Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements

Ruth Tunn; Isabelle Boutron; An-Wen Chan; Gary S Collins; Asbjørn Hróbjartsson; David Moher; Kenneth F Schulz; Jennifer A de Beyer; Camilla Hansen Nejstgaard; Lasse Østengaard; Sally Hopewell

doi:10.1016/j.jclinepi.2024.111309

Methods used to develop the SPIRIT 2024 and CONSORT 2024 Statements

J Clin Epidemiol. 2024 Feb 29:169:111309. doi: 10.1016/j.jclinepi.2024.111309. Online ahead of print.

Authors

Affiliations

¹ Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK; Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
² Université Paris Cité and Université Sorbonne Paris Nord, Inserm, INRAE, Centre for Research in Epidemiology and Statistics (CRESS), F-75004 Paris, France; Centre d'Epidémiologie Clinique, AP-HP, Hôpital Hôtel Dieu, Paris, France.
³ Department of Medicine, Women's College Research Institute, University of Toronto, Toronto, Ontario, Canada.
⁴ Centre for Statistics in Medicine, University of Oxford, Oxford, UK; UK EQUATOR Centre, University of Oxford, Oxford, UK.
⁵ Centre for Evidence-Based Medicine Odense and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Open Patient data Explorative Network, Odense University Hospital, Odense, Denmark.
⁶ Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
⁷ Department of Obstetrics and Gynecology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁸ Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK; Centre for Statistics in Medicine, University of Oxford, Oxford, UK. Electronic address: sally.hopewell@csm.ox.ac.uk.

PMID: 38428538
DOI: 10.1016/j.jclinepi.2024.111309

Abstract

Objectives: To describe, and explain the rationale for, the methods used and decisions made during development of the updated SPIRIT 2024 and CONSORT 2024 reporting guidelines.

Methods: We developed SPIRIT 2024 and CONSORT 2024 together to facilitate harmonization of the two guidelines, and incorporated content from key extensions. We conducted a scoping review of comments suggesting changes to SPIRIT 2013 and CONSORT 2010, and compiled a list of other possible revisions based on existing SPIRIT and CONSORT extensions, other reporting guidelines, and personal communications. From this, we generated a list of potential modifications or additions to SPIRIT and CONSORT, which we presented to stakeholders for feedback in an international online Delphi survey. The Delphi survey results were discussed at an online expert consensus meeting attended by 30 invited international participants. We then drafted the updated SPIRIT and CONSORT checklists and revised them based on further feedback from meeting attendees.

Results: We compiled 83 suggestions for revisions or additions to SPIRIT and/or CONSORT from the scoping review and 85 from other sources, from which we generated 33 potential changes to SPIRIT (n = 5) or CONSORT (n = 28). Of 463 participants invited to take part in the Delphi survey, 317 (68%) responded to Round 1, 303 (65%) to Round 2 and 290 (63%) to Round 3. Two additional potential checklist changes were added to the Delphi survey based on Round 1 comments. Overall, 14/35 (SPIRIT n = 0; CONSORT n = 14) proposed changes reached the predefined consensus threshold (≥80% agreement), and participants provided 3580 free-text comments. The consensus meeting participants agreed with implementing 11/14 of the proposed changes that reached consensus in the Delphi and supported implementing a further 4/21 changes (SPIRIT n = 2; CONSORT n = 2) that had not reached the Delphi threshold. They also recommended further changes to refine key concepts and for clarity.

Conclusion: The forthcoming SPIRIT 2024 and CONSORT 2024 Statements will provide updated, harmonized guidance for reporting randomized controlled trial protocols and results, respectively. The simultaneous development of the SPIRIT and CONSORT checklists has been informed by current empirical evidence and extensive input from stakeholders. We hope that this report of the methods used will be helpful for developers of future reporting guidelines.

Keywords: CONSORT (CONsolidated Standards Of Reporting Trials); Randomized controlled trials; Reporting guidelines; Reproducibility; SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials); Trial protocols.