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Category: Ethics

Hot Topics: Primary Care Guidelines for Transgender Patients

Jackie Werner Ethics, Family Medicine, Hot Topics in Research

Care of the Transgender Patient

Safer JD, Tangpricha V. Care of the transgender patient. Annals of Internal Medicine. 2019;171(1):ITC16. https://doi.org/10.7326/AITC201907020.

Transgender persons are a diverse group whose gender identity differs from their sex recorded at birth. Some choose to undergo medical treatment to align their physical appearance with their gender identity. Barriers to accessing appropriate and culturally competent care contribute to health disparities in transgender persons, such as increased rates of certain types of cancer, substance abuse, mental health conditions, infections, and chronic diseases. Thus, it is important that clinicians understand the specific medical issues that are relevant to this population.

Hot Topics: Bias Minimizes Girls’ Pain

Jackie Werner Ethics, Hot Topics in Research, Pediatrics

Gender bias in pediatric pain assessment

Earp BD, Monrad JT, LaFrance M, Bargh JA, Cohen LL, Richeson JA. Gender bias in pediatric pain assessment. 2019. https://dx.doi.org/10.1093/jpepsy/jsy104.

Objective
Accurate assessment of pain is central to diagnosis and treatment in healthcare, especially in pediatrics. However, few studies have examined potential biases in adult observer ratings of children’s pain. Cohen, Cobb, & Martin (2014. Gender biases in adult ratings of pediatric pain. Children’s Health Care, 43, 87–95) reported that adult participants rated a child undergoing a medical procedure as feeling more pain when the child was described as a boy as compared to a girl, suggesting a possible gender bias. To confirm, clarify, and extend this finding, we conducted a replication experiment and follow-up study examining the role of explicit gender stereotypes in shaping such asymmetric judgments.

Methods
In an independent, pre-registered, direct replication and extension study with open data and materials (https://osf.io/t73c4/), we showed participants the same video from Cohen et al. (2014), with the child described as a boy or a girl depending on condition. We then asked adults to rate how much pain the child experienced and displayed, how typical the child was in these respects, and how much they agreed with explicit gender stereotypes concerning pain response in boys versus girls.

Results
Similar to Cohen et al. (2014), but with a larger and more demographically diverse sample, we found that the “boy” was rated as experiencing more pain than the “girl” despite identical clinical circumstances and identical pain behavior across conditions. Controlling for explicit gender stereotypes eliminated the effect.

Conclusions
Explicit gender stereotypes—for example, that boys are more stoic or girls are more emotive—may bias adult assessment of children’s pain.

Hot Topics: Orientation and Gender Assumptions Can Harm Patient/Doctor Relationship

Jackie Werner Ethics, Hot Topics in Research, Psychology and Psychiatry

Provider Perspectives on the Application of Patient Sexual Orientation and Gender Identity in Clinical Care: A Qualitative Study

Dichter ME, Ogden SN, Scheffey KL. Provider perspectives on the application of patient sexual orientation and gender identity in clinical care: A qualitative study. Journal of General Internal Medicine. 2018. https://doi.org/10.1007/s11606-018-4489-4.

Background
The federal government and other organizations have recommended that healthcare institutions collect and document patient sexual orientation and gender identity (SO/GI) information in order to advance the understanding of the health of sexual and gender minority populations and to combat existing health disparities. Little is known, however, about provider perception of the clinical relevance of, or how they might use, patient SO/GI information in individual care.

Objective
To explore providers’ perspectives on and experiences with collection of patient SO/GI information and how the knowledge of this information may impact clinical care.

Design
Qualitative study using in-depth individual interviews of healthcare providers.

Participants
Twenty-five healthcare providers, including physicians, physician assistants, and nurse practitioners, from the fields of family medicine, internal medicine, gynecology, and urology within a single healthcare system in an east coast city.

Approach
Interviews were recorded and transcribed verbatim. Transcripts were coded and analyzed using principles of grounded theory and thematic analysis to identify themes emerging from the data.

Key results
Providers recognized the importance of collecting patient SO/GI information for understanding population-level public health concerns and disparities, as well as understanding and respecting the context of patients’ lives. However, providers also emphasized the importance of knowing patients’ sexual behaviors and physical anatomy for addressing health risk and preventive care needs—and noted the distinction between these characteristics and patient SO/GI. Providers cautioned that assumptions based on knowledge of patient SO/GI may unintentionally obscure accurate profiles of patient behavior and anatomy.

Conclusions
Along with the potential benefits of routine collection of patient SO/GI, it is important that providers continue to inquire about patient behaviors and anatomy to inform individual risk and needs assessments. Findings from this study can inform the development of guidelines, trainings, and practices for incorporation of patient SO/GI along with existing assessment practices to improve individual and population health.

Hot Topics: Medical Journal Editor Conflicts of Interest Common and Underreported

Jackie Werner Ethics, Hot Topics in Research, Research and Scholarly Communication

Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: retrospective observational study

Liu, J. J., Bell, C. M., Matelski, J. J., Detsky, A. S., & Cram, P. (2017). Payments by US pharmaceutical and medical device manufacturers to US medical journal editors: Retrospective observational study. BMJ, 359 doi:10.1136/bmj.j4619

Objective To estimate financial payments from industry to US journal editors.

Design Retrospective observational study.

Setting 52 influential (high impact factor for their specialty) US medical journals from 26 specialties and US Open Payments database, 2014.

Participants 713 editors at the associate level and above identified from each journal’s online masthead.

Main outcome measures All general payments (eg, personal income) and research related payments from pharmaceutical and medical device manufacturers to eligible physicians in 2014. Percentages of editors receiving payments and the magnitude of such payments were compared across journals and by specialty. Journal websites were also reviewed to determine if conflict of interest policies for editors were readily accessible.

Results Of 713 eligible editors, 361 (50.6%) received some (>$0) general payments in 2014, and 139 (19.5%) received research payments. The median general payment was $11 (£8; €9) (interquartile range $0-2923) and the median research payment was $0 ($0-0). The mean general payment was $28 136 (SD $415 045), and the mean research payment was $37 963 (SD $175 239). The highest median general payments were received by journal editors from endocrinology ($7207, $0-85 816), cardiology ($2664, $0-12 912), gastroenterology ($696, $0-20 002), rheumatology ($515, $0-14 280), and urology ($480, $90-669). For high impact general medicine journals, median payments were $0 ($0-14). A review of the 52 journal websites revealed that editor conflict of interest policies were readily accessible (ie, within five minutes) for 17/52 (32.7%) of journals.

Conclusions Industry payments to journal editors are common and often large, particularly for certain subspecialties. Journals should consider the potential impact of such payments on public trust in published research.

Hot Topics: Marketing Restrictions Change Prescribing Patterns

Jackie Werner Ethics, Hot Topics in Research

Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing

Larkin I, Ang D, Steinhart J, Chao M, Patterson M, Sah S, Wu T, Schoenbaum M, Hutchins D, Brennan T, Loewenstein G. Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing. JAMA. 2017;317(17):1785-1795. doi:10.1001/jama.2017.4039

Importance  In an effort to regulate physician conflicts of interest, some US academic medical centers (AMCs) enacted policies restricting pharmaceutical representative sales visits to physicians (known as detailing) between 2006 and 2012. Little is known about the effect of these policies on physician prescribing.

Objective  To analyze the association between detailing policies enacted at AMCs and physician prescribing of actively detailed and not detailed drugs.

Design, Setting, and Participants  The study used a difference-in-differences multivariable regression analysis to compare changes in prescribing by physicians before and after implementation of detailing policies at AMCs in 5 states (California, Illinois, Massachusetts, Pennsylvania, and New York) that made up the intervention group with changes in prescribing by a matched control group of similar physicians not subject to a detailing policy.

Exposures  Academic medical center implementation of policies regulating pharmaceutical salesperson visits to attending physicians.

Main Outcomes and Measures  The monthly within-drug class market share of prescriptions written by an individual physician for detailed and nondetailed drugs in 8 drug classes (lipid-lowering drugs, gastroesophageal reflux disease drugs, diabetes drugs, antihypertensive drugs, hypnotic drugs approved for the treatment of insomnia [sleep aids], attention-deficit/hyperactivity disorder drugs, antidepressant drugs, and antipsychotic drugs) comparing the 10- to 36-month period before implementation of the detailing policies with the 12- to 36-month period after implementation, depending on data availability.

Results  The analysis included 16 121 483 prescriptions written between January 2006 and June 2012 by 2126 attending physicians at the 19 intervention group AMCs and by 24 593 matched control group physicians. The sample mean market share at the physician-drug-month level for detailed and nondetailed drugs prior to enactment of policies was 19.3% and 14.2%, respectively. Exposure to an AMC detailing policy was associated with a decrease in the market share of detailed drugs of 1.67 percentage points (95% CI, −2.18 to −1.18 percentage points; P < .001) and an increase in the market share of nondetailed drugs of 0.84 percentage points (95% CI, 0.54 to 1.14 percentage points; P < .001). Associations were statistically significant for 6 of 8 study drug classes for detailed drugs (lipid-lowering drugs, gastroesophageal reflux disease drugs, antihypertensive drugs, sleep aids, attention-deficit/hyperactivity disorder drugs, and antidepressant drugs) and for 9 of the 19 AMCs that implemented policies. Eleven of the 19 AMCs regulated salesperson gifts to physicians, restricted salesperson access to facilities, and incorporated explicit enforcement mechanisms. For 8 of these 11 AMCs, there was a significant change in prescribing. In contrast, there was a significant change at only 1 of 8 AMCs that did not enact policies in all 3 areas.

Conclusions and Relevance  Implementation of policies at AMCs that restricted pharmaceutical detailing between 2006 and 2012 was associated with modest but significant reductions in prescribing of detailed drugs across 6 of 8 major drug classes; however, changes were not seen in all of the AMCs that enacted policies.

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes

PJ Grier Ethics, Hot Topics in Research, September

Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes

Modern approaches for research with human biospecimens employ a variety of substantially different types of ethics approval and informed consent. In most cases, standard ethics reporting such as “consent and approval was obtained” is no longer meaningful. A structured analysis of 120 biospecimen studies recently published in top journals revealed that more than 85% reported on consent and approval, but in more than 90% of cases, this reporting was insufficient and thus potentially misleading. Editorial policies, reporting guidelines, and material transfer agreements should include recommendations for meaningful ethics reporting in biospecimen research. Meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research.

 

Chin, W. W. L., Wieschowski, S., Prokein, J., Illig, T., & Strech, D. (2016). Ethics Reporting in Biospecimen and Genetic Research: Current Practice and Suggestions for Changes. PLoS Biology, 14(8), e1002521. http://doi.org/10.1371/journal.pbio.1002521