Non-pharmacological Treatments (NPT) cover a wide range of interventions including surgery, technical procedures (e.g., angioplasty), implanted devices (e.g., pacemaker), non-implantable devices, rehabilitation, physiotherapy, behavioural therapy, and psychotherapy.
Assessing NPT in randomized controlled trials raises specific issues linked to the complexity of the interventions, the influence of care providers and centres' volume, and the difficulties of blinding. However, the quality of reporting these issues in NPT trials raises some concern and is a barrier to adequately appraise the risk of bias and the applicability of the trial results.
While the CONSORT checklist can be applied to reports of such trials, these issues are not dealt with in depth by the CONSORT Group. This might explain, in part, the inconsistency in the quality of reporting of trials of NPTs.
In February 2006 an international group of 30 individuals comprising trialists, methodologists, surgeons, and journal editors, met in Paris. They reached consensus on a specific reporting guidance for RCTs using NPTs. The following eleven items of the CONSORT checklist were modified: 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 (discussion - generalisability). In each case the modification was to expand the text. In addition, one new item related to implementation of the intervention was added. To facilitate a better understanding and dissemination of this CONSORT initiative the meeting participants also developed an NPT "explanatory and elaboration" document.
The CONSORT extension for NPT and the accompanying explanatory document have beeen submitted for publication.