Improving Randomized-Controlled Trials in Foot and Ankle Orthopaedics: The Need to Include Sociodemographic Patient Data.

Abstract

The representation of sociodemographic data within randomized-controlled trials (RCT) regarding foot and ankle surgery is undefined. The purpose of this study was to determine the incidence of sociodemographic data being reported in contemporary foot and ankle RCTs. Randomized-controlled trials within the PubMed database from 2016 to 2021 were searched and the full text of 40 articles was reviewed to identify sociodemographic variables reported in the manuscript. Data regarding race, ethnicity, insurance status, income, work status, and education were collected. Race was reported in the results in 4 studies (10.0%), ethnicity in 1 (2.5%), insurance status in 0 (0%), income in 1 (2.5%), work status in 3 (7.5%) and education in 2 (5.0%). In any section other than the results, race was reported in 6 studies (15.0%), ethnicity in 1 (2.5%), insurance status in 3 (7.5%), income in 6 (15.0%), work status in 6 (15.0%), and education in 3 (7.5%). There was no difference in sociodemographic data by journal (P = .212), year of publication (P = .216), or outcome study (P = .604). The overall rate of sociodemographic data reported in foot and ankle RCTs is low. There was no difference in the reporting of sociodemographic data between journal, year of publication, or outcome study. Level II.