The importance of the new CONSORT Statement for clinicians.

155 Editorial The Consolidated Standard of Reporting Trials (CONSORT) Statement is an international consensus guide and checklist to improve reports on randomised clinical trials (RCTs). The standard was developed in response to evidence that RCTs have been reported inadequately over the last three decades (Chan and Bhandari 2007, Dickinson et al 2000, Poolman et al 2006), in spite of educational efforts. The CONSORT group of international journal editors, clinical trialists, epidemiologists, and methodologists published their original statement 12 years ago, having designed it primarily for pharmacological trials (Begg et al 1996). After an update 7 years ago, it now contains a 22-item content checklist and a participant flow chart (Moher et al 2001). An even more useful version for the physiotherapy profession is a new extended CONSORT Statement for non-pharmacological treatment (Boutron et al 2008a and b). The extended version adds 1 item and 4 sub-items relating to therapists, centres, and settings – with keywords like eligibility, skills, experience, and randomisation. What might the new CONSORT Statement mean to clinicians? Imagine you have read a recent trial report, eg Harts et al (2008) published in this journal. Its conclusion partially confirms that strengthening back extensor muscles is a more effective treatment for non-specific low back pain than passive modalities or doing nothing. Yet, you might still be uncertain how the report can help you treat your current client with this very problem. Why? It might be because you feel the report lacks some key information. How could you, by using the new CONSORT checklist (Boutron et al 2008a and b), assess whether the report contains sufficient information? To comply with the new CONSORT Statement, the Method must report eligibility of patients, therapist, centres, and settings, and the Conclusion (the most important part of the report) must report how these factors restrict generalisation of results. Therefore, the Conclusion should address: participants, intervention, therapists, centres, outcome measure(s), comparator(s), and setting(s) (which can be abbreviated to the acronym PITCOCS.) It is instructive to appraise the Participants and Intervention sections from the Method section of the Harts et al (2008) paper using the CONSORT checklist, to see whether there is sufficient information to form a full PITCOCS conclusion about the generalisability of the results. First we look for information on the trial participants. There were 66 patients, 1 therapist, and 1 centre (and 4 scientists). We look for the criteria for including and excluding …