Data stewardship in FTLD research: Investigator and research participant views.

INTRODUCTION: 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. METHODS: 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. RESULTS: 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. DISCUSSION: 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.

Barriers to Ensuring Access to Affordable Prescription Drugs.

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.

Ethical Responsibilities for Companies That Process Personal Data.

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.

Do you mind if I record?: Perceptions and practice regarding patient requests to record clinic visits in oncology.

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.

Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA.

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.

Changes in Practice among Physicians with Malpractice Claims.

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.).

Clinical Trial Participants' Views of the Risks and Benefits of Data Sharing.

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.).

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California.

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.

Prospects for Enforcing Prohibitions on Off-Label Drug Promotion after United States v. Caronia: An Analysis of Litigated Cases.

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 of restrictions 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.

Malpractice Liability and Health Care Quality: A Review.

IMPORTANCE: 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. OBJECTIVE: 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. DATA SOURCES AND STUDY SELECTION: 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. DATA EXTRACTION AND SYNTHESIS: 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. MAIN OUTCOMES AND MEASURES: 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. RESULTS: 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. CONCLUSIONS AND RELEVANCE: 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.