Rehabilitation clinical trials in global registries: reporting of participant inclusion by sex, age, race and ethnicity.

Abstract

Registries of clinical trials exist in part to standardize data for the scientific community. Studies in the United States demonstrated gaps in reporting on ClinicalTrials.gov. The purpose of this cross-sectional study was to evaluate clinical trial participation among global registries. This study identified registries with results reported and assessed available results for physical and rehabilitation medicine (PRM) diagnosis, intervention, primary outcome, and the International Classification of Functioning, Disability and Health (ICF) categories. Participant characteristics including sex, age, and race/ethnicity were assessed. A total of 93 rehabilitation trials from eight registries met inclusion criteria. Most trials included persons with musculoskeletal disorders (50.5%), technology such as robotics (25.8%) and outcomes in ICF category of body functions and structures (54.7%). Sex was reported in 61.3% of trials and varied among registries (0 to 100%). Participation of women in trials showed variability from 0 to 75%. Reporting of age of the participants was not uniform and six registries did not include age in all trials. Information about race/ethnicity was absent in most trials and registries. Based on trials registered with accessible results, these findings may reveal either a gap in reporting results or a lack of trials investigating important PRM diagnoses, interventions, and outcomes.Implications for RehabilitationThis study contributes to the growing body of evidence that there are gaps in standardization of rehabilitation results reported on clinical trials registries.The uniform reporting of results is an important component of advancing rehabilitation science and may be a factor in high-quality study design and improved transparency.