RESUMEN
Background: We previously examined National Institutes of Health (NIH)-funded randomized controlled trials (RCTs) published in 2004, 2009, and 2015 and found low compliance with NIH policies on inclusion, analysis, and reporting results for female and minoritized subgroups, with no improvement over time. We conducted a fourth wave of data collection using RCTs published in 2021, comparing current results with previous years. Materials and Methods: The authors used PubMed to find 657 RCTs published in print in 14 leading US medical journals in 2021. Of those, 93 (14.2%) were eligible for analysis. We reviewed all parts of eligible studies and any published commentary. Fisher's exact statistics compared proportions of studies analyzing or reporting results for subgroups in 2021 compared with RCTs studied in previous waves. Posthoc analysis compared eligible RCTs about the Covid-19 pandemic to eligible RCTs on other topics. Results: Twenty-five of 93 studies (26.9%) analyzed or reported outcomes by race or ethnicity, an increase over previous years (p < 0.01). Among 79 RCTs with participants of both sexes, the median proportion of female participants was 43%. Moreover, 34 (43.0%) reported an outcome by sex, included sex as a covariate in statistical analysis, or reported results by sex, also an increase over previous waves (p < 0.01). Eleven eligible studies (11.8%) were on a SARS-CoV-2 topic; there was no difference between SARS-CoV-2 RCTs and RCTs on other topics. Conclusions: Analysis and reporting by sex, race, and ethnicity for NIH-funded RCTs published in 2021 significantly increased from previous waves, despite no corresponding increase in enrollment.
Asunto(s)
COVID-19 , Etnicidad , Masculino , Femenino , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de Investigación , SARS-CoV-2RESUMEN
BACKGROUND: It remained unknown about the status of and trends in racial/ethnic subgroup reporting in the diabetes trials over the past two decades. OBJECTIVES: In this survey, we aimed to evaluate the current state of and temporal trends in subgroup reporting by race/ethnicity regarding the effects of interventions in diabetes randomized controlled trials (RCTs) from year 2000-2020 and to explore the potential trial factors in relation to racial/ethnic subgroup reporting. METHODS: We searched electronic databases for eligible diabetes RCTs. The outcome was whether the trials had the event of racial/ethnic subgroup reporting regarding the intervention effects on trial primary outcomes. Poisson regression was used to assess the temporal trends in racial/ethnic subgroup reporting, and univariable logistic regression models were employed for evaluating trial factors related to racial/ethnic subgroup reporting. RESULTS: A total of 405 diabetes RCTs were eligible for inclusion. There were 26 (6.42%) trials with racial/ethnic subgroup reporting. A chronological trend towards increased rates of racial/ethnic subgroup reporting was observed; however, the trend was not statistically significant (p = 0.07). Advanced patients' age (Odds ratio [OR] = 2.92, 95% confidence interval [CI]: 1.24-6.88), follow-up duration (OR = 3.53, 95% CI: 1.13-11.00), and BIPOC (Black, Indigenous, and People of Colour) enrolment (OR = 2.39, 95% CI: 1.01-5.62) were found to positively relate with racial/ethnic subgroup reporting, while the industrial funding was associated with decreased reporting (OR = 0.43, 95% CI: 0.19-0.97). Less than one fourth of the trials with racial/ethnic subgroup reporting predefined the subgroup analysis. CONCLUSIONS: The majority of diabetes RCTs did not report intervention effects by racial/ethnic subgroup, which was not temporally improved over the past two decades. More efforts and strategies are needed to improve the racial/ethnic subgroup consideration and reporting in diabetes trials.