Camilla Hansen Nejstgaard,1,2 Isabelle Boutron,3,4 An-Wen Chan,5 Ryan Chow,6 Sally Hopewell,7 Mouayad Masalkhi,8 David Moher,9,10 Kenneth F. Schulz,11 Nathan A. Shlobin,12 Lasse Østengaard,1,2,13 Asbjørn Hróbjartsson1,2
When appropriately designed, conducted, and reported, randomized trials provide trustworthy assessments of the effects of health care interventions. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guideline was developed in 2013 to facilitate complete and transparent reporting in trial protocols. Similarly, the CONSORT (Consolidated Standards of Reporting Trials) guideline was developed in 1996, with subsequent updates in 2001 and 2010, to facilitate complete and transparent reporting of trial methods and results. Periodic guideline updates are essential to reflect evolving trial methodologies and experiences with implementation. The objective of this study was to identify, summarize, and analyze comments on both guidelines, with special emphasis on suggestions for guideline modifications.
This mapping review (reported in accordance with PRISMA-ScR [Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews]), included documents (eg, empirical studies and letters) written in English and published after 2010 with explicit comments on SPIRIT 2013 or CONSORT 2010. Three bibliographic databases (Embase, Medline to June 2020, and Web of Science to April 2022) and other sources (eg, Google Scholar, BMC Blog Network, The BMJ rapid responses, and proceedings from Cochrane Colloquia) were searched. Two authors independently assessed documents for eligibility and extracted data on basic characteristics and exact wording of the main comments. Comments were categorized as suggestions for modification to the wording of existing guideline item, suggestions for new item, or reflections on challenges or strengths. The SPIRIT or CONSORT topic addressed (eg, methods or results) and the item number were noted. Suggestions were summarized and categorized into those that were directly linked to empirical investigations, were continuations of previous methodological discussions, or reflected new methodological developments.
Searches identified 7324 records, of which 82 documents with 99 comments were included. In total, 36 comments suggested modifying existing guideline items. The section most commented on was the participant flow section of CONSORT (eg, add numbers on nonrandomized screened participants, n = 8). There were 37 suggestions for new items in both SPIRIT and CONSORT. Multiple comments addressed intervention (eg, add content on cointerventions, n = 7), blinding (eg, add content on risk of unblinding, n = 7), participant flow (eg, add content on missing data, n = 5), and statistical methods (eg, add content on blinding of statisticians, n = 4). Thirty-six of the suggestions (49%) were directly linked to empirical investigations. Six of the suggestions (8%) were continuations of previous methodological discussions, and 4 suggestions (5%) reflected new methodological developments.
Ninety-nine comments on SPIRIT 2013 and CONSORT 2010 were identified. The suggestions for modifying the wording or adding new items were often related to participant flow, intervention, blinding, and statistical methods. Approximately half of the suggestions were directly linked to empirical investigations. The issues raised may provide helpful context to authors, peer reviewers, editors, and readers of trials using SPIRIT 2013 and CONSORT 2010 and inform future updates to these guidelines.
1Centre for Evidence-Based Medicine Odense (CEBMO) and Cochrane Denmark, Department of Clinical Research, University of Southern Denmark, Odense, Denmark, firstname.lastname@example.org; 2Open Patient Data Explorative Network (OPEN), Odense University Hospital, Odense, Denmark; 3Université de Paris, Centre of Research in Epidemiology and Statistics (CRESS), Inserm, France; 4Cochrane France, Paris, France; 5Department of Medicine, Women’s College Research Institute, University of Toronto, Canada; 6Faculty of Medicine, University of Ottawa, Canada; 7Oxford Clinical Trials Research Unit/Centre for Statistics in Medicine, University of Oxford, UK; 8School of Medicine, University College Dublin, Dublin, Ireland; 9Centre for Journalology, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Canada; 10School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Canada; 11Department of Obstetrics and Gynecology, School of Medicine, The University of North Carolina at Chapel Hill; 12Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois; 13University Library of Southern Denmark, Odense, Denmark
Conflict of Interest Disclosures:
David Moher is an associate director and Isabelle Boutron and An-Wen Chan are advisory board members of the International Congress on Peer Review and Scientific Publication but were not involved in the review or decision of this abstract. No other disclosures were reported.