The devil is in the details: Reporting and transparent research practices in sports medicine and orthopedic clinical trials

Schulz, R.; Langen, G.; Prill, R.; Cassel, M.; Weissgerber, T.

Introduction: While transparent reporting of clinical trials is essential to assess the risk of bias and translate research findings into clinical practice, earlier studies have shown that deficiencies are common. This study examined current clinical trial reporting and transparent research practices in sports medicine and orthopedics. Methods: The sample included clinical trials published in the top 25% of sports medicine and orthopedics journals over eight months. Two independent reviewers assessed pre-registration, open data and criteria related to scientific rigor, the study sample, and data analysis. Results: The sample included 163 clinical trials from 27 journals. While the majority of trials mentioned rigor criteria, essential details were often missing. Sixty percent (confidence interval [CI] 53-68%) of trials reported sample size calculations, but only 32% (CI 25-39%) justified the expected effect size. Few trials indicated the blinding status of all main stakeholders (4%; CI 1-7%). Only 18% (CI 12-24%) included information on randomization type, method, and concealed allocation. Most trials reported participants' sex/gender (95%; CI 92-98%) and information on inclusion and exclusion criteria (78%; CI 72-84%). Only 20% (CI 14-26%) of trials were pre-registered. No trials deposited data in open repositories. Conclusions: These results will aid the sports medicine and orthopedics community in developing tailored interventions to improve reporting. While authors typically mention blinding, randomization and other factors, essential details are often missing. Greater acceptance of open science practices, like pre-registration and open data, is needed. These practices have been widely encouraged, we discuss systemic interventions that may improve clinical trial reporting. Registration: https://doi.org/10.17605/OSF.IO/9648H