CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts.

By I. Boutron, Douglas G. Altman, David Moher, K. F. Schulz, Philippe Ravaud. Annals of Internal Medicine, 2017

1,200 citations recorded by the source corpus.

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.

Subfields: Economics and Econometrics, Public Health, Environmental and Occupational Health, Statistics and Probability

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Citations in the corpus

CONSORT 2025 statement: updated guideline for reporting randomised trials. (2025, neutral): “We have added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions (Harms, 24 Outcomes, 25 Non-pharmacological Treatment 27 ) and other related reporting guidelines (TIDieR 28 ).”
The STROCSS statement: Strengthening the Reporting of Cohort Studies in Surgery (2017, methodology): “Relevant points from the PROCESS [7], STROBE [8] and CONSORT guidelines [9], were used to create a list of applicable items which were used as baseline material in the Delphi rounds.”
Updating guidance for reporting systematic reviews: development of the PRISMA 2020 statement. (2020, methodology): “However, no methodological advice for updating a reporting guideline exists, and only a few reporting guidelines have been updated (15-18).”
CONSORT 2025 statement: updated guideline for reporting randomised trials (2025, neutral): “We have added seven new checklist items, revised three items, deleted one item, and integrated several items from key CONSORT extensions (Harms, 24 Outcomes, 25 Non-pharmacological Treatment 27 ) and other related reporting guidelines (TIDieR 28 ).”