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.

Keywords: clinical trials; medical education & training; orthopaedic & trauma surgery; rehabilitation medicine; sports medicine; statistics & research methods.

Figure 1

Reporting prevalence for rigour and sample criteria. This plot displays the percentage of trials that addressed each criteria. For information on the actual randomisation or blinding status, please refer to the text. The different coloured data points are for better visual differentiation of each subcategory. Created by the authors.

Figure 2

The blinding status across the main different stakeholder groups across all clinical trials (n=163). Created by the authors.

Figure 3

Reporting prevalence for data analysis and transparency criteria. This plot displays the percentage of trials that addressed each criteria. Created by the authors. ES, effect size; NHST, null hypothesis statistical testing.

Figure 4

A priori sample size calculations are essential for generating meaningful results with clinical trials. Created by the authors. This infographic focuses on key elements a priori sample size calculations that should be reported in clinical trial publication. However, it is important to note that each element should be justified individually including the thresholds for type 1 and type 2 errors, and the expected effect size. Lakens free article on sample size justification provides an excellent overview of aspects to consider when planning empirical research studies.