In development: CONSORT extension for Non-Pharmacological Treatment interventions
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.
Page last edited: 28 June 2007
