A framework for assessment of adverse events occurring in psychedelic-assisted therapies.

OBJECTIVE: Despite considerable research examining the efficacy of psychedelic-assisted therapies (PATs) for treating psychiatric disorders, assessment of adverse events (AEs) in PAT research has lagged. Current AE reporting standards in PAT trials are poorly calibrated to features of PAT that distinguish it from other treatments, leaving many potential AEs unassessed. METHODS: A multidisciplinary working group of experts involved in PAT pooled formally and informally documented AEs observed through research experience and published literature. This information was integrated with (a) current standards and practices for AE reporting in pharmacotherapy and psychotherapy trials and (b) published findings documenting post-acute dosing impacts of psychedelics on subjective states, meaning, and psychosocial health variables, to produce a set of AE constructs important to evaluate in PAT as well as recommended methods and time frames for their assessment and monitoring. Correspondence between identified potential AEs and current standards for AE assessment was examined, including the extent of coverage of identified AE constructs by 25 existing measures used in relevant research. RESULTS: Fifty-four potential AE terms warranting systematized assessment in PAT were identified, defined, and categorized. Existing measures demonstrated substantial gaps in their coverage of identified AE constructs. Recommendations were developed for how to assess PAT AEs (including patient, clinician, and informant reports), and when to assess over preparation, dosing session, integration, and follow-up. Application of this framework is demonstrated in a preliminary assessment protocol (available in the supplement). CONCLUSIONS: This assessment framework addresses the need to capture post-acute dosing AEs in PAT, accounting for its pharmacotherapy and psychotherapy components, as well as documented impacts of psychedelics on worldviews and spirituality.

Beyond Men, Women, or Both: A Comprehensive, LGBTQ-Inclusive, Implicit-Bias-Aware, Standardized-Patient-Based Sexual History Taking Curriculum.

Introduction: This standardized-patient-based module prepares medical students to take inclusive, comprehensive sexual histories from patients of all sexual orientations and gender identities. Health disparities faced by lesbian, gay, bisexual, transgender, and queer (LGBTQ) people are at least partially the result of inadequate access to health care and insufficient provider training. This module incorporates implicit bias activities to emphasize the important role providers can play in mitigating these disparities through compassionate, competent care. Furthermore, two of the three included cases highlight the negative impact sexual dysfunction can have on emotional well-being. Methods: Over 3 hours, students participate in a 30-minute large-group lecture and three 40-minute small-group standardized patient encounters with debrief. Prework consists of a short video on sexual history taking, assigned readings, and an implicit bias activity. These materials are included in this resource, along with lecture slides, facilitator guide, and standardized patient cases. Though the cases are adaptable to all levels of medical education, this module is designed for second-year and early third-year medical students. Results: Qualitative student evaluations were positive, and postparticipation surveys revealed statistically significant improvement in comfort with their ability to take a sexual history in general, and take one from patients with a differing sexual orientation. Deployed in the second year of our Doctoring curriculum, this module continues to receive positive evaluations. Discussion: Introducing these skills begins to address the curricular deficiencies seen across medical education and lays the foundation for a more competent health care workforce to address the needs of LGBTQ patients.