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

Abstract

ObjectivesTransparent 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.SettingExploratory meta-research study on reporting quality and transparent research practices in orthopaedics and sports medicine clinical trials.ParticipantsThe sample included clinical trials published in the top 25% of sports medicine and orthopaedics journals over 9 months.Primary and secondary outcome measuresTwo 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.ResultsThe 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.ConclusionsThese 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.

Why there is a need to improve evaluation standards for clinical studies in orthopaedic and sports medicine

“…Despite the general eagerness of authors to improve the quality of their studies, a recent paper highlighted the diversity in reporting clinical trials and the transparency in orthopaedics and sports medicine research practices [8]. The definition of the primary outcome and a clear presentation of the hypothesis for a study are essential at the end of its introduction, and the clinical importance of its findings should be emphasized.…”

Evidence‐based research in orthopaedics, sports medicine and rehabilitation—Why new studies should rely on earlier work

“…This supports the idea for the need for transparent justification of new studies and the need for strong research methods in orthopaedics, sports medicine and rehabilitation [2, 4]. Applying checklists and reporting guidelines during the production and publication process and ensuring the implementation of research findings are relevant steps to improve research practice, which in turn makes the research outcome more valuable for daily practice [5, 6].…”

A Pilot Study on the Reliability of Ultrasound-Based Assessment of Patella Diameter and Sulcus Angle

“…An important limitation for further generalization is the sample size of this study due to the nature of its pilot character. For reaching high method standards, as nowadays recommended for orthopedic trials [ 18 , 19 ], funding is usually needed and the value of the study must be proven in advance. Whenever possible, new studies should be justified through high standard Systematic Reviews showing the need for further studies on the topic [ 20 , 21 , 22 ].…”