Research Article: Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

Date Published: June 8, 2010

Publisher: Public Library of Science

Author(s): Hugh MacPherson, Douglas G. Altman, Richard Hammerschlag, Li Youping, Wu Taixiang, Adrian White, David Moher

Abstract: Hugh MacPherson and colleagues present an updated reporting guideline called STRICTA, which stands for Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture.

Partial Text: The STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) reporting guidelines, first published in 2001 [1]–[9], were designed to improve the completeness and transparency of reporting of interventions in controlled trials of acupuncture, in order that such trials may be more accurately interpreted and readily replicated. STRICTA comprised a checklist that expanded the generic content of Item 4 of the CONSORT statement [10],[11], which relates to the reporting of the intervention.

In the summer of 2008, a group of 47 experts from the original STRICTA Group, the CONSORT Group, the World Federation of Acupuncture and Moxibustion Societies, the Acupuncture Trialists’ Collaboration [18], the Society for Acupuncture Research [19], and clinical trial authors were surveyed [12]. The experts were from 15 countries, 41 had academic positions, 31 were acupuncturists, 18 were involved with journals, such as board members, 15 were physicians, and 11 had been involved previously in developing reporting guidelines. These experts were consulted in regard to a draft of revised STRICTA items that had evolved from previous research [12],[13]. Feedback was collated and forwarded (with permission) to those invited to a consensus development workshop, the next phase of the revision process.

Note: In the Examples that follow, the embedded terms (ref) and (refs) refer to sources that are reported in the original published studies, but the details of these sources are not provided in this article for reasons of brevity.

This revised STRICTA Statement has been designed to help improve the reporting of interventions in clinical trials of acupuncture, with the intention that it will help authors of acupuncture trials provide readers with a clear, accurate and transparent account of their acupuncture protocols as well as their control and/or comparator procedures. In addition to revising the STRICTA checklist, we have improved the explanations of each item and provided examples of good reporting. To enhance awareness, endorsement and adherence, the revised STRICTA Statement has been developed as an extension to CONSORT. Authors of clinical trials of acupuncture should use the STRICTA recommendations for the acupuncture intervention (Item 5 in the CONSORT 2010 Statement) in conjunction with the other 25 items of the checklist in the main CONSORT guidelines [10],[11]. The extension to CONSORT for non-pharmacological interventions is also highly relevant to acupuncture trials [14],[15]. There are other extensions to CONSORT that may be relevant, depending on the type of trial design, including extensions for cluster trials, equivalence and non-inferiority trials, and pragmatic trials, and the reporting of abstracts and of harms (e.g. adverse events) associated with the intervention. The most recent versions of all CONSORT guidance documents can be found on the CONSORT website (http://www.consort-statement.org).

Source:

http://doi.org/10.1371/journal.pmed.1000261

 

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