Editor's note - reporting of trials of non-pharmacological interventions.

Clinical practice should be informed by good quality research. Our ability to appraise methodological rigour depends, in part, on the quality of research publications. The CONSORT (Consolidated Standards of Reporting Trials) Statement (Altman et al., 2001; Begg et al., 1996) aims to improve the quality of reporting of randomised controlled trials (RCTs). CONSORT comprises a checklist of 22 items to include in reports of RCTs along with the CONSORT diagram, or flowchart of participants through the trial. Other tools exist for appraising the quality of RCTs (Law et al., 1998; Critical Appraisal Skills Programme, 2006) and in assigning a quality rating (Maher, Sherrington, Herbert, Moseley, & Elkins, 2003). The CONSORT statement is most applicable to drug trials. There are issues in the design, reporting and appraisal of trials of non-pharmacological interventions that require additional consideration. These issues include difficulty achieving blinding, the frequently complex nature of non-pharmacological interventions and the consequent difficulties of objectively standardising and describing the interventions (Boutron et al., 2005; Boutron, Moher, Altman, Schulz, & Ravaud, 2008). Variability in the expertise of intervention providers may impact on the outcomes. These issues affect RCTs in occupational therapy, rehabilitation, surgery and other allied health areas. Two tools have been developed to complement the existing CONSORT Statement. The Extension to the CONSORT Statement for Randomised Trials of NonPharmacologic Treatment (Boutron et al., 2008) aims to improve the reporting of such trials. It consists of extensions to 11 of the CONSORT items, an additional item and a modification to the flow diagram. The items include a rationale, examples of appropriate reporting and, where possible, evidence to support the inclusion of the item. The second tool, the CLEAR NPT (Checklist to Evaluate a Report of a Nonpharmacological Trial) consists of 10 items and five sub-items to use, alongside existing appraisal tools, to critically appraise reports of non-pharmacological RCTs (Boutron et al., 2005). As with CONSORT, both tools were developed using consensusbased methods, enlisting the expertise of clinicians, medical journal editors, methodologists, statisticians and epidemiologists, and both tools would also be useful to consult when designing, appraising and reporting RCTs. Many journal editors require authors to include a CONSORT diagram and to consult the Statement in manuscript preparation. There is mounting evidence that the use of CONSORT has improved the reporting of RCTs (Altman et al., 2001; Moher, Altman, Schulz, & Elbourne, 2004). Increasingly, occupational therapists are engaged in conducting RCTs or use RCTs to inform practice. Should occupational therapy journals join the ranks of journals that endorse the CONSORT and also recommend consultation with the additional tools now available for non-pharmacological trials? Certainly, occupational therapists and other stakeholders need to incorporate the extension to the CONSORT and CLEAR NPT into design, appraisal and reporting of non-pharmacological RCTs. The outcome could improve selection of responsible intervention options to offer to our clients, informed by the best available evidence, to assist them in making decisions about their health care.