Randomized Controlled Trials in the Shoulder Arthroplasty Literature Rarely Include Key Demographic and Socioeconomic Patient Data

Abstract

BackgroundIt is well known that socioeconomic and demographic variables can greatly affect health outcomes. Previous studies across medical and surgical subspecialties have demonstrated that these variables are frequently under-reported in randomized controlled trials (RCTs). No such study currently exists that examines rates of reporting sociodemographic variables in shoulder arthroplasty RCTs. This study aims to present these rates and explore the impacting of failing to report socioeconomic variables in shoulder arthroplasty RCTs. MethodsThe PubMed database was queried for the term “shoulder arthroplasty.” 65 RCTs from the last ten years were identified for inclusion from five high-impact orthopedic surgery journals. Each RCT was analyzed for patient age and sex or gender as well as the following sociodemographic variables: race, ethnicity, insurance status, income, work status, and education. It was also noted whether each above variable was mentioned in the results section of the paper. Data was presented in a descriptive fashion as well as analyzed using Chi-squared and Fisher’s exact test where appropriate. ResultsFrom 2014-2023, 65 shoulder arthroplasty RCTs published reported age in 40/65 (61.5%) of results sections and 61/65 (93.8%) of any section. Sex or gender were reported in 27/65 (41.5%) of results sections and 61/65 (93.8%) of any section. No manuscripts included any sociodemographic variables in the results section. Reporting rates for sociodemographic variables in any section were: race 6/65 (9.2%), ethnicity 5/65 (7.7%), work status 4/65 (6.2%), and insurance status 1/65 (1.5%). No studies included income or education of the enrolled patients. There was no difference in reporting sociodemographic variables by journal (p = 0.45) or by year of publication (p = 0.57). However, no study prior to 2020 included any sociodemographic variable (0/27, 0%) whereas from 2020 onward six studies included at least one (6/38, 15.8%). Sociodemographic variables were reported significantly less frequently than age and sex or gender (p = 0.001). DiscussionOur study found sociodemographic variables are rarely reported in shoulder arthroplasty RCTs, whereas age and sex or gender are reported with great frequency. In order to understand the results of shoulder arthroplasty RCTs, apply their findings to the care of our patients and address health disparities we must ensure these studies include patient sociodemographic data.