Only Nine Percent of Orthopaedic Clinical Trials Report and One Percent Analyze a Social Determinant of Health: A Systematic Review.

Abstract

Social determinants of health (SDOHs) can impact patients' injury risks, access to surgery, access to rehabilitation, and response to treatment; however, clinicians are yet to be consistently incorporating SDOHs into clinical practice and orthopaedic research. While several smaller studies have assessed the proportion of studies reporting and analyzing SDOHs in a select few orthopaedic journals or subspecialties, the proportion of orthopaedic clinical trials reporting and analyzing SDOHs across the top orthopaedic journals and various subspecialties is currently unclear. In this systematic review, we (1) determined the proportion of studies in 10 leading orthopaedic surgery journals that reported and analyzed SDOHs in clinical trials and (2) compared those proportions by journal, publication year, and orthopaedic subspecialty. The 10 orthopaedic journals with the highest 2-year Impact Factors for 2021 were screened for RCTs published from January 2018 to February 2023. Review articles and nonrandomized original research studies were excluded. Overall, 1616 publications were screened, of which 51% (826) met inclusion criteria. Two investigators collected whether various control demographics (age, gender, BMI, race, ethnicity) and SDOHs as defined by the WHO were reported and/or analyzed. Subanalyses compared percentages of reporting and analyzing SDOHs based on journal, publication year, and subspecialty. Nine percent (78 of 826) of studies reported any SDOH. Education (50 of 826) and unemployment/job insecurity (33 of 826) were reported in 6% and 4% of orthopaedic clinical trials, respectively, with early childhood development (0 of 826), food insecurity (1 of 826), social inclusion (1 of 826), and access to healthcare (3 of 826) being reported in only 0.0% to 0.4% of trials. The proportion of studies reporting at least one SDOH by journal ranged 3% to 33% and by subspecialty ranged 5% to 26%. Only 1% of RCTs (6 of 826) performed an analysis of any SDOH. Income/social protection, education, unemployment/job insecurity, working conditions, housing/environment, and insurance were not analyzed in any included studies. With SDOHs underreported in orthopaedic clinical trials despite their emerging clinical relevance, researchers should incorporate SDOH questionnaires into patient registration or prospective studies to enhance the collection of SDOH data. While SDOHs may not have an important clinical impact on all orthopaedic procedures or interventions, the authors would encourage investigators to consider the inclusion and evaluation of SDOHs as the default when designing orthopaedic clinical trials. Inclusion of SDOHs can help better control for potential confounders and allow for analysis of outcomes across any SDOH deemed clinically relevant. Level I, therapeutic study.