IntroductionThe STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) reporting guidelines, first published in 2001 [1][2][3][4][5][6][7][8][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.A survey of authors of clinical trials and systematic reviews was subsequently conducted to determine the usefulness of STRICTA in helping them 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 treatments [14,15] and pragmatic trials [16]. Since there are acupuncture specific 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.The combination of these developments led to an agreement between the CONSORT Group and the STRICTA Group, in collaboration with the Chinese Cochrane Centre and the Chinese Centre for Evidence-based Medicine, to revise STRICTA as a formal extension to CONSORT. The revision processes have been described in more detail elsewhere [17]. This paper describes the outcome in terms of a new checklist, updated explanations, and published examples of good reporting.
MethodsIn 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.Twenty-one individuals attended a workshop in Freiburg, Germany, in October 2008. The attendees included experts in epidemiology, trial methodology, statistics, and medical journal editing. Just over half the participants were ...