The CONSORT extension for reporting harms outcomes extends 10 checklist items of the CONSORT (2001) checklist. Considerable evidence suggests that reporting of harms-related data from RCTs needs improvement.
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The main CONSORT flow diagram should be used.
Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, Moher D. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 2004; 141(10):781-788. PMID: 15545678
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|
|Pilot and Feasibility Trials|
|Within Person Trials|