Jacobs Institute of Women's Health
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A Collective Case Study of How Researchers Describe Their Experiences, Challenges, and Perceived Impact of Patient Engagement
No full textBackground: Patient engagement (PE) in clinical research has become “extensively and internationally recognized as important and gained growing policy attention, supported by scientific evidence” (Al-Tannir et al., 2017, Background section). The proliferation of PE directives has driven the paradigm shift in drug development from a paternalistic approach to a more patient-centric approach influenced by regulatory agencies, funders, and academic initiatives (Bombak & Hanson, 2017). However, too often, PE activities are not well considered for discovering actionable insights but are merely an empty formality. For PE to be meaningful, patient involvement must be planned, supported, and valued by clinical researchers.
Objectives: The aim of this study was to explore how researchers have incorporated PE activities into their clinical research. The central question was how significant researchers view PE and what opportunities and barriers they have encountered to incorporate meaningful PE activities into their research.
Methods: A collective case study involved professional clinical researchers from academic institutions and industry. Purposive sampling from professional networks and public research sites identified participants integrating PE activities into their research. Data were collected from one-on-one semistructured interviews after informed consent review. Interviews were recorded via Zoom, and data were uploaded to ATLAS.ti for transcription, then to NVivo for coding and thematic identification. This study was exempted by the George Washington University Institutional Review Board.
Results: Thirteen participants consented to semistructured interviews, with research experience spanning from under 10 to over 20 years. Four participants (38.8%) had 0−10 years, five (38.5%) had 11−15 years, two (15.4%) had 16−20 years, and two (15.4%) had more than 20 years. Participants were geographically diverse, residing in the Southwest (n = 1, 7.7%), Southeast (n = 2, 15.4%), New England (n = 2, 15.4%), Northwest (n = 5, 38.5%), North Central (n = 1, 7.7%), and Midwest (n = 2, 15.4%). Although offering varied definitions, most aligned with the U.S. Food and Drug Administration’s (2022) definition of “intentional, meaningful interactions with patients that provide opportunities for mutual learning and effective collaborations” (para. 3). PE was commonly described as, actively centering the patient’s voice in research. Some participants mentioned conducting research without patient input but acknowledged the importance of patient involvement in enhancing study design, recruitment, diversity, community engagement, and dissemination activities. Barriers included financial constraints, lack of knowledge and training, superficial views of PE, and insufficient regulatory guidance.
Conclusion: Despite PE’s recognized importance, the findings underscored the challenges and opportunities in integrating it into research activities. Participants acknowledged the advantages of PE; and stressed the need for organizational and systemic reforms to improve current conditions, funding methods, and regulatory guidance. Sustainable engagement strategies—such as regulatory support, financial assistance, best practice training, and institutional commitment—are essential for transforming PE from a beneficial approach to a best practice. Addressing these challenges and providing training and clear regulatory guidance will ensure PE is central to high-quality, patient-centered research, ultimately enhancing patient lives and outcomes
Neurodivergence, Minority Stress, and Tobacco Use in a Sample of US Sexual and Gender Minoritized Young Adults
No full textBACKGROUND: Minority stress is related to tobacco use inequities among sexual and gender minoritized young adults (SGM YAs). Neurodivergent SGM YAs may experience greater minority stress (from dual-minoritized identities) and tobacco use. METHODS: A 2023 survey assessed neurodivergence (defined as attention-deficit hyperactivity disorder [ADHD] or a learning-related condition), minority stressors (mental health symptoms, internalized SGM stigma, SGM community connectedness), and tobacco use (past-month cigarette, e-cigarette, any tobacco product use; number of products used) among SGM YAs (aged 18-34) in the United States. Multivariable regression examined associations of neurodivergence with minority stressors and tobacco use. RESULTS: Among SGM YAs (N = 1115; M = 25.34 [SD = 4.84]; 65.2% bisexual+, 29.5% monosexual, 4.8% another identity; 52.2% cisgender women, 29.8% cisgender men, 17.2% gender minority), 36.1% reported neurodivergence, 23.4% reported current cigarette use, 30.0% e-cigarette use, and 40.4% any tobacco use. On average, participants reporting current tobacco use used 2 to 3 products (M = 2.06 [SD = 1.25]). Neurodivergence was associated with higher odds of experiencing mental health symptoms (aOR = 1.53, 95% CI [1.19-1.95]), cigarette use (aOR = 1.48, 95% CI [1.07-2.05]), e-cigarette use (aOR = 1.80, 95% CI [1.35-2.42]), and any tobacco product use (aOR = 1.63, 95% CI [1.23-2.17]). Mental health symptoms were associated with cigarette (aOR = 1.63, 95% CI [1.19-2.25]), e-cigarette (aOR = 1.58, 95% CI [1.19-2.11]), and any tobacco product use (aOR = 1.48, 95% CI [1.13-1.96]). CONCLUSIONS: Neurodivergent SGM YAs (vs those without ADHD or learning-related conditions) may have greater risk for mental health symptoms and related tobacco use, underscoring the need for appropriate and culturally competent mental healthcare to reduce tobacco use
Impact of Achieving Optimal Treatment Targets and Minimal Disease Activity on Health-Related Quality of Life and Satisfaction in Patients with Atopic Dermatitis
No full textINTRODUCTION: Guidance from the Aiming Higher in Eczema/Atopic Dermatitis initiative identified moderate and optimal treatment targets for clinician-reported outcomes (ClinROs) and patient-reported outcomes (PROs) and defined minimal disease activity (MDA) as simultaneously meeting optimal targets in ClinRO and PRO. This post hoc analysis investigates the impact of achieving individual optimal targets or MDA on patient health-related quality of life (HRQoL) outcomes in patients with atopic dermatitis. METHODS: Patients from phase 3 Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and AD UP (NCT03568318) were randomized 1:1:1 to receive daily oral upadacitinib at either 15 mg or 30 mg, or placebo for the first 16 weeks. Patients were pooled for this analysis regardless of intervention and stratified into three mutually exclusive response groups meeting optimal, moderate, or neither treatment target for each ClinRO or PRO, and the achievement of MDA at week 16. Impact on the patient\u27s HRQoL was measured across eight outcomes: itch, skin symptoms, quality of life, sleep, daily activities, emotional state, work productivity, and treatment satisfaction. RESULTS: Patients who achieved optimal treatment targets, compared with those achieving moderate or neither treatment target, reported greater improvement in patient HRQoL outcomes (1.1-20.2-fold for optimal versus moderate, 1.3 to \u3e 50-fold for optimal versus neither target, and 1.2-16.3-fold for moderate versus neither target groups). In addition, patients who achieved MDA, versus those achieving optimal ClinRO or PRO alone, were more likely to report improved patient HRQoL outcomes. CONCLUSIONS: These results highlight the value of reaching optimal treatment targets and MDA in disease management of atopic dermatitis
Trends in Female Authorship at American Academy of Otolaryngology-HNS Annual Meetings From 2007 to 2022
No full textOBJECTIVE: This study aims to trends in female authorship in poster and oral presentations at American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) annual meetings. STUDY DESIGN: Retrospective analysis of AAO-HNS annual meeting presentations. SETTING: Abstract data from scientific contributions at AAO-HNS annual meetings. METHODS: ChatGPT 3.5 API was used to predict gender identities of author names extracted from publicly available scientific oral and poster presentation abstracts between 2007 and 2022. Secondary variables included presentation type (oral or poster presentation), presentation topic, and authorship order (first author, presenter, and senior author). Logistic regression models were explored to determine the probability of female author participation as first, presenting, and senior author. RESULTS: Our analysis included 48,877 authors extracted from 11,850 abstracts. For all oral and poster presentations, 29% of authors were female, increasing from 21.2% in 2007 to 37.9% in 2022 (P \u3c .001). Although female authors accounted for 32% of presenters and 31% of first authors, they represented 22% of senior authors. Logistic regression models determined that the probability of female author participation increased by 5% each year; however, there remained a significant gap of 24.2% between male and female author participation in 2022. CONCLUSION: Representation of female authors at annual AAO-HNS meetings has increased from 2007 to 2022 as demonstrated by artificial intelligence (AI)-generated gender identification of authors in this study. These trends reflect the changing demographics of otolaryngology trainees and their mentors. Future studies exploring methods to promote gender diversity are crucial for increasing female representation at all levels within otolaryngology research
High-resolution inventories for Reactive Nitrogen Emissions from China\u27s livestock during 2005-2022
No full textChina is a global hotspot for reactive nitrogen (N) emissions driven by its large livestock sector, which contribute to air pollution, climate change, and biodiversity losses. Despite their importance, current emission inventory development efforts often address singular N species, lacking a comprehensive presentation of all N species together and their interconnected features. This may jeopardize China\u27s achievements of carbon neutrality and clean air. In this study, we developed a high-resolution (0.1° × 0.1°) inventory of monthly N emissions from livestock manure in China for 23 livestock types from 2005 to 2022. Based on a unified dataset, our inventory provides detailed estimates of multiple N emissions from livestock, including ammonia, nitrogen oxides, and nitrous oxide. The inventory can serve as a valuable resource for atmospheric modelling and support integrated nitrogen management strategies in response to China\u27s evolving agricultural landscape, facilitating future decision-making to tackle environmental challenges associated with the agriculture sector
Exposing Inequality: Environmental Injustice and Cardiovascular Health Disparities
No full textThis review explores the intersection between environmental injustice and cardiovascular (CV) health disparities, highlighting how climate change, pollution, and environmental exposures disproportionately impact vulnerable populations. It delves into environmental racism, showing how non-Hispanic Black, Hispanic, and Native American communities face higher exposure to pollutants and climate-related hazards. This increased exposure contributes to greater CV morbidity and mortality, exacerbated by historical practices such as redlining and insufficient exposure regulations. The review points out the limitations of traditional CV risk models that overlook these environmental factors. Promoting transparency, community-driven solutions, and linking macro policies with local implementation are crucial to combating environmental injustice. It suggests that the emerging field of environmental cardiology can adopt eco-friendly sustainable practices and remote care solutions to reduce health care\u27s carbon footprint, integrate environmental risks into prevention and treatment plans, and advocate for policies that reduce disparities in CV disease outcomes
Analysis of the Political Viewpoint of Policy Statements From Professional Medical Organizations Using ChatGPT With GPT-4: Cross-Sectional Study
No full textBACKGROUND: Professional medical organizations publish policy statements that are used to impact legislation or address societal issues. Many organizations are nonpartisan, yet it is uncertain whether their policy statements balance liberal and conservative values. OBJECTIVE: This study aims to evaluate the political viewpoint of policy statements from 6 influential medical organizations, including the American Academy of Pediatrics, American College of Surgeons, American Psychiatric Association, American College of Obstetricians and Gynecologists, American College of Physicians, and American Academy of Family Physicians. METHODS: Between December 2023 and February 2024, policy statements from the 6 organizations were identified and evaluated using ChatGPT with GPT-4 to reduce bias. Each statement was pasted into a new ChatGPT session following the phrase Does this text align with a liberal or conservative viewpoint? Two authors reviewed each response and categorized the statement as liberal, probably liberal, neutral, probably conservative, or conservative. RESULTS: One-third of policy statements (529/1592, 33.2%) were found to be aligned with a political ideology. Among these 529 statements, 516 (97.5%) were liberal or probably liberal and 13 (2.5%) were conservative or probably conservative. For each organization, among policy statements with a political leaning, the percentage of liberal or probably liberal statements was as follows: 100% (69/69) for the American Academy of Pediatrics, 100% (24/24) for the American College of Obstetricians and Gynecologists, 100% (12/12) for the American College of Surgeons, 99% (72/73) for the American Psychiatric Association, 97% (174/180) for the American Academy of Family Physicians, and 96% (165/171) for the American College of Physicians. CONCLUSIONS: One in 3 policy statements from these 6 professional organizations align with a partisan political viewpoint. Among these, positions are 40 times more likely to be liberal or probably liberal than conservative or probably conservative. Whether or not organizations are politically neutral and seek viewpoint diversity warrants further exploration
Safety, pharmacokinetics, and neutralisation activity of PGDM1400LS, a V2 specific HIV-1 broadly neutralising antibody, infused intravenously or subcutaneously in people without HIV-1 in the USA (HVTN 140/HPTN 101 part A): a first-in-human, phase 1 randomised trial
No full textBACKGROUND: PGDM1400LS is a human monoclonal antibody targeting the HIV envelope V2 apex with a lysine-serine modification intended to enhance serum and tissue half-lives and is being considered for use in combination monoclonal antibody trials. We sought to test whether PGDM1400LS was safe and had favourable serum concentration, pharmacokinetics, and neutralising ability in healthy adults. METHODS: HVTN 140/HPTN 101 part A is an open-label, dose escalation, first-in-human phase 1 trial of PGDM1400LS given intravenously or subcutaneously to healthy adults aged 18-50 years without HIV-1. The study enrolled participants at four sites in the USA, across five groups, each receiving one dose of PGDM1400-LS intravenously (group 1: 5 mg/kg; group 2: 20 mg/kg; and group 4: 40 mg/kg) or subcutaneously (group 3: 20 mg/kg; and group 5: 40 mg/kg). Participants in group 1 were enrolled sequentially without random assignment. Participants in groups 2 and 3 were block randomised and enrolled simultaneously after group 1 safety review. Groups 4 and 5 followed the same process, contingent on groups 2 and 3 safety review. The primary endpoints were safety and tolerability of PGDM1400LS, serum concentration of PGDM1400LS, and serum neutralising activity after single administration of PGDM1400LS. Serum PGDM1400LS concentrations collected at seven timepoints (day 0, day 3, day 6, day 28, day 56, day 112, and day 168) were assessed via an anti-idiotype binding assay and characterised via non-compartmental pharmacokinetic analysis. Serum neutralisation activity (ID) was assessed by a TZM-bl assay. The study is registered with ClinicalTrials.gov, NCT05184452. FINDINGS: Between Nov 15, 2021, and March 4, 2022, 15 participants were enrolled into the five study groups (three participants per group) with 6 months of follow-up. Ten of 15 participants were female, 14 of 15 participants were non-Hispanic, and 11 of 15 participants were White, with a median age of 27 years (range 24-47). PGDM1400LS was safe and well tolerated, with mild to moderate solicited symptoms. Serum concentrations showed dose proportionality by administration route, with peak concentrations observed immediately after intravenous infusion (range 95·7-727·4 μg/mL) or on day 6 after subcutaneous infusion (205·6-547·1 μg/mL). The median elimination half-life was 55 days (range 48-59), representing a 2-to-3-times increase versus parental PDGM1400. Estimated subcutaneous (vs intravenous) bioavailability was 50-60%. ID titres showed agreement with concentration-predicted ID titres, indicating maintenance of neutralisation activity in vivo. INTERPRETATION: PGDM1400LS is a promising candidate for combination monoclonal antibody efficacy trials going forward. FUNDING: National Institute of Allergy and Infectious Diseases-National Institutes of Health
Perceptions of research experience during internal medicine training: insights from a national survey
No full textBACKGROUND: There is limited insights into how internal medicine (IM) residents perceive research. This study aimed to assess residents\u27 perceptions across five domains: well-being, research competence, research support, effect on training, and research quality. METHODS: In 2022, a survey instrument was developed to assess residents\u27 perceptions of research across five domains. All IM programs listed in Fellowship and Residency Electronic Interactive Database (FREIDA) were contacted by email, and residents were invited to participate. RESULTS: A total of 530 residents from 67 IM programs completed our survey. Just over 80% of respondents had participated in research during residency. Residents were dissatisfied with research opportunities and infrastructure but viewed research funding more positively. Negative views were held regarding the impact of publication pressure on well-being and the quality of research produced. Publication pressure was perceived to compromise clinical work and limit career paths. Some residents acknowledged that research enriched their training. Residents who had already matched into a fellowship program reported higher research competency and better impressions of the impact of research on their medical training compared to those who had not yet or did not plan to match into a fellowship. Residents who planned to prioritize research in their future careers held positive perceptions of research across multiple domains. CONCLUSIONS: This study provides valuable insights into the impact of publication pressure on IM residents. The findings suggest a need to realign expectations for research productivity or target interventions to better support research for all residents, regardless of track or career goals
The Global Neuroanatomy Network: A new repository of open educational resources
No full textMany parts of the world, especially low- and middle-income countries, lack access to supplemental, time-efficient, and engaging teaching resources. Additionally, many anatomy educators may feel ill-equipped to teach in neuro-related fields. To address these issues, the Global Neuroanatomy Network (GNN) is a new repository of open educational resources (ROER) developed for neuroanatomy educators worldwide. The GNN expands on existing ROERs within health professions and anatomical sciences education while filling the neuroanatomy gap through peer-reviewed, multilingual teaching resources and clinical cases. Funded by the American Association for Anatomy, the GNN is freely available to neuroanatomy educators at all academic institutions. GNN members can submit their teaching resources or clinical cases for peer review and view or download content that global colleagues have submitted. The GNN aims to enhance neuroanatomy education by creating and supporting the expansion of a novel repository and further growing a community of neuroanatomy educators