Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010

Lasse Østengaard^{1

2

3}, Ariel Barrientos⁴, Isabelle Boutron^{5

6}, An-Wen Chan⁷, Gary Collins⁸, Sally Hopewell⁹, David Moher^{10

11}, Camilla Hansen Nejstgaard^{1

2}, Kenneth F Schulz¹², Benjamin Speich^{9

13}, Evan Tang¹⁴, Ruth Tunn⁹, Nozomi Watanabe¹⁵, Chenchen Xu^{10

16}, Asbjørn Hróbjartsson^{1

2}

Affiliations

¹ Department of Clinical Research, Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark University of Southern Denmark Odense Denmark.
² Open Patient data Explorative Network (OPEN) Odense University Hospital Odense Denmark.
³ University Library of Southern Denmark Odense Denmark.
⁴ Temerty School of Medicine University of Toronto Toronto Ontario Canada.
⁵ Centre for Research in Epidemiology and Statistics (CRESS) Université Paris Cité, Université Sorbonne Paris Nord, Inserm, INRAE Paris France.
⁶ Cochrane France Paris France.
⁷ Department of Medicine, Women's College Research Institute University of Toronto Toronto Ontario Canada.
⁸ Centre for Statistics in Medicine University of Oxford Oxford UK.
⁹ Oxford Clinical Trials Research Unit/Centre for Statistics in Medicine University of Oxford Oxford UK.
¹⁰ Clinical Epidemiology Program Centre for Journalology, Ottawa Hospital Research Institute Ottawa Ontario Canada.
¹¹ School of Epidemiology and Public Health, Faculty of Medicine University of Ottawa Ottawa Ontario Canada.
¹² Department of Obstetrics and Gynecology, School of Medicine The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA.
¹³ Department of Clinical Research, CLEAR-Methods Center, Division of Clinical Epidemiology, University Hospital Basel University of Basel Basel Switzerland.
¹⁴ Faculty of Medicine University of Toronto Toronto Ontario Canada.
¹⁵ Cardiovascular European Research Center (CERC) Massy France.
¹⁶ Faculty of Medicine University of Ottawa Ottawa Ontario Canada.

PMID: 40476263
PMCID: PMC11795946
DOI: 10.1002/cesm.12057

Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010

Lasse Østengaard et al. Cochrane Evid Synth Methods. 2024.

. 2024 May 15;2(5):e12057.

doi: 10.1002/cesm.12057. eCollection 2024 May.

Authors

Affiliations

¹ Department of Clinical Research, Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark University of Southern Denmark Odense Denmark.
² Open Patient data Explorative Network (OPEN) Odense University Hospital Odense Denmark.
³ University Library of Southern Denmark Odense Denmark.
⁴ Temerty School of Medicine University of Toronto Toronto Ontario Canada.
⁵ Centre for Research in Epidemiology and Statistics (CRESS) Université Paris Cité, Université Sorbonne Paris Nord, Inserm, INRAE Paris France.
⁶ Cochrane France Paris France.
⁷ Department of Medicine, Women's College Research Institute University of Toronto Toronto Ontario Canada.
⁸ Centre for Statistics in Medicine University of Oxford Oxford UK.
⁹ Oxford Clinical Trials Research Unit/Centre for Statistics in Medicine University of Oxford Oxford UK.
¹⁰ Clinical Epidemiology Program Centre for Journalology, Ottawa Hospital Research Institute Ottawa Ontario Canada.
¹¹ School of Epidemiology and Public Health, Faculty of Medicine University of Ottawa Ottawa Ontario Canada.
¹² Department of Obstetrics and Gynecology, School of Medicine The University of North Carolina at Chapel Hill Chapel Hill North Carolina USA.
¹³ Department of Clinical Research, CLEAR-Methods Center, Division of Clinical Epidemiology, University Hospital Basel University of Basel Basel Switzerland.
¹⁴ Faculty of Medicine University of Toronto Toronto Ontario Canada.
¹⁵ Cardiovascular European Research Center (CERC) Massy France.
¹⁶ Faculty of Medicine University of Ottawa Ottawa Ontario Canada.

PMID: 40476263
PMCID: PMC11795946
DOI: 10.1002/cesm.12057

Abstract

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.

Keywords: CONSORT (CONsolidated Standards Of Reporting Trials); SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials); bibliographic database; reporting guidelines.

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Conflict of interest statement

B. S. received unrestricted grants from Moderna (2021/22) for studies unrelated to the presented work. I. B., A.‐W. C., G. C., S. H., D. M., K. F. S., R. T., and A. H. are part of the joint executive group for the planned updates of SPIRIT and CONSORT. The remaining authors declare no conflict of interest.

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References

1. Bornmann L, Haunschild R, Mutz R. Growth rates of modern science: a latent piecewise growth curve approach to model publication numbers from established and new literature databases. Humanit Soc Sci Commun. 2021;8(1):224. 10.1057/s41599-021-00903-w - DOI
1. Chalmers I, Bracken MB, Djulbegovic B, et al. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383(9912):156‐165. 10.1016/S0140-6736(13)62229-1 - DOI - PubMed
1. Sawin VI, Robinson KA. Biased and inadequate citation of prior research in reports of cardiovascular trials is a continuing source of waste in research. J Clin Epidemiol. 2016;69:174‐178. 10.1016/j.jclinepi.2015.03.026 - DOI - PubMed
1. Lund H, Brunnhuber K, Juhl C, et al. Towards evidence based research. BMJ. 2016;355:i5440. 10.1136/bmj.i5440 - DOI - PubMed
1. Hrobjartsson A. Rapid response: wrong information on previous studies of the clinical use of placebo. BMJ. 2004;329:944. https://www.bmj.com/rapid-response/2011/10/30/wrong-information-previous...

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Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010

Affiliations

Development of a topic-specific bibliographic database supporting the updates of SPIRIT 2013 and CONSORT 2010

Authors

Affiliations

Abstract

Conflict of interest statement

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