Non-Pharmacologic Treatment Interventions
In 2008, the CONSORT Group developed an extension to the original statement that addressed methodological issues specific to trials of nonpharmacologic treatments (NPTs), such as surgery, rehabilitation, or psychotherapy. This 2017 update of CONSORT-NPT updates that work and presents an extension for reporting abstracts of NPT trials. To develop these materials, the authors reviewed pertinent literature published up to July 2016; surveyed authors of NPT trials; and conducted a consensus meeting with editors, trialists, and methodologists.
NPT-relevant methodological issues include complexities of blinding, interventions, and the influence of care providers’ expertise and volume of care of centres on treatment effect. For example, the CONSORT-NPT flow diagram requests data on the number of care providers and centres in each group and the number of patients treated by each care provider. The reporting of trials of NPTs such as surgery, technical interventions, rehabilitation, psychotherapy, behavioural interventions, implantable and non-implantable devices, and complementary medicine remains suboptimal.
Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, DJ C, et al. CONSORT Statement for Randomized Trials of Nonpharmacologic Treatments: A 2017 Update and a CONSORT Extension for Nonpharmacologic Trial Abstracts. Annals of Internal Medicine. American College of Physicians; 2017 Jul 4;167(1):40. PMID: 28630973
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-Outcomes 2022 Checklist (for combined completion of CONSORT 2010)||CONSORT-PRO|
|Non-Inferiority and Equivalence Trials||Non-Pharmacologic Treatment Interventions||CONSORT-Outcomes 2022 Extension items only (for separate completion of CONSORT 2010 and CONSORT-Outcomes 2022 items)||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|