Has the reporting quality of published randomised controlled trial protocols improved since the SPIRIT statement? A methodological study
Open accessAbstract
Objectives: To determine the reporting quality of published randomised controlled trial (RCT) protocols before and after the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement (2013), and any association with author, trial or journal factors. Design: Methodological study. Data sources: MEDLINE, Embase and CENTRAL were electronically searched using optimised search strategies. Eligibility criteria: Protocols written for an RCT of living humans, published in full text in a peer-reviewed journal and published in the English language. Main outcome: Primary outcome was the overall proportion of checklist items which were adequately reported in RCT protocols published before and after the SPIRIT statement. Results: 300 RCT protocols were retrieved; 150 from the period immediately before the SPIRIT statement (9 July 2012 to 28 December 2012) and 150 from a recent period after the SPIRIT statement (25 January 2019 to 20 March 2019). 47.9% (95% CI, 46.5% to 49.3%) of checklist items were adequately reported in RCT protocols before the SPIRIT statement and 56.7% (95% CI, 54.9% to 58.5%) after the SPIRIT statement. This represents an 8.8% (95% CI, 6.6% to 11.1%; p<0.0001) mean improvement in the overall proportion of checklist items adequately reported since the SPIRIT statement. While 40% of individual checklist items had a significant improvement in adequate reporting after the SPIRIT statement, 11.3% had a significant deterioration and there were no RCT protocols in which all individual checklist items were complete. The factors associated with higher reporting quality of RCT protocols in multiple regression analysis were author expertise or experience in epidemiology or statistics, multicentre trials, longer protocol word length and publicly reported journal policy of compliance with the SPIRIT statement. Conclusion: The overall reporting quality of RCT protocols has significantly improved since the SPIRIT statement, although a substantial proportion of individual checklist items remain poorly reported. Continued and concerted efforts are required by journals, editors, reviewers and investigators to improve the completeness and transparency of RCT protocols.
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The reporting of protocols for randomised trials has improved somewhat since 2013 but remains far from adequate.
“Although the reporting of protocols for randomised trials has improved somewhat since 2013 it remains far from adequate.9 10 11 12”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [11]
Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.
“Trial monitoring was addressed in 13% to 76% of protocols approved in 2016 or published in 2019-20.9 10 11 467”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [11]
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- Authors
- Tan, Z. W., Tan, A. C., Li, T., Harris, I., Naylor, J. M., Siebelt, M., van Tiel, J., Pinheiro, M., Harris, L., Chamberlain, K., & Adie, S.
- Affiliations
- UNSW Sydney (AU)
- Erasmus MC (NL)
- Orthopaedics, Erasmus Medical Center, Rotterdam, Zuid-Holland, The Netherlands
- The University of Sydney (AU)
- Sydney Orthopaedic Trauma and Reconstructive Surgery, Sydney, New South Wales, Australia
- Corresponding author
- Adie, Sam
- ORCID
- Venue
- BMJ Open
- Publisher
- BMJ
- Published
- 2020-08
- Volume
- 10
- Issue
- 8
- Pages
- e038283
- ISSN
- 2044-6055 (ISSN-L)
- PMC
- PMC7451949
- OpenAlex
- W3080884027
- Cited by
- 37
- References
- 21
- Citations by year
- 2026: 7 · 2025: 14 · 2024: 7 · 2023: 4 · 2022: 5
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMJ Open (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- HighWire Press Open Archive (acceptedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (acceptedVersion, cc-by-nc)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion, other-oa)
- RePub (Erasmus University Rotterdam) (submittedVersion, other-oa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UNSWorks (UNSW Sydney) (submittedVersion, cc-by-nc)
- 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
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- reporting quality, reporting guidelines, checklist adherence, protocol transparency, author expertise
- MeSH terms
- Humans, Publications, Research Personnel, Randomized Controlled Trials as Topic, Checklist
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