The CONSORT extension for pragmatic trials builds upon the existing CONSORT checklist and gives specific guidance for 8 of the 22 checklist items in relation to pragmatic trials. 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. Importantly, these suggestions should be seen as additional to the general guidance in the main CONSORT explanatory paper and where relevant, other CONSORT guidance.
Pragmatic trials are designed to measure effectiveness; that is whether an intervention works when used in usual conditions of care. To ensure applicability (also called generalisability) in a wide range of usual care settings, pragmatic trials should, so far as possible, include in the trial the kinds of participants to whom the intervention will be applied in the real world, once its effectiveness is established. The need for purchasers, providers and recipients of health care to use evidence from trials in policy decisions has increased the focus on pragmatic trials, however, poor reporting can reduce their usefulness.
The main CONSORT flow diagram should be used.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D for the CONSORT and Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ 2008; 337;a2390. PMID: 19001484
The main CONSORT Statement is based on the "standard" two-group parallel design. However, there are several variations to the standard trial methodology, including different design aspects (e.g., cluster), interventions (e.g., herbals) and data (e.g., harms).
To help improve the reporting of these trials the main CONSORT Statement has been extended and modified by members of the CONSORT group for application in these various areas. The resulting CONSORT extensions are presented in this section. This list is, by no means, exhaustive; and work is constantly in progress.
Please note that modifications to the CONSORT checklist or flow diagram that are not developed with the involvement of the CONSORT Group do not have permission to name their work "CONSORT".
Some work, however, has been done to modify the CONSORT Statement without the involvement of the Group. These unofficial extensions of the CONSORT Statement can be found here.
The table below lists the current official extensions of the CONSORT statement. You can click on each extension to learn more about it or to explore that extension in the checklist viewer application.
|Cluster Trials||Herbal Medicinal Interventions||CONSORT-PRO|
|Non-Inferiority and Equivalence Trials||Non-Pharmacologic Treatment Interventions||Harms|
|Pragmatic Trials||Acupuncture Interventions|
|N-of-1 Trials||Chinese Herbal Medicine Formulas||Equity|
|Pilot and Feasibility Trials||Social and Psychological Interventions||Randomised Crossover Trial Reporting|
|Within Person Trials|
|Multi-Arm Parallel-Group Randomized Trials|