Curricular Reform in Serious Illness Communication and Palliative Care: Using Medical Students' Voices to Guide Change.

PURPOSE: To gather and leverage the voices of students to drive creation of required, integrated palliative care curricula within undergraduate medical education in Massachusetts, which is lacking in a majority of U.S. medical schools. METHOD: The study was conducted by the Massachusetts Medical Schools' Collaborative, a working group committed to ensuring all medical students in Massachusetts receive foundational training in serious illness communication (SIC) and palliative care. Eight focus groups (2 per participating medical school) were conducted during January-May 2021 and included a total of 50 students from Boston University Chobanian & Avedisian School of Medicine, Harvard Medical School, Tufts University School of Medicine, and the UMass Chan Medical School. Data collected from focus groups were discussed and coded. Themes were identified using the immersion/crystallization qualitative data analysis approach. RESULTS: Six key themes emerged. Students viewed SIC as essential to high-quality medical practice regardless of specialty, and believed training in SIC skills and palliative care should be required in medical school curricula. Students preferred to learn and practice these skills using frameworks, particularly in real-world situations. Students recognized the expertise of palliative care specialists and described them as a scarce, often misunderstood resource in health care. Students reported it was mostly "luck" if they were included in family meetings and observed good role models. Finally, students desired practice in debriefing after difficult and emotional situations. CONCLUSIONS: This study confirms long-standing themes on students' experiences with SIC and palliative care topics, including feeling inadequately prepared to care for seriously ill patients as future physicians. Our study collected students' perspectives as actionable data to develop recommendations for curricular change. Collaborative faculty also created recommendations based on the focus group data for immediate and ongoing SIC and palliative care curricular change in Massachusetts, which can apply to medical schools nationwide.

Rigor, reproducibility, and transparency of randomized controlled trials in obstetrics and gynecology.

BACKGROUND: Randomized controlled trials are considered the highest level of evidence but fewer than half are reproducible. A rigorous methodology improves trial quality, but reproducibility may be limited by a lack of transparency in reporting. The Consolidated Standards of Reporting Trials guidelines define reporting standards, and pretrial registration requires a predefined methodology and predefined outcomes. OBJECTIVE: We evaluated obstetrics and gynecology trials published in 6 journals in terms of their adherence to the Consolidated Standards of Reporting Trials guidelines. Second, we evaluated pretrial registration compliance and concordance between the registry and publication. Furthermore, we evaluated the differences in trial characteristics among randomized controlled trials with the highest level of compliance and those with lower levels of compliance and adherence to guidelines by journal type. STUDY DESIGN: This was a cross-sectional study of obstetrics and gynecology trials published between 2017 and 2019 in 6 journals (American Journal of Obstetrics & Gynecology, BJOG: An International Journal of Obstetrics and Gynaecology, Obstetrics & Gynecology, The Journal of the American Medical Association, The Lancet, and The New England Journal of Medicine). Randomized controlled trials were identified via PubMed and manual journal archive searches. The primary outcome was adequate compliance with the Consolidated Standards of Reporting Trials guidelines defined as ≥80% of the checklist items present. Secondary outcomes included completion of pretrial registration and concordance between the pretrial registration and publication in terms of the outcomes and sample size. We compared the characteristics between trials with adequate compliance and those with inadequate compliance. Secondary analyses included comparisons of characteristics of the trials in the top quartile for compliance with the Consolidated Standards of Reporting Trials guidelines with those of the trials in lower quartiles and compliance with guidelines in obstetrics-gynecology vs non-obstetrics-gynecology journals. In an exploratory analysis, trends in compliance with the Consolidated Standards of Reporting Trials guidelines across the study period were assessed. A post hoc sensitivity analysis evaluated the outcomes after the exclusion of 2 retracted trials. RESULTS: Of the 170 trials included, 80% (95% confidence interval, 74%-86%) were adequately compliant with the Consolidated Standards of Reporting Trials manuscript guidelines and 66% (95% confidence interval, 59%-73%) were compliant with the abstract guidelines. Nearly all trials (98%) reported pretrial registration. Concordance between pretrial registration and publication in terms of the primary outcomes was identified for 77% of the trials, concordance in terms of the secondary outcomes was observed in 32% of the trials, and concordance in terms of sample size was observed in 60% of the trials. Trials with adequate compliance were more likely to be preregistered, include an a priori power calculation, and use an intent to treat analysis. Trials in the top quartile for compliance with the Consolidated Standards of Reporting Trials guidelines were more likely to be multicenter, international, and government funded. More trials from non-obstetrics-gynecology journals were in the top quartile for compliance with the Consolidated Standards of Reporting Trials guidelines than trials from obstetrics-gynecology journals (64.9% vs 25.7%; P<.001). No significant trends in adequate compliance were identified across the study period. Results did not differ significantly in the sensitivity analysis. CONCLUSION: Of all the trials included, 20% of obstetrics-gynecology trials published in 6 high-impact journals were not compliant with the Consolidated Standards of Reporting Trials guidelines, and there were major discrepancies between pretrial registration and publication. Transparency, reproducibility, and scientific rigor in obstetrics and gynecology trial reporting needs to be improved.