extending the CONSORT statement in Clinical Trials of Acupuncture (STRICTA): Revised STandards for Reporting Interventions

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in fi ve journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an offi cial extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. This paper is freely available online under the BMJ Journals unlocked scheme, see http:// aim.bmj.com/info/unlocked.dtl Hugh MacPherson,1 Douglas G Altman,2 Richard Hammerschlag,3 Youping Li,4 Taixiang Wu,4 Adrian White,5 David Moher6; on behalf of the STRICTA Revision Group of STRICTA in helping them to write their reports.12 In addition, a survey of 90 acupuncture trials was undertaken to assess whether use of the STRICTA checklist was associated with improved reporting over time.13 The results of these initiatives led to conclusions that most STRICTA items were found to be necessary and easy to use, though some were seen as poorly reported, ambiguous or possibly redundant and a number of suggestions were made for additional items. A revision of STRICTA was therefore proposed. Meanwhile, extensions to CONSORT have been developed to cover the reporting of non-pharmacological treatments14 15 and pragmatic trials.16 Since there are acupuncture-specifi c aspects to reporting not covered by these extensions, it was decided that STRICTA should be revised in a manner congruent with CONSORT and its extensions for non-pharmacological treatments and pragmatic trials. 09_acupmed1370.indd 83 5/28/2010 10:12:21 AM group.bmj.com on June 10, 2010 Published by aim.bmj.com Downloaded from