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 2017 update of CONSORT-NPT updates that work 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.
NPT-relevant methodological issues include complexities of blinding, interventions, and the influence of care providers’ expertise and volume of care of centres on treatment effect. For example, the CONSORT-NPT flow diagram requests data on the number of care providers and centres in each group and the number of patients treated by each care provider. The reporting of trials of NPTs such as surgery, technical interventions, rehabilitation, psychotherapy, behavioural interventions, implantable and non-implantable devices, and complementary medicine remains suboptimal.
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Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, DJ C, et al. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Annals of Internal Medicine. American College of Physicians; 2017 Jul 4;167(1):40. PMID: 28630973