Person:

Campbell, Eric

Background: The authors aimed to determine US and UK doctors’ professional values and reported behaviours, and the extent to which these vary with the context of care. Method: 1891 US and 1078 UK doctors completed the survey (64.4% and 40.3% response rate respectively). Multivariate logistic regression was used to compare responses to identical questions in the two surveys. Results: UK doctors were more likely to have developed practice guidelines (82.8% UK vs 49.6% US, p<0.001) and to have taken part in a formal medical errorreduction programme (70.9% UK vs 55.7% US, p<0.001). US doctors were more likely to agree about the need for periodic recertification (completely agree 23.4% UK vs 53.9% US, p<0.001). Nearly a fifth of doctors had direct experience of an impaired or incompetent colleague in the previous 3 years. Where the doctor had not reported the colleague to relevant authorities, reasons included thinking that someone else was taking care of the problem, believing that nothing would happen as a result, or fear of retribution. UK doctors were more likely than US doctors to agree that significant medical errors should always be disclosed to patients. More US doctors reported that they had not disclosed an error to a patient because they were afraid of being sued. Discussion: The context of care may influence both how professional values are expressed and the extent to which behaviours are in line with stated values. Doctors have an important responsibility to develop their healthcare systems in ways which will support good professional behavior.

Over the last decade, there have been significant changes in data sharing policies and in the data sharing environment faced by life science researchers. Using data from a 2013 survey of over 1600 life science researchers, we analyze the effects of sharing policies of funding agencies and journals. We also examine the effects of new sharing infrastructure and tools (i.e., third party repositories and online supplements). We find that recently enacted data sharing policies and new sharing infrastructure and tools have had a sizable effect on encouraging data sharing. In particular, third party repositories and online supplements as well as data sharing requirements of funding agencies, particularly the NIH and the National Human Genome Research Institute, were perceived by scientists to have had a large effect on facilitating data sharing. In addition, we found a high degree of compliance with these new policies, although noncompliance resulted in few formal or informal sanctions. Despite the overall effectiveness of data sharing policies, some significant gaps remain: about one third of grant reviewers placed no weight on data sharing plans in their reviews, and a similar percentage ignored the requirements of material transfer agreements. These patterns suggest that although most of these new policies have been effective, there is still room for policy improvement.

Background: Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors. Methods and Findings: Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11–0.44; marketing representative access policies, r = 0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis. Conclusions: As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions. Please see later in the article for the Editors' Summary

Recent policies and proposed regulations, including the Notice of Proposed Rulemaking for the Common Rule and the 2014 NIH Genetic Data Sharing Policy, seek to improve research subject protections. Protections for subjects whose genetic data is shared are critical to reduce risks such as loss of confidentiality, stigma, and discrimination. In the article ‘It depends whose data are being shared: considerations for genomic data sharing policies’, Robinson et al. provide a response to our article, ‘The Growth and Gaps of Genetic Data Sharing Policies’. Robinson et al. highlight the importance of individual and group preferences. In this article, we extend the conversation on models for improving protections which will mitigate consequences for individuals and groups that are vulnerable to stigma and discrimination.

The 1996 Bermuda Principles launched a new era in data sharing, reflecting a growing belief that the rapid public dissemination of research data was crucial to scientific progress in genetics. A historical review of data sharing policies in the field of genetics and genomics reflects changing scientific norms and evolving views of genomic data, particularly related to human subjects’ protections and privacy concerns. The 2013 NIH Draft Genomic Data Sharing (GDS) Policy incorporates the most significant protections and guidelines to date. The GDS Policy, however, will face difficult challenges ahead as geneticists seek to balance the very real concerns of research participants and the scientific norms that propel research forward. This article provides a novel evaluation of genetic and GDS policies’ treatment of human subjects’ protections. The article examines not only the policies, but also some of the most pertinent scientific, legal, and regulatory developments that occurred alongside data sharing policies. This historical perspective highlights the challenges that future data sharing policies, including the recently disseminated NIH GDS Draft Policy, will encounter.

Background: Generic drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process.

Methods and Findings: A survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians’ perceptions of the FDA’s generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA’s process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13–26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues.

Conclusions: Physicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

Background: To assess mentorship experiences among the faculty of a large academic department of medicine and to examine how those experiences relate to academic advancement and job satisfaction. Methods: Among faculty members in the Massachusetts General Hospital Department of Medicine, we assessed personal and professional characteristics as well as job satisfaction and examined their relationship with two mentorship dimensions: (1) currently have a mentor and (2) role as a mentor. We also developed a mentorship quality score and examined the relationship of each mentorship variable to academic advancement and job satisfaction. Results: 553/988 (56.0%) of eligible participants responded. 64.9% reported currently having a mentor, of whom 21.3% provided their mentor a low quality score; 66.6% reported serving as a mentor to others. Faculty with a current mentor had a 3.50-fold increased odds of serving as a mentor to others (OR 3.50, 95% CI 1.84–6.67, p < 0.001). Faculty who reported their mentorship as high quality had a decreased likelihood of being stalled in rank (OR 0.28, 95% CI: 0.10–0.78, p = 0.02) and an increased likelihood of high job satisfaction (OR 3.91, 95% CI 1.77–8.63, p < 0.001) compared with those who reported their mentorship of low quality; further, having a low mentorship score had a similar relationship to job satisfaction as not having a mentor. Conclusions: A majority of faculty survey respondents had mentorship, though not all of it of high caliber. Because quality mentorship significantly and substantially impacts both academic progress and job satisfaction, efforts devoted to improve the adoption and the quality of mentorship should be prioritized. Electronic supplementary material The online version of this article (10.1186/s12909-018-1191-5) contains supplementary material, which is available to authorized users.

Background: Three-quarters of homeless people smoke cigarettes. Competing priorities for shelter, food, and other subsistence needs may be one explanation for low smoking cessation rates in this population. We analyzed data from two samples of homeless smokers to examine the associations between subsistence difficulties and 1) smoking cessation readiness, confidence, and barriers in a cross-sectional study, and 2) smoking abstinence during follow-up in a longitudinal study. Methods: We conducted a survey of homeless smokers (N = 306) in 4/2014–7/2014 and a pilot randomized controlled trial (RCT) for homeless smokers (N = 75) in 10/2015–6/2016 at Boston Health Care for the Homeless Program. In both studies, subsistence difficulties were characterized as none, low, or high based on responses to a 5-item scale assessing the frequency of past-month difficulty finding shelter, food, clothing, a place to wash, and a place to go to the bathroom. Among survey participants, we used linear regression to assess the associations between subsistence difficulty level and readiness to quit, confidence to quit, and a composite measure of perceived barriers to quitting. Among RCT participants, we used repeated-measures logistic regression to examine the association between baseline subsistence difficulty level and carbon monoxide-defined brief smoking abstinence assessed 14 times over 8 weeks of follow-up. Analyses adjusted for demographic characteristics, substance use, mental illness, and nicotine dependence. Results: Subsistence difficulties were common in both study samples. Among survey participants, greater subsistence difficulties were associated with more perceived barriers to quitting (p < 0.001) but not with cessation readiness or confidence. A dose-response relationship was observed for most barriers, particularly psychosocial barriers. Among RCT participants, greater baseline subsistence difficulties predicted less smoking abstinence during follow-up in a dose-response fashion. In adjusted analyses, individuals with the highest level of subsistence difficulty had one-third the odds of being abstinent during follow-up compared to those without subsistence difficulties (OR 0.33, 95% CI 0.11–0.93) despite making a similar number of quit attempts. Conclusions: Homeless smokers with greater subsistence difficulties perceive more barriers to quitting and are less likely to do so despite similar readiness, confidence, and attempts. Future studies should assess whether addressing subsistence difficulties improves cessation outcomes in this population. Trial registration ClinicalTrials.gov: NCT02565381.