Methods and processes of the CONSORT Group: example of an extension for trials assessing nonpharmacologic treatments.

BACKGROUND: The conduct of randomized, controlled trials of nonpharmacologic treatments presents specific challenges that are not adequately addressed in trial reports. OBJECTIVE: To develop an extension of the CONSORT (Consolidated Standards of Reporting Trials) Statement for trials of nonpharmacologic treatments. DESIGN: A consensus meeting was organized to develop an extension of the CONSORT Statement that addresses randomized trials of nonpharmacologic treatments. To prepare for the meeting, a survey was conducted to identify the specific issues for discussion. SETTING: Consensus meeting in Paris, France. PARTICIPANTS: A total of 33 experts attended the meeting. The experts were methodologists (n = 17); surgeons (n = 6); editors (n = 5); and clinicians involved in rehabilitation (n = 1), psychotherapy (n = 2), education (n = 1), and implantable devices (n = 1). MEASUREMENTS: Experts indicated which of the 22 items on the CONSORT checklist should be modified or which additional items should be added specifically for nonpharmacologic treatments. During a 3-day consensus meeting, all items were discussed and additional methodological issues related to nonpharmacologic research were identified. RESULTS: The consensus was that 11 items on the CONSORT checklist needed some modifications for nonpharmacologic 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), and item 21 (generalizability). In addition, the meeting participants added 1 item related to implementation of the intervention. LIMITATION: Evidence was not always available to support the inclusion of each checklist item. CONCLUSION: The methods and processes used to develop this extension could be used for other reporting guidelines. The use of this extension to the CONSORT Statement should improve the quality of reporting randomized, controlled trials assessing nonpharmacologic treatments