Isabelle Boutron, MD, PhD; Douglas G. Altman, DSc; David Moher, PhD; Kenneth F. Schulz, PhD, MBA; Philippe Ravaud, MD, PhD; for the CONSORT NPT Group (*)
Financial Support: Funding was provided by the research funds of the Centre d'Epidémiologie Clinique, Assistance Publique des Hôpitaux de Paris, and the METHODS Team of the Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité – CRESS-UMR1153.
Disclosures: Dr. Ravaud reports that he is a member of the CONSORT Group, director of EQUATOR France, and a member of the EQUATOR steering group. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M17-0046.
Requests for Single Reprints: Isabelle Boutron, MD, PhD, Equipe METHODS (CRESS-UMR1153), Centre d'épidémiologie clinique, Hôpital Hôtel-Dieu, 1 place du Parvis Notre-Dame, 75004 Paris, France.
Current Author Addresses: Drs. Boutron and Ravaud: Equipe METHODS (CRESS-UMR1153), Centre d'épidémiologie clinique, Hôpital Hôtel-Dieu, 1 place du Parvis Notre-Dame, 75004 Paris, France.
Dr. Altman: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Botnar Research Centre, Windmill Road, Oxford OX3 7LD, United Kingdom.
Dr. Moher: Centre for Journalology, Ottawa Hospital Research Institute, The Ottawa Hospital, General Campus, 501 Smyth Road, Room L1288, Ottawa, Ontario K1H 8L6, Canada.
Dr. Schulz: FHI 360, 359 Blackwell Street, Suite 200, Durham, NC 27701.
Author Contributions: Conception and design: I. Boutron, D.G. Altman, D. Moher, K.F. Schulz, P. Ravaud.
Analysis and interpretation of the data: I. Boutron, D.G. Altman, D. Moher, P. Ravaud.
Drafting of the article: I. Boutron, D. Moher, P. Ravaud.
Critical revision of the article for important intellectual content: I. Boutron, D.G. Altman, D. Moher, K.F. Schulz, P. Ravaud.
Final approval of the article: I. Boutron, D.G. Altman, D. Moher, K.F. Schulz, P. Ravaud.
Statistical expertise: D.G. Altman, K.F. Schulz.
Obtaining of funding: P. Ravaud.
Administrative, technical, or logistic support: P. Ravaud.
Collection and assembly of data: I. Boutron, D. Moher, P. Ravaud.
Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidence-based reporting guideline that aims to improve research transparency and reduce waste. In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This article describes an update of that extension and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists.
Changes to the CONSORT Statement extension for NPT trials include wording modifications to improve readers' understanding and the addition of 3 new items. These items address whether and how adherence of participants to interventions is assessed or enhanced, description of attempts to limit bias if blinding is not possible, and specification of the delay between randomization and initiation of the intervention. The CONSORT extension for abstracts of NPT trials includes 2 new items that were not specified in the original CONSORT Statement for abstracts. The first addresses reporting of eligibility criteria for centers where the intervention is performed and for care providers. The second addresses reporting of important changes to the intervention versus what was planned. Both the updated CONSORT extension for NPT trials and the CONSORT extension for NPT trial abstracts should help authors, editors, and peer reviewers improve the transparency of NPT trial reports.
Appendix Table 1. Characteristics of Corresponding Authors Surveyed About the CONSORT Statement Extension for RCTs of NPTs (n = 194)*
Appendix Table 2. Survey Results
Table 1. 2017 CONSORT Checklist of Information to Include When Reporting Randomized Trials Assessing NPTs*
Appendix Table 3. Extended CONSORT Checklist of Information to Include When Reporting RCTs Assessing NPTs, With Examples for 2 Types of Interventions*
Appendix Table 3. Continued
Example of a participant flow diagram for a single-center trial of surgery.
Adapted from reference 87.
Example of a participant flow diagram for a multicenter trial of participative interventions.
Assessments refer to the weekly or sustained outcomes. Immediate outcome data collection occurred in conjunction with every treatment session. IQR = interquartile range; max = maximum; min = minimum. Reproduced from reference 81, with permission.
* Number who had any treatment: 113 + 38 for massage therapy and 93 + 54 for control.
† Number with baseline or any sustained outcome assessments: 188 − 17 for massage therapy and 192 − 15 for control.
Modified CONSORT flow diagram for individual randomized controlled trials of nonpharmacologic treatments.
An extra box relating to care providers and centers has been added for each intervention group. CONSORT = Consolidated Standards of Reporting Trials; IQR = interquartile range; max = maximum; min = minimum.
Table 2. Items to Include When Reporting RCTs Assessing NPTs in a Journal or Conference Abstract*
Appendix Table 4. Examples of Abstracts Adherent to the CONSORT Extension for Abstracts of NPT Trials*
Appendix Table 5. Allocation of Care Providers to Each Trial Group
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Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, for the CONSORT NPT Group. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Ann Intern Med. 2017;167:40–47. doi: 10.7326/M17-0046
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Published: Ann Intern Med. 2017;167(1):40-47.
Published at www.annals.org on 20 June 2017
Research and Reporting Methods.
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