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Non-Pharmacologic Treatment (NPT) Interventions

Lack of clear, transparent, and sufficiently detailed reporting of randomized controlled trials (RCTs) is a barrier to adequately appraising the quality and applicability of published trials.

Although the adoption by journals of the CONSORT Statement has been associated with improved quality of reporting, the reporting of trials of non-pharmacologic treatments (NPT) such as surgery, technical interventions, rehabilitation, psychotherapy, behavioural interventions, implantable and non-implantable devices, and complementary medicine remains suboptimal.

This extension to the CONSORT Statement for RCTs of NPT [1], built upon the CONSORT checklist, 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.

To facilitate a better understanding and dissemination of this CONSORT initiative, an explanatory and elaboration document [2] was also developed. Specific documents detailing the different categories of NPT (i.e., surgery, rehabilitation, behavioural interventions) should be developed soon.

We encourage journals to endorse the use of the CONSORT Statement extension for RCTs of NPT by modifying their Instructions to Authors and by drawing their readers’ attention to this guideline for reporting. Please notify us of your endorsement so that we may acknowledge you on our website. We believe that the promotion of this CONSORT Statement extension will improve the quality of reporting of RCTs of NPT.

References

1.    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. Full text pdf.

2.    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. Full text pdf.

Page last edited: 23 August 2010