Background: Evidence suggests that the conduct of randomized controlled trials of nonpharmacological treatment (NPT) presents specific challenges that are not adequately addressed in trial reports.
Objective: To develop an extension of the CONSORT Statement for trials of NPT.
Methods: A total of 30 experts participated in a consensus meeting to develop an extension of the CONSORT Statement to randomized trials of NPT. To prepare for the meeting, we conducted a survey to identify the specific issues for discussion during the meeting. The survey development was informed by the results of a systematic review. Experts were invited to indicate which of the 22 CONSORT checklist items they believed should be modified or additional items that should be added specifically for NPT. A 3-day consensus meeting allowed for discussion of all items highlighted in responses to the preliminary survey.
Results: Following discussion the consensus was that eleven items on the CONSORT checklist needed some modifications for NPT trials: 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), item 21 (generalisability). In addition, 1 item related to implementation of the intervention was added (item 13 B).
Conclusions: The promotion of this extension to the CONSORT Statement should improve the quality of reporting randomized controlled trials assessing NPT.