CONSORT Statement for randomized Trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic Trial Abstracts

Virginia Barbour, Kamaldeep Bhui, Nancy Chescheir, Pierre Alain Clavien, Markus K. Diener, Paul Glasziou, Robert M. Golub, Jeremy M. Grimshaw, Trish Groves, Sally Hopewell, Sarah E. Lamb, Peter McCulloch, Cynthia Mulrow, Daniel Riddle, Joseph S. Ross, Paula P. Schnurr, David Schriger, Larissa Shamseer, David Torgerson, Isabelle Boutron*Douglas G Altman, David Moher, Kenneth F. Schulz, Philippe Ravaud

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

231 Citations (Scopus)

Abstract

Incomplete and inadequate reporting is an avoidable waste that reduces the usefulness of research. The CONSORT (Consolidated Standards of Reporting Trials) Statement is an evidencebased 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.

Original languageEnglish
Pages (from-to)40-47
Number of pages8
JournalAnnals of Internal Medicine
Volume167
Issue number1
DOIs
Publication statusPublished - 4 Jul 2017

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    Barbour, V., Bhui, K., Chescheir, N., Clavien, P. A., Diener, M. K., Glasziou, P., Golub, R. M., Grimshaw, J. M., Groves, T., Hopewell, S., Lamb, S. E., McCulloch, P., Mulrow, C., Riddle, D., Ross, J. S., Schnurr, P. P., Schriger, D., Shamseer, L., Torgerson, D., ... Ravaud, P. (2017). CONSORT Statement for randomized Trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic Trial Abstracts. Annals of Internal Medicine, 167(1), 40-47. https://doi.org/10.7326/M17-0046