Reporting and transparent research practices in sports medicine and orthopaedic clinical trials: a meta-research study

Abstract

Objectives: Transparent reporting of clinical trials is essential to assess the risk of bias and translate research findings into clinical practice. While existing studies have shown that deficiencies are common, detailed empirical and field-specific data are scarce. Therefore, this study aimed to examine current clinical trial reporting and transparent research practices in sports medicine and orthopaedics.

Setting: Exploratory meta-research study on reporting quality and transparent research practices in orthopaedics and sports medicine clinical trials.

Participants: The sample included clinical trials published in the top 25% of sports medicine and orthopaedics journals over 9 months.

Primary and secondary outcome measures: Two independent reviewers assessed pre-registration, open data and criteria related to scientific rigour, like randomisation, blinding, and sample size calculations, as well as the study sample, and data analysis.

Results: The sample included 163 clinical trials from 27 journals. While the majority of trials mentioned rigour criteria, essential details were often missing. Sixty per cent (95% confidence interval (CI) 53% to 68%) of trials reported sample size calculations, but only 32% (95% CI 25% to 39%) justified the expected effect size. Few trials indicated the blinding status of all main stakeholders (4%; 95% CI 1% to 7%). Only 18% (95% CI 12% to 24%) included information on randomisation type, method and concealed allocation. Most trials reported participants' sex/gender (95%; 95% CI 92% to 98%) and information on inclusion and exclusion criteria (78%; 95% CI 72% to 84%). Only 20% (95% CI 14% to 26%) of trials were pre-registered. No trials deposited data in open repositories.

Conclusions: These results will aid the sports medicine and orthopaedics community in developing tailored interventions to improve reporting. While authors typically mention blinding, randomisation and other factors, essential details are often missing. Greater acceptance of open science practices, like pre-registration and open data, is needed. As these practices have been widely encouraged, we discuss systemic interventions that may improve clinical trial reporting.