Reporting of socio-demographic characteristics of trial participants in infectious diseases clinical trials: a systematic review

BackgroundReporting of demographic characteristics in randomised clinical trials (RCT) is recommended to facilitate assessment of generalisability 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. MethodsWe conducted a systematic review of all infectious diseases-related RCTs published between January 2014 to August 2023 in ten selected high impact journals. Outcomes of interest were the reporting of five patient-level sociodemographic characteristics, as recommended by the CONSORT-Equity 2017 extension to the CONSORT reporting guidelines: (a) ethnicity, (b) sex and/or gender, (c) education level, (d) socioeconomic status (SES), and (e) rurality. We summarised 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. Results4234 articles were screened and 1343 were included. Almost all trials (97.4%) reported sex and/or gender. In contrast, less than half (49.3%) reported ethnicity, and only a minority reported education level (9.0%), SES (9.0%), and rurality (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. ConclusionReporting of socio-demographic characteristics in infectious diseases RCTs is inconsistent and has not improved over time.