Doug Owens

All Publications

• Populationwide Screening for Chronic Kidney Disease: A Cost-Effectiveness Analysis. JAMA health forum Cusick, M. M., Tisdale, R. L., Chertow, G. M., Owens, D. K., Goldhaber-Fiebert, J. D., Salomon, J. A. 2024; 5 (11): e243892

  Abstract

  Sodium-glucose cotransporter-2 (SGLT2) inhibitors have changed clinical management of chronic kidney disease (CKD) and made populationwide screening for CKD a viable strategy. Optimal age of screening initiation has yet to be evaluated.To compare the clinical benefits, costs, and cost-effectiveness of population-wide CKD screening at different initiation ages and screening frequencies.This cost-effectiveness study used a previously published decision-analytic Markov cohort model that simulated progression of CKD among US adults from age 35 years and older and was calibrated to population-level data from the National Health and Nutrition Examination Survey (NHANES). Effectiveness of SGLT2 inhibitors was derived from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. Mortality, quality-of-life weights, and cost estimates were obtained from published cohort studies, randomized clinical trials, and US Centers for Medicare & Medicaid Services data. Analyses were performed from June 2023 through September 2024.One-time or periodic (every 10 or 5 years) screening for albuminuria, initiated at ages between 35 and 75 years, with and without addition of SGLT2 inhibitors to conventional CKD therapy (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers).Cumulative incidence of kidney failure requiring kidney replacement therapy (KRT); life years, quality-adjusted life years (QALYs), lifetime health care costs (2024 US currency), and incremental cost-effectiveness ratios discounted at 3% annually.For those aged 35 years, starting screening at age 55 years, and continuing every 5 years through age 75 years, combined with SGLT2 inhibitors, decreased the cumulative incidence of kidney failure requiring KRT from 2.4% to 1.9%, increased life expectancy by 0.13 years, and cost $128 400 per QALY gained. Although initiation of screening every 5 years at age 35 or 45 years yielded greater gains in population-wide health benefits, these strategies cost more than $200 000 per additional QALY gained. The comparative values of starting screening at different ages were sensitive to the cost and effectiveness of SGLT2 inhibitors; if SGLT2 inhibitor prices drop due to patent expirations, screening at age 55 years continued to be cost-effective even if SGLT2 inhibitor effectiveness were 30% lower than in the base case.This study found that, based on conventional benchmarks for cost-effectiveness in medicine, initiating population-wide CKD screening with SGLT2 inhibitors at age 55 years would be cost-effective.

  View details for DOI 10.1001/jamahealthforum.2024.3892

  View details for PubMedID 39514193

• Acceptance of SARS-CoV-2 Surveillance Testing Among Patients Receiving Dialysis: A Cluster Randomized Trial. JAMA network open Montez-Rath, M., Varkila, M., Yu, X., Brillhart, S., Morgan, C., Leppink, A., Block, M. S., Mehta, S., Hunsader, P., Fountaine, A., Subramanian, N., Dittrich, M., Owens, D. K., Chertow, G. M., Parsonnet, J., Anand, S., Block, G. A. 2024; 7 (9): e2434159

  Abstract

  Integrating routine SARS-CoV-2 testing in dialysis facilities may benefit patients receiving dialysis by mitigating risks of serious illness and reducing transmission. Patient acceptance of nonmandatory testing is unknown.To evaluate the acceptance of 2 SARS-CoV-2 testing strategies among patients in hemodialysis facilities nationwide.This nationwide cluster (dialysis facility-level) randomized trial investigated the acceptance of SARS-CoV-2 testing among patients receiving maintenance hemodialysis at facilities located in 22 states.Anterior nares real-time reverse transcriptase-polymerase chain reaction tests offered once every 2 weeks (static testing facilities) vs offered once a week, once every 2 weeks, or once a month depending on county COVID-19 infection prevalence (dynamic testing facilities). Facilities were randomized by county, and tests were offered for 3 months between February 4 and July 24, 2023.The primary outcome was test acceptance. Secondary outcomes included the proportion of patients who accepted at least 1 test.In total, 62 hemodialysis facilities were randomized and 57 participated. Among 2389 participating patients, the median age was 64 (IQR, 54-74) years, 1341 (56%) were male, 138 (6%) were categorized as American Indian, 60 (3%) Asian, 885 (37%) Black, 75 (3%) Native Hawaiian or Pacific Islander, 338 (14%) Hispanic, and 876 (37%) White; and 1603 (67%) had diabetes. A median of 6 (IQR, 6-6) tests were offered per patient in the static arm and 4 (3-6) tests in the dynamic arm. Test acceptance was low: 8% of offered tests were accepted in each of the test arms. Among 503 patients who accepted at least 1 test, the median percentage of offered tests that were accepted was 16% (IQR, 17%-42%) using the static testing strategy and 50% (IQR, 33%-75%) using the dynamic testing strategy (P < .001). Older patients (odds ratio [OR], 1.08 [95% CI, 1.01-1.16] per 5-year age increment), patients with (vs without) diabetes (OR, 1.59 [95% CI, 1.18-2.16]), and women compared with men (OR, 1.30 [95% CI, 0.98-1.73]) were more likely to accept multiple tests. Patients designated in the electronic health record as Hispanic were more likely than patients designated as White (OR, 1.78 [95% CI, 1.15-2.76]) to accept at least 1 test, whereas patients living in zip codes electing Republican representatives to Congress were less likely than patients living in zip codes electing Democratic representatives (OR, 0.34 [95% CI, 0.17-0.69]) to accept multiple tests.In this cluster randomized trial evaluating 2 SARS-CoV-2 testing strategies in dialysis facilities, test acceptance was low, and a dynamic testing strategy anchored to COVID-19 infection prevalence did not outperform a static testing strategy of every 2 weeks.ClinicalTrials.gov Identifier: NCT05225298.

  View details for DOI 10.1001/jamanetworkopen.2024.34159

  View details for PubMedID 39298171

  View details for PubMedCentralID PMC11413714

• Nonpharmacologic and Pharmacologic Treatments of Adults in the Acute Phase of Major Depressive Disorder: A Living Clinical Guideline From the American College of Physicians (Version 1, Update Alert 2). Annals of internal medicine Qaseem, A., Owens, D. K., Etxeandia-Ikobaltzeta, I., Tufte, J. E., Cross, J. T., Wilt, T. J. 2024

  View details for DOI 10.7326/ANNALS-24-00593

  View details for PubMedID 39008855

• Resource Utilization and Costs Associated with Approaches to Identify Infants with Early-Onset Sepsis. MDM policy & practice Guan, G., Joshi, N. S., Frymoyer, A., Achepohl, G. D., Dang, R., Taylor, N. K., Salomon, J. A., Goldhaber-Fiebert, J. D., Owens, D. K. 2024; 9 (1): 23814683231226129

  Abstract

  Objective. To compare resource utilization and costs associated with 3 alternative screening approaches to identify early-onset sepsis (EOS) in infants born at ≥35 wk of gestational age, as recommended by the American Academy of Pediatrics (AAP) in 2018. Study Design. Decision tree-based cost analysis of the 3 AAP-recommended approaches: 1) categorical risk assessment (categorization by chorioamnionitis exposure status), 2) neonatal sepsis calculator (a multivariate prediction model based on perinatal risk factors), and 3) enhanced clinical observation (assessment based on serial clinical examinations). We evaluated resource utilization and direct costs (2022 US dollars) to the health system. Results. Categorical risk assessment led to the greatest neonatal intensive care unit usage (210 d per 1,000 live births) and antibiotic exposure (6.8%) compared with the neonatal sepsis calculator (112 d per 1,000 live births and 3.6%) and enhanced clinical observation (99 d per 1,000 live births and 3.1%). While the per-live birth hospital costs of the 3 approaches were similar-categorical risk assessment cost $1,360, the neonatal sepsis calculator cost $1,317, and enhanced clinical observation cost $1,310-the cost of infants receiving intervention under categorical risk assessment was approximately twice that of the other 2 strategies. Results were robust to variations in data parameters. Conclusion. The neonatal sepsis calculator and enhanced clinical observation approaches may be preferred to categorical risk assessment as they reduce the number of infants receiving intervention and thus antibiotic exposure and associated costs. All 3 approaches have similar costs over all live births, and prior literature has indicated similar health outcomes. Inclusion of downstream effects of antibiotic exposure in the neonatal period should be evaluated within a cost-effectiveness analysis.Of the 3 approaches recommended by the American Academy of Pediatrics in 2018 to identify early-onset sepsis in infants born at ≥35 weeks, the categorical risk assessment approach leads to about twice as many infants receiving evaluation to rule out early-onset sepsis compared with the neonatal sepsis calculator and enhanced clinical observation approaches.While the hospital costs of the 3 approaches were similar over the entire population of live births, the neonatal sepsis calculator and enhanced clinical observation approaches reduce antibiotic exposure, neonatal intensive care unit admission, and hospital costs associated with interventions as part of the screening approach compared with the categorical risk assessment approach.

  View details for DOI 10.1177/23814683231226129

  View details for PubMedID 38293656

  View details for PubMedCentralID PMC10826394

• Preoperative Proteinuria is Independently Associated with Mortality after Fenestrated Endovascular Aneurysm Repair. Journal of vascular surgery Dossabhoy, S. S., Fisher, A. T., Chang, T. I., Owens, D. K., Arya, S., Stern, J. R., Lee, J. T. 2024

  Abstract

  Fenestrated endovascular aneurysm repair (FEVAR) has become mainstay in treating complex aortic aneurysms, though baseline patient factors predicting long-term outcomes remain poorly understood. Proteinuria is an early marker for chronic kidney disease and associated with adverse cardiovascular outcomes, but its utility in aneurysm patients is unknown. We aimed to determine whether preoperative proteinuria impacts long-term survival after FEVAR.A single-institution retrospective review of all elective FEVAR was performed. Preoperative proteinuria was assessed by urinalysis: negative (0-29 mg/dL), 1+ (30-100 mg/dL), 2+ (101-299 mg/dL), and 3+ (≥300 mg/dL). The cohort was stratified by patients with proteinuria (≥30 mg/dL) vs those without (<30 mg/dL). Baseline, perioperative, and long-term outcomes were compared. The primary outcome, all-cause mortality, was evaluated by Kaplan-Meier analysis and independent predictors with Cox proportional hazards modeling.Among 181 patients undergoing standard FEVAR from 2012-2022 (mean follow-up 33 months), any proteinuria was noted in 30 patients (16.6%). Those with proteinuria were more likely to be Black (10.0% vs 1.3%) with lower estimated glomerular filtration rate ([eGFR] 52.7 ± 24.7 vs 67.7 ± 20.5 mL/min/1.73m2), higher Society for Vascular Surgery comorbidity score (10.9 ± 4.3 vs 8.2 ± 4.7) and calcium channel blocker therapy (50.0% vs 29.1%), and larger maximal aneurysm diameter (67.2 ± 16.9 vs 59.8 ± 9.8) (all P<.05). Thirty-day mortality was higher in the proteinuria group (10.0% vs 1.3%, P=.03). Overall survival at 1 and 5 years was significantly lower for those with proteinuria (71.5% vs 92.3% and 29.5% vs 68.1%, log-rank P<.001). On multivariable analysis, preoperative proteinuria was independently associated with over three-fold higher hazard of mortality (hazard ratio [HR] 3.21, 95% confidence interval [CI] 1.66-6.20, P<.001), while preoperative eGFR was not predictive (HR 0.99, 95% CI 0.98-1.01, P=.28). Additional significant predictors included chronic obstructive pulmonary disease (HR 2.04), older age (HR 1.05), and larger maximal aneurysm diameter (HR 1.03, all P<.05).In our ten-year experience with FEVAR, preoperative proteinuria was observed in 17% of patients and was significantly associated with worse survival. In this cohort, proteinuria was independently associated with all-cause mortality, while eGFR was not, suggesting that urinalysis may provide an additional simple metric for risk stratifying patients prior to FEVAR.

  View details for DOI 10.1016/j.jvs.2024.01.013

  View details for PubMedID 38219966

• Nonpharmacologic and Pharmacologic Treatments of Adults in the Acute Phase of Major Depressive Disorder: A Living Clinical Guideline From the American College of Physicians (Version 1, Update Alert). Annals of internal medicine Qaseem, A., Owens, D. K., Etxeandia-Ikobaltzeta, I., Tufte, J. E., Cross, J. T., Wilt, T. J., Clinical Guidelines Committee of the American College of Physicians 2024

  View details for DOI 10.7326/L23-0440

  View details for PubMedID 38498880

• Population-Wide Screening for Chronic Kidney Disease. Annals of internal medicine Cusick, M. M., Tisdale, R. L., Chertow, G. M., Owens, D. K., Goldhaber-Fiebert, J. D. 2024; 177 (1): eL230370

  View details for DOI 10.7326/L23-0370

  View details for PubMedID 38224602

• Putting Evidence Into Practice: An Update on the US Preventive Services Task Force Methods for Developing Recommendations for Preventive Services. Annals of family medicine Barry, M. J., Wolff, T. A., Pbert, L., Davidson, K. W., Fan, T. M., Krist, A. H., Lin, J. S., Mabry-Hernandez, I. R., Mangione, C. M., Mills, J., Owens, D. K., Nicholson, W. K. 2023; 21 (2): 165-171

  Abstract

  The US Preventive Services Task Force (USPSTF) is an independent body that makes evidence-based recommendations regarding preventive services to improve health for people nationwide. Here, we summarize current USPSTF methods, describe how methods are evolving to address preventive health equity, and define evidence gaps for future research.We summarize current USPSTF methods as well as ongoing methods development.The USPSTF prioritizes topics on the basis of disease burden, extent of new evidence, and whether the service can be provided in primary care and going forward will increasingly consider health equity. Analytic frameworks specify the key questions and linkages connecting the preventive service to health outcomes. Contextual questions provide information on natural history, current practice, health outcomes in high-risk groups, and health equity. The USPSTF assigns a level of certainty to the estimate of net benefit of a preventive service (high, moderate, or low). The magnitude of net benefit is also judged (substantial, moderate, small, or zero/negative). The USPSTF uses these assessments to assign a letter grade from A (recommend) to D (recommend against). I statements are issued when evidence is insufficient.The USPSTF will continue to evolve its methods for simulation modeling and to use evidence to address conditions for which there are limited data for population groups who bear a disproportionate burden of disease. Additional pilot work is underway to better understand the relations of the social constructs of race, ethnicity, and gender with health outcomes to inform the development of a USPSTF health equity framework.

  View details for DOI 10.1370/afm.2946

  View details for PubMedID 36973047

  View details for PubMedCentralID PMC10042553

• Healthcare costs and use before and after opioid overdose in Veterans Health Administration patients with opioid use disorder. Addiction (Abingdon, England) Joyce, V. R., Oliva, E. M., Garcia, C. C., Trafton, J., Asch, S. M., Wagner, T. H., Humphreys, K., Owens, D. K., Bounthavong, M. 2023

  Abstract

  To compare healthcare costs and use between United States (US) Veterans Health Administration (VHA) patients with opioid use disorder (OUD) who experienced an opioid overdose (OD cohort) and patients with OUD who did not experience an opioid overdose (non-OD cohort).This is a retrospective cohort study of administrative and clinical data.The largest integrated national health-care system is the US Veterans Health Administration's healthcare systems.We included VHA patients diagnosed with OUD from October 1, 2017 through September 30, 2018. We identified the index date of overdose for patients who had an overdose. Our control group, which included patients with OUD who did not have an overdose, was randomly assigned an index date. A total of 66 513 patients with OUD were included for analysis (OD cohort: n = 1413; non-OD cohort: n = 65 100).Monthly adjusted healthcare-related costs and use in the year before and after the index date. We used generalized estimating equation models to compare patients with an opioid overdose and controls in a difference-in-differences framework.Compared with the non-OD cohort, an opioid overdose was associated with an increase of $16 890 [95% confidence interval (CI) = $15 611-18 169; P < 0.001] in healthcare costs for an estimated $23.9 million in direct costs to VHA (95% CI = $22.1 million, $25.7 million) within the 30 days following overdose after adjusting for baseline characteristics. Inpatient costs ($13 515; 95% CI = $12 378-14 652; P < 0.001) reflected most of this increase. Inpatient days (+6.15 days; 95% CI, = 5.33-6.97; P < 0.001), inpatient admissions (+1.01 admissions; 95% CI = 0.93-1.10; P < 0.001) and outpatient visits (+1.59 visits; 95% CI = 1.34-1.84; P < 0.001) also increased in the month after opioid overdose. Within the overdose cohort, healthcare costs and use remained higher in the year after overdose compared with pre-overdose trends.The US Veterans Health Administration patients with opioid use disorder (OUD) who have experienced an opioid overdose have increased healthcare costs and use that remain significantly higher in the month and continuing through the year after overdose than OUD patients who have not experienced an overdose.

  View details for DOI 10.1111/add.16289

  View details for PubMedID 37465971

• Use of Wastewater Metrics to Track COVID-19 in the US. JAMA network open Varkila, M. R., Montez-Rath, M. E., Salomon, J. A., Yu, X., Block, G. A., Owens, D. K., Chertow, G. M., Parsonnet, J., Anand, S. 2023; 6 (7): e2325591

  Abstract

  Importance: Widespread use of at-home COVID-19 tests hampers determination of community COVID-19 incidence.Objective: To examine the association of county-level wastewater metrics with high case and hospitalization rates nationwide both before and after widespread use of at-home tests.Design, Setting, and Participants: This observational cohort study with a time series analysis was conducted from January to September 2022 in 268 US counties in 22 states participating in the US Centers for Disease Control and Prevention's National Wastewater Surveillance System. Participants included the populations of those US counties.Exposures: County level of circulating SARS-CoV-2 as determined by metrics based on viral wastewater concentration relative to the county maximum (ie, wastewater percentile) and 15-day percentage change in SARS-CoV-2 (ie, percentage change).Main Outcomes and Measures: High county incidence of COVID-19 as evidenced by dichotomized reported cases (current cases ≥200 per 100 000 population) and hospitalization (≥10 per 100 000 population lagged by 2 weeks) rates, stratified by calendar quarter.Results: In the first quarter of 2022, use of the wastewater percentile detected high reported case (area under the curve [AUC], 0.95; 95% CI, 0.94-0.96) and hospitalization (AUC, 0.86; 95% CI, 0.84-0.88) rates. The percentage change metric performed poorly, with AUCs ranging from 0.51 (95% CI, 0.50-0.53) to 0.57 (95% CI, 0.55-0.59) for reported new cases, and from 0.50 (95% CI, 0.48-0.52) to 0.55 (95% CI, 0.53-0.57) for hospitalizations across the first 3 quarters of 2022. The Youden index for detecting high case rates was wastewater percentile of 51% (sensitivity, 0.82; 95% CI, 0.80-0.84; specificity, 0.93; 95% CI, 0.92-0.95). A model inclusive of both metrics performed no better than using wastewater percentile alone. The performance of wastewater percentile declined over time for cases in the second quarter (AUC, 0.84; 95% CI, 0.82-0.86) and third quarter (AUC, 0.72; 95% CI, 0.70-0.75) of 2022.Conclusions and Relevance: In this study, nationwide, county wastewater levels relative to the county maximum were associated with high COVID-19 case and hospitalization rates in the first quarter of 2022, but there was increasing dissociation between wastewater and clinical metrics in subsequent quarters, which may reflect increasing underreporting of cases, reduced testing, and possibly lower virulence of infection due to vaccines and treatments. This study offers a strategy to operationalize county wastewater percentile to improve the accurate assessment of community SARS-CoV-2 infection prevalence when reliability of conventional surveillance data is declining.

  View details for DOI 10.1001/jamanetworkopen.2023.25591

  View details for PubMedID 37494040

• Population-Wide Screening for Chronic Kidney Disease : A Cost-Effectiveness Analysis. Annals of internal medicine Cusick, M. M., Tisdale, R. L., Chertow, G. M., Owens, D. K., Goldhaber-Fiebert, J. D. 2023

  Abstract

  BACKGROUND: Sodium-glucose cotransporter-2 (SGLT2) inhibitors have the potential to alter the natural history of chronic kidney disease (CKD), and they should be included in cost-effectiveness analyses of screening for CKD.OBJECTIVE: To determine the cost-effectiveness of adding population-wide screening for CKD.DESIGN: Markov cohort model.DATA SOURCES: NHANES (National Health and Nutrition Examination Survey), U.S. Centers for Medicare & Medicaid Services data, cohort studies, and randomized clinical trials, including the DAPA-CKD (Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease) trial.TARGET POPULATION: Adults.TIME HORIZON: Lifetime.PERSPECTIVE: Health care sector.INTERVENTION: Screening for albuminuria with and without adding SGLT2 inhibitors to the current standard of care for CKD.OUTCOME MEASURES: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), all discounted at 3% annually.RESULTS OF BASE-CASE ANALYSIS: One-time CKD screening at age 55 years had an ICER of $86300 per QALY gained by increasing costs from $249800 to $259000 and increasing QALYs from 12.61 to 12.72; this was accompanied by a decrease in the incidence of kidney failure requiring dialysis or kidney transplant of 0.29 percentage points and an increase in life expectancy from 17.29 to 17.45 years. Other options were also cost-effective. During ages 35 to 75 years, screening once prevented dialysis or transplant in 398000 people and screening every 10 years until age 75 years cost less than $100000 per QALY gained.RESULTS OF SENSITIVITY ANALYSIS: When SGLT2 inhibitors were 30% less effective, screening every 10 years during ages 35 to 75 years cost between $145400 and $182600 per QALY gained, and price reductions would be required for screening to be cost-effective.LIMITATION: The efficacy of SGLT2 inhibitors was derived from a single randomized controlled trial.CONCLUSION: Screening adults for albuminuria to identify CKD could be cost-effective in the United States.PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality, Veterans Affairs Office of Academic Affiliations, and National Institute of Diabetes and Digestive and Kidney Diseases.

  View details for DOI 10.7326/M22-3228

  View details for PubMedID 37216661

• An Effectiveness Analysis of Walk-in Stroke Centres in Northern Alberta Purdy, K., Jeerakathil, T., Owens, D., Bendavid, E. LIPPINCOTT WILLIAMS & WILKINS. 2023

  View details for DOI 10.1212/WNL.0000000000202003

  View details for Web of Science ID 001053672107069

• Feasibility and Acceptability of SARS-CoV-2 Screening among Patients Receiving Hemodialysis: A Pilot Study. Clinical journal of the American Society of Nephrology : CJASN Anand, S., Montez-Rath, M., Varkila, M., Yu, X., Block, M., Brillhart, S., Leppink, A., Hunsader, P., Owens, D. K., Chertow, G. M., Parsonnet, J., Block, G. 2023

  View details for DOI 10.2215/CJN.0000000000000137

  View details for PubMedID 36976655

• Use of wastewater metrics to track COVID-19 in the U.S.: a national time-series analysis over the first three quarters of 2022. medRxiv : the preprint server for health sciences Varkila, M., Montez-Rath, M., Salomon, J., Yu, X., Block, G., Owens, D. K., Chertow, G. M., Parsonnet, J., Anand, S. 2023

  Abstract

  Widespread use of at-home COVID-19 tests hampers determination of community COVID-19 incidence. Using nationwide data available through the US National Wastewater Surveillance System, we examined the performance of two wastewater metrics in predicting high case and hospitalizations rates both before and after widespread use of at-home tests.We performed area under the receiver operating characteristic (ROC) curve analysis (AUC) for two wastewater metrics-viral concentration relative to the peak of January 2022 ("wastewater percentile") and 15-day percent change in SARS-CoV-2 ("percent change"). Dichotomized reported cases (≥ 200 or <200 cases per 100,000) and new hospitalizations (≥ 10 or <10 per 100,000) were our dependent variables, stratified by calendar quarter. Using logistic regression, we assessed the performance of combining wastewater metrics.Among 268 counties across 22 states, wastewater percentile detected high reported case and hospitalizations rates in the first quarter of 2022 (AUC 0.95 and 0.86 respectively) whereas the percent change did not (AUC 0.54 and 0.49 respectively). A wastewater percentile of 51% maximized sensitivity (0.93) and specificity (0.82) for detecting high case rates. A model inclusive of both metrics performed no better than using wastewater percentile alone. The predictive capability of wastewater percentile declined over time (AUC 0.84 and 0.72 for cases for second and third quarters of 2022).Nationwide, county wastewater levels above 51% relative to the historic peak predicted high COVID rates and hospitalization in the first quarter of 2022, but performed less well in subsequent quarters. Decline over time in predictive performance of this metric likely reflects underreporting of cases, reduced testing, and possibly lower virulence of infection due to vaccines and treatments.

  View details for DOI 10.1101/2023.02.06.23285542

  View details for PubMedID 36798337

  View details for PubMedCentralID PMC9934789

• Nonpharmacologic and Pharmacologic Treatments of Adults in the Acute Phase of Major Depressive Disorder: A Living Clinical Guideline From the American College of Physicians. Annals of internal medicine Qaseem, A., Owens, D. K., Etxeandia-Ikobaltzeta, I., Tufte, J., Cross, J. T., Wilt, T. J., Clinical Guidelines Committee of the American College of Physicians 2023

  Abstract

  DESCRIPTION: The purpose of this guideline from the American College of Physicians (ACP) is to present updated clinical recommendations on nonpharmacologic and pharmacologic interventions as initial and second-line treatments during the acute phase of a major depressive disorder (MDD) episode, based on the best available evidence on the comparative benefits and harms, consideration of patient values and preferences, and cost.METHODS: The ACP Clinical Guidelines Committee based these recommendations on an updated systematic review of the evidence.AUDIENCE AND PATIENT POPULATION: The audience for this guideline includes clinicians caring for adult patients in the acute phase of MDD in ambulatory care. The patient population includes adults in the acute phase of MDD.RECOMMENDATION 1A: ACP recommends monotherapy with either cognitive behavioral therapy or a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (strong recommendation; moderate-certainty evidence). RECOMMENDATION 1B: ACP suggests combination therapy with cognitive behavioral therapy and a second-generation antidepressant as initial treatment in patients in the acute phase of moderate to severe major depressive disorder (conditional recommendation; low-certainty evidence). The informed decision on the options of monotherapy with cognitive behavioral therapy versus second-generation antidepressants or combination therapy should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences.RECOMMENDATION 2: ACP suggests monotherapy with cognitive behavioral therapy as initial treatment in patients in the acute phase of mild major depressive disorder (conditional recommendation; low-certainty evidence). RECOMMENDATION 3: ACP suggests one of the following options for patients in the acute phase of moderate to severe major depressive disorder who did not respond to initial treatment with an adequate dose of a second-generation antidepressant: Switching to or augmenting with cognitive behavioral therapy (conditional recommendation; low-certainty evidence) Switching to a different second-generation antidepressant or augmenting with a second pharmacologic treatment (see Clinical Considerations) (conditional recommendation; low-certainty evidence) The informed decision on the options should be personalized and based on discussion of potential treatment benefits, harms, adverse effect profiles, cost, feasibility, patients' specific symptoms (such as insomnia, hypersomnia, or fluctuation in appetite), comorbidities, concomitant medication use, and patient preferences.

  View details for DOI 10.7326/M22-2056

  View details for PubMedID 36689752

• Cost-effectiveness of office-based buprenorphine treatment for opioid use disorder. Drug and alcohol dependence Qian, G., Rao, I., Humphreys, K., Owens, D. K., Brandeau, M. L. 2022; 243: 109762

  Abstract

  To assess the effectiveness and cost-effectiveness of office-based buprenorphine treatment (OBBT) in the U.S.We performed a model-based analysis of buprenorphine treatment provided in a primary care setting for the U.S. population with OUD.Buprenorphine treatment provided in a primary care setting.Fatal and nonfatal overdoses and deaths over five years, discounted lifetime quality-adjusted life years (QALYs), costs.For a cohort of 100,000 untreated individuals who enter OBBT, approximately 9350 overdoses would be averted over five years; of these, approximately 900 would have been fatal. OBBT compared to no treatment would yield 1.07 incremental lifetime QALYs per person at an incremental cost of $17,000 per QALY gained when using a healthcare perspective. If OBBT is half as effective and twice as expensive as assumed in the base case, the incremental cost when using a healthcare perspective is $25,500 per QALY gained. Using a limited societal perspective that additionally includes patient costs and criminal justice costs, OBBT is cost-saving compared to no treatment even under pessimistic assumptions about efficacy and cost.Expansion of OBBT would be highly cost-effective compared to no treatment when considered from a healthcare perspective, and cost-saving when reduced criminal justice costs are included. Given the continuing opioid crisis in the U.S., expansion of this care option should be a high priority.

  View details for DOI 10.1016/j.drugalcdep.2022.109762

  View details for PubMedID 36621198

• A Framework for Synthesizing Intervention Evidence from Multiple Sources Into a Single Certainty of Evidence Rating: Methodological Developments from a US National Academies of Sciences, Engineering, and Medicine committee. Research synthesis methods Calonge, B., Shekelle, G. P., Owens, D. K., Teutsch, M. S., Downey, A., Brown, L., Noyes, J. 2022

  Abstract

  BACKGROUND: Despite research investment and a growing body of diverse evidence there has been no comprehensive review and grading of evidence for public health emergency preparedness and response practices comparable to those in medicine and other public health fields.AIMS: The National Academies of Sciences, Engineering, and Medicine convened an ad hoc committee to develop and use methods for grading and synthesizing diverse type of evidence to create a single certainty of intervention-related evidence to support recommendations for Public Health Emergency Preparedness and Response Research.METHODS: A 13 step consensus building method was used. Experts were first canvassed in public meetings, and a comprehensive review of existing methods was undertaken. Although aspects of existing review methodologies and evidence grading systems were relevant, none adequately covered all requirements for this specific context. Starting with a desire to synthesize diverse sources of evidence not usually included in systematic reviews and using GRADE for assessing certainty and confidence in quantitative and qualitative evidence as the foundation, we developed a mixed-methods synthesis review and grading methodology that drew on (and in some cases adapted) those elements of existing frameworks and methods that were most applicable. Four topics were selected as test cases. The process was operationalized with a suite of method-specific reviews of diverse evidence types for each topic. Further consensus building was undertaken through stakeholder engagement and feedback CONCLUSION: The NASEM committee's GRADE adaption for mixed-methods reviews will further evolve over time and has yet to be endorsed by the GRADE working group. This article is protected by copyright. All rights reserved.

  View details for DOI 10.1002/jrsm.1582

  View details for PubMedID 35722864

• Analytical Frameworks in Colorectal Cancer Guidelines: Development of Methods for Systematic Reviews, their Application and Practical Guidance for their use. Journal of clinical epidemiology Karam, S., Darzi, A. J., Bognanni, A., Morsi, R. Z., Tannous, E. E., Charide, R., Choe, S., Stalteri, R., Lee, Y., Piggott, T., Jewell, L., Schunemann, F., Langendam, M., Parmelli, E., Saz-Parkinson, Z., Roi, A., Vilahur, N., Vali, Y., Waffenschmidt, S., Owens, D. K., Leontiadis, G. I., Moayyedi, P., Brozek, J. L., Schunemann, H. J. 2022

  Abstract

  OBJECTIVES: Analytical frameworks are graphical representation of the key questions answered by a systematic review and can support the development of guideline recommendations. Our objectives were to a) conduct a systematic review to identify, describe and compare all analytical frameworks published as part of a systematic and guideline development process related to colorectal cancer (CRC); and b) to use this case study to develop guidance on how to conduct systematic reviews of analytical frameworks.METHODS: We developed a search strategy to identify eligible studies in Medline and Embase from 1996 until December 2020. We also manually searched guideline databases and websites to identify all guidelines and systematic reviews in CRC that utilized an analytical framework. We assessed the quality of the guidelines using the Appraisal of Guidelines for Research and Evaluation II tool. The systematic review was registered in PROSPERO, registration CRD42020172117.RESULTS: We screened 34,505 records and identified 1,166 guidelines and 3,127 systematic reviews on CRC of which 5 met our inclusion criteria. These 5 publications included 4 analytical frameworks in colorectal cancer (one update). We also describe our methodological approach to systematic reviews for analytical frameworks and underlying concepts for developing analytical framework using a bottom up or top-down approach.CONCLUSION: Few guidelines and systematic reviews are utilizing analytical frameworks in the development of recommendations. Development of analytical frameworks should begin with a systematic search for existing analytical frameworks and follow a structured conceptual approach for their development to support guideline recommendations. Our methods may be helpful in achieving these objectives.

  View details for DOI 10.1016/j.jclinepi.2022.06.005

  View details for PubMedID 35724863

• Cost effectiveness of computed tomography versus ultrasound-based surveillance following endovascular aortic repair of intact infrarenal abdominal aortic aneurysms. Journal of vascular surgery Ho, V. T., Nguyen, A. T., Stern, J. R., Asch, S. M., Owens, D. K., Salomon, J. A., Dalman, R. L., Lee, J. T. 2022

  Abstract

  BACKGROUND: While Society for Vascular Surgery guidelines recommend computed tomography angiography (CTA) or ultrasound for surveillance following infrarenal endovascular aortic repair (EVAR), there is a lack of consensus regarding optimal timing and modalities. We hypothesized that ultrasound-based approaches would be more cost-effective and developed a cost-effectiveness analysis to estimate the lifetime costs and outcomes of various strategies.METHODS: We developed a decision tree with nested Markov models to compare five surveillance strategies: yearly CTA, yearly CDU, yearly CEU, CTA at first year followed by CDU, and CTA at first year followed by CEU. The model accounted for differential sensitivity, specificity, and risk of acute kidney injury after CTA, and was implemented on a monthly cycle with a willingness-to-pay threshold of $50,000 per quality-adjusted life year (QALY) and 3% annual discounting.RESULTS: Under base case assumptions, the CTA-CDU strategy was cost effective with a lifetime cost of $77950 for 7.74 QALYs. In sensitivity analysis, the CTA-CDU approach remained cost-effective when CEU specificity was less than 95%, and risk of acute kidney injury following CTA was less than 20%. At diagnostic sensitivities below 75% for CEU and 55% for CDU, a yearly CTA strategy maximized QALYs.CONCLUSION: A hybrid strategy in which CTA is performed in the first year and CDU is performed annually thereafter is the most cost-effective strategy for infrarenal EVAR surveillance in patients with less than a 20% risk of contrast-induced nephropathy. If the sensitivity of CEU and CDU are at the lower end of plausible estimates, a yearly CTA strategy is reasonable. Further research should aim to identify patients who may benefit from alternative surveillance strategies.

  View details for DOI 10.1016/j.jvs.2022.02.057

  View details for PubMedID 35278655

• Cost-Effectiveness of Dapagliflozin for Non-diabetic Chronic Kidney Disease. Journal of general internal medicine Tisdale, R. L., Cusick, M. M., Aluri, K. Z., Handley, T. J., Joyner, A. K., Salomon, J. A., Chertow, G. M., Goldhaber-Fiebert, J. D., Owens, D. K. 2022

  Abstract

  BACKGROUND: In the USA, chronic kidney disease (CKD) affects 1 in 7 adults and costs $100 billion annually. The DAPA-CKD trial found dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, to be effective in reducing CKD progression and mortality in patients with diabetic and non-diabetic CKD. Currently, SGLT2 inhibitors are not considered standard of care for patients with non-diabetic CKD.OBJECTIVE: Determine the cost-effectiveness of adding dapagliflozin to standard management of patients with non-diabetic CKD.DESIGN: Markov model with lifetime time horizon and US healthcare sector perspective.PATIENTS: Patients with non-diabetic CKD INTERVENTION: Dapagliflozin plus standard care versus standard care only.MAIN MEASURES: Quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs), all discounted at 3% annually; total incidence of kidney failure on kidney replacement therapy; average years on kidney replacement therapy.KEY RESULTS: Adding dapagliflozin to standard care improved life expectancy by 2 years, increased discounted QALYS (from 6.75 to 8.06), and reduced the total incidence of kidney failure on kidney replacement therapy (KRT) (from 17.4 to 11.0%) and average years on KRT (from 0.77 to 0.43) over the lifetime of the cohort. Dapagliflozin plus standard care was more effective than standard care alone while increasing lifetime costs (from $245,900 to $324,8900, or $60,000 per QALY gained). Results were robust to variations in assumptions about dapagliflozin's efficacy over time and by CKD stage, added costs of kidney replacement therapy, and expected population annual CKD progression rates and sensitive to the cost of dapagliflozin. The net 1-year budgetary implication of treating all US patients with non-diabetic CKD could be up to $21 billion.CONCLUSIONS: Dapagliflozin improved life expectancy and reduced progression of CKD, the proportion of patients requiring kidney replacement therapy, and time on kidney replacement therapy in patients with non-diabetic CKD. Use of dapagliflozin meets conventional criteria for cost-effectiveness.

  View details for DOI 10.1007/s11606-021-07311-5

  View details for PubMedID 35137296

• USPSTF Approach to Addressing Sex and Gender When Making Recommendations for Clinical Preventive Services. JAMA Caughey, A. B., Krist, A. H., Wolff, T. A., Barry, M. J., Henderson, J. T., Owens, D. K., Davidson, K. W., Simon, M. A., Mangione, C. M. 2021

  Abstract

  Clinical preventive service recommendations from the US Preventive Services Task Force (USPSTF) are based on transparent, systematic, and rigorous methods that consider the certainty of the evidence and magnitude of net benefit. These guidelines aim to address the needs of diverse populations. Biological sex and gender identity are sources of diversity that are not often considered in studies of clinical preventive services that inform the recommendations, resulting in challenges when evaluating the evidence and communicating recommendations for persons in specific gender identification categories (man/woman/gender nonbinary/gender nonconforming/transgender). To advance its methods, the USPSTF reviewed its past recommendations that included the use of sex and gender terms, reviewed the approaches of other guideline-making bodies, and pilot tested strategies to address sex and gender diversity. Based on the findings, the USPSTF intends to use an inclusive approach to identify issues related to sex and gender at the start of the guideline development process; assess the applicability, variability, and quality of evidence as a function of sex and gender; ensure clarity in the use of language regarding sex and gender; and identify evidence gaps related to sex and gender. Evidence reviews will identify the limitations of applying findings to diverse groups from underlying studies that used unclear terminology regarding sex and gender. The USPSTF will use gender-neutral language when appropriate to communicate that recommendations are inclusive of people of any gender and will clearly state when recommendations apply to individuals with specific anatomy associated with biological sex (male/female) or to specific categories of gender identity. The USPSTF recognizes limited evidence to inform the preventive care of populations based on gender identity.

  View details for DOI 10.1001/jama.2021.15731

  View details for PubMedID 34694343

• Cost Effectiveness of Computed Tomography Versus Ultrasound-Based Surveillance Following Endovascular Aortic Repair of Intact Abdominal Aortic Aneurysms Ho, V. T., Nguyen, A. T., Stern, J. R., Asch, S. M., Owens, D. K., Salomon, J. A., Dalman, R. L., Lee, J. T. MOSBY-ELSEVIER. 2021: E414-E415

  View details for Web of Science ID 000707158200208

• Cost Effectiveness of Computed Tomography Versus Ultrasound-Based Surveillance After Endovascular Aortic Repair of Intact Abdominal Aortic Aneurysms Ho, V. T., Nguyen, A. T., Stern, J. R., Asch, S. M., Owens, D. K., Salomon, J. A., Dalman, R. L., Lee, J. T. MOSBY-ELSEVIER. 2021: E190-E191

  View details for Web of Science ID 000691401100304

• Screening for Prediabetes and Type 2 Diabetes: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Davidson, K. W., Barry, M. J., Mangione, C. M., Cabana, M., Caughey, A. B., Davis, E. M., Donahue, K. E., Doubeni, C. A., Krist, A. H., Kubik, M., Li, L., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Stevermer, J., Tseng, C., Wong, J. B. 2021; 326 (8): 736-743

  Abstract

  Importance: An estimated 13% of all US adults (18 years or older) have diabetes, and 34.5% meet criteria for prediabetes. The prevalences of prediabetes and diabetes are higher in older adults. Estimates of the risk of progression from prediabetes to diabetes vary widely, perhaps because of differences in the definition of prediabetes or the heterogeneity of prediabetes. Diabetes is the leading cause of kidney failure and new cases of blindness among adults in the US. It is also associated with increased risks of cardiovascular disease, nonalcoholic fatty liver disease, and nonalcoholic steatohepatitis and was estimated to be the seventh leading cause of death in the US in 2017. Screening asymptomatic adults for prediabetes and type 2 diabetes may allow earlier detection, diagnosis, and treatment, with the ultimate goal of improving health outcomes.Objective: To update its 2015 recommendation, the USPSTF commissioned a systematic review to evaluate screening for prediabetes and type 2 diabetes in asymptomatic, nonpregnant adults and preventive interventions for those with prediabetes.Population: Nonpregnant adults aged 35 to 70 years seen in primary care settings who have overweight or obesity (defined as a body mass index ≥25 and ≥30, respectively) and no symptoms of diabetes.Evidence Assessment: The USPSTF concludes with moderate certainty that screening for prediabetes and type 2 diabetes and offering or referring patients with prediabetes to effective preventive interventions has a moderate net benefit.Conclusions and Recommendation: The USPSTF recommends screening for prediabetes and type 2 diabetes in adults aged 35 to 70 years who have overweight or obesity. Clinicians should offer or refer patients with prediabetes to effective preventive interventions. (B recommendation).

  View details for DOI 10.1001/jama.2021.12531

  View details for PubMedID 34427594

• Analysis of Survival Among Adults With Early-Onset Colorectal Cancer. JAMA network open Yelorda, K. L., Fu, S. J., Owens, D. K. 2021; 4 (6): e2112878

  View details for DOI 10.1001/jamanetworkopen.2021.12878

  View details for PubMedID 34132797

• Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Davidson, K. W., Barry, M. J., Mangione, C. M., Cabana, M., Caughey, A. B., Davis, E. M., Donahue, K. E., Doubeni, C. A., Krist, A. H., Kubik, M., Li, L., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Stevermer, J., Tseng, C., Wong, J. B. 2021; 325 (19): 1965-1977

  Abstract

  Importance: Colorectal cancer is the third leading cause of cancer death for both men and women, with an estimated 52 980 persons in the US projected to die of colorectal cancer in 2021. Colorectal cancer is most frequently diagnosed among persons aged 65 to 74 years. It is estimated that 10.5% of new colorectal cancer cases occur in persons younger than 50 years. Incidence of colorectal cancer (specifically adenocarcinoma) in adults aged 40 to 49 years has increased by almost 15% from 2000-2002 to 2014-2016. In 2016, 26% of eligible adults in the US had never been screened for colorectal cancer and in 2018, 31% were not up to date with screening.Objective: To update its 2016 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the benefits and harms of screening for colorectal cancer in adults 40 years or older. The review also examined whether these findings varied by age, sex, or race/ethnicity. In addition, as in 2016, the USPSTF commissioned a report from the Cancer Intervention and Surveillance Modeling Network Colorectal Cancer Working Group to provide information from comparative modeling on how estimated life-years gained, colorectal cancer cases averted, and colorectal cancer deaths averted vary by different starting and stopping ages for various screening strategies.Population: Asymptomatic adults 45 years or older at average risk of colorectal cancer (ie, no prior diagnosis of colorectal cancer, adenomatous polyps, or inflammatory bowel disease; no personal diagnosis or family history of known genetic disorders that predispose them to a high lifetime risk of colorectal cancer [such as Lynch syndrome or familial adenomatous polyposis]).Evidence Assessment: The USPSTF concludes with high certainty that screening for colorectal cancer in adults aged 50 to 75 years has substantial net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 45 to 49 years has moderate net benefit. The USPSTF concludes with moderate certainty that screening for colorectal cancer in adults aged 76 to 85 years who have been previously screened has small net benefit. Adults who have never been screened for colorectal cancer are more likely to benefit.Recommendation: The USPSTF recommends screening for colorectal cancer in all adults aged 50 to 75 years. (A recommendation) The USPSTF recommends screening for colorectal cancer in adults aged 45 to 49 years. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for colorectal cancer in adults aged 76 to 85 years. Evidence indicates that the net benefit of screening all persons in this age group is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the patient's overall health, prior screening history, and preferences. (C recommendation).

  View details for DOI 10.1001/jama.2021.6238

  View details for PubMedID 34003218

• Impact of Treatment Duration on Mortality Among Veterans with Opioid Use Disorder in the United States Veterans Health Administration. Addiction (Abingdon, England) Ching, J. H., Owens, D. K., Trafton, J. A., Goldhaber-Fiebert, J. D., Salomon, J. A. 2021

  Abstract

  BACKGROUND AND AIMS: While long-term medication-assisted treatment (MAT) using methadone or buprenorphine is associated with significantly lower all-cause mortality for individuals with opioid use disorder (OUD), periods of initiating or discontinuing treatment are associated with higher mortality risks relative to stable treatment. This study aimed to identify the OUD treatment durations necessary for the elevated mortality risks during treatment transitions to be balanced by reductions in mortality while receiving treatment.DESIGN: Simulation model based on a compartmental model of OUD diagnosis, MAT receipt, and all-cause mortality among Veterans with OUD in the United States Veteran Health Administration (VA) in 2017-2018. We simulated methadone and buprenorphine treatments of varying durations using parameters obtained through calibration and published meta-analyses of studies from North America, Europe, and Australia.SETTING: USA PARTICIPANTS: Simulated cohorts of 10,000 individuals with OUD MEASUREMENTS: All-cause mortality over 12 months FINDINGS: Receiving methadone for 4 months or longer or buprenorphine for 2 months or longer resulted in 54 (95% CI: 5-90) and 65 (95% CI: 21-89) fewer deaths relative to not receiving MAT for the same duration, using VA-specific mortality rates. We estimated shorter treatment durations necessary to achieve net mortality benefits of 2 months or longer for methadone and 1 month or longer for buprenorphine, using non-VA population literature estimates. Sensitivity analyses demonstrated that necessary treatment durations increased more with smaller mortality reductions on treatment than with larger relative risks during treatment transitions.CONCLUSIONS: Short periods (<6 months) of treatment with either methadone or buprenorphine are likely to yield net mortality benefits for people with opioid use disorder relative to receiving no medications, despite periods of elevated all-cause mortality risk during transitions into and out of treatment. Retaining people with opioid use disorder in treatment longer can increase these benefits.

  View details for DOI 10.1111/add.15574

  View details for PubMedID 33999485

• MODELING INTERVENTIONS TO EXPAND MEDICATION-ASSISTED TREATMENT AMONG VETERANS WITH OPIOID USE DISORDER IN THE VETERANS HEALTH ADMINISTRATION Ching, J. H., Trafton, J. A., Owens, D. K., Salomon, J. A., Goldhaber-Fiebert, J. D. SAGE PUBLICATIONS INC. 2021: E189-E190

  View details for Web of Science ID 000648637500155

• Cost-effectiveness of Treatments for Opioid Use Disorder. JAMA psychiatry Fairley, M., Humphreys, K., Joyce, V. R., Bounthavong, M., Trafton, J., Combs, A., Oliva, E. M., Goldhaber-Fiebert, J. D., Asch, S. M., Brandeau, M. L., Owens, D. K. 2021

  Abstract

  Importance: Opioid use disorder (OUD) is a significant cause of morbidity and mortality in the US, yet many individuals with OUD do not receive treatment.Objective: To assess the cost-effectiveness of OUD treatments and association of these treatments with outcomes in the US.Design and Setting: This model-based cost-effectiveness analysis included a US population with OUD.Interventions: Medication-assisted treatment (MAT) with buprenorphine, methadone, or injectable extended-release naltrexone; psychotherapy (beyond standard counseling); overdose education and naloxone distribution (OEND); and contingency management (CM).Main Outcomes and Measures: Fatal and nonfatal overdoses and deaths throughout 5 years, discounted lifetime quality-adjusted life-years (QALYs), and costs.Results: In the base case, in the absence of treatment, 42 717 overdoses (4132 fatal, 38 585 nonfatal) and 12 660 deaths were estimated to occur in a cohort of 100 000 patients over 5 years, and 11.58 discounted lifetime QALYs were estimated to be experienced per person. An estimated reduction in overdoses was associated with MAT with methadone (10.7%), MAT with buprenorphine or naltrexone (22.0%), and when combined with CM and psychotherapy (range, 21.0%-31.4%). Estimated deceased deaths were associated with MAT with methadone (6%), MAT with buprenorphine or naltrexone (13.9%), and when combined with CM, OEND, and psychotherapy (16.9%). MAT yielded discounted gains of 1.02 to 1.07 QALYs per person. Including only health care sector costs, methadone cost $16 000/QALY gained compared with no treatment, followed by methadone with OEND ($22 000/QALY gained), then by buprenorphine with OEND and CM ($42 000/QALY gained), and then by buprenorphine with OEND, CM, and psychotherapy ($250 000/QALY gained). MAT with naltrexone was dominated by other treatment alternatives. When criminal justice costs were included, all forms of MAT (with buprenorphine, methadone, and naltrexone) were associated with cost savings compared with no treatment, yielding savings of $25 000 to $105 000 in lifetime costs per person. The largest cost savings were associated with methadone plus CM. Results were qualitatively unchanged over a wide range of sensitivity analyses. An analysis using demographic and cost data for Veterans Health Administration patients yielded similar findings.Conclusions and Relevance: In this cost-effectiveness analysis, expanded access to MAT, combined with OEND and CM, was associated with cost-saving reductions in morbidity and mortality from OUD. Lack of widespread MAT availability limits access to a cost-saving medical intervention that reduces morbidity and mortality from OUD. Opioid overdoses in the US likely reached a record high in 2020 because of COVID-19 increasing substance use, exacerbating stress and social isolation, and interfering with opioid treatment. It is essential to understand the cost-effectiveness of alternative forms of MAT to treat OUD.

  View details for DOI 10.1001/jamapsychiatry.2021.0247

  View details for PubMedID 33787832

• Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Krist, A. H., Davidson, K. W., Mangione, C. M., Barry, M. J., Cabana, M., Caughey, A. B., Davis, E. M., Donahue, K. E., Doubeni, C. A., Kubik, M., Landefeld, C. S., Li, L., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Stevermer, J., Tseng, C., Wong, J. B. 2021; 325 (10): 962–70

  Abstract

  Importance: Lung cancer is the second most common cancer and the leading cause of cancer death in the US. In 2020, an estimated 228 820 persons were diagnosed with lung cancer, and 135 720 persons died of the disease. The most important risk factor for lung cancer is smoking. Increasing age is also a risk factor for lung cancer. Lung cancer has a generally poor prognosis, with an overall 5-year survival rate of 20.5%. However, early-stage lung cancer has a better prognosis and is more amenable to treatment.Objective: To update its 2013 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on the accuracy of screening for lung cancer with low-dose computed tomography (LDCT) and on the benefits and harms of screening for lung cancer and commissioned a collaborative modeling study to provide information about the optimum age at which to begin and end screening, the optimal screening interval, and the relative benefits and harms of different screening strategies compared with modified versions of multivariate risk prediction models.Population: This recommendation statement applies to adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years.Evidence Assessment: The USPSTF concludes with moderate certainty that annual screening for lung cancer with LDCT has a moderate net benefit in persons at high risk of lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking.Recommendation: The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. (B recommendation) This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years.

  View details for DOI 10.1001/jama.2021.1117

  View details for PubMedID 33687470

• Gastrostomy Tubes Placed in Children With Neurologic Impairment: Associated Morbidity and Mortality. Journal of child neurology Lin, J. L., Rigdon, J. n., Van Haren, K. n., Buu, M. n., Saynina, O. n., Bhattacharya, J. n., Owens, D. K., Sanders, L. M. 2021: 8830738211000179

  Abstract

  Gastrostomy tube (G-tube) placement for children with neurologic impairment with dysphagia has been suggested for pneumonia prevention. However, prior studies demonstrated an association between G-tube placement and increased risk of pneumonia. We evaluate the association between timing of G-tube placement and death or severe pneumonia in children with neurologic impairment.We included all children enrolled in California Children's Services between July 1, 2009, and June 30, 2014, with neurologic impairment and 1 pneumonia hospitalization. Prior to analysis, children with new G-tubes and those without were 1:2 propensity score matched on sociodemographics, medical complexity, and severity of index hospitalization. We used a time-varying Cox proportional hazard model for subsequent death or composite outcome of death or severe pneumonia to compare those with new G-tubes vs those without, adjusting for covariates described above.A total of 2490 children met eligibility criteria, of whom 219 (9%) died and 789 (32%) had severe pneumonia. Compared to children without G-tubes, children with new G-tubes had decreased risk of death (hazard ratio [HR] 0.47, 95% confidence interval [CI] 0.39-0.55) but increased risk of the composite outcome (HR 1.21, CI 1.14-1.27). Sensitivity analyses using varied time criteria for definitions of G-tube and outcome found that more recent G-tube placement had greater associated risk reduction for death but increased risk of severe pneumonia.Recent G-tube placement is associated with reduced risk of death but increased risk of severe pneumonia. Decisions to place G-tubes for pulmonary indications in children with neurologic impairment should weigh the impact of severe pneumonia on quality of life.

  View details for DOI 10.1177/08830738211000179

  View details for PubMedID 33750232

• Screening for Vitamin D Deficiency in Adults: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Krist, A. H., Davidson, K. W., Mangione, C. M., Cabana, M., Caughey, A. B., Davis, E. M., Donahue, K. E., Doubeni, C. A., Epling, J. W., Kubik, M., Li, L., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Stevermer, J., Tseng, C., Wong, J. B. 2021; 325 (14): 1436–42

  Abstract

  Importance: Vitamin D is a fat-soluble vitamin that performs an important role in calcium homeostasis and bone metabolism and also affects many other cellular regulatory functions outside the skeletal system. Vitamin D requirements may vary by individual; thus, no one serum vitamin D level cutpoint defines deficiency, and no consensus exists regarding the precise serum levels of vitamin D that represent optimal health or sufficiency.Objective: To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a systematic review on screening for vitamin D deficiency, including the benefits and harms of screening and early treatment.Population: Community-dwelling, nonpregnant adults who have no signs or symptoms of vitamin D deficiency or conditions for which vitamin D treatment is recommended.Evidence Assessment: The USPSTF concludes that the overall evidence on the benefits of screening for vitamin D deficiency is lacking. Therefore, the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults cannot be determined.Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for vitamin D deficiency in asymptomatic adults. (I statement).

  View details for DOI 10.1001/jama.2021.3069

  View details for PubMedID 33847711

• Screening for Hepatitis B Virus Infection in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Krist, A. H., Davidson, K. W., Mangione, C. M., Barry, M. J., Cabana, M., Caughey, A. B., Donahue, K., Doubeni, C. A., Epling, J. W., Kubik, M., Ogedegbe, G., Owens, D. K., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2020; 324 (23): 2415–22

  Abstract

  Importance: An estimated 862 000 persons in the US are living with chronic infection with hepatitis B virus (HBV). Persons born in regions with a prevalence of HBV infection of 2% or greater, such as countries in Africa and Asia, the Pacific Islands, and parts of South America, often become infected at birth and account for up to 95% of newly reported chronic infections in the US. Other high-prevalence populations include persons who inject drugs; men who have sex with men; persons with HIV infection; and sex partners, needle-sharing contacts, and household contacts of persons with chronic HBV infection. Up to 60% of HBV-infected persons are unaware of their infection, and many remain asymptomatic until onset of cirrhosis or end-stage liver disease.Objective: To update its 2014 recommendation, the USPSTF commissioned a review of new randomized clinical trials and cohort studies published from 2014 to August 2019 that evaluated the benefits and harms of screening and antiviral therapy for preventing intermediate outcomes or health outcomes and the association between improvements in intermediate outcomes and health outcomes. New key questions focused on the yield of alternative HBV screening strategies and the accuracy of tools to identify persons at increased risk.Population: This recommendation statement applies to asymptomatic, nonpregnant adolescents and adults at increased risk for HBV infection, including those who were vaccinated before being screened for HBV infection.Evidence Assessment: The USPSTF concludes with moderate certainty that screening for HBV infection in adolescents and adults at increased risk for infection has moderate net benefit.Recommendation: The USPSTF recommends screening for HBV infection in adolescents and adults at increased risk for infection. (B recommendation).

  View details for DOI 10.1001/jama.2020.22980

  View details for PubMedID 33320230

• Screening for Hepatitis C Virus Infection in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Donahue, K., Doubeni, C. A., Epling, J. W., Kubik, M., Ogedegbe, G., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2020

  Abstract

  Importance: Hepatitis C virus (HCV) is the most common chronic blood-borne pathogen in the US and a leading cause of complications from chronic liver disease. HCV is associated with more deaths than the top 60 other reportable infectious diseases combined, including HIV. Cases of acute HCV infection have increased approximately 3.8-fold over the last decade because of increasing injection drug use and improved surveillance.Objective: To update its 2013 recommendation, the USPSTF commissioned a review of the evidence on screening for HCV infection in adolescents and adults.Population: This recommendation applies to all asymptomatic adults aged 18 to 79 years without known liver disease.Evidence Assessment: The USPSTF concludes with moderate certainty that screening for HCV infection in adults aged 18 to 79 years has substantial net benefit.Recommendation: The USPSTF recommends screening for HCV infection in adults aged 18 to 79 years. (B recommendation).

  View details for DOI 10.1001/jama.2020.1123

  View details for PubMedID 32119076

• Health and Economic Outcomes of Posterior Spinal Fusion for Children With Neuromuscular Scoliosis. Hospital pediatrics Lin, J. L., Tawfik, D. S., Gupta, R., Imrie, M., Bendavid, E., Owens, D. K. 2020

  Abstract

  OBJECTIVES: Neuromuscular scoliosis (NMS) can result in severe disability. Nonoperative management minimally slows scoliosis progression, but operative management with posterior spinal fusion (PSF) carries high risks of morbidity and mortality. In this study, we compare health and economic outcomes of PSF to nonoperative management for children with NMS to identify opportunities to improve care.METHODS: We performed a cost-effectiveness analysis. Our decision analytic model included patients aged 5 to 20 years with NMS and a Cobb angle ≥50°, with a base case of 15-year-old patients. We estimated costs, life expectancy, quality-adjusted life-years (QALYs), and incremental cost-effectiveness from published literature and conducted sensitivity analyses on all model inputs.RESULTS: We estimated that PSF resulted in modestly decreased discounted life expectancy (10.8 years) but longer quality-adjusted life expectancy (4.84 QALYs) than nonoperative management (11.2 years; 3.21 QALYs). PSF costs $75400 per patient. Under base-case assumptions, PSF costs $50100 per QALY gained. Our findings were sensitive to quality of life (QoL) and life expectancy, with PSF favored if it significantly increased QoL.CONCLUSIONS: In patients with NMS, whether PSF is cost-effective depends strongly on the degree to which QoL improved, with larger improvements when NMS is the primary cause of debility, but limited data on QoL and life expectancy preclude a definitive assessment. Improved patient-centered outcome assessments are essential to understanding the effectiveness of NMS treatment alternatives. Because the degree to which PSF influences QoL substantially impacts health outcomes and varies by patient, clinicians should consider shared decision-making during PSF-related consultations.

  View details for DOI 10.1542/hpeds.2019-0153

  View details for PubMedID 32079619

• Recommendations Related to Genetic Testing for Breast Cancer-Reply. JAMA Krist, A. H., Owens, D. K., Mangione, C. M. 2020; 323 (2): 188–89

  View details for DOI 10.1001/jama.2019.18222

  View details for PubMedID 31935025

• Cost-Effectiveness of Transitional Care Services After Hospitalization With Heart Failure. Annals of internal medicine Blum, M. R., Øien, H. n., Carmichael, H. L., Heidenreich, P. n., Owens, D. K., Goldhaber-Fiebert, J. D. 2020

  Abstract

  Patients with heart failure (HF) discharged from the hospital are at high risk for death and rehospitalization. Transitional care service interventions attempt to mitigate these risks.To assess the cost-effectiveness of 3 types of postdischarge HF transitional care services and standard care.Decision analytic microsimulation model.Randomized controlled trials, clinical registries, cohort studies, Centers for Disease Control and Prevention life tables, Centers for Medicare & Medicaid Services data, and National Inpatient Sample (Healthcare Cost and Utilization Project) data.Patients with HF who were aged 75 years at hospital discharge.Lifetime.Health care sector.Disease management clinics, nurse home visits (NHVs), and nurse case management.Quality-adjusted life-years (QALYs), costs, net monetary benefits, and incremental cost-effectiveness ratios (ICERs).All 3 transitional care interventions examined were more costly and effective than standard care, with NHVs dominating the other 2 interventions. Compared with standard care, NHVs increased QALYs (2.49 vs. 2.25) and costs ($81 327 vs. $76 705), resulting in an ICER of $19 570 per QALY gained.Results were largely insensitive to variations in in-hospital mortality, age at baseline, or costs of rehospitalization. Probabilistic sensitivity analysis confirmed that transitional care services were preferred over standard care in nearly all 10 000 samples, at willingness-to-pay thresholds of $50 000 or more per QALY gained.Transitional care service designs and implementations are heterogeneous, leading to uncertainty about intervention effectiveness and costs when applied in particular settings.In older patients with HF, transitional care services are economically attractive, with NHVs being the most cost-effective strategy in many situations. Transitional care services should become the standard of care for postdischarge management of patients with HF.Swiss National Science Foundation, Research Council of Norway, and an Intermountain-Stanford collaboration.

  View details for DOI 10.7326/M19-1980

  View details for PubMedID 31986526

• Screening for Bacterial Vaginosis in Pregnant Persons to Prevent Preterm Delivery: US Preventive Services Task Force Recommendation Statement. JAMA Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M. n., Caughey, A. B., Donahue, K. n., Doubeni, C. A., Epling, J. W., Kubik, M. n., Ogedegbe, G. n., Pbert, L. n., Silverstein, M. n., Simon, M. A., Tseng, C. W., Wong, J. B. 2020; 323 (13): 1286–92

  Abstract

  Bacterial vaginosis is common and is caused by a disruption of the microbiological environment in the lower genital tract. In the US, reported prevalence of bacterial vaginosis among pregnant women ranges from 5.8% to 19.3% and is higher in some races/ethnicities. Bacterial vaginosis during pregnancy has been associated with adverse obstetrical outcomes including preterm delivery, early miscarriage, postpartum endometritis, and low birth weight.To update its 2008 recommendation, the USPSTF commissioned a review of the evidence on the accuracy of screening and the benefits and harms of screening for and treatment of bacterial vaginosis in asymptomatic pregnant persons to prevent preterm delivery.This recommendation applies to pregnant persons without symptoms of bacterial vaginosis.The USPSTF concludes with moderate certainty that screening for asymptomatic bacterial vaginosis in pregnant persons not at increased risk for preterm delivery has no net benefit in preventing preterm delivery. The USPSTF concludes that for pregnant persons at increased risk for preterm delivery, the evidence is conflicting and insufficient, and the balance of benefits and harms cannot be determined.The USPSTF recommends against screening for bacterial vaginosis in pregnant persons not at increased risk for preterm delivery. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for bacterial vaginosis in pregnant persons at increased risk for preterm delivery. (I statement).

  View details for DOI 10.1001/jama.2020.2684

  View details for PubMedID 32259236

• Screening for Cognitive Impairment in Older Adults: US Preventive Services Task Force Recommendation Statement. JAMA Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M. n., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kubik, M. n., Landefeld, C. S., Mangione, C. M., Pbert, L. n., Silverstein, M. n., Simon, M. A., Tseng, C. W., Wong, J. B. 2020; 323 (8): 757–63

  Abstract

  Dementia (also known as major neurocognitive disorder) is defined by a significant decline in 1 or more cognitive domains that interferes with a person's independence in daily activities. Dementia affects an estimated 2.4 to 5.5 million individuals in the United States, and its prevalence increases with age.To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on screening for cognitive impairment, including mild cognitive impairment and mild to moderate dementia, in community-dwelling adults, including those 65 years or older residing in independent living facilities.This recommendation applies to community-dwelling older adults 65 years or older, without recognized signs or symptoms of cognitive impairment.The USPSTF concludes that the evidence is lacking, and the balance of benefits and harms of screening for cognitive impairment cannot be determined.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for cognitive impairment in older adults. (I statement).

  View details for DOI 10.1001/jama.2020.0435

  View details for PubMedID 32096858

• Evolution of the U.S. Preventive Services Task Force's Methods. American journal of preventive medicine Krist, A. H., Barry, M. J., Wolff, T. A., Owens, D. K., Fan, T. M., Davidson, K. W. 2020; 58 (3): 332–35

  View details for DOI 10.1016/j.amepre.2019.11.003

  View details for PubMedID 32087861

• Primary Care Interventions for Prevention and Cessation of Tobacco Use in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M. n., Caughey, A. B., Curry, S. J., Donahue, K. n., Doubeni, C. A., Epling, J. W., Kubik, M. n., Ogedegbe, G. n., Pbert, L. n., Silverstein, M. n., Simon, M. A., Tseng, C. W., Wong, J. B. 2020; 323 (16): 1590–98

  Abstract

  Tobacco use is the leading cause of preventable death in the US. An estimated annual 480 000 deaths are attributable to tobacco use in adults, including from secondhand smoke. It is estimated that every day about 1600 youth aged 12 to 17 years smoke their first cigarette and that about 5.6 million adolescents alive today will die prematurely from a smoking-related illness. Although conventional cigarette use has gradually declined among children in the US since the late 1990s, tobacco use via electronic cigarettes (e-cigarettes) is quickly rising and is now more common among youth than cigarette smoking. e-Cigarette products usually contain nicotine, which is addictive, raising concerns about e-cigarette use and nicotine addiction in children. Exposure to nicotine during adolescence can harm the developing brain, which may affect brain function and cognition, attention, and mood; thus, minimizing nicotine exposure from any tobacco product in youth is important.To update its 2013 recommendation, the USPSTF commissioned a review of the evidence on the benefits and harms of primary care interventions for tobacco use prevention and cessation in children and adolescents. The current systematic review newly included e-cigarettes as a tobacco product.This recommendation applies to school-aged children and adolescents younger than 18 years.The USPSTF concludes with moderate certainty that primary care-feasible behavioral interventions, including education or brief counseling, to prevent tobacco use in school-aged children and adolescents have a moderate net benefit. The USPSTF concludes that there is insufficient evidence to determine the balance of benefits and harms of primary care interventions for tobacco cessation among school-aged children and adolescents who already smoke, because of a lack of adequately powered studies on behavioral counseling interventions and a lack of studies on medications.The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use among school-aged children and adolescents. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care-feasible interventions for the cessation of tobacco use among school-aged children and adolescents. (I statement).

  View details for DOI 10.1001/jama.2020.4679

  View details for PubMedID 32343336

• Cost-Effectiveness of Initial Versus Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors. Journal of the National Comprehensive Cancer Network : JNCCN Barnes, J. I., Lin, J. K., Gupta, D. n., Owens, D. K., Goldhaber-Fiebert, J. D., Kunz, P. L. 2020; 18 (9): 1200–1209

  Abstract

  The Controlled Study of Lanreotide Antiproliferative Response in Neuroendocrine Tumors (CLARINET) trial showed prolonged progression-free survival in patients initially treated with lanreotide versus placebo. We evaluated the cost-effectiveness of upfront lanreotide versus active surveillance with lanreotide administered after progression in patients with metastatic enteropancreatic neuroendocrine tumors (NETs), both of which are treatment options recommended in NCCN Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors.We developed a Markov model calibrated to the CLARINET trial and its extension. We based the active surveillance strategy on the CLARINET placebo arm. We calculated incremental cost-effectiveness ratios (ICERs) in dollars per quality-adjusted life-year (QALY). We modeled lanreotide's cost at $7,638 per 120 mg (average sales price plus 6%), used published utilities (stable disease, 0.77; progressed disease, 0.61), adopted a healthcare sector perspective and lifetime time horizon, and discounted costs and benefits at 3% annually. We examined sensitivity to survival extrapolation and modeled octreotide long-acting release (LAR) ($6,183 per 30 mg). We conducted one-way, multiway, and probabilistic sensitivity analyses.Upfront lanreotide led to 5.21 QALYs and a cost of $804,600. Active surveillance followed by lanreotide after progression led to 4.84 QALYs and a cost of $590,200, giving an ICER of $578,500/QALY gained. Reducing lanreotide's price by 95% (to $370) or 85% (to $1,128) per 120 mg would allow upfront lanreotide to reach ICERs of $100,000/QALY or $150,000/QALY. Across a range of survival curve extrapolation scenarios, pricing lanreotide at $370 to $4,000 or $1,130 to $5,600 per 120 mg would reach ICERs of $100,000/QALY or $150,000/QALY, respectively. Our findings were robust to extensive sensitivity analyses. The ICER modeling octreotide LAR is $482,700/QALY gained.At its current price, lanreotide is not cost-effective as initial therapy for patients with metastatic enteropancreatic NETs and should be reserved for postprogression treatment. To be cost-effective as initial therapy, the price of lanreotide would need to be lowered by 48% to 95% or 27% to 86% to reach ICERs of $100,000/QALY or $150,00/QALY, respectively.

  View details for DOI 10.6004/jnccn.2020.7563

  View details for PubMedID 32886901

• Methods for Model Calibration under High Uncertainty: Modeling Cholera in Bangladesh. Medical decision making : an international journal of the Society for Medical Decision Making Ryckman, T. n., Luby, S. n., Owens, D. K., Bendavid, E. n., Goldhaber-Fiebert, J. D. 2020: 272989X20938683

  Abstract

  Background. Published data on a disease do not always correspond directly to the parameters needed to simulate natural history. Several calibration methods have been applied to computer-based disease models to extract needed parameters that make a model's output consistent with available data. Objective. To assess 3 calibration methods and evaluate their performance in a real-world application. Methods. We calibrated a model of cholera natural history in Bangladesh, where a lack of active surveillance biases available data. We built a cohort state-transition cholera natural history model that includes case hospitalization to reflect the passive surveillance data-generating process. We applied 3 calibration techniques: incremental mixture importance sampling, sampling importance resampling, and random search with rejection sampling. We adapted these techniques to the context of wide prior uncertainty and many degrees of freedom. We evaluated the resulting posterior parameter distributions using a range of metrics and compared predicted cholera burden estimates. Results. All 3 calibration techniques produced posterior distributions with a higher likelihood and better fit to calibration targets as compared with prior distributions. Incremental mixture importance sampling resulted in the highest likelihood and largest number of unique parameter sets to better inform joint parameter uncertainty. Compared with naïve uncalibrated parameter sets, calibrated models of cholera in Bangladesh project substantially more cases, many of which are not detected by passive surveillance, and fewer deaths. Limitations. Calibration cannot completely overcome poor data quality, which can leave some parameters less well informed than others. Calibration techniques may perform differently under different circumstances. Conclusions. Incremental mixture importance sampling, when adapted to the context of high uncertainty, performs well. By accounting for biases in data, calibration can improve model projections of disease burden.

  View details for DOI 10.1177/0272989X20938683

  View details for PubMedID 32639859

• COMPARING METHODS FOR MODEL CALIBRATION WITH HIGH UNCERTAINTY: MODELING CHOLERA IN BANGLADESH Ryckman, T., Luby, S., Owens, D. K., Bendavid, E., Goldhaber-Fiebert, J. D. SAGE PUBLICATIONS INC. 2020: E186–E187

  View details for Web of Science ID 000509275600163

• CO-MORBIDITIES AND SEVERE ADVERSE EVENTS AMONG TREATED AND UNTREATED VETERANS WITH OPIOID USE DISORDER IN THE VETERANS HEALTH ADMINISTRATION Ching, J. H., Owens, D. K., Trafton, J. A. SAGE PUBLICATIONS INC. 2020: E167–E168

  View details for Web of Science ID 000509275600147

• ESTIMATED MORTALITY RATES AMONG TREATED AND UNTREATED VETERANS WITH OPIOID USE DISORDER IN THE VETERANS HEALTH ADMINISTRATION Ching, J. H., Trafton, J. A., Goldhaber-Fiebert, J. D., Owens, D. K., Salomon, J. A. SAGE PUBLICATIONS INC. 2020: E105–E106

  View details for Web of Science ID 000509275600095

• Cost Effectiveness of Endoscopic Resection vs Transanal Resection of Complex Benign Rectal Polyps CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Yu, J. X., Russell, W., Ching, J. H., Kim, N., Bendavid, E., Owens, D. K., Kaltenbach, T. 2019; 17 (13): 2740-+

  View details for DOI 10.1016/j.cgh.2019.02.041

  View details for Web of Science ID 000497972200024

• Open vs Laparoscopic vs Robotic Surgery for Rectal Cancer: A Cost-Effectiveness Analysis Chandler, J. M., Conway, A. A., Huckels, J., Pooni, R. K., Zarnett, L. J., Lee, K., Kin, C. J., Salomon, J. A., Owens, D. K. ELSEVIER SCIENCE INC. 2019: S67

  View details for Web of Science ID 000492740900109

• Medication Use to Reduce Risk of Breast Cancer: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Tseng, C., Wong, J. B. 2019; 322 (9): 857–67

  Abstract

  Importance: Breast cancer is the most common nonskin cancer among women in the United States and the second leading cause of cancer death. The median age at diagnosis is 62 years, and an estimated 1 in 8 women will develop breast cancer at some point in their lifetime. African American women are more likely to die of breast cancer compared with women of other races.Objective: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on medications for risk reduction of primary breast cancer.Evidence Review: The USPSTF reviewed evidence on the accuracy of risk assessment methods to identify women who could benefit from risk-reducing medications for breast cancer, as well as evidence on the effectiveness, adverse effects, and subgroup variations of these medications. The USPSTF reviewed evidence from randomized trials, observational studies, and diagnostic accuracy studies of risk stratification models in women without preexisting breast cancer or ductal carcinoma in situ.Findings: The USPSTF found convincing evidence that risk assessment tools can predict the number of cases of breast cancer expected to develop in a population. However, these risk assessment tools perform modestly at best in discriminating between individual women who will or will not develop breast cancer. The USPSTF found convincing evidence that risk-reducing medications (tamoxifen, raloxifene, or aromatase inhibitors) provide at least a moderate benefit in reducing risk for invasive estrogen receptor-positive breast cancer in postmenopausal women at increased risk for breast cancer. The USPSTF found that the benefits of taking tamoxifen, raloxifene, and aromatase inhibitors to reduce risk for breast cancer are no greater than small in women not at increased risk for the disease. The USPSTF found convincing evidence that tamoxifen and raloxifene and adequate evidence that aromatase inhibitors are associated with small to moderate harms. Overall, the USPSTF determined that the net benefit of taking medications to reduce risk of breast cancer is larger in women who have a greater risk for developing breast cancer.Conclusions and Recommendation: The USPSTF recommends that clinicians offer to prescribe risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women who are at increased risk for breast cancer and at low risk for adverse medication effects. (B recommendation) The USPSTF recommends against the routine use of risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, in women who are not at increased risk for breast cancer. (D recommendation) This recommendation applies to asymptomatic women 35 years and older, including women with previous benign breast lesions on biopsy (such as atypical ductal or lobular hyperplasia and lobular carcinoma in situ). This recommendation does not apply to women who have a current or previous diagnosis of breast cancer or ductal carcinoma in situ.

  View details for DOI 10.1001/jama.2019.11885

  View details for PubMedID 31479144

• Screening for Pancreatic Cancer: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Curry, S. J., Doubeni, C. A., Epling, J. W., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 322 (5): 438–44

  Abstract

  Importance: Pancreatic cancer is an uncommon cancer with an age-adjusted annual incidence of 12.9 cases per 100 000 person-years. However, the death rate is 11.0 deaths per 100 000 person-years because the prognosis of pancreatic cancer is poor. Although its incidence is low, pancreatic cancer is the third most common cause of cancer death in the United States. Because of the increasing incidence of pancreatic cancer, along with improvements in early detection and treatment of other types of cancer, it is estimated that pancreatic cancer may soon become the second-leading cause of cancer death in the United States.Objective: To update the 2004 US Preventive Services Task Force (USPSTF) recommendation on screening for pancreatic cancer.Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for pancreatic cancer, the diagnostic accuracy of screening tests for pancreatic cancer, and the benefits and harms of treatment of screen-detected or asymptomatic pancreatic cancer.Findings: The USPSTF found no evidence that screening for pancreatic cancer or treatment of screen-detected pancreatic cancer improves disease-specific morbidity or mortality, or all-cause mortality. The USPSTF found adequate evidence that the magnitude of the benefits of screening for pancreatic cancer in asymptomatic adults can be bounded as no greater than small. The USPSTF found adequate evidence that the magnitude of the harms of screening for pancreatic cancer and treatment of screen-detected pancreatic cancer can be bounded as at least moderate. The USPSTF reaffirms its previous conclusion that the potential benefits of screening for pancreatic cancer in asymptomatic adults do not outweigh the potential harms.Conclusions and Recommendation: The USPSTF recommends against screening for pancreatic cancer in asymptomatic adults. (D recommendation).

  View details for DOI 10.1001/jama.2019.10232

  View details for PubMedID 31386141

• The Costs of Hepatitis C by Liver Disease Stage: Estimates from the Veterans Health Administration APPLIED HEALTH ECONOMICS AND HEALTH POLICY Gidwani-Marszowski, R., Owens, D. K., Lo, J., Goldhaber-Fiebert, J. D., Asch, S. M., Barnett, P. G. 2019; 17 (4): 513–21

  View details for DOI 10.1007/s40258-019-00468-5

  View details for Web of Science ID 000475518500007

• Screening for Hepatitis B Virus Infection in Pregnant Women: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 322 (4): 349–54

  Abstract

  Importance: Screening for hepatitis B virus (HBV) infection during pregnancy identifies women whose infants are at risk of perinatal transmission. Data from a nationally representative sample showed a prevalence of maternal HBV infection of 85.8 cases per 100 000 deliveries from 1998 to 2011 (0.09% of live-born singleton deliveries in the United States). Although there are guidelines for universal infant HBV vaccination, rates of maternal HBV infection have increased annually by 5.5% since 1998. Children infected with HBV during infancy or childhood are more likely to develop chronic infection. Chronic HBV infection increases long-term morbidity and mortality by predisposing infected persons to cirrhosis of the liver and liver cancer.Objective: To update the 2009 US Preventive Services Task Force (USPSTF) recommendation on screening for HBV infection in pregnant women.Evidence Review: The USPSTF commissioned a reaffirmation evidence update to identify substantial new evidence sufficient enough to change the prior recommendation. The USPSTF targeted its evidence review on the effectiveness and potential harms of screening and the effectiveness and harms of case management to prevent perinatal transmission.Findings: The USPSTF previously found adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infection. Interventions are effective for preventing perinatal transmission, based on foundational evidence and observational studies of US case management programs. In addition, there is evidence that over time, perinatal transmission has decreased among women and infants enrolled in case management, providing an overall substantial health benefit. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that screening for HBV infection in pregnant women provides substantial benefit.Conclusions and Recommendation: The USPSTF recommends screening for HBV infection in pregnant women at their first prenatal visit. (A recommendation).

  View details for DOI 10.1001/jama.2019.9365

  View details for PubMedID 31334800

• Cost-effectiveness of Screening for Nasopharyngeal Carcinoma among Asian American Men in the United States OTOLARYNGOLOGY-HEAD AND NECK SURGERY Harris, J. P., Saraswathula, A., Kaplun, B., Qian, Y., Chan, K., Chan, A. C., Quynh-Thu Le, Owens, D. K., Goldhaber-Fiebert, J. D., Pollom, E. 2019; 161 (1): 82–90

  View details for DOI 10.1177/0194599819832593

  View details for Web of Science ID 000473507100011

• Operative Versus Nonoperative Management of Appendicitis: A Long-Term Cost Effectiveness Analysis. MDM policy & practice Sceats, L. A., Ku, S., Coughran, A., Barnes, B., Grimm, E., Muffly, M., Spain, D. A., Kin, C., Owens, D. K., Goldhaber-Fiebert, J. D. 2019; 4 (2): 2381468319866448

  Abstract

  Background. Recent clinical trials suggest that nonoperative management (NOM) of patients with acute, uncomplicated appendicitis is an acceptable alternative to surgery. However, limited data exist comparing the long-term cost-effectiveness of nonoperative treatment strategies. Design. We constructed a Markov model comparing the cost-effectiveness of three treatment strategies for uncomplicated appendicitis: 1) laparoscopic appendectomy, 2) inpatient NOM, and 3) outpatient NOM. The model assessed lifetime costs and outcomes from a third-party payer perspective. The preferred strategy was the one yielding the greatest utility without exceeding a $50,000 willingness-to-pay threshold. Results. Outpatient NOM cost $233,700 over a lifetime; laparoscopic appendectomy cost $2500 more while inpatient NOM cost $7300 more. Outpatient NOM generated 24.9270 quality-adjusted life-years (QALYs), while laparoscopic appendectomy and inpatient NOM yielded 0.0709 and 0.0005 additional QALYs, respectively. Laparoscopic appendectomy was cost-effective compared with outpatient NOM (incremental cost-effectiveness ratio $32,300 per QALY gained); inpatient NOM was dominated by laparoscopic appendectomy. In one-way sensitivity analyses, the preferred strategy changed when varying perioperative mortality, probability of appendiceal malignancy or recurrent appendicitis after NOM, probability of a complicated recurrence, and appendectomy cost. A two-way sensitivity analysis showed that the rates of NOM failure and appendicitis recurrence described in randomized trials exceeded the values required for NOM to be preferred. Limitations. There are limited NOM data to generate long-term model probabilities. Health state utilities were often drawn from single studies and may significantly influence model outcomes. Conclusion. Laparoscopic appendectomy is a cost-effective treatment for acute uncomplicated appendicitis over a lifetime time horizon. Inpatient NOM was never the preferred strategy in the scenarios considered here. These results emphasize the importance of considering long-term costs and outcomes when evaluating NOM.

  View details for DOI 10.1177/2381468319866448

  View details for PubMedID 31453362

• Screening for HIV Infection: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Curry, S. J., Doubeni, C. A., Epling, J. W., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019

  Abstract

  Importance: Approximately 1.1 million persons in the United States are currently living with HIV, and more than 700 000 persons have died of AIDS since the first cases were reported in 1981. There were approximately 38 300 new diagnoses of HIV infection in 2017. The estimated prevalence of HIV infection among persons 13 years and older in the United States is 0.4%, and data from the Centers for Disease Control and Prevention show a significant increase in HIV diagnoses starting at age 15 years. An estimated 8700 women living with HIV give birth each year in the United States. HIV can be transmitted from mother to child during pregnancy, labor, delivery, and breastfeeding. The incidence of perinatal HIV infection in the United States peaked in 1992 and has declined significantly following the implementation of routine prenatal HIV screening and the use of effective therapies and precautions to prevent mother-to-child transmission.Objective: To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on screening for HIV infection in adolescents, adults, and pregnant women.Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for HIV infection in nonpregnant adolescents and adults, the yield of screening for HIV infection at different intervals, the effects of initiating antiretroviral therapy (ART) at a higher vs lower CD4 cell count, and the longer-term harms associated with currently recommended ART regimens. The USPSTF also reviewed the evidence on the benefits (specifically, reduced risk of mother-to-child transmission of HIV infection) and harms of screening for HIV infection in pregnant persons, the yield of repeat screening for HIV at different intervals during pregnancy, the effectiveness of currently recommended ART regimens for reducing mother-to-child transmission of HIV infection, and the harms of ART during pregnancy to the mother and infant.Findings: The USPSTF found convincing evidence that currently recommended HIV tests are highly accurate in diagnosing HIV infection. The USPSTF found convincing evidence that identification and early treatment of HIV infection is of substantial benefit in reducing the risk of AIDS-related events or death. The USPSTF found convincing evidence that the use of ART is of substantial benefit in decreasing the risk of HIV transmission to uninfected sex partners. The USPSTF also found convincing evidence that identification and treatment of pregnant women living with HIV infection is of substantial benefit in reducing the rate of mother-to-child transmission. The USPSTF found adequate evidence that ART is associated with some harms, including neuropsychiatric, renal, and hepatic harms, and an increased risk of preterm birth in pregnant women. The USPSTF concludes with high certainty that the net benefit of screening for HIV infection in adolescents, adults, and pregnant women is substantial.Conclusions and Recommendation: The USPSTF recommends screening for HIV infection in adolescents and adults aged 15 to 65 years. Younger adolescents and older adults who are at increased risk of infection should also be screened. (A recommendation) The USPSTF recommends screening for HIV infection in all pregnant persons, including those who present in labor or at delivery whose HIV status is unknown. (A recommendation).

  View details for DOI 10.1001/jama.2019.6587

  View details for PubMedID 31184701

• Preexposure Prophylaxis for the Prevention of HIV Infection: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Curry, S. J., Doubeni, C. A., Epling, J. W., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 321 (22): 2203–13

  Abstract

  Importance: An estimated 1.1 million individuals in the United States are currently living with HIV, and more than 700 000 persons have died of AIDS since the first cases were reported in 1981. In 2017, there were 38 281 new diagnoses of HIV infection reported in the United States; 81% of these new diagnoses were among males and 19% were among females. Although treatable, HIV infection has no cure and has significant health consequences.Objective: To issue a new US Preventive Services Task Force (USPSTF) recommendation on preexposure prophylaxis (PrEP) for the prevention of HIV infection.Evidence Review: The USPSTF reviewed the evidence on the benefits of PrEP for the prevention of HIV infection with oral tenofovir disoproxil fumarate monotherapy or combined tenofovir disoproxil fumarate and emtricitabine and whether the benefits vary by risk group, population subgroup, or regimen or dosing strategy; the diagnostic accuracy of risk assessment tools to identify persons at high risk of HIV acquisition; the rates of adherence to PrEP in primary care settings; the association between adherence and effectiveness of PrEP; and the harms of PrEP when used for HIV prevention.Findings: The USPSTF found convincing evidence that PrEP is of substantial benefit in decreasing the risk of HIV infection in persons at high risk of HIV acquisition. The USPSTF also found convincing evidence that adherence to PrEP is highly associated with its efficacy in preventing the acquisition of HIV infection; thus, adherence to PrEP is central to realizing its benefit. The USPSTF found adequate evidence that PrEP is associated with small harms, including kidney and gastrointestinal adverse effects. The USPSTF concludes with high certainty that the magnitude of benefit of PrEP with oral tenofovir disoproxil fumarate-based therapy to reduce the risk of acquisition of HIV infection in persons at high risk is substantial.Conclusions and Recommendation: The USPSTF recommends offering PrEP with effective antiretroviral therapy to persons at high risk of HIV acquisition. (A recommendation).

  View details for DOI 10.1001/jama.2019.6390

  View details for PubMedID 31184747

• Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Multiply Relapsed or Refractory Adult Large B-Cell Lymphoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Lin, J. K., Muffly, L. S., Spinner, M. A., Barnes, J. I., Owens, D. K., Goldhaber-Fiebert, J. D. 2019: JCO1802079

  Abstract

  Two anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapies are approved for diffuse large B-cell lymphoma, axicabtagene ciloleucel (axi-cel) and tisagenlecleucel; each costs $373,000. We evaluated their cost effectiveness.We used a decision analytic Markov model informed by recent multicenter, single-arm trials to evaluate axi-cel and tisagenlecleucel in multiply relapsed/refractory, adult, diffuse large B-cell lymphoma from a US health payer perspective over a lifetime horizon. Under a range of plausible long-term effectiveness assumptions, each therapy was compared with salvage chemoimmunotherapy regimens and stem-cell transplantation. Main outcomes were undiscounted life years, discounted lifetime costs, discounted quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (3% annual discount rate). Sensitivity analyses explored uncertainty.In an optimistic scenario, assuming a 40% 5-year progression-free survival (PFS), axi-cel increased life expectancy by 8.2 years at $129,000/QALY gained (95% uncertainty interval, $90,000 to $219,000). At a 30% 5-year PFS, improvements in life expectancy were more modest (6.4 years) and expensive ($159,000/QALY gained [95% uncertainty interval, $105,000 to $284,000]). In an optimistic scenario, assuming a 35% 5-year PFS, tisagenlecleucel increased life expectancy by 4.6 years at $168,000/QALY gained (95% uncertainty interval, $105,000 to $414,000/QALY). At a 25% 5-year PFS, improvements in life expectancy were smaller (3.4 years) and more expensive ($223,000/QALY gained [95% uncertainty interval, $123,000 to $1,170,000/QALY]). Administering CAR-T to all indicated patients would increase US health care costs by approximately $10 billion over 5 years. Price reductions to $250,000 and $200,000, respectively, or payment only for initial complete response (at current prices) would allow axi-cel and tisagenlecleucel to cost less than $150,000/QALY, even at 25% PFS.At 2018 prices, it is possible that both CAR-T therapies meet a less than $150,000/QALY threshold. This depends on long-term outcomes compared with chemoimmunotherapy and stem-cell transplantation, which are uncertain. Widespread adoption would substantially increase non-Hodgkin lymphoma health care costs. Price reductions or payment for initial response would improve cost effectiveness, even with modest long-term outcomes.

  View details for DOI 10.1200/JCO.18.02079

  View details for PubMedID 31157579

• Cost-Effectiveness Analysis of Fenestrated Endovascular Aneurysm Repair Compared With Open Surgical Repair for Patients With Juxtarenal Abdominal Aortic Aneurysms George, E. L., Nardacci, L., Sinawang, P., Rao, I., Owens, D. K., Garcia-Toca, M. MOSBY-ELSEVIER. 2019: E244–E245

  View details for DOI 10.1016/j.jvs.2019.04.367

  View details for Web of Science ID 000469220300359

• Cost-effectiveness of chimeric antigen receptor T-cell therapy in multiply relapsed or refractory adult large B-cell lymphoma. Lin, J., Muffly, L. S., Spinner, M., Barnes, J. I., Owens, D. K., Goldhaber-Fiebert, J. D. AMER SOC CLINICAL ONCOLOGY. 2019

  View details for Web of Science ID 000487345806323

• Screening for Elevated Blood Lead Levels in Children and Pregnant Women US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Cabana, M., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2019; 321 (15): 1502–9

  View details for DOI 10.1001/jama.2019.3326

  View details for Web of Science ID 000464765900017

• Screening for Elevated Blood Lead Levels in Children and Pregnant Women: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Cabana, M., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 321 (15): 1502–9

  Abstract

  Importance: Elevated blood lead levels in children are associated with neurologic effects such as behavioral and learning problems, lower IQ, hyperactivity, hearing problems, and impaired growth. In pregnant women, lead exposure can impair organ systems such as the hematopoietic, hepatic, renal, and nervous systems, and increase the risk of preeclampsia and adverse perinatal outcomes. Many of the adverse health effects of lead exposure are irreversible.Objective: To update the 2006 US Preventive Services Task Force (USPSTF) recommendation on screening for elevated blood lead levels in children and pregnant women.Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of elevated blood lead levels. In this update, an elevated blood lead level was defined according to the Centers for Disease Control and Prevention reference level of 5 mug/dL.Findings: The USPSTF found adequate evidence that questionnaires and other clinical prediction tools to identify asymptomatic children with elevated blood lead levels are inaccurate. The USPSTF found adequate evidence that capillary blood testing accurately identifies children with elevated blood lead levels. The USPSTF found inadequate evidence on the effectiveness of treatment of elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women. The USPSTF found inadequate evidence regarding the accuracy of questionnaires and other clinical prediction tools to identify asymptomatic pregnant women with elevated blood lead levels. The USPSTF found inadequate evidence on the harms of screening for or treatment of elevated blood lead levels in asymptomatic children and pregnant women. The USPSTF concluded that the current evidence is insufficient, and that the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children 5 years and younger and in pregnant women cannot be determined.Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic children. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for elevated blood lead levels in asymptomatic pregnant persons. (I statement).

  View details for PubMedID 30990556

• Weight Loss Interventions in Adults Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Owens, D. K., Krist, A. H. 2019; 321 (9): 900–901

  View details for DOI 10.1001/jama.2018.20291

  View details for Web of Science ID 000460351600024

• Cost Effectiveness of Endoscopic Resection vs Transanal Resection of Complex Benign Rectal Polyps. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association Yu, J. X., Russell, W. A., Ching, J. H., Kim, N., Bendavid, E., Owens, D. K., Kaltenbach, T. 2019

  Abstract

  BACKGROUND & AIMS: Complex benign rectal polyps can be managed with transanal surgery or with endoscopic resection (ER). Though the complication rate after ER is lower than transanal surgery, recurrence is higher. Patients lost to follow up after ER might therefore be at increased risk for rectal cancer. We evaluated the costs, benefits, and cost effectiveness of ER compared to 2 surgical techniques for removing complex rectal polyps, using a 50-year time horizon-this allowed us to capture rates of cancer development among patients lost from follow-up surveillance.METHODS: We created a Markov model to simulate the lifetime outcomes and costs of ER, transanal endoscopic microsurgery (TEM), and transanal minimally invasive surgery (TAMIS) for the management of a complex benign rectal polyp. We assessed the effect of surveillance by allowing a portion of the patients to be lost to follow up. We calculated the cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio or each intervention over a 50-year time horizon.RESULTS: We found that TEM was slightly more effective than TAMIS and ER (TEM, 19.54 QALYs; TAMIS, 19.53 QALYs; and ER19.53, QALYs), but ER had a lower lifetime discounted cost (ER cost $7161, TEM cost $10,459, and TAMIS cost $11,253). TEM was not cost effective compared to ER, with an incremental cost-effectiveness ratio of $485,333/QALY. TAMIS was ruled out by extended dominance. TEM became cost effective when the mortality from ER exceeded 0.63%, or if loss to follow up exceeded 25.5%.CONCLUSIONS: Using a Markov model, we found that ER, TEM, and TAMIS have similar effectiveness, but ER is less expensive, in management of benign rectal polyps. As the rate of loss to follow up increases, transanal surgery becomes more effective relative to ER.

  View details for PubMedID 30849517

• Cost-effectiveness of Screening for Nasopharyngeal Carcinoma among Asian American Men in the United States. Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery Harris, J. P., Saraswathula, A., Kaplun, B., Qian, Y., Chan, K. C., Chan, A. T., Le, Q., Owens, D. K., Goldhaber-Fiebert, J. D., Pollom, E. 2019: 194599819832593

  Abstract

  OBJECTIVE: Most patients with nasopharyngeal carcinoma (NPC) in the United States are diagnosed with stage III-IV disease. Screening for NPC in endemic areas results in earlier detection and improved outcomes. We examined the cost-effectiveness of screening for NPC with plasma Epstein-Barr virus DNA among Asian American men in the United States.STUDY DESIGN: We used a Markov cohort model to estimate discounted life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios for screening as compared with usual care without screening.SETTING: The base case analysis considered onetime screening for 50-year-old Asian American men.SUBJECTS AND METHODS: Confirmatory testing was magnetic resonance imaging and nasopharyngoscopy. Cancer-specific outcomes, health utility values, and costs were determined from cancer registries and the published literature.RESULTS: For Asian American men, usual care without screening resulted in the detection of NPC at stages I, II, III-IVB, and IVC among 6%, 29%, 54%, and 11% of those with cancer, respectively, whereas screening resulted in earlier detection with a stage distribution of 43%, 24%, 32%, and 1%. This corresponded to an additional 0.00055 QALYs gained at a cost of $63 per person: an incremental cost of $113,341 per QALY gained. In probabilistic sensitivity analysis, screening Asian American men was cost-effective at $100,000 per QALY gained in 35% of samples.CONCLUSION: Although screening for NPC with plasma Epstein-Barr virus DNA for 50-year-old Asian American men may result in earlier detection, in this study it was unlikely to be cost-effective. Screening may be reasonable for certain subpopulations at higher risk for NPC, but clinical studies are necessary before implementation.

  View details for PubMedID 30832545

• The Cost-Effectiveness of Initial vs Delayed Lanreotide for Treatment of Metastatic Enteropancreatic Neuroendocrine Tumors in the United States Barnes, J. I., Lin, J., Owens, D. K., Goldhaber-Fiebert, J., Kunz, P. L. LIPPINCOTT WILLIAMS & WILKINS. 2019: 429

  View details for Web of Science ID 000462541800031

• Interventions to Prevent Perinatal Depression US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2019; 321 (6): 580–87

  View details for DOI 10.1001/jama.2019.0007

  View details for Web of Science ID 000458456700019

• Interventions to Prevent Perinatal Depression: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 321 (6): 580–87

  Abstract

  Importance: Perinatal depression, which is the occurrence of a depressive disorder during pregnancy or following childbirth, affects as many as 1 in 7 women and is one of the most common complications of pregnancy and the postpartum period. It is well established that perinatal depression can result in adverse short- and long-term effects on both the woman and child.Objective: To issue a new US Preventive Services Task Force (USPSTF) recommendation on interventions to prevent perinatal depression.Evidence Review: The USPSTF reviewed the evidence on the benefits and harms of preventive interventions for perinatal depression in pregnant or postpartum women or their children. The USPSTF reviewed contextual information on the accuracy of tools used to identify women at increased risk of perinatal depression and the most effective timing for preventive interventions. Interventions reviewed included counseling, health system interventions, physical activity, education, supportive interventions, and other behavioral interventions, such as infant sleep training and expressive writing. Pharmacological approaches included the use of nortriptyline, sertraline, and omega-3 fatty acids.Findings: The USPSTF found convincing evidence that counseling interventions, such as cognitive behavioral therapy and interpersonal therapy, are effective in preventing perinatal depression. Women with a history of depression, current depressive symptoms, or certain socioeconomic risk factors (eg, low income or young or single parenthood) would benefit from counseling interventions and could be considered at increased risk. The USPSTF found adequate evidence to bound the potential harms of counseling interventions as no greater than small, based on the nature of the intervention and the low likelihood of serious harms. The USPSTF found inadequate evidence to assess the benefits and harms of other noncounseling interventions. The USPSTF concludes with moderate certainty that providing or referring pregnant or postpartum women at increased risk to counseling interventions has a moderate net benefit in preventing perinatal depression.Conclusions and Recommendation: The USPSTF recommends that clinicians provide or refer pregnant and postpartum persons who are at increased risk of perinatal depression to counseling interventions. (B recommendation).

  View details for PubMedID 30747971

• Cost-effectiveness of Canakinumab for Prevention of Recurrent Cardiovascular Events JAMA CARDIOLOGY Sehested, T. G., Bjerre, J., Ku, S., Chang, A., Jahansouz, A., Owens, D. K., Hlatky, M. A., Goldhaber-Fiebert, J. D. 2019; 4 (2): 128–35

  View details for DOI 10.1001/jamacardio.2018.4566

  View details for Web of Science ID 000459481900009

• Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: US Preventive Services Task Force Reaffirmation Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 321 (4): 394–98

  Abstract

  Importance: In the United States, the rate of gonococcal ophthalmia neonatorum was an estimated 0.4 cases per 100 000 live births per year from 2013 to 2017. Gonococcal ophthalmia neonatorum can cause corneal scarring, ocular perforation, and blindness as early as 24 hours after birth. In the absence of ocular prophylaxis, transmission rates of gonococcal infection from mother to newborn are 30% to 50%.Objective: To reaffirm the US Preventive Services Task Force (USPSTF) 2011 recommendation on ocular prophylaxis for gonococcal ophthalmia neonatorum.Evidence Review: The USPSTF commissioned a reaffirmation evidence update to identify new and substantial evidence sufficient enough to change its prior recommendation.Findings: Using a reaffirmation process, the USPSTF found no new data that would change its previous conclusion that topical ocular prophylaxis is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions. The USPSTF found no new data that would change its previous conclusion that there is convincing evidence that topical ocular prophylaxis of all newborns is not associated with serious harms. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that topical ocular prophylaxis for all newborns provides substantial benefit.Conclusions and Recommendation: The USPSTF recommends prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum. (A recommendation).

  View details for PubMedID 30694327

• Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum US Preventive Services Task Force Reaffirmation Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., Us Preventive Serv Task Force 2019; 321 (4): 394–98

  View details for DOI 10.1001/jama.2018.21367

  View details for Web of Science ID 000457130400025

• Cost-effectiveness of Canakinumab for Prevention of Recurrent Cardiovascular Events. JAMA cardiology Sehested, T. S., Bjerre, J., Ku, S., Chang, A., Jahansouz, A., Owens, D. K., Hlatky, M. A., Goldhaber-Fiebert, J. D. 2019

  Abstract

  Importance: In the Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) trial, the anti-inflammatory monoclonal antibody canakinumab significantly reduced the risk of recurrent cardiovascular events in patients with previous myocardial infarction (MI) and high-sensitivity C-reactive protein (hs-CRP) levels of 2 mg/L or greater.Objective: To estimate the cost-effectiveness of adding canakinumab to standard of care for the secondary prevention of major cardiovascular events over a range of potential prices.Design, Setting, and Participants: A state-transition Markov model was constructed to estimate costs and outcomes over a lifetime horizon by projecting rates of recurrent MI, coronary revascularization, infection, and lung cancer with and without canakinumab treatment. We used a US health care sector perspective, and the base case used the current US market price of canakinumab of $73 000 per year. A hypothetical cohort of patients after MI aged 61 years with an hs-CRP level of 2 mg/L or greater was constructed.Interventions: Canakinumab, 150 mg, administered every 3 months plus standard of care compared with standard of care alone.Main Outcomes and Measures: Lifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually.Results: Adding canakinumab to standard of care increased life expectancy from 11.31 to 11.36 years, QALYs from 9.37 to 9.50, and costs from $242 000 to $1 074 000, yielding an incremental cost-effectiveness ratio of $6.4 million per QALY gained. The price would have to be reduced by more than 98% (to $1150 per year or less) to meet the $100 000 per QALY willingness-to-pay threshold. These results were generally robust across alternative assumptions, eg, substantially lower health-related quality of life after recurrent cardiovascular events, lower infection rates while receiving canakinumab, and reduced all-cause mortality while receiving canakinumab. Including a potential beneficial effect of canakinumab on lung cancer incidence improved the incremental cost-effectiveness ratio to $3.5 million per QALY gained. A strategy of continuing canakinumab selectively in patients with reduction in hs-CRP levels to less than 2 mg/L would have a cost-effectiveness ratio of $819 000 per QALY gained.Conclusions and Relevance: Canakinumab is not cost-effective at current US prices for prevention of recurrent cardiovascular events in patients with a prior MI. Substantial price reductions would be needed for canakinumab to be considered cost-effective.

  View details for PubMedID 30649147

• Annual report to the nation on the status of cancer, part II: Recent changes in prostate cancer trends and disease characteristics CANCER Curry, S. J., Krist, A. H., Owens, D. K. 2019; 125 (2): 317–18

  View details for DOI 10.1002/cncr.31846

  View details for Web of Science ID 000455536300019

• Would You Recommend Prostate-Specific Antigen Screening for This Patient?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center. Annals of internal medicine Burns, R. B., Olumi, A. F., Owens, D. K., Smetana, G. W. 2019; 170 (11): 770–78

  Abstract

  Prostate cancer is the third most common cancer type in the United States overall, accounting for 9.5% of new cancer cases and 5% of cancer deaths. The goal of prostate-specific antigen (PSA)-based screening is to identify early-stage disease that can be treated successfully. The U.S. Preventive Services Task Force (USPSTF) reviewed evidence on the benefits and harms of PSA-based screening and treatment of screen-detected prostate cancer. It found that PSA-based screening in men aged 55 to 69 years prevents approximately 1.3 deaths from prostate cancer over 13 years per 1000 men screened and 3 cases of metastatic cancer per 1000 men screened, with no reduction in all-cause mortality. No benefit was found for PSA-based screening in men aged 70 years and older. On the basis of its review, the USPSTF concluded that the decision for men aged 55 to 69 years to have PSA-based screening should be an individual one and should include a discussion of the potential benefits and harms. Here, 2 experts-an internist and a urologist-discuss the key points of a shared decision-making conversation about PSA-based prostate cancer screening, the PSA-based screening strategy that optimizes benefit and minimizes harm, and the PSA threshold at which they would recommend further diagnostic testing.

  View details for DOI 10.7326/M19-1072

  View details for PubMedID 31158876

• Screening for Abdominal Aortic Aneurysm: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kubik, M., Landefeld, C. S., Mangione, C. M., Pbert, L., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2019; 322 (22): 2211–18

  Abstract

  Importance: An abdominal aortic aneurysm (AAA) is typically defined as aortic enlargement with a diameter of 3.0 cm or larger. The prevalence of AAA has declined over the past 2 decades among screened men 65 years or older in various European countries. The current prevalence of AAA in the United States is unclear because of the low uptake of screening. Most AAAs are asymptomatic until they rupture. Although the risk for rupture varies greatly by aneurysm size, the associated risk for death with rupture is as high as 81%.Objective: To update its 2014 recommendation, the USPSTF commissioned a review of the evidence on the effectiveness of 1-time and repeated screening for AAA, the associated harms of screening, and the benefits and harms of available treatments for small AAAs (3.0-5.4 cm in diameter) identified through screening.Population: This recommendation applies to asymptomatic adults 50 years or older. However, the randomized trial evidence focuses almost entirely on men aged 65 to 75 years.Evidence Assessment: Based on a review of the evidence, the USPSTF concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have ever smoked is of moderate net benefit. The USPSTF concludes with moderate certainty that screening for AAA in men aged 65 to 75 years who have never smoked is of small net benefit. The USPSTF concludes that the evidence is insufficient to determine the net benefit of screening for AAA in women aged 65 to 75 years who have ever smoked or have a family history of AAA. The USPSTF concludes with moderate certainty that the harms of screening for AAA in women aged 65 to 75 years who have never smoked and have no family history of AAA outweigh the benefits.Recommendations: The USPSTF recommends 1-time screening for AAA with ultrasonography in men aged 65 to 75 years who have ever smoked. (B recommendation) The USPSTF recommends that clinicians selectively offer screening for AAA with ultrasonography in men aged 65 to 75 years who have never smoked rather than routinely screening all men in this group. (C recommendation) The USPSTF recommends against routine screening for AAA with ultrasonography in women who have never smoked and have no family history of AAA. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for AAA with ultrasonography in women aged 65 to 75 years who have ever smoked or have a family history of AAA. (I statement).

  View details for DOI 10.1001/jama.2019.18928

  View details for PubMedID 31821437

• Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: US Preventive Services Task Force Recommendation Statement. JAMA Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M. n., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kubik, M. n., Landefeld, C. S., Mangione, C. M., Pbert, L. n., Silverstein, M. n., Simon, M. A., Tseng, C. W., Wong, J. B. 2019; 322 (7): 652–65

  Abstract

  Potentially harmful mutations of the breast cancer susceptibility 1 and 2 genes (BRCA1/2) are associated with increased risk for breast, ovarian, fallopian tube, and peritoneal cancer. For women in the United States, breast cancer is the most common cancer after nonmelanoma skin cancer and the second leading cause of cancer death. In the general population, BRCA1/2 mutations occur in an estimated 1 in 300 to 500 women and account for 5% to 10% of breast cancer cases and 15% of ovarian cancer cases.To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on risk assessment, genetic counseling, and genetic testing for BRCA-related cancer.The USPSTF reviewed the evidence on risk assessment, genetic counseling, and genetic testing for potentially harmful BRCA1/2 mutations in asymptomatic women who have never been diagnosed with BRCA-related cancer, as well as those with a previous diagnosis of breast, ovarian, tubal, or peritoneal cancer who have completed treatment and are considered cancer free. In addition, the USPSTF reviewed interventions to reduce the risk for breast, ovarian, tubal, or peritoneal cancer in women with potentially harmful BRCA1/2 mutations, including intensive cancer screening, medications, and risk-reducing surgery.For women whose family or personal history is associated with an increased risk for harmful mutations in the BRCA1/2 genes, or who have an ancestry associated with BRCA1/2 gene mutations, there is adequate evidence that the benefits of risk assessment, genetic counseling, genetic testing, and interventions are moderate. For women whose personal or family history or ancestry is not associated with an increased risk for harmful mutations in the BRCA1/2 genes, there is adequate evidence that the benefits of risk assessment, genetic counseling, genetic testing, and interventions are small to none. Regardless of family or personal history, the USPSTF found adequate evidence that the overall harms of risk assessment, genetic counseling, genetic testing, and interventions are small to moderate.The USPSTF recommends that primary care clinicians assess women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have an ancestry associated with BRCA1/2 gene mutations with an appropriate brief familial risk assessment tool. Women with a positive result on the risk assessment tool should receive genetic counseling and, if indicated after counseling, genetic testing. (B recommendation) The USPSTF recommends against routine risk assessment, genetic counseling, or genetic testing for women whose personal or family history or ancestry is not associated with potentially harmful BRCA1/2 gene mutations. (D recommendation).

  View details for DOI 10.1001/jama.2019.10987

  View details for PubMedID 31429903

• Screening for Asymptomatic Bacteriuria in Adults: US Preventive Services Task Force Recommendation Statement. JAMA Owens, D. K., Davidson, K. W., Krist, A. H., Barry, M. J., Cabana, M. n., Caughey, A. B., Doubeni, C. A., Epling, J. W., Kubik, M. n., Landefeld, C. S., Mangione, C. M., Pbert, L. n., Silverstein, M. n., Simon, M. A., Tseng, C. W., Wong, J. B. 2019; 322 (12): 1188–94

  Abstract

  Among the general adult population, women (across all ages) have the highest prevalence of asymptomatic bacteriuria, although rates increase with age among both men and women. Asymptomatic bacteriuria is present in an estimated 1% to 6% of premenopausal women and an estimated 2% to 10% of pregnant women and is associated with pyelonephritis, one of the most common nonobstetric reasons for hospitalization in pregnant women. Among pregnant persons, pyelonephritis is associated with perinatal complications including septicemia, respiratory distress, low birth weight, and spontaneous preterm birth.To update its 2008 recommendation, the USPSTF commissioned a review of the evidence on potential benefits and harms of screening for and treatment of asymptomatic bacteriuria in adults, including pregnant persons.This recommendation applies to community-dwelling adults 18 years and older and pregnant persons of any age without signs and symptoms of a urinary tract infection.Based on a review of the evidence, the USPSTF concludes with moderate certainty that screening for and treatment of asymptomatic bacteriuria in pregnant persons has moderate net benefit in reducing perinatal complications. There is adequate evidence that pyelonephritis in pregnancy is associated with negative maternal outcomes and that treatment of screen-detected asymptomatic bacteriuria can reduce the incidence of pyelonephritis in pregnant persons. The USPSTF found adequate evidence of harms associated with treatment of asymptomatic bacteriuria (including adverse effects of antibiotic treatment and changes in the microbiome) to be at least small in magnitude. The USPSTF concludes with moderate certainty that screening for and treatment of asymptomatic bacteriuria in nonpregnant adults has no net benefit. The known harms associated with treatment include adverse effects of antibiotic use and changes to the microbiome. Based on these known harms, the USPSTF determined the overall harms to be at least small in this group.The USPSTF recommends screening pregnant persons for asymptomatic bacteriuria using urine culture. (B recommendation) The USPSTF recommends against screening for asymptomatic bacteriuria in nonpregnant adults. (D recommendation).

  View details for DOI 10.1001/jama.2019.13069

  View details for PubMedID 31550038

• The Costs of Hepatitis C by Liver Disease Stage: Estimates from the Veterans Health Administration. Applied health economics and health policy Gidwani-Marszowski, R. n., Owens, D. K., Lo, J. n., Goldhaber-Fiebert, J. D., Asch, S. M., Barnett, P. G. 2019

  Abstract

  The release of highly effective but costly medications for the treatment of hepatitis C virus combined with a doubling in the incidence of hepatitis C virus have posed substantial financial challenges for many healthcare systems. We provide estimates of the cost of treating patients with hepatitis C virus that can inform the triage of pharmaceutical care in systems with limited healthcare resources.We conducted an observational study using a national US cohort of 206,090 veterans with laboratory-identified hepatitis C virus followed from Fiscal Year 2010 to 2014. We estimated the cost of: non-advanced Fibrosis-4; advanced Fibrosis-4; hepatocellular carcinoma; liver transplant; and post-liver transplant. The former two stages were ascertained using laboratory result data; the latter stages were ascertained using administrative data. Costs were obtained from the Veterans Health Administration's activity-based cost accounting system and more closely represent the actual costs of providing care, an improvement on the charge data that generally characterizes the hepatitis C virus cost literature. Generalized estimating equations were used to estimate and predict costs per liver disease stage. Missing data were multiply imputed.Annual costs of care increased as patients progressed from non-advanced Fibrosis-4 to advanced Fibrosis-4, hepatocellular carcinoma, and liver transplant (all p < 0.001). Post-liver transplant, costs decreased significantly (p < 0.001). In simulations, patients were estimated to incur the following annual costs: US $17,556 for non-advanced Fibrosis-4; US $20,791 for advanced Fibrosis-4; US $46,089 for liver cancer; US $261,959 in the year of the liver transplant; and US $18,643 per year after the liver transplant.Cost differences of treating non-advanced and advanced Fibrosis-4 are relatively small. The greatest cost savings would be realized from avoiding progression to liver cancer and transplant.

  View details for PubMedID 31030359

• Weight Loss Interventions in Adults-Reply. JAMA Curry, S. J., Owens, D. K., Krist, A. H. 2019; 321 (9): 900–901

  View details for PubMedID 30835304

• Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Multiply Relapsed or Refractory Adult Large B-Cell Lymphoma Journal of Clinical Oncology Lin, J. K., Muffly, L. S., Spinner, M. A., Barnes, J. I., Owens, D. K., Goldhaber-Fiebert, J. D. 2019

  View details for DOI 10.1200/JCO.18.02079

• Missing data strategies for time-varying confounders in comparative effectiveness studies of non-missing time-varying exposures and right-censored outcomes. Statistics in medicine Desai, M. n., Montez-Rath, M. E., Kapphahn, K. n., Joyce, V. R., Mathur, M. B., Garcia, A. n., Purington, N. n., Owens, D. K. 2019

  Abstract

  The treatment of missing data in comparative effectiveness studies with right-censored outcomes and time-varying covariates is challenging because of the multilevel structure of the data. In particular, the performance of an accessible method like multiple imputation (MI) under an imputation model that ignores the multilevel structure is unknown and has not been compared to complete-case (CC) and single imputation methods that are most commonly applied in this context. Through an extensive simulation study, we compared statistical properties among CC analysis, last value carried forward, mean imputation, the use of missing indicators, and MI-based approaches with and without auxiliary variables under an extended Cox model when the interest lies in characterizing relationships between non-missing time-varying exposures and right-censored outcomes. MI demonstrated favorable properties under a moderate missing-at-random condition (absolute bias <0.1) and outperformed CC and single imputation methods, even when the MI method did not account for correlated observations in the imputation model. The performance of MI decreased with increasing complexity such as when the missing data mechanism involved the exposure of interest, but was still preferred over other methods considered and performed well in the presence of strong auxiliary variables. We recommend considering MI that ignores the multilevel structure in the imputation model when data are missing in a time-varying confounder, incorporating variables associated with missingness in the MI models as well as conducting sensitivity analyses across plausible assumptions.

  View details for DOI 10.1002/sim.8174

  View details for PubMedID 31099433

• Electrocardiography Screening for Atrial Fibrillation Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K. 2018; 320 (24): 2598–99

  View details for DOI 10.1001/jama.2018.17768

  View details for Web of Science ID 000454693000023

• Electrocardiography Screening for Atrial Fibrillation-Reply. JAMA Curry, S. J., Krist, A. H., Owens, D. K. 2018; 320 (24): 2598–99

  View details for PubMedID 30575872

• Screening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement OBSTETRICAL & GYNECOLOGICAL SURVEY Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2018; 73 (12): 689–90

  View details for DOI 10.1097/01.ogx.0000549540.69362.81

  View details for Web of Science ID 000454111800014

• Interventions to Prevent Child Maltreatment US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Services Task Force 2018; 320 (20): 2122–28

  View details for DOI 10.1001/jama.2018.17772

  View details for Web of Science ID 000451395000019

• Interventions to Prevent Child Maltreatment: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2018; 320 (20): 2122–28

  Abstract

  Importance: In 2016, approximately 676 000 children in the United States experienced maltreatment (abuse, neglect, or both), with 75% of these children experiencing neglect, 18% experiencing physical abuse, and 8% experiencing sexual abuse. Approximately 14% of abused children experienced multiple forms of maltreatment, and more than 1700 children died as a result of maltreatment.Objective: To update the US Preventive Services Task Force (USPSTF) 2013 recommendation on primary care interventions to prevent child maltreatment.Evidence Review: The USPSTF commissioned a review of the evidence on primary care interventions to prevent maltreatment in children and adolescents without signs or symptoms of maltreatment.Findings: The USPSTF found limited and inconsistent evidence on the benefits of primary care interventions, including home visitation programs, to prevent child maltreatment and found no evidence related to the harms of such interventions. The USPSTF concludes that the evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. The level of certainty of the magnitude of the benefits and harms of these interventions is low.Conclusions and Recommendation: The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. (I statement).

  View details for PubMedID 30480735

• Annual Report to the Nation on the Status of Cancer, Part II: Recent changes in prostate cancer trends and disease characteristics. Cancer Curry, S. J., Krist, A. H., Owens, D. K. 2018

  View details for PubMedID 30427532

• Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (18): 1899–1909

  View details for DOI 10.1001/jama.2018.16789

  View details for Web of Science ID 000449945900017

• A Cost-Effectiveness Analysis of Interstage Home Monitoring for Infants With Hypoplastic Left Heart Syndrome. Priromprintr, B., Owens, D., Almond, C. S., Hong, T., Kondragunta, R., Mathur, S., Shin, A. Y. LIPPINCOTT WILLIAMS & WILKINS. 2018

  View details for Web of Science ID 000528619400405

• Cost-Effectiveness of Screening for Nasopharyngeal Carcinoma with Plasma Epstein-Barr Virus DNA Harris, J. P., Saraswathula, A., Kaplun, B. D., Qian, Y., Chan, K. A., Chan, A. C., Le, Q. T., Owens, D., Goldhaber-Fiebert, J. D., Pollom, E. ELSEVIER SCIENCE INC. 2018: E401

  View details for DOI 10.1016/j.ijrobp.2018.07.1184

  View details for Web of Science ID 000447811601207

• Screening for Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults: US Preventive Services Task Force Final Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Kurth, A., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2018; 320 (16): 1678–87

  Abstract

  Importance: Intimate partner violence (IPV) and abuse of older or vulnerable adults are common in the United States but often remain undetected. In addition to the immediate effects of IPV, such as injury and death, there are other health consequences, many with long-term effects, including development of mental health conditions such as depression, posttraumatic stress disorder, anxiety disorders, substance abuse, and suicidal behavior; sexually transmitted infections; unintended pregnancy; and chronic pain and other disabilities. Long-term negative health effects from elder abuse include death, higher risk of nursing home placement, and adverse psychological consequences.Objective: To update the US Preventive Services Task Force (USPSTF) 2013 recommendation on screening for IPV, elder abuse, and abuse of vulnerable adults.Evidence Review: The USPSTF commissioned a review of the evidence on screening for IPV in adolescents, women, and men; for elder abuse; and for abuse of vulnerable adults.Findings: The USPSTF concludes with moderate certainty that screening for IPV in women of reproductive age and providing or referring women who screen positive to ongoing support services has a moderate net benefit. There is adequate evidence that available screening instruments can identify IPV in women. The evidence does not support the effectiveness of brief interventions or the provision of information about referral options in the absence of ongoing supportive intervention components. The evidence demonstrating benefit of ongoing support services is predominantly found in studies of pregnant or postpartum women. The benefits and harms of screening for elder abuse and abuse of vulnerable adults are uncertain, and the balance of benefits and harms cannot be determined.Conclusions and Recommendation: The USPSTF recommends that clinicians screen for IPV in women of reproductive age and provide or refer women who screen positive to ongoing support services. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for abuse and neglect in all older or vulnerable adults. (I statement).

  View details for PubMedID 30357305

• Screening for Intimate Partner Violence, Elder Abuse, and Abuse of Vulnerable Adults US Preventive Services Task Force Final Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., US Prevent Serv Task Force 2018; 320 (16): 1678–87

  View details for DOI 10.1001/jama.2018.14741

  View details for Web of Science ID 000448069100017

• Future Directions for Cost-effectiveness Analyses in Health and Medicine MEDICAL DECISION MAKING Neumann, P. J., Kim, D. D., Trikalinos, T. A., Sculpher, M. J., Salomon, J. A., Prosser, L. A., Owens, D. K., Meltzer, D. O., Kuntz, K. M., Krahn, M., Feeny, D., Basu, A., Russell, L. B., Siegel, J. E., Ganiats, T. G., Sanders, G. D. 2018; 38 (7): 767–77

  Abstract

  In 2016, the Second Panel on Cost-effectiveness in Health and Medicine updated the seminal work of the original panel from 2 decades earlier. The Second Panel had an opportunity to reflect on the evolution of cost-effectiveness analysis (CEA) and to provide guidance for the next generation of practitioners and consumers. In this article, we present key topics for future research and policy.During the course of its deliberations, the Second Panel discussed numerous topics for advancing methods and for improving the use of CEA in decision making. We identify and consider 7 areas for which the panel believes that future research would be particularly fruitful. In each of these areas, we highlight outstanding research needs. The list is not intended as an exhaustive inventory but rather a set of key items that surfaced repeatedly in the panel's discussions. In the online Appendix , we also list and expound briefly on 8 other important topics.We highlight 7 key areas: CEA and perspectives (determining, valuing, and summarizing elements for the analysis), modeling (comparative modeling and model transparency), health outcomes (valuing temporary health and path states, as well as health effects on caregivers), costing (a cost catalogue, valuing household production, and productivity effects), evidence synthesis (developing theory on learning across studies and combining data from clinical trials and observational studies), estimating and using cost-effectiveness thresholds (empirically representing 2 broad concepts: opportunity costs and public willingness to pay), and reporting and communicating CEAs (written protocols and a quality scoring system).Cost-effectiveness analysis remains a flourishing and evolving field with many opportunities for research. More work is needed on many fronts to understand how best to incorporate CEA into policy and practice.

  View details for PubMedID 30248277

• Operative vs Nonoperative Management of Appendicitis: A Long-Term Cost-Effectiveness Analysis Sceats, L. A., Coughran, A., Barnes, B., Grimm, E. L., Muffly, M., Spain, D. A., Kin, C. J., Owens, D. K., Fiebert, J. ELSEVIER SCIENCE INC. 2018: S157–S158

  View details for DOI 10.1016/j.jamcollsurg.2018.07.334

  View details for Web of Science ID 000447760600305

• Behavioral Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (11): 1163–71

  View details for DOI 10.1001/jama.2018.13022

  View details for Web of Science ID 000444878600016

• Behavioral Weight Loss Interventions to Prevent Obesity-Related Morbidity and Mortality in Adults: US Preventive Services Task Force Recommendation Statement. JAMA Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Grossman, D. C., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C. W., Wong, J. B. 2018; 320 (11): 1163-1171

  Abstract

  More than 35% of men and 40% of women in the United States are obese. Obesity is associated with health problems such as increased risk for coronary heart disease, type 2 diabetes, various types of cancer, gallstones, and disability. Obesity is also associated with an increased risk for death, particularly among adults younger than 65 years.To update the US Preventive Services Task Force (USPSTF) 2012 recommendation on screening for obesity in adults.The USPSTF reviewed the evidence on interventions (behavioral and pharmacotherapy) for weight loss or weight loss maintenance that can be provided in or referred from a primary care setting. Surgical weight loss interventions and nonsurgical weight loss devices (eg, gastric balloons) are considered to be outside the scope of the primary care setting.The USPSTF found adequate evidence that intensive, multicomponent behavioral interventions in adults with obesity can lead to clinically significant improvements in weight status and reduce the incidence of type 2 diabetes among adults with obesity and elevated plasma glucose levels; these interventions are of moderate benefit. The USPSTF found adequate evidence that behavior-based weight loss maintenance interventions are of moderate benefit. The USPSTF found adequate evidence that the harms of intensive, multicomponent behavioral interventions (including weight loss maintenance interventions) in adults with obesity are small to none. Therefore, the USPSTF concludes with moderate certainty that offering or referring adults with obesity to intensive behavioral interventions or behavior-based weight loss maintenance interventions has a moderate net benefit.The USPSTF recommends that clinicians offer or refer adults with a body mass index of 30 or higher to intensive, multicomponent behavioral interventions. (B recommendation).

  View details for DOI 10.1001/jama.2018.13022

  View details for PubMedID 30326502

• Cost Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Relapsed or Refractory Pediatric B-Cell Acute Lymphoblastic Leukemia. Journal of clinical oncology : official journal of the American Society of Clinical Oncology Lin, J. K., Lerman, B. J., Barnes, J. I., Boursiquot, B. C., Tan, Y. J., Robinson, A. Q., Davis, K. L., Owens, D. K., Goldhaber-Fiebert, J. D. 2018: JCO2018790642

  Abstract

  Purpose The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel was recently approved to treat relapsed or refractory pediatric acute lymphoblastic leukemia. With a one-time infusion cost of $475,000, tisagenlecleucel is currently the most expensive oncologic therapy. We aimed to determine whether tisagenlecleucel is cost effective compared with currently available treatments. Methods Markov modeling was used to evaluate tisagenlecleucel in pediatric relapsed or refractory acute lymphoblastic leukemia from a US health payer perspective over a lifetime horizon. The model was informed by recent multicenter, single-arm clinical trials. Tisagenlecleucel (under a range of plausible long-term effectiveness) was compared with blinatumomab, clofarabine combination therapy (clofarabine, etoposide, and cyclophosphamide), and clofarabine monotherapy. Scenario and probabilistic sensitivity analyses were used to explore uncertainty. Main outcomes were life-years, discounted lifetime costs, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (3% discount rate). Results With an assumption of a 40% 5-year relapse-free survival rate, tisagenlecleucel increased life expectancies by 12.1 years and cost $61,000/QALY gained. However, at a 20% 5-year relapse-free survival rate, life-expectancies were more modest (3.8 years) and expensive ($151,000/QALY gained). At a 0% 5-year relapse-free survival rate and with use as a bridge to transplant, tisagenlecleucel increased life expectancies by 5.7 years and cost $184,000/QALY gained. Reduction of the price of tisagenlecleucel to $200,000 or $350,000 would allow it to meet a $100,000/QALY or $150,000/QALY willingness-to-pay threshold in all scenarios. Conclusion The long-term effectiveness of tisagenlecleucel is a critical but uncertain determinant of its cost effectiveness. At its current price, tisagenlecleucel represents reasonable value if it can keep a substantial fraction of patients in remission without transplantation; however, if all patients ultimately require a transplantation to remain in remission, it will not be cost effective at generally accepted thresholds. Price reductions would favorably influence cost effectiveness even if long-term clinical outcomes are modest.

  View details for DOI 10.1200/JCO.2018.79.0642

  View details for PubMedID 30212291

• Screening for Syphilis Infection in Pregnant Women US Preventive Services Task Force Reaffirmation Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Kurth, A. E., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (9): 911–17

  Abstract

  Untreated syphilis infection in pregnant women can be transmitted to the fetus (congenital syphilis) at any time during pregnancy or at birth. Congenital syphilis is associated with stillbirth, neonatal death, and significant morbidity in infants (eg, bone deformities and neurologic impairment). After a steady decline from 2008 to 2012, cases of congenital syphilis markedly increased from 2012 to 2106, from 8.4 to 15.7 cases per 100 000 live births (an increase of 87%). At the same time, national rates of syphilis increased among women of reproductive age.To update the US Preventive Services Task Force (USPSTF) 2009 recommendation on screening for syphilis infection in pregnant women.The USPSTF commissioned a reaffirmation evidence update to identify new and substantial evidence sufficient enough to change its prior recommendation. Given the established benefits and practice of screening for syphilis in pregnant women, the USPSTF targeted its evidence review on the direct benefits of screening on the prevention of congenital syphilis morbidity and mortality and the harms of screening for and treatment of syphilis infection in pregnant women.Using a reaffirmation process, the USPSTF found that accurate screening algorithms are available to identify syphilis infection. Effective treatment with antibiotics can prevent congenital syphilis and significantly decrease adverse pregnancy outcomes, with small associated harms, providing an overall substantial health benefit. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that screening for syphilis infection in pregnant women provides substantial benefit.The USPSTF recommends early screening for syphilis infection in all pregnant women. (A recommendation).

  View details for PubMedID 30193283

• Screening for Cervical Cancer US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (7): 674–86

  Abstract

  The number of deaths from cervical cancer in the United States has decreased substantially since the implementation of widespread cervical cancer screening and has declined from 2.8 to 2.3 deaths per 100 000 women from 2000 to 2015.To update the US Preventive Services Task Force (USPSTF) 2012 recommendation on screening for cervical cancer.The USPSTF reviewed the evidence on screening for cervical cancer, with a focus on clinical trials and cohort studies that evaluated screening with high-risk human papillomavirus (hrHPV) testing alone or hrHPV and cytology together (cotesting) compared with cervical cytology alone. The USPSTF also commissioned a decision analysis model to evaluate the age at which to begin and end screening, the optimal interval for screening, the effectiveness of different screening strategies, and related benefits and harms of different screening strategies.Screening with cervical cytology alone, primary hrHPV testing alone, or cotesting can detect high-grade precancerous cervical lesions and cervical cancer. Screening women aged 21 to 65 years substantially reduces cervical cancer incidence and mortality. The harms of screening for cervical cancer in women aged 30 to 65 years are moderate. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone in women aged 21 to 29 years substantially outweigh the harms. The USPSTF concludes with high certainty that the benefits of screening every 3 years with cytology alone, every 5 years with hrHPV testing alone, or every 5 years with both tests (cotesting) in women aged 30 to 65 years outweigh the harms. Screening women older than 65 years who have had adequate prior screening and women younger than 21 years does not provide significant benefit. Screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer provides no benefit. The USPSTF concludes with moderate to high certainty that screening women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer, screening women younger than 21 years, and screening women who have had a hysterectomy with removal of the cervix for indications other than a high-grade precancerous lesion or cervical cancer does not result in a positive net benefit.The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women aged 21 to 29 years. (A recommendation) The USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years with hrHPV testing alone, or every 5 years with hrHPV testing in combination with cytology (cotesting) in women aged 30 to 65 years. (A recommendation) The USPSTF recommends against screening for cervical cancer in women younger than 21 years. (D recommendation) The USPSTF recommends against screening for cervical cancer in women older than 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer. (D recommendation) The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and do not have a history of a high-grade precancerous lesion or cervical cancer. (D recommendation).

  View details for PubMedID 30140884

• Cost-effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia in older adults without deletion 17p BLOOD ADVANCES Barnes, J., Divi, V., Begaye, A., Wong, R., Coutre, S., Owens, D. K., Goldhaber-Fiebert, J. D. 2018; 2 (15): 1946–56

  Abstract

  Ibrutinib is a novel oral therapy that has shown significant efficacy as initial treatment of chronic lymphocytic leukemia (CLL). It is a high-cost continuous therapy differing from other regimens that are given for much shorter courses. Our objective was to evaluate the cost-effectiveness of ibrutinib for first-line treatment of CLL in patients older than age 65 years without a 17p deletion. We developed a semi-Markov model to analyze the cost-effectiveness of ibrutinib vs a comparator therapy from a US Medicare perspective. No direct comparison between ibrutinib and the best available treatment alternative, obinutuzumab plus chlorambucil (chemoimmunotherapy), exists. Therefore, we compared ibrutinib to a theoretical treatment alternative, which was modeled to confer the effectiveness of an inferior treatment (chlorambucil alone) and the costs and adverse events of chemoimmunotherapy, which would provide ibrutinib with the best chance of being cost-effective. Even so, the incremental cost-effectiveness ratio of ibrutinib vs the modeled comparator was $189 000 per quality-adjusted life-year (QALY) gained. To reach a willingness-to-pay threshold (WTP) of $150 000 per QALY, the monthly cost of ibrutinib would have to be at most $6800, $1700 less than the modeled cost of $8500 per month (a reduction of $20 400 per year). When the comparator efficacy is increased to more closely match that seen in trials evaluating chemoimmunotherapy, ibrutinib costs more than $262 000 per QALY gained, and the monthly cost of ibrutinib would need to be lowered to less than $5000 per month to be cost-effective. Ibrutinib is not cost-effective as initial therapy at a WTP threshold of $150 000 per QALY gained.

  View details for PubMedID 30097461

  View details for PubMedCentralID PMC6093732

• Screening for Atrial Fibrillation With Electrocardiography US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., Us Preventive Services Task Force 2018; 320 (5): 478–84

  Abstract

  Atrial fibrillation is the most common type of cardiac arrhythmia (irregular heartbeat), and its prevalence increases with age, affecting about 3% of men and 2% of women aged 65 to 69 years and about 10% of adults 85 years and older. Atrial fibrillation is a major risk factor for ischemic stroke, increasing risk of stroke by as much as 5-fold. Approximately 20% of patients who have a stroke associated with atrial fibrillation are first diagnosed with atrial fibrillation at the time of stroke or shortly thereafter.To issue a new US Preventive Services Task Force (USPSTF) recommendation on screening for atrial fibrillation with electrocardiography (ECG).The USPSTF reviewed the evidence on the benefits and harms of screening for atrial fibrillation with ECG in adults 65 years and older, the effectiveness of screening with ECG for detecting previously undiagnosed atrial fibrillation compared with usual care, and the benefits and harms of anticoagulant or antiplatelet therapy for the treatment of screen-detected atrial fibrillation in older adults.Most older adults with previously undiagnosed atrial fibrillation have a stroke risk above the threshold for anticoagulant therapy and would be eligible for treatment. Anticoagulant therapy is effective for stroke prevention in symptomatic persons with atrial fibrillation and high stroke risk. However, the USPSTF found inadequate evidence to determine whether screening with ECG and subsequent treatment in asymptomatic adults is more effective than usual care. At the same time, the harms of diagnostic follow-up and treatment prompted by abnormal ECG results are well established and include misdiagnosis and invasive testing. Given these uncertainties, it is not possible to determine the net benefit of screening with ECG.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for atrial fibrillation with ECG. (I statement).

  View details for PubMedID 30088016

• Poverty and Community-Acquired Antimicrobial Resistance with Extended-Spectrum ss-Lactamase-Producing Organisms, Hyderabad, India EMERGING INFECTIOUS DISEASES Alsan, M., Kammili, N., Lakshmi, J., Xing, A., Khan, A., Rani, M., Kolli, P., Relman, D. A., Owens, D. K. 2018; 24 (8): 1490–96

  Abstract

  The decreasing effectiveness of antimicrobial agents is a global public health threat, yet risk factors for community-acquired antimicrobial resistance (CA-AMR) in low-income settings have not been clearly elucidated. Our aim was to identify risk factors for CA-AMR with extended-spectrum β-lactamase (ESBL)-producing organisms among urban-dwelling women in India. We collected microbiological and survey data in an observational study of primigravidae women in a public hospital in Hyderabad, India. We analyzed the data using multivariate logistic and linear regression and found that 7% of 1,836 women had bacteriuria; 48% of isolates were ESBL-producing organisms. Women in the bottom 50th percentile of income distribution were more likely to have bacteriuria (adjusted odds ratio 1.44, 95% CI 0.99-2.10) and significantly more likely to have bacteriuria with ESBL-producing organisms (adjusted odds ratio 2.04, 95% CI 1.17-3.54). Nonparametric analyses demonstrated a negative relationship between the prevalence of ESBL and income.

  View details for DOI 10.3201/eid2408.171030

  View details for Web of Science ID 000439050300012

  View details for PubMedID 30014842

  View details for PubMedCentralID PMC6056104

• Cost-effectiveness of canakinumab to prevent recurrent cardiovascular events Sehested, T. G., Bjerre, J., Chang, A., Ku, S., Jahansouz, A., Owens, D. K., Hlatky, M. A., Goldhaber-Fiebert, J. D. OXFORD UNIV PRESS. 2018: 503–4

  View details for Web of Science ID 000459824001584

• Risk Assessment for Cardiovascular Disease With Nontraditional Risk Factors US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (3): 272–80

  Abstract

  Cardiovascular disease (CVD) is the most common cause of death among adults in the United States. Treatment to prevent CVD events by modifying risk factors is currently informed by the Framingham Risk Score, the Pooled Cohort Equations, or similar CVD risk assessment models. If current CVD risk assessment models could be improved by adding more risk factors, treatment might be better targeted, thereby maximizing the benefits and minimizing the harms.To update the 2009 US Preventive Services Task Force (USPSTF) recommendation on using nontraditional risk factors in coronary heart disease risk assessment.The USPSTF reviewed the evidence on using nontraditional risk factors in CVD risk assessment, focusing on the ankle-brachial index (ABI), high-sensitivity C-reactive protein (hsCRP) level, and coronary artery calcium (CAC) score; the health benefits and harms of CVD risk assessment and treatment guided by nontraditional risk factors combined with the Framingham Risk Score or Pooled Cohort Equations compared with using either risk assessment model alone; and whether adding nontraditional risk factors to existing CVD risk assessment models improves measures of calibration, discrimination, and risk reclassification.The USPSTF found adequate evidence that adding the ABI, hsCRP level, and CAC score to existing CVD risk assessment models results in small improvements in discrimination and risk reclassification; however, the clinical meaning of these changes is largely unknown. Evidence on adding the ABI, hsCRP level, and CAC score to the Pooled Cohort Equations is limited. The USPSTF found inadequate evidence to assess whether treatment decisions guided by the ABI, hsCRP level, or CAC score, in addition to risk factors in existing CVD risk assessment models, leads to reduced incidence of CVD events or mortality. The USPSTF found adequate evidence to conceptually bound the harms of early detection and interventions as small. The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of using the ABI, hsCRP level, or CAC score in risk assessment for CVD in asymptomatic adults to prevent CVD events.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adding the ABI, hsCRP level, or CAC score to traditional risk assessment for CVD in asymptomatic adults to prevent CVD events. (I statement).

  View details for PubMedID 29998297

• Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K., Doubeni, C. A., Epling, J., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 320 (2): 177–83

  Abstract

  Peripheral artery disease (PAD) is a manifestation of atherosclerosis in the lower limbs. It can impair walking and, in severe cases, can lead to tissue loss, infection, and amputation. In addition to morbidity directly caused by PAD, patients with PAD are at increased risk for cardiovascular disease (CVD) events, because atherosclerosis is a systemic disease that also causes coronary and cerebrovascular events.To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on screening for PAD and CVD risk with the ankle-brachial index (ABI).The USPSTF reviewed the evidence on whether screening for PAD with the ABI in generally asymptomatic adults reduces morbidity or mortality from PAD or CVD. The current review expanded on the previous review to include individuals with diabetes and interventions that include supervised exercise and physical therapy intended to improve outcomes in the lower limbs.The USPSTF found few data on the accuracy of the ABI for identifying asymptomatic persons who can benefit from treatment of PAD or CVD. There are few studies addressing the benefits of treating screen-detected patients with PAD; 2 good-quality studies showed no benefit of using the ABI to manage daily aspirin therapy in unselected populations, and 2 studies showed no benefit from exercise therapy. No studies addressed the harms of screening, although the potential exists for overdiagnosis, labeling, and opportunity costs. Studies that addressed the harms of treatment showed nonsignificant results. Therefore, the USPSTF concludes that the current evidence is insufficient and that the balance of benefits and harms of screening for PAD with the ABI in asymptomatic adults cannot be determined.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for PAD and CVD risk with the ABI in asymptomatic adults. (I statement).

  View details for PubMedID 29998344

• Screening for Osteoporosis to Prevent Fractures US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, S., Mangione, C. M., Phipps, M. G., Pignone, M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Services Task Force 2018; 319 (24): 2521–31

  Abstract

  By 2020, approximately 12.3 million individuals in the United States older than 50 years are expected to have osteoporosis. Osteoporotic fractures, particularly hip fractures, are associated with limitations in ambulation, chronic pain and disability, loss of independence, and decreased quality of life, and 21% to 30% of patients who experience a hip fracture die within 1 year. The prevalence of primary osteoporosis (ie, osteoporosis without underlying disease) increases with age and differs by race/ethnicity. With the aging of the US population, the potential preventable burden is likely to increase in future years.To update the 2011 US Preventive Services Task Force (USPSTF) recommendation on screening for osteoporosis.The USPSTF reviewed the evidence on screening for and treatment of osteoporotic fractures in men and women, as well as risk assessment tools, screening intervals, and efficacy of screening and treatment in subgroups. The screening population was postmenopausal women and older men with no known previous osteoporotic fractures and no known comorbid conditions or medication use associated with secondary osteoporosis.The USPSTF found convincing evidence that bone measurement tests are accurate for detecting osteoporosis and predicting osteoporotic fractures in women and men. The USPSTF found adequate evidence that clinical risk assessment tools are moderately accurate in identifying risk of osteoporosis and osteoporotic fractures. The USPSTF found convincing evidence that drug therapies reduce subsequent fracture rates in postmenopausal women. The USPSTF found that the evidence is inadequate to assess the effectiveness of drug therapies in reducing subsequent fracture rates in men without previous fractures.The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in women 65 years and older. (B recommendation) The USPSTF recommends screening for osteoporosis with bone measurement testing to prevent osteoporotic fractures in postmenopausal women younger than 65 years at increased risk of osteoporosis, as determined by a formal clinical risk assessment tool. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men. (I statement).

  View details for PubMedID 29946735

• Screening for Cardiovascular Disease Risk With Electrocardiography US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B., US Preventive Serv Task Force 2018; 319 (22): 2308–14

  Abstract

  Cardiovascular disease (CVD), which encompasses atherosclerotic conditions such as coronary heart disease, cerebrovascular disease, and peripheral arterial disease, is the most common cause of death among adults in the United States. Treatment to prevent CVD events by modifying risk factors is currently informed by CVD risk assessment with tools such as the Framingham Risk Score or the Pooled Cohort Equations, which stratify individual risk to inform treatment decisions.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on screening for coronary heart disease with electrocardiography (ECG).The USPSTF reviewed the evidence on whether screening with resting or exercise ECG improves health outcomes compared with the use of traditional CVD risk assessment alone in asymptomatic adults.For asymptomatic adults at low risk of CVD events (individuals with a 10-year CVD event risk less than 10%), it is very unlikely that the information from resting or exercise ECG (beyond that obtained with conventional CVD risk factors) will result in a change in the patient's risk category as assessed by the Framingham Risk Score or Pooled Cohort Equations that would lead to a change in treatment and ultimately improve health outcomes. Possible harms are associated with screening with resting or exercise ECG, specifically the potential adverse effects of subsequent invasive testing. For asymptomatic adults at intermediate or high risk of CVD events, there is insufficient evidence to determine the extent to which information from resting or exercise ECG adds to current CVD risk assessment models and whether information from the ECG results in a change in risk management and ultimately reduces CVD events. As with low-risk adults, possible harms are associated with screening with resting or exercise ECG in asymptomatic adults at intermediate or high risk of CVD events.The USPSTF recommends against screening with resting or exercise ECG to prevent CVD events in asymptomatic adults at low risk of CVD events. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening with resting or exercise ECG to prevent CVD events in asymptomatic adults at intermediate or high risk of CVD events. (I statement).

  View details for PubMedID 29896632

• Cost Effectiveness of Radiation and Chemotherapy for High-Risk Low Grade Glioma Qian, Y., Maruyama, S., Kim, H., Pollom, E. L., Kumar, K. A., Harris, J. P., Chin, A. L., Pitt, A., Bendavid, E., Owens, D. K., Durkee, B. Y., Soltys, S. G. ELSEVIER SCIENCE INC. 2018: E26

  View details for Web of Science ID 000432447200062

• Screening for Prostate Cancer US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Bibbins-Domingo, K., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Ebel, M., Epling, J. W., Kemper, A. R., Krist, A. H., Kubik, M., Landefeld, C., Mangione, C. M., Silverstein, M., Simon, M. A., Siu, A. L., Tseng, C., US Preventive Serv Task Force 2018; 319 (18): 1901–13

  View details for DOI 10.1001/jama.2018.3710

  View details for Web of Science ID 000431668600019

• Screening for Prostate Cancer: US Preventive Services Task Force Recommendation Statement. JAMA Grossman, D. C., Curry, S. J., Owens, D. K., Bibbins-Domingo, K., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Ebell, M., Epling, J. W., Kemper, A. R., Krist, A. H., Kubik, M., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Siu, A. L., Tseng, C. W. 2018; 319 (18): 1901-1913

  Abstract

  In the United States, the lifetime risk of being diagnosed with prostate cancer is approximately 13%, and the lifetime risk of dying of prostate cancer is 2.5%. The median age of death from prostate cancer is 80 years. Many men with prostate cancer never experience symptoms and, without screening, would never know they have the disease. African American men and men with a family history of prostate cancer have an increased risk of prostate cancer compared with other men.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on prostate-specific antigen (PSA)-based screening for prostate cancer.The USPSTF reviewed the evidence on the benefits and harms of PSA-based screening for prostate cancer and subsequent treatment of screen-detected prostate cancer. The USPSTF also commissioned a review of existing decision analysis models and the overdiagnosis rate of PSA-based screening. The reviews also examined the benefits and harms of PSA-based screening in patient subpopulations at higher risk of prostate cancer, including older men, African American men, and men with a family history of prostate cancer.Adequate evidence from randomized clinical trials shows that PSA-based screening programs in men aged 55 to 69 years may prevent approximately 1.3 deaths from prostate cancer over approximately 13 years per 1000 men screened. Screening programs may also prevent approximately 3 cases of metastatic prostate cancer per 1000 men screened. Potential harms of screening include frequent false-positive results and psychological harms. Harms of prostate cancer treatment include erectile dysfunction, urinary incontinence, and bowel symptoms. About 1 in 5 men who undergo radical prostatectomy develop long-term urinary incontinence, and 2 in 3 men will experience long-term erectile dysfunction. Adequate evidence shows that the harms of screening in men older than 70 years are at least moderate and greater than in younger men because of increased risk of false-positive results, diagnostic harms from biopsies, and harms from treatment. The USPSTF concludes with moderate certainty that the net benefit of PSA-based screening for prostate cancer in men aged 55 to 69 years is small for some men. How each man weighs specific benefits and harms will determine whether the overall net benefit is small. The USPSTF concludes with moderate certainty that the potential benefits of PSA-based screening for prostate cancer in men 70 years and older do not outweigh the expected harms.For men aged 55 to 69 years, the decision to undergo periodic PSA-based screening for prostate cancer should be an individual one and should include discussion of the potential benefits and harms of screening with their clinician. Screening offers a small potential benefit of reducing the chance of death from prostate cancer in some men. However, many men will experience potential harms of screening, including false-positive results that require additional testing and possible prostate biopsy; overdiagnosis and overtreatment; and treatment complications, such as incontinence and erectile dysfunction. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the balance of benefits and harms on the basis of family history, race/ethnicity, comorbid medical conditions, patient values about the benefits and harms of screening and treatment-specific outcomes, and other health needs. Clinicians should not screen men who do not express a preference for screening. (C recommendation) The USPSTF recommends against PSA-based screening for prostate cancer in men 70 years and older. (D recommendation).

  View details for DOI 10.1001/jama.2018.3710

  View details for PubMedID 29801017

• Studies Omitted From the US Preventive Services Task Force Recommendations for Child Vision Screening JAMA OPHTHALMOLOGY Grossman, D. C., Curry, S. J., Owens, D. K. 2018; 136 (5): 600

  View details for PubMedID 29677236

• Diagnostic staging laparoscopy in gastric cancer treatment: A cost-effectiveness analysis JOURNAL OF SURGICAL ONCOLOGY Li, K., Cannon, J. D., Jiang, S. Y., Sambare, T. D., Owens, D. K., Bendavid, E., Poultsides, G. A. 2018; 117 (6): 1288–96

  View details for DOI 10.1002/jso.24942

  View details for Web of Science ID 000439810400024

• Interventions to Prevent Falls in Community-Dwelling Older Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kubik, M., Landefeld, S., Mangione, C. M., Pignone, M., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Services Task Force 2018; 319 (16): 1696–1704

  Abstract

  Falls are the leading cause of injury-related morbidity and mortality among older adults in the United States. In 2014, 28.7% of community-dwelling adults 65 years or older reported falling, resulting in 29 million falls (37.5% of which needed medical treatment or restricted activity for a day or longer) and an estimated 33 000 deaths in 2015.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on the prevention of falls in community-dwelling older adults.The USPSTF reviewed the evidence on the effectiveness and harms of primary care-relevant interventions to prevent falls and fall-related morbidity and mortality in community-dwelling older adults 65 years or older who are not known to have osteoporosis or vitamin D deficiency.The USPSTF found adequate evidence that exercise interventions have a moderate benefit in preventing falls in older adults at increased risk for falls and that multifactorial interventions have a small benefit. The USPSTF found adequate evidence that vitamin D supplementation has no benefit in preventing falls in older adults. The USPSTF found adequate evidence to bound the harms of exercise and multifactorial interventions as no greater than small. The USPSTF found adequate evidence that the overall harms of vitamin D supplementation are small to moderate.The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults 65 years or older who are at increased risk for falls. (B recommendation) The USPSTF recommends that clinicians selectively offer multifactorial interventions to prevent falls in community-dwelling adults 65 years or older who are at increased risk for falls. Existing evidence indicates that the overall net benefit of routinely offering multifactorial interventions to prevent falls is small. When determining whether this service is appropriate for an individual, patients and clinicians should consider the balance of benefits and harms based on the circumstances of prior falls, presence of comorbid medical conditions, and the patient's values and preferences. (C recommendation) The USPSTF recommends against vitamin D supplementation to prevent falls in community-dwelling adults 65 years or older. (D recommendation) These recommendations apply to community-dwelling adults who are not known to have osteoporosis or vitamin D deficiency.

  View details for PubMedID 29710141

• Vitamin D, Calcium, or Combined Supplementation for the Primary Prevention of Fractures in Community-Dwelling Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kubik, M., Landefeld, S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Services Task Force 2018; 319 (15): 1592–99

  Abstract

  Because of the aging population, osteoporotic fractures are an increasingly important cause of morbidity and mortality in the United States. Approximately 2 million osteoporotic fractures occurred in the United States in 2005, and annual incidence is projected to increase to more than 3 million fractures by 2025. Within 1 year of experiencing a hip fracture, many patients are unable to walk independently, more than half require assistance with activities of daily living, and 20% to 30% of patients will die.To update the 2013 US Preventive Services Task Force (USPSTF) recommendation on vitamin D supplementation, with or without calcium, to prevent fractures.The USPSTF reviewed the evidence on vitamin D, calcium, and combined supplementation for the primary prevention of fractures in community-dwelling adults (defined as not living in a nursing home or other institutional care setting). The review excluded studies conducted in populations with a known disorder related to bone metabolism (eg, osteoporosis or vitamin D deficiency), taking medications known to be associated with osteoporosis (eg, long-term steroids), or with a previous fracture.The USPSTF found inadequate evidence to estimate the benefits of vitamin D, calcium, or combined supplementation to prevent fractures in community-dwelling men and premenopausal women. The USPSTF found adequate evidence that daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium has no benefit for the primary prevention of fractures in community-dwelling, postmenopausal women. The USPSTF found inadequate evidence to estimate the benefits of doses greater than 400 IU of vitamin D or greater than 1000 mg of calcium to prevent fractures in community-dwelling postmenopausal women. The USPSTF found adequate evidence that supplementation with vitamin D and calcium increases the incidence of kidney stones.The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of vitamin D and calcium supplementation, alone or combined, for the primary prevention of fractures in community-dwelling, asymptomatic men and premenopausal women. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of the benefits and harms of daily supplementation with doses greater than 400 IU of vitamin D and greater than 1000 mg of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (I statement) The USPSTF recommends against daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium for the primary prevention of fractures in community-dwelling, postmenopausal women. (D recommendation) These recommendations do not apply to persons with a history of osteoporotic fractures, increased risk for falls, or a diagnosis of osteoporosis or vitamin D deficiency.

  View details for PubMedID 29677309

• Cost-effectiveness analysis of asymptomatic peripheral artery disease screening with the ABI test VASCULAR MEDICINE Itoga, N. K., Minami, H. R., Chelvakumar, M., Pearson, K., Mell, M. M., Bendavid, E., Owens, D. K. 2018; 23 (2): 97–106

  Abstract

  Screening for asymptomatic peripheral artery disease (aPAD) with the ankle-brachial index (ABI) test is hypothesized to reduce disease progression and cardiovascular (CV) events by identifying individuals who may benefit from early initiation of medical therapy. Using a Markov model, we evaluated the cost effectiveness of initiating medical therapy (e.g. statin and ACE-inhibitor) after a positive ankle-brachial index (ABI) screen in 65-year-old patients. We modeled progression to symptomatic PAD (sPAD) and CV events with and without ABI screening, evaluating differences in costs and quality-adjusted life years (QALYs). The cost of the ABI test, physician visit, new medication, CV events, and interventions for sPAD were incorporated in the model. We performed sensitivity analysis on model variables with uncertainty. Our model found an incremental cost of US $338 and an incremental QALY of 0.00380 with one-time ABI screening, resulting in an incremental cost-effectiveness ratio (ICER) of $88,758/QALY over a 35-year period. The variables with the largest effects in the ICER were aPAD disease prevalence, cost of monthly medication after a positive screen and 2-year medication adherence rates. Screening high-risk populations, such as tobacco users, where the prevalence of PAD may be 2.5 times higher, decreases the ICER to $24,092/QALY. Our analysis indicates the cost effectiveness of one-time screening for aPAD depends on prevalence, medication costs, and adherence to therapies for CV disease risk reduction. Screening in higher-risk populations under favorable assumptions about medication adherence results in the most favorable cost effectiveness, but limitations in the primary data preclude definitive assessment of cost effectiveness.

  View details for PubMedID 29345540

  View details for PubMedCentralID PMC5893367

• Behavioral Counseling to Prevent Skin Cancer US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kubik, M., Landefeld, S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Serv Task Force 2018; 319 (11): 1134–42

  Abstract

  Skin cancer is the most common type of cancer in the United States. Although invasive melanoma accounts for only 2% of all skin cancer cases, it is responsible for 80% of skin cancer deaths. Basal and squamous cell carcinoma, the 2 predominant types of nonmelanoma skin cancer, represent the vast majority of skin cancer cases.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on behavioral counseling for the primary prevention of skin cancer and the 2009 recommendation on screening for skin cancer with skin self-examination.The USPSTF reviewed the evidence on whether counseling patients about sun protection reduces intermediate outcomes (eg, sunburn or precursor skin lesions) or skin cancer; the link between counseling and behavior change, the link between behavior change and skin cancer incidence, and the harms of counseling or changes in sun protection behavior; and the link between counseling patients to perform skin self-examination and skin cancer outcomes, as well as the harms of skin self-examination.The USPSTF determined that behavioral counseling interventions are of moderate benefit in increasing sun protection behaviors in children, adolescents, and young adults with fair skin types. The USPSTF found adequate evidence that behavioral counseling interventions result in a small increase in sun protection behaviors in adults older than 24 years with fair skin types. The USPSTF found inadequate evidence on the benefits and harms of counseling adults about skin self-examination to prevent skin cancer.The USPSTF recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to UV radiation for persons aged 6 months to 24 years with fair skin types to reduce their risk of skin cancer. (B recommendation) The USPSTF recommends that clinicians selectively offer counseling to adults older than 24 years with fair skin types about minimizing their exposure to UV radiation to reduce risk of skin cancer. Existing evidence indicates that the net benefit of counseling all adults older than 24 years is small. In determining whether this service is appropriate in individual cases, patients and clinicians should consider the presence of risk factors for skin cancer. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of counseling adults about skin self-examination to prevent skin cancer. (I statement).

  View details for PubMedID 29558558

• Cost-effectiveness of alternative strategies for provision of HIV preexposure prophylaxis for people who inject drugs AIDS Fu, R., Owens, D. K., Brandeau, M. L. 2018; 32 (5): 663–72

  Abstract

  Oral HIV preexposure prophylaxis (PrEP) has been recommended as a means of HIV prevention among people who inject drugs (PWIDs) but, at current prices, is unlikely to be cost-effective for all PWID.To determine the cost-effectiveness of alternative strategies for enrolling PWID in PrEP.Dynamic network model that captures HIV transmission and progression among PWID in a representative US urban center.HIV infections averted, discounted costs and quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.We assume 25% PrEP coverage and investigate four strategies: first, random PWID are enrolled (Unselected Enrollment); second, individuals are randomly selected and enrolled together with their partners (Enroll Partners); third, individuals with the highest number of sexual and needle-sharing partnerships are enrolled (Most Partners); fourth, individuals with the greatest number of infected partners are enrolled (Most Positive Partners).PrEP can achieve significant health benefits: compared with the status quo of no PrEP, the strategies gain 1114 QALYs (Unselected Enrollment), 2194 QALYs (Enroll Partners), 2481 QALYs (Most Partners), and 3046 QALYs (Most Positive Partners) over 20 years in a population of approximately 8500 people. The incremental cost-effectiveness ratio of each strategy compared with the status quo (cost per QALY gained) is $272 000 (Unselected Enrollment), $158 000 (Enroll Partners), $124 000 (Most Partners), and $101 000 (Most Positive Partners). All strategies except Unselected Enrollment are cost-effective according to WHO criteria.Selection of high-risk PWID for PrEP can improve the cost-effectiveness of PrEP for PWID.

  View details for PubMedID 29334549

  View details for PubMedCentralID PMC5906044

• Screening for Ovarian Cancer US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, S., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Serv Task Force 2018; 319 (6): 588–94

  Abstract

  With approximately 14 000 deaths per year, ovarian cancer is the fifth most common cause of cancer death among US women and the leading cause of death from gynecologic cancer. More than 95% of ovarian cancer deaths occur among women 45 years and older.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on screening for ovarian cancer.The USPSTF reviewed the evidence on the benefits and harms of screening for ovarian cancer in asymptomatic women not known to be at high risk for ovarian cancer (ie, high risk includes women with certain hereditary cancer syndromes that increase their risk for ovarian cancer). Outcomes of interest included ovarian cancer mortality, quality of life, false-positive rate, surgery and surgical complication rates, and psychological effects of screening.The USPSTF found adequate evidence that screening for ovarian cancer does not reduce ovarian cancer mortality. The USPSTF found adequate evidence that the harms from screening for ovarian cancer are at least moderate and may be substantial in some cases, and include unnecessary surgery for women who do not have cancer. Given the lack of mortality benefit of screening, and the moderate to substantial harms that could result from false-positive screening test results and subsequent surgery, the USPSTF concludes with moderate certainty that the harms of screening for ovarian cancer outweigh the benefit, and the net balance of the benefit and harms of screening is negative.The USPSTF recommends against screening for ovarian cancer in asymptomatic women. (D recommendation) This recommendation applies to asymptomatic women who are not known to have a high-risk hereditary cancer syndrome.

  View details for PubMedID 29450531

• Screening for Adolescent Idiopathic Scoliosis US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Davidson, K. W., Doubeni, C. A., Epling, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, S., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Serv Task Force 2018; 319 (2): 165–72

  Abstract

  Adolescent idiopathic scoliosis, a lateral curvature of the spine of unknown cause with a Cobb angle of at least 10°, occurs in children and adolescents aged 10 to 18 years. Idiopathic scoliosis is the most common form and usually worsens during adolescence before skeletal maturity. Severe spinal curvature may be associated with adverse long-term health outcomes (eg, pulmonary disorders, disability, back pain, psychological effects, cosmetic issues, and reduced quality of life). Early identification and effective treatment of mild scoliosis could slow or stop curvature progression before skeletal maturity, thereby improving long-term outcomes in adulthood.To update the 2004 US Preventive Services Task Force (USPSTF) recommendation on screening for idiopathic scoliosis in asymptomatic adolescents.The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of adolescent idiopathic scoliosis.The USPSTF found no direct evidence on screening for adolescent idiopathic scoliosis and health outcomes and no evidence on the harms of screening. The USPSTF found inadequate evidence on treatment with exercise and surgery. It found adequate evidence that treatment with bracing may slow curvature progression in adolescents with mild or moderate curvature severity (Cobb angle <40° to 50°); however, evidence on the association between reduction in spinal curvature in adolescence and long-term health outcomes in adulthood is inadequate. The USPSTF found inadequate evidence on the harms of treatment. Therefore, the USPSTF concludes that the current evidence is insufficient and that the balance of benefits and harms of screening for adolescent idiopathic scoliosis cannot be determined.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for adolescent idiopathic scoliosis in children and adolescents aged 10 to 18 years. (I statement).

  View details for PubMedID 29318284

• Collaborative Modeling: Experience of the US Preventive Services Task Force AMERICAN JOURNAL OF PREVENTIVE MEDICINE Petitti, D. B., Lin, J. S., Owens, D. K., Croswell, J. M., Feuer, E. J. 2018; 54 (1): S53–S62

  View details for DOI 10.1016/j.amepre.2017.07.003

  View details for Web of Science ID 000418764300007

• Screening and Behavioral Counseling Interventions to Reduce Unhealthy Alcohol Use in Adolescents and Adults: US Preventive Services Task Force Recommendation Statement. JAMA US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Kubik, M., Landefeld, C. S., Mangione, C. M., Silverstein, M., Simon, M. A., Tseng, C., Wong, J. B. 2018; 320 (18): 1899–1909

  Abstract

  Importance: Excessive alcohol use is one of the most common causes of premature mortality in the United States. From 2006 to 2010, an estimated 88 000 alcohol-attributable deaths occurred annually in the United States, caused by both acute conditions (eg, injuries from motor vehicle collisions) and chronic conditions (eg, alcoholic liver disease). Alcohol use during pregnancy is also one of the major preventable causes of birth defects and developmental disabilities.Objective: To update the US Preventive Services Task Force (USPSTF) 2013 recommendation on screening for unhealthy alcohol use in primary care settings.Evidence Review: The USPSTF commissioned a review of the evidence on the effectiveness of screening to reduce unhealthy alcohol use (defined as a spectrum of behaviors, from risky drinking to alcohol use disorder, that result in increased risk for health consequences) morbidity, mortality, or risky behaviors and to improve health, social, or legal outcomes; the accuracy of various screening approaches; the effectiveness of counseling interventions to reduce unhealthy alcohol use, morbidity, mortality, or risky behaviors and to improve health, social, or legal outcomes; and the harms of screening and behavioral counseling interventions.Findings: The net benefit of screening and brief behavioral counseling interventions for unhealthy alcohol use in adults, including pregnant women, is moderate. The evidence is insufficient to assess the balance of benefits and harms of screening and brief behavioral counseling interventions for unhealthy alcohol use in adolescents.Conclusions and Recommendation: The USPSTF recommends screening for unhealthy alcohol use in primary care settings in adults 18 years or older, including pregnant women, and providing persons engaged in risky or hazardous drinking with brief behavioral counseling interventions to reduce unhealthy alcohol use. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening and brief behavioral counseling interventions for alcohol use in primary care settings in adolescents aged 12 to 17 years. (I statement).

  View details for PubMedID 30422199

• Update on the Methods of the U.S. Preventive Services Task Force: Linking Intermediate Outcomes and Health Outcomes in Prevention. American journal of preventive medicine Wolff, T. A., Krist, A. H., LeFevre, M., Jonas, D. E., Harris, R. P., Siu, A., Owens, D. K., Gillman, M. W., Ebell, M. H., Herzstein, J., Chou, R., Whitlock, E., Bibbins-Domingo, K. 2018; 54 (1S1): S4-S10

  Abstract

  The U.S. Preventive Services Task Force (USPSTF) is an independent body of experts who make evidence-based recommendations about clinical preventive services using a transparent and objective process. Developing recommendations on a clinical preventive service requires evidence of its effect on health outcomes. Health outcomes are symptoms, functional levels, and conditions that affect a patient's quantity or quality of life and are measured by assessments of physical or psychologic well-being. Intermediate outcomes are pathologic, physiologic, psychologic, social, or behavioral measures related to a preventive service. Given the frequent lack of evidence on health outcomes, the USPSTF uses evidence on intermediate outcomes when appropriate. The ultimate goal is to determine precisely a consistent relationship between the direction and magnitude of change in an intermediate outcome with a predictable resultant direction and magnitude of change in the health outcomes. The USPSTF reviewed its historical use of intermediate outcomes, reviewed methods of other evidence-based guideline-making bodies, consulted with other experts, and reviewed scientific literature. Most important were the established criteria for causation, tenets of evidence-based medicine, and consistency with its current standards. Studies that follow participants over time following early treatment, stratify patients according to treatment response, and adjust for important confounders can provide useful information about the association between intermediate and health outcomes. However, such studies remain susceptible to residual confounding. The USPSTF will exercise great caution when making a recommendation that depends on the evidence linking intermediate and health outcomes because of inherent evidence limitations.

  View details for DOI 10.1016/j.amepre.2017.08.032

  View details for PubMedID 29254525

• Collaborative Modeling: Experience of the U.S. Preventive Services Task Force. American journal of preventive medicine Petitti, D. B., Lin, J. S., Owens, D. K., Croswell, J. M., Feuer, E. J. 2018; 54 (1S1): S53-S62

  Abstract

  Models can be valuable tools to address uncertainty, trade-offs, and preferences when trying to understand the effects of interventions. Availability of results from two or more independently developed models that examine the same question (comparative modeling) allows systematic exploration of differences between models and the effect of these differences on model findings. Guideline groups sometimes commission comparative modeling to support their recommendation process. In this commissioned collaborative modeling, modelers work with the people who are developing a recommendation or policy not only to define the questions to be addressed but ideally, work side-by-side with each other and with systematic reviewers to standardize selected inputs and incorporate selected common assumptions. This paper describes the use of commissioned collaborative modeling by the U.S. Preventive Services Task Force (USPSTF), highlighting the general challenges and opportunities encountered and specific challenges for some topics. It delineates other approaches to use modeling to support evidence-based recommendations and the many strengths of collaborative modeling compared with other approaches. Unlike systematic reviews prepared for the USPSTF, the commissioned collaborative modeling reports used by the USPSTF in making recommendations about screening have not been required to follow a common format, sometimes making it challenging to understand key model features. This paper presents a checklist developed to critically appraise commissioned collaborative modeling reports about cancer screening topics prepared for the USPSTF.

  View details for DOI 10.1016/j.amepre.2017.07.003

  View details for PubMedID 29254526

• Effect of Interferon-Free Regimens on Disparities in Hepatitis C Treatment of US Veterans. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research Barnett, P. G., Joyce, V. R., Lo, J. n., Gidwani-Marszowski, R. n., Goldhaber-Fiebert, J. D., Desai, M. n., Asch, S. M., Holodniy, M. n., Owens, D. K. 2018; 21 (8): 921–30

  Abstract

  To determine whether implementation of interferon-free treatment for hepatitis C virus (HCV) reached groups less likely to benefit from earlier therapies, including patients with genotype 1 virus or contraindications to interferon treatment, and groups that faced treatment disparities: African Americans, patients with HIV co-infection, and those with drug use disorder.Electronic medical records of the US Veterans Health Administration (VHA) were used to characterize patients with chronic HCV infection and the treatments they received. Initiation of treatment in 206,544 patients with chronic HCV characterized by viral genotype, demographic characteristics, and comorbid medical and mental illness was studied using a competing events Cox regression over 6 years.With the advent of interferon-free regimens, the proportion treated increased from 2.4% in 2010 to 18.1% in 2015, an absolute increase of 15.7%. Patients with genotype 1 virus, poor response to previous treatment, and liver disease had the greatest increase. Large absolute increases in the proportion treated were observed in patients with HIV co-infection (18.6%), alcohol use disorder (11.9%), and drug use disorder (12.6%) and in African American (13.7%) and Hispanic (13.5%) patients, groups that were less likely to receive interferon-containing treatment. The VHA spent $962 million on interferon-free treatments in 2015, 1.5% of its operating budget.The proportion of patients with HCV treated in VHA increased sevenfold. The VHA was successful in implementing interferon treatment in previously undertreated populations, and this may become the community standard of care.

  View details for PubMedID 30098669

• Cost-Effectiveness of Chimeric Antigen Receptor T-Cell Therapy in Relapsed or Refractory Pediatric B-Cell Acute Lymphoblastic Leukemia Journal of Clinical Oncology Lin, J., Lerman, B. J., Barnes, J., Boursiquot, B., Tan, Y., Robinson, A., Davis, K., Owens, D., Goldhaber-Fiebert, J. 2018

  View details for DOI 10.1200/JCO.2018.79.0642

• Update on the Methods of the US Preventive Services Task Force: Linking Intermediate Outcomes and Health Outcomes in Prevention AMERICAN JOURNAL OF PREVENTIVE MEDICINE Wolff, T. A., Krist, A. H., LeFevre, M., Jonas, D. E., Harris, R. P., Siu, A., Owens, D. K., Gillman, M. W., Ebell, M. H., Herzstein, J., Chou, R., Whitlock, E., Bibbins-Domingo, K. 2018; 54 (1): S4–S10

  View details for DOI 10.1016/j.amepre.2017.08.032

  View details for Web of Science ID 000418764300002

• Hormone Therapy for the Primary Prevention of Chronic Conditions in Postmenopausal Women US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Davidson, K., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Serv Task Force 2017; 318 (22): 2224–33

  Abstract

  Menopause occurs at a median age of 51.3 years, and the average US woman who reaches menopause is expected to live another 30 years. The prevalence and incidence of most chronic conditions, such as coronary heart disease, dementia, stroke, fractures, and breast cancer, increase with age; however, the excess risk for these conditions that can be attributed to menopause alone is uncertain. Since the publication of findings from the Women's Health Initiative that hormone therapy use is associated with serious adverse health effects in postmenopausal women, use of menopausal hormone therapy has declined.To update the 2012 US Preventive Services Task Force (USPSTF) recommendation on the use of menopausal hormone therapy for the primary prevention of chronic conditions.The USPSTF reviewed the evidence on the benefits and harms of systemic (ie, oral or transdermal) hormone therapy for the prevention of chronic conditions in postmenopausal women and whether outcomes vary among women in different subgroups or by timing of intervention after menopause. The review did not address hormone therapy for preventing or treating menopausal symptoms.Although the use of hormone therapy to prevent chronic conditions in postmenopausal women is associated with some benefits, there are also well-documented harms. The USPSTF determined that the magnitude of both the benefits and the harms of hormone therapy in postmenopausal women is small to moderate. Therefore, the USPSTF concluded with moderate certainty that combined estrogen and progestin has no net benefit for the primary prevention of chronic conditions for most postmenopausal women with an intact uterus and that estrogen alone has no net benefit for the primary prevention of chronic conditions for most postmenopausal women who have had a hysterectomy.The USPSTF recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal women. (D recommendation) The USPSTF recommends against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal women who have had a hysterectomy. (D recommendation).

  View details for PubMedID 29234814

• Cost-Effectiveness of Radiation and Chemotherapy for High-Risk Low Grade Glioma Qian, Y., Maruyama, S., Kim, H., Pollom, E., Kumar, K. A., Harris, J. P., Chin, A. L., Pitt, A., Bendavid, E., Owens, D., Durkee, B. Y., Soltys, S. G. ELSEVIER SCIENCE INC. 2017: S37

  View details for DOI 10.1016/j.ijrobp.2017.06.098

  View details for Web of Science ID 000411559106163

• Guideline Recommendations for Statin Therapy JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K. 2017; 318 (10): 963–64

  View details for PubMedID 28898373

• Vision Screening in Children Aged 6 Months to 5 Years US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Grossman, D. C., Curry, S. J., Owens, D. K., Barry, M. J., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, C., Mangione, C. M., Phipps, M. G., Silverstein, M., Simon, M. A., Tseng, C., US Preventive Serv Task Force 2017; 318 (9): 836–44

  Abstract

  One of the most important causes of vision abnormalities in children is amblyopia (also known as "lazy eye"). Amblyopia is an alteration in the visual neural pathway in a child's developing brain that can lead to permanent vision loss in the affected eye. Among children younger than 6 years, 1% to 6% have amblyopia or its risk factors (strabismus, anisometropia, or both). Early identification of vision abnormalities could prevent the development of amblyopia.Studies show that screening rates among children vary by race/ethnicity and family income. Data based on parent reports from 2009-2010 indicated identical screening rates among black non-Hispanic children and white non-Hispanic children (80.7%); however, Hispanic children were less likely than non-Hispanic children to report vision screening (69.8%). Children whose families earned 200% or more above the federal poverty level were more likely to report vision screening than families with lower incomes.To update the 2011 US Preventive Services Task Force (USPSTF) recommendation on screening for amblyopia and its risk factors in children.The USPSTF reviewed the evidence on the accuracy of vision screening tests and the benefits and harms of vision screening and treatment. Surgical interventions were considered to be out of scope for this review.Treatment of amblyopia is associated with moderate improvements in visual acuity in children aged 3 to 5 years, which are likely to result in permanent improvements in vision throughout life. The USPSTF concluded that the benefits are moderate because untreated amblyopia results in permanent, uncorrectable vision loss, and the benefits of screening and treatment potentially can be experienced over a child's lifetime. The USPSTF found adequate evidence to bound the potential harms of treatment (ie, higher false-positive rates in low-prevalence populations) as small. Therefore, the USPSTF concluded with moderate certainty that the overall net benefit is moderate for children aged 3 to 5 years.The USPSTF recommends vision screening at least once in all children aged 3 to 5 years to detect amblyopia or its risk factors. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of vision screening in children younger than 3 years. (I statement).

  View details for PubMedID 28873168

• Mapping MOS-HIV to HUI3 and EQ-5D-3L in Patients With HIV. MDM policy & practice Joyce, V. R., Sun, H., Barnett, P. G., Bansback, N., Griffin, S. C., Bayoumi, A. M., Anis, A. H., Sculpher, M., Cameron, W., Brown, S. T., Holodniy, M., Owens, D. K. 2017; 2 (2): 2381468317716440

  Abstract

  Objectives: The Medical Outcomes Study HIV Health Survey (MOS-HIV) is frequently used in HIV clinical trials; however, scores generated from the MOS-HIV are not suited for cost-effectiveness analyses as they do not assign utility values to health states. Our objective was to estimate and externally validate several mapping algorithms to predict Health Utilities Index Mark 3 (HUI3) and EQ-5D-3L utility values from the MOS-HIV. Methods: We developed and validated mapping algorithms using data from two HIV clinical trials. Data from the first trial (n = 367) formed the estimation data set for the HUI3 (4,610 observations) and EQ-5D-3L (4,662 observations) mapping algorithms; data from the second trial (n = 168) formed the HUI3 (1,135 observations) and EQ-5D-3L (1,152 observations) external validation data set. We compared ordinary least squares (OLS) models of increasing complexity with the more flexible two-part, beta regression, and finite mixture models. We assessed model performance using mean absolute error (MAE) and mean squared error (MSE). Results: The OLS model that used MOS-HIV dimension scores along with squared terms gave the best HUI3 predictions (mean observed 0.84; mean predicted 0.80; MAE 0.0961); the finite mixture model gave the best EQ-5D-3L predictions (mean observed 0.90; mean predicted 0.88; MAE 0.0567). All models produced higher prediction errors at the lower end of the HUI3 and EQ-5D-3L score ranges (<0.40). Conclusions: The proposed mapping algorithms can be used to predict HUI3 and EQ-5D-3L utility values from the MOS-HIV, although greater error may pose a problem in samples where a substantial proportion of patients are in poor health. These algorithms may be useful for estimating utility values from the MOS-HIV for cost-effectiveness studies when HUI3 or EQ-5D-3L data are not available.

  View details for DOI 10.1177/2381468317716440

  View details for PubMedID 30288427

  View details for PubMedCentralID PMC6125043

• Aspirin for Primary Prevention. Medical clinics of North America Richman, I. B., Owens, D. K. 2017; 101 (4): 713-724

  Abstract

  Aspirin reduces the risk of nonfatal myocardial infarction and stroke, and the risk of colorectal cancer. Aspirin increases the risk of gastrointestinal and intracranial bleeding. The best available evidence supports initiating aspirin in select populations. In 2016, the US Preventive Services Task Force recommended initiating aspirin for the primary prevention of both cardiovascular disease and colorectal cancer among adults ages 50 to 59 who are at increased risk for cardiovascular disease. Adults 60 to 69 who are at increased cardiovascular disease risk may also benefit. There remains considerable uncertainty about whether younger and older patients may benefit.

  View details for DOI 10.1016/j.mcna.2017.03.004

  View details for PubMedID 28577622

• Estimation of the cost-effectiveness of HIV prevention portfolios for people who inject drugs in the United States: A model-based analysis. PLoS medicine Bernard, C. L., Owens, D. K., Goldhaber-Fiebert, J. D., Brandeau, M. L. 2017; 14 (5)

  Abstract

  The risks of HIV transmission associated with the opioid epidemic make cost-effective programs for people who inject drugs (PWID) a public health priority. Some of these programs have benefits beyond prevention of HIV-a critical consideration given that injection drug use is increasing across most United States demographic groups. To identify high-value HIV prevention program portfolios for US PWID, we consider combinations of four interventions with demonstrated efficacy: opioid agonist therapy (OAT), needle and syringe programs (NSPs), HIV testing and treatment (Test & Treat), and oral HIV pre-exposure prophylaxis (PrEP).We adapted an empirically calibrated dynamic compartmental model and used it to assess the discounted costs (in 2015 US dollars), health outcomes (HIV infections averted, change in HIV prevalence, and discounted quality-adjusted life years [QALYs]), and incremental cost-effectiveness ratios (ICERs) of the four prevention programs, considered singly and in combination over a 20-y time horizon. We obtained epidemiologic, economic, and health utility parameter estimates from the literature, previously published models, and expert opinion. We estimate that expansions of OAT, NSPs, and Test & Treat implemented singly up to 50% coverage levels can be cost-effective relative to the next highest coverage level (low, medium, and high at 40%, 45%, and 50%, respectively) and that OAT, which we assume to have immediate and direct health benefits for the individual, has the potential to be the highest value investment, even under scenarios where it prevents fewer infections than other programs. Although a model-based analysis can provide only estimates of health outcomes, we project that, over 20 y, 50% coverage with OAT could avert up to 22,000 (95% CI: 5,200, 46,000) infections and cost US$18,000 (95% CI: US$14,000, US$24,000) per QALY gained, 50% NSP coverage could avert up to 35,000 (95% CI: 8,900, 43,000) infections and cost US$25,000 (95% CI: US$7,000, US$76,000) per QALY gained, 50% Test & Treat coverage could avert up to 6,700 (95% CI: 1,200, 16,000) infections and cost US$27,000 (95% CI: US$15,000, US$48,000) per QALY gained, and 50% PrEP coverage could avert up to 37,000 (22,000, 58,000) infections and cost US$300,000 (95% CI: US$162,000, US$667,000) per QALY gained. When coverage expansions are allowed to include combined investment with other programs and are compared to the next best intervention, the model projects that scaling OAT coverage up to 50%, then scaling NSP coverage to 50%, then scaling Test & Treat coverage to 50% can be cost-effective, with each coverage expansion having the potential to cost less than US$50,000 per QALY gained relative to the next best portfolio. In probabilistic sensitivity analyses, 59% of portfolios prioritized the addition of OAT and 41% prioritized the addition of NSPs, while PrEP was not likely to be a priority nor a cost-effective addition. Our findings are intended to be illustrative, as data on achievable coverage are limited and, in practice, the expansion scenarios considered may exceed feasible levels. We assumed independence of interventions and constant returns to scale. Extensive sensitivity analyses allowed us to assess parameter sensitivity, but the use of a dynamic compartmental model limited the exploration of structural sensitivities.We estimate that OAT, NSPs, and Test & Treat, implemented singly or in combination, have the potential to effectively and cost-effectively prevent HIV in US PWID. PrEP is not likely to be cost-effective in this population, based on the scenarios we evaluated. While local budgets or policy may constrain feasible coverage levels for the various interventions, our findings suggest that investments in combined prevention programs can substantially reduce HIV transmission and improve health outcomes among PWID.

  View details for DOI 10.1371/journal.pmed.1002312

  View details for PubMedID 28542184

• Cost Effectiveness of Endoscopic Mucosal Resection Compared to Transanal Resection of Complex Rectal Polyps Yu, J. X., Russell, W. A., Kim, N. G., Ching, J., Bendavid, E., Owens, D. K., Kaltenbach, T. R. MOSBY-ELSEVIER. 2017: AB371

  View details for DOI 10.1016/j.gie.2017.03.858

  View details for Web of Science ID 000403087401055

• Cost Effectiveness Analysis of Peripheral Arterial Disease Screening With the Ankle-Brachial Index Test Itoga, N. K., Minami, H., Chelvakumar, M., Pearson, K., Mell, M. W., Bendavid, E., Owens, D. K. LIPPINCOTT WILLIAMS & WILKINS. 2017

  View details for Web of Science ID 000408316600195

• ACCESS TO MEDICAL CARE FOR AMERICANS WITH EXCHANGE-BASED INSURANCE: EARLY EVIDENCE FROM THE NATIONAL HEALTH INTERVIEW SURVEY Richman, I. B., Owens, D. K., Bhattacharya, J., Asch, S. SPRINGER. 2017: S104–S105

  View details for Web of Science ID 000440259000049

• Cost-effectiveness of Intensive Blood Pressure Management-Is There an Additional Price to Pay?-Reply. JAMA cardiology Richman, I. B., Owens, D. K., Goldhaber-Fiebert, J. 2017

  View details for DOI 10.1001/jamacardio.2016.5837

  View details for PubMedID 28199457

• Aspirin for the Prevention of Cardiovascular Disease and Colorectal Cancer: New Recommendations from the USPSTF AMERICAN FAMILY PHYSICIAN Owens, D. K. 2017; 95 (4): 222–23

  View details for PubMedID 28290628

• Cost-Effectiveness of Left Ventricular Assist Devices in Ambulatory Patients With Advanced Heart Failure. JACC. Heart failure Baras Shreibati, J., Goldhaber-Fiebert, J. D., Banerjee, D., Owens, D. K., Hlatky, M. A. 2017; 5 (2): 110-119

  Abstract

  This study assessed the cost-effectiveness of left ventricular assist devices (LVADs) as destination therapy in ambulatory patients with advanced heart failure.LVADs improve survival and quality of life in inotrope-dependent heart failure, but data are limited as to their value in less severely ill patients.We determined costs of care among Medicare beneficiaries before and after LVAD implantation from 2009 to 2010. We used these costs and efficacy data from published studies in a Markov model to project the incremental cost-effectiveness ratio (ICER) of destination LVAD therapy compared with that of medical management. We discounted costs and benefits at 3% annually and report costs as 2016 U.S. dollars.The mean cost of LVAD implantation was $175,420. The mean cost of readmission was lower before LVAD than after ($12,377 vs. $19,465, respectively; p < 0.001), while monthly outpatient costs were similar ($3,364 vs. $2,974, respectively; p = 0.54). In the lifetime simulation model, LVAD increased quality-adjusted life-years (QALYs) (4.41 vs. 2.67, respectively), readmissions (13.03 vs. 6.35, respectively), and costs ($726,200 vs. $361,800, respectively) compared with medical management, yielding an ICER of $209,400 per QALY gained and $597,400 per life-year gained. These results were sensitive to LVAD readmission rates and outpatient care costs; the ICER would be $86,900 if these parameters were 50% lower.LVADs in non-inotrope-dependent heart failure patients improved quality of life but substantially increased lifetime costs because of frequent readmissions and costly follow-up care. LVADs may provide good value if outpatient costs and adverse events can be reduced.

  View details for DOI 10.1016/j.jchf.2016.09.008

  View details for PubMedID 28017351

• Cost-effectiveness of Stereotactic Body Radiation Therapy versus Radiofrequency Ablation for Hepatocellular Carcinoma: A Markov Modeling Study. Radiology Pollom, E. L., Lee, K., Durkee, B. Y., Grade, M., Mokhtari, D. A., Wahl, D. R., Feng, M., Kothary, N., Koong, A. C., Owens, D. K., Goldhaber-Fiebert, J., Chang, D. T. 2017: 161509-?

  Abstract

  Purpose To assess the cost-effectiveness of stereotactic body radiation therapy (SBRT) versus radiofrequency ablation (RFA) for patients with inoperable localized hepatocellular carcinoma (HCC) who are eligible for both SBRT and RFA. Materials and Methods A decision-analytic Markov model was developed for patients with inoperable, localized HCC who were eligible for both RFA and SBRT to evaluate the cost-effectiveness of the following treatment strategies: (a) SBRT as initial treatment followed by SBRT for local progression (SBRT-SBRT), (b) RFA followed by RFA for local progression (RFA-RFA), (c) SBRT followed by RFA for local progression (SBRT-RFA), and (d) RFA followed by SBRT for local progression (RFA-SBRT). Probabilities of disease progression, treatment characteristics, and mortality were derived from published studies. Outcomes included health benefits expressed as discounted quality-adjusted life years (QALYs), costs in U.S. dollars, and cost-effectiveness expressed as an incremental cost-effectiveness ratio. Deterministic and probabilistic sensitivity analysis was performed to assess the robustness of the findings. Results In the base case, SBRT-SBRT yielded the most QALYs (1.565) and cost $197 557. RFA-SBRT yielded 1.558 QALYs and cost $193 288. SBRT-SBRT was not cost-effective, at $558 679 per QALY gained relative to RFA-SBRT. RFA-SBRT was the preferred strategy, because RFA-RFA and SBRT-RFA were less effective and more costly. In all evaluated scenarios, SBRT was preferred as salvage therapy for local progression after RFA. Probabilistic sensitivity analysis showed that at a willingness-to-pay threshold of $100 000 per QALY gained, RFA-SBRT was preferred in 65.8% of simulations. Conclusion SBRT for initial treatment of localized, inoperable HCC is not cost-effective. However, SBRT is the preferred salvage therapy for local progression after RFA. (©) RSNA, 2017 Online supplemental material is available for this article.

  View details for DOI 10.1148/radiol.2016161509

  View details for PubMedID 28045603

• Cost-Effectiveness of Radiation and Chemotherapy for High-Risk Low-Grade Glioma. Neuro-oncology Qian, Y. n., Maruyama, S. n., Kim, H. n., Pollom, E. L., Kumar, K. A., Chin, A. L., Harris, J. P., Chang, D. T., Pitt, A. n., Bendavid, E. n., Owens, D. K., Durkee, B. Y., Soltys, S. G. 2017

  Abstract

  The addition of PCV (procarbazine, lomustine, vincristine) chemotherapy to radiotherapy (RT) for patients with high-risk (≥ 40 years old or sub-totally resected) low-grade glioma (LGG) results in an absolute median survival benefit of over 5 years. We evaluated the cost-effectiveness of this treatment strategy.A decision tree with an integrated three-state Markov model was created to follow patients with high risk LGG after surgery treated with RT vs. RT+PCV. Patients existed in one of 3 health states: stable, progressive, and dead. Survival and freedom from progression were modeled to reflect the results of RTOG 9802 using time-dependent transition probabilities. Health utility values and costs of care were derived from the literature and national registry databases. Analysis was conducted from the healthcare perspective. Deterministic and probabilistic sensitivity analysis explored uncertainty in model parameters.Modeled outcomes demonstrated agreement with clinical data in expected benefit of addition of PCV to RT. The addition of PCV to RT yielded an incremental benefit of 4.77 quality-adjusted life-years (QALYs) (9.94 for RT+PCV vs. 5.17 for RT alone) at an incremental cost of $48,635 ($188,234 for RT+PCV vs. $139,598 for RT alone), resulting in an incremental cost-effectiveness ratio of $10,186 per QALY gained. Probabilistic sensitivity analysis demonstrates that within modeled distributions of parameters, RT+PCV has 99.96% probability of being cost-effectiveness at a willingness-to-pay threshold of $100,000 per QALY.The addition of PCV to RT is a cost-effective treatment strategy for patients with high-risk LGG.

  View details for PubMedID 28666368

• Mapping MOS-HIV to HUI3 and EQ-5D-3L in Patients With HIV MDM Policy and Practice Joyce, V., Sun, H., Barnett, P., Bansback, N., Griffin, S., Bayoumi, A., Anis, A., Sculpher, M., Cameron, W., Brown, S., Holodniy, M., Owens, D. 2017; 2 (2): 2381468317716440

  View details for DOI 10.1177/2381468317716440

• Diagnostic staging laparoscopy in gastric cancer treatment: A cost-effectiveness analysis. Journal of surgical oncology Li, K. n., Cannon, J. G., Jiang, S. Y., Sambare, T. D., Owens, D. K., Bendavid, E. n., Poultsides, G. A. 2017

  Abstract

  Accurate preoperative staging helps avert morbidity, mortality, and cost associated with non-therapeutic laparotomy in gastric cancer (GC) patients. Diagnostic staging laparoscopy (DSL) can detect metastases with high sensitivity, but its cost-effectiveness has not been previously studied. We developed a decision analysis model to assess the cost-effectiveness of preoperative DSL in GC workup.Analysis was based on a hypothetical cohort of GC patients in the U.S. for whom initial imaging shows no metastases. The cost-effectiveness of DSL was measured as cost per quality-adjusted life-year (QALY) gained. Drivers of cost-effectiveness were assessed in sensitivity analysis.Preoperative DSL required an investment of $107 012 per QALY. In sensitivity analysis, DSL became cost-effective at a threshold of $100 000/QALY when the probability of occult metastases exceeded 31.5% or when test sensitivity for metastases exceeded 86.3%. The likelihood of cost-effectiveness increased from 46% to 93% when both parameters were set at maximum reported values.The cost-effectiveness of DSL for GC patients is highly dependent on patient and test characteristics, and is more likely when DSL is used selectively where procedure yield is high, such as for locally advanced disease or in detecting peritoneal and superficial versus deep liver lesions.

  View details for PubMedID 29205366

• Statin Use for the Primary Prevention of Cardiovascular Disease in Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Bibbins-Domingo, K., Grossman, D. C., Curry, S. J., Davidson, K., Epling, J. W., Garcia, F. A., Gillman, M. W., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, C. S., LeFevre, M. L., Mangione, C. M., Phillips, W. R., Owens, D. K., Phipps, M. G., Pignone, M. P. 2016; 316 (19): 1997-2007

  Abstract

  Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States, accounting for 1 of every 3 deaths among adults.To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in adults.The USPSTF reviewed the evidence on the benefits and harms of screening for and treatment of dyslipidemia in adults 21 years and older; the benefits and harms of statin use in reducing CVD events and mortality in adults without a history of CVD events; whether the benefits of statin use vary by subgroup, clinical characteristics, or dosage; and the benefits of various treatment strategies in adults 40 years and older without a history of CVD events.The USPSTF recommends initiating use of low- to moderate-dose statins in adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors (dyslipidemia, diabetes, hypertension, or smoking) and a calculated 10-year CVD event risk of 10% or greater (B recommendation). The USPSTF recommends that clinicians selectively offer low- to moderate-dose statins to adults aged 40 to 75 years without a history of CVD who have 1 or more CVD risk factors and a calculated 10-year CVD event risk of 7.5% to 10% (C recommendation). The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of initiating statin use in adults 76 years and older (I statement).

  View details for DOI 10.1001/jama.2016.15450

  View details for PubMedID 27838723

• Breast Density Notification Legislation and Breast Cancer Stage at Diagnosis: Early Evidence from the SEER Registry. Journal of general internal medicine Richman, I., Asch, S. M., Bendavid, E., Bhattacharya, J., Owens, D. K. 2016: -?

  Abstract

  Twenty-eight states have passed breast density notification laws, which require physicians to inform women of a finding of dense breasts on mammography.To evaluate changes in breast cancer stage at diagnosis after enactment of breast density notification legislation.Using a difference-in-differences analysis, we examined changes in stage at diagnosis among women with breast cancer in Connecticut, the first state to enact legislation, compared to changes among women in control states. We used data from the Surveillance, Epidemiology, and End Results Program (SEER) registry, 2005-2013.Women ages 40-74 with breast cancer.Breast density notification legislation, enacted in Connecticut in October of 2009.Breast cancer stage at diagnosis.Our study included 466,930 women, 25,592 of whom lived in Connecticut. Legislation was associated with a 1.38-percentage-point (95 % CI 0.12 to 2.63) increase in the proportion of women in Connecticut versus control states who had localized invasive cancer at the time of diagnosis, and a 1.12-percentage-point (95 % CI -2.21 to -0.08) decline in the proportion of women with ductal carcinoma in situ at diagnosis. Breast density notification legislation was not associated with a change in the proportion of women in Connecticut versus control states with regional-stage (-0.09 percentage points, 95 % CI -1.01 to 1.02) or metastatic disease (-0.24, 95 % CI -0.75 to 0.28). County-level analyses and analyses limited to women younger than 50 found no statistically significant associations.Single intervention state, limited follow-up, potential confounding from unobserved trends.Breast density notification legislation in Connecticut was associated with a small increase in the proportion of women diagnosed with localized invasive breast cancer in individual-level but not county-level analyses. Whether this finding reflects potentially beneficial early detection or potentially harmful overdiagnosis is not known. Legislation was not associated with changes in regional or metastatic disease.

  View details for PubMedID 27844260

• Cost-effectiveness of Intensive Blood Pressure Management. JAMA cardiology Richman, I. B., Fairley, M., Jørgensen, M. E., Schuler, A., Owens, D. K., Goldhaber-Fiebert, J. D. 2016; 1 (8): 872-879

  Abstract

  Among high-risk patients with hypertension, targeting a systolic blood pressure of 120 mm Hg reduces cardiovascular morbidity and mortality compared with a higher target. However, intensive blood pressure management incurs additional costs from treatment and from adverse events.To evaluate the incremental cost-effectiveness of intensive blood pressure management compared with standard management.This cost-effectiveness analysis conducted from September 2015 to August 2016 used a Markov cohort model to estimate cost-effectiveness of intensive blood pressure management among 68-year-old high-risk adults with hypertension but not diabetes. We used the Systolic Blood Pressure Intervention Trial (SPRINT) to estimate treatment effects and adverse event rates. We used Centers for Disease Control and Prevention Life Tables to project age- and cause-specific mortality, calibrated to rates reported in SPRINT. We also used population-based observational data to model development of heart failure, myocardial infarction, stroke, and subsequent mortality. Costs were based on published sources, Medicare data, and the National Inpatient Sample.Treatment of hypertension to a systolic blood pressure goal of 120 mm Hg (intensive management) or 140 mm Hg (standard management).Lifetime costs and quality-adjusted life-years (QALYs), discounted at 3% annually.Standard management yielded 9.6 QALYs and accrued $155 261 in lifetime costs, while intensive management yielded 10.5 QALYs and accrued $176 584 in costs. Intensive blood pressure management cost $23 777 per QALY gained. In a sensitivity analysis, serious adverse events would need to occur at 3 times the rate observed in SPRINT and be 3 times more common in the intensive management arm to prefer standard management.Intensive blood pressure management is cost-effective at typical thresholds for value in health care and remains so even with substantially higher adverse event rates.

  View details for DOI 10.1001/jamacardio.2016.3517

  View details for PubMedID 27627731

• Use of Decision Models in the Development of Evidence-Based Clinical Preventive Services Recommendations: Methods of the US Preventive Services Task Force ANNALS OF INTERNAL MEDICINE Owens, D. K., Whitlock, E. P., Henderson, J., Pignone, M. P., Krist, A. H., Bibbins-Domingo, K., Curry, S. J., Davidson, K. W., Ebel, M., Gillman, M. W., Grossman, D. C., Kemper, A. R., Kurth, A. E., Maciosek, M., Siu, A. L., LeFevre, M. L. 2016; 165 (7): 501-?

  Abstract

  The U.S. Preventive Services Task Force (USPSTF) develops evidence-based recommendations about preventive care based on comprehensive systematic reviews of the best available evidence. Decision models provide a complementary, quantitative approach to support the USPSTF as it deliberates about the evidence and develops recommendations for clinical and policy use. This article describes the rationale for using modeling, an approach to selecting topics for modeling, and how modeling may inform recommendations about clinical preventive services. Decision modeling is useful when clinical questions remain about how to target an empirically established clinical preventive service at the individual or program level or when complex determinations of magnitude of net benefit, overall or among important subpopulations, are required. Before deciding whether to use decision modeling, the USPSTF assesses whether the benefits and harms of the preventive service have been established empirically, assesses whether there are key issues about applicability or implementation that modeling could address, and then defines the decision problem and key questions to address through modeling. Decision analyses conducted for the USPSTF are expected to follow best practices for modeling. For chosen topics, the USPSTF assesses the strengths and limitations of the systematically reviewed evidence and the modeling analyses and integrates the results of each to make preventive service recommendations.

  View details for DOI 10.7326/M15-2531

  View details for Web of Science ID 000384771300008

• Use of Decision Models in the Development of Evidence-Based Clinical Preventive Services Recommendations: Methods of the U.S. Preventive Services Task Force. Annals of internal medicine Owens, D. K., Whitlock, E. P., Henderson, J., Pignone, M. P., Krist, A. H., Bibbins-Domingo, K., Curry, S. J., Davidson, K. W., Ebell, M., Gillman, M. W., Grossman, D. C., Kemper, A. R., Kurth, A. E., Maciosek, M., Siu, A. L., LeFevre, M. L. 2016; 165 (7): 501-508

  Abstract

  The U.S. Preventive Services Task Force (USPSTF) develops evidence-based recommendations about preventive care based on comprehensive systematic reviews of the best available evidence. Decision models provide a complementary, quantitative approach to support the USPSTF as it deliberates about the evidence and develops recommendations for clinical and policy use. This article describes the rationale for using modeling, an approach to selecting topics for modeling, and how modeling may inform recommendations about clinical preventive services. Decision modeling is useful when clinical questions remain about how to target an empirically established clinical preventive service at the individual or program level or when complex determinations of magnitude of net benefit, overall or among important subpopulations, are required. Before deciding whether to use decision modeling, the USPSTF assesses whether the benefits and harms of the preventive service have been established empirically, assesses whether there are key issues about applicability or implementation that modeling could address, and then defines the decision problem and key questions to address through modeling. Decision analyses conducted for the USPSTF are expected to follow best practices for modeling. For chosen topics, the USPSTF assesses the strengths and limitations of the systematically reviewed evidence and the modeling analyses and integrates the results of each to make preventive service recommendations.

  View details for DOI 10.7326/M15-2531

  View details for PubMedID 27379742

• Cost-Effectiveness of Treatments for Genotype 1 Hepatitis C Virus Infection in non-VA and VA Populations. MDM policy & practice Liu, S., Barnett, P. G., Holodniy, M., Lo, J., Joyce, V. R., Gidwani, R., Asch, S. M., Owens, D. K., Goldhaber-Fiebert, J. D. 2016; 1

  Abstract

  Chronic hepatitis C viral (HCV) infection affects millions of Americans. Healthcare systems face complex choices between multiple highly efficacious, costly treatments. This study assessed the cost-effectiveness of HCV treatments for chronic, genotype 1 HCV monoinfected, treatment-naïve individuals in the Department of Veterans Affairs (VA) and general U.S. healthcare systems.We conducted a decision-analytic Markov model-based cost-effectiveness analysis, employing appropriate payer perspectives and time horizons, and discounting benefits and costs at 3% annually. Interventions included: Sofosbuvir/ledipasvir (SOF-LDV); ombitasvir/paritaprevir/ritonavir/dasabuvir (3D); sofosbuvir/simeprevir (SOF-SMV); sofosbuvir/pegylated interferon/ribavirin (SOF-RBV-PEG); boceprevir/pegylated interferon/ribavirin (BOC-RBV-PEG); and pegylated interferon/ribavirin (PEG-RBV). Outcomes were sustained virologic response (SVR), advanced liver disease, costs, quality adjusted life years (QALYs), and incremental cost-effectiveness.SOF-LDV and 3D achieve higher SVR rates compared to older regimens and reduce advanced liver disease (>20% relative to no treatment), increasing QALYs by over 2 years per person. For the non-VA population, at current prices ($5,040 per week for SOF-LDV and $4,796 per week for 3D), SOF-LDV's lifetime cost ($293,370) is $18,000 lower than 3D's because of its shorter treatment duration in subgroups. SOF-LDV costs $17,100 per QALY gained relative to no treatment. 3D costs $208,000 per QALY gained relative to SOF-LDV. Both dominate other treatments and are even more cost-effective for the VA, though VA aggregate treatment costs still exceed $4 billion at SOF-LDV prices of $3,308 per week. Drug prices strongly determine relative cost-effectiveness for SOF-LDV and 3D; With sufficient price reductions (approximately 20-30% depending on the health system), 3D could be cost-effective relative to SOF-LDV. Limitations include the lack of long-term head-to-head regimen effectiveness trials.New HCV treatments are cost-effective in multiple healthcare systems if trial-estimated efficacy is achieved in practice, though, at current prices, total expenditures could present substantial challenges.

  View details for DOI 10.1177/2381468316671946

  View details for PubMedID 29756049

  View details for PubMedCentralID PMC5942888

• Cost-Effectiveness of Local Therapies for Inoperable, Localized Hepatocellular Carcinoma Pollom, E., Lee, K., Durkee, B. Y., Grade, M., Mokhtari, D., Weeks, B., Feng, M., Wahl, D. R., Kothary, N., Koong, A. C., Owens, D., Goldhaber-Fiebert, J., Chang, D. T. ELSEVIER SCIENCE INC. 2016: E138

  View details for DOI 10.1016/j.ijrobp.2016.06.938

  View details for Web of Science ID 000387655802337

• Recommendations for Conduct, Methodological Practices, and Reporting of Cost-effectiveness Analyses: Second Panel on Cost-Effectiveness in Health and Medicine. JAMA Sanders, G. D., Neumann, P. J., Basu, A., Brock, D. W., Feeny, D., Krahn, M., Kuntz, K. M., Meltzer, D. O., Owens, D. K., Prosser, L. A., Salomon, J. A., Sculpher, M. J., Trikalinos, T. A., Russell, L. B., Siegel, J. E., Ganiats, T. G. 2016; 316 (10): 1093-1103

  Abstract

  Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years.To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers.In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process.The concept of a "reference case" and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an "impact inventory," which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses.The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences.

  View details for DOI 10.1001/jama.2016.12195

  View details for PubMedID 27623463

• US Preventive Services Task Force. Screening for Lipid Disorders in Children and Adolescents: US Preventive Services Task Force Recommendation Statement (vol 316, pg 625, 2016) JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Owens, D. K. 2016; 316 (10): 1116

  View details for Web of Science ID 000382991100033

• Screening for Lipid Disorders in Children and Adolescents: US Preventive Services Task Force Recommendation Statement. JAMA Bibbins-Domingo, K., Grossman, D. C., Curry, S. J., Davidson, K. W., Epling, J. W., García, F. A., Gillman, M. W., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, C. S., Lefevre, M., Mangione, C. M., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P., Siu, A. L. 2016; 316 (6): 625-633

  Abstract

  Elevations in levels of total, low-density lipoprotein, and non-high-density lipoprotein cholesterol; lower levels of high-density lipoprotein cholesterol; and, to a lesser extent, elevated triglyceride levels are associated with risk of cardiovascular disease in adults.To update the 2007 US Preventive Services Task Force (USPSTF) recommendation on screening for lipid disorders in children, adolescents, and young adults.The USPSTF reviewed the evidence on screening for lipid disorders in children and adolescents 20 years or younger--1 review focused on screening for heterozygous familial hypercholesterolemia, and 1 review focused on screening for multifactorial dyslipidemia.Evidence on the quantitative difference in diagnostic yield between universal and selective screening approaches, the effectiveness and harms of long-term treatment and the harms of screening, and the association between changes in intermediate outcomes and improvements in adult cardiovascular health outcomes are limited. Therefore, the USPSTF concludes that the balance of benefits and harms cannot be determined.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for lipid disorders in children and adolescents 20 years or younger. (I statement).

  View details for DOI 10.1001/jama.2016.9852

  View details for PubMedID 27532917

• Cost-Effectiveness of HIV Preexposure Prophylaxis for People Who Inject Drugs in the United States ANNALS OF INTERNAL MEDICINE Bernard, C. L., Brandeau, M. L., Humphreys, K., Bendavid, E., Holodniy, M., Weyant, C., Owens, D. K., Goldhaber-Fiebert, J. D. 2016; 165 (1): 10-?

  View details for DOI 10.7326/M15-2634

  View details for Web of Science ID 000379215800003

• Screening for Colorectal Cancer US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Bibbins-Domingo, K., Grossman, D. C., Curry, S. J., Davidson, K. W., Epling, J. W., Garcia, F. A., Gillman, M. W., Harper, D. M., Kemper, A. R., Krist, A. H., Kurth, A. E., Landefeld, C. S., Mangione, C. M., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P., Siu, A. L. 2016; 315 (23): 2564-2575

  Abstract

  Colorectal cancer is the second leading cause of cancer death in the United States. In 2016, an estimated 134,000 persons will be diagnosed with the disease, and about 49,000 will die from it. Colorectal cancer is most frequently diagnosed among adults aged 65 to 74 years; the median age at death from colorectal cancer is 68 years.To update the 2008 US Preventive Services Task Force (USPSTF) recommendation on screening for colorectal cancer.The USPSTF reviewed the evidence on the effectiveness of screening with colonoscopy, flexible sigmoidoscopy, computed tomography colonography, the guaiac-based fecal occult blood test, the fecal immunochemical test, the multitargeted stool DNA test, and the methylated SEPT9 DNA test in reducing the incidence of and mortality from colorectal cancer or all-cause mortality; the harms of these screening tests; and the test performance characteristics of these tests for detecting adenomatous polyps, advanced adenomas based on size, or both, as well as colorectal cancer. The USPSTF also commissioned a comparative modeling study to provide information on optimal starting and stopping ages and screening intervals across the different available screening methods.The USPSTF concludes with high certainty that screening for colorectal cancer in average-risk, asymptomatic adults aged 50 to 75 years is of substantial net benefit. Multiple screening strategies are available to choose from, with different levels of evidence to support their effectiveness, as well as unique advantages and limitations, although there are no empirical data to demonstrate that any of the reviewed strategies provide a greater net benefit. Screening for colorectal cancer is a substantially underused preventive health strategy in the United States.The USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 years (A recommendation). The decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patient's overall health and prior screening history (C recommendation).

  View details for DOI 10.1001/jama.2016.5989

  View details for Web of Science ID 000378306700020

  View details for PubMedID 27304597

• Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Freeman, J. V., Hutton, D. W., Barnes, G. D., Zhu, R. P., Owens, D. K., Garber, A. M., Go, A. S., Hlatky, M. A., Heidenreich, P. A., Wang, P. J., Al-Ahmad, A., Turakhia, M. P. 2016; 9 (6)

  Abstract

  Randomized trials of left atrial appendage (LAA) closure with the Watchman device have shown varying results, and its cost effectiveness compared with anticoagulation has not been evaluated using all available contemporary trial data.We used a Markov decision model to estimate lifetime quality-adjusted survival, costs, and cost effectiveness of LAA closure with Watchman, compared directly with warfarin and indirectly with dabigatran, using data from the long-term (mean 3.8 year) follow-up of Percutaneous Closure of the Left Atrial Appendage Versus Warfarin Therapy for Prevention of Stroke in Patients With Atrial Fibrillation (PROTECT AF) and Prospective Randomized Evaluation of the Watchman LAA Closure Device in Patients With Atrial Fibrillation (PREVAIL) randomized trials. Using data from PROTECT AF, the incremental cost-effectiveness ratios compared with warfarin and dabigatran were $20 486 and $23 422 per quality-adjusted life year, respectively. Using data from PREVAIL, LAA closure was dominated by warfarin and dabigatran, meaning that it was less effective (8.44, 8.54, and 8.59 quality-adjusted life years, respectively) and more costly. At a willingness-to-pay threshold of $50 000 per quality-adjusted life year, LAA closure was cost effective 90% and 9% of the time under PROTECT AF and PREVAIL assumptions, respectively. These results were sensitive to the rates of ischemic stroke and intracranial hemorrhage for LAA closure and medical anticoagulation.Using data from the PROTECT AF trial, LAA closure with the Watchman device was cost effective; using PREVAIL trial data, Watchman was more costly and less effective than warfarin and dabigatran. PROTECT AF enrolled more patients and has substantially longer follow-up time, allowing greater statistical certainty with the cost-effectiveness results. However, longer-term trial results and postmarketing surveillance of major adverse events will be vital to determining the value of the Watchman in clinical practice.

  View details for DOI 10.1161/CIRCEP.115.003407

  View details for PubMedID 27307517

• Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL CIRCULATION-ARRHYTHMIA AND ELECTROPHYSIOLOGY Freeman, J. V., Hutton, D. W., Barnes, G. D., Zhu, R. P., Owens, D. K., Garber, A. M., Go, A. S., Hlatky, M. A., Heidenreich, P. A., Wang, P. J., Al-Ahmad, A., Turakhia, M. P. 2016; 9 (6)

  View details for DOI 10.1161/CIRCEP.115.003407

  View details for Web of Science ID 000378143300006

• Cost-Effectiveness of Implantable Pulmonary Artery Pressure Monitoring in Chronic Heart Failure JACC-HEART FAILURE Sandhu, A. T., Goldhaber-Fiebert, J. D., Owens, D. K., Turakhia, M. P., Kaiser, D. W., Heidenreich, P. A. 2016; 4 (5): 368-375

  Abstract

  This study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure.The CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial.We developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials.CardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost <$100,000 per QALY gained. The cost-effectiveness was most sensitive to the device's durability.In populations similar to that of the CHAMPION trial, the CardioMEMS device is cost-effective if the trial effectiveness is sustained over long periods. Post-marketing surveillance data on durability will further clarify its value.

  View details for DOI 10.1016/j.jchf.2015.12.015

  View details for PubMedID 26874380

• EVALUATING THE EFFECT OF BREAST DENSITY NOTIFICATION LEGISLATION ON BREAST CANCER STAGE AT DIAGNOSIS Richman, I. B., Asch, S., Bendavid, E., Bhattacharya, J., Owens, D. K. SPRINGER. 2016: S214

  View details for Web of Science ID 000392201600224

• Screening for Depression in Adults: US Preventive Services Task Force Recommendation Statement EDITORIAL COMMENT OBSTETRICAL & GYNECOLOGICAL SURVEY Siu, A. L., Bibbins-Domingo, K., Grossman, D. C., Baumann, L., Davidson, K. W., Ebell, M., Garcia, F. R., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P., USPSTF 2016; 71 (5): 283–85

  View details for Web of Science ID 000376274700011

• COST-EFFECTIVENESS OF INTENSIVE BLOOD PRESSURE CONTROL Richman, I. B., Fairley, M., Joergensen, M., Schuler, A., Rastatter, E., Owens, D. K., Goldhaber-Fiebert, J. SPRINGER. 2016: S170

  View details for Web of Science ID 000392201600150

• Evaluating the Productivity of VA, NIH, and AHRQ Health Services Research Career Development Awardees ACADEMIC MEDICINE Finney, J. W., Amundson, E. O., Bi, X., Cucciare, M. A., Eisen, S. A., Finlay, A. K., Halvorson, M. A., Hayashi, K., Owens, D. K., Maisel, N. C., Timko, C., Weitlauf, J. C., Cronkite, R. C. 2016; 91 (4): 563-569

  Abstract

  To evaluate the academic advancement and productivity of Department of Veterans Affairs Health Services Research and Development (HSR&D) Career Development Award (CDA) program recipients, National Institutes of Health (NIH) K awardees in health services research (HSR), and Agency for Healthcare Research and Quality (AHRQ) K awardees.In all, 219 HSR&D CDA recipients from fiscal year (FY) 1991 through FY2010; 154 NIH K01, K08, and K23 awardees FY1991-FY2010; and 69 AHRQ K01 and K08 awardees FY2000-FY2010 were included. Most data were obtained from curricula vitae. Academic advancement, publications, grants, recognition, and mentoring were compared after adjusting for years since award, and personal characteristics, training, and productivity prior to the award.No significant differences emerged in covariate-adjusted tenure-track academic rank, number of grants as primary investigator (PI), major journal articles as first/sole author, Hirsch h-index scores, likelihood of a journal editorship position or membership in a major granting review panel, or mentoring postgraduate researchers between the HSR&D CDA and NIH K awardees from FY1991-FY2010, or among the three groups of awardees from FY2000 or later. Among those who reported grant funding levels, HSR&D CDAs from FY1991-2010 had been PI on more grants of $100,000 than NIH K awardees. HSR&D CDAs had a higher mean number of major journal articles than NIH K awardees from FY1991-2010.Findings show that all three HSR career development programs are successfully selecting and mentoring awardees, ensuring additional HSR capacity to improve the quality and delivery of high-value care.

  View details for PubMedID 26556291

• Evaluating the Productivity of VA, NIH, and AHRQ Health Services Research Career Development Awardees ACADEMIC MEDICINE Finney, J. W., Amundson, E. O., Bi, X., Cucciare, M. A., Eisen, S. A., Finlay, A. K., Halvorson, M. A., Hayashi, K., Owens, D. K., Maisel, N. C., Timko, C., Weitlauf, J. C., Cronkite, R. C. 2016; 91 (4): 563–69

  View details for DOI 10.1097/ACM.0000000000000982

  View details for Web of Science ID 000439259300033

• Colorectal Cancer Screening in the Era of the Affordable Care Act. Journal of general internal medicine Richman, I., Asch, S. M., Bhattacharya, J., Owens, D. K. 2016; 31 (3): 315-320

  Abstract

  The Affordable Care Act (ACA) eliminated cost-sharing for evidence-based preventive services in an effort to encourage use.To evaluate use of colorectal cancer (CRC) screening in a national population-based sample before and after implementation of the ACA.Repeated cross-sectional analysis of the Medical Expenditure Panel Survey (MEPS) between 2009 and 2012 comparing CRC screening rates before and after implementation of the ACA.Adults 50-64 with private health insurance and adults 65-75 with Medicare.Self-reported receipt of screening colonoscopy, sigmoidoscopy, or fecal occult blood test (FOBT) within the past year among those eligible for screening.Our study included 8617 adults aged 50-64 and 3761 adults aged 65-75. MEPS response rates ranged from 58 to 63%. Among adults aged 50-64, 18.9-20.9% received a colonoscopy in the survey year, 0.59-2.1% received a sigmoidoscopy, and 7.9-10.4% received an FOBT. For adults aged 65-75, 23.6-27.7% received a colonoscopy, 1.3-3.2% a sigmoidoscopy, and 13.5-16.4% an FOBT. In adjusted analyses, among participants aged 50-64, there was no increase in yearly rates of colonoscopy (-0.28 percentage points, 95% CI -2.3 to 1.7, p = 0.78), sigmoidoscopy (-1.1%, 95% CI -1.7 to -0.46, p = <0.001), or FOBT (-1.6%, 95% CI -3.2 to -0.03, p = 0.046) post-ACA. For those aged 65-75, rates of colonoscopy (+2.3%, 95% CI -1.4 to 6.0, p = 0.22), sigmoidoscopy (+0.34%, 95% CI 0.88 to 1.6, p = 0.58) and FOBT (-0.65, 95% CI -4.1 to 2.8, p = 0.72) did not increase. Among those aged 65-75 with Medicare and no additional insurance, the use of colonoscopy rose by 12.0% (95% CI 3.3 to 20.8, p = 0.007). Among participants with Medicare living in poverty, colonoscopy use also increased (+5.7%, 95% CI 0.18 to 11.3, p = 0.043).Eliminating cost-sharing for CRC screening has not resulted in changes in the use of CRC screening services for many Americans, although use may have increased in the post-ACA period among some Medicare beneficiaries.

  View details for DOI 10.1007/s11606-015-3504-2

  View details for PubMedID 26349953

• Ten-Year Publication Trajectories of Health Services Research Career Development Award Recipients: Collaboration, Awardee Characteristics, and Productivity Correlates EVALUATION & THE HEALTH PROFESSIONS Halvorson, M. A., Finlay, A. K., Cronkite, R. C., Bi, X., Hayashi, K., Maisel, N. C., Amundson, E. O., Weitlauf, J. C., Litt, I. F., Owens, D. K., Timko, C., Cucciare, M. A., Finney, J. W. 2016; 39 (1): 49-64

  Abstract

  This study's purpose was to identify distinct publishing trajectories among 442 participants in three prominent mentored health services research career development programs (Veterans Affairs, National Institutes of Health, and Agency for Healthcare Research & Quality) in the 10 years after award receipt and to examine awardee characteristics associated with different trajectories. Curricula vitae (CVs) of researchers receiving awards between 1991 and 2010 were coded for publications, grants, and awardee characteristics. We found that awardees published at constant or increasing rates despite flat or decreasing rates of first-author publications. Senior-author publications rose concurrently with rates of overall publications. Higher overall publication trajectories were associated with receiving more grants, more citations as measured by the h-index, and more authors per article. Lower trajectory groups were older and had a greater proportion of female awardees. Career development awards supported researchers who generally published successfully, but trajectories varied across individual researchers. Researchers' collaborative efforts produced an increasing number of articles, whereas first author articles were written at a more consistent rate. Career development awards in health services research supported the careers of researchers who published at a high rate; future research should further examine reasons for variation in publishing among early career researchers.

  View details for DOI 10.1177/0163278714542848

  View details for PubMedID 25015081

• Screening for Impaired Visual Acuity in Older Adults: US Preventive Services Task Force Recommendation Statement. JAMA Siu, A. L., Bibbins-Domingo, K., Grossman, D. C., Baumann, L. C., Davidson, K. W., Ebell, M., García, F. A., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P. 2016; 315 (9): 908-914

  Abstract

  Update of the US Preventive Services Task Force (USPSTF) recommendation on screening for impaired visual acuity in older adults.The USPSTF reviewed the evidence on screening for visual acuity impairment associated with uncorrected refractive error, cataracts, and age-related macular degeneration among adults 65 years or older in the primary care setting; the benefits and harms of screening; the accuracy of screening; and the benefits and harms of treatment of early vision impairment due to uncorrected refractive error, cataracts, and age-related macular degeneration.This recommendation applies to asymptomatic adults 65 years or older who do not present to their primary care clinician with vision problems.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for impaired visual acuity in older adults. (I statement).

  View details for DOI 10.1001/jama.2016.0763

  View details for PubMedID 26934260

• Screening for Breast Cancer: US Preventive Services Task Force Recommendation Statement ANNALS OF INTERNAL MEDICINE Siu, A. L., Bibbins-Domingo, K., Grossman, D. C., Baumann, L. C., Davidson, K. W., Ebell, M., Garcia, F. A., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P., Lefevre, M. 2016; 164 (4): 279-?

  Abstract

  Update of the 2009 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for breast cancer.The USPSTF reviewed the evidence on the following: effectiveness of breast cancer screening in reducing breast cancer-specific and all-cause mortality, as well as the incidence of advanced breast cancer and treatment-related morbidity; harms of breast cancer screening; test performance characteristics of digital breast tomosynthesis as a primary screening strategy; and adjunctive screening in women with increased breast density. In addition, the USPSTF reviewed comparative decision models on optimal starting and stopping ages and intervals for screening mammography; how breast density, breast cancer risk, and comorbidity level affect the balance of benefit and harms of screening mammography; and the number of radiation-induced breast cancer cases and deaths associated with different screening mammography strategies over the course of a woman's lifetime.This recommendation applies to asymptomatic women aged 40 years or older who do not have preexisting breast cancer or a previously diagnosed high-risk breast lesion and who are not at high risk for breast cancer because of a known underlying genetic mutation (such as a BRCA1 or BRCA2 gene mutation or other familial breast cancer syndrome) or a history of chest radiation at a young age.The USPSTF recommends biennial screening mammography for women aged 50 to 74 years. (B recommendation) The decision to start screening mammography in women prior to age 50 years should be an individual one. Women who place a higher value on the potential benefit than the potential harms may choose to begin biennial screening between the ages of 40 and 49 years. (C recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening mammography in women aged 75 years or older. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the benefits and harms of digital breast tomosynthesis (DBT) as a primary screening method for breast cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of adjunctive screening for breast cancer using breast ultrasonography, magnetic resonance imaging (MRI), DBT, or other methods in women identified to have dense breasts on an otherwise negative screening mammogram. (I statement).

  View details for DOI 10.7326/M15-2886

  View details for Web of Science ID 000370135300018

• Screening for Autism Spectrum Disorder in Young Children: US Preventive Services Task Force Recommendation Statement. JAMA Siu, A. L., Bibbins-Domingo, K., Grossman, D. C., Baumann, L. C., Davidson, K. W., Ebell, M., García, F. A., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P. 2016; 315 (7): 691-696

  Abstract

  New US Preventive Services Task Force (USPSTF) recommendation on screening for autism spectrum disorder (ASD) in young children.The USPSTF reviewed the evidence on the accuracy, benefits, and potential harms of brief, formal screening instruments for ASD administered during routine primary care visits and the benefits and potential harms of early behavioral treatment for young children identified with ASD through screening.This recommendation applies to children aged 18 to 30 months who have not been diagnosed with ASD or developmental delay and for whom no concerns of ASD have been raised by parents, other caregivers, or health care professionals.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for ASD in young children for whom no concerns of ASD have been raised by their parents or a clinician. (I statement).

  View details for DOI 10.1001/jama.2016.0018

  View details for PubMedID 26881372

• Screening for Depression in Adults US Preventive Services Task Force Recommendation Statement JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Siu, A. L., Bibbins-Domingo, K., Grossman, D. C., Baumann, L. C., Davidson, K. W., Ebell, M., Garcia, F. A., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P. 2016; 315 (4): 380-387

  Abstract

  Update of the 2009 US Preventive Services Task Force (USPSTF) recommendation on screening for depression in adults.The USPSTF reviewed the evidence on the benefits and harms of screening for depression in adult populations, including older adults and pregnant and postpartum women; the accuracy of depression screening instruments; and the benefits and harms of depression treatment in these populations.This recommendation applies to adults 18 years and older.The USPSTF recommends screening for depression in the general adult population, including pregnant and postpartum women. Screening should be implemented with adequate systems in place to ensure accurate diagnosis, effective treatment, and appropriate follow-up. (B recommendation).

  View details for DOI 10.1001/jama.2015.18392

  View details for Web of Science ID 000368589500016

• Recommendations on perspectives for the reference case. Cost-Effectiveness in Health and Medicine Neumann, P. J., Sanders, G. D., Basu, A., Brock, D. W., Feeny, D., Krahn, M., Kuntz, K. M., Meltzer, D. O., Owens, D. K., Prosser, L. A., Salomon, J. A., Sculpher, M. J., Trikalinos, T. A., Russell, L. B., Siegel, J. E., Ganiats, T. G. Oxford University Press. 2016; 2
• Cost-Effectiveness of Treatments for Genotype 1 Hepatitis C Virus Infection in Non-VA and VA Populations Medical Decision Making Policy and Practice Liu, S., Barnett, P. G., Holodniy, M., Lo, J., Joyce, V. R., Gadwani, R., Asch, S. M., Owens, D. K., Goldhaber-Fiebert, J. D. 2016; 1 (1): 1-12

  View details for DOI 10.1177/2381468316671946

• Decision models in cost-effectiveness analysis Cost-Effectiveness in Health and Medicine Kuntz, K. M., Russell, L. B., Owens, D. K., Sanders, G. D., Trikalinos, T. A., Salomon, J. A. Oxford University Press. 2016; 2nd
• Designing a cost-effectiveness analysis Cost-Effectiveness in Health and Medicine Owens, D. K., Siegel, J. E., Sculpher, M. J., Salomon, J. A. Oxford University Press. 2016; 2nd
• Overview Cost-Effectiveness in Health and Medicine Neumann, P. J., Sanders, G. D., Basu, A., Brock, D. W., Feeny, D., Krahn, M., Kuntz, K. M., Meltzer, D. O., Owens, D. K., Prosser, L. A., Salomon, J. A., Sculpher, M. J., Trikalinos, T. A., Russell, L. B., Siegel, J. E., Ganiats, T. G. Oxford University Press. 2016; 2
• Reply to Young et al. Clinical infectious diseases Desai, M., Joyce, V., Bendavid, E., Olshen, R. A., Hlatky, M., Chow, A., Holodniy, M., Barnett, P., Owens, D. K. 2015; 61 (7): 1207-1208

  View details for DOI 10.1093/cid/civ517

  View details for PubMedID 26123931

• Screening for Iron Deficiency Anemia in Young Children: USPSTF Recommendation Statement PEDIATRICS Siu, A. L., Bibbins-Domingo, K., Grossman, D., Baumann, L. C., Davidson, K. W., Ebell, M., Garcia, F. A., Gillman, M., Herzstein, J., Kemper, A. R., Krist, A. H., Kurth, A. E., Owens, D. K., Phillips, W. R., Phipps, M. G., Pignone, M. P., Moyer, V., Flores, G. 2015; 136 (4): 746-752

  Abstract

  Update of the US Preventive Services Task Force (USPSTF) 2006 recommendation on screening for iron deficiency anemia.The USPSTF reviewed the evidence on the association between change in iron status as a result of intervention and improvement in child health outcomes, as well as screening for and treatment of iron deficiency anemia with oral iron formulations, in children ages 6 to 24 months.This recommendation applies to children ages 6 to 24 months living in the United States who are asymptomatic for iron deficiency anemia. It does not apply to children younger than age 6 months or older than 24 months, children who are severely malnourished, children who were born prematurely or with low birth weight, or children who have symptoms of iron deficiency anemia.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for iron deficiency anemia in children ages 6 to 24 months. (I statement).

  View details for DOI 10.1542/peds.2015-2567

  View details for Web of Science ID 000362944300061

• Cost-Effectiveness of Adding Cardiac Resynchronization Therapy to an Implantable Cardioverter-Defibrillator Among Patients With Mild Heart Failure. Annals of internal medicine Woo, C. Y., Strandberg, E. J., Schmiegelow, M. D., Pitt, A. L., Hlatky, M. A., Owens, D. K., Goldhaber-Fiebert, J. D. 2015; 163 (6): 417-426

  Abstract

  Cardiac resynchronization therapy (CRT) reduces mortality and heart failure hospitalizations in patients with mild heart failure.To estimate the cost-effectiveness of adding CRT to an implantable cardioverter-defibrillator (CRT-D) compared with implantable cardioverter-defibrillator (ICD) alone among patients with left ventricular systolic dysfunction, prolonged intraventricular conduction, and mild heart failure.Markov decision model.Clinical trials, clinical registries, claims data from Centers for Medicare & Medicaid Services, and Centers for Disease Control and Prevention life tables.Patients aged 65 years or older with a left ventricular ejection fraction (LVEF) of 30% or less, QRS duration of 120 milliseconds or more, and New York Heart Association (NYHA) class I or II symptoms.Lifetime.Societal.CRT-D or ICD alone.Life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).Use of CRT-D increased life expectancy (9.8 years versus 8.8 years), QALYs (8.6 years versus 7.6 years), and costs ($286 500 versus $228 600), yielding a cost per QALY gained of $61 700.The cost-effectiveness of CRT-D was most dependent on the degree of mortality reduction: When the risk ratio for death was 0.95, the ICER increased to $119 600 per QALY. More expensive CRT-D devices, shorter CRT-D battery life, and older age also made the cost-effectiveness of CRT-D less favorable.The estimated mortality reduction for CRT-D was largely based on a single trial. Data on patients with NYHA class I symptoms were limited. The cost-effectiveness of CRT-D in patients with NYHA class I symptoms remains uncertain.In patients with an LVEF of 30% or less, QRS duration of 120 milliseconds or more, and NYHA class II symptoms, CRT-D appears to be economically attractive relative to ICD alone when a reduction in mortality is expected.National Institutes of Health, University of Copenhagen, U.S. Department of Veterans Affairs.

  View details for DOI 10.7326/M14-1804

  View details for PubMedID 26301323

• Cost-Effectiveness of Adding Cardiac Resynchronization Therapy to an Implantable Cardioverter-Defibrillator Among Patients With Mild Heart Failure. Annals of internal medicine Woo, C. Y., Strandberg, E. J., Schmiegelow, M. D., Pitt, A. L., Hlatky, M. A., Owens, D. K., Goldhaber-Fiebert, J. D. 2015; 163 (6): 417-426

  View details for DOI 10.7326/M14-1804

  View details for PubMedID 26301323

• Risk of Cardiovascular Events Associated With Current Exposure to HIV Antiretroviral Therapies in a US Veteran Population. Clinical infectious diseases Desai, M., Joyce, V., Bendavid, E., Olshen, R. A., Hlatky, M., Chow, A., Holodniy, M., Barnett, P., Owens, D. K. 2015; 61 (3): 445-452

  Abstract

   To characterize the association of antiretroviral drug combinations on risk of cardiovascular events. Certain antiretroviral medications for human immunodeficiency virus (HIV) have been implicated in increasing risk of cardiovascular disease. However, antiretroviral drugs are typically prescribed in combination. We characterized the association of current exposure to antiretroviral drug combinations on risk of cardiovascular events including myocardial infarction, stroke, percutaneous coronary intervention, and coronary artery bypass surgery. We used the Veterans Health Administration Clinical Case Registry to analyze data from 24 510 patients infected with HIV from January 1996 through December 2009. We assessed the association of current exposure to 15 antiretroviral drugs and 23 prespecified combinations of agents on the risk of cardiovascular event by using marginal structural models and Cox models extended to accommodate time-dependent variables. Over 164 059 person-years of follow-up, 934 patients had a cardiovascular event. Current exposure to abacavir, efavirenz, lamivudine, and zidovudine was significantly associated with increased risk of cardiovascular event, with odds ratios ranging from 1.40 to 1.53. Five combinations were significantly associated with increased risk of cardiovascular event, all of which involved lamivudine. One of these-efavirenz, lamivudine, and zidovudine-was the second most commonly used combination and was associated with a risk of cardiovascular event that is 1.60 times that of patients not currently exposed to the combination (odds ratio = 1.60, 95% confidence interval, 1.25-2.04). In the VA cohort, exposure to both individual drugs and drug combinations was associated with modestly increased risk of a cardiovascular event.

  View details for DOI 10.1093/cid/civ316

  View details for PubMedID 25908684

• Uptake and utilization of directly acting antiviral medications for hepatitis C infection in US veterans JOURNAL OF VIRAL HEPATITIS Gidwani, R., Barnett, P. G., Goldhaber-Fiebert, J. D., Asch, S. M., Lo, J., Dally, S. K., Owens, D. K. 2015; 22 (5): 489-495

  Abstract

  New drugs therapies have revolutionized the treatment of hepatitis C virus (HCV) infection. The objectives of this study were to evaluate uptake and utilization of boceprevir and telaprevir in the Department of Veterans Affairs (VA). We evaluated whether therapies conformed to response-guided protocols, whether they replaced standard interferon plus ribavirin treatment, and whether IL-28B was used to guide treatment. We performed an administrative data-based analysis of all patients receiving pharmacologic treatment for HCV in VA from October 2009 to July 2013. There were 12 737 new HCV prescriptions in VA during this time, with 5564 boceprevir or telaprevir prescriptions (44%) and 7173 prescriptions (56%) written for standard interferon plus ribavirin treatment. Prescriptions for the new treatments heavily favoured boceprevir vs telaprevir (83% vs 17%). Sixty-two percent (62%) of boceprevir-treated patients completed their minimum-specified protocol, while 69.2% of telaprevir-treated patients completed their minimum-specified protocol. From October 2010 to July 2012, 4090 patients had an IL-28B test; less than 16% of these tests guided subsequent HCV prescriptions. Uptake of boceprevir and telaprevir was rapid; the number of patients initiating treatment approximately doubled in the period after their introduction. While new prescriptions favor boceprevir or telaprevir over standard interferon plus ribavirin therapy, there appears to still be a strong role of interferon plus ribavirin in treating HCV patients. This work can inform our understanding of how other new effective HCV therapies will be used, their diffusion, and the timing of their diffusion in actual clinical practice.

  View details for DOI 10.1111/jvh.12344

  View details for PubMedID 25417805

• USE OF COLORECTAL CANCER SCREENING SERVICES IN THE ERA OF THE AFFORDABLE CARE ACT Richman, I. B., Asch, S., Owens, D. K. SPRINGER. 2015: S293–S294

  View details for Web of Science ID 000358386901165

• Automating Identification of Multiple Chronic Conditions in Clinical Practice Guidelines. AMIA Joint Summits on Translational Science proceedings AMIA Summit on Translational Science Leung, T. I., Jalal, H., Zulman, D. M., Dumontier, M., Owens, D. K., Musen, M. A., Goldstein, M. K. 2015; 2015: 456-460

  Abstract

  Many clinical practice guidelines (CPGs) are intended to provide evidence-based guidance to clinicians on a single disease, and are frequently considered inadequate when caring for patients with multiple chronic conditions (MCC), or two or more chronic conditions. It is unclear to what degree disease-specific CPGs provide guidance about MCC. In this study, we develop a method for extracting knowledge from single-disease chronic condition CPGs to determine how frequently they mention commonly co-occurring chronic diseases. We focus on 15 highly prevalent chronic conditions. We use publicly available resources, including a repository of guideline summaries from the National Guideline Clearinghouse to build a text corpus, a data dictionary of ICD-9 codes from the Medicare Chronic Conditions Data Warehouse (CCW) to construct an initial list of disease terms, and disease synonyms from the National Center for Biomedical Ontology to enhance the list of disease terms. First, for each disease guideline, we determined the frequency of comorbid condition mentions (a disease-comorbidity pair) by exactly matching disease synonyms in the text corpus. Then, we developed an annotated reference standard using a sample subset of guidelines. We used this reference standard to evaluate our approach. Then, we compared the co-prevalence of common pairs of chronic conditions from Medicare CCW data to the frequency of disease-comorbidity pairs in CPGs. Our results show that some disease-comorbidity pairs occur more frequently in CPGs than others. Sixty-one (29.0%) of 210 possible disease-comorbidity pairs occurred zero times; for example, no guideline on chronic kidney disease mentioned depression, while heart failure guidelines mentioned ischemic heart disease the most frequently. Our method adequately identifies comorbid chronic conditions in CPG recommendations with precision 0.82, recall 0.75, and F-measure 0.78. Our work identifies knowledge currently embedded in the free text of clinical practice guideline recommendations and provides an initial view of the extent to which CPGs mention common comorbid conditions. Knowledge extracted from CPG text in this way may be useful to inform gaps in guideline recommendations regarding MCC and therefore identify potential opportunities for guideline improvement.

  View details for PubMedID 26306285

• Models in the Development of Clinical Practice Guidelines ANNALS OF INTERNAL MEDICINE Habbema, J. D., Wilt, T. J., Etzioni, R., Nelson, H. D., Schechter, C. B., Lawrence, W. F., Melnikow, J., Kuntz, K. M., Owens, D. K., Feuer, E. J. 2014; 161 (11): 812-U105

  Abstract

  Clinical practice guidelines should be based on the best scientific evidence derived from systematic reviews of primary research. However, these studies often do not provide evidence needed by guideline development groups to evaluate the tradeoffs between benefits and harms. In this article, the authors identify 4 areas where models can bridge the gaps between published evidence and the information needed for guideline development applying new or updated information on disease risk, diagnostic test properties, and treatment efficacy; exploring a more complete array of alternative intervention strategies; assessing benefits and harms over a lifetime horizon; and projecting outcomes for the conditions for which the guideline is intended. The use of modeling as an approach to bridge these gaps (provided that the models are high-quality and adequately validated) is considered. Colorectal and breast cancer screening are used as examples to show the utility of models for these purposes. The authors propose that a modeling study is most useful when strong primary evidence is available to inform the model but critical gaps remain between the evidence and the questions that the guideline group must address. In these cases, model results have a place alongside the findings of systematic reviews to inform health care practice and policy.

  View details for DOI 10.7326/M14-0845

  View details for Web of Science ID 000347247200010

  View details for PubMedID 25437409

• Cost-effectiveness of genotype-guided and dual antiplatelet therapies. In response. Annals of internal medicine Kazi, D. S., Owens, D. K., Hlatky, M. A. 2014; 161 (5): 378-379

  View details for DOI 10.7326/L14-5017-6

  View details for PubMedID 25178577

• Diagnosis of obstructive sleep apnea in adults: a clinical practice guideline from the american college of physicians. Annals of internal medicine Qaseem, A., Dallas, P., Owens, D. K., Starkey, M., Holty, J. C., Shekelle, P. 2014; 161 (3): 210-220

  Abstract

  The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the diagnosis of obstructive sleep apnea in adults.This guideline is based on published literature on this topic that was identified by using MEDLINE (1966 through May 2013), the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included all-cause mortality, cardiovascular mortality, nonfatal cardiovascular disease, stroke, hypertension, type 2 diabetes, postsurgical outcomes, and quality of life. Sensitivities, specificities, and likelihood ratios were also assessed as outcomes of diagnostic tests. This guideline grades the evidence and recommendations by using ACP's clinical practice guidelines grading system.ACP recommends a sleep study for patients with unexplained daytime sleepiness. (Grade: weak recommendation, low-quality evidence).ACP recommends polysomnography for diagnostic testing in patients suspected of obstructive sleep apnea. ACP recommends portable sleep monitors in patients without serious comorbidities as an alternative to polysomnography when polysomnography is not available for diagnostic testing. (Grade: weak recommendation, moderate-quality evidence).

  View details for DOI 10.7326/M12-3187

  View details for PubMedID 25089864

• A New Cost-effectiveness Microsimulation Model for Glatiramer Acetate and Dimethyl Fumarate Goodyear, A., Leeper, A., Owens, D., Goldhaber-Fiebert, J. SAGE PUBLICATIONS LTD. 2014: 932–33

  View details for Web of Science ID 000337854400120

• Lowering Blood Pressure to Lower the Risk of Cardiovascular Events in CKD AMERICAN JOURNAL OF KIDNEY DISEASES Chang, T. I., Owens, D. K., Chertow, G. M. 2014; 63 (6): 900–902

  View details for PubMedID 24685064

• Health and Economic Benefits of Early Vaccination and Nonpharmaceutical Interventions for a Human Influenza A (H7N9) Pandemic: A Modeling Study. Annals of internal medicine Khazeni, N., Hutton, D. W., Collins, C. I., Garber, A. M., Owens, D. K. 2014; 160 (10): 684-694

  Abstract

  Vaccination for the 2009 pandemic did not occur until late in the outbreak, which limited its benefits. Influenza A (H7N9) is causing increasing morbidity and mortality in China, and researchers have modified the A (H5N1) virus to transmit via aerosol, which again heightens concerns about pandemic influenza preparedness.To determine how quickly vaccination should be completed to reduce infections, deaths, and health care costs in a pandemic with characteristics similar to influenza A (H7N9) and A (H5N1).Dynamic transmission model to estimate health and economic consequences of a severe influenza pandemic in a large metropolitan city.Literature and expert opinion.Residents of a U.S. metropolitan city with characteristics similar to New York City.Lifetime.Societal.Vaccination of 30% of the population at 4 or 6 months.Infections and deaths averted and cost-effectiveness.In 12 months, 48 254 persons would die. Vaccinating at 9 months would avert 2365 of these deaths. Vaccinating at 6 months would save 5775 additional lives and $51 million at a city level. Accelerating delivery to 4 months would save an additional 5633 lives and $50 million.If vaccination were delayed for 9 months, reducing contacts by 8% through nonpharmaceutical interventions would yield a similar reduction in infections and deaths as vaccination at 4 months.The model is not designed to evaluate programs targeting specific populations, such as children or persons with comorbid conditions.Vaccination in an influenza A (H7N9) pandemic would need to be completed much faster than in 2009 to substantially reduce morbidity, mortality, and health care costs. Maximizing non-pharmaceutical interventions can substantially mitigate the pandemic until a matched vaccine becomes available.Agency for Healthcare Research and Quality, National Institutes of Health, and Department of Veterans Affairs.

  View details for DOI 10.7326/M13-2071

  View details for PubMedID 24842415

• Health and Economic Benefits of Early Vaccination and Nonpharmaceutical Interventions for a Human Influenza A (H7N9) Pandemic ANNALS OF INTERNAL MEDICINE Khazeni, N., Hutton, D. W., Collins, C. I., Garber, A. M., Owens, D. K. 2014; 160 (10): 684-?

  Abstract

  Vaccination for the 2009 pandemic did not occur until late in the outbreak, which limited its benefits. Influenza A (H7N9) is causing increasing morbidity and mortality in China, and researchers have modified the A (H5N1) virus to transmit via aerosol, which again heightens concerns about pandemic influenza preparedness.To determine how quickly vaccination should be completed to reduce infections, deaths, and health care costs in a pandemic with characteristics similar to influenza A (H7N9) and A (H5N1).Dynamic transmission model to estimate health and economic consequences of a severe influenza pandemic in a large metropolitan city.Literature and expert opinion.Residents of a U.S. metropolitan city with characteristics similar to New York City.Lifetime.Societal.Vaccination of 30% of the population at 4 or 6 months.Infections and deaths averted and cost-effectiveness.In 12 months, 48 254 persons would die. Vaccinating at 9 months would avert 2365 of these deaths. Vaccinating at 6 months would save 5775 additional lives and $51 million at a city level. Accelerating delivery to 4 months would save an additional 5633 lives and $50 million.If vaccination were delayed for 9 months, reducing contacts by 8% through nonpharmaceutical interventions would yield a similar reduction in infections and deaths as vaccination at 4 months.The model is not designed to evaluate programs targeting specific populations, such as children or persons with comorbid conditions.Vaccination in an influenza A (H7N9) pandemic would need to be completed much faster than in 2009 to substantially reduce morbidity, mortality, and health care costs. Maximizing non-pharmaceutical interventions can substantially mitigate the pandemic until a matched vaccine becomes available.Agency for Healthcare Research and Quality, National Institutes of Health, and Department of Veterans Affairs.

  View details for Web of Science ID 000337347100015

  View details for PubMedCentralID PMC4053659

• Effect of Management Strategies and Clinical Status on Costs of Care for Advanced HIV AMERICAN JOURNAL OF MANAGED CARE Barnett, P. G., Chow, A., Joyce, V. R., Bayoumi, A. M., Griffin, S. C., Sun, H., Holodniy, M., Brown, S. T., Cameron, D. W., Sculpher, M., Youle, M., Anis, A. H., Owens, D. K. 2014; 20 (5): E129-E137

  Abstract

  To determine the association between preexisting characteristics and current health and the cost of different types of advanced human immunodeficiency virus (HIV) care.Treatment-experienced patients failing highly active antiretroviral treatment (ART) in the United States, Canada, and the United Kingdom were factorial randomized to an antiretroviral-free period and ART intensification. Cost was estimated by multiplying patient-reported utilization by a unit cost.A total of 367 participants were followed for a mean of 15.3 quarters (range 1-26). Medication accounted for most (61.8%) of the $26,832 annual cost. Cost averaged $4147 per quarter for ART, $1981 for inpatient care, $580 for outpatient care, and $346 for other medications. Cost for inpatient stays, outpatient visits, and other medications was 171% higher (P <.01) and cost of ART was 32% lower (P <.01) when cluster of differentiation 4 (CD4) count was <50 cells/μL compared with periods when CD4 count was >200 cells/μL. Some baseline characteristics, including low CD4 count, high viral load, and HIV from injection drug use with hepatitis C coinfection, had a sustained effect on cost.The association between health status and cost depended on the type of care. Indicators of poor health were associated with higher inpatient and concomitant medication costs and lower cost for ART medication. Although ART has supplanted hospitalization as the most important cost in HIV care, some patients continue to incur high hospitalization costs in periods when they are using less ART. The cost of interventions to improve the use of ART might be offset by the reduction of other costs.

  View details for Web of Science ID 000339146800002

• Effect of management strategies and clinical status on costs of care for advanced HIV. American journal of managed care Barnett, P. G., Chow, A., Joyce, V. R., Bayoumi, A. M., Griffin, S. C., Sun, H., Holodniy, M., Brown, S. T., Cameron, W., Sculpher, M., Youle, M., Anis, A. H., Owens, D. K. 2014; 20 (5): e129-37

  Abstract

  To determine the association between preexisting characteristics and current health and the cost of different types of advanced human immunodeficiency virus (HIV) care.Treatment-experienced patients failing highly active antiretroviral treatment (ART) in the United States, Canada, and the United Kingdom were factorial randomized to an antiretroviral-free period and ART intensification. Cost was estimated by multiplying patient-reported utilization by a unit cost.A total of 367 participants were followed for a mean of 15.3 quarters (range 1-26). Medication accounted for most (61.8%) of the $26,832 annual cost. Cost averaged $4147 per quarter for ART, $1981 for inpatient care, $580 for outpatient care, and $346 for other medications. Cost for inpatient stays, outpatient visits, and other medications was 171% higher (P <.01) and cost of ART was 32% lower (P <.01) when cluster of differentiation 4 (CD4) count was <50 cells/μL compared with periods when CD4 count was >200 cells/μL. Some baseline characteristics, including low CD4 count, high viral load, and HIV from injection drug use with hepatitis C coinfection, had a sustained effect on cost.The association between health status and cost depended on the type of care. Indicators of poor health were associated with higher inpatient and concomitant medication costs and lower cost for ART medication. Although ART has supplanted hospitalization as the most important cost in HIV care, some patients continue to incur high hospitalization costs in periods when they are using less ART. The cost of interventions to improve the use of ART might be offset by the reduction of other costs.

  View details for PubMedID 25326927

• Management of obstructive sleep apnea in adults. Annals of internal medicine Shekelle, P., Holty, J. C., Owens, D. K., Qaseem, A. 2014; 160 (5): 367-368

  View details for DOI 10.7326/L14-5005-2

  View details for PubMedID 24737275

• Cost-Effectiveness of Genotype-Guided and Dual Antiplatelet Therapies in Acute Coronary Syndrome ANNALS OF INTERNAL MEDICINE Kazi, D. S., Garber, A. M., Shah, R. U., Dudley, R. A., Mell, M. W., Rhee, C., Moshkevich, S., Boothroyd, D. B., Owens, D. K., Hlatky, M. A. 2014; 160 (4): 221-232

  Abstract

  The choice of antiplatelet therapy after acute coronary syndrome (ACS) is complicated: Ticagrelor and prasugrel are novel alternatives to clopidogrel, patients with some genotypes may not respond to clopidogrel, and low-cost generic formulations of clopidogrel are available.To determine the most cost-effective strategy for dual antiplatelet therapy after percutaneous coronary intervention for ACS.Decision-analytic model.Published literature, Medicare claims, and life tables.Patients having percutaneous coronary intervention for ACS.Lifetime.Societal.Five strategies were examined: generic clopidogrel, prasugrel, ticagrelor, and genotyping for polymorphisms of CYP2C19 with carriers of loss-of-function alleles receiving either ticagrelor (genotyping with ticagrelor) or prasugrel (genotyping with prasugrel) and noncarriers receiving clopidogrel.Direct medical costs, quality-adjusted life years(QALYs), and incremental cost-effectiveness ratios (ICERs).The clopidogrel strategy produced$179 301 in costs and 9.428 QALYs. Genotyping with prasugrel was superior to prasugrel alone, with an ICER of $35 800 per QALY relative to clopidogrel. Genotyping with ticagrelor was more effective than genotyping with prasugrel ($30 200 per QALY relative to clopidogrel). Ticagrelor was the most effective strategy($52 600 per QALY relative to genotyping with ticagrelor).Stronger associations between genotype and thrombotic outcomes rendered ticagrelor substantially less cost-effective ($104 800 per QALY). Genotyping with prasugrel was the preferred therapy among patients who could not tolerate ticagrelor.No randomized trials have directly compared genotyping strategies or prasugrel with ticagrelor.Genotype-guided personalization may improve the cost-effectiveness of prasugrel and ticagrelor after percutaneous coronary intervention for ACS, but ticagrelor for all patients may bean economically reasonable alternative in some settings.

  View details for Web of Science ID 000331666500002

• Cost-Effectiveness of Treatment of Diabetic Macular Edema ANNALS OF INTERNAL MEDICINE Pershing, S., Enns, E. A., Matesic, B., Owens, D. K., Goldhaber-Fiebert, J. D. 2014; 160 (1): 18-?

  Abstract

  Macular edema is the most common cause of vision loss among patients with diabetes.To determine the cost-effectiveness of different treatments of diabetic macular edema (DME).Markov model.Published literature and expert opinion.Patients with clinically significant DME.Lifetime.Societal.Laser treatment, intraocular injections of triamcinolone or a vascular endothelial growth factor (VEGF) inhibitor, or a combination of both.Discounted costs, gains in quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs).All treatments except laser monotherapy substantially reduced costs, and all treatments except triamcinolone monotherapy increased QALYs. Laser treatment plus a VEGF inhibitor achieved the greatest benefit, gaining 0.56 QALYs at a cost of $6975 for an ICER of $12 410 per QALY compared with laser treatment plus triamcinolone. Monotherapy with a VEGF inhibitor achieved similar outcomes to combination therapy with laser treatment plus a VEGF inhibitor. Laser monotherapy and triamcinolone monotherapy were less effective and more costly than combination therapy.VEGF inhibitor monotherapy was sometimes preferred over laser treatment plus a VEGF inhibitor, depending on the reduction in quality of life with loss of visual acuity. When the VEGF inhibitor bevacizumab was as effective as ranibizumab, it was preferable because of its lower cost.Long-term outcome data for treated and untreated diseases are limited.The most effective treatment of DME is VEGF inhibitor injections with or without laser treatment. This therapy compares favorably with cost-effective interventions for other conditions.Agency for Healthcare Research and Quality.

  View details for Web of Science ID 000330249700003

  View details for PubMedCentralID PMC4020006

• Effectiveness and Cost Effectiveness of Oral Pre-Exposure Prophylaxis in a Portfolio of Prevention Programs for Injection Drug Users in Mixed HIV Epidemics. PloS one Alistar, S. S., Owens, D. K., Brandeau, M. L. 2014; 9 (1)

  Abstract

  Pre-exposure prophylaxis with oral antiretroviral treatment (oral PrEP) for HIV-uninfected injection drug users (IDUs) is potentially useful in controlling HIV epidemics with a significant injection drug use component. We estimated the effectiveness and cost effectiveness of strategies for using oral PrEP in various combinations with methadone maintenance treatment (MMT) and antiretroviral treatment (ART) in Ukraine, a representative case for mixed HIV epidemics.We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs who inject opiates, and IDUs in MMT, adding an oral PrEP program (tenofovir/emtricitabine, 49% susceptibility reduction) for uninfected IDUs. We analyzed intervention portfolios consisting of oral PrEP (25% or 50% of uninfected IDUs), MMT (25% of IDUs), and ART (80% of all eligible patients). We measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, HIV infections averted, and incremental cost effectiveness. A combination of PrEP for 50% of IDUs and MMT lowered HIV prevalence the most in both IDUs and the general population. ART combined with MMT and PrEP (50% access) averted the most infections (14,267). For a PrEP cost of $950, the most cost-effective strategy was MMT, at $520/QALY gained versus no intervention. The next most cost-effective strategy consisted of MMT and ART, costing $1,000/QALY gained compared to MMT alone. Further adding PrEP (25% access) was also cost effective by World Health Organization standards, at $1,700/QALY gained. PrEP alone became as cost effective as MMT at a cost of $650, and cost saving at $370 or less.Oral PrEP for IDUs can be part of an effective and cost-effective strategy to control HIV in regions where injection drug use is a significant driver of the epidemic. Where budgets are limited, focusing on MMT and ART access should be the priority, unless PrEP has low cost.

  View details for DOI 10.1371/journal.pone.0086584

  View details for PubMedID 24489747

• Organizational factors affecting implementation of the ATHENA-Hypertension clinical decision support system during the VA’s nation-wide information technology restructuring: a case study Health System Shluzas, L. M., Cronkite, R. C., Hoffman, B. B., Breeling, J., Musen, M. A., Owens, D. K., Goldstein, M. K. 2014

  View details for DOI 10.1057/hs.2014.5

• Cost-Effectiveness of Newer Antiretroviral Drugs in Treatment-Experienced Patients With Multidrug-Resistant HIV Disease. Journal of acquired immune deficiency syndromes Bayoumi, A. M., Barnett, P. G., Joyce, V. R., Griffin, S. C., Sun, H., Bansback, N. J., Holodniy, M., Sanders, G., Brown, S. T., Kyriakides, T. C., Angus, B., Cameron, D. W., Anis, A. H., Sculpher, M., Owens, D. K. 2013; 64 (4): 382-391

  Abstract

  Newer antiretroviral drugs provide substantial benefits but are expensive. The cost-effectiveness of using antiretroviral drugs in combination for patients with multidrug-resistant HIV disease was determined.A cohort state-transition model was built representing treatment-experienced patients with low CD4 counts, high viral load levels, and multidrug-resistant virus. The effectiveness of newer drugs (those approved in 2005 or later) was estimated from published randomized trials. Other parameters were estimated from a randomized trial and from the literature. The model had a lifetime time horizon and used the perspective of an ideal insurer in the United States. The interventions were combination antiretroviral therapy, consisting of 2 newer drugs and 1 conventional drug, compared with 3 conventional drugs. Outcome measures were life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness.Substituting newer antiretroviral drugs increased expected survival by 3.9 years in advanced HIV disease. The incremental cost-effectiveness ratio of newer, compared with conventional, antiretroviral drugs was $75,556/QALY gained. Sensitivity analyses showed that substituting only one newer antiretroviral drug cost $54,559 to $68,732/QALY, depending on assumptions about efficacy. Substituting 3 newer drugs cost $105,956 to $117,477/QALY. Cost-effectiveness ratios were higher if conventional drugs were not discontinued.In treatment-experienced patients with advanced HIV disease, use of newer antiretroviral agents can be cost-effective, given a cost-effectiveness threshold in the range of $50,000 to $75,000 per QALY gained. Newer antiretroviral agents should be used in carefully selected patients for whom less expensive options are clearly inferior.

  View details for DOI 10.1097/QAI.0000000000000002

  View details for PubMedID 24129369

• Cost-Effectiveness of Same-Day Discharge After Elective Percutaneous Coronary intervention Brayton, K., Suen, S., Patel, V. G., Owens, D. K., Goldhaber-Fiebert, J. D. LIPPINCOTT WILLIAMS & WILKINS. 2013

  View details for Web of Science ID 000332162900413

• Primary Care Interventions to Prevent Tobacco Use in Children and Adolescents: U.S. Preventive Services Task Force Recommendation Statement ANNALS OF INTERNAL MEDICINE Moyer, V. A., LeFevre, M. L., Siu, A. L., Peters, J. J., Baumann, L. C., Bibbins-Domingo, K., Curry, S. J., Ebell, M., Flores, G., Garcia, F. A., Cantu, A. G., Grossman, D. C., Herzstein, J., Nicholson, W. K., Owens, D. K., Phillips, W. R., Pignone, M. P. 2013; 159 (8): 552-557

  Abstract

  Update of the 2003 U.S. Preventive Services Task Force (USPSTF) recommendation on primary care interventions to prevent tobacco use in children and adolescents.The USPSTF reviewed the evidence on the effectiveness of primary care interventions on the rates of initiation or cessation of tobacco use in children and adolescents and on health outcomes, such as respiratory health, dental and oral health, and adult smoking. The USPSTF also reviewed the evidence on the potential harms of these interventions.This recommendation applies to school-aged children and adolescents. The USPSTF has issued a separate recommendation statement on tobacco use counseling in adults and pregnant women.The USPSTF recommends that primary care clinicians provide interventions, including education or brief counseling, to prevent initiation of tobacco use in school-aged children and adolescents.

  View details for DOI 10.7326/0003-4819-159-8-201310150-00697

  View details for Web of Science ID 000326751200018

  View details for PubMedID 23974083

• Cost-effectiveness of helicopter versus ground emergency medical services for trauma scene transport in the United States. Annals of emergency medicine Delgado, M. K., Staudenmayer, K. L., Wang, N. E., Spain, D. A., Weir, S., Owens, D. K., Goldhaber-Fiebert, J. D. 2013; 62 (4): 351-364 e19

  Abstract

  STUDY OBJECTIVE: We determine the minimum mortality reduction that helicopter emergency medical services (EMS) should provide relative to ground EMS for the scene transport of trauma victims to offset higher costs, inherent transport risks, and inevitable overtriage of patients with minor injury. METHODS: We developed a decision-analytic model to compare the costs and outcomes of helicopter versus ground EMS transport to a trauma center from a societal perspective during a patient's lifetime. We determined the mortality reduction needed to make helicopter transport cost less than $100,000 and $50,000 per quality-adjusted life-year gained compared with ground EMS. Model inputs were derived from the National Study on the Costs and Outcomes of Trauma, National Trauma Data Bank, Medicare reimbursements, and literature. We assessed robustness with probabilistic sensitivity analyses. RESULTS: Helicopter EMS must provide a minimum of a 17% relative risk reduction in mortality (1.6 lives saved/100 patients with the mean characteristics of the National Study on the Costs and Outcomes of Trauma cohort) to cost less than $100,000 per quality-adjusted life-year gained and a reduction of at least 33% (3.7 lives saved/100 patients) to cost less than $50,000 per quality-adjusted life-year. Helicopter EMS becomes more cost-effective with significant reductions in patients with minor injury who are triaged to air transport or if long-term disability outcomes are improved. CONCLUSION: Helicopter EMS needs to provide at least a 17% mortality reduction or a measurable improvement in long-term disability to compare favorably with other interventions considered cost-effective. Given current evidence, it is not clear that helicopter EMS achieves this mortality or disability reduction. Reducing overtriage of patients with minor injury to helicopter EMS would improve its cost-effectiveness.

  View details for DOI 10.1016/j.annemergmed.2013.02.025

  View details for PubMedID 23582619

• A new cost-effectiveness microsimulation model for glatiramer acetate and dimethyl fumarate Leeper, A., Goldhaber-Fiebert, J., Owens, D., Goodyear, A. SAGE PUBLICATIONS LTD. 2013: 361–62

  View details for Web of Science ID 000328751402247

• Screening for Glaucoma: U.S. Preventive Services Task Force Recommendation Statement ANNALS OF INTERNAL MEDICINE Moyer, V. A., LeFevre, M. L., Siu, A. L., Peters, J. J., Baumann, L. C., Bibbins-Domingo, K., Curry, S. J., Ebell, M., Flores, G., Garcia, F. A., Cantu, A. G., Grossman, D. C., Herzstein, J., Nicholson, W. K., Owens, D. K., Phillips, W. R., Pignone, M. P., Leipzig, R., Petitti, D., Wilt, T. 2013; 159 (7): 484-489

  Abstract

  Update of the 2004 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for glaucoma.The USPSTF reviewed evidence on the benefits and harms of screening for glaucoma and of medical and surgical treatment of early glaucoma. Beneficial outcomes of interest included improved vision-related quality of life and reduced progression of early asymptomatic glaucoma to vision-related impairment. The USPSTF also considered evidence on the accuracy of glaucoma screening tests.This recommendation applies to adults who do not have vision symptoms and are seen in a primary care setting.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for primary open-angle glaucoma in adults. (I statement)

  View details for DOI 10.7326/0003-4819-159-6-201309170-00686

  View details for Web of Science ID 000325628000006

• Cost-effectiveness of helicopter versus ground emergency medical services for trauma scene transport in the United States. Annals of emergency medicine Delgado, M. K., Staudenmayer, K. L., Wang, N. E., Spain, D. A., Weir, S., Owens, D. K., Goldhaber-Fiebert, J. D. 2013; 62 (4): 351-364 e19

  Abstract

  STUDY OBJECTIVE: We determine the minimum mortality reduction that helicopter emergency medical services (EMS) should provide relative to ground EMS for the scene transport of trauma victims to offset higher costs, inherent transport risks, and inevitable overtriage of patients with minor injury. METHODS: We developed a decision-analytic model to compare the costs and outcomes of helicopter versus ground EMS transport to a trauma center from a societal perspective during a patient's lifetime. We determined the mortality reduction needed to make helicopter transport cost less than $100,000 and $50,000 per quality-adjusted life-year gained compared with ground EMS. Model inputs were derived from the National Study on the Costs and Outcomes of Trauma, National Trauma Data Bank, Medicare reimbursements, and literature. We assessed robustness with probabilistic sensitivity analyses. RESULTS: Helicopter EMS must provide a minimum of a 17% relative risk reduction in mortality (1.6 lives saved/100 patients with the mean characteristics of the National Study on the Costs and Outcomes of Trauma cohort) to cost less than $100,000 per quality-adjusted life-year gained and a reduction of at least 33% (3.7 lives saved/100 patients) to cost less than $50,000 per quality-adjusted life-year. Helicopter EMS becomes more cost-effective with significant reductions in patients with minor injury who are triaged to air transport or if long-term disability outcomes are improved. CONCLUSION: Helicopter EMS needs to provide at least a 17% mortality reduction or a measurable improvement in long-term disability to compare favorably with other interventions considered cost-effective. Given current evidence, it is not clear that helicopter EMS achieves this mortality or disability reduction. Reducing overtriage of patients with minor injury to helicopter EMS would improve its cost-effectiveness.

  View details for DOI 10.1016/j.annemergmed.2013.02.025

  View details for PubMedID 23582619

• Cost-effectiveness of preoperative imaging for appendicitis after indeterminate ultrasonography in the second or third trimester of pregnancy. Obstetrics and gynecology Kastenberg, Z. J., Hurley, M. P., Luan, A., Vasu-Devan, V., Spain, D. A., Owens, D. K., Goldhaber-Fiebert, J. D. 2013; 122 (4): 821-829

  Abstract

  To assess the cost-effectiveness of diagnostic laparoscopy, computed tomography (CT), and magnetic resonance imaging (MRI) after indeterminate ultrasonography in pregnant women with suspected appendicitis.A decision-analytic model was developed to simulate appendicitis during pregnancy taking into consideration the health outcomes for both the pregnant women and developing fetuses. Strategies included diagnostic laparoscopy, CT, and MRI. Outcomes included positive appendectomy, negative appendectomy, maternal perioperative complications, preterm delivery, fetal loss, childhood cancer, lifetime costs, discounted life expectancy, and incremental cost-effectiveness ratios.Magnetic resonance imaging is the most cost-effective strategy, costing $6,767 per quality-adjusted life-year gained relative to CT, well below the generally accepted $50,000 per quality-adjusted life-year threshold. In a setting where MRI is unavailable, CT is cost-effective even when considering the increased risk of radiation-associated childhood cancer ($560 per quality-adjusted life-year gained relative to diagnostic laparoscopy). Unless the negative appendectomy rate is less than 1%, imaging of any type is more cost-effective than proceeding directly to diagnostic laparoscopy.Depending on imaging costs and resource availability, both CT and MRI are potentially cost-effective. The risk of radiation-associated childhood cancer from CT has little effect on population-level outcomes or cost-effectiveness but is a concern for individual patients. For pregnant women with suspected appendicitis, an extremely high level of clinical diagnostic certainty must be reached before proceeding to operation without preoperative imaging.

  View details for DOI 10.1097/AOG.0b013e3182a4a085

  View details for PubMedID 24084540

• Management of Obstructive Sleep Apnea in Adults: A Clinical Practice Guideline From the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Holty, J. C., Owens, D. K., Dallas, P., Starkey, M., Shekelle, P. 2013; 159 (7): 471-U94

  Abstract

  The American College of Physicians (ACP) developed this guideline to present the evidence and provide clinical recommendations on the management of obstructive sleep apnea (OSA) in adults.This guideline is based on published literature from 1966 to September 2010 that was identified by using MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews. A supplemental MEDLINE search identified additional articles through October 2012. Searches were limited to English-language publications. The clinical outcomes evaluated for this guideline included cardiovascular disease (such as heart failure, hypertension, stroke, and myocardial infarction), type 2 diabetes, death, sleep study measures (such as the Apnea-Hypopnea Index), measures of cardiovascular status (such as blood pressure), measures of diabetes status (such as hemoglobin A1c levels), and quality of life. This guideline grades the evidence and recommendations using ACP's clinical practice guidelines grading system.ACP recommends that all overweight and obese patients diagnosed with OSA should be encouraged to lose weight. (Grade: strong recommendation; low-quality evidence)ACP recommends continuous positive airway pressure treatment as initial therapy for patients diagnosed with OSA. (Grade: strong recommendation; moderate-quality evidence)ACP recommends mandibular advancement devices as an alternative therapy to continuous positive airway pressure treatment for patients diagnosed with OSA who prefer mandibular advancement devices or for those with adverse effects associated with continuous positive airway pressure treatment. (Grade: weak recommendation; low-quality evidence).

  View details for DOI 10.7326/00030003-4819-159-7-201310010-00704

  View details for Web of Science ID 000325628000005

• Screening for Peripheral Artery Disease and Cardiovascular Disease Risk Assessment With the Ankle-Brachial Index in Adults: U.S. Preventive Services Task Force Recommendation Statement ANNALS OF INTERNAL MEDICINE Moyer, V. A., LeFevre, M. L., Siu, A. L., Peters, J. J., Baumann, L. C., Bibbins-Domingo, K., Curry, S. J., Ebell, M., Flores, G., Garcia, F. A., Cantu, A. G., Grossman, D. C., Herzstein, J., Nicholson, W. K., Owens, D. K., Phillips, W. R., Pignone, M. P., Wilt, T. 2013; 159 (5): 342-348

  Abstract

  Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for peripheral artery disease (PAD).The USPSTF reviewed the evidence on the use of resting ankle-brachial index (ABI) as a screening test for PAD or as a risk predictor for cardiovascular disease (CVD). The review focused on resting ABI as the sole screening method; the diagnostic performance of ABI testing in primary care populations, unselected populations, and asymptomatic populations; the predictive value of ABI testing for major CVD outcomes in primary care or unselected populations; and the effect of treatment on general CVD and PAD-specific morbidity in patients with asymptomatic or minimally symptomatic PAD.This recommendation applies to asymptomatic adults who do not have a known diagnosis of PAD, CVD, severe chronic kidney disease, or diabetes.The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for PAD and CVD risk assessment with the ABI in adults. (I statement).

  View details for DOI 10.7326/0003-4819-159-5-201309030-00008

  View details for Web of Science ID 000324245900005

• Reducing ambulance diversion at hospital and regional levels: systemic review of insights from simulation models. The western journal of emergency medicine Delgado, M. K., Meng, L. J., Mercer, M. P., Pines, J. M., Owens, D. K., Zaric, G. S. 2013; 14 (5): 489-498

  Abstract

  Optimal solutions for reducing diversion without worsening emergency department (ED) crowding are unclear. We performed a systematic review of published simulation studies to identify: 1) the tradeoff between ambulance diversion and ED wait times; 2) the predicted impact of patient flow interventions on reducing diversion; and 3) the optimal regional strategy for reducing diversion.Systematic review of articles using MEDLINE, Inspec, Scopus. Additional studies identified through bibliography review, Google Scholar, and scientific conference proceedings.Only simulations modeling ambulance diversion as a result of ED crowding or inpatient capacity problems were included.Independent extraction by two authors using predefined data fields.We identified 5,116 potentially relevant records; 10 studies met inclusion criteria. In models that quantified the relationship between ED throughput times and diversion, diversion was found to only minimally improve ED waiting room times. Adding holding units for inpatient boarders and ED-based fast tracks, improving lab turnaround times, and smoothing elective surgery caseloads were found to reduce diversion considerably. While two models found a cooperative agreement between hospitals is necessary to prevent defensive diversion behavior by a hospital when a nearby hospital goes on diversion, one model found there may be more optimal solutions for reducing region wide wait times than a regional ban on diversion.Smoothing elective surgery caseloads, adding ED fast tracks as well as holding units for inpatient boarders, improving ED lab turnaround times, and implementing regional cooperative agreements among hospitals are promising avenues for reducing diversion.

  View details for DOI 10.5811/westjem.2013.3.12788

  View details for PubMedID 24106548

• Reducing Ambulance Diversion at Hospital and Regional Levels: Systemic Review of Insights from Simulation Models WESTERN JOURNAL OF EMERGENCY MEDICINE Delgado, M., Meng, L. J., Mercer, M. P., Pines, J. M., Owens, D. K., Zaric, G. S. 2013; 14 (5): 489–98

  View details for DOI 10.5811/westjem.2013.3.12788

  View details for Web of Science ID 000422601800022

• Prioritizing guideline-recommended interventions. Annals of internal medicine Owens, D. K., Goldhaber-Fiebert, J. D. 2013; 159 (3): 223-224

  View details for DOI 10.7326/0003-4819-159-3-201308060-00014

  View details for PubMedID 23922066

• Transcatheter Aortic Valve Replacement in Nonsurgical Candidates With Severe, Symptomatic Aortic Stenosis: A Cost-Effectiveness Analysis CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Simons, C. T., Cipriano, L. E., Shah, R. U., Garber, A. M., Owens, D. K., Hlatky, M. A. 2013; 6 (4): 419-428

  Abstract

  Background- Transcatheter aortic valve replacement (TAVR) seems to improve the survival and quality of life of patients with aortic stenosis ineligible for surgical aortic valve replacement. Methods and Results- We used a decision analytic Markov model to estimate lifetime costs and benefits in a hypothetical cohort of patients with severe, symptomatic aortic stenosis who were ineligible for surgical aortic valve replacement. The model compared transfemoral TAVR with medical management and was calibrated to the Placement of Aortic Transcatheter Valves (PARTNER) trial. TAVR increased life expectancy from 2.08 to 2.93 years and quality-adjusted life expectancy from 1.19 to 1.93 years. TAVR also reduced subsequent hospitalizations by 1.40 but increased complications, particularly stroke (from 1% to 11% lifetime risk), and also increased lifetime costs from $83 600 to $1 69 100. The incremental cost-effectiveness of TAVR was $1 16 500 per quality-adjusted life-year gained ($99 900 per life-year gained). Results were robust to reasonable changes in individual variables but were sensitive to the level of annual healthcare costs caused by noncardiac diseases and to the projected life expectancy of medically treated patients. Conclusions- TAVR seems to be an effective but somewhat expensive alternative to medical management among patients with symptomatic aortic stenosis ineligible for surgery. TAVR is more cost-effective for patients with a lower burden of noncardiac disease.

  View details for DOI 10.1161/CIRCOUTCOMES.113.000280

  View details for Web of Science ID 000321898000009

  View details for PubMedID 23838104

• Quality of Life, Utilities, Quality-Adjusted Life-years, and Health Care Decision Making: Comment on "Estimating Quality of Life in Acute Venous Thrombosis". JAMA internal medicine Owens, D. K., Shekelle, P. G. 2013; 173 (12): 1073-1074

  View details for DOI 10.1001/jamainternmed.2013.7396

  View details for PubMedID 23689602

• Screening for prostate cancer: a guidance statement from the clinical guidelines committee of the american college of physicians. Annals of internal medicine Qaseem, A., Barry, M. J., Denberg, T. D., Owens, D. K., Shekelle, P. 2013; 158 (10): 761-769

  Abstract

  Chinese translationProstate cancer is an important health problem in men. It rarely causes death in men younger than 50 years; most deaths associated with it occur in men older than 75 years. The benefits of screening with the prostate-specific antigen (PSA) test are outweighed by the harms for most men. Prostate cancer never becomes clinically significant in a patient's lifetime in a considerable proportion of men with prostate cancer detected with the PSA test. They will receive no benefit and are subject to substantial harms from the treatment of prostate cancer. The American College of Physicians (ACP) developed this guidance statement for clinicians by assessing current prostate cancer screening guidelines developed by other organizations. ACP believes that it is more valuable to provide clinicians with a rigorous review of available guidelines rather than develop a new guideline on the same topic when several guidelines are available on a topic or when existing guidelines conflict. The purpose of this guidance statement is to critically review available guidelines to help guide internists and other clinicians in making decisions about screening for prostate cancer. The target patient population for this guidance statement is all adult men.This guidance statement is derived from an appraisal of available guidelines on screening for prostate cancer. Authors searched the National Guideline Clearinghouse to identify prostate cancer screening guidelines in the United States and selected 4 developed by the American College of Preventive Medicine, American Cancer Society, American Urological Association, and U.S. Preventive Services Task Force. The AGREE II (Appraisal of Guidelines, Research and Evaluation in Europe) instrument was used to evaluate the guidelines. GUIDANCE STATEMENT 1: ACP recommends that clinicians inform men between the age of 50 and 69 years about the limited potential benefits and substantial harms of screening for prostate cancer. ACP recommends that clinicians base the decision to screen for prostate cancer using the prostate-specific antigen test on the risk for prostate cancer, a discussion of the benefits and harms of screening, the patient's general health and life expectancy, and patient preferences. ACP recommends that clinicians should not screen for prostate cancer using the prostate-specific antigen test in patients who do not express a clear preference for screening. GUIDANCE STATEMENT 2: ACP recommends that clinicians should not screen for prostate cancer using the prostate-specific antigen test in average-risk men under the age of 50 years, men over the age of 69 years, or men with a life expectancy of less than 10 to 15 years.

  View details for DOI 10.7326/0003-4819-158-10-201305210-00633

  View details for PubMedID 23567643

• Cost-Effectiveness of Statins for Primary Cardiovascular Prevention in Chronic Kidney Disease JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Erickson, K. F., Japa, S., Owens, D. K., Chertow, G. M., Garber, A. M., Goldhaber-Fiebert, J. D. 2013; 61 (12): 1250-1258

  Abstract

  The authors sought to evaluate the cost-effectiveness of statins for primary prevention of myocardial infarction (MI) and stroke in patients with chronic kidney disease (CKD).Patients with CKD have an elevated risk of MI and stroke. Although HMG Co-A reductase inhibitors (“statins”) may prevent cardiovascular events in patients with non–dialysis-requiring CKD, adverse drug effects and competing risks could materially influence net effects and clinical decision-making.We developed a decision-analytic model of CKD and cardiovascular disease (CVD) to determine the cost-effectiveness of low-cost generic statins for primary CVD prevention in men and women with hypertension and mild-to-moderate CKD. Outcomes included MI and stroke rates, discounted quality-adjusted life years (QALYs) and lifetime costs (2010 USD), and incremental cost-effectiveness ratios.For 65-year-old men with moderate hypertension and mild-to-moderate CKD, statins reduced the combined rate of MI and stroke, yielded 0.10 QALYs, and increased costs by $1,800 ($18,000 per QALY gained). For patients with lower baseline cardiovascular risks, health and economic benefits were smaller; for 65-year-old women, statins yielded 0.06 QALYs and increased costs by $1,900 ($33,400 per QALY gained). Results were sensitive to rates of rhabdomyolysis and drug costs. Statins are less cost-effective when obtained at average retail prices, particularly in patients at lower CVD risk.Although statins reduce absolute CVD risk in patients with CKD, the increased risk of rhabdomyolysis, and competing risks associated with progressive CKD, partly offset these gains. Low-cost generic statins appear cost-effective for primary prevention of CVD in patients with mild-to-moderate CKD and hypertension.

  View details for DOI 10.1016/j.jacc.2012.12.034

  View details for PubMedID 23500327

• Risk of Cardiovascular Disease from Antiretroviral Therapy for HIV: A Systematic Review PLOS ONE Bavinger, C., Bendavid, E., Niehaus, K., Olshen, R. A., Olkin, I., Sundaram, V., Wein, N., Holodniy, M., Hou, N., Owens, D. K., Desai, M. 2013; 8 (3)

  Abstract

  Recent studies suggest certain antiretroviral therapy (ART) drugs are associated with increases in cardiovascular disease.We performed a systematic review and meta-analysis to summarize the available evidence, with the goal of elucidating whether specific ART drugs are associated with an increased risk of myocardial infarction (MI).We searched Medline, Web of Science, the Cochrane Library, and abstract archives from the Conference on Retroviruses and Opportunistic Infections and International AIDS Society up to June 2011 to identify published articles and abstracts.Eligible studies were comparative and included MI, strokes, or other cardiovascular events as outcomes.Eligibility screening, data extraction, and quality assessment were performed independently by two investigators.Random effects methods and Fisher's combined probability test were used to summarize evidence.Twenty-seven studies met inclusion criteria, with 8 contributing to a formal meta-analysis. Findings based on two observational studies indicated an increase in risk of MI for patients recently exposed (usually defined as within last 6 months) to abacavir (RR 1.92, 95% CI 1.51-2.42) and protease inhibitors (PI) (RR 2.13, 95% CI 1.06-4.28). Our analysis also suggested an increased risk associated with each additional year of exposure to indinavir (RR 1.11, 95% CI 1.05-1.17) and lopinavir (RR 1.22, 95% CI 1.01-1.47). Our findings of increased cardiovascular risk from abacavir and PIs were in contrast to four published meta-analyses based on secondary analyses of randomized controlled trials, which found no increased risk from cardiovascular disease.Although observational studies implicated specific drugs, the evidence is mixed. Further, meta-analyses of randomized trials did not find increased risk from abacavir and PIs. Our findings that implicate specific ARTs in the observational setting provide sufficient evidence to warrant further investigation of this relationship in studies designed for that purpose.

  View details for DOI 10.1371/journal.pone.0059551

  View details for Web of Science ID 000317418500051

  View details for PubMedID 23555704

  View details for PubMedCentralID PMC3608726

• Comparative Effectiveness Research and Formulary Placement: The Case of Diabetes AMERICAN JOURNAL OF MANAGED CARE Chernew, M. E., McKellar, R., Aubry, W., Beck, R., Benner, J., Berger, J. E., Fendrick, A. M., Forma, F., Goldman, D., Harmel, A. P., Killion, R., Lakdawalla, D., Owens, D. K., Stahl, J. 2013; 19 (2): 93-96

  View details for Web of Science ID 000315657600001

  View details for PubMedID 23448106

• Risk of cardiovascular disease from antiretroviral therapy for HIV: a systematic review. PloS one Bavinger, C., Bendavid, E., Niehaus, K., Olshen, R. A., Olkin, I., Sundaram, V., Wein, N., Holodniy, M., Hou, N., Owens, D. K., Desai, M. 2013; 8 (3)

  Abstract

  Recent studies suggest certain antiretroviral therapy (ART) drugs are associated with increases in cardiovascular disease.We performed a systematic review and meta-analysis to summarize the available evidence, with the goal of elucidating whether specific ART drugs are associated with an increased risk of myocardial infarction (MI).We searched Medline, Web of Science, the Cochrane Library, and abstract archives from the Conference on Retroviruses and Opportunistic Infections and International AIDS Society up to June 2011 to identify published articles and abstracts.Eligible studies were comparative and included MI, strokes, or other cardiovascular events as outcomes.Eligibility screening, data extraction, and quality assessment were performed independently by two investigators.Random effects methods and Fisher's combined probability test were used to summarize evidence.Twenty-seven studies met inclusion criteria, with 8 contributing to a formal meta-analysis. Findings based on two observational studies indicated an increase in risk of MI for patients recently exposed (usually defined as within last 6 months) to abacavir (RR 1.92, 95% CI 1.51-2.42) and protease inhibitors (PI) (RR 2.13, 95% CI 1.06-4.28). Our analysis also suggested an increased risk associated with each additional year of exposure to indinavir (RR 1.11, 95% CI 1.05-1.17) and lopinavir (RR 1.22, 95% CI 1.01-1.47). Our findings of increased cardiovascular risk from abacavir and PIs were in contrast to four published meta-analyses based on secondary analyses of randomized controlled trials, which found no increased risk from cardiovascular disease.Although observational studies implicated specific drugs, the evidence is mixed. Further, meta-analyses of randomized trials did not find increased risk from abacavir and PIs. Our findings that implicate specific ARTs in the observational setting provide sufficient evidence to warrant further investigation of this relationship in studies designed for that purpose.

  View details for DOI 10.1371/journal.pone.0059551

  View details for PubMedID 23555704

  View details for PubMedCentralID PMC3608726

• Medical Decision Making Sox, H. C., Higgins, M. C., Owens, D. K. Wiley-Blackwell. 2013

  View details for DOI 10.1002/9781118341544.ch1

• Diagnosis of Stable Ischemic Heart Disease: Summary of a Clinical Practice Guideline From the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons ANNALS OF INTERNAL MEDICINE Qaseem, A., Fihn, S. D., Williams, S., Dallas, P., Owens, D. K., Shekelle, P. 2012; 157 (10): 729-?

  Abstract

  The American College of Physicians (ACP) developed this guideline in collaboration with the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, and Society of Thoracic Surgeons to help clinicians diagnose known or suspected stable ischemic heart disease.Literature on this topic published before November 2011 was identified by using MEDLINE, Embase, Cochrane CENTRAL, PsychINFO, AMED, and SCOPUS. Searches were limited to human studies published in English. This guideline grades the evidence and recommendations according to a translation of the ACCF/AHA grading system into ACP's clinical practice guidelines grading system.This guideline includes 28 recommendations that address the following issues: the initial diagnosis of the patient who might have stable ischemic heart disease, cardiac stress testing to assess the risk for death or myocardial infarction in patients diagnosed with stable ischemic heart disease, and coronary angiography for risk assessment.

  View details for Web of Science ID 000311580000018

  View details for PubMedID 23165664

• Management of Stable Ischemic Heart Disease: Summary of a Clinical Practice Guideline From the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons ANNALS OF INTERNAL MEDICINE Qaseem, A., Fihn, S. D., Dallas, P., Williams, S., Owens, D. K., Shekelle, P. 2012; 157 (10): 735-?

  Abstract

  The American College of Physicians (ACP) developed this guideline with the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, and Society of Thoracic Surgeons to present the available evidence on the management of stable known or suspected ischemic heart disease.Literature on this topic published before November 2011 was identified by using MEDLINE, Embase, Cochrane CENTRAL, PsychINFO, AMED, and SCOPUS. Searches were limited to human studies published in English. This guideline grades the evidence and recommendations according to a translation of the ACCF/AHA grading system into ACP's clinical practice guidelines grading system.The guideline includes 48 specific recommendations that address the following issues: patient education, management of proven risk factors (dyslipidemia, hypertension, diabetes, physical activity body weight, and smoking), risk factor reduction strategies of unproven benefit, medical therapy to prevent myocardial infarction and death and to relieve symptoms, alternative therapy, revascularization to improve survival and symptoms, and patient follow-up.

  View details for Web of Science ID 000311580000019

• Management of stable ischemic heart disease: summary of a clinical practice guideline from the American College of Physicians/American College of Cardiology Foundation/American Heart Association/American Association for Thoracic Surgery/Preventive Cardiovascular Nurses Association/Society of Thoracic Surgeons. Annals of internal medicine Qaseem, A., Fihn, S. D., Dallas, P., Williams, S., Owens, D. K., Shekelle, P. 2012; 157 (10): 735-743

  Abstract

  The American College of Physicians (ACP) developed this guideline with the American College of Cardiology Foundation (ACCF), American Heart Association (AHA), American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, and Society of Thoracic Surgeons to present the available evidence on the management of stable known or suspected ischemic heart disease.Literature on this topic published before November 2011 was identified by using MEDLINE, Embase, Cochrane CENTRAL, PsychINFO, AMED, and SCOPUS. Searches were limited to human studies published in English. This guideline grades the evidence and recommendations according to a translation of the ACCF/AHA grading system into ACP's clinical practice guidelines grading system.The guideline includes 48 specific recommendations that address the following issues: patient education, management of proven risk factors (dyslipidemia, hypertension, diabetes, physical activity body weight, and smoking), risk factor reduction strategies of unproven benefit, medical therapy to prevent myocardial infarction and death and to relieve symptoms, alternative therapy, revascularization to improve survival and symptoms, and patient follow-up.

  View details for DOI 10.7326/0003-4819-157-10-201211200-00011

  View details for PubMedID 23165665

• Balancing Immunological Benefits and Cardiovascular Risks of Antiretroviral Therapy: When Is Immediate Treatment Optimal? CLINICAL INFECTIOUS DISEASES Negoescu, D. M., Owens, D. K., Brandeau, M. L., Bendavid, E. 2012; 55 (10): 1392-1399

  Abstract

  We developed a mathematical model to identify the timing of antiretroviral therapy (ART) initiation that optimizes patient outcomes as a function of patient CD4 count, age, cardiac mortality risk, sex, and personal preferences. Our goal was to find the conditions that maximize patient quality-adjusted life expectancy (QALE) in the context of our model. Under the assumption that ART confers disease progression and mortality benefits at any CD4 count, immediate treatment initiation yields the greatest remaining QALE for young patients under most circumstances. The timing of ART initiation depends on the magnitude of benefit from ART at high CD4 counts, the magnitude of increases in cardiac risk, and patients' preferences. If ART reduces HIV progression at high CD4 counts, immediate ART is preferable for most newly infected individuals <35 years even if ART doubles age- and sex-specific cardiac risk.

  View details for DOI 10.1093/cid/cis731

  View details for PubMedID 22942203

• Screening and Rapid Molecular Diagnosis of Tuberculosis in Prisons in Russia and Eastern Europe: A Cost-Effectiveness Analysis PLOS MEDICINE Winetsky, D. E., Negoescu, D. M., Demarchis, E. H., Almukhamedova, O., Dooronbekova, A., Pulatov, D., Vezhnina, N., Owens, D. K., Goldhaber-Fiebert, J. D. 2012; 9 (11)

  Abstract

  Prisons of the former Soviet Union (FSU) have high rates of multidrug-resistant tuberculosis (MDR-TB) and are thought to drive general population tuberculosis (TB) epidemics. Effective prison case detection, though employing more expensive technologies, may reduce long-term treatment costs and slow MDR-TB transmission.We developed a dynamic transmission model of TB and drug resistance matched to the epidemiology and costs in FSU prisons. We evaluated eight strategies for TB screening and diagnosis involving, alone or in combination, self-referral, symptom screening, mass miniature radiography (MMR), and sputum PCR with probes for rifampin resistance (Xpert MTB/RIF). Over a 10-y horizon, we projected costs, quality-adjusted life years (QALYs), and TB and MDR-TB prevalence. Using sputum PCR as an annual primary screening tool among the general prison population most effectively reduced overall TB prevalence (from 2.78% to 2.31%) and MDR-TB prevalence (from 0.74% to 0.63%), and cost US$543/QALY for additional QALYs gained compared to MMR screening with sputum PCR reserved for rapid detection of MDR-TB. Adding sputum PCR to the currently used strategy of annual MMR screening was cost-saving over 10 y compared to MMR screening alone, but produced only a modest reduction in MDR-TB prevalence (from 0.74% to 0.69%) and had minimal effect on overall TB prevalence (from 2.78% to 2.74%). Strategies based on symptom screening alone were less effective and more expensive than MMR-based strategies. Study limitations included scarce primary TB time-series data in FSU prisons and uncertainties regarding screening test characteristics.In prisons of the FSU, annual screening of the general inmate population with sputum PCR most effectively reduces TB and MDR-TB prevalence, doing so cost-effectively. If this approach is not feasible, the current strategy of annual MMR is both more effective and less expensive than strategies using self-referral or symptom screening alone, and the addition of sputum PCR for rapid MDR-TB detection may be cost-saving over time.

  View details for DOI 10.1371/journal.pmed.1001348

  View details for PubMedID 23209384

• Cost Effectiveness of Screening Strategies for Early Identification of HIV and HCV Infection in Injection Drug Users PLOS ONE Cipriano, L. E., Zaric, G. S., Holodniy, M., Bendavid, E., Owens, D. K., Brandeau, M. L. 2012; 7 (9)

  Abstract

  To estimate the cost, effectiveness, and cost effectiveness of HIV and HCV screening of injection drug users (IDUs) in opioid replacement therapy (ORT).Dynamic compartmental model of HIV and HCV in a population of IDUs and non-IDUs for a representative U.S. urban center with 2.5 million adults (age 15-59).We considered strategies of screening individuals in ORT for HIV, HCV, or both infections by antibody or antibody and viral RNA testing. We evaluated one-time and repeat screening at intervals from annually to once every 3 months. We calculated the number of HIV and HCV infections, quality-adjusted life years (QALYs), costs, and incremental cost-effectiveness ratios (ICERs).Adding HIV and HCV viral RNA testing to antibody testing averts 14.8-30.3 HIV and 3.7-7.7 HCV infections in a screened population of 26,100 IDUs entering ORT over 20 years, depending on screening frequency. Screening for HIV antibodies every 6 months costs $30,700/QALY gained. Screening for HIV antibodies and viral RNA every 6 months has an ICER of $65,900/QALY gained. Strategies including HCV testing have ICERs exceeding $100,000/QALY gained unless awareness of HCV-infection status results in a substantial reduction in needle-sharing behavior.Although annual screening for antibodies to HIV and HCV is modestly cost effective compared to no screening, more frequent screening for HIV provides additional benefit at less cost. Screening individuals in ORT every 3-6 months for HIV infection using both antibody and viral RNA technologies and initiating ART for acute HIV infection appears cost effective.

  View details for DOI 10.1371/journal.pone.0045176

  View details for PubMedID 23028828

• State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3 MEDICAL DECISION MAKING Siebert, U., Alagoz, O., Bayoumi, A. M., Jahn, B., Owens, D. K., Cohen, D. J., Kuntz, K. M. 2012; 32 (5): 690-700

  Abstract

  State-transition modeling (STM) is an intuitive, flexible, and transparent approach of computer-based decision-analytic modeling, including both Markov model cohort simulation as well as individual-based (first-order Monte Carlo) microsimulation. Conceptualizing a decision problem in terms of a set of (health) states and transitions among these states, STM is one of the most widespread modeling techniques in clinical decision analysis, health technology assessment, and health-economic evaluation. STMs have been used in many different populations and diseases, and their applications range from personalized health care strategies to public health programs. Most frequently, state-transition models are used in the evaluation of risk factor interventions, screening, diagnostic procedures, treatment strategies, and disease management programs.

  View details for DOI 10.1177/0272989X12455463

  View details for PubMedID 22990084

• State-Transition Modeling: A Report of the ISPOR-SMDM Modeling Good Research Practices Task Force-3 VALUE IN HEALTH Siebert, U., Alagoz, O., Bayoumi, A. M., Jahn, B., Owens, D. K., Cohen, D. J., Kuntz, K. M. 2012; 15 (6): 812-820

  Abstract

  State-transition modeling is an intuitive, flexible, and transparent approach of computer-based decision-analytic modeling including both Markov model cohort simulation and individual-based (first-order Monte Carlo) microsimulation. Conceptualizing a decision problem in terms of a set of (health) states and transitions among these states, state-transition modeling is one of the most widespread modeling techniques in clinical decision analysis, health technology assessment, and health-economic evaluation. State-transition models have been used in many different populations and diseases, and their applications range from personalized health care strategies to public health programs. Most frequently, state-transition models are used in the evaluation of risk factor interventions, screening, diagnostic procedures, treatment strategies, and disease management programs. The goal of this article was to provide consensus-based guidelines for the application of state-transition models in the context of health care. We structured the best practice recommendations in the following sections: choice of model type (cohort vs. individual-level model), model structure, model parameters, analysis, reporting, and communication. In each of these sections, we give a brief description, address the issues that are of particular relevance to the application of state-transition models, give specific examples from the literature, and provide best practice recommendations for state-transition modeling. These recommendations are directed both to modelers and to users of modeling results such as clinicians, clinical guideline developers, manufacturers, or policymakers.

  View details for DOI 10.1016/j.jval.2012.06.014

  View details for Web of Science ID 000309109800006

  View details for PubMedID 22999130

• The Cost-Effectiveness of Preexposure Prophylaxis for HIV Prevention in the United States in Men Who Have Sex With Men ANNALS OF INTERNAL MEDICINE Juusola, J. L., Brandeau, M. L., Owens, D. K., Bendavid, E. 2012; 156 (8): 541-U144

  Abstract

  A recent randomized, controlled trial showed that daily oral preexposure chemoprophylaxis (PrEP) was effective for HIV prevention in men who have sex with men (MSM). The Centers for Disease Control and Prevention recently provided interim guidance for PrEP in MSM at high risk for HIV. Previous studies did not reach a consistent estimate of its cost-effectiveness.To estimate the effectiveness and cost-effectiveness of PrEP in MSM in the United States.Dynamic model of HIV transmission and progression combined with a detailed economic analysis.Published literature.MSM aged 13 to 64 years in the United States.Lifetime.Societal.PrEP was evaluated in both the general MSM population and in high-risk MSM and was assumed to reduce infection risk by 44% on the basis of clinical trial results.New HIV infections, discounted quality-adjusted life-years (QALYs) and costs, and incremental cost-effectiveness ratios.Initiating PrEP in 20% of MSM in the United States would reduce new HIV infections by an estimated 13% and result in a gain of 550,166 QALYs over 20 years at a cost of $172,091 per QALY gained. Initiating PrEP in a larger proportion of MSM would prevent more infections but at an increasing cost per QALY gained (up to $216,480 if all MSM receive PrEP). Preexposure chemoprophylaxis in only high-risk MSM can improve cost-effectiveness. For MSM with an average of 5 partners per year, PrEP costs approximately $50,000 per QALY gained. Providing PrEP to all high-risk MSM for 20 years would cost $75 billion more in health care-related costs than the status quo and $600,000 per HIV infection prevented, compared with incremental costs of $95 billion and $2 million per infection prevented for 20% coverage of all MSM.PrEP in the general MSM population would cost less than $100,000 per QALY gained if the daily cost of antiretroviral drugs for PrEP was less than $15 or if PrEP efficacy was greater than 75%.When examining PrEP in high-risk MSM, the investigators did not model a mix of low- and high-risk MSM because of lack of data on mixing patterns.PrEP in the general MSM population could prevent a substantial number of HIV infections, but it is expensive. Use in high-risk MSM compares favorably with other interventions that are considered cost-effective but could result in annual PrEP expenditures of more than $4 billion.National Institute on Drug Abuse, Department of Veterans Affairs, and National Institute of Allergy and Infectious Diseases.

  View details for DOI 10.1059/0003-4819-156-8-201204170-00001

  View details for PubMedID 22508731

• PANACEA OR PERSONALIZED MEDICINE? OPTIMIZING ANTIPLATELET THERAPY IN ACUTE CORONARY SYNDROME - A COST-EFFECTIVENESS ANALYSIS 61st Annual Scientific Session and Expo of the American-College-of-Cardiology (ACC)/Conference on ACC-i2 with TCT Kazi, D., Garber, A. M., Shah, R., Rhee, C., Moshkevich, S., Mell, M. W., Boothroyd, D., Owens, D. K., Hlatky, M. ELSEVIER SCIENCE INC. 2012: E348–E348

  View details for Web of Science ID 000302326700349

• New Protease Inhibitors for the Treatment of Chronic Hepatitis C A Cost-Effectiveness Analysis ANNALS OF INTERNAL MEDICINE Liu, S., Cipriano, L. E., Holodniy, M., Owens, D. K., Goldhaber-Fiebert, J. D. 2012; 156 (4): 279-U68

  Abstract

  Chronic hepatitis C virus is difficult to treat and affects approximately 3 million Americans. Protease inhibitors increase the effectiveness of standard therapy, but they are costly. A genetic assay may identify patients most likely to benefit from this treatment advance.To assess the cost-effectiveness of new protease inhibitors and an interleukin (IL)-28B genotyping assay for treating chronic hepatitis C virus.Decision-analytic Markov model.Published literature and expert opinion.Treatment-naive patients with chronic, genotype 1 hepatitis C virus monoinfection.Lifetime.Societal.Strategies are defined by the use of IL-28B genotyping and type of treatment (standard therapy [pegylated interferon with ribavirin]; triple therapy [standard therapy and a protease inhibitor]). Interleukin-28B-guided triple therapy stratifies patients with CC genotypes to standard therapy and those with non-CC types to triple therapy.Discounted costs (in 2010 U.S. dollars) and quality-adjusted life-years (QALYs); incremental cost-effectiveness ratios.For patients with mild and advanced fibrosis, universal triple therapy reduced the lifetime risk for hepatocellular carcinoma by 38% and 28%, respectively, and increased quality-adjusted life expectancy by 3% and 8%, respectively, compared with standard therapy. Gains from IL-28B-guided triple therapy were smaller. If the protease inhibitor costs $1100 per week, universal triple therapy costs $102,600 per QALY (mild fibrosis) or $51,500 per QALY (advanced fibrosis) compared with IL-28B-guided triple therapy and $70,100 per QALY (mild fibrosis) and $36,300 per QALY (advanced fibrosis) compared with standard therapy.Results were sensitive to the cost of protease inhibitors and treatment adherence rates.Data on the long-term comparative effectiveness of the new protease inhibitors are lacking.Both universal triple therapy and IL-28B-guided triple therapy are cost-effective when the least-expensive protease inhibitor are used for patients with advanced fibrosis.Stanford University.

  View details for PubMedID 22351713

• Effect of Treatment Interruption and Intensification of Antiretroviral Therapy on Health-Related Quality of Life in Patients with Advanced HIV: A Randomized, Controlled Trial MEDICAL DECISION MAKING Joyce, V. R., Barnett, P. G., Chow, A., Bayoumi, A. M., Griffin, S. C., Sun, H., Holodniy, M., Brown, S. T., Kyriakides, T. C., Cameron, D. W., Youle, M., Sculpher, M., Anis, A. H., Owens, D. K. 2012; 32 (1): 70-82

  Abstract

  The effect of antiretroviral therapy (ART) interruption or intensification on health-related quality of life (HRQoL) in advanced HIV patients is unknown.To assess the impact of temporary treatment interruption and intensification of ART on HRQoL.A 2 x 2 factorial open label randomized controlled trial.Hospitals in the United States, Canada, and the United Kingdom.Multidrug resistant (MDR) HIV patients.Patients were randomized to receive a 12-wk interruption or not, and ART intensification or standard ART.The Health Utilities Index (HUI3), EQ-5D, standard gamble (SG), time tradeoff (TTO), visual analog scale (VAS), and the Medical Outcomes Study HIV Health Survey (MOS-HIV).There were no significant differences in HRQoL among the four groups during follow-up; however, there was a temporary significant decline in HRQoL on some measures within the interruption group during interruption (HUI3 -0.05, P = 0.03; VAS -5.9, P = 0.002; physical health summary -2.9, P = 0.001; mental health summary -1.9, P = 0.02). Scores declined slightly overall during follow-up. Multivariate analysis showed significantly lower HRQoL associated with some clinical events. Limitations. The results may not apply to HIV patients who have not experienced multiple treatment failures or who have not developed MDR HIV.Temporary ART interruption and ART intensification provided neither superior nor inferior HRQoL compared with no interruption and standard ART. Among surviving patients, HRQoL scores declined only slightly over years of follow-up in this advanced HIV cohort; however, approximately one-third of patients died during the trial follow up. Lower HRQoL was associated with adverse clinical events.

  View details for DOI 10.1177/0272989X10397615

  View details for PubMedID 21383086

• The cost-effectiveness of symptom-based testing and routine screening for acute HIV infection in men who have sex with men in the USA AIDS Juusola, J. L., Brandeau, M. L., Long, E. F., Owens, D. K., Bendavid, E. 2011; 25 (14): 1779-1787

  Abstract

  Acute HIV infection often causes influenza-like illness (ILI) and is associated with high infectivity. We estimated the effectiveness and cost-effectiveness of strategies to identify and treat acute HIV infection in men who have sex with men (MSM) in the USA.Dynamic model of HIV transmission and progression.We evaluated three testing approaches: viral load testing for individuals with ILI, expanded screening with antibody testing, and expanded screening with antibody and viral load testing. We included treatment with antiretroviral therapy for individuals identified as acutely infected.New HIV infections, discounted quality-adjusted life years (QALYs) and costs, and incremental cost-effectiveness ratios.At the present rate of HIV-antibody testing, we estimated that 538,000 new infections will occur among MSM over the next 20 years. Expanding antibody screening coverage to 90% of MSM annually reduces new infections by 2.8% and costs US$ 12,582 per QALY gained. Symptom-based viral load testing with ILI is more expensive than expanded antibody screening, but is more effective and costs US$ 22,786 per QALY gained. Combining expanded antibody screening with symptom-based viral load testing prevents twice as many infections compared to expanded antibody screening alone, and costs US$ 29,923 per QALY gained. Adding viral load testing to all annual HIV tests costs more than US$ 100,000 per QALY gained.Use of HIV viral load testing in MSM with ILI prevents more infections than does expanded annual antibody screening alone and is inexpensive relative to other screening interventions. Clinicians should consider symptom-based viral load testing in MSM, in addition to encouraging annual antibody screening.

  View details for DOI 10.1097/QAD.0b013e328349f067

  View details for PubMedID 21716076

• Determinants of the Cost of Health Services Used by Veterans With HIV MEDICAL CARE Barnett, P. G., Chow, A., Joyce, V. R., Bayoumi, A. M., Griffin, S. C., Nosyk, B., Holodniy, M., Brown, S. T., Sculpher, M., Anis, A. H., Owens, D. K. 2011; 49 (9): 848-856

  Abstract

  The effect of adherence, treatment failure, and comorbidities on the cost of HIV care is not well understood.To characterize the cost of HIV care including combination antiretroviral treatment (ART).Observational study of administrative data.Total 1896 randomly selected HIV-infected patients and 288 trial participants with multidrug-resistant HIV seen at the US Veterans Health Administration (VHA).Comorbidities, cost, pharmacy, and laboratory data.Many HIV-infected patients (24.5%) of the random sample did not receive ART. Outpatient pharmacy accounted for 62.8% of the costs of patients highly adherent with ART, 32.2% of the cost of those with lower adherence, and 6.2% of the cost of those not receiving ART. Compared with patients not receiving ART, high adherence was associated with lower hospital cost, but no greater total cost. Individuals with a low CD4 count (<50 cells/mm) incurred 1.9 times the cost of patients with counts >500. Most patients had medical, psychiatric, or substance abuse comorbidities. These conditions were associated with greater cost. Trial participants were less likely to have psychiatric and substance abuse comorbidities than the random sample of VHA patients with HIV.Patients receiving combination ART had higher medication costs but lower acute hospital cost. Poor control of HIV was associated with higher cost. The cost of psychiatric, substance abuse, rehabilitation, and long-term care and medications other than ART, often overlooked in HIV studies, was substantial.

  View details for DOI 10.1097/MLR.0b013e31821b34c0

  View details for Web of Science ID 000294206700015

  View details for PubMedID 21610542

• The cost-effectiveness of a modestly effective HIV vaccine in the United States VACCINE Long, E. F., Owens, D. K. 2011; 29 (36): 6113-6124

  Abstract

  The recent RV144 clinical trial showed that an ALVAC/AIDSVAX prime-boost HIV vaccine regimen may confer partial immunity in recipients and reduce transmission by 31%. Trial data suggest that efficacy may initially exceed 70% but decline over the following 3.5 years. Estimating the potential health benefits associated with a one-time vaccination campaign, as well as the projected benefits of repeat booster vaccination, may inform future HIV vaccine research and licensing decisions.We developed a mathematical model to project the future course of the HIV epidemic in the United States under varying HIV vaccine scenarios. The model accounts for disease progression, infection transmission, antiretroviral therapy, and HIV-related morbidity and mortality. We projected HIV prevalence and incidence over time in multiple risk groups, and we estimated quality-adjusted life years (QALYs) and costs over a 10-year time horizon. We assumed an exponentially declining efficacy curve fit to trial data, and that subsequent vaccine boosters confer similar immunity. Variations in vaccine parameters were examined in sensitivity analysis.Under existing HIV prevention and treatment efforts, an estimated 590,000 HIV infections occur over 10 years. One-time vaccination achieving 60% coverage of adults could prevent 9.8% of projected new infections over 10 years (and prevent 34% of new infections in the first year) and cost approximately $91,000/QALY gained relative to the status quo, assuming $500 per vaccination series. Targeted vaccination strategies result in net cost savings for vaccines costing less than $750. One-time vaccination of 60% of all adults coupled with three-year boosters only for men who have sex with men and people who inject drugs could prevent 21% of infections for $81,000/QALY gained relative to vaccination of higher risk sub-populations only. A program attaining 90% vaccination coverage prevents 15% of new HIV cases over 10 years (and approximately 50% of infections in the first year).A partially effective HIV vaccine with effectiveness similar to that observed in the RV144 trial would provide large health benefits in the United States and could meet conventionally accepted cost-effectiveness thresholds. Strategies that prioritize key populations are most efficient, but broader strategies provide greater total population health benefit.

  View details for DOI 10.1016/j.vaccine.2011.04.013

  View details for Web of Science ID 000295497100008

  View details for PubMedID 21510996

  View details for PubMedCentralID PMC3156325

• The potential impact of an HIV vaccine with rapidly waning protection on the epidemic in Southern Africa: Examining the RV144 trial results VACCINE Andersson, K. M., Paltiel, A. D., Owens, D. K. 2011; 29 (36): 6107-6112

  Abstract

  The prime-boost HIV vaccine regimen used in the recent RV144 trial resulted in modest efficacy of 31% over 3.5 years, but was substantially higher in the first year post-vaccination. We sought to explore the potential impact of a vaccine with rapidly waning efficacy in a South African population.We explored two strategies using a dynamic compartmental epidemic model for heterosexual transmission of HIV: [1] vaccination of a single cohort (30%, 60% or 90% of the initial population), with exponentially waning efficacy, but booster vaccinations at 5- or 2-year intervals, and [2] continuous vaccination of the unvaccinated population at the same coverage levels (30%, 60% or 90%) but with a constant efficacy vaccine of short duration. We also examined potential changes in post-vaccination condom use.The single cohort vaccination strategies did not have a substantial impact on HIV prevalence, although without boosters they still prevented 2-6% of the expected infections at 20 years, depending on the population coverage. The 5-year and 2-year booster strategies prevented 8-24% and 17-45% of the expected infections, respectively. Continuous vaccination to maintain population coverage levels resulted in more substantial reductions in population HIV prevalence and greater numbers of infections prevented: HIV prevalence at 20 years was reduced from 23% to 8-14% and the number of expected infections was decreased by 34-59%, depending on the population coverage level. Moderate changes in post-vaccination condom use did not substantially affect these outcomes.An HIV vaccine with partial efficacy and declining protection similar to the RV144 vaccine could prevent a substantial proportion of HIV infections if booster vaccinations were effective and available. Our estimates of the population impact of vaccination would be improved by further understanding of the duration of protection, the effectiveness of booster vaccination, and whether the vaccine efficacy varies between subpopulations at higher and lower risk of exposure.

  View details for DOI 10.1016/j.vaccine.2011.06.076

  View details for Web of Science ID 000295497100007

  View details for PubMedID 21736912

  View details for PubMedCentralID PMC3164284

• Scaling Up Circumcision Programs in Southern Africa: The Potential Impact of Gender Disparities and Changes in Condom Use Behaviors on Heterosexual HIV Transmission AIDS AND BEHAVIOR Andersson, K. M., Owens, D. K., Paltiel, A. D. 2011; 15 (5): 938-948

  Abstract

  Circumcision significantly reduces female-to-male transmission of HIV infection, but changes in behavior may influence the overall impact on transmission. We sought to explore these effects, particularly for societies where women have less power to negotiate safe sex. We developed a compartmental epidemic model to simulate the population-level impact of various circumcision programs on heterosexual HIV transmission in Soweto. We incorporated gender-specific negotiation of condom use in sexual partnerships and explored post-circumcision changes in condom use. A 5-year prevention program in which only an additional 10% of uncircumcised males undergo circumcision each year, for example, would prevent 13% of the expected new HIV infections over 20 years. Outcomes were sensitive to potential changes in behavior and differed by gender. For Southern Africa, even modest programs offering circumcision would result in significant benefits. Because decreases in male condom use could diminish these benefits, particularly for women, circumcision programs should emphasize risk-reduction counseling.

  View details for DOI 10.1007/s10461-010-9784-y

  View details for Web of Science ID 000292268300007

  View details for PubMedID 20924783

  View details for PubMedCentralID PMC3112296

• Improving Practice Guidelines With Patient-Specific Recommendations ANNALS OF INTERNAL MEDICINE Owens, D. K. 2011; 154 (9): 638-639

  View details for DOI 10.1059/0003-4819-154-9-201105030-00010

  View details for Web of Science ID 000290112300008

  View details for PubMedID 21536940

• Systematic Review: Benefits and Harms of In-Hospital Use of Recombinant Factor VIIa for Off-Label Indications ANNALS OF INTERNAL MEDICINE Yank, V., Tuohy, C. V., Logan, A. C., Bravata, D. M., Staudenmayer, K., Eisenhut, R., Sundaram, V., McMahon, D., Olkin, I., McDonald, K. M., Owens, D. K., Stafford, R. S. 2011; 154 (8): 529-W190

  Abstract

  Recombinant factor VIIa (rFVIIa), a hemostatic agent approved for hemophilia, is increasingly used for off-label indications.To evaluate the benefits and harms of rFVIIa use for 5 off-label, in-hospital indications: intracranial hemorrhage, cardiac surgery, trauma, liver transplantation, and prostatectomy.Ten databases (including PubMed, EMBASE, and the Cochrane Library) queried from inception through December 2010. Articles published in English were analyzed.Two reviewers independently screened titles and abstracts to identify clinical use of rFVIIa for the selected indications and identified all randomized, controlled trials (RCTs) and observational studies for full-text review.Two reviewers independently assessed study characteristics and rated study quality and indication-wide strength of evidence.16 RCTs, 26 comparative observational studies, and 22 noncomparative observational studies met inclusion criteria. Identified comparators were limited to placebo (RCTs) or usual care (observational studies). For intracranial hemorrhage, mortality was not improved with rFVIIa use across a range of doses. Arterial thromboembolism was increased with medium-dose rFVIIa use (risk difference [RD], 0.03 [95% CI, 0.01 to 0.06]) and high-dose rFVIIa use (RD, 0.06 [CI, 0.01 to 0.11]). For adult cardiac surgery, there was no mortality difference, but there was an increased risk for thromboembolism (RD, 0.05 [CI, 0.01 to 0.10]) with rFVIIa. For body trauma, there were no differences in mortality or thromboembolism, but there was a reduced risk for the acute respiratory distress syndrome (RD, -0.05 [CI, -0.02 to -0.08]). Mortality was higher in observational studies than in RCTs.The amount and strength of evidence were low for most outcomes and indications. Publication bias could not be excluded.Limited available evidence for 5 off-label indications suggests no mortality reduction with rFVIIa use. For some indications, it increases thromboembolism.

  View details for PubMedID 21502651

• Results of Antiretroviral Treatment Interruption and Intensification in Advanced Multi-Drug Resistant HIV Infection from the OPTIMA Trial PLOS ONE Holodniy, M., Brown, S. T., Cameron, D. W., Kyriakides, T. C., Angus, B., Babiker, A., Singer, J., Owens, D. K., Anis, A., Goodall, R., Hudson, F., Piaseczny, M., Russo, J., Schechter, M., Deyton, L., Darbyshire, J. 2011; 6 (3)

  Abstract

  Guidance is needed on best medical management for advanced HIV disease with multidrug resistance (MDR) and limited retreatment options. We assessed two novel antiretroviral (ARV) treatment approaches in this setting.We conducted a 2×2 factorial randomized open label controlled trial in patients with a CD4 count≤300 cells/µl who had ARV treatment (ART) failure requiring retreatment, to two options (a) re-treatment with either standard (≤4 ARVs) or intensive (≥5 ARVs) ART and b) either treatment starting immediately or after a 12-week monitored ART interruption. Primary outcome was time to developing a first AIDS-defining event (ADE) or death from any cause. Analysis was by intention to treat. From 2001 to 2006, 368 patients were randomized. At baseline, mean age was 48 years, 2% were women, median CD4 count was 106/µl, mean viral load was 4.74 log(10) copies/ml, and 59% had a prior AIDS diagnosis. Median follow-up was 4.0 years in 1249 person-years of observation. There were no statistically significant differences in the primary composite outcome of ADE or death between re-treatment options of standard versus intensive ART (hazard ratio 1.17; CI 0.86-1.59), or between immediate retreatment initiation versus interruption before re-treatment (hazard ratio 0.93; CI 0.68-1.30), or in the rate of non-HIV associated serious adverse events between re-treatment options.We did not observe clinical benefit or harm assessed by the primary outcome in this largest and longest trial exploring both ART interruption and intensification in advanced MDR HIV infection with poor retreatment options.Clinicaltrials.gov NCT00050089.

  View details for DOI 10.1371/journal.pone.0014764

  View details for PubMedID 21483491

• Effectiveness and Cost Effectiveness of Expanding Harm Reduction and Antiretroviral Therapy in a Mixed HIV Epidemic: A Modeling Analysis for Ukraine PLOS MEDICINE Alistar, S. S., Owens, D. K., Brandeau, M. L. 2011; 8 (3)

  Abstract

  Injection drug use (IDU) and heterosexual virus transmission both contribute to the growing mixed HIV epidemics in Eastern Europe and Central Asia. In Ukraine-chosen in this study as a representative country-IDU-related risk behaviors cause half of new infections, but few injection drug users (IDUs) receive methadone substitution therapy. Only 10% of eligible individuals receive antiretroviral therapy (ART). The appropriate resource allocation between these programs has not been studied. We estimated the effectiveness and cost-effectiveness of strategies for expanding methadone substitution therapy programs and ART in mixed HIV epidemics, using Ukraine as a case study.We developed a dynamic compartmental model of the HIV epidemic in a population of non-IDUs, IDUs using opiates, and IDUs on methadone substitution therapy, stratified by HIV status, and populated it with data from the Ukraine. We considered interventions expanding methadone substitution therapy, increasing access to ART, or both. We measured health care costs, quality-adjusted life years (QALYs), HIV prevalence, infections averted, and incremental cost-effectiveness. Without incremental interventions, HIV prevalence reached 67.2% (IDUs) and 0.88% (non-IDUs) after 20 years. Offering methadone substitution therapy to 25% of IDUs reduced prevalence most effectively (to 53.1% IDUs, 0.80% non-IDUs), and was most cost-effective, averting 4,700 infections and adding 76,000 QALYs compared with no intervention at US$530/QALY gained. Expanding both ART (80% coverage of those eligible for ART according to WHO criteria) and methadone substitution therapy (25% coverage) was the next most cost-effective strategy, adding 105,000 QALYs at US$1,120/QALY gained versus the methadone substitution therapy-only strategy and averting 8,300 infections versus no intervention. Expanding only ART (80% coverage) added 38,000 QALYs at US$2,240/QALY gained versus the methadone substitution therapy-only strategy, and averted 4,080 infections versus no intervention. Offering ART to 80% of non-IDUs eligible for treatment by WHO criteria, but only 10% of IDUs, averted only 1,800 infections versus no intervention and was not cost effective.Methadone substitution therapy is a highly cost-effective option for the growing mixed HIV epidemic in Ukraine. A strategy that expands both methadone substitution therapy and ART to high levels is the most effective intervention, and is very cost effective by WHO criteria. When expanding ART, access to methadone substitution therapy provides additional benefit in infections averted. Our findings are potentially relevant to other settings with mixed HIV epidemics. Please see later in the article for the Editors' Summary.

  View details for DOI 10.1371/journal.pmed.1000423

  View details for PubMedID 21390264

• High-Value, Cost-Conscious Health Care: Concepts for Clinicians to Evaluate the Benefits, Harms, and Costs of Medical Interventions ANNALS OF INTERNAL MEDICINE Owens, D. K., Qaseem, A., Chou, R., Shekelle, P. 2011; 154 (3): 174-?

  Abstract

  Health care costs in the United States are increasing unsustainably, and further efforts to control costs are inevitable and essential. Efforts to control expenditures should focus on the value, in addition to the costs, of health care interventions. Whether an intervention provides high value depends on assessing whether its health benefits justify its costs. High-cost interventions may provide good value because they are highly beneficial; conversely, low-cost interventions may have little or no value if they provide little benefit. Thus, the challenge becomes determining how to slow the rate of increase in costs while preserving high-value, high-quality care. A first step is to decrease or eliminate care that provides no benefit and may even be harmful. A second step is to provide medical interventions that provide good value: medical benefits that are commensurate with their costs. This article discusses 3 key concepts for understanding how to assess the value of health care interventions. First, assessing the benefits, harms, and costs of an intervention is essential to understand whether it provides good value. Second, assessing the cost of an intervention should include not only the cost of the intervention itself but also any downstream costs that occur because the intervention was performed. Third, the incremental cost-effectiveness ratio estimates the additional cost required to obtain additional health benefits and provides a key measure of the value of a health care intervention.

  View details for DOI 10.1059/0003-4819-154-3-201102010-00007

  View details for Web of Science ID 000286729200005

  View details for PubMedID 21282697

• Diagnostic Imaging for Low Back Pain: Advice for High-Value Health Care From the American College of Physicians ANNALS OF INTERNAL MEDICINE Chou, R., Qaseem, A., Owens, D. K., Shekelle, P. 2011; 154 (3): 181-?

  Abstract

  Diagnostic imaging is indicated for patients with low back pain only if they have severe progressive neurologic deficits or signs or symptoms that suggest a serious or specific underlying condition. In other patients, evidence indicates that routine imaging is not associated with clinically meaningful benefits but can lead to harms. Addressing inefficiencies in diagnostic testing could minimize potential harms to patients and have a large effect on use of resources by reducing both direct and downstream costs. In this area, more testing does not equate to better care. Implementing a selective approach to low back imaging, as suggested by the American College of Physicians and American Pain Society guideline on low back pain, would provide better care to patients, improve outcomes, and reduce costs.

  View details for DOI 10.1059/0003-4819-154-3-201102010-00008

  View details for PubMedID 21282698

• Cost-effectiveness of elective induction of labor at 41 weeks in nulliparous women AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY Kaimal, A. J., Little, S. E., Odibo, A. O., Stamilio, D. M., Grobman, W. A., Long, E. F., Owens, D. K., Caughey, A. B. 2011; 204 (2)

  Abstract

  To investigate the cost-effectiveness of elective induction of labor at 41 weeks in nulliparous women.A decision analytic model comparing induction of labor at 41 weeks vs expectant management with antenatal testing until 42 weeks in nulliparas was designed. Baseline assumptions were derived from the literature as well as from analysis of the National Birth Cohort dataset and included an intrauterine fetal demise rate of 0.12% in the 41st week and a cesarean rate of 27% in women induced at 41 weeks. One-way and multiway sensitivity analyses were conducted to examine the robustness of the findings.Compared with expectant management, induction of labor is cost-effective with an incremental cost of $10,945 per quality-adjusted life year gained. Induction of labor at 41 weeks also resulted in a lower rate of adverse obstetric outcomes, including neonatal demise, shoulder dystocia, meconium aspiration syndrome, and severe perineal lacerations.Elective induction of labor at 41 weeks is cost-effective and improves outcomes.

  View details for DOI 10.1016/j.ajog.2010.08.012

  View details for Web of Science ID 000286874900018

  View details for PubMedID 20965482

• Cost-Effectiveness of Dabigatran Compared With Warfarin for Stroke Prevention in Atrial Fibrillation ANNALS OF INTERNAL MEDICINE Freeman, J. V., Zhu, R. P., Owens, D. K., Garber, A. M., Hutton, D. W., Go, A. S., Wang, P. J., Turakhia, M. P. 2011; 154 (1): 1-U129

  Abstract

  Warfarin reduces the risk for ischemic stroke in patients with atrial fibrillation (AF) but increases the risk for hemorrhage. Dabigatran is a fixed-dose, oral direct thrombin inhibitor with similar or reduced rates of ischemic stroke and intracranial hemorrhage in patients with AF compared with those of warfarin.To estimate the quality-adjusted survival, costs, and cost-effectiveness of dabigatran compared with adjusted-dose warfarin for preventing ischemic stroke in patients 65 years or older with nonvalvular AF.Markov decision model.The RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial and other published studies of anticoagulation. The cost of dabigatran was estimated on the basis of pricing in the United Kingdom.Patients aged 65 years or older with nonvalvular AF and risk factors for stroke (CHADS₂ score ≥1 or equivalent) and no contraindications to anticoagulation.Lifetime.Societal.Warfarin anticoagulation (target international normalized ratio, 2.0 to 3.0); dabigatran, 110 mg twice daily (low dose); and dabigatran, 150 mg twice daily (high dose).Quality-adjusted life-years (QALYs), costs (in 2008 U.S. dollars), and incremental cost-effectiveness ratios.The quality-adjusted life expectancy was 10.28 QALYs with warfarin, 10.70 QALYs with low-dose dabigatran, and 10.84 QALYs with high-dose dabigatran. Total costs were $143 193 for warfarin, $164 576 for low-dose dabigatran, and $168 398 for high-dose dabigatran. The incremental cost-effectiveness ratios compared with warfarin were $51 229 per QALY for low-dose dabigatran and $45 372 per QALY for high-dose dabigatran.The model was sensitive to the cost of dabigatran but was relatively insensitive to other model inputs. The incremental cost-effectiveness ratio increased to $50 000 per QALY at a cost of $13.70 per day for high-dose dabigatran but remained less than $85 000 per QALY over the full range of model inputs evaluated. The cost-effectiveness of high-dose dabigatran improved with increasing risk for stroke and intracranial hemorrhage.Event rates were largely derived from a single randomized clinical trial and extrapolated to a 35-year time frame from clinical trials with approximately 2-year follow-up.In patients aged 65 years or older with nonvalvular AF at increased risk for stroke (CHADS₂ score ≥1 or equivalent), dabigatran may be a cost-effective alternative to warfarin depending on pricing in the United States.American Heart Association and Veterans Affairs Health Services Research & Development Service.

  View details for PubMedID 21041570

• Cost-Effectiveness of Genetic Testing in Family Members of Patients With Long-QT Syndrome CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES Perez, M. V., Kumarasamy, N. A., Owens, D. K., Wang, P. J., Hlatky, M. A. 2011; 4 (1): 76-84

  Abstract

  Family members of patients with established long-QT syndrome (LQTS) often lack definitive clinical findings, yet may have inherited an LQTS mutation and be at risk of sudden death. Genetic testing can identify mutations in 75% of patients with LQTS, but genetic testing of family members remains controversial.We used a Markov model to assess the cost-effectiveness of 3 strategies for treating an asymptomatic 10-year-old, first-degree relative of a patient with clinically evident LQTS. In the genetic testing strategy, relatives undergo genetic testing only for the mutation identified in the index patient, and relatives who test positive for the mutation are treated with β-blockers. This strategy was compared with (1) empirical treatment of relatives with β-blockers and (2) watchful waiting, with treatment only after development of symptoms. The genetic testing strategy resulted in better survival and quality-adjusted life years at higher cost, with a cost-effectiveness ratio of $67 400 per quality-adjusted life year gained compared with watchful waiting. The cost-effectiveness of the genetic testing strategy improved to less than $50 000 per quality-adjusted life year gained when applied selectively either to (1) relatives with higher clinical suspicion of LQTS (pretest probability 65% to 81%), or to (2) families with a higher than average risk of sudden death, or to (3) larger families (2 or more first-degree relatives tested).Genetic testing of young first-degree relatives of patients with definite LQTS is moderately expensive, but can reach acceptable thresholds of cost-effectiveness when applied to selected patients.

  View details for DOI 10.1161/CIRCOUTCOMES.110.957365

  View details for PubMedID 21139095

• Cost-effectiveness of antiretroviral regimens in the World Health Organization's treatment guidelines: a South African analysis AIDS Bendavid, E., Grant, P., Talbot, A., Owens, D. K., Zolopa, A. 2011; 25 (2): 211-220

  Abstract

  the World Health Organization (WHO) recently changed its first-line antiretroviral treatment guidelines in resource-limited settings. The cost-effectiveness of the new guidelines is unknown.comparative effectiveness and cost-effectiveness analysis using a model of HIV disease progression and treatment.using a simulation of HIV disease and treatment in South Africa, we compared the life expectancy, quality-adjusted life expectancy, lifetime costs, and cost-effectiveness of five initial regimens. Four are currently recommended by the WHO: tenofovir/lamivudine/efavirenz; tenofovir/lamivudine/nevirapine; zidovudine/lamivudine/efavirenz; and zidovudine/lamivudine/nevirapine. The fifth is the most common regimen in current use: stavudine/lamivudine/nevirapine. Virologic suppression and toxicities determine regimen effectiveness and cost-effectiveness.choice of first-line regimen is associated with a difference of nearly 12 months of quality-adjusted life expectancy, from 135.2 months (tenofovir/lamivudine/efavirenz) to 123.7 months (stavudine/lamivudine/nevirapine). Stavudine/lamivudine/nevirapine is more costly and less effective than zidovudine/lamivudine/nevirapine. Initiating treatment with a regimen containing tenofovir/lamivudine/nevirapine is associated with an incremental cost-effectiveness ratio of $1045 per quality-adjusted life year compared with zidovudine/lamivudine/nevirapine. Using tenofovir/lamivudine/efavirenz was associated with the highest survival, fewest opportunistic diseases, lowest rate of regimen substitution, and an incremental cost-effectiveness ratio of $5949 per quality-adjusted life year gained compared with tenofovir/lamivudine/nevirapine. Zidovudine/lamivudine/efavirenz was more costly and less effective than tenofovir/lamivudine/nevirapine. Results were sensitive to the rates of toxicities and the disutility associated with each toxicity.among the options recommended by WHO, we estimate only three should be considered under normal circumstances. Choice among those depends on available resources and willingness to pay. Stavudine/lamivudine/nevirapine is associated with the poorest quality-adjusted survival and higher costs than zidovudine/lamivudine/nevirapine.

  View details for DOI 10.1097/QAD.0b013e328340fdf8

  View details for PubMedID 21124202

• The Cost-Effectiveness and Population Outcomes of Expanded HIV Screening and Antiretroviral Treatment in the United States ANNALS OF INTERNAL MEDICINE Long, E. F., Brandeau, M. L., Owens, D. K. 2010; 153 (12): 778-?

  Abstract

  Although recent guidelines call for expanded routine screening for HIV, resources for antiretroviral therapy (ART) are limited, and all eligible persons are not currently receiving treatment.To evaluate the effects on the U.S. HIV epidemic of expanded ART, HIV screening, or interventions to reduce risk behavior.Dynamic mathematical model of HIV transmission and disease progression and cost-effectiveness analysis.Published literature.High-risk (injection drug users and men who have sex with men) and low-risk persons aged 15 to 64 years in the United States.Twenty years and lifetime (costs and quality-adjusted life-years [QALYs]).Societal.Expanded HIV screening and counseling, treatment with ART, or both.New HIV infections, discounted costs and QALYs, and incremental cost-effectiveness ratios.One-time HIV screening of low-risk persons coupled with annual screening of high-risk persons could prevent 6.7% of a projected 1.23 million new infections and cost $22,382 per QALY gained, assuming a 20% reduction in sexual activity after screening. Expanding ART utilization to 75% of eligible persons prevents 10.3% of infections and costs $20,300 per QALY gained. A combination strategy prevents 17.3% of infections and costs $21,580 per QALY gained.With no reduction in sexual activity, expanded screening prevents 3.7% of infections. Earlier ART initiation when a CD4 count is greater than 0.350 × 10(9) cells/L prevents 20% to 28% of infections. Additional efforts to halve high-risk behavior could reduce infections by 65%.The model of disease progression and treatment was simplified, and acute HIV screening was excluded.Expanding HIV screening and treatment simultaneously offers the greatest health benefit and is cost-effective. However, even substantial expansion of HIV screening and treatment programs is not sufficient to markedly reduce the U.S. HIV epidemic without substantial reductions in risk behavior.National Institute on Drug Abuse, National Institutes of Health, and Department of Veterans Affairs.

  View details for Web of Science ID 000285453700027

  View details for PubMedID 21173412

  View details for PubMedCentralID PMC3173812

• Cost-Effectiveness of Using High-Sensitivity C-Reactive Protein to Identify Intermediate- and Low-Cardiovascular-Risk Individuals for Statin Therapy CIRCULATION Lee, K. K., Cipriano, L. E., Owens, D. K., Go, A. S., Hlatky, M. A. 2010; 122 (15): 1478-U89

  Abstract

  Many myocardial infarctions and strokes occur in individuals with low-density lipoprotein cholesterol levels below recommended treatment thresholds. High sensitivity C-reactive protein (hs-CRP) testing has been advocated to identify low- and intermediate-risk individuals who may benefit from statin therapy.A decision analytic Markov model was used to follow hypothetical cohorts of individuals with normal lipid levels but without coronary artery disease, peripheral arterial disease, or diabetes mellitus. The model compared current Adult Treatment Panel III practice guidelines, a strategy of hs-CRP screening in those without an indication for statin treatment by current practice guidelines followed by treatment only in those with elevated hs-CRP levels, and a strategy of statin therapy at specified predicted risk thresholds without hs-CRP testing. Risk-based treatment without hs-CRP testing was the most cost-effective strategy, assuming that statins were equally effective regardless of hs-CRP status. However, if normal hs-CRP levels identified a subgroup with little or no benefit from statin therapy (<20% relative risk reduction), then hs-CRP screening would be the optimal strategy. If harms from statin use were greater than generally recognized, then use of current clinical guidelines would be the optimal strategy.Risk-based statin treatment without hs-CRP testing is more cost-effective than hs-CRP screening, assuming that statins have good long-term safety and provide benefits among low-risk people with normal hs-CRP.

  View details for DOI 10.1161/CIRCULATIONAHA.110.947960

  View details for PubMedID 20876434

• Population Strategies to Decrease Sodium Intake RESPONSE ANNALS OF INTERNAL MEDICINE Smith-Spangler, C. M., Owens, D. K., Garber, A. M. 2010; 153 (4): 277-277

  View details for Web of Science ID 000280973000018

• Comparative Effectiveness of HIV Testing and Treatment in Highly Endemic Regions ARCHIVES OF INTERNAL MEDICINE Bendavid, E., Brandeau, M. L., Wood, R., Owens, D. K. 2010; 170 (15): 1347-1354

  Abstract

  Universal testing and treatment holds promise for reducing the burden of human immunodeficiency virus (HIV) in sub-Saharan Africa, but linkage from testing to treatment sites and retention in care are inadequate.We developed a simulation of the HIV epidemic and HIV disease progression in South Africa to compare the outcomes of the present HIV treatment campaign (status quo) with 4 HIV testing and treating strategies that increase access to antiretroviral therapy: (1) universal testing and treatment without changes in linkage to care and loss to follow-up; (2) universal testing and treatment with improved linkage to care; (3) universal testing and treatment with reduced loss to follow-up; and (4) comprehensive HIV care with universal testing and treatment, improved linkage to care, and reduced loss to follow-up. The main outcome measures were survival benefits, new HIV infections, and HIV prevalence.Compared with the status quo strategy, universal testing and treatment (1) was associated with a mean (95% uncertainty bounds) life expectancy gain of 12.0 months (11.3-12.2 months), and 35.3% (32.7%-37.5%) fewer HIV infections over a 10-year time horizon. Improved linkage to care (2), prevention of loss to follow-up (3), and comprehensive HIV care (4) provided substantial additional benefits: life expectancy gains compared with the status quo strategy were 16.1, 18.6, and 22.2 months, and new infections were 55.5%, 51.4%, and 73.2% lower, respectively. In sensitivity analysis, comprehensive HIV care reduced new infections by 69.7% to 76.7% under a broad set of assumptions.Universal testing and treatment with current levels of linkage to care and loss to follow-up could substantially reduce the HIV death toll and new HIV infections. However, increasing linkage to care and preventing loss to follow-up provides nearly twice the benefits of universal testing and treatment alone.

  View details for PubMedID 20696960

• The Development of Clinical Practice Guidelines and Guidance Statements of the American College of Physicians: Summary of Methods ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Owens, D. K., Shekelle, P. 2010; 153 (3): 194-U95

  Abstract

  The American College of Physicians (ACP) established its evidence-based clinical practice guidelines program in 1981. The ACP's Guidelines Committee and the staff of the Clinical Programs and Quality of Care Department develop the clinical recommendations. The ACP develops 2 different types of clinical recommendations: clinical practice guidelines and clinical guidance statements. The ACP clinical practice guidelines and guidance statements follow a multistep development process that includes a systematic review of the evidence, deliberation of the evidence by the committee, summary recommendations, and evidence and recommendation grading. All ACP clinical practice guidelines and clinical guidance statements, if not updated, are considered automatically withdrawn or invalid 5 years after publication or once an update has been issued.

  View details for Web of Science ID 000280557600008

  View details for PubMedID 20679562

• Cost-Effectiveness of Strategies to Improve HIV Testing and Receipt of Results: Economic Analysis of a Randomized Controlled Trial JOURNAL OF GENERAL INTERNAL MEDICINE Sanders, G. D., Anaya, H. D., Asch, S., Hoang, T., Golden, J. F., Bayoumi, A. M., Owens, D. K. 2010; 25 (6): 556-563

  Abstract

  The CDC recommends routine voluntary HIV testing of all patients 13-64 years of age. Despite this recommendation, HIV testing rates are low even among those at identifiable risk, and many patients do not return to receive their results.To examine the costs and benefits of strategies to improve HIV testing and receipt of results.Cost-effectiveness analysis based on a Markov model. Acceptance of testing, return rates, and related costs were derived from a randomized trial of 251 patients; long-term costs and health outcomes were derived from the literature. SETTING/TARGET POPULATION: Primary-care patients with unknown HIV status.Comparison of three intervention models for HIV counseling and testing: Model A = traditional HIV counseling and testing; Model B = nurse-initiated routine screening with traditional HIV testing and counseling; Model C = nurse-initiated routine screening with rapid HIV testing and streamlined counseling.Life-years, quality-adjusted life-years (QALYs), costs and incremental cost-effectiveness.Without consideration of the benefit from reduced HIV transmission, Model A resulted in per-patient lifetime discounted costs of $48,650 and benefits of 16.271 QALYs. Model B increased lifetime costs by $53 and benefits by 0.0013 QALYs (corresponding to 0.48 quality-adjusted life days). Model C cost $66 more than Model A with an increase of 0.0018 QALYs (0.66 quality-adjusted life days) and an incremental cost-effectiveness of $36,390/QALY. When we included the benefit from reduced HIV transmission, Model C cost $10,660/QALY relative to Model A. The cost-effectiveness of Model C was robust in sensitivity analyses.In a primary-care population, nurse-initiated routine screening with rapid HIV testing and streamlined counseling increased rates of testing and receipt of test results and was cost-effective compared with traditional HIV testing strategies.

  View details for DOI 10.1007/s11606-010-1265-5

  View details for Web of Science ID 000277712200015

  View details for PubMedID 20204538

  View details for PubMedCentralID PMC2869414

• AHRQ Series Paper 5: Grading the strength of a body of evidence when comparing medical interventions-Agency for Healthcare Research and Quality and the Effective Health-Care Program JOURNAL OF CLINICAL EPIDEMIOLOGY Owens, D. K., Lohr, K. N., Atkins, D., Treadwell, J. R., Reston, J. T., Bass, E. B., Chang, S., Helfand, M. 2010; 63 (5): 513-523

  Abstract

  To establish guidance on grading strength of evidence for the Evidence-based Practice Center (EPC) program of the U.S. Agency for Healthcare Research and Quality.Authors reviewed authoritative systems for grading strength of evidence, identified domains and methods that should be considered when grading bodies of evidence in systematic reviews, considered public comments on an earlier draft, and discussed the approach with representatives of the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group.The EPC approach is conceptually similar to the GRADE system of evidence rating; it requires assessment of four domains: risk of bias, consistency, directness, and precision. Additional domains to be used when appropriate include dose-response association, presence of confounders that would diminish an observed effect, strength of association, and publication bias. Strength of evidence receives a single grade: high, moderate, low, or insufficient. We give definitions, examples, mechanisms for scoring domains, and an approach for assigning strength of evidence.EPCs should grade strength of evidence separately for each major outcome and, for comparative effectiveness reviews, all major comparisons. We will collaborate with the GRADE group to address ongoing challenges in assessing the strength of evidence.

  View details for DOI 10.1016/j.jclinepi.2009.03.009

  View details for PubMedID 19595577

• Population Strategies to Decrease Sodium Intake and the Burden of Cardiovascular Disease A Cost-Effectiveness Analysis ANNALS OF INTERNAL MEDICINE Smith-Spangler, C. M., Juusola, J. L., Enns, E. A., Owens, D. K., Garber, A. M. 2010; 152 (8): 481-U21

  Abstract

  Sodium consumption raises blood pressure, increasing the risk for heart attack and stroke. Several countries, including the United States, are considering strategies to decrease population sodium intake.To assess the cost-effectiveness of 2 population strategies to reduce sodium intake: government collaboration with food manufacturers to voluntarily cut sodium in processed foods, modeled on the United Kingdom experience, and a sodium tax.A Markov model was constructed with 4 health states: well, acute myocardial infarction (MI), acute stroke, and history of MI or stroke.Medical Panel Expenditure Survey (2006), Framingham Heart Study (1980 to 2003), Dietary Approaches to Stop Hypertension trial, and other published data.U.S. adults aged 40 to 85 years.Lifetime.Societal.Incremental costs (2008 U.S. dollars), quality-adjusted life-years (QALYs), and MIs and strokes averted.Collaboration with industry that decreases mean population sodium intake by 9.5% averts 513 885 strokes and 480 358 MIs over the lifetime of adults aged 40 to 85 years who are alive today compared with the status quo, increasing QALYs by 2.1 million and saving $32.1 billion in medical costs. A tax on sodium that decreases population sodium intake by 6% increases QALYs by 1.3 million and saves $22.4 billion over the same period.Results are sensitive to the assumption that consumers have no disutility with modest reductions in sodium intake.Efforts to reduce population sodium intake could result in other dietary changes that are difficult to predict.Strategies to reduce sodium intake on a population level in the United States are likely to substantially reduce stroke and MI incidence, which would save billions of dollars in medical expenses.Department of Veterans Affairs, Stanford University, and National Science Foundation.

  View details for Web of Science ID 000277054400001

  View details for PubMedID 20194225

• Cost Effectiveness of Alternative Imaging Strategies for the Diagnosis of Small-Bowel Crohn's Disease CLINICAL GASTROENTEROLOGY AND HEPATOLOGY Levesque, B. G., Cipriano, L. E., Chang, S. L., Lee, K. K., Owens, D. K., Garber, A. M. 2010; 8 (3): 261-267

  Abstract

  The cost effectiveness of alternative approaches to the diagnosis of small-bowel Crohn's disease is unknown. This study evaluates whether computed tomographic enterography (CTE) is a cost-effective alternative to small-bowel follow-through (SBFT) and whether capsule endoscopy is a cost-effective third test in patients in whom a high suspicion of disease remains after 2 previous negative tests.A decision-analytic model was developed to compare the lifetime costs and benefits of each diagnostic strategy. Patients were considered with low (20%) and high (75%) pretest probability of small-bowel Crohn's disease. Effectiveness was measured in quality-adjusted life-years (QALYs) gained. Parameter assumptions were tested with sensitivity analyses.With a moderate to high pretest probability of small-bowel Crohn's disease, and a higher likelihood of isolated jejunal disease, follow-up evaluation with CTE has an incremental cost-effectiveness ratio of less than $54,000/QALY-gained compared with SBFT. The addition of capsule endoscopy after ileocolonoscopy and negative CTE or SBFT costs greater than $500,000 per QALY-gained in all scenarios. Results were not sensitive to costs of tests or complications but were sensitive to test accuracies.The cost effectiveness of strategies depends critically on the pretest probability of Crohn's disease and if the terminal ileum is examined at ileocolonoscopy. CTE is a cost-effective alternative to SBFT in patients with moderate to high suspicion of small-bowel Crohn's disease. The addition of capsule endoscopy as a third test is not a cost-effective third test, even in patients with high pretest probability of disease.

  View details for DOI 10.1016/j.cgh.2009.10.032

  View details for PubMedID 19896559

• Health Outcomes and Costs of Community Mitigation Strategies for an Influenza Pandemic in the United States CLINICAL INFECTIOUS DISEASES Perlroth, D. J., Glass, R. J., Davey, V. J., Cannon, D., Garber, A. M., Owens, D. K. 2010; 50 (2): 165-174

  Abstract

  The optimal community-level approach to control pandemic influenza is unknown.We estimated the health outcomes and costs of combinations of 4 social distancing strategies and 2 antiviral medication strategies to mitigate an influenza pandemic for a demographically typical US community. We used a social network, agent-based model to estimate strategy effectiveness and an economic model to estimate health resource use and costs. We used data from the literature to estimate clinical outcomes and health care utilization.At 1% influenza mortality, moderate infectivity (R(o) of 2.1 or greater), and 60% population compliance, the preferred strategy is adult and child social distancing, school closure, and antiviral treatment and prophylaxis. This strategy reduces the prevalence of cases in the population from 35% to 10%, averts 2480 cases per 10,000 population, costs $2700 per case averted, and costs $31,300 per quality-adjusted life-year gained, compared with the same strategy without school closure. The addition of school closure to adult and child social distancing and antiviral treatment and prophylaxis, if available, is not cost-effective for viral strains with low infectivity (R(o) of 1.6 and below) and low case fatality rates (below 1%). High population compliance lowers costs to society substantially when the pandemic strain is severe (R(o) of 2.1 or greater).Multilayered mitigation strategies that include adult and child social distancing, use of antivirals, and school closure are cost-effective for a moderate to severe pandemic. Choice of strategy should be driven by the severity of the pandemic, as defined by the case fatality rate and infectivity.

  View details for DOI 10.1086/649867

  View details for Web of Science ID 000273069100003

  View details for PubMedID 20021259

• Role of single photon emission computed tomography in the diagnosis of chronic low back pain SPINE JOURNAL O'Neill, C., Owens, D. K. 2010; 10 (1): 70-72

  View details for DOI 10.1016/j.spinee.2009.11.010

  View details for Web of Science ID 000208284500011

  View details for PubMedID 20129239

• Effectiveness and Cost-Effectiveness of Vaccination Against Pandemic Influenza (H1N1) 2009 ANNALS OF INTERNAL MEDICINE Khazeni, N., Hutton, D. W., Garber, A. M., Hupert, N., Owens, D. K. 2009; 151 (12): 829-U2

  Abstract

  Decisions on the timing and extent of vaccination against pandemic (H1N1) 2009 virus are complex.To estimate the effectiveness and cost-effectiveness of pandemic influenza (H1N1) vaccination under different scenarios in October or November 2009.Compartmental epidemic model in conjunction with a Markov model of disease progression.Literature and expert opinion.Residents of a major U.S. metropolitan city with a population of 8.3 million.Lifetime.Societal.Vaccination in mid-October or mid-November 2009.Infections and deaths averted, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness.Assuming each primary infection causes 1.5 secondary infections, vaccinating 40% of the population in October or November would be cost-saving. Vaccination in October would avert 2051 deaths, gain 69 679 QALYs, and save $469 million compared with no vaccination; vaccination in November would avert 1468 deaths, gain 49 422 QALYs, and save $302 million.Vaccination is even more cost-saving if longer incubation periods, lower rates of infectiousness, or increased implementation of nonpharmaceutical interventions delay time to the peak of the pandemic. Vaccination saves fewer lives and is less cost-effective if the epidemic peaks earlier than mid-October.The model assumed homogenous mixing of case-patients and contacts; heterogeneous mixing would result in faster initial spread, followed by slower spread. Additional costs and savings not included in the model would make vaccination more cost-saving.Earlier vaccination against pandemic (H1N1) 2009 prevents more deaths and is more cost-saving. Complete population coverage is not necessary to reduce the viral reproductive rate sufficiently to help shorten the pandemic.Agency for Healthcare Research and Quality and National Institute on Drug Abuse.

  View details for PubMedID 20008759

• Effectiveness and Cost-Effectiveness of Expanded Antiviral Prophylaxis and Adjuvanted Vaccination Strategies for an Influenza A (H5N1) Pandemic ANNALS OF INTERNAL MEDICINE Khazeni, N., Hutton, D. W., Garber, A. M., Owens, D. K. 2009; 151 (12): 840-U3

  Abstract

  The pandemic potential of influenza A (H5N1) virus is a prominent public health concern of the 21st century.To estimate the effectiveness and cost-effectiveness of alternative pandemic (H5N1) mitigation and response strategies.Compartmental epidemic model in conjunction with a Markov model of disease progression.Literature and expert opinion.Residents of a U.S. metropolitan city with a population of 8.3 million.Lifetime.Societal.3 scenarios: 1) vaccination and antiviral pharmacotherapy in quantities similar to those currently available in the U.S. stockpile (stockpiled strategy), 2) stockpiled strategy but with expanded distribution of antiviral agents (expanded prophylaxis strategy), and 3) stockpiled strategy but with adjuvanted vaccine (expanded vaccination strategy). All scenarios assumed standard nonpharmaceutical interventions.Infections and deaths averted, costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness.Expanded vaccination was the most effective and cost-effective of the 3 strategies, averting 68% of infections and deaths and gaining 404 030 QALYs at $10 844 per QALY gained relative to the stockpiled strategy.Expanded vaccination remained incrementally cost-effective over a wide range of assumptions.The model assumed homogenous mixing of cases and contacts; heterogeneous mixing would result in faster initial spread, followed by slower spread. We did not model interventions for children or older adults; the model is not designed to target interventions to specific groups.Expanded adjuvanted vaccination is an effective and cost-effective mitigation strategy for an influenza A (H5N1) pandemic. Expanded antiviral prophylaxis can help delay the pandemic while additional strategies are implemented.National Institutes of Health and Agency for Healthcare Research and Quality.

  View details for PubMedID 20008760

• Comparison of Thromboembolic Event Rates in Randomized Controlled Trials and Observational Studies of Recombinant Factor VIIa for Off-Label Indications. 51st Annual Meeting and Exposition of the American-Society-of-Hematology Yank, V., Logan, A. C., Tuohy, C. V., Bravata, D. M., Staudenmayer, K., Eisenhut, R., Sundaram, V., McMahon, D., McDonald, K. M., Owens, D., Stafford, R. S. AMER SOC HEMATOLOGY. 2009: 571–72

  View details for Web of Science ID 000272725801583

• Hormonal Testing and Pharmacologic Treatment of Erectile Dysfunction: A Clinical Practice Guideline From the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Denberg, T. D., Casey, D. E., Forciea, M. A., Owens, D. K., Shekelle, P. 2009; 151 (9): 639-W208

  Abstract

  The American College of Physicians developed this guideline to present the available evidence on hormonal testing in and pharmacologic management of erectile dysfunction. Current pharmacologic therapies include phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil, vardenafil, tadalafil, mirodenafil, and udenafil, and hormonal treatment.Published literature on this topic was identified by using MEDLINE (1966 to May 2007), EMBASE (1980 to week 22 of 2007), Cochrane Central Register of Controlled Trials (second quarter of 2007), PsycINFO (1985 to June 2007), AMED (1985 to June 2007), and SCOPUS (2006). The literature search was updated by searching for articles in MEDLINE and EMBASE published between May 2007 and April 2009. Searches were limited to English-language publications. This guideline grades the evidence and recommendations by using the American College of Physicians' clinical practice guidelines grading system. RECOMMENDATION 1: The American College of Physicians recommends that clinicians initiate therapy with a PDE-5 inhibitor in men who seek treatment for erectile dysfunction and who do not have a contraindication to PDE-5 inhibitor use (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: The American College of Physicians recommends that clinicians base the choice of a specific PDE-5 inhibitor on the individual preferences of men with erectile dysfunction, including ease of use, cost of medication, and adverse effects profile (Grade: weak recommendation; low-quality evidence). RECOMMENDATION 3: The American College of Physicians does not recommend for or against routine use of hormonal blood tests or hormonal treatment in the management of patients with erectile dysfunction (Grade: insufficient evidence to determine net benefits and harms).

  View details for Web of Science ID 000271387700006

  View details for PubMedID 19884625

• Opt-Out Testing for Stigmatized Diseases: A Social Psychological Approach to Understanding the Potential Effect of Recommendations for Routine HIV Testing HEALTH PSYCHOLOGY Young, S. D., Monin, B., Owens, D. 2009; 28 (6): 675-681

  Abstract

  Little research has studied experimentally whether an opt-out policy will increase testing rates or whether this strategy is especially effective in the case of stigmatized diseases such as HIV.In Study 1, a 2 x 2 factorial design asked participants to make moral judgments about a person's decision to test for stigmatized diseases under an opt-in versus an opt-out policy. In Study 2, a 2 x 2 factorial design measuring testing rates explored whether opt-out methods reduce stigma and increase testing for stigmatized diseases.Study 1 results suggest that getting tested draws suspicion regarding moral conduct in an opt-in system, whereas not getting tested draws suspicion in an opt-out system. Study 2 results suggest that an opt-out policy may increase testing rates for stigmatized diseases and lessen the effects of stigma in people's reluctance to test.A social psychological approach to health services can be used to show how testing policies can influence both the stigmatization associated with testing and participation rates. An understanding of how testing policies may affect patient decision making and behavior is imperative for creating effective testing policies.

  View details for DOI 10.1037/a0016395

  View details for Web of Science ID 000271817400004

  View details for PubMedID 19916635

  View details for PubMedCentralID PMC2965185

• Cost-Effectiveness of a Potential Prophylactic Helicobacter pylori Vaccine in the United States JOURNAL OF INFECTIOUS DISEASES Rupnow, M. F., Chang, A. H., Shachter, R. D., Owens, D. K., Parsonnet, J. 2009; 200 (8): 1311-1317

  Abstract

  Helicobacter pylori vaccines are under development to prevent infection. We quantified the cost-effectiveness of such a vaccine in the United States, using a dynamic transmission model.We compartmentalized the population by age, infection status, and clinical disease state and measured effectiveness in quality-adjusted life years (QALYs). We simulated no intervention, vaccination of infants, and vaccination of school-age children. Variables included costs of vaccine, vaccine administration, and gastric cancer treatment (in 2007 US dollars), vaccine efficacy, quality adjustment due to gastric cancer, and discount rate. We evaluated possible outcomes for periods of 10-75 years.H. pylori vaccination of infants would cost $2.9 billion over 10 years; savings from cancer prevention would be realized decades later. Over a long time horizon (75 years), incremental costs of H. pylori vaccination would be $1.8 billion, and incremental QALYs would be 0.5 million, yielding a cost-effectiveness ratio of $3871/QALY. With school-age vaccination, the cost-effectiveness ratio would be $22,137/QALY. With time limited to <40 years, the cost-effectiveness ratio exceeded $50,000/QALY.When evaluated with a time horizon beyond 40 years, the use of a prophylactic H. pylori vaccine was cost-effective in the United States, especially with infant vaccination.

  View details for DOI 10.1086/605845

  View details for PubMedID 19751153

• Expanding Antiretroviral Options in Resource-Limited Settings-A Cost-Effectiveness Analysis JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Bendavid, E., Wood, R., Katzenstein, D. A., Bayoumi, A. M., Owens, D. K. 2009; 52 (1): 106-113

  Abstract

  Current World Health Organization (WHO) guidelines for treatment of HIV in resource-limited settings call for 2 antiretroviral regimens. The effectiveness and cost-effectiveness of increasing the number of antiretroviral regimens is unknown.Using a simulation model, we compared the survival and costs of current WHO regimens with two 3-regimen strategies: an initial regimen of 3 nucleoside reverse transcriptase inhibitors followed by the WHO regimens and the WHO regimens followed by a regimen with a second-generation boosted protease inhibitor (2bPI). We evaluated monitoring with CD4 counts only and with both CD4 counts and viral load. We used cost and effectiveness data from Cape Town and tested all assumptions in sensitivity analyses.Over the lifetime of the cohort, 25.6% of individuals failed both WHO regimens by virologic criteria. However, when patients were monitored using CD4 counts alone, only 6.5% were prescribed additional highly active antiretroviral therapy due to missed and delayed detection of failure. The life expectancy gain for individuals who took a 2bPI was 6.7-8.9 months, depending on the monitoring strategy. When CD4 alone was available, adding a regimen with a 2bPI was associated with an incremental cost-effectiveness ratio of $2581 per year of life gained, and when viral load was available, the ratio was $6519 per year of life gained. Strategies with triple-nucleoside reverse transcriptase inhibitor regimens in initial therapy were dominated. Results were sensitive to the price of 2bPIs.About 1 in 4 individuals who start highly active antiretroviral therapy in sub-Saharan Africa will fail currently recommended regimens. At current prices, adding a regimen with a 2bPI is cost effective for South Africa and other middle-income countries by WHO standards.

  View details for PubMedID 19448557

• The concurrent validity and responsiveness of the health utilities index (HUI 3) among patients with advanced HIV/AIDS QUALITY OF LIFE RESEARCH Nosyk, B., Sun, H., Bansback, N., Guh, D. P., Li, X., Barnett, P., Bayoumi, A., Griffin, S., Joyce, V., Holodniy, M., Owens, D. K., Anis, A. H. 2009; 18 (7): 815-824

  Abstract

  To assess the concurrent validity and responsiveness of the Health Utility Index 3 (HUI3) in patients with advanced HIV/AIDS, and to determine the responsiveness of this measure, the MOS-HIV and EQ-5D to HIV-related clinical events.Data from the OPTIMA (OPTions In Management with Antiretrovirals) trial was analyzed. Two aspects of the validity of the HUI3 were considered: concurrent validity was evaluated using Spearman correlations with MOS-HIV component and summary scores. Responsiveness to AIDS-defining events (ADE) and all adverse events (our external change criterion) was assessed using area under the receiver operating characteristic (AUROC) curves.The study enrolled 368 patients (mean follow-up: 3.66 years); 82% had at least one severe adverse event and 27% had at least one ADE. The HUI3 scale and items showed good concurrent validity, with 85% of the expected relationships with the MOS-HIV subscales verified. The HUI3 was responsive to both adverse events (AUROC [95%CI]: 0.68 [0.57, 0.80]) and ADEs (0.62 [0.51, 0.74]). The EQ-5D was responsive to ADEs (0.66 [0.56, 0.76]), but not responsive to adverse events (0.56 [0.46, 0.68]).The HUI3 is a valid and responsive measure of the change in HRQoL associated with clinical events in an advanced HIV/AIDS population.

  View details for DOI 10.1007/s11136-009-9504-0

  View details for Web of Science ID 000268881000003

  View details for PubMedID 19562514

• Potential population health outcomes and expenditures of HIV vaccination strategies in the United States VACCINE Long, E. F., Brandeau, M. L., Owens, D. K. 2009; 27 (39): 5402-5410

  Abstract

  Estimating the potential health benefits and expenditures of a partially effective HIV vaccine is an important consideration in the debate about whether HIV vaccine research should continue. We developed an epidemic model to estimate HIV prevalence, new infections, and the cost-effectiveness of vaccination strategies in the U.S. Vaccines with modest efficacy could prevent 300,000-700,000 HIV infections and save $30 billion in healthcare expenditures over 20 years. Targeted vaccination of high-risk individuals is economically efficient, but difficulty in reaching these groups may mitigate these benefits. Universal vaccination is cost-effective for vaccines with 50% efficacy and price similar to other infectious disease vaccines.

  View details for DOI 10.1016/j.vaccine.2009.06.063

  View details for Web of Science ID 000269629800018

  View details for PubMedID 19591796

  View details for PubMedCentralID PMC2757634

• Systematic Review: Elective Induction of Labor Versus Expectant Management of Pregnancy ANNALS OF INTERNAL MEDICINE Caughey, A. B., Sundaram, V., Kaimal, A. J., Gienger, A., Cheng, Y. W., McDonald, K. M., Shaffer, B. L., Owens, D. K., Bravata, D. M. 2009; 151 (4): 252-W63

  Abstract

  The rates of induction of labor and elective induction of labor are increasing. Whether elective induction of labor improves outcomes or simply leads to greater complications and health care costs is commonly debated in the literature.To compare the benefits and harms of elective induction of labor and expectant management of pregnancy.MEDLINE (through February 2009), Web of Science, CINAHL, Cochrane Central Register of Controlled Trials (through March 2009), bibliographies of included studies, and previous systematic reviews.Experimental and observational studies of elective induction of labor reported in English.Two authors abstracted study design; patient characteristics; quality criteria; and outcomes, including cesarean delivery and maternal and neonatal morbidity.Of 6117 potentially relevant articles, 36 met inclusion criteria: 11 randomized, controlled trials (RCTs) and 25 observational studies. Overall, expectant management of pregnancy was associated with a higher odds ratio (OR) of cesarean delivery than was elective induction of labor (OR, 1.22 [95% CI, 1.07 to 1.39]; absolute risk difference, 1.9 percentage points [CI, 0.2 to 3.7 percentage points]) in 9 RCTs. Women at or beyond 41 completed weeks of gestation who were managed expectantly had a higher risk for cesarean delivery (OR, 1.21 [CI, 1.01 to 1.46]), but this difference was not statistically significant in women at less than 41 completed weeks of gestation (OR, 1.73 [CI, 0.67 to 4.5]). Women who were expectantly managed were more likely to have meconium-stained amniotic fluid than those who were electively induced (OR, 2.04 [CI, 1.34 to 3.09]). Limitations: There were no recent RCTs of elective induction of labor at less than 41 weeks of gestation. The 2 studies conducted at less than 41 weeks of gestation were of poor quality and were not generalizable to current practice.RCTs suggest that elective induction of labor at 41 weeks of gestation and beyond is associated with a decreased risk for cesarean delivery and meconium-stained amniotic fluid. There are concerns about the translation of these findings into actual practice; thus, future studies should examine elective induction of labor in settings where most obstetric care is provided.

  View details for PubMedID 19687492

• Comments on the Recent Clinical Guidance Statement on HIV Screening Response ANNALS OF INTERNAL MEDICINE Qaseem, A., Shekelle, P., Owens, D. K. 2009; 151 (4): 287-287

  View details for Web of Science ID 000269038900014

• Lumbar facet joint pain: time to hit the reset button SPINE JOURNAL O'Neill, C., Owens, D. K. 2009; 9 (8): 619-622

  View details for DOI 10.1016/j.spinee.2009.05.017

  View details for Web of Science ID 000268786300001

  View details for PubMedID 19622412

• A randomized trial of computer-based reminders and audit and feedback to improve HIV screening in a primary care setting INTERNATIONAL JOURNAL OF STD & AIDS Sundaram, V., Lazzeroni, L. C., Douglass, L. R., Sanders, G. D., Tempio, P., Owens, D. K. 2009; 20 (8): 527-533

  Abstract

  Despite recommendations for voluntary HIV screening, few medical centres have implemented screening programmes. The objective of the study was to determine whether an intervention with computer-based reminders and feedback would increase screening for HIV in a Department of Veterans Affairs (VA) health-care system. The design of the study was a randomized controlled trial at five primary care clinics at the VA Palo Alto Health Care System. All primary care providers were eligible to participate in the study. The study intervention was computer-based reminders to either assess HIV risk behaviours or to offer HIV testing; feedback on adherence to reminders was provided. The main outcome measure was the difference in HIV testing rates between intervention and control group providers. The control group providers tested 1.0% (n = 67) and 1.4% (n = 106) of patients in the preintervention and intervention period, respectively; intervention providers tested 1.8% (n = 98) and 1.9% (n = 114), respectively (P = 0.75). In our random sample of 753 untested patients, 204 (27%) had documented risk behaviours. Providers were more likely to adhere to reminders to test rather than with reminders to perform risk assessment (11% versus 5%, P < 0.01). Sixty-one percent of providers felt that lack of time prevented risk assessment. In conclusion, in primary care clinics in our setting, HIV testing rates were low. Providers were unaware of the high rates of risky behaviour in their patient population and perceived important barriers to testing. Low-intensity clinical reminders and feedback did not increase rates of screening.

  View details for DOI 10.1258/ijsa.2008.008423

  View details for PubMedID 19625582

• Quality Improvement Strategies for Children With Asthma A Systematic Review ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE Bravata, D. M., Gienger, A. L., Holty, J. C., Sundaram, V., Khazeni, N., Wise, P. H., McDonald, K. M., Owens, D. K. 2009; 163 (6): 572-581

  Abstract

  To evaluate the evidence that quality improvement (QI) strategies can improve the processes and outcomes of outpatient pediatric asthma care.Cochrane Effective Practice and Organisation of Care Group database (January 1966 to April 2006), MEDLINE (January 1966 to April 2006), Cochrane Consumers and Communication Group database (January 1966 to May 2006), and bibliographies of retrieved articles.Randomized controlled trials, controlled before-after trials, or interrupted time series trials of English-language QI evaluations.Must have included 1 or more QI strategies for the outpatient management of children with asthma.Clinical status (eg, spirometric measures); functional status (eg, days lost from school); and health services use (eg, hospital admissions).Seventy-nine studies met inclusion criteria: 69 included at least some component of patient education, self-monitoring, or self-management; 13 included some component of organizational change; and 7 included provider education. Self-management interventions increased symptom-free days by approximately 10 days/y (P = .02) and reduced school absenteeism by about 0.1 day/mo (P = .03). Interventions of provider education and those that incorporated organizational changes were likely to report improvements in medication use. Quality improvement interventions that provided multiple educational sessions, had longer durations, and used combinations of instructional modalities were more likely to result in improvements for patients than interventions lacking these characteristics.A variety of QI interventions improve the outcomes and processes of care for children with asthma. Use of similar outcome measures and thorough descriptions of interventions would advance the study of QI for pediatric asthma care.

  View details for Web of Science ID 000266566700011

  View details for PubMedID 19487615

• CABG versus PCl for multivessel coronary artery disease Reply LANCET Hlatky, M. A., Bravata, D. M., McDonald, K. M., Owens, D. K. 2009; 373 (9682): 2200-2200

  View details for Web of Science ID 000267444500029

• Quality Improvement Strategies for Children With Asthma A Systematic Review ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE Bravata, D. M., Gienger, A. L., Holty, J. C., Sundaram, V., Khazeni, N., Wise, P. H., McDonald, K. M., Owens, D. K. 2009; 163 (6): E1-E5

  View details for Web of Science ID 000266566700016

• Cost-effectiveness of Strategies for Monitoring the Response to Antiretroviral Therapy in Resource-Limited Settings Reply ARCHIVES OF INTERNAL MEDICINE Bendavid, E., Owens, D. K. 2009; 169 (9): 904-905

  View details for Web of Science ID 000265994000017

• Interventional Therapies, Surgery, and Interdisciplinary Rehabilitation for Low Back Pain An Evidence-Based Clinical Practice Guideline From the American Pain Society SPINE Chou, R., Loeser, J. D., Owens, D. K., Rosenquist, R. W., Atlas, S. J., Baisden, J., Carragee, E. J., Grabois, M., Murphy, D. R., Resnick, D. K., Stanos, S. P., Shaffer, W. O., Wall, E. M. 2009; 34 (10): 1066-1077

  Abstract

  Clinical practice guideline.To develop evidence-based recommendations on use of interventional diagnostic tests and therapies, surgeries, and interdisciplinary rehabilitation for low back pain of any duration, with or without leg pain.Management of patients with persistent and disabling low back pain remains a clinical challenge. A number of interventional diagnostic tests and therapies and surgery are available and their use is increasing, but in some cases their utility remains uncertain or controversial. Interdisciplinary rehabilitation has also been proposed as a potentially effective noninvasive intervention for persistent and disabling low back pain.A multidisciplinary panel was convened by the American Pain Society. Its recommendations were based on a systematic review that focused on evidence from randomized controlled trials. Recommendations were graded using methods adapted from the US Preventive Services Task Force and the Grading of Recommendations, Assessment, Development, and Evaluation Working Group.Investigators reviewed 3348 abstracts. A total of 161 randomized trials were deemed relevant to the recommendations in this guideline. The panel developed a total of 8 recommendations.Recommendations on use of interventional diagnostic tests and therapies, surgery, and interdisciplinary rehabilitation are presented. Due to important trade-offs between potential benefits, harms, costs, and burdens of alternative therapies, shared decision-making is an important component of a number of the recommendations.

  View details for DOI 10.1097/BRS.0b013e3181a1390d

  View details for PubMedID 19363457

• Coronary artery bypass surgery compared with percutaneous coronary interventions for multivessel disease: a collaborative analysis of individual patient data from ten randomised trials LANCET Hlatky, M. A., Boothroyd, D. B., Bravata, D. M., Boersma, E., Booth, J., Brooks, M. M., Carrie, D., Clayton, T. C., Danchin, N., Flather, M., Hamm, C. W., Hueb, W. A., Kaehler, J., Kelsey, S. F., King, S. B., Kosinski, A. S., Lopes, N., McDonald, K. M., Rodriguez, A., Serruys, P., Sigwart, U., Stables, R. H., Owens, D. K., Pocock, S. J. 2009; 373 (9670): 1190-1197

  Abstract

  Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are alternative treatments for multivessel coronary disease. Although the procedures have been compared in several randomised trials, their long-term effects on mortality in key clinical subgroups are uncertain. We undertook a collaborative analysis of data from randomised trials to assess whether the effects of the procedures on mortality are modified by patient characteristics.We pooled individual patient data from ten randomised trials to compare the effectiveness of CABG with PCI according to patients' baseline clinical characteristics. We used stratified, random effects Cox proportional hazards models to test the effect on all-cause mortality of randomised treatment assignment and its interaction with clinical characteristics. All analyses were by intention to treat.Ten participating trials provided data on 7812 patients. PCI was done with balloon angioplasty in six trials and with bare-metal stents in four trials. Over a median follow-up of 5.9 years (IQR 5.0-10.0), 575 (15%) of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0.91, 95% CI 0.82-1.02; p=0.12). In patients with diabetes (CABG, n=615; PCI, n=618), mortality was substantially lower in the CABG group than in the PCI group (HR 0.70, 0.56-0.87); however, mortality was similar between groups in patients without diabetes (HR 0.98, 0.86-1.12; p=0.014 for interaction). Patient age modified the effect of treatment on mortality, with hazard ratios of 1.25 (0.94-1.66) in patients younger than 55 years, 0.90 (0.75-1.09) in patients aged 55-64 years, and 0.82 (0.70-0.97) in patients 65 years and older (p=0.002 for interaction). Treatment effect was not modified by the number of diseased vessels or other baseline characteristics.Long-term mortality is similar after CABG and PCI in most patient subgroups with multivessel coronary artery disease, so choice of treatment should depend on patient preferences for other outcomes. CABG might be a better option for patients with diabetes and patients aged 65 years or older because we found mortality to be lower in these subgroups.

  View details for DOI 10.1016/S0140-6736(09)60552-3

  View details for PubMedID 19303634

• Maternal and neonatal outcomes of elective induction of labor. Evidence report/technology assessment Caughey, A. B., Sundaram, V., Kaimal, A. J., Cheng, Y. W., Gienger, A., Little, S. E., Lee, J. F., Wong, L., Shaffer, B. L., Tran, S. H., Padula, A., McDonald, K. M., Long, E. F., Owens, D. K., Bravata, D. M. 2009: 1-257

  Abstract

  Induction of labor is on the rise in the U.S., increasing from 9.5 percent in 1990 to 22.1 percent in 2004. Although, it is not entirely clear what proportion of these inductions are elective (i.e. without a medical indication), the overall rate of induction of labor is rising faster than the rate of pregnancy complications that would lead to a medically indicated induction. However, the maternal and neonatal effects of induction of labor are unclear. Many studies compare women with induction of labor to those in spontaneous labor. This is problematic, because at any point in the management of the woman with a term gestation, the clinician has the choice between induction of labor and expectant management, not spontaneous labor. Expectant management of the pregnancy involves nonintervention at any particular point in time and allowing the pregnancy to progress to a future gestational age. Thus, women undergoing expectant management may go into spontaneous labor or may require indicated induction of labor at a future gestational age.The Stanford-UCSF Evidence-Based Practice Center examined the evidence regarding four Key Questions: What evidence describes the maternal risks of elective induction versus expectant management? What evidence describes the fetal/neonatal risks of elective induction versus expectant management? What is the evidence that certain physical conditions/patient characteristics are predictive of a successful induction of labor? How is a failed induction defined?We performed a systematic review to answer the Key Questions. We searched MEDLINE(1966-2007) and bibliographies of prior systematic reviews and the included studies for English language studies of maternal and fetal outcomes after elective induction of labor. We evaluated the quality of included studies. When possible, we synthesized study data using random effects models. We also evaluated the potential clinical outcomes and cost-effectiveness of elective induction of labor versus expectant management of pregnancy labor at 41, 40, and 39 weeks' gestation using decision-analytic models.Our searches identified 3,722 potentially relevant articles, of which 76 articles met inclusion criteria. Nine RCTs compared expectant management with elective induction of labor. We found that overall, expectant management of pregnancy was associated with an approximately 22 percent higher odds of cesarean delivery than elective induction of labor (OR 1.22, 95 percent CI 1.07-1.39; absolute risk difference 1.9, 95 percent CI: 0.2-3.7 percent). The majority of these studies were in women at or beyond 41 weeks of gestation (OR 1.21, 95 percent CI 1.01-1.46). In studies of women at or beyond 41 weeks of gestation, the evidence was rated as moderate because of the size and number of studies and consistency of the findings. Among women less than 41 weeks of gestation, there were three trials which reported no difference in risk of cesarean delivery among women who were induced as compared to expectant management (OR 1.73; 95 percent CI: 0.67-4.5, P=0.26), but all of these trials were small, non-U.S., older, and of poor quality. When we stratified the analysis by country, we found that the odds of cesarean delivery were higher in women who were expectantly managed compared to elective induction of labor in studies conducted outside the U.S. (OR 1.22; 95 percent CI 1.05-1.40) but were not statistically different in studies conducted in the U.S. (OR 1.28; 95 percent CI 0.65-2.49). Women who were expectantly managed were also more likely to have meconium-stained amniotic fluid than those who were electively induced (OR 2.04; 95 percent CI: 1.34-3.09). Observational studies reported a consistently lower risk of cesarean delivery among women who underwent spontaneous labor (6 percent) compared with women who had an elective induction of labor (8 percent) with a statistically significant decrease when combined (OR 0.63; 95 percent CI: 0.49-0.79), but again utilized the wrong control group and did not appropriately adjust for gestational age. We found moderate to high quality evidence that increased parity, a more favorable cervical status as assessed by a higher Bishop score, and decreased gestational age were associated with successful labor induction (58 percent of the included studies defined success as achieving a vaginal delivery anytime after the onset of the induction of labor; in these instances, induction was considered a failure when it led to a cesarean delivery). In the decision analytic model, we utilized a baseline assumption of no difference in cesarean delivery between the two arms as there was no statistically significant difference in the U.S. studies or in women prior to 41 0/7 weeks of gestation. In each of the models, women who were electively induced had better overall outcomes among both mothers and neonates as estimated by total quality-adjusted life years (QALYs) as well as by reduction in specific perinatal outcomes such as shoulder dystocia, meconium aspiration syndrome, and preeclampsia. Additionally, induction of labor was cost-effective at $10,789 per QALY with elective induction of labor at 41 weeks of gestation, $9,932 per QALY at 40 weeks of gestation, and $20,222 per QALY at 39 weeks of gestation utilizing a cost-effectiveness threshold of $50,000 per QALY. At 41 weeks of gestation, these results were generally robust to variations in the assumed ranges in univariate and multi-way sensitivity analyses. However, the findings of cost-effectiveness at 40 and 39 weeks of gestation were not robust to the ranges of the assumptions. In addition, the strength of evidence for some model inputs was low, therefore our analyses are exploratory rather than definitive.Randomized controlled trials suggest that elective induction of labor at 41 weeks of gestation and beyond may be associated with a decrease in both the risk of cesarean delivery and of meconium-stained amniotic fluid. The evidence regarding elective induction of labor prior to 41 weeks of gestation is insufficient to draw any conclusion. There is a paucity of information from prospective RCTs examining other maternal or neonatal outcomes in the setting of elective induction of labor. Observational studies found higher rates of cesarean delivery with elective induction of labor, but compared women undergoing induction of labor to women in spontaneous labor and were subject to potential confounding bias, particularly from gestational age. Such studies do not inform the question of how elective induction of labor affects maternal or neonatal outcomes. Elective induction of labor at 41 weeks of gestation and potentially earlier also appears to be a cost-effective intervention, but because of the need for further data to populate these models our analyses are not definitive. Despite the evidence from the prospective, RCTs reported above, there are concerns about the translation of such findings into actual practice, thus, there is a great need for studying the translation of such research into settings where the majority of obstetric care is provided.

  View details for PubMedID 19408970

• Agranulocytosis After Consumption of Cocaine Adulterated With Levamisole ANNALS OF INTERNAL MEDICINE Qaseem, A., Shekelle, P., Owens, D. K. 2009; 150 (4): 287-289

  View details for Web of Science ID 000263562500019

  View details for PubMedID 19153405

• Is Too Much Intervention Recommended in the ACP Osteoporosis Treatment Guidelines? RESPONSE ANNALS OF INTERNAL MEDICINE Qaseem, A., Shekelle, P., Owens, D. K. 2009; 150 (4): 286-287

  View details for Web of Science ID 000263562500018

• Screening for HIV in Health Care Settings: A Guidance Statement From the American College of Physicians and HIV Medicine Association ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Shekelle, P., Hopkins, R., Owens, D. K. 2009; 150 (2): 125-U86

  Abstract

  The American College of Physicians (ACP) developed this guidance statement to present the available evidence on screening for HIV in health care settings.This guidance statement is derived from an appraisal of available guidelines on screening for HIV. Authors searched the National Guideline Clearinghouse to identify guidelines on screening for HIV in the United States and used the AGREE (Appraisal of Guidelines Research and Evaluation) instrument to evaluate guidelines from the U.S. Preventive Services Task Force and the Centers for Disease Control and Prevention. GUIDANCE STATEMENT 1: ACP recommends that clinicians adopt routine screening for HIV and encourage patients to be tested. GUIDANCE STATEMENT 2: ACP recommends that clinicians determine the need for repeat screening on an individual basis.

  View details for Web of Science ID 000262655200007

  View details for PubMedID 19047022

• Cost-effectiveness of voluntary HIV screening in Russia INTERNATIONAL JOURNAL OF STD & AIDS Tole, S. P., Sanders, G. D., Bayoumi, A. M., Galvin, C. M., Vinichenko, T. N., Brandeau, M. L., Owens, D. K. 2009; 20 (1): 46-51

  Abstract

  Russia has one of the world's fastest growing HIV epidemics, and HIV screening has been widespread. Whether such screening is an effective use of resources is unclear. We used epidemiologic and economic data from Russia to develop a Markov model to estimate costs, quality of life and survival associated with a voluntary HIV screening programme compared with no screening in Russia. We measured discounted lifetime health-care costs and quality-adjusted life years (QALYs) gained. We varied our inputs in sensitivity analysis. Early identification of HIV through screening provided a substantial benefit to persons with HIV, increasing life expectancy by 2.1 years and 1.7 QALYs. At a base-case prevalence of 1.2%, once-per-lifetime screening cost $13,396 per QALY gained, exclusive of benefit from reduced transmission. Cost-effectiveness of screening remained favourable until prevalence dropped below 0.04%. When HIV-transmission-related costs and benefits were included, once-per-lifetime screening cost $6910 per QALY gained and screening every two years cost $27,696 per QALY gained. An important determinant of the cost-effectiveness of screening was effectiveness of counselling about risk reduction. Early identification of HIV infection through screening in Russia is effective and cost-effective in all but the lowest prevalence groups.

  View details for DOI 10.1258/ijsa.2008.008128

  View details for PubMedID 19103893

• Effectiveness and Cost-Effectiveness of Surgical Masks and N-95 Respirators for the Next Influenza Pandemic Khazeni, N., Hutton, D. W., Garber, A. M., Owens, D. K. AMER THORACIC SOC. 2009

  View details for Web of Science ID 000208733100636

• Health-Related Quality of Life in a Randomized Trial of Antiretroviral Therapy for Advanced HIV Disease 26th Annual Meeting of the Society-for-Medical-Decision-Making Joyce, V. R., Barnett, P. G., Bayoumi, A. M., Griffin, S. C., Kyriakides, T. C., Yu, W., Sundaram, V., Holodniy, M., Brown, S. T., Cameron, W., Youle, M., Sculpher, M., Anis, A. H., Owens, D. K. LIPPINCOTT WILLIAMS & WILKINS. 2009: 27–36

  Abstract

  To assess and compare alternative approaches of measuring preference-based health-related quality of life (HRQoL) in treatment-experienced HIV patients and evaluate their association with health status and clinical variables.Cross-sectional study.Twenty-eight Veterans Affairs hospitals in the United States, 13 hospitals in Canada, and 8 hospitals in the United Kingdom.Three hundred sixty-eight treatment-experienced HIV-infected patients enrolled in the Options in Management with Antiretrovirals randomized trial.Baseline sociodemographic and clinical indicators and baseline HRQoL using the Medical Outcome Study HIV Health Survey (MOS-HIV), the EQ-5D, the EQ-5D visual analog scale (EQ-5D VAS), the Health Utilities Index Mark 3 (HUI3), and standard gamble (SG) and time trade-off (TTO) techniques.The mean (SD) baseline HRQoL scores were as follows: MOS-HIV physical health summary score 41.70 (11.16), MOS-HIV mental health summary score 44.76 (11.38), EQ-5D 0.77 (0.19), HUI3 0.59 (0.32), EQ-5D VAS 65.94 (21.71), SG 0.75 (0.29), and TTO 0.80 (0.31). Correlations between MOS-HIV summary scores and EQ-5D, EQ-5D VAS, and HUI3 ranged from 0.60 to 0.70; the correlation between EQ-5D and HUI3 was 0.73; and the correlation between SG and TTO was 0.43. Preference-based HRQoL scores were related to physical, mental, social, and overall health as measured by MOS-HIV. Concomitant medication use, CD4 cell count, and HIV viral load were related to some instruments' scores.On average, preference-based HRQoL for treatment-experienced HIV patients was decreased relative to national norms but also highly variable. Health status and clinical variables were related to HRQoL.

  View details for Web of Science ID 000262019100004

  View details for PubMedID 19295332

• Using Second-Generation Antidepressants to Treat Depressive Disorders: A Clinical Practice Guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Denberg, T. D., Forciea, M. A., Owens, D. K. 2008; 149 (10): 725-U10

  Abstract

  The American College of Physicians developed this guideline to present the available evidence on the pharmacologic management of the acute, continuation, and maintenance phases of major depressive disorder; dysthymia; subsyndromal depression; and accompanying symptoms, such as anxiety, insomnia, or neurovegetative symptoms, by using second-generation antidepressants.Published literature on this topic was identified by using MEDLINE, EMBASE, PsychLit, the Cochrane Central Register of Controlled Trials, and International Pharmaceutical Abstracts from 1980 to April 2007. Searches were limited to English-language studies in adults older than 19 years of age. Keywords for search included terms for depressive disorders and 12 specific second-generation antidepressants-bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazodone, and venlafaxine-and their specific trade names. This guideline grades the evidence and recommendations by using the American College of Physicians clinical practice guidelines grading system. RECOMMENDATION 1: The American College of Physicians recommends that when clinicians choose pharmacologic therapy to treat patients with acute major depression, they select second-generation antidepressants on the basis of adverse effect profiles, cost, and patient preferences (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 2: The American College of Physicians recommends that clinicians assess patient status, therapeutic response, and adverse effects of antidepressant therapy on a regular basis beginning within 1 to 2 weeks of initiation of therapy (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 3: The American College of Physicians recommends that clinicians modify treatment if the patient does not have an adequate response to pharmacotherapy within 6 to 8 weeks of the initiation of therapy for major depressive disorder (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 4: The American College of Physicians recommends that clinicians continue treatment for 4 to 9 months after a satisfactory response in patients with a first episode of major depressive disorder. For patients who have had 2 or more episodes of depression, an even longer duration of therapy may be beneficial (Grade: strong recommendation; moderate-quality evidence).

  View details for Web of Science ID 000260956300005

  View details for PubMedID 19017591

• Cost-effectiveness of Genetic Testing in Family Members of Patients with Long QT Syndrome 81st Annual Scientific Session of the American-Heart-Association Perez, M. V., Kumarasamy, N. A., Owens, D. K., Wang, P. J., Hlatky, M. A. LIPPINCOTT WILLIAMS & WILKINS. 2008: S882–S882

  View details for Web of Science ID 000262104503243

• Isolated Disease of the Proximal Left Anterior Descending Artery Comparing the Effectiveness of Percutaneous Coronary Interventions and Coronary Artery Bypass Surgery JACC-CARDIOVASCULAR INTERVENTIONS Kapoor, J. R., Gienger, A. L., Ardehali, R., Varghese, R., Perez, M. V., Sundaram, V., McDonald, K. M., Owens, D. K., Hlatky, M. A., Bravata, D. M. 2008; 1 (5): 483-491

  Abstract

  This study sought to systematically compare the effectiveness of percutaneous coronary intervention and coronary artery bypass surgery in patients with single-vessel disease of the proximal left anterior descending (LAD) coronary artery.It is uncertain whether percutaneous coronary interventions (PCI) or coronary artery bypass grafting (CABG) surgery provides better clinical outcomes among patients with single-vessel disease of the proximal LAD.We searched relevant databases (MEDLINE, EMBASE, and Cochrane from 1966 to 2006) to identify randomized controlled trials that compared outcomes for patients with single-vessel proximal LAD assigned to either PCI or CABG.We identified 9 randomized controlled trials that enrolled a total of 1,210 patients (633 received PCI and 577 received CABG). There were no differences in survival at 30 days, 1 year, or 5 years, nor were there differences in the rates of procedural strokes or myocardial infarctions, whereas the rate of repeat revascularization was significantly less after CABG than after PCI (at 1 year: 7.3% vs. 19.5%; at 5 years: 7.3% vs. 33.5%). Angina relief was significantly greater after CABG than after PCI (at 1 year: 95.5% vs. 84.6%; at 5 years: 84.2% vs. 75.6%). Patients undergoing CABG spent 3.2 more days in the hospital than those receiving PCI (95% confidence interval: 2.3 to 4.1 days, p < 0.0001), required more transfusions, and were more likely to have arrhythmias immediately post-procedure.In patients with single-vessel, proximal LAD disease, survival was similar in CABG-assigned and PCI-assigned patients; CABG was significantly more effective in relieving angina and led to fewer repeat revascularizations.

  View details for DOI 10.1016/j.jcin.2008.07.001

  View details for PubMedID 19463349

• Partially-Effective HIV Prevention Programs and Risk Compensation: The Impact of Vaccination versus Circumcision on HIV Transmission in South Africa AIDS Vaccine 2008 Conference Andersson, K. M., Owens, D. K., Paltiel, A. MARY ANN LIEBERT INC. 2008: 114–115

  View details for Web of Science ID 000260530800291

• Cost-effectiveness of HIV monitoring strategies in resource-limited settings - A Southern African analysis ARCHIVES OF INTERNAL MEDICINE Bendavid, E., Young, S. D., Katzenstein, D. A., Bayoumi, A. M., Sanders, G. D., Owens, D. K. 2008; 168 (17): 1910-1918

  Abstract

  Although the number of infected persons receiving highly active antiretroviral therapy (HAART) in low- and middle-income countries has increased dramatically, optimal disease management is not well defined.We developed a model to compare the costs and benefits of 3 types of human immunodeficiency virus monitoring strategies: symptom-based strategies, CD4-based strategies, and CD4 counts plus viral load strategies for starting, switching, and stopping HAART. We used clinical and cost data from southern Africa and performed a cost-effectiveness analysis. All assumptions were tested in sensitivity analyses.Compared with the symptom-based approaches, monitoring CD4 counts every 6 months and starting treatment at a threshold of 200/muL was associated with a gain in life expectancy of 6.5 months (61.9 months vs 68.4 months) and a discounted lifetime cost savings of US $464 per person (US $4069 vs US $3605, discounted 2007 dollars). The CD4-based strategies in which treatment was started at the higher threshold of 350/microL provided an additional gain in life expectancy of 5.3 months at a cost-effectiveness of US $107 per life-year gained compared with a threshold of 200/microL. Monitoring viral load with CD4 was more expensive than monitoring CD4 counts alone, added 2.0 months of life, and had an incremental cost-effectiveness ratio of US $5414 per life-year gained relative to monitoring of CD4 counts. In sensitivity analyses, the cost savings from CD4 count monitoring compared with the symptom-based approaches was sensitive to cost of inpatient care, and the cost-effectiveness of viral load monitoring was influenced by the per test costs and rates of virologic failure.Use of CD4 monitoring and early initiation of HAART in southern Africa provides large health benefits relative to symptom-based approaches for HAART management. In southern African countries with relatively high costs of hospitalization, CD4 monitoring would likely reduce total health care expenditures. The cost-effectiveness of viral load monitoring depends on test prices and rates of virologic failure.

  View details for PubMedID 18809819

• Pharmacologic treatment of low bone density or osteoporosis to prevent fractures: A clinical practice guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Shekelle, P., Hopkins, R., Forciea, M. A., Owens, D. K. 2008; 149 (6): 404-W77

  Abstract

  The American College of Physicians (ACP) developed this guideline to present the available evidence on various pharmacologic treatments to prevent fractures in men and women with low bone density or osteoporosis.Published literature on this topic was identified by using MEDLINE (1966 to December 2006), the ACP Journal Club database, the Cochrane Central Register of Controlled Trials (no date limits), the Cochrane Database of Systematic Reviews (no date limits), Web sites of the United Kingdom National Institute of Health and Clinical Excellence (no date limits), and the United Kingdom Health Technology Assessment Program (January 1998 to December 2006). Searches were limited to English-language publications and human studies. Keywords for search included terms for osteoporosis, osteopenia, low bone density, and the drugs listed in the key questions. This guideline grades the evidence and recommendations according to the ACP's clinical practice guidelines grading system. RECOMMENDATION 1: ACP recommends that clinicians offer pharmacologic treatment to men and women who have known osteoporosis and to those who have experienced fragility fractures (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: ACP recommends that clinicians consider pharmacologic treatment for men and women who are at risk for developing osteoporosis (Grade: weak recommendation; moderate-quality evidence). RECOMMENDATION 3: ACP recommends that clinicians choose among pharmacologic treatment options for osteoporosis in men and women on the basis of an assessment of risk and benefits in individual patients (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 4: ACP recommends further research to evaluate treatment of osteoporosis in men and women.

  View details for Web of Science ID 000259230200005

  View details for PubMedID 18794560

• Management of acute kidney injury in the intensive care unit - A cost-effectiveness analysis of daily vs alternate-day hemodialysis ARCHIVES OF INTERNAL MEDICINE Desai, A. A., Baras, J., Berk, B. B., Nakajima, A., Garber, A. M., Owens, D., Chertow, G. M. 2008; 168 (16): 1761-1767

  Abstract

  Although evidence suggests that a higher hemodialysis dose and/or frequency may be associated with improved outcomes, the cost-effectiveness of a daily hemodialysis strategy for critically ill patients with acute kidney injury (AKI) is unknown.We developed a Markov model of the cost, quality of life, survival, and incremental cost-effectiveness of daily hemodialysis, compared with alternate-day hemodialysis, for patients with AKI in the intensive care unit (ICU). We employed a societal perspective with a lifetime analytic time horizon. We modeled the efficacy of daily hemodialysis as a reduction in the relative risk of death on the basis of data reported in the 2004 clinical trial published by Schiffl et al. We performed 1- and 2-way sensitivity analyses across cost, efficacy, and utility input variables. The main outcome measure was cost per quality-adjusted life-year (QALY).In the base case for a 60-year-old man, daily hemodialysis was projected to add 2.14 QALYs and $10,924 in cost. We found that the cost-effectiveness of daily hemodialysis compared with alternate-day hemodialysis was $5084 per QALY gained. The incremental cost-effectiveness ratio became less favorable (>$50,000 per QALY gained) when the maintenance hemodialysis rate of the daily hemodialysis group was varied to more than 27% and when the difference in 14-day postdischarge mortality between the alternatives was varied to less than 0.5%.Daily hemodialysis is a cost-effective strategy compared with alternate-day hemodialysis for patients with severe AKI in the ICU.

  View details for PubMedID 18779463

• Cost-effectiveness of HIV screening in patients older than 55 years of age ANNALS OF INTERNAL MEDICINE Sanders, G. D., Bayoumi, A. M., Holodnly, M., Owens, D. K. 2008; 148 (12): 889-?

  Abstract

  Although HIV infection is more prevalent in people younger than age 45 years, a substantial number of infections occur in older persons. Recent guidelines recommend HIV screening in patients age 13 to 64 years. The cost-effectiveness of HIV screening in patients age 55 to 75 years is uncertain.To examine the costs and benefits of HIV screening in patients age 55 to 75 years.Markov model.Derived from the literature.Patients age 55 to 75 years with unknown HIV status.Lifetime.Societal.HIV screening program for patients age 55 to 75 years compared with current practice.Life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness.For a 65-year-old patient, HIV screening using traditional counseling costs $55,440 per QALY compared with current practice when the prevalence of HIV was 0.5% and the patient did not have a sexual partner at risk. In sexually active patients, the incremental cost-effectiveness ratio was $30,020 per QALY. At a prevalence of 0.1%, HIV screening cost less than $60,000 per QALY for patients younger than age 75 years with a partner at risk if less costly streamlined counseling is used.Cost-effectiveness of HIV screening depended on HIV prevalence, age of the patient, counseling costs, and whether the patient was sexually active. Sensitivity analyses with other variables did not change the results substantially.The effects of age on the toxicity and efficacy of highly active antiretroviral therapy and death from AIDS were uncertain. Sensitivity analyses exploring these variables did not qualitatively affect the results.If the tested population has an HIV prevalence of 0.1% or greater, HIV screening in persons from age 55 to 75 years reaches conventional levels of cost-effectiveness when counseling is streamlined and if the screened patient has a partner at risk. Screening patients with advanced age for HIV is economically attractive in many circumstances.

  View details for Web of Science ID 000257425000001

  View details for PubMedID 18559840

  View details for PubMedCentralID PMC3428219

• Improving HIV screening and receipt of results by nurse-initiated streamlined counseling and rapid testing JOURNAL OF GENERAL INTERNAL MEDICINE Anaya, H. D., Hoang, T., Golden, J. F., Goetz, M. B., Gifford, A., Bowman, C., Osborn, T., Owens, D. K., Sanders, G. D., Asch, S. M. 2008; 23 (6): 800-807

  Abstract

  HIV testing is cost-effective in unselected general medical populations, yet testing rates among those at risk remain low, even among those with regular primary care. HIV rapid testing is effective in many healthcare settings, but scant research has been done within primary care settings or within the US Department of Veteran's Affairs Healthcare System.We evaluated three methods proven effective in other diseases/settings: nurse standing orders for testing, streamlined counseling, and HIV rapid testing.Randomized, controlled trial with three intervention models: model A (traditional counseling/testing); model B (nurse-initiated screening, traditional counseling/testing); model C (nurse-initiated screening, streamlined counseling/rapid testing).Two hundred fifty-one patients with primary/urgent care appointments in two VA clinics in the same city (one large urban hospital, one freestanding outpatient clinic in a high HIV prevalence area).Rates of HIV testing and receipt of results; sexual risk reduction; HIV knowledge improvement.Testing rates were 40.2% (model A), 84.5% (model B), and 89.3% (model C; p = <.01). Test result receipt rates were 14.6% (model A), 31.0% (model B), 79.8% (model C; all p = <.01). Sexual risk reduction and knowledge improvement did not differ significantly between counseling methods.Streamlined counseling with rapid testing significantly increased testing and receipt rates over current practice without changes in risk behavior or posttest knowledge. Increased testing and receipt of results could lead to earlier disease identification, increased treatment, and reduced morbidity/mortality. Policymakers should consider streamlined counseling/rapid testing when implementing routine HIV testing into primary/urgent care.

  View details for DOI 10.1007/s11606-008-0617-x

  View details for Web of Science ID 000256027500015

  View details for PubMedID 18421508

  View details for PubMedCentralID PMC2517869

• Overviews and systematic reviews on low back pain - In response ANNALS OF INTERNAL MEDICINE Chou, R., Shekelle, P., Qaseem, A., Owens, D. K. 2008; 148 (10): 791-792

  View details for Web of Science ID 000256372200013

• Screening for osteoporosis in men: A clinical practice guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Shekelle, P., Hopkins, R., Forciea, M. A., Owens, D. K. 2008; 148 (9): 680-684

  Abstract

  The American College of Physicians developed this guideline to present the available evidence on risk factors and screening tests for osteoporosis in men.Published literature on this topic was identified by using MEDLINE (1990 to July 2007). Reference mining was done on the retrieved articles, references of previous reviews, and solicited articles from experts. The inclusion criteria for the studies were measuring risk factors for low bone mineral density or osteoporotic fracture in men or comparing 2 different methods of assessment for the presence of osteoporosis in men. This guideline grades the evidence and recommendations by using the American College of Physicians' clinical practice guidelines grading system. RECOMMENDATION 1: The American College of Physicians recommends that clinicians periodically perform individualized assessment of risk factors for osteoporosis in older men (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 2: The American College of Physicians recommends that clinicians obtain dual-energy x-ray absorptiometry for men who are at increased risk for osteoporosis and are candidates for drug therapy (Grade: strong recommendation; moderate-quality evidence). RECOMMENDATION 3: The American College of Physicians recommends further research to evaluate osteoporosis screening tests in men.

  View details for Web of Science ID 000255731800006

  View details for PubMedID 18458281

• Modeling the logistics of response to anthrax bioterrorism MEDICAL DECISION MAKING Zaric, G. S., Bravata, D. M., Holty, J. C., McDonald, K. M., Owens, D. K., Brandeau, M. L. 2008; 28 (3): 332-350

  Abstract

  A bioterrorism attack with an agent such as anthrax will require rapid deployment of medical and pharmaceutical supplies to exposed individuals. How should such a logistical system be organized? How much capacity should be built into each element of the bioterrorism response supply chain?The authors developed a compartmental model to evaluate the costs and benefits of various strategies for preattack stockpiling and postattack distribution and dispensing of medical and pharmaceutical supplies, as well as the benefits of rapid attack detection.The authors show how the model can be used to address a broad range of logistical questions as well as related, nonlogistical questions (e.g., the cost-effectiveness of strategies to improve patient adherence to antibiotic regimens). They generate several key insights about appropriate strategies for local communities. First, stockpiling large local inventories of medical and pharmaceutical supplies is unlikely to be the most effective means of reducing mortality from an attack, given the availability of national and regional supplies. Instead, communities should create sufficient capacity for dispensing prophylactic antibiotics in the event of a large-scale bioterror attack. Second, improved surveillance systems can significantly reduce deaths from such an attack but only if the local community has sufficient antibiotic-dispensing capacity. Third, mortality from such an attack is significantly affected by the number of unexposed individuals seeking prophylaxis and treatment. Fourth, full adherence to treatment regimens is critical for reducing expected mortality.Effective preparation for response to potential bioterror attacks can avert deaths in the event of an attack. Models such as this one can help communities more effectively prepare for response to potential bioterror attacks.

  View details for DOI 10.1177/0272989X07312721

  View details for Web of Science ID 000256264500006

  View details for PubMedID 18349432

• The cost-effectiveness of counseling strategies to improve adherence to highly active antiretroviral therapy among men who have sex with men MEDICAL DECISION MAKING Zaric, G. S., Bayoumi, A. M., Deau, M. L., Owens, D. K. 2008; 28 (3): 359-376

  Abstract

  Inadequate adherence to highly active antiretroviral therapy (HAART) may lead to poor health outcomes and the development of HIV strains that are resistant to HAART. The authors developed a model to evaluate the cost-effectiveness of counseling interventions to improve adherence to HAART among men who have sex with men (MSM).The authors developed a dynamic compartmental model that incorporates HIV treatment, adherence to treatment, and infection transmission and progression. All data estimates were obtained from secondary sources. The authors evaluated a counseling intervention given prior to initiation of HAART and before all changes in drug regimens, combined with phone-in support while on HAART. They considered a moderate-prevalence and a high-prevalence population of MSM.If the impact of HIV transmission is ignored, the counseling intervention has a cost-effectiveness ratio of $25,500 per quality-adjusted life year (QALY) gained. When HIV transmission is included, the cost-effectiveness ratio is much lower: $7400 and $8700 per QALY gained in the moderate- and high-prevalence populations, respectively. When the intervention is twice as costly per counseling session and half as effective as estimated in the base case (in terms of the number of individuals who become highly adherent, and who remain highly adherent), then the intervention costs $17,100 and $19,600 per QALY gained in the 2 populations, respectively.Counseling to improve adherence to HAART increased length of life, modestly reduced HIV transmission, and cost substantially less than $50,000 per QALY gained over a wide range of assumptions but did not reduce the proportion of drug-resistant strains. Such counseling provides only modest benefit as a tool for HIV prevention but can provide significant benefit for individual patients at an affordable cost.

  View details for DOI 10.1177/0272989X07312714

  View details for Web of Science ID 000256264500008

  View details for PubMedID 18349433

• Guideline adaptation: An appealing alternative to be novo guideline development - Reply ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Owens, D. 2008; 148 (7): 564-565

  View details for Web of Science ID 000254701000019

• Implementing Effective Hypertension Quality Improvement Strategies: Barriers and Potential Solutions JOURNAL OF CLINICAL HYPERTENSION Walsh, J. M., Sundaram, V., McDonald, K., Owens, D. K., Goldstein, M. K. 2008; 10 (4): 311-316

  Abstract

  Many quality improvement strategies have focused on improving blood pressure control, and these strategies can target the patient, the provider, and/or the system. Strategies that seem to have the biggest effect on blood pressure outcomes are team change, patient education, facilitated relay of clinical information, and promotion of self-management. Barriers to effective blood pressure control can affect the patient, the physician, the system, and/or "cues to action."We review the barriers to achieving blood pressure control and describe current and potential creative strategies for optimizing blood pressure control. These include home-based disease management, combined patient and provider education, and automatic decision support systems. Future research must address which components of quality improvement interventions are most successful in achieving blood pressure control.

  View details for Web of Science ID 000261099600008

  View details for PubMedID 18401229

• Validation of two models to estimate the probability of malignancy in patients with solitary pulmonary nodules THORAX Schultz, E. M., Sanders, G. D., TROTTER, P. R., Patz, E. F., Silvestri, G. A., Owens, D. K., Gould, M. K. 2008; 63 (4): 335-341

  Abstract

  Effective strategies for managing patients with solitary pulmonary nodules (SPN) depend critically on the pre-test probability of malignancy.To validate two previously developed models that estimate the probability that an indeterminate SPN is malignant, based on clinical characteristics and radiographic findings.Data on age, smoking and cancer history, nodule size, location and spiculation were collected retrospectively from the medical records of 151 veterans (145 men, 6 women; age range 39-87 years) with an SPN measuring 7-30 mm (inclusive) and a final diagnosis established by histopathology or 2-year follow-up. Each patient's final diagnosis was compared with the probability of malignancy predicted by two models: one developed by investigators at the Mayo Clinic and the other developed from patients enrolled in a VA Cooperative Study. The accuracy of each model was assessed by calculating areas under the receiver operating characteristic (ROC) curve and the models were calibrated by comparing predicted and observed rates of malignancy.The area under the ROC curve for the Mayo Clinic model (0.80; 95% CI 0.72 to 0.88) was higher than that of the VA model (0.73; 95% CI 0.64 to 0.82), but this difference was not statistically significant (Delta = 0.07; 95% CI -0.03 to 0.16). Calibration curves showed that the probability of malignancy was underestimated by the Mayo Clinic model and overestimated by the VA model.Two existing prediction models are sufficiently accurate to guide decisions about the selection and interpretation of subsequent diagnostic tests in patients with SPNs, although clinicians should also consider the prevalence of malignancy in their practice setting when choosing a model.

  View details for DOI 10.1136/thx.2007.084731

  View details for Web of Science ID 000254289500010

  View details for PubMedID 17965070

  View details for PubMedCentralID PMC2882437

• Current Pharmacologic treatment of dementia: A clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Cross, J. T., Forciea, M. A., Hopkins, R., Shekelle, P., Adelman, A., Mehr, D., Schellhase, K., Campos-Outcalt, D., Santaguida, P., Owens, D. K. 2008; 148 (5): 370-W82

  Abstract

  The American College of Physicians and American Academy of Family Physicians developed this guideline to present the available evidence on current pharmacologic treatment of dementia.The targeted literature search included evidence related to the effectiveness of 5 U.S. Food and Drug Administration-approved pharmacologic therapies for dementia for outcomes in the domains of cognition, global function, behavior/mood, and quality of life/activities of daily living. RECOMMENDATION 1: Clinicians should base the decision to initiate a trial of therapy with a cholinesterase inhibitor or memantine on individualized assessment. (Grade: weak recommendation, moderate-quality evidence.) RECOMMENDATION 2: Clinicians should base the choice of pharmacologic agents on tolerability, adverse effect profile, ease of use, and cost of medication. The evidence is insufficient to compare the effectiveness of different pharmacologic agents for the treatment of dementia. (Grade: weak recommendation, low-quality evidence.) RECOMMENDATION 3: There is an urgent need for further research on the clinical effectiveness of pharmacologic management of dementia.

  View details for Web of Science ID 000253600800006

  View details for PubMedID 18316755

• The cost-effectiveness of osteoporosis screening strategies for postmenopausal women 31st Annual Meeting of the Society-of-General-Internal-Medicine Nayak, S., Greenspan, S. L., Liu, H., Michaud, K., Owens, D. K., Roberts, M. S. SPRINGER. 2008: 410–411

  View details for Web of Science ID 000254237100876

• Correction: Diagnosis and treatment of low back pain. Annals of internal medicine Chou, R., Shekelle, P., Qaseem, A., Owens, D. K. 2008; 148 (3): 247-248

  View details for PubMedID 18257154

• Evidence-based interventions to improve the palliative care of pain, dyspnea, and depression at the end of life: A clinical practice guideline from the American college of physicians ANNALS OF INTERNAL MEDICINE Claseem, A., Snow, V., Shekelle, P., Casey, D. E., Cross, J. T., Owens, D. K. 2008; 148 (2): 141-146

  Abstract

  RECOMMENDATION 1: In patients with serious illness at the end of life, clinicians should regularly assess patients for pain, dyspnea, and depression. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 2: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage pain. For patients with cancer, this includes nonsteroidal anti-inflammatory drugs, opioids, and bisphosphonates. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 3: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage dyspnea, which include opioids in patients with unrelieved dyspnea and oxygen for short-term relief of hypoxemia. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 4: In patients with serious illness at the end of life, clinicians should use therapies of proven effectiveness to manage depression. For patients with cancer, this includes tricyclic antidepressants, selective serotonin reuptake inhibitors, or psychosocial intervention. (Grade: strong recommendation, moderate quality of evidence.) RECOMMENDATION 5: Clinicians should ensure that advance care planning, including completion of advance directives, occurs for all patients with serious illness. (Grade: strong recommendation, low quality of evidence.).

  View details for Web of Science ID 000252594600007

  View details for PubMedID 18195338

• Optimal Spending on HIV Prevention and Treatment: A Framework for Evaluating Cost-Effectiveness with Example Application to the India AIDS Initiative OPTIMIZATION IN MEDICINE AND BIOLOGY Brandeau, M. L., Long, E. F., Hutton, D. W., Owens, D. K., Lim, G. J., Lee, E. K. 2008: 147–75

  View details for Web of Science ID 000268012400005

• Prevalence of HIV infection among inpatients and outpatients in department of veterans affairs health care systems: Implications for screening programs for HIV AMERICAN JOURNAL OF PUBLIC HEALTH Owens, D. K., Sundaram, V., Lazzeroni, L. C., Douglass, L. R., Sanders, G. D., Taylor, K., VanGroningen, R., Shadle, V. M., McWhorter, V. C., Agoncillo, T., Haren, N., Nyland, J., Tempio, P., Khayr, W., Dietzen, D. J., Jensen, P., Simberkoff, M. S., Bozzette, S. A., Holodniy, M. 2007; 97 (12): 2173-2178

  Abstract

  We sought to determine the prevalence of HIV in both inpatient and outpatient settings in 6 Department of Veterans Affairs (VA) health care sites.We collected demographic data and data on comorbid conditions and then conducted blinded, anonymous HIV testing. We conducted a multivariate analysis to determine predictors of HIV infection.We tested 4500 outpatient blood specimens and 4205 inpatient blood specimens; 326 (3.7%) patients tested positive for HIV. Inpatient HIV prevalence ranged from 1.2% to 6.9%; outpatient HIV prevalence ranged from 0.9% to 8.9%. Having a history of hepatitis B or C infection, a sexually transmitted disease, or pneumonia also predicted HIV infection. The prevalence of previously undocumented HIV infection varied from 0.1% to 2.8% among outpatients and from 0.0% to 1.7% among inpatients.The prevalence of undocumented HIV infection was sufficiently high for routine voluntary screening to be cost effective in each of the 6 sites we evaluated. Many VA health care systems should consider expanded routine voluntary HIV screening.

  View details for DOI 10.2105/AJPH.2007.110700

  View details for PubMedID 17971545

• Systematic review: The comparative effectiveness of percutaneous coronary interventions and coronary artery bypass graft surgery ANNALS OF INTERNAL MEDICINE Bravata, D. M., Gienger, A. L., McDonald, K. M., Sundaram, V., Perez, M. V., Varghese, R., Kapoor, J. R., Ardehali, R., Owens, D. K., Hlatky, M. A. 2007; 147 (10): 703-U139

  Abstract

  The comparative effectiveness of coronary artery bypass graft (CABG) surgery and percutaneous coronary intervention (PCI) for patients in whom both procedures are feasible remains poorly understood.To compare the effectiveness of PCI and CABG in patients for whom coronary revascularization is clinically indicated.MEDLINE, EMBASE, and Cochrane databases (1966-2006); conference proceedings; and bibliographies of retrieved articles.Randomized, controlled trials (RCTs) reported in any language that compared clinical outcomes of PCI with those of CABG, and selected observational studies.Information was extracted on study design, sample characteristics, interventions, and clinical outcomes.The authors identified 23 RCTs in which 5019 patients were randomly assigned to PCI and 4944 patients were randomly assigned to CABG. The difference in survival after PCI or CABG was less than 1% over 10 years of follow-up. Survival did not differ between PCI and CABG for patients with diabetes in the 6 trials that reported on this subgroup. Procedure-related strokes were more common after CABG than after PCI (1.2% vs. 0.6%; risk difference, 0.6%; P = 0.002). Angina relief was greater after CABG than after PCI, with risk differences ranging from 5% to 8% at 1 to 5 years (P < 0.001). The absolute rates of angina relief at 5 years were 79% after PCI and 84% after CABG. Repeated revascularization was more common after PCI than after CABG (risk difference, 24% at 1 year and 33% at 5 years; P < 0.001); the absolute rates at 5 years were 46.1% after balloon angioplasty, 40.1% after PCI with stents, and 9.8% after CABG. In the observational studies, the CABG-PCI hazard ratio for death favored PCI among patients with the least severe disease and CABG among those with the most severe disease.The RCTs were conducted in leading centers in selected patients. The authors could not assess whether comparative outcomes vary according to clinical factors, such as extent of coronary disease, ejection fraction, or previous procedures. Only 1 small trial used drug-eluting stents.Compared with PCI, CABG was more effective in relieving angina and led to fewer repeated revascularizations but had a higher risk for procedural stroke. Survival to 10 years was similar for both procedures.

  View details for PubMedID 17938385

• Diagnosis and management of stable chronic obstructive pulmonary disease: A clinical practice guideline from the American college of physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Shekelle, P., Sherif, K., Wilt, T. J., Weinberger, S., Owens, D. K. 2007; 147 (9): 633-638

  Abstract

  RECOMMENDATION 1: In patients with respiratory symptoms, particularly dyspnea, spirometry should be performed to diagnose airflow obstruction. Spirometry should not be used to screen for airflow obstruction in asymptomatic individuals. (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 2: Treatment for stable chronic obstructive pulmonary disease (COPD) should be reserved for patients who have respiratory symptoms and FEV1 less than 60% predicted, as documented by spirometry. (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 3: Clinicians should prescribe 1 of the following maintenance monotherapies for symptomatic patients with COPD and FEV1 less than 60% predicted: long-acting inhaled beta-agonists, long-acting inhaled anticholinergics, or inhaled corticosteroids. (Grade: strong recommendation, high-quality evidence.) RECOMMENDATION 4: Clinicians may consider combination inhaled therapies for symptomatic patients with COPD and FEV1 less than 60% predicted. (Grade: weak recommendation, moderate-quality evidence.) RECOMMENDATION 5: Clinicians should prescribe oxygen therapy in patients with COPD and resting hypoxemia (Pao2 < or =55 mm Hg). (Grade: strong recommendation, moderate-quality evidence.) RECOMMENDATION 6: Clinicians should consider prescribing pulmonary rehabilitation in symptomatic individuals with COPD who have an FEV1 less than 50% predicted. (Grade: weak recommendation, moderate-quality evidence.).

  View details for Web of Science ID 000250672900006

  View details for PubMedID 17975186

• Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American college of physicians and the American pain society ANNALS OF INTERNAL MEDICINE Chou, R., Qaseem, A., Snow, V., Casey, D., Cross, J. T., Shekelle, P., Owens, D. K. 2007; 147 (7): 478-491

  Abstract

  RECOMMENDATION 1: Clinicians should conduct a focused history and physical examination to help place patients with low back pain into 1 of 3 broad categories: nonspecific low back pain, back pain potentially associated with radiculopathy or spinal stenosis, or back pain potentially associated with another specific spinal cause. The history should include assessment of psychosocial risk factors, which predict risk for chronic disabling back pain (strong recommendation, moderate-quality evidence). RECOMMENDATION 2: Clinicians should not routinely obtain imaging or other diagnostic tests in patients with nonspecific low back pain (strong recommendation, moderate-quality evidence). RECOMMENDATION 3: Clinicians should perform diagnostic imaging and testing for patients with low back pain when severe or progressive neurologic deficits are present or when serious underlying conditions are suspected on the basis of history and physical examination (strong recommendation, moderate-quality evidence). RECOMMENDATION 4: Clinicians should evaluate patients with persistent low back pain and signs or symptoms of radiculopathy or spinal stenosis with magnetic resonance imaging (preferred) or computed tomography only if they are potential candidates for surgery or epidural steroid injection (for suspected radiculopathy) (strong recommendation, moderate-quality evidence). RECOMMENDATION 5: Clinicians should provide patients with evidence-based information on low back pain with regard to their expected course, advise patients to remain active, and provide information about effective self-care options (strong recommendation, moderate-quality evidence). RECOMMENDATION 6: For patients with low back pain, clinicians should consider the use of medications with proven benefits in conjunction with back care information and self-care. Clinicians should assess severity of baseline pain and functional deficits, potential benefits, risks, and relative lack of long-term efficacy and safety data before initiating therapy (strong recommendation, moderate-quality evidence). For most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs. RECOMMENDATION 7: For patients who do not improve with self-care options, clinicians should consider the addition of nonpharmacologic therapy with proven benefits-for acute low back pain, spinal manipulation; for chronic or subacute low back pain, intensive interdisciplinary rehabilitation, exercise therapy, acupuncture, massage therapy, spinal manipulation, yoga, cognitive-behavioral therapy, or progressive relaxation (weak recommendation, moderate-quality evidence).

  View details for PubMedID 17909209

• Glycemic control and type 2 diabetes mellitus: The optimal hemoglobin A(1c) targets. A guidance statement from the American college of physicians ANNALS OF INTERNAL MEDICINE Qaseern, A., Vijan, S., Snow, V., Cross, J. T., Weiss, K. B., Owens, D. K. 2007; 147 (6): 417-422

  Abstract

  This guidance statement is derived from other organizations' guidelines and is based on an evaluation of the strengths and weaknesses of the available guidelines. We used the Appraisal of Guidelines, Research and Evaluation in Europe (AGREE) appraisal instrument to evaluate the guidelines from various organizations. On the basis of the review of the available guidelines, we recommend: STATEMENT 1: To prevent microvascular complications of diabetes, the goal for glycemic control should be as low as is feasible without undue risk for adverse events or an unacceptable burden on patients. Treatment goals should be based on a discussion of the benefits and harms of specific levels of glycemic control with the patient. A hemoglobin A1c level less than 7% based on individualized assessment is a reasonable goal for many but not all patients. STATEMENT 2: The goal for hemoglobin A1c level should be based on individualized assessment of risk for complications from diabetes, comorbidity, life expectancy, and patient preferences. STATEMENT 3: We recommend further research to assess the optimal level of glycemic control, particularly in the presence of comorbid conditions.

  View details for Web of Science ID 000249726200013

  View details for PubMedID 17876024

• Predicting the impact of a partially effective HIV vaccine and subsequent risk behavior change on the heterosexual HIV epidemic in low- and middle-income countries - A South African example 13th Conference on Retroviruses and Opportunistic Infections Andersson, K. M., Owens, D. K., Vardas, E., Gray, G. E., McIntyre, J. A., Paltiel, A. D. LIPPINCOTT WILLIAMS & WILKINS. 2007: 78–90

  Abstract

  We developed a mathematical model to simulate the impact of various partially effective preventive HIV vaccination scenarios in a population at high risk for heterosexually transmitted HIV. We considered an adult population defined by gender (male/female), disease stage (HIV-negative, HIV-positive, AIDS, and death), and vaccination status (unvaccinated/vaccinated) in Soweto, South Africa. Input data included initial HIV prevalence of 20% (women) and 12% (men), vaccination coverage of 75%, and exclusive male negotiation of condom use. We explored how changes in vaccine efficacy and postvaccination condom use would affect HIV prevalence and total HIV infections prevented over a 10-year period. In the base-case scenario, a 40% effective HIV vaccine would avert 61,000 infections and reduce future HIV prevalence from 20% to 13%. A 25% increase (or decrease) in condom use among vaccinated individuals would instead avert 75,000 (or only 46,000) infections and reduce the HIV prevalence to 12% (or only 15%). Furthermore, certain combinations of increased risk behavior and vaccines with <43% efficacy could worsen the epidemic. Even modestly effective HIV vaccines can confer enormous benefits in terms of HIV infections averted and decreased HIV prevalence. However, programs to reduce risk behavior may be important components of successful vaccination campaigns.

  View details for Web of Science ID 000249201900012

  View details for PubMedID 17589368

  View details for PubMedCentralID PMC3570247

• Planning the bioterrorism response supply chain: learn and live. American journal of disaster medicine Brandeau, M. L., Hutton, D. W., Owens, D. K., Bravata, D. M. 2007; 2 (5): 231-247

  Abstract

  Responses to bioterrorism require rapid procurement and distribution of medical and pharmaceutical supplies, trained personnel, and information. Thus, they present significant logistical challenges. On the basis of a review of the manufacturing and service supply chain literature, the authors identified five supply chain strategies that can potentially increase the speed of response to a bioterrorism attack, reduce inventories, and save money: effective supply chain network design; effective inventory management; postponement of product customization and modularization of component parts; coordination of supply chain stakeholders and appropriate use of incentives; and effective information management. The authors describe how concepts learned from published evaluations of manufacturing and service supply chains, as well as lessons learned from responses to natural disasters, naturally occurring outbreaks, and the 2001 US anthrax attacks, can be applied to design, evaluate, and improve the bioterrorism response supply chain. Such lessons could also be applied to the response supply chains for disease outbreaks and natural and manmade disasters.

  View details for PubMedID 18491839

• Inhalational, gastrointestinal, and cutaneous anthrax in children ARCHIVES OF PEDIATRICS & ADOLESCENT MEDICINE Bravata, D. M., Holty, J. C., Wang, E., Lewis, R., Wise, P. H., McDonald, K. M., Owens, D. K. 2007; 161 (9): 896-905

  Abstract

  To systematically review all published case reports of children with anthrax to evaluate the predictors of disease progression and mortality.Fourteen selected journal indexes (1900-1966), MEDLINE (1966-2005), and the bibliographies of all retrieved articles.Case reports (any language) of anthrax in persons younger than 18 years published between January 1, 1900, and December 31, 2005. Main Exposures Cases with symptoms and culture or Gram stain or autopsy evidence of anthrax infection.Disease progression, treatment responses, and mortality.Of 2499 potentially relevant articles, 73 case reports of pediatric anthrax (5 inhalational cases, 22 gastrointestinal cases, 37 cutaneous cases, 6 cases of primary meningoencephalitis, and 3 atypical cases) met the inclusion criteria. Only 10% of the patients were younger than 2 years, and 24% were girls. Of the few children with inhalational anthrax, none had nonheadache neurologic symptoms, a key finding that distinguishes adult inhalational anthrax from more common illnesses, such as influenza. Overall, observed mortality was 60% (3 of 5) for inhalational anthrax, 65% (13 of 20) for gastrointestinal anthrax, 14% (5 of 37) for cutaneous anthrax, and 100% (6 of 6) for primary meningoencephalitis. Nineteen of the 30 children (63%) who received penicillin-based antibiotics survived, and 9 of the 11 children (82%) who received anthrax antiserum survived.The clinical presentation of children with anthrax is varied. The mortality rate is high in children with inhalational anthrax, gastrointestinal anthrax, and anthrax meningoencephalitis. Rapid diagnosis and effective treatment of anthrax in children requires recognition of the broad spectrum of clinical presentations of pediatric anthrax.

  View details for PubMedID 17768291

• Screening mammography for women 40 to 49 years of age: A clinical practice guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Sherif, K., Aronson, M., Weiss, K. B., Owens, D. K. 2007; 146 (7): 511-515

  Abstract

  Breast cancer is one of the most common causes of death for women in their 40s in the United States. Individualized risk assessment plays an important role when making decisions about screening mammography, especially for women 49 years of age or younger. The purpose of this guideline is to present the available evidence for screening mammography in women 40 to 49 years of age and to increase clinicians' understanding of the benefits and risks of screening mammography.

  View details for Web of Science ID 000245463200005

  View details for PubMedID 17404353

• Comparative effectiveness of percutaneous coronary interventions and coronary artery bypass grafting for coronary artery disease 30th Annual Meeting of the Society-of-General-Internal-Medicine Bravata, D. M., McDonald, K., Gienger, A., Sundaram, V., Owens, D. K., Hlatky, M. A. SPRINGER. 2007: 47–47

  View details for Web of Science ID 000251610700159

• Current diagnosis of venous thromboembolism in primary care: A clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Barry, P., Hornbake, E. R., Rodnick, J. E., Tobolic, T., Ireland, B., Segal, J. B., Bass, E. B., Weiss, K. B., Green, L., Owens, D. K. 2007; 146 (6): 454-458

  Abstract

  This guideline summarizes the current approaches for the diagnosis of venous thromboembolism. The importance of early diagnosis to prevent mortality and morbidity associated with venous thromboembolism cannot be overstressed. This field is highly dynamic, however, and new evidence is emerging periodically that may change the recommendations. The purpose of this guideline is to present recommendations based on current evidence to clinicians to aid in the diagnosis of lower extremity deep venous thrombosis and pulmonary embolism.

  View details for Web of Science ID 000245192200008

  View details for PubMedID 17371890

• HIV testing of at risk patients in a large integrated health care system JOURNAL OF GENERAL INTERNAL MEDICINE Owens, D. K., Sundaram, V., Lazzeroni, L. C., Douglass, L. R., Tempio, P., Holodniy, M., Sanders, G. D., Shadle, V. M., McWhorter, V. C., Agoncillo, T., Haren, N., Chavis, D., Borowsky, L. H., Yano, E. M., Jensen, P., Simberkoff, M. S., Bozzette, S. A. 2007; 22 (3): 315-320

  Abstract

  Early identification of HIV infection is critical for patients to receive life-prolonging treatment and risk-reduction counseling. Understanding HIV screening practices and barriers to HIV testing is an important prelude to designing successful HIV screening programs. Our objective was to evaluate current practice patterns for identification of HIV.We used a retrospective cohort analysis of 13,991 at-risk patients seen at 4 large Department of Veterans Affairs (VA) health-care systems. We also reviewed 1,100 medical records of tested patients. We assessed HIV testing rates among at-risk patients, the rationale for HIV testing, and predictors of HIV testing and of HIV infection.Of the 13,991 patients at risk for HIV, only 36% had been HIV-tested. The prevalence of HIV ranged from 1% to 20% among tested patients at the 4 sites. Approximately 90% of patients who were tested had a documented reason for testing.One-half to two-thirds of patients at risk for HIV had not been tested within our selected VA sites. Among tested patients, the rationale for HIV testing was well documented. Further testing of at-risk patients could clearly benefit patients who have unidentified HIV infection by providing earlier access to life-prolonging therapy.

  View details for DOI 10.1007/s11606-006-0028-9

  View details for PubMedID 17356961

• Management of venous thromboembolism: A clinical practice guideline from the American college of physicians and the American academy of family physicians ANNALS OF INTERNAL MEDICINE Snow, V., Qaseem, A., Barry, P., Hornbake, E. R., Rodnick, J. E., Tobolic, T., Ireland, B., Segal, J. B., Bass, E. B., Weiss, K. B., Green, L., Owens, D. K. 2007; 146 (3): 204-210

  Abstract

  Venous thromboembolism is a common condition affecting 7.1 persons per 10,000 person-years among community residents. Incidence rates for venous thromboembolism are higher in men and African Americans and increase substantially with age. It is critical to treat deep venous thrombosis at an early stage to avoid development of further complications, such as pulmonary embolism or recurrent deep venous thrombosis. The target audience for this guideline is all clinicians caring for patients who have been given a diagnosis of deep venous thrombosis or pulmonary embolism. The target patient population is patients receiving a diagnosis of pulmonary embolism or lower-extremity deep venous thrombosis.

  View details for Web of Science ID 000243957400007

  View details for PubMedID 17261857

• Management of venous thromboembolism: A clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians ANNALS OF FAMILY MEDICINE Snow, V., Qaseem, A., Barry, P., Hornbake, E. R., Rodnick, J. E., Tobolic, T., Ireland, B., Segal, J., Bass, E., Weiss, K. B., Green, L., Owens, D. K. 2007; 5 (1): 74-80

  Abstract

  Venous thromboembolism is a common condition affecting 7.1 persons per 10,000 person-years among community residents. Incidence rates for venous thromboembolism are higher in men, African-Americans, and increase substantially with age. It is critical to treat deep venous thrombosis at an early stage to avoid development of further complications, such as pulmonary embolism or recurrent deep venous thrombosis. The target audience for this guideline is all clinicians caring for patients who have been given a diagnosis of deep venous thrombosis or pulmonary embolism. The target patient population is patients receiving a diagnosis of pulmonary embolism or lower-extremity deep venous thrombosis.

  View details for DOI 10.1370/afm.668

  View details for Web of Science ID 000244469700011

  View details for PubMedID 17261867

  View details for PubMedCentralID PMC1783925

• Current diagnosis of venous thromboembolism in primary care: A clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians ANNALS OF FAMILY MEDICINE Qaseem, A., Snow, V., Barry, P., Hornbake, E. R., Rodnick, J. E., Tobolic, T., Ireland, B., Segal, J., Bass, E., Weiss, K. B., Green, L., Owens, D. K. 2007; 5 (1): 57-62

  Abstract

  This guideline summarizes the current approaches for the diagnosis of venous thromboembolism. The importance of early diagnosis to prevent mortality and morbidity associated with venous thromboembolism cannot be overstressed. This field is highly dynamic, however, and new evidence is emerging periodically that may change the recommendations. The purpose of this guideline is to present recommendations based on current evidence to clinicians to aid in the diagnosis of lower extremity deep venous thrombosis and pulmonary embolism.

  View details for DOI 10.1370/afm.667

  View details for Web of Science ID 000244469700009

  View details for PubMedID 17261865

• Quality improvement strategies for type 2 diabetes - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Shojania, K. G., Ranji, S. R., McDonald, K. M., Grimshaw, J. M., Rushakoff, R. J., Owens, D. K. 2006; 296 (22): 2681-2681

  View details for Web of Science ID 000242765700019

• Evaluating detection of an inhalational anthrax outbreak EMERGING INFECTIOUS DISEASES Buckeridge, D. L., Owens, D. K., Switzer, P., Frank, J., Musen, M. A. 2006; 12 (12): 1942-1949

  Abstract

  Timely detection of an inhalational anthrax outbreak is critical for clinical and public health management. Syndromic surveillance has received considerable investment, but little is known about how it will perform relative to routine clinical case finding for detection of an inhalational anthrax outbreak. We conducted a simulation study to compare clinical case finding with syndromic surveillance for detection of an outbreak of inhalational anthrax. After simulated release of 1 kg of anthrax spores, the proportion of outbreaks detected first by syndromic surveillance was 0.59 at a specificity of 0.9 and 0.28 at a specificity of 0.975. The mean detection benefit of syndromic surveillance was 1.0 day at a specificity of 0.9 and 0.32 days at a specificity of 0.975. When syndromic surveillance was sufficiently sensitive to detect a substantial proportion of outbreaks before clinical case finding, it generated frequent false alarms.

  View details for Web of Science ID 000242301900022

  View details for PubMedID 17326949

  View details for PubMedCentralID PMC3291344

• Effectiveness and cost-effectiveness of strategies to expand antiretroviral therapy in St. Petersburg, Russia AIDS Long, E. F., Brandeau, M. L., Galvin, C. M., Vinichenko, T., Tole, S. P., Schwartz, A., Sanders, G. D., Owens, D. K. 2006; 20 (17): 2207-2215

  Abstract

  To assess the effectiveness and cost-effectiveness of treating HIV-infected injection drug users (IDUs) and non-IDUs in Russia with highly active antiretroviral therapy HAART.A dynamic HIV epidemic model was developed for a population of IDUs and non-IDUs. The location for the study was St. Petersburg, Russia. The adult population aged 15 to 49 years was subdivided on the basis of injection drug use and HIV status. HIV treatment targeted to IDUs and non-IDUs, and untargeted treatment interventions were considered. Health care costs and quality-adjusted life years (QALYs) experienced in the population were measured, and HIV prevalence, HIV infections averted, and incremental cost-effectiveness ratios of different HAART strategies were calculated.With no incremental HAART programs, HIV prevalence reached 64% among IDUs and 1.7% among non-IDUs after 20 years. If treatment were targeted to IDUs, over 40 000 infections would be prevented (75% among non-IDUs), adding 650 000 QALYs at a cost of USD 1501 per QALY gained. If treatment were targeted to non-IDUs, fewer than 10 000 infections would be prevented, adding 400 000 QALYs at a cost of USD 2572 per QALY gained. Untargeted strategies prevented the most infections, adding 950 000 QALYs at a cost of USD 1827 per QALY gained. Our results were sensitive to HIV transmission parameters.Expanded use of antiretroviral therapy in St. Petersburg, Russia would generate enormous population-wide health benefits and be economically efficient. Exclusively treating non-IDUs provided the least health benefit, and was the least economically efficient. Our findings highlight the urgency of initiating HAART for both IDUs and non-IDUs in Russia.

  View details for PubMedID 17086061

• Pediatric anthrax: implications for bioterrorism preparedness. Evidence report/technology assessment Bravata, D. M., Wang, E., Holty, J., Lewis, R., Wise, P. H., Nayak, S., Liu, H., McDonald, K. M., Owens, D. K. 2006: 1-48

  Abstract

  To systematically review the literature about children with anthrax to describe their clinical course, treatment responses, and the predictors of disease progression and mortality.MEDLINE (1966-2005), 14 selected journal indexes (1900-1966) and bibliographies of all retrieved articles.We sought case reports of pediatric anthrax published between 1900 and 2005 meeting predefined criteria. We abstracted three types of data from the English-language reports: (1) Patient information (e.g., age, gender, nationality), (2) symptom and disease progression information (e.g., whether the patient developed meningitis); (3) treatment information (e.g., treatments received, year of treatment). We compared the clinical symptoms and disease progression variables for the pediatric cases with data on adult anthrax cases reviewed previously.We identified 246 titles of potentially relevant articles from our MEDLINE(R) search and 2253 additional references from our manual search of the bibliographies of retrieved articles and the indexes of the 14 selected journals. We included 62 case reports of pediatric anthrax including two inhalational cases, 20 gastrointestinal cases, 37 cutaneous cases, and three atypical cases. Anthrax is a relatively common and historically well-recognized disease and yet rarely reported among children, suggesting the possibility of significant under-diagnosis, underreporting, and/or publication bias. Children with anthrax present with a wide range of clinical signs and symptoms, which differ somewhat from the presenting features of adults with anthrax. Like adults, children with gastrointestinal anthrax have two distinct clinical presentations: Upper tract disease characterized by dysphagia and oropharyngeal findings and lower tract disease characterized by fever, abdominal pain, and nausea and vomiting. Additionally, children with inhalational disease may have "atypical" presentations including primary meningoencephalitis. Children with inhalational anthrax have abnormal chest roentgenograms; however, children with other forms of anthrax usually have normal roentgenograms. Nineteen of the 30 children (63%) who received penicillin-based antibiotics survived; whereas nine of 11 children (82%) who received anthrax antiserum survived.There is a broad spectrum of clinical signs and symptoms associated with pediatric anthrax. The limited data available regarding disease progression and treatment responses for children infected with anthrax suggest some differences from adult populations. Preparedness planning efforts should specifically address the needs of pediatric victims.

  View details for PubMedID 17764208

• Effects of quality improvement strategies for type 2 diabetes on glycemic control - A meta-regression analysis JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Shojania, K. G., Ranji, S. R., McDonald, K. M., Grimshaw, J. M., Sundaram, V., Rushakoff, R. J., Owens, D. K. 2006; 296 (4): 427-440

  Abstract

  There have been numerous reports of interventions designed to improve the care of patients with diabetes, but the effectiveness of such interventions is unclear.To assess the impact on glycemic control of 11 distinct strategies for quality improvement (QI) in adults with type 2 diabetes.MEDLINE (1966-April 2006) and the Cochrane Collaboration's Effective Practice and Organisation of Care Group database, which covers multiple bibliographic databases. Eligible studies included randomized or quasi-randomized controlled trials and controlled before-after studies that evaluated a QI intervention targeting some aspect of clinician behavior or organizational change and reported changes in glycosylated hemoglobin (HbA1c) values.Postintervention difference in HbA1c values were estimated using a meta-regression model that included baseline glycemic control and other key intervention and study features as predictors.Fifty randomized controlled trials, 3 quasi-randomized trials, and 13 controlled before-after trials met all inclusion criteria. Across these 66 trials, interventions reduced HbA(1c) values by a mean of 0.42% (95% confidence interval [CI], 0.29%-0.54%) over a median of 13 months of follow-up. Trials with fewer patients than the median for all included trials reported significantly greater effects than did larger trials (0.61% vs 0.27%, P = .004), strongly suggesting publication bias. Trials with mean baseline HbA1c values of 8.0% or greater also reported significantly larger effects (0.54% vs 0.20%, P = .005). Adjusting for these effects, 2 of the 11 categories of QI strategies were associated with reductions in HbA(1c) values of at least 0.50%: team changes (0.67%; 95% CI, 0.43%-0.91%; n = 26 trials) and case management (0.52%; 95% CI, 0.31%-0.73%; n = 26 trials); these also represented the only 2 strategies conferring significant incremental reductions in HbA1c values. Interventions involving team changes reduced values by 0.33% more (95% CI, 0.12%-0.54%; P = .004) than those without this strategy, and those involving case management reduced values by 0.22% more (95% CI, 0.00%-0.44%; P = .04) than those without case management. Interventions in which nurse or pharmacist case managers could make medication adjustments without awaiting physician authorization reduced values by 0.80% (95% CI, 0.51%-1.10%), vs only 0.32% (95% CI, 0.14%-0.49%) for all other interventions (P = .002).Most QI strategies produced small to modest improvements in glycemic control. Team changes and case management showed more robust improvements, especially for interventions in which case managers could adjust medications without awaiting physician approval. Estimates of the effectiveness of other specific QI strategies may have been limited by difficulty in classifying complex interventions, insufficient numbers of studies, and publication bias.

  View details for Web of Science ID 000239242500029

  View details for PubMedID 16868301

• Quality improvement strategies for hypertension management - A systematic review MEDICAL CARE Walsh, J. M., McDonald, K. M., Shojania, K. G., Sundaram, V., Nayak, S., Lewis, R., Owens, D. K., Goldstein, M. K. 2006; 44 (7): 646-657

  Abstract

  Care remains suboptimal for many patients with hypertension.The purpose of this study was to assess the effectiveness of quality improvement (QI) strategies in lowering blood pressure.MEDLINE, Cochrane databases, and article bibliographies were searched for this study.Trials, controlled before-after studies, and interrupted time series evaluating QI interventions targeting hypertension control and reporting blood pressure outcomes were studied.Two reviewers abstracted data and classified QI strategies into categories: provider education, provider reminders, facilitated relay of clinical information, patient education, self-management, patient reminders, audit and feedback, team change, or financial incentives were extracted.Forty-four articles reporting 57 comparisons underwent quantitative analysis. Patients in the intervention groups experienced median reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) that were 4.5 mm Hg (interquartile range [IQR]: 1.5 to 11.0) and 2.1 mm Hg (IQR: -0.2 to 5.0) greater than observed for control patients. Median increases in the percentage of individuals achieving target goals for SBP and DBP were 16.2% (IQR: 10.3 to 32.2) and 6.0% (IQR: 1.5 to 17.5). Interventions that included team change as a QI strategy were associated with the largest reductions in blood pressure outcomes. All team change studies included assignment of some responsibilities to a health professional other than the patient's physician.Not all QI strategies have been assessed equally, which limits the power to compare differences in effects between strategies.QI strategies are associated with improved hypertension control. A focus on hypertension by someone in addition to the patient's physician was associated with substantial improvement. Future research should examine the contributions of individual QI strategies and their relative costs.

  View details for Web of Science ID 000238806300006

  View details for PubMedID 16799359

• The cost-effectiveness of therapy with Teriparatide and alendronate in women with severe osteoporosis ARCHIVES OF INTERNAL MEDICINE Liu, H., Michaud, K., Nayak, S., Karpf, D. B., Owens, D. K., Garber, A. M. 2006; 166 (11): 1209-1217

  Abstract

  Teriparatide is a promising new agent for the treatment of osteoporosis.The objective of this study was to evaluate the cost-effectiveness of teriparatide-based strategies compared with alendronate sodium for the first-line treatment of high-risk osteoporotic women. We developed a microsimulation with a societal perspective. Key data sources include the Study of Osteoporotic Fractures, the Fracture Intervention Trial, and the Fracture Prevention Trial. We evaluated postmenopausal white women with low bone density and prevalent vertebral fracture. The interventions were usual care (UC) (calcium or vitamin D supplementation) compared with 3 strategies: 5 years of alendronate therapy, 2 years of teriparatide therapy, and 2 years of teriparatide therapy followed by 5 years of alendronate therapy (sequential teriparatide/alendronate). The main outcome measure was cost per quality-adjusted life-year (QALY).For the base-case analysis, the cost of alendronate treatment was 11,600 dollars per QALY compared with UC. The cost of sequential teriparatide/alendronate therapy was 156,500 dollars per QALY compared with alendronate. Teriparatide treatment alone was more expensive and produced a smaller increase in QALYs than alendronate. For sensitivity analysis, teriparatide alone was less cost-effective than alendronate even if its efficacy lasted 15 years after treatment cessation. Sequential teriparatide/alendronate therapy was less cost-effective than alendronate even if fractures were eliminated during the alendronate phase, although its cost-effectiveness was less than 50,000 dollars per QALY if the price of teriparatide decreased 60%, if used in elderly women with T scores of -4.0 or less, or if 6 months of teriparatide therapy had comparable efficacy to 2 years of treatment.Alendronate compares favorably to interventions accepted as cost-effective. Therapy with teriparatide alone is more expensive and produces a smaller increase in QALYs than therapy with alendronate. Sequential teriparatide/alendronate therapy appear expensive but could become more cost-effective with reductions in teriparatide price, with restriction to use in exceptionally high-risk women, or if short courses of treatment have comparable efficacy to that observed in clinical trials.

  View details for PubMedID 16772249

• Meta-analysis: Accuracy of quantitative ultrasound for identifying patients with osteoporosis ANNALS OF INTERNAL MEDICINE Nayak, S., Olkin, I., Liu, H., Grabe, M., Gould, M. K., Allen, I. E., Owens, D. K., Bravata, D. M. 2006; 144 (11): 832-841

  Abstract

  There is increased interest in quantitative ultrasound for osteoporosis screening because it predicts fracture risk, is portable, and is relatively inexpensive. However, there is no consensus regarding its accuracy for identifying patients with osteoporosis.To determine the sensitivity and specificity of calcaneal quantitative ultrasound for identifying patients who meet the World Health Organization's diagnostic criteria for osteoporosis. Dual-energy x-ray absorptiometry (DXA) was used as the reference standard.MEDLINE (1966 to October 2005), EMBASE (1993 to May 2004), Cochrane Central Register of Controlled Trials and Cochrane Database of Systematic Reviews (1952 to March 2004), and the Science Citation Index (1945 to April 2004).English-language articles that evaluated the sensitivity and specificity of calcaneal quantitative ultrasound for identifying adults with DXA T-scores of -2.5 or less at the hip or spine.Two authors independently reviewed articles and abstracted data.The authors identified 1908 potentially relevant articles, of which 25 met the inclusion criteria, and calculated the sensitivity and specificity of quantitative ultrasound over a range of thresholds. For the quantitative ultrasound index parameter T-score cutoff threshold of -1, sensitivity was 79% (95% CI, 69% to 86%) and specificity was 58% (CI, 44% to 70%) for identifying individuals with DXA T-scores of -2.5 or less at the hip or spine. For a T-score threshold of 0, sensitivity improved to 93% (CI, 87% to 97%) but specificity decreased to 24% (CI, 10% to 47%). At a pretest probability of 22% (for example, a 65-year-old white woman at average risk), the post-test probability of DXA-determined osteoporosis was 34% (CI, 26% to 41%) after a positive result and 10% (CI, 5% to 12%) after a negative result when using a T-score cutoff threshold of -1. Analysis of other quantitative ultrasound parameters (for example, broadband ultrasound attenuation) revealed similar estimates of accuracy.The relatively small number of included studies limited the authors' ability to evaluate the effects of heterogeneous study characteristics on the diagnostic accuracy of quantitative ultrasound.The currently available literature suggests that results of calcaneal quantitative ultrasound at commonly used cutoff thresholds do not definitively exclude or confirm DXA-determined osteoporosis. Additional research is needed before use of this test can be recommended in evidence-based screening programs for osteoporosis.

  View details for PubMedID 16754925

• Risk assessment for and strategies to reduce perioperative pulmonary complications for patients undergoing noncardiothoracic surgery: A guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Snow, V., Fitterman, N., Hornbake, E. R., Lawrence, V. A., Smetana, G. W., Weiss, K., Owens, D. K. 2006; 144 (8): 575-580

  Abstract

  Postoperative pulmonary complications play an important role in the risk for patients undergoing noncardiothoracic surgery. Postoperative pulmonary complications are as prevalent as cardiac complications and contribute similarly to morbidity, mortality, and length of stay. Pulmonary complications may even be more likely than cardiac complications to predict long-term mortality after surgery. The purpose of this guideline is to provide guidance to clinicians on clinical and laboratory predictors of perioperative pulmonary risk before noncardiothoracic surgery. It also evaluates strategies to reduce the perioperative pulmonary risk and focuses on atelectasis, pneumonia, and respiratory failure. The target audience for this guideline is general internists or other clinicians involved in perioperative management of surgical patients. The target patient population is all adult persons undergoing noncardiothoracic surgery.

  View details for Web of Science ID 000237017900005

  View details for PubMedID 16618955

• Systematic review: A century of inhalational anthrax cases from 1900 to 2005 ANNALS OF INTERNAL MEDICINE Holty, J. E., Bravata, D. M., Liu, H., Olshen, R. A., McDonald, K. M., Owens, D. K. 2006; 144 (4): 270-280

  Abstract

  Mortality from inhalational anthrax during the 2001 U.S. attack was substantially lower than that reported historically.To systematically review all published inhalational anthrax case reports to evaluate the predictors of disease progression and mortality.MEDLINE (1966-2005), 14 selected journal indexes (1900-1966), and bibliographies of all retrieved articles.Case reports (in any language) between 1900 and 2005 that met predefined criteria.Two authors (1 author for non-English-language reports) independently abstracted patient data.The authors found 106 reports of 82 cases of inhalational anthrax. Mortality was statistically significantly lower for patients receiving antibiotics or anthrax antiserum during the prodromal phase of disease, multidrug antibiotic regimens, or pleural fluid drainage. Patients in the 2001 U.S. attack were less likely to die than historical anthrax case-patients (45% vs. 92%; P < 0.001) and were more likely to receive antibiotics during the prodromal phase (64% vs. 13%; P < 0.001), multidrug regimens (91% vs. 50%; P = 0.027), or pleural fluid drainage (73% vs. 11%; P < 0.001). Patients who progressed to the fulminant phase had a mortality rate of 97% (regardless of the treatment they received), and all patients with anthrax meningoencephalitis died.This was a retrospective case review of previously published heterogeneous reports.Despite advances in supportive care, fulminant-phase inhalational anthrax is usually fatal. Initiation of antibiotic or anthrax antiserum therapy during the prodromal phase is associated with markedly improved survival, although other aspects of care, differences in clinical circumstances, or unreported factors may contribute to this observed reduction in mortality. Efforts to improve early diagnosis and timely initiation of appropriate antibiotics are critical to reducing mortality.

  View details for PubMedID 16490913

• The effect of diagnosis with HIV infection on health-related quality of life QUALITY OF LIFE RESEARCH Honiden, S., Sundaram, V., Nease, R. F., Holodniy, M., Lazzeroni, L. C., Zolopa, A., Owens, D. K. 2006; 15 (1): 69-82

  Abstract

  We sought to understand how diagnosis with HIV affects health-related quality of life. We assessed health-related quality of life using utility-based measures in a Department of Veterans Affairs (VA) clinic and a University-based clinic. Respondents assessed health-related quality of life regarding their current health, and retrospectively assessed their health 1 month prior to and 2 months after diagnosis with HIV infection. Sixty-six patients completed the study. The overall mean utilities for health 1 month before and 2 months after diagnosis were 0.87 (standard error 0.037), and 0.80 (0.043) (p<0.005 by rank sign test), but the effect of diagnosis differed between the two clinics, with a substantial decrease in the university clinic and a small non-significant decrease in the VA clinic. The overall mean utility for current health was 0.85 (0.034), assessed on average 7.5 years after diagnosis. When asked directly whether diagnosis of HIV decreased health-related quality of life, 47% agreed, but 35% stated that HIV diagnosis positively affected health-related quality of life. Diagnosis with HIV decreased health-related quality of life at 2 months on average, but this effect diminished over time, and differed among patient populations. Years after diagnosis, although half of the patients believed that diagnosis reduced health-related quality of life, one-third reported improved health-related quality of life.

  View details for DOI 10.1007/s11136-005-8485-x

  View details for PubMedID 16411032

• Cost-effectiveness of ICDs - Reply NEW ENGLAND JOURNAL OF MEDICINE Sanders, G. D., Hlatky, M. A., Owens, D. K. 2006; 354 (2): 206-207

  View details for Web of Science ID 000234528600026

• Addressing resource allocation issues in recommendations from clinical practice guideline panels - Suggestions from an American College of Chest Physicians task force CHEST Guyatt, G., Baumann, M., Pauker, S., Halperin, J., Maurer, J., Owens, D. K., Tosteson, A. N., Carlin, B., Gutterman, D., Prins, M., Lewis, S. Z., Schunemann, H. 2006; 129 (1): 182-187

  Abstract

  Most panels that develop clinical practice guidelines are poorly equipped to address resource allocation or cost issues associated with management options. This risks neglect, arbitrariness, lack of transparency, and methodological flaws in consideration of resource allocation. We provide recommendations for guideline panels to promote greater transparency and rigor. We suggest focusing on resource allocation issues for only a limited number of recommendations and provide criteria for selecting those in which economic considerations are likely to influence the direction or strength of the recommendation. Panels should involve a health economist to assist with the systematic review and critical interpretation of relevant economic analyses. They should carefully define the intended audience and may consider issuing alternative recommendations when available resources vary widely across target clinical settings. Targeting a limited number of recommendations for the consideration of resource allocation issues, and ensuring methodologically high-quality review, will best serve guideline panels, and the health-care providers and patients they hope to assist.

  View details for Web of Science ID 000234944900029

  View details for PubMedID 16424430

• Cost-effectiveness as an outcome in randomized clinical trials 10th International Symposium on Long-Term Clinical Trials Hlatky, M. A., Owens, D. K., Sanders, G. D. SAGE PUBLICATIONS LTD. 2006: 543–51

  Abstract

  Economic outcomes are now included in many contemporary randomized trials and provide an additional dimension to the assessment of interventions. Economic data collection and analysis pose several methodologic challenges, however.This paper reviews methods of incorporating economic outcomes in clinical trials.Data on medical resource utilization and cost can readily be collected along with data on clinical outcomes. The cost of planned interventions can be measured with reasonable accuracy, but costs due to unplanned clinical events are more difficult to measure reliably. The total cost depends critically on these relatively infrequent, yet costly, adverse outcomes, which may partially, or even completely, offset any difference between the planned costs of the randomized therapies. Newer therapies are typically more expensive than older therapies, so the most important question is whether patient outcomes are improved sufficiently to justify the added expense. Cost-effectiveness analysis helps gauge the value provided by a new therapy. The cost-effectiveness of an intervention compared with an alternative is defined as the ratio of the incremental costs and the incremental clinical benefits, measured as dollars per quality-adjusted life-year added. The follow-up period in most clinical trials is generally long enough to measure the added cost of therapy, but may not capture the full benefits of treatment. The limited time horizon of clinical trials makes it necessary to use a model to extrapolate the observed effect of treatment and project the increase in life expectancy. The resulting cost-effectiveness ratio is sensitive to assumptions about the long-term efficacy of treatment, particularly whether the treatment effect will continue or dissipate over time.Economic outcomes can be measured alongside clinical outcomes in randomized trial. While the use of cost-effectiveness models falls outside the strictly empirical, within-trial analysis framework that is embraced by most clinical trialists, it provides an explicit approach to assessing whether the intervention under study provides a clinically meaningful improvement in outcome that is worthwhile.

  View details for DOI 10.1177/1740774506073105

  View details for PubMedID 17170039

• Reducing mortality from anthrax bioterrorism: Strategies for stockpiling and dispensing medical and pharmaceutical supplies BIOSECURITY AND BIOTERRORISM-BIODEFENSE STRATEGY PRACTICE AND SCIENCE Bravata, D. M., Zaric, G. S., Holty, J. C., Brandeau, M. L., Wilhelm, E. R., McDonald, K. M., Owens, D. K. 2006; 4 (3): 244-262

  Abstract

  A critical question in planning a response to bioterrorism is how antibiotics and medical supplies should be stockpiled and dispensed. The objective of this work was to evaluate the costs and benefits of alternative strategies for maintaining and dispensing local and regional inventories of antibiotics and medical supplies for responses to anthrax bioterrorism. We modeled the regional and local supply chain for antibiotics and medical supplies as well as local dispensing capacity. We found that mortality was highly dependent on the local dispensing capacity, the number of individuals requiring prophylaxis, adherence to prophylactic antibiotics, and delays in attack detection. For an attack exposing 250,000 people and requiring the prophylaxis of 5 million people, expected mortality fell from 243,000 to 145,000 as the dispensing capacity increased from 14,000 to 420,000 individuals per day. At low dispensing capacities (<14,000 individuals per day), nearly all exposed individuals died, regardless of the rate of adherence to prophylaxis, delays in attack detection, or availability of local inventories. No benefit was achieved by doubling local inventories at low dispensing capacities; however, at higher dispensing capacities, the cost-effectiveness of doubling local inventories fell from 100,000 US dollars to 20,000 US dollars/life year gained as the annual probability of an attack increased from 0.0002 to 0.001. We conclude that because of the reportedly rapid availability of regional inventories, the critical determinant of mortality following anthrax bioterrorism is local dispensing capacity. Bioterrorism preparedness efforts directed at improving local dispensing capacity are required before benefits can be reaped from enhancing local inventories.

  View details for PubMedID 16999586

• Cost-effectiveness of implantable cardioverter-defibrillators NEW ENGLAND JOURNAL OF MEDICINE Sanders, G. D., Hlatky, M. A., Owens, D. K. 2005; 353 (14): 1471-1480

  Abstract

  Eight randomized trials have evaluated whether the prophylactic use of an implantable cardioverter-defibrillator (ICD) improves survival among patients who are at risk for sudden death due to left ventricular systolic dysfunction but who have not had a life-threatening ventricular arrhythmia. We assessed the cost-effectiveness of the ICD in the populations represented in these primary-prevention trials.We developed a Markov model of the cost, quality of life, survival, and incremental cost-effectiveness of the prophylactic implantation of an ICD, as compared with control therapy, among patients with survival and mortality rates similar to those in each of the clinical trials. We modeled the efficacy of the ICD as a reduction in the relative risk of death on the basis of the hazard ratios reported in the individual clinical trials.Use of the ICD increased lifetime costs in every trial. Two trials--the Coronary Artery Bypass Graft (CABG) Patch Trial and the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT)--found that the prophylactic implantation of an ICD did not reduce the risk of death and thus was both more expensive and less effective than control therapy. For the other six trials--the Multicenter Automatic Defibrillator Implantation Trial (MADIT) I, MADIT II, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)--the use of an ICD was projected to add between 1.01 and 2.99 quality-adjusted life-years (QALY) and between 68,300 dollars and 101,500 dollars in cost. Using base-case assumptions, we found that the cost-effectiveness of the ICD as compared with control therapy in these six populations ranged from 34,000 dollars to 70,200 dollars per QALY gained. Sensitivity analyses showed that this cost-effectiveness ratio would remain below 100,000 dollars per QALY as long as the ICD reduced mortality for seven or more years.Prophylactic implantation of an ICD has a cost-effectiveness ratio below 100,000 dollars per QALY gained in populations in which a significant device-related reduction in mortality has been demonstrated.

  View details for Web of Science ID 000232313000007

  View details for PubMedID 16207849

• Screening or hereditary hemochromatosis: A clinical practice guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Qaseem, A., Aronson, M., Fitterman, N., Snow, V., Weiss, K. B., Owens, D. K. 2005; 143 (7): 517-521

  Abstract

  Hereditary hemochromatosis is a genetic disorder of iron metabolism. Diagnosis of hereditary hemochromatosis is usually based on a combination of various genetic or phenotypic criteria. Decisions regarding screening are difficult because of the variable penetrance of mutations of the HFE gene and the absence of any definitive trials addressing the benefits and risks of therapeutic phlebotomy in asymptomatic patients or those with only laboratory abnormalities. The purpose of this guideline is to increase physician awareness of hereditary hemochromatosis, particularly the variable penetrance of genetic mutations; aid in case finding; and explain the role of genetic testing. This guideline provides recommendations based on a review of evidence in the accompanying background paper by Schmitt and colleagues. The target audience for this guideline is internists and other primary care physicians. The target patient population is all persons who have a probability or susceptibility of developing hereditary hemochromatosis, including the relatives of individuals who already have the disease.

  View details for Web of Science ID 000232290600006

  View details for PubMedID 16204164

• The cost-effectiveness of parathyroid hormone and alendronate in high-risk osteoporotic women. 69th Annual Scientific Meeting of the American-College-of-Rheumatology/40th Annual Scientific Meeting of the Association-of-Rheumatology-Health-Professionals Michaud, K., Liu, H., Nayak, S., Owens, D. K., Garber, A. M. WILEY-BLACKWELL. 2005: S266–S266

  View details for Web of Science ID 000232207801177

• The cost-effectiveness of parathyroid hormone and alendronate in high-risk osteoporotic women. 27th Annual Meeting of the American-Society-for-Bone-and-Mineral-Research Liu, H., Michaud, K., Nayak, S., Karpf, D. B., Owens, D. K., Garber, A. M. WILEY-BLACKWELL. 2005: S409–S409

  View details for Web of Science ID 000233503805169

• An evaluation model for syndromic surveillance: assessing the performance of a temporal algorithm. MMWR. Morbidity and mortality weekly report Buckeridge, D. L., Switzer, P., Owens, D., SIEGRIST, D., Pavlin, J., Musen, M. 2005; 54: 109-115

  Abstract

  Syndromic surveillance offers the potential to rapidly detect outbreaks resulting from terrorism. Despite considerable experience with implementing syndromic surveillance, limited evidence exists to describe the performance of syndromic surveillance systems in detecting outbreaks.To describe a model for simulating cases that might result from exposure to inhalational anthrax and then use the model to evaluate the ability of syndromic surveillance to detect an outbreak of inhalational anthrax after an aerosol release.Disease progression and health-care use were simulated for persons infected with anthrax. Simulated cases were then superimposed on authentic surveillance data to create test data sets. A temporal outbreak detection algorithm was applied to each test data set, and sensitivity and timeliness of outbreak detection were calculated by using syndromic surveillance.The earliest detection using a temporal algorithm was 2 days after a release. Earlier detection tended to occur when more persons were infected, and performance worsened as the proportion of persons seeking care in the prodromal disease state declined. A shorter median incubation state led to earlier detection, as soon as 1 day after release when the incubation state was < or =5 days.Syndromic surveillance of a respiratory syndrome using a temporal detection algorithm tended to detect an anthrax attack within 3-4 days after exposure if >10,000 persons were infected. The performance of surveillance (i.e., timeliness and sensitivity) worsened as the number of persons infected decreased.

  View details for PubMedID 16177701

• Challenges in systematic reviews: Synthesis of topics related to the delivery, organization, and financing of health care ANNALS OF INTERNAL MEDICINE Bravata, D. M., McDonald, K. M., Shojania, K. G., Sundaram, V., Owens, D. K. 2005; 142 (12): 1056-1065

  Abstract

  Some important health policy topics, such as those related to the delivery, organization, and financing of health care, present substantial challenges to established methods for evidence synthesis. For example, such reviews may ask: What is the effect of for-profit versus not-for-profit delivery of care on patient outcomes? Or, which strategies are the most effective for promoting preventive care? This paper describes innovative methods for synthesizing evidence related to the delivery, organization, and financing of health care. We found 13 systematic reviews on these topics that described novel methodologic approaches. Several of these syntheses used 3 approaches: conceptual frameworks to inform problem formulation, systematic searches that included nontraditional literature sources, and hybrid synthesis methods that included simulations to address key gaps in the literature. As the primary literature on these topics expands, so will opportunities to develop additional novel methods for performing high-quality comprehensive syntheses.

  View details for PubMedID 15968030

• Cost-effectiveness of screening for HIV - Reply NEW ENGLAND JOURNAL OF MEDICINE Sanders, G. D., Bayoumi, A. M., Owens, D. K. 2005; 352 (20): 2138-2138

  View details for Web of Science ID 000229180100028

• Assessing the benefits and costs of new therapies for hepatitis B virus infection ANNALS OF INTERNAL MEDICINE Owens, D. K., Black, M. 2005; 142 (10): 863-864

  View details for Web of Science ID 000229099600009

  View details for PubMedID 15897538

• Cost-effectiveness of defending against bioterrorism: A comparison of vaccination and antibiotic prophylaxis against anthrax ANNALS OF INTERNAL MEDICINE Fowler, R. A., Sanders, G. D., Bravata, D. M., Nouri, B., Gastwirth, J. M., Peterson, D., Broker, A. G., Garber, A. M., Owens, D. K. 2005; 142 (8): 601-610

  Abstract

  Weaponized Bacillus anthracis is one of the few biological agents that can cause death and disease in sufficient numbers to devastate an urban setting.To evaluate the cost-effectiveness of strategies for prophylaxis and treatment of an aerosolized B. anthracis bioterror attack.Decision analytic model.We derived probabilities of anthrax exposure, vaccine and treatment characteristics, and their costs and associated clinical outcomes from the medical literature and bioterrorism-preparedness experts.Persons living and working in a large metropolitan U.S. city.Patient lifetime.Societal.We evaluated 4 postattack strategies: no prophylaxis, vaccination alone, antibiotic prophylaxis alone, or vaccination and antibiotic prophylaxis, as well as preattack vaccination versus no vaccination.Costs, quality-adjusted life-years, life-years, and incremental cost-effectiveness.If an aerosolized B. anthracis bioweapon attack occurs, postexposure prophylactic vaccination and antibiotic therapy for those potentially exposed is the most effective (0.33 life-year gained per person) and least costly (355 dollars saved per person) strategy, as compared with vaccination alone. At low baseline probabilities of attack and exposure, mass previous vaccination of a metropolitan population is more costly (815 million dollars for a city of 5 million people) and not more effective than no vaccination.If prophylactic antibiotics cannot be promptly distributed after exposure, previous vaccination may become cost-effective.The probability of exposure and disease critically depends on the probability and mechanism of bioweapon release.In the event of an aerosolized B. anthracis bioweapon attack over an unvaccinated metropolitan U.S. population, postattack prophylactic vaccination and antibiotic therapy is the most effective and least expensive strategy.

  View details for Web of Science ID 000228410400002

  View details for PubMedID 15838066

• Cost-effectiveness of screening for HIV in the era of highly active antiretroviral therapy NEW ENGLAND JOURNAL OF MEDICINE Sanders, G. D., Bayoumi, A. M., Sundaram, V., Bilir, S. P., Neukermans, C. P., Rydzak, C. E., Douglass, L. R., Lazzeroni, L. C., Holodniy, M., Owens, D. K. 2005; 352 (6): 570-585

  Abstract

  The costs, benefits, and cost-effectiveness of screening for human immunodeficiency virus (HIV) in health care settings during the era of highly active antiretroviral therapy (HAART) have not been determined.We developed a Markov model of costs, quality of life, and survival associated with an HIV-screening program as compared with current practice. In both strategies, symptomatic patients were identified through symptom-based case finding. Identified patients started treatment when their CD4 count dropped to 350 cells per cubic millimeter. Disease progression was defined on the basis of CD4 levels and viral load. The likelihood of sexual transmission was based on viral load, knowledge of HIV status, and efficacy of counseling.Given a 1 percent prevalence of unidentified HIV infection, screening increased life expectancy by 5.48 days, or 4.70 quality-adjusted days, at an estimated cost of 194 dollars per screened patient, for a cost-effectiveness ratio of 15,078 dollars per quality-adjusted life-year. Screening cost less than 50,000 dollars per quality-adjusted life-year if the prevalence of unidentified HIV infection exceeded 0.05 percent. Excluding HIV transmission, the cost-effectiveness of screening was 41,736 dollars per quality-adjusted life-year. Screening every five years, as compared with a one-time screening program, cost 57,138 dollars per quality-adjusted life-year, but was more attractive in settings with a high incidence of infection. Our results were sensitive to the efficacy of behavior modification, the benefit of early identification and therapy, and the prevalence and incidence of HIV infection.The cost-effectiveness of routine HIV screening in health care settings, even in relatively low-prevalence populations, is similar to that of commonly accepted interventions, and such programs should be expanded.

  View details for Web of Science ID 000226862100007

  View details for PubMedID 15703422

• Creative cost-effectiveness analysis of CAPRIE data - dust in our eyes - Reply AMERICAN JOURNAL OF MEDICINE Schleinitz, M. D., Owens, D. K. 2005; 118 (2): 200-200

  View details for DOI 10.1016/j.amjmed.2004.11.011

  View details for Web of Science ID 000226706500025

• How can modeling best contribute to the assessment of secondary stroke prevention strategies? Reply AMERICAN JOURNAL OF MEDICINE Schleinitz, M. D., Owens, D. K. 2005; 118 (2): 199-199

  View details for DOI 10.1016/j.amjmed.2004.11.010

  View details for Web of Science ID 000226706500023

• Cost-effectiveness of training unselected laypersons in cardiopulmonary resuscitation and defibrillation AMERICAN JOURNAL OF MEDICINE Groeneveld, P. W., Owens, D. K. 2005; 118 (1): 58-67

  Abstract

  The cost-effectiveness of cardiopulmonary resuscitation (CPR) and defibrillation training for laypersons unselected for risk of encountering cases of cardiac arrest is not known. We compared the costs and health benefits of alternative resuscitation training strategies for adults without professional first-responder duties who are at average risk of encountering cases of out-of-hospital cardiac arrest.We constructed a cost-effectiveness analytic model. Data on cardiac arrest epidemiology and the effectiveness of CPR/defibrillation training were obtained from the medical literature. Instructional costs were determined from a survey of training programs. Downstream cardiac arrest survivor quality-adjusted life expectancy and long-term health care costs were derived from prior studies. We compared three strategies for training unselected laypersons: CPR/defibrillation training alone, training combined with home defibrillator purchase, and no training. The main outcome measures were total instructional costs for trainees combined with health care costs for additional cardiac arrest survivors, and quality-adjusted survival for additional patients resuscitated by trainees.CPR/defibrillation training yielded 2.7 quality-adjusted hours of life at a cost of 62 US dollars per trainee (202,400 US dollars per quality-adjusted life-year [QALY] gained). Training laypersons in CPR/defibrillation with subsequent defibrillator purchase cost 2,489,700 US dollars per QALY. In contrast, CPR/defibrillation training cost less than 75,000 US dollars per QALY if trainees lived with persons older than 75 years or with persons who had cardiac disease, or if total training costs were less than 10 US dollars.Training unselected laypersons in CPR/defibrillation is costly compared with other public health initiatives. Conversely, training laypersons selected by occupation, low training costs, or having high-risk household companions is substantially more efficient.

  View details for DOI 10.1016/j.amjmed.2004.08.014

  View details for Web of Science ID 000226359700012

  View details for PubMedID 15639211

• THE COST EFFECTIVENESS OF PARTIALLY EFFECTIVE HIV VACCINES OPERATIONS RESEARCH AND HEALTH CARE: A HANDBOOK OF METHODS AND APPLICATIONS Owens, D. K., Edwards, D. M., Cavallaro, J. F., Shachter, R. D., Brandeau, M. L., Sainfort, F., Pierskalla, W. P. 2005; 70: 403–18

  View details for DOI 10.1007/1-4020-8066-2_15

  View details for Web of Science ID 000270672800015

• Evidence-based medicine and policy: The case of the implantable cardioverter defibrillator HEALTH AFFAIRS Hlatky, M. A., Sanders, G. D., Owens, D. K. 2005; 24 (1): 42-51

  Abstract

  The implantable cardioverter defibrillator (ICD) is a costly new treatment for patients at high risk of sudden cardiac death. Randomized trials of the ICD showed it to be effective in some groups of patients but not in others. While new trials testing the ICD were ongoing to clarify the evidence, policymakers faced immediate decisions about providing insurance coverage for the device. The high cost of ICDs, the large population of patients potentially eligible to receive them, the potential to reduce preventable deaths, and the unsettled state of the medical evidence provided a challenge to evidence-based medicine and to policymakers.

  View details for DOI 10.1377/hlthaff.24.1.42

  View details for PubMedID 15647214

• Cost-effectiveness of photodynamic therapy for high-grade dysplasia in Barrett's esophagus 25th Annual Meeting of the Society-for-Medical-Decision-Making Vij, R., Triadafilopoulos, G., Owens, D. K., Kunz, P., Sanders, G. D. MOSBY-ELSEVIER. 2004: 739–56

  Abstract

  Photodynamic therapy appears to be effective in ablating high-grade dysplasia in Barrett's esophagus. Our aim was to identify the most effective and cost-effective strategy for managing high-grade dysplasia in Barrett's esophagus without associated endoscopically visible abnormalities.By using decision analysis, the lifetime costs and benefits of 4 strategies for which long-term data exist were estimated by us: esophagectomy, endoscopic surveillance, photodynamic therapy, followed by esophagectomy for residual high-grade dysplasia; and photodynamic therapy followed by endoscopic surveillance for residual high-grade dysplasia. It was assumed by us that there was a 30% prevalence of cancer in high-grade dysplasia patients and a 77% efficacy of photodynamic therapy for high-grade dysplasia and early cancer.Esophagectomy cost 24,045 dollars, with life expectancy of 11.82 quality-adjusted life years. In comparison, photodynamic therapy followed by surveillance for residual high-grade dysplasia was the most effective strategy, with a quality-adjusted life expectancy of 12.31 quality-adjusted life years, but it also incurred the greatest lifetime cost (47,310 dollars) for an incremental cost-effectiveness of 47,410 dollars/quality-adjusted life years. The results were sensitive to post-surgical quality of life and survival, and to cancer prevalence if photodynamic therapy efficacy for cancer was less than 50%.Photodynamic therapy followed by endoscopic surveillance for residual high-grade dysplasia appears to be cost effective compared with esophagectomy for patients diagnosed with high-grade dysplasia in Barrett's esophagus. Clinical trials directly comparing these strategies are warranted.

  View details for PubMedID 15557950

• Primary care management of chronic stable angina and asymptomatic suspected or known coronary artery disease: A clinical practice guideline from the American College of Physicians ANNALS OF INTERNAL MEDICINE Snow, V., Barry, P., Fihn, S. D., Gibbons, R. J., Owens, D. K., Williams, S. V., Mottur-Pilson, C., Weiss, K. B. 2004; 141 (7): 562-567

  Abstract

  In 1999, the American College of Physicians (ACP), then the American College of Physicians-American Society of Internal Medicine, and the American College of Cardiology/American Heart Association (ACC/AHA) developed joint guidelines on the management of patients with chronic stable angina. The ACC/AHA then published an updated guideline in 2002, which ACP recognized as a scientifically valid review of the evidence and background paper. This ACP guideline summarizes the recommendations of the 2002 ACC/AHA updated guideline and underscores the recommendations most likely to be important to physicians seeing patients in the primary care setting. This guideline is the second of 2 that provide guidance on the management of patients with chronic stable angina. This document covers treatment and follow-up of symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months. Sections addressing asymptomatic patients are also included. Asymptomatic refers to patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests. A previous guideline covered diagnosis and risk stratification for symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months and asymptomatic patients with known or suspected coronary disease based on a history or electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests.

  View details for Web of Science ID 000224467800009

  View details for PubMedID 15466774

• Evaluation of primary care patients with chronic stable angina: Guidelines from the American College of Physicians ANNALS OF INTERNAL MEDICINE Snow, V., Barry, P., Fihn, S. D., Gibbons, R. J., Owens, D. K., Williams, S. V., Weiss, K. B., Mottur-Pilson, C. 2004; 141 (1): 57-64

  Abstract

  In 1999, the American College of Physicians (ACP), then the American College of Physicians-American Society of Internal Medicine, and the American College of Cardiology/American Heart Association (ACC/AHA) developed joint guidelines on the management of patients with chronic stable angina. The ACC/AHA then published an updated guideline in 2002, which the ACP recognized as a scientifically valid review of the evidence and background paper. This ACP guideline summarizes the recommendations of the 2002 ACC/AHA updated guideline and underscores the recommendations most likely to be important to physicians seeing patients in the primary care setting. This guideline is the first of 2 that will provide guidance on the management of patients with chronic stable angina. This document will cover diagnosis and risk stratification for symptomatic patients who have not had an acute myocardial infarction or revascularization procedure in the previous 6 months. Sections addressing asymptomatic patients are also included. Asymptomatic refers to patients with known or suspected coronary disease based on history or on electrocardiographic evidence of previous myocardial infarction, coronary angiography, or abnormal results on noninvasive tests. A future guideline will cover pharmacologic therapy and follow-up.

  View details for Web of Science ID 000222427600008

  View details for PubMedID 15238371

• Clopidogrel versus aspirin for secondary prophylaxis of vascular events: A cost-effectiveness analysis AMERICAN JOURNAL OF MEDICINE Schleinitz, M. D., Weiss, J. P., Owens, D. K. 2004; 116 (12): 797-806

  Abstract

  Clopidogrel is more effective than aspirin in preventing recurrent vascular events, but concerns about its cost-effectiveness have limited its use. We evaluated the cost-effectiveness of clopidogrel and aspirin as secondary prevention in patients with a prior myocardial infarction, a prior stroke, or peripheral arterial disease.We constructed Markov models assuming a societal perspective, and based analyses on the lifetime treatment of a 63-year-old patient facing event probabilities derived from the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) trial as the base case. Outcome measures included costs, life expectancy in quality-adjusted life-years (QALYs), incremental cost-effectiveness ratios, and events averted.In patients with peripheral arterial disease, clopidogrel increased life expectancy by 0.55 QALYs at an incremental cost-effectiveness ratio of $25,100 per QALY, as compared with aspirin. In poststroke patients, clopidogrel increased life expectancy by 0.17 QALYs at a cost of $31,200 per QALY. Aspirin was both less expensive and more effective than clopidogrel in post-myocardial infarction patients. In probabilistic sensitivity analyses, our evaluation for patients with peripheral vascular disease was robust. Evaluations of stroke and myocardial infarction patients were sensitive predominantly to the cost and efficacy of clopidogrel, with aspirin therapy more effective and less expensive in 153 of 1000 simulations (15.3%) in poststroke patients and clopidogrel more effective in 119 of 1000 simulations (11.9%) in the myocardial infarction sample.Clopidogrel provides a substantial increase in quality-adjusted life expectancy at a cost that is within traditional societal limits for patients with either peripheral arterial disease or a recent stroke. Current evidence does not support increased efficacy with clopidogrel relative to aspirin in patients following myocardial infarction.

  View details for DOI 10.1016/j.amjmed.2004.01.014

  View details for PubMedID 15178495

• Systematic review: Surveillance systems for early detection of bioterrorism-related diseases ANNALS OF INTERNAL MEDICINE Bravata, D. M., McDonald, K. M., Smith, W. M., Rydzak, C., Szeto, H., Buckeridge, D. L., Haberland, C., Owens, D. K. 2004; 140 (11): 910-922

  Abstract

  Given the threat of bioterrorism and the increasing availability of electronic data for surveillance, surveillance systems for the early detection of illnesses and syndromes potentially related to bioterrorism have proliferated.To critically evaluate the potential utility of existing surveillance systems for illnesses and syndromes related to bioterrorism.Databases of peer-reviewed articles (for example, MEDLINE for articles published from January 1985 to April 2002) and Web sites of relevant government and nongovernment agencies.Reports that described or evaluated systems for collecting, analyzing, or presenting surveillance data for bioterrorism-related illnesses or syndromes.From each included article, the authors abstracted information about the type of surveillance data collected; method of collection, analysis, and presentation of surveillance data; and outcomes of evaluations of the system.17,510 article citations and 8088 government and nongovernmental Web sites were reviewed. From these, the authors included 115 systems that collect various surveillance reports, including 9 syndromic surveillance systems, 20 systems collecting bioterrorism detector data, 13 systems collecting influenza-related data, and 23 systems collecting laboratory and antimicrobial resistance data. Only the systems collecting syndromic surveillance data and detection system data were designed, at least in part, for bioterrorism preparedness applications. Syndromic surveillance systems have been deployed for both event-based and continuous bioterrorism surveillance. Few surveillance systems have been comprehensively evaluated. Only 3 systems have had both sensitivity and specificity evaluated.Data from some existing surveillance systems (particularly those developed by the military) may not be publicly available.Few surveillance systems have been specifically designed for collecting and analyzing data for the early detection of a bioterrorist event. Because current evaluations of surveillance systems for detecting bioterrorism and emerging infections are insufficient to characterize the timeliness or sensitivity and specificity, clinical and public health decision making based on these systems may be compromised.

  View details for PubMedID 15172906

• Cost-effectiveness of screening for hepatocellular carcinoma in patients with cirrhosis due to chronic hepatitis C ALIMENTARY PHARMACOLOGY & THERAPEUTICS Lin, O. S., Keeffe, E. B., Sanders, G. D., Owens, D. K. 2004; 19 (11): 1159-1172

  Abstract

  Screening for hepatocellular carcinoma in cirrhotic patients using abdominal ultrasonography and alpha-foetoprotein levels is widely practiced.To evaluate its cost-effectiveness using a Markov decision model.Several screening strategies with abdominal ultrasonography or computerized tomography and serum alpha-foetoprotein at 6-12-month intervals in 40-year-old patients with chronic hepatitis C and compensated cirrhosis were simulated from a societal perspective, resulting in discounted costs per quality-adjusted life-year saved. Extensive sensitivity analysis was performed.For the least efficacious strategy, annual alpha-foetoprotein/ultrasonography, the incremental cost-effectiveness ratio (vs. no screening) was $23 043/quality-adjusted life-year. Biannual alpha-foetoprotein/annual ultrasonography, the most commonly used strategy in the United States, was more efficacious, with a cost-effectiveness ratio of $33 083/quality-adjusted life-year vs. annual alpha-foetoprotein/ultrasonography. The most efficacious strategy, biannual alpha-foetoprotein/ultrasonography, resulted in a cost-effectiveness ratio of $73 789/quality-adjusted life-year vs. biannual alpha-foetoprotein/annual ultrasonography. Biannual alpha-foetoprotein/annual computerized tomography screening resulted in a cost-effectiveness ratio of $51 750/quality-adjusted life-year vs. biannual alpha-foetoprotein/annual ultrasonography screening.Screening for hepatocellular carcinoma is as cost-effective as other accepted screening protocols. Of the strategies evaluated, biannual alpha-foetoprotein/annual ultrasonography gives the most quality-adjusted life-year gain while still maintaining a cost-effectiveness ratio <$50 000/quality-adjusted life-year. Biannual alpha-foetoprotein/annual computerized tomography screening may be cost-effective.

  View details for DOI 10.1111/j.1365-2036.2004.01963.x

  View details for Web of Science ID 000221532600004

  View details for PubMedID 15153169

• Regionalization of bioterrorism preparedness and response. Evidence report/technology assessment (Summary) Bravata, D. M., McDonald, K. M., Owens, D. K., Wilhelm, E. R., Brandeau, M. L., Zaric, G. S., Holty, J. E., Liu, H., Sundaram, V. 2004: 1-7

  View details for PubMedID 15133889

• A conceptual framework for evaluating information technologies and decision support systems for bioterrorism preparedness and response 24th Annual Meeting of the Society-for-Medical-Decision-Making Bravata, D. M., McDonald, K. M., Szeto, H., Smith, W. M., Rydzak, C., Owens, D. K. SAGE PUBLICATIONS INC. 2004: 192–206

  Abstract

  The authors sought to develop a conceptual framework for evaluating whether existing information technologies and decision support systems (IT/DSSs) would assist the key decisions faced by clinicians and public health officials preparing for and responding to bioterrorism.They reviewed reports of natural and bioterrorism related infectious outbreaks, bioterrorism preparedness exercises, and advice from experts to identify the key decisions, tasks, and information needs of clinicians and public health officials during a bioterrorism response. The authors used task decomposition to identify the subtasks and data requirements of IT/DSSs designed to facilitate a bioterrorism response. They used the results of the task decomposition to develop evaluation criteria for IT/DSSs for bioterrorism preparedness. They then applied these evaluation criteria to 341 reports of 217 existing IT/DSSs that could be used to support a bioterrorism response. Main Results: In response to bioterrorism, clinicians must make decisions in 4 critical domains (diagnosis, management, prevention, and reporting to public health), and public health officials must make decisions in 4 other domains (interpretation of bioterrorism surveillance data, outbreak investigation, outbreak control, and communication). The time horizons and utility functions for these decisions differ. From the task decomposition, the authors identified critical subtasks for each of the 8 decisions. For example, interpretation of diagnostic tests is an important subtask of diagnostic decision making that requires an understanding of the tests' sensitivity and specificity. Therefore, an evaluation criterion applied to reports of diagnostic IT/DSSs for bioterrorism asked whether the reports described the systems' sensitivity and specificity. Of the 217 existing IT/DSSs that could be used to respond to bioterrorism, 79 studies evaluated 58 systems for at least 1 performance metric.The authors identified 8 key decisions that clinicians and public health officials must make in response to bioterrorism. When applying the evaluation system to 217 currently available IT/DSSs that could potentially support the decisions of clinicians and public health officials, the authors found that the literature provides little information about the accuracy of these systems.

  View details for DOI 10.1177/0272989X04263254

  View details for PubMedID 15090105

• Evaluating detection and diagnostic decision support systems for bioterrorism response EMERGING INFECTIOUS DISEASES Bravata, D. M., Sundaram, V., McDonald, K. M., Smith, W. M., Szeto, H., Schleinitz, M. D., Owens, D. K. 2004; 10 (1): 100-108

  Abstract

  We evaluated the usefulness of detection systems and diagnostic decision support systems for bioterrorism response. We performed a systematic review by searching relevant databases (e.g., MEDLINE) and Web sites for reports of detection systems and diagnostic decision support systems that could be used during bioterrorism responses. We reviewed over 24,000 citations and identified 55 detection systems and 23 diagnostic decision support systems. Only 35 systems have been evaluated: 4 reported both sensitivity and specificity, 13 were compared to a reference standard, and 31 were evaluated for their timeliness. Most evaluations of detection systems and some evaluations of diagnostic systems for bioterrorism responses are critically deficient. Because false-positive and false-negative rates are unknown for most systems, decision making on the basis of these systems is seriously compromised. We describe a framework for the design of future evaluations of such systems.

  View details for Web of Science ID 000187962800016

  View details for PubMedID 15078604

  View details for PubMedCentralID PMC3322751

• Management of newly detected atrial fibrillation: A clinical practice guideline from the American Academy of Family Physicians and the American College of Physicians ANNALS OF INTERNAL MEDICINE Snow, V., Weiss, K. B., Lefevre, M., McNamara, R., Bass, E., Green, L. A., Michl, K., Owens, D. K., Susman, J., Allen, D. I., Mottur-Pilson, C. 2003; 139 (12): 1009-1017

  Abstract

  The Joint Panel of the American Academy of Family Physicians and the American College of Physicians, in collaboration with the Johns Hopkins Evidence-based Practice Center, systematically reviewed the available evidence on the management of newly detected atrial fibrillation and developed recommendations for adult patients with first-detected atrial fibrillation. The recommendations do not apply to patients with postoperative or post-myocardial infarction atrial fibrillation, patients with class IV heart failure, patients already taking antiarrhythmic drugs, or patients with valvular disease. The target physician audience is internists and family physicians dedicated to primary care. The recommendations are as follows: RECOMMENDATION 1: Rate control with chronic anticoagulation is the recommended strategy for the majority of patients with atrial fibrillation. Rhythm control has not been shown to be superior to rate control (with chronic anticoagulation) in reducing morbidity and mortality and may be inferior in some patient subgroups to rate control. Rhythm control is appropriate when based on other special considerations, such as patient symptoms, exercise tolerance, and patient preference. Grade: 2A. RECOMMENDATION 2: Patients with atrial fibrillation should receive chronic anticoagulation with adjusted-dose warfarin, unless they are at low risk of stroke or have a specific contraindication to the use of warfarin (thrombocytopenia, recent trauma or surgery, alcoholism). Grade: 1A. RECOMMENDATION 3: For patients with atrial fibrillation, the following drugs are recommended for their demonstrated efficacy in rate control during exercise and while at rest: atenolol, metoprolol, diltiazem, and verapamil (drugs listed alphabetically by class). Digoxin is only effective for rate control at rest and therefore should only be used as a second-line agent for rate control in atrial fibrillation. Grade: 1B. RECOMMENDATION 4: For those patients who elect to undergo acute cardioversion to achieve sinus rhythm in atrial fibrillation, both direct-current cardioversion (Grade: 1C+) and pharmacological conversion (Grade: 2A) are appropriate options. RECOMMENDATION 5: Both transesophageal echocardiography with short-term prior anticoagulation followed by early acute cardioversion (in the absence of intracardiac thrombus) with postcardioversion anticoagulation versus delayed cardioversion with pre- and postanticoagulation are appropriate management strategies for those patients who elect to undergo cardioversion. Grade: 2A. RECOMMENDATION 6: Most patients converted to sinus rhythm from atrial fibrillation should not be placed on rhythm maintenance therapy since the risks outweigh the benefits. In a selected group of patients whose quality of life is compromised by atrial fibrillation, the recommended pharmacologic agents for rhythm maintenance are amiodarone, disopyramide, propafenone, and sotalol (drugs listed in alphabetical order). The choice of agent predominantly depends on specific risk of side effects based on patient characteristics. Grade: 2A.

  View details for Web of Science ID 000187443200017

  View details for PubMedID 14678921

• Test performance of positron emission tomography and computed tomography for mediastinal staging in patients with non-small-cell lung cancer - A meta-analysis ANNALS OF INTERNAL MEDICINE Gould, M. K., Kuschner, W. G., Rydzak, C. E., Maclean, C. C., Demas, A. N., Shigemitsu, H., Chan, J. K., Owens, D. K. 2003; 139 (11): 879-892

  Abstract

  To compare the diagnostic accuracy of computed tomography (CT) and positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) for mediastinal staging in patients with non-small-cell lung cancer and to determine whether test results are conditionally dependent (the sensitivity and specificity of FDG-PET depend on the presence or absence of enlarged mediastinal lymph nodes on CT).Computerized search of MEDLINE, EMBASE, BIOSIS, and CancerLit through March 2003 and reference lists of retrieved studies and review articles.Studies in any language that examined FDG-PET for mediastinal staging in patients with known or suspected non-small-cell lung cancer, enrolled at least 10 participants (including at least 5 participants with mediastinal metastasis), and provided enough data to permit calculation of sensitivity and specificity for identifying lymph node involvement.One reviewer (of non-English-language studies) or 2 reviewers (of English-language studies) independently evaluated studies for inclusion, rated methodologic quality, and abstracted relevant data.Thirty-nine studies met inclusion criteria. Methodologic quality varied, but few aspects of study quality affected diagnostic accuracy. The authors constructed summary receiver-operating characteristic curves for CT and FDG-PET. Positron emission tomography with 18-fluorodeoxyglucose was more accurate than CT for identifying lymph node involvement (P < 0.001). For CT, median sensitivity and specificity were 61% (interquartile range, 50% to 71%) and 79% (interquartile range, 66% to 89%), respectively. For FDG-PET, median sensitivity and specificity were 85% (interquartile range, 67% to 91%) and 90% (interquartile range, 82% to 96%), respectively. Fourteen studies provided information about the conditional test performance of CT and FDG-PET. Positron emission tomography with 18-fluorodeoxyglucose was more sensitive but less specific when CT showed enlarged lymph nodes (median sensitivity, 100% [interquartile range, 90% to 100%]; median specificity, 78% [interquartile range, 68% to 100%]) than when CT showed no lymph node enlargement (median sensitivity, 82% [interquartile range, 65% to 100%]; median specificity, 93% [interquartile range, 92% to 100%]; P = 0.002).Positron emission tomography with 18-fluorodeoxyglucose is more accurate than CT for mediastinal staging. Positron emission tomography with 18-fluorodeoxyglucose is more sensitive but less specific when CT shows enlarged mediastinal lymph nodes.

  View details for Web of Science ID 000186884800001

  View details for PubMedID 14644890

• Cost-effectiveness of the implantable cardioverter defibrillator. Cardiac electrophysiology review Hlatky, M. A., Sanders, G. D., Owens, D. K. 2003; 7 (4): 479-482

  Abstract

  Many clinicians and policymakers are concerned whether use of the implantable defibrillator (ICD) is justified in view of its high cost. Three randomized trials of the ICD have reported economic outcomes. Each trial found a large difference in cost between patients assigned to an ICD versus patients assigned to conventional therapy that persisted over three to six years of follow-up. Each trial also found better survival among ICD patients, and calculated ICD cost-effectiveness (CE) ratios between 27,000 dollars per life year added and 139,000 dollars per life year added. The variability in the cost-effectiveness ratios among trials is mainly due to variability in the years of life added by the ICD among the trials and, by extension, among patient subgroups. A rough rule of thumb is that the ICD will be economically attractive when it prolongs mean survival by six months or more, which is attainable in higher risk patient subgroups.

  View details for PubMedID 15071279

• Cost-effectiveness of bypass surgery versus stenting in patients with multivessel coronary artery disease AMERICAN JOURNAL OF MEDICINE Yock, C. A., Boothroyd, D. B., Owens, D. K., Garber, A. M., Hlatky, M. A. 2003; 115 (5): 382-389

  Abstract

  To compare the cost-effectiveness of surgical and angioplasty-based coronary artery revascularization techniques, in particular, angioplasty with primary stenting.We used data from the Study of Economics and Quality of Life, a substudy of the Bypass Angioplasty Revascularization Investigation (BARI), to measure the outcomes and costs of angioplasty and bypass surgery in patients with multivessel coronary artery disease who had not undergone prior coronary artery revascularization. Using a Markov decision model, we updated the outcomes and costs to reflect technology changes since the time of enrollment in BARI, and projected the lifetime costs and quality-adjusted life-years (QALYs) for the two procedures from the time of initial treatment through death. We accounted for the effects of improved procedural safety and efficiency, and prolonged therapeutic effects of both surgery and stenting. This study was conducted from a societal perspective.Surgical revascularization was less costly and resulted in better outcomes than catheter-based intervention including stenting. It remained the preferred strategy after adjusting the stent outcomes to eliminate the costs and events associated with target lesion restenosis. Among angioplasty-based strategies, primary stent use cost an additional 189,000 US dollars per QALY gained compared with a strategy that reserved stent use for treatment of suboptimal balloon angioplasty results.Bypass surgery results in better outcomes than angioplasty in patients with multivessel disease, and at a lower cost.

  View details for DOI 10.1016/S0002-9343(03)00296-1

  View details for PubMedID 14553874

• Cost-effectiveness of alternative management strategies for patients with solitary pulmonary nodules ANNALS OF INTERNAL MEDICINE Gould, M. K., Sanders, G. D., Barnett, P. G., Rydzak, C. E., Maclean, C. C., McClellan, M. B., Owens, D. K. 2003; 138 (9): 724-735

  Abstract

  Positron emission tomography (PET) with 18-fluorodeoxyglucose (FDG) is a potentially useful but expensive test to diagnose solitary pulmonary nodules.To evaluate the cost-effectiveness of strategies for pulmonary nodule diagnosis and to specifically compare strategies that did and did not include FDG-PET.Decision model.Accuracy and complications of diagnostic tests were estimated by using meta-analysis and literature review. Modeled survival was based on data from a large tumor registry. Cost estimates were derived from Medicare reimbursement and other sources.All adult patients with a new, noncalcified pulmonary nodule seen on chest radiograph.Patient lifetime.Societal.40 clinically plausible combinations of 5 diagnostic interventions, including computed tomography, FDG-PET, transthoracic needle biopsy, surgery, and watchful waiting.Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios.The cost-effectiveness of strategies depended critically on the pretest probability of malignancy. For patients with low pretest probability (26%), strategies that used FDG-PET selectively when computed tomography results were possibly malignant cost as little as 20 000 dollars per QALY gained. For patients with high pretest probability (79%), strategies that used FDG-PET selectively when computed tomography results were benign cost as little as 16 000 dollars per QALY gained. For patients with intermediate pretest probability (55%), FDG-PET strategies cost more than 220 000 dollars per QALY gained because they were more costly but only marginally more effective than computed tomography-based strategies.The choice of strategy also depended on the risk for surgical complications, the probability of nondiagnostic needle biopsy, the sensitivity of computed tomography, and patient preferences for time spent in watchful waiting. In probabilistic sensitivity analysis, FDG-PET strategies were cost saving or cost less than 100 000 dollars per QALY gained in 76.7%, 24.4%, and 99.9% of computer simulations for patients with low, intermediate, and high pretest probability, respectively.FDG-PET should be used selectively when pretest probability and computed tomography findings are discordant or in patients with intermediate pretest probability who are at high risk for surgical complications. In most other circumstances, computed tomography-based strategies result in similar quality-adjusted life-years and lower costs.

  View details for Web of Science ID 000182661400005

  View details for PubMedID 12729427

• The cost effectiveness of improved adherence to antiretroviral treatment Zaric, G. S., Bayoumi, A. M., Brandeau, M. L., Owens, D. K. ELSEVIER SCIENCE INC. 2003: 266–66

  View details for Web of Science ID 000183419000219

• Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator AMERICAN HEART JOURNAL Owens, D. K., Sanders, G. D., Heidenreich, P. A., McDonald, K. M., Hlatky, M. A. 2002; 144 (3): 440-448

  Abstract

  Implantable cardioverter defibrillators (ICDs) effectively prevent sudden cardiac death, but selection of appropriate patients for implantation is complex. We evaluated whether risk stratification based on risk of sudden cardiac death alone was sufficient to predict the effectiveness and cost-effectiveness of the ICD.We developed a Markov model to evaluate the cost-effectiveness of ICD implantation compared with empiric amiodarone treatment. The model incorporated mortality rates from sudden and nonsudden cardiac death, noncardiac death and costs for each treatment strategy. We based our model inputs on data from randomized clinical trials, registries, and meta-analyses. We assumed that the ICD reduced total mortality rates by 25%, relative to use of amiodarone.The relationship between cost-effectiveness of the ICD and the total annual cardiac mortality rate is U-shaped; cost-effectiveness becomes unfavorable at both low and high total cardiac mortality rates. If the annual total cardiac mortality rate is 12%, the cost-effectiveness of the ICD varies from $36,000 per quality-adjusted life-year (QALY) gained when the ratio of sudden cardiac death to nonsudden cardiac death is 4 to $116,000 per QALY gained when the ratio is 0.25.The cost-effectiveness of ICD use relative to amiodarone depends on total cardiac mortality rates as well as the ratio of sudden to nonsudden cardiac death. Studies of candidate diagnostic tests for risk stratification should distinguish patients who die suddenly from those who die nonsuddenly, not just patients who die suddenly from those who live.

  View details for DOI 10.1067/mhj.2002.125501

  View details for Web of Science ID 000178086800011

  View details for PubMedID 12228780

• Analytic tools for public health decision making MEDICAL DECISION MAKING Owens, D. K. 2002; 22 (5): S3-S10

  View details for DOI 10.1177/027298902237969

  View details for Web of Science ID 000178170400001

  View details for PubMedID 12369229

• Cost-effectiveness of the pneumococcal vaccine in healthy younger adults MEDICAL DECISION MAKING Pepper, P. V., Owens, D. K. 2002; 22 (5): S45-S57

  Abstract

  Routine vaccination for Streptococcus pneumoniae has been recommended as a cost-effective measure for elderly and immunocompromised patients, yet no analysis has been performed for healthy younger adults in America. The authors evaluated the cost-effectiveness of the pneumococcal vaccine and determined the net health benefits conferred for the healthy young adult population.The authors developed a decision model to compare the health and economic outcomes of vaccinate versus do not vaccinate for S. pneumoniae.Vaccinating patients for S. pneumoniae generates benefits that are dependent on incidence rates and the efficacy of the vaccine. In the 22-year-old patient with a pneumonia incidence of 0.3/1000, the vaccine would need to be > 71 percent effective for the vaccination strategy to cost less than $50,000/QALY gained. At an incidence of 0.4/1000, the threshold efficacy is 53 percent, whereas at 0.5/1000 it is 43 percent. In the 35-year-old patient where the incidence of pneumococcal pneumonia is higher (0.85/1000), the vaccine would be cost-effective with an efficacy as low as 30 percent.Use of the S. pneumoniae vaccine in young adults would provide modest reductions in pneumonia-associated morbidity and mortality. Vaccination of young adults is moderately expensive unless vaccine efficacy is above 50% to 60%. In 35-year-old adults, use of the vaccine is cost-effective even with moderate efficacy.

  View details for DOI 10.1177/027298902237705

  View details for Web of Science ID 000178170400006

  View details for PubMedID 12369231

• Bioterrorism preparedness and response: use of information technologies and decision support systems. Evidence report/technology assessment (Summary) Bravata, D. M., McDonald, K., Owens, D. K., Buckeridge, D., Haberland, C., Rydzak, C., Schleinitz, M., Smith, W. M., Szeto, H., Wilkening, D., Musen, M., Duncan, B. W., Nouri, B., Dangiolo, M. B., Liu, H., Shofer, S., Graham, J., Davies, S. 2002: 1-8

  View details for PubMedID 12154489

• Surveillance systems for bioterrorism: A systematic review. Bravata, D. M., McDonald, K., Smith, W. M., Rydzak, C., Szeto, H., Buckeridge, D., Haberland, C., Dangiolo, M. B., Graham, J., Owens, D. K. SPRINGER. 2002: 184–185

  View details for Web of Science ID 000175158200733

• Costs and benefits of imperfect HIV vaccines: Implications for vaccine development and use 14th Conference on Quantitative Evaluation of HIV Prvention Programs Owens, D. K., Edwards, D. M., Shachter, R. D. YALE UNIV PRESS. 2002: 143–171

  View details for Web of Science ID 000180918400007

• Quantifying the population impact of a prophylactic Helicobacter pylori vaccine VACCINE Rupnow, M. F., Shachter, R. D., Owens, D. K., Parsonnet, J. 2001; 20 (5-6): 879-885

  Abstract

  Helicobacter pylori vaccines, which have been suggested as promising interventions to control infection, are under development. We sought to quantify the potential population impact of a prophylactic H. pylori vaccine.We developed a mathematical model that compartmentalized the population according to age, infection status and clinical state. A proportion of individuals was assumed to acquire infection and develop gastritis, duodenal ulcer (DU), chronic atrophic gastritis and gastric cancer (GC). We first simulated the model without vaccine intervention, to obtain estimates of H. pylori prevalence, and GC and DU incidences based on intrinsic dynamics. We then incorporated a prophylactic vaccine (80% efficacy, lifetime protection, 80% coverage) targeting all infants. We tested vaccination programs over unlimited as well as limited time spans. Analyses were performed for the US, Japan and a prototypical developing country.In the US, our model predicted a decrease in H. pylori prevalence from 12.0% in 2010 to 4.2% in 2100 without intervention. With 10 years of vaccination beginning in 2010, prevalence would decrease to 0.7% by year 2100. In the same period, incidence of H. pylori-attributable GC would decrease from 4.5 to 0.4 per 100,000 with vaccine (compared to 1.3 per 100,000 without vaccine). Incidence of H. pylori-attributable DU would decrease from 33.3 to 2.5 per 100,000 with vaccine (compared to 12.2 per 100,000 without vaccine). In Japan, incidence of H. pylori-attributable GC would decrease from 17.6 to 1.0 per 100,000 after 10 years of vaccination (compared to 3.0 per 100,000 without vaccine). In a prototypical developing country, after 10 years of vaccination, H. pylori-attributable GC would decrease from 31.8 to 22.5 per 100,000 by 2090, returning to the original level by mid-2100s. Under continuous vaccination, it would decrease to 5.8 per 100,000 by 2100.In the US and Japan, a 10-year vaccination program would confer almost the same reduction in H. pylori and associated diseases as a vaccination effort that extends beyond 10 years. In developing countries, a continuous vaccination effort would be required to eliminate the pathogen and its associated diseases.

  View details for PubMedID 11738753

• Potential cost-effectiveness of prophylactic use of the implantable cardioverter defibrillator or amiodarone after myocardial infarction ANNALS OF INTERNAL MEDICINE Sanders, G. D., Hlatky, M. A., Every, N. R., McDonald, K. M., Heidenreich, P. A., Parsons, L. S., Owens, D. K. 2001; 135 (10): 870-883

  Abstract

  Clinical trials have shown that implantable cardioverter defibrillators (ICDs) improve survival in patients with sustained ventricular arrhythmias.To determine the efficacy necessary to make prophylactic ICD or amiodarone therapy cost-effective in patients with myocardial infarction.Markov model-based cost utility analysis.Survival, cardiac death, and inpatient costs were estimated on the basis of the Myocardial Infarction Triage and Intervention registry. Other data were derived from the literature.Patients with past myocardial infarction who did not have sustained ventricular arrhythmia.Lifetime.Societal.ICD or amiodarone compared with no treatment.Life-years, quality-adjusted life-years (QALYs), costs, number needed to treat, and incremental cost-effectiveness.Compared with no treatment, ICD use led to the greatest QALYs and the highest expenditures. Amiodarone use resulted in intermediate QALYs and costs. To obtain acceptable cost-effectiveness thresholds (

  View details for PubMedID 11712877

• Cost-effectiveness of a potential vaccine for Coccidioides immitis EMERGING INFECTIOUS DISEASES Barnato, A. E., Sanders, G. D., Owens, D. K. 2001; 7 (5): 797-806

  Abstract

  Coccidioidomycosis, a systemic fungal infection, affects Americans living in the Southwest. We evaluated the cost- effectiveness of a potential vaccine against Coccidioides immitis. Using a decision model we developed, we estimate that among children, vaccination would saved 1.9 quality-adjusted life days (QALD) and $33 per person. Among adults, screening followed by vaccination would save 0.5 QALD per person and cost $62,000 per quality adjusted life year gained over no vaccination. If the birth cohort in highly endemic counties of California and Arizona were immunized in 2001, 11 deaths would be averted and $3 million would be saved (in net present value) over the lifetime of these infants. Vaccination of adults to prevent disseminated coccidioidomycosis would provide a modest health benefit similar in magnitude to other vaccines but would increase net expenditures. Vaccination of children in highly endemic regions would provide a larger health benefit and would reduce total health care expenditures.

  View details for Web of Science ID 000171979400005

  View details for PubMedID 11747691

  View details for PubMedCentralID PMC2631863

• Positron emission tomography to evaluate lung lesions - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gould, M. K., Owens, D. K. 2001; 285 (21): 2711-2712

  View details for Web of Science ID 000168985800012

• Publishing web-based guidelines using interactive decision models JOURNAL OF EVALUATION IN CLINICAL PRACTICE Sanders, G. D., Nease, R. F., Owens, D. K. 2001; 7 (2): 175-189

  Abstract

  Commonly used methods for guideline development and dissemination do not enable developers to tailor guidelines systematically to specific patient populations and update guidelines easily. We developed a web-based system, ALCHEMIST, that uses decision models and automatically creates evidence-based guidelines that can be disseminated, tailored and updated over the web. Our objective was to demonstrate the use of this system with clinical scenarios that provide challenges for guideline development. We used the ALCHEMIST system to develop guidelines for three clinical scenarios: (1) Chlamydia screening for adolescent women, (2) antiarrhythmic therapy for the prevention of sudden cardiac death; and (3) genetic testing for the BRCA breast-cancer mutation. ALCHEMIST uses information extracted directly from the decision model, combined with the additional information from the author of the decision model, to generate global guidelines. ALCHEMIST generated electronic web-based guidelines for each of the three scenarios. Using ALCHEMIST, we demonstrate that tailoring a guideline for a population at high-risk for Chlamydia changes the recommended policy for control of Chlamydia from contact tracing of reported cases to a population-based screening programme. We used ALCHEMIST to incorporate new evidence about the effectiveness of implantable cardioverter defibrillators (ICD) and demonstrate that the cost-effectiveness of use of ICDs improves from $74 400 per quality-adjusted life year (QALY) gained to $34 500 per QALY gained. Finally, we demonstrate how a clinician could use ALCHEMIST to incorporate a woman's utilities for relevant health states and thereby develop patient-specific recommendations for BRCA testing; the patient-specific recommendation improved quality-adjusted life expectancy by 37 days. The ALCHEMIST system enables guideline developers to publish both a guideline and an interactive decision model on the web. This web-based tool enables guideline developers to tailor guidelines systematically, to update guidelines easily, and to make the underlying evidence and analysis transparent for users.

  View details for PubMedID 11489042

• Employment and alcohol use after liver transplantation for alcoholic and nonalcoholic liver disease: A systematic review LIVER TRANSPLANTATION Bravata, D. M., Olkin, I., Barnato, A. E., Keeffe, E. B., Owens, D. K. 2001; 7 (3): 191-203

  Abstract

  The purpose of the study is to evaluate patterns of employment and alcohol use among liver transplant recipients with alcoholic (ALD) and nonalcoholic liver disease (non-ALD). MEDLINE, EMBASE, and bibliographic searches identified 5,505 potentially relevant articles published between January 1966 and October 1998. Eighty-two studies reporting data on 5,020 transplant recipients met our inclusion criteria. Pre-orthotopic liver transplantation (OLT), 29% of transplant recipients with ALD and 59% of those with non-ALD worked versus 33% and 80% at 3 years for transplant recipients with ALD and non-ALD, respectively (P <.00001 for each interval). We found no difference in the proportion of transplant recipients with ALD and non-ALD reporting early alcohol use post-OLT: 4% versus 5% at 6 months and 17% versus 16% at 12 months. However, among post-OLT drinkers, transplant recipients with non-ALD were more likely to drink moderately and those with ALD to drink excessively. At 7 years post-OLT, 32% of the patients with ALD reported using alcohol. The odds ratio for alcohol use among patients who maintained abstinence for fewer than 6 months pre-OLT versus those who maintained abstinence for greater than 6 months was 7.8 (95% confidence interval, 4.0 to 15.3). Before OLT and at long-term follow-up, substantially more transplant recipients with non-ALD than ALD were employed. The proportions of transplant recipients with ALD and non-ALD reporting alcohol use did not differ, although those with ALD tended to consume greater quantities.

  View details for DOI 10.1053/jlts.2001.22326

  View details for Web of Science ID 000167424900005

  View details for PubMedID 11244159

• Accuracy of positron emission tomography for diagnosis of pulmonary nodules and mass lesions - A meta-analysis JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gould, M. K., Maclean, C. C., Kuschner, W. G., Rydzak, C. E., Owens, D. K. 2001; 285 (7): 914-924

  Abstract

  Focal pulmonary lesions are commonly encountered in clinical practice, and positron emission tomography (PET) with the glucose analog 18-fluorodeoxyglucose (FDG) may be an accurate test for identifying malignant lesions.To estimate the diagnostic accuracy of FDG-PET for malignant focal pulmonary lesions.Studies published between January 1966 and September 2000 in the MEDLINE and CANCERLIT databases; reference lists of identified studies; abstracts from recent conference proceedings; and direct contact with investigators.Studies that examined FDG-PET or FDG with a modified gamma camera in coincidence mode for diagnosis of focal pulmonary lesions; enrolled at least 10 participants with pulmonary nodules or masses, including at least 5 participants with malignant lesions; and presented sufficient data to permit calculation of sensitivity and specificity were included in the analysis.Two reviewers independently assessed study quality and abstracted data regarding prevalence of malignancy and sensitivity and specificity of the imaging test. Disagreements were resolved by discussion.We used a meta-analytic method to construct summary receiver operating characteristic curves. Forty studies met inclusion criteria. Study methodological quality was fair. Sample sizes were small and blinding was often incomplete. For 1474 focal pulmonary lesions of any size, the maximum joint sensitivity and specificity (the upper left point on the receiver operating characteristic curve at which sensitivity and specificity are equal) of FDG-PET was 91.2% (95% confidence interval, 89.1%-92.9%). In current practice, FDG-PET operates at a point on the summary receiver operating characteristic curve that corresponds approximately to a sensitivity and specificity of 96.8% and 77.8%, respectively. There was no difference in diagnostic accuracy for pulmonary nodules compared with lesions of any size (P =.43), for semiquantitative methods of image interpretation compared with qualitative methods (P =.52), or for FDG-PET compared with FDG imaging with a modified gamma camera in coincidence mode (P =.19).Positron emission tomography with 18-fluorodeoxyglucose is an accurate noninvasive imaging test for diagnosis of pulmonary nodules and larger mass lesions, although few data exist for nodules smaller than 1 cm in diameter. In current practice, FDG-PET has high sensitivity and intermediate specificity for malignancy.

  View details for PubMedID 11180735

• Computer-based decision support: wishing on a star? Effective clinical practice : ECP Owens, D. K., Bravata, D. M. 2001; 4 (1): 34-38

  View details for PubMedID 11234184

• The cost effectiveness of voluntary prenatal and routine newborn HIV screening in the United States JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES Zaric, G. S., Bayoumi, A. M., Brandeau, M. L., Owens, D. K. 2000; 25 (5): 403-416

  Abstract

  To evaluate the cost effectiveness of voluntary prenatal and routine postnatal HIV screening in the cohort of pregnant women and newborns in the United States.Cost-effectiveness analysis. We developed a decision model to analyze the cost effectiveness of enhanced prenatal screening and routine newborn screening for HIV. We also analyzed the incremental cost effectiveness of routine newborn screening when improved voluntary prenatal screening is already in place.Analysis of the cohort of pregnant women and newborns in the United States.Enhanced prenatal screening, or routine newborn screening for HIV.Infections averted, life expectancy, costs, and incremental cost effectiveness.Improved participation in voluntary prenatal HIV screening would result in an additional 1.1 million women being screened annually, would identify an additional 527 HIV-infected mothers annually, would avert 150 infections in newborns, and would cost $8,900 U.S. per life-year gained. Routine newborn HIV screening would test 3.9 million infants annually, would identify 1061 HIV-infected mothers, would avert 266 infections in newborns, and would cost $7,000 U.S. per life-year gained. If improved voluntary prenatal screening is already in place, routine newborn screening would avert an additional 135 infections in newborns, at an incremental cost of $10, 600 U.S. per life-year gained. The screening programs are likely to be cost effective over a wide range of assumptions regarding key factors in the analysis.Improved voluntary prenatal HIV screening of women and routine screening of newborns are cost effective. Routine newborn screening becomes less attractive as the rate of voluntary prenatal screening increases. Improved participation in voluntary prenatal screening has the added benefit that mothers maintain their right to determine whether they are tested for HIV.

  View details for Web of Science ID 000166017000004

  View details for PubMedID 11141240

• Cost-effectiveness of radiofrequency ablation for supraventricular tachycardia ANNALS OF INTERNAL MEDICINE Cheng, C. H., Sanders, G. D., Hlatky, M. A., Heidenreich, P., McDonald, K. M., Lee, B. K., Larson, M. S., Owens, D. K. 2000; 133 (11): 864-876

  Abstract

  Radiofrequency ablation is an established but expensive treatment option for many forms of supraventricular tachycardia. Most cases of supraventricular tachycardia are not life-threatening; the goal of therapy is therefore to improve the patient's quality of life.To compare the cost-effectiveness of radiofrequency ablation with that of medical management of supraventricular tachycardia.Markov model.Costs were estimated from a major academic hospital and the literature, and treatment efficacy was estimated from reports from clinical studies at major medical centers. Probabilities of clinical outcomes were estimated from the literature. To account for the effect of radiofrequency ablation on quality of life, assessments by patients who had undergone the procedure were used.Cohort of symptomatic patients who experienced 4.6 unscheduled visits per year to an emergency department or a physician's office while receiving long-term drug therapy for supraventricular tachycardia.Patient lifetime.Societal.Initial radiofrequency ablation, long-term antiarrhythmic drug therapy, and treatment of acute episodes of arrhythmia with antiarrhythmic drugs.Costs, quality-adjusted life-years, life-years, and marginal cost-effectiveness ratios.Among patients who have monthly episodes of supraventricular tachycardia, radiofrequency ablation was the most effective and least expensive therapy and therefore dominated the drug therapy options. Radiofrequency ablation improved quality-adjusted life expectancy by 3.10 quality-adjusted life-years and reduced lifetime medical expenditures by $27 900 compared with long-term drug therapy. Long-term drug therapy was more effective and had lower costs than episodic drug therapy.The findings were highly robust over substantial variations in assumptions about the efficacy and complication rate of radiofrequency ablation, including analyses in which the complication rate was tripled and efficacy was decreased substantially.Radiofrequency ablation substantially improves quality of life and reduces costs when it is used to treat highly symptomatic patients. Although the benefit of radiofrequency ablation has not been studied in less symptomatic patients, a small improvement in quality of life is sufficient to give preference to radiofrequency ablation over drug therapy.

  View details for PubMedID 11103056

• Electronic trial banks: a complementary method for reporting randomized trials. Medical decision making Sim, I., Owens, D. K., Lavori, P. W., Rennels, G. D. 2000; 20 (4): 440-450

  Abstract

  Randomized clinical trial (RCT) results are often difficult to find, interpret, or apply to clinical care. The authors propose that RCTs be reported into electronic knowledge bases-trial banks-in addition to being reported in text. What information should these trial-bank reports contain?Using the competency decomposition method, the authors specified the ideal trial-bank contents as the information necessary and sufficient for completing the task of systematic reviewing.They decomposed the systematic reviewing task into four top-level tasks and 62 subtasks. 162 types of trial information were necessary and sufficient for completing these subtasks. These items relate to a trial's design, execution, administration, and results.Trial-bank publishing of these 162 items would capture into computer-understandable form all the trial information needed for critically appraising and synthesizing trial results. Decision-support systems that access shared, up-to-date trial banks could help clinicians manage, synthesize, and apply RCT evidence more effectively.

  View details for PubMedID 11059477

• A complementary method far reporting randomized trials MEDICAL DECISION MAKING Sim, I., Owens, D. K., Lavori, P. W., Rennels, G. D. 2000; 20 (4): 440-450

  Abstract

  Randomized clinical trial (RCT) results are often difficult to find, interpret, or apply to clinical care. The authors propose that RCTs be reported into electronic knowledge bases-trial banks-in addition to being reported in text. What information should these trial-bank reports contain?Using the competency decomposition method, the authors specified the ideal trial-bank contents as the information necessary and sufficient for completing the task of systematic reviewing.They decomposed the systematic reviewing task into four top-level tasks and 62 subtasks. 162 types of trial information were necessary and sufficient for completing these subtasks. These items relate to a trial's design, execution, administration, and results.Trial-bank publishing of these 162 items would capture into computer-understandable form all the trial information needed for critically appraising and synthesizing trial results. Decision-support systems that access shared, up-to-date trial banks could help clinicians manage, synthesize, and apply RCT evidence more effectively.

  View details for Web of Science ID 000089886800008

• Projected long-term costs of coronary stenting in multivessel coronary disease based on the experience of the Bypass Angioplasty Revascularisation Investigation (BARI) AMERICAN HEART JOURNAL Yock, C. A., Boothroyd, D. B., Owens, D. K., Winston, C., Hlatky, M. A. 2000; 140 (4): 556-564

  Abstract

  Stents are now used in the majority of percutaneous coronary revascularization procedures. It is not clear whether the higher initial cost of stenting is later repaid by reducing costly complications and repeat revascularization procedures, especially for patients with multivessel disease.To project the long-term costs of using coronary stents, angioplasty, or bypass surgery to treat patients with multivessel coronary artery disease, we developed a decision model based on the outcomes documented in the Bypass Angioplasty Revascularization Investigation (BARI) randomized trial of coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). We studied 2 clinical strategies: provisional stenting of suboptimal PTCA results and primary stenting of all angiographically eligible lesions. The cost of CABG was also updated to reflect contemporary practice.Provisional stenting had lower projected costs over a 4-year period than either traditional PTCA (-$1742, or -3.4%) or contemporary CABG (-$832, or -1.7%), mostly because of reductions in emergency CABG after PTCA. In contrast, primary stenting had higher projected costs over a 4-year period than either PTCA (+$333, or +0. 7%) or contemporary CABG (+$1243, or +2.5%), mainly because of the higher initial procedure costs. These results were not substantially altered when we systematically varied the key parameters of the models in 1-way and 2-way sensitivity analyses.A primary stenting strategy in patients with multivessel disease has higher projected long-term costs than CABG. In contrast, a provisional stenting strategy in multivessel disease has lower projected costs than either PTCA or CABG.

  View details for DOI 10.1067/mhj.2000.109915

  View details for PubMedID 11011328

• Effect and outcomes of the ASGE guidelines on the periendoscopic management of patients who take anticoagulants AMERICAN JOURNAL OF GASTROENTEROLOGY Gerson, L. B., Gage, B. F., Owens, D. K., Triadafilopoulos, G. 2000; 95 (7): 1717-1724

  Abstract

  In December 1997, the American Society of Gastrointestinal Endoscopy (ASGE) issued guidelines regarding periendoscopic management of patients who take anticoagulants. They recommended that physicians substitute heparin for warfarin in their patients who have highly thrombotic conditions (e.g., a mechanical valve in the mitral position), and who will undergo high-risk procedures (e.g., polypectomy). The purpose of this study was to assess whether patient outcomes and anticoagulant management changed after the publication of the 1997 guidelines.We collected utilization data on all 104 patients at the Veterans Affairs Palo Alto Health Care System who were taking chronic warfarin therapy and who underwent endoscopic procedures during the study period (1996-1999). These patients underwent 99 colonoscopies, 63 upper endoscopies, and nine endoscopic retrograde cholangiopancreatographies. According to the ASGE guidelines, 18 of these patients had highly thrombotic conditions, whereas the remaining 86 patients had relatively low thrombotic conditions. We calculated their costs for intravenous or subcutaneous heparin therapy from the perspective of society. We followed-up all patients for 3 months, to determine the incidence of thrombotic and hemorrhagic outcomes.No patient suffered a thromboembolism or a hemorrhage; thus, the adverse-event rate (95% confidence interval) was 0% (0-3%). As recommended by the ASGE guidelines, all five (100%) patients who had highly thrombotic conditions had heparin substituted for warfarin before undergoing high-risk procedures. This strategy was also followed in 44 (27%) of the 166 procedures in other patients: 16 high-risk procedures in low-risk patients, and 28 low-risk procedures (in 20 low-thrombotic patients and in eight high-thrombotic patients). There was no significant difference between the management of any patients before and after the publication of the guidelines. The average cost per course of heparin therapy (typically 2 days intravenous heparin preprocedure, and 3 days heparin administered subcutaneously postendoscopy) was $1684. In all, 44 (90%) of 49 courses of heparin substituted for warfarin therapy were not recommended by the guidelines.Patients treated by the ASGE guidelines had the same 0% rate of thrombosis as patients who received periendoscopic heparin outside of the guidelines. Following the ASGE guidelines in all patients would have reduced the use of heparin therapy by 90%, for a net savings of $74,100.

  View details for PubMedID 10925974

• Quality enhancement research initiative for human immunodeficiency virus/acquired immunodeficiency syndrome - Framework and plan MEDICAL CARE Bozzette, S. A., Phillips, B., Asch, S., Gifford, A. L., Lenert, L., Menke, T., ORTIZ, E., Owens, D., Deyton, L. 2000; 38 (6): S60-S69

  View details for Web of Science ID 000087462300007

• Quality Enhancement Research Initiative for human immunodeficiency virus/acquired immunodeficiency syndrome: framework and plan. HIV-QUERI Executive Committee. Medical care Bozzette, S. A., Phillips, B., Asch, S., Gifford, A. L., Lenert, L., Menke, T., ORTIZ, E., Owens, D., Deyton, L. 2000; 38 (6): I60-9

  Abstract

  The Veterans Health Administration (VHA) sees approximately equal to 17,000 human immunodeficiency virus (HIV)-infected patients each year, which makes it the largest provider of HIV care in the United States. HIV causes chronic progressive disease that leads to early death. Newer combination antiretro viral treatments are effective but expensive and difficult to use. The HIV Quality Enhancement Research Initiative (HIV-QUERI) uses the QUERI process to identify high-risk and high-volume populations (step 1), which includes those already under VHA care for HIV, those who do not know of their infection, and those at risk for HIV. In identifying best practices (step 2), the HIV-QUERI will benefit greatly from existing guidelines for the care of established HIV infection, but gaps in knowledge regarding adherence to medication regimens and cost-effective screening are large. To identify existing practice patterns (step 3), the HIV-QUERI will develop a clean analytic data set based on Immunology Case Registry files and expand it through a survey of veterans. Interventions to improve care (step 4) will include national, regional, and site-specific feedback on performance relative to quality standards, as well as patient-level and provider-level interventions to improve adherence and support medical decision-making. To document that best practices improve outcomes and quality of life (steps 5 and 6), HIV-QUERI will track indicators on an ongoing basis by use of the Immunology Case Registry database and possible future waves of the survey. In addition, we will require that these issues be addressed in evaluations of HIV-QUERI interventions. In the present article, we present these steps within a framework and plan.

  View details for PubMedID 10843271

• A dynamic transmission model for predicting trends in Helicobacter pylori and associated diseases in the United States EMERGING INFECTIOUS DISEASES Rupnow, M. F., Shachter, R. D., Owens, D. K., Parsonnet, J. 2000; 6 (3): 228-237

  Abstract

  To assess the benefits of intervention programs against Helicobacter pylori infection, we estimated the baseline curves of its incidence and prevalence. We developed a mathematical (compartmental) model of the intrinsic dynamics of H. pylori, which represents the natural history of infection and disease progression. Our model divided the population according to age, infection status, and clinical state. Case-patients were followed from birth to death. A proportion of the population acquired H. pylori infection and became ill with gastritis, duodenal ulcer, chronic atrophic gastritis, or gastric cancer. We simulated the change in transmissibility consistent with the incidence of gastric cancer and duodenal ulcer over time, as well as current H. pylori prevalence. In the United States, transmissibility of H. pylori has decreased to values so low that, should this trend continue, the organism will disappear from the population without targeted intervention; this process, however, will take more than a century.

  View details for PubMedID 10827112

• Quality of life, work and alcohol use after liver transplantation. Bravata, D. M., Olkin, I., Barnato, A. E., Keeffe, E. B., Owens, D. K. BLACKWELL SCIENCE INC. 2000: 55–55

  View details for Web of Science ID 000086690400139

• Design and pilot evaluation of a system to develop computer-based site-specific practice guidelines from decision models 20th Annual Conference of the Society-for-Medical-Decision-Making Sanders, G. D., Nease, R. F., Owens, D. K. SAGE PUBLICATIONS INC. 2000: 145–59

  Abstract

  Local tailoring of clinical practice guidelines (CPGs) requires experts in medicine and evidence synthesis unavailable in many practice settings. The authors' computer-based system enables developers and users to create, disseminate, and tailor CPGs, using normative decision models (DMs).ALCHEMIST, a web-based system, analyzes a DM, creates a CPG in the form of an annotated algorithm, and displays for the guideline user the optimal strategy. ALCHEMIST'S interface enables remote users to tailor the guideline by changing underlying input variables and observing the new annotated algorithm that is developed automatically. In a pilot evaluation of the system, a DM was used to evaluate strategies for staging non-small-cell lung cancer. Subjects (n = 15) compared the automatically created CPG with published guidelines for this staging and critiqued both using a previously developed instrument to rate the CPGs' usability, accountability, and accuracy on a scale of 0 (worst) to 2 (best), with higher scores reflecting higher quality.The mean overall score for the ALCHEMIST CPG was 1.502, compared with the published-CPG score of 0.987 (p = 0.002). The ALCHEMIST CPG scores for usability, accountability, and accuracy were 1.683, 1.393, and 1.430, respectively; the published CPG scores were 1.192, 0.941, and 0.830 (each comparison p < 0.05). On a scale of 1 (worst) to 5 (best), users' mean ratings of ALCHEMIST'S ease of use, usefulness of content, and presentation format were 4.76, 3.98, and 4.64, respectively.The results demonstrate the feasibility of a web-based system that automatically analyzes a DM and creates a CPG as an annotated algorithm, enabling remote users to develop site-specific CPGs. In the pilot evaluation, the ALCHEMIST guidelines met established criteria for quality and compared favorably with national CPGs. The high usability and usefulness ratings suggest that such systems can be a good tool for guideline development.

  View details for PubMedID 10772353

• Serum des-gamma-carboxyprothrombin for the screening of hepatocellular carcinoma in cirrhotic patients: A meta-analysis Lin, O. S., Gerson, L. B., Keeffe, E. B., Owens, D. K. W B SAUNDERS CO-ELSEVIER INC. 2000: A262–A262

  View details for Web of Science ID 000086783701055

• Should survivors of myocardial infarction be screened for risk of sudden death? A cost-effectiveness analysis Heidenreich, P. A., Sanders, G. D., Hlatky, M. A., McDonald, K. M., Owens, D. K. ELSEVIER SCIENCE INC. 2000: 550A–551A

  View details for Web of Science ID 000085209702088

• Response: does the emperor have clothes? The Pharos of Alpha Omega Alpha-Honor Medical Society. Alpha Omega Alpha Owens, D. K. 2000; 63 (1): 29-30

  View details for PubMedID 10752351

• Publishing web-based guidelines using interactive decision models Sanders, G. D., Nease, R. F., Owens, D. K. HANLEY & BELFUS INC. 2000: 1129–1129

  View details for Web of Science ID 000170207500380

• Cost-effectiveness of the pneumococcal vaccine in the United States Navy and Marine Corps CLINICAL INFECTIOUS DISEASES Pepper, P. V., Owens, D. K. 2000; 30 (1): 157-164

  Abstract

  Vaccination for Streptococcus pneumoniae has been recommended for its efficacy and cost-effectiveness in elderly and immunocompromised populations. However, its use in active-duty military personnel has not been analyzed. We developed a Markov model to evaluate health and economic outcomes of vaccinating or not vaccinating all members of the active-duty cohort, measuring quality-adjusted life years (QALYs) gained, costs, and marginal cost-effectiveness. Pneumococcal pneumonia vaccination increased each person's life expectancy by 0. 03 days and decreased costs by $9.88 per person. The magnitude of the benefit of immunization is moderately sensitive to the rate of serious side effects caused by the vaccine, the incidence of pneumonia, the length of protection, and the efficacy of the vaccine. Vaccinating all 575,000 active-duty US Navy and Marine Corps members could save $5.7 million during the time the members are alive and on active duty and could provide a total gain of 54 QALYs. On the basis of these results, the military should consider expanding current guidelines to include pneumococcal vaccine immunization for all active-duty members of the military.

  View details for Web of Science ID 000085004800024

  View details for PubMedID 10619745

• Helicobacter pylori vaccine development and use: A cost-effectiveness analysis using the institute of medicine methodology HELICOBACTER Rupnow, M. F., Owens, D. K., Shachter, R., Parsonnet, J. 1999; 4 (4): 272-280

  Abstract

  Prophylactic vaccination has been suggested as a better strategy than antibiotics to control Helicobacter pylori infection. We evaluated the cost-effectiveness (CE) of H. pylori vaccine development and use in the United States and developing countries, using a method developed by the Institute of Medicine (IOM).The IOM model includes costs of vaccine development, vaccination program, and averted medical treatments; morbidity and mortality prevented; expected efficacy and use; and proportion of disease that is vaccine-preventable. The model employs infant mortality equivalence (IME) to estimate disease burden; with IME, the societal cost of infection-related morbidity is expressed as equivalent to a specific rate of infant deaths. We tested model assumptions by univariate sensitivity analyses.In the United States, H. pylori vaccine would save 1,176 IME and would cost $58.71 million (1997 dollars) annually, yielding a CE ratio of $49,932 per IME; the health benefits would exceed all IOM-studied vaccines, even when efficacy dropped to 55%. H. pylori vaccine could be cost-saving if priced at less than $60 per course. In developing countries, H. pylori vaccine would rank unfavorably both in terms of health benefits (33,518 IME) and costs ($5,254 million). None of the changes in assumptions improved significantly the H. pylori vaccine's ranking relative to other IOM-studied vaccines.Compared to other vaccines evaluated in the IOM study, H. pylori vaccine warrants public resource allocation for accelerated development and use in the United States but not for use in developing countries.

  View details for PubMedID 10597398

• Echocardiography in patients with suspected endocarditis: A cost-effectiveness analysis AMERICAN JOURNAL OF MEDICINE Heidenreich, P. A., Masoudi, F. A., Maini, B., Chou, T. M., Foster, E., Schiller, N. B., Owens, D. K. 1999; 107 (3): 198-208

  Abstract

  We sought to determine the appropriate use of echocardiography for patients with suspected endocarditis.We constructed a decision tree and Markov model using published data to simulate the outcomes and costs of care for patients with suspected endocarditis.Transesophageal imaging was optimal for patients who had a prior probability of endocarditis that is observed commonly in clinical practice (4% to 60%). In our base-case analysis (a 45-year-old man with a prior probability of endocarditis of 20%), use of transesophageal imaging improved quality-adjusted life expectancy (QALYs) by 9 days and reduced costs by $18 per person compared with the use of transthoracic echocardiography. Sequential test strategies that reserved the use of transesophageal echocardiography for patients who had an inadequate transthoracic study provided similar QALYs compared with the use of transesophageal echocardiography alone, but cost $230 to $250 more. For patients with prior probabilities of endocarditis greater than 60%, the optimal strategy is to treat for endocarditis without reliance on echocardiography for diagnosis. Patients with a prior probability of less than 2% should receive treatment for bacteremia without imaging. Transthoracic imaging was optimal for only a narrow range of prior probabilities (2% or 3%) of endocarditis.The appropriate use of echocardiography depends on the prior probability of endocarditis. For patients whose prior probability of endocarditis is 4% to 60%, initial use of transesophageal echocardiography provides the greatest quality-adjusted survival at a cost that is within the range for commonly accepted health interventions.

  View details for Web of Science ID 000082557100003

  View details for PubMedID 10492311

• Health-related quality of life after liver transplantation: A meta-analysis LIVER TRANSPLANTATION AND SURGERY Bravata, D. M., Olkin, I., Barnato, A. E., Keeffe, E. B., Owens, D. K. 1999; 5 (4): 318-331

  Abstract

  The goal of this study is to assess health-related quality of life (HRQL) after orthotopic liver transplantation (OLT). Structured MEDLINE and Embase literature searches identified 5473 potentially relevant articles. Thirty-two additional references were collected from the bibliographies. Of the 5505 identified articles, 49 studies reporting data on 3576 transplant recipients met our inclusion criteria, which were an assessment of quality of life (QOL) in adult patients reported as either pretransplantation and posttransplantation data or with a comparison group and written in English. We combined posttransplantation QOL scores from 15 studies that reported data from the same QOL scales to assess the magnitude of the effect of OLT on QOL scales. We also performed a sign test on the 49 studies to evaluate the direction (positive or negative) of the effect of transplantation on QOL. Transplantation resulted in an improvement of 32% in Karnofsky scores, 11% in Sickness Impact Profile scores, and 20% to 50% in the domains of the Nottingham Health Profile. The sign test showed significant improvement in posttransplantation physical health (P <.0004), sexual functioning (P <.008), daily activities (P <.02), general HRQL (P <.02), and social functioning (P <.05), but not psychological health (P <.08). In general, the HRQL of the 3576 patients was impaired pretransplantation and improved posttransplantation. Transplant recipients reported large gains in those aspects of QOL most affected by physical health and smaller improvements in areas affected by psychological functioning.

  View details for Web of Science ID 000081427900008

  View details for PubMedID 10388505

• Helicobacter pylori and gastric cancer: What are the benefits of screening only for the CagA phenotype of H. pylori? HELICOBACTER Harris, R. A., Owens, D. K., Witherell, H., Parsonnet, J. 1999; 4 (2): 69-76

  Abstract

  Strains of Helicobacter pylori that express the CagA protein are associated with a threefold increased gastric cancer risk as compared to H. pylori strains that do not express CagA. Screening and treatment only for CagA antibodies should target those individuals at highest gastric cancer risk while reducing the number of patients requiring antibiotics. We compared the costs and benefits of screening asymptomatic 50-year-old individuals for CagA, screening for all H. pylori strains, and no screening, both in the United States and abroad.We employed Markov cost-effectiveness analysis using data from randomized, case-control, and cohort studies.In the United States, CagA screening would result in 1.5 million fewer antibiotic treatments but would prevent 1,400 fewer gastric cancers than would screening for all H. pylori. The incremental cost-effectiveness of CagA screening is $23,900 per life-year gained; for H. pylori screening, it is $25,100. Screening in countries with epidemiological characteristics similar to those of Colombia, Finland, and Japan costs less than $5,000 per life-year gained, and the difference between CagA and H. pylori screening is smaller than that in the United States.Screening only for CagA-positive H. pylori is not substantially better than is screening for all H. pylori, either in the United States nor abroad. Screening is substantially more cost-effective outside the United States. Whether population screening is justified, however, is uncertain pending conclusive data regarding the reduction in gastric cancer risk from antibiotics.

  View details for PubMedID 10382118

• Predicting the next century of H-pylori prevalence and associated diseases in the United States Tsugawa, M. F., Shachter, R., Owens, D. K., Parsonnet, J. W B SAUNDERS CO-ELSEVIER INC. 1999: A339–A339

  View details for Web of Science ID 000079778401483

• Distributed decision support using a Web-based interface: Prevention of sudden cardiac death 19th Annual Meeting of the Society-for-Medical-Decision-Making Sanders, G. D., Hagerty, C. G., Sonnenberg, F. A., Hlatky, M. A., Owens, D. K. SAGE PUBLICATIONS INC. 1999: 157–66

  Abstract

  Although decision models can provide a formal foundation for guideline development and clinical decision support, their widespread use is often limited by the lack of platform-independent software that geographically dispersed users can access and use easily without extensive training. To address these limitations the authors developed a World Wide Web-based interface for previously developed decision models. They describe the use and functionality of the interface using a decision model that evaluates the cost-effectiveness of strategies for preventing sudden cardiac death. The system allows an analyst to use a web browser to interact with the decision model and to change the values of input variables within pre-specified ranges, to specify sensitivity or threshold analyses, to evaluate the decision model, and to view the results generated dynamically. The web site also provides linkages to an explanation of the model, and evidence tables for input variables. The system demonstrates a method for providing distributed decision support to remote users such as guideline developers, decision analysts, and potentially practicing physicians. The web interface provides platform-independent and almost universal access to a decision model. This approach can make distributed decision support both practical and economical, and has the potential to increase the usefulness of decision models by enabling a broader audience to incorporate systematic analyses into both policy and clinical decisions.

  View details for PubMedID 10231078

• Management of patients on anticoagulants prior to endoscopy Gerson, L. B., Gage, B. F., Owens, D. K., Triadafilopoulos, G. MOSBY-ELSEVIER. 1999: AB142–AB142

  View details for Web of Science ID 000079848100352

• Learning about H-pylori transmission dynamics from the distinct patterns of duodenal ulcer and gastric cancer Tsugawa, M. F., Shachter, R., Owens, D. K., Parsonnet, J. W B SAUNDERS CO-ELSEVIER INC. 1999: A338–A338

  View details for Web of Science ID 000079778401482

• An analysis of optimal resource allocation for prevention of infection with human immunodeficiency virus (HIV) in injection drug users and non-users MEDICAL DECISION MAKING Richter, A., Brandeau, M. L., Owens, D. K. 1999; 19 (2): 167-179

  Abstract

  Millions of dollars are spent annually to prevent infection with human immunodeficiency virus (HIV) without a thorough understanding of the most effective way to allocate these resources. The authors' objective was to determine the allocation of new resources among prevention programs targeted to a population of injection drug users (IDUs) and a population of non-injection drug users (non-IDUs) that would minimize the total number of incident cases of HIV infection over a given time horizon. They developed a dynamic model of HIV transmission in IDUs and non-IDUs and estimated the relationship between prevention program expenditures and reductions in HIV transmission. They evaluated three prevention programs: HIV testing with routine counseling, HIV testing with intensive counseling, and HIV testing and counseling linked to methadone maintenance programs. They modeled a low-risk IDU population (5% HIV prevalence) and a moderate-risk IDU population (10% HIV prevalence). For different available budgets, they determined the allocation of resources among the prevention programs and populations that would minimize the number of new cases of HIV infection over a five-year period, as well as the incremental value of additional prevention funds. The study framework provides a quantitative, systematic approach to funding programs to prevent HIV infection that accounts for HIV transmission dynamics, population size, and the costs and effectiveness of the interventions in reducing HIV transmission. The approach is general and can be used to evaluate a broader group of prevention programs and risk populations. This framework thus could enable policy makers and clinicians to identify a portfolio of programs that provide, collectively, the most benefit for a given budget.

  View details for Web of Science ID 000079539000007

  View details for PubMedID 10231079

• Evaluation of genetic tests: APOE genotyping for the diagnosis of Alzheimer disease 49th Annual Meeting of the American-Society-of-Human-Genetics McConnell, L. M., Sanders, G. D., Owens, D. K. MARY ANN LIEBERT INC. 1999: 47–53

  Abstract

  Many studies have now confirmed the association between inheritance of the epsilon 4 allele of the apolipoprotein E (APOE) gene and Alzheimer disease (AD). However, although the medical community holds the near-unanimous opinion that APOE genotyping should not be used for prediction in asymptomatic individuals, controversy remains about whether it should be used for diagnosis in patients who show signs of dementia. We assessed critically the recent clinical studies, on the basis of four criteria recommended to ensure safety and effectiveness of genetic tests. We also developed a formal framework for evaluating the usefulness of APOE genotyping using decision-theoretic principles. We conclude that neither the presence nor absence of an epsilon 4 allele provides diagnostic certainty, and the proper interpretation of either result in heterogeneous populations requires further investigation. The appropriate role of APOE genotyping among elements of a traditional assessment for AD has not been determined. Whether APOE genotyping provides sufficient information to change patient management decisions has not been determined. APOE genotyping presents foreseeable, significant psychosocial consequences for family members that must be weighed against any psychosocial benefits. Therefore, the diagnostic use of APOE genotyping outside research settings is premature until such testing is shown to be of practical value.

  View details for Web of Science ID 000087218200007

  View details for PubMedID 10464577

• Design and implementation of a computer-based system to annotate decision models for use in guideline development Sanders, G. D., Nease, R. F., Owens, D. K. SAGE PUBLICATIONS INC. 1998: 469–69

  View details for Web of Science ID 000076422700100

• Development and pilot evaluation of automated computer-based creation of site-specific clinical-practice guidelines from decision models Sanders, G. D., Nease, R. F., Owens, D. K. SAGE PUBLICATIONS INC. 1998: 462–62

  View details for Web of Science ID 000076422700056

• Interpretation of cost-effectiveness analyses JOURNAL OF GENERAL INTERNAL MEDICINE Owens, D. K. 1998; 13 (10): 716-717

  View details for Web of Science ID 000076451100012

  View details for PubMedID 9798822

  View details for PubMedCentralID PMC1497852

• Cost effectiveness of radiofrequency ablation for treatment of paroxysmal supraventricular tachycardias. Cheng, C. H., Sanders, G. D., Heidenreich, P. A., McDonald, K. M., Lee, B. K., Larson, M. S., Hlatky, M. A., Owens, D. K. SAGE PUBLICATIONS INC. 1998: 458–58

  View details for Web of Science ID 000076422700033

• Cost effectiveness of the pneumococcal vaccine in the healthy young adult population. Pepper, P. V., Owens, D. K. SAGE PUBLICATIONS INC. 1998: 471–71

  View details for Web of Science ID 000076422700114

• The effects of protease inhibitors on the spread of HIV and the development of drug-resistant HIV strains: A simulation study SIMULATION Zaric, G. S., Bayoumi, A. M., Brandeau, M. L., Owens, D. K. 1998; 71 (4): 262-275

  View details for Web of Science ID 000078219200006

• Selection of patients with atrial fibrillation for a trial of the implantable atrial defibrillator vs. amiodarone Gage, B. F., Woods, K., Weimer, C., Reuter, D., Owens, D. K. SAGE PUBLICATIONS INC. 1998: 486–86

  View details for Web of Science ID 000076422700199

• Population effects of preventive and therapeutic HIV vaccines in early- and late-stage epidemics AIDS Owens, D. K., Edwards, D. M., Shachter, R. D. 1998; 12 (9): 1057-1066

  Abstract

  To evaluate the population effects of potential preventive and therapeutic vaccines in early- and late-stage epidemics in a population of homosexual men.An epidemic model was used that simulated the course of the epidemic for a population of homosexual men in San Francisco, California. Vaccine programs were evaluated by the number of cases of HIV averted, the effect on the prevalence of HIV, and by the gain in quality-adjusted life years (QALY) for the total population.In the model, a preventive vaccine prevented 3877 cases of HIV infection during a 20-year period, reduced the projected prevalence of HIV infection from 12 to 7% in a late-stage epidemic, and gained 15,908 QALY. A therapeutic vaccine that did not affect the infectivity of vaccine recipients increased the number of cases of HIV infection by 210, resulted in a slight increase in the prevalence of HIV infection from 12 to 15% in a late-stage epidemic, and gained 8854 QALY. If therapeutic vaccines reduced infectivity, their use could produce net gains of QALY in the population that were similar to gains from the use of preventive vaccines. In an early-stage epidemic, the advantage of a preventive vaccine program relative to a therapeutic vaccine program was markedly enhanced.Both preventive and therapeutic vaccine programs provided substantial benefit, but their relative merit depended on which outcome measures were assessed. Evaluation of HIV vaccine programs based solely on cases averted or on prevalence of HIV in the population underestimates the benefit associated with therapeutic vaccine programs. The effect of a therapeutic HIV vaccine on the epidemic outcomes depended markedly on whether the therapeutic vaccine reduced the infectivity of the vaccine recipient. The relative merits of preventive and therapeutic vaccines depend on the stage of the epidemic. Field vaccine trials should evaluate correlates of infectivity, such as HIV viral load. HIV vaccine implementation strategies should be tailored to the dynamics of the epidemic in specific populations.

  View details for PubMedID 9662203

• Monitored isoniazid prophylaxis for low-risk tuberculin reactors - In response ANNALS OF INTERNAL MEDICINE Salpeter, S. R., Sanders, G. D., Owens, D. K. 1998; 128 (12): 1048-1048

  View details for Web of Science ID 000074201300022

• Cost-effectiveness of preference-based antithrombotic therapy for patients with nonvalvular atrial fibrillation STROKE Gage, B. F., Cardinalli, A. B., Owens, D. K. 1998; 29 (6): 1083-1091

  Abstract

  Recent atrial fibrillation guidelines recommend the incorporation of patient preferences into the selection of antithrombotic therapy. However, no trial has examined how incorporating such preferences would affect quality-adjusted survival or medical expenditure. We compared 10-year projections of quality-adjusted survival and medical expenditure associated with two atrial fibrillation treatment strategies: warfarin-for-all therapy versus preference-based therapy. The preference-based strategy prescribed whichever antithrombotic therapy, warfarin or aspirin, had the greater projected quality-adjusted survival.We used decision analysis stratified by the number of stroke risk factors (history of stroke, transient ischemic attack, hypertension, diabetes, or heart disease). The base case focused on compliant 65-year-old patients who had nonvalvular atrial fibrillation and no contraindications to antithrombotic therapy.In patients whose only risk factor for stroke was atrial fibrillation, preference-based therapy improved projected quality-adjusted survival by 0.05 quality-adjusted life year (QALY) and saved $670. For patients who had atrial fibrillation and one additional risk factor for stroke, preference-based therapy improved quality-adjusted survival by 0.02 QALY and saved $90. In patients who had atrial fibrillation and multiple additional risk factors for stroke, preference-based therapy increased medical expenditures and did not improve quality-adjusted survival substantially. The benefits of preference-flexible therapy arose from the minority of patients who would have had a longer quality-adjusted survival if they had been prescribed aspirin rather than warfarin.As do risks of stroke and of hemorrhage, patients' preferences help to determine which antithrombotic therapy is optimal. Preference-based treatment should improve quality-adjusted survival and reduce medical expenditure in patients who have nonvalvular atrial fibrillation and not more than one additional risk factor for stroke.

  View details for Web of Science ID 000073979900001

  View details for PubMedID 9626276

• Cost-effectiveness of tests to assess the risk of sudden death after acute myocardial infarction JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY Hlatky, M. A., Owens, D. K. 1998; 31 (7): 1490-1492

  View details for Web of Science ID 000073982100006

  View details for PubMedID 9626824

• Patient preferences and the development of practice guidelines SPINE Owens, D. K. 1998; 23 (9): 1073-1079

  Abstract

  One shortcoming of clinical practice guidelines is that generic, one-for-all guideline recommendations do not account for differences among patients' views about the desirability (or undesirability) of specific health outcomes, such as low back pain. Because differences in patients' preferences may lead to differences in the preferred therapy, a clinical practice guideline that does not consider patients' preferences may provide recommendations that are not optimal. Recently developed methodologic approaches enable guideline developers to assess the role of patients' preferences in clinical decisions and guideline recommendations, and to develop preference-based guidelines. Preference-based guidelines are more likely to meet criteria for high-quality guidelines than are guidelines developed without consideration of the role of patients' preferences. Guideline developers should identify decisions in which patient preferences are important and note these decisions clearly in the written guideline; indicate the specific health states for which preferences are important; and, if possible, provide recommendations about options for preference assessment. These options range from informal discussions with patients to computer-based utility assessments. Patients' preferences are an important factor in clinical decisions regarding management of low-back pain, particularly in decisions about surgical management and symptom control. Although further research is needed to define the role of techniques for assessing patients' preferences in routine clinical practice, guideline developers can determine when patients' preferences should play a prominent role in guideline recommendations.

  View details for Web of Science ID 000073427000023

• A dynamic HIV-transmission model for evaluating the costs and benefits of vaccine programs INTERFACES Edwards, D. M., Shachter, R. D., Owens, D. K. 1998; 28 (3): 144-166

  View details for Web of Science ID 000075316200010

• Effect of relapse to high-risk behavior on the costs and benefits of a program to screen women for human immunodeficiency virus INTERFACES Owens, D. K., Brandeau, M. L., Sox, C. H. 1998; 28 (3): 52-74

  View details for Web of Science ID 000075316200005

• Cost-effectiveness of vaccine development for H-pylori using the Institute of Medicine (IOM) model. Tsugawa, M., Shachter, R., Owens, D. K., Parsonnet, J. W B SAUNDERS CO. 1998: A313

  View details for DOI 10.1016/S0016-5085(98)81269-9

  View details for Web of Science ID 000073089601269

• Use of medical informatics to implement and develop clinical practice guidelines WESTERN JOURNAL OF MEDICINE Owens, D. K. 1998; 168 (3): 166-175

  Abstract

  Clinical practice guidelines have enormous potential to improve the quality of and accountability in health care. Making the most of this potential should become easier as guideline developers integrate guidelines within information systems and electronic medical records. A major barrier to such integration is the lack of computing infrastructure in many clinical settings. To successfully implement guidelines in information systems, developers must create more specific recommendations than those that have been required for traditional guidelines. Using reusable software components to create guidelines can make the development of protocols faster and less expensive. In addition, using decision models to produce guidelines enables developers to structure guideline problems systematically, to prioritize information acquisition, to develop site-specific guidelines, and to evaluate the cost-effectiveness of the explicit incorporation of patient preferences into guideline recommendations. Ongoing research provides a foundation for the use of guideline development tools that can help developers tailor guidelines appropriately to their practice settings. This article explores how medical informatics can help clinicians find, use, and create practice guidelines.

  View details for PubMedID 9549415

• Design of a modular, extensible decision support system for arrhythmia therapy JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION Cheng, C. H., Sanders, G. D., McDonald, K. M., Heidenreich, P. A., Hlatky, M. A., Owens, D. K. 1998: 693-697

  Abstract

  We developed a decision-support system for evaluation of treatment alternatives for supraventricular and ventricular arrhythmias. The system uses independent decision models that evaluate the costs and benefits of treatment for recurrent atrioventricular-node reentrant tachycardia (AVNRT), and of therapies to prevent sudden cardiac death (SCD) in patients at risk for life-threatening ventricular arrhythmias. Each of the decision models is accessible through a web-based interface that enables remote users to browse the model's underlying evidence and to perform analyses of effectiveness, cost effectiveness, and sensitivity to input variables. Because the web-based interface is independent of the models, we can extend the functionality of the system by adding decision models. This system illustrates that the use of a library of web-accessible decision models provides decision support economically to widely dispersed users.

  View details for PubMedID 9929308

• In the eye of the beholder: Assessment of health-related quality of life HEPATOLOGY Owens, D. K. 1998; 27 (1): 292-293

  View details for Web of Science ID 000071240300043

  View details for PubMedID 9425950

• Simulating the effects of protease inhibitors on the HIV epidemic: Treatment, compliance, and drug resistance Medical Sciences Simulation Conference held at the 1998 Western MultiConference Zaric, G. S., Brandeau, M. L., Bayoumi, A. M., Owens, D. K. SOC MODELING SIMULATION INT-SCS. 1998: 65–72

  View details for Web of Science ID 000082161100011

• Defensive diagnostic testing - A case of stolen utility? MEDICAL DECISION MAKING Owens, D. K. 1998; 18 (1): 33-34

  View details for PubMedID 9456205

• Monitored isoniazid prophylaxis for low-risk tuberculin reactors older than 35 years of age: A risk-benefit and cost-effectiveness analysis ANNALS OF INTERNAL MEDICINE Salpeter, S. R., Sanders, G. D., Salpeter, E. E., Owens, D. K. 1997; 127 (12): 1051-1061

  Abstract

  Isoniazid chemoprophylaxis effectively prevents the development of active infectious tuberculosis. Current guidelines recommend withholding this prophylaxis for low-risk tuberculin reactors older than 35 years of age because of the risk for fatal isoniazid-induced hepatitis. However, recent studies have shown that monitoring for hepatotoxicity can significantly reduce the risk for isoniazid-related death.To evaluate the effectiveness and cost-effectiveness of monitored isoniazid prophylaxis for low-risk tuberculin reactors older than 35 years of age.A Markov model was used to compare the health and economic outcomes of prescribing or withholding a course of prophylaxis for low-risk reactors 35, 50, or 70 years of age. Subsequent analyses evaluated costs and benefits when the effect of transmission of Mycobacterium tuberculosis to contacts was included.Probability of survival at 1 year, number needed to treat, life expectancy, and cost per year of life gained for individual persons and total population.Isoniazid prophylaxis increased the probability of survival at 1 year and for all subsequent years. For 35-year old, 50-year-old, and 70-year-old tuberculin reactors, life expectancy increased by 4.9 days, 4.7 days, and 3.1 days, respectively, and costs per person decreased by $101, $69, and $11, respectively. When the effect of secondary transmission to contacts was included, the gains in life expectancy per person receiving prophylaxis were 10.0 days for 35-year-old reactors, 9.0 days for 50-year-old reactors, and 6.0 days for 70-year-old reactors. Costs per person for these cohorts decreased by $259, $203, and $100, respectively. The magnitude of the benefit of isoniazid prophylaxis is moderately sensitive to the effect of isoniazid on quality of life. The hypothetical provision of isoniazid prophylaxis for all low-risk reactors older than 35 years of age in the U.S. population could prevent 35,176 deaths and save $2.11 billion.Monitored isoniazid prophylaxis reduces mortality rates and health care costs for low-risk tuberculin reactors older than 35 years of age, although reductions for individual patients are small. For the U.S. population, however, the potential health benefits and economic savings resulting from wider use of monitored isoniazid prophylaxis are substantial. We should consider expanding current recommendations to include prophylaxis for tuberculin reactors of all ages with no contraindications.

  View details for Web of Science ID 000070936600001

  View details for PubMedID 9412307

• Use of faculty development to improve ambulatory-care education MEDICAL TEACHER Stratos, G. A., Bergen, M. R., Albright, C. L., Skeff, K. M., Owens, D. K. 1997; 19 (4): 285-292

  View details for Web of Science ID 000071407000008

• A normative analytic framework for development of practice guidelines for specific clinical populations MEDICAL DECISION MAKING Owens, D. K., Nease, R. F. 1997; 17 (4): 409-426

  Abstract

  A central problem in practice guideline development is how to develop guidelines that appropriately account for variations in clinical populations and practice settings. Despite recognition of this problem, there is no formal mechanism for assessing what the need is for flexibility in guidelines, or for deciding how to incorporate such flexibility into recommendations.This research sought to provide a formal basis to determine when clinical circumstances vary sufficiently that guideline recommendations should differ, how recommendations should be tailored for a specific clinical setting, and whether the benefit associated with such site-specific guidelines justifies the expense of their development.The authors describe an approach for estimating the maximum health benefit that developers can obtain by eliminating uncertainty about differences in the patient populations and practice settings in which a guideline will be used. This estimate, the expected value of customization, provides a mechanism to evaluate the cost-effectiveness of the development of site-specific guidelines that account explicitly for variation in clinical circumstances. Application of this method to the development of screening guidelines for human immunodeficiency virus (HIV) infection indicates that the development of site-specific guidelines potentially is cost-effective. Site-specific guidelines either improve, or leave unchanged, the efficiency of HIV screening; whether they increase or decrease total expenditures and health benefits depends on the choice of a cost-effectiveness threshold, and the clinical problem.Development of guideline recommendations based on decision models provides a normative approach for evaluating the need for and the cost-effectiveness of site-specific guidelines that have been tailored to specific practice settings. Such site-specific guidelines can improve substantially the expected health benefit and the economic efficiency of practice guidelines.

  View details for PubMedID 9343799

• Use of influence diagrams to structure medical decisions MEDICAL DECISION MAKING Nease, R. F., Owens, D. K. 1997; 17 (3): 263-275

  Abstract

  Influence diagrams are compact representations of decision problems that are mathematically equivalent to decision trees. The authors present five important principles for structuring a decision as an influence diagram: 1) start at the value node and work back to the decision nodes; 2) draw the arcs in the direction that makes the probabilities easiest to assess; 3) use informational arcs to specify which events will have been observed at the time each decision is made; 4) ensure that missing arcs reflect intentional assertions about conditional independence and the timing of observations; and 5) ensure that there are no cycles in the influence diagram. They then build an influence diagram for the problem of staging non-small-cell lung cancer as an illustration. Influence diagrams offer several strengths for structuring medical decisions. They represent graphically and compactly the probabilistic relationships between parameters in the model. Influence diagrams also allow the model to be structured in a fashion that eases the necessary probability assessments, regardless of whether the assessments are based on available evidence or on expert judgment. Influence diagrams provide an important complement to decision trees, especially for representing probabilistic relationships among variables in a decision model.

  View details for Web of Science ID A1997XG99200002

  View details for PubMedID 9219186

• Representation and analysis of medical decision problems with influence diagrams MEDICAL DECISION MAKING Owens, D. K., Shachter, R. D., Nease, R. F. 1997; 17 (3): 241-262

  Abstract

  Influence diagrams are a powerful graphic representation for decision models, complementary to decision trees. Influence diagrams and decision trees are different graphic representations for the same underlying mathematical model and operations. This article describes the elements of an influence diagram, and shows several familiar decision problems represented as decision trees and as influence diagrams. The authors also contrast the information highlighted in each graphic representation, demonstrate how to calculate the expected utilities of decision alternatives modeled with an influence diagram, provide an overview of the conceptual basis of the solution algorithms that have been developed for influence diagrams, discuss the strengths and limitations of influence diagrams relative to decision trees, and describe the mathematical operations that are used to evaluate both decision trees and influence diagrams. They use clinical examples to illustrate the mathematical operations of the influence-diagram-evaluation algorithm; these operations are arc reversal, chance node removal by averaging, and decision node removal by policy determination. Influence diagrams may be helpful when problems have a high degree of conditional independence, when large models are needed, when communication of the probabilistic relationships is important, or when the analysis requires extensive Bayesian updating. The choice of graphic representation should be governed by convenience, and will depend on the problem being analyzed, on the experience of the analyst, and on the background of the consumers of the analysis.

  View details for PubMedID 9219185

• Polymerase chain reaction for diagnosis of HIV infection - Response ANNALS OF INTERNAL MEDICINE Owens, D. K., Holodniy, M., Garber, A. M. 1997; 126 (9): 740-740

  View details for Web of Science ID A1997WW14700016

• Should we treat H. pylori infection to prevent gastric cancer? Gastroenterology Parsonnet, J., Harris, R. A., HACK, H. M., Owens, D. K. 1997; 112 (3): 1044-1045

  View details for PubMedID 9041272

• Cost-effectiveness of implantable cardioverter defibrillators relative to amiodarone for prevention of sudden cardiac death ANNALS OF INTERNAL MEDICINE Owens, D. K., Sanders, G. D., Harris, R. A., McDonald, K. M., Heidenreich, P. A., Dembitzer, A. D., Hlatky, M. A. 1997; 126 (1): 1-12

  Abstract

  Implantable cardioverter defibrillators (ICDs) are remarkably effective in terminating ventricular arrhythmias, but they are expensive and the extent to which they extend life is unknown. The marginal cost-effectiveness of ICDs relative to amiodarone has not been clearly established.To compare the cost-effectiveness of a third-generation implantable ICD with that of empirical amiodarone treatment for preventing sudden cardiac death in patients at high or intermediate risk.A Markov model was used to evaluate health and economic outcomes of patients who received an ICD, amiodarone, or a sequential regimen that reserved ICD for patients who had an arrhythmia during amiodarone treatment.Life-years gained, quality-adjusted life-years gained, costs, and marginal cost-effectiveness.For the base-case analysis, it was assumed that treatment with an ICD would reduce the total mortality rate by 20% to 40% at 1 year compared with amiodarone and that the ICD generator would be replaced every 4 years. In high-risk patients, if an ICD reduces total mortality by 20%, patients who receive an ICD live for 4.18 quality-adjusted life-years and have a lifetime expenditure of $88,400. Patients receiving amiodarone live for 3.68 quality-adjusted life-years and have a lifetime expenditure of $51,000. Marginal cost-effectiveness of an ICD relative to amiodarone is $74,400 per quality-adjusted life-year saved. If an ICD reduces mortality by 40%, the cost-effectiveness of ICD use is $37,300 per quality-adjusted life-year saved. Both choice of therapy (an ICD or amiodarone) and the cost-effectiveness ratio are sensitive to assumptions about quality of life.Use of an ICD will cost more than $50,000 per quality-adjusted life-year gained unless it reduces all-cause mortality by 30% or more relative to amiodarone. Current evidence does not definitively support or exclude a benefit of this magnitude, but ongoing randomized trials have sufficient statistical power to do so.

  View details for Web of Science ID A1997WA16500001

  View details for PubMedID 8992917

• Physicians' assessments of the utility of health states associated with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) infection QUALITY OF LIFE RESEARCH Owens, D. K., Cardinalli, A. B., Nease, R. F. 1997; 6 (1): 77-86

  Abstract

  An understanding of quality of life (QOL) with human immunodeficiency virus (HIV) is important because the merits of prevention and treatment alternatives may depend substantially on how these interventions affect QOL. Physicians' views about QOL are important, because they influence the therapeutic options that physicians consider or offer, the recommendations that physicians make, and because they are important for the analysis of certain policy questions. We assessed physicians' utilities of health states associated with HIV infection, and hepatitis B virus (HBV) infection; assessment of utilities for HBV was induced to provide a comparison with HIV utilities. We surveyed 200 housestaff and staff physicians in an academic medical centre by anonymous paper-based questionnaire and used the time-tradeoff method to assess physicians' utilities of the health states. On a scale in which 0 was equivalent to death, and 1 was equivalent to good health, the median utilities for asymptomatic HIV infection, symptomatic HIV infection, and AIDS were 0.833, 0.417, and 0.167, respectively (p < 0.01 or each two-way comparison). Median utilities for asymptomatic HBV infection, mildly symptomatic HBV infection, and severely symptomatic HBV infection were 0.917, 0.667, and 0.167, respectively (p < 0.01 for each two-way comparison). Although physicians varied substantially in the ratings of health states, they assessed the utility of life with HIV disease, including asymptomatic infection, as severely reduced. Studies of the effectiveness and cost-effectiveness of preventive and therapeutic interventions for HIV should evaluate the effect of the intervention on utility-based assessments of QOL. Studies that do not assess such effects may significantly underestimate or overestimate the value of these interventions, depending on the intervention's effect on QOL.

  View details for PubMedID 9062445

• The effect of stroke and stroke prophylaxis with aspirin or warfarin on quality of life ARCHIVES OF INTERNAL MEDICINE Gage, B. F., Cardinalli, A. B., Owens, D. K. 1996; 156 (16): 1829-1836

  Abstract

  Because most strokes cause neurological impairment rather than death, stroke prophylaxis may improve quality of life more than length of life. Thus, an understanding of how stroke and stroke prophylaxis affect quality of life is central to clinical decision making for many patients.We elicited quality-of-life estimates, known as utilities, for 3 degrees of severity of anticipated stroke-mild, moderate, and major- and for stroke prophylaxis with either warfarin sodium or aspirin therapy. We used the time tradeoff and standard gamble methods to elicit these utilities from 83 patients who had atrial fibrillation.Seventy patients completed the interview successfully. Their utilities for stroke ranged from worse than death (< 0) to as good as current health (1.0). The median utilities for mild, moderate, and major stroke were 0.94, 0.07, and 0.0, respectively. Although the median utilities decreased with increasing severity of stroke (P < .001), there was high interpatient variability within each degree of stroke severity. For example, 7 subjects (10%) rated a major stroke above 0.5, while 58 subjects (83%) rated it as equal to or worse than death. In contrast to the stroke utilities, the median utilities for warfarin and aspirin therapy were high-0.997 and 1.0, respectively. However, the interpatient variability for warfarin therapy was also important: 11 patients (16%) with atrial fibrillation rated the utility of warfarin therapy so low that their quality-adjusted life expectancy would be greater with aspirin.Patients' utilities for stroke prophylaxis and anticipated stroke vary substantially. Many patients view the quality of life with major stroke as tantamount to or worse than death. These findings highlight the relevance of incorporating patient preferences when choosing stroke prophylaxis.

  View details for Web of Science ID A1996VF62700007

  View details for PubMedID 8790077

• A randomized controlled trial of a computer-based physician workstation in an outpatient setting: Implementation barriers to outcome evaluation JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION ROTMAN, B. L., SULLIVAN, A. N., McDonald, T. W., Brown, B. W., Desmedt, P., Goodnature, D., HIGGINS, M. C., SUERMONDT, H. J., Young, C., Owens, D. K. 1996; 3 (5): 340-348

  Abstract

  A research prototype Physician Workstation (PWS) incorporating a graphical user interface and a drug ordering module was compared with the existing hospital information system in an academic Veterans Administration General Medical Clinic. Physicians in the intervention group received recommendations for drug substitutions to reduce costs and were alerted to potential drug interactions. The objective was to evaluate the effect of the PWS on user satisfaction, on health-related outcomes, and on costs.A one-year, two-period, randomized controlled trial with 37 subjects.Differences in the reliance on noncomputer sources of information, in user satisfaction, in the cost of prescribed medications, and in the rate of clinically relevant drug interactions were assessed.The study subjects logged onto the workstation an average of 6.53 times per provider and used it to generate 2.8% of prescriptions during the intervention period. On a five-point scale (5 = very satisfied, 1 = very dissatisfied), user satisfaction declined in the PWS group (3.44 to 2.98 p = 0.008), and increased in the control group (3.23 to 3.72, p < 0.0001).The intervention physicians did not use the PWS frequently enough to influence information-seeking behavior, health outcomes, or cost. The study design did not determine whether the poor usage resulted from satisfaction with the control system, problems using the PWS intervention, or the functions provided by the PWS intervention. Evaluative studies should include provisions to improve the chance of successful implementation as well as to yield maximum information if a negative study occurs.

  View details for Web of Science ID A1996VJ04200005

  View details for PubMedID 8880681

  View details for PubMedCentralID PMC116318

• Modelling cost-effectiveness of Helicobacter pylori screening to prevent gastric cancer: A mandate for clinical trials LANCET Parsonnet, J., Harris, R. A., HACK, H. M., Owens, D. K. 1996; 348 (9021): 150-154

  Abstract

  It is unknown whether eradication of Helicobacter pylori infection prevents development of gastric adenocarcinoma. To determine whether screening and treatment trials are warranted, we conducted a cost-effectiveness analysis to estimate the costs and benefits associated with screening for H pylori at age 50 and treating those individuals infected with antibiotics.We compared two interventions: (1) screen for H pylori and treat those with a positive test, and (2) do not screen and do not treat. Estimates of risks and costs were obtained by review of published reports. Since the efficacy of H pylori therapy in cancer prevention is unknown, we did sensitivity analyses, varying this estimate widely. In our base-case analysis, we assumed that H pylori treatment prevented 30% of attributable gastric cancers.In the base-case analysis, 11,646,000 persons in the US would be screened and 4,658,400 treated, at a cost of $996 million. Cost-effectiveness was $25,000 per year of life saved. Cost-effectiveness was sensitive to the efficacy of the cancer prevention strategy. At low efficacy rates (< 10%), the screening programme was more expensive (> $75,000 per year of life saved). In a high-risk group such as Japanese-Americans, however, screening and treatment required less than $50,000 per year of life saved, even at 5% treatment efficacy.Screening and treatment for H pylori infection is potentially cost-effective in the prevention of gastric cancer, particularly in high-risk populations. Cancer prevention trials are strongly recommended.

  View details for PubMedID 8684154

• Polymerase chain reaction for the diagnosis of HIV infection in adults - A meta-analysis with recommendations for clinical practice and study design ANNALS OF INTERNAL MEDICINE Owens, D. K., Holodniy, M., Garber, A. M., Scott, J., Sonnad, S., Moses, L., Kinosian, B., Schwartz, J. S. 1996; 124 (9): 803-?

  Abstract

  To do a meta-analysis of studies that have evaluated the sensitivity and specificity of polymerase chain reaction (PCR) assay for the diagnosis of human immunodeficiency virus (HIV) infection in adults. Evaluating the performance of PCR is difficult because in certain clinical situations, the sensitivity or specificity of PCR may exceed those of the current reference standard tests (enzyme immunoassay followed by confirmatory Western blot analysis). Therefore, an additional goal was to develop recommendations for 1) the design of future evaluative studies of PCR and 2) the use of PCR in persons with suspected HIV infection.Studies published between 1988 and 1994 that were identified in a search of 17 computer databases, including MEDLINE, and abstracts identified from conference proceedings.Studies were included if DNA amplification by PCR was done on peripheral blood mononuclear cells from adults. Ninety-six studies met the inclusion criteria.Data were extracted independently by two reviewers. Study design was assessed independently by two investigators blinded to study results.Reported sensitivities for PCR range from 10% to 100%, and specificities range from 40% to 100%. A summary receiver-operating characteristic curve based on all 96 studies has a maximum joint sensitivity and specificity (upper left point on the curve, where sensitivity equals specificity) of 97.0% to 98.1%. If the threshold value that defines a positive PCR result is chosen so that sensitivity is higher than 98.1%, specificity will decrease to less than 98.1%. Conversely, if the threshold value that defines a positive PCR result is chosen so that specificity is greater than 98.1%, sensitivity will decrease to less than 98.1%. If sensitivity and specificity are chosen to be equal, the corresponding false-positive rate is 1.9% to 3.0%. At the maximum joint sensitivity and specificity, the positive predictive value of PCR ranges from 34% to 85% as the prevalence of HIV increases from 1.0% to 10%. We identified seven areas in which study design could be modified to 1) reduce susceptibility to bias in estimates of the sensitivity and specificity of PCR and 2) to increase the generalizability of the study results. These modifications will also help to overcome methodologic problems created by the lack of a reference standard test.The PCR assay is not sufficiently accurate to be used for the diagnosis of HIV infection without confirmation. Use of PCR for the diagnosis of HIV in adults should be limited to situations in which antibody tests are known to be insufficient. Future studies of PCR performance should be sufficiently large and should use adequate reference standard tests and standardized methods for the performance of PCR. Specimens should be evaluated by persons blinded to clinical status and to the results of other diagnostic tests for HIV infection.

  View details for Web of Science ID A1996UG25400004

  View details for PubMedID 8610949

• A meta-analytic evaluation of the polymerase chain reaction for the diagnosis of HIV infection in infants JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Owens, D. K., Holodniy, M., McDonald, T. W., Scott, J., Sonnad, S. 1996; 275 (17): 1342-1348

  Abstract

  To evaluate the sensitivity and specificity of the polymerase chain reaction (PCR) for the diagnosis of infection with human immunodeficiency virus (HIV) in infants.We used studies published between 1988 and 1994 identified in a literature search of 17 databases, including MEDLINE.Studies were included if DNA amplification by PCR was performed on peripheral blood mononuclear cells from infants or children.Two investigators independently extracted data. The study design was assessed independently by 2 investigators who were blinded to study results.Thirty-two studies met the inclusion criteria and were analyzed. The median reported sensitivity was 91.6% (range, 31%-100%), and the median specificity was 100% (range, 50%-100%). A summary receiver operating characteristic curve based on all 32 studies indicated that PCR has a maximum joint sensitivity and specificity between 93.2% and 94.9%. Subgroup analysis indicated that the joint sensitivity and specificity was significantly (P = .04) higher in older infants (98.2%) than in neonates (aged < or = 30 days; 93.3%). For infants at low risk of perinatal transmission (probability of transmission, 8.3%), the positive predictive value for PCR is 55.8% in neonates and 83.2% in older infants. A negative PCR result reduces the probability of HIV infection to less than 3%. No studies met all criteria for study design.Although PCR is one of the best available tests for diagnosis of HIV infection in neonates and infants, it is not definitive. Therefore, PCR should be interpreted with the aid of careful clinical follow-up examinations. The sensitivity and specificity of PCR in neonates is lower than in older infants, which results in a low positive predictive value; however, negative tests are informative. Delaying the use of PCR until after the neonatal period or repeating PCR on independent samples obtained 30 to 60 days later will reduce test errors.

  View details for PubMedID 8614121

• Cost-effectiveness of stroke prophylaxis for nonvalvular atrial fibrillation - Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gage, B. F., Cardinalli, A. B., Albers, G. W., Owens, D. K. 1996; 275 (12): 910-910

  View details for Web of Science ID A1996UA56300023

• Cost-effectiveness of HIV screening in acute care settings ARCHIVES OF INTERNAL MEDICINE Owens, D. K., Nease, R. F., Harris, R. A. 1996; 156 (4): 394-404

  Abstract

  Although screening inpatients for human immunodeficiency virus (HIV) in acute care hospital settings has been recommended, the cost-effectiveness of screening is not known.To estimate the cost-effectiveness of a voluntary screening program in acute care hospitals and associated clinics.During the first year, an HIV screening program implemented in acute care hospital settings in which the seroprevalence of HIV infection is 1% or more would result in the identification of approximately 110,000 undetected cases of HIV infection. The program would result in expenditures of approximately $171 million for testing and counseling, and expenditures of approximately $2 billion for incremental medical care for the patients identified as having HIV infection during the first year of screening. When the seroprevalence of HIV is 1%, the cost-effectiveness of screening is $47,200 per year of life saved. When the effect of early identification of HIV infection on the patient's quality of life also is considered, screening is less cost-effective. Screening-induced reductions in risk behavior improve the cost-effectiveness of screening by preventing the transmission of HIV.

  View details for Web of Science ID A1996TW32800005

  View details for PubMedID 8607724

• Presentation and explanation of medical decision models using the World Wide Web. Proceedings : a conference of the American Medical Informatics Association / ... AMIA Annual Fall Symposium. AMIA Fall Symposium Sanders, G. D., Dembitzer, A. D., Heidenreich, P. A., McDonald, K. M., Owens, D. K. 1996: 60-64

  Abstract

  We demonstrated the use of the World Wide Web for the presentation and explanation of a medical decision model. We put on the web a treatment model developed as part of the Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team (CARD PORT). To demonstrate the advantages of our web-based presentation, we critiqued both the conventional paper-based and the web-based formats of this decision-model presentation with reference to an accepted published guide to understanding clinical decision models. A web-based presentation provides a useful supplement to paper-based publications by allowing authors to present their model in greater detail, to link model inputs to the primary evidence, and to disseminate the model to peer investigators for critique and collaborative modeling.

  View details for PubMedID 8947628

• polymerase chain reaction for the diagnosis of HIV infection in adults: A meta-analysis with recommendations for clinical practice and study design. Annals of Internal Medicine Owens DK, Holodniy M, Garber AM, Scott J, Sonnad S, Moses L, Kinosian B, Schwartz JS. 1996
• COST-EFFECTIVENESS OF WARFARIN AND ASPIRIN FOR PROPHYLAXIS OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL-FIBRILLATION JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Gage, B. F., Cardinalli, A. B., Albers, G. W., Owens, D. K. 1995; 274 (23): 1839-1845

  Abstract

  To examine the cost-effectiveness of prescribing warfarin sodium in patients who have nonvalvular atrial fibrillation (NVAF) with or without additional stroke risk factors (a prior stroke or transient ischemic attack, diabetes, hypertension, or heart disease).Decision and cost-effectiveness analyses. The probabilities for stroke, hemorrhage, and death were obtained from published randomized controlled trials. The quality-of-life estimates were obtained by interviewing 74 patients with atrial fibrillation. Costs were estimated from literature review, phone survey, and Medicare reimbursement.In the base case, the patients were 65 years of age and good candidates for warfarin therapy.Treatment with warfarin, aspirin, or no therapy in the decision analytic model.Quality-adjusted survival and marginal cost-effectiveness of warfarin as compared with aspirin or no therapy.For patients with NVAF and additional risk factors for stroke, warfarin therapy led to a greater quality-adjusted survival and to cost savings. For patients with NVAF and one additional risk factor, warfarin therapy cost $8000 per quality-adjusted life-year saved. For 65-year-old patients with NVAF alone, warfarin cost about $370,000 per quality-adjusted life-year saved, as compared with aspirin therapy. However, for 75-year-old patients with NVAF alone, prescribing warfarin cost $110,000 per quality-adjusted life-year saved. For patients who were not prescribed warfarin, aspirin was preferred to no therapy on the basis of both quality-adjusted survival and cost in all patients, regardless of the number of risk factors present.Treatment with warfarin is cost-effective in patients with NVAF and one or more additional risk factors for stroke. In 65-year-old patients with NVAF but no other risk factors for stroke, prescribing warfarin instead of aspirin would affect quality-adjusted survival minimally but increase costs significantly.

  View details for Web of Science ID A1995TK14700024

  View details for PubMedID 7500532

• SCREENING SURGEONS FOR HIV-INFECTION - IN RESPONSE ANNALS OF INTERNAL MEDICINE Owens, D. K., Harris, R. A., Nease, R. F. 1995; 123 (10): 812-813

  View details for Web of Science ID A1995TE17200028

• THE ROLE OF CORONARY ANGIOGRAPHY AND CORONARY REVASCULARIZATION BEFORE NONCARDIAC VASCULAR-SURGERY JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mason, J. J., Owens, D. K., Harris, R. A., Cooke, J. P., Hlatky, M. A. 1995; 273 (24): 1919-1925

  Abstract

  To determine whether preoperative coronary angiography and revascularization improve short-term outcomes in patients undergoing noncardiac vascular surgery.Decision analysis.Patients undergoing elective vascular surgery who had either no angina or mild angina and a positive dipyridamole-thallium scan result.Three strategies were compared. The first strategy was to proceed directly to vascular surgery. The second was to perform coronary angiography, followed by selective coronary revascularization, before proceeding to vascular surgery and to cancel vascular surgery in patients with severe inoperable coronary artery disease (CAD). The third was to perform coronary angiography, followed by selective coronary revascularization, before proceeding to vascular surgery and to perform vascular surgery in patients with inoperable CAD.Mortality, nonfatal myocardial infarction, stroke, uncorrected vascular disease, and cost. All outcomes were assessed within 3 months.Proceeding directly to vascular surgery led to lower morbidity and cost in the base case analysis. The coronary angiography strategy led to higher mortality if vascular surgery would proceed in patients with inoperable CAD, but led to slightly lower mortality if vascular surgery were canceled in patients with inoperable CAD. The coronary angiography strategy also led to lower mortality when vascular surgery was particularly risky.Decision analysis indicates vascular surgery without preoperative coronary angiography generally leads to better outcomes. Preoperative coronary angiography should be reserved for patients whose estimated mortality from vascular surgery is substantially higher than average.

  View details for PubMedID 7783301

• SCREENING SURGEONS FOR HIV-INFECTION - A COST-EFFECTIVENESS ANALYSIS ANNALS OF INTERNAL MEDICINE Owens, D. K., Harris, R. A., Scott, P. M., Nease, R. F. 1995; 122 (9): 641-652

  Abstract

  OBJECTIVE. To determine the cost-effectiveness of a policy to screen surgeons for human immunodeficiency virus (HIV) infection to prevent transmission of HIV to patients having invasive procedures.Cost-effectiveness analysis.A one-time national screening program would identify approximately 137 surgeons with HIV infection (range, 28 to 423 surgeons) and would prevent approximately 4.3 infections (range, 1.9 to 21.3 infections) in patients treated by infected surgeons and 0.9 infections (range, 0 to 12.9 infections) in sexual partners of infected surgeons at a direct cost of $8.1 million and an induced cost of approximately $44 million. It would result in expenditures of $458,000 per year of life saved (range, $147,000 to $687,000 per year of life saved), whereas an annual screening program would result in expenditures of approximately $1.1 million per year of life saved (range, $338,000 to $1,886,000 per year of life saved). If the prevalence of HIV infection in surgeons is estimated to be three times our base-case estimate (an increase from 0.1% to 0.3%), annual screening would result in expenditures of approximately $741,000 per year of life saved. If the probability of seroconversion after a patient is exposed to a contaminated instrument is increased to 5.0% from our base-case estimate of 0.29%, an annual screening program would still cost more than $228,000 per year of life saved.Screening surgeons for HIV to prevent transmission of HIV to patients having invasive procedures requires expenditures per year of life saved that are considerably in excess of those of most accepted health interventions. Surveillance studies of patients treated by surgeons infected with HIV should be continued to confirm that transmission of HIV to patients having invasive procedures is rare.

  View details for Web of Science ID A1995QV15100001

  View details for PubMedID 7702225

• Prevention of sudden cardiac death: a probabilistic model for decision support. Proceedings / the ... Annual Symposium on Computer Application [sic] in Medical Care. Symposium on Computer Applications in Medical Care Sanders, G. D., Harris, R. A., Hlatky, M. A., Owens, D. K. 1995: 258-262

  Abstract

  As part of the Cardiac Arrhythmia and Risk of Death Patient Outcomes Research Team (CARD PORT) study we are developing a comprehensive decision model to help physicians identify preferred strategies for preventing sudden cardiac death. The model integrates three components: a screening model, a treatment model, and a value model. Ultimately this model will use the CARD PORT's collective findings to produce policy recommendations and will support patient-specific clinical decision making. Our initial modeling suggests the importance of patient-specific value models in an analysis of treatment options. Although our model is specific to cardiac sudden death, other medical domains that exhibit similar characteristics--the importance of patient preferences and the uncertainty regarding the benefits of strategies for risk stratification and treatment--can use a conceptual framework similar to the approach we used to represent strategies to prevent sudden cardiac death.

  View details for PubMedID 8563280

  View details for PubMedCentralID PMC2579095

• A randomized evaluation of a computer-based physician's workstation: design considerations and baseline results. Proceedings / the ... Annual Symposium on Computer Application [sic] in Medical Care. Symposium on Computer Applications in Medical Care ROTMAN, B. L., SULLIVAN, A. N., McDonald, T., Desmedt, P., Goodnature, D., Higgins, M., SUERMONDT, H. J., Young, C. Y., Owens, D. K. 1995: 693-697

  Abstract

  We are performing a randomized, controlled trial of a Physician's Workstation (PWS), an ambulatory care information system, developed for use in the General Medical Clinic (GMC) of the Palo Alto VA. Goals for the project include selecting appropriate outcome variables and developing a statistically powerful experimental design with a limited number of subjects. As PWS provides real-time drug-ordering advice, we retrospectively examined drug costs and drug-drug interactions in order to select outcome variables sensitive to our short-term intervention as well as to estimate the statistical efficiency of alternative design possibilities. Drug cost data revealed the mean daily cost per physician per patient was 99.3 cents +/- 13.4 cents, with a range from 0.77 cent to 1.37 cents. The rate of major interactions per prescription for each physician was 2.9% +/- 1%, with a range from 1.5% to 4.8%. Based on these baseline analyses, we selected a two-period parallel design for the evaluation, which maximized statistical power while minimizing sources of bias.

  View details for PubMedID 8563376

• A METHOD FOR ESTIMATING THE GOST EFFECTIVENESS OR INCORPORATING PATIENT PREFERENCES INTO PRACTICE GUIDELINES MEDICAL DECISION MAKING Nease, R. F., Owens, D. K. 1994; 14 (4): 382-392

  Abstract

  Many clinical practice guidelines fail to account for the preferences of the individual patient. Approaches that seek to include the preferences of the individual patient in the decision-making process (e.g., interactive videodisks for patient education), however, may incur substantial incremental costs. Developers of clinical practice guidelines must therefore determine whether it is appropriate to make their guidelines flexible with regard to patient preferences. The authors present a formal method for determining the cost-effectiveness of incorporating the preferences of individual patients into clinical practice guidelines. Based on utilities assessed from 37 patients, they apply the method in the setting of mild hypertension. In this example, they estimate that the cost-effectiveness ratio for individualized utility assessment is $48,565 per quality-adjusted year of life, a ratio that compares favorably with other health interventions that are promoted actively. This approach, which can be applied to any clinical domain, offers a formal method for determining whether the incorporation of individual patient preferences is important clinically and is justified economically.

  View details for Web of Science ID A1994PL43300009

  View details for PubMedID 7808213

• PREVENTION OF GASTRIC-CANCER - A COST-EFFECTIVENESS ANALYSIS OF SCREENING FOR HELICOBACTER-PYLORI HACK, H. M., Harris, R. A., Owens, D. K., Parsonnet, J. SLACK INC. 1994: A226–A226

  View details for Web of Science ID A1994NF02000655

• THE COST-EFFECTIVENESS OF INCORPORATING PATIENT PREFERENCES INTO PRACTICE GUIDELINES FOR MILD HYPERTENSION NEASE, R., HYNES, L., TOSTESON, A., LITTENBERG, B., SUMNER, W., OWENS, D. SLACK INC. 1994: A226

  View details for Web of Science ID A1994NF02000654

• PREVENTION OF GASTRIC-CANCER - A COST-EFFECTIVENESS ANALYSIS OF SCREENING FOR HELICOBACTER-PYLORI HACK, H. M., Harris, R., Owens, D. K., Parsonnet, J. SLACK INC. 1994: A23–A23

  View details for Web of Science ID A1994MR21400121

• A COMPUTER-BASED INTERVIEW TO IDENTIFY HIV RISK BEHAVIORS AND TO ASSESS PATIENT PREFERENCES FOR HIV-RELATED HEALTH STATES 18th Annual Symposium on Computer Applications in Medical Care - Transforming Information, Changing Health Care Sanders, G. D., Owens, D. K., Padian, N., Cardinalli, A. B., SULLIVAN, A. N., Nease, R. F. BMJ PUBLISHING GROUP. 1994: 20–24

  Abstract

  We developed a computer-based utility assessment tool to assess the preferences of patients towards HIV-related health states and identify risk behaviors (both sexual and drug related) of the patient being interviewed. The reliability of the computer-based interview was assessed through comparison with person-to-person interviews. Our pilot study included 22 patients. Twelve of these patients were also interviewed by the research assistants in person-to-person interviews. The agreement between the person-to-person and computer-based interviews was excellent (3 discrepancies of 180 compared answers), and the majority of the patients preferred to use the computer to disclose sensitive information regarding risk behaviors. Our study suggests that assessment of patient preferences and risk factors can be performed reliably through a computer-based interview.

  View details for Web of Science ID A1994QF21600005

  View details for PubMedID 7949919

  View details for PubMedCentralID PMC2247747

• PAYING FOR EVALUATIVE RESEARCH 4th Workshop on Examining Coverage and Adoption Decisions about Medical Technologies Garber, A. M., Owens, D. K. NATL ACADEMY PRESS. 1994: 172–192

  View details for Web of Science ID A1994BB97Z00013

• WHEN WOMEN RETURN TO RISK - COSTS AND BENEFITS OF HIV SCREENING IN THE PRESENCE OF RELAPSE 34th Joint National Meeting of the Operations-Research-Society-of-America and The Institute-of-Management-Sciences Brandeau, M. L., Owens, D. K. RAVEN PRESS. 1994: 121–136

  View details for Web of Science ID A1994BA41L00007

• TRANSMISSION OF HIV-INFECTION BETWEEN PROVIDER AND PATIENT - A QUANTITATIVE-ANALYSIS OF RISK 34th Joint National Meeting of the Operations-Research-Society-of-America and The Institute-of-Management-Sciences Owens, D. K., Nease, R. F. RAVEN PRESS. 1994: 153–177

  View details for Web of Science ID A1994BA41L00009

• Development of outcome-based practice guidelines: a method for structuring problems and synthesizing evidence. Joint Commission journal on quality improvement Owens, D. K., Nease, R. F. 1993; 19 (7): 248-263

  Abstract

  The growth in guidance development projects has focused attention on the methods used in developing the guideline. For a guideline to be sound it should be linked on the basis of scientific evidence to the very health outcome that the guideline is designed to promote.Structuring a health intervention as an influence diagram, a decision model (1) allows for the identification of the relevant benefits, harms, and costs that may result from an intervention; (2) provides an explicit link between the intervention and these outcomes, a crucial prerequisite for the development of an outcome-based guideline; and (3) identifies the evidence that must be synthesized to predict the effect of the intervention on the health outcomes. EXAMPLE: In the development of a guideline related to prevention of opportunistic infections in HIV-infected persons, we would define the interventions (for example, use of medication for PCP pneumonia), the intended health outcome (a potential reduction in the number of opportunistic infections), and the evidence that demonstrates that the intervention produces the desired outcome. If PCP prophylaxis is delayed, the HIV-infected person is exposed to a undue risk of PCP, with its attendant morbidity and mortality. If it is initiated too early, the person incurs excess monetary costs and may experience additional side-effect-associated morbidity. EXAMPLE: The intervention in question is screening for HIV infection, and the outcomes of interest are the medical benefits and harms associated with screening and the financial costs (and savings) that a screening program would incur. Screening for HIV infection differs from many clinical questions because it has potential benefit both to the persons screened and to public health if the screened person reduces risk behaviors that might transmit HIV infection.Structuring a problem with an influence diagram: delineates an explicit link between interventions and outcomes; focuses the questions to be addressed (a series of more sharply defined questions, each of which we may be able to answer based on direct evidence, replaces a much broader question [should we screen for HIV?], which cannot be answered directly); and highlights the importance of a clear, unambiguous statement whose benefit and costs are under consideration.

  View details for PubMedID 8401810

• SCREENING WOMEN OF CHILDBEARING AGE FOR HUMAN-IMMUNODEFICIENCY-VIRUS - A MODEL-BASED POLICY ANALYSIS MANAGEMENT SCIENCE Brandeau, M. L., Owens, D. K., Sox, C. H., Wachter, R. M. 1993; 39 (1): 72-92

  View details for Web of Science ID A1993KM62000006

• SCREENING WOMEN OF CHILDBEARING AGE FOR HUMAN-IMMUNODEFICIENCY-VIRUS - A COST-BENEFIT-ANALYSIS ARCHIVES OF INTERNAL MEDICINE Brandeau, M. L., Owens, D. K., Sox, C. H., Wachter, R. M. 1992; 152 (11): 2229-2237

  Abstract

  In light of the increasing problem of perinatal human immunodeficiency virus (HIV) transmission, the issue of screening women for HIV is receiving considerable attention. We analyzed the costs and benefits of screening women of childbearing age for HIV. The analysis was based on a dynamic model of the HIV epidemic that incorporated disease transmission and progression, behavioral changes, and effects of screening and counseling. We found that the primary benefit of screening programs targeted to women of childbearing age lies not in the prevention of HIV infection in their newborns but in the prevention of infection in their adult contacts. Because of this benefit, screening medium- and high-risk women is likely to be cost-beneficial over a wide range of assumptions about program cost and behavioral changes in response to screening.

  View details for PubMedID 1444682

• IMPACT OF A CLINICAL PREVENTIVE MEDICINE CURRICULUM FOR PRIMARY CARE FACULTY - RESULTS OF A DISSEMINATION MODEL PREVENTIVE MEDICINE Albright, C. L., Farquhar, J. W., Fortmann, S. P., Sachs, D. P., Owens, D. K., Gottlieb, L., Stratos, G. A., Bergen, M. R., Skeff, K. M. 1992; 21 (4): 419-435

  Abstract

  This study was designed to test a dissemination model for providing clinical preventive medicine (CPM) training to general internal medicine faculty across the United States.The model incorporated direct instruction of a few faculty as seminar facilitators who, in turn, taught a CPM curriculum to their faculty colleagues, who then could teach it to housestaff and students. The CPM curriculum consisted of six seminars that focused primarily on the risk factors for chronic diseases and on behavior change methods for modifying smoking, diet, and exercise.Faculty who participated in the seminars had significant pre- to post-test increase in knowledge and reported self-efficacy to implement CPM strategies with patients, as well as changes in CPM clinical practices. These faculty, in turn, successfully disseminated CPM information to their housestaff, who also had increases in self-efficacy and changed clinical practices regarding CPM topics.The successful implementation of the dissemination model attests to its viability as a mechanism for disseminating CPM curricula and increasing the emphasis on CMP issues in both clinical teaching and clinical encounters with patients.

  View details for Web of Science ID A1992JH41200003

  View details for PubMedID 1409485

• OCCUPATIONAL EXPOSURE TO HUMAN-IMMUNODEFICIENCY-VIRUS AND HEPATITIS-B VIRUS - A COMPARATIVE-ANALYSIS OF RISK AMERICAN JOURNAL OF MEDICINE Owens, D. K., Nease, R. F. 1992; 92 (5): 503-512

  Abstract

  To estimate the occupational risk from infection with the human immunodeficiency virus (HIV) in terms of loss of (quality-adjusted) life expectancy, and to compare that risk to those posed by other hazards faced by health care workers.Decision-analytic model.For a 30-year-old female health care worker (unvaccinated for hepatitis B virus [HBV]), the loss of life expectancy from a needlestick from a symptomatic HIV-positive (HIV+) patient is 39 days (range, 17 to 93 days), as compared with a loss of 17 days from a needlestick from a patient who is hepatitis-B-surface-antigen-positive (HBsAg+), and 38 days from a needlestick from a patient who is hepatitis-B-e-antigen-positive (HBeAg+). When morbidity is included in the analysis of risk (through calculation of the quality-adjusted loss of life expectancy), the risk from both HBV and HIV increases. The quality-adjusted loss of life expectancy due to a needlestick exposure from a symptomatic HIV+ patient is 45 days (range, 20 to 108 days), as compared with a quality-adjusted loss of life expectancy of 48 days from a needlestick from an HBsAg+ patient, and 109 days from a needlestick from a patient who is known to be HBeAg+. By comparison, a cross-country automobile trip is associated with a loss of life expectancy of approximately 1 day. The 45- to 50-day loss of quality-adjusted life expectancy from percutaneous exposures to HIV and HBV is approximately the same magnitude as the gain in life expectancy from 10 years of annual screening for breast cancer with mammography and physical examination.The risk associated with percutaneous exposures to symptomatic HIV+ patients is comparable to other risks that health care workers have faced knowingly and have accepted in the recent past. However, the loss of quality-adjusted life expectancy associated with a needlestick exposure is significant. Identification of cost-effective methods that increase the safety of medical personnel but also ensure full access to high-quality care for HIV+ patients should be a high priority.

  View details for Web of Science ID A1992HU61200009

  View details for PubMedID 1580297

• USE OF THE POLYMERASE CHAIN-REACTION FOR THE DIAGNOSIS OF HIV-INFECTION IN ADULTS - A META-ANALYTIC EVALUATION OF TEST-PERFORMANCE OWENS, D. K., HOLODNIY, M., GARBER, A. M., SONNAD, S., SCOTT, J., KINOSIAN, B., SCHWARTZ, J. S. SLACK INC. 1992: A588

  View details for Web of Science ID A1992HN74102608

• A POLICY MODEL OF HUMAN-IMMUNODEFICIENCY-VIRUS SCREENING AND INTERVENTION INTERFACES Brandeau, M. L., Lee, H. L., Owens, D. K., Sox, C. H., Wachter, R. M. 1991; 21 (3): 5-25

  View details for Web of Science ID A1991FR52300002

• OPTIMAL TEST STRATEGY FOR STAGING PERIPHERAL NON-SMALL-CELL LUNG-CANCER WITH POTENTIAL CHEST-WALL INVASION OWENS, D. K., NEASE, R. F., SOX, H. C. SLACK INC. 1991: A160

  View details for Web of Science ID A1991FH32300114

• HIV TESTING OF PREGNANT-WOMEN AND NEWBORNS JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Wachter, R. M., Cooke, M., Brandeau, M. L., Owens, D. K. 1991; 265 (12): 1525-1525

  View details for Web of Science ID A1991FC60400009

• ASSESSMENT AND REPRESENTATION OF PRIOR BELIEFS - UNEXPECTED IMPLICATIONS OF THE UNIFORM-DISTRIBUTION MEDICAL DECISION MAKING Nease, R. F., Owens, D. K. 1990; 10 (2): 112-114

  View details for Web of Science ID A1990CX24300004

  View details for PubMedID 2348753

• STRATEGIES FOR TEST SELECTION IN THE STAGING OF LUNG NEOPLASMS SEMINARS IN RESPIRATORY MEDICINE Owens, D. K., Sox, H. C., Inouye, S. K. 1989; 10 (3): 195-202

  View details for Web of Science ID A1989AF32900002

• THRESHOLD ANALYSIS USING DIAGNOSTIC-TESTS WITH MULTIPLE RESULTS MEDICAL DECISION MAKING Nease, R. F., Owens, D. K., Sox, H. C. 1989; 9 (2): 91-103

  Abstract

  Clinical problems represented by decision trees can be analyzed in terms of the probability threshold model, which provides management recommendations based on the prior probability of disease, the test threshold, and the test-treatment threshold. As originally proposed, the threshold model assumes that diagnostic tests provide information about a single event that is relevant to the decision. For some problems, however, a diagnostic test may provide information about more than one such event (e.g., a computed tomography [CT] scan gives information about both mediastinal and hilar metastases in lung cancer). The authors extend the probability threshold model to cases in which a single test provides information about two events that are relevant to the decision. They derive four thresholds that determine the best strategy for any combination of test results. The approach is illustrated for the decision to use a CT scan to stage lung cancer. The analysis reveals that: 1) the range of prior probabilities for which testing is optimal increases; 2) for some prior probabilities only test results about one event are important; 3) for some prior probabilities test results about both events are important; and 4) failure to account fully for information provided by a test can lead to erroneous test and treatment recommendations.

  View details for PubMedID 2664405

• METHODOLOGIC IMPLICATIONS OF AGGREGATION IN MEASURING TEST-PERFORMANCE NEASE, R. F., OWENS, D. K. SLACK INC. 1989: A322

  View details for Web of Science ID A1989U004400507

• INVASIVE VERSUS NON-INVASIVE TESTS FOR STAGING NON-SMALL CELL LUNG-CANCER OF UNKNOWN EXTENT - A DECISION ANALYTIC MODEL OWENS, D. K., NEASE, R. F., SOX, H. C. SLACK INC. 1989: A780

  View details for Web of Science ID A1989U004403233

• DECISION-ANALYSIS FOR CHEST CLINICIANS AMERICAN REVIEW OF RESPIRATORY DISEASE Haponik, E. F., Sox, H. C., LILLINGTON, G., Owens, D. K., Gottlieb, J., Reichman, L., Jordan, T., Colice, G. 1988; 138 (4): 1058-1060

  View details for Web of Science ID A1988Q562500056

  View details for PubMedID 3059880

• THE RELEASE OF ENDOGENOUS AMINO-ACIDS INTO THE VITREOUS OF THE INTACT EYE OF THE ALBINO-RAT - EFFECT OF LIGHT, POTASSIUM, AND OUABAIN BRAIN RESEARCH Coull, B. M., Owens, D. K., CUTLER, R. W. 1981; 210 (1-2): 301-309

  Abstract

  The vitreal space of the intact eye of albino rats was perfused in vivo. The concentration of several endogenous amino acids in the vitreal effluent was measured by the [3H]microdansylation procedure. GABA was never detected despite a sensitivity of the method of 0.5 pmol. In contrast to previous results obtained in pigmented rats, photic stimulation with flashing white light did not alter the release of glycine or any of the other amino acids. Potassium (60 mM) and ouabain (0.1 mM) evoked a specific release of glycine. The potassium-evoked release was blocked by magnesium suggesting a neuronal site of origin of glycine. Ouabain-evoked release was not blocked by magnesium. The results were contrasted with experiments on radiolabeled amino acid release from retinas preloaded and superfused in vitro, a condition in which glial localization of exogenous amino acids predominates.

  View details for Web of Science ID A1981LH87600024

  View details for PubMedID 7225812