Sarno Danielle L, Silver Emily M, Goldstein Richard, Frontera Walter R, Silver Julie K
Department of Physical Medicine and Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital, Massachusetts General Hospital, Brigham and Women's Hospital, Boston, MA, USA.
Department of Psychology, University of Chicago, Chicago, IL, USA.
Disabil Rehabil. 2024 Jun;46(13):2946-2954. doi: 10.1080/09638288.2023.2231844. Epub 2023 Jul 14.
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.
临床试验注册库部分目的在于为科学界规范数据。美国的研究表明ClinicalTrials.gov上的报告存在差距。这项横断面研究的目的是评估全球注册库中的临床试验参与情况。
本研究确定了报告结果的注册库，并评估了物理和康复医学（PRM）诊断、干预、主要结局以及国际功能、残疾和健康分类（ICF）类别的可用结果。评估了包括性别、年龄和种族/族裔在内的参与者特征。
来自八个注册库的93项康复试验符合纳入标准。大多数试验纳入了肌肉骨骼疾病患者（50.5%）、机器人技术等技术（25.8%）以及ICF身体功能和结构类别的结局（54.7%）。61.3%的试验报告了性别，各注册库之间存在差异（0至100%）。女性参与试验的比例在0至75%之间变化。参与者年龄的报告不统一，六个注册库并非在所有试验中都包含年龄信息。大多数试验和注册库都没有关于种族/族裔的信息。
基于已注册且有可获取结果的试验，这些发现可能揭示了报告结果方面的差距，或者缺乏对重要PRM诊断、干预和结局的试验。
对康复的启示
这项研究进一步证明了临床试验注册库报告的康复结果标准化存在差距。结果的统一报告是推进康复科学的重要组成部分，可能是高质量研究设计和提高透明度的一个因素。
