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Objective: Glycemic control remains suboptimal despite the wide range of available medications. More effective medication prescription might result in better control. However, the process by which physicians choose glucose-lowering medicines is poorly understood. We sought to study the means by which physicians choose medications for type 2 diabetic patients.Research Design and Methods: We surveyed 886 physician members of either the Society of General Internal Medicine (academic generalists, response rate 30%) or the American Diabetes Association (specialists, response rate 23%) currently managing patients with type 2 diabetes. Respondents weighed the importance of 15 patient, physician, and nonclinical factors when deciding which medications to prescribe for type 2 diabetic subjects at each of three management stages (initiation, use of second-line oral agents, and insulin).Results: Respondents reported using a median of five major considerations (interquartile range 4-6) at each stage. Frequently cited major considerations included overall assessment of the patient's health/comorbidity, A1C level, and patient's adherence behavior but not expert guidelines/hospital algorithms or patient age. For insulin initiation, academic generalists placed greater emphasis on patient adherence (76 vs. 60% of specialists, P < 0.001). These generalists also identified patient fear of injections (68%) and patient desire to prolong noninsulin therapy (68%) as major insulin barriers. Overall, qualitative factors (e.g., adherence, motivation, overall health assessment) were somewhat more highly considered than quantitative factors (e.g., A1C, age, weight) with mean aggregate scores of 7.3 vs. 6.9 on a scale of 0-10, P < 0.001.Conclusions: The physicians in our survey considered a wide range of qualitative and quantitative factors when making medication choices for hyperglycemia management. The apparent complexity of the medication choice process contrasts with current evidence-based treatment guidelines. [ABSTRACT FROM AUTHOR]

Importance: Sponsorship of promotional events for health professionals is a key facet of marketing campaigns for pharmaceuticals and medical devices; however, there appears to be limited transparency regarding the scope and scale of this spending., Objective: To develop a novel method for describing the scope and quantifying the spending by US pharmaceutical and medical companies on industry-sponsored promotional events for particular products., Design and Setting: This was a cross-sectional study using records from the Centers for Medicare & Medicaid's Open Payments database on payments made to prescribing clinicians from January 1 to December 21, 2022., Main Outcomes and Measures: An event-centric approach was used to define sponsored events as groupings of payment records with matching variables. Events were characterized by value (coffee, lunch, dinner, or banquet) and number of attendees (small vs large). To test the method, the number of and total spending for each type of event across professional groups were calculated and used to identify the top 10 products related to dinner events. To validate the method, we extracted all event details advertised on the websites of 4 state-level nurse practitioner associations that regularly hosted industry-sponsored dinner events during 2022 and compared these with events identified in the Open Payments database., Results: A total of 1 154 806 events sponsored by pharmaceutical and medical device companies were identified for 2022. Of these, 1 151 351 (99.7%) had fewer than 20 attendees, and 922 214 (80.0%) were considered to be a lunch ($10-$30 per person). Seven companies sponsored 16 031 dinners for the top 10 products. Of the 227 sponsored in-person dinner events hosted by the 4 state-level nurse practitioner associations, 168 (74.0%) matched events constructed from the Open Payments dataset., Conclusions and Relevance: These findings indicate that an event-centric analysis of Open Payments data is a valid method to understand the scope and quantify spending by pharmaceutical and medical device companies on industry-sponsored promotional events attended by prescribers. Expanding and enforcing the reporting requirements to cover all payments to all registered health professionals would improve the accuracy of estimates of the true extent of all sponsored events and their impact on clinical practice.

Background: There is limited data regarding how clinicians operationalize shared decision-making (SDM) with athletes with cardiovascular diagnoses. This study was designed to explore sports cardiologists' conceptions of SDM and approaches to sports eligibility decisions., Methods: 20 sports cardiologists were interviewed by telephone or video conference from October 2022 to May 2023. Qualitative descriptive analysis was conducted with the transcripts., Results: All participants endorsed SDM for eligibility decisions, however, SDM was defined and operationalized heterogeneously. Only 6 participants specifically referenced eliciting patient preferences during SDM. Participants described variable roles for the physician in SDM and variable views on athletes' understanding, perception, and tolerance of risk. Participants thresholds for prohibitive annual risk of sudden cardiac death ranged from <1 % to >10 %., Conclusions: These findings reinforce the general acceptance of SDM for sports eligibility decisions and highlight the need to better understand this process and identify the most effective approach for operationalization., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Dickert reports consulting and research funding from Abiomed, Inc. and research funding from NIH and AHRQ. Dr. Baggish receives compensation for his role as consultant / team cardiologist from the US Olympic Committee / US Olympic Training Centers, International Olympic Committee, National Football League Players Association, US Soccer, and US Rowing. Dr. Campbell has served as a paid expert witness on law cases related to financial conflicts of interest in medicine. The other authors report no conflicts., (© 2024 The Authors.)

In Colorado, medical aid in dying (MAiD) is legal, allowing a terminally ill person to request a prescription and self-administer a medication to end their life. Such requests are granted under certain circumstances, including a malignant neoplasm diagnosis, with a goal of peaceful death. This study examined differences in attitudes and actual participation in MAiD between oncologists and non-oncologists, using data from a recent survey of physicians regarding MAiD., (© The Author(s) 2023. Published by Oxford University Press.)

Background: Approximately 20% of the US population live in states where MAiD is a legal, though highly contentious, practice. Little generalizable data exists on the experiences of MAiD providers who comprise a small, and intentionally hidden, population., Objective: To examine the nature, extent, and consequences of physicians' participation in MAiD., Design: An anonymous, multi-wave, mailed survey (RR= 55%)., Participants: An enriched sample (n=583) of Colorado physicians caring for potential MAiD patients., Main Measures: Physician willingness, preparedness, and participation in a continuum of MAiD activities. Other outcomes include the effects of providing MAiD and the barriers physicians face related to MAiD., Key Results: Overall, 81.1% of respondents were willing to discuss MAiD with a patient, 88.3% to refer for MAiD, 46.3% to be a consultant, and 28.1% to be an attending. Fewer felt prepared to discuss MAiD (54.4%), provide a MAiD referral (62.8%), be a consultant (30.7%), or be an attending (18.0%). More than half of respondents (52.3%) had discussed MAiD with a patient, 27.3% provided a MAiD referral, 12.8% had been a MAiD consultant, and 8.5% had been a MAiD attending. Among MAiD consultants and attendings, 75% reported that their most recent MAiD case was emotionally fulfilling and professionally rewarding, though 75% also reported that it was time consuming and 46.9% reported that it was ethically challenging. Common barriers to physician participation in MAiD include lack of knowledge about MAiD (46.8%), the emotional (45.6%) and time (41.7%) investments, and ethical concerns (41.7%)., Conclusions: Many physicians in our sample are both willing and prepared to discuss MAiD with patients and to provide MAiD referrals. Fewer are prepared and willing to serve as an attending or consultant and fewer have provided these services. MAID consultants and attendings largely report the experience to be emotionally fulfilling and professionally rewarding, but all respondents reported multiple barriers to participation., (© 2021. The Author(s) under exclusive licence to Society of General Internal Medicine.)

Physicians who participate in medical-aid-in-dying (MAID) cannot be easily identified and studied due to cost and anonymity barriers. We developed and empirically tested a novel methodology to identify and survey physicians highly likely to participate in MAID activities. We used a state-level comprehensive administrative claims database to identify a cohort of patients with diagnoses and hospice enrollment similar to those known to have filled a prescription for MAID from 2017-2018. We then identified physicians who provided routine outpatient care to these patients using National Provider Identifier numbers. We surveyed these physicians in 3 waves (n = 583 total surveys), ranking physicians in order of their likelihood of being asked about MAID for each wave based on characteristics including specialty and the number of unique patients they had provided care to. We re-ranked physicians in waves 2 and 3 based on responses from prior waves. Physicians were surveyed only once and there was no follow-up to preserve anonymity. Surveys assessed the proportion of respondents who participated in MAID activities (discussions, referrals, and/or prescriptions). We identified 6369 physicians that provided care to 2960 patients. In survey waves one, two, and three respectively, response rates (55%, 52%, and 55%; p = 0.98) and the proportion of respondents that participated in MAID activities (58%, 56%, and 42%; p = 0.05) were similar. Small adjustments made to physician ranking criteria in waves two and three did not increase the proportion of physicians that participated in MAID activities. We used a novel methodology using administrative data to identify and survey physicians at high likelihood of participating in MAID activities. We achieved good overall response rates (52%), and a high proportion of respondents that participated in MAID activities (52%), demonstrating that it is possible to overcome cost and anonymity barriers to conducting quantitative research on MAID. This methodology could be used in larger scale studies of MAID or other bioethical issues with "hidden" physician populations., (© 2022. The Author(s).)

Objectives: To better understand patients' and pharmacists' preferences for and experiences with changes in pill appearance (size, shape, color, and markings)., Study Design: Cross-sectional., Methods: We conducted independent national surveys of patients 50 years and older taking generic drugs for depression, diabetes, epilepsy, HIV, hyperlipidemia, or hypertension and of licensed pharmacists practicing in chain, franchise, or independent pharmacies. Responses were collected between January and April 2016., Results: Of 1000 patient respondents (30% response rate), most reported experiencing changes in pill appearance (51%) and preferred to be notified about them (82%), but less than half recalled being notified (verbally: 36%; via sticker: 45%). Among patients who reported experiencing a change, 12% reported stopping their medication or using it less frequently. Of 710 pharmacist respondents (33% response rate), many reported changes in pill appearance occurring frequently in their pharmacies (47% reported that changes occurred 6 or more times per month) and more than three-fourths reported notifying patients about them often (verbally: 88%; via sticker: 77%)., Conclusions: Our findings reveal opportunities to improve patients' experiences with pill appearance changes through better notification practices and patient education.

Background: Patient-centered care for people with disability requires effective communication and compliance with the Americans with Disabilities Act (ADA)., Objective: To understand physicians' perspectives on communication experiences with people with disability., Design: Twenty semi-structured individual interviews. Interview recordings were transcribed verbatim for analysis., Setting: Massachusetts, October 2017-January 2018., Participants: Twenty physicians ranging from 8 to 51 years in practice in primary care or 4 other specialties., Measurements: Commonly expressed themes around communication with people with disability., Results: Concerns coalesced around 4 broad categories: communication experiences with people who are deaf or hard of hearing, communication with people who are blind or have vision impairment, communication with people who have intellectual disability, and recommendations for improving communication. Although participants in this study reported various efforts to communicate effectively with patients with hearing or vision loss or intellectual disability, many gaps appear to remain, as well as instances where physicians' preferences run counter to patients' wishes and the ADA. Examples include physicians' preferences for remote, online sign language interpreters despite patients desiring in-person interpreters and suggesting that patients arrange for their own interpreters. Few educational materials are available in braille, and electronic medical records may not allow documents to be printed in large font for persons with low vision. Communicating with patients with intellectual disability raised particular concerns, with participants often preferring to interact with caregivers and minimal efforts to involve patients., Conclusions: Effective communication is necessary for ensuring the quality of health care for people with disability, and it is legally required under the ADA. Our results suggest that important gaps may remain in ensuring effective communication, and some practicing physicians could benefit from formal training in effective methods for communicating with patients with disability.

Background: Generic versions of a drug can vary in appearance, which can impact adherence., Objective: To assess the preferences, perceptions, and responses of patients who experienced a change in the appearance of a generic medication., Design: Cross-sectional survey of patients from a large commercial health plan., Participants: Adults receiving generic versions of lisinopril, fluoxetine, lamotrigine, or simvastatin who experienced a change in the color or shape of their pills between March 2014 and November 2015., Main Measures: Likert-scale responses to questions concerning perceptions of generic drug safety and effectiveness, reliance on and preferences for pill appearance, and responses to pill appearance changes. Multivariable logistic regression-modeled predictors of seeking advice and adjusting use following a pill appearance change., Key Results: Of 814 respondents (response rate = 41%), 72% relied on pill appearance to ensure they took the correct medication. A similar percentage wanted their pills to remain the same color (72%), shape (71%), and size (75%) upon refill, but 58% would not have paid a $1 premium on a $5 co-pay to ensure such consistency. Most respondents (86%) wanted their pharmacists to notify them about pill appearance changes, but only 37% recalled such notification; 21% thought they received the wrong medication, and 8% adjusted medication use. Younger respondents (18-33 vs. 50-57 years) were more likely to seek advice (odds ratio [OR] = 1.91; 95% confidence interval [CI],1.02-3.59), and respondents with lower household income (< $30,000 vs. > $100,000) were more likely to adjust medication use (OR = 3.40; 95% CI,1.09-10.67)., Conclusions: Requiring uniform pill appearance may help increase adherence but presents challenges. Standardized pharmacy notification and education policies may be a more feasible short-term solution.

Objectives: Michigan expanded Medicaid under the Affordable Care Act (ACA) through a federal waiver that permitted state-mandated features, including an emphasis on primary care. We investigated the factors associated with Michigan primary care providers (PCPs)' decision to accept new Medicaid patients under Medicaid expansion., Study Design: Statewide survey of PCPs informed by semistructured interviews., Methods: After Michigan expanded Medicaid on April 1, 2014, we surveyed 2104 PCPs (including physician and nonphysician providers, such as nurse practitioners and physician assistants) with 12 or more assigned Medicaid expansion enrollees (response rate, 56%). To guide survey development and interpretation, we interviewed a separate group of 19 PCPs with Medicaid expansion enrollees from diverse urban and rural regions. Survey questions assessed PCPs' current acceptance of new Medicaid patients., Results: Of the 2104 surveyed PCPs, 78% reported that they were currently accepting additional Medicaid patients; 58% reported having at least some influence on the decision. Factors considered very/moderately important to the Medicaid acceptance decision included practice capacity to accept any new patients (69%), availability of specialists for Medicaid patients (56%), reimbursement amount (56%), psychosocial needs of Medicaid patients (50%), and illness burden of Medicaid patients (46%). PCPs accepting new Medicaid patients tended to be female, minorities, nonphysician providers, specialized in internal medicine, paid by salary, or working in practices with Medicaid-predominant payer mixes., Conclusions: In the era after Medicaid expansion, PCPs placed importance on practice capacity, specialist availability, and patients' medical and psychosocial needs when deciding whether to accept new Medicaid patients. To maintain primary care access for low-income patients with Medicaid, future efforts should focus on enhancing the diversity of the PCP workforce, encouraging healthcare professional training in underserved settings, and promoting practice-level innovations in scheduling and integration of specialist care.

Policy Points Engaging and involving underrepresented communities when setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. Groups and individuals from minority and underserved communities strongly prioritized child health and mental health research, often choosing to invest at the highest possible level. Groups consisting of predominantly Native American or Arab American participants invested in culture and beliefs research at the highest level, while many groups did not select it at all. The priority given to culture and beliefs research by these groups illustrates the importance of paying special attention to unique preferences, and not just commonly held views, when getting public input on spending priorities for research., Context: A major contributor to health disparities is the relative lack of resources-including resources for science-allocated to address the health problems of those with disproportionately greater needs. Engaging and involving underrepresented communities in setting research priorities could make the scientific research agenda more equitable, more just, and more responsive to their needs and values. We engaged minority and underserved communities in informed deliberations and report here their priorities for health research., Methods: Academic-community partnerships adapted the simulation exercise CHAT for setting health research priorities. We had participants from minority and medically underserved communities (47 groups, n = 519) throughout Michigan deliberate about health research priorities, and we used surveys and CHAT software to collect the demographic characteristics and priorities selected by individuals and groups., Findings: The participants ranged in age (18 to 88), included more women than men, and were overrepresented by minority groups. Nearly all the deliberating groups selected child health and mental health research (93.6% and 95.7%), and most invested at the highest level. Aging, access, promote health, healthy environment, and what causes disease were also prioritized by groups. Research on mental health and child health were high priorities for individuals both before and after group deliberations. Access was the only category more likely to be selected by individuals after group deliberation (77.0 vs 84.0%, OR = 1.63, p = .005), while improve research, health policy, and culture and beliefs were less likely to be selected after group deliberations (all, p < .001). However, the level of investment in many categories changed after the group deliberations. Participants identifying as Black/African American were less likely to prioritize mental health research, and those of Other race were more likely to prioritize culture and beliefs research., Conclusions: Minority and medically underserved communities overwhelmingly prioritized mental health and child health research in informed deliberations about spending priorities., (© 2018 Milbank Memorial Fund.)

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., Competing Interests: The authors have declared that no competing interests exist.

Background: Michigan's approach to Medicaid expansion, the Healthy Michigan Plan (HMP), emphasizes primary care, prevention, and incentives for patients and primary care practitioners (PCPs)., Objective: Assess PCPs' perspectives about the impact of HMP on their patients and practices., Design: In 2014-2015, we conducted semi-structured interviews then a statewide survey of PCPs., Setting: Interviewees came from varied types of practices in five Michigan regions selected for racial/ethnic diversity and a mix of rural and urban settings. Surveys were sent via mail., Participants: Interviewees were physician (n = 16) and non-physician practitioners (n = 3). All Michigan PCPs caring for ≥ 12 HMP enrollees were surveyed (response rate 55.5%, N = 2104)., Measurements: PCPs' experiences with HMP patients and recent changes in their practices., Results: Interviews include examples of the impact of Medicaid expansion on patients and practices. A majority of surveyed PCPs reported recent increases in new patients (52.3%) and patients who had not seen a PCP in many years (56.2%). For previously uninsured patients, PCPs reported positive impact on control of chronic conditions (74.4%), early detection of serious illness (71.1%), medication adherence (69.1%), health behaviors (56.5%), emotional well-being (57.0%), and the ability to work, attend school, or live independently (41.5%). HMP patients reportedly still had more difficulty than privately insured patients accessing some services. Most PCPs reported that their practices had, in the past year, hired clinicians (53.2%) and/or staff (57.5%); 15.4% had colocated mental health care. Few (15.8%) reported established patients' access to urgent appointments worsened., Limitations: PCP reports of patient experiences may not be accurate. Results reflect the experiences of PCPs with ≥ 12 Medicaid patients. Differences between respondents and non-respondents present the possibility for response bias., Conclusions: PCPs reported improved patient access to care, medication adherence, chronic condition management, and detection of serious illness. Established patients' access did not diminish, perhaps due to reported practice changes.

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.

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 .

Background: 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., Objective: 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., Design: Cross-sectional survey conducted in late September and early October 2014, with data linkage of respondents' physicians to Open Payments data., Participants: A total of 3542 adults drawn from a large, nationally representative household panel., Main Measures: 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., Key Results: 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., Conclusions: 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.

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., Competing Interests: The study was funded by a grant from the FDA Office of Generic Drugs. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Over 84 % of all prescriptions in the US are filled as generic drugs, though in prior surveys, patients reported concerns about their quality., Objective: We aimed to survey patients' perceptions and use of generic drugs., Design: Our survey (administered August 2014) assessed patients' skepticism about generic drug safety and effectiveness and how often they requested brand-name drugs. Chi-square tests and two-sample t-tests assessed associations between patient demographics and the outcomes., Participants: Our sample frame was the CVS Advisor Panel, a national database of 124,621 CVS customers. We randomly selected 1450 patients with self-reported chronic conditions who filled at least one prescription in the prior 3 months., Main Measures: We assessed how often patients reported asking their physicians to prescribe a brand-name over a generic drug in the last year, and "generic skepticism," defined as not believing generic drugs were as safe, effective, had the same side effects, and contained the same active ingredients as brand-name drugs., Key Results: Of the 1,442 patients with valid addresses, 933 responded (65 % response rate) and 753 took the full survey. A vast majority (83 %) agreed that physicians should prescribe generic drugs when available, and 54 % said they had not asked their physicians to prescribe a brand-name drug over a generic in the past year. Most respondents considered generic drugs to be as effective (87 %) and safe (88 %) as their brand-name counterparts, and to have the same side effects (80 %) and active ingredients (84 %). Non-Caucasians were more likely than Caucasians to request a brand-name drug over a generic (56 % vs. 43 %, p < 0.01), and were also more skeptical of generic drugs' clinical equivalence (43 % vs. 29 %, p < 0.01)., Conclusions: We found a substantial shift towards more patients having positive views of generic drugs, but lingering negative perceptions will have to be overcome to ensure continued cost-savings and improved patient outcomes from generic drugs.

Background: Medical students attending schools with policies limiting industry/student interactions report fewer relationships with pharmaceutical representatives., Objective: To investigate whether associations between students' medical school policies and their more limited industry interaction behaviors persist into residency., Methods: We randomly sampled 1800 third-year residents who graduated from 120 allopathic US-based medical schools, using the American Medical Association Physician Masterfile. We surveyed them in 2011 to determine self-reported behavior and preferences for brand-name prescriptions, and we calculated the strength of their medical schools' industry interaction policies using the 2008 American Medical Student Association and Institute on Medicine as a Profession databases. We used logistic regression to estimate the association between strength of school policies and residents' behaviors with adjustments for class size, postresidency career plan, and concern about medical school debt., Results: We achieved a 44% survey response rate (n = 739). Residents who graduated from schools with restrictive policies were no more or less likely to accept industry gifts or industry-sponsored meals, speak with marketing representative about drug products, attend industry-sponsored lectures, or prefer brand-name medications than residents who graduated from schools with less restrictive policies. Residents who correctly answered evidence-based prescription questions were about 30% less likely to have attended industry-sponsored lectures (OR = 0.72, 95% CI 0.56-0.98)., Conclusions: Any effect that medical school industry interaction policies had on insulating students from pharmaceutical marketing did not persist in the behavior of residents in our sample. This suggests that residency training environments are important in influencing behavior.

Objectives: Evaluating unnecessary US medical practices, and the strategies that reduce them, are increasingly recognized as crucial to healthcare financing sustainability. Provider factors are known to affect unnecessary medical practices, yet little is known about how physician responses to patient requests for unnecessary care affect these practices. Among primary care physicians (PCPs), we investigated 2 types of unnecessary medical practices triggered by patient requests: a) unnecessary specialty referrals and b) prescriptions for brand-name drugs when generic alternatives are available., Study Design and Methods: We used data from a survey of a nationally representative sample of 840 US PCPs in 2009. Response rates for family practice (n = 274), internal medicine (n = 257), and pediatrics (n = 309) were 67.5%, 60.8%, and 72.7%, respectively., Results: In response to patient requests, 51.9% of PCPs reported making unnecessary specialty referrals and 38.7% prescribed brand-name drugs. Family physicians (odds ratio [OR], 2.77; 95% CI, 1.77-4.34) and internal medicine physicians (OR, 4.51; 95% CI, 2.87-7.06) were more likely than pediatricians to prescribe brand-name drugs. PCP specialty was similarly associated with unnecessary referrals. Other predictors of acquiescence to patient requests included interactions with drug/device representatives, more years of clinical experience, seeing fewer safety net patients, and solo/2-person practice organizations. Area-level Medicare spending was not associated with the 2 unnecessary practices., Conclusions: Many PCPs reported acquiescing to patient requests for unnecessary care. Provider and organizational factors predicted this behavior. Policies aimed at reducing such practice could improve care quality and lower cost. Patient and physician incentives that can potentially reduce unnecessary medical practices warrant exploration.

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: 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.

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: Physicians have dual responsibilities to make medical decisions that serve their patients' best interests but also utilize health care resources wisely. Their ability to practice cost-consciously is particularly challenged when faced with patient expectations or requests for medical services that may be unnecessary., Objective: To understand how physicians consider health care resources and the strategies they use to exercise cost-consciousness in response to patient expectations and requests for medical care., Design: Exploratory, qualitative focus groups of practicing physicians were conducted. Participants were encouraged to discuss their perceptions of resource constraints, and experiences with redundant, unnecessary and marginally beneficial services, and were asked about patient requests or expectations for particular services., Participants: Sixty-two physicians representing a variety of specialties and practice types participated in nine focus groups in Michigan, Ohio, and Minnesota in 2012 MEASUREMENTS: Iterative thematic content analysis of focus group transcripts, Principal Findings: Physicians reported making trade-offs between a variety of financial and nonfinancial resources, considering not only the relative cost of medical decisions and alternative services, but the time and convenience of patients, their own time constraints, as well as the logistics of maintaining a successful practice. They described strategies and techniques to educate patients, build trust, or substitute less costly alternatives when appropriate, often adapting their management to the individual patient and clinical environment., Conclusions: Physicians often make nuanced trade-offs in clinical practice aimed at efficient resource use within a complex flow of clinical work and patient expectations. Understanding the challenges faced by physicians and the strategies they use to exercise cost-consciousness provides insight into policy measures that will address physician's roles in health care resource use.

Background: Increasingly, medical school policies limit pharmaceutical representatives' access to students and gifts from drugmakers, but little is known about how these policies affect student attitudes toward industry., Objective: To assess interactions between trainees and the pharmaceutical industry, and to determine whether learning environment characteristics influence students' practices and attitudes., Design, Participants: We conducted a cross-sectional survey with a nationally-representative sample of first- and fourth-year medical students and third-year residents, stratified by medical school, including ≥ 14 randomly selected trainees at each level per school., Main Measures: We measured frequency of industry interactions and attitudes regarding how such interactions affect medical training and the profession. Chi-squared tests assessed bivariate linear trend, and hierarchical logistic regression models were fitted to assess associations between trainees' attitudes and their schools' National Institutes of Health (NIH) funding levels and American Medical Student Association (AMSA) PharmFree Scorecard grades reflecting industry-related conflict of interest policies., Key Results: Among 1,610 student (49.3 % response rate) and 739 resident (43.1 %) respondents, industry-sponsored gifts were common, rising from 33.0 % (first-year students) to 56.8 % (fourth-year students) and 54 % (residents) (p < 0.001). These gifts included meals outside the hospital (reported by 5 % first-year students, 13.4 % fourth-year students, 27.5 % residents (p < 0.001)) and free drug samples (reported by 7.4 % first-year students, 14.1 % fourth-year students, 14.3 % residents (p < 0.001)). The perception that industry interactions lead to bias was prevalent, but the belief that physicians receive valuable education through these interactions increased (64.1 % to 67.5 % to 79.8 %, p < 0.001). Students in schools receiving more NIH funding reported industry gifts less often (OR = 0.51, 95 % CI: 0.38-0.68, p < 0.001), but the strength of institutional conflict of interest policies was not associated with this variable., Conclusions: Despite recent policy changes, a substantial number of trainees continue to receive gifts from pharmaceutical representatives. We found no relation between these outcomes and a school's policies concerning interactions with industry.

Objectives: To update the status of electronic health record (EHR) adoption in US hospitals and assess their readiness for "Meaningful Use" (MU)., Study Design: We used data from the 2010 American Hospital Association Annual Information Technology Survey. The survey was first conducted in 2007 and is made available both online and through the mail to all non-federal acute-care hospitals in the United States., Methods: We measure the percentages of applicable hospitals that have adopted "basic" and "comprehensive" EHRs as defined in previous literature. Additionally, we report the percentage of hospitals planning to apply for MU in the near term, and assess hospitals' readiness for the program and how readiness varies by key characteristics., Results: We received responses from 2902 hospitals (64% of all non-federal acute-care hospitals). More than 15% have adopted at least a "basic" EHR, representing nearly 75% growth since 2008. Approximately two-thirds plan to apply for MU before 2013; however, only 4.4% had implemented each of the "core" MU functionalities we measured. Hospitals closer to achieving MU are more likely to be larger non-profits (P <.001) and vary by other key characteristics. Certain functionalities included in MU, such as computerized provider order entry, electronic generation of quality measures, and electronic access to records for patients are proving more challenging to implement for all hospitals., Conclusions: Broad enthusiasm exists among hospitals for participation in MU. However, adoption will have to accelerate above its current pace for readiness to match intention. Gaps in adoption show bringing all hospitals along is the key policy challenge.

Objective: To examine variation in the adoption of electronic health record (EHR) functionalities and their use patterns, barriers to adoption, and perceived benefits by physician practice size., Design: Mailed survey of a nationally representative random sample of practicing physicians identified from the Physician Masterfile of the American Medical Association. Measurements We measured, stratified by practice size: (1) availability of EHR functionalities, (2) functionality use, (3) barriers to the adoption and use of EHR, and (4) impact of the EHR on the practice and quality of patient care., Results: With a response rate of 62%, we found that < 2% of physicians in solo or two-physician (small) practices reported a fully functional EHR and 5% reported a basic EHR compared with 13% of physicians from 11+ group (largest group) practices with a fully functional system and 26% with a basic system. Between groups, a 21-46% difference in specific functionalities available was reported. Among adopters there were moderate to large differences in the use of the EHR systems. Financial barriers were more likely to be reported by smaller practices, along with concerns about future obsolescence. These differences were sizable (13-16%) and statistically significant (p < 0.001). All adopters reported similar benefits. Limitations Although we have adjusted for response bias, influences may still exist., Conclusion: Our study found that physicians in small practices have lower levels of EHR adoption and that these providers were less likely to use these systems. Ensuring that unique barriers are addressed will be critical to the widespread meaningful use of EHR systems among small practices.

The objective of this study was to investigate the effects of technology commercialization on researcher practice and productivity at U.S. universities. Using data drawn from licensing contract documents and databases of university-industry linkages and faculty research output, the study findings suggest that the common practice of licensing technologies exclusively to singular firms may have a dampening effect on faculty inventor propensity to conduct published research and to collaborate with others on research. Furthermore, faculty who are more actively engaged in patenting may be less likely to collaborate with outsiders on research while faculty at public universities may experience particularly strong norms to engage in commercialization vis-à-vis traditional routes to research dissemination. These circumstances appear to be hindering innovation via the traditional mechanisms (research publication and collaboration), questioning the success of policymaking to date for the purpose of speeding the movement of research from the lab bench to society.

Background: Sexual dysfunction is an important issue that affects many cancer survivors who are increasingly being cared for by internists., Objective: To examine the attitudes and reported practices of internists regarding survivorship care as it pertains to sexual dysfunction., Design: Surveys were sent to 406 physicians affiliated with the Department of Internal Medicine at the University of Colorado Denver School of Medicine. Of the 319 eligibles, 227 were returned (71% RR)., Main Results: Of the 227 responders, 46% were "somewhat/very" likely to initiate a conversation about sexual dysfunction; 62% "never/rarely" addressed sexual dysfunction. Each additional weekly hour spent in patient care was associated with a 2% increase in the likelihood of sexual dysfunction being addressed or discussions about sexual dysfunction being initiated. Reported inadequate preparation/formal training around survivorship issues was associated with sexual dysfunction being addressed less often (odds ratio [OR] = 0.45). Perception of patient anxiety or fears about health was associated with sexual dysfunction being addressed more often (OR = 2.38). Perceived preparedness to evaluate long-term effects was associated with a greater likelihood of physicians initiating discussions about sexual functioning (OR = 2.49)., Conclusions: Cancer survivors receive their long-term care from internists. Our results suggest that sexual dysfunction is often not addressed during their follow-up care. Additional training is needed to prepare physicians to negotiate this difficult issue.

THE EFFECTS OF CONFLICTS OF INTEREST on the conduct of human research have been roundly debated, but less attention has been paid to the role of Institutional Review Boards (IRBs) in their identification and management. Government and private policy recommendations disagree about IRBs' responsibility in this area. A survey focusing on respondents' attitudes and behaviors regarding consideration of investigator and institutional financial relationships with industry when reviewing research protocols was mailed to a random sample of 893 IRB members and 316 IRB chairs at 115 academic institutions (response rates of 67% and 72%, respectively). More than half of IRB members and chairs felt that industry relationships posed a moderate or big problem for research integrity nationally, and about one-third thought such relationships were a problem at their own institution. Approximately two-thirds felt that investigator-industry relationships should be considered when reviewing protocols regardless of whether they are deemed to be conflicts of interest. While more than 90% of IRB members and chairs believed that investigators' relationships should be disclosed to research participants, 61% of members and chairs reported that these relationships were not always disclosed to participants. While more than 80% believed that institutional relationships should be disclosed to research participants, only 39% of members and chairs said this happened all the time. Some beliefs of IRB members and chairs are at odds with recommendations to limit the role of IRBs in the management of potential investigator conflicts. Lack of unambiguous guidelines has led to inconsistent practices among IRBs.

Background: Information technology (IT) has been advocated as an important means to improve the practice of clinical medicine., Objectives: To determine current prevalence of non-electronic health record (EHR) IT use by a national sample of U.S. physicians, and to identify associated physician, practice, and patient panel characteristics., Design, Setting, and Participants: Survey conducted in early 2004 of 1,662 U.S. physicians engaged in direct patient care selected from 3 primary care specialties (family practice, internal medicine, pediatrics) and 3 nonprimary care specialties (anesthesiology, general surgery, cardiology)., Measurements: Self-reported frequency of e-mail communication with patients or other clinicians, online access to continuing medical education or professional journals, and use of any computerized decision support (CDS) during clinical care. Survey results were weighted by specialty and linked via practice zip codes to measures of area income and urbanization., Results: Response rate was 52.5%. Respondents spent 49 (+/-19) (mean [+/-standard deviation]) hours per week in direct patient care and graduated from medical school 23 (+/-11) years earlier. "Frequent" use was highest for CDS (40.8%) and online professional journal access (39.0%), and lowest for e-mail communication with patients (3.4%). Ten percent of physicians never used any of the 5 IT tools. In separate logistic regression analyses predicting usage of each of the 5 IT tools, the strongest associations with IT use were primary care practice (adjusted odds ratios [aORs] ranging from 1.34 to 2.26) and academic practice setting (aORs 2.17 to 5.41). Years since medical school graduation (aOR 0.85 to 0.87 for every 5 years after graduation) and solo/2-person practice setting (aORs 0.21 to 0.55) were negatively associated with IT use. Practice location and patient panel characteristics were not independently associated with IT use., Conclusions: In early 2004, the majority of physicians did not regularly use basic, inexpensive, and widely available IT tools in clinical practice. Efforts to increase the use of IT in medicine should focus on practice-level barriers to adoption.

Access to care by low-income persons and residents of rural and poor inner-city areas is a persistent problem, yet physicians tend to be maldistributed relative to need. The objectives were to describe preferences of resident physicians to locate in underserved areas and to assess their preparedness to provide service to low-income populations. A national survey was made of residents completing their training in eight specialties at 162 US academic health center hospitals in 1998, with 2,626 residents responding. (Of 4,832 sampled, 813 had invalid addresses or were no longer in the residency program. Among the valid sample of 4,019, the response rate was 65%.) The percentage of residents ranking public hospitals, rural areas, and poor inner-city areas as desirable employment locations and the percentage feeling prepared to provide specified services associated with indigent populations were ascertained. Logistic regressions were used to calculate adjusted percentages, controlling for sex, race/ethnicity, international medical graduate (IMG) status, plans to subspecialize, ownership of hospital, specialty, and exposure to underserved patients during residency. Only one third of residents rated public hospitals as desirable settings, although there were large variations by specialty. Desirability was not associated with having trained in a public hospital or having greater exposure to underserved populations. Only about one quarter of respondents ranked rural (26%) or poor inner-city (25%) areas as desirable. Men (29%, P <.01) and noncitizen IMGs (43%, P <.01) were more likely than others to prefer rural settings. Residents who were more likely to rate poor inner-city settings as desirable included women (28%, P =.03), noncitizen IMGs (35%, P =.01), and especially underrepresented minorities (52%, P <.01). Whereas about 90% or more of residents felt prepared to treat common clinical conditions, only 67% of residents in four primary care specialties felt prepared to counsel patients about domestic violence or to care for human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) or substance abuse patients (all 67%). Women were more likely than men to feel prepared to counsel patients about domestic violence (70% vs. 63%, P =.002) and depression (83% vs. 75%, P <.01). Underrepresented minority residents were more likely than other residents to feel prepared to counsel patients about domestic violence (P <.01) and compliance with care (P =.04). Residents with greater exposure to underserved groups were more prepared to counsel patients about domestic violence (P =.01), substance abuse (P =.01), and to treat patients with HIV/AIDS (P =.01) or with substance abuse problems (P <.01). This study demonstrates the need to expose graduate trainees to underserved populations and suggests a continuing role of minorities, women, and noncitizen physicians in caring for low-income populations.