Non-Pharmacologic Treatment Interventions

This extension to the CONSORT Statement for RCTs of non-pharmacologic treatments (NPT), takes into consideration specific issues when assessing NPT, such as difficulties of blinding, the complexity of the intervention and the influence of care providers’ expertise and volume of care of centres on treatment effect. For example, the CONSORT flow diagram was modified to include 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.

Available Downloads

Document Word Format PDF Format
Statement Document n/a download
Checklist download download
Flow Diagram n/a n/a
Explanation & Elaboration n/a download

Reference

Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments. Ann Intern Med. 2008:W60-W67. PMID: 18283201

Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT group. Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med. 2008:295-309. PMID: 18283207

Extensions of the CONSORT Statement

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.

 

Finding the Appropriate Extension

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.

 

Designs
Interventions
Data
Cluster Trials Herbal Medicinal Interventions CONSORT-PRO
Non-Inferiority and Equivalence Trials Non-Pharmacologic Treatment Interventions Harms
Pragmatic Trials Acupuncture Interventions

Abstracts

N-of-1 Trials    
Pilot and Feasibility Trials