A systematic review of sociodemographic characteristic reporting in orthopaedic trauma clinical trials.

Abstract

Sociodemographic factors play a critical role in shaping outcomes in orthopaedic trauma, yet they remain inconsistently reported across the literature. This review evaluated the extent and types of sociodemographic variables reported in orthopaedic trauma randomized controlled trials (RCTs) to identify recent trends and study design characteristics associated with the inclusion of sociodemographic criteria. A systematic review of English-language articles in the PubMed, MEDLINE, and Scopus literature databases from January 2015 to December 2024 was performed. RCTs involving human participants with a primary focus on orthopaedic trauma published in five leading orthopaedic journals were included. The inclusion of thirteen selected sociodemographic variables and other study-related characteristics was evaluated. Descriptive statistics were used to summarize reporting frequency for each sociodemographic variable as well as to describe temporal trends across the study inclusion period. Multivariable logistic regression models were constructed to identify study-level predictors of sociodemographic reporting. 243 articles met the inclusion criteria. While age (241 of 243; 99.2 %) and sex (234 of 243; 96.3 %) were nearly universally reported, variables such as race/ethnicity (20 of 243; 8.2 %), education level (12 of 243; 4.9 %), employment status (20 of 243; 8.2 %), and residency status (12 of 243; 4.9 %) were infrequently reported. There were no significant changes in the number of studies including sociodemographic variables over 10 years, except for body mass index (<i>p</i> = 0.031). Studies outside of the United States were less likely to report sociodemographic variables as compared to those within the United States. Funding was a significant indicator of the likelihood that a study reported employment status (<i>p</i> = 0.0095). Registered trials were more likely to report alcohol history (<i>p</i> = 0.018) and race/ethnicity (<i>p</i> = 0.0098). Multi-center trials were more likely to report body mass index (<i>p</i> = 0.0037), smoking disclosure (<i>p</i> = 0.004), and race/ethnicity (<i>p</i> = 0.0089). The overall reporting frequency of sociodemographic variables remains low. Several study design characteristics, including trial registration, number of settings, and funding source, significantly influence the odds of a study disclosing participants' demographics.