针刺临床试验干预措施报告标准的修订：CONSORT声明的扩展

doi:10.3736/jcim20100902

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 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.

Key words: Acupuncture, Clinical trials, Randomized controlled trials, Guidelines, Intervention studies, STRICTA, CONSORT

Hugh MacPherson , Douglas G Altman , Richard Hammerschlag , Youping Li , Taixiang Wu , Adrian White, David Moher . Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement (Chinese version). Journal of Chinese Integrative Medicine, 2010, 8(9): 804-818.

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URL: http://www.jcimjournal.com/EN/10.3736/jcim20100902

http://www.jcimjournal.com/EN/Y2010/V8/I9/804

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Figures/Tables 2

论文章节/主题	条目号	CONSORT 2010声明* 对清单条目^[10]的描述	非药物临床试验的CONSORT 扩展版附加条目^[14]中增加的内容
文题和摘要
	1a	文题能识别是随机临床试验	在摘要中描述试验措施、对照措施、医护提供者、试验中心和施盲情况
	1b	结构式摘要,包括试验设计、方法、结果、结论几个部分（具体的指导建议参见“CONSORT for abstracts”^[58,59]）
引言
背景和目的	2a	科学背景和对试验理由的解释
	2b	具体目的或假设
方法
试验设计	3a	描述试验设计（诸如平行设计、析因设计）,包括受试者分配入各组的比例
	3b	试验开始后对试验方法所作的重要改变（如合格受试者的挑选标准）,并说明原因
受试者	4a	受试者合格标准	条件允许时,详述试验中心以及实施干预者的合格标准
	4b	资料收集的场所和地点
干预措施	5	详细描述各组干预措施的细节以使他人能够重复,包括它们实际上是在何时、如何实施的	精确地描述试验措施和对照措施的细节,详见表1
结局指标	6a	完整而确切地说明预先设定的主要和次要结局指标,包括它们是在何时、如何测评的
	6b	试验开始后对结局指标是否有任何更改,并说明原因
样本量	7a	如何确定样本量	如存在相应情况,详述是否及如何由医护人员或中心将患者分类
	7b	必要时,解释中期分析和试验中止原则
随机方法
序列的产生	8a	产生随机分配序列的方法	如存在相应情况,如何分配医护人员到各试验组
	8b	随机方法的类型,任何限定的细节（如怎样分区组和各区组样本多少）
分配隐藏机制	9	用于执行随机分配序列的机制（例如按序编码的封藏法）,描述干预措施分配之前为隐藏序列号所采取的步骤
实施	10	谁产生随机分配序列,谁招募受试者,谁给受试者分配干预措施
盲法	11a	如果实施了盲法,分配干预措施之后对谁设盲（例如受试者、医护提供者、结局评估者）,以及盲法是如何实施的	是否在分组时对联合干预实施者设盲。如果设盲,设盲的方法及描述干预措施的相似之处
	11b	如有必要,描述干预措施的相似之处
统计学方法	12a	用于比较各组主要和次要结局指标的统计学方法	如有相关情况,描述是否及如何由医护人员或中心将患者分类
	12b	附加分析的方法,诸如亚组分析和校正分析
结果
受试者流程（极力推荐使用流程图）	13a	随机分配到各组的受试者例数,接受已分配治疗的例数,以及纳入主要结局分析的例数	每组中实施干预的医护人员或中心数量以及每个医护人员或在每个试验中心治疗的患者例数
	13b	随机分组后,各组脱落和被剔除的例数,并说明原因
干预的实施			实施过程中描述试验措施和对照措施的细节
招募受试者	14a	招募期和随访时间的长短,并说明具体日期
	14b	为什么试验中断或停止
基线资料	15	用一张表格列出每一组受试者的基线数据,包括人口学资料和临床特征	尽可能描述每组中的医护提供者（病例数量、资质、专业技能等）和中心（数量）
纳入分析的例数	16	各组纳入每一种分析的受试者数目（分母）,以及是否按最初的分组分析
结局和估计值	17a	各组每一项主要和次要结局指标的结果,效应估计值及其精确性（如95%可信区间）
	17b	对于二分类结局,建议同时提供相对效应值和绝对效应值
辅助分析	18	所做的其他分析的结果,包括亚组分析和校正分析,指出哪些是预先设定的分析,哪些是新尝试的分析
危害	19	各组出现的所有严重危害或意外效应（具体的指导建议参见“CONSORT for harms”^[60]）
讨论
局限性	20	试验的局限性,报告潜在偏倚和不精确的原因,以及出现多种分析结果的原因（如果有这种情况的话）
可推广性	21	试验结果被推广的可能性（外部可靠性,实用性）	根据试验涉及的干预、对照、患者以及医护人员和中心得出的试验结果的可推广性（外部真实性）
解释	22	与结果相对应的解释,权衡试验结果的利弊,并且考虑其他相关证据	此外,还要考虑对照的选择,缺乏盲法或部分盲法,各组医护人员或中心专业技能的不一致
其他信息
试验注册	23	临床试验注册号和注册机构名称
试验方案	24	如果有的话,在哪里可以获取完整的试验方案
资助	25	资助和其他支持（如提供药品）的来源,提供资助者所起的作用

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条目	细节
1. 针刺治疗的合理性	1a）针刺治疗的类型（如中医针刺、日本汉方医学针刺、韩医针刺、西医针刺、五行针、耳针等）。
	1b）所提供的针刺治疗的理由、依据的历史背景、文献来源和（或）形成共识的方法,在适当的地方引用文献。
	1c）说明对何种治疗作了变动。
2. 针刺的细节	2a）每一受试对象每个治疗单元用针的数目（如可能,用均数和范围表示）。
	2b）使用的穴位名称（单侧/双侧）（如无标准名称则说明位置）。
	2c）进针的深度,采用指定的计量单位或特定的组织层面描述。
	2d）引发的机体反应（如得气或肌肉抽动反应）。
	2e）针刺刺激方式（如手针刺激或电针刺激）。
	2f）留针时间。
	2g）针具类型（直径、长度和生产厂家或材质）。
3. 治疗方案	3a）治疗单元数。
	3b）治疗单元的频数和持续时间。
4. 其他干预措施	4a）对针刺组施加的其他干预措施的细节（如艾灸、拔罐、中药、锻炼、生活方式建议）。
	4b）治疗场所和相关信息,包括对治疗师的操作指导,以及给患者的信息和解释。
5. 治疗师的背景	5）对参与研究的针灸师的描述（资质或从业部门,从事针刺实践的年数,其他相关经历）。
6. 对照或对照干预	6a）在研究问题的阐述中援引资料说明选择对照或对照措施的合理性。
	6b）精确地描述对照或对照措施。如果采用假针刺或其他任何一种类似针刺的对照措施,则提供条目1到条目3所要求的详细信息。

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

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