Reporting of sociodemographic characteristics of trial participants in infectious diseases clinical trials—a systematic review
Authors:
- Ong, Sean W.X.
- Blagojevic, Christina
- Bryce, Aliya
- Ovadia, Aaron
- Slater, Matthew
- Pryal, Daire
- Careaga, Rodrigo Escobar
- Moffroid, Hadrien
- Yerramilli, Arvind
- Charani, Esmita
- Daneman, Nick
- Tong, Steven Y.C.
Details:
Clinical Microbiology and Infection, Volume 31, Issue 8, 2025-08-31
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Background Reporting of demographic characteristics in randomized clinical trials (RCTs) is recommended to facilitate assessment of generalizability to other populations. However, there is a lack of consensus as to what variables should be reported, and there are limited data describing current research practice. Objectives We aimed to evaluate reporting of sociodemographic characteristics of participants in infectious diseases RCTs and identify gaps in current practice. Methods We conducted a systematic review of all infectious diseases-related RCTs published between January 2014 and August 2023 in ten selected high-impact journals by searching the Ovid MEDLINE database. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarized descriptive results for the reporting of each characteristic overall, by trial type (health equity-related vs. non-health equity-related), subject area, and year of publication. We fitted multivariable logistic regression models to identify trial characteristics associated with the reporting of each characteristic. Risk of bias of trials was not assessed as our objective was to assess trial reporting and not results. Results We screened 4234 articles and included 1343. Almost all trials (1201/1233, 97.4%) reported sex and/or gender. In contrast, less than half (654/1326, 49.3%) reported ethnicity, and only a minority reported education level (113/1252, 9.0%), SES (120/1340, 9.0%), and rurality (45/1269, 3.9%). There was no improvement in reporting of each characteristic over the 10-year period. Subject area, funding source, whether a trial was health equity-related, use of a medical writer, and trial setting (high vs. low/middle-income country) were significantly associated with the reporting of ethnicity, education level, and SES. Conclusions Reporting of sociodemographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.