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修订后的针刺临床试验干预报告标准(STRICTA):扩展 CONSORT 声明。

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

机构信息

Department of Health Sciences, University of York, United Kingdom.

出版信息

J Evid Based Med. 2010 Aug;3(3):140-55. doi: 10.1111/j.1756-5391.2010.01086.x.

DOI:10.1111/j.1756-5391.2010.01086.x
PMID:21349059
Abstract

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five 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 official extension of CONSORT, includes six items and 17 sub-items. 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, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

摘要

《针刺临床试验干预措施报告标准(STRICTA)》于 2001 年和 2002 年在五本期刊上发表。这些指南以清单的形式呈现,并附有作者和期刊编辑使用的说明,旨在提高针刺试验的报告质量,特别是干预措施的报告质量,从而促进其解释和复制。随后对 STRICTA 的应用和影响进行的审查强调了 STRICTA 的价值以及改进和修订的范围。为了管理修订过程,STRICTA 小组、CONSORT 小组和中国 Cochrane 中心于 2008 年进行了合作。召集了一个由 47 名参与者组成的专家小组,对清单的修订草案提供电子反馈。在随后于弗莱堡举行的面对面会议上,21 名参与者进一步修订了 STRICTA 清单并计划进行传播。新的 STRICTA 清单是 CONSORT 的正式扩展,包括六个项目和 17 个子项目。这些项目列出了针刺原理、针刺细节、治疗方案、治疗的其他组成部分、从业者背景以及对照或比较干预措施的报告指南。此外,作为修订过程的一部分,每个项目的说明都进行了详细阐述,并提供了每个项目的良好报告示例。此外,STRICTA 中的“controlled”一词已被“clinical”取代,以表明 STRICTA 适用于广泛的临床评估设计,包括无对照结局研究和病例报告。修订后的 STRICTA 与主要的 CONSORT 声明及其对非药物治疗的扩展一起,旨在提高针刺临床试验报告的质量。

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