The CONSORT Group is pleased to announce the publication of a new extension to the CONSORT Statement for reporting randomized controlled trials (RCTs) assessing non-pharmacologic treatments (NPT) [1, 2]. NPT concerns a wide range of treatments such as surgery, technical interventions, rehabilitation, psychotherapy, behavioral interventions, implantable and non-implantable devices and complementary medicine. Assessing these treatments raises specific issues such as difficulties of blinding, complexity of the intervention and influence of care providers' expertise and volume of care of centres on treatment effect. These issues are inadequately reported in published RCTs. The CONSORT Group has extended the current CONSORT Statement to address the consideration of these issues of NPT when reporting a RCT.
The checklist for the extension to NPT was developed according to the process and methods of the CONSORT Group. A systematic review and a web-based survey were conducted to identify possible modifications. Then 33 experts - 17 methodologists, 6 surgeons, 5 editors, and clinicians involved in the field of rehabilitation (1), psychotherapy (2), education (1) and implantable devices (1) - attended a consensus meeting in February 2006 in Paris, France. The experts agreed that 11 items on the CONSORT checklist needed some modifications for trials of NPT: item 1 (title and abstract), item 3 (participants), item 4 (interventions), item 7 (sample size), item 8 (randomization), item 11 (blinding), item 12 (statistical methods), item 13 (participant flow), item 15 (baseline data), item 20 (discussion - interpretation), and item 21 (generalizability). In addition, 1 item related to implementation of the intervention was added.
We encourage authors to use the CONSORT Statement extension for RCTs of NPT by referring to the publication that explains and elaborates on the extension [1, 2]. We encourage journals to endorse the use of this CONSORT Statement extension by modifying their Instructions to Authors and by drawing their readers' attention to this guideline for reporting. Please notify us of your endorsement so that your journal may be acknowledged on our website.
1. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008:W60-W67.
2. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008:295-309.