Michelle Mello

All Publications

• Ensuring Safe Practice by Late Career Physicians: Institutional Policies and Implementation Experiences. Annals of internal medicine White, A. A., Gallagher, T. H., Osinska, P. H., Kramer, D. B., Garrett, K. D., Mello, M. M. 2024

  Abstract

  Late career physicians (LCPs; physicians working beyond age 65 to 75 years) may be at higher risk for delivering unsafe care. To oversee LCPs, some health care organizations (HCOs) have adopted LCP policies requiring cognitive, physical, and practice performance screening assessments. Despite recent controversies, little is known about the content and implementation of such policies.To characterize key features of LCP policies and the perspectives of medical leaders responsible for policy development and implementation.Mixed-methods study using content analysis and key informant interviews.29 U.S. HCOs with LCP policies active in 2020.21 purposively sampled interviewees in physician leadership roles at 18 HCOs.Descriptive statistics of policy features and content analysis of interviews.Although policies had many commonalities-mandatory universal screening at a trigger age around 70 years, a strategy of screening followed by in-depth assessment of positive results, and commitment to patient safety as the key motive-they varied substantially in the testing required, funding, processes after a positive screening result, and decision making around concerning results. Policies prioritized institutional discretion in interpreting and responding to test results; many lacked clear language about appeals or other procedural protections for physicians. Leaders were generally satisfied with policies but reported preemptive retirements as physicians approached the screening age and cautioned that substantial investment in cultivating physicians' buy-in was required for successful rollout.Sampled policies and interviews may not be representative of all HCOs. The analysis excluded the experiences of HCOs that tried and failed to implement LCP screening.Policies about LCPs are considered successful by institutional leaders. Policy variations and early adopters' implementation experiences highlight opportunities to improve physician acceptance and program rigor.The Greenwall Foundation.

  View details for DOI 10.7326/ANNALS-24-00829

  View details for PubMedID 39496180

• Avoiding Financial Toxicity for Patients from Clinicians' Use of AI. The New England journal of medicine Jain, S. S., Mello, M. M., Shah, N. H. 2024

  View details for DOI 10.1056/NEJMp2406135

  View details for PubMedID 39348681

• Ramifications of the Supreme Court's Latest Term for Health Regulation. JAMA Fleisher, L. A., O'Connell, A. J., Mello, M. M. 2024

  View details for DOI 10.1001/jama.2024.16994

  View details for PubMedID 39186688

• Antidiscrimination Law Meets Artificial Intelligence-New Requirements for Health Care Organizations and Insurers. JAMA health forum Mello, M. M., Roberts, J. L. 2024; 5 (8): e243397

  View details for DOI 10.1001/jamahealthforum.2024.3397

  View details for PubMedID 39207771

• Judicial Decisions Constraining Public Health Powers During COVID-19: Implications For Public Health Policy Making. Health affairs (Project Hope) Mello, M. M., Jiang, D. H., Parmet, W. E. 2024: 101377hlthaff202400073

  Abstract

  Public health legal powers are increasingly under pressure from the courts in the United States. During the COVID-19 pandemic, individuals and organizations successfully challenged many community mitigation orders (for example, mask mandates, vaccination mandates, and restrictions on gatherings), demonstrating the legal vulnerability of disease control measures. Analyzing 112 judicial decisions in which the plaintiff prevailed from March 2020 through March 2023, we examined the ways in which courts constrained public health powers during the COVID-19 pandemic. We found that in these 112 decisions, courts shifted how they analyze religious liberty claims and reviewed challenges to the exercise of statutory powers by health officials in novel ways. We discuss implications for public health policy going forward, and we recommend ways in which legislatures and health officials can design policies to maximize their prospects of surviving legal challenges.

  View details for DOI 10.1377/hlthaff.2024.00073

  View details for PubMedID 38776478

• Data stewardship in FTLD research: Investigator and research participant views. Alzheimer's & dementia : the journal of the Alzheimer's Association Arias, J. J., Tyler, A. M., Beskow, L. M., Carillo, M. C., Dickinson, S., Goldman, J., Majumder, M. A., Mello, M. M., Snyder, H. M., Yokoyama, J. S. 2024

  Abstract

  Federal policies and guidelines have expanded the return of individual results to participants and expectations for data sharing between investigators and through repositories. Here, we report investigators' and study participants' views and experiences with data stewardship practices within frontotemporal lobal degeneration (FTLD) research, which reveal unique ethical challenges.Semi-structured interviews with (1) investigators conducting FTLD research that includes genetic data collection and/or analysis and (2) participants enrolled in a single site longitudinal FTLD study.Analysis of the interviews identified three meta themes: perspectives on data sharing, experiences with enrollment and participation, and data management and security as mechanisms for participant protections.This study identified a set of preliminary gaps and needs regarding data stewardship within FTLD research. The results offer initial insights on ethical challenges to data stewardship aimed at informing future guidelines and policies.

  View details for DOI 10.1002/alz.13719

  View details for PubMedID 38456576

• Denial-Artificial Intelligence Tools and Health Insurance Coverage Decisions. JAMA health forum Mello, M. M., Rose, S. 2024; 5 (3): e240622

  Abstract

  This JAMA Forum discusses the potential and the pitfalls in the use of artificial intelligence in the coverage decisions made by health insurance companies.

  View details for DOI 10.1001/jamahealthforum.2024.0622

  View details for PubMedID 38451493

• Legal infrastructure for pandemic response: lessons not learnt in the US. BMJ (Clinical research ed.) Mello, M. M., Jiang, D., Platt, E., Moran-McCabe, K., Burris, S. 2024; 384: e076269

  View details for DOI 10.1136/bmj-2023-076269

  View details for PubMedID 38346813

• Understanding Liability Risk from Using Health Care Artificial Intelligence Tools. The New England journal of medicine Mello, M. M., Guha, N. 2024; 390 (3): 271-278

  View details for DOI 10.1056/NEJMhle2308901

  View details for PubMedID 38231630

• President Biden's Executive Order on Artificial Intelligence-Implications for Health Care Organizations. JAMA Mello, M. M., Shah, N. H., Char, D. S. 2023

  View details for DOI 10.1001/jama.2023.25051

  View details for PubMedID 38032634

• Reply to LeCraw, Montanera, and Mroz on Hospitals' Malpractice Claims and Costs ECON JOURNAL WATCH Yitshak-Sade, M., Kachalia, A., Novack, V., Mello, M. M. 2023; 20 (2): 349-356

  View details for Web of Science ID 001109164200006

• Accommodating Religious Objections to Vaccination Mandates-Implications of Groff v DeJoy for Health Care Employers. JAMA health forum Mello, M. M., Parmet, W. E. 2023; 4 (9): e233672

  View details for DOI 10.1001/jamahealthforum.2023.3672

  View details for PubMedID 37676675

• Vaccination Mandates-An Old Public Health Tool Faces New Challenges. JAMA Gostin, L. O., Reiss, D., Mello, M. M. 2023

  View details for DOI 10.1001/jama.2023.11059

  View details for PubMedID 37486681

• Medicare's Plan for Drug-Price Negotiation - The Importance of Defining Generic Entry. The New England journal of medicine Dusetzina, S. B., Keating, N. L., Huskamp, H. A., Mello, M. M. 2023

  View details for DOI 10.1056/NEJMp2304289

  View details for PubMedID 37428191

• Discrepancies Between Clearance Summaries and Marketing Materials of Software-Enabled Medical Devices Cleared by the US Food and Drug Administration. JAMA network open Shah, N. H., Mello, M. M. 2023; 6 (7): e2321753

  View details for DOI 10.1001/jamanetworkopen.2023.21753

  View details for PubMedID 37405777

• Ethical Responsibilities for Companies That Process Personal Data. The American journal of bioethics : AJOB McCoy, M. S., Allen, A. L., Kopp, K., Mello, M. M., Patil, D. J., Ossorio, P., Joffe, S., Emanuel, E. J. 2023: 1-13

  Abstract

  It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data Practices framework. The framework outlines six principles relevant to the collection and use of personal data-minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion-and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices.

  View details for DOI 10.1080/15265161.2023.2209535

  View details for PubMedID 37262312

• Decisions about College Football during Covid-19: An Ethical Analysis. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Baugh, C. M., Glantz, L., Mello, M. M. 2023; 51 (1): 104-118

  Abstract

  This manuscript uses competitive college football as a lens into the complexities of decision-making amid the Covid-19 pandemic. Pulling together what is known about the decision-makers, the decision-making processes, the social and political context, the risks and benefits, and the underlying obligations of institutions to these athletes, we conduct an ethical analysis of the decisions surrounding the 2020 fall football season. Based on this ethical analysis, we provide key recommendations to improve similar decision processes moving forward.

  View details for DOI 10.1017/jme.2023.45

  View details for PubMedID 37226745

• Navigating a Path Towards Routine Recording in the Operating Room. Annals of surgery Langerman, A., Hammack-Aviran, C., Cohen, I. G., Agarwala, A. V., Cortez, N., Feigenson, N. R., Fried, G. M., Grantcharov, T., Greenberg, C. C., Mello, M. M., Shuman, A. G. 2023

  View details for DOI 10.1097/SLA.0000000000005906

  View details for PubMedID 37212390

• ChatGPT and Physicians' Malpractice Risk. JAMA health forum Mello, M. M., Guha, N. 2023; 4 (5): e231938

  Abstract

  This JAMA Forum discusses the possibilities, limitations, and risks of physician use of large language models (such as ChatGPT) along with the improvements required to improve the accuracy of the technology.

  View details for DOI 10.1001/jamahealthforum.2023.1938

  View details for PubMedID 37200013

• Examining Opportunities to Increase Savings From Medicare Price Negotiations. JAMA internal medicine Reitsma, M. B., Dusetzina, S. B., Ballreich, J. M., Trujillo, A. J., Mello, M. M. 2023

  Abstract

  Allowing the US Centers for Medicare & Medicaid Services to negotiate prescription drug prices for Medicare may improve drug affordability.To estimate savings from Medicare price negotiation under the Inflation Reduction Act (IRA) and examine opportunities to increase savings.This cross-sectional, population-based study used data from 2020 Medicare prescription drug claims. The study was conducted and data were analyzed in 2022.Eligibility for Medicare price negotiation under the IRA and alternative criteria.Minimum savings under the IRA's eligibility criteria were estimated and compared with savings within alternative scenarios, including (1) selecting drugs for negotiation based on net spending after rebates rather than gross spending; (2) extending eligibility to drugs with biosimilar or generic competitors; (3) reducing the minimum years since US Food and Drug Administration approval for eligibility; and (4) changing 2 or 3 of these factors. Estimated savings were calculated at different levels of scale-up of price negotiation under the IRA, from 10 Part D drugs in 2026 to 60 Part B and D drugs in 2029. Gross spending was calculated using the US Centers for Medicare & Medicaid Services 2020 Medicare drug spending dashboard. Rebates were estimated using SSR Health data. Information on FDA approvals, generics, and biosimilars was obtained from FDA websites.Under IRA rules, estimated minimum savings from price negotiation in 2026 for 10 Part D drugs would be $3.2 billion. For 2029 for 60 Part D and B drugs, estimated savings were $16.0 billion. Selecting drugs for negotiation based on net rather than gross spending would be associated with estimated savings of $4.6 billion (a 45% increase) in 2026 and $18.9 billion (an 18% increase) in 2029. Including drugs with generic competitors or biosimilars would be associated with an estimated savings of $6.6 billion (a 109% increase) in 2026 and $24.9 billion (a 56% increase) in 2029. Making both changes would be associated with savings of $9.5 billion (a 200% increase) in 2026 and $28.3 billion (a 77% increase) in 2029. A sensitivity analysis suggested that reducing the required number of years since marketing approval by 2 years would be associated with increased estimated savings of 4% when 10 Part D drugs are negotiated and 12% when 60 Part D and B drugs are negotiated. Changing all 3 criteria would be associated with the greatest increase in estimated savings in 2029 (119% increase when 10 Part D drugs are negotiated and 93% increase for 60 Part D and B drugs).The results of this cross-sectional study suggest that adjusting the eligibility criteria for Medicare prescription drug price negotiation to permit inclusion of drugs with biosimilar or generic competitors and selecting drugs based on net rather than gross spending may be a promising approach to substantially increase estimated savings.

  View details for DOI 10.1001/jamainternmed.2023.0763

  View details for PubMedID 37067794

• Mainstreaming Wastewater Surveillance for Infectious Disease. The New England journal of medicine Mello, M. M., Meschke, J. S., Palmer, G. H. 2023

  View details for DOI 10.1056/NEJMp2301042

  View details for PubMedID 37070700

• Discharging Patients against Medical Advice NEW ENGLAND JOURNAL OF MEDICINE Lee, C. D., Bradfield, O., Mello, M. M., Beach, M. 2023; 388 (13): 1230-1232

  View details for DOI 10.1056/NEJMclde2210118

  View details for Web of Science ID 000989319200018

  View details for PubMedID 36988605

• Confronting the evolution and expansion of anti-vaccine activism in the USA in the COVID-19 era. Lancet (London, England) Carpiano, R. M., Callaghan, T., DiResta, R., Brewer, N. T., Clinton, C., Galvani, A. P., Lakshmanan, R., Parmet, W. E., Omer, S. B., Buttenheim, A. M., Benjamin, R. M., Caplan, A., Elharake, J. A., Flowers, L. C., Maldonado, Y. A., Mello, M. M., Opel, D. J., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Hotez, P. J. 2023

  View details for DOI 10.1016/S0140-6736(23)00136-8

  View details for PubMedID 36871571

• Public Health Law Modernization 2.0: Rebalancing Public Health Powers And Individual Liberty In The Age Of COVID-19. Health affairs (Project Hope) Mello, M. M., Gostin, L. O. 2023; 42 (3): 318-327

  Abstract

  Public health emergency powers laws in the US underwent a profound stress test during the COVID-19 pandemic. Designed with bioterrorism in mind, they struggled to meet the challenges of a multiyear pandemic. Public health legal powers in the US are both too limited, in that they don't clearly permit officials to implement measures necessary to combat epidemics, and too broad, in that their accountability mechanisms fall short of public expectations. Recently, some courts and state legislatures have cut deeply into emergency powers, jeopardizing future emergency response. Instead of this curtailment of essential powers, the states and Congress should modernize emergency powers laws to balance powers and individual rights in more productive ways. In this analysis we propose reforms including meaningful legislative checks on executive power, stronger substantive standards for executive orders, mechanisms for public and legislative input, and clearer authority to issue orders affecting groups of people.

  View details for DOI 10.1377/hlthaff.2022.01292

  View details for PubMedID 36877897

• The Public Health Fixes That Missed the Omnibus. JAMA health forum Mello, M. M., Lurie, N., Sharfstein, J. M. 2023; 4 (2): e230263

  View details for DOI 10.1001/jamahealthforum.2023.0263

  View details for PubMedID 36757704

• Metrics, baseline scores, and a tool to improve sponsor performance on clinical trial diversity: retrospective cross sectional study. BMJ medicine Varma, T., Mello, M., Ross, J. S., Gross, C., Miller, J. 2023; 2 (1): e000395

  Abstract

  Objective: To develop a measure for fair inclusion in pivotal trials by assessing transparency and representation of enrolled women, older adults (aged 65 years and older), and racially and ethnically minoritized patients.Design: Retrospective cross sectional study.Population: Sponsors of novel oncology therapeutics that were approved by the US Food and Drug Administration over 1 January 2012 to 31 December 2017.Data sources: Trial data from Drugs@FDA, ClinicalTrials.gov, and corresponding publications; cancer incidence demographics from US Cancer Statistics and the American Cancer Society.Main outcome measures: Transparency measures assess whether trials publicly report participant sex, age, and racial and ethnic identity. Representation measures assess whether trial participant demographics represent more than 80% of the US patient population for studied conditions, calculated by dividing the percentage of study participants in each demographic subgroup by the percentage of the US cancer population with the studied condition per group. Composite fair inclusion measures assess average transparency and representation scores, overall and for each demographic group. Results are reported at the trial, product, and sponsor levels.Results: Between 1 January 2012 and 31 December 2017, the FDA approved 59 novel cancer therapeutics, submitted by 25 sponsors (all industry companies) on the basis of 64 pivotal trials. All 25 sponsors (100%) reported participant sex, 10 (40%) reported age, and six (24%) reported race and ethnicity. Although 14 (56%) sponsors had adequate representation of women in trials, only six (24%) adequately represented older adults, and four (16%) adequately represented racially and ethnically minoritized patients (black, Asian, Hispanic or Latinx). On overall fair inclusion, one sponsor scored 100% and the median sponsor score was 81% (interquartile range 75-87%). More than half of sponsors (13 (56%) of 25) fairly included women, 20% (n=5) fairly included older adults, and 4% (n=1) fairly included racially and ethnically minoritized patients in trials. 80% of product had pivotal trials that fairly included women, 24% fairly included older adults, and 5% fairly included racially and ethnically minoritized patients.Conclusions: This novel approach evaluates trials, products, and sponsors on their fair inclusion of demographic groups in research. For oncology trials, substantial room was noted for improved inclusion of older adults and patients who identify as black or Latinx and transparency around the number of participants identifying as Native Hawaiian, Pacific Islander, American Indian, and Alaska Native. These measures can be used by sponsors, ethics committees, among others, to set and evaluate trial diversity goals to help spur progress toward greater research equity in the US.

  View details for DOI 10.1136/bmjmed-2022-000395

  View details for PubMedID 36936269

• The Fresh Assault on Insurance Coverage Mandates. The New England journal of medicine Mello, M. M., O'Connell, A. J. 2022

  View details for DOI 10.1056/NEJMp2213835

  View details for PubMedID 36449734

• The legacy of the COVID-19 pandemic for childhood vaccination in the USA. Lancet (London, England) Opel, D. J., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Carpiano, R. M., Clinton, C., Elharake, J. A., Flowers, L. C., Galvani, A. P., Hotez, P. J., Schwartz, J. L., Benjamin, R. M., Caplan, A., DiResta, R., Lakshmanan, R., Maldonado, Y. A., Mello, M. M., Parmet, W. E., Salmon, D. A., Sharfstein, J. M., Omer, S. B. 2022

  View details for DOI 10.1016/S0140-6736(22)01693-2

  View details for PubMedID 36309017

• Resuscitating Abortion Rights in Emergency Care JAMA HEALTH FORUM Mello, M. M. 2022; 3 (9)

  View details for DOI 10.1001/jamahealthforum.2022.3781

  View details for Web of Science ID 000855206400001

• Effectiveness of vaccination mandates in improving uptake of COVID-19 vaccines in the USA. Lancet (London, England) Mello, M. M., Opel, D. J., Benjamin, R. M., Callaghan, T., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Salmon, D. A., Schwartz, J. L., Brewer, N. T., Buttenheim, A. M., Carpiano, R. M., Clinton, C., Hotez, P. J., Lakshmanan, R., Maldonado, Y. A., Omer, S. B., Sharfstein, J. M., Caplan, A. 2022

  View details for DOI 10.1016/S0140-6736(22)00875-3

  View details for PubMedID 35817078

• Protecting the Privacy of Reproductive Health Information After the Fall of Roe v Wade JAMA HEALTH FORUM Spector-Bagdady, K., Mello, M. M. 2022; 3 (6)

  View details for DOI 10.1001/jamahealthforum.2022.2656

  View details for Web of Science ID 000837497800001

• Assessment of Perioperative Outcomes Among Surgeons Who Operated the Night Before. JAMA internal medicine Sun, E. C., Mello, M. M., Vaughn, M. T., Kheterpal, S., Hawn, M. T., Dimick, J. B., Jena, A. B. 2022

  Abstract

  Importance: The association between physician fatigue and patient outcomes is important to understand but has been difficult to examine given methodological and data limitations. Surgeons frequently perform urgent procedures overnight and perform additional procedures the following day, which could adversely affect outcomes for those daytime operations.Objective: To examine the association between an attending surgeon operating overnight and outcomes for operations performed by that surgeon the next day.Design, Setting, and Participants: In this cross-sectional study, a retrospective analysis of a large multicenter registry of surgical procedures was done using a within-surgeon analysis to address confounding, with data from 20 high-volume US institutions. This study included 498 234 patients who underwent a surgical procedure during the day (between 7 am and 5 pm) between January 1, 2010, and August 30, 2020.Exposures: Whether the attending surgeon for the current day's procedures operated between 11 pm and 7 am the previous night. Two exposure measures were examined: whether the surgeon operated at all the previous night and the number of hours spent operating the previous night (including having performed no work at all).Main Outcomes and Measures: The primary composite outcome was in-hospital death or major complication (sepsis, pneumonia, myocardial infarction, thromboembolic event, or stroke). Secondary outcomes included operation length and individual outcomes of death, major complications, and minor complications (surgical site infection or urinary tract infection).Results: Among 498 234 daytime operations performed by 1131 surgeons, 13 098 (2.6%) involved an attending surgeon who operated the night before. The mean (SD) age of the patients who underwent an operation was 55.3 (16.4) years, and 264 740 (53.1%) were female. After adjusting for operation type, surgeon fixed effects, and observable patient characteristics (ie, age and comorbidities), the adjusted incidence of in-hospital death or major complications was 5.89% (95% CI, 5.41%-6.36%) among daytime operations when the attending surgeon operated the night before compared with 5.87% (95% CI, 5.85%-5.89%) among daytime operations when the same surgeon did not (absolute adjusted difference, 0.02%; 95% CI, -0.47% to 0.51%; P=.93). No significant associations were found between overnight work and secondary outcomes except for operation length. Operating the previous night was associated with a statistically significant decrease in length of daytime operations (adjusted length, 112.7 vs 117.4 minutes; adjusted difference, -4.7 minutes; 95% CI, -8.7 to -0.8, P=.02), although this difference is unlikely to be meaningful.Conclusions and Relevance: The findings of this cross-sectional study suggest that operating overnight was not associated with worse outcomes for operations performed by surgeons the subsequent day. These results provide reassurance concerning the practice of having attending surgeons take overnight call and still perform operations the following morning.

  View details for DOI 10.1001/jamainternmed.2022.1563

  View details for PubMedID 35604661

• Incentives for COVID-19 vaccination. Lancet Regional Health. Americas Brewer, N. T., Buttenheim, A. M., Clinton, C. V., Mello, M. M., Benjamin, R. M., Callaghan, T., Caplan, A., Carpiano, R. M., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Hotez, P. J., Lakshmanan, R., Maldonado, Y. A., Omer, S. B., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Opel, D. J. 2022; 8: 100205

  View details for DOI 10.1016/j.lana.2022.100205

  View details for PubMedID 35229080

• Vaccine Misinformation and the First Amendment-The Price of Free Speech JAMA HEALTH FORUM Mello, M. M. 2022; 3 (3)

  View details for DOI 10.1001/jamahealthforum.2022.0732

  View details for Web of Science ID 000837247500001

• Population health science as a unifying foundation for translational clinical and public health research. SSM - population health Cullen, M. R., Baiocchi, M., Chamberlain, L., Chu, I., Horwitz, R. I., Mello, M., O'Hara, A., Roosz, S. 2022: 101047

  Abstract

  Separated both in academics and practice since the Rockefeller Foundation effort to "liberate" public health from perceived subservience to clinical medicine a century ago, research in public health and clinical medicine have evolved separately. Today, translational research in population health science offers a means of fostering their convergence, with potentially great benefit to both domains. Although evidence that the two fields need not and should not be entirely distinct in their methods and goals has been accumulating for over a decade, the prodigious efforts of biomedical and social sciences over the past year to address the COVID-19 pandemic has placed this unifying approach to translational research in both fields in a new light. Specifically, the coalescence of clinical and population-level strategies to control disease and novel uses of population-level data and tools in research relating to the pandemic have illuminated a promising future for translational research. We exploit this unique window to re-examine how translational research is conducted and where it may be going. We first discuss the transformation that has transpired in the research firmament over the past two decades and the opportunities these changes afford. Next, we present some of the challenges-technical, cultural, legal, and ethical- that need attention if these opportunities are to be successfully exploited. Finally, we present some recommendations for addressing these challenges.

  View details for DOI 10.1016/j.ssmph.2022.101047

  View details for PubMedID 35252530

• Vaccine Misinformation and the First Amendment-The Price of Free Speech. JAMA health forum Mello, M. M. 2022; 3 (3): e220732

  View details for DOI 10.1001/jamahealthforum.2022.0732

  View details for PubMedID 36218875

• U.S. Public Health Law - Foundations and Emerging Shifts. The New England journal of medicine Mello, M. M., Parmet, W. E. 2022

  View details for DOI 10.1056/NEJMp2200794

  View details for PubMedID 35213103

• Vaccine Verification in the COVID-19 World. Lancet Regional Health. Americas Salmon, D. A., Elharake, J. A., Brewer, N. T., Carpiano, R. M., DiResta, R., Maldonado, Y. A., Sgaier, S. K., Omer, S. B., Lancet Commission on Vaccine Refusal, A. 1800; 6: 100161

  View details for DOI 10.1016/j.lana.2021.100161

  View details for PubMedID 34961857

• THE ROLE OF STATE ATTORNEYS GENERAL IN IMPROVING PRESCRIPTION DRUG AFFORDABILITY SOUTHERN CALIFORNIA LAW REVIEW Mello, M. M., Riley, T., Sachs, R. E. 2022; 95 (3): 595-662

  View details for Web of Science ID 000970792100001

• Vaccine verification in the COVID-19 world Lancet Reg Health Am Salmon, D. A., Elharake, J. A., Brewer, N. T., et al 2022; 6: 100161

  View details for DOI 10.1016/j.lana.2021.100161

• The role of state attorneys general in improving prescription drug affordability Southern California Law Review Mello, M. M., Riley, T., Sachs, R. E. 2022; 95 (3): 595-662
• Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA. Lancet (London, England) Omer, S. B., Benjamin, R. M., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Caplan, A., Carpiano, R. M., Clinton, C., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Lakshmanan, R., Maldonado, Y. A., McFadden, S. M., Mello, M. M., Opel, D. J., Reiss, D. R., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Hotez, P. J. 2021

  Abstract

  Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA.

  View details for DOI 10.1016/S0140-6736(21)02507-1

  View details for PubMedID 34793741

• Do you mind if I record?: Perceptions and practice regarding patient requests to record clinic visits in oncology. Cancer Jimenez, R. B., Johnson, A. E., Horick, N. K., Hlubocky, F. J., Lei, Y., Matsen, C. B., Mayer, E. L., Collyar, D. E., LeBlanc, T. W., Donelan, K., Mello, M. M., Peppercorn, J. M. 2021

  Abstract

  BACKGROUND: Audio recordings of oncology clinic discussions can help patients retain and understand information about their disease and treatment decisions. Access to this tool relies on acceptance of recordings by oncologists. This is the first study to evaluate experience and attitudes of oncologists toward patients recording clinic visits.METHODS: Medical, radiation, and surgical oncologists from 5 US cancer centers and community affiliates were surveyed to evaluate clinicians' experience, beliefs, and practices regarding patient-initiated recordings.RESULTS: Among 360 oncologists (69% response rate), virtually all (93%)have experienced patients seeking to record visits. Although 75% are comfortable with recording,25% are uncomfortable and 56% report concerns ranging from less thorough discussions to legal liability. Most (85%) always agree when patients ask to record, but 15% never or selectively allow recording. Although 51% believe recording is positive for the patient-physician relationship, a sizable minority report that it can lead to less detailed conversations (28%) or avoidance of difficult topics, including prognosis (33%). Views did not vary based on subspecialty, practice setting, or geographic region, but older age and years in practice were associated with more positive views of recording. The majority of clinicians (72%) desire institutional policies to govern guidelines about recordings.CONCLUSIONS: Most oncologists are comfortable with patient requests to record visits, but a sizable minority remain uncomfortable, and access to recording varies solely on physician preference. This difference in care delivery may benefit from institutional policies that promote access while addressing legitimate physician concerns over privacy and appropriate use of recordings.

  View details for DOI 10.1002/cncr.33910

  View details for PubMedID 34633655

• The Political and Judicial Battles Over Mask Mandates for Schools. JAMA health forum Mello, M. M., Studdert, D. M. 2021; 2 (10): e214192

  View details for DOI 10.1001/jamahealthforum.2021.4192

  View details for PubMedID 36218902

• Uncoupling vaccination from politics: a call to action LANCET Sharfstein, J. M., Callaghan, T., Carpiano, R. M., Sgaier, S. K., Brewer, N. T., Galvani, A. P., Lakshmanan, R., McFadden, S. M., Reiss, D. R., Salmon, D. A., Hotez, P. J., Lancet Commission Vaccine Refusal 2021; 398 (10307): 1211-1212

  View details for DOI 10.1016/S0140-6736(21)02099-7

  View details for Web of Science ID 000704393000012

  View details for PubMedID 34537104

  View details for PubMedCentralID PMC8445735

• Public Health Law after Covid-19 NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Parmet, W. E. 2021

  View details for DOI 10.1056/NEJMp2112193

  View details for Web of Science ID 000691736100001

  View details for PubMedID 34469644

• Clinical trial transparency and data sharing among biopharmaceutical companies and the role of company size, location and product type: a cross-sectional descriptive analysis. BMJ open Axson, S., Mello, M. M., Lincow, D., Yang, C., Gross, C., Ross, J. S., Miller, J. 2021; 11 (7): e053248

  Abstract

  OBJECTIVES: To examine company characteristics associated with better transparency and to apply a tool used to measure and improve clinical trial transparency among large companies and drugs, to smaller companies and biologics.DESIGN: Cross-sectional descriptive analysis.SETTING AND PARTICIPANTS: Novel drugs and biologics Food and Drug Administration (FDA) approved in 2016 and 2017 and their company sponsors.MAIN OUTCOME MEASURES: Using established Good Pharma Scorecard (GPS) measures, companies and products were evaluated on their clinical trial registration, results dissemination and FDA Amendments Act (FDAAA) implementation; companies were ranked using these measures and a multicomponent data sharing measure. Associations between company transparency scores with company size (large vs non-large), location (US vs non-US) and sponsored product type (drug vs biologic) were also examined.RESULTS: 26% of products (16/62) had publicly available results for all clinical trials supporting their FDA approval and 67% (39/58) had public results for trials in patients by 6 months after their FDA approval; 58% (32/55) were FDAAA compliant. Large companies were significantly more transparent than non-large companies (overall median transparency score of 95% (IQR 91-100) vs 59% (IQR 41-70), p<0.001), attributable to higher FDAAA compliance (median of 100% (IQR 88-100) vs 57% (0-100), p=0.01) and better data sharing (median of 100% (IQR 80-100) vs 20% (IQR 20-40), p<0.01). No significant differences were observed by company location or product type.CONCLUSIONS: It was feasible to apply the GPS transparency measures and ranking tool to non-large companies and biologics. Large companies are significantly more transparent than non-large companies, driven by better data sharing procedures and implementation of FDAAA trial reporting requirements. Greater research transparency is needed, particularly among non-large companies, to maximise the benefits of research for patient care and scientific innovation.

  View details for DOI 10.1136/bmjopen-2021-053248

  View details for PubMedID 34281933

• Drug Pricing Reform in 2021-Going Big or Going Bipartisan? JAMA health forum Dusetzina, S. B., Mello, M. M. 2021; 2 (7): e212372

  View details for DOI 10.1001/jamahealthforum.2021.2372

  View details for PubMedID 36218771

• The Medical Liability Environment: Is It Really Any Worse for Hospitalists? Journal of hospital medicine Kachalia, A., Mello, M. M. 2021; 16 (7): 446

  View details for DOI 10.12788/jhm.3629

  View details for PubMedID 34197313

• Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California. American journal of public health Largent, E. A., Persad, G., Mello, M. M., Wenner, D. M., Kramer, D. B., Tucker Edmonds, B., Peek, M. 2021: e1-e8

  Abstract

  California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans. (Am J Public Health. Published online ahead of print June 10, 2021: e1-e8. https://doi.org/10.2105/AJPH.2021.306263).

  View details for DOI 10.2105/AJPH.2021.306263

  View details for PubMedID 34111945

• Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California. American journal of public health Largent, E. A., Persad, G., Mello, M. M., Wenner, D. M., Kramer, D. B., Tucker Edmonds, B., Peek, M. 2021: e1-e8

  Abstract

  California has focused on health equity in the state's COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California's 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier's test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans. (Am J Public Health. Published online ahead of print June 10, 2021: e1-e8. https://doi.org/10.2105/AJPH.2021.306272).

  View details for DOI 10.2105/AJPH.2021.306272

  View details for PubMedID 34111359

• Assessing Patients' Experiences with Medical Injury Reconciliation Processes: Item Generation for a Novel Survey Questionnaire JOINT COMMISSION JOURNAL ON QUALITY AND PATIENT SAFETY Schulz-Moore, J. S., Bismark, M., Jenkinson, C., Mello, M. M. 2021; 47 (6): 376-384

  Abstract

  Many health care organizations want to improve their responses to patients who suffer medical injuries. Their ability to understand how well they meet patients' needs is limited by the lack of suitable instruments for assessing injured patients' experiences.This study aimed to generate items for a patient experience questionnaire that medical facilities can use to assess how well resolution met patients' needs. The Medical Injury Reconciliation Experiences Survey (MIRES) was based on findings from previous studies of New Zealand and American patients' experiences of non-litigation resolution of medical injuries. The researchers performed a content analysis of 24 transcripts from a stratified random sample of 92 interviews from the prior studies. Themes were extracted to develop a draft questionnaire, which was revised following feedback from experts. Cognitive debriefing interviews were conducted with 24 New Zealand and American injured patients.There were 40 items in the following domains: perceptions of communications with health care providers after the injury (15 items), perceptions of remedial gestures (11 items), indicia of the patient's overall satisfaction with the reconciliation process (4 items), the nature and impacts of the injury (5 items), and patients' characteristics (5 items). Participants' feedback about the questionnaire was predominantly positive. Their suggestions led to 37 revisions.The MIRES was comprehensible and acceptable to this group of post-injury patients. While further testing is desirable, the MIRES offers promise as a practicable approach that health care organizations can use to assess how well their reconciliation processes met patients' needs.

  View details for DOI 10.1016/j.jcjq.2021.03.004

  View details for Web of Science ID 000654633800007

  View details for PubMedID 33836941

• Evaluation of Drug Trials in High-, Middle-, and Low-Income Countries and Local Commercial Availability of Newly Approved Drugs. JAMA network open Miller, J. E., Mello, M. M., Wallach, J. D., Gudbranson, E. M., Bohlig, B., Ross, J. S., Gross, C. P., Bach, P. B. 2021; 4 (5): e217075

  Abstract

  Importance: Clinical research supporting US Food and Drug Administration (FDA) drug approvals is largely conducted outside the US.Objective: To characterize where drugs were tested for FDA approval and to determine how commonly and quickly these drugs received marketing approval in the countries where they were tested, both overall and by country income level and geographical region.Design, Setting, and Participants: This cross-sectional analysis of trials supporting FDA approval of novel drugs in 2012 and 2014, sponsored by large drug companies, did not involve human participants. The settings were the countries hosting trials supporting US drug approval. Data sources included Drugs@FDA, ClinicalTrials.gov, PubMed, Google Scholar, EMBASE, and drug regulatory agency websites. Data analysis was completed March through September 2020.Main Outcomes and Measures: The primary outcomes were the proportion of drugs approved for marketing in the countries where they were tested for FDA approval within 1, 2, 3, 4, and 5 years of FDA approval and the proportion of countries contributing participants to trials supporting FDA approvals receiving market access to the drugs they helped test within 1, 2, 3, 4, and 5 years of FDA approval.Results: In 2012 and 2014, the FDA approved 34 novel drugs sponsored by large companies, on the basis of a total of 898 trials, 563 of which had location information available. Each drug was tested in a median (interquartile range [IQR]) of 25 (18-37) unique countries, including a median (IQR) of 20 (13-25) high-income countries, 6 (4-11) upper-middle-income countries, and 1 (0-2) low-middle-income country. One drug was approved for marketing in all testing countries within 1 year of FDA approval and 15% (5 of 34 drugs) were approved in all testing countries within 5 years of FDA approval. Of the 70 countries contributing research participants for FDA drug approvals, 7% (5 countries) received market access to drugs they helped test within 1 year of FDA approval and 31% (22 countries) did so within 5 years. Access within 1 year occurred in 13% (5 of 39) of high-income countries, 0 of 22 upper-middle-income countries (0%), and 0 of 9 lower-middle-income countries (0%), whereas at 5 years access rates were 46% (18 of 39 countries), 9% (2 of 22 countries), and 22% (2 of 9 countries), respectively. Approvals were faster in high-income countries (median [IQR], 8 [0-11] months) than in upper-middle-income countries (median [IQR], 11 [5-29] months) or lower-middle-income countries (median [IQR], 17 [11-27] months) after FDA approval. Access was lowest in African countries.Conclusions and Relevance: These findings suggest that substantial gaps exist between where FDA-approved drugs are tested and where they ultimately become available to patients, raising concerns about the equitable distribution of research benefits at the population level.

  View details for DOI 10.1001/jamanetworkopen.2021.7075

  View details for PubMedID 33950209

• To Address Drug Affordability, Grab the Low-hanging Fruit. JAMA Mello, M. M., Riley, T. 2021; 325 (16): 1599–1600

  View details for DOI 10.1001/jama.2021.4619

  View details for PubMedID 33904881

• Announcing the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA LANCET Hotez, P. J., USA, L., Cooney, R. E., Benjamin, R. M., Brewer, N. T., Buttenheim, A. M., Callaghan, T., Caplan, A., Carpiano, R. M., Clinton, C., DiResta, R., Elharake, J. A., Flowers, L. C., Galvani, A. P., Lakshmanan, R., Maldonado, Y. A., McFadden, S. M., Mello, M. M., Opel, D. J., Reiss, D. R., Salmon, D. A., Schwartz, J. L., Sharfstein, J. M., Omer, S. B. 2021; 397 (10280): 1165–67

  View details for DOI 10.1016/S0140-6736(21)00372-X

  View details for Web of Science ID 000633010800006

  View details for PubMedID 33639088

• Choices in a Crisis - Individual Preferences among SARS-CoV-2 Vaccines. The New England journal of medicine Kramer, D. B., Opel, D. J., Parasidis, E., Mello, M. M. 2021

  View details for DOI 10.1056/NEJMp2102146

  View details for PubMedID 33657289

• Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases. Journal of health politics, policy and law Liu, S., Mello, M. M., Kesselheim, A. S. 2021

  Abstract

  CONTEXT: Food and Drug Administration (FDA) rules restrict pharmaceutical manufacturers from promoting drugs for non-FDA-approved (off-label) indications. When manufacturers violate this rule, it has in many cases led to unsafe prescribing. However, in 2012, a federal circuit court ruled in United States v. Caronia that truthful off-label promotion was protected under the First Amendment, threatening government enforcement in this area.METHODS: The authors extracted cases from the WestLawNext database that mentioned Caronia from 2012 to 2019. They collected information about plaintiff, procedural history, product and manufacturer involved, and case outcome. Cases were categorized as either "follows," "does not follow," or "distinguishes" from Caronia. The authors qualitatively reviewed the full text of each case to verify whether Caronia was given substantive discussion for perceptions of off-label promotion, application of commercial speech rights, and how courts interpreted Caronia.FINDINGS: Among 42 cases in the study cohort, 22 (52%) followed Caronia's core holding that truthful, non-misleading off-label promotion was not actionable under FDA rules. By contrast, 20 cases (48%) treated Caronia negatively, either declining to follow (9 cases) or distinguishing it (11 cases).CONCLUSIONS: Enforcement on off-label marketing became more challenging after Caronia. This gives manufacturers greater flexibility to promote drugs for unapproved uses despite the substantial public health risks.

  View details for DOI 10.1215/03616878-8893571

  View details for PubMedID 33647951

• To Address Drug Affordability, Grab the Low-Hanging Fruit. JAMA health forum Mello, M. M., Riley, T. 2021; 2 (2): e210260

  View details for DOI 10.1001/jamahealthforum.2021.0260

  View details for PubMedID 36218799

• How US law will evaluate artificial intelligence for covid-19. BMJ (Clinical research ed.) Krass, M. n., Henderson, P. n., Mello, M. M., Studdert, D. M., Ho, D. E. 2021; 372: n234

  View details for DOI 10.1136/bmj.n234

  View details for PubMedID 33722811

• Supporting Hospitals During a New Wave of COVID-19. Journal of hospital medicine Kachalia, A. n., Mello, M. n. 2021; 16 (5): 311–12

  View details for DOI 10.12788/jhm.3610

  View details for PubMedID 33929952

• When Physicians Engage in Practices That Threaten the Nation's Health. JAMA Pizzo, P. A., Spiegel, D. n., Mello, M. M. 2021

  View details for DOI 10.1001/jama.2021.0122

  View details for PubMedID 33538765

• The Missing Piece - SARS-CoV-2 Testing and School Reopening. The New England journal of medicine Rafiei, Y., Mello, M. M. 2020

  View details for DOI 10.1056/NEJMp2028209

  View details for PubMedID 33085856

• Oncologist experiences regarding patient-recorded clinical encounters: Implications for the patient-doctor relationship. Jimenez, R., Johnson, A., Horick, N. K., Hlubocky, F. J., Lei, Y. Y., Matsen, C., Mayer, E. L., Collyar, D. E., LeBlanc, T., Donelan, K., Mello, M., Peppercorn, J. M. AMER SOC CLINICAL ONCOLOGY. 2020

  View details for Web of Science ID 000607202800287

• School Reopenings and the Community During the COVID-19 Pandemic. JAMA health forum Goldhaber-Fiebert, J. D., Studdert, D. M., Mello, M. M. 2020; 1 (10): e201294

  View details for DOI 10.1001/jamahealthforum.2020.1294

  View details for PubMedID 36218562

• Attacks on Public Health Officials During COVID-19. JAMA Mello, M. M., Greene, J. A., Sharfstein, J. M. 2020

  View details for DOI 10.1001/jama.2020.14423

  View details for PubMedID 32777019

• Partitioning the Curve - Interstate Travel Restrictions During the Covid-19 Pandemic. The New England journal of medicine Studdert, D. M., Hall, M. A., Mello, M. M. 2020

  View details for DOI 10.1056/NEJMp2024274

  View details for PubMedID 32757517

• Ensuring Uptake of Vaccines against SARS-CoV-2. The New England journal of medicine Mello, M. M., Silverman, R. D., Omer, S. B. 2020

  View details for DOI 10.1056/NEJMp2020926

  View details for PubMedID 32589371

• Respecting Disability Rights - Toward Improved Crisis Standards of Care. The New England journal of medicine Mello, M. M., Persad, G., White, D. B. 2020

  View details for DOI 10.1056/NEJMp2011997

  View details for PubMedID 32427433

• Diagnostic Testing for the Novel Coronavirus JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Sharfstein, J. M., Becker, S. J., Mello, M. M. 2020; 323 (15): 1437–38

  View details for DOI 10.1001/0ma.2020.3864

  View details for Web of Science ID 000529969700006

• Diagnostic Testing for the Novel Coronavirus. JAMA Sharfstein, J. M., Becker, S. J., Mello, M. M. 2020

  View details for DOI 10.1001/jama.2020.3864

  View details for PubMedID 32150622

• Ensuring successful implementation of communication-and-resolution programmes. BMJ quality & safety Mello, M. M., Roche, S., Greenberg, Y., Folcarelli, P. H., Van Niel, M. B., Kachalia, A. 2020

  Abstract

  BACKGROUND: Communication-and-resolution programmes (CRP) aim to increase transparency surrounding adverse events, improve patient safety and promote reconciliation by proactively meeting injured patients' needs. Although early adopters of CRP models reported relatively smooth implementation, other organisations have struggled to achieve the same. However, two Massachusetts hospital systems implementing a CRP demonstrated high fidelity to protocol without raising liability costs.STUDY QUESTION: What factors may account for the Massachusetts hospitals' ability to implement their CRP successfully?SETTING: The CRP was collaboratively designed by two academic medical centres, four of their community hospitals and a multistakeholder coalition.DATA AND METHODS: Data were synthesised from (1) key informant interviews around the time of implementation and 2 years later with individuals important to the CRP's success and (2) notes from 89 teleconferences between hospitals' CRP implementation teams and study staff to discuss implementation progress. Interview transcripts and teleconference notes were analysed using standard methods of thematic content analysis. A total of 45 individuals participated in interviews (n=24 persons in 38 interviews), teleconferences (n=32) or both (n=11).RESULTS: Participants identified facilitators of the hospitals' success as: (1) the support of top institutional leaders, (2) heavy investments in educating physicians about the programme, (3) active cultivation of the relationship between hospital risk managers and representatives from the liability insurer, (4) the use of formal decision protocols, (5) effective oversight by full-time project managers, (6) collaborative group implementation, and (7) small institutional size.CONCLUSION: Although not necessarily causal, several distinctive factors appear to be associated with successful CRP implementation.

  View details for DOI 10.1136/bmjqs-2019-010296

  View details for PubMedID 31959716

• Waiting for data: Barriers to executing data use agreements. Science (New York, N.Y.) Mello, M. M., Triantis, G. n., Stanton, R. n., Blumenkranz, E. n., Studdert, D. M. 2020; 367 (6474): 150–52

  View details for DOI 10.1126/science.aaz7028

  View details for PubMedID 31919212

• Standing Up against Gender Bias and Harassment - A Matter of Professional Ethics. The New England journal of medicine Mello, M. M., Jagsi, R. n. 2020; 382 (15): 1385–87

  View details for DOI 10.1056/NEJMp1915351

  View details for PubMedID 32268023

• The Legal Authority for States' Stay-at-Home Orders. The New England journal of medicine Hall, M. A., Mello, M. M., Studdert, D. M. 2020

  View details for DOI 10.1056/NEJMp2019662

  View details for PubMedID 32492296

• Thinking Globally, Acting Locally - The U.S. Response to Covid-19. The New England journal of medicine Haffajee, R. L., Mello, M. M. 2020

  View details for DOI 10.1056/NEJMp2006740

  View details for PubMedID 32240580

• Apology laws and malpractice liability: what have we learned? BMJ quality & safety Fields, A. C., Mello, M. M., Kachalia, A. n. 2020

  View details for DOI 10.1136/bmjqs-2020-010955

  View details for PubMedID 32561590

• Ethics and Governance for Digital Disease Surveillance Science Mello, M., Wang, C. J. 2020; 368 (6494): 951-954

  View details for DOI 10.1126/science.abb9045

• Ethics and governance for digital disease surveillance. Science (New York, N.Y.) Mello, B. M., Wang, C. J. 2020

  Abstract

  The question is not whether to use new data sources but how.

  View details for DOI 10.1126/science.abb9045

  View details for PubMedID 32393527

• Malpractice Liability and Health Care Quality: A Review. JAMA Mello, M. M., Frakes, M. D., Blumenkranz, E. n., Studdert, D. M. 2020; 323 (4): 352–66

  Abstract

  The tort liability system is intended to serve 3 functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence. Deterrence, in theory, occurs because clinicians know that they may experience adverse consequences if they negligently injure patients.To review empirical findings regarding the association between malpractice liability risk (ie, the extent to which clinicians face the threat of being sued and having to pay damages) and health care quality and safety.Systematic search of multiple databases for studies published between January 1, 1990, and November 25, 2019, examining the relationship between malpractice liability risk measures and health outcomes or structural and process indicators of health care quality.Information on the exposure and outcome measures, results, and acknowledged limitations was extracted by 2 reviewers. Meta-analytic pooling was not possible due to variations in study designs; therefore, studies were summarized descriptively and assessed qualitatively.Associations between malpractice risk measures and health care quality and safety outcomes. Exposure measures included physicians' malpractice insurance premiums, state tort reforms, frequency of paid claims, average claim payment, physicians' claims history, total malpractice payments, jury awards, the presence of an immunity from malpractice liability, the Centers for Medicare & Medicaid Services' Medicare malpractice geographic practice cost index, and composite measures combining these measures. Outcome measures included patient mortality; hospital readmissions, avoidable admissions, and prolonged length of stay; receipt of cancer screening; Agency for Healthcare Research and Quality patient safety indicators and other measures of adverse events; measures of hospital and nursing home quality; and patient satisfaction.Thirty-seven studies were included; 28 examined hospital care only and 16 focused on obstetrical care. Among obstetrical care studies, 9 found no significant association between liability risk and outcomes (such as Apgar score and birth injuries) and 7 found limited evidence for an association. Among 20 studies of patient mortality in nonobstetrical care settings, 15 found no evidence of an association with liability risk and 5 found limited evidence. Among 7 studies that examined hospital readmissions and avoidable initial hospitalizations, none found evidence of an association between liability risk and outcomes. Among 12 studies of other measures (eg, patient safety indicators, process-of-care quality measures, patient satisfaction), 7 found no association between liability risk and these outcomes and 5 identified significant associations in some analyses.In this systematic review, most studies found no association between measures of malpractice liability risk and health care quality and outcomes. Although gaps in the evidence remain, the available findings suggested that greater tort liability, at least in its current form, was not associated with improved quality of care.

  View details for DOI 10.1001/jama.2019.21411

  View details for PubMedID 31990319

• HIPAA in the Era of Data Sharing-Reply. JAMA Cohen, I. G., Mello, M. M. 2020; 323 (5): 477

  View details for DOI 10.1001/jama.2019.19655

  View details for PubMedID 32016304

• Assessment of Out-of-Network Billing for Privately Insured Patients Receiving Care in In-Network Hospitals. JAMA internal medicine Sun, E. C., Mello, M. M., Moshfegh, J., Baker, L. C. 2019

  Abstract

  Importance: Although surprise medical bills are receiving considerable attention from lawmakers and the news media, to date there has been little systematic study of the incidence and financial consequences of out-of-network billing.Objective: To examine out-of-network billing among privately insured patients with an inpatient admission or emergency department (ED) visit at in-network hospitals.Design, Setting, and Participants: A retrospective analysis using data from the Clinformatics Data Mart database (Optum), which includes health insurance claims for individuals from all 50 US states receiving private health insurance from a large commercial insurer was conducted of all inpatient admissions (n=5 457 981) and ED visits (n=13 579 006) at in-network hospitals between January 1, 2010, and December 31, 2016. Data were collected and analyzed in March 2019.Exposures: Receipt of a bill for care from at least 1 out-of-network physician or medical transport service associated with patient admission or ED visit.Main Outcomes and Measures: The incidence of out-of-network billing and the potential amount of patients' financial liability associated with out-of-network bills from the admission or visit.Results: Of 5 457 981 inpatient admissions and 13 579 006 ED admissions between 2010 and 2016, the percentage of ED visits with an out-of-network bill increased from 32.3% to 42.8% (P<.001) during the study period, and the mean (SD) potential financial responsibility for these bills increased from $220 ($420) to $628 ($865) (P<.001; all dollar values in 2018 US$). Similarly, the percentage of inpatient admissions with an out-of-network bill increased from 26.3% to 42.0% (P<.001), and the mean (SD) potential financial responsibility increased from $804 ($2456) to $2040 ($4967) (P<.001).Conclusions and Relevance: Out-of-network billing appears to have become common for privately insured patients even when they seek treatment at in-network hospitals. The mean amounts billed appear to be sufficiently large that they may create financial strain for a substantial proportion of patients.

  View details for DOI 10.1001/jamainternmed.2019.3451

  View details for PubMedID 31403651

• Big Data, Big Tech, and Protecting Patient Privacy. JAMA Cohen, I. G., Mello, M. M. 2019

  View details for DOI 10.1001/jama.2019.11365

  View details for PubMedID 31397838

• Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices BMJ-BRITISH MEDICAL JOURNAL Miller, J., Ross, J. S., Wilenzick, M., Mello, M. M. 2019; 366

  View details for DOI 10.1136/bmj.l4127

  View details for Web of Science ID 000475735600006

• 'Poking the skunk': Ethical and medico-legal concerns in research about patients' experiences of medical injury. Bioethics Schulz Moore, J., Mello, M. M., Bismark, M. 2019

  Abstract

  Improving how health care providers respond to medical injury requires an understanding of patients' experiences. Although many injured patients strongly desire to be heard, research rarely involves them. Institutional review boards worry about harming participants by asking them to revisit traumatic events, and hospital staff worry about provoking lawsuits. Institutions' reluctance to approve this type of research has slowed progress toward responses to injuries that are better able to meet patients' needs. In 2015-2016, we were able to surmount these challenges and interview 92 injured patients and families in the USA and New Zealand. This article explores whether the ethical and medico-legal concerns are, in fact, well-founded. Consistent with research about trauma-research-related distress, our participants' accounts indicate that the pervasive fears about retraumatization are unfounded. Our experience also suggests that because being heard is an important (but often unmet) need for injured patients, talking provides psychological benefits and may decrease rather than increase the impetus to sue. Our article makes recommendations to institutional review boards and researchers. The benefits to responsibly conducted research with injured patients outweigh the risks to participants and institutions.

  View details for DOI 10.1111/bioe.12599

  View details for PubMedID 31222898

• Effect of the public disclosure of industry payments information on patients: results from a population-based natural experiment BMJ OPEN Kanter, G. P., Carpenter, D., Lehmann, L., Mello, M. M. 2019; 9 (2)

  View details for DOI 10.1136/bmjopen-2018-024020

  View details for Web of Science ID 000471124600106

• Barriers to Ensuring Access to Affordable Prescription Drugs. Annual review of pharmacology and toxicology Mello, M. M. 2019

  Abstract

  High and rising prescription drug costs have become a preoccupying policy problem in the United States. Notwithstanding broad, bipartisan interest in finding effective policy solutions, several aspects of the drug affordability problem make it an uncommonly difficult one to solve. This article reviews the moral, market, and political factors contributing to the difficulty. Among the moral problems is lack of agreement about how to weigh the fundamental tradeoff involved in regulating drug prices-affordability versus incentives for innovation-and about what constitutes a fair price. Market-related factors include the lack of price transparency and a myriad of perverse incentives in the system through which prescription drugs are supplied to patients. Finally, current policy choices are constrained by past political compromises, and an atmosphere of scandal focusing on egregious instances of price gouging has made rational deliberation about fixes to deeper problems in the system difficult. Expected final online publication date for the Annual Review of Pharmacology and Toxicology Volume 60 is January 9, 2020. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

  View details for DOI 10.1146/annurev-pharmtox-010919-023518

  View details for PubMedID 31136248

• US Nationwide Disclosure of Industry Payments and Public Trust in Physicians. JAMA network open Kanter, G. P., Carpenter, D., Lehmann, L. S., Mello, M. M. 2019; 2 (4): e191947

  Abstract

  Importance: Transparency of industry payments to physicians could engender greater public trust in physicians but might also lead to greater mistrust of physicians and the medical profession, adversely affecting the patient-physician relationship.Objective: To examine the association between nationwide public disclosure of industry payments and Americans' trust in their physicians and trust in the medical profession.Design, Setting, and Participants: Survey study using difference-in-difference analyses of a national longitudinal survey comparing changes in states where industry payments were newly disclosed by Open Payments with changes in states where payments information was already available because of state sunshine laws. The US population-based surveys were conducted in September 2014-shortly before the initial public disclosure of industry payments-and again in September 2016. Final analyses were conducted September through December 2018. Participants were adults 18 years and older (n=1388).Exposures: National public disclosure through Open Payments of payments made by pharmaceutical and medical device firms to physicians.Main Outcomes and Measures: Wake Forest measure of trust in one's own physician and Wake Forest measure of trust in the medical profession.Results: Of the 3542 original survey respondents, 2180 (61.5%) completed the second survey 2 years later, and 1388 named the same most frequently seen physician in both surveys. The mean age of respondents at the time of the first survey was 53 years, and 749 (54.0%) were women. Race/ethnicity was white in 76.6% (1063 of 1388) and non-Hispanic black in 8.0% (111 of 1388). Public disclosure of payments was associated with lower trust in one's own physician regardless of whether respondents knew their physicians had received payments (decrease in Wake Forest measure of trust in one's own physician of 0.56 point; 95% CI, -0.79 to -0.32 point; P<.001). Open Payments was also associated with lower trust in the medical profession (decrease in Wake Forest measure of trust in the medical profession of 0.35 point; 95% CI, -0.58 to -0.12 point; P=.004).Conclusions and Relevance: Nationwide public disclosure of industry payments may be associated with decreased trust in physicians and in the medical profession. More judicious presentation of payments information may counteract unintended negative trust and spillover consequences of public disclosure.

  View details for PubMedID 30977850

• US Nationwide Disclosure of Industry Payments and Public Trust in Physicians JAMA NETWORK OPEN Kanter, G. P., Carpenter, D., Lehmann, L. S., Mello, M. M. 2019; 2 (4)

  View details for DOI 10.1001/jamanetworkopen.2019.1947

  View details for Web of Science ID 000476798700027

• Changes in Practice among Physicians with Malpractice Claims NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Spittal, M. J., Zhang, Y., Wilkinson, D. S., Singh, H., Mello, M. M. 2019; 380 (13): 1247–55

  View details for DOI 10.1056/NEJMsa1809981

  View details for Web of Science ID 000463251600009

• Changes in Practice among Physicians with Malpractice Claims. The New England journal of medicine Studdert, D. M., Spittal, M. J., Zhang, Y., Wilkinson, D. S., Singh, H., Mello, M. M. 2019; 380 (13): 1247–55

  Abstract

  BACKGROUND: Physicians with poor malpractice liability records may pose a risk to patient safety. There are long-standing concerns that such physicians tend to relocate for a fresh start, but little is known about whether, how, and where they continue to practice.METHODS: We linked an extract of the National Practitioner Data Bank to the Medicare Data on Provider Practice and Specialty data set to create a national cohort of physicians 35 to 65 years of age who practiced during the period from 2008 through 2015. We analyzed associations between the number of paid malpractice claims that physicians accrued and exits from medical practice, changes in clinical volume, geographic relocation, and change in practice-group size.RESULTS: The cohort consisted of 480,894 physicians who had 68,956 paid claims from 2003 through 2015. A total of 89.0% of the physicians had no claims, 8.8% had 1 claim, and the remaining 2.3% had 2 or more claims and accounted for 38.9% of all claims. The number of claims was positively associated with the odds of leaving the practice of medicine (odds ratio for 1 claim vs. no claims, 1.09; 95% confidence interval [CI], 1.06 to 1.11; odds ratio for ≥5 claims, 1.45; 95% CI, 1.20 to 1.74). The number of claims was not associated with geographic relocation but was positively associated with shifts into smaller practice settings. For example, physicians with 5 or more claims had more than twice the odds of moving into solo practice than physicians with no claims (odds ratio, 2.39; 95% CI, 1.79 to 3.20).CONCLUSIONS: Physicians with multiple malpractice claims were no more likely to relocate geographically than those with no claims, but they were more likely to stop practicing medicine or switch to smaller practice settings. (Funded by SUMIT Insurance and the Australian Research Council.).

  View details for PubMedID 30917259

• Effect of the public disclosure of industry payments information on patients: results from a population-based natural experiment. BMJ open Kanter, G. P., Carpenter, D., Lehmann, L., Mello, M. M. 2019; 9 (2): e024020

  Abstract

  OBJECTIVE: To determine the effect of the public disclosure of industry payments to physicians on patients' awareness of industry payments and knowledge about whether their physicians had accepted industry payments.DESIGN: Interrupted time series with comparison group (difference-in-difference analyses of longitudinal survey).SETTING: Nationally representative US population-based surveys. Surveys were conducted in September 2014, shortly prior to the public release of Open Payments information, and again in September 2016.PARTICIPANTS: Adults aged 18 and older (n=2180).MAIN OUTCOME MEASURES: Awareness of industry payments as an issue; awareness that industry payments information was publicly available; knowledge of whether own physician had received industry payments.RESULTS: Public disclosure of industry payments information through Open Payments did not significantly increase the proportion of respondents who knew whether their physician had received industry payments (p=0.918). It also did not change the proportion of respondents who became aware of the issue of industry payments (p=0.470) but did increase the proportion who knew that payments information was publicly available (9.6% points, p=0.011).CONCLUSIONS: Two years after the public disclosure of industry payments information, Open Payments does not appear to have achieved its goal of increasing patient knowledge of whether their physicians have received money from pharmaceutical and medical device firms. Additional efforts will be required to improve the use and effectiveness of Open Payments for consumers.

  View details for PubMedID 30826793

• Association of Federal Mental Health Parity Legislation With Health Care Use and Spending Among High Utilizers of Services. Medical care Haffajee, R. L., Mello, M. M., Zhang, F., Busch, A. B., Zaslavsky, A. M., Wharam, J. F. 2019

  Abstract

  BACKGROUND: Decades-long efforts to require parity between behavioral and physical health insurance coverage culminated in the comprehensive federal Mental Health Parity and Addiction Equity Act.OBJECTIVES: To determine the association between federal parity and changes in mental health care utilization and spending, particularly among high utilizers.RESEARCH DESIGN: Difference-in-differences analyses compared changes before and after exposure to federal parity versus a comparison group.SUBJECTS: Commercially insured enrollees aged 18-64 with a mental health disorder drawn from 24 states where self-insured employers were newly subject to federal parity in 2010 (exposure group), but small employers were exempt before-and-after parity (comparison group). A total of 11,226 exposure group members were propensity score matched (1:1) to comparison group members, all of whom were continuously enrolled from 1 year prepolicy to 1-2 years postpolicy.MEASURES: Mental health outpatient visits, out-of-pocket spending for these visits, emergency department visits, and hospitalizations.RESULTS: Relative to comparison group members, mean out-of-pocket spending per outpatient mental health visit declined among exposure enrollees by $0.74 (1.40, 0.07) and $2.03 (3.17, 0.89) in years 1 and 2 after the policy, respectively. Corresponding annual mental health visits increased by 0.31 (0.12, 0.51) and 0.59 (0.37, 0.81) per enrollee. Difference-in-difference changes were larger for the highest baseline quartile mental health care utilizers [year 2: 0.76 visits per enrollee (0.14, 1.38); relative increase 10.07%] and spenders [year 2: $-2.28 (-3.76, -0.79); relative reduction 5.91%]. There were no significant difference-in-differences changes in emergency department visits or hospitalizations.CONCLUSIONS: In 24 states, commercially insured high utilizers of mental health services experienced modest increases in outpatient mental health visits 2 years postparity.

  View details for PubMedID 30807450

• Sharing of clinical trial data and results reporting practices among large pharmaceutical companies: cross sectional descriptive study and pilot of a tool to improve company practices. BMJ (Clinical research ed.) Miller, J., Ross, J. S., Wilenzick, M., Mello, M. M. 2019; 366: l4217

  Abstract

  OBJECTIVES: To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices.DESIGN: Cross sectional descriptive analysis.SETTING: Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015.DATA SOURCES: Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies.MAIN OUTCOME MEASURES: Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices.RESULTS: Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval.CONCLUSIONS: It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.

  View details for DOI 10.1136/bmj.l4217

  View details for PubMedID 31292127

• Narrowing Vaccination Exemption Laws: Lessons From California and Beyond. Annals of internal medicine Mello, M. M. 2019

  View details for DOI 10.7326/M19-3111

  View details for PubMedID 31683316

• Multilevel legal approaches to obesity prevention: A conceptual and methodological toolkit. PloS one Abiola, S. E., Mello, M. M. 2019; 14 (10): e0220971

  Abstract

  INTRODUCTION: State lawmakers have explored numerous policy alternatives to reduce overweight and obesity. Evaluating effects of these laws is important but presents substantial methodological challenges. We present a conceptual framework that allows for classification of obesity prevention laws based on ecological level of influence and the underlying legal mechanism involved to guide analysis of the relationship between a substantial range of obesity prevention laws and BMI.METHODS: Obesity prevention laws (OPLs) for all 50 states and DC were obtained via primary legal research using the LexisNexis Advanced Legislative Services (ALS) database. For legal provisions that met inclusion criteria, reviewers abstracted information on bill state, citation, passage and effective dates, target population, and obesity prevention mechanism. Laws were categorized by ecological level of influence on weight-related behaviors and the legal mechanism utilized to change behavioral determinants of BMI.RESULTS: Laws designed to increase community-level opportunities for physical activity were the most frequently enacted OPL while laws designed to alter nutrition standards for school meals or competitive foods were comparatively less common, appearing in only 16% and 34% of states, respectively.CONCLUSION: Prior studies of obesity policies have focused on specific interventions. We identified and categorized state-level laws that operate at all ecological levels and found that laws passed during the initial burst of lawmaking were largely confined to measures aimed at increasing opportunities for physical activity. Creating public spaces for recreation is an important step to promoting healthier lifestyles to reduce obesity risk; more comprehensive, multilevel legal approaches should also be pursued.

  View details for DOI 10.1371/journal.pone.0220971

  View details for PubMedID 31574096

• Association of Overlapping Surgery With Perioperative Outcomes. JAMA Sun, E. n., Mello, M. M., Rishel, C. A., Vaughn, M. T., Kheterpal, S. n., Saager, L. n., Fleisher, L. A., Damrose, E. J., Kadry, B. n., Jena, A. B. 2019; 321 (8): 762–72

  Abstract

  Overlapping surgery, in which more than 1 procedure performed by the same primary surgeon is scheduled so the start time of one procedure overlaps with the end time of another, is of concern because of potential adverse outcomes.To determine the association between overlapping surgery and mortality, complications, and length of surgery.Retrospective cohort study of 66 430 operations in patients aged 18 to 90 years undergoing total knee or hip arthroplasty; spine surgery; coronary artery bypass graft (CABG) surgery; and craniotomy at 8 centers between January 1, 2010, and May 31, 2018. Patients were followed up until discharge.Overlapping surgery (≥2 operations performed by the same surgeon in which ≥1 hour of 1 case, or the entire case for those <1 hour, occurs when another procedure is being performed).Primary outcomes were in-hospital mortality or complications (major: thromboembolic event, pneumonia, sepsis, stroke, or myocardial infarction; minor: urinary tract or surgical site infection) and surgery duration.The final sample consisted of 66 430 operations (mean patient age, 59 [SD, 15] years; 31 915 women [48%]), of which 8224 (12%) were overlapping. After adjusting for confounders, overlapping surgery was not associated with a significant difference in in-hospital mortality (1.9% overlapping vs 1.6% nonoverlapping; difference, 0.3% [95% CI, -0.2% to 0.7%]; P = .21) or risk of complications (12.8% overlapping vs 11.8% nonoverlapping; difference, 0.9% [95% CI, -0.1% to 1.9%]; P = .08). Overlapping surgery was associated with increased surgery length (204 vs 173 minutes; difference, 30 minutes [95% CI, 24 to 37 minutes]; P < .001). Overlapping surgery was significantly associated with increased mortality and increased complications among patients having a high preoperative predicted risk for mortality and complications, compared with low-risk patients (mortality: 5.8% vs 4.7%; difference, 1.2% [95% CI, 0.1% to 2.2%]; P = .03; complications: 29.2% vs 27.0%; difference, 2.3% [95% CI, 0.3% to 4.3%]; P = .03).Among adults undergoing common operations, overlapping surgery was not significantly associated with differences in in-hospital mortality or postoperative complication rates but was significantly associated with increased surgery length. Further research is needed to understand the association of overlapping surgery with these outcomes among specific patient subgroups.

  View details for PubMedID 30806696

• LEGAL STRATEGIES FOR REINING IN "UNCONSCIONABLE" PRICES FOR PRESCRIPTION DRUGS NORTHWESTERN UNIVERSITY LAW REVIEW Mello, M. M., Wolitz, R. E. 2019; 114 (4): 859–968

  View details for Web of Science ID 000508240700001

• Disclosing Prescription-Drug Prices in Advertisements - Legal and Public Health Issues. The New England journal of medicine Dusetzina, S. B., Mello, M. M. 2018

  View details for PubMedID 30428275

• Can Communication-And-Resolution Programs Achieve Their Potential? Five Key Questions. Health affairs (Project Hope) Gallagher, T. H., Mello, M. M., Sage, W. M., Bell, S. K., McDonald, T. B., Thomas, E. J. 2018; 37 (11): 1845–52

  Abstract

  Communication-and-resolution programs (CRPs) are intended to promote accountability, transparency, and learning after adverse events. In this article we address five key challenges to the programs' future success: implementation fidelity, the evidence base for CRPs and their link to patient safety, fair compensation of harmed patients, alignment of CRP design with participants' needs, and public policy on CRPs. While the field has arrived at an understanding of the core communication-and-resolution practices, limited adherence fuels skepticism that programs are meeting the needs of patients and families who have been injured by care or improving patient safety. Adherence to communication-and-resolution practices could be enhanced by adopting measures of CRP quality and implementing programs in a comprehensive, principled, and systematic manner. Of particular importance is offering fair compensation to patients in CRPs and supporting their right to attorney representation. There is evidence that the use of CRPs reduces liability costs, but research on other outcomes is limited. Additional research is especially needed on the links between CRPs and quality and on the programs' alignment with patients' and families' needs. By honoring principles of transparency, quality improvement, and patient and family empowerment, organizations can use their CRPs to help revitalize the medical profession.

  View details for PubMedID 30395493

• Effects Of A Communication-And-Resolution Program On Hospitals' Malpractice Claims And Costs. Health affairs (Project Hope) Kachalia, A., Sands, K., Niel, M. V., Dodson, S., Roche, S., Novack, V., Yitshak-Sade, M., Folcarelli, P., Benjamin, E. M., Woodward, A. C., Mello, M. M. 2018; 37 (11): 1836–44

  Abstract

  To promote communication with patients after medical injuries and improve patient safety, numerous hospitals have implemented communication-and-resolution programs (CRPs). Through these programs, hospitals communicate transparently with patients after adverse events; investigate what happened and offer an explanation; and, when warranted, apologize, take responsibility, and proactively offer compensation. Despite growing consensus that CRPs are the right thing to do, concerns over liability risks remain. We evaluated the liability effects of CRP implementation at four Massachusetts hospitals by examining before-and-after trends in claims volume, cost, and time to resolution and comparing them to trends among nonimplementing peer institutions. CRP implementation was associated with improved trends in the rate of new claims and legal defense costs at some hospitals, but it did not significantly alter trends in other outcomes. None of the hospitals experienced worsening liability trends after CRP implementation, which suggests that transparency, apology, and proactive compensation can be pursued without adverse financial consequences.

  View details for PubMedID 30395501

• Behind Schedule - Reconciling Federal and State Marijuana Policy. The New England journal of medicine Haffajee, R. L., MacCoun, R. J., Mello, M. M. 2018

  View details for PubMedID 29996065

• Clinical Trial Participants' Views of the Risks and Benefits of Data Sharing NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Lieou, V., Goodman, S. N. 2018; 378 (23): 2202–11

  Abstract

  Background Sharing of participant-level clinical trial data has potential benefits, but concerns about potential harms to research participants have led some pharmaceutical sponsors and investigators to urge caution. Little is known about clinical trial participants' perceptions of the risks of data sharing. Methods We conducted a structured survey of 771 current and recent participants from a diverse sample of clinical trials at three academic medical centers in the United States. Surveys were distributed by mail (350 completed surveys) and in clinic waiting rooms (421 completed surveys) (overall response rate, 79%). Results Less than 8% of respondents felt that the potential negative consequences of data sharing outweighed the benefits. A total of 93% were very or somewhat likely to allow their own data to be shared with university scientists, and 82% were very or somewhat likely to share with scientists in for-profit companies. Willingness to share data did not vary appreciably with the purpose for which the data would be used, with the exception that fewer participants were willing to share their data for use in litigation. The respondents' greatest concerns were that data sharing might make others less willing to enroll in clinical trials (37% very or somewhat concerned), that data would be used for marketing purposes (34%), or that data could be stolen (30%). Less concern was expressed about discrimination (22%) and exploitation of data for profit (20%). Conclusions In our study, few clinical trial participants had strong concerns about the risks of data sharing. Provided that adequate security safeguards were in place, most participants were willing to share their data for a wide range of uses. (Funded by the Greenwall Foundation.).

  View details for PubMedID 29874542

• HIPAA and Protecting Health Information in the 21st Century. JAMA Cohen, I. G., Mello, M. M. 2018

  View details for PubMedID 29800120

• Ethics of randomized trials in a public health emergency PLOS NEGLECTED TROPICAL DISEASES London, A., Omotade, O. O., Mello, M. M., Keusch, G. T. 2018; 12 (5): e0006313

  View details for PubMedID 29771907

• Commentary: How Should Hospitals Respond to Surgeons' Requests to Schedule Overlapping Surgeries? Neurosurgery Morris, A. J., Mello, M. M., Sanford, J. A., Green, R. B., Wald, S. H., Kadry, B., Macario, A. 2018; 82 (4): E91–E98

  View details for PubMedID 29351634

• Avoiding Malpractice Suits: The Authors Reply HEALTH AFFAIRS Mello, M. M., Benjamin, E. M., Kachalia, A. 2018; 37 (4): 676

  View details for PubMedID 29608350

• What Patients Expect and Deserve Reply JAMA INTERNAL MEDICINE Moore, J., Mello, M. M. 2018; 178 (4): 578-+

  View details for PubMedID 29610888

• Legal Barriers to the Growth of Health Information ExchangeBoulders or Pebbles? MILBANK QUARTERLY Mello, M. M., Adler-Milstein, J., Ding, K. L., Savage, L. 2018; 96 (1): 110–43

  Abstract

  Policy Points: Historically, in addition to economic and technical hurdles, state and federal health information privacy laws have been cited as a significant obstacle to expanding electronic health information exchange (HIE) in the United States. Our review finds that over the past decade, several helpful developments have ameliorated the legal barriers to HIE, although variation in states' patient consent requirements remains a challenge. Today, health care providers' complaints about legal obstacles to HIE may be better understood as reflecting concerns about the economic and competitive risks of information sharing.Although the clinical benefits of exchanging patients' health information electronically across providers have long been recognized, participation in health information exchange (HIE) has lagged behind adoption of electronic health records. Barriers erected by federal and state health information privacy law have been cited as a leading reason for the slow progress. A comprehensive assessment of these issues has not been undertaken for nearly a decade, despite a number of salient legal developments.Analysis of federal and state health information privacy statutes and regulations and secondary materials.Although some legal barriers to HIE persist, many have been ameliorated-in some cases, simply through improved understanding of what the law actually requires. It is now clear that the Health Insurance Portability and Accountability Act presents no obstacles to electronically sharing protected health information for treatment purposes and does not hold providers who properly disclose information liable for privacy breaches by recipients. The failure of federal efforts to establish a unique patient identifier number does slow HIE by inhibiting optimal matching of patient records, but other action to facilitate matching will be taken under the 21st Century Cures Act. The Cures Act also creates the legal architecture to begin to combat "information blocking." Varying patient consent requirements under federal and state law are the most important remaining legal barrier to HIE progress. However, federal rules relating to disclosure of substance-abuse treatment information were recently liberalized, and development of a technical standard, Data Segmentation for Privacy, or DS4P, now permits sensitive data requiring special handling to be segmented within a patient's record. Even with these developments, state-law requirements for patient consent remain daunting to navigate.Although patient consent requirements make HIE challenging, providers' expressed worries about legal barriers to participating in HIE likely primarily reflect concerns that are economically motivated. Lowering the cost of HIE or increasing financial incentives may boost provider participation more than further reducing legal barriers.

  View details for PubMedID 29504197

  View details for PubMedCentralID PMC5835678

• Vaccination without Litigation - Addressing Religious Objections to Hospital Influenza-Vaccination Mandates NEW ENGLAND JOURNAL OF MEDICINE Opel, D. J., Sonne, J. A., Mello, M. M. 2018; 378 (9): 785–88

  View details for PubMedID 29384718

• What Makes Ensuring Access to Affordable Prescription Drugs the Hardest Problem in Health Policy? MINNESOTA LAW REVIEW Mello, M. M. 2018; 102 (6): 2273–2305

  View details for Web of Science ID 000442543500001

• Beyond financial conflicts of interest: Institutional oversight of faculty consulting agreements at schools of medicine and public health. PloS one Mello, M. M., Murtagh, L., Joffe, S., Taylor, P. L., Greenberg, Y., Campbell, E. G. 2018; 13 (10): e0203179

  Abstract

  IMPORTANCE: Approximately one-third of U.S. life sciences faculty engage in industry consulting. Despite reports that consulting contracts often impinge on faculty and university interests, institutional approaches to regulating consulting agreements are largely unknown.OBJECTIVE: To investigate the nature of institutional oversight of faculty consulting contracts at U.S. schools of medicine and public health.DESIGN: Structured telephone interviews with institutional administrators. Questions included the nature of oversight for faculty consulting agreements, if any, and views about consulting as a private versus institutional matter. Interviews were analyzed using a structured coding scheme.SETTING: All accredited schools of medicine and public health in the U.S.PARTICIPANTS: Administrators responsible for faculty affairs were identified via internet searches and telephone and email follow-up. The 118 administrators interviewed represented 73% of U.S. schools of medicine and public health, and 75% of those invited to participate.INTERVENTION: Structured, 15-30 minute telephone interviews.MAIN OUTCOMES AND MEASURES: Prevalence and type of institutional oversight; responses to concerning provisions in consulting agreements; perceptions of institutional oversight.RESULTS: One third of institutions (36%) required faculty to submit at least some agreements for institutional review and 36% reviewed contracts upon request, while 35% refused to review contracts. Among institutions with review, there was wide variation the issues covered. The most common topic was intellectual property rights (64%), while only 23% looked at publication rights and 19% for inappropriately broad confidentiality provisions. Six in ten administrators reported they had no power to prevent faculty from signing consulting agreements. Although most respondents identified institutional risks from consulting relationships, many maintained that consulting agreements are "private."CONCLUSIONS AND RELEVANCE: Oversight of faculty consulting agreements at U.S. schools of medicine and public health is inconsistent across institutions and usually not robust. The interests at stake suggest the need for stronger oversight.

  View details for PubMedID 30372431

• Four States With Robust Prescription Drug Monitoring Programs Reduced Opioid Dosages. Health affairs (Project Hope) Haffajee, R. L., Mello, M. M., Zhang, F., Zaslavsky, A. M., Larochelle, M. R., Wharam, J. F. 2018; 37 (6): 964–74

  Abstract

  State prescription drug monitoring programs (PDMPs) aim to reduce risky controlled-substance prescribing, but early programs had limited impact. Several states implemented robust features in 2012-13, such as mandates that prescribers register with the program and regularly check its registry database. Some states allow prescribers to fulfill the latter requirement by designating delegates to check the registry. The effects of robust PDMP features have not been fully assessed. We used commercial claims data to examine the effects of implementing robust PDMPs in four states on overall and high-risk opioid prescribing, comparing those results to trends in similar states without robust PDMPs. By the end of 2014 the absolute mean morphine-equivalent dosages that providers dispensed declined in a range of 6-77mg per person per quarter in the four states, relative to comparison states. Only in one of the four states, Kentucky, did the percentage of people who filled opioid prescriptions decline versus its comparator state, with an absolute reduction of 1.6percent by the end of 2014. Robust PDMPs may be able to significantly reduce opioid dosages dispensed, percentages of patients receiving opioids, and high-risk prescribing.

  View details for PubMedID 29863921

• Length of Stay After Overlapping Surgery Reply JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Livingston, E. H., Mello, M. M. 2017; 318 (21): 2140–41

  View details for DOI 10.1001/jama.2017.16631

  View details for Web of Science ID 000417093500024

• Length of Stay After Overlapping Surgery-Reply. JAMA Livingston, E. H., Mello, M. M. 2017; 318 (21): 2140-2141

  View details for DOI 10.1001/jama.2017.16631

  View details for PubMedID 29209717

• In search of global governance for research in epidemics. Lancet (London, England) Peters, D. H., Keusch, G. T., Cooper, J., Davis, S., Lundgren, J., Mello, M. M., Omatade, O., Wabwire-Mangen, F., McAdam, K. P. 2017; 390 (10103): 1632-1633

  View details for DOI 10.1016/S0140-6736(17)32546-1

  View details for PubMedID 29131784

• The Evolving Story of Overlapping Surgery JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mello, M. M., Livingston, E. H. 2017; 318 (3): 233–34

  View details for PubMedID 28658474

• Medical Liability - Prospects for Federal Reform NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Kachalia, A., Studdert, D. M. 2017; 376 (19): 1806-1808

  View details for DOI 10.1056/NEJMp1701174

  View details for Web of Science ID 000400891100003

  View details for PubMedID 28402244

• Relationship Between State Malpractice Environment and Quality of Health Care in the United States. Joint Commission journal on quality and patient safety Bilimoria, K. Y., Chung, J. W., Minami, C. A., Sohn, M., Pavey, E. S., Holl, J. L., Mello, M. M. 2017; 43 (5): 241-250

  Abstract

  One major intent of the medical malpractice system in the United States is to deter negligent care and to create incentives for delivering high-quality health care. A study was conducted to assess whether state-level measures of malpractice risk were associated with hospital quality and patient safety.In an observational study of short-term, acute-care general hospitals in the United States that publicly reported in the Centers for Medicaid & Medicare Services Hospital Compare in 2011, hierarchical regression models were used to estimate associations between state-specific malpractice environment measures (rates of paid claims, average Medicare Malpractice Geographic Practice Cost Index [MGPCI], absence of tort reform laws, and a composite measure) and measures of hospital quality (processes of care, imaging utilization, 30-day mortality and readmission, Agency for Healthcare Research and Quality Patient Safety Indicators, and patient experience from the Hospital Consumer Assessment of Healthcare Providers and Systems [HCAHPS]).No consistent association between malpractice environment and hospital process-of-care measures was found. Hospitals in areas with a higher MGPCI were associated with lower adjusted odds of magnetic resonance imaging overutilization for lower back pain but greater adjusted odds of overutilization of cardiac stress testing and brain/sinus computed tomography (CT) scans. The MGPCI was negatively associated with 30-day mortality measures but positively associated with 30-day readmission measures. Measures of malpractice risk were also negatively associated with HCAHPS measures of patient experience.Overall, little evidence was found that greater malpractice risk improves adherence to recommended clinical standards of care, but some evidence was found that malpractice risk may encourage defensive medicine.

  View details for DOI 10.1016/j.jcjq.2017.02.004

  View details for PubMedID 28434458

• Improving reconciliation following medical injury: a qualitative study of responses to patient safety incidents in New Zealand. BMJ quality & safety Moore, J., Mello, M. M. 2017

  Abstract

  Despite the investment in exploring patient-centred alternatives to medical malpractice in New Zealand (NZ), the UK and the USA, patients' experiences with these processes are not well understood. We sought to explore factors that facilitate and impede reconciliation following patient safety incidents and identify recommendations for strengthening institution-led alternatives to malpractice litigation.We conducted semistructured interviews with 62 patients injured by healthcare in NZ, administrators of 12 public hospitals, 5 lawyers specialising in Accident Compensation Corporation (ACC) claims and 3 ACC staff. NZ was chosen as the research site because it has replaced medical malpractice litigation with a no-fault scheme. Thematic analysis was used to identify key themes from interview transcripts.Interview responses converged on five elements of the reconciliation process that were important: (1) ask, rather than assume, what patients and families need from the process and recognise that, for many patients, being heard is important and should occur early in the reconciliation process; (2) support timely, sincere, culturally appropriate and meaningful apologies, avoiding forced or tokenistic quasi-apologies; (3) choose words that promote reconciliation; (4) include the people who patients want involved in the reconciliation discussion, including practitioners involved in the harm event; and (5) engage the support of lawyers and patient relations staff as appropriate.Policymakers and healthcare institutions are keenly interested in non-litigation approaches to resolving malpractice incidents. Interviewing participants involved in patient safety incident reconciliation processes suggests that healthcare institutions should not view apology as a substitute for other remedial actions; use flexible guidelines that distil best-practice principles, ensuring that steps are not missed, while not prescribing a 'one size fits all' communication approach.

  View details for DOI 10.1136/bmjqs-2016-005804

  View details for PubMedID 28280075

• Public Awareness of and Contact With Physicians Who Receive Industry Payments: A National Survey. Journal of general internal medicine Pham-Kanter, G., Mello, M. M., Lehmann, L. S., Campbell, E. G., Carpenter, D. 2017

  Abstract

  The Physician Payments Sunshine Act, part of the Affordable Care Act, requires pharmaceutical and medical device firms to report payments they make to physicians and, through its Open Payments program, makes this information publicly available.To establish estimates of the exposure of the American patient population to physicians who accept industry payments, to compare these population-based estimates to physician-based estimates of industry contact, and to investigate Americans' awareness of industry payments.Cross-sectional survey conducted in late September and early October 2014, with data linkage of respondents' physicians to Open Payments data.A total of 3542 adults drawn from a large, nationally representative household panel.Respondents' contact with physicians reported in Open Payments to have received industry payments; respondents' awareness that physicians receive payments from industry and that payment information is publicly available; respondents' knowledge of whether their own physician received industry payments.Among the 1987 respondents who could be matched to a specific physician, 65% saw a physician who had received an industry payment during the previous 12 months. This population-based estimate of exposure to industry contact is much higher than physician-based estimates from the same period, which indicate that 41% of physicians received an industry payment. Across the six most frequently visited specialties, patient contact with physicians who had received an industry payment ranged from 60 to 85%; the percentage of physicians with industry contact in these specialties was much lower (35-56%). Only 12% of survey respondents knew that payment information was publicly available, and only 5% knew whether their own doctor had received payments.Patients' contact with physicians who receive industry payments is more prevalent than physician-based measures of industry contact would suggest. Very few Americans know whether their own doctor has received industry payments or are aware that payment information is publicly available.

  View details for DOI 10.1007/s11606-017-4012-3

  View details for PubMedID 28265803

• Association of Unsolicited Patient Observations With the Quality of a Surgeon's Care. JAMA surgery Kachalia, A., Mello, M. M., Studdert, D. M. 2017

  View details for DOI 10.1001/jamasurg.2016.5705

  View details for PubMedID 28199449

• Testing the Immunity of the Firearm Industry to Tort Litigation JAMA INTERNAL MEDICINE Studdert, D. M., Donohue, J. J., Mello, M. M. 2017; 177 (1): 102-105

  Abstract

  In the absence of congressional action to reinstate the federal ban on assault weapons, tort litigation offers an alternative strategy for regulating what have become the weapons of choice in mass shootings. However, opportunities to bring successful claims are limited. To prevail, plaintiffs must show that their suit fits within exceptions to the broad immunity from tort actions that Congress gave the firearm industry in the 2005 Protection of Lawful Commerce in Arms Act. In one particularly high-profile lawsuit, families of victims of the school shooting in Newtown, Connecticut, in 2012 sued the makers and sellers of the military-style rifle used in the attack, alleging negligence and deceptive marketing. The trial court dismissed the case on October 14, 2016, but the plaintiffs plan to appeal. We review the history of tort litigation against the firearm industry, outline the Newtown families' claims, and describe the decision.

  View details for DOI 10.1001/jamainternmed.2016.7043

  View details for Web of Science ID 000392196200023

  View details for PubMedID 27842188

• Relationship between state malpractice environment and quality of health care in the United States Jt Comm J Qual Patient Saf Bilimoria, K. Y., Chung, J. W., Minami, C. A., Sohn, M. W., Pavey, E., Holl, J., Mello, M. M. 2017; 43 (5): 241-250
• Outcomes In Two Massachusetts Hospital Systems Give Reason For Optimism About Communication-And-Resolution Programs. Health affairs (Project Hope) Mello, M. M., Kachalia, A. n., Roche, S. n., Niel, M. V., Buchsbaum, L. n., Dodson, S. n., Folcarelli, P. n., Benjamin, E. M., Sands, K. E. 2017; 36 (10): 1795–1803

  Abstract

  Through communication-and-resolution programs, hospitals and liability insurers communicate with patients when adverse events occur; investigate and explain what happened; and, where appropriate, apologize and proactively offer compensation. Using data recorded by program staff members and from surveys of involved clinicians, we examined case outcomes of a program used by two academic medical centers and two of their community hospitals in Massachusetts in the period 2013-15. The hospitals demonstrated good adherence to the program protocol. Ninety-one percent of the program events did not meet compensation eligibility criteria, and those events that did were not costly to resolve (the median payment was $75,000). Only 5 percent of events led to malpractice claims or lawsuits. Clinicians were supportive of the program but desired better communication about it from staff members. Our findings suggest that communication-and-resolution programs will not lead to higher liability costs when hospitals adhere to their commitment to offer compensation proactively.

  View details for PubMedID 28971925

• Patients' Experiences With Communication-and-Resolution Programs After Medical Injury. JAMA internal medicine Moore, J. n., Bismark, M. n., Mello, M. M. 2017; 177 (11): 1595–1603

  Abstract

  Dissatisfaction with medical malpractice litigation has stimulated interest by health care organizations in developing alternatives to meet patients' needs after medical injury. In communication-and-resolution programs (CRPs), hospitals and liability insurers communicate with patients about adverse events, use investigation findings to improve patient safety, and offer compensation when substandard care caused harm. Despite increasing interest in this approach, little is known about patients' and family members' experiences with CRPs.To explore the experiences of patients and family members with medical injuries and CRPs to understand different aspects of institutional responses to injury that promoted and impeded reconciliation.From January 6 through June 30, 2016, semistructured interviews were conducted with patients (n = 27), family members (n = 3), and staff (n = 10) at 3 US hospitals that operate CRPs. Patients and families were eligible for participation if they experienced a CRP, spoke English, and could no longer file a malpractice claim because they had accepted a settlement or the statute of limitations had expired. The CRP administrators identified hospital and insurer staff who had been involved in a CRP event and had a close relationship with the injured patient and/or family. They identified patients and families by applying the inclusion criteria to their CRP databases. Of 66 possible participants, 40 interviews (61%) were completed, including 30 of 50 invited patients and families (60%) and 10 of 16 invited staff (63%).Patients' reported satisfaction with disclosure and reconciliation efforts made by hospitals.A total of 40 participants completed interviews (15 men and 25 women; mean [range] age, 46 [18-67] years). Among the 30 patients and family members interviewed, 27 patients experienced injuries attributed to error and received compensation. The CRP experience was positive overall for 18 of the 30 patients and family members, and 18 patients continued to receive care at the hospital. Satisfaction was highest when communications were empathetic and nonadversarial, including compensation negotiations. Patients and families expressed a strong need to be heard and expected the attending physician to listen without interrupting during conversations about the event. Thirty-five of the 40 respondents believed that including plaintiffs' attorneys in these discussions was helpful. Sixteen of the 30 patients and family members deemed their compensation to be adequate but 17 reported that the offer was not sufficiently proactive. Patients and families strongly desired to know what the hospital did to prevent recurrences of the event, but 24 of 30 reported receiving no information about safety improvement efforts.As hospitals strive to provide more patient-centered care, opportunities exist to improve institutional responses to injuries and promote reconciliation.

  View details for PubMedID 29052704

  View details for PubMedCentralID PMC5710270

• Drug Companies' Liability for the Opioid Epidemic. The New England journal of medicine Haffajee, R. L., Mello, M. M. 2017; 377 (24): 2301–5

  View details for PubMedID 29236640

• Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ open Miller, J. E., Wilenzick, M. n., Ritcey, N. n., Ross, J. S., Mello, M. M. 2017; 7 (12): e017917

  Abstract

  To define a series of clinical trial transparency measures and apply them to large pharmaceutical and biotechnology companies and their 2014 FDA-approved drugs.Cross-sectional descriptive analysis of all clinical trials supporting 2014 Food and Drugs Administration (FDA)-approved new drug applications (NDAs) for novel drugs sponsored by large companies.Data from over 45 sources, including Drugs@FDA.gov, ClinicalTrials.gov, corporate and international registries; PubMed, Google Scholar, EMBASE, corporate press releases, Securities and Exchange Commission (SEC) filings and personal communications with drug manufacturers.Trial registration, results reporting, clinical study report (CSR) synopsis sharing, biomedical journal publication, and FDA Amendments Acts (FDAAA) compliance, analysed on the drug level.The FDA approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials, in 2014. We analysed 505 relevant trials. Per drug, a median of 100% (IQR 86%-100%) of trials in patients were registered, 71% (IQR 57%-100%) reported results or shared a CSR synopsis, 80% (70%-100%) were published and 96% (80%-100%) were publicly available in some form by 13 months after FDA approval. Disclosure rates were lower at FDA approval (65%) and improved significantly by 6 months post FDA approval. Per drug, a median of 100% (IQR 75%-100%) of FDAAA-applicable trials were compliant. Half of reviewed drugs had publicly disclosed results for all trials in patients in our sample. One trial was uniquely registered in a corporate registry, and not ClinicalTrials.gov; 0 trials were uniquely registered in international registries.Among large pharmaceutical companies and new drugs, clinical trial transparency is high based on several standards, although opportunities for improvement remain. Transparency is markedly higher for trials in patients than among all trials supporting drug approval, including trials in healthy volunteers. Ongoing efforts to publicly track companies' transparency records and recognise exemplary companies may encourage further progress.

  View details for PubMedID 29208616

  View details for PubMedCentralID PMC5728266

• The evolving story of overlapping surgery JAMA Mello, M. M., Livingston, E. H. 2017; 318 (3): 233-234
• Collaboration with Regulators to Support Quality and Accountability Following Medical Errors: The Communication and Resolution Program Certification Pilot HEALTH SERVICES RESEARCH Gallagher, T. H., Farrell, M. L., Karson, H., Armstrong, S. J., Maldon, J. T., Mello, M. M., Cullen, B. F. 2016; 51: 2569-2582

  Abstract

  Communication and resolution programs (CRPs) involve institutions responding to adverse events using transparency with patients, event analysis, recurrence prevention, and compensation. Collaboration with regulators around CRPs could enhance health care quality.Health care institutions, liability insurers, and the Medical Quality Assurance Commission (MQAC, board of medicine) in Washington State.MQAC has collaborated with the Foundation for Health Care Quality (FHCQ) on the CRP Certification pilot. A panel of physicians, risk managers, and patient advocates at FHCQ will review cases for use of the CRP key elements. Cases meeting this standard will be "CRP Certified." If MQAC determines that the CRP enhanced patient safety comparable or better than board action, the Commission may close the case.Developing this process identified the following issues: (1) protecting information submitted for CRP Certification; (2) determining what information the Commission needs to assess whether additional investigation is warranted; (3) preserving the Commission's responsibility to protect the public while working with health care organizations; and (4) addressing concerns that CRP Certification not shield incompetent providers.The CRP Certification program is a promising example of collaboration among institutions, insurers, and regulators to promote patient-centered accountability and learning following adverse events.

  View details for DOI 10.1111/1475-6773.12557

  View details for Web of Science ID 000389146300011

  View details for PubMedID 27601424

  View details for PubMedCentralID PMC5134339

• Challenges of Implementing a Communication-and-Resolution Program Where Multiple Organizations Must Cooperate. Health services research Mello, M. M., Armstrong, S. J., Greenberg, Y., McCotter, P. I., Gallagher, T. H. 2016

  Abstract

  To implement a communication-and-resolution program (CRP) in a setting in which liability insurers and health care facilities must collaborate to resolve incidents involving a facility and separately insured clinicians.Six hospitals and clinics and a liability insurer in Washington State.Sites designed and implemented CRPs and contributed information about cases and operational challenges over 20 months. Data were qualitatively analyzed.Data from interviews with personnel responsible for CRP implementation were triangulated with data on program cases collected by sites and notes recorded during meetings with sites and among project team members.Sites experienced small victories in resolving particular cases and streamlining some working relationships, but they were unable to successfully implement a collaborative CRP. Barriers included the insurer's distance from the point of care, passive rather than active support from top leaders, coordinating across departments and organizations, workload, nonparticipation by some physicians, and overcoming distrust.Operating CRPs where multiple organizations must collaborate can be highly challenging. Success likely requires several preconditions, including preexisting trust among organizations, active leadership engagement, physicians' commitment to participate, mechanisms for quickly transmitting information to insurers, tolerance for missteps, and clear protocols for joint investigations and resolutions.

  View details for DOI 10.1111/1475-6773.12580

  View details for PubMedID 27807858

  View details for PubMedCentralID PMC5134344

• Case Outcomes in a Communication-and-Resolution Program in New York Hospitals. Health services research Mello, M. M., Greenberg, Y., Senecal, S. K., Cohn, J. S. 2016

  Abstract

  To determine case outcomes in a communication-and-resolution program (CRP) implemented to respond to adverse events in general surgery.Five acute-care hospitals in New York City.Following CRP implementation, hospitals recorded information about each CRP event for 22 months.Risk managers prospectively collected data in collaboration with representatives from the hospital's insurer. External researchers administered an online satisfaction survey to clinicians involved in CRP events.Among 125 CRP cases, disclosure conversations were carried out in 92 percent, explanations were conveyed in 88 percent, and apologies were offered in 72.8 percent. Three quarters of events did not involve substandard care. Compensation offers beyond bill waivers were deemed appropriate in 9 of 30 of cases in which substandard care caused harm and communicated in six such cases. In 44 percent of cases, hospitals identified steps that could be taken to improve safety. Clinicians had low awareness of the workings of the CRP, but high satisfaction with their experiences.The bulk of CRPs' work is in investigating and communicating about events not caused by substandard care. These CRPs were quite successful in handling such events, but less consistent in offering compensation in cases involving substandard care.

  View details for DOI 10.1111/1475-6773.12594

  View details for PubMedID 27781266

• When are primary care physicians untruthful with patients? A qualitative study. AJOB empirical bioethics Morain, S. R., Iezzoni, L. I., Mello, M. M., Park, E. R., Metlay, J. P., Horner, G., Campbell, E. G. 2016; 8 (1): 32-39

  Abstract

  Notwithstanding near-universal agreement on the theoretical importance of truthfulness, empirical research has documented gaps between ethical norms and physician behaviors. Although prior research has explored situations in which physicians may not be truthful with patients, it has focused on contexts within specialty practice. In this article, we report on a qualitative study of truthfulness in primary care.We conducted a qualitative study during December 2014-March 2015 involving both focus groups and in-depth, semistructured interviews with 32 primary care physicians from the Boston, MA, and Baltimore, MD, metro areas in three specialties: internal medicine, family practice, and pediatrics. Interviews and focus groups were led using a semistructured guide, which explored situations in which primary care physicians find it difficult to be honest with patients; factors shaping truthfulness; and rationales for truthful and untruthful communication.While physicians described outright lying to patients as rare, other deviations from truthfulness were not uncommon, including slanting and deliberately withholding information. Physicians described a range of factors as influencing truthfulness, from patient-level characteristics such as educational background to societal considerations including avoiding unnecessary tests and procedures. Physicians described truthfulness as an ethical requirement, deviations from which required further justification. Perceived justifications included promoting patient well-being and avoiding harm.Our results suggest a potential need to augment opportunities for training in "everyday ethics" challenges, such as the appropriateness of deception in response to patient requests for inappropriate tests or pain medications. Furthermore, they indicate that, in various circumstances encountered in primary care, physicians perceive other moral duties as potentially in conflict with the duty of truthfulness. Further ethical analysis should focus on identifying when deviations from complete truthfulness do and do not serve patients' interests, to guide physicians in striking a reasonable balance among principles of medical ethics that may conflict with one another.

  View details for DOI 10.1080/23294515.2016.1226987

  View details for PubMedID 28949868

• Association Between State Medical Malpractice Environment and Surgical Quality and Cost in the United States ANNALS OF SURGERY Bilimoria, K. Y., Sohn, M., Chung, J. W., Minami, C. A., Oh, E. H., Pavey, E. S., Holl, J. L., Black, B. S., Mello, M. M., Bentrem, D. J. 2016; 263 (6): 1126-1132

  Abstract

  The US medical malpractice system is designed to deter negligence and encourage quality of care through threat of liability.To examine whether state-level malpractice environment is associated with outcomes and costs of colorectal surgery.Observational study of 116,977 Medicare fee-for-service beneficiaries who underwent colorectal surgery using administrative claims data. State-level malpractice risk was measured using mean general surgery malpractice insurance premiums; paid claims per surgeon; state tort reforms; and a composite measure. Associations between malpractice environment and postoperative outcomes and price-standardized Medicare payments were estimated using hierarchical logistic regression and generalized linear models.thirty-day postoperative mortality; complications (pneumonia, myocardial infarction, venous thromboembolism, acute renal failure, surgical site infection, postoperative sepsis, any complication); readmission; total price-standardized Medicare payments for index hospitalization and 30-day postdischarge episode-of-care.Few associations between measures of state malpractice risk environment and outcomes were identified. However, analyses using the composite measure showed that patients treated in states with greatest malpractice risk were more likely than those in lowest risk states to experience any complication (OR: 1.31; 95% CI: 1.22-1.41), pneumonia (OR: 1.36; 95%: CI, 1.16-1.60), myocardial infarction (OR: 1.44; 95% CI: 1.22-1.70), venous thromboembolism (OR:2.11; 95% CI: 1.70-2.61), acute renal failure (OR: 1.34; 95% CI; 1.22-1.47), and sepsis (OR: 1.38; 95% CI: 1.24-1.53; all P < 0.001). There were no consistent associations between malpractice environment and Medicare payments.There were no consistent associations between state-level malpractice risk and higher quality of care or Medicare payments for colorectal surgery.

  View details for DOI 10.1097/SLA.0000000000001538

  View details for Web of Science ID 000377765400022

  View details for PubMedID 27167562

• Have Tobacco 21 Laws Come of Age? NEW ENGLAND JOURNAL OF MEDICINE Morain, S. R., Winickoff, J. P., Mello, M. M. 2016; 374 (17): 1601-1604

  View details for DOI 10.1056/NEJMp1603294

  View details for Web of Science ID 000374843400002

  View details for PubMedID 27007697

• Managing the Risks of Concurrent Surgeries JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mello, M. M., Livingston, E. H. 2016; 315 (15): 1563-1564

  View details for DOI 10.1001/jama.2016.2305

  View details for Web of Science ID 000374289300010

  View details for PubMedID 26985632

• Legal and Policy Interventions to Improve Patient Safety CIRCULATION Kachalia, A., Mello, M. M., Nallamothu, B. K., Studdert, D. M. 2016; 133 (7): 661-671

  View details for DOI 10.1161/CIRCULATIONAHA.115.015880

  View details for Web of Science ID 000371010100006

  View details for PubMedID 26884621

• Prevalence and Characteristics of Physicians Prone to Malpractice Claims. New England journal of medicine Studdert, D. M., Bismark, M. M., Mello, M. M., Singh, H., Spittal, M. J. 2016; 374 (4): 354-362

  Abstract

  The distribution of malpractice claims among physicians is not well understood. If claim-prone physicians account for a substantial share of all claims, the ability to reliably identify them at an early stage could guide efforts to improve care.Using data from the National Practitioner Data Bank, we analyzed 66,426 claims paid against 54,099 physicians from 2005 through 2014. We calculated concentrations of claims among physicians. We used multivariable recurrent-event survival analysis to identify characteristics of physicians at high risk for recurrent claims and to quantify risk levels over time.Approximately 1% of all physicians accounted for 32% of paid claims. Among physicians with paid claims, 84% incurred only one during the study period (accounting for 68% of all paid claims), 16% had at least two paid claims (accounting for 32% of the claims), and 4% had at least three paid claims (accounting for 12% of the claims). In adjusted analyses, the risk of recurrence increased with the number of previous paid claims. For example, as compared with physicians who had one previous paid claim, the 2160 physicians who had three paid claims had three times the risk of incurring another (hazard ratio, 3.11; 95% confidence interval [CI], 2.84 to 3.41); this corresponded in absolute terms to a 24% chance (95% CI, 22 to 26) of another paid claim within 2 years. Risks of recurrence also varied widely according to specialty--for example, the risk among neurosurgeons was four times as great as the risk among psychiatrists.Over a recent 10-year period, a small number of physicians with distinctive characteristics accounted for a disproportionately large number of paid malpractice claims.

  View details for DOI 10.1056/NEJMsa1506137

  View details for PubMedID 26816012

• Sociodemographic Predictors of Vaccination Exemptions on the Basis of Personal Belief in California AMERICAN JOURNAL OF PUBLIC HEALTH Yang, Y. T., Delamater, P. L., Leslie, T. F., Mello, M. M. 2016; 106 (1): 172-177

  Abstract

  We examined the variability in the percentage of students with personal belief exemptions (PBEs) from mandatory vaccinations in California schools and communities according to income, education, race, and school characteristics.We used spatial lag models to analyze 2007-2013 PBE data from the California Department of Public Health. The analyses included school- and regional-level models, and separately examined the percentage of students with exemptions in 2013 and the change in percentages over time.The percentage of students with PBEs doubled from 2007 to 2013, from 1.54% to 3.06%. Across all models, higher median household income and higher percentage of White race in the population, but not educational attainment, significantly predicted higher percentages of students with PBEs in 2013. Higher income, White population, and private school type significantly predicted greater increases in exemptions from 2007 to 2013, whereas higher educational attainment was associated with smaller increases.Personal belief exemptions are more common in areas with a higher percentage of White race and higher income.

  View details for DOI 10.2105/AJPH.2015.302926

  View details for Web of Science ID 000373428000041

  View details for PubMedID 26562114

• Building a National Surveillance System for Malpractice Claims. Health services research Mello, M. M., Studdert, D. M. 2016; 51 Suppl 3: 2642–48

  View details for PubMedID 27892620

  View details for PubMedCentralID PMC5134343

• Acquisition, Analysis, and Sharing of Data in 2015 and Beyond: A Survey of the Landscape A Conference Report From the American Heart Association Data Summit 2015 JOURNAL OF THE AMERICAN HEART ASSOCIATION Antman, E. M., Benjamin, E. J., Harrington, R. A., Houser, S. R., Peterson, E. D., Bauman, M. A., Brown, N., Bufalino, V., Califf, R. M., Creager, M. A., Daugherty, A., DeMets, D. L., Dennis, B. P., Ebadollahi, S., Jessup, M., Lauer, M. S., Lo, B., MacRae, C. A., McConnell, M. V., McCray, A. T., Mello, M. M., Mueller, E., Newburger, J. W., Okun, S., Packer, M., Philippakis, A., Ping, P., Prasoon, P., Roger, V. L., Singer, S., Temple, R., Turner, M. B., Vigilante, K., Warner, J., Wayte, P. 2015; 4 (11)

  Abstract

  A 1.5-day interactive forum was convened to discuss critical issues in the acquisition, analysis, and sharing of data in the field of cardiovascular and stroke science. The discussion will serve as the foundation for the American Heart Association's (AHA's) near-term and future strategies in the Big Data area. The concepts evolving from this forum may also inform other fields of medicine and science.A total of 47 participants representing stakeholders from 7 domains (patients, basic scientists, clinical investigators, population researchers, clinicians and healthcare system administrators, industry, and regulatory authorities) participated in the conference. Presentation topics included updates on data as viewed from conventional medical and nonmedical sources, building and using Big Data repositories, articulation of the goals of data sharing, and principles of responsible data sharing. Facilitated breakout sessions were conducted to examine what each of the 7 stakeholder domains wants from Big Data under ideal circumstances and the possible roles that the AHA might play in meeting their needs. Important areas that are high priorities for further study regarding Big Data include a description of the methodology of how to acquire and analyze findings, validation of the veracity of discoveries from such research, and integration into investigative and clinical care aspects of future cardiovascular and stroke medicine. Potential roles that the AHA might consider include facilitating a standards discussion (eg, tools, methodology, and appropriate data use), providing education (eg, healthcare providers, patients, investigators), and helping build an interoperable digital ecosystem in cardiovascular and stroke science.There was a consensus across stakeholder domains that Big Data holds great promise for revolutionizing the way cardiovascular and stroke research is conducted and clinical care is delivered; however, there is a clear need for the creation of a vision of how to use it to achieve the desired goals. Potential roles for the AHA center around facilitating a discussion of standards, providing education, and helping establish a cardiovascular digital ecosystem. This ecosystem should be interoperable and needs to interface with the rapidly growing digital object environment of the modern-day healthcare system.

  View details for DOI 10.1161/JAHA.115.002810

  View details for Web of Science ID 000366615600032

  View details for PubMedID 26541391

  View details for PubMedCentralID PMC4845234

• Shifting Vaccination Politics - The End of Personal-Belief Exemptions in California NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Studdert, D. M., Parmet, W. E. 2015; 373 (9): 785-787

  View details for DOI 10.1056/NEJMp1508701

  View details for Web of Science ID 000360171700002

  View details for PubMedID 26200843

• Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine Studdert, D. M., Flanders, J., Mello, M. M. 2015; 12 (7)

  Abstract

  David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.

  View details for DOI 10.1371/journal.pmed.1001848

  View details for PubMedID 26151360

  View details for PubMedCentralID PMC4494810

• Searching for Public Health Law's Sweet Spot: The Regulation of Sugar-Sweetened Beverages. PLoS medicine Studdert, D. M., Flanders, J., Mello, M. M. 2015; 12 (7): e1001848

  Abstract

  David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks.

  View details for DOI 10.1371/journal.pmed.1001848

  View details for PubMedID 26151360

  View details for PubMedCentralID PMC4494810

• Should Malpractice Settlements Be Secret? JAMA INTERNAL MEDICINE Mello, M. M., Catalano, J. N. 2015; 175 (7): 1135-1137

  View details for DOI 10.1001/jamainternmed.2015.1038

  View details for Web of Science ID 000357604400018

  View details for PubMedID 25961316

• Institutional Oversight of Faculty-Industry Consulting Relationships in US Medical Schools: A Delphi Study JOURNAL OF LAW MEDICINE & ETHICS Morain, S. R., Joffe, S., Campbell, E. G., Mello, M. M. 2015; 43 (2): 383-396

  Abstract

  The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful.

  View details for DOI 10.1111/jlme.12255

  View details for Web of Science ID 000359087400026

  View details for PubMedID 26242961

• Half-baked--the retail promotion of marijuana edibles. New England journal of medicine MacCoun, R. J., Mello, M. M. 2015; 372 (11): 989-991

  View details for DOI 10.1056/NEJMp1416014

  View details for PubMedID 25760351

• Medical liability and reporting malpractice payments--reply. JAMA Mello, M. M., Studdert, D. M., Kachalia, A. 2015; 313 (10): 1058-1059

  View details for DOI 10.1001/jama.2015.0688

  View details for PubMedID 25756448

• Supporting Those Who Go to Fight Ebola PLOS MEDICINE Mello, M. M., Merritt, M. W., Halpern, S. D. 2015; 12 (1)

  View details for DOI 10.1371/journal.pmed.1001781

  View details for Web of Science ID 000351715800006

  View details for PubMedID 25622033

  View details for PubMedCentralID PMC4306478

• The Medical Liability Climate and Prospects for Reform JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Mello, M. M., Studdert, D. M., Kachalia, A. 2014; 312 (20): 2146-2155

  Abstract

  For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects. These nontraditional reforms have considerable promise for addressing some of the system's most challenging issues, including high costs and barriers to accessing compensation. In this Special Communication, we review recent national trends in medical liability claims and costs, which indicate a sharp reduction in the rate of paid claims and flat or declining levels in compensation payments and liability insurance costs over the last 7 to 10 years. We discuss a number of nontraditional reform approaches--communication-and-resolution programs, presuit notification and apology laws, safe harbor legislation, judge-directed negotiation, and administrative compensation systems--and we conclude by describing several forces likely to shape change in the medical liability environment over the next decade.

  View details for DOI 10.1001/jama.2014.10705

  View details for Web of Science ID 000345626800018

• The medical liability climate and prospects for reform. JAMA Mello, M. M., Studdert, D. M., Kachalia, A. 2014; 312 (20): 2146-55

  Abstract

  For many physicians, the prospect of being sued for medical malpractice is a singularly disturbing aspect of modern clinical practice. State legislatures have enacted tort reforms, such as caps on damages, in an effort to reduce the volume and costs of malpractice litigation. Attempts to introduce similar traditional reform measures at the federal level have so far failed. Much less prominent, but potentially more important, are proposed alternative approaches for resolving medical injuries; a number of these efforts are currently being tested in federally sponsored demonstration projects. These nontraditional reforms have considerable promise for addressing some of the system's most challenging issues, including high costs and barriers to accessing compensation. In this Special Communication, we review recent national trends in medical liability claims and costs, which indicate a sharp reduction in the rate of paid claims and flat or declining levels in compensation payments and liability insurance costs over the last 7 to 10 years. We discuss a number of nontraditional reform approaches--communication-and-resolution programs, presuit notification and apology laws, safe harbor legislation, judge-directed negotiation, and administrative compensation systems--and we conclude by describing several forces likely to shape change in the medical liability environment over the next decade.

  View details for DOI 10.1001/jama.2014.10705

  View details for PubMedID 25358122

• What Is a Public Health "Emergency"? NEW ENGLAND JOURNAL OF MEDICINE Haffajee, R., Parmet, W. E., Mello, M. M. 2014; 371 (11): 986-988

  View details for DOI 10.1056/NEJMp1406167

  View details for Web of Science ID 000341382800003

  View details for PubMedID 25207765

• Clinical Trials and the Right to Remain Silent JAMA INTERNAL MEDICINE Mello, M. M., Cohen, I. G. 2014; 174 (9): 1505-?

  View details for DOI 10.1001/jamainternmed.2014.2341

  View details for Web of Science ID 000341574400020

  View details for PubMedID 25047003

• Tobacco 21--an idea whose time has come. The New England journal of medicine Winickoff, J. P., Gottlieb, M., Mello, M. M. 2014; 370 (4): 295-7

  View details for DOI 10.1056/NEJMp1314626

  View details for PubMedID 24401021

• Communication-And-Resolution Programs: The Challenges And Lessons Learned From Six Early Adopters HEALTH AFFAIRS Mello, M. M., Boothman, R. C., McDonald, T., Driver, J., Lembitz, A., Bouwmeester, D., Dunlap, B., Gallagher, T. 2014; 33 (1): 20-29

  Abstract

  In communication-and-resolution programs (CRPs), health systems and liability insurers encourage the disclosure of unanticipated care outcomes to affected patients and proactively seek resolutions, including offering an apology, an explanation, and, where appropriate, reimbursement or compensation. Anecdotal reports from the University of Michigan Health System and other early adopters of CRPs suggest that these programs can substantially reduce liability costs and improve patient safety. But little is known about how these early programs achieved success. We studied six CRPs to identify the major challenges in and lessons learned from implementing these initiatives. The CRP participants we interviewed identified several factors that contributed to their programs' success, including the presence of a strong institutional champion, investing in building and marketing the program to skeptical clinicians, and making it clear that the results of such transformative change will take time. Many of the early CRP adopters we interviewed expressed support for broader experimentation with these programs even in settings that differ from their own, such as systems that do not own and control their liability insurer, and in states without strong tort reforms.

  View details for DOI 10.1377/hlthaff.2013.0828

  View details for Web of Science ID 000330289300004

  View details for PubMedID 24395931

• Making the Case for Health-Enhancing Laws after Bloomberg HASTINGS CENTER REPORT Mello, M. M., Studdert, D. M. 2014; 44 (1): 8

  View details for PubMedID 24408591

• Implementing Hospital-Based Communication-And-Resolution Programs: Lessons Learned In New York City HEALTH AFFAIRS Mello, M. M., Senecal, S. K., Kuznetsov, Y., Cohn, J. S. 2014; 33 (1): 30-38

  Abstract

  In 2010 five New York City hospitals implemented a communication-and-resolution program (CRP) in general surgery. The program's goals were to improve reporting of serious adverse events to risk management, support clinical staff in discussing these events with patients, rapidly investigate why injuries occurred, communicate to patients what was discovered, and offer apologies and compensation when the standard of care was not met. We report the hospitals' experiences with implementing the CRP over a twenty-two-month period. We found that all five hospitals improved disclosure and surveillance of adverse events but were not able to fully implement the program's compensation component. These experiences suggest that strong support from top leadership at the hospital and insurer levels, and adequate staff resources, are critical for the success of CRPs. Hospitals considering adopting a CRP should ensure that their organizations can tolerate risk, their leaders are willing to reinforce CRP implementation, and resources are in place to educate clinical staff about how the program can benefit them.

  View details for DOI 10.1377/hlthaff.2013.0849

  View details for Web of Science ID 000330289300005

  View details for PubMedID 24395932

• How Policy Makers Can Smooth The Way For Communication-And-Resolution Programs HEALTH AFFAIRS Sage, W. M., Gallagher, T. H., Armstrong, S., Cohn, J. S., McDonald, T., Gale, J., Woodward, A. C., Mello, M. M. 2014; 33 (1): 11-19

  Abstract

  Communication-and-resolution programs (CRPs) in health care organizations seek to identify medical injuries promptly; ensure that they are disclosed to patients compassionately; pursue timely resolution through patient engagement, explanation, and, where appropriate, apology and compensation; and use lessons learned to improve patient safety. CRPs have existed for years, but they are being tested in new settings and primed for broad implementation through grants from the Agency for Healthcare Research and Quality. These projects do not require changing laws. However, grantees' experiences suggest that the path to successful dissemination of CRPs would be smoother if the legal environment supported them. State and federal policy makers should try to allay potential defendants' fears of litigation (for example, by protecting apologies from use in court), facilitate patient participation (for example, by ensuring access to legal representation), and address the reputational and economic concerns of health care providers (for example, by clarifying practices governing National Practitioner Data Bank reporting and payers' financial recourse following medical error).

  View details for DOI 10.1377/hlthaff.2013.0930

  View details for Web of Science ID 000330289300003

  View details for PubMedID 24395930

• Critical Opportunities for Public Health Law: A Call for Action AMERICAN JOURNAL OF PUBLIC HEALTH Mello, M. M., Wood, J., Burris, S., Wagenaar, A. C., Ibrahim, J. K., Swanson, J. W. 2013; 103 (11): 1979-1988

  Abstract

  Although legal interventions are responsible for many sentinel public health achievements, law is underutilized as a tool for advancing population health. Our purpose was to identify critical opportunities for public health lawmaking. We articulated key criteria and illustrated their use with 5 examples. These opportunities involve significant health problems that are potentially amenable to change through law and for which an effective legal intervention is available: optimizing graduated driver licensing laws, increasing tax rates on alcoholic beverages, regulating sodium in foods, enacting laws to facilitate reversal of opioid overdoses, and improving mental health interventions in the college setting. We call for a national conversation about critical opportunities for public health law to advance evidence-based policymaking.

  View details for DOI 10.2105/AJPH.2013.301281

  View details for Web of Science ID 000331038500036

  View details for PubMedID 24028265

  View details for PubMedCentralID PMC3828690

• Talking with patients about other clinicians' errors. The New England journal of medicine Gallagher, T. H., Mello, M. M., Levinson, W., Wynia, M. K., Sachdeva, A. K., Snyder Sulmasy, L., Truog, R. D., Conway, J., Mazor, K., Lembitz, A., Bell, S. K., Sokol-Hessner, L., Shapiro, J., Puopolo, A. L., Arnold, R. 2013; 369 (18): 1752-7

  View details for DOI 10.1056/NEJMsb1303119

  View details for PubMedID 24171522

• Gene patenting--the Supreme Court finally speaks. The New England journal of medicine Kesselheim, A. S., Cook-Deegan, R. M., Winickoff, D. E., Mello, M. M. 2013; 369 (9): 869-75

  View details for DOI 10.1056/NEJMhle1308199

  View details for PubMedID 23841703

  View details for PubMedCentralID PMC3777541

• A new era in noninvasive prenatal testing. The New England journal of medicine Morain, S., Greene, M. F., Mello, M. M. 2013; 369 (6): 499-501

  View details for DOI 10.1056/NEJMp1304843

  View details for PubMedID 23862975

• High Physician Concern About Malpractice Risk Predicts More Aggressive Diagnostic Testing In Office-Based Practice HEALTH AFFAIRS Carrier, E. R., Reschovsky, J. D., Katz, D. A., Mello, M. M. 2013; 32 (8): 1383-1391

  Abstract

  Despite widespread agreement that physicians who practice defensive medicine drive up health care costs, the extent to which defensive medicine increases costs is unclear. The differences in findings to date stem in part from the use of two distinct approaches for assessing physicians' perceived malpractice risk. In this study we used an alternative strategy: We linked physicians' responses regarding their levels of malpractice concern as reported in the 2008 Health Tracking Physician Survey to Medicare Parts A and B claims for the patients they treated during the study period, 2007-09. We found that physicians who reported a high level of malpractice concern were most likely to engage in practices that would be considered defensive when diagnosing patients who visited their offices with new complaints of chest pain, headache, or lower back pain. No consistent relationship was seen, however, when state-level indicators of malpractice risk replaced self-rated concern. Reducing defensive medicine may require approaches focused on physicians' perceptions of legal risk and the underlying factors driving those perceptions.

  View details for DOI 10.1377/hlthaff.2013.0233

  View details for Web of Science ID 000323154800008

  View details for PubMedID 23918482

• The Politics of HPV Vaccination Policy Formation in the United States JOURNAL OF HEALTH POLITICS POLICY AND LAW Abiola, S. E., Colgrove, J., Mello, M. M. 2013; 38 (4): 645-681

  Abstract

  This article explores the political dimensions of policy formation for the human papillomavirus (HPV) vaccine through case studies of six states: California, Indiana, New Hampshire, New York, Texas, and Virginia. Using thematic content analysis of semistructured key informant interviews with policy stakeholders, newspaper articles, and archival materials, we describe the trajectory of public health policy developments for HPV immunization and analyze key influences on policy outcomes through the theoretical lens of the Multiple Streams framework. Specifically, we examine factors influencing the extent to which HPV was perceived as a problem meriting policy action; political forces that facilitated and impeded policy adoption, including interest-group opposition and structural and ideological features of the states' political environments; and factors affecting which policy alternatives received consideration. We find that effective policy entrepreneurship played a critical role in determining policy outcomes. We conclude by discussing lessons from the case of HPV vaccination for future efforts to craft vaccination policies.

  View details for DOI 10.1215/03616878-2208567

  View details for Web of Science ID 000323186800003

  View details for PubMedID 23645875

• Breast cancer screening: conflicting guidelines and medicolegal risk. JAMA Kachalia, A., Mello, M. M. 2013; 309 (24): 2555-6

  View details for DOI 10.1001/jama.2013.7100

  View details for PubMedID 23722969

• Defensive medicine--legally necessary but ethically wrong?: Inpatient stress testing for chest pain in low-risk patients. JAMA internal medicine Kachalia, A., Mello, M. M. 2013; 173 (12): 1056-7

  View details for DOI 10.1001/jamainternmed.2013.7293

  View details for PubMedID 23689540

• Sunlight as disinfectant--new rules on disclosure of industry payments to physicians. The New England journal of medicine Rosenthal, M. B., Mello, M. M. 2013; 368 (22): 2052-4

  View details for DOI 10.1056/NEJMp1305090

  View details for PubMedID 23718162

• Survey Finds Public Support For Legal Interventions Directed At Health Behavior To Fight Noncommunicable Disease HEALTH AFFAIRS Morain, S., Mello, M. M. 2013; 32 (3): 486-496

  Abstract

  The high prevalence of chronic diseases in the United States with lifestyle-related risk factors, such as obesity and tobacco use, has sparked interest in legal strategies to influence health behavior. However, little is known about the public's willingness to accept these policies as legitimate, which in turn may affect compliance. We present results from a national survey of 1,817 US adults concerning the acceptability of different public health legal interventions that address noncommunicable, or chronic, diseases. We found that support for these new interventions is high overall; substantially greater among African Americans and Hispanics than among whites; and tied to perceptions of democratic representation in policy making. There was much support for strategies that enable people to exercise healthful choices--for example, menu labeling and improving access to nicotine patches--but considerably less for more coercive measures, such as insurance premium surcharges. These findings suggest that the least coercive path will be the smoothest and that support for interventions may be widespread among different social groups. In addition, the findings underscore the need for policy makers to involve the public in decision making, understand the public's values, and communicate how policy decisions reflect this understanding.

  View details for DOI 10.1377/hlthaff.2012.0609

  View details for Web of Science ID 000316557900007

  View details for PubMedID 23459727

• FDA regulation of off-label drug promotion under attack. JAMA Kesselheim, A. S., Mello, M. M., Avorn, J. 2013; 309 (5): 445-6

  View details for DOI 10.1001/jama.2012.207972

  View details for PubMedID 23385267

• Disclosure, Apology, and Offer Programs: Stakeholders' Views of Barriers to and Strategies for Broad Implementation MILBANK QUARTERLY Bell, S. K., Smulowitz, P. B., Woodward, A. C., Mello, M. M., Duva, A. M., Boothman, R. C., Sands, K. 2012; 90 (4): 682-705

  Abstract

  The Disclosure, Apology, and Offer (DA&O) model, a response to patient injuries caused by medical care, is an innovative approach receiving national attention for its early success as an alternative to the existing inherently adversarial, inefficient, and inequitable medical liability system. Examples of DA&O programs, however, are few.Through key informant interviews, we investigated the potential for more widespread implementation of this model by provider organizations and liability insurers, defining barriers to implementation and strategies for overcoming them. Our study focused on Massachusetts, but we also explored themes that are broadly generalizable to other states.We found strong support for the DA&O model among key stakeholders, who cited its benefits for both the liability system and patient safety. The respondents did not perceive any insurmountable barriers to broad implementation, and they identified strategies that could be pursued relatively quickly. Such solutions would permit a range of organizations to implement the model without legislative hurdles.Although more data are needed about the outcomes of DA&O programs, the model holds considerable promise for transforming the current approach to medical liability and patient safety.

  View details for DOI 10.1111/j.1468-0009.2012.00679.x

  View details for Web of Science ID 000312137000003

  View details for PubMedID 23216427

  View details for PubMedCentralID PMC3530738

• Disclosure-And-Resolution Programs That Include Generous Compensation Offers May Prompt A Complex Patient Response HEALTH AFFAIRS Murtagh, L., Gallagher, T. H., Andrew, P., Mello, M. M. 2012; 31 (12): 2681-2689

  Abstract

  Under "disclosure-and-resolution" programs, health systems disclose adverse events to affected patients and their families; apologize; and, where appropriate, offer compensation. Early adopters of this approach have reported reduced liability costs, but the extent to which these results stem from effective disclosure and apology practices, versus compensation offers, is unknown. Using survey vignettes, we examined the effects of different compensation offers on individuals' responses to disclosures of medical errors compared to explanation and apology alone. Our results show that although two-thirds of these individuals desired compensation offers, increasing the offer amount did not improve key outcomes. Full-compensation offers did not decrease the likelihood of seeking legal advice and increased the likelihood that people perceived the disclosure and apology as motivated by providers' desire to avoid litigation. Hospitals, physicians, and malpractice insurers should consider this complex interplay as they implement similar initiatives. They may benefit from separating disclosure conversations and compensation offers and from excluding physicians from compensation discussions.

  View details for DOI 10.1377/hlthaff.2012.0185

  View details for Web of Science ID 000312602100011

  View details for PubMedID 23213152

• The taxing power and the public's health. The New England journal of medicine Mello, M. M., Cohen, I. G. 2012; 367 (19): 1777-9

  Abstract

  In its decision on the Affordable Care Act, the Supreme Court opened the door for Congress to use its taxing power to achieve myriad policy objectives. The federal government may now increasingly make creative use of taxes to pursue public health goals.

  View details for DOI 10.1056/NEJMp1209648

  View details for PubMedID 23075142

• Ethical Considerations in Studying Drug Safety - The Institute of Medicine Report NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Goodman, S. N., Faden, R. R. 2012; 367 (10): 959-964

  View details for DOI 10.1056/NEJMhle1207160

  View details for Web of Science ID 000308343300017

  View details for PubMedID 22913661

• Legal and policy approaches to the obesity epidemic SURGERY FOR OBESITY AND RELATED DISEASES Mello, M. 2012; 8 (5): 507-513

  Abstract

  Although 85% of the American public believes that obesity is an "epidemic," great controversy exists what role the government, public policy, and law should play in addressing the problem. This keynote address discusses the philosophical and economic justifications for treating obesity as a public health problem meriting government intervention and explores the possible legal and policy solutions.

  View details for DOI 10.1016/j.soard.2012.05.001

  View details for Web of Science ID 000309695100003

  View details for PubMedID 22695172

• Does Tort Law Improve the Health of Newborns, or Miscarry? A Longitudinal Analysis of the Effect of Liability Pressure on Birth Outcomes JOURNAL OF EMPIRICAL LEGAL STUDIES Yang, Y. T., Studdert, D. M., Subramanian, S. V., Mello, M. M. 2012; 9 (2): 217-245

  View details for DOI 10.1111/j.1740-1461.2012.01252.x

  View details for Web of Science ID 000303807100002

• Pharmaceutical Companies' Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination AMERICAN JOURNAL OF PUBLIC HEALTH Mello, M. M., Abiola, S., Colgrove, J. 2012; 102 (5): 893-898

  Abstract

  We sought to investigate roles that Merck & Co Inc played in state human papillomavirus (HPV) immunization policymaking, to elicit key stakeholders' perceptions of the appropriateness of these activities, and to explore implications for relationships between health policymakers and industry.We used a series of state case studies combining data from key informant interviews with analysis of media reports and archival materials. We interviewed 73 key informants in 6 states that were actively engaged in HPV vaccine policy deliberations.Merck promoted school-entry mandate legislation by serving as an information resource, lobbying legislators, drafting legislation, mobilizing female legislators and physician organizations, conducting consumer marketing campaigns, and filling gaps in access to the vaccine. Legislators relied heavily on Merck for scientific information. Most stakeholders found lobbying by vaccine manufacturers acceptable in principle, but perceived that Merck had acted too aggressively and nontransparently in this case.Although policymakers acknowledge the utility of manufacturers' involvement in vaccination policymaking, industry lobbying that is overly aggressive, not fully transparent, or not divorced from financial contributions to lawmakers risks undermining the prospects for legislation to foster uptake of new vaccines.

  View details for DOI 10.2105/AJPH.2011.300576

  View details for Web of Science ID 000302969300022

  View details for PubMedID 22420796

  View details for PubMedCentralID PMC3483914

• "Pay for delay" settlements of disputes over pharmaceutical patents. The New England journal of medicine Kesselheim, A. S., Murtagh, L., Mello, M. M. 2011; 365 (15): 1439-45

  View details for DOI 10.1056/NEJMhle1102235

  View details for PubMedID 21916635

• Restrictions on the use of prescribing data for drug promotion. The New England journal of medicine Mello, M. M., Messing, N. A. 2011; 365 (13): 1248-54

  View details for DOI 10.1056/NEJMhle1107678

  View details for PubMedID 21812664

• Administrative compensation for medical injuries: lessons from three foreign systems. Issue brief (Commonwealth Fund) Mello, M. M., Kachalia, A., Studdert, D. M. 2011; 14: 1-18

  Abstract

  The United States requires patients injured by medical negligence to seek compensation through lawsuits, an approach that has drawbacks related to fairness, cost, and impact on medical care. Several countries, including New Zealand, Sweden, and Denmark, have replaced litigation with administrative compensation systems for patients who experience an avoidable medical injury. Sometimes called "no-fault" systems, such schemes enable patients to file claims for compensation without using an attorney. A governmental or private adjudicating organization uses neutral medical experts to evaluate claims of injury and does not require patients to prove that health care providers were negligent in order to receive compensation. Information from claims is used to analyze opportunities for patient safety improvement. The systems have successfully limited liability costs while improving injured patients' access to compensation. American policymakers may find many of the elements of these countries' systems to be transferable to demonstration projects in the U.S.

  View details for PubMedID 21770079

• New directions in medical liability reform. The New England journal of medicine Kachalia, A., Mello, M. M. 2011; 364 (16): 1564-72

  View details for DOI 10.1056/NEJMhpr1012821

  View details for PubMedID 21506746

• Strategies and Practices in Off-Label Marketing of Pharmaceuticals: A Retrospective Analysis of Whistleblower Complaints PLOS MEDICINE Kesselheim, A. S., Mello, M. M., Studdert, D. M. 2011; 8 (4)

  Abstract

  Despite regulatory restrictions, off-label marketing of pharmaceutical products has been common in the US. However, the scope of off-label marketing remains poorly characterized. We developed a typology for the strategies and practices that constitute off-label marketing.We obtained unsealed whistleblower complaints against pharmaceutical companies filed in US federal fraud cases that contained allegations of off-label marketing (January 1996-October 2010) and conducted structured reviews of them. We coded and analyzed the strategic goals of each off-label marketing scheme and the practices used to achieve those goals, as reported by the whistleblowers. We identified 41 complaints arising from 18 unique cases for our analytic sample (leading to US$7.9 billion in recoveries). The off-label marketing schemes described in the complaints had three non-mutually exclusive goals: expansions to unapproved diseases (35/41, 85%), unapproved disease subtypes (22/41, 54%), and unapproved drug doses (14/41, 34%). Manufacturers were alleged to have pursued these goals using four non-mutually exclusive types of marketing practices: prescriber-related (41/41, 100%), business-related (37/41, 90%), payer-related (23/41, 56%), and consumer-related (18/41, 44%). Prescriber-related practices, the centerpiece of company strategies, included self-serving presentations of the literature (31/41, 76%), free samples (8/41, 20%), direct financial incentives to physicians (35/41, 85%), and teaching (22/41, 54%) and research activities (8/41, 20%).Off-label marketing practices appear to extend to many areas of the health care system. Unfortunately, the most common alleged off-label marketing practices also appear to be the most difficult to control through external regulatory approaches.

  View details for DOI 10.1371/journal.pmed.1000431

  View details for Web of Science ID 000289937700004

  View details for PubMedID 21483716

  View details for PubMedCentralID PMC3071370

• Medical malpractice - april 2011 update. The Synthesis project. Research synthesis report Mello, M. M., Kachalia, A., Goodell, S. 2011

  Abstract

  Although the malpractice crisis--the inability of health care providers to obtain affordable liability insurance--has abated in many states, medical liability costs and pressures remain a concern. In addition, the perceived threat of litigation spurs "defensive medicine"--the practice of ordering services primarily to reduce the physician's liability exposure rather than because they are medically necessary. There is wide consensus that liability pressure undermines efforts to curb overuse of health services, although there is disagreement about the magnitude of its effect. This Update reviews the evidence on the effects of medical malpractice reforms published since the Medical Malpractice: Impact of the Crisis and Effects of State Tort Reforms synthesis was released in 2006. Key findings include: Except for caps on noneconomic damages, there is little evidence that other traditional tort reforms affect medical liability costs or defensive medicine. Average awards are reduced by 20 percent to 30 percent, and premiums in states with caps on noneconomic damages rise 6 percent to 13 percent more slowly than premiums in states without caps. There is evidence that tort reforms-particularly caps on noneconomic damages-reduce health spending, but the size of the reduction is subject to debate. Because of the lack of success of many traditional tort reforms, a number of innovated tort reforms are receiving increased attention. Although they show promise in theory, they have not been widely evaluated so the evidence of their effectiveness is weak.

  View details for DOI 72097

  View details for PubMedID 22052245

• Relationship between Quality of Care and Negligence Litigation in Nursing Homes NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Spittal, M. J., Mello, M. M., O'Malley, A. J., Stevenson, D. G. 2011; 364 (13): 1243-1250

  Abstract

  It is unclear whether high-quality health care institutions are less likely to be sued for negligence than their low-performing counterparts.We linked information on tort claims brought against 1465 nursing homes between 1998 and 2006 to 10 indicators of nursing home quality drawn from two U.S. national data sets: the Online Survey, Certification, and Reporting system and the Minimum Data Set Quality Measure/Indicator Report. We tested for associations between the incidence of claims and the quality measures at the facility calendar-quarter level, correcting for facility clustering and adjusting for case mix, ownership, occupancy, year, and state. Odds ratios were calculated for the effect of a change of 1 SD in each quality measure on the odds of one or more claims in each facility calendar-quarter.Nursing homes with more deficiencies (odds ratio, 1.09; 95% confidence interval [CI], 1.05 to 1.13) and those with more serious deficiencies (odds ratio, 1.04; 95% CI, 1.00 to 1.08) had higher odds of being sued; this was also true for nursing homes that had more residents with weight loss (odds ratio, 1.05; 95% CI, 1.01 to 1.10) and with pressure ulcers (odds ratio, 1.09; 95% CI, 1.05 to 1.14). The odds of being sued were lower in nursing homes with more nurse's aide-hours per resident-day (odds ratio, 0.95; 95% CI, 0.91 to 0.99). However, all these effects were relatively small. For example, nursing homes with the best deficiency records (10th percentile) had a 40% annual risk of being sued, as compared with a 47% risk among nursing homes with the worst deficiency records (90th percentile).The best-performing nursing homes are sued only marginally less than the worst-performing ones. Such weak discrimination may subvert the capacity of litigation to provide incentives to deliver safer care.

  View details for Web of Science ID 000288951300008

  View details for PubMedID 21449787

• Malpractice reform--opportunities for leadership by health care institutions and liability insurers. Obstetrics and gynecology Mello, M. M., Gallagher, T. H. 2010; 116 (6): 1254-6

  View details for DOI 10.1097/AOG.0b013e3181e9358f

  View details for PubMedID 21099588

• Physicians' Fears Of Malpractice Lawsuits Are Not Assuaged By Tort Reforms HEALTH AFFAIRS Carrier, E. R., Reschovsky, J. D., Mello, M. M., Mayrell, R. C., Katz, D. 2010; 29 (9): 1585-1592

  Abstract

  Physicians contend that the threat of malpractice lawsuits forces them to practice defensive medicine, which in turn raises the cost of health care. This argument underlies efforts to change malpractice laws through legislative tort reform. We evaluated physicians' perceptions about malpractice claims in states where more objective indicators of malpractice risk, such as malpractice premiums, varied considerably. We found high levels of malpractice concern among both generalists and specialists in states where objective measures of malpractice risk were low. We also found relatively modest differences in physicians' concerns across states with and without common tort reforms. These results suggest that many policies aimed at controlling malpractice costs may have a limited effect on physicians' malpractice concerns.

  View details for DOI 10.1377/hlthaff.2010.0135

  View details for Web of Science ID 000281601300005

  View details for PubMedID 20820012

• The Flaws In State 'Apology' And 'Disclosure' Laws Dilute Their Intended Impact On Malpractice Suits HEALTH AFFAIRS Mastroianni, A. C., Mello, M. M., Sommer, S., Hardy, M., Gallagher, T. H. 2010; 29 (9): 1611-1619

  Abstract

  Apologies are rare in the medical world, where health care providers fear that admissions of guilt or expressions of regret could be used by plaintiffs in malpractice lawsuits. Nevertheless, some states are moving toward giving health care providers legal protection so that they feel free to apologize to patients for a medical mistake. Advocates believe that these laws are beneficial for patients and providers. However, our analysis of "apology" and "disclosure" laws in thirty-four states and the District of Columbia finds that most of the laws have major shortcomings. These may actually discourage comprehensive disclosures and apologies and weaken the laws' impact on malpractice suits. Many could be resolved by improved statutory design and communication of new legal requirements and protections.

  View details for DOI 10.1377/hlthaff.2009.0134

  View details for Web of Science ID 000281601300009

  View details for PubMedID 20820016

• National Costs Of The Medical Liability System HEALTH AFFAIRS Mello, M. M., Chandra, A., Gawande, A. A., Studdert, D. M. 2010; 29 (9): 1569-1577

  Abstract

  Concerns about reducing the rate of growth of health expenditures have reignited interest in medical liability reforms and their potential to save money by reducing the practice of defensive medicine. It is not easy to estimate the costs of the medical liability system, however. This article identifies the various components of liability system costs, generates national estimates for each component, and discusses the level of evidence available to support the estimates. Overall annual medical liability system costs, including defensive medicine, are estimated to be $55.6 billion in 2008 dollars, or 2.4 percent of total health care spending.

  View details for DOI 10.1377/hlthaff.2009.0807

  View details for Web of Science ID 000281601300003

  View details for PubMedID 20820010

  View details for PubMedCentralID PMC3048809

• HPV Vaccination Mandates - Lawmaking amid Political and Scientific Controversy NEW ENGLAND JOURNAL OF MEDICINE Colgrove, J., Abiola, S., Mello, M. M. 2010; 363 (8): 785-791

  View details for Web of Science ID 000280996600016

  View details for PubMedID 20818883

• The Havasupai Indian tribe case--lessons for research involving stored biologic samples. The New England journal of medicine Mello, M. M., Wolf, L. E. 2010; 363 (3): 204-7

  View details for DOI 10.1056/NEJMp1005203

  View details for PubMedID 20538622

• Regulation of smoking in public housing. The New England journal of medicine Winickoff, J. P., Gottlieb, M., Mello, M. M. 2010; 362 (24): 2319-25

  View details for DOI 10.1056/NEJMhle1000941

  View details for PubMedID 20554988

  View details for PubMedCentralID PMC3210023

• Making the Case for Laws That Improve Health: A Framework for Public Health Law Research MILBANK QUARTERLY Burris, S., Wagenaar, A. C., Swanson, J., Ibrahim, J. K., Wood, J., Mello, M. M. 2010; 88 (2): 169-210

  Abstract

  Public health law has received considerable attention in recent years and has become an essential field in public health. Public health law research, however, has received less attention.Expert commentary.This article explores public health law research, defined as the scientific study of the relation of law and legal practices to population health. The article offers a logic model of public health law research and a typology of approaches to studying the effects of law on public health. Research on the content and prevalence of public health laws, processes of adopting and implementing laws, and the extent to which and mechanisms through which law affects health outcomes can use methods drawn from epidemiology, economics, sociology, and other disciplines. The maturation of public health law research as a field depends on methodological rigor, adequate research funding, access to appropriate data sources, and policymakers' use of research findings.Public health law research is a young field but holds great promise for supporting evidence-based policy making that will improve population health.

  View details for Web of Science ID 000278933700002

  View details for PubMedID 20579282

• Gene patenting--is the pendulum swinging back? The New England journal of medicine Kesselheim, A. S., Mello, M. M. 2010; 362 (20): 1855-8

  View details for DOI 10.1056/NEJMp1004026

  View details for PubMedID 20375396

• Whistle-Blowers' Experiences in Fraud Litigation against Pharmaceutical Companies NEW ENGLAND JOURNAL OF MEDICINE Kesselheim, A. S., Studdert, D. M., Mello, M. M. 2010; 362 (19): 1832-1839

  View details for Web of Science ID 000277555500014

  View details for PubMedID 20463344

• Malpractice reform--opportunities for leadership by health care institutions and liability insurers. The New England journal of medicine Mello, M. M., Gallagher, T. H. 2010; 362 (15): 1353-6

  View details for DOI 10.1056/NEJMp1001603

  View details for PubMedID 20357276

• Federal Trade Commission Regulation of Food Advertising to Children: Possibilities for a Reinvigorated Role JOURNAL OF HEALTH POLITICS POLICY AND LAW Mello, M. M. 2010; 35 (2): 227-276

  Abstract

  Growing awareness of the role that food and beverage advertising plays in the epidemic of childhood obesity has prompted calls for stricter oversight of advertising practices. The food and beverage industries have taken voluntary steps in this direction, but many commentators have called for increased government regulation. The mission of the Federal Trade Commission (FTC) makes it an obvious candidate to lead a new regulatory effort. However, the FTC has a troubled history in the area of children's advertising regulation, and several political and legal factors constrain its ability to act. This article reviews those obstacles as well as the opportunities that exist at present to expand FTC oversight of food advertising to children. The FTC has considerable latitude to regulate individual food advertisements more rigorously, either on the basis that they are deceptive or on the basis that they are unfair. Broader rule making under the unfairness authority would require congressional intervention to expand the FTC's scope of authority, but there exist possibilities for rule making under the deception doctrine. Finally, the FTC could strengthen its efforts to encourage the food industry to regulate its own advertising practices more stringently and could provide mechanisms for making voluntary initiatives more meaningful.

  View details for DOI 10.1215/03616878-2009-051

  View details for Web of Science ID 000276941200005

  View details for PubMedID 20388868

• Disclosing Harmful Medical Errors to Patients Tackling Three Tough Cases CHEST Gallagher, T. H., Bell, S. K., Smith, K. M., Mello, M. M., McDonald, T. B. 2009; 136 (3): 897-903

  Abstract

  A gap exists between recommendations to disclose errors to patients and current practice. This gap may reflect important, yet unanswered questions about implementing disclosure principles. We explore some of these unanswered questions by presenting three real cases that pose challenging disclosure dilemmas. The first case involves a pancreas transplant that failed due to the pancreas graft being discarded, an error that was not disclosed partly because the family did not ask clarifying questions. Relying on patient or family questions to determine the content of disclosure is problematic. We propose a standard of materiality that can help clinicians to decide what information to disclose. The second case involves a fatal diagnostic error that the patient's widower was unaware had happened. The error was not disclosed out of concern that disclosure would cause the widower more harm than good. This case highlights how institutions can overlook patients' and families' needs following errors and emphasizes that benevolent deception has little role in disclosure. Institutions should consider whether involving neutral third parties could make disclosures more patient centered. The third case presents an intraoperative cardiac arrest due to a large air embolism where uncertainty around the clinical event was high and complicated the disclosure. Uncertainty is common to many medical errors but should not deter open conversations with patients and families about what is and is not known about the event. Continued discussion within the medical profession about applying disclosure principles to real-world cases can help to better meet patients' and families' needs following medical errors.

  View details for DOI 10.1378/chest.09-0030

  View details for Web of Science ID 000269733400035

  View details for PubMedID 19736193

• Commentary: A legal perspective on diabetes surveillance--privacy and the police power. The Milbank quarterly Mello, M. M., Gostin, L. O. 2009; 87 (3): 575-80

  View details for DOI 10.1111/j.1468-0009.2009.00570.x

  View details for PubMedID 19751281

  View details for PubMedCentralID PMC2881454

• The role of medical liability reform in federal health care reform. The New England journal of medicine Mello, M. M., Brennan, T. A. 2009; 361 (1): 1-3

  View details for DOI 10.1056/NEJMp0903765

  View details for PubMedID 19528190

• New York City's war on fat. The New England journal of medicine Mello, M. M. 2009; 360 (19): 2015-20

  View details for DOI 10.1056/NEJMhle0806121

  View details for PubMedID 19420372

• Shifting Terrain in the Regulation of Off-Label Promotion of Pharmaceuticals. NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Studdert, D. M., Brennan, T. A. 2009; 360 (15): 1557–66

  View details for PubMedID 19357413

• Relationship Between Malpractice Litigation Pressure and Rates of Cesarean Section and Vaginal Birth After Cesarean Section MEDICAL CARE Yang, Y. T., Mello, M. M., Subramanian, S. V., Studdert, D. M. 2009; 47 (2): 234-242

  Abstract

  Since the 1990s, nationwide rates of vaginal birth after cesarean section (VBAC) have decreased sharply and rates of cesarean section have increased sharply. Both trends are consistent with clinical behavior aimed at reducing obstetricians' exposure to malpractice litigation.To estimate the effects of malpractice pressure on rates of VBAC and cesarean section.We used state-level longitudinal mixed-effects regression models to examine data from the Natality Detail File on births in the United States (1991-2003). Malpractice pressure was measured by liability insurance premiums and tort reforms. Outcome measures were rates of VBAC, cesarean section, and primary cesarean section.Malpractice premiums were positively associated with rates of cesarean section (beta = 0.15, P = 0.02) and primary cesarean section (beta = 0.16, P = 0.009), and negatively associated with VBAC rates (beta = -0.35, P = 0.01). These estimates imply that a $10,000 decrease in premiums for obstetrician-gynecologists would be associated with an increase of 0.35 percentage points (1.45%) in the VBAC rate and decreases of 0.15 and 0.16 percentage points (0.7% and 1.18%) in the rates of cesarean section and primary cesarean section, respectively; this would correspond to approximately 1600 more VBACs, 6000 fewer cesarean sections, and 3600 fewer primary cesarean sections nationwide in 2003. Two types of tort reform-caps on noneconomic damages and pretrial screening panels-were associated with lower rates of cesarean section and higher rates of VBAC.The liability environment influences choice of delivery method in obstetrics. The effects are not large, but reduced litigation pressure would likely lead to decreases in the total number cesarean sections and total delivery costs.

  View details for Web of Science ID 000262913200014

  View details for PubMedID 19169125

  View details for PubMedCentralID PMC3096673

• Spillover Effects of State Mandated Benefit Laws: The Case of Outpatient Breast Cancer Surgery INQUIRY-THE JOURNAL OF HEALTH CARE ORGANIZATION PROVISION AND FINANCING Bian, J., Lipscomb, J., Mello, M. M. 2009; 46 (4): 433-447

  Abstract

  This paper examines the "spillover effects" of state laws that mandate inpatient coverage for breast cancer surgery. It looks at outpatient utilization of two types of breast cancer surgery among Medicare fee-for-service patients, who are exempt from state regulation. Using data from the Surveillance, Epidemiology and End Results cancer registries and Medicare claims, we performed difference-in-differences analyses of patients in nine states from 1993 to 2002. The analyses show that state laws had a significant impact on only the likelihood of outpatient mastectomy, which was reduced by five percentage points. Such a spillover effect may diminish the expected impact of federal coverage laws for inpatient breast cancer surgery, which have been proposed to achieve similar ends.

  View details for Web of Science ID 000274842100007

  View details for PubMedID 20184169

• Administrative compensation of medical injuries: A hardy perennial blooms again JOURNAL OF HEALTH POLITICS POLICY AND LAW Barringer, P. J., Studdert, D. M., Kachalia, A. B., Mello, M. M. 2008; 33 (4): 725-760

  Abstract

  Periods in which the costs of personal injury litigation and liability insurance have risen dramatically have often provoked calls for reform of the tort system, and medical malpractice is no exception. One proposal for fundamental reform made during several of these volatile periods has been to relocate personal injury disputes from the tort system to an alternative, administrative forum. In the medical injury realm, a leading incarnation of such proposals in recent years has been the idea of establishing specialized administrative "health courts." Despite considerable stakeholder and policy-maker interest, administrative compensation proposals have tended to struggle for broad political acceptance. In this article, we consider the historical experience of administrative medical injury compensation proposals, particularly in light of comparative examples in the context of workplace injuries, automobile injuries, and vaccine injuries. We conclude by examining conditions that may facilitate or impede progress toward establishing demonstration projects of health courts.

  View details for DOI 10.1215/03616878-2008-014

  View details for Web of Science ID 000257747100004

  View details for PubMedID 18617673

• Wellness programs and lifestyle discrimination--the legal limits. The New England journal of medicine Mello, M. M., Rosenthal, M. B. 2008; 359 (2): 192-9

  View details for DOI 10.1056/NEJMhle0801929

  View details for PubMedID 18614787

• Incidental findings in human subjects research: What do investigators owe research participants? JOURNAL OF LAW MEDICINE & ETHICS Miller, F. G., Mello, M. M., Joffe, S. 2008; 36 (2): 271-279

  Abstract

  The use of brain imaging technology as a common tool of research has spawned concern and debate over how investigators should respond to incidental findings discovered in the course of research. In this article, we argue that investigators have an obligation to respond to incidental findings in view of their entering into a professional relationship with research participants in which they are granted privileged access to private information with potential relevance to participants' health. We discuss the scope and limits of this professional obligation to respond to incidental findings, bearing in mind that the relationship between investigators and research participants differs fundamentally from the doctor-patient relationship.

  View details for Web of Science ID 000256411400005

  View details for PubMedID 18547194

• The interplay of public health law and industry self-regulation: The case of sugar-sweetened beverage sales in schools AMERICAN JOURNAL OF PUBLIC HEALTH Mello, M. M., Pomeranz, J., Moran, P. 2008; 98 (4): 595-604

  Abstract

  It is increasingly recognized that sugar-sweetened beverage consumption contributes to childhood obesity. Most states have adopted laws that regulate the availability of sugar-sweetened beverages in school settings. However, such policies have encountered resistance from consumer and parent groups, as well as the beverage industry. The beverage industry's recent adoption of voluntary guidelines, which call for the curtailment of sugar-sweetened beverage sales in schools, raises the question, Is further policy intervention in this area needed, and if so, what form should it take? We examine the interplay of public and private regulation of sugar-sweetened beverage sales in schools, by drawing on a 50-state legal and regulatory analysis and a review of industry self-regulation initiatives.

  View details for DOI 10.2105/AJPH.2006.107680

  View details for Web of Science ID 000254595500011

  View details for PubMedID 17901427

  View details for PubMedCentralID PMC2376983

• A Longitudinal Analysis of the Impact of Liability Pressure on the Supply of Obstetrician-Gynecologists JOURNAL OF EMPIRICAL LEGAL STUDIES Yang, Y. T., Studdert, D. M., Subramanian, S. V., Mello, M. M. 2008; 5 (1): 21-53

  View details for DOI 10.1111/j.1740-1461.2007.00117.x

  View details for Web of Science ID 000207805400002

• Rationalizing vaccine injury compensation BIOETHICS Mello, M. M. 2008; 22 (1): 32-42

  Abstract

  Legislation recently adopted by the United States Congress provides producers of pandemic vaccines with near-total immunity from civil lawsuits without making individuals injured by those vaccines eligible for compensation through the Vaccine Injury Compensation Program. The unusual decision not to provide an alternative mechanism for compensation is indicative of a broader problem of inconsistency in the American approach to vaccine-injury compensation policy. Compensation policies have tended to reflect political pressures and economic considerations more than any cognizable set of principles. This article identifies a set of ethical principles bearing on the circumstances in which vaccine injuries should be compensated, both inside and outside public health emergencies. A series of possible bases for compensation rules, some grounded in utilitarianism and some nonconsequentialist, are discussed and evaluated. Principles of fairness and reasonableness are found to constitute the strongest bases. An ethically defensible compensation policy grounded in these principles would make a compensation fund available to all individuals with severe injuries and to individuals with less-severe injuries whenever the vaccination was required by law or professional duty.

  View details for DOI 10.1111/j.1467-8519.2007.00590.x

  View details for Web of Science ID 000251627400006

  View details for PubMedID 18154587

• Obesity--personal choice or public health issue? Nature clinical practice. Endocrinology & metabolism Mello, M. M. 2008; 4 (1): 2-3

  View details for DOI 10.1038/ncpendmet0695

  View details for PubMedID 17998922

• Beyond negligence: Avoidability and medical injury compensation SOCIAL SCIENCE & MEDICINE Kachalia, A. B., Mello, M. M., Brennan, T. A., Studdert, D. M. 2008; 66 (2): 387-402

  Abstract

  Disenchantment with the tort system and negligence standard in the United States is fueling interest in alternate compensation systems for medical injury. One possibility is experimentation with administrative "health courts," through which specialized adjudicators would utilize neutral experts to render compensability determinations. Compensation would be based not on negligence, but rather on a broader avoidable medical injury (avoidability) standard. Although considerable interest in health courts exists, stakeholders frequently express uncertainty about the meaning and operation of an avoidability standard. Three nations-Sweden, Denmark, and New Zealand-have long operated administrative schemes. We conducted interviews with administrators and stakeholders in these systems. Our goal was to garner lessons on how to operate a health court, and specifically, how to develop and apply alternate compensation criteria such as avoidability. This article reports our findings on the origins and operations of the systems, the evolution of their compensation criteria, and how these criteria are actually applied. We found that all three systems had their primary genesis in ensuring compensation for the injured, as opposed to sanctioning providers. All have abandoned the negligence standard. The Nordic systems use an avoidability standard, principally defined as injury that would not occur in the hands of the best practitioner. Their experience demonstrates that this definition is feasible to apply. New Zealand's recent move to a no-fault system sheds light on the benefits and drawbacks of a variety of compensation standards. Key lessons for successfully applying an alternate standard, such as avoidability, include a strict adherence to national precedent, the use of neutral and experienced experts, and a block on routine transfer of information from compensation investigations to disciplinary authorities. Importantly, all three nations are harnessing their systems' power to improve patient safety, and the avoidability standard appears to be well suited for this task.

  View details for DOI 10.1016/j.socscimed.2007.08.020

  View details for Web of Science ID 000252822000016

  View details for PubMedID 17931762

• Deconstructing negligence: The role of individual and system factors in causing medical injuries GEORGETOWN LAW JOURNAL Mello, M. M., Studdert, D. M. 2008; 96 (2): 599-623

  View details for Web of Science ID 000253035300013

• Empirical health law scholarship: The state of the field GEORGETOWN LAW JOURNAL Mello, M. M., Zeiler, K. 2008; 96 (2): 649-702

  View details for Web of Science ID 000253035300015

• Policy experimentation with administrative compensation for medical injury: Issues under state constitutional law HARVARD JOURNAL ON LEGISLATION Mello, M. A., Studdert, D. M., Moran, P., Dauer, E. A. 2008; 45 (1): 59-105

  View details for Web of Science ID 000253913100002

• Adjudicating Severe Birth Injury Claims in Florida and Virginia: The Experience of a Landmark Experiment in Personal Injury Compensation AMERICAN JOURNAL OF LAW & MEDICINE Siegal, G., Mello, M. M., Studdert, D. M. 2008; 34 (4): 493-537

  View details for Web of Science ID 000262868600003

  View details for PubMedID 19216246

• Compact versus contract--industry sponsors' obligations to their research subjects. The New England journal of medicine Mello, M. M., Joffe, S. 2007; 356 (26): 2737-43

  View details for DOI 10.1056/NEJMhle067499

  View details for PubMedID 17596610

• When tort resolutions are "wrong": Predictors of discordant outcomes in medical malpractice litigation Conference on Current Research on Medical Malpractice Liability Studdert, D. M., Mello, M. M. UNIV CHICAGO PRESS. 2007: S47–S78

  View details for Web of Science ID 000254223400003

• Changes in physician supply and scope of practice during a malpractice crisis: Evidence from Pennsylvania HEALTH AFFAIRS Mello, M. M., Studdert, D. M., Schumi, J., Brennan, T. A., Sage, W. M. 2007; 26 (3): W425-W435

  Abstract

  The extent to which liability costs cause physicians to restrict their scope of practice or cease practicing is controversial in policy debates over malpractice "crises." We used insurance department administrative data to analyze specialist physician scope-of-practice changes and exits in Pennsylvania in 1993-2002. In most specialties the proportions of high-risk specialists restricting their scope of practice did not increase during the crisis; however, the supply of obstetrician-gynecologists decreased by 8 percent in the three years following premium increases in 1999. We discuss methodological issues that could explain the disparate findings regarding physician supply effects in studies using administrative data sets and survey data.

  View details for DOI 10.1377/hlthaff.26.3.w425

  View details for Web of Science ID 000246458300066

  View details for PubMedID 17456502

• Confidentiality laws and secrecy in medical research: Improving public access to data on drug safety HEALTH AFFAIRS Kesselheim, A. S., Mello, M. M. 2007; 26 (2): 483-491

  Abstract

  Pharmaceutical manufacturers have long considered results collected from drugs' clinical trials to be confidential information or trade secrets, even after submission to the Food and Drug Administration (FDA). We describe FDA policies regarding disclosure of clinical trial data and evaluate how courts have interpreted the Freedom of Information Act in cases seeking access to unreleased information. Recent examples of approved drugs later found to have dangerous side effects show the importance of complete dissemination of safety information. We suggest regulatory and legislative policy changes regarding how the FDA handles confidential information that can improve understanding of the risks of prescription drugs.

  View details for DOI 10.1377/hlthaff.26.2.483

  View details for Web of Science ID 000244763500022

  View details for PubMedID 17339677

• Regulatory and judicial oversight of nonprofit hospitals NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Mello, M. M., Jedrey, C. M., Brennan, T. A. 2007; 356 (6): 625-631

  View details for Web of Science ID 000244012700013

  View details for PubMedID 17287484

• Advance care planning in patients undergoing hematopoietic cell transplantation BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION Joffe, S., Mello, M. M., Cook, E. F., Lee, S. J. 2007; 13 (1): 65-73

  Abstract

  Few data are available on the prevalence of advance care planning (ACP) in patients undergoing hematopoietic cell transplantation (HCT). We surveyed adult patients pre-HCT to ascertain completion of various elements of ACP. We also reviewed medical records for documentation of discussions regarding ACP and for the presence of written advance directives. Evaluable surveys were returned by 155 of 335 patients (46%) who underwent HCT during the study period; we obtained permission for medical record review from 137 of these 155 survey respondents (88%). We found that 69% of the respondents reported having designated a health care proxy, 44% had completed a living will, 61% had prepared an estate will, and 63% had discussed their wishes regarding life support with family and friends. In contrast, only 16% had discussed their wishes regarding life support with their clinicians. Documentation of discussions between clinicians and patients regarding most elements of ACP was rare. Written advance directives were present in the charts of 54 patients (39%). ACP was more common in older, college-educated, and allogeneic transplant patients. Even though ACP was more prevalent among this sample than in the general population, its use still could be enhanced, given the high risks of decisional incapacity and death that HCT patients face.

  View details for DOI 10.1016/j.bbmt.2006.08.042

  View details for Web of Science ID 000243959300007

  View details for PubMedID 17222754

• Disclosure of medical injury to patients: An improbable risk management strategy HEALTH AFFAIRS Studdert, D. M., Mello, M. M., Gawande, A. A., Brennan, T. A., Wang, Y. C. 2007; 26 (1): 215-226

  Abstract

  Pressure mounts on physicians and hospitals to disclose adverse outcomes of care to patients. Although such transparency diverges from traditional risk management strategy, recent commentary has suggested that disclosure will actually reduce providers' liability exposure. We tested this theory by modeling the litigation consequences of disclosure. We found that forecasts of reduced litigation volume or cost do not withstand close scrutiny. A policy question more pressing than whether moving toward routine disclosure will expand litigation is the question of how large such an expansion might be.

  View details for DOI 10.1377/hlthaff.26.1.215

  View details for Web of Science ID 000244223200024

  View details for PubMedID 17211031

• The role of law in public health: The case of family planning in the Philippines SOCIAL SCIENCE & MEDICINE Mello, M. M., Powlowski, M., Nanagas, J. M., Bossert, T. 2006; 63 (2): 384-396

  Abstract

  Compared to neighboring countries, the Philippines has high fertility rates and a low prevalence of modern-method contraception use. The Philippine government faces political and cultural barriers to addressing family planning needs, but also legal barriers erected by its own policies. We conducted a review of laws and policies relating to family planning in the Philippines in order to examine how the law may facilitate or constrain service provision. The methodology consisted of three phases. First, we collected and analyzed laws and regulations relating to the delivery of family planning services. Second, we conducted a qualitative interview study. Third, we synthesized findings to formulate policy recommendations. We present a conceptual model for understanding the impact of law on public health and discuss findings in relation to the roles of health care provider regulation, drug regulation, tax law, trade policies, insurance law, and other laws on access to modern-method contraceptives.

  View details for DOI 10.1016/j.socscimed.2006.01.010

  View details for PubMedID 16488063

• Obesity--the new frontier of public health law. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2006; 354 (24): 2601-10

  View details for DOI 10.1056/NEJMhpr060227

  View details for PubMedID 16775242

• Claims, errors, and compensation payments in medical malpractice litigation NEW ENGLAND JOURNAL OF MEDICINE Studdert, D. M., Mello, M. M., Gawande, A. A., Gandhi, T. K., Kachalia, A., Yoon, C., Puopolo, A. L., Brennan, T. A. 2006; 354 (19): 2024-2033

  Abstract

  In the current debate over tort reform, critics of the medical malpractice system charge that frivolous litigation--claims that lack evidence of injury, substandard care, or both--is common and costly.Trained physicians reviewed a random sample of 1452 closed malpractice claims from five liability insurers to determine whether a medical injury had occurred and, if so, whether it was due to medical error. We analyzed the prevalence, characteristics, litigation outcomes, and costs of claims that lacked evidence of error.For 3 percent of the claims, there were no verifiable medical injuries, and 37 percent did not involve errors. Most of the claims that were not associated with errors (370 of 515 [72 percent]) or injuries (31 of 37 [84 percent]) did not result in compensation; most that involved injuries due to error did (653 of 889 [73 percent]). Payment of claims not involving errors occurred less frequently than did the converse form of inaccuracy--nonpayment of claims associated with errors. When claims not involving errors were compensated, payments were significantly lower on average than were payments for claims involving errors (313,205 dollars vs. 521,560 dollars, P=0.004). Overall, claims not involving errors accounted for 13 to 16 percent of the system's total monetary costs. For every dollar spent on compensation, 54 cents went to administrative expenses (including those involving lawyers, experts, and courts). Claims involving errors accounted for 78 percent of total administrative costs.Claims that lack evidence of error are not uncommon, but most are denied compensation. The vast majority of expenditures go toward litigation over errors and payment of them. The overhead costs of malpractice litigation are exorbitant.

  View details for Web of Science ID 000237413100007

  View details for PubMedID 16687715

• Medical malpractice: impact of the crisis and effect of state tort reforms. The Synthesis project. Research synthesis report Mello, M. M., Williams, C. H. 2006

  Abstract

  As a result of rapidly rising medical malpractice insurance premiums, reduced availability of coverage, and financially distressed liability insurers, many states have passed tort reforms. This synthesis examines the medical malpractice "crisis" and the effect of state tort reforms. Evidence shows that caps on non-economic damages reduce the average size of malpractice awards by 20 to 30 percent and have a modest impact on malpractice insurance premium growth There is also evidence that the most severely injured patients are disproportionately affected by caps, however. Other state reforms such as changes to joint-and-several liability, statutes of limitations, or attorney contingency fees have had little impact. Studies do not support the notion that overall physician supply has decreased, nor that there is a relationship between malpractice cost and physician supply. There is "good evidence" that doctors "often" engage in defensive medicine, ordering referrals, medications and tests to protect themselves from liability, but the impact of this practice is difficult to quantify.

  View details for DOI 15168

  View details for PubMedID 22051629

• "Health courts" and accountability for patient safety MILBANK QUARTERLY Mello, M. M., Studdert, D. M., Kachalia, A. B., Brennan, T. A. 2006; 84 (3): 459-492

  Abstract

  Proposals that medical malpractice claims be removed from the tort system and processed in an alternative system, known as administrative compensation or "health courts," attract considerable policy interest during malpractice "crises," including the current one. This article describes current proposals for the design of a health court system and the system's advantages for improving patient safety. Among these advantages are the cultivation of a culture of transparency regarding medical errors and the creation of mechanisms to gather and analyze data on medical injuries. The article discusses the experiences of foreign countries with administrative compensation systems for medical injury, including their use of claims data for research on patient safety; choices regarding the compensation system's relationship to physician disciplinary processes; and the proposed system's possible limitations.

  View details for Web of Science ID 000240027400002

  View details for PubMedID 16953807

• Understanding medical malpractice insurance: a primer. The Synthesis project. Research synthesis report Mello, M. M. 2006

  Abstract

  As the policy debate over the medical malpractice insurance crisis continues, dueling claims about its causes and suggestions for policy solutions have highlighted the need for a better understanding of how medical malpractice insurance works, why premiums change and what can be done about it. This primer on malpractice insurance discusses these issues and also analyzes the causes of and potential solutions to address malpractice crises. Key issues include: Rate regulation may have an important influence on insurance prices, but whether it raises or lowers them is not clear. Rising claims costs driven by an increase in average payments not claims frequency have contributed to rising premiums, but do not explain the sudden spike in premiums around 1999-2000. Along with claims costs, the insurance cycle has contributed to the current crisis.

  View details for DOI 15091

  View details for PubMedID 22052324

• Effects of a malpractice crisis on specialist supply and patient access to care ANNALS OF SURGERY Mello, M. M., Studdert, D. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A., Sage, W. M. 2005; 242 (5): 621-628

  Abstract

  To investigate specialist physicians' practice decisions in response to liability concerns and their perceptions of the impact of the malpractice environment on patient access to care.A perennial concern during "malpractice crises" is that liability costs will drive physicians in high-risk specialties out of practice, creating specialist shortages and access-to-care problems.Mail survey of 824 Pennsylvania physicians in general surgery, neurosurgery, orthopedic surgery, obstetrics/gynecology, emergency medicine, and radiology eliciting information on practice decisions made in response to rising liability costs.Strong majorities of specialists reported increases over the last 3 years in patients' driving distances (58%) and waiting times (83%) for specialist care or surgery, waiting times for emergency department care (82%), and the number of patients forced to switch physicians (89%). Professional liability costs and managed care were both considered important contributing factors. Small proportions of specialists reported that they would definitely retire (7%) or relocate their practice out of state (4%) within the next 2 years; another third (32% and 29%, respectively) said they would likely do so. Forty-two percent of specialists have reduced or eliminated high-risk aspects of their practice, and 50% are likely to do so over the next 2 years.Our data suggest that claims of a "physician exodus" from Pennsylvania due to rising liability costs are overstated, but the malpractice situation is having demonstrable effects on the supply of specialist physicians in affected areas and their scope of practice, which likely impinges upon patients' access to care.

  View details for DOI 10.1097/01.sla.0000182957.54783.9a

  View details for Web of Science ID 000233215500001

  View details for PubMedID 16244532

  View details for PubMedCentralID PMC1409847

• Managing malpractice crises. The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics Mello, M. M. 2005; 33 (3): 414-5

  View details for PubMedID 16240725

• Legal concerns and the influenza vaccine shortage. JAMA Mello, M. M., Brennan, T. A. 2005; 294 (14): 1817-20

  View details for DOI 10.1001/jama.294.14.1817

  View details for PubMedID 16219886

• Are medical malpractice damages caps constitutional? An overview of state litigation JOURNAL OF LAW MEDICINE & ETHICS KELLY, C. N., Mello, M. M. 2005; 33 (3): 515-?

  View details for Web of Science ID 000231961000009

  View details for PubMedID 16240732

• The future of surgery: today's residents speak. Current surgery Breen, E., Irani, J. L., Mello, M. M., Whang, E. E., Zinner, M. J., Ashley, S. W. 2005; 62 (5): 543-546

  Abstract

  New Accreditation Council for Graduate Medical Education (ACGME) resident duty hour requirements were implemented in July 2003. A recent study suggests that these requirements have resulted in substantial work-hour reductions and improvements in quality of life for general surgery residents. The impact of these changes on the culture of surgery and attitudes about future practice patterns among current surgical residents is unknown.To characterize future practice patterns desired by the current generation of general surgery residents.A confidential survey was administered to all residents enrolled in 21 general surgery residency programs in New England (n = 668).Completed responses were received from 238 residents. Three quarters of the respondents wish to limit their practice to a subspecialty, and two thirds wish to work 60 hours or less per week as attending surgeons. About one quarter find a job-sharing arrangement desirable. Seventy-one percent report that being on-call for their patients at all times with no night or weekend cross-coverage would be undesirable. Over 90% desire sharing on-call responsibilities with members of a group. Over one quarter would feel comfortable allowing cross-covering colleagues to manage their operative complications routinely, including reoperation. Over one quarter would pass off a scheduled operation that was delayed into the night or weekend.The current surgical residents desire practice patterns that substantially differ from those of today's surgeons. To the extent that these attitudes spring from changes in resident working conditions wrought by the ACGME duty hour requirements, these requirements have the potential to change the nature of surgical practice in this country.

  View details for PubMedID 16125618

• Surgical residents' perceptions of the effects of the ACGME duty hour requirements 1 year after implementation SURGERY Irani, J. L., Mello, M. M., Ashley, S. W., Whang, E. E., Zinner, M. J., Breen, E. 2005; 138 (2): 246-253

  Abstract

  In July 2003, the Accreditation Council for Graduate Medical Education implemented nationwide requirements on resident duty hours with the aim of improving quality of care. Our objectives were (1) to determine the extent and means of compliance with the ACGME requirements within general surgery residency programs and (2) to examine general surgery residents' perceptions of the effects of the ACGME requirements on patient care and residents' training experience.A survey was mailed to residents in 19 New England general surgery programs in spring 2004 (n=238).The overall response rate was 36%. More than 89% of respondents reported that the requirements generally were being enforced, and respondents' mean work hours (80.8 +/- 11.7 per week) supported this claim. Forty-three percent felt that quality of care had deteriorated. Although 70% perceived decrements in continuity of care, only 32% believed that the risk of patient management errors had increased. Sixty percent reported doing fewer operations, and half felt that residents missed out on too many learning opportunities. Yet, only 39% reported that the requirements had worsened the quality of training. Residents consistently reported an improved quality of life. Seventy-five percent felt that, overall, the requirements were a good thing.Most surgical residents do not believe that the ACGME duty hour requirements have had their intended effect of improving quality of care and are ambivalent about effects on the quality of their training. However, they report an improved quality of life, and most residents do support the requirements overall.

  View details for DOI 10.1016/j.surg.2005.06.010

  View details for Web of Science ID 000232019800017

  View details for PubMedID 16153433

• Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors. Accountability in research Mello, M. M., Clarridge, B. R., Studdert, D. M. 2005; 12 (3): 163-191

  Abstract

  We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

  View details for PubMedID 16634168

• Effects of a professional liability crisis on residents' practice decisions OBSTETRICS AND GYNECOLOGY Mello, M. M., KELLY, C. N. 2005; 105 (6): 1287-1295

  Abstract

  Pennsylvania, like many states, is in a professional liability crisis characterized by escalating cost and decreasing availability of liability insurance. Medical and surgical specialists have experienced especially large increases in insurance premiums. The objective of this study was to estimate the impact of liability concerns during a professional liability crisis on Pennsylvania residents' decisions regarding their future practice. It was hypothesized that liability concerns would negatively affect Pennsylvania residents' propensity to practice in the state following residency.Statewide mail surveys were completed in 2003 by 68 Pennsylvania residency program directors and 360 residents nearing the end of their training in anesthesiology, general surgery, emergency medicine, obstetrics and gynecology, orthopedics, and radiology residencies.One third of residents in their final or next-to-last year of residency planned to leave Pennsylvania because of the lack of availability of affordable malpractice coverage. Although, in general, residents' geographic decisions are influenced by a range of factors, those who are about to leave Pennsylvania named malpractice costs as the primary reason 3 times more often than any other factor. Seventy-one percent of residency program directors reported a decrease in retention of residents in the state since the onset of the professional liability crisis. For some programs the decreases were very large.An environment of mounting liability costs in Pennsylvania appears to have dissuaded substantial numbers of residents in high-risk specialties from locating their clinical practices in the state. The impact of decreased resident retention on the future availability of specialist services in high-cost states merits close monitoring.

  View details for DOI 10.1097/01.AOG.0000163255.56004.b5

  View details for Web of Science ID 000229361200003

  View details for PubMedID 15932819

• Fostering rational regulation of patient safety JOURNAL OF HEALTH POLITICS POLICY AND LAW Mello, M. M., KELLY, C. N., Brennan, T. A. 2005; 30 (3): 375-426

  Abstract

  After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.

  View details for Web of Science ID 000237158400004

  View details for PubMedID 16089110

• Defensive medicine among high-risk specialist physicians in a volatile malpractice environment JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Studdert, D. M., Mello, M. M., Sage, W. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A. 2005; 293 (21): 2609-2617

  Abstract

  How often physicians alter their clinical behavior because of the threat of malpractice liability, termed defensive medicine, and the consequences of those changes, are central questions in the ongoing medical malpractice reform debate.To study the prevalence and characteristics of defensive medicine among physicians practicing in high-liability specialties during a period of substantial instability in the malpractice environment.Mail survey of physicians in 6 specialties at high risk of litigation (emergency medicine, general surgery, orthopedic surgery, neurosurgery, obstetrics/gynecology, and radiology) in Pennsylvania in May 2003.Number of physicians in each specialty reporting defensive medicine or changes in scope of practice and characteristics of defensive medicine (assurance and avoidance behavior).A total of 824 physicians (65%) completed the survey. Nearly all (93%) reported practicing defensive medicine. "Assurance behavior" such as ordering tests, performing diagnostic procedures, and referring patients for consultation, was very common (92%). Among practitioners of defensive medicine who detailed their most recent defensive act, 43% reported using imaging technology in clinically unnecessary circumstances. Avoidance of procedures and patients that were perceived to elevate the probability of litigation was also widespread. Forty-two percent of respondents reported that they had taken steps to restrict their practice in the previous 3 years, including eliminating procedures prone to complications, such as trauma surgery, and avoiding patients who had complex medical problems or were perceived as litigious. Defensive practice correlated strongly with respondents' lack of confidence in their liability insurance and perceived burden of insurance premiums.Defensive medicine is highly prevalent among physicians in Pennsylvania who pay the most for liability insurance, with potentially serious implications for cost, access, and both technical and interpersonal quality of care.

  View details for Web of Science ID 000229443400019

  View details for PubMedID 15928282

• Academic medical centers' standards for clinical-trial agreements with industry NEW ENGLAND JOURNAL OF MEDICINE Mello, M. M., Clarridge, B. R., Studdert, D. M. 2005; 352 (21): 2202-2210

  Abstract

  Although industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.We used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.Of 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent).Standards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.

  View details for Web of Science ID 000229333300008

  View details for PubMedID 15917385

• Financial conflicts of interest in physicians' relationships with the pharmaceutical industry--self-regulation in the shadow of federal prosecution. The New England journal of medicine Studdert, D. M., Mello, M. M., Brennan, T. A. 2004; 351 (18): 1891-900

  View details for DOI 10.1056/NEJMlim042229

  View details for PubMedID 15509824

• The experience of a community representative on an ethics consult team JOURNAL OF CLINICAL ETHICS Mello, M. 2004; 15 (3): 296-301

  View details for Web of Science ID 000225560700012

  View details for PubMedID 15630873

• Medical malpractice as an epidemiological problem SOCIAL SCIENCE & MEDICINE Mello, M. M., Hemenway, D. 2004; 59 (1): 39-46

  Abstract

  The notion that the tort liability system deters negligence in health care has been invoked to make the "business case for patient safety." However, existing data on the relationship between hospital adverse events and malpractice claims typically are interpreted as evidence that the tort system does not deter negligence because of the poor fit between those who are negligently injured and those who sue. Using a familiar analogy from epidemiology--the problem of false positives in screening tests for rare diseases--and data from two large studies of medical injuries and malpractice claims in the United States, this paper presents an argument that the standard interpretation overlooks a complexity in the data. Although most malpractice claims do not actually involve a negligent injury, a patient who suffers a negligent injury is more than 20 times more likely, on average, to file a claim than a patient who does not. However, because malpractice claiming is a rare event with many false positives, for the average hospital or group practice, even substantial improvements in rates of negligent injury will not lead to a large reduction in claims rates. These findings suggest that the strength of the business case for patient safety depends on the perspective from which one views the data.

  View details for DOI 10.1016/j.socscimed.2003.09.034

  View details for Web of Science ID 000221190600004

  View details for PubMedID 15087141

• Caring for patients in a malpractice crisis: Physician satisfaction and quality of care HEALTH AFFAIRS Mello, M. M., Studdert, D. M., DesRoches, C. M., Peugh, J., Zapert, K., Brennan, T. A., Sage, W. M. 2004; 23 (4): 42-53

  Abstract

  The rhetoric of malpractice reform is at fever pitch, but political advocacy does not necessarily reflect grassroots opinion. To determine whether the ongoing liability crisis has greatly reduced physicians' professional satisfaction, we surveyed specialist physicians in Pennsylvania. We found widespread discontent among physicians practicing in high-liability environments, which seems to be compounded by other financial and administrative pressures. Opinion alone should not determine public policy, but physicians' perceptions matter for two reasons. First, perceptions influence behavior with respect to practice environment and clinical decision making. Second, perceptions influence the physician-patient relationship and the interpersonal quality of care.

  View details for DOI 10.1377/hlthaff.23.4.42

  View details for Web of Science ID 000222499600006

  View details for PubMedID 15318566

• Are damages caps regressive? A study of malpractice jury verdicts in California HEALTH AFFAIRS Studdert, D. M., Yang, Y. T., Mello, M. M. 2004; 23 (4): 54-67

  Abstract

  Caps on damages have emerged as the most controversial legislative response to the new malpractice crisis. We analyzed a sample of high-end jury verdicts in California that were subjected to the state's dollars 250,000 cap on noneconomic damages. We found strong evidence that the cap's fiscal impact was distributed inequitably across different types of injuries. In absolute dollar terms, the reductions imposed on grave injury were seven times larger than those for minor injury; the largest proportional reductions were for injuries that centered on pain and disfigurement. Use of sliding scales of damages instead of or in conjunction with caps would mitigate their adverse impacts on fairness.

  View details for DOI 10.1377/hlthaff.23.4.54

  View details for Web of Science ID 000222499600007

  View details for PubMedID 15318567

• The pharmaceutical industry versus Medicaid--limits on state initiatives to control prescription-drug costs. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2004; 350 (6): 608-13

  View details for DOI 10.1056/NEJMlim035683

  View details for PubMedID 14762190

• Medical malpractice. The New England journal of medicine Studdert, D. M., Mello, M. M., Brennan, T. A. 2004; 350 (3): 283-92

  View details for DOI 10.1056/NEJMhpr035470

  View details for PubMedID 14724310

• Decision making and satisfaction with care in the pediatric intensive care unit: findings from a controlled clinical trial. Pediatric critical care medicine Mello, M. M., Burns, J. P., Truog, R. D., Studdert, D. M., Puopolo, A. L., Brennan, T. A. 2004; 5 (1): 40-47

  Abstract

  To facilitate critical decision making and improve satisfaction with care among families of patients in a pediatric intensive care unit.Prospective observational study followed by a nonrandomized controlled trial of a clinical intervention to identify conflicts and facilitate communication between families and the clinical team.The pediatric intensive care unit of a Boston teaching hospital.A total of 127 patients receiving care in the pediatric intensive care unit in 1998-1999 and their families.Interviews were conducted with surrogates and decisionally capable older children concerning the adequacy of information provided, understanding, communication, and perceived decisional conflicts. Findings were relayed to the clinical team, who then developed tailored follow-up recommendations.A survey administered to surrogates at baseline and day 7 or intensive care unit discharge measured satisfaction with care. Information on patient acuity and hospital stay were extracted from medical records and hospital databases. Wilcoxon rank-sum tests and incidence rate comparisons were used to assess the impact of the intervention on satisfaction and sentinel decision making, respectively. Incidence rates of care plan decision making, including decisions to adopt a comfort-care-only plan and decisions to forego resuscitation, were lower among families who received the intervention. The intervention did not significantly affect satisfaction with care.Prospectively screening for and intervening to mitigate potential conflict did not increase decision making or parental satisfaction with the care provided in this pediatric intensive care unit.

  View details for PubMedID 14697107

• From the field - Hospitals' behavior in a tort crisis: Observations from Pennsylvania HEALTH AFFAIRS Mello, M. M., KELLY, C. N., Studdert, D. M., Brennan, T. A., Sage, W. M. 2003; 22 (6): 225-233

  View details for Web of Science ID 000186632200029

• Hospitals' behavior in a tort crisis: observations from Pennsylvania. Health affairs Mello, M. M., Kelly, C. N., Studdert, D. M., Brennan, T. A., Sage, W. M. 2003; 22 (6): 225-233

  Abstract

  Pennsylvania, like many states around the country, is in the throes of a "tort crisis." The cost of professional liability insurance for physicians and hospitals is escalating rapidly, as its availability shrinks. Many hospitals are poorly situated to bear these rising costs, especially in an environment of flat reimbursement rates and poor investment returns. This paper examines the impact of the liability crisis on Pennsylvania hospitals and the strategies being used to weather the storm, including alternative risk financing and closer ties between hospitals and affiliated physicians. It concludes by connecting these trends to larger medical malpractice policy issues.

  View details for PubMedID 14649450

• Trends - The McLawsult: The fast-food industry and legal accountability for obesity HEALTH AFFAIRS Mello, M. M., Rimm, E. B., Studdert, D. M. 2003; 22 (6): 207-216

  Abstract

  Recent litigation brought by a group of overweight children against the McDonald's Corporation that seeks compensation for obesity-related health problems has provoked an intense public response. Many have derided this lawsuit as representing the worst excesses of the tort liability system, while others have drawn parallels to tobacco litigation. Fast-food litigation raises the question of where accountability for the economic and public health consequences of obesity properly rests. In this paper we consider the reasonableness of the claims against fast-food companies and discuss several social effects that the litigation may have irrespective of its outcome in court.

  View details for Web of Science ID 000186632200027

  View details for PubMedID 14649448

• Work hours reform: Perceptions and desires of contemporary surgical residents JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS Whang, E. E., Perez, A., Ito, H., Mello, M. M., Ashley, S. W., Zinner, M. J. 2003; 197 (4): 624-630

  Abstract

  New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. General surgery residents, because of their long duty hours, are likely to be among those most affected by changes imposed to comply with the ACGME requirements. There are few contemporary data on their attitudes toward work hours reform.The study entailed a region-wide survey of residents enrolled in general surgery residencies in New England to characterize the perceptions and desires of surgical residents on the issue of work hours reform.Respondents reported working a mean of 105 +/- 0.7 hours per week, considerably more than the 80-hour limit stipulated by the ACGME. Of the respondents, 81% reported that sleep deprivation had negatively affected their work. A strong majority of respondents believe that work hours reform would improve their quality of life but less than one half expect it to have a positive impact on patient care. A greater percentage of senior residents than junior residents (p < 0.05) have negative perceptions of work hour limitations, particularly with respect to consequences for patient care. Other findings suggest that residents who have actually experienced work hour restrictions are less positive about such restrictions than these residents who had not yet experienced them.Changes imposed by residency programs to comply with work hour requirements might have detrimental effects on senior residents and patient care. The impact of such changes should be carefully monitored as the ACGME requirements are implemented.

  View details for DOI 10.1016/S1072-7515(03)00602-1

  View details for Web of Science ID 000185765700019

  View details for PubMedID 14522334

• Due process in investigations of research misconduct. The New England journal of medicine Mello, M. M., Brennan, T. A. 2003; 349 (13): 1280-6

  View details for DOI 10.1056/NEJMhpr035095

  View details for PubMedID 14507953

• Conflict in the care of patients with prolonged stay in the ICU: types, sources, and predictors INTENSIVE CARE MEDICINE Studdert, D. M., Mello, M. M., Burns, J. P., Puopolo, A. L., Galper, B. Z., Truog, R. D., Brennan, T. A. 2003; 29 (9): 1489-1497

  Abstract

  To determine types, sources, and predictors of conflicts among patients with prolonged stay in the ICU.We prospectively identified conflicts by interviewing treating physicians and nurses at two stages during the patients' stays. We then classified conflicts by type and source and used a case-control design to identify predictors of team-family conflicts.Seven medical and surgical ICUs at four teaching hospitals in Boston, USA.All patients admitted to the participating ICUs over an 11-month period whose stay exceeded the 85th percentile length of stay for their respective unit ( n=656).Clinicians identified 248 conflicts involving 209 patients; hence, nearly one-third of patients had conflict associated with their care: 142 conflicts (57%) were team-family disputes, 76 (31%) were intrateam disputes, and 30 (12%) occurred among family members. Disagreements over life-sustaining treatment led to 63 team-family conflicts (44%). Other leading sources were poor communication (44%), the unavailability of family decision makers (15%), and the surrogates' (perceived) inability to make decisions (16%). Nurses detected all types of conflict more frequently than physicians, especially intrateam conflicts. The presence of a spouse reduced the probability of team-family conflict generally (odds ratio 0.64) and team-family disputes over life-sustaining treatment specifically (odds ratio 0.49).Conflict is common in the care of patients with prolonged stays in the ICU. However, efforts to improve the quality of care for critically ill patients that focus on team-family disagreements over life-sustaining treatment miss significant discord in a variety of other areas.

  View details for DOI 10.1007/s00134-003-1853-5

  View details for Web of Science ID 000185665800015

  View details for PubMedID 12879243

• Nature of conflict in the care of pediatric intensive care patients with prolonged stay PEDIATRICS Studdert, D. M., Burns, J. P., Mello, M. M., Puopolo, A. L., Truog, R. D., Brennan, T. A. 2003; 112 (3): 553-558

  Abstract

  To determine the frequency, types, sources, and predictors of conflict surrounding the care of pediatric intensive care unit (PICU) patients with prolonged stay.A tertiary care, university-affiliated PICU in Boston.All patients admitted over an 11-month period whose stay exceeded 8 days (the 85th percentile length of stay for the PICU under study), and intensive care physicians and nurses who were responsible for their care.We prospectively identified conflicts by interviewing the treating physicians and nurses at 2 stages during the patients' PICU stay. All conflicts detected were classified by type (team-family, intrateam, or intrafamily) and source. Using a case-control design, we then identified predictors of conflict through bivariate and multivariate analyses.We enrolled 110 patients based on the length-of-stay criterion. Clinicians identified 55 conflicts involving 51 patients in this group. Hence, nearly one half of all patients followed had a conflict associated with their care. Thirty-three of the conflicts (60%) were team-family, 21 (38%) were intrateam, and the remaining 1 was intrafamily. The most commonly cited sources of team-family conflict were poor communication (48%), unavailability of parents (39%), and disagreements over the care plan (39%). Medicaid insurance status was independently associated with the occurrence of conflict generally (odds ratio = 4.97) and team-family conflict specifically (odds ratio = 7.83).Efforts to reduce and manage conflicts that arise in the care of critically ill children should be sensitive to the distinctive features of these conflicts. Knowledge of risk factors for conflict may also help to target such interventions at the patients and families who need them most.

  View details for Web of Science ID 000185035100027

  View details for PubMedID 12949283

• Patient safety and medical malpractice: A case study ANNALS OF INTERNAL MEDICINE Brennan, T. A., Mello, M. M. 2003; 139 (4): 267-273

  Abstract

  The system of tort liability for medical malpractice is frequently criticized for poorly performing its theoretical functions of compensating injured patients, deterring negligence, and dispensing corrective justice. Working from an actual malpractice case involving serious injury but no apparent negligence, the authors explore these criticisms from the perspectives of both the plaintiff-patient and the defendant-physician. They then examine the tort system through the lens of patient safety and conclude that the tensions between the system and patient safety initiatives suggest a need to reexamine our attachment to adversarial dispute resolution in health care. They propose targeted reforms that could improve the functioning of the system and create incentives to improve safety and quality.

  View details for Web of Science ID 000184795600005

  View details for PubMedID 12965982

• Results of a clinical trial on care improvement for the critically ill CRITICAL CARE MEDICINE Burns, J. P., Mello, M. M., Studdert, D. M., Puopolo, A. L., Truog, R. D., Brennan, T. A. 2003; 31 (8): 2107-2117

  Abstract

  To develop, deploy, and evaluate an intervention designed to identify and mitigate conflict in decision making in the intensive care unit.Nonrandomized, controlled trial.Seven intensive care units at four Boston teaching hospitals.A total of 1,752 critically ill patients, including 873 study cases analyzed here.Social workers interviewed families of patients deemed at high risk for decisional conflict and provided feedback to the clinical team, who then implemented measures to address the problems identified.Patient or surrogate satisfaction with intensive care unit care and the probability of choosing a specific plan for treatment in the intensive care unit was studied. Inclusion criteria identified 873 patients at risk for decisional conflict. Thirty-nine percent of the patients in the intervention phase of the study (172 patients) received the intervention. In multivariate analyses, receiving the intervention significantly increased the likelihood of deciding to forgo resuscitation (odds ratio [OR] = 1.81, p =.017), the likelihood of choosing a treatment plan for comfort-care only (OR = 1.94, p =.018), and the likelihood of choosing an aggressive-care treatment plan (OR = 2.30, p =.002). Receiving the intervention did not significantly affect overall satisfaction with the care provided (OR = 0.68, p =.14), satisfaction with the amount of information provided (OR = 0.86, p =.44), or satisfaction with the degree of involvement in decision making (OR = 0.84, p =.54).Although there was no impact on patient or surrogate satisfaction with care provided in the intensive care unit, the intervention did facilitate deliberative decision making in cases deemed at high risk for conflict. The lessons learned from the experience with this intervention should be helpful in ongoing efforts to improve care and to achieve outcomes desired by critically ill patients, their families, and critical care clinicians.

  View details for DOI 10.1097/01.CCM.0000069732.65524.72

  View details for Web of Science ID 000184797600005

  View details for PubMedID 12973167

• The rise of litigation in human subjects research ANNALS OF INTERNAL MEDICINE Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 139 (1): 40-45

  Abstract

  Owing to widespread public concern about the adequacy of protections for human research subjects and recent instances of serious injury to subjects at several major research institutions, lawsuits against investigators, institutional review boards, and academic institutions are becoming increasingly common. Several claim-promoting conditions are ripe to promote the further growth of this litigation and raise the stakes for research institutions. While this litigation may serve a valuable compensation function for injured subjects, it will also have profound effects on institutional review boards, leading to a more legalistic, mechanistic approach to ethical review that does not further the interests of human subjects or scientific progress.

  View details for Web of Science ID 000183823200006

  View details for PubMedID 12834317

• The new medical malpractice crisis. The New England journal of medicine Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 348 (23): 2281-4

  View details for DOI 10.1056/NEJMp030064

  View details for PubMedID 12788991

• Understanding biased selection in Medicare HMOs HEALTH SERVICES RESEARCH Mello, M. M., Stearns, S. C., Norton, E. C., Ricketts, T. C. 2003; 38 (3): 961-992

  Abstract

  To investigate the extent of favorable health maintenance organization (HMO) selection for a longitudinal cohort of Medicare beneficiaries, examine whether the extent of favorable selection varies with the degree of Medicare HMO market penetration in a county, and explain conflicting findings in the literature on favorable HMO selection.A panel of 1992-1996 data from the Medicare Current Beneficiary Survey (MCBS), supplemented with linked data from the Area Resource File and Medicare administrative datasets.Using random effects probit estimation, we model a beneficiary's HMO enrollment status as a function of self-reported health status and Medicare HMO market penetration.The MCBS data for beneficiaries residing in states served by Medicare HMOs in 1992-1996 were linked by county to the supplementary datasets.We find that favorable selection persists in the cohort over time on some, but not all, measures. We find no substantial association between favorable HMO selection and HMO market penetration. We find that conflicting findings in the literature on favorable HMO selection may be explained by several methodological choices, including the choice of health status measure and the structure of the sample.Our results support further risk adjustment of the adjusted average per capita cost (AAPCC) payment formula.

  View details for Web of Science ID 000183315500012

  View details for PubMedID 12822921

• Implementing resident work hour limitations - Lessons from the New York State experience ANNALS OF SURGERY Whang, E. E., Mello, M. M., Ashley, S. W., Zinner, M. J. 2003; 237 (4): 449-455

  Abstract

  To determine the impact of work hour limitations imposed by the 405 (Bell) Regulations as perceived by general surgery residents in New York State.New Accreditation Council for Graduate Medical Education (ACGME) requirements on resident duty hours are scheduled to undergo nationwide implementation in July 2003. State regulations stipulating similar resident work hour limitations have already been enacted in New York.A statewide survey of residents enrolled in general surgery residencies in New York was administered.Most respondents reported general compliance with 405 Regulations in their residency programs, a finding corroborated by reported work hours and call schedules. Whereas a majority of residents reported improved quality of life as a result of the work hour limitations, a substantial portion reported negative impacts on surgical training and quality and continuity of patient care. Negative perceptions of the impact of duty hour restrictions were more prevalent among senior residents and residents at academic medical centers than among junior residents and residents at community hospitals.Implementation of resident work hour limitations in general surgery residencies may have negative consequences for patient care and resident education. As surgical residency programs develop strategies for complying with ACGME requirements, these negative consequences must be addressed.

  View details for Web of Science ID 000185834400001

  View details for PubMedID 12677136

• Reduced medicolegal risk by compliance with obstetric clinical pathways: A case-control study OBSTETRICS AND GYNECOLOGY Ransom, S. B., Studdert, D. M., DOMBROWSKI, M. P., Mello, M. M., Brennan, T. A. 2003; 101 (4): 751-755

  Abstract

  To estimate whether guideline compliance affected medicolegal risk in obstetrics and whether malpractice claims data can provide useful information on guideline noncompliance by focusing on the claims experience of a large health system delivering approximately 12000 infants annually.We retrospectively identified 290 delivery-related (diagnosis-related groups 370-374) malpractice claims and 262 control deliveries at the health system during the period from 1988 to 1998. Clinical pathways for vaginal and cesarean delivery implemented in 1998 were used as a "standard of care." We compared rates of noncompliance with the pathways in the claims and control groups, calculated an odds ratio for increased risk of being sued given departure from the guideline standards, and calculated the elevated risk of litigation introduced by noncompliance. We also compared the frequencies of different types of departures across claims and control groups.Claims closely resembled controls on several descriptive measures (mother's age, location of delivery, type of delivery, and complication rates), but noncompliance with the clinical pathway was significantly more common among claims than controls (43.2% versus 11.7%, P <.001; odds ratio = 5.76, 95% confidence interval 3.59, 9.2). In 81 (79.4%) of the claims involving noncompliance with the pathway, the main allegation in the claim related directly to the departure from the pathway. The excess malpractice risk attributable to noncompliance explained approximately one third (104 of 290) of the claims filed (attributable risk = 82.6%). There were no significant differences in the types of deviation from the guidelines across claims and control groups.In addition to reducing clinical variation and improving clinical quality of care, adherence to clinical pathways might protect clinicians and institutions against malpractice litigation. Malpractice data might also be a useful resource in understanding breakdowns in processes of care.

  View details for DOI 10.1016/S0029-7844(02)03129-0

  View details for Web of Science ID 000181899700023

  View details for PubMedID 12681881

• The leapfrog standards: Ready to jump from marketplace to courtroom? HEALTH AFFAIRS Mello, M. M., Studdert, D. M., Brennan, T. A. 2003; 22 (2): 46-59

  Abstract

  The Leapfrog Group, a consortium of large employers, aims to use its collective purchasing power to motivate hospitals to implement particular measures designed to improve patient safety and the quality of care. While these criteria are meant to be purely aspirational, and while Leapfrog's effort is praiseworthy, we caution that the articulation of these standards of care may have unintended legal consequences. Efforts by aggressive medical malpractice attorneys could rapidly transform Leapfrog's standards from marketplace advantages for compliant hospitals to performance expectations required by law. This undesirable potential outcome compounds the importance of selecting these standards with the utmost care.

  View details for Web of Science ID 000181450400011

  View details for PubMedID 12674407

• Medical monitoring for pharmaceutical injuries - Tort law for the public's health? JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Studdert, D. M., Mello, M. M., Brennan, T. A. 2003; 289 (7): 889-894

  Abstract

  A remarkable development in personal injury litigation in recent years involves attempts to expand legal claims beyond existing injuries to anticipated future harms. Attorneys have begun to sue on behalf of individuals exposed to defective pharmaceutical products who have no current injury, but who may be at risk for developing one after a latency period. This strategy seeks to make drug manufacturers pay for medical monitoring, a court-ordered program that provides diagnostic tests to exposed individuals to facilitate early detection of adverse health effects. Because medical monitoring does not depend on the existence of an actual injury and large populations may be exposed, some commentators have warned that it has the potential to spiral out of control. We examine medical monitoring in the context of 2 major cases involving diet drugs and an oral hypoglycemic drug. We conclude that this expansion of tort law should be applied sparingly, but that the performance of courts to date in these cases gives cause for optimism. Judges appear to be paying close attention to sophisticated epidemiological, clinical, and cost-effectiveness considerations. Medical monitoring arms the courts with a new mechanism for addressing harms proactively rather than reactively, which could yield new victories for public health.

  View details for Web of Science ID 000181072200034

  View details for PubMedID 12588274

• Direct-to-consumer advertising and shared liability for pharmaceutical manufacturers. JAMA Mello, M. M., Rosenthal, M., Neumann, P. J. 2003; 289 (4): 477-81

  View details for PubMedID 12533128

• Do Medicare HMOs still reduce health services use after controlling for selection bias? HEALTH ECONOMICS Mello, M. M., Stearns, S. C., Norton, E. C. 2002; 11 (4): 323-340

  Abstract

  This study models the relationship between Medicare beneficiary decisions to join Medicare HMOs and subsequent health services utilization. The relationship between health plan choice and utilization is thought to be endogenous because of favorable selection into HMOs. Previous studies found significantly lower inpatient utilization among Medicare HMO enrollees than among nonenrollees, but lacked strong controls for selection bias. Thus, a firm conclusion could not be drawn as to whether the observed differences were attributable to the HMO practice setting or to baseline differences in the illness profiles of the two groups studied. The present study uses simultaneous equations methods, including discrete factor estimation, to test the effect of Medicare HMOs on utilization when strong controls for selection bias are imposed. The model was run on a panel of 1993-1996 data from the Medicare Current Beneficiary Survey, supplemented with linked data on Medicare HMO characteristics and area supply characteristics. The study found that even when favorable selection is controlled for, Medicare HMOs significantly reduce both the probability of hospitalization and the number of inpatient days used by those who are hospitalized. Medicare HMOs do not, however, appear to reduce the use of physician services.

  View details for DOI 10.1002/hec.664

  View details for Web of Science ID 000175873700003

  View details for PubMedID 12007164

• Policing Medicaid and Medicare managed care: The role of courts and administrative agencies JOURNAL OF HEALTH POLITICS POLICY AND LAW Mello, M. M. 2002; 27 (3): 465-494

  Abstract

  The much-publicized 2000 case of Frew v. Gilbert, in which a federal judge castigated the State of Texas for deficiencies in its Medicaid program, brought renewed attention to the issue of regulating the quality of care in Medicaid and Medicare HMOs. Frew and other recent cases highlight both the promise and the pitfalls of relying on courts to correct deficiencies in public managed care programs. This article argues that while litigation over inadequacies in Medicare and Medicaid managed care can serve an important signaling function in alerting agencies and legislatures about the need for reform, the role of the courts in policing public managed care is circumscribed by several constraints. Barriers to class action litigation and differences in the institutional capacities of courts and administrative agencies mean that litigation is best viewed as a supplement, not an alternative, to a renewed commitment to strong quality monitoring on the part of Centers for Medicare and Medicaid Services and state Medicaid agencies.

  View details for Web of Science ID 000176264400006

  View details for PubMedID 12092677

• Deterrence of medical errors: Theory and evidence for malpractice reform TEXAS LAW REVIEW Mello, M. M., Brennan, T. A. 2002; 80 (7): 1595-1637

  View details for Web of Science ID 000176824900004

• The controversy over high-dose chemotherapy with autologous bone marrow transplant for breast cancer HEALTH AFFAIRS Mello, M. M., Brennan, T. A. 2001; 20 (5): 101-117

  Abstract

  In the 1990s more than 41,000 patients underwent high-dose chemotherapy plus autologous bone marrow transplant (HDC-ABMT) for breast cancer, despite a paucity of clinical evidence of its efficacy. Most health plans reluctantly agreed to cover the treatment in response to intensive political lobbying and the threat of litigation. The results of five recent major randomized trials showed that HDC-ABMT offers no advantage over standard-dose treatment for breast cancer. Our experience with HDC-ABMT coverage cautions against allowing politics to overwhelm science in the area of evaluating experimental procedures, and against relying on the courts as a means of resolving disagreements about coverage of these interventions.

  View details for Web of Science ID 000170862800010

  View details for PubMedID 11558695

• Demystifying the law/science disconnect JOURNAL OF HEALTH POLITICS POLICY AND LAW Mello, M. M., Brennan, T. A. 2001; 26 (2): 429-438

  View details for Web of Science ID 000168073700012

  View details for PubMedID 11330088

• Of swords and shields: The role of clinical practice guidelines in medical malpractice litigation UNIVERSITY OF PENNSYLVANIA LAW REVIEW Mello, M. M. 2001; 149 (3): 645-710

  View details for Web of Science ID 000167553100001