Uterine Sacculation With Entrapped Placenta After Delivery.

BACKGROUND: Uterine sacculation refers to a temporary pouch or sac within the uterus that may contain the placenta or fetal parts and that may be diagnosed antepartum or after delivery. There is very limited published information about this rare condition and its management. CASES: We report two cases of uterine sacculation with entrapped placenta diagnosed immediately postpartum, managed with two different approaches. In one case, the patient underwent immediate laparotomy and placental extraction. In the second case, the patient was managed conservatively but ultimately developed signs of infection and underwent laparotomy. CONCLUSION: Uterine sacculation with entrapped placenta is a rare condition that is a potential etiology of retained placenta. Obstetric clinicians should be aware of this diagnosis and the management strategies available.

Multifaceted Approach to Evaluation in a Pediatric and Adolescent Gynecology Rotation for Medical Students.

STUDY OBJECTIVE: We evaluated whether and to what extent a novel medical student rotation in pediatric and adolescent gynecology (PAG) increases clinical knowledge and skills and meets student needs and expectations. DESIGN: Constructivist prospective pre-post study and post-rotation student survey SETTING: Academic medical center PARTICIPANTS: Pilot study of 9 medical students, which represents the entire population of those who completed the rotation. INTERVENTIONS: Four-week clinical rotation in PAG MAIN OUTCOME MEASURES: Changes in clinical knowledge were measured by a pre- and post-intervention multiple-choice assessment, and clinical skills were assessed before and after the intervention using entrustable professional activities (EPAs); these data were analyzed with paired Student's t tests. Student evaluations of the rotation were measured through an anonymous, end-of-rotation, closed- and open-ended survey and were analyzed using descriptive statistics. RESULTS: A statistically significant increase in clinical knowledge was observed post-rotation, with a mean pretest score of 67.0% (standard deviation [SD] 1.7%) and a mean posttest score of 75.2% (SD 3.2%, P = 0.02). Statistically significant increases were observed for all EPAs between the first and final day of the rotation. Eight students who completed the post-rotation survey rated the rotation favorably (5 on a scale from 1 to 5). CONCLUSION: A multipronged evaluation showed that a new PAG clinical rotation significantly increased medical students' clinical skills and knowledge. This multifaceted evaluation method provides valuable insights to educators on how best to tailor a rotation to individual learners' levels of clinical skills and knowledge. If comparable rotations could be instituted and similarly evaluated in other medical schools, a noticeable knowledge/skill gap among trainees might be addressed.

Association Between Sexual Orientation, Mistreatment, and Burnout Among US Medical Students.

Importance: Medical trainee burnout is associated with poor quality care and attrition. Medical students in sexual minority groups report fear of discrimination and increased mistreatment, but the association between sexual orientation, burnout, and mistreatment is unknown. Objective: To evaluate whether medical student burnout differs by sexual orientation and whether this association is mediated by experiences of mistreatment. Design, Setting, and Participants: This cross-sectional study surveyed US medical students graduating from Association of American Medical Colleges (AAMC)-accredited US allopathic medical schools who responded to the AAMC graduation questionnaire in 2016 and 2017. Statistical analyses were performed from March 15, 2019, to July 2, 2020, and from November 20 to December 9, 2020. Main Outcomes and Measures: Burnout was measured using the Oldenburg Burnout Inventory for Medical Students, and sexual orientation was categorized as either heterosexual or lesbian, gay, or bisexual (LGB). Logistic regression models were constructed to evaluate the association between sexual orientation and experiencing burnout (defined as being in the top quartile of exhaustion and disengagement burnout dimensions) and to test the mediating association of mistreatment. Results: From 2016 to 2017, 30 651 students completed the AAMC Graduation Questionnaire, and 26 123 responses were analyzed. Most respondents were younger than 30 years (82.9%) and White (60.3%). A total of 13 470 respondents (51.6%) were male, and 5.4% identified as LGB. Compared with heterosexual students, a greater proportion of LGB students reported experiencing mistreatment in all categories, including humiliation (27.0% LGB students vs 20.7% heterosexual students; P < .001), mistreatment not specific to identity (17.0% vs 10.3%; P < .001), and mistreatment specific to gender (27.3% vs 17.9%; P < .001), race/ethnicity (11.9% vs 8.6%; P < .001), and sexual orientation (23.3% vs 1.0%; P < .001). Being LGB was associated with increased odds of burnout (adjusted odds ratio, 1.63 [95% CI, 1.41-1.89]); this association persisted but was attenuated after adjusting for mistreatment (odds ratio, 1.36 [95% CI, 1.16-1.60]). The odds of burnout increased in a dose-response manner with mistreatment intensity. Lesbian, gay, or bisexual students reporting higher mistreatment specific to sexual orientation had and 8-fold higher predicted probability of burnout compared with heterosexual students (19.8% [95% CI, 8.3%-31.4%] vs 2.3% [95% CI, 0.2%-4.5%]; P < .001). Mediation analysis showed that mistreatment accounts for 31% of the total association of LGB sexual orientation with overall burnout (P < .001). Conclusions and Relevance: This study suggests that LGB medical students are more likely than their heterosexual peers to experience burnout, an association that is partly mediated by mistreatment. Further work is needed to ensure that medical schools offer safe and inclusive learning environments for LGB medical students.

Medicare Prescription Drug Plan Coverage of Hormone Therapies Used by Transgender Individuals.

Purpose: Although pharmacologic hormone therapy represents one of the mainstays of gender-affirming therapy for transgender individuals, there are many access barriers for these therapies, including insurance coverage of these drugs. The purpose of this study was to examine Medicare coverage of hormone therapies used by transgender individuals. Methods: Using Centers for Medicare and Medicaid Services prescription drug plan formulary files, we determined plan coverage, coverage restrictions, and out-of-pocket (OOP) costs for all 10 drugs recommended in the 2009 and 2017 Endocrine Society treatment guidelines for transgender patients. Results: For masculinizing therapies, the proportion of plans providing unrestricted coverage ranged from 22% to 79% in 2010 and from 5% to 75% in 2018. For feminizing therapies, the proportion providing unrestricted coverage ranged from 24% to 100% in 2010 and from 13% to 100% in 2018. Median annual OOP costs for masculinizing therapies ranged from $232 to $1112 in 2010 and from $180 to $2176 in 2018. For feminizing therapies, OOP costs ranged from $84 to $2716 in 2010 and from $72 to $3792 in 2018. Conclusion: Our findings highlight the variability in access to guideline-recommended hormone therapies for individuals insured through Medicare.

Exploring crowdfunding campaigns for abortion services.

OBJECTIVES: To examine the use of crowdfunding to pay for abortion services for individuals in the United States. STUDY DESIGN: Cross-sectional analysis of data abstracted from publicly available campaigns for abortion services on four major crowdfunding sites. RESULTS: Among 92 crowdfunding campaigns, the median amount requested was $610 (IQR $500-$1000), the median raised was $0 (IQR $0-$444), and 19 (21%) campaigns successfully reached their fundraising goal. Campaign success did not differ by state abortion policy, but campaigns written in third person or describing maternal/fetal diagnoses raised significantly more money. CONCLUSIONS: Although individuals use crowdfunding to finance abortion services, the success rate is low.

A Rare and Extreme Case of Vulvar Swelling in the Setting of Nephrotic Syndrome in a Prepubertal Girl.

BACKGROUND: We present a rare case of severe vulvar edema secondary to steroid-refractory nephrotic syndrome in a prepubertal girl. CASE: The patient is an 8-year-old girl who presented during nephrotic syndrome relapse. She exhibited severe mons pubis and labial edema. She was treated with local symptomatic measures such as sitz baths, barrier ointment, and labial sling, with minimal relief. Improvement ultimately occurred after bilateral nephrectomy. SUMMARY AND CONCLUSION: Vulvar edema is rare in prepubertal girls. In this case, the edema was secondary to steroid-refractory nephrotic syndrome and was not responsive to local treatment measures. There is a paucity of data on effective treatment of vulvar edema in young girls. Our goal is to raise awareness of such pathology, which might lead to development of uniform guidelines for treatment of this condition.

An Analysis of the Presence and Composition of OutLists at United States, Canadian, and European Medical Institutions.

Sexual and gender minority (SGM) medical students and physicians are exposed to bias in professional contexts. One strategy for promoting SGM visibility and inclusion within medicine is the development of institutional OutLists, which are online, opt-in lists of SGM-identified individuals affiliated with an academic institution. We present the first quantitative evaluation of publicly accessible OutLists at medical institutions in the United States, Canada, and Europe. Nineteen OutLists were identified in the United States; no OutLists were identified in other countries. All OutLists in the United States were identified at allopathic institutions with no institutional religious affiliation. Clinicians in high-prestige specialties and more senior clinicians were underrepresented on OutLists. A state-level measure of SGM equality predicted presence of OutLists within the state (odds ratio 1.429, p = .047) but was not associated with the total number of individuals on OutLists. Future research would benefit from incorporating qualitative methodologies to explore the effectiveness of OutLists and the individual experiences of participants in these lists.

Establishing a Pediatric and Adolescent Gynecology Subinternship for Medical Students.

Within the pediatric and adolescent gynecology (PAG) community, an important issue deserving of our attention is expansion of formalized PAG training opportunities for medical students. In addition to those in obstetrics and gynecology, many physicians practicing family medicine, internal medicine, and surgery provide care to young female patients. However, residency programs provide inconsistent training in addressing specific PAG health care needs and communication skills required for delivery of care to pediatric and adolescent patients; opportunities for supervised clinical experience in these areas at the medical school level therefore have great importance because they might not be offered again during some residencies. At the undergraduate medical education level, training opportunities in PAG are currently limited, with only 3 PAG subinternships in North American medical schools. In contrast, other available subinternships include 113 in maternal fetal medicine and 82 in gynecologic oncology. To address this gap in opportunities for medical students, we developed a PAG subinternship and elective for medical students, which we describe in this report. Our 4-week PAG subinternship and 2-week elective expose students to a variety of ambulatory and surgical opportunities, with formal, informal, and self-guided learning activities. In this article, we explain the process of developing the curriculum, gaining alignment from key stakeholders, obtaining formal approval for the course, and advertising the opportunity to medical students. We also provide resources and guidance for medical educators who wish to establish a PAG subinternship or elective course at their institutions.

Medicare Prescription Drug Plan Formulary Restrictions After Postmarket FDA Black Box Warnings.

BACKGROUND: The boxed warning (also known as "black box warning") is one of the FDA's strongest safety actions for pharmaceuticals. After the FDA issues black box warnings for drugs, prescribing changes have been inconsistent. Formulary management may provide an opportunity to restrict access to drugs with serious safety concerns. OBJECTIVE: To examine Medicare prescription drug plan formulary changes after new FDA postmarket black box warnings and major updates to preexisting black box warnings. METHODS: In this cohort study, we identified each drug that received a new FDA postmarket black box warning or a major update to a preexisting black box warning from January 2008 through June 2015 and examined its formulary coverage. The main outcome measure was the proportion of Medicare prescription drug plan formularies providing unrestrictive coverage immediately before the black box warning, at least 1 year after the warning and at least 2 years after the warning. Unrestrictive formulary coverage was defined as coverage of a drug without prior authorization or step-therapy requirements. RESULTS: Of 101 new black box warnings and major updates to preexisting warnings affecting 68 unique drug formulations, the mean percentage of formularies providing unrestrictive coverage changed from 65.4% (95% CI = 59.6%-71.2%) prewarning; 62.6% (95% CI = 56.3%-68.9%, P = 0.04) at least 1 year postwarning; and 61.9% (95% CI = 55.4%-68.5%, P = 0.10) at least 2 years postwarning. CONCLUSIONS: The mean percentage of Medicare prescription drug plan formularies providing unrestrictive coverage decreased modestly by approximately 3 percentage points after drugs received postmarket FDA black box warnings. Formulary restrictions may present an underused mechanism to reduce use of potentially unsafe medications. DISCLOSURES: This study was supported by a student research grant received by Solotke and provided by the Yale School of Medicine Office of Student Research under National Institutes of Health training grant award T35DK104689. Karaca-Mandic, Shah, and Ross acknowledge support from Agency for Healthcare Research and Quality (AHRQ) grant R01 HS025164, which studies factors associated with de-adoption of drug therapies shown to be ineffective or unsafe. The content of this study is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors assume full responsibility for the accuracy and completeness of the ideas presented. Ross has received support from the following: the U.S. Food and Drug Administration (FDA) as part of the Centers for Excellence in Regulatory Science and Innovation (CERSI) program; Johnson and Johnson through Yale University to develop methods of clinical trial data sharing; Medtronic and the FDA to develop methods for postmarket surveillance of medical devices; the Blue Cross Blue Shield Association to better understand medical technology evaluation; the Centers for Medicare & Medicaid Services (CMS) to develop and maintain performance measures that are used for public reporting; the AHRQ to examine community predictors of health care quality; and the Laura and John Arnold Foundation, which established the Collaboration for Research Integrity and Transparency at Yale University. Shah has received support from the FDA as part of the CERSI program. In addition, he has received support through the Mayo Clinic from CMS, AHRQ, National Science Foundation, and Patient-centered Outcomes Research Institute. Karaca-Mandic has provided consulting services to Precision Health Economics and Tactile Medical for work unrelated to this manuscript. Dhruva and Solotke have no conflicts of interest to report.

New and incremental FDA black box warnings from 2008 to 2015.

BACKGROUND: The boxed warning (also known as 'black box warning [BBW]') is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval. METHODS: We identified all post-marketing BBWs from January 2008 through June 2015 listed on FDA's MedWatch and Drug Safety Communications websites. We used each drug's prescribing information to classify its BBW as new, major update to a preexisting BBW, or minor update. We then characterized these BBWs with respect to pre-specified BBW-specific and drug-specific features. RESULTS: There were 111 BBWs issued to drugs on the US market, of which 29% (n = 32) were new BBWs, 32% (n = 35) were major updates, and 40% (n = 44) were minor updates. New BBWs and major updates were most commonly issued for death (51%) and cardiovascular risk (27%). The new BBWs and major updates impacted 200 drug formulations over the study period, of which 64% were expected to be used chronically and 58% had available alternatives without a BBW. CONCLUSIONS: New BBWs and incremental updates to existing BBWs are frequently added to drug labels after regulatory approval.