Quantifying Industry Spending on Promotional Events Using Open Payments Data.

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.

Conscience-Based Barriers to Medical Aid in Dying: A Survey of Colorado Physicians.

BACKGROUND: Approximately 20% of the United States' population lives in a state or jurisdiction where medical aid in dying (MAiD) is legal. It is unknown how physicians' own barriers are associated with their provision of the spectrum of MAiD services. OBJECTIVE: To measure physicians' religious and/or ethical barriers to providing MAiD services and how such barriers relate to physicians' intentions and behaviors. DESIGN: Three-wave cross-sectional survey fielded in Colorado in 2020-2021. PARTICIPANTS: Physicians providing care to patients likely clinically eligible for MAiD according to probabilistic sampling. MAIN MEASURES: Physicians self-reported barriers to their own participation in MAiD. We considered large ethical and/or religious barriers to be conscience-based barriers. We measured physicians' self-reported intention to participate and self-reported prior participation in MAiD since it was legalized in Colorado in 2017. We estimated differences in intention and behavior outcomes according to presence of conscience-based barriers, adjusting for physician gender, race/ethnicity, time in practice, and specialty. KEY RESULTS: Among 300 respondents, 26% reported "large" ethical and/or religious barriers to their involvement in MAiD. Physicians with longer time in practice and those identifying as non-White were more likely to report conscience-based barriers to MAiD. Comparing physicians with and without conscience-based barriers to MAiD, we found no difference in ancillary participation (discussing, referring) but significant differences in direct participation (serving as consultant [5% vs. 31%] or attending [0% vs. 22%]). CONCLUSIONS: Approximately one-quarter of physicians likely to care for MAiD-eligible patients in Colorado reported religious and/or ethical barriers to MAiD. Despite religious and/or ethical barriers, the vast majority of physicians were willing to discuss MAiD and/or refer patients seeking MAiD services. These data provide important empirical foundation for policy from hospitals and health systems as well as medical specialty groups with official positions on MAiD.

Trust in the Food and Drug Administration: A National Survey Study.

Building trust in public health agencies like the US Food and Drug Administration (FDA) has become a key government priority. Understanding the roots of FDA mistrust is important if the agency is to develop targeted messaging and reforms aimed at building confidence in the agency. We conducted a survey of 2,021 respondents in the US probing attitudes toward the FDA. The primary outcome was FDA trust, defined as the mean score that each respondent assigned to the FDA across four prespecified axes: (1) competence and effectiveness; (2) commitment to acting in the best interests of the American public; (3) abiding by the rules and regulations set forth by policy or law; and (4) expertise in health, science, and medicine. On multivariable ordinal logistic regression, FDA mistrust was associated with female gender (odds ratio [OR] = 0.74, 95% confidence interval [CI] 0.62-0.88), rural community (OR 0.85, 95% CI 0.75-0.96), conservative political views (OR 0.77, 95% CI 0.74-0.81), worse self-reported health (OR 0.89, 95% CI 0.80-0.98), lower satisfaction with health care received (OR 0.63, 95% CI 0.56-0.71), less attention to health and science news (OR 0.72, 95% CI 0.64-0.80), and not having children under the age of 18 (OR 0.72, 95% CI 0.60-0.86). These findings underscore the challenges faced by US political leaders in convincing a heterogeneous American public to trust the FDA. The FDA should develop and deploy targeted outreach strategies to populations with lower levels of trust and strengthen internal processes that minimize biases and ensure sound decision-making.

Patient Perceptions of Chatbot Supervision in Health Care Settings.

This survey study assesses whether patients communicating with a chatbot in a large health care system were able to accurately identify it as an unsupervised computer application.

Physicians approach shared decision-making for sports eligibility decisions heterogeneously.

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.

Ethics and Medical Aid in Dying: Physicians' Perspectives on Disclosure, Presence, and Eligibility.

Medical aid in dying (MAiD), despite being legal in many jurisdictions, remains controversial ethically. Existing surveys of physicians' perceptions of MAiD tend to focus on the legal or moral permissibility of MAiD in general. Using a novel sampling strategy, we surveyed physicians likely to have engaged in MAiD-related activities in Colorado to assess their attitudes toward contemporary ethical issues in MAiD.

Characteristics of Advanced Practice Nurses Receiving Top Industry Payments and Their Practice Settings: a Cross-sectional Study.

BACKGROUND: The pharmaceutical industry promotes prescribing through the cultivation of key opinion leaders. Advanced practice nurses (APNs) are a growing and influential group of prescribers across generalist and specialty practice. Public reporting of industry payments to APNs allows for exploration of their influence within practice settings. OBJECTIVE: To understand the characteristics of APNs with top industry payments including their positions of influence and other payment recipients at the same address. DESIGN AND SETTING: Cross-sectional study of US national Open Payments reports of industry payments made between January 1, 2021, and December 31, 2021. PARTICIPANTS: APNs who received > $50,000 USD in industry payments for speaking, consulting, and honoraria ("personal fees"). MEASURES: Description of top APN recipients' practice setting type, clinical specialty, presence of other payment recipients, value of payments attributed to the same address, and top manufacturers and therapeutic categories associated with payments to top APN recipients. Structured content analysis of public-facing websites for evidence of APNs' clinical, research, and teaching leadership. RESULTS: A total of 99 APNs received > $50,000 USD in aggregate personal fees and a median $74,080 USD (IQR $57,303-101,702) in aggregate payments. They shared a practice setting with a median of 1 (IQR 0-5) physician and 0 (IQR 0-3) other APN payment recipients and were often the only (39%, 42/109) or the dominant (45%, 30/67) payment recipient in their practice setting. In total, 36% held clinical leadership positions, 25% led scientific research, and 18% had university appointments. Forty-two percent (37/88) owned a clinical practice, including cosmetic clinics (51%, 19/37) and mental/behavioral health clinics (24%, 9/37). CONCLUSIONS: Top APN payment recipients attracted high-value payments in practice settings and specialities associated with high-cost drug development; however, there may be little oversight of APNs' industry relationships. Policy development related to industry relationships must be inclusive of and responsive to the activities of interprofessional providers.

Specialty Differences in Medical Aid in Dying Experiences: Results of a Survey of Physicians in Colorado.

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.

Modelling the Gastrointestinal Carriage of Klebsiella pneumoniae Infections.

Klebsiella pneumoniae is a leading cause of nosocomial and community acquired infections, making K. pneumoniae the pathogen that is associated with the second largest number of deaths attributed to any antibiotic resistant infection. K. pneumoniae colonizes the nasopharynx and the gastrointestinal tract in an asymptomatic manner without dissemination to other tissues. Importantly, gastrointestinal colonization is a requisite for infection. Our understanding of K. pneumoniae colonization is still based on interrogating mouse models in which animals are pretreated with antibiotics to disturb the colonization resistance imposed by the gut microbiome. In these models, infections disseminate to other tissues. Here, we report a murine model to allow for the study of the gastrointestinal colonization of K. pneumoniae without tissue dissemination. Hypervirulent and antibiotic resistant strains stably colonize the gastrointestinal tract of in an inbred mouse population without antibiotic treatment. The small intestine is the primary site of colonization and is followed by a transition to the colon over time, without dissemination to other tissues. Our model recapitulates the disease dynamics of the metastatic K. pneumoniae strains that are able to disseminate from the gastrointestinal tract to other sterile sites. Colonization is associated with mild to moderate histopathology, no significant inflammation, and no effect on the richness of the microbiome. Our model sums up the clinical scenario in which antibiotic treatment disturbs the colonization of K. pneumoniae and results in dissemination to other tissues. Finally, we establish that the capsule polysaccharide is necessary for the colonization of the large intestine, whereas the type VI secretion system contributes to colonization across the gastrointestinal tract. IMPORTANCE Klebsiella pneumoniae is one of the pathogens that is sweeping the world in the antibiotic resistance pandemic. Klebsiella colonizes the nasopharynx and the gut of healthy subjects in an asymptomatic manner, making gut colonization a requisite for infection. This makes it essential to understand the gastrointestinal carriage in preventing Klebsiella infections. Current research models rely on the perturbation of the gut microbiome by antibiotics, resulting in an invasive infection. Here, we report a new model of K. pneumoniae gut colonization that recapitulates key features of the asymptomatic human gastrointestinal tract colonization. In our model, there is no need to disturb the microbiota to achieve stable colonization, and there is no dissemination to other tissues. Our model sums up the clinical scenario in which antibiotic treatment triggers invasive infection. We envision that our model will be an excellent platform upon which to investigate factors enhancing colonization and invasive infections and to test therapeutics to eliminate Klebsiella asymptomatic colonization.

Caring for Adults With Significant Levels of Intellectual Disability in Outpatient Settings: Results of a National Survey of Physicians.

Between 1% and 2% of the U.S. population has an intellectual disability (ID) and often experience disparities in health care. Communication patterns and sedation use for routine medical procedures are important aspects of care for this population. We explored physicians' communication patterns and sedation use in caring for patients with significant levels of ID through a mailed survey of 1,400 physicians among seven specialties in outpatient settings (response rate = 61.0%). Among physicians who saw at least one patient with significant levels of ID in an average month, 74.8% reported usually/always communicating primarily with someone other than the patient. Among specialists, 85.5% (95% CI: 80.5%-90.5%) reported doing so, compared to 69.9% (95% CI: 64.4%-75.4%) for primary care physicians (p < 0.001). Also, 11.4% reported sedating at least one patient with significant levels of ID for a routine procedure. Three quarters of physicians reported communicating primarily with persons other than the patient usually or always-an approach that, in some instances, may not align with best medical practice. The percentage of physicians who report sedating at least one individual is associated with significant ID and the physician's volume of patients with significant ID.

Use and Influence of Medical Aid in Dying Service on Physician Experiences.

Background: The involvement of Medical Aid in Dying (MAiD) experts to guide MAiD prescribers who may be unfamiliar with the process is unknown. Objective: To examine the involvement of consulting services on physician experiences participating in MAiD activities. Design: This is an anonymous survey. Participants: Colorado physicians (n = 583) likely to care for MAiD-eligible patients. Measures: Consulting services used in a recent MAiD case and perspectives on use of a MAiD service. Results: Of 300 physicians (response rate 55%), 49 physicians had served as a MAiD attending and/or consulting physician. In a recent MAiD case, commonly used services included palliative care (92%), hospice (81%), social work (78%), or a MAiD service (63%). When a MAiD service was not used vs. used, respondents felt the MAiD case was less professionally risky (28% vs. 7%, p = 0.04). Conclusion: Along with palliative care, hospice, and social work, use of an experienced MAiD service was relatively common. The role and function of MAiD services warrant further exploration.

A novel in vitro model of the small intestinal epithelium in co-culture with 'gut-like' dendritic cells.

Cross-talk between dendritic cells (DCs) and the intestinal epithelium is important in the decision to mount a protective immune response to a pathogen or to regulate potentially damaging responses to food antigens and the microbiota. Failures in this decision-making process contribute to the development of intestinal inflammation, making the molecular signals that pass between DCs and intestinal epithelial cells potential therapeutic targets. Until now, in vitro models with sufficient complexity to understand these interactions have been lacking. Here, we outline the development of a co-culture model of in vitro differentiated 'gut-like' DCs with small intestinal organoids (enteroids). Sequential exposure of murine bone marrow progenitors to Flt3L, granulocyte macrophage colony-stimulating factor (GM-CSF) and all-trans-retinoic acid (RA) resulted in the generation of a distinct population of conventional DCs expressing CD11b+SIRPα+CD103+/- (cDC2) exhibiting retinaldehyde dehydrogenase (RALDH) activity. These 'gut-like' DCs extended transepithelial dendrites across the intact epithelium of enteroids. 'Gut-like' DC in co-culture with enteroids can be utilized to define how epithelial cells and cDCs communicate in the intestine under a variety of different physiological conditions, including exposure to different nutrients, natural products, components of the microbiota, or pathogens. Surprisingly, we found that co-culture with enteroids resulted in a loss of RALDH activity in 'gut-like' DCs. Continued provision of GM-CSF and RA during co-culture was required to oppose putative negative signals from the enteroid epithelium. Our data contribute to a growing understanding of how intestinal cDCs assess environmental conditions to ensure appropriate activation of the immune response.

Barriers to metabolic bariatric surgery in adolescents: results of a qualitative study.

BACKGROUND: It is estimated that 4.5 million youth in the United States have severe obesity (SO). Metabolic and bariatric surgery (MBS) is the most effective and longitudinally durable treatment for adolescents with SO, but only an estimated 1600 adolescents undergo the procedure annually. OBJECTIVE: To understand patients' perceptions and experiences with the barriers to MBS as an adolescent. SETTING: This research was conducted at Children's Hospital Colorado, an urban academic medical center, and the University of Colorado Anschutz School of Medicine and Sanford Research, a rural medical center. METHODS: We conducted 14 qualitative interviews with individuals who received MBS between the ages of 19 and 25 years in the last 5 years regarding the barriers to MBS they experienced as an adolescent. A formal qualitative analysis was conducted using the constant comparative techniques of grounded theory generally guided by Anderson's behavioral model of health service use. RESULTS: We identified 3 principal groups of barriers related to (1) a lack of information that MBS was an option and the absence of discussions about MBS with medical providers while an adolescent, (2) a lack of access to MBS primarily related to insurance coverage, costs, and family-related issues, and (3) a general stigma around MBS as a treatment for obesity. CONCLUSION: This study suggests that the primary barriers to MBS for adolescents with SO are related to a general lack of information about MBS, social stigma, and access issues related to costs that decrease or limit access.

A novel methodology to identify and survey physicians participating in medical aid-in-dying.

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.

Physicians' Attitudes and Experiences with Medical Aid in Dying in Colorado: a "Hidden Population" Survey.

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.

US Physicians' Knowledge About The Americans With Disabilities Act And Accommodation Of Patients With Disability.

More than thirty years since the enactment of the Americans with Disabilities Act (ADA), people with disability continue to experience health care disparities. The ADA mandates that patients with disability receive reasonable accommodations. In our survey of 714 US physicians in outpatient practices, 35.8 percent reported knowing little or nothing about their legal responsibilities under the ADA, 71.2 percent answered incorrectly about who determines reasonable accommodations, 20.5 percent did not correctly identify who pays for these accommodations, and 68.4 felt that they were at risk for ADA lawsuits. Physicians who felt that lack of formal education or training was a moderate or large barrier to caring for patients with disability were more likely to report little or no knowledge of their responsibilities under the law and were more likely to believe that they were at risk for an ADA lawsuit. To achieve equitable care and social justice for patients with disability, considerable improvements are needed to educate physicians and make health care delivery systems more accessible and accommodating.

Incidence of Accommodations for Patients With Significant Vision Limitations in Physicians' Offices in the US.

IMPORTANCE: Despite documented disparities in health care for patients with significant vision impairments and legal mandates that patients with disability receive equitable care, little is known about the extent to which physicians practicing in the US accommodate these patients in outpatient clinical settings. OBJECTIVE: To empirically explore the extent of basic accommodations physicians practicing in the US provide to patients with significant vision limitations in outpatient care. DESIGN, SETTING, AND PARTICIPANTS: In this physician survey study, randomly selected physicians were surveyed throughout the US on their attitudes toward patients with disability. A total of 1400 randomly selected active board-certified physicians representing 7 specialties (family medicine, general internal medicine, rheumatology, neurology, ophthalmology, orthopedic surgery, and obstetrics-gynecology) were surveyed. Data were collected from October 2019 to June 2020. MAIN OUTCOMES AND MEASURES: Reported use of basic accommodations when caring for patients with significant vision limitations (defined here as blind or significant difficulty seeing even with glasses or other corrective lenses). Physicians' accommodation performance was assessed based on whether they always or usually described the clinic space and always or usually provided printed material in large font. Use of Braille materials was reported too rarely to include in analyses. RESULTS: Of the 462 survey participants, 297 of 457 (65.0%) were male. The weighted response rate was 61.0%. Only 48 physicians (9.1%; 95% CI, 6.6-12.3) provided both accommodations (always or usually describing clinic spaces and providing large-font materials), while 267 (60.2%; 95% CI, 55.3-65.0) provided neither of these accommodations. Although 62.8% (95% CI, 57.5-67.8; n = 245) of nonophthalmologists did not provide either accommodation, 29.3% (95% CI, 20.1-40.7; n = 22) of ophthalmologists also did not do so; only 24.0% (95% CI, 15.6-35.0; n = 18) of ophthalmologists provided both accommodations compared with 8.4% (95% CI, 5.4-12.7) of other physicians. CONCLUSIONS AND RELEVANCE: This survey study suggests that less than one-tenth of physicians practicing in the US who care for patients with significant vision limitations usually or always describe clinic spaces or provide large-font materials, and less than one-third of ophthalmologists do so. Actions to address this seem warranted.

Use of Accessible Weight Scales and Examination Tables/Chairs for Patients with Significant Mobility Limitations by Physicians Nationwide.

BACKGROUND: Mobility limitations are the most common disability type among the 61 million Americans with disability. Studies of patients with mobility limitations suggest that inaccessible medical diagnostic equipment poses significant barriers to care. METHODS: The study team surveyed randomly selected US physicians nationwide representing seven specialties about their reported use of accessible weight scales and exam tables/chairs when caring for patients with mobility limitations. A descriptive analysis of responses was performed, and multivariable logistic regression was used to examine associations between accessible equipment and participants' characteristics. RESULTS: The 714 participants (survey response rate = 61.0%) were primarily male, White, and urban, and had practiced for 20 or more years. Among those reporting routinely recording patients' weights (n = 399), only 22.6% (standard error [SE] = 2.2) reported always or usually using accessible weight scales for patients with significant mobility limitations. To determine weights of patients with mobility limitations, 8.1% always, 24.3% usually, and 40.0% sometimes asked patients. Physicians practicing ≥ 20 years were much less likely than other physicians to use accessible weight scales: odds ratio (OR) = 0.51 (95% confidence interval [CI] = 0.26-0.99). Among participants seeing patients with significant mobility limitations (n = 584), only 40.3% (SE = 2.2) always or usually used accessible exam tables or chairs. Specialists were much more likely than primary care physicians to use accessible exam tables/chairs: OR = 1.96 (95% CI = 1.29-2.99). CONCLUSION: More than 30 years after enactment of the Americans with Disabilities Act, most physicians surveyed do not use accessible equipment for routine care of patients with chronic significant mobility limitations.