Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration

Adequate reporting of randomized, controlled trials (RCTs) is nec-essary to allow accurate critical appraisal of the validity and appli-cability of the results. The CONSORT (Consolidated Standards of Reporting Trials) Statement, a 22-item checklist and flow diagram, is intended to address this problem by improving the reporting of RCTs. However, some specific issues that apply to trials of non-pharmacologic treatments (for example, surgery, technical interven-tions, devices, rehabilitation, psychotherapy, and behavioral inter-vention) are not specifically addressed in the CONSORT Statement. Furthermore, considerable evidence suggests that the reporting of nonpharmacologic trials still needs improvement. Therefore, the CONSORT group developed an extension of the CONSORT State-ment for trials assessing nonpharmacologic treatments. A consensus meeting of 33 experts was organized in Paris, France, in February 2006, to develop an extension of the CONSORT Statement for trials of nonpharmacologic treatments. The participants extended 11 items from the CONSORT Statement, added 1 item, and de-veloped a modified flow diagram. To allow adequate understanding and implementation of the CONSORT extension, the CONSORT group developed this elabo-ration and explanation document from a review of the literature to provide examples of adequate reporting. This extension, in conjunc-tion with the main CONSORT Statement and other CONSORT extensions, should help to improve the reporting of RCTs per-formed in this field. Ann Intern Med. 2008;148:295-309. www.annals.or