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

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusions

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 Rehabilitation

• This 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.

Keywords:

• Physical and rehabilitation medicine
• disparities
• women in trials
• ethnic groups
• aging

Authors’ contributions

All authors contributed to the conception and design of the study, the conduct of the study, data analysis and interpretation, and writing of the manuscript. All authors read and approved the final version of the manuscript.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

Unrelated to this study, JKS discloses that she participates in research funded by the Binational Scientific Foundation and is a Venture Partner at Third Culture Capital. WRF’s research is partially funded by Grant S21 MD001830-04, NIMHD, NIH. The content of this report is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.