Reporting of Participant Demographics in Clinical Trials Published in General Radiology Journals

Abstract

Objectives: The reporting of research participant demographics provides insights into study generalizability. Our study aimed to determine the frequency at which participant age, sex/gender, race/ethnicity, and socioeconomic status (SES) are reported and used for subgroup analyses in radiology randomized controlled trials (RCTs) and their secondary analyses; as well as the study characteristics associated with, and the classification systems used for demographics reporting. Methods: RCTs and their secondary analyses published in 8 leading radiology journals between 2013 and 2021 were included. Associations between study characteristics and demographic reporting were tested with the chi-square goodness of fit test for categorical variables, Wilcoxon-Mann-Whitney test for impact factor, and logistic regression for publication year. Results: Among 432 included articles, 89.4% (386) reported age, 90.3% (390) sex/gender, 5.6% (24) race/ethnicity, and 3.0% (13) SES. Among articles that reported these demographics and were not specific to a subgroup, results were analyzed by age in 14.2% (55/386), sex/gender in 19.4% (66/340), race/ethnicity in 13.6% (3/22), and SES in 46.2% (6/13). Journal, impact factor, and last author continent were predictors of race/ethnicity and SES reporting. Funding was associated with race/ethnicity reporting. No study reported sex and gender separately, or documented transgender, nonbinary gender spectrum or intersex participants. A single category for race/ethnicity was used in 37.5% (9/24) of studies, consisting of either “White” or “Caucasian.” Conclusion: The reporting of participant demographics in radiology trials is variable and not always representative of the population diversity. Editorial guidelines on the reporting and analysis of participant demographics could help standardize practices.