., Mark, D. B., Schulman, K. A., Jollis, J. G. 2007; 153 (2): 245–52

  Abstract

  Although heart failure (HF) afflicts nearly 5 million Americans, the long-term cost of HF care has not been described previously. In a prospective, longitudinal cohort of community-dwelling elderly from 4 regions, we examined the long-term costs and resource use of elderly patients with HF.We linked 4860 elderly participants in the National Heart, Lung, and Blood Institute Cardiovascular Health Study to Medicare part A and part B claims from 1992 to 2003. Costs were calculated from Medicare payments and discounted at 3% annually. We applied nonparametric estimators to calculate mean costs and resource use per patient for a 10-year period. To describe the relationship between patient characteristics and long-term costs, we constructed censoring-adjusted regression models.There were 343 participants (84.8% white; 50.1% men; mean age, 78.2 years) with prevalent HF and 4517 participants without HF at study entry. Mean follow-up was 6.7 years (median, 6.4 years). The 10-year survival rates were 33% and 63% for the prevalent HF and nonprevalent HF groups (P < .001), respectively. The mean 10-year medical costs were significantly higher for the prevalent HF cohort (54,704 dollars vs 41 dollars,780, P < .001). The higher costs associated with HF were also reflected in greater resource use with more hospitalizations (P < .05) and more intensive care unit days (P < .05). Participants with HF had more physician visits (P < .05), with most of these encounters involving noncardiology physicians. However, in multivariate models, prevalent HF was not an independent predictor of higher costs.Patients with HF consume substantially more health care resources than their elderly peers, and these higher costs persist through 10 years of follow-up. Many of these costs may be related to other comorbid conditions.

  View details for DOI 10.1016/j.ahj.2006.11.010

  View details for Web of Science ID 000244047600015

  View details for PubMedID 17239685

• Financial implications of a model heart failure disease management program for providers, hospital, healthcare systems, and payer perspectives AMERICAN JOURNAL OF CARDIOLOGY Whellan, D. J., Reed, S. D., Liao, L., Gould, S. D., O'Connor, C. M., Schulman, K. A. 2007; 99 (2): 256–60

  Abstract

  Although heart failure disease management (HFDM) programs improve patient outcomes, the implementation of these programs has been limited because of financial barriers. We undertook the present study to understand the economic incentives and disincentives for adoption of disease management strategies from the perspectives of a physician (group), a hospital, an integrated health system, and a third-party payer. Using the combined results of a group of randomized controlled trials and a set of financial assumptions from a single academic medical center, a financial model was developed to compute the expected costs before and after the implementation of a HFDM program by 3 provider types (physicians, hospitals, and health systems), as well as the costs incurred from a payer perspective. The base-case model showed that implementation of HFDM results in a net financial loss to all potential providers of HFDM. Implementation of HFDM as described in our base-case analysis would create a net loss of US dollars 179,549 in the first year for a physician practice, US dollars 464,132 for an integrated health system, and US dollars 652,643 in the first year for a hospital. Third-party payers would be able to save US dollars 713,661 annually for the care of 350 patients with heart failure in a HFDM program. In conclusion, although HFDM programs may provide patients with improved clinical outcomes and decreased hospitalizations that save third-party payers money, limited financial incentives are currently in place for healthcare providers and hospitals to initiate these programs.

  View details for DOI 10.1016/j.amjcard.2006.08.019

  View details for Web of Science ID 000243545900021

  View details for PubMedID 17223429

• Cost of cancer care: Issues and implications Meropol, N. J., Schulman, K. A. AMER SOC CLINICAL ONCOLOGY. 2007: 180–86

  Abstract

  Medical technology is increasingly costly in most fields of clinical medicine. Oncology has not been spared from issues related to cost, in part resulting from the tremendous scientific progress that has lead to new tools for diagnosis, treatment, and follow-up of our patients. The increasing cost of health care in general (and cancer care in particular) raises complex questions related to its effects on our economy and the citizens of our society. This article reviews the macroeconomic principles and individual behaviors that govern medical spending, and examines how cost disproportionately affects various populations. Our overall goal is to frame debate about health policy concerns that influence the clinical practice of oncology.

  View details for DOI 10.1200/JCO.2006.09.6081

  View details for Web of Science ID 000243729100004

  View details for PubMedID 17210937

• Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA Eisenstein, E. L., Anstrom, K. J., Kong, D. F., Shaw, L. K., Tuttle, R. H., Mark, D. B., Kramer, J. M., Harrington, R. A., Matchar, D. B., Kandzari, D. E., Peterson, E. D., Schulman, K. A., Califf, R. M. 2007; 297 (2): 159-68

  Abstract

  Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis.To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease.An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel.Death, nonfatal MI, and the composite of death or MI at 24-month follow-up.Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, -3.3%; 95% CI, -6.3% to -0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, -4.1%; 95% CI, -7.6% to -0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, -0.7%; 95% CI, -2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, -0.5%; 95% CI, -3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, -3.5%; 95% CI, -5.9% to -1.1%; P = .004) and death or MI (0% vs 4.5%; difference, -4.5%; 95% CI, -7.1% to -1.9%; P<.001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, -1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, -1.6% to 3.6%; P = .44).The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.

  View details for DOI 10.1001/jama.297.2.joc60179

  View details for PubMedID 17148711

• Perspectives on the cost of cancer care JOURNAL OF CLINICAL ONCOLOGY Meropol, N. J., Schulman, K. A. 2007; 25 (2): 169–70

  View details for DOI 10.1200/JCO.2006.09.9648

  View details for Web of Science ID 000243729100001

• Is there a price to pay for short-term savings in the clinical development of new pharmaceutical products? DRUG INFORMATION JOURNAL Reed, S. D., Califf, R. M., Schulman, K. A. 2007; 41 (4): 491–99

  View details for DOI 10.1177/009286150704100407

  View details for Web of Science ID 000247714200007

• Curbing the cardiovascular disease epidemic: Aligning industry, government, payers, and academics HEALTH AFFAIRS Califf, R. M., Harrington, R. A., Madre, L. K., Peterson, E. D., Roth, D., Schulman, K. A. 2007; 26 (1): 62–74

  Abstract

  Despite decades of progress in the diagnosis, treatment, and prevention of cardiovascular disease, its prevalence continues to grow in both developed and developing countries. We have constructed a model, the "cycle of quality," which connects the innovation of initial scientific discovery with validated methods of translating research into effective delivery. This model can serve as a basis for evaluating proposed efforts to improve interactions among private and public aspects of health care to accelerate development and appropriate adoption of new treatments, and to achieve greater penetration of effective behavioral therapies and established technologies, resulting in major improvements in cardiovascular health.

  View details for DOI 10.1377/hlthaff.26.1.62

  View details for Web of Science ID 000244223200008

  View details for PubMedID 17211015

• Perspectives of clinical research coordinators on disclosing financial conflicts of interest to potential research participants CLINICAL TRIALS Friedman, J. Y., Sugarman, J., Dhillon, J. K., DePuy, V., Pierre, C. K., Dinan, M. A., Allsbrook, J. S., Schulman, K. A., Weinfurt, K. P. 2007; 4 (3): 272–78

  Abstract

  Disclosing financial interests to potential research participants during the informed consent process is one strategy for managing conflicts of interest. Given that clinical research coordinators are typically charged with administering the informed consent process, it is critical to understand their experiences, attitudes and beliefs regarding the disclosure of financial interests in research.To understand the role of clinical research coordinators in disclosing financial interests in research, and potential barriers to such disclosures.We developed a survey designed to measure clinical research coordinators' awareness of financial interests in clinical research, previous experience with disclosing financial interests, comfort with answering questions about financial interests and barriers to disclosing financial interests to potential research participants. Next we conducted cognitive interviews with 10 clinical research coordinators to assess understandability and content validity and to further refine the survey. We then administered the survey to clinical research coordinators attending the 2006 Global Conference of the Association of Clinical Research Professionals.Among 300 clinical research coordinators who completed the survey, there was a general awareness of financial interests in research. Forty-one percent reported disclosing such financial interests to potential research participants, and 28% reported being asked about them. Greater comfort in responding to questions about financial interests was associated with previous experience with disclosure, previous experience answering questions about financial interests, and greater length of time obtaining informed consent. Respondents indicated that there were barriers to disclosure, including lack of information (76%) and that participants would not understand disclosures (26%).Possible sample bias due to using a convenience sample.Making information about financial interests in research readily available to clinical research coordinators, as well as providing education and training, should facilitate the disclosure of financial interests in research to potential research participants during the informed consent process.

  View details for DOI 10.1177/1740774507079239

  View details for Web of Science ID 000249489200012

  View details for PubMedID 17715256

• How changes in drug-safety regulations affect the way drug and biotech companies invest in innovation. Health affairs (Project Hope) Reed, S. D., Califf, R. M., Schulman, K. A. 2006; 25 (5): 1309-17

  Abstract

  Changes in the economics of product development resulting from heightened safety regulations could have a sizable negative impact on drug and biotechnology companies' decisions about investing in innovation. We developed a model to compare the potential economic effects of pre- and postmarketing strategies to identify safety problems with new drugs. Although expanding Phase III clinical testing and postmarketing safety surveillance are not perfect substitutes, our findings suggest that even a large increase in funding for the latter will have a relatively small adverse impact on investment decisions by drug companies and venture capital firms, compared with the former.

  View details for DOI 10.1377/hlthaff.25.5.1309

  View details for PubMedID 16966727

• Analytic considerations in economic evaluations of multinational cardiovascular clinical trials. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research Torti, F. M., Reed, S. D., Schulman, K. A. 2006; 9 (5): 281-91

  Abstract

  The growing number of economic evaluations that use data collected in multinational clinical trials raises numerous questions regarding their execution and interpretation. Although recommendations for conducting economic evaluations have been widely disseminated, relatively little guidance has been given for conducting economic evaluations alongside clinical trials, particularly multinational trials.Building on a literature review that was conducted in preparation for an expert workshop, we evaluated a subset of methodological issues related to conducting economic evaluations alongside multinational clinical trials.We found wide variation in the types of costs included as part of the analyses and in the methods used to assign costs to hospitalization events. Furthermore, we found that the extrapolation of costs and survival outcomes beyond the trial period is an inconsistent practice and is often not dependent on whether a survival benefit was observed in the trial or on the epidemiology or practice patterns in the country to which the findings are directed.Although the limited sample size precluded a quantitative analysis of trial characteristics and their associations with the methodologies employed, our findings highlight the need for more guidance to analysts regarding the execution of economic evaluations using data from multinational clinical trials. As the research community grapples with the complexities of methodological and logistical issues involved in multinational economic evaluations, the development of a standardized format to report the basic methodological characteristics of such studies would help to improve transparency and comparability for other analysts and decision-makers.

  View details for DOI 10.1111/j.1524-4733.2006.00117.x

  View details for PubMedID 16961546

• Geographic variation in the treatment of acute myocardial infarction in the VALsartan In Acute myocardial iNfarcTion (VALIANT) trial. American heart journal Reed, S. D., McMurray, J. J., Velazquez, E. J., Schulman, K. A., Califf, R. M., Kober, L., Maggioni, A. P., Van de Werf, F., White, H. D., Diaz, R., Mareev, V., Murin, J. 2006; 152 (3): 500-8

  Abstract

  The VALIANT trial compared the efficacy and safety of captopril, valsartan, and their combination in patients with left ventricular systolic dysfunction, heart failure, or both after acute myocardial infarction (MI). By examining this international trial population of high-risk patients, we sought to determine geographic variations in the use of 3 key treatments for MI.We analyzed data from 14,512 high-risk patients with MI in the VALIANT trial from the 20 countries that had enrolled >100 patients. International variation in the proportion of patients receiving (1) reperfusion therapy (thrombolysis or primary percutaneous coronary intervention), (2) beta-blockers, or (3) aspirin at the time of MI was measured by using adjusted W scores. These scores correspond to the number of additional or fewer patients who received each of the therapies compared with the number expected, as estimated from multivariable regression models that account for patients' baseline characteristics.There was marked variation between countries in the use of reperfusion therapy (equivalent to a difference of up to 36/100 potentially eligible patients) and beta-blockers (41/100), whereas there was much less variation in the use of aspirin (13/100).Marked geographic variation persists in the use of standard evidence-based therapy advocated by international guidelines. Our findings have implications not only for care of patients but also for the conduct of international trials.

  View details for DOI 10.1016/j.ahj.2006.02.032

  View details for PubMedID 16923421

• Prostate specific antigen testing in men older than 75 years in the United States. The Journal of urology Scales, C. D., Curtis, L. H., Norris, R. D., Schulman, K. A., Albala, D. M., Moul, J. W. 2006; 176 (2): 511-4

  Abstract

  Although there is general agreement that men older than 75 years are unlikely to benefit from prostate specific antigen testing, patient reported testing rates in these patients exceed 30%. We examined physician reported PSA testing in elderly men, and physician and practice characteristics associated with testing.Using the 1999 to 2002 National Ambulatory Medical Care Survey, a nationally representative sample of outpatient visits to nonfederal office based physicians, we measured rates of prostate specific antigen testing by age group in men without prostate cancer who were 40 years or older and who visited outpatient family medicine, internal medicine or urology clinics.An estimated 42.3 million prostate specific antigen tests were performed from 1999 to 2002, of which 5.91 million (14.0%) were performed in men older than 75 years. The population based testing rate was 6.1% in patients 40 to 49-year-old, 26.0% in patients 50 to 75-year-old and 27.8% in patients older than 75 years. Urologists performed 35.4% of prostate specific antigen tests in men older than 75 years. Controlling for sociodemographic variables physicians with a laboratory on site were more likely to perform a prostate specific antigen test (OR 1.35, 95% CI 1.07 to 1.71). In men older than 75 years the odds of prostate specific antigen testing were 1.58 times higher (95% CI 1.01 to 2.50) in practices with a laboratory on site.Up to a third of men older than 75 years undergo prostate specific antigen testing despite an average life expectancy of less than 10 years. Physician and practice characteristics are associated with prostate specific antigen PSA testing.

  View details for DOI 10.1016/j.juro.2006.03.060

  View details for PubMedID 16813879

• Effect of zoledronic acid on pain associated with bone metastasis in patients with prostate cancer Weinfurt, K. P., Anstrom, K. J., Castel, L. D., Schulman, K. A., Saad, F. OXFORD UNIV PRESS. 2006: 986–89

  Abstract

  Zoledronic acid reduces skeletal-related events associated with prostate cancer and has long-term efficacy in pain outcomes. Findings of treatment group differences in pain early in treatment are less reliable. We used a recently recommended analytic approach to examine the effect of zoledronic acid on pain.In a trial of zoledronic acid (n = 214) versus placebo (n = 208), we used the Brief Pain Inventory to assess pain at baseline, 3 weeks, 6 weeks and every 6 weeks thereafter for a total of 60 weeks. We used a modified longitudinal rank test to determine whether clinically meaningful changes in pain were related to treatment group.Seventy-six of 214 patients (35.5%) receiving zoledronic acid and 62 of 208 patients (29.8%) receiving placebo completed the 60-week visit (P = 0.22). In all 11 pain assessments, patients receiving zoledronic acid reported more favorable, clinically meaningful changes in pain scores. Overall, patients receiving zoledronic acid had a 33% chance of a favorable response, compared with 25% for patients receiving placebo (P = 0.04; 95% CI 0.5% to 15.6%).Zoledronic acid was more likely than placebo to be associated with clinically meaningful reductions in pain. Thus, zoledronic acid may help to avert the pain experienced by patients with progressing metastatic disease secondary to prostate cancer.

  View details for DOI 10.1093/annonc/mdl041

  View details for Web of Science ID 000237696000017

  View details for PubMedID 16533874

• Geographic variation in the prescription of schedule II opioid analgesics among outpatients in the United States Curtis, L. H., Stoddard, J., Radeva, J. I., Hutchison, S., Dans, P. E., Wright, A., Woosley, R. L., Schulman, K. A. WILEY. 2006: 837–55

  Abstract

  To measure geographic variation in opioid use in a large, commercially insured, outpatient population in the United States.Outpatient prescription drug claims database of a national pharmaceutical benefit manager for 7,873,337 subjects with at least one prescription drug claim in 2000.We measured the period prevalence of claims for opioid analgesics and controlled-release oxycodone at the state level. We measured geographic variation using the weighted coefficient of variation and systematic component of variation. In county-level multivariable regression, we explored associations between potential explanatory variables and claims for opioid analgesics and controlled-release oxycodone.A total of 567,778 (64.2 per 1,000 total claims) were for oral opioid analgesics. Claim rates by state ranged from <20 to >100 claims per 1,000 total claims. States with long-standing prescription monitoring programs had among the lowest rates. In the county-level data, presence of a statewide prescription monitoring program and proportions of the population aged 15-24 and 65 years and older were independently and negatively associated with claim rates for all opioid analgesics. Surgeons per 1,000, proportion of the population reporting illicit drug use, and proportion who were female were independently and positively associated with claim rates for all opioid analgesics. Only the proportion of the population aged 25-34 and number of surgeons per 1,000 were independently and positively associated with claim rates for oxycodone.Claim rates for opioid analgesics vary significantly by state. Presence of a statewide prescription monitoring program is associated with lower claim rates at the county level. Future research should use individual-level data to assess whether these findings reflect a reduction in abuse and diversion or suboptimal treatment of pain.

  View details for DOI 10.1111/j.1475-6773.2006.00511.x

  View details for Web of Science ID 000237464400014

  View details for PubMedID 16704515

  View details for PubMedCentralID PMC1713206

• Economic evaluation of weekly epoetin alfa versus biweekly darbepoetin alfa for chemotherapy-induced anaemia: evidence from a 16-week randomised trial. PharmacoEconomics Reed, S. D., Radeva, J. I., Daniel, D. B., Mody, S. H., Forlenza, J. B., McKenzie, R. S., Schulman, K. A. 2006; 24 (5): 479-94

  Abstract

  A 16-week, open-label, multicentre, randomised trial of weekly epoetin alfa 40 000 units versus biweekly darbepoetin alfa 200microg among 358 patients with solid-tumour cancers and chemotherapy-induced anaemia demonstrated superior haematological outcomes with epoetin alfa. We sought to compare resource use, costs and clinical outcomes between treatment groups and report the results using a cost-consequences framework.Pre-specified methods were used to assign costs (US dollars, year 2004-5 values) to medical resources and patient time using a societal perspective. Costs for inpatient care, outpatient care and physician services were based on US Medicare reimbursement rates. Indirect costs assigned to patient time spent receiving study medication were based on the mean hourly wage in the US. In the base-case analysis, the average wholesale price was used to assign costs to medications. Clinical outcomes included all haemoglobin levels and transfusions recorded throughout the trial. Sensitivity analyses were performed to evaluate the impact of different costing methods, cost sources, perspectives and methods to assign haemoglobin values following a blood transfusion.Over a mean follow-up duration of 11.8 weeks, the average cost of study medications and their administration was the single largest component of total costs and was similar between groups (epoetin alfa 5979 US dollars and darbepoetin alfa 5935 US dollars, difference 44 US dollars; 95% CI -590, 692). There were no significant differences in the proportions of patients hospitalised (epoetin alfa 24.6%, darbepoetin alfa 22.0%; p = 0.57). Patients randomised to epoetin alfa experienced more inpatient days, on average, than patients randomised to darbepoetin alfa (2.6 vs 1.6, 95% CI for the difference, 0.07, 2.27). However, with regard to transfusions, patients in the epoetin alfa arm required fewer units of blood than patients in the darbepoetin alfa arm (0.46 vs 0.88, 95% CI for the difference -0.77, -0.08). Mean total costs, comprising costs for study medications and their administration, inpatient care, transfusions, unplanned radiation therapy, haematology and laboratory services, chemotherapy and non-chemotherapy drugs and indirect costs were 14,976 US dollars in the epoetin alfa arm compared with 14,101 US dollars in the darbepoetin alfa arm, a difference of 875 US dollars (95% CI for difference -849, 2607), of which 98% of the difference was attributable to higher inpatient costs in the epoetin alfa arm (2374 US dollars vs 1520 US dollars; 95% CI for difference -33, 1955). Assessments of multiple clinical measures demonstrated improved outcomes with epoetin alfa relative to darbepoetin alfa.Most clinical outcome measures suggested greater improvement with epoetin alfa relative to darbepoetin alfa, but most costs for both agents appeared similar. Decision makers must evaluate the differences in costs and efficacy measures that are most relevant from their perspectives.

  View details for DOI 10.2165/00019053-200624050-00006

  View details for PubMedID 16706573

• Relationship between clinical outcomes and vascular access type among hemodialysis patients with Staphylococcus aureus bacteremia. Clinical journal of the American Society of Nephrology : CJASN Inrig, J. K., Reed, S. D., Szczech, L. A., Engemann, J. J., Friedman, J. Y., Corey, G. R., Schulman, K. A., Reller, L. B., Fowler, V. G. 2006; 1 (3): 518-24

  Abstract

  The association between hemodialysis vascular access type, costs, and outcome of Staphylococcus aureus bacteremia (SAB) among patients with ESRD remains incompletely characterized. This study was undertaken to compare resource utilization, costs, and clinical outcomes among SAB-infected patients with ESRD by hemodialysis access type. Adjusted comparisons of costs and outcomes were based on multivariable linear regression and multivariable logistic regression models, respectively. A total of 143 hospitalized hemodialysis-dependent patients had SAB at Duke University Medical Center between July 1996 and August 2001. A total of 111 (77.6%) patients were hospitalized as a result of suspected bacteremia; 32 (22.4%) were hospitalized for other reasons. Of the 111 patients, 59.5% (n = 66) had catheters as their primary access type, 36% (n = 40) had arteriovenous (AV) grafts, and 4.5% (n = 5) had AV fistulas. Patients with fistulas were excluded from analyses because of small numbers. Patients with catheters were more likely to be white, had shorter dialysis vintage, and had higher Acute Physiology and Chronic Health Evaluation II scores compared with patients with grafts. Unadjusted 12-wk mortality did not significantly differ between patients with catheters compared with patients with grafts (22.7 versus 10.0%; P = 0.098); neither did 12-wk costs differ by access type ($22,944 +/- 18,278 versus $23,969 +/- 13,731, catheter versus graft; P > 0.05). In adjusted analyses, there was no difference in 12-wk mortality (odds ratio 1.63; 95% confidence interval 0.29 to 9.02; catheter versus graft) or 12-wk costs (means ratio 0.84; 95% confidence interval 0.60 to 1.17; catheter versus graft) among SAB-infected patients with ESRD on the basis of hemodialysis access type. Twelve-week mortality and costs that are associated with an episode of SAB are high in hemodialysis patients, regardless of vascular access type. Efforts should focus on the prevention of SAB in this high-risk group.

  View details for DOI 10.2215/CJN.01301005

  View details for PubMedID 17699254

• Spending on postapproval drug safety. Health affairs (Project Hope) Ridley, D. B., Kramer, J. M., Tilson, H. H., Grabowski, H. G., Schulman, K. A. 2006; 25 (2): 429-36

  Abstract

  Withdrawals of high-profile pharmaceuticals have focused attention on post-approval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was 56 million dollars (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that total spending on postapproval safety by the top twenty drug manufacturers was 800 million dollars in 2003. We also examined, using regression analysis, the relationship between the number of safety personnel and the number of initial adverse-event reports. This study offers information for the debate on proposed changes to safety surveillance.

  View details for DOI 10.1377/hlthaff.25.2.429

  View details for PubMedID 16522583

• Medicine. A portfolio model of drug development for tuberculosis. Science (New York, N.Y.) Glickman, S. W., Rasiel, E. B., Hamilton, C. D., Kubataev, A., Schulman, K. A. 2006; 311 (5765): 1246-7

  View details for DOI 10.1126/science.1119299

  View details for PubMedID 16513969

• Geographic variations in the use of medical and surgical therapies for benign prostatic hyperplasia. The Journal of urology Sung, J. C., Curtis, L. H., Schulman, K. A., Albala, D. M. 2006; 175 (3 Pt 1): 1023-7

  Abstract

  Patients with BPH have several treatment options. Little is known about geographic variations in surgical rates for BPH and the market relationships to medical therapy, health resources and sociodemographic factors.We conducted a cross-sectional study using administrative data from 5 states in 2000. Rates of surgical and medical therapy were calculated per 100,000 men 55 years old or older. Main outcome measures were county level weighted coefficient of variation and systematic component of variation in therapy rates, as well as surgery rates as a function of medication dispensing rates, health care resources and sociodemographic characteristics.North Carolina had the lowest surgery rates (26.3 minimally invasive procedures and 332.1 invasive surgeries per 100,000) and finasteride dispensing rates (503.5 per 100,000). Overall rates of medical therapy were 5 times higher than surgery rates. Geographic variations in surgical and medical therapy rates were significant for each state, and North Carolina had the greatest variation. An increase of 11.6 per 100,000 (95% CI, 6.5-55.8) in annual county level finasteride dispensing would be associated with a decrease in the surgery rate of 1 per 100,000, controlling for other variables.There is significant systematic variation in rates of surgical and medical therapy for BPH at county and state levels. The relationship between finasteride and surgery in randomized clinical trials is generalizable to the marketplace. Finasteride rates are inversely related to surgery rates, and tamsulosin rates are positively associated with surgery rates. Surgery rates are not significantly associated with urologists per capita.

  View details for DOI 10.1016/S0022-5347(05)00409-X

  View details for PubMedID 16469610

• Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Academic medicine : journal of the Association of American Medical Colleges Weinfurt, K. P., Dinan, M. A., Allsbrook, J. S., Friedman, J. Y., Hall, M. A., Schulman, K. A., Sugarman, J. 2006; 81 (2): 113-8

  Abstract

  To document the current state of institutional review board (IRB) and conflict of interest committee policies regarding disclosures of financial conflicts of interest to potential research participants, and to use this information to identify and share models for effectively achieving disclosure.The authors identified the 123 U.S. academic medical centers that have IRBs and sought their IRB and institutional policies regarding financial conflicts of interest. In February and March 2004, using manual and key word searches, each institution's Web site was searched to identify documents containing information regarding the disclosure of financial conflicts of interest. Letters were sent to 24 institutions that had either no information or incomplete information posted on their Web sites. To assess institutions' guidelines for disclosure, the authors extracted and content coded each institution's information on disclosure.Relevant information was obtained from 120 (98%) academic medical centers (AMCs), of which 57 (48%) mentioned disclosing financial conflicts to potential research participants. Of these 57, 33 (58%) included verbatim language that could be used in informed consent documents. AMCs' recommendations and requirements for disclosure included details of the financial arrangement, administrative management of conflicts of interest, and encouragement of dialogue between the investigator and the potential research participant.Considerable variability exists concerning the specific information that should be disclosed. Most of the AMCs' policies were consistent with the goal of protection from legal liability. Significant questions remain, however, concerning the goals of disclosure and the most effective methods for achieving those goals.

  View details for DOI 10.1097/00001888-200602000-00003

  View details for PubMedID 16436571

  View details for PubMedCentralID PMC1820630

• Racial differences in health concern. Journal of the National Medical Association Voils, C. I., Oddone, E. Z., Weinfurt, K. P., Friedman, J. Y., Bright, C. M., Schulman, K. A., Bosworth, H. B. 2006; 98 (1): 36-42

  Abstract

  An understanding of racial differences in risk-related affect may help explain racial differences in health behaviors and outcomes and provide additional opportunities for intervention. In phone interviews with a random community sample of 197 whites, 155 blacks and 163 Latinos, we assessed concern that respondents' health would be hurt by their diet, an inability to exercise, an inability to follow a doctor's recommendations and disease. A multivariate analysis of variance with follow-up profile analysis revealed that whites were less concerned than blacks and Latinos about an inability to follow their doctors' recommendations (ps < 0.01). There were no racial differences in the other health concern variables. Interventions to inform blacks and Latinos about their health risks must strike a balance between creating enough health concern to encourage health behavior but not so much that it interferes with health-promoting behaviors.

  View details for PubMedID 16532976

  View details for PubMedCentralID PMC2594806

• The cost of acute myocardial infarction in the new millennium: evidence from a multinational registry. American heart journal Kauf, T. L., Velazquez, E. J., Crosslin, D. R., Weaver, W. D., Diaz, R., Granger, C. B., McMurray, J. J., Rouleau, J. L., Aylward, P. E., White, H. D., Califf, R. M., Schulman, K. A. 2006; 151 (1): 206-12

  Abstract

  Although geographic variation in the treatment of acute myocardial infarction (AMI) has been recognized, the impact of evidence-based international treatment guidelines on such variation is unclear. We sought to characterize resource use and cost of initial hospitalization for AMI in 9 countries and compare the contribution of length of stay (LOS) and procedure use to cost.We applied country-specific cost estimates to data from the international AMI registry associated with the VALIANT trial. The registry includes demographic, medical history, treatment, and discharge information for 5573 patients with AMI admitted to 84 sites in 9 countries from November 1999 to June 2001. Hospitalization cost was estimated by imputed discharge diagnosis-related group code and adjusted for the LOS and procedures. Generalized linear regression was used to adjust cost by country; the contribution of LOS and procedures to cost was assessed by ordinary least squares regression.Unadjusted mean cost for initial AMI hospitalization was 9993 dollars (95% CI 9702 dollars-10,228 dollars). After adjustment for baseline patient-level variation, the lowest average cost was 1605 dollars (Argentina) and the highest was 9196 dollars (United States). Length of stay explained more of the variation in cost (50.7%) than did procedure intensity (31.9%).International differences in the cost of AMI persist, reflecting variations in procedure use and especially LOS. Relative differences in resource costs and incentives inherent in the provision and financing of health care likely contribute to treatment and cost variation and limit the widespread adoption of international practice guidelines.

  View details for DOI 10.1016/j.ahj.2005.02.028

  View details for PubMedID 16368320

• Costs for heart failure with normal vs reduced ejection fraction. Archives of internal medicine Liao, L. n., Jollis, J. G., Anstrom, K. J., Whellan, D. J., Kitzman, D. W., Aurigemma, G. P., Mark, D. B., Schulman, K. A., Gottdiener, J. S. 2006; 166 (1): 112–18

  Abstract

  Among the elderly population, heart failure (HF) with normal ejection fraction (EF) is more common than classic HF with low EF. However, there are few data regarding the costs of HF with normal EF. In a prospective, population-based cohort of elderly participants, we compared the costs and resource use of patients with HF and normal and reduced EF.A total of 4549 participants (84.5% white; 40.6% male) in the National Heart, Lung, and Blood Institute Cardiovascular Health Study were linked to Medicare claims from 1992 through 1998. By protocol echo examinations or clinical EF assessments, 881 participants with HF were characterized as having abnormal or normal EF. We applied semiparametric estimators to calculate mean costs per subject for a 5-year period.There were 495 HF participants with normal EF (186 prevalent at study entry and 309 incident during the study period) and 386 participants with abnormal EF (166 prevalent and 220 incident). Participants with abnormal EF had more cardiology encounters and cardiac procedures. However, compared with abnormal EF participants, the 5-year costs for normal EF participants were similar in both the prevalent ($33,023 with abnormal EF and $32,580 with normal EF; P=.93) and incident ($49,128 with abnormal EF and $45,604 with normal EF; P=.55) groups. In models accounting for comorbid conditions, the costs with normal and abnormal EF remained similar.Over a 5-year period, patients with HF and normal EF consume as many health care resources as those with reduced EF. These data highlight the substantial financial burden of HF with normal EF among the elderly population.

  View details for PubMedID 16401819

• Staphylococcus aureus bacteremia in patients with prosthetic devices: costs and outcomes. The American journal of medicine Chu, V. H., Crosslin, D. R., Friedman, J. Y., Reed, S. D., Cabell, C. H., Griffiths, R. I., Masselink, L. E., Kaye, K. S., Corey, G. R., Reller, L. B., Stryjewski, M. E., Schulman, K. A., Fowler, V. G. 2005; 118 (12): 1416

  Abstract

  Although Staphylococcus aureus is a leading cause of nosocomial infection, little is known about the impact of S. aureus bacteremia on patients with prosthetic devices. This investigation sought to define the clinical outcome, health care resource use, and infection-associated costs of S. aureus bacteremia in patients with prostheses.All hospitalized patients with a prosthetic device and S. aureus bacteremia during the 96-month study period were identified prospectively. Clinical data were collected at the time of hospitalization. Data regarding infection-related resource utilization and infection-related costs within 12 weeks of the initial bacteremia were also recorded.298 patients with > or =1 prosthesis and S. aureus bacteremia were identified (cardiovascular device--122 patients, orthopedic device--73 patients, long-term catheter--71 patients, and other devices-32 patients). Overall, 58% of patients underwent surgery as a consequence of the infection. Infection-related complications occurred in 41% and the overall 12-week mortality was 27%. The mean infection-related cost was 67439 dollars for patients with hospital-acquired S. aureus bacteremia and 37868 dollars for community-acquired S. aureus bacteremia (cost difference 29571 dollars; 95% confidence interval, 14370 dollars-49826 dollars). Rates of device infection, complications, 12-week mortality, and mean cost varied by prosthesis type.S. aureus bacteremia in patients with prosthetic devices is associated with frequent complications, substantial cost, and significant health care resource utilization.

  View details for DOI 10.1016/j.amjmed.2005.06.011

  View details for PubMedID 16378797

• Trends in health care resource use for hepatitis C virus infection in the United States. Hepatology (Baltimore, Md.) Grant, W. C., Jhaveri, R. R., McHutchison, J. G., Schulman, K. A., Kauf, T. L. 2005; 42 (6): 1406-13

  Abstract

  Chronic hepatitis C virus (HCV) infection affects approximately 3 million people in the United States and places tremendous demands on the health care system. As many observers have predicted, the disease burden continues to grow as the infected population ages. In this study, we analyzed inpatient data from the Healthcare Cost and Utilization Project, outpatient data from the National Ambulatory Medical Care Survey, and drug data from the Verispan Source Prescription Audit. We examined recent growth in the use of health care resources among HCV patients by age group and found average annual increases of 25% to 30% for hospitalizations, charges, hospital days, and physician visits. Corresponding time-trend coefficients were positive (P < .001). From 1994 to 2001, the HCV burden increased among patients aged 40 to 60 years, reflecting the natural history of disease progression. In sensitivity analysis, HCV outcome growth rates remained significant, unless more than 3 out of 4 cases were initially underreported. Also, patients co-infected with HIV and HCV in 2001 constituted 7.5 times as many hospitalizations and incurred 2.9 times the charges in 1994, relative to all HIV hospitalizations and charges. Our findings highlight the urgency concerning HCV outcomes. In conclusion, as patients continue to age and disease burden progresses, suboptimal decisions regarding HCV treatments will bring increasing opportunity costs for the health care system and society.

  View details for DOI 10.1002/hep.20941

  View details for PubMedID 16317670

• Implications of pharmacogenomics for drug development and clinical practice. Archives of internal medicine Ginsburg, G. S., Konstance, R. P., Allsbrook, J. S., Schulman, K. A. 2005; 165 (20): 2331-6

  Abstract

  Pharmacogenomics is likely to be among the first clinical applications of the Human Genome Project and is certain to have an enormous impact on the clinical practice of medicine. Herein, we discuss the potential implications of pharmacogenomics on the drug development process, including drug safety, productivity, market segmentation, market expansion, differentiation, and personalized health care. We also review 3 challenges facing the translation of pharmacogenomics into clinical practice: dependence on information technology, limited health care financing, and the scientific uncertainty surrounding validation of specific applications of the technology. To our knowledge, there is currently no formal agenda to promote and cultivate innovation, to develop progressive information technology, or to obtain the financing that would be required to advance the use of pharmacogenomic technologies in patient care. Although the potential of these technologies is driving change in the development of clinical sciences, it remains to be seen which health care systems level needs will be addressed.

  View details for DOI 10.1001/archinte.165.20.2331

  View details for PubMedID 16287761

• Can prospect theory explain risk-seeking behavior by terminally ill patients? Medical decision making : an international journal of the Society for Medical Decision Making Rasiel, E. B., Weinfurt, K. P., Schulman, K. A. 2005; 25 (6): 609-13

  Abstract

  Patients with life-threatening conditions sometimes appear to make risky treatment decisions as their condition declines, contradicting the risk-averse behavior predicted by expected utility theory. Prospect theory accommodates such decisions by describing how individuals evaluate outcomes relative to a reference point and how they exhibit risk-seeking behavior over losses relative to that point. The authors show that a patient's reference point for his or her health is a key factor in determining which treatment option the patient selects, and they examine under what circumstances the more risky option is selected. The authors argue that patients' reference points may take time to adjust following a change in diagnosis, with implications for predicting under what circumstances a patient may select experimental or conventional therapies or select no treatment.

  View details for DOI 10.1177/0272989X05282642

  View details for PubMedID 16282211

• Perceived racial/ethnic bias in healthcare in Durham County, North Carolina: a comparison of community and national samples. North Carolina medical journal Friedman, J. Y., Anstrom, K. J., Weinfurt, K. P., McIntosh, M., Bosworth, H. B., Oddone, E. Z., Bright, C. M., Schulman, K. A. 2005; 66 (4): 267-75

  Abstract

  We sought to compare findings of a national survey of perceptions of racial/ethnic discrimination in healthcare to those of a community survey, with emphasis on the perceptions of Latinos.Responses from a national survey were compared to a telephone survey of residents of Durham County, North Carolina.Black respondents in the Durham sample were more likely than those in the national sample to feel that a healthcare provider had treated them with disrespect because of health insurance status (28% vs 14%; P < 0.001). Approximately one third of Durham Latinos and 14% of Latinos in the national sample felt they had been treated with disrespect because of their English-language ability (P < 0.01). Compared to a national sample of white participants, white respondents in Durham were more likely to believe that black persons are worse off in terms of receiving routine medical care (40% vs 27%; P < 0.01) and having health insurance (58% vs 43%; P < 0.01). As compared to their national counterparts, there was a similar trend for how white respondents in Durham perceived how Latinos fared (P < 0.001 for all comparisons).Overall the perception of bias in healthcare was greater among Durham residents, especially among newly immigrated Latinos, than among their national counterparts.

  View details for PubMedID 16206530

• Evidence-based therapies and mortality in patients hospitalized in December with acute myocardial infarction. Annals of internal medicine Meine, T. J., Patel, M. R., DePuy, V., Curtis, L. H., Rao, S. V., Gersh, B. J., Schulman, K. A., Jollis, J. G. 2005; 143 (7): 481-5

  Abstract

  Previous studies suggest that patients hospitalized with acute myocardial infarction (MI) in December have poor outcomes, and some studies have hypothesized that the cause may be the infrequent use of evidence-based therapies during the December holiday season.To compare the care and outcomes of patients with acute MI hospitalized in December and patients hospitalized during other months.Retrospective analysis of data from the Cooperative Cardiovascular Project.Nonfederal, acute care hospitals in the United States.127 959 Medicare beneficiaries hospitalized between January 1994 and February 1996 with confirmed acute MI.Use of aspirin, beta-blockers, and reperfusion therapy (thrombolytic therapy or percutaneous coronary intervention), and 30-day mortality.When the authors controlled for patient, hospital, and physician characteristics, the use of evidence-based therapies was not significantly lower but 30-day mortality was higher (21.7% vs. 20.1%; adjusted odds ratio, 1.07 [95% CI, 1.02 to 1.12]) among patients hospitalized in December.This was a nonrandomized, observational study. Unmeasured characteristics may have contributed to outcome differences.Thirty-day mortality rates were higher for Medicare patients hospitalized with acute MI in December than in other months, although the use of evidence-based therapies was not significantly lower.

  View details for PubMedID 16204160

• Early hemoglobin response and alternative metrics of efficacy with erythropoietic agents for chemotherapy-related anemia Reed, S. D., Radeva, J. I., Daniel, D. B., Fastenau, J. M., Williams, D., Schulman, K. A. TAYLOR & FRANCIS LTD. 2005: 1527–33

  Abstract

  To examine associations between early hemoglobin response and alternative measures of efficacy following treatment with an erythropoietic agent for chemotherapy-related anemia.Preliminary data from an ongoing randomized, multicenter, 16-week, open-label clinical trial of epoetin alfa versus darbepoetin alfa were used to dichotomize patients based on attainment of early hemoglobin response (> or = 1 g/dL increase in hemoglobin level within 4 weeks of treatment initiation). Measures of efficacy were compared between patients with early hemoglobin response and those without. Sensitivity analyses were then performed to evaluate the impact of various methods for handling censored data and hemoglobin values following blood transfusion.Efficacy measures included: the proportion of patients with a > or = 1 g/dL increase in hemoglobin by 4 weeks or a > or = 2 g/dL increase by 8 weeks; mean hemoglobin levels at 4, 8, 12, and 16 weeks; area under the curve for change in hemoglobin level; proportion of patients who required a blood transfusion after 4 weeks; proportion of follow-up days on which patients had hemoglobin levels within the therapeutic range of 11 g/dL to 13 g/dL; and proportion of patients who never had a hemoglobin level within this range.A total of 274 patients were included (66.1% female, mean age 62.4), of whom 48.9% had an early hemoglobin response and 51.1% did not. Mean duration of follow-up was 10.1 +/- 5.05 weeks. All metrics indicated superior longer-term response among patients with early hemoglobin response compared to patients without early response. The findings were robust across sensitivity analyses. Although the analysis establishes a significant relationship between early hemoglobin response and alternative efficacy metrics, causality cannot be inferred.Early hemoglobin response is significantly associated with various metrics of clinical response to erythropoietic agents and is an appropriate measure for evaluating treatment effects.

  View details for DOI 10.1185/030079905X65394

  View details for Web of Science ID 000232716300003

  View details for PubMedID 16238892

• Resource use, costs, and quality of life among patients in the multinational Valsartan in Acute Myocardial Infarction Trial (VALIANT). American heart journal Reed, S. D., Radeva, J. I., Weinfurt, K. P., McMurray, J. J., Pfeffer, M. A., Velazquez, E. J., Allsbrook, J. S., Masselink, L. E., Sellers, M. A., Califf, R. M., Schulman, K. A. 2005; 150 (2): 323-9

  Abstract

  In a multinational clinical trial, valsartan was statistically not inferior to captopril in reducing mortality and cardiovascular morbidity after myocardial infarction (MI) in patients with signs of heart failure and/or left ventricular dysfunction. We conducted a prospective economic evaluation to compare within-trial resource use, costs, and quality of life in patients receiving valsartan, captopril, or both after MI.We assigned country-specific unit costs to resource use data for 14703 patients and measured health-related quality of life in a subset of 4524 patients. We used the nonparametric bootstrap method to compare rates of resource use and costs, and a piecewise linear mixed-effects regression analysis to compare longitudinal measures of quality of life.There were no significant differences in rates of resource use between the valsartan and captopril groups. During an average follow-up of 2 years, total costs for patients receiving valsartan were significantly higher than for patients receiving captopril (USD 14103 vs USD 13038; 95% CI USD 369-USD 1875). The cost differential was caused primarily by the cost of the study medications (USD 1056 for valsartan vs USD 165 for captopril; 95% CI USD 867 to USD 912). Quality of life did not differ significantly between groups.For most patients at high risk after MI, the availability of generic captopril confers a cost advantage over valsartan because of lower medication costs. The difference will be smaller or nonexistent in settings where brand-name ACE inhibitors are prescribed.

  View details for DOI 10.1016/j.ahj.2004.08.037

  View details for PubMedID 16086938

• Impact of disease severity and gastrointestinal side effects on the health state preferences of patients with osteoarthritis. Arthritis and rheumatism Chang, J., Kauf, T. L., Mahajan, S., Jordan, J. M., Kraus, V. B., Vail, T. P., Reed, S. D., Omar, M. A., Kahler, K. H., Schulman, K. A. 2005; 52 (8): 2366-75

  Abstract

  To describe the health state preferences of patients with osteoarthritis (OA) according to the level of pain and disability and the extent of gastrointestinal side effects from nonsteroidal antiinflammatory drugs (NSAIDs).Using combinations of 5 OA health states (4 specifying medication use) and 6 gastrointestinal side effect profiles, we developed 25 scenarios. In an Internet survey, adults with OA evaluated 5 randomly chosen health state-side effect scenarios (in addition to scenarios for congestive heart failure and wearing dentures, as benchmarks). They rated the scenarios on a 0-100 scale, in which 100 corresponds to best imaginable health. Unadjusted mean ratings were calculated using a difference-in-difference approach. A generalized linear model was used to estimate the effects of disease severity and side effect severity on the ratings, after controlling for patient characteristics.A total of 4,386 respondents whose mean age was 55.3 years, of whom 3,107 (70.8%) were women and 4,007 (91.4%) were white, completed the survey. Mean adjusted ratings for health state-side effect scenarios ranged from 94.9 for the mildest scenario to 25.3 for the most severe scenario. Severity of NSAID side effects had a greater negative influence on the ratings in milder OA states than in more severe OA states. Ratings were lower among men (P < 0.001) and among respondents with OA pain in the previous 24 hours (P < 0.001). Disease severity had a greater effect on ratings than did side effect severity.Patients consider pain and functional limitations associated with OA to be important determinants of well-being. Future research should attempt to determine whether patients prefer reductions in their OA-related pain and disability over improvements in treatment side effect profiles.

  View details for DOI 10.1002/art.21227

  View details for PubMedID 16052538

• Perceived discrimination and reported delay of pharmacy prescriptions and medical tests. Journal of general internal medicine Van Houtven, C. H., Voils, C. I., Oddone, E. Z., Weinfurt, K. P., Friedman, J. Y., Schulman, K. A., Bosworth, H. B. 2005; 20 (7): 578-83

  Abstract

  Access to health care varies according to a person's race and ethnicity. Delaying treatment is one measure of access with important health consequences.Determine whether perceptions of unfair treatment because of race or ethnicity are associated with reported treatment delays, controlling for economic constraints, self-reported health, depression, and demographics.Cross-sectional, observational study.A randomly selected community sample of 181 blacks, 148 Latinos, and 193 whites in Durham County, NC.A phone survey conducted in 2002 to assess discrimination, trust in medical care, quality of care, and access to care. Treatment delays were measured by whether or not a person reported delaying or forgoing filling a prescription and delaying or forgoing having a medical test/treatment in the past 12 months. Perceived discrimination was measured as unfair treatment in health care and as racism in local health care institutions.The odds of delaying filling prescriptions were significantly higher (odds ratio (OR)=2.02) for persons who perceived unfair treatment, whereas the odds of delaying tests or treatments were significantly higher (OR=2.42) for persons who thought racism was a problem in health care locally. People with self-reported depression and people who reported not working had greater odds of delaying both types of care.A prospective cohort study with both personal and macro measures of discrimination, as well as more refined measures of treatment delays, would help us better understand the relationship between perceived discrimination and treatment delays.

  View details for DOI 10.1111/j.1525-1497.2005.0123.x

  View details for PubMedID 16050850

  View details for PubMedCentralID PMC1490147

• Variations in coronary procedure utilization depending on body mass index ARCHIVES OF INTERNAL MEDICINE Yancy, W. S., Olsen, M. K., Curtis, L. H., Schulman, K. A., Cuffe, M. S., Oddone, E. Z. 2005; 165 (12): 1381–87

  Abstract

  Increased body mass index (BMI) (calculated as weight in kilograms divided by the square of height in meters) is a risk factor for coronary heart disease and is associated with lower preventive services utilization. The relationship between BMI and utilization of diagnostic or therapeutic procedures for coronary heart disease has not been examined.We evaluated 109 664 Medicare patients who were hospitalized for acute myocardial infarction in a nongovernmental acute care hospital between 1994 and 1996, were 65 years or older, and weighed 159 kg or less. We used logistic regression to examine the relationship of BMI with utilization of cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass grafting while adjusting for patient and hospital characteristics.Participants had a mean age of 75.8 years; 53% were men and 90% were white. Individuals with a BMI of 25.0 to 35.0 had the highest rates of coronary procedure utilization. Compared with patients with a BMI of 25.0 to 29.9, those with a BMI of 35.0 to 39.9 had a reduced adjusted odds ratio (OR) of receiving coronary artery bypass grafting (OR, 0.88; 95% confidence interval [CI], 0.79-0.98), whereas patients with a BMI of 40.0 or greater had the lowest odds of receiving cardiac catheterization (OR, 0.82; 95% CI, 0.73-0.92), percutaneous coronary intervention (OR, 0.89; 95% CI, 0.77-1.03), and coronary artery bypass grafting (OR, 0.68; 95% CI, 0.57-0.82). Patients who did not receive coronary revascularization had higher mortality rates than those who did.For patients hospitalized with acute myocardial infarction, those with a very high BMI were less likely to receive invasive coronary procedures. Future research should investigate reasons for these variations in coronary procedure utilization.

  View details for DOI 10.1001/archinte.165.12.1381

  View details for Web of Science ID 000230119200008

  View details for PubMedID 15983287

• Atypical antipsychotic drugs and diabetes mellitus in a large outpatient population: a retrospective cohort study. Pharmacoepidemiology and drug safety Østbye, T., Curtis, L. H., Masselink, L. E., Hutchison, S., Wright, A., Dans, P. E., Schulman, K. A., Krishnan, R. R. 2005; 14 (6): 407-15

  Abstract

  Previous research has suggested an association between use of atypical antipsychotics and onset of diabetes mellitus. We sought to compare the incidence of new onset diabetes among patients receiving atypical antipsychotics, traditional antipsychotics or antidepressants.Retrospective cohort study of outpatients with claims for atypical antipsychotics (n = 10 265) compared to controls with claims for traditional antipsychotics (n = 4607), antidepressants (n = 60 856) or antibiotics (n = 59 878) in the administrative claims database of a large pharmaceutical benefit manager between June 2000 and May 2002. Main outcome measures were adjusted and unadjusted incidence rates of diabetes (new cases per 1000 per year) in a 12-month period, as measured using new prescriptions for antidiabetic drugs after a 6-month lead-in period.Annual unadjusted incidence rates of diabetes (new cases per 1000 per year) were 7.5 for atypical antipsychotics, 11.3 for traditional antipsychotics, 7.8 for antidepressants and 5.1 for antibiotics. In multivariable analyses, age, male sex and Chronic Disease Score were associated with greater odds of diabetes onset. There were no statistically significant differences in outcome between the atypical antipsychotic, traditional antipsychotic and antidepressant groups. Multivariable comparisons among specific agents showed increased odds of diabetes for clozapine, olanzapine, ziprasidone and thioridazine (relative to risperidone), but these comparisons did not reach statistical significance.In a large prescription claims database, outpatients taking atypical antipsychotics did not have higher rates of diabetes onset, compared to subjects taking traditional antipsychotics or antidepressants.

  View details for DOI 10.1002/pds.1016

  View details for PubMedID 15372671

• Metaanalysis and review of heart failure disease management randomized controlled clinical trials AMERICAN HEART JOURNAL Whellan, D. J., Hasselblad, Peterson, E., O'Connor, C. M., Schulman, K. A. 2005; 149 (4): 722–29

  Abstract

  The medical community has turned to disease management (DM) to bridge the gap between proven therapies and clinical practice for patients with heart failure (HF). The aim of this study was to assess the effectiveness of DM programs in reducing hospitalization and mortality in patients with HF on the basis of the results of existing trials.We compared the published results from 19 randomized controlled clinical trials evaluating HF DM programs. A random effects model was used to combine the hazards ratio for all-cause hospitalization across the studies evaluating specific types of HF DM programs.We identified 19 relevant studies, with 5752 enrolled patients, which assessed the benefits of HF DM programs. The overall effect was a significant decrease in all-cause hospitalization for patients with HF. There was significant heterogeneity in the results (P < .0001).The results of this analysis indicate that HF DM is an intervention that could significantly decrease hospitalization for patients with HF. However, due to differences in the types of strategies and the variety of health care settings in which they were evaluated, further studies of HF DM programs with multiple participating centers are required.

  View details for DOI 10.1016/j.ahj.2004.09.023

  View details for Web of Science ID 000228717600025

  View details for PubMedID 15990759

• Prevalence of atypical antipsychotic drug use among commercially insured youths in the United States. Archives of pediatrics & adolescent medicine Curtis, L. H., Masselink, L. E., Østbye, T., Hutchison, S., Dans, P. E., Wright, A., Krishnan, R. R., Schulman, K. A. 2005; 159 (4): 362-6

  Abstract

  Use of atypical antipsychotic medications in pediatric populations is increasing. Although previous studies have presented data by age or sex, none has documented sex-specific prevalence by age group.To estimate the 1-year prevalence of atypical antipsychotic use by age and sex among commercially insured youths in the United States.Period prevalence study, January through December 2001.Administrative claims database of a large pharmaceutical benefit manager for 6 213 824 outpatients.Period prevalence of outpatient prescription claims for atypical antipsychotic drugs among commercially insured, continuously enrolled youths.The prevalence of atypical antipsychotic use was 267.1 per 100 000 subjects aged 19 years and younger (16 599/6 213 824) and was more than twice as high for male patients as for female patients, although male and female patients were nearly equally represented in the overall population. Prevalence peaked at 594.3 per 100 000 subjects among male patients aged 10 to 14 years and 291.0 per 100 000 subjects among female patients aged 15 to 19 years. Nearly one fourth (3830/16 599) of patients with a claim for an atypical antipsychotic were aged 9 years and younger, and nearly 80% of these (3021/3830) were boys.Although evidence regarding the safety and efficacy of atypical antipsychotics in young children is limited, nearly one fourth of patients with claims for these drugs were aged 9 years or younger, and a large majority of these were boys. Understanding the long-term effects on the developing brain of early and prolonged exposure to atypical antipsychotics is crucial given their use in pediatric populations.

  View details for DOI 10.1001/archpedi.159.4.362

  View details for PubMedID 15809391

• The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer ANNALS OF ONCOLOGY Weinfurt, K. P., Li, Y., Castel, L. D., Saad, F., Timbie, J. W., Glendenning, G. A., Schulman, K. A. 2005; 16 (4): 579–84

  Abstract

  We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases.Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE.There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively.SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.

  View details for DOI 10.1093/annonc/mdi122

  View details for Web of Science ID 000228415100008

  View details for PubMedID 15734776

• Reducing the costs of phase III cardiovascular clinical trials. American heart journal Eisenstein, E. L., Lemons, P. W., Tardiff, B. E., Schulman, K. A., Jolly, M. K., Califf, R. M. 2005; 149 (3): 482-8

  Abstract

  The pharmaceutical industry spends approximately 26.4 billion dollars annually for research and development (4.1 billion dollars in cardiovascular products). We compared pharmaceutical companies' planned resource use and costs in Phase III cardiovascular trials and identified cost-saving strategies.We developed 2 case scenarios (a 17,000-patient, open-label acute coronary syndromes [ACS] trial and a 14,500-patient, double-blind congestive heart failure [CHF]) trial and surveyed 6 pharmaceutical experts about expected resources (e.g., number of sites, case report form [CRF] pages, and monitoring visits) needed for the trials. Using a validated model, we estimated costs under each expert's assumptions. ACS trial costs averaged 83 million dollars (median, 67 million dollars; range, 57 dollars to 158 million dollars) and 142 million dollars (median, 135 million dollars; range, 102 dollars to 207 million dollars) for the CHF trial. Site-related expenses (site management and payments) were >65% of total costs for both trials. In sensitivity analyses, total costs were reduced >40% by simultaneously reducing CRF pages, monitoring visits, and site-payment amounts but maintaining the numbers of patients and sites.With a set number of sites and patients, the most efficient way to reduce trial costs and still meet the trial's scientific objectives is to reduce management complexity. Modest changes in management parameters release significant monies to answer more research questions.

  View details for DOI 10.1016/j.ahj.2004.04.049

  View details for PubMedID 15864237

• Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus AMERICAN HEART JOURNAL Reed, S. D., Anstrom, K. J., Bakhai, A., Briggs, A. H., Califf, R. M., Cohen, D. J., Drummond, M. F., Glick, H. A., Gnanasakthy, A., Hlatky, M. A., O'Brien, B. J., Torti, F. M., Tsiatis, A. A., Willan, A. R., Mark, D. B., Schulman, K. A. 2005; 149 (3): 434-443

  Abstract

  Demand for economic evaluations in multinational clinical trials is increasing, but there is little consensus about how such studies should be conducted and reported. At a workshop in Durham, North Carolina, we sought to identify areas of agreement about how the primary findings of economic evaluations in multinational clinical trials should be generated and presented. In this paper, we propose a framework for classifying multinational economic evaluations according to (a) the sources of an analyst's estimates of resource use and clinical effectiveness and (b) the analyst's method of estimating costs. We review existing studies in the cardiology literature in the context of the proposed framework. We then describe important methodological and practical considerations in conducting multinational economic evaluations and summarize the advantages and disadvantages of each approach. Finally, we describe opportunities for future research. Delineation of the various approaches to multinational economic evaluation may assist researchers, peer reviewers, journal editors, and decision makers in evaluating the strengths and limitations of particular studies.

  View details for DOI 10.1016/j.ahj.2004.11.001

  View details for Web of Science ID 000228487800010

  View details for PubMedID 15864231

• Who trusts healthcare institutions? Results from a community-based sample. Ethnicity & disease Voils, C. I., Oddone, E. Z., Weinfurt, K. P., Friedman, J. Y., Schulman, K. A., Bosworth, H. B. 2005; 15 (1): 97-103

  Abstract

  The goal of this research was to examine racial differences in trust in various healthcare institutions.In telephone interviews, 195 Whites, 183 Blacks, and 171 Latinos from Durham, NC indicated how often they trust various institutions (community doctors, local hospitals, county health department, insurance companies, and state and federal government) to do what is best for patients.In bivariate analyses, trust in various healthcare institutions was associated with race; Whites and Latinos trusted physicians more often than Blacks, and Latinos trusted the health department, insurance companies, and both government entities more often than Whites and Blacks (Ps < .01). In adjusted analyses controlling for marital status, financial status, and education, race was still associated with trust. Whites trusted physicians more often than Blacks, and Latinos trusted insurance companies, the state government, and the federal government more often than Whites and Blacks (Ps < .01).Racial differences in trust of healthcare institutions vary by institution type. Future studies of trust and interventions designed to improve trust must account for race and target institution differences.

  View details for PubMedID 15720055

• Perceptions of racial and ethnic differences in access to healthcare. North Carolina medical journal Seils, D. M., Schulman, K. A. 2005; 65 (6): 350-2

  View details for PubMedID 15714723

• Costs and outcomes among hemodialysis-dependent patients with methicillin-resistant or methicillin-susceptible Staphylococcus aureus bacteremia INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY Reed, S. D., Friedman, J. Y., Engemann, J. J., Griffiths, R. I., Anstrom, K. J., Kaye, K. S., Stryjewski, M. E., Szczech, L. A., Reller, L. B., Corey, G. R., Schulman, K. A., Fowler, V. G. 2005; 26 (2): 175–83

  Abstract

  Comorbid conditions have complicated previous analyses of the consequences of methicillin resistance for costs and outcomes of Staphylococcus aureus bacteremia. We compared costs and outcomes of methicillin resistance in patients with S. aureus bacteremia and a single chronic condition.We conducted a prospective cohort study of hemodialysis-dependent patients with end-stage renal disease and S. aureus bacteremia hospitalized between July 1996 and August 2001. We used propensity scores to reduce bias when comparing patients with methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) S. aureus bacteremia. Outcome measures were resource use, direct medical costs, and clinical outcomes at 12 weeks after initial hospitalization.Fifty-four patients (37.8%) had MRSA and 89 patients (62.2%) had MSSA. Compared with patients with MSSA bacteremia, patients with MRSA bacteremia were more likely to have acquired the infection while hospitalized for another condition (27.8% vs 12.4%; P = .02). To attribute all inpatient costs to S. aureus bacteremia, we limited the analysis to 105 patients admitted for suspected S. aureus bacteremia from a community setting. Adjusted costs were higher for MRSA bacteremia for the initial hospitalization (21,251 dollars vs 13,978 dollars; P = .012) and after 12 weeks (25,518 dollars vs 17,354 dollars; P = .015). At 12 weeks, patients with MRSA bacteremia were more likely to die (adjusted odds ratio, 5.4; 95% confidence interval, 1.5 to 18.7) than were patients with MSSA bacteremia.Community-dwelling, hemodialysis-dependent patients hospitalized with MRSA bacteremia face a higher mortality risk, longer hospital stays, and higher inpatient costs than do patients with MSSA bacteremia.

  View details for DOI 10.1086/502523

  View details for Web of Science ID 000227014000013

  View details for PubMedID 15756889

• Economic evaluation of zoledronic acid versus pamidronate for the prevention of skeletal-related events in metastatic breast cancer and multiple myeloma. American journal of clinical oncology Reed, S. D., Radeva, J. I., Glendenning, G. A., Coleman, R. E., Schulman, K. A. 2005; 28 (1): 8-16

  Abstract

  Skeletal complications of cancer decrease health-related quality of life. Bisphosphonates can prevent skeletal-related events. We collected resource use data prospectively for 930 patients alongside a multinational trial of zoledronic acid versus pamidronate for patients with metastatic multiple myeloma or breast cancer and > or =1 bone lesion. Country-specific unit costs were assigned to counts of resource use from randomization through last trial visit. Total costs were calculated by summing costs for medical resources, plus costs of institutional care and study medications and administration. Resource use was similar for both groups. Approximately half of the patients were hospitalized at least once during the mean follow-up of 10 months (52.8% for zoledronic acid versus 52.6% for pamidronate; P = 0.9504). The average number of hospital days was 8.9 for zoledronic acid versus 9.2 for pamidronate (P = 0.728). The mean total cost was 16,434 dollars for zoledronic acid and 15,735 dollars for pamidronate, an incremental cost of 699 dollars (95% confidence interval [CI], -1047 to 2163). Mean total costs for patients with multiple myeloma were 1982 dollars (95% CI, -1491 to 5335) higher for zoledronic acid (17,958 dollars) than for pamidronate (15,976 dollars). However, among patients with breast cancer, total costs in both groups were approximately equal (15,703 dollars for zoledronic acid versus 15,680 dollars for pamidronate; 95% CI for the difference: -1875 to 2012). There were no significant cost differences between patients receiving zoledronic acid and those receiving pamidronate.

  View details for PubMedID 15685028

• Economic evaluation of everolimus vs. azathioprine at one year after de novo heart transplantation. Clinical transplantation Radeva, J. I., Reed, S. D., Kaló, Z., Kauf, T. L., Cantu, E., Cretin, N., Schulman, K. A. 2005; 19 (1): 122-9

  Abstract

  Everolimus decreases acute rejection and cardiac allograft vasculopathy after heart transplantation. We compared within-trial costs and resource use over 1 yr of follow-up in de novo heart transplant patients randomized to everolimus 1.5 mg/d (n = 209), everolimus 3.0 mg/d (n = 211), or azathioprine (n = 214).Resource use data were collected prospectively for 634 patients from 14 countries. We used the nonparametric bootstrap method to test for differences in mean costs and to estimate confidence intervals for cost-effectiveness ratios.Everolimus patients had lower incidence of efficacy failure compared with azathioprine patients (41.6%, everolimus 1.5 mg; 32.2%, everolimus 3.0 mg; 52.8%, azathioprine). Compared with patients receiving azathioprine, everolimus patients spent more days in the hospital [36.3 d for everolimus 1.5 mg/d (p = 0.21); 38.4 d for everolimus 3.0 mg/d (p = 0.01); 32.2 d for azathioprine]. Mean total costs, excluding the study medications, were not significantly different among treatment groups ($72 065 for everolimus 1.5 mg; $72 631 for everolimus 3.0 mg; $70 815 for azathioprine).Over 1 yr of follow-up after heart transplantation, everolimus did not significantly increase treatment costs, excluding the costs of the study medications, while reducing efficacy failure. Longer follow-up and the cost of everolimus are required to fully evaluate the cost-effectiveness of everolimus vs. azathioprine in post-transplant maintenance.

  View details for DOI 10.1111/j.1399-0012.2004.00312.x

  View details for PubMedID 15659145

• Clinical outcomes and costs due to Staphylococcus aureus bacteremia among patients receiving long-term hemodialysis. Infection control and hospital epidemiology Engemann, J. J., Friedman, J. Y., Reed, S. D., Griffiths, R. I., Szczech, L. A., Kaye, K. S., Stryjewski, M. E., Reller, L. B., Schulman, K. A., Corey, G. R., Fowler, V. G. 2005; 26 (6): 534–39

  Abstract

  To examine the clinical outcomes and costs associated with Staphylococcus aureus bacteremia among hemodialysis-dependent patients.Prospectively identified cohort study.A tertiary-care university medical center in North Carolina.Two hundred ten hemodialysis-dependent adults with end-stage renal disease hospitalized with S. aureus bacteremia.The majority of the patients (117; 55.7%) underwent dialysis via tunneled catheters, and 29.5% (62) underwent dialysis via synthetic arteriovenous fistulas. Vascular access was the suspected source of bacteremia in 185 patients (88.1%). Complications occurred in 31.0% (65), and the overall 12-week mortality rate was 19.0% (40). The mean cost of treating S. aureus bacteremia, including readmissions and outpatient costs, was $24,034 per episode. The mean initial hospitalization cost was significantly greater for patients with complicated versus uncomplicated S. aureus bacteremia ($32,462 vs $17,011; P = .002).Interventions to decrease the rate of S. aureus bacteremia are needed in this high-risk, hemodialysis-dependent population.

  View details for PubMedID 16018428

• Economics and quality of life in the advanced heart failure patient Managing Acute Decompensated Heart Failure Whellen, D. J., Yager, J. E., Friedman, J. Y., Schulman, K. A. Taylor & Francis. 2005
• Pharmacoeconomics: economic evaluation of pharmaceuticals Pharmacoepidemiology Schulman, K. A., Glick, H. A., Polsky, D. 2005; 4th ed.: 629–652
• Understanding of an aggregate probability statement by patients who are offered participation in Phase I clinical trials. Cancer Weinfurt, K. P., Depuy, V., Castel, L. D., Sulmasy, D. P., Schulman, K. A., Meropol, N. J. 2005; 103 (1): 140-7

  Abstract

  There is concern that patients with poor numeracy may have difficulty understanding the information necessary to make informed treatment decisions. The authors sought to characterize a special form of numeracy among patients with advanced cancer who were offered participation in Phase I oncology clinical trials.Surveys were administered to 328 cancer patients who were considering Phase I trials. Their frequency-type numeracy was assessed using a multiple-choice question involving a hypothetical scenario in which a physician stated that an experimental treatment would control cancer in "40% of cases like yours." In univariate and multivariable analyses, patient characteristics that were associated with better numeracy were identified.The correct frequency-type interpretation was selected by 72% of respondents. Fourteen percent of respondents incorrectly selected a belief-type answer, "The doctor is 40% confident that the treatment will control my cancer." In a multivariable model, patients who answered incorrectly tended to have less formal education and less experience with experimental therapies.Because the misunderstandings some patients demonstrated may influence their treatment decision making adversely, it is critical to identify such patients and to give them special consideration when communicating information about potential risks and benefits of treatment.

  View details for DOI 10.1002/cncr.20730

  View details for PubMedID 15534885

• Commentary: The unknown benefit of complementary and alternative medicine. Journal of alternative and complementary medicine (New York, N.Y.) Schulman, K. A. 2004; 10 (6): 911

  View details for DOI 10.1089/acm.2004.10.911

  View details for PubMedID 15673982

• Long-term survival estimates for imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia. Cancer Anstrom, K. J., Reed, S. D., Allen, A. S., Glendenning, G. A., Schulman, K. A. 2004; 101 (11): 2584-92

  Abstract

  The authors estimated survival among patients with chronic myeloid leukemia for a cost-effectiveness analysis of imatinib versus interferon-alpha plus low-dose cytarabine (IFN+LDAC).Two-year survival and cytogenetic response were determined using data from 553 patients who received first-line imatinib in the International Randomized Interferon versus ST571 Study (IRIS). Long-term survival was modeled on complete cytogenetic response (CCyR) after 2 years. Long-term survival for patients with a CCyR was modeled using data from a cohort study of 317 patients with CCyRs. Long-term survival for patients without a CCyR was modeled using data from a trial of 275 patients who were treated with IFN+LDAC. Computation of lifetime survival estimates for imatinib assumed a proportional hazards relation between survival for an age-matched and gender-matched cohort and survival for patients with and without a CCyR.For IRIS patients receiving imatinib, the estimated survival was 95.8% and the CCyR rate was 73.8%. The average residual life expectancy was estimated to be 16.71 years for CCyR patients and 5.78 years for non-CCyR patients. The estimated life expectancy after treatment with imatinib was 15.30 years, compared with 9.07 years for patients who were treated with IFN+LDAC in previous studies.Assuming the relation between CCyR and survival with interferon-alpha holds for imatinib, higher CCyR rates with imatinib therapy will result in an estimated 6.23 life-years gained compared with treatment with IFN+LDAC.

  View details for DOI 10.1002/cncr.20674

  View details for PubMedID 15493041

• Cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine for patients with newly diagnosed chronic-phase chronic myeloid leukemia. Cancer Reed, S. D., Anstrom, K. J., Ludmer, J. A., Glendenning, G. A., Schulman, K. A. 2004; 101 (11): 2574-83

  Abstract

  Despite a lack of long-term data, imatinib has become standard therapy for patients with newly diagnosed chronic-phase chronic myeloid leukemia (CML) who are not candidates for allogeneic stem cell transplantation. In the current study, the authors estimated the incremental cost-effectiveness of imatinib versus interferon-alpha plus low-dose cytarabine (IFN+LDAC) as first-line therapy for these patients.Data from the International Randomized Interferon versus STI571 Study and the literature were used to estimate lifetime costs, survival, and quality-adjusted survival. Survival estimates were based on published survival curves for patients who achieved and those who did not achieve a complete cytogenetic response after treatment with interferon-alpha.The mean estimated survival with first-line imatinib therapy was 15.30 years, compared with 9.07 years with IFN+LDAC. Undiscounted lifetime costs were approximately $424,600 with imatinib and $182,800 with IFN+LDAC. Using a 3% discount rate, the incremental survival gain with imatinib was 3.93 life-years and 3.89 quality-adjusted life-years (QALYs). Incremental discounted lifetime costs were found to be $168,100 higher with imatinib, resulting in incremental cost-effectiveness ratios of $43,100 per life-year saved (95% confidence interval [95% CI], $37,600-51,100) and $43,300 per QALY (95% CI, $38,300-49,100).The results of the current study demonstrate that compared with IFN+LDAC, imatinib is a cost-effective first-line therapy in patients with newly diagnosed chronic-phase CML.

  View details for DOI 10.1002/cncr.20694

  View details for PubMedID 15493042

• An exploration of relative health stock in advanced cancer patients MEDICAL DECISION MAKING Gaskin, D. J., Weinfurt, K. R., Castel, L. D., DePuy, Li, Y., Balshem, A., Benson, A., Burnett, C. B., Corbett, S., Marshall, J., Slater, E., Sulmasy, D. R., Van Echo, D., Meropol, N. J., Schulman, K. A. 2004; 24 (6): 614–24

  Abstract

  The authors sought to empirically test whether relative health stock, a measure of patients' sense of loss in their health due to illness, influences the treatment decisions of patients facing life-threatening conditions. Specifically, they estimated the effect of relative health stock on advanced cancer patients' decisions to participate in phase I clinical trials.A multicenter study was conducted to survey 328 advanced cancer patients who were offered the opportunity to participate in phase I trials. The authors asked patients to estimate the probabilities of therapeutic benefits and toxicity, their relative health stock, risk preference, and the importance of quality of life.Controlling for health-related quality of life, an increase in relative health stock by 10 percentage points reduced the odds of choosing to participate in a phase I trial by 16% (odds ratio = 0.84, 95% confidence interval = 0.72, 0.97).Relative health stock affects advanced cancer patients' treatment decisions.

  View details for DOI 10.1177/0272989X04271041

  View details for Web of Science ID 000225206600005

  View details for PubMedID 15534342

• Parents' reported preference scores for childhood atopic dermatitis disease states. BMC pediatrics Friedman, J. Y., Reed, S. D., Weinfurt, K. P., Kahler, K. H., Walter, E. B., Schulman, K. A. 2004; 4 (1): 21

  Abstract

  We sought to elicit preference weights from parents for health states corresponding to children with various levels of severity of atopic dermatitis. We also evaluated the hypothesis that parents with children who had been diagnosed with atopic dermatitis would assign different preferences to the health state scenarios compared with parents who did not have a child with atopic dermatitis.Subjects were parents of children aged 3 months to 18 years. The sample was derived from the General Panel, Mommies Sub-Panel, and Chronic Illness Sub-Panel of Harris Interactive. Participants rated health scenarios for atopic dermatitis, asthma, and eyeglasses on a visual analog scale, imagining a child was experiencing the described state.A total of 3539 parents completed the survey. Twenty-nine percent had a child with a history of atopic dermatitis. Mean preference scores for atopic dermatitis were as follows: mild, 91 (95% confidence interval [CI], 90.7 to 91.5); mild/moderate, 84 (95%CI, 83.5 to 84.4); moderate, 73 (95%CI, 72.5 to 73.6); moderate/severe, 61 (95%CI, 60.6 to 61.8); severe, 49 (95% CI, 48.7 to 50.1); asthma, 58 (95%CI, 57.4 to 58.8); and eyeglasses, 87(95%CI, 86.3 to 87.4).Parents perceive that atopic dermatitis has a negative effect on quality of life that increases with disease severity. Estimates of parents' preferences can provide physicians with insight into the value that parents place on their children's treatment and can be used to evaluate new medical therapies for atopic dermatitis.

  View details for DOI 10.1186/1471-2431-4-21

  View details for PubMedID 15491500

  View details for PubMedCentralID PMC529264

• Regionalization of percutaneous transluminal coronary angioplasty and implications for patient travel distance. JAMA Kansagra, S. M., Curtis, L. H., Schulman, K. A. 2004; 292 (14): 1717-23

  Abstract

  Minimum procedure volume thresholds have been proposed to improve outcomes among patients undergoing percutaneous transluminal coronary angioplasty (PTCA). How regionalization policies would affect patient travel distances is not known.To examine the effect of regionalization of PTCA on patient travel distances.A retrospective cohort study of discharge records, which were examined to determine hospital and operator procedure volumes, of 97,401 patients undergoing PTCA in New York, New Jersey, and Florida in 2001. Travel distances were measured at baseline and under 2 regionalization scenarios in which hospital-operator pairs not meeting minimum volume standards stopped providing services.Observed and expected patient travel distances, and risk-adjusted mortality.With a minimum volume standard of 175 per operator and 400 per hospital (class 1), 25% of patients had a shorter travel distance, 10% had a longer travel distance, and 65% experienced no change. Most patients with longer travel distances under this standard would travel no more than 25 miles farther, and most patients with shorter travel distances would save no more than 10 miles. With a minimum volume standard of 75 per operator and 400 per hospital (class 2), 11% of patients had a shorter travel distance, 2% had a longer travel distance, and 87% experienced no change. Under both standards, less than 1% of patients would travel more than 50 miles farther than their observed travel distance. Risk-adjusted mortality was higher for lower-volume hospital-operator pairs (1.2% for class 3 vs 0.9% for class 2 and 0.8% for class 1; P<.001 for both comparisons).Regionalization of PTCA would not increase travel distance for most patients; however, potential costs of regionalization not related to travel must be examined before such policies can be recommended.

  View details for DOI 10.1001/jama.292.14.1717

  View details for PubMedID 15479937

• Inappropriate prescribing for elderly Americans in a large outpatient population ARCHIVES OF INTERNAL MEDICINE Curtis, L. H., Ostbye, T., Sendersky, Hutchison, S., Dans, P. E., Wright, A., Woosley, R. L., Schulman, K. A. 2004; 164 (15): 1621–25

  Abstract

  We sought to determine the extent of potentially inappropriate outpatient prescribing for elderly patients, as defined by the Beers revised list of drugs to be avoided in elderly populations.We conducted a retrospective cohort study using the outpatient prescription claims database of a large, national pharmaceutical benefit manager. The cohort included 765,423 subjects 65 years or older, who were covered by a pharmaceutical benefit manager and filed 1 or more prescription drug claims during 1999. Main outcome measures were the proportion of subjects who filled a prescription for 1 or more drugs of concern and the proportion of subjects who filled prescriptions for 2 or more of the drugs.A total of 162,370 subjects (21%) filled a prescription for 1 or more drugs of concern. Amitriptyline and doxepin accounted for 23% of all claims for Beers list drugs, and 51% of those claims were for drugs with the potential for severe adverse effects. More than 15% of subjects filled prescriptions for 2 drugs of concern, and 4% filled prescriptions for 3 or more of the drugs within the same year. The most commonly prescribed classes were psychotropic drugs and neuromuscular agents.The common use of potentially inappropriate drugs should serve as a reminder to monitor their use closely. Pharmaceutical claims databases can be important tools for accomplishing this task, though clinical and laboratory data are needed to improve the sensitivity and specificity of patient-specific alerts.

  View details for DOI 10.1001/archinte.164.15.1621

  View details for Web of Science ID 000223233100004

  View details for PubMedID 15302631

• Differential pricing of pharmaceuticals in the internet age. The Journal of ambulatory care management Ridley, D. B., Schulman, K. A. 2004; 27 (3): 210-4

  Abstract

  The Internet provides healthcare consumers with more information about available prices and provides pharmaceutical manufacturers with more information about consumers' willingness to pay. The former effect tends to undermine price differences while the latter tends to support them. We believe that the former effect will dominate and that the Internet will undermine differential pricing of pharmaceuticals. This should be a concern for manufacturers and policy makers, because differential pricing of pharmaceuticals can increase access for the poor and increase incentives for innovation. We suggest strategic responses for manufacturers and policy makers.

  View details for PubMedID 15287210

• State-mandated continuing medical education and the use of proven therapies in patients with an acute myocardial infarction JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Patel, M. R., Meine, T. J., Radeva, J., Curtis, L., Rao, S. V., Schulman, K. A., Jollis, J. G. 2004; 44 (1): 192–98

  Abstract

  The purpose of this study was to determine whether state-mandated continuing medical education (CME) requirements affect the use of evidence-based therapies and outcomes in patients with acute myocardial infarction (AMI).The Institute of Medicine recommends that educational programs demonstrate their effect through process and outcome measures.We analyzed 134,609 patients according to whether or not CME was mandated in the state of physician practice. A hierarchical multivariable model was developed that controlled for state, hospital, physician, and patient level characteristics to determine the association between state CME requirements and the use of evidence-based therapies. Primary outcome measures were admission aspirin use and reperfusion therapy, and discharge aspirin and beta-blocker prescription. Thirty-day and one-year mortality were secondary outcome measures.States with and without CME requirements had similar rates of aspirin use at admission and discharge (79.9% vs. 79.4% and 72.5% vs. 72.5%, respectively) and beta-blocker prescription at discharge (53.6% vs. 55.3%). The rate of reperfusion therapy at admission was significantly higher in states requiring CME (53.1%) compared with states without CME (47.9%) (p < 0.0001). After adjustment, patients admitted in CME-requiring states were significantly more likely to receive reperfusion therapy, mainly owing to "patented" thrombolytic therapy (odds ratio 1.15; p = 0.016). There was no association between CME requirements and one-year mortality.State-mandated CME had little association with AMI care or outcome, other than an increased use of patented thrombolytic therapy. Further research is needed to maximize the measurable effect of CME on the use of proven therapies irrespective of whether patented or generic medications are involved.

  View details for DOI 10.1016/j.jacc.2004.03.070

  View details for Web of Science ID 000222421500038

  View details for PubMedID 15234433

• Multinational economic evaluation of valsartan in patients with chronic heart failure: Results from the Valsartan Heart Failure Trial (Val-HeFT) AMERICAN HEART JOURNAL Reed, S. D., Friedman, J. Y., Velazquez, E. J., Gnanasakthy, A., Califf, R. M., Schulman, K. A. 2004; 148 (1): 122–28

  Abstract

  The Valsartan Heart Failure Trial (Val-HeFT) compared valsartan versus placebo in 5010 patients taking prescribed background therapy for New York Heart Association class II to IV heart failure. Valsartan reduced the risk of heart failure hospitalization and improved clinical signs and symptoms of heart failure. We sought to compare resource use, costs, and health outcomes among patients taking prescribed therapy for heart failure and randomly assigned to receive valsartan or placebo.Measures of resource use were based on data collected during the trial. Unit cost estimates were collected from individual countries and converted to 1999 US dollars. Total costs were estimated for hospitalizations, inpatient and outpatient physician services, ambulance transportation, deaths outside the hospital, and outpatient cardiovascular medications.Mean follow-up was 23 months. Mean costs for heart failure hospitalizations were 423 dollars lower among patients receiving valsartan (95% CI, -706 to -146). Mean total costs were 9008 dollars for patients receiving valsartan and 8464 dollars for patients receiving placebo, a net incremental cost of 545 dollars (95% CI, -149 to 1148), including the cost of valsartan. There was an overall reduction in total costs of 929 dollars (95% CI, -3243 to 1533) among patients not receiving an ACE inhibitor at baseline but a slight increase in costs of 334 dollars (95% CI, -497 to 1199) among those receiving an ACE inhibitor without a beta-blocker and a 1246 dollars increase (95% CI, 54 to 2230) in patients receiving both an ACE inhibitor and a beta-blocker at baseline.Valsartan provided clinical benefits at a mean incremental cost of 285 dollars per year during the trial. In patients not taking ACE inhibitors, valsartan was economically attractive, increasing survival while reducing or marginally increasing overall costs.

  View details for DOI 10.1016/j.ahj.2003.12.040

  View details for Web of Science ID 000222357700022

  View details for PubMedID 15215801

• Socioeconomic status and outcome following acute myocardial infarction in elderly patients ARCHIVES OF INTERNAL MEDICINE Rao, S. V., Schulman, K. A., Curtis, L. H., Gersh, B. J., Jollis, J. G. 2004; 164 (10): 1128–33

  Abstract

  Although the Medicare entitlement provides universal hospital care coverage for elderly Americans, disparities in care processes after acute myocardial infarction still exist. Whether these disparities account for increased mortality among elderly poor patients is not known.To determine the association between socioeconomic status and acute myocardial infarction treatment, procedure use, and 30-day and 1-year mortality, we analyzed data from 132 130 elderly Medicare beneficiaries hospitalized for acute myocardial infarction between January 1994 and February 1996. Patients were categorized into 10 groups of increasing income using the median income of the ZIP code of residence.The highest-income beneficiaries received higher rates of evidence-based medical therapy and had lower adjusted 30-day and 1-year mortality rates compared with the middle-income beneficiaries (30-day relative risk, 0.89 [95% confidence interval, 0.85-0.94]; and 1-year relative risk, 0.92 [95% confidence interval, 0.88-0.97]). Conversely, the lowest-income beneficiaries received lower rates of evidence-based medical treatment and had higher adjusted 30-day and 1-year mortality rates relative to the middle-income beneficiaries (30-day relative risk, 1.09 [95% confidence interval, 1.04-1.13]; and 1-year relative risk, 1.05 [95% confidence interval, 1.00-1.10]). Coronary revascularization rates were similar among income groups.Despite the Medicare entitlement, there remain significant socioeconomic disparities in medical treatment and mortality among elderly patients following acute myocardial infarction. Income was independently associated with short- and long-term mortality. More research is required to determine the mechanisms contributing to adverse outcomes among poor elderly patients and to determine whether expansion of Medicare coverage will alleviate these disparities.

  View details for DOI 10.1001/archinte.164.10.1128

  View details for Web of Science ID 000221623600011

  View details for PubMedID 15159271

• The insurance effect on prescription drug expenditures among the elderly: findings from the 1997 Medical Expenditure Panel Survey. Medical care Curtis, L. H., Law, A. W., Anstrom, K. J., Schulman, K. A. 2004; 42 (5): 439-46

  Abstract

  Despite continuing debate over a prescription drug benefit for the Medicare program, there has been relatively little research estimating the potential cost of providing such a benefit.The objective of this study was to estimate the effect of prescription drug insurance on outpatient prescription drug expenditures among the elderly.We studied respondents aged > or =65 years to the 1997 Medical Expenditure Panel Survey, a representative survey of the U.S. noninstitutionalized population. Survey-weighted linear regression models were used to estimate the probability of any expenditures and total expenditures while controlling for sociodemographic characteristics, chronic conditions, and health status.We used prescription drug insurance status and outpatient prescription drug expenditures.An estimated 34 million elderly people filled 630 million prescriptions in 1997. Thirty-seven percent did not have prescription drug insurance. Total prescription drug expenditures exceeded $23 billion. Persons without prescription drug insurance spent slightly less than $7 billion; those with insurance spent more than $16 billion. After controlling for health status, comorbidity, and demographic characteristics, prescription drug insurance increased expenditures by $183 per person. The marginal increase in total expenditures of extending the average observed benefit to those currently uninsured is $2.3 billion (95% confidence interval, $1.2-3.5 billion).Proposals for a Medicare drug benefit provide high copayments to protect against insurance effects and to address uncertainty in cost estimates of the proposed benefit. By quantifying the insurance effect on expenditures among the elderly, the data reported here could reduce uncertainty in the budget estimation process.

  View details for PubMedID 15083104

• The warfarin and Antiplatelet Therapy in Heart Failure Trial (WATCH): Rationale, design, and baseline patient characteristics JOURNAL OF CARDIAC FAILURE Massie, B. M., Krol, W. F., Ammon, S. E., Armstrong, P. W., Cleland, J. G., Collins, J. F., Ezekowitz, M., Jafri, S. M., O'Connor, C. M., Packer, M., Schulman, K. A., Warren, S. 2004; 10 (2): 101–12

  Abstract

  The role of anticoagulation in patients with chronic heart failure has long been an area of interest and controversy. Traditionally the goal of anticoagulation has been to prevent embolic events, but recent trials also demonstrated that oral anticoagulation also prevents vascular events in patients with prior myocardial infarction, who constitute the majority of heart failure patients. Although antiplatelet agents also reduce postinfarction vascular events, few data are available in heart failure patients, and some evidence suggests that aspirin may also have the potential to worsen heart failure morbidity and mortality, possibly by interfering with the effects of angiotensin-converting enzyme inhibitors. Methods and results The Warfarin and Antiplatelet Therapy in Chronic Heart Failure (WATCH) trial was undertaken to determine the optimal antithrombotic agent for heart failure patients. WATCH was a prospective-randomized trial in which symptomatic heart failure patients in sinus rhythm with ejection fractions < or =35% taking angiotensin-converting enzyme inhibitors (unless not tolerated) and diuretics were randomized to open-label warfarin (target International Normalized Ratio 2.5-3.0) or double-blind antiplatelet therapy with aspirin 162 mg or clopidogrel 75 mg. Two primary comparisons were specified: anticoagulation with warfarin versus antiplatelet therapy with aspirin and antiplatelet therapy with clopidogrel versus antiplatelet therapy with aspirin. The primary outcome is the composite of death from all causes, nonfatal myocardial infarction, and nonfatal stroke analyzed as time to first event using the intent-to-treat approach. The secondary endpoint was the broader composite of death from all causes, nonfatal myocardial infarction, non-fatal stroke, and hospitalizations for worsening heart failure, unstable angina pectoris, and systemic or pulmonary artery embolic events. Additional prespecified analyses include heart failure events, coronary events, and resource utilization.Although the trial was designed to enter 4500 patients, it was terminated 18 months prematurely in June 2003 by the VA Cooperative Study Program because of poor enrollment with a resulting reduction of its power to achieve its original objective. This manuscript describes the study rationale, protocol design, and the baseline characteristics of the 1587 patients who were entered into the study. The WATCH trial will help define the optimal approach to antithrombotic therapy in the contemporary management of patients with chronic heart failure resulting from left ventricular systolic dysfunction.

  View details for DOI 10.1016/j.cardfail.2004.02.006

  View details for Web of Science ID 000221147600002

  View details for PubMedID 15101020

• Cost-effectiveness of zoledronic acid for the prevention of skeletal complications in patients with prostate cancer. The Journal of urology Reed, S. D., Radeva, J. I., Glendenning, G. A., Saad, F., Schulman, K. A. 2004; 171 (4): 1537-42

  Abstract

  We estimated the cost-effectiveness of zoledronic acid vs placebo for decreasing skeletal complications in men with prostate cancer.We performed a cost-effectiveness analysis alongside a multinational clinical trial of zoledronic acid. Cost estimation was based on prospectively collected resource use data for 85.3% of enrolled patients. Cost-effectiveness ratios were based on within-trial data on clinical outcomes, quality of life and study medication cost.Patients receiving zoledronic acid experienced fewer hospital days during a mean followup of 9 months (average 5.6 vs 8.0 days; p = 0.1910). Mean direct costs excluding study medication were US dollars 5365 for patients receiving zoledronic acid and US dollars 5689 for patients receiving placebo, a difference of US dollars 324 (95% CI US dollars 1781 to US dollars 1146). The global average cost of zoledronic acid plus its administration during the trial was US dollars 5677 (US dollars 450 per dose). The nominal cost per skeletal complication avoided was US dollars 112300 (95% CI US dollars 6900 to US dollars 48700) and the cost per additional patient free of skeletal complications was US dollars 51400 (95% CI US dollars 26900 to US dollars 243700). Nominal within-trial cost per quality adjusted life-year was US dollars 159200, which varied widely in sensitivity analyses.The nominal base case estimate of the cost per quality adjusted life-year for zoledronic acid in the prevention of skeletal complications of prostate cancer is consistent with that of bisphosphonates in breast cancer. However, the cost-effectiveness ratios for bisphosphonates are higher than commonly cited thresholds for conferring cost-effectiveness.

  View details for DOI 10.1097/01.ju.0000116777.94426.60

  View details for PubMedID 15017215

• Differences in care-seeking behavior for acute chest pain in the United States and Japan. American heart journal Liao, L., Whellan, D. J., Tabuchi, K., Schulman, K. A. 2004; 147 (4): 630-5

  Abstract

  Delay from onset of acute myocardial infarction symptoms to the delivery of medical care is a major determinant of prognosis. Although studies have explored patient factors for delay in seeking care, there are limited data on international differences in care-seeking behavior.We surveyed 1032 people in the United States and 1422 people in Japan in January 1997 on decision-making responses to a chest pain scenario representing acute MI. Participants were asked about how they would seek initial care and how promptly they would seek care.The mean age was 43.6 years in the United States and 48.3 years in Japan. For the hypothetical scenario, US respondents were more likely to seek care at an emergency department (22.9% vs 16.2% in Japan) or through emergency medical services/911 (55.9% vs 32.9% in Japan, P =.001). American subjects were also more likely to seek care immediately (83.1% vs 56.4% in Japan, P =.001).Respondents in the United States and Japan differed substantially in their responses to a hypothetical chest pain scenario. Whether these differences result from cultural or health care system factors and whether these apparent attitudes produce gaps in real responses to acute coronary syndromes must be explored in further studies.

  View details for DOI 10.1016/j.ahj.2003.10.006

  View details for PubMedID 15077077

• A multinational review of recent trends and reports in dementia caregiver burden ALZHEIMER DISEASE & ASSOCIATED DISORDERS Torti, F. M., Gwyther, L. P., Reed, S. D., Friedman, J. Y., Schulman, K. A. 2004; 18 (2): 99–109

  Abstract

  This systematic review of the literature focuses on the influence of ethnic, cultural, and geographic factors on the caregivers of patients with dementia. In particular, we explore the impact of cultural expectations on five important questions: 1) Do the characteristics of dementia affect caregiver burden? 2) Do characteristics of the caregiver independently predict burden? 3) Does the caregiver affect patient outcomes? 4) Does support or intervention for caregiver result in reduced caregiver burden or improved patient outcomes? 5) Finally, do patient interventions result in reduced caregiver burden or improved patient outcomes? Our findings suggest that noncognitive, behavioral disturbances of patients with dementia result in increased caregiver burden and that female caregivers bear a particularly heavy burden across cultures, particularly in Asian societies. Caregiver burden influences time to medical presentation of patients with dementia, patient condition at presentation, and patient institutionalization. Moreover, interventions designed to reduce caregiver burden have been largely, although not universally, unsuccessful. Pharmacological treatments for symptoms of dementia were found to be beneficial in reducing caregiver burden. The consistency of findings across studies, geographic regions, cultural differences, and heathcare delivery systems is striking. Yet, there are critical differences in cultural expectations and social resources. Future interventions to reduce caregiver burden must consider these differences, identify patients and caregivers at greatest risk, and develop targeted programs that combine aspects of a number of interventional strategies.

  View details for DOI 10.1097/01.wad.0000126902.37908.b2

  View details for Web of Science ID 000221894500009

  View details for PubMedID 15249854

• Health-related quality of life among patients with breast cancer receiving zoledronic acid or pamidronate disodium for metastatic bone lesions MEDICAL CARE Weinfurt, K. P., Castel, L. D., Li, Y., Timbie, J. W., Glendenning, G. A., Schulman, K. A. 2004; 42 (2): 164–75

  Abstract

  Research on individual differences in health-related quality of life (HRQOL) can identify intervention targets and important covariates in analyses of treatment outcomes.The objectives of this study were to describe HRQOL trajectories for women with metastatic breast cancer in a randomized trial of bisphosphonates and to identify characteristics associated with variations in HRQOL.We conducted a prospective quality-of-life study within a randomized, controlled trial.We studied women with metastatic breast cancer receiving zoledronic acid or pamidronate disodium to reduce the incidence of skeletal-related events (SREs).HRQOL was measured at fixed time points during the trial. Individual growth-curve modeling was used to describe longitudinal trajectories and to identify predictors of trajectories.For most domains of HRQOL, the mean trajectory reflected a mild increase, which leveled off later in the trial. Older age and full-time employment were associated with higher baseline HRQOL. Longer time from cancer diagnosis to randomization, lower Eastern Cooperative Oncology Group (ECOG) status (score of 2 ["inactive"]), and a history of SREs were associated with lower baseline HRQOL. Significant differences across geographic regions were observed for all domains. Active ECOG status (score of 0-1) at baseline was predictive of greater increases in all domains of HRQOL except Social/Family Well-Being. Age, geographic region, and time from first bone metastases to randomization were associated with longitudinal changes in some domains.Women with metastatic breast cancer receiving bisphosphonates for prevention of SREs experienced an overall increase in HRQOL. Variations among women's experiences are explained partly by such characteristics as a history of SREs.

  View details for DOI 10.1097/01.mlr.0000108746.69256.45

  View details for Web of Science ID 000188432100010

  View details for PubMedID 14734954

• Physician-patient communication in phase I cancer trials - Reply JOURNAL OF CLINICAL ONCOLOGY Meropol, N. J., Castel, L. D., Schulman, K. A., Weinfurt, K. P. 2004; 22 (3): 572–73

  View details for DOI 10.1200/JCO.2004.99.273

  View details for Web of Science ID 000188738900032

• Impact of managed care on the treatment, costs, and outcomes of fee-for-service medicare patients with acute myocardial infarction HEALTH SERVICES RESEARCH Bundorf, M. K., Schulman, K. A., Stafford, J. A., Gaskin, D., Jollis, J. G., Escarce, J. J. 2004; 39 (1): 131-152

  Abstract

  To examine the effects of market-level managed care activity on the treatment, cost, and outcomes of care for Medicare fee-for-service acute myocardial infarction (AMI) patients.Patients from the Cooperative Cardiovascular Project (CCP), a sample of Medicare beneficiaries discharged from nonfederal acute-care hospitals with a primary discharge diagnosis of AMI from January 1994 to February 1996.We estimated models of patient treatment, costs, and outcomes using ordinary least squares and logistic regression. The independent variables of primary interest were market-area managed care penetration and competition. The models included controls for patient, hospital, and other market area characteristics.We merged the CCP data with Medicare claims and other data sources. The study sample included CCP patients aged 65 and older who were admitted during 1994 and 1995 with a confirmed AMI to a nonrural hospital.Rates of revascularization and cardiac catheterization for Medicare fee-for-service patients with AMI are lower in high-HMO penetration markets than in low-penetration ones. Patients admitted in high-HMO-competition markets, in contrast, are more likely to receive cardiac catheterization for treatment of their AMI and had higher treatment costs than those admitted in low-competition markets.The level of managed care activity in the health care market affects the process of care for Medicare fee-for-service AMI patients. Spillovers from managed care activity to patients with other types of insurance are more likely when managed care organizations have greater market power.

  View details for PubMedID 14965081

• The effect of dementia on outcomes and process of care for Medicare beneficiaries admitted with acute myocardial infarction. Journal of the American Geriatrics Society Sloan, F. A., Trogdon, J. G., Curtis, L. H., Schulman, K. A. 2004; 52 (2): 173-81

  Abstract

  To determine differences in mortality after admission for acute myocardial infarction (AMI) and in use of noninvasive and invasive treatments for AMI between patients with and without dementia.Retrospective chart review.Cooperative Cardiovascular Project.Medicare patients admitted for AMI (N=129,092) in 1994 and 1995.Dementia noted on medical chart as history of dementia, Alzheimer's disease, chronic confusion, or senility. Outcome measures included mortality at 30 days and 1-year postadmission; use of aspirin, beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, thrombolytic therapy, cardiac catheterization, coronary angioplasty, and cardiac bypass surgery compared by dementia status.Dementia was associated with higher mortality at 30 days (relative risk (RR)=1.16, 95% confidence interval (CI)=1.09-1.22) and at 1-year postadmission (RR=1.18, 95% CI=1.13-1.23). There were few to no differences in the use of aspirin and beta-blockers between patients with and without a history of dementia. Patients with a history of dementia were less likely to receive ACE inhibitors during the stay (RR=0.89, 95% CI=0.86-0.93) or at discharge (RR=0.90, 95% CI=0.86-0.95), thrombolytic therapy (RR=0.82, 95% CI=0.74-0.90), catheterization (RR=0.51, 95% CI=0.47-0.55), coronary angioplasty (RR=0.58, 95% CI=0.51-0.66), and cardiac bypass surgery (RR=0.41, 95% CI=0.33-0.50) than patients without a history of dementia.The results imply that the presence of dementia had a major effect on mortality and care patterns for this condition.

  View details for PubMedID 14728624

• Commentary: Garson's "Physicians, coverage, quality, and cost: The intertwined caduceus" JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Schulman, K. A. 2004; 43 (1): 6–7

  View details for DOI 10.1016/j.jacc.2003.07.038

  View details for Web of Science ID 000187795400002

• Exploring options for improving healthcare. American heart journal Wang, S. S., Mendelson, D. N., Schulman, K. A., Mark, D. B. 2004; 147 (1): 23-30

  Abstract

  New medical technologies generally must receive clearance or approval for marketing by the US Food and Drug Administration and be covered by an insurer, such as the Centers for Medicare and Medicaid Services, before becoming available for widespread clinical use. These 2 approval processes are discrete and usually occur sequentially rather than collaboratively and simultaneously. To explore potential mechanisms for increasing regulatory collaboration between these 2 key health care agencies, the Duke Clinical Research Institute and Health Strategies Consultancy convened an informal meeting of agency, academic, and industry leaders on December 8 and 9, 2002, titled "Registration/Approval and Coverage/Payment: Exploring Options for Improving Healthcare." This article arises from the discussion at this conference; it does not represent the official views of any person or institution involved. Although the group did not attempt to reach a consensus, it examined several important issues surrounding this regulatory debate. Herein are proposed options for enhancing regulatory efficiency through greater coordination between the FDA and CMS, and discussion of these proposals from the perspectives of members of both agencies, members of stakeholder organizations, and academic observers.

  View details for PubMedID 14691414

• Phase I trials: Physician and patient perceptions - In Reply JOURNAL OF CLINICAL ONCOLOGY Meropol, N. J., Weinfurt, K. P., Schulman, K. A. 2003; 21 (24): 4659–60

  View details for DOI 10.1200/JCO.2003.99.198

  View details for Web of Science ID 000187432300040

• Does the ownership of the admitting hospital make a difference? Outcomes and process of care of Medicare beneficiaries admitted with acute myocardial infarction. Medical care Sloan, F. A., Trogdon, J. G., Curtis, L. H., Schulman, K. A. 2003; 41 (10): 1193-205

  Abstract

  Concerns have been expressed about quality of for-profit hospitals and their use of expensive technologies.To determine differences in mortality after admission for acute myocardial infarction (AMI) and in the use of low- and high-tech services for AMI among for-profit, public, and private nonprofit hospitals.Cooperative Cardiovascular Project data for 129,092 Medicare patients admitted for AMI from 1994 to 1995.Mortality at 30 days and 1 year postadmission; use of aspirin, angiotensin-converting enzyme (ACE) inhibitors, beta-blockers at discharge, thrombolytic therapy, catheterization, percutaneous transluminal coronary angioplasty (PTCA), and coronary artery bypass graft (CABG) compared by ownership.Mortality rates at 30 days and at 1 year at for-profit hospitals were no different from those at public and private nonprofit hospitals. Without patient illness variables, nonprofit hospitals had lower mortality rates at 30 days (relative risk [RR], 0.95; 95% confidence interval [CI], 0.91-0.99) and at 1 year (RR, 0.96; 95% CI, 0.93-0.99) than did for-profit hospitals, but there was no difference in mortality between public and for-profit hospitals. Beneficiaries at nonprofit hospitals were more likely to receive aspirin (RR, 1.04; 95% CI, 1.03-1.05) and ACE inhibitors (RR, 1.05; 95% CI, 1.02-1.08) than at for-profit hospitals, but had lower rates of PTCA (RR, 0.91; 95% CI, 0.86-0.96) and CABG (RR, 0.93; 95% CI, 0.86-1.00).Although outcomes did not vary by ownership, for-profit hospitals were more likely to use expensive, high-tech procedures. This pattern appears to be the result of for-profit hospitals' propensity to locate in areas with demand for high-tech care for AMI.

  View details for DOI 10.1097/01.MLR.0000088569.50763.15

  View details for PubMedID 14515115

• The cost of inefficiency in US hospitals, 1985-1997. Journal of health care finance Shah, B. R., Reed, S. D., Francis, J., Ridley, D. B., Schulman, K. A. 2003; 30 (1): 1-9

  Abstract

  We conducted a descriptive analysis of data from the Hospital Cost Report Information System from 1985 through 1997 on nonfederal, short-stay hospitals in the United States with 12-month reporting periods and valid data for the primary outcomes. The main outcome measures were change in number of beds, inpatient days, overhead cost per bed, and overhead cost per inpatient day. Actual outcomes were compared to predicted outcomes from: (1) a scenario holding the ratio of overhead cost per volume constant throughout the study period; and (2) a scenario holding overhead expenditures for 1985 constant as volume changed. The sample contained a mean of 3,605 hospitals per year. Volume declined annually by 2.2 beds (95 percent confidence interval [CI], 2.1 to 2.2; P < .001) and 997 inpatient days (95 percent CI, 992 to 1,003; P < .001). Overhead cost per bed increased by 3,388 dollars annually (95 percent CI, 3,049 to 3,737; P < .001) and overhead cost per inpatient day increased by 40 dollars annually (95 percent CI, 36 to 44; P < .001). In the constant ratio scenario, mean overhead cost per bed increased by 42,523 dollars (32 percent), and mean overhead cost per inpatient day increased by 435 dollars (59 percent). In the constant overhead cost scenario, overhead cost per bed increased 15 percent and overhead cost per inpatient day increased 19 percent. Hospital overhead costs are increasing faster than would be expected if efficiency were the primary goal of hospital management.

  View details for PubMedID 12967239

• Comparison of hospital costing methods in an economic evaluation of a multinational clinical trial. International journal of technology assessment in health care Reed, S. D., Friedman, J. Y., Gnanasakthy, A., Schulman, K. A. 2003; 19 (2): 396-406

  Abstract

  To develop and evaluate strategies for estimating hospitalization costs in multinational clinical trials.Hospital cost estimates for eleven diagnoses were collected from twelve countries participating in a trial of therapies for congestive heart failure. Estimates were combined with U.S.-based diagnosis-related group weights to compute country-specific unit cost estimates for all reasons for hospitalization. Variations of hospital costing methods were developed. The unit cost method assigns a country-specific unit cost estimate to each hospitalization. The other methods adjust for length of stay using a daily cost (DC) estimate for each diagnosis, based on either the mean length of stay (DC-mean method) or the median length of stay (DC-median method) for each diagnosis in each country. Additional modifications were explored through adjustment of the distribution of daily costs incurred during a hospital stay.The mean cost for all hospitalizations was dollars 10,242 (SD, 10,042) using the unit cost method, dollars 10,242 (SD, 12,760) using the standard DC-mean method, and dollars 13,967 (SD, 18,762) using the standard DC-median method. In comparisons of costs for all 5,486 hospitalizations incurred by a subset of 2,352 patients in the trial, the unit cost method provided 92% power to detect a dollars 1,000 cost difference. The standard DC-mean method provided 76% power, and the standard DC-median method provided 44% power.Hospital costing methods that adjust for differences in length of stay require a significantly larger sample to attain comparable statistical power as methods that assign unadjusted unit cost estimates to hospitalization events.

  View details for PubMedID 12862196

• Perceptions of patients and physicians regarding phase I cancer clinical trials: Implications for physician-patient communication Meropol, N. J., Weinfurt, K. P., Burnett, C. B., Balshem, A., Benson, A. B., Castel, L., Corbett, S., Diefenbach, M., Gaskin, D., Li, Y., Manne, S., Marshall, J., Rowland, J. H., Slater, E., Sulmasy, D. P., Van Echo, D., Washington, S., Schulman, K. A. AMER SOC CLINICAL ONCOLOGY. 2003: 2589–96

  Abstract

  To describe and compare the perceptions of cancer patients and their physicians regarding phase I clinical trials.Eligible patients had been offered phase I trial participation and had decided to participate but had not yet begun treatment. Each patient's physician also served as a study subject. Patients and physicians completed questionnaires with domains including perceptions of potential benefit and harm from treatment (experimental and standard), relative value of quality and length of life, and perceived content of patient-physician consultations.Three hundred twenty-eight patients and 48 physicians completed surveys. Patients had high expectations regarding treatment outcomes (eg, median 60% benefit from experimental therapy), with those choosing to participate in a phase I trial being more optimistic than those declining phase I participation. Patients predicted a higher likelihood of both benefit and adverse reactions from treatment (experimental and standard) than their physicians (P <.0001 for all comparisons). Although 95% of patients reported that quality of life was at least as important as length of life, only 28% reported that changes in quality of life with treatment were discussed with their physicians. In contrast, 73% of physicians reported that this topic was discussed (P <.0001).Cancer patients offered phase I trial participation have expectations for treatment benefit that exceed those of their physicians. The discordant perceptions of patients and physicians may possibly be explained by patient optimism and confidence; however, the discrepancies in reports of consultation content, particularly given patients' stated values regarding quality of life, raise the possibility that communication in this context is suboptimal.

  View details for DOI 10.1200/JCO.2003.10.072

  View details for Web of Science ID 000183818800022

  View details for PubMedID 12829680

• The correlation between patient characteristics and expectations of benefit from Phase I clinical trials. Cancer Weinfurt, K. P., Castel, L. D., Li, Y., Sulmasy, D. P., Balshem, A. M., Benson, A. B., Burnett, C. B., Gaskin, D. J., Marshall, J. L., Slater, E. F., Schulman, K. A., Meropol, N. J. 2003; 98 (1): 166-75

  Abstract

  Patients in Phase I clinical trials sometimes report high expectations regarding the benefit of treatment. The authors examined a range of patient characteristics to determine which factors were associated with greater expectations of benefit from Phase I trials.Participants were adult patients with cancer who had been offered participation in Phase I studies and had decided to participate. Patients completed interviewer-administered surveys before initiation of treatment. Physicians assessed Eastern Cooperative Oncology Group performance status for each patient. Statistical analyses (Pearson product moment correlation and t tests) used multiple imputation to account for missing data.Overall, 593 patients who were offered participation in Phase I trials were contacted, and 328 patients agreed to participate in a study of decision making by cancer patients. Of these, 260 patients (79%) enrolled in a Phase I trial. Patients' expectations regarding the chance that their disease would be controlled with experimental therapy were unrelated to age, gender, living situation, education level, or functional status. Expectations were correlated positively with beliefs about the benefit of standard therapy and the maximum benefit patients may experience from experimental therapy. Greater expectations of benefit were associated with better health-related quality of life, stronger religious faith, optimism, relative health stock, monetary risk seeking, and poorer numeracy.Expectations expressed as beliefs in personal outcomes may be related more to quality of life and personality variables than to patients' knowledge or functional status. Whether such expectations are accurate reflections of knowledge has important implications for evaluating the informed consent process.

  View details for DOI 10.1002/cncr.11483

  View details for PubMedID 12833469

• Economic evaluation of breast cancer treatment: Considering the value of patient choice JOURNAL OF CLINICAL ONCOLOGY Polsky, D., Mandelblatt, J. S., Weeks, J. C., Venditti, L., Hwang, Y. T., Glick, H. A., Hadley, J., Schulman, K. A. 2003; 21 (6): 1139–46

  Abstract

  To use 5 years of primary data to compare the incremental cost-effectiveness of breast conservation and radiation versus mastectomy with the restriction of choice to a single therapy versus providing a choice of either therapy.We evaluated a random retrospective cohort of 2,517 Medicare beneficiaries treated for newly diagnosed stage I or II breast cancer from 1992 through 1994. The outcome measures were quality-adjusted life-years (QALYs) and 5-year medical costs. Risk and propensity score adjustments were used in the analysis.A breast conservation and radiation regimen has significantly higher costs than mastectomy in the first year after surgery; the adjusted 5-year costs are $14,054 (95% confidence interval, $9,791 to $18,312) greater than those of mastectomy. The adjusted incremental cost-effectiveness ratio comparing breast conservation and radiation to mastectomy was $219,594 per QALY for the comparison of the two strategies. If the possibility of patient choice from maintaining the availability of multiple treatments versus restricting choice to mastectomy alone provides a quality-of-life gain of 0.031 QALYs, then the cost-effectiveness ratio of this choice option is $80,440 per QALY.The current system of providing a choice between mastectomy and breast conservation surgery is economically attractive when the economic analysis includes the benefit of patient choice of treatment.

  View details for DOI 10.1200/JCO.2003.03.126

  View details for Web of Science ID 000181678300027

  View details for PubMedID 12637482

• Economic analysis of conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer BONE MARROW TRANSPLANTATION Schulman, K. A., Stadtmauer, E. A., Reed, S. D., Glick, H. A., Goldstein, L. J., Pines, J. M., Jackman, J. A., Suzuki, S., Styler, M. J., Crilley, P. A., Klumpp, T. R., Mangan, K. F., Glick, J. H. 2003; 31 (3): 205–10

  Abstract

  We performed an economic analysis of data from 180 women in a clinical trial of conventional-dose chemotherapy vs high-dose chemotherapy plus stem-cell transplantation for metastatic breast cancer responding to first-line chemotherapy. Data on resource use, including hospitalizations, medical procedures, medications, and diagnostic tests, were abstracted from subjects' clinical trial records. Resources were valued using the Medicare Fee Schedule for inpatient costs at one academic medical center and average wholesale prices for medications. Monthly costs were calculated and stratified by treatment group and clinical phase. Mean follow-up was 690 days in the transplantation group and 758 days in the conventional-dose chemotherapy group. Subjects in the transplantation group were hospitalized for more days (28.6 vs 17.8, P=0.0041) and incurred higher costs (US dollars 84055 vs US dollars 28169) than subjects receiving conventional-dose chemotherapy, with a mean difference of US dollars 55886 (95% CI, US dollars 47298-US dollars 63666). Sensitivity analyses resulted in cost differences between the treatment groups from US dollars 36528 to US dollars 75531. High-dose chemotherapy plus stem-cell transplantation resulted in substantial additional morbidity and costs at no improvement in survival. Neither the survival results nor the economic findings support the use of this procedure outside of the clinical trial setting.

  View details for DOI 10.1038/sj.bmt.1703795

  View details for Web of Science ID 000181300400009

  View details for PubMedID 12621482

• Prescription of QT-prolonging drugs in a cohort of about 5 million outpatients. The American journal of medicine Curtis, L. H., Østbye, T., Sendersky, V., Hutchison, S., Allen LaPointe, N. M., Al-Khatib, S. M., Usdin Yasuda, S., Dans, P. E., Wright, A., Califf, R. M., Woosley, R. L., Schulman, K. A. 2003; 114 (2): 135-41

  Abstract

  Many drugs prolong the QT interval and increase the risk of torsade de pointes. Concurrent use of two or more of these drugs can further increase the risk, but the prevalence of concurrent prescription of QT-prolonging drugs is not known. Using the administrative claims database of a national pharmaceutical benefit manager, we conducted a retrospective cohort study in 4,825,345 subjects aged 18 years or older. After identifying 50 drugs with QT-prolonging potential, and an additional 26 drugs that inhibit the metabolic clearance of QT-prolonging drugs, we measured the frequency of overlapping prescriptions for two or more of these drugs in the outpatient setting in 1999. Nearly 1.1 million subjects (22.8%) filled 4.4 million prescriptions for QT-prolonging drugs. Of these, 103,119 subjects (9.4%) filled overlapping prescriptions for two or more of the drugs or for a QT-prolonging drug and another drug that inhibits its clearance; 7249 subjects (0.7%) filled overlapping prescriptions for three or more of these drugs. Twenty-two percent of subjects who filled overlapping prescriptions were aged 65 or older; 74% were women. Antidepressants were involved in nearly 50% of the cases. Concurrent prescription of QT-prolonging drugs is common in the outpatient setting, and antidepressants are involved in half of these cases. Large pharmaceutical claims databases are useful for detecting potentially harmful prescribing behaviors, but better clinical evidence on medication safety is needed before such a system can be implemented fully.

  View details for PubMedID 12586234

• Outcomes research in oncology: improving patients' experiences with cancer treatment. Clinical therapeutics Schulman, K. A., Seils, D. M. 2003; 25 (2): 665-70

  Abstract

  Outcomes research in oncology is a relatively young field, but its potential for expanding our understanding of patients' experiences with cancer gives it increasing relevance to clinical oncology research. We provide a brief overview of the growing prevalence of oncology outcomes research, and we discuss some of the key areas of inquiry currently engaging outcomes researchers. In doing so, we introduce the articles in this supplemental section, which address some of the unique concerns of outcomes researchers and outline the most important challenges confronting this research community.

  View details for PubMedID 12749520

• Direct costs of allergic rhinitis in the United States: estimates from the 1996 Medical Expenditure Panel Survey Law, A. W., Reed, S. D., Sundy, J. S., Schulman, K. A. MOSBY, INC. 2003: 296–300

  Abstract

  Previous estimates of the cost of allergic rhinitis predate the substantial increase in the use of second-generation antihistamines and intranasal corticosteroids.We sought to update estimates of the direct costs of allergic rhinitis in the United States and to estimate prescription medication expenditures by type of insurance coverage.Data from the 1996 Medical Expenditure Panel Survey were used in a cross-sectional analysis of resource use and costs.Approximately 7.7% of the population are estimated to have had allergic rhinitis in 1996. The total direct medical cost of allergic rhinitis was estimated at $3.4 billion, with the majority attributable to prescription medications (46.6%) and outpatient visits (51.9%). Fifty-one percent of the prescription medication expenditures were for second-generation antihistamines, 25% for intranasal corticosteroids, and 5% for first-generation antihistamines. Fifty-eight percent of patients with allergic rhinitis received 1 or more prescription drugs for its treatment during the study year. Among these patients, mean prescription expenditures were $131 (95% CI, $119-$143), of which $50 (95% CI, $43-$56) were paid out of pocket. The mean prescription medication expenditure was $103 (95% CI, $70-$136) for persons with Medicaid, $155 (95% CI, $140-$169) for private insurance, $213 (95% CI, $0-$521) for other insurance, and $69 (95% CI, $57-$80) for no prescription drug insurance.The direct costs of allergic rhinitis have increased substantially since the introduction of second-generation antihistamines and intranasal corticosteroids, especially costs attributable to prescription medications. Individuals with no insurance coverage have higher total out-of-pocket prescription expenditures than those with coverage.

  View details for DOI 10.1067/mai.2003.68

  View details for Web of Science ID 000180942700012

  View details for PubMedID 12589348

• Understanding attitudes toward clinical research. The Journal of ambulatory care management Schulman, K. A. 2003; 26 (1): 88-90

  Abstract

  General attitudes toward clinical research can have substantial effects on the research process. Recent studies, including the study by Apolone and Mosconi in this issue, suggest that certain attitudes toward research and evaluations of the risks and benefits of therapies may differ according to various cultural, rhetorical, and health contexts. Researchers must work to further understand societal attitudes toward research and to improve the attractiveness of clinical research for the general population.

  View details for PubMedID 12545518

• Toward estimating the impact of changes in immigrants' insurance eligibility on hospital expenditures for uncompensated care. BMC health services research Castel, L. D., Timbie, J. W., Sendersky, V., Curtis, L. H., Feather, K. A., Schulman, K. A. 2003; 3 (1): 1

  Abstract

  The Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) of 1996 gave states the option to withdraw Medicaid coverage of nonemergency care from most legal immigrants. Our goal was to assess the effect of PRWORA on hospital uncompensated care in the United States.We collected the following state-level data for the period from 1994 through 1999: foreign-born, noncitizen population and health uninsurance rates (US Census Current Population Survey); percentage of teaching hospitals (American Hospital Association Annual Survey of Hospitals); and each state's decision whether to implement the PRWORA Medicaid bar for legal permanent residents or to continue offering nonemergency Medicaid coverage using state-only funds (Urban Institute). We modeled uncompensated care expenditures by state (also from the Annual Survey of Hospitals) in both univariate and multivariable regression analyses.When measured at the state level, there was no significant relationship between uncompensated care expenditures and states' percentage of noncitizen immigrants. Uninsurance rates were the only significant factor in predicting uncompensated hospital care expenditures by state.Reducing the number of uninsured patients would most surely reduce hospital expenditures for uncompensated care. However, data limitations hampered our efforts to obtain a monetary estimate of hospitals' financial losses due specifically to the immigrant eligibility changes in PRWORA. Quantifying the impact of these provisions on hospitals will require better data sources.

  View details for PubMedID 12523939

  View details for PubMedCentralID PMC140321

• Patient expectations of benefit from phase I clinical trials: Linguistic considerations in diagnosing a therapeutic misconception THEORETICAL MEDICINE AND BIOETHICS Weinfurt, K. P., Sulmasy, D. P., Schulman, K. A., Meropol, N. J. 2003; 24 (4): 329–44

  Abstract

  The ethical treatment of cancer patients participating in clinical trials requires that patients are well-informed about the potential benefits and risks associated with participation. When patients enrolled in phase I clinical trials report that their chance of benefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type (e.g., "On average, 5 out of every 100 patients will benefit") can be confused with expressions of uncertainty of the belief type (e.g., "The chance that I will benefit is about 80%"). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subserve multiple speech acts, some of which may be indirect. For example, a patient reporting a high expected benefit may be reporting a belief about the future, reassuring family members, and/or attempting to improve his or her outcome by a public assertion of optimism. These sources of linguistic confusion should be considered in judging whether the patient's reported expectation is grounds for a bioethical concern that there has been a failure in the informed consent process.

  View details for DOI 10.1023/A:1026072409595

  View details for Web of Science ID 000185646500003

  View details for PubMedID 14620488

• Costs of care and cost-effectiveness analysis: primary prevention of coronary artery disease Cardiovascular Health Care Economics Kaul, P., Schulman, K. A. The Humana Press. 2003: 157–172
• Introduction to decision analysis Evidence Based Cardiology Schulman, K. A., Glick, H. A., Detsky, A. S. BMJ Books. 2003; 2nd ed.: 56–70
• Patient choice of breast cancer treatment - Impact on health state preferences MEDICAL CARE Polsky, D., Keating, N. L., Weeks, J. C., Schulman, K. A. 2002; 40 (11): 1068–79

  Abstract

  Multiple treatment options exist for many medical conditions. The extent to which physicians should involve the patient in the choice the treatment to be delivered is not well understood.To test the impact of breast cancer treatment choice on patients' health state preferences.A cohort from 29 hospitals (primarily referral centers) in Massachusetts, Texas, Washington DC, and New York. Subjects were surveyed at 5 months, 1 year, and 2 years following surgery and asked whether they had a choice in the type of treatment received.Women age 67 or older treated in 1996 to 1997 for localized breast cancer (n = 683).Patient preferences for current health state, assessed with patient valuations using the visual analogue scale (VAS) from the EuroQol instrument and with general public valuations using the Health Utilities Index (HUI), and 1-year medical costs.For the adjusted analysis at 5 months, the adjusted mean VAS score was 78.7 for women who reported a choice and 75.3 for women who reported no choice, a difference of 3.4 (P = 0.03). The difference in the HUI score was 3.6 (P= 0.10) and the difference in the 1-year medical costs was -4363 dollars (P = 0.01). There were no statistically significant differences at the 1-year and 2-year interviews.A woman's perception of choice of surgical treatment for breast cancer is associated with a short-term benefit on her preference of health state, suggesting choice helps with recovery, but does not provide long-term benefits.

  View details for DOI 10.1097/00005650-200211000-00008

  View details for Web of Science ID 000179001400008

  View details for PubMedID 12409852

• Treatment patterns and costs associated with sessile colorectal polyps. The American journal of gastroenterology Onken, J. E., Friedman, J. Y., Subramanian, S., Weinfurt, K. P., Reed, S. D., Malenbaum, J. H., Schmidt, T., Schulman, K. A. 2002; 97 (11): 2896-901

  Abstract

  Because of the paucity of existing literature on treatment and costs associated with sessile lesions, the objectives of this study were to perform a retrospective analysis on patients with sessile polyps to identify patient and polyp characteristics, to determine treatment patterns, and to estimate the cost of treating these patients.We conducted a retrospective, observational cohort study of 280 patients who presented to a large teaching hospital between 1997 and 2000 with at least one sessile or broad-based pedunculated colorectal polyp of any size or histology, not including adenocarcinoma greater than stage T1.Mean polyp size was 1.3 cm, and two thirds of polyps were removed in a single procedure. The number of repeat procedures increased with polyp size (Kendall T-b = 0.47; 95% CI = 0.39-0.55). Patients with polyps > or = 2 cm were 5.88 times more likely than patients with smaller polyps to undergo a surgical procedure. Surgical procedures required 88.01 min longer than nonsurgical procedures (95% CI = 74.43-102.42). Mean total cost of treatment was $2,038 (range $153 to $14,838). Open resection ($6,165) was the most costly surgical procedure, and piecemeal polypectomy ($892) was the most costly nonsurgical therapeutic procedure.One third of polyps required more than one procedure. Surgical procedures accounted for the majority of resource use in this sample. Finally, patients with polyps > or = 2 cm incurred almost half the total costs while accounting for only 22% of the sample. The greatest economic gains could be made by improving efficiency of polyp removal for these patients.

  View details for DOI 10.1111/j.1572-0241.2002.07058.x

  View details for PubMedID 12425565

• The determinants of HMOs' contracting with hospitals for bypass surgery. Health services research Gaskin, D. J., Escarce, J. J., Schulman, K., Hadley, J. 2002; 37 (4): 963-84

  Abstract

  Selective contracting with health care providers is one of the mechanisms HMOs (Health Maintenance Organizations) use to lower health care costs for their enrollees. However, are HMOs compromising quality to lower costs? To address this and other questions we identify factors that influence HMOs' selective contracting for coronary artery bypass surgery (CABG).Using a logistic regression analysis, we estimated the effects of hospitals' quality, costliness, and geographic convenience on HMOs' decision to contract with a hospital for CABG services. We also estimated the impact of HMO characteristics and market characteristics on HMOs' contracting decision.A 1997 survey of a nationally representative sample of 50 HMOs that could have potentially contracted with 447 hospitals.About 44 percent of the HMO-hospital pairs had a contract. We found that the probability of an HMO contracting with a hospital increased as hospital quality increased and decreased as distance increased. Hospital costliness had a negative but borderline significant (0.10 < p < 0.05) effect on the probability of a contract across all types of HMOs. However, this effect was much larger for IPA (Independent Practice Association)-model HMOs than for either group/staff or network HMOs. An increase in HMO competition increased the probability of a contract while an increase in hospital competition decreased the probability of a contract. HMO penetration did not affect the probability of contracting. HMO characteristics also had significant effects on contracting decisions.The results suggest that HMOs value quality, geographic convenience, and costliness, and that the importance of quality and costliness vary with HMO. Greater HMO competition encourages broader hospital networks whereas greater hospital competition leads to more restrictive networks.

  View details for DOI 10.1034/j.1600-0560.2002.61.x

  View details for PubMedID 12236393

  View details for PubMedCentralID PMC1464015

• Measuring agreement between patient and proxy responses to multidimensional health-related quality-of-life measures in clinical trials. An application of psychometric profile analysis. Journal of clinical epidemiology Weinfurt, K. P., Trucco, S. M., Willke, R. J., Schulman, K. A. 2002; 55 (6): 608-18

  Abstract

  When patients cannot provide responses to health-related quality-of-life (HRQOL) measures in clinical trials, family or friends may be asked to respond. We present a simple, comprehensive method for assessing agreement between patients with head injury and their proxy responders. In contrast to more traditional approaches, this method defines agreement separately for each patient-proxy pair, and compares HRQOL profiles along three dimensions-level, or the average of the ratings; scatter, or the variability in the ratings; and shape, or the ranks of the ratings. We demonstrate this method in the context of a clinical trial of a treatment for traumatic head injury and compare the results to those obtained using traditional analyses. Options for incorporating proxy responses into clinical trial analyses are discussed.

  View details for PubMedID 12063103

• Economic evaluation of filgrastim, sargramostim, and sequential sargramostim and filgrastim after myelosuppressive chemotherapy BONE MARROW TRANSPLANTATION Weaver, C. H., Buckner, C. D., Curtis, L. H., Bajwa, K., Weinfurt, K. P., Wilson-Relyea, B. J., Schulman, K. A. 2002; 29 (2): 159–64

  Abstract

  Filgrastim alone and sequential sargramostim and filgrastim have been shown to be more effective than sargramostim alone in the mobilization of CD34(+) cells after myelosuppressive chemotherapy (MC). We sought to compare costs and resource use associated with these regimens. Data were collected prospectively alongside a multicenter, randomized trial of filgrastim, sargramostim, and sequential sargramostim and filgrastim. Direct medical costs were calculated for inpatient and outpatient visits and procedures, including administration of growth factors and MC. We followed 156 patients for 30 days or until initiation of high-dose chemotherapy. The main outcome measures were resource use and costs of inpatient and outpatient visits, platelet and red blood cell transfusions, antibiotic use, and apheresis procedures. Hospital admissions, red blood cell transfusions, and use of i.v. antibiotics were significantly more common in the sargramostim group than in the other treatment arms. In univariate and multivariable analyses, total costs were higher for patients receiving sargramostim alone than for patients in the other groups. Mean costs in multivariable analysis for the filgrastim and sequential sargramostim and filgrastim arms were not significantly different. Filgrastim alone and sequential sargramostim and filgrastim are less costly than sargramostim alone after MC, as well as therapeutically more beneficial.

  View details for DOI 10.1038/sj.bmt.1703341

  View details for Web of Science ID 000173711700011

  View details for PubMedID 11850711

• Clinical economics Interactive Textbook on Clinical Symptom Research [online book] Schulman, K. A., Seils, D. M. National Institute of Dental and Craniofacial Research. 2002
• A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. The New England journal of medicine Schulman, K. A., Seils, D. M., Timbie, J. W., Sugarman, J. n., Dame, L. A., Weinfurt, K. P., Mark, D. B., Califf, R. M. 2002; 347 (17): 1335–41

  Abstract

  Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards.From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials.Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions--from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50])--demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items.Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed.

  View details for PubMedID 12397192

• A microcosting analysis of zoledronic acid and pamidronate therapy in patients with metastatic bone disease Castel, L. D., Bajwa, K., Markle, J. P., Timbie, J. W., Zacker, C., Schulman, K. A. SPRINGER. 2001: 545–51

  Abstract

  Our goal was to calculate resource use associated with administration of zoledronic acid, compared with pamidronate, as palliative care for patients with metastatic bone lesions. We conducted a time-and-motion study of therapy administration at each of three outpatient chemotherapy infusion sites participating in clinical trials of zoledronic acid and pamidronate. We developed a data-collection instrument to record all staff effort and patient resource use in drug administration. The main outcome measures were (a) direct costs of therapy administration per patient and (b) opportunity benefits expressed as the availability of resources gained per year. The average visit time for patients receiving the study dose of zoledronic acid, 4 mg, was 1 h, 6 min, compared to 2 h, 52 min for patients receiving a 90-mg dose of pamidronate. Infusion time accounted for much of the difference. In the base-case analysis, total direct costs per patient were $728 for zoledronic acid and $776 for pamidronate. The opportunity benefit for infusion of zoledronic acid vs pamidronate in the base case was 1.8 chairs per day, or 426 chairs per 240-workday year. Results were sensitive to changes in infusion facility size, days of operation, and average number of patients treated. Shorter infusion time associated with the administration of zoledronic acid, compared with pamidronate, yields substantial time savings for patients, as well as opportunity benefits for outpatient oncology facilities.

  View details for DOI 10.1007/s005200100249

  View details for Web of Science ID 000171468200009

  View details for PubMedID 11680835

• The role of reperfusion therapy in paced patients with acute myocardial infarction AMERICAN HEART JOURNAL Rathore, S. S., Gersh, B. J., Weinfurt, K. P., Oetgen, W. J., Schulman, K. A., Solomon, A. J. 2001; 142 (3): 516–19

  Abstract

  Our purpose was to evaluate the effectiveness of reperfusion therapy among elderly paced patients with acute myocardial infarction (MI). Current guidelines make no recommendation for the use of reperfusion therapy among patients who have a paced rhythm during MI.We evaluated 1954 Medicare beneficiaries 65 years and older treated for acute MI between 1994 and 1996 who had a paced rhythm for use of reperfusion therapy. Use of reperfusion therapy was evaluated for associations with outcomes by logistic regression and Cox proportional hazards models incorporating propensity score analysis.Reperfusion therapy was used in 171 (8.8%) patients; 70 were treated with primary PTCA and 101 with thrombolytic therapy. Patients who received reperfusion therapy had 30-day mortality rates similar to those who did not receive reperfusion (26.3% vs 25.7%, P =.87). Multivariate adjustment for mortality risk factors and treatment propensity indicated no survival benefit associated with reperfusion therapy at 30 days (relative risk [RR] 1.07, 95% confidence interval [CI] 0.77-1.43) or long-term follow-up (hazard ratio [HR] 0.86, 95% CI 0.68-1.10). Mortality risks varied by type of reperfusion therapy. Patients treated with primary percutaneous transluminal coronary angioplasty were at comparable risk of mortality at 30 days (RR 0.73, 95% CI 0.40-1.23) but at lower risk at long-term follow-up (HR 0.60, 95% CI 0.40-0.88). Mortality risks were unchanged among patients treated with thrombolytics at 30 days (RR 1.32, 95% CI 0.92-1.79) and long-term follow-up (HR 1.08, 95% CI 0.82-1.43).We find suggestive evidence that primary percutaneous transluminal coronary angioplasty provides a long-term survival benefit in the treatment of elderly patients with acute MI who have a paced rhythm.

  View details for DOI 10.1067/mhj.2001.117602

  View details for Web of Science ID 000170780400020

  View details for PubMedID 11526367

• An economic and quality-of-life assessment of basiliximab vs antithymocyte globulin immunoprophylaxis in renal transplantation NEPHROLOGY DIALYSIS TRANSPLANTATION Polsky, D., Weinfurt, K. P., Kaplan, B., Kim, J., Fastenau, J., Schulman, K. A. 2001; 16 (5): 1028–33

  Abstract

  Immunosuppressive therapy with cyclosporin A has substantially improved clinical outcomes for renal transplantation. Whether basiliximab (a chimeric monoclonal antibody) demonstrates economic and quality-of-life advantages over other induction therapies has not yet been shown.A multi-centre open-label clinical trial was conducted among renal transplant recipients in the US, in which patients were randomized into two induction therapy regimens: basiliximab and antithymocyte globulin (ATG) as part of a quadruple immunosuppressive regimen. Medical resources used and a EuroQol visual analogue scale (VAS) rating of quality of life were collected prospectively for the 135 dosed subjects for a period of 1 year post-treatment. We analysed the differences between treatment groups in 1-year costs and 1-year quality-adjusted survival. We also conducted a post hoc analysis of outcomes among the subgroup of patients identified as high risk.A significant difference was observed in first-year post-treatment costs (basiliximab, $45857; ATG, $54729; difference, $8872 (95% CI, $1169 to $16573). The savings from basiliximab can be attributed to the less expensive induction therapy (basiliximab, $2378; ATG, $8670; difference, $6292 (95% CI, $5165 to $7419)) and other savings during the initial hospitalization totalling $2609. One-year quality-adjusted survival was the same in both groups (basiliximab, 81.5; ATG, 81.1; difference, 0.45 (95% CI, -5.9 to 6.8)). The results of the post hoc analysis of the 48 high-risk patients were comparable to the analysis of all patients.These results demonstrate lower first-year post-treatment costs in renal-transplant recipients receiving basiliximab compared to ATG with no differences in quality-adjusted survival. The results also suggest similar differences among high-risk subjects.

  View details for DOI 10.1093/ndt/16.5.1028

  View details for Web of Science ID 000168569000025

  View details for PubMedID 11328911

• Treatment of patients with myocardial infarction who present with a paced rhythm ANNALS OF INTERNAL MEDICINE Rathore, S. S., Weinfurt, K. P., Gersh, B. J., Oetgen, W. J., Schulman, K. A., Solomon, A. J. 2001; 134 (8): 644–51

  Abstract

  A paced rhythm can mask the electrocardiographic features of an acute myocardial infarction, complicating timely recognition and treatment.To evaluate characteristics, treatment, and outcomes among patients presenting with paced rhythms during myocardial infarction.Retrospective cohort study.U.S. acute care hospitals.102 249 Medicare beneficiaries at least 65 years of age who were treated for acute myocardial infarction between 1994 and 1996.Provision of three treatments for acute myocardial infarction (emergent reperfusion, aspirin, and beta-blockers), death at 30 days, and long-term follow-up.1954 patients (1.9%) presented with paced rhythms during myocardial infarction. These patients were older; were predominantly male; and had higher rates of congestive heart failure, diabetes, and previous infarction. They were significantly less likely to receive emergent reperfusion (relative risk [RR], 0.27 [95% CI, 0.22 to 0.33]), aspirin (RR at admission, 0.91 [CI, 0.88 to 0.94]; RR at discharge, 0.87 [CI, 0.83 to 0.92]), and beta-blockers at admission (RR, 0.89 [CI, 0.82 to 0.96]). In addition, there was a trend toward decreased use of beta-blockers at discharge (RR, 0.91 [CI, 0.76 to 1.06]). Crude mortality rates were higher among patients with paced rhythms than among those without at 30 days (25.8% vs. 21.3%; P = 0.001) and at 1 year (47.1% vs. 36.1%; P = 0.001). Among patients with paced rhythms, risk for death at 30 days decreased after adjustment for illness severity and decreased use of therapy (RR, 1.03 [CI, 0.93 to 1.14]). Patients with paced rhythms remained at additional risk for long-term mortality (hazard ratio, 1.12 [CI, 1.06 to 1.18]).Patients with paced rhythms were less likely than those without to receive treatment for acute myocardial infarction and had poorer short- and long-term outcomes. However, this mortality risk diminished after adjustment for treatment. This suggests that improved recognition and treatment of myocardial infarction may improve outcomes, particularly in the short term.

  View details for DOI 10.7326/0003-4819-134-8-200104170-00009

  View details for Web of Science ID 000168177500003

  View details for PubMedID 11304104

• Effect of diabetes mellitus and insulin use on survival after acute myocardial infarction in the elderly (the Cooperative Cardiovascular Project). The American journal of cardiology Berger, A. K., Breall, J. A., Gersh, B. J., Johnson, A. E., Oetgen, W. J., Marciniak, T. A., Schulman, K. A. 2001; 87 (3): 272-7

  Abstract

  Using data from a retrospective cohort study of Medicare beneficiaries hospitalized with an acute myocardial infarction (AMI), we evaluated the role of diabetes mellitus on 30-day and 1-year mortality. We classified subjects as nondiabetics, diabetics controlled with diet alone, diabetics receiving an oral hypoglycemic agent, and diabetics on insulin at time of admission. We compared baseline admission characteristics of subgroups using chi-square and Wilcoxon rank-sum tests and evaluated the effect of each diabetic state using sequential logistic models. We identified 80,832 nondiabetic patients, 9,862 diet-controlled diabetic patients, 14,664 diabetics receiving an oral hypoglycemic agent, and 12,241 diabetic patients on insulin therapy. Although mean age was similar among the groups, prevalence of hypertension, prior AMI, prior congestive heart failure, and prior revascularization were higher among diabetic patients, particularly those taking insulin. Diabetic patients, particularly those taking insulin, were less likely to receive aspirin and beta blockers and to undergo coronary revascularization. Diabetic patients had higher 30-day and 1-year mortality than nondiabetic patients. After adjustment for demographics, clinical and hospital characteristics, and treatment strategies, insulin-treated diabetics had the highest risk of mortality, followed by diabetics receiving oral hypoglycemic agents, followed by diet-controlled diabetics. Thus, diabetes is highly prevalent among elderly patients with an AMI. Mortality rates for these patients, particularly insulin-using diabetics, are higher than among their nondiabetic counterparts. Preventive and therapeutic strategies must be developed to ensure improved short- and long-term outcomes for elderly patients with diabetes and AMI.

  View details for DOI 10.1016/s0002-9149(00)01357-6

  View details for PubMedID 11165959

• Sex differences in the referral process for invasive cardiac procedures. Journal of the American Medical Women's Association (1972) Seils, D. M., Friedman, J. Y., Schulman, K. A. 2001; 56 (4): 151-4, 160

  Abstract

  Nearly twice as many women in the United States die of heart disease and stroke every year as die from all types of cancer. Several studies have shown that women are less likely than men to be referred for invasive cardiac procedures. Despite extensive literature documenting sex differences in invasive cardiac procedure use, few studies have investigated the ways in which sex may affect the patient and physician decision-making process in referrals for cardiac care. This paper presents a framework outlining 8 stages of the referral process and discusses the role sex plays in each one. This framework was adapted from one describing the influence of race on the referral process for invasive cardiac procedures. A representative sample of the literature is reviewed to describe the influence of sex at each stage.

  View details for PubMedID 11759782

• A comparison of scoring weights for the EuroQol derived from patients and the general public. Health economics Polsky, D., Willke, R. J., Scott, K., Schulman, K. A., Glick, H. A. 2001; 10 (1): 27-37

  Abstract

  General health state classification systems, such as the EuroQol instrument, have been developed to improve the systematic measurement and comparability of health state preferences. In this paper we generate valuations for EuroQol health states using responses to this instrument's visual analogue scale made by patients enrolled in a randomized clinical trial evaluating tirilazad mesylate, a new drug used to treat subarachnoid haemorrhage. We then compare these valuations derived from patients with published valuations derived from responses made by a sample from the general public.The data were derived from two sources: (1) responses to the EuroQol instrument from 649 patients 3 months after enrollment in the clinical trial, and (2) from a published study reporting a scoring rule for the EuroQol instrument that was based upon responses made by the general public. We used a linear regression model to develop an additive scoring rule. This rule enables direct valuation of all 243 EuroQol health states using patients' scores for their own health states elicited using a visual analogue scale. We then compared predicted scores generated using our scoring rule with predicted scores derived from a sample from the general public.The predicted scores derived using the additive scoring rules met convergent validity criteria and explained a substantial amount of the variation in visual analogue scale scores (R(2)=0.57). In the pairwise comparison of the predicted scores derived from the study sample with those derived from the general public, we found that the former set of scores were higher for 223 of the 243 states. Despite the low level of correspondence in the pairwise comparison, the overall correlation between the two sets of scores was 87%.The model presented in this paper demonstrated that scoring weights for the EuroQol instrument can be derived directly from patient responses from a clinical trial and that these weights can explain a substantial amount of variation in health valuations. Scoring weights based on patient responses are significantly higher than those derived from the general public. Further research is required to understand the source of these differences.

  View details for DOI 10.1002/1099-1050(200101)10:1<27::aid-hec561>3.0.co;2-r

  View details for PubMedID 11180567

• Pharmacoeconomics: economic evaluation of pharmaceuticals Textbook of Pharmacoepidemiology Schulman, K. A., Glick, H. A., Polsky, D. John Wiley & Sons. 2001: 333–343
• Pharmacoeconomics Drug Benefits and Risks: International Textbook on Clinical Pharmacology Schulman, K. A., Glick, H. A., Polsky, D., John, K. R., Eisenberg, J. M. John Wiley & Sons. 2001: 37–53
• Trial-based economic evaluations: an overview of design and analysis. Economic Evaluation in Health Care: Merging Theory With Practice. Glick, H. A., Polsky, D. P., Schulman, K. A. Oxford University Press. 2001: 113–140
• Acute myocardial infarction complicated by heart block in the elderly: Prevalence and outcomes Rathore, S. S., Gersh, B. J., Berger, P. B., Weinfurt, K. P., Oetgen, W. J., Schulman, K. A., Solomon, A. J. MOSBY-ELSEVIER. 2001: 47–54

  Abstract

  Although second- and third-degree heart block (HB) are common conduction disorders associated with acute myocardial infarction (MI), patient characteristics and HBs association with outcomes, particularly among the elderly, remain poorly defined.We evaluated 106,780 Medicare beneficiaries aged 65 years and older treated for acute MI between January 1994 and February 1996 for development of HB. HB and non-HB patients were compared by univariate analysis, and the influence of HB on outcomes was evaluated by unadjusted and multiple logistic regression.HB was documented in 5048 (4.7%) patients; 1646 presented with HB and 3402 developed HB during hospitalization. HB was more common among patients with inferior infarctions than anterior infarctions (7.3% vs 3.0%, P =.001), particularly the cohort of patients with inferior MI treated with reperfusion therapy (8.3%). HB patients had higher rates of in-hospital mortality (29.6% vs. 17.5% vs. non-HB patients, P =.001). After adjustment for demographic and clinical factors, HB remained an independent predictor of in-hospital mortality (relative risk [RR] 1.41, 95% confidence interval [CI] 1. 34-1.48), but HB had no prognostic significance at 1 year among hospital survivors (RR 0.94, 95% CI 0.88-1.01). Mortality risks varied on the basis of MI location. Both anterior MI (RR 1.46, 95% CI 1.30-1.63) and inferior MI (RR 1.52, 95% CI 1.39-1.66) patients with HB had increased risks of in-hospital mortality. There was a trend toward increased mortality among patients with anterior MI (RR 1.15, 95% CI 0.99-1.32) at 1 year, whereas those with inferior MI were at lower risk (RR 0.83, 95% CI 0.75-0.98).HB is a common complication of acute MI in elderly patients, particularly among patients with inferior MIs who received reperfusion therapy. HB is independently associated with short-term but not long-term mortality.

  View details for DOI 10.1067/mhj.2001.111259

  View details for Web of Science ID 000166262100009

  View details for PubMedID 11136486

• The effect of race on the referral process for invasive cardiac procedures. Medical care research and review : MCRR Einbinder, L. C., Schulman, K. A. 2000; 57 Suppl 1: 162-80

  Abstract

  Coronary artery disease is the leading cause of death in the United States. Blacks are more likely than whites to experience premature disease, and they have poorer prognosis after acute myocardial infarction. Multiple studies have demonstrated that blacks are less likely to be referred for certain invasive cardiac procedures. Few studies have examined the effect of race on physician and patient decision making in referrals for cardiac procedures. The authors present a framework for the complex series of steps involved in obtaining invasive cardiac care. Patient race can affect each of these steps, and differences in physician and patient race may be a particular impediment to effective communication about symptoms and preferences and to the establishment of a therapeutic partnership. The potential role of communication in race-discordant physician-patient relationships suggests a need for more research in physician decision making and for efforts to promote cultural competency as a core component of medical education.

  View details for DOI 10.1177/1077558700057001S08

  View details for PubMedID 11092162

• Time to presentation with acute myocardial infarction in the elderly - Associations with race, sex, and socioeconomic characteristics CIRCULATION Sheifer, S. E., Rathore, S. S., Gersh, B. J., Weinfurt, K. P., Oetgen, W. J., Breall, J. A., Schulman, K. A. 2000; 102 (14): 1651–56

  Abstract

  Although prompt treatment is a cornerstone of the management of acute myocardial infarction (AMI), prior studies have shown that one fourth of AMI patients arrive at the hospital >6 hours after symptom onset. It would be valuable to identify individuals at highest risk for late arrival, but predisposing factors have yet to be fully characterized.Data from the Cooperative Cardiovascular Project, involving Medicare beneficiaries aged >65 years hospitalized between January 1994 and February 1996 with confirmed AMI, were used to identify patients who presented "late" (>/=6 hours after symptom onset). Patient characteristics were tested for associations with late presentation by use of backward stepwise logistic regression. Among 102 339 subjects, 29.4% arrived late. Significant predictors of late arrival (odds ratio, 95% CI) included diabetes (1.11, 1.07 to 1.14) and a history of angina (1.32, 1.28 to 1.35), whereas prior MI (0.82, 0.79 to 0.85), prior angioplasty (0.80, 0.75 to 0.85), prior bypass surgery (0.93, 0.89 to 0.98), and cardiac arrest (0.52, 0.46 to 0. 58) predicted early presentation. Additionally, initial evaluation at an outpatient clinic (2.63, 2.51 to 2.75) and daytime presentation (1.67, 1.59 to 1.72) predicted late arrival. Finally, female sex, black race, and poverty, which were evaluated with an 8-level race-sex-socioeconomic status interaction term, were also risk factors for delay.Delayed hospital presentation is a common problem among Medicare beneficiaries with AMI. Factors associated with delay include not only clinical and logistical issues but also race, sex, and socioeconomic characteristics. Education efforts designed to hasten AMI treatment should be directed at individuals with risk factors for late arrival.

  View details for DOI 10.1161/01.CIR.102.14.1651

  View details for Web of Science ID 000089593000011

  View details for PubMedID 11015343

• Mobilization, collection, and processing of autologous peripheral blood stem cells: Development of a clinical process with associated costs Meehan, K. R., Areman, E. M., Ericson, S. G., Matias, C., Seifeldin, R., Schulman, K. MARY ANN LIEBERT INC PUBL. 2000: 767–71

  Abstract

  We surveyed five academic medical centers to develop a clinical process for patients undergoing cytokine mobilization and leukapheresis prior to autologous peripheral blood stem cell transplantation. Costs were obtained from three centers and applied to each component of the pathway. Costs were divided into three categories: (1) pre-apheresis evaluation; (2) process of apheresis; (3) post-apheresis and peripheral blood stem cells processing. All centers participated in the development of the leukapheresis pathway. Because charges vary greatly among institutions, costs were determined from three of the institutions and a mean was calculated for each of the components of the process. Pre-apheresis costs consisted of central line placement, blood work, and the price of cytokine (rhG-CSF). Costs associated with apheresis included professional fees (for physicians and nurses), leukapheresis with stem cell cryopreservation, storage, sterility testing, analysis of circulating CD34+ cell counts, and 1 day of cytokine therapy. The post-apheresis process included thawing with sterility testing along with CD34+ cell number analysis and the performance of clonogenic assays. Total costs were as follows: (1) pre-apheresis, $2711; (2) apheresis, $2990; and, (3) post-apheresis/stem cell processing, $754. This survey from five academic medical centers provides the average costs associated with three main components of the apheresis procedure. Because many patients require multiple aphereses, interventions to achieve target CD34+ cell collections in as few collections as possible would result in significant cost reduction.

  View details for DOI 10.1089/15258160050196812

  View details for Web of Science ID 000165432700021

  View details for PubMedID 11091501

• The development of standard economic datasets for use in the economic evaluation of medicines Backhouse, M. E., Gnanasakthy, A., Schulman, K. A., Akehurst, R., Glick, H. SAGE PUBLICATIONS INC. 2000: 1273–91

  View details for DOI 10.1177/009286150003400435

  View details for Web of Science ID 000165343200035

• The role of the food and drug administration in pharmacoeconomic evaluation during the drug development process DRUG INFORMATION JOURNAL Kim, J., Morris, C. B., Schulman, K. A. 2000; 34 (4): 1207–13

  View details for DOI 10.1177/009286150003400428

  View details for Web of Science ID 000165343200028

• Race, sex, poverty, and the medical treatment of acute myocardial infarction in the elderly CIRCULATION Rathore, S. S., Berger, A. K., Weinfurt, K. P., Feinleib, M., Oetgen, W. J., Gersh, B. J., Schulman, K. A. 2000; 102 (6): 642–48

  Abstract

  Race, sex, and poverty are associated with the use of diagnostic cardiac catheterization and coronary revascularization during treatment of acute myocardial infarction (AMI). However, the association of sociodemographic characteristics with the use of less costly, more readily available medical therapies remains poorly characterized.We evaluated 169 079 Medicare beneficiaries >/=65 years of age treated for AMI between January 1994 and February 1996 to determine the association of patient race, sex, and poverty with the use of medical therapy. Multivariable regression models were constructed to evaluate the unadjusted and adjusted influence of sociodemographic characteristics on the use of 2 admission (aspirin, reperfusion) and 2 discharge therapies (aspirin, beta-blockers) indicated during the treatment of AMI. Therapy use varied by patient race, sex, and poverty status. Black patients were less likely to undergo reperfusion (RR 0.84, 95% CI 0. 78, 0.91) or receive aspirin on admission (RR 0.97, 95% CI 0.96, 0. 99) and beta-blockers (RR 0.94, 95% CI 0.88, 1.00) at discharge. Female patients were less likely to receive aspirin on admission (RR 0.98, 95% CI 0.97, 0.99) and discharge (RR 0.98, 95% CI 0.96, 0.99). Poor patients were less likely to receive aspirin (RR 0.97, 95% CI 0. 96, 0.98) or reperfusion (RR 0.97, 95% CI 0.93, 1.00) on admission and aspirin (RR 0.98, 95% CI 0.96, 1.00), or beta-blockers (RR 0.95, 95% CI 0.91, 0.99) on discharge.Medical therapies are currently underused in the treatment of black, female, and poor patients with AMI.

  View details for DOI 10.1161/01.CIR.102.6.642

  View details for Web of Science ID 000088638400017

  View details for PubMedID 10931804

• Patterns of breast carcinoma treatment in older women: patient preference and clinical and physical influences. Cancer Mandelblatt, J. S., Hadley, J., Kerner, J. F., Schulman, K. A., Gold, K., Dunmore-Griffith, J., Edge, S., Guadagnoli, E., Lynch, J. J., Meropol, N. J., Weeks, J. C., Winn, R. 2000; 89 (3): 561-73

  Abstract

  Older women have high rates of breast carcinoma, and there are substantial variations in the patterns of care for this population group.The authors studied 718 breast carcinoma patients age 67 years and older who were diagnosed with localized disease between 1995 and 1997 from 29 hospitals in 5 regions. Data were collected from patients, charts, and surgeons. Logistic regression analysis was used to evaluate determinants of treatment.Women who were concerned about body image were 1.8 times more likely (95% confidence interval [95% CI], 1.1-2.8) to receive breast conservation surgery and radiotherapy than women without this preference, controlling for other factors. In contrast, women who preferred receiving no therapy beyond surgery were 3.9 times more likely (95% CI, 2.9-6.1) to undergo mastectomy than other women, after considering other factors. Radiotherapy was omitted after breast conservation 3.4 times more often (95% CI, 2.0-5.6) among women age 80 years and older than among women ages 67-79 years, controlling for covariates. Black women tended to have radiotherapy omitted after breast conservation surgery 2.0 times more often (95% CI, 0.9-4.4) than white women (P = 0.09). Women age 80 years and older also were 70% less likely (odds ratio = 0.3; 95% CI, 0.1-0.8) to receive chemotherapy than women ages 67-79 years, controlling for health, functional status, and other covariates.After considering other factors, patient preferences and age were found to be associated with breast carcinoma treatment patterns in older women. Further research and training are needed to provide care for the growing population of older women that is both clinically appropriate and consonant with a woman's preferences.

  View details for PubMedID 10931455

• Mandated coverage for cancer-screening services: whose guidelines do states follow? American journal of preventive medicine Rathore, S. S., McGreevey, J. D., Schulman, K. A., Atkins, D. 2000; 19 (2): 71-8

  Abstract

  To determine the prevalence and nature of state coverage mandates for cancer screening.We contacted insurance departments in 50 states, Washington, DC, and Puerto Rico for copies of state codes that mandate coverage of screening for breast, cervical, prostate, and colorectal cancer by private insurers. We further compared mandates, when identified, with American Cancer Society (ACS) and U.S. Preventive Services Task Force (USPSTF) guidelines for likely sources of screening recommendations.Forty-three states and the District of Columbia currently mandate coverage of cancer screening. Breast cancer-screening coverage was most frequently mandated (n =44), followed by cervical (n =22), prostate (n =18), and colorectal cancer screening (n =1). Twenty-three states used ACS guidelines only, 18 states used ACS and non-ACS/non-USPSTF guidelines, and 3 states used only non-ACS/non-USPSTF guidelines in development of coverage mandates. No state screening coverage mandate reflected USPSTF-screening guidelines. Of 85 mandates in place, 57 have been passed since 1990.Although state mandates for insurer coverage of cancer screening are common and increasing, we found noticeable inter- and intra-state variation in coverage, selection, and use of screening guidelines.

  View details for DOI 10.1016/s0749-3797(00)00179-3

  View details for PubMedID 10913895

• Platelet transfusions: utilization and associated costs in a tertiary care hospital. American journal of hematology Meehan, K. R., Matias, C. O., Rathore, S. S., Sandler, S. G., Kallich, J., LaBrecque, J., Erder, H., Schulman, K. A. 2000; 64 (4): 251-6

  Abstract

  We implemented a prospective study to evaluate platelet transfusion utilization, resource use, and costs in a tertiary care hospital over a 6-month period. All hospitalized patients receiving platelet transfusions between July and December 1996 were followed prospectively to determine platelet use and costs. Clinical and financial data were collected, evaluated, and compared to identify trends in resource utilization based on admitting service and platelet-refractory status. One thousand nine hundred forty-four platelet units were transfused to 245 hospitalized patients (50.6% male, mean age 49 years) during the study period. The majority of platelet units transfused were single donor (N = 1,460, 75%) and administered to bone marrow patients and patients with a hematological malignancy/disorder. Median hospitalization costs per admission were $27,750, ranging from a high of $58,729 for admission to the Bone Marrow Transplant service to $13,856 per admission to the Internal Medicine/Other service. Patients were refractory to platelet transfusions during 21.6% of hospitalizations. Hospital stays were longer (35.0 days vs. 14.4 days, P < 0.001) and inpatient hospital costs ($103,956 vs. $37,817, P < 0.001) were more than two and a half times higher for patients refractory to platelet transfusions. Platelet utilization, resource use, and costs vary by admitting service. Refractoriness to platelet transfusion was associated with significantly greater costs and lengths of stay. Monitoring platelet transfusion practices, particularly for patients refractory to platelet transfusions, may be beneficial for limiting costs and improving efficacy.

  View details for DOI 10.1002/1096-8652(200008)64:4<251::aid-ajh3>3.0.co;2-n

  View details for PubMedID 10911376

• Medical errors: how the US Government is addressing the problem. Current controlled trials in cardiovascular medicine Schulman, K. A., Kim, J. J. 2000; 1 (1): 35-37

  Abstract

  November's Institute of Medicine (IOM) report on medical errors has sparked debate among US health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nationwide mandatory reporting with public release of performance data to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. Any successful safety program will require a national effort to make significant investments in information technology infrastructure, and to provide an environment and education that enables providers to contribute to an active quality-improvement process.

  View details for DOI 10.1186/cvm-1-1-035

  View details for PubMedID 11714405

  View details for PubMedCentralID PMC59595

• The association between institutional primary angioplasty procedure volume and outcome in elderly Americans. The Journal of invasive cardiology Every, N. R., Maynard, C., Schulman, K., Ritchie, J. L. 2000; 12 (6): 303-8

  Abstract

  The association between greater procedure volume and improved patient outcome in cardiac procedures has been established in percutaneous transluminal coronary angioplasty (PTCA), coronary stent placement and coronary bypass surgery. The association between primary angioplasty volume and outcome has not been evaluated.We evaluated the association between the volume of primary angioplasty procedures with short- and long-term outcome in 6,124 patients with documented acute myocardial infarction. Patients without shock on presentation treated with primary coronary angioplasty within 12 hours of hospital admission were selected from consecutive infarct patients included in the Cooperative Cardiovascular Project database. Patients were divided into quartiles based on the volume of primary PTCA procedures performed at their admitting hospital.The majority of United States (US) hospitals performed less than three primary PTCA procedures per month. Patients admitted to hospitals in the lowest volume quartile of primary PTCA had 31% higher 30-day mortality than those admitted to the highest volume quartile. After adjustment for baseline differences in patient characteristics, there was an association between admission to higher volume primary PTCA hospitals and lower 30-day mortality (odds ratio per volume quartile = 0.91; 95% confidence interval = 0.83-0.99).Eighty-two percent of US hospitals perform less than three primary PTCA procedures per month. In elderly Americans treated with primary PTCA, we observed an association between admission to higher volume hospitals and lower short- and long-term mortality. This association was independent of total PTCA volumes.

  View details for PubMedID 10859715

• The effects of patient sex and race on medical students' ratings of quality of life. The American journal of medicine Rathore, S. S., Lenert, L. A., Weinfurt, K. P., Tinoco, A., Taleghani, C. K., Harless, W., Schulman, K. A. 2000; 108 (7): 561-6

  Abstract

  Although previous studies have examined race and sex differences in health care, few studies have investigated the possible role of physician bias. We evaluated the influence of race and sex on medical students' perceptions of patients' symptoms to determine if there are differences in these perceptions early in medical training.One-hundred sixty-four medical students were randomly assigned to view a video of a black female or white male actor portraying patients with identical symptoms of angina. We evaluated students' perceptions of the actors' health state (based on their assessment of quality of life) using a visual analog scale and a standard rating technique, as well as the type of chest pain diagnosis.Students assigned a lower value (indicating a less desirable health state) to the black woman than to the white man with identical symptoms [visual scale (mean +/- SD): 72 +/- 13 vs 67 +/- 12, P <0.02; standard gamble: 87 +/- 10 vs 80 +/- 15, P < 0.001). Nonminority students reported higher mean values for the white male patient (standard gamble: 89 +/- 8 vs 81 +/- 14 for the black female patient), whereas minority students' assessments did not differ by patient. Male students assigned a slightly lower value to the black female patient (standard gamble: 76 +/- 16 vs 87 +/- 10 for the white male patient). Students were less likely to characterize the black female patient's symptoms as angina (46% vs 74% for the white male patient, P = 0.001).The way that medical students perceive patient symptoms appears to be affected by nonmedical factors.

  View details for DOI 10.1016/s0002-9343(00)00352-1

  View details for PubMedID 10806285

• Race and sex differences in the management of coronary artery disease. American heart journal Sheifer, S. E., Escarce, J. J., Schulman, K. A. 2000; 139 (5): 848-57

  Abstract

  Although numerous studies have documented race and sex differences in the treatment of coronary artery disease, the available analyses have not been comprehensively evaluated. In this review, we summarize prior estimates of race and sex disparities in the utilization of standard tests and therapies, and we evaluate studies of factors that may contribute to gaps in care. The studies presented consistently demonstrate that blacks and women with coronary artery disease, compared with whites and men, are substantially less likely to receive standard interventions. Studies also indicate that racial differences relate in part to socioeconomic factors, process-of-care variables, and patient preferences, whereas sex differences relate in part to clinical factors. In both cases, however, our understanding is limited by deficiencies in currently available datasets. Moreover, factors that have been shown to contribute to race and sex disparities in medical care fail to explain them fully. In both cases, physician decision-making appears to contribute as well, suggesting that subconscious biases may contribute to treatment disparities. We conclude by proposing initiatives to remedy race and sex disparities in medical care. Efforts should focus on increasing physician awareness of this problem. Studies should gather data that are currently unavailable for analysis, including detailed clinical variables and patient-level socioeconomic information. Finally, novel quality assurance programs, designed to evaluate and improve the care of blacks and women with coronary artery disease, should be promptly undertaken.

  View details for DOI 10.1016/s0002-8703(00)90017-6

  View details for PubMedID 10783219

• Relationship between CD4 count, viral burden, and quality of life over time in HIV-1-infected patients. Medical care Weinfurt, K. P., Willke, R. J., Glick, H. A., Freimuth, W. W., Schulman, K. A. 2000; 38 (4): 404-10

  Abstract

  Although surrogate markers such as CD4 counts and viral burden (HIV-1 RNA) are predictive of AIDS-related disease progression, little is known about the relationship between changes in surrogate markers and health-related quality of life (HRQOL) outcomes. This study investigated how changes in CD4/mm3 and viral burden (RNA copies/mL) are related to changes in HRQOL as indexed by the Medical Outcomes Study HIV Health Survey (MOS-HIV-30).Subjects were HIV-1-infected patients with CD4 counts <300/mm3 enrolled in a double-blind, randomized clinical trial of delavirdine. As part of the clinical protocol, patients completed the MOS-HIV-30, from which the Physical Health (PHS) and Mental Health (MHS) summary scores were used for analyses. HRQOL and surrogate marker data assessed up to 2 years after randomization were analyzed for a total of 1,112 patients.Individual patients' initial status (intercepts) and rates of change (slopes) over time for log CD4, log RNA, PHS, and MHS were estimated with the use of empirical Bayes. Early response to treatment correlated with HRQOL better for RNA than for CD4. However, the relationship between weekly change and HRQOL was stronger for CD4 than for RNA.Surrogate markers are significantly associated with HRQOL outcomes. Improvements in HRQOL over time are associated with lower initial viral load and with increases in CD4 counts. Limitations concerning the restricted variability of the change scores are addressed.

  View details for DOI 10.1097/00005650-200004000-00007

  View details for PubMedID 10752972

• Acute myocardial infarction complicated by atrial fibrillation in the elderly - Prevalence and outcomes CIRCULATION Rathore, S. S., Berger, A. K., Weinfurt, K. P., Schulman, K. A., Oetgen, W. J., Gersh, B. J., Solomon, A. J. 2000; 101 (9): 969–74

  Abstract

  Although atrial fibrillation (AF) is a common complication of acute myocardial infarction (MI), patient characteristics and association with outcomes remain poorly defined in the elderly.We evaluated 106 780 Medicare beneficiaries > or =65 years of age from the Cooperative Cardiovascular Project treated for acute MI between January 1994 and February 1996 to determine the prevalence and prognostic significance of AF complicating acute MI in elderly patients. Patients were categorized on the basis of the presence of AF, and those with AF were further subdivided by time of AF (present on arrival versus developing during hospitalization). AF and non-AF patients were compared by univariate analysis, and logistic regression modeling was used to identify clinical predictors of AF. The influence of AF on outcomes was evaluated by unadjusted Kaplan-Meier survival curves and logistic regression models. AF was documented in 23 565 patients (22. 1%): 11 510 presented with AF and 12,055 developed AF during hospitalization. AF patients were older, had more advanced heart failure, and were more likely to have had a prior MI and undergone coronary revascularization. AF patients had poorer outcomes, including higher in-hospital (25.3% versus 16.0%), 30-day (29.3% versus 19.1%), and 1-year (48.3% versus 32.7%) mortality. AF remained an independent predictor of in-hospital (odds ratio [OR], 1. 21), 30-day (OR, 1.20), and 1-year (OR, 1.34) mortality after multivariate adjustment. Patients developing AF during hospitalization had a worse prognosis than patients who presented with AF.AF is a common complication of acute MI in elderly patients and independently influences mortality, particularly when it develops during hospitalization.

  View details for DOI 10.1161/01.CIR.101.9.969

  View details for Web of Science ID 000085750600006

  View details for PubMedID 10704162

• Primary angioplasty vs thrombolysis in elderly patients - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Berger, A. K., Schulman, K. A., Gersh, B. J., Every, N. R. 2000; 283 (5): 601–2

  View details for Web of Science ID 000084956500013

• Impact of quality of life on patient expectations regarding phase I clinical trials Cheng, J. D., Hitt, J., Koczwara, B., Schulman, K. A., Burnett, C. B., Gaskin, D. J., Rowland, J. H., Meropol, N. J. W B SAUNDERS CO. 2000: 421–28

  Abstract

  Quality of life (QOL) is increasingly recognized as a critical cancer-treatment outcome measure, but little is known about the impact of QOL on the patient decision-making process. A pilot study was conducted in an effort to (1) measure the expectations of patients, physicians, and research nurses regarding the potential benefits and toxicities from experimental and standard therapies, and (2) determine the relationship of QOL to patient perceptions regarding treatment options.Thirty cancer patients enrolling in phase I clinical trials, their physicians, and their research nurses were administered questionnaires that assessed demographics, QOL, and treatment expectations.Compared with their physicians, patients overestimated potential benefits and toxicities from experimental therapy (mean expected benefit, 59.8% v 23.8%, P <.01; mean expected toxicity, 29.8% v 16.0%, P <.01). Patients estimated a greater potential for benefit (59.8% v 36.8%, P <.01) and less potential for toxicity (29.8% v 45.6%, P =.01) for experimental therapy, compared with standard therapy. Short Form-36 general health perception correlated with patient perception of potential benefit from experimental therapy (r =.48, P =.01).Participants in phase I clinical trial have high expectations regarding the success of experimental therapy and discount potential toxicity. Patient QOL may affect the expectation of benefit from experimental therapy and, ultimately, treatment choice. Understanding the interactions between QOL and patient expectations may guide the development of improved strategies to present appropriate information to patients considering early-phase clinical trials.

  View details for DOI 10.1200/JCO.2000.18.2.421

  View details for Web of Science ID 000084836100024

  View details for PubMedID 10637258

• Pharmacoeconomics: economic evaluation of pharmaceuticals. Pharmacoepidemiology Schulman, K. A., Glick, H., Polsky, D., Eisenberg, J. M. John Wiley & Sons. 2000; 2nd ed.: 573–601
• Randomized trial of filgrastim, sargramostim, or sequential sargramostim and filgrastim after myelosuppressive chemotherapy for the harvesting of peripheral-blood stem cells JOURNAL OF CLINICAL ONCOLOGY Weaver, C. H., Schulman, K. A., Wilson-Relyea, B., Birch, R., West, W., Buckner, C. D. 2000; 18 (1): 43–53

  Abstract

  The purpose of this study was to compare the effects of filgrastim, sargramostim, or sequential sargramostim and filgrastim on CD34(+) cell yields and morbidity after myelosuppressive mobilization chemotherapy (MC).One hundred fifty-six patients were randomized to receive filgrastim (n = 51), sargramostim (n = 52), or sargramostim for 5 days followed by filgrastim (n = 53) after MC with either cyclophosphamide and etoposide (n = 75) or paclitaxel and cyclophosphamide (n = 81).Compared with those who received sargramostim, patients who received filgrastim had faster recovery of an absolute neutrophil count of 0.5 x 10(9)/L or greater (a median of 11 v 14 days; P =. 0001), with fewer patients requiring RBC transfusions (P =.008), fewer patients with fever (18% v 52%; P = 0.001), fewer hospital admissions (20% v 42%; P =.013), and less intravenous antibiotic therapy (24% v 69%; P =.001). Patients who received filgrastim yielded more CD34(+) cells (median, 7.1 v 2.0 x 10(6)/kg/apheresis; P =.0001), and a higher fraction achieved 2.5 x 10(6) (94% v 78%; P =.021) and 5 x 10(6) (88% v 53%; P =.001) or more CD34(+) cells/kg with fewer aphereses (median, 2 v 3; P =.002) and fewer days of growth-factor treatment (median, 12 v 14; P =.0001). There were no major differences in outcomes between the filgrastim alone and the sequential regimens. After high-dose chemotherapy, patients who had peripheral-blood stem cells (PBSCs) mobilized with filgrastim or the sequential regimen received higher numbers of CD34(+) cells and had faster platelet recovery (P =.015), with fewer patients (P =.014) receiving fewer platelet transfusions (P =.001) than patients receiving sargramostim-mobilized PBSCs.It was concluded that filgrastim alone or sequential sargramostim and filgrastim were superior to sargramostim alone for the mobilization of CD34(+) cells and reduction of toxicities after MC.

  View details for DOI 10.1200/JCO.2000.18.1.43

  View details for Web of Science ID 000084581500008

  View details for PubMedID 10623692

• Characteristics of hospitalizations of HIV-infected patients: An analysis of data from the 1994 Healthcare Cost and Utilization Project JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Bentham, W. D., Cai, L. M., Schulman, K. A. 1999; 22 (5): 503–8

  Abstract

  Hospitals are significant resources for care of HIV/AIDS patients. Previous studies that have attempted to identify and track the characteristics of these patients and their hospitalizations have been limited in their ability to produce national estimates of patient use of such resources. This study, using data from the Healthcare Cost and Utilization Project (HCUP-3) attempted to characterize and estimate the cost of hospital usage by HIV/AIDS patients. We estimate that in 1994 approximately 188,506 admissions of HIV/AIDS patients occurred with an average charge of $19,244 U.S. per admission, for an estimated total cost of $3.63 billion. Compared with non-HIV-infected patients, HIV/AIDS patients tended to be male (75.83% versus 41.49%), a member of a minority group (53.51% versus 20.77%), hospitalized in a private, nonprofit, urban teaching hospital with a longer average length of stay (10.27 versus 5.52 days), and to have a higher in-hospital mortality (11.45% versus 2.58%). Approximately half of the hospital charges (47%) for these admissions were absorbed by Medicaid, and 25% by private insurance. The remainder of the charges were borne by the patients themselves. The results presented here for 1994 predate the widespread use of protease inhibitor/ highly active antiretroviral therapy (HAART), thus making this study an important benchmark for the delineation of the effects of HAART and any other future developments in HIV therapy on the characteristics of HIV/AIDS patient resource use on a national level. This study further demonstrates that HCUP is a powerful tool for the estimation and costing of hospital resource use.

  View details for Web of Science ID 000085336600012

  View details for PubMedID 10961613

• Lying for patients - Physician deception of third-party payers Freeman, V. G., Rathore, S. S., Weinfurt, K. P., Schulman, K. A., Sulmasy, D. P. AMER MEDICAL ASSOC. 1999: 2263–70

  Abstract

  Some physicians may resort to deception to secure third-party payer approval for patient procedures. Related physician attitudes, including willingness to use deception, are not well understood.To determine physician willingness to deceive a third-party payer and physician attitudes toward deception of third-party payers.A cross-sectional mailed survey was used to evaluate physician willingness to use deception in 6 vignettes of varying clinical severity: coronary bypass surgery, arterial revascularization, intravenous pain medication and nutrition, screening mammography, emergent psychiatric referral, and cosmetic rhinoplasty. We evaluated 169 board-certified internists randomly selected from 4 high- and 4 low-managed care penetration metropolitan markets nationwide for willingness to use deception in each vignette.Physicians were willing to use deception in the coronary bypass surgery (57.7%), arterial revascularization (56.2%), intravenous pain medication and nutrition (47.5%), screening mammography (34.8%), and emergent psychiatric referral (32.1%) vignettes. There was little willingness to use deception for cosmetic rhinoplasty (2.5%). Rates were highest for physicians practicing in predominantly managed care markets, for clinically severe vignettes, and for physicians spending less time in clinical practice. Physician ratings of the justifiability of deception varied by perspective and vignette.Many physicians sanction the use of deception to secure third-party payers' approval of medically indicated care. Such deception may reflect a tension between the traditional ethic of patient advocacy and the new ethic of cost control that restricts patient and physician choice in the use of limited resources.

  View details for DOI 10.1001/archinte.159.19.2263

  View details for Web of Science ID 000083356400004

  View details for PubMedID 10547165

• Study of Hypertensive Prescribing Practices (SHyPP): A National Survey of Primary Care Physicians. Journal of clinical hypertension (Greenwich, Conn.) Schulman, K. A., Mehta, S. S., Gersh, B. J., Schneider, E. C., Wilcox, C. S. 1999; 1 (2): 106-114

  Abstract

  BACKGROUND: Approximately 50 million people in the U.S. have hypertension. The Joint National Committee (JNC V) guidelines provide treatment recommendations for hypertension. These guidelines promote initiating therapy with diuretics and à -blockers because these agents have been shown to reduce hypertension related morbidity and mortality. OBJECTIVES: To survey primary care physicians' antihypertensive prescribing practices, their perceptions about antihypertensive medication cost and safety, and their perceptions of the effects of managed care. DESIGN: A direct mail survey was distributed to a national random sample of 500 office based, primary care internists, family practitioners, and general practitioners. RESULTS: 72% of the physicians who responded reported being aware of the JNC V guidelines. Younger physicians claimed to be more aware of and more likely to follow JNC V guidelines than older physicians. Only 25% of physicians reported initiating treatment at systolic blood pressures greater than 140 mm Hg as recommended by the JNC V guidelines. Most physicians reported initiating treatment at higher pressures. Diuretics were selected for initial antihypertensive treatment by 36% of physicians, ACE inhibitors by 35%, à -blockers by 16%, and calcium channel blockers (CCBs) by 7%. Up to 27% of physicians admitted not knowing the cost of specific medications. Approximately half of the physicians reported that they and their patients were more concerned about medication cost and safety today than 18 months ago. A greater number of younger physicians reported that managed care formularies infringed upon their prescribing practices. CONCLUSIONS: Antihypertensive prescribing patterns are inconsistent with JNC V guidelines. Actual practice may deviate even more from these guidelines than reported in this survey. Also, physicians perceive that managed care is increasingly affecting their prescribing practices. (c)1999 by Le Jacq Communications, Inc.

  View details for PubMedID 11416601

• ACI-TIPI clinical trial. Acute cardiac ischemia time-insensitive predictive instrument. Annals of internal medicine Weinfurt, K. P., Rathore, S. S., Schulman, K. A. 1999; 131 (6): 476-7

  View details for DOI 10.7326/0003-4819-131-6-199909210-00023

  View details for PubMedID 10498573

• Racial differences in the use of invasive cardiac procedures: A continuous quality improvement approach. American heart journal Sheifer, S. E., Schulman, K. A. 1999; 138 (3 Pt 1): 396-9

  View details for DOI 10.1016/s0002-8703(99)70138-9

  View details for PubMedID 10467186

• Primary coronary angioplasty vs thrombolysis for the management of acute myocardial infarction in elderly patients JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Berger, A. K., Schulman, K. A., Gersh, B. J., Pirzada, S., Breall, J. A., Johnson, A. E., Every, N. R. 1999; 282 (4): 341–48

  Abstract

  Despite evidence from randomized trials that, compared with early thrombolysis, primary percutaneous transluminal coronary angioplasty (PTCA) after acute myocardial infarction (AMI) reduces mortality in middle-aged adults, whether elderly patients with AMI are more likely to benefit from PTCA or early thrombolysis is not known.To determine survival after primary PTCA vs thrombolysis in elderly patients.The Cooperative Cardiovascular Project, a retrospective cohort study using data from medical charts and administrative files.Acute care hospitals in the United States.A total of 20683 Medicare beneficiaries, who arrived within 12 hours of the onset of symptoms, were admitted between January 1994 and February 1996 with a principal discharge diagnosis of AMI, and were eligible for reperfusion therapy.Thirty-day and 1-year survival.A total of 80356 eligible patients had an AMI at hospital arrival and met the inclusion criteria, of whom 23.2% received thrombolysis and 2.5% underwent primary PTCA within 6 hours of hospital arrival. Patients undergoing primary PTCA had lower 30-day (8.7% vs 11.9%, P=.001) and 1-year mortality (14.4% vs 17.6%, P=.001). After adjusting for baseline cardiac risk factors and admission and hospital characteristics, primary PTCA was associated with improved 30-day (hazard ratio [HR] of death, 0.74; 95% confidence interval [CI], 0.63-0.88) and 1-year (HR, 0.88; 95% CI, 0.73-0.94) survival. The benefits of primary coronary angioplasty persisted when stratified by hospitals' AMI volume and the presence of on-site angiography. In patients classified as ideal for reperfusion therapy, the mortality benefit of primary PTCA was not significant at 1-year follow-up (HR, 0.92; 95% CI, 0.78-1.08).In elderly patients who present with AMI, primary PTCA is associated with modestly lower short- and long-term mortality rates. In the subgroup of patients who were classified as ideal for reperfusion therapy, the observed benefit of primary PTCA was no longer significant.

  View details for DOI 10.1001/jama.282.4.341

  View details for Web of Science ID 000081596800029

  View details for PubMedID 10432031

• Race, sex, and physicians' referrals for cardiac catheterization - Reply NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Berlin, J. A., Escarce, J. J. 1999; 341 (4): 286

  View details for Web of Science ID 000081528800014

• A comparison of preference assessment instruments used in a clinical trial: Responses to the visual analog scale from the EuroQol EQ-5D and the health utilities index MEDICAL DECISION MAKING Glick, H. A., Polsky, D., Willke, R. J., Schulman, K. A. 1999; 19 (3): 265–75

  Abstract

  To compare preference assessments that were made by using the EuroQol EQ-5D and the Health Utilities Index Mark II.561 patients in a randomized trial of tirilazad mesylate for aneurysmal subarachnoid hemorrhage.Three preference assessments (a value score for the EuroQol instrument and value and utility scores for the Health Utilities Index) made three months after randomization. The averages for each of the three scores, stratified by clinical outcomes and attributes of the Health Utilities Index health status classification system, were compared. To evaluate potential sources of difference between the instruments, the authors estimated two alternative Health Utilities Index scoring rules that were based on patient responses to the EuroQol instrument.Patients' ratings of their current health made by using the 100-point visual analog scale from the EuroQol instrument were more similar to the utility scores for the Health Utilities Index than they were to the value scores for the Health Utilities Index. The biggest differences between the visual analog scores for the EuroQol instrument and the utility scores for the Health Utilities index were seen at higher levels of functioning.For states representing higher levels of functioning, differences were seen between patients' self-ratings obtained by using the EuroQol instrument and the patients' utility scores on the Health Utilities Index; for states representing lower levels of functioning, substantial agreement was observed between these two scores. Differences observed at the higher levels of functioning suggest that further research is needed to determine whether the Health Utility Index's assignment of a score of 1.0 to the reference state representing being healthy is appropriate.

  View details for DOI 10.1177/0272989X9901900305

  View details for Web of Science ID 000081383700005

  View details for PubMedID 10424833

• Determining an episode of care using claims data - Diabetic foot ulcer DIABETES CARE Mehta, S. S., Suzuki, S., Glick, H. A., Schulman, K. A. 1999; 22 (7): 1110–15

  Abstract

  Amid changes in the organization and financing of health care, health care decision makers are increasingly interested in episodes of care. We sought to determine an episode of care for diabetic foot ulcer using an administrative claims database.We used 1993-1995 claims data to assess resource utilization for privately insured patients with diabetic foot ulcers. Over a 26-week period, we determined the episode length by comparing differences in average daily charges and proportion of patients with charges before and after foot ulcer diagnosis. All 13 weeks before diagnosis were used to calculate baseline values. Significance was determined by CIs, which were calculated by a nonparametric bootstrap technique. Costs associated with the episode were also calculated. A sensitivity analysis using weeks with highest and lowest values as baseline was also conducted.Based on average daily charges, the episode of care for diabetic foot ulcer was 5 weeks. Using proportion of patients with charges, the episode was longer than 13 weeks. The cost for an episode of care ranged from $900 to $2,600. In the sensitivity analyses, episodes of care ranged from 1 to 13 weeks.Episodes of care can be defined by the period beginning with increased resource consumption and ending when resource consumption returns to baseline levels. With the growth of managed care and disease management programs, episode-of-care analysis may have an increasingly important role in health care provision and delivery.

  View details for DOI 10.2337/diacare.22.7.1110

  View details for Web of Science ID 000081018900017

  View details for PubMedID 10388976

• A claims data approach to defining an episode of care. Health services research Schulman, K. A., Yabroff, K. R., Kong, J., Gold, K. F., Rubenstein, L. E., Epstein, A. J., Glick, H. 1999; 34 (2): 603-21

  Abstract

  To utilize health services research techniques in developing an episode of care using an administrative data set. This method is demonstrated for an episodic clinical condition, migraine.Medicaid administrative data set of 3,372 patients with a diagnosis of migraine (ICD-9-CM 346.0, 346.1) in the state of Pennsylvania between May 1990 and March 1992.The duration of a migraine episode was measured by assessing the magnitude of resource utilization and the proportion of patients with charges in the period after the index migraine as compared to the period before the index migraine. A confidence interval (CI) was developed around each measure using bootstrap techniques.All charge data were extracted daily for a 113-day observation period surrounding each index migraine in order to observe the duration of impact of a migraine diagnosis on resource utilization.The lower limits of both the 95% and 99% CIs for the difference in charges are greater than 0 for three weeks. The lower limits of both CIs for the difference in the proportion of patients with charges are above 0 for six weeks.Our analysis demonstrates that a health services research framework can be used to define an episode of care for a chronic disease category such as migraine. This method can be used to evaluate episodes of care for clinical studies of limited or episodic conditions and to complement clinical expertise in developing time horizons for clinical trials.

  View details for PubMedID 10357292

  View details for PubMedCentralID PMC1089025

• Regulating manufacturer-affiliated communication in the information age CLINICAL PHARMACOLOGY & THERAPEUTICS Schulman, K. A., Abernethy, D. R., Rathore, S. S., Woosley, R. L. 1999; 65 (6): 593–97

  View details for DOI 10.1016/S0009-9236(99)90080-2

  View details for Web of Science ID 000081145500001

  View details for PubMedID 10391664

• Economics and cost-effectiveness in evaluating the value of cardiovascular therapies. ACE inhibitors in the management of congestive heart failure: comparative economic data. American heart journal Boyko, W. L., Glick, H. A., Schulman, K. A. 1999; 137 (5): S115-9

  View details for DOI 10.1016/s0002-8703(99)70443-6

  View details for PubMedID 10220611

• Telemedicine: Future promise for dialysis management SEMINARS IN DIALYSIS Winchester, J. F., Levine, B., Collmann, J., Schulman, K. A., Turner, J. W., Rathore, S., Khanafer, N., Alaoui, A., Pania, N., Al-Awaa, A., Hoffman, L., Hofilena, M., Mun, S. K. 1999; 12: S101–S103

  View details for Web of Science ID 000080637000022

• Treatment of hypertension in patients with comorbidities: results from the study of hypertensive prescribing practices (SHyPP). American journal of hypertension Mehta, S. S., Wilcox, C. S., Schulman, K. A. 1999; 12 (4 Pt 1): 333-40

  Abstract

  Approximately 50 million people have hypertension. Many agents with differing efficacy, side effects, dosing schedules, and costs are available to treat hypertension. Joint National Committee (JNC) guidelines attempt to simplify this decision by recommending specific agents based on special considerations such as comorbidities. The objective of this study was to survey primary care physicians' antihypertensive prescribing practices and their treatment recommendations for patients with comorbidities. A direct mail survey was sent to a national random sample of 500 office-based primary care internists, family practitioners, and general practitioners. There were no significant differences between initial treatment recommendations at the time of the survey and those recommended before the survey. However, there were several therapeutic classes whose reported utilization for specific comorbidities significantly changed over 18 months. Angiotensin converting enzyme (ACE) inhibitors reportedly increased in patients with congestive heart failure and diabetes. In addition, the reported use of selective beta-blockers increased for patients with a history of myocardial infarction. Physicians did not follow JNC recommendations when initiating treatment in black patients, older patients, or those with mild renal failure. Younger physicians were more likely than older physicians to select agents consistent with guideline recommendations. Physicians did not adhere to JNC guidelines when initiating treatment in patients with comorbidities; however, more physicians are prescribing recommended agents today as compared to 18 months ago. Younger physicians were more likely to prescribe agents consistent with the guidelines. More direct efforts are needed to ensure awareness and compliance with these guidelines.

  View details for PubMedID 10232492

• Effect of CD34(+) cell dose on resource utilization in patients after high-dose chemotherapy with peripheral-blood stem-cell support JOURNAL OF CLINICAL ONCOLOGY Schulman, K. A., Birch, R., Zhen, B., Pania, N., Weaver, C. H. 1999; 17 (4): 1227–33

  Abstract

  The mean time to neutrophil and platelet recovery for patients receiving high-dose chemotherapy (HDC) supported with peripheral-blood stem cells (PBSCs) is related to the dose of CD34(+) cells infused. The effect of cell dose on resource utilization after transplantation has not been previously reported.We assessed CD34(+) cell dose and resource utilization for 1,317 patients undergoing transplantation with PBSCs from April 1991 to June 1997. PBSCs were collected after mobilization with chemotherapy and recombinant human granulocyte colony-stimulating factor (rhG-CSF). Daily measurement of the CD34(+) content of the PBSC collection was performed by a central laboratory using a single CD34(+) analysis technique. Resource utilization included engraftment parameters, length of stay, and transfusion requirements for 100 days posttransplantation. Analysis included descriptive statistics and multiple regression.Mean patient age was 47 years, and 86% of patients were female. Median cell dose was 3.6 x 10(6)/kg and 13.2 x 10(6)/kg for patients receiving less than 5.0 x 10(6) CD34(+) cells/kg and 5.0 x 10(6) or more CD34(+) cells/kg, respectively. Patients receiving less than 5. 0 x 10(6) CD34(+) cells/kg were more likely to have metastatic breast cancer or non-Hodgkin's lymphoma and required more platelet and RBC transfusions, 3.3 more hospital days, and increased antibiotic and antifungal use. In univariate analysis, the cost of care was $41,516 (+/-$20,876 SD) and $32,382 (+/-$16,353 SD) for patients with less than 5.0 x 10(6) CD34(+) cells/kg and 5.0 x 10(6) or more CD34(+) cells/kg, respectively. In multivariate analysis, patients with less than 5.0 x 10(6) CD34(+) cells/kg had an increase in costs of $5,062 (+/- $1,262 SE).Infusion of more than 5.0 x 10(6) CD34(+) cells/kg was associated with a reduction in resource utilization. Achieving a target of 5.0 x 10(6) CD34(+) cells/kg should have important clinical and economic benefits for patients.

  View details for DOI 10.1200/JCO.1999.17.4.1227

  View details for Web of Science ID 000079496300019

  View details for PubMedID 10561183

• The timing of do-not-resuscitate orders and hospital costs. Journal of general internal medicine De Jonge, K. E., Sulmasy, D. P., Gold, K. G., Epstein, A., Harper, M. G., Eisenberg, J. M., Schulman, K. A. 1999; 14 (3): 190-2

  Abstract

  The relation between the timing of do-not-resuscitate (DNR) orders and the cost of medical care is not well understood. This prospective observational study compares hospital costs and length of stay of 265 terminally ill patients with admission DNR orders, delayed DNR orders (occurring after 24 hours), or no DNR orders (full code). Patients whose orders remained full code throughout a hospital stay had similar lengths of stay, total hospital costs, and daily costs as patients with admission DNR orders. Patients with delayed DNR orders, by contrast, had a greater mortality, longer length of stay, and higher total costs than full code or admission DNR patients, but similar daily costs. The causes of delay in DNR orders and the associated higher costs are a matter for future research.

  View details for DOI 10.1046/j.1525-1497.1999.00312.x

  View details for PubMedID 10203626

  View details for PubMedCentralID PMC1496551

• Clinical economics in clinical trials: the measurement of cost and outcomes in the assessment of clinical services through clinical trials. The Keio journal of medicine Schulman, K. A., Ohishi, A., Park, J., Glick, H. A., Eisenberg, J. M. 1999; 48 (1): 1-11

  Abstract

  As the population ages and more expensive high-technology services become available, health care costs continue to spiral upward. Because the financial resources for health care are limited, economic analysis can help to evaluate expenditures and set priorities. Economic analysis of medical technology or medical care evaluates a medical service by comparing its dollar cost with its dollar benefit (cost-benefit), by measuring its dollar cost in relation to its outcomes (cost-effectiveness) as well as in relation to its utility or quality-adjusted outcomes (cost-utility), or simply by tabulating the costs involved (cost-identification). Direct costs are generated as services are provided. In addition, patients' productivity is affected, and these costs can be considered, especially in determining the benefit of a service that decreases morbidity or mortality. Intangible costs are those of pain, suffering, and grief. The point of view, or perspective, of the study determines the costs and benefits that will be measured in the analysis. Sensitivity analysis, which can evaluate the stability of the conclusions to the data used, is an important assessment within economic analysis. Economic analysis of new pharmaceutical therapies is increasingly being incorporated into clinical trials. Although there are some limitations of pharmacoeconomic information in clinical studies of drug safety and efficacy, these trials are often the only opportunity for economic data collection before adoption and reimbursement decisions are made. Validation after the drug has been introduced should complement economic information developed from clinical trials.

  View details for DOI 10.2302/kjm.48.1

  View details for PubMedID 10206013

• The effect of race and sex on physicians' recommendations for cardiac catheterization NEW ENGLAND JOURNAL OF MEDICINE Schulman, K. A., Berlin, J. A., Harless, W., Kerner, J. F., Sistrunk, S., Gersh, B. J., Dube, R., Taleghani, C. K., Burke, J. E., Williams, S., Eisenberg, J. M., Escarce, J. J. 1999; 340 (8): 618–26

  Abstract

  Epidemiologic studies have reported differences in the use of cardiovascular procedures according to the race and sex of the patient. Whether the differences stem from differences in the recommendations of physicians remains uncertain.We developed a computerized survey instrument to assess physicians' recommendations for managing chest pain. Actors portrayed patients with particular characteristics in scripted interviews about their symptoms. A total of 720 physicians at two national meetings of organizations of primary care physicians participated in the survey. Each physician viewed a recorded interview and was given other data about a hypothetical patient. He or she then made recommendations about that patient's care. We used multivariate logistic-regression analysis to assess the effects of the race and sex of the patients on treatment recommendations, while controlling for the physicians' assessment of the probability of coronary artery disease as well as for the age of the patient, the level of coronary risk, the type of chest pain, and the results of an exercise stress test.The physicians' mean (+/-SD) estimates of the probability of coronary artery disease were lower for women (probability, 64.1+/-19.3 percent, vs. 69.2+/-18.2 percent for men; P<0.001), younger patients (63.8+/-19.5 percent for patients who were 55 years old, vs. 69.5+/-17.9 percent for patients who were 70 years old; P<0.001), and patients with nonanginal pain (58.3+/-19.0 percent, vs. 64.4+/-18.3 percent for patients with possible angina and 77.1+/-14.0 percent for those with definite angina; P=0.001). Logistic-regression analysis indicated that women (odds ratio, 0.60; 95 percent confidence interval, 0.4 to 0.9; P=0.02) and blacks (odds ratio, 0.60; 95 percent confidence interval, 0.4 to 0.9; P=0.02) were less likely to be referred for cardiac catheterization than men and whites, respectively. Analysis of race-sex interactions showed that black women were significantly less likely to be referred for catheterization than white men (odds ratio, 0.4; 95 percent confidence interval, 0.2 to 0.7; P=0.004).Our findings suggest that the race and sex of a patient independently influence how physicians manage chest pain.

  View details for DOI 10.1056/NEJM199902253400806

  View details for Web of Science ID 000078755700006

  View details for PubMedID 10029647

• Towards a composite scoring solution for the Neurobehavioral Functioning Inventory QUALITY OF LIFE RESEARCH Weinfurt, K. P., Willke, R., Glick, H. A., Schulman, K. A. 1999; 8 (1-2): 17–24

  Abstract

  Little research has been conducted towards the development and evaluation of a measure of quality of life specific to head/brain injury populations. Accordingly, we examined responses to the Neurobehavioral Functioning Inventory in the context of a clinical trial for head injury patients (n = 655) conducted in 14 countries. To reduce the 66 item scale into a smaller number of composite scales, principal components analysis was conducted. Scales were constructed assessing four categories of symptoms: cognitive deficits, depression, aggression and somatization. The internal reliabilities (alpha coefficient) of the four scales were generally acceptable (range = 0.79-0.92). Scores on all four scales correlated significantly with patient-rated overall quality of life and all but the aggression scale correlated significantly with overall clinical severity. The need for more formal evaluation of this and other disease-specific measures is discussed.

  View details for DOI 10.1023/A:1026411129270

  View details for Web of Science ID 000081799200003

  View details for PubMedID 10457735

• Pharmacoeconomics Maintenance Pharmacotherapies for Neuropsychiatric Disorders Gonzales, J., Schulman, K. A. Brunner/Mazel. 1999: 29–54
• Item responsiveness of a rhinitis and asthma symptom score during a pollen season JOURNAL OF ASTHMA Wasserfallen, J. B., Gold, K., Schulman, K. A., Baraniuk, J. N. 1999; 36 (5): 459–65

  Abstract

  Twenty-one asthma patients with allergic rhinitis completed a series of self-administered questionnaires (21-item symptom score for rhinosinusitis and asthma, bother scale, McMaster Asthma Quality of Life Questionnaire [MAQOL] and Euroqol) at 2-week intervals from August to November 1994. Relative responsiveness of the instruments was assessed in reference to the maximum and minimum average scores for MAQOL, with area under the curve (AUC) and correlation coefficients between the different instruments. Symptom score, MAQOL, and bother scale provided similar results for both extreme values and AUC, whereas Euroqol utilities were less responsive. These results suggest that the symptom scores and bother scales are responsive and valid, and might prove valuable in everyday practice, clinical trials, and quality assurance programs.

  View details for DOI 10.3109/02770909909087288

  View details for Web of Science ID 000082012900007

  View details for PubMedID 10461935

• Economic analysis of tirilazad mesylate for aneurysmal subarachnoid hemorrhage - Economic evaluation of a phase III clinical trial in Europe and Australia INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE Glick, H., Willke, R., Polsky, D., Llana, T., Alves, W. M., Kassell, N., Schulman, K. 1998; 14 (1): 145–60

  Abstract

  This study used data from a multinational phase III randomized, double-blind, vehicle-controlled trial to evaluate the cost-effectiveness of tirilazad mesylate (Freedox) in the treatment of aneurysmal subarachnoid hemorrhage. In men, therapy with 6 mg/kg per day of tirilazad mesylate was associated with significantly increased survival, increased cost of care, and ratios of cost per death averted that compare favorably with the ratios of other life and death interventions. In women, it appeared to have no effects on costs or survival. Further clinical studies may provide additional information about the cost-effectiveness of this intervention.

  View details for DOI 10.1017/S026646230001059X

  View details for Web of Science ID 000072188000013

  View details for PubMedID 9509802

• Prescription medication use in older Americans: a national report card on prescribing. Family medicine Rathore, S. S., Mehta, S. S., Boyko, W. L., Schulman, K. A. 1998; 30 (10): 733-9

  Abstract

  Due to their high prevalence of disease, older Americans receive more prescription medication than any other age group. We evaluated prescription medication use in patients age 50 or older; categorized and reported medication use by age group, drug class, and therapeutic class; and examined differences in prescribing patterns for older patients.All prescription medications reported in the 1995 National Ambulatory Medical Care Survey, a nationally representative sample of ambulatory care visits in the United States for patients age 50 and older (n = 16,289), were evaluated in a cross-sectional analysis. We evaluated the number of prescription medications reported for each patient visit and ranked use of drug and therapeutic classes.Most patients seeing physicians (61%) had a prescription for at least one medication, ranging from a mean of 1.27 medications in patients ages 50-64 to 1.58 in patients over 85. Calcium channel blockers and angiotensin-converting enzyme inhibitors were prescribed more than beta blockers in all patients. Data also indicated a significant decrease in estrogen/progestin and antidepressant medication use in older patients.Our findings indicate prescribing patterns inconsistent with national guidelines and decreased medication use, suggesting underprescription. Active intervention may be needed to improve the pharmacological treatment of older patients.

  View details for PubMedID 9827345

• Resource costing for multinational neurologic clinical trials: Methods and results HEALTH ECONOMICS Schulman, K., Burke, J., Drummond, M., Davies, L., Carlsson, P., Gruger, J., Harris, A., Lucioni, C., Gisbert, R., Llana, T., Tom, E., Bloom, B., Willke, R., Glick, H. 1998; 7 (7): 629–38

  Abstract

  We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

  View details for DOI 10.1002/(SICI)1099-1050(1998110)7:7<629::AID-HEC378>3.0.CO;2-N

  View details for Web of Science ID 000077046200007

  View details for PubMedID 9845256

• Estimating country-specific cost-effectiveness from multinational clinical trials. Health economics Willke, R. J., Glick, H. A., Polsky, D., Schulman, K. 1998; 7 (6): 481-93

  Abstract

  Because costs and outcomes of medical treatments may vary from country to country in important ways, decision makers are increasingly interested in having data based on their own country's health care situations. This paper proposes methods for estimating country-specific cost-effectiveness ratios from data available from multinational clinical trials. It examines how clinical and economic outcomes interact when estimating treatment effects on cost and proposes empirical methods for capturing these interactions and incorporating them when making country-specific estimates. We use data from a multinational phase III trial of tirilazad mesylate for the treatment of subarachnoid haemorrhage to illustrate these methods. Our findings suggest that it is possible for meaningful country-by-country differences to be found in such trial data. These differences can be useful in informing reimbursement, utilization, and other decisions taken at the country level.

  View details for DOI 10.1002/(sici)1099-1050(199809)7:6<481::aid-hec353>3.0.co;2-k

  View details for PubMedID 9809707

• Evaluating cancer costs in NCI trials. Cancer treatment and research Schulman, K. A., Boyko, W. L. 1998; 97: 37-52

  Abstract

  Economic evaluation is playing an increasingly important role in the assessment of clinical treatment strategies for cancer patients. Physicians and patients can use the comprehensive data on the cost and effectiveness of cancer therapies emerging from economic studies to help make treatment decisions. The data from economic analyses will afford clinical investigators an increasingly important tool to help determine the optimal treatment strategies for cancer patients and to help inform health policy decision-makers about the importance of specific cancer therapeutic strategies. In this chapter, we have outlined a set of procedures that can be used to assess the costs of care within NCI clinical trials. We review the economic framework for assessment of clinical trials, then review a proposed strategy for economic assessment. The design was successfully implemented, and the results have been recently published.

  View details for DOI 10.1007/978-0-585-30498-4_4

  View details for PubMedID 9711408

• Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: Report of a workshop EUROPEAN JOURNAL OF CANCER Neymark, N., Kiebert, W., Torfs, K., Davies, L., Fayers, P., Hillner, B., Gelber, R., Guyatt, G., Kind, P., Machin, D., Nord, E., Osoba, D., Revicki, D., Schulman, K., Simpson, K. 1998; 34 (9): 1317–33

  Abstract

  In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.

  View details for DOI 10.1016/S0959-8049(98)00074-4

  View details for Web of Science ID 000075290600007

  View details for PubMedID 9849412

• Outcomes and costs within a disease management program for advanced congestive heart failure AMERICAN HEART JOURNAL Schulman, K. A., Mark, D. B., Califf, R. M. 1998; 135 (6): S285–S292

  View details for DOI 10.1016/S0002-8703(98)70256-X

  View details for Web of Science ID 000074222000007

  View details for PubMedID 9630091

• Physician resource use and willingness to participate in assisted suicide ARCHIVES OF INTERNAL MEDICINE Sulmasy, D. P., Linas, B. P., Gold, K. F., Schulman, K. A. 1998; 158 (9): 974–78

  Abstract

  To explore the relationship between general internists' tendency to conserve medical resources and their willingness to participate in physician-assisted suicide (PAS).Survey of a random sample of general internists in 6 urban areas of the United States.We assessed the physicians' use of medical resources by constructing a scale based on 6 hypothetical clinical scenarios in which respondents were given a choice between resource-intensive and resource-conserving options. We then presented a scenario of a competent terminally ill patient with breast cancer making stable and persistent requests for PAS.Sixty-seven (33%) of the 206 respondents indicated that they would participate in the suicide of the depicted patient. In a multivariate model, physicians who were more conservative with resources were 6.4 times more likely than their resource-intensive counterparts to prescribe the requested drugs (P = .02); minority physicians were less willing than whites to participate in PAS (odds ratio, 0.34; P = .03). Physicians' number of years in practice, location, sex, reported percentage of fee-for-service patients, and self-reported strength and direction of financial incentives in the respondents' practices were not associated with willingness to prescribe drugs for PAS.Most general internists, especially minority physicians, are personally reluctant to participate in PAS. While the characteristics of their practices do not affect PAS, physicians who tend to practice resource-conserving medicine are significantly more likely than their resource-intensive counterparts to provide a lethal prescription at the request of a terminally ill patient.

  View details for DOI 10.1001/archinte.158.9.974

  View details for Web of Science ID 000073483600005

  View details for PubMedID 9588430

• Prospective economic evaluation accompanying a trial of GM-CSF/IL-3 in patients undergoing autologous bone marrow transplantation for Hodgkin's and non-Hodgkin's lymphoma BONE MARROW TRANSPLANTATION Schulman, K. A., Dorsainvil, D., Yabroff, K. R., DiCesare, J., Felser, J., Eisenberg, J. M., Glick, H. A., IL-3 BMT Study Team 1998; 21 (6): 607–14

  Abstract

  Our objective was to assess the economic impact of a new cytokine therapy that was being compared to standard therapy as supportive care in patients receiving autologous bone marrow transplantation for treatment of lymphoma. We performed an economic study accompanying a multicenter, randomized, controlled clinical trial in academic medical centers. One hundred and fifteen patients consented to participate in a parallel economic study of a randomized controlled trial of sequential IL-3 followed by GM-CSF vs GM-CSF alone after autologous bone marrow transplantation. We measured costs and quality-adjusted survival over a 13-month follow-up period. For the 13-month study period, the total cost estimates were $79892 (95% CI $69343 to $90544) for patients receiving GM-CSF alone and $89651 (95% CI $79769 to $102114) for patients receiving IL-3/GM-CSF. The difference was not statistically significant. During the 13-month study period, the total number of quality-adjusted life-months in the GM-CSF arm was 6.67 (95% CI 5.75 to 7.56) months, while the total number of quality-adjusted life-months in the IL-3 arm was 6.26 (95% CI 5.34 to 7.15) months. The difference in quality-adjusted life-months between the two treatment arms was not statistically significant. We conclude that economic analysis of a phase III clinical trial of IL-3/GM-CSF compared with GM-CSF alone showed no significant effect of IL-3 on the costs of care for patients undergoing bone marrow transplantation for a period of up to 13 months after the procedure. This study demonstrates the feasibility of prospective economic evaluation within phase III trials of new cancer therapies. Data from this type of economic protocol could be used to help physicians, patients and managed care organizations understand the effect of new treatments from both a clinical and an economic perspective.

  View details for DOI 10.1038/sj.bmt.1701142

  View details for Web of Science ID 000072653400010

  View details for PubMedID 9543065

• Comparison of the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage between Canada and the United States STROKE Glick, H. A., Polsky, D., Willke, R. J., Alves, W. M., Kassell, N., Schulman, K. 1998; 29 (2): 351–58

  Abstract

  Using data from a randomized trial of tirilazad mesylate, we assessed the differences between Canada and the United States in the use of medical resources and outcomes in the treatment of aneurysmal subarachnoid hemorrhage during the first 90 days after admission to the hospital.Of the 877 patients for whom economic data were available, 194 were enrolled in Canada and 683 were enrolled in the United States. The differences between the countries in patient characteristics, use of medical resources, and outcomes were analyzed by comparing means and the 95% confidence intervals (CIs) around the differences in means. These differences also were predicted with use of multivariable regression analysis.The average hospital stay was 4.2 days longer (95% CI, 1.3 to 7.1 days) in Canada, but most of the extra stay was among patients admitted to the study in poor neurological condition. In general, however, hospital stays in Canada were substantially less intensive. Patients treated in Canada spent 3.7 fewer days (95% CI, 1.2 to 6.1 days) in nursing homes and rehabilitation centers than did patients in the United States. No statistically significant differences were seen for Glasgow Outcome Scale score, death, and occurrence of vasospasm.For patients admitted to the study in good neurological condition, the apparent difference in length of stay between Canada and the United States was caused by a shift in the sites of formal care rather than to the length of this care. For those admitted in poor neurological condition, both the length and sites of care differed between the two countries. No significant difference in outcomes appeared to justify these differences in the use of medical resources.

  View details for DOI 10.1161/01.STR.29.2.351

  View details for Web of Science ID 000071932100003

  View details for PubMedID 9472873

• Beyond survival: economic analyses of chemotherapy in advanced, inoperable NSCLC. Oncology (Williston Park, N.Y.) Mather, D., Sullivan, S. D., Parasuraman, T. V. 1998; 12 (2): 199-209; discussion 210, 215-6 pass

  Abstract

  Research shows that chemotherapy for inoperable non-small-cell lung cancer (NSCLC) improves survival. The economic implications of this treatment choice may be substantial. This paper reviews studies examining the cost-effectiveness of chemotherapy in this setting. MEDLINE, PDQ, Cancerlit, EMBASE, and the Nursing & Allied Health databases were searched using the terms cost, cost-effectiveness, chemotherapy, and non-small-cell lung cancer. The search identified 17 studies. Most of these studies utilized data from various sources to model the impact and cost of chemotherapy. The remaining studies were concurrent or retrospective analyses of individual clinical trials. Findings suggest that chemotherapy for stages IIIb and IV non-small-cell lung cancer can be cost-effective and, in some cases, may actually be less expensive than supportive care alone. Economic analyses also indicate that allocating resources for chemotherapy in this setting can be justified relative to many treatment expenditures for other types of cancer and other disease. Application of these findings may be hindered by the wide variety of techniques used and by several methodologic issues, including the failure to address patients' treatment preferences. Yet, economic analyses of inoperable non-small-cell lung cancer can provide important information to complement survival and quality-of-life data in resource allocation decisions.

  View details for PubMedID 9507521

• Treatment choices by seriously Ill patients: The health stock risk adjustment model MEDICAL DECISION MAKING Gaskin, D. J., Kong, J., Meropol, N. J., Yabroff, K. R., Weaver, C., Schulman, K. A. 1998; 18 (1): 84–94

  Abstract

  Anecdotal evidence suggests that patients who have life-threatening conditions often choose to undergo high-cost, high-risk treatments for them. This kind of risk-seeking behavior seems irrational because most patients are risk-averse. The Health Stock Risk Adjustment (HSRA) model seeks to explain this phenomenon. The model is based on the concept of relative health stock--the ratio of patients' expected quality-adjusted life years (QALYs) after a diagnosis to their expected QALYs before the diagnosis. The model predicts risk-averse patients will behave in a risk-seeking manner as their relative health stocks deteriorate. The HSRA model can help physicians better understand why some seriously ill patients seek high-risk treatments while others elect to forgo treatment. State legislatures and insurers are attempting to appropriately design insurance benefits for patients with life-threatening conditions. The HSRA model can help predict which patients will most likely take advantage of these benefits.

  View details for DOI 10.1177/0272989X9801800116

  View details for Web of Science ID 000071405300016

  View details for PubMedID 9456213

• Costs and outcomes Internal Medicine Schulman, K. A. Mosby. 1998
• Evaluating cancer costs in NCI trials Cancer Policy: Research and Methods Schulman, K. A., Boyko, W. L. Kluwer Academic Publishers. 1998
• . Introduction to decision analysis Evidence Based Cardiology Schulman, K. A., Glick, H. A., Detsky, A. S. BMJ Books. 1998: 92–111
• Remote management of haemodialysis patients: design and implementation of a telemedicine network MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES Tohme, W. G., Winchester, J. F., Collmann, J., Johnson, A. E., Khanafer, N., Meissner, M. C., Rathore, S., Schulman, K. A., Freedman, M. T., Mun, S. K. 1997; 6 (5-6): 421–28

  View details for DOI 10.3109/13645709709153344

  View details for Web of Science ID 000071661300010

• Hemodialysis patient management by telemedicine: design and implementation. ASAIO journal (American Society for Artificial Internal Organs : 1992) Winchester, J. F., Tohme, W. G., Schulman, K. A., Collmann, J., Johnson, A., Meissner, M. C., Rathore, S., Khanafer, N., Eisenberg, J. M., Mun, S. K. 1997; 43 (5): M763-6

  Abstract

  The authors describe the design and implementation of a personal computer based telemedicine system for managing patients by telemedicine. With three identical systems connected by high speed T1 lines, the physician (or allied healthcare giver) can interact, by videoconferencing, and by using multimedia files, with patients at two remote hemodialysis sites. The physician is able to visualize specifically the patient's fistula/graft, and auscultate fistula, heart and lung sounds, and incorporate still pictures or audio sounds in the patient's multimedia database folder, which also contains an electronic and paperless medical record. In addition there is the capability of downloading into this database all the machine parameters during dialysis.

  View details for PubMedID 9360149

• Resource utilization control processes as indicators of quality in managed care organizations: a proposal. The American journal of medicine Roulidis, Z. C., DeChant, H. K., Schulman, K. A. 1997; 103 (2): 146-51

  Abstract

  Central to the development of a competitive market for managed care products is the ability to measure the quality of care provided by individual managed care organizations (MCOs). Several types of quality measures could be considered for this purpose: patient and provider satisfaction, a listing of specific services provided to patients, or clinical outcomes of such services. Although assessing quality with measures of the process of care is commonplace, we propose developing measures of the production processes that control utilization of health care resources within an organization. Evaluation of these production or resource utilization control processes, although not a substitute for health outcomes assessment, may improve our knowledge of the delivery of services within managed care organizations. We present a paradigm for evaluation of health care resource utilization control processes within managed care organizations based on our description of internal and external controls for health care resource management. This paradigm can serve as a framework for further research into the quality of care provided by these organizations and the processes of health care resource management in MCOs.

  View details for DOI 10.1016/s0002-9343(97)00154-x

  View details for PubMedID 9274898

• A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST). American heart journal Califf, R. M., Adams, K. F., McKenna, W. J., Gheorghiade, M., Uretsky, B. F., McNulty, S. E., Darius, H., Schulman, K., Zannad, F., Handberg-Thurmond, E., Harrell, F. E., Wheeler, W., Soler-Soler, J., Swedberg, K. 1997; 134 (1): 44-54

  Abstract

  This trial evaluated the effects of epoprostenol on patients with severe left ventricular failure. Patients with class IIIB/IV congestive heart failure and decreased left ventricular ejection fraction were eligible for enrollment if angiography documented severely compromised hemodynamics while the patient was receiving a regimen of digoxin, diuretics, and an angiotensin-converting enzyme inhibitor. We randomly assigned 471 patients to epoprostenol infusion or standard care. The primary end point was survival; secondary end points were clinical events, congestive heart failure symptoms, distance walked in 6 minutes, and quality-of-life measures. The median dose of epoprostenol was 4.0 ng/kg/min, resulting in a significant increase in cardiac index (1.81 to 2.61 L/min/m2), a decrease in pulmonary capillary wedge pressure (24.5 to 20.0 mm Hg), and a decrease in systemic vascular resistance (20.76 to 12.33 units). The trial was terminated early because of a strong trend toward decreased survival in the patients treated with epoprostenol. Chronic intravenous epoprostenol therapy is not associated with improvement in distance walked, quality of life, or morbid events and is associated with an increased risk of death.

  View details for DOI 10.1016/s0002-8703(97)70105-4

  View details for PubMedID 9266782

• Development and validation of a rhinoconjunctivitis and asthma symptom score for use as an outcome measure in clinical trials. The Journal of allergy and clinical immunology Wasserfallen, J. B., Gold, K., Schulman, K. A., Baraniuk, J. N. 1997; 100 (1): 16-22

  Abstract

  The measurement of health outcomes has become a priority for assessing and containing health care costs.To develop and fully validate a simple symptom scale assessing both asthma and rhinoconjunctivitis, two interdependent conditions.A self-administered questionnaire of 31 items was tested in 102 patients with asthma and rhinoconjunctivitis between September 1992 and December 1994. The items were rated on a six-point Likert scale ranging from none to extremely severe and included commonly recorded symptoms of inflammation such as irritation, congestion, and discharge in the skin, eyes, nose, sinus, pharynx, and chest.Validation included (1) responsiveness: scores for 18 patients evaluated during an emergency room visit were statistically significantly different from those recorded after recovery and in a control group of 24 patients with asthma; (2) reliability: external consistency was 0.8 at 1 week, and internal consistency was 0.8 for individual organs and 0.7 for individual symptoms; (3) validity: a five-point scale better captured the distribution of values; irrelevant and redundant items were eliminated. The optimal questionnaire included 21 items.The symptom score was applicable, responsive, reliable, and valid. Used with existing validated tools such as treatment needs and quality of life assessment, it may provide a comprehensive picture of allergic airway disease for quality assurance or research purposes.

  View details for DOI 10.1016/s0091-6749(97)70189-1

  View details for PubMedID 9257782

• Access to bone marrow transplantation for leukemia and lymphoma: The role of sociodemographic factors JOURNAL OF CLINICAL ONCOLOGY Mitchell, J. M., Meehan, K. R., Kong, J., Schulman, K. A. 1997; 15 (7): 2644–51

  Abstract

  Use of bone marrow transplantation (BMT), a complex, costly treatment for many forms of cancers, has increased significantly in recent years. The increasingly competitive health care marketplace raises concerns about patient access to costly medical procedures such as BMT. We attempted to evaluate patient access to BMT for the treatment of leukemias and lymphomas.We analyzed inpatient hospital discharge data from four states (California, Maryland, Massachusetts, and New York) for 2 years (1988 and 1991) to examine whether the use of BMT for patients with either leukemia or lymphoma varies by sociodemographic characteristics and insurance coverage. We developed a sorting algorithm to collapse the discharge data into patient level records. We used logistic regression to analyze the odds of receiving a BMT stratified by disease type (leukemia or lymphoma).After controlling for other factors, black patients with leukemia are 51% to 53% as likely as whites, while black patients with lymphoma are 34% to 45% as likely as white patients to undergo a BMT (P < .05). Medicaid, self-pay patients, and Health Maintenance Organization (HMO) enrollees with either leukemia or lymphoma are significantly less likely to undergo a BMT compared with patients with private insurance. Younger patients are significantly more predisposed to undergo a BMT than older patients. The odds of receiving a BMT have increased over time, but the rates of increase vary by state. Consistent with clinical expectations, the relative odds of BMT vary significantly by type of leukemia or lymphoma.Substantial variation exists in access to BMT for patients with either leukemia or lymphoma. Black patients, those enrolled in HMOs, those covered by Medicaid, and self-pay patients were less likely to receive a BMT when admitted for either leukemia or lymphoma. These findings raise concerns about access to cancer treatments for patients in the current health care system.

  View details for DOI 10.1200/JCO.1997.15.7.2644

  View details for Web of Science ID A1997XH44200022

  View details for PubMedID 9215836

• Confidence intervals for cost-effectiveness ratios: A comparison of four methods HEALTH ECONOMICS Polsky, D., Glick, H. A., Willke, R., Schulman, K. 1997; 6 (3): 243–52

  Abstract

  We evaluated four methods for computing confidence intervals for cost-effectiveness ratios developed from randomized controlled trials: the box method, the Taylor series method, the nonparametric bootstrap method and the Fieller theorem method. We performed a Monte Carlo experiment to compare these methods. We investigated the relative performance of each method and assessed whether or not it was affected by differing distributions of costs (normal and log normal) and effects (10% absolute difference in mortality resulting from mortality rates of 25% versus 15% in the two groups as well as from mortality rates of 55% versus 45%) or by differing levels of correlation between the costs and effects (correlations of -0.50, -0.25, 0.0, 0.25 and 0.50). The principal criterion used to evaluate the performance of the methods was the probability of miscoverage. Symmetrical miscoverage of the intervals was used as a secondary criterion for evaluating the four methods. Overall probabilities of miscoverage for the nonparametric bootstrap method and the Fieller theorem method were more accurate than those for the other the methods. The Taylor series method had confidence intervals that asymmetrically underestimated the upper limit of the interval. Confidence intervals for cost-effectiveness ratios resulting from the nonparametric bootstrap method and the Fieller theorem method were more dependably accurate than those estimated using the Taylor series or box methods. Routine reporting of these intervals will allow individuals using cost-effectiveness ratios to make clinical and policy judgments to better identify when an intervention is a good value for its cost.

  View details for DOI 10.1002/(SICI)1099-1050(199705)6:3<243::AID-HEC269>3.0.CO;2-Z

  View details for Web of Science ID A1997XH34300003

  View details for PubMedID 9226142

• Quality assessment in contracting for tertiary care services by HMOs: a case study of three markets. The Joint Commission journal on quality improvement Schulman, K. A., Rubenstein, L. E., Seils, D. M., Harris, M., Hadley, J., Escarce, J. J. 1997; 23 (2): 117-27

  Abstract

  Few studies have examined the provision of tertiary care services by managed care organizations (MCOs). Moreover, little is known about the role of quality assessment and quality assurance mechanisms in the contracting process. Site visits were conducted in 1995 in three geographic areas to describe and evaluate the contracting processes for tertiary care services, especially neonatal intensive care and coronary artery bypass graft surgery, of health maintenance organizations (HMOs).Three market areas in the United States, each with differing levels of "maturity", as primarily defined in terms of managed care penetration, were selected for study. Interviews were conducted with HMO and hospital managers about the processes for identifying potential tertiary care hospitals and mechanisms for quality assessment and quality improvement (QI) that are considered in the contracting process.The most sophisticated contracting arrangements were found in the most mature market-where HMOs select hospitals for tertiary care services based on both the price and quality of services, with quality assessed through both objective and subjective data. Yet in all three markets, quality assessment was the least well-developed component of tertiary care contracting. Even in the mature market, we found inconsistent use of even validated quality or outcomes measures in hospital contracting.The potential of MCOs to increase quality depends on their ability to identify high-quality hospitals and their willingness to direct enrollees to those hospitals. Yet inconsistent evidence was found that mechanisms for evaluating and rewarding quality are being fully adopted in the three markets studied.

  View details for DOI 10.1016/s1070-3241(16)30304-2

  View details for PubMedID 9061441

• Pharmacoeconomics: state of the art in 1997. Annual review of public health Schulman, K. A., Linas, B. P. 1997; 18: 529-48

  Abstract

  Economic evaluation of pharmaceutical products, or pharmacoeconomics, is a rapidly growing area of research. Pharmacoeconomic evaluation is important in helping clinicians and managers make choices about new pharmaceutical products and in helping patients obtain access to new medications. Over the last few years, the scientific rigor of this field has increased greatly. At the same time, new types of analysis, based on prospective data collection, have been developed. This article reviews the basic concept of pharmacoeconomics, the types of data available for economic evaluation, and the "state of the art" in pharmacoeconomics as reported in the medical literature.

  View details for DOI 10.1146/annurev.publhealth.18.1.529

  View details for PubMedID 9143730

• Mathematical models in decision analysis. Infection control and hospital epidemiology Tom, E., Schulman, K. A. 1997; 18 (1): 65-73

  Abstract

  Decision analysis offers powerful techniques to understand and evaluate uncertain clinical situations better. Decision analytic models are appearing with increasing frequency in health policy planning, clinical information and decision-support computer systems, evaluations of clinical pathways, development of clinical practice or utilization review guidelines, and epidemiologic research. This article describes the structure, application, and limitations of the more popular decision analytic methods, including decision trees, Markov models, Monte Carlo simulation, survival and hazard functions, fuzzy logic, and sensitivity analysis. Understanding the nature of these methods will help readers to assess better the appropriateness of their use in published reports.

  View details for DOI 10.1086/647503

  View details for PubMedID 9013249

• Economic assessment within the clinical development program Schulman, K. A., Llana, T., Yabroff, K. R. LIPPINCOTT-RAVEN PUBL. 1996: DS89–DS95

  View details for Web of Science ID A1996VY39300012

  View details for PubMedID 8969317

• Assessment of joint review of radiologic studies by a primary care physician and a radiologist Knollmann, B. C., Corson, A. P., Twigg, H. L., Schulman, K. A. BLACKWELL SCIENCE INC. 1996: 608–12

  Abstract

  To assess whether the joint review of radiologic studies by the primary care physician and the radiologist affects patient care and health care costs.Prospective study.Student health clinic at a university hospital.University students seen during acute care visits.Joint weekly review of all radiologic studies ordered at the student health clinic between July 1992 and June 1993 by a staff radiologist and internist.The outcome measures were: (1) change of radiologic diagnosis after review process and its effect on patient management; (2) expenses saved or incurred by the review process. Of 323 films ordered, 305 were reviewed, resulting in revisions of 23 (8%) of the initial readings. Sixteen revisions (5%) led to a change in patient management; the remainder were clinically insignificant. In these 16 cases, cancellation or simplification of further workup resulted in savings of $1,967. The cost for extra physician time was $5,499. Thus, the review process incurred a net cost of $3,532. Except for the reduction in diagnostic studies, no therapeutic benefit for the patients could be identified. Film readings in our radiology department were conservative, with a positive predictive value of 85% and a negative predictive value of 99.7%.Routinely reviewing every radiologic study did not affect patient outcome in an outpatient clinic with low prevalence of disease. Given our radiologists' conservative film-reading practice, a review of only abnormal studies may prove more cost-effective in a healthy population. This type of assessment has implications for improving the efficiency of a changing health care system.

  View details for DOI 10.1007/BF02599028

  View details for Web of Science ID A1996WA56900005

  View details for PubMedID 8945692

• Results of the economic evaluation of the first study - A multinational prospective economic evaluation INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE Schulman, K. A., Buxton, M., Glick, H., Sculpher, M., Guzman, G., Kong, J., Backhouse, M., Mauskopf, J., Bell, L., Eisenberg, J. M., Califf, R. M., McKenna, W. J., Harrell, F. E., Uretsky, B. F., Adams, K. F., Swedberg, K. B., Gheorghiade, M., Zannad, F., Handberg, E., Darius, H., SolerSoler, J., Wheeler, W. S., Armstrong, P. W., Patterson, H., Murali, S., Butman, S., Kirlin, P. C., Miller, L. W., Jafri, S., Rich, S., CostanzoNordin, M. R., McGoon, M., Hosenpud, J. D., Ratkovec, R., Brundage, B., Pritzker, M., Bourge, R., Reeves, W., Forgosh, L., Ventura, H., Young, J. B., Mancini, D., Mills, R. M., Limacher, M. C., Lee, F., Revkin, J., Kalbfleisch, J. M., Fishbein, D., Pressler, M., Haeusslein, E., Karlsberg, R. P., OConnell, J., LeJemtel, T. H., Thomas, H. M., Smith, W. B., McIvor, M., Cintron, G. B., Hager, W. D., Messineo, F. C., Dougherty, J. E., Hassapoyannes, C., Hood, W., McGrew, F., Sanford, C. F., OConner, C. M., Hobbs, R. E., Yardley, D., Kay, R., Minotti, J., Eastburn, T. E., Lindenfeld, J., Litman, G., Wickemeyer, W., Horton, S., Gilbert, E. M., Eichorn, E., Ribner, H. S., Corder, C., Philbin, E., Nocero, M., Elkayam, U., Jessup, M., Crawford, M., Carson, P., Reddy, H. K., Klapholz, M., Heywood, J. T., Salinger, M., Karlsberg, R., Bush, D., Hunter, C., Wohns, D., Eisenberg, P., Winston, S., Butcher, C., Massin, E., Wynne, J., Tonkon, M., Spaccavento, L., Diver, D., Ghali, J., Hutchins, S., Anand, Beanlands, D., Kostuk, W., Pflugfelder, P., Langleben, D., Latour, P., Mizgala, H., Ricci, D., Manyari, D., Dargie, H. J., Davidson, C., Swanton, H., Hubner, P. J., Oakley, D., Brooks, N., Jennings, K., Greenbaum, R. A., Penny, W. J., Nicholls, P., Walsh, M., Sugrue, D., Fennell, W., Horgan, J. H., Jondeau, G., Castaigne, A., LeMarec, H., Walger, P., Park, J. W., deBerrazueta, Mol, M. G., Sanchez, M. A., Caponnetto, S., Magnani, B., Galie, N., DeVita, C., Maseri, A., Bagger, J. P., Remes, J., Waldenstrom, A., Schaufelberger, M., Diensti, F., Simoons, M. L., Klein, W., Pacher, R., Keogh, A., Harley, A. 1996; 12 (4): 698–713

  Abstract

  We present the prospective economic evaluation that served as a secondary endpoint for the FIRST study, a randomized international multicenter trial of patients with severe congestive heart failure. Although the clinical results of this study were disappointing, we demonstrated the feasibility of incorporating prospective economic evaluation in phase III clinical trials.

  View details for DOI 10.1017/S0266462300010989

  View details for Web of Science ID A1996WE15000012

  View details for PubMedID 9136477

• The economic evaluation of the FIRST study: design of a prospective analysis alongside a multinational phase III clinical trial. Flolan International Randomized Survival Trial. Controlled clinical trials Schulman, K. A., Glick, H., Buxton, M., Sculpher, M., Backhouse, M., Bell, L., Eisenberg, J. M. 1996; 17 (4): 304-15

  Abstract

  Prospective economic assessments of new pharmaceutical therapies are increasingly being incorporated into phase III clinical trials. We report on the design of an economic evaluation integrated into the Flolan International Randomized Survival Trial (FIRST). Economic evaluation was considered a critical component of the assessment of this therapy given the resources required to administer epoprostenol (Flolan), a therapy that would require lifelong continuous intravenous infusion. Economic secondary endpoints were incorporated in the clinical trial. The economic evaluation of the treatment was integrated into all aspects of study development, including study design, implementation, and monitoring. Since this was a multinational trial, special care was required to ensure that the protocol design was appropriate for all study countries. The economic assessment required the development of several methodologic components: a set of background economic concepts to guide protocol development, a set of resource items to be recorded when required for study participants; a set of data collection instruments for assessment of health-related quality of life for study patients; and a protocol for a resource costing exercise for the study. We report the data elements included in the study design, as well as a discussion of some of the issues faced in developing the economic evaluation for this trial.

  View details for DOI 10.1016/0197-2456(95)00166-2

  View details for PubMedID 8889345

• Clinical assessment of MR of the brain in nonsurgical inpatients AMERICAN JOURNAL OF NEURORADIOLOGY Hirsch, J. A., Langlotz, C. P., Lee, J., Tanio, C. P., Grossman, R. I., Schulman, K. A. 1996; 17 (7): 1245-1253

  Abstract

  To evaluate the effect of MR imaging of the brain on four domains of patient care: diagnosis, diagnostic workup, therapy, and prognosis.Pre- and post-MR written questionnaires and oral interviews were administered to the referring clinicians of 103 medical and neurologic inpatients at a tertiary care institution. Additional information was obtained from radiologic reports and records.The study population had a diverse array of signs and symptoms and of presumptive clinical diagnoses, reflecting the breadth of disease seen at our institution. The vast majority of physicians (89%) reported that MR imaging added significant diagnostic information, playing an important role in guiding diagnostic workup (24%), planning treatment (34%), and estimating prognosis (47%). MR imaging was significantly more likely to decrease than to increase confidence in the presumptive clinical diagnosis. Thus, MR imaging may be most useful in the setting of diagnostic uncertainty.Our results show that MR imaging of the brain has important effects on each of the four domains of care for medical inpatients.

  View details for Web of Science ID A1996VC32900008

  View details for PubMedID 8871707

• BRCA1 testing in families with hereditary breast-ovarian cancer. A prospective study of patient decision making and outcomes. JAMA Lerman, C., Narod, S., Schulman, K., Hughes, C., Gomez-Caminero, A., Bonney, G., Gold, K., Trock, B., Main, D., Lynch, J., Fulmore, C., Snyder, C., Lemon, S. J., Conway, T., Tonin, P., Lenoir, G., Lynch, H. 1996; 275 (24): 1885-92

  Abstract

  To identify predictors of utilization of breast-ovarian cancer susceptibility (BRCA1 gene) testing and to evaluate outcomes of participation in a testing program.Prospective cohort study with baseline interview assessment of predictor variables (eg, sociodemographic factors, knowledge about hereditary cancer and genetic testing, perceptions of testing benefits, limitations, and risks). BRCA1 test results were offered after an education and counseling session in a research setting. Outcome variables (including depression, functional health status, and prophylactic surgery plans [follow-up only]) were assessed at baseline and 1-month follow-up interviews.Adult male and female members (n=279) of families with BRCA1-linked hereditary breast-ovarian cancer (HBOC).Of subjects who completed a baseline interview (n=192), 60% requested BRCA1 test results (43% of all study subjects requested results). Requests for results were more frequent for persons with health insurance (odds ration [OR], 3.74; 95% confidence interval [CI], 2.06-6.80); more first-degree relatives affected with breast cancer (OR, 1.59; 95% CI, 1.16-2.16); more knowledge about BRCA1 testing (OR, 1.85; 95% CI, 1.36-2.50); and indicating that test benefits are important (OR, 1.45; 95% CI, 1.13-1.86). At follow-up, noncarriers of BRCA1 mutations showed statistically significant reductions in depressive symptoms and functional impairment compared with carriers and nontested individuals. Individuals identified as mutation carriers did not exhibit increases in depression and functional impairment. Among unaffected women with no prior prophylactic surgery, 17% of carriers (2/12) intended to have mastectomies and 33% (4/12) to have oophorectomies.Only a subset of HBOC family members are likely to request BRCA1 testing when available. Rates of test use may be higher in persons of a higher socioeconomic status and those with more relatives affected with breast cancer. For some high-risk individuals who receive test results in a research setting that includes counseling, there may be psychological benefits. More research is needed to assess the generalizability of these results and evaluate the long-term consequences of BRCA1 testing.

  View details for PubMedID 8648868

• The effect of pharmaceutical benefits managers: Is it being evaluated? ANNALS OF INTERNAL MEDICINE Schulman, K. A., Rubenstein, L. E., Abernethy, D. R., Seils, D. M., Sulmasy, D. P. 1996; 124 (10): 906–13

  Abstract

  Over the last decade, the number of pharmaceutical benefits managers has increased, and their influence has expanded rapidly. These managers now provide prescription drug coverage to more than 100 million Americans. The effect of pharmaceutical benefits managers on health care delivery remains unclear. We review the development of these organizations, their current role in the delivery of pharmaceutical therapies to patients, and their relationship with pharmaceutical manufacturers. We discuss potential advantages and disadvantages of pharmaceutical benefits manager practices and suggest ways in which these organizations can be made more accountable to the employer groups that hire them.

  View details for DOI 10.7326/0003-4819-124-10-199605150-00008

  View details for Web of Science ID A1996UJ80100008

  View details for PubMedID 8610921

• Economics of bone marrow transplantation JOURNAL OF CLINICAL ONCOLOGY Schulman, K. A. 1996; 14 (5): 1409–10

  View details for DOI 10.1200/JCO.1996.14.5.1409

  View details for Web of Science ID A1996UJ40300001

  View details for PubMedID 8622052

• A strategy for collecting pharmacoeconomic data during phase II/III clinical trials PHARMACOECONOMICS Mauskopf, J., Schulman, K., Bell, L., Glick, H. 1996; 9 (3): 264–77

  Abstract

  This article presents an overview of the process and organisational aspects required to support the collection of pharmacoeconomic (PE) data during phase II and phase III clinical trials of pharmaceutical products. The process described requires early involvement of the PE study team in clinical trials design and planning, as well as continuing close collaboration between the PE study team and the clinical study team as the data collection plans are implemented. Adequate resources must be made available for staffing and funding the PE component of data collection and analysis. If the suggested procedures are adequately resourced and implemented, the result should be a comprehensive, complete and accurate database that will allow the PE study team to characterise the economic value of the new drug at the same time as the clinical study team characterise its safety and efficacy. Integrated clinical and economic evaluations are essential for the appropriate use of pharmaceutical products in rapidly changing markets.

  View details for DOI 10.2165/00019053-199609030-00007

  View details for Web of Science ID A1996UA24200007

  View details for PubMedID 10160101

• Health systems evaluation of telemedicine: a staged approach. Telemedicine journal : the official journal of the American Telemedicine Association DeChant, H. K., Tohme, W. G., Mun, S. K., Hayes, W. S., Schulman, K. A. 1996; 2 (4): 303-12

  Abstract

  Telemedicine promises greater access to health care of higher quality, potentially at lower cost. The diverse applications of telemedicine technology developed to date have not been evaluated systematically in terms of their ability to achieve these goals. Furthermore, the great variety in telemedicine applications and the far-reaching consequences of new information systems for health care delivery pose challenges to traditional methods of technology assessment. Methods appropriate for mature technologies may not be suitable for emerging ones and, indeed, may risk stifling their development with premature negative conclusions. The staged approach to technology assessment proposed here matches the analysis to the technology's stage of development. It focuses on access, quality, and cost and considers the communication pathway employed in the telemedicine application. A staged approach to technology assessment can inform and foster the development of new telemedicine technology while allowing health care delivery systems to make rational decisions about adopting telemedicine.

  View details for DOI 10.1089/tmj.1.1996.2.303

  View details for PubMedID 10165367

• Pharmacoeconomics and clinical practice: a physician's view Principles of Pharmacoeconomics Schulman, K. A. 1996: 252–270
• Evaluation of quality of life for diverse patient populations. Breast cancer research and treatment Yabroff, K. R., Linas, B. P., Schulman, K. 1996; 40 (1): 87-104

  Abstract

  Quality of life is used increasingly as a primary and secondary endpoint of clinical investigations of new therapies. Quality of life information may be especially useful for the assessment of cancer treatments, where increases in survival may be accompanied by detrimental side effects. The recognition of the importance of quality of life has led to the recent proliferation of cancer specific quality of life instruments. As more is understood about the heterogeneity of patient populations, however, we must assess how culturally defined factors may impact patient quality of life and its assessment. Quality of life instruments are diverse, ranging from those focusing on objective measures of functionality to those assessing subjective measures of patient preferences for their current health state. These instruments have been developed for use in the general population and for disease-specific populations. Assessment of the appropriateness of potential quality of life instruments in specific clinical settings, in addition to understanding the cultural diversity of the clinical population being studied, will guide the researcher in the choice of an appropriate quality of life instrument for cancer clinical trials.

  View details for DOI 10.1007/bf01806005

  View details for PubMedID 8888155

• Measuring the cost-effectiveness of cancer care. Oncology (Williston Park, N.Y.) Schulman, K. A., Yabroff, K. R. 1995; 9 (6): 523-30, 533; discussion 533-8

  Abstract

  Historically, new therapeutic strategies for cancer have been evaluated on the basis of safety and clinical efficacy. However, the current national emphasis on efficiency of resource allocation has led to the inclusion of economic assessments in oncology studies. Economic assessments measure patients' health status and resource consumption associated with a therapeutic strategy, and combine these in a cost-effectiveness analysis. Study design can include prospective analysis of clinical trials, retrospective analysis of a clinical trial or administrative databases, or a decision analytic model. Economic analysis is being used increasingly in oncology and will continue to provide meaningful data to assist clinicians in determining the optimal treatment strategies for cancer patients and to help inform health policy decision-makers about the importance of specific cancer therapeutic strategies.

  View details for PubMedID 8719099

• The roles of race and socioeconomic factors in health services research. Health services research Schulman, K. A., Rubenstein, L. E., Chesley, F. D., Eisenberg, J. M. 1995; 30 (1 Pt 2): 179-95

  Abstract

  For decades data have been collected comparing health care in racial and ethnic groups. The use of such groups in health services research assumes that standard, reliable, and valid definitions of race and ethnicity exist and that these definitions are used consistently. In fact, race is a term often used, but ill defined. It can incorporate biological, social, and cultural characteristics of patients and can refer to both genetic and behavioral traits. Various investigators have reported differences between racial and ethnic groups in health status, disease manifestation and outcome, resource utilization, and health care access, often specifying neither a definition of race nor the measurement they used to classify their study populations. The role of race as an explanatory variable in health services research requires greater scrutiny than many researchers currently provide. Many studies use race as a proxy for other socioeconomic factors not collected in the research effort. This article explores the ambiguities about race as an explanatory variable that render such research difficult to interpret. We suggest that health services researchers focus on nonracial socioeconomic characteristics that might be both more informative and more useful in guiding policy formation.

  View details for PubMedID 7721591

  View details for PubMedCentralID PMC1070048

• RELATIONSHIPS BETWEEN SPONSORS AND INVESTIGATORS IN PHARMACOECONOMIC AND CLINICAL RESEARCH PHARMACOECONOMICS SCHULMAN, K. A., RUBENSTEIN, L. E., GLICK, H. A., EISENBERG, J. M. 1995; 7 (3): 206–20

  Abstract

  Potential conflict between the goals of the investigators and the sponsors of pharmacoeconomic and clinical research has been well documented. Although there have been efforts to formalise relationships between sponsors and investigators in some areas of clinical research, no set of guidelines or standardised contract to govern pharmacoeconomic research relationships is currently in use. In this paper, we discuss a number of provisions that should be included in a sponsored research agreement to define the responsibilities and clarify the rights of the parties in the collaborative research relationship. We also present an example of a sponsored research agreement that we have designed as a model formal contract between sponsors and investigators. The most salient areas in the research agreement include: publication, specification of analysis, data access/ownership, confidentiality, termination and payment to investigators. While this paper focuses on pharmacoeconomic research, many of the principles have relevance to a broader range of research relationships and to other clinical economics and clinical trials research.

  View details for DOI 10.2165/00019053-199507030-00004

  View details for Web of Science ID A1995QK75300004

  View details for PubMedID 10155310

• An interactive computer system for formulary management using cost-effectiveness analysis. M.D. computing : computers in medical practice Lee, J. H., Glick, H. A., Kinosian, B., Schulman, K. A. 1995; 12 (1): 59-65

  View details for PubMedID 7854081

• Introduction to clinical economics: assessment of cancer therapies. Journal of the National Cancer Institute. Monographs Schulman, K. A., Glick, H. A., Yabroff, K. R., Eisenberg, J. M. 1995: 1-9

  Abstract

  Recent changes in the health care environment have led to the assessment of the costs and benefits of cancer treatment as criteria for the evaluation of new cancer therapies. The methodological framework for these assessments is provided by the field of clinical economics, a discipline that combines the techniques from clinical medicine, economics, epidemiology, and biostatistics. This article reviews the concepts of clinical economics and issues related to economic analysis of new therapies. This type of information is increasingly important to patients, clinicians, and health policy decision makers to help assure patients' access to effective cancer therapies.

  View details for PubMedID 7577196

• Economic evaluation of high-dose chemotherapy and bone marrow transplantation for patients with breast cancer of stage II or IIIA with more than 10 positive lymph nodes at surgical excision. Journal of the National Cancer Institute. Monographs Schulman, K. A., Glick, H. A. 1995: 45-50

  Abstract

  Several issues related to the design of a multi-year study of the outcome of high-dose chemotherapy with bone marrow transplant for patients with metastatic breast cancer have been discussed. Important considerations include an understanding of the types of data that would be collected through the study period, an assessment of treatment benefits and complications, an understanding of the valuation of differences in resource consumption across treatment arms, and an informed definition of the study population to include in the economic assessment. The resulting analysis will help patients and policy makers better understand the impact of aggressive treatment options for breast cancer patients.

  View details for PubMedID 7577205

• Physician communication in managed care organizations: opinions of primary care physicians. The Journal of family practice Roulidis, Z. C., Schulman, K. A. 1994; 39 (5): 446-51

  Abstract

  One method of achieving appropriate patient treatment and continuity of care is to ensure good communication between primary care physicians and specialist physicians. We undertook an exploratory study designed to assess primary care physicians' opinions regarding communication patterns between primary care physicians and specialist physicians participating in fee-for-service and managed care health insurance plans.A 26-question survey instrument was mailed to 110 general internists on the clinical faculty of a university hospital. Each question solicited a response for "managed care plans" and "nonmanaged care plans," with responses scored on a 5-point Likert scale ranging from 1 = never to 5 = always. Results were analyzed using the Wilcoxon signed-ranks test of the difference between responses for managed care and nonmanaged care settings.Eighty-four physicians (76%) responded to the survey. Forty-one of these physicians participated in both managed and nonmanaged care plans and thus were eligible for the analysis. These primary care physicians reported that patients were referred more often to an unknown specialist for managed care (MC) plans than for nonmanaged care (NMC) plans (MC mean = 2.8, NMC mean = 1.4; P < .01). They also reported that when referring patients in managed care plans to a specialist, they spoke personally with specialists less often (MC mean = 2.8, NMC mean = 3.5; P < .01) and sent a written summary to specialists less often (MC mean = 2.6, NMC mean = 2.9; P < .05). Primary care physicians in this study perceived that patients in managed care plans charged primary care providers much more frequently than did those in nonmanaged care plans (MC mean = 3.8, NMC mean = 2.2; P < .01).In this exploratory study, we found that communication between primary care and specialist physicians may be impaired when multiple health insurance plans with restricted panels of participating physicians are implemented in communities. Further research is required to confirm these findings and to assess how patient-related communication is managed.

  View details for PubMedID 7964542

• PATIENT PREFERENCES FOR STROKE OUTCOMES STROKE Solomon, N. A., Glick, H. A., Russo, C. J., Lee, J., Schulman, K. A. 1994; 25 (9): 1721-1725

  Abstract

  In clinical trials stroke is reported as a major morbid outcome, but the impact of stroke on patients is not directly assessed. This study examines patient preferences for different outcomes of stroke, including death.We presented patients with written case scenarios of stroke outcomes. The scenarios represented four categories of stroke severity (mild, moderate, severe, and fatal), and for nonfatal strokes the scenarios described motor, language, and cognitive deficits. Patients reported values for each of the 10 stroke scenarios using a rank-and-scale method over a 100-point range, with 100 representing perfect health and 0 corresponding to the worst possible health state.One hundred seventeen of 209 consecutive patients at risk for stroke participated in this study. Severe strokes were uniformly rated as having low preference weights (mean +/- SD [median]: 3 +/- 4 [1] for disabling hemiplegia, 8 +/- 9 [5] for confusion, and 15 +/- 14 [10] for global aphasia), and severe motor impairment (a disabling hemiplegia) was rated as significantly worse than death. Even mild deficits resulted in substantial loss to patients (54 +/- 21 [55] for dysarthria and 53 +/- 21 [50] for mild anomia).Strokes may result in a wide variety of post-stroke consequences for patients. Severe strokes may be viewed by patients as tantamount to or worse than death. Even mild strokes may cause significant declines in patient preferences for health states. These data are useful in interpreting studies that report stroke and death, in designing new studies that measure stroke in at-risk populations, and in helping patients reach treatment decisions about therapies designed to prevent strokes.

  View details for PubMedID 8073449

• Ethics, economics, and the publication policies of major medical journals. JAMA Schulman, K., Sulmasy, D. P., Roney, D. 1994; 272 (2): 154-6

  Abstract

  To evaluate aspects of the publication process that may affect the quality of the literature in clinical economics and biomedical ethics, and to learn about the policies of medical journals regarding disclosure of relationships between investigators and research sponsors.Mail survey.Editors in chief of 15 major medical journals.Twelve editors responded to the survey. Ten reported having statisticians among their editors, while only two had health economists and none had ethicists. Clinicians in the specialty field were almost always the primary reviewers of submissions, while methodologists (statisticians, health economists, or ethicists) were involved less frequently. Journals reported little knowledge of the training of their reviewers in these fields. While nine journals requested disclosure of the financial relationship between author and sponsor, only one inquired whether the sponsor's written approval was required prior to manuscript submission, and only one knew whether there was an independent steering committee for the study.These findings suggest that the peer review process can be strengthened to improve the quality of the medical literature in clinical economics and biomedical ethics. Journal editors also need to better understand the terms of research sponsorship agreements.

  View details for PubMedID 8015131

• SCREENING SURGEONS FOR HIV-INFECTION - ASSESSMENT OF A POTENTIAL PUBLIC-HEALTH PROGRAM INFECTION CONTROL AND HOSPITAL EPIDEMIOLOGY SCHULMAN, K. A., MCDONALD, R. C., LYNN, L. A., FRANK, CHRISTAKIS, N. A., SCHWARTZ, J. S. 1994; 15 (3): 147–55

  Abstract

  To develop a model to assess the impact of a program of testing surgeons for human immunodeficiency virus (HIV) on the risk of HIV acquisition by their patients.A Monte Carlo simulation model of physician-to-patient transmission of human immunodeficiency virus (HIV) infection using three different rates of physician-to-patient transmission per percutaneous exposure event (0.15%, 0.3%, 0.6%). Data from the model were developed from a review of the medical literature and from subjective probability estimates when data were not available. We used this model to estimate on a national basis the annual number of cases of HIV transmission from surgeons to patients with and without surgeon testing and practice limitations.The annual number of transmitted cases would range from 0.5 (+/- 0.3), assuming a surgeon HIV prevalence of 0.1% and a surgeon-to-patient transmission rate of 0.15%, to 36.9 (+/- 11.6), assuming a surgeon HIV prevalence of 2% and a surgeon-to-patient transmission rate of 0.6%. After one screening cycle, a mandatory screening program would be expected to reduce the annual transmissions to 0.05 (+/- 0.03) and 3.1 (+/- 1.1), respectively.Patients are at low risk of acquiring HIV infection from an infected physician during an invasive procedure. The potential costs of such a program extended beyond the costs of testing and counseling. In communities with high HIV prevalence, screening surgeons and limiting their practices may decrease patient access to care. A disability insurance program also would be required to protect surgeons and trainees performing invasive procedures. Screening surgeons for HIV infection would be a costly undertaking that would reduce but not completely eliminate this risk.

  View details for Web of Science ID A1994NA63200005

  View details for PubMedID 8207171

• Pharmacoeconomics: economic evaluation of pharmaceuticals. Pharmacoepidemiology Eisenberg, J. M., Schulman, K. A., Glick, H., Koffer, H. John Wiley & Sons. 1994: 462–493
• Patient attitudes toward rooming with persons with HIV infection. The Journal of family practice Seltzer, E., Schulman, K. A., Brennan, P. J., Lynn, L. A. 1993; 37 (6): 564-8

  Abstract

  Early in the HIV epidemic, hospitals developed strict isolation policies for patients with HIV infection, some of which have not been revised. The objectives of this study were to examine patient attitudes about rooming with persons with various medical conditions, including HIV, and to assess their knowledge about the transmission of HIV.One hundred four inpatients at a university hospital were surveyed by means of a structured interviewer-administered questionnaire. Patients were asked about preference for a single or double room, and about their objections to rooming with patients with HIV infection and other medical conditions. The questionnaire also examined subject's knowledge about the transmission of HIV.Of 104 inpatients surveyed, 55% objected to rooming with an HIV-seropositive patient. Patients who objected to rooming with an HIV-seropositive patient were also more likely to object to rooming with a disfigured patient (relative risk = 1.5; 95% CI, 1.1 to 2.2), or with a demented patient (relative risk = 1.7; 95% CI, 1.0 to 2.9). Also, patients who objected to rooming with an HIV-seropositive patient had greater misconceptions about the transmissibility of HIV infection.A significant proportion of patients reported an unwillingness to room with patients with HIV infection, but also had misconceptions about the transmissibility of HIV. Current rooming policies may perpetuate misconceptions about the possibility of causal transmission of HIV.

  View details for PubMedID 8245807

• The use of evaluation in pharmaceutical reimbursement decisions in the United States. Proceedings: The Canadian Collaborative Workshop on Pharmacoeconomics Schulman, K. A. Excerpta Medica. 1993: 19–23
• ASSESSING PHYSICIANS ESTIMATES OF THE PROBABILITY OF CORONARY-ARTERY DISEASE - THE INFLUENCE OF PATIENT CHARACTERISTICS MEDICAL DECISION MAKING SCHULMAN, K. A., ESCARCE, J. J., EISENBERG, J. M., HERSHEY, J. C., YOUNG, M. J., MCCARTHY, D. M., WILLIAMS, S. V. 1992; 12 (2): 109–14

  Abstract

  The authors assessed physicians' probability estimates of coronary artery disease (CAD) in 250 patients undergoing a screening exercise stress test. True likelihood of disease (prevalence) was derived from the literature. Discrimination and calibration were assessed by comparing physicians' probability estimates and prevalence using pairwise comparisons, rank correlation, and linear regression. There were differences in the discriminative abilities of the physicians based on patient characteristics. For example, the physicians had better discriminative ability for patients with typical cardiac chest pain compared with atypical chest pain. The physicians were able to predict the prevalence of CAD in broad groups of patients. However, they overestimated probabilities for patients with low prevalence of disease and underestimated probabilities for patients with high prevalence of disease. The authors conclude that physicians make consistent errors in the use of probability estimates. The quality of these estimates depends on patient characteristics such as type of chest pain and true likelihood of disease.

  View details for DOI 10.1177/0272989X9201200203

  View details for Web of Science ID A1992JF24300003

  View details for PubMedID 1306640

• COST-EFFECTIVENESS OF HA-1A MONOCLONAL-ANTIBODY FOR GRAM-NEGATIVE SEPSIS - ECONOMIC-ASSESSMENT OF A NEW THERAPEUTIC AGENT JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION SCHULMAN, K. A., GLICK, H. A., RUBIN, H., EISENBERG, J. M. 1991; 266 (24): 3466–71

  Abstract

  To assess the cost-effectiveness of the HA-1A monoclonal antibody for the treatment of gram-negative bacteremia.Cost-effectiveness analysis of a randomized, double-blind, placebo-controlled trial using clinical efficacy data reported in the medical literature.Hospitalized patients with sepsis.543 patients with sepsis and suspected gram-negative infection. Patients enrolled in the study met strict criteria for sepsis, including fever or hypothermia (less than 35.6 degrees C or greater than 38.3 degrees C), tachycardia (greater than 90 beats per minute), tachypnea (greater than 20 breaths per minute), and hypotension or two of six signs of systemic toxicity.HA-1A vs placebo in addition to usual care.We determined the range of possible cost-effectiveness ratios for HA-1A therapy, using modeling techniques when clinical or economic variables were unknown. We subjected the model to rigorous sensitivity analysis. We calculated the incremental cost of care and years of life saved for patients with sepsis and modeled two different treatment strategies: treat all patients with sepsis or test and then treat only patients with positive test results. $24,100 per year of life saved based on the treat strategy and $14,900 based on the test strategy. In sensitivity analysis the ratios ranged from $5200 to $110,200 per year of life gained. Annual costs of care for these two strategies are $1.3 billion for the test strategy and $2.3 billion for the treat strategy.Economic assessment of new technologies early in their development can be used to guide their efficient clinical introduction.

  View details for DOI 10.1001/jama.266.24.3466

  View details for Web of Science ID A1991GV87800034

  View details for PubMedID 1744962

• Gastric obstruction with extended-release tablets. DICP : the annals of pharmacotherapy Hennessy, S., Fogarty, P. M., Schulman, K. A., Mignott, H. 1991; 25 (6): 678-9

  View details for DOI 10.1177/106002809102500623

  View details for PubMedID 1877282

• COST-EFFECTIVENESS OF LOW-DOSE ZIDOVUDINE THERAPY FOR ASYMPTOMATIC PATIENTS WITH HUMAN-IMMUNODEFICIENCY-VIRUS (HIV) INFECTION ANNALS OF INTERNAL MEDICINE SCHULMAN, K. A., LYNN, L. A., GLICK, H. A., EISENBERG, J. M. 1991; 114 (9): 798–802

  Abstract

  We did a cost-effectiveness analysis of zidovudine therapy for asymptomatic patients with human immunodeficiency virus (HIV) infection. The incremental direct medical costs of zidovudine therapy were determined, and data on the effects of therapy were derived from the report of the Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Protocol 019. Zidovudine therapy has an annual incremental cost of $2653 per person. The cost per year of life saved ranges between $6553 and $70 526, depending on which epidemiologic model of potential long-term zidovudine effect is used (in sensitivity analyses, the cost per year of life saved ranges between $2649 and $250 546). Although expensive, zidovudine therapy has the potential to yield a substantial survival benefit to patients. The cost effectiveness of zidovudine therapy compares favorably with that of other common medical therapies.

  View details for DOI 10.7326/0003-4819-114-9-798

  View details for Web of Science ID A1991FJ11700012

  View details for PubMedID 1672806

• REDUCING HIGH BLOOD CHOLESTEROL LEVEL WITH DRUGS - COST-EFFECTIVENESS OF PHARMACOLOGICAL MANAGEMENT JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION SCHULMAN, K. A., KINOSIAN, B., JACOBSON, T. A., GLICK, H., WILLIAN, M. K., KOFFER, H., EISENBERG, J. M. 1990; 264 (23): 3025–33

  Abstract

  We performed a cost-effectiveness analysis of pharmacologic treatment of high blood cholesterol levels. Agents modeled were cholestyramine, colestipol, gemfibrozil, lovastatin, niacin, and probucol. Pharmacologic effectiveness was estimated from reported studies. Cost estimates reflect societal resource consumption. Annual costs for therapy ranged from $327 (niacin) to $1881 (lovastatin, 80 mg/d). Niacin was the most efficient agent for reducing low-density lipoprotein cholesterol levels, having an average cost over 5 years of $139 per percent reduction in low-density lipoprotein cholesterol level. Lovastatin (20 mg/d) was also efficient ($177 per percent reduction). Cholestyramine was least efficient at $347. For high-density lipoprotein cholesterol, niacin was most efficient, at $116 per percent increase in high-density lipoprotein cholesterol level, followed by gemfibrozil at $271. Analyses combining low-density lipoprotein cholesterol and high-density lipoprotein cholesterol effects suggest that niacin and lovastatin (20 mg/d) were most efficient for reducing cardiovascular risk.

  View details for DOI 10.1001/jama.264.23.3025

  View details for Web of Science ID A1990EM76300026

  View details for PubMedID 2123013

• SCREENING FOR COLORECTAL-CANCER ANNALS OF INTERNAL MEDICINE SCHULMAN, K. 1990; 113 (4): 333

  View details for DOI 10.7326/0003-4819-113-4-333_1

  View details for Web of Science ID A1990DU08100021

  View details for PubMedID 2242156

• RANITIDINE TO PREVENT RECURRENCE OF DUODENAL-ULCER NEW ENGLAND JOURNAL OF MEDICINE MERKEL, P. A., SCHULMAN, K. A. 1989; 321 (12): 835

  View details for Web of Science ID A1989AQ24800024

  View details for PubMedID 2770818

• PROJECTING THE IMPACT OF AIDS ON HOSPITALS HEALTH AFFAIRS GREEN, J., SINGER, M., WINTFELD, N., SCHULMAN, K., PASSMAN, L. 1987; 6 (3): 19–31

  View details for DOI 10.1377/hlthaff.6.3.19

  View details for Web of Science ID A1987K426300002

  View details for PubMedID 3679073