228. Surprisingly few randomized controlled trials in spine surgery include sociodemographic patient data

Abstract

<h3>BACKGROUND CONTEXT</h3> Due to the prospective designs, randomized controlled trials (RCTs) select the particular demographic data to be included within the study, whereas retrospective designs are often limited by data availability. The importance of sociodemographic factors such as race, education, and income on spine surgery outcomes has been well established, yet the representation of sociodemographic data within RCTs in the spine literature remains undefined. <h3>PURPOSE</h3> To determine the incidence of sociodemographic patient data being reported within contemporary RCTs in the spine literature. <h3>STUDY DESIGN/SETTING</h3> Retrospective bibliometric study. <h3>OUTCOME MEASURES</h3> The primary outcome is inclusion of sociodemographic data within the results or tables of RCTs and the secondary outcome is sociodemographic factors included in any section of the published study. <h3>METHODS</h3> The literature was reviewed within PubMed for RCTs with "spine" in the title or abstract published with the last five years (2017-2021) in nine major journals: <i>Spine (Phila Pa 1976), The Spine Journal, Journal of Neurosurgery, Journal of Neurosurgery Spine, Neurosurgery, The Journal of Bone and Joint Surgery</i> (American and British volumes), <i>New England Journal of Medicine and Journal of the American Medical Association</i>. This yielded 74 results, and after application of inclusion criteria (RCTs concerning adult spine pathologies), 68 RCTs remained for analysis. Each article's journal of publication, year of publication and surgery type was recorded. The full text of each article was reviewed for inclusion of sociodemographic variables either within the results, tables or any other part of the article. Sociodemographic variables collected were race, ethnicity, insurance status, income, work status and education. The Fisher exact test was used to compare inclusion of sociodemographic data by journal, year and surgery type. <h3>RESULTS</h3> Sociodemographic data were included in the results of 25.0% (17/68) of RCTs, and overall inclusion of sociodemographic data in any section was 27.9% (19/68). RCTs reported work status in 17.6% (12/68) of results and 20.6% (14/68) of RCTs included work status in any section. Race was included in 14.7% (10/68) of results and mentioned in any section of 16.2% (11/68) of RCTs. Education was in the results or any section of 14.7% (10/68) and 17.6% (12/68) of RCTs, respectively. Variables for ethnicity, insurance status and income were less commonly found in results or any other section. There was no association with inclusion of sociodemographic data within the results of RCTs as a factor of journal (p=0.546), year of publication (p=0.389), or surgery type (p=0.426). <h3>CONCLUSIONS</h3> Despite evidence of the importance of sociodemographic factors on the natural history and treatment outcomes of myriad spine pathologies, this study identifies a surprising absence of sociodemographic data within contemporary RCTs in spine surgery. Failure to include sociodemographic factors in RCTs may lead to delayed recognition of disparities in patient care and valid outcome data. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.