The CONSORT Group is pleased to announce the publication of a new extension to the CONSORT Statement for reporting of pragmatic randomized controlled trials [1,2]. Pragmatic trials are designed to inform decisions about practice and help choose between options for care, however, poor reporting can reduce their usefulness.
In developing this checklist, two, two-day, meetings were held in Toronto, Canada (January 2005 and March 2008) to discuss ways to increase the contribution of randomized controlled trials to healthcare decision making, focusing on pragmatic trials. Participants included people with experience in clinical care, commissioning research, healthcare financing, developing clinical practice guidelines, and trial methodology and reporting. Twenty four people participated in 2005 and 42 in 2008, including members of the CONSORT and Pragmatic Trials in Healthcare (Practihc) Groups. After the 2005 meeting a draft revised checklist and summary paper for the extension was circulated. At the 2008 meeting the draft was discussed, modified and then circulated to the CONSORT Group for feedback before submitting it for publication.
The experts agreed that eight items on the CONSORT checklist needed additional text specific to the reporting of pragmatic trials: item 2 (background), item 3 (participants), item 4 (interventions), item 6 (outcomes), item 7 (sample size) item 11 (blinding (masking)), item 13 (participant flow), and item 21 (generalisability). For each of the eight items the standard CONSORT text and additional guidance, an example of good reporting for the item, and an explanation of the issues are presented. These suggestions should be seen as additional to the general guidance in the main CONSORT explanatory paper and where relevant, other CONSORT guidance.
We hope that this extension will help editors, reviewers, trialists, and policy makers in reporting, reviewing, and using pragmatic trials. We encourage journals that have endorsed the CONSORT Statement to also support CONSORT for pragmatic trials, by including reference to this extension paper in the journal's 'Instructions to Authors'. Please notify us of your endorsement so that your journal may be acknowledged on our website.
1. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337:1223-1226 [abridged version] (PDF).
2. Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D. Improving the reporting of pragmatic trials: an extension of the CONSORT statement:www.bmj.com/cgi/content/full/337/nov11_2/a2390?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=1&andorexacttitle=and&andorexacttitleabs=and&fulltext=CONSORT+pragmatic&andorexactfulltext=and&searchid=1&FIRSTINDEX=0&sortspec=relevance&fdate=1/1/2008&resourcetype=HWCIT[full version]