4 July 2017 | Isabelle Boutron, MD, PhD; Douglas G. Altman, DSc; David Moher, PhD; Kenneth F. Schulz, PhD, MBA; and Philippe Ravaud, MD, PhD, for the CONSORT NPT Group
The CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments (NPTs) was updated in 2017 to improve the reporting of NPT trials and enhance transparency. The original CONSORT extension for NPT trials, published in 2008, addressed methodological issues specific to NPTs, such as surgery, rehabilitation, and psychotherapy. The 2017 update includes wording changes and three new items to address adherence to interventions, attempts to limit bias when blinding is not possible, and the delay between randomization and intervention initiation. Additionally, a new CONSORT extension was developed for reporting abstracts of NPT trials, including two new items: reporting eligibility criteria for centers and care providers, and reporting important changes to the intervention.
The update was based on a review of literature, surveys of NPT trial authors, and a consensus meeting with editors, trialists, and methodologists. The revised CONSORT NPT extension includes items to describe the complexity of NPTs, the influence of center and care provider expertise, clustering, and difficulties in blinding. It also addresses the delay between randomization and intervention initiation and the adherence of participants and care providers to interventions.
The updated guidelines aim to improve the transparency and accuracy of NPT trial reports, which are often poorly described. The guidelines are consistent with the TIDieR checklist for better reporting of interventions. The CONSORT extension for abstracts includes items to report eligibility criteria and important changes to the intervention. The guidelines are intended to help authors, editors, and peer reviewers improve the quality of NPT trial reporting, ensuring that results are interpretable and applicable. The guidelines do not aim to discourage the publication of imperfect trials but to ensure transparency and a coherent approach to testing and reporting complex interventions.The CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments (NPTs) was updated in 2017 to improve the reporting of NPT trials and enhance transparency. The original CONSORT extension for NPT trials, published in 2008, addressed methodological issues specific to NPTs, such as surgery, rehabilitation, and psychotherapy. The 2017 update includes wording changes and three new items to address adherence to interventions, attempts to limit bias when blinding is not possible, and the delay between randomization and intervention initiation. Additionally, a new CONSORT extension was developed for reporting abstracts of NPT trials, including two new items: reporting eligibility criteria for centers and care providers, and reporting important changes to the intervention.
The update was based on a review of literature, surveys of NPT trial authors, and a consensus meeting with editors, trialists, and methodologists. The revised CONSORT NPT extension includes items to describe the complexity of NPTs, the influence of center and care provider expertise, clustering, and difficulties in blinding. It also addresses the delay between randomization and intervention initiation and the adherence of participants and care providers to interventions.
The updated guidelines aim to improve the transparency and accuracy of NPT trial reports, which are often poorly described. The guidelines are consistent with the TIDieR checklist for better reporting of interventions. The CONSORT extension for abstracts includes items to report eligibility criteria and important changes to the intervention. The guidelines are intended to help authors, editors, and peer reviewers improve the quality of NPT trial reporting, ensuring that results are interpretable and applicable. The guidelines do not aim to discourage the publication of imperfect trials but to ensure transparency and a coherent approach to testing and reporting complex interventions.