Development of a topic‐specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010
Open accessAbstract
Introduction: An important mechanism of research waste is inadequate incorporation of, and references to, previous relevant research. Identifying references for a research manuscript can be challenging, in part due to the exponential rise in potentially relevant literature to consider. For large research projects, such as developing or updating reporting guidelines, it may be helpful to construct a supportive topic-specific bibliographic database. Methods: In support of updating the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 and the CONsolidated Standards Of Reporting Trials (CONSORT) 2010, we developed the SPIRIT-CONSORT Evidence Bibliographic database (SCEBdb): a freely available topic-specific bibliographic database of publications providing an evidence foundation for the updates. We searched multiple sources of potential publications and tagged included ones with database-specific keywords. For context, we also formulated 10 core considerations for constructing topic-specific bibliographic databases and identified and described 5 illustrative other databases. Results: As of April 2024, the SCEBdb included 846 publications. The database proved useful as a supplementary information source for our scoping review of published comments on SPIRIT 2013 and CONSORT 2010, for a supplementary Delphi process, and in the writing phase of the guidance documents. We expect that the database will be useful for future projects within the fields of clinical research methodology, bias, evidence synthesis, and randomized trials. Conclusion: The methods involved in constructing the SCEBdb, and our suggested core considerations for topic-specific bibliographic databases, could be helpful for researchers reflecting on whether, and how, to develop a topic-specific bibliographic database.
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A project-specific database (SCEBdb) was developed for empirical and theoretical evidence related to CONSORT and risk of bias in randomised trials.
“We also developed a project specific database (SCEBdb) for empirical and theoretical evidence related to CONSORT and risk of bias in randomised trials [23].”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [23]
For each checklist item, references to core empirical studies supporting its inclusion were provided, identified through a continuously updated project database.
“For each checklist item, we provided references to core empirical studies supporting its inclusion, which we identified through a continuously updated project database.20”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [20]
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“We also developed a project specific database (SCEBdb) for empirical and theoretical evidence related to CON-SORT and risk of bias in randomised trials [23].”
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- Authors
- Østengaard, L., Barrientos, A., Boutron, I., Chan, A., Collins, G., Hopewell, S., Moher, D., Nejstgaard, C. H., Schulz, K. F., Speich, B., Tang, E., Tunn, R., Watanabe, N., Xu, C., & Hróbjartsson, A.
- Affiliations
- University of Southern Denmark (DK)
- University of Toronto (CA)
- Inserm (FR)
- Centre for Statistics in Medicine University of Oxford Oxford UK
- University of Oxford (GB)
- University of Ottawa (CA)
- University of North Carolina at Chapel Hill (US)
- University of Basel (CH)
- Cardiovascular European Research Center (FR)
- Corresponding author
- Østengaard, Lasse
- ORCID
- Venue
- Cochrane Evidence Synthesis and Methods
- Publisher
- Wiley
- Published
- 2024-05
- Volume
- 2
- Issue
- 5
- Pages
- e12057-e12057
- ISSN
- 2832-9023 (ISSN-L)
- PMC
- PMC11795946
- OpenAlex
- W4396939505
- Cited by
- 15
- References
- 18
- Citations by year
- 2025: 15
- FWCI
- 4.17
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Cochrane Evidence Synthesis and Methods (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- University of Birmingham Research Portal (University of Birmingham) (submittedVersion, other-oa)
- University of Southern Denmark Research Portal (University of Southern Denmark) (submittedVersion, cc-by)
- Funders
- Moderna
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- CONSORT 2010, reporting guidelines, clinical trial reporting, research waste, literature search strategies, evidence synthesis, Delphi method, scoping review
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