Cited by 23Meta-analysis and systematic reviewsAcademic Publishing and Open AccessPharmaceutical industry and healthcare

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

Open access
Schulz, Robert, Langen, Georg, Prill, Robert, Cassel, Michael, Weissgerber, Tracey L·2022·BMJ Open

Published version of a preprint

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.

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  • The literature contains studies with questionable methodologies, missing or incomplete data, false or exaggerated effect measures, and many studies do not mention funding or potential conflicts of interest.

    “However, the literature contains studies with questionable methodologies, missing or incomplete data, false or exaggerated effect measures, and many studies do not mention funding or potential conflicts of interest [4–8].”

    From Assessing transparency practices in dental randomized controlled trials (2024) · cites this paper as [6]

    The Results report substantial gaps in trial-method reporting and incomplete information about participant exclusions; the Introduction discusses questionable research practices, and the Discussion suggests that some effect sizes may be inflated. The paper does not establish that the trials reported false effect measures, and the passages found do not substantiate the claim that many studies omitted funding or conflict-of-interest disclosures. (LLM, conf=0.87)

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  • Although many authors agree on the importance of transparent practices, they are often neglected.

    “Studies indicate that, although many authors agree on the importance of these transparent practices, they are often neglected [6, 7].”

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Research works printed but not linked: 4

  1. [23]SCImago (SJR — SCImago Journal & Country Rank [Portal] [Internet], 2020. Available: https://www.scimagojr.com/journalrank.php?category=2732 [Accessed 22 Feb 2021].
  2. [57]BMC. Advancing peer review at BMC [Internet], 2021. Available: https://www.biomedcentral.com/about/advancing-peer-review
  3. [62]EU Trials Tracker. EU Trials Tracker — Who’s not sharing clinical trial results? [Internet]: Evidence-Based Medicine Data Lab; University of Oxford, 2021. Available: https://eu.trialstracker.net/
  4. [79]ICMJE. Recommendations | Preparing a Manuscript for Submission to a Medical Journal: Methods - statistics [Internet], 2021. Available: http://www.icmje.org/recommendations/browse/manuscript-preparation/preparing-for-submission.html

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Authors
Schulz, R., Langen, G., Prill, R., Cassel, M., & Weissgerber, T. L.
Affiliations
  • University of Potsdam (DE)
  • Department of Strength, Power and Tactical Sports, Institute for Applied Training Science, Leipzig, Germany
  • Medizinische Hochschule Brandenburg Theodor Fontane (DE)
  • Berlin Institute of Health at Charité - Universitätsmedizin Berlin (DE)
Corresponding author
Weissgerber, Tracey L
Venue
BMJ Open
Publisher
BMJ
Published
2022-08
Volume
12
Issue
8
Pages
e059347
ISSN
2044-6055 (ISSN-L)
OpenAlex
W4290673869
Cited by
23
References
90
Citations by year
2026: 3 · 2025: 7 · 2024: 2 · 2023: 5 · 2022: 6
FWCI
3.02
Type
journal article
Language
en
Open access
Locations
  • BMJ Open (publishedVersion, cc-by-nc)
  • medRxiv (acceptedVersion, cc-by-nd)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Refubium (Universitätsbibliothek der Freien Universität Berlin) (submittedVersion, cc-by-nc)
  • Universitätsbibliothek der FU Berlin Hochschulschriftenstelle u. Dokumentenserver
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
Keywords
trial reporting quality, preregistration, open data, sample size justification, blinding, randomization, open science, research transparency, risk of bias
MeSH terms
Humans, Orthopedics, Sports Medicine

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