摘要
"针刺临床试验干预措施报告标准"(STandards for Reporting Interventions in Clinical Trials of Acupuncture,STRICTA)于2001年和2002年在5种期刊上发表。该指南以对照检查清单及解释的形式供作者和期刊编辑使用,旨在提高针刺临床试验报告的质量,尤其是对其中干预措施的报告,因而有助于对这些试验的解释和重复。随后对STRICTA的应用及影响的述评都强调了STRICTA的价值,也提出了改进和修订的建议。为使修订过程顺利进行,STRICTA工作组、CONSORT工作组和中国Cochrane中心于2008年开始合作。召集成立的有47名成员的专家组对清单的修改稿提出了电子版反馈意见。在后来于弗莱堡(Freiburg)召开的见面会上,由21名专家组成的工作组进一步修订了STRICTA对照检查清单,并计划如何对其进行发布。新的STRICTA对照检查清单作为CONSORT的正式扩展版,包含6项条目及17条二级条目。这些条目为报告针刺治疗的合理性、针刺的细节、治疗方案、其他干预措施、治疗师的背景以及对照或对照干预提供了指南。而且,作为修订工作的一部分,对每一条目作了详尽解释,并针对每一条目给出了报告良好的实例。此外,STRICTA中的"对照"(controlled)一词被替换成了"临床"(clinical),以示STRICTA适用于更广泛的各类临床评价设计,包括非对照结局研究和病例报道。修订的STRICTA对照检查清单有望与CONSORT声明及其非药物治疗扩展版一起共同提高针刺临床试验的报告质量。
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 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.
出处
《中西医结合学报》
CAS
2010年第9期804-818,共15页
Journal of Chinese Integrative Medicine
基金
White RoseHealth Innovation Partnership
Enterprise and Innovation Office
Charles Thackrah Building
101 Clarendon Road
Leeds LS2 9LJ
Leeds
UK提供资金支持
UK National Institute for Health Research的一项Career Scientist Award资助
Cancer Research UK资助
University of Ottawa Research Chair资助
