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Journal of Chinese Integrative Medicine ›› 2009, Vol. 7 ›› Issue (9): 889-896.doi: 10.3736/jcim20090918

• Biomedical Publication • Previous Articles     Next Articles

Preferred reporting items for systematic reviews and meta-analyses:The PRISMA statement (Chinese edition)

David Mohera,b,Alessandro Liberatic,d,Jennifer Tetzlaffa,Douglas G. Altmanf,The PRISMA Group   

  1. a Ottawa Methods Centre, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
    b Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
    c Universita di Modena e Reggio Emilia, Modena, Italy
    d Centro Cochrane Italiano, Istituto Ricerche Farmacologiche Mario Negri, Milan, Italy
    e Centre for Statistics in Medicine, University of Oxford，Oxford，United Kingdom
  • Received:2009-08-11 Accepted:2009-08-25 Online:2009-09-20 Published:2009-09-15

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Key words: Systematic review, Meta-analysis, PRISMA

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项目 编号 条目清单 所在页码
标题
标题 1 明确本研究报告是系统综述、meta分析,还是两者兼有
摘要
结构式摘要 2 提供结构式摘要包括背景、目的、资料来源、纳入研究的标准、研究对象和干预措施、研究评价和综合的方法、结果、局限性、结论和主要发现、系统综述的注册号
前言
理论基础 3 介绍当前已知的研究理论基础
目的 4 通过对研究对象、干预措施、对照措施、结局指标和研究类型（participants, interventions, comparisons, outcomes, study design, PICOS）5个方面为导向的问题提出所需要解决的清晰明确的研究问题
方法
方案和注册 5 如果已有研究方案,则说明方案内容并给出可获得该方案的途径（如网址）,并且提供现有的已注册的研究信息,包括注册号
纳入标准 6 将指定的研究特征（如PICOS和随访的期限）和报告的特征（如检索年限、语种和发表情况）作为纳入研究的标准,并给出合理的说明
信息来源 7 针对每次检索及最终检索的结果描述所有文献信息的来源（如资料库文献,与研究作者联系获取相应的文献）
检索 8 至少说明一个资料库的检索方法,包含所有的检索策略的使用,使得检索结果可以重现
研究选择 9 说明纳入研究被选择的过程（包括初筛、合格性鉴定及纳入系统综述等步骤,据实还可包括纳入meta分析的过程）
资料提取 10 描述资料提取的方法（例如预提取表格、独立提取、重复提取）以及任何向报告作者获取或确认资料的过程
资料条目 11 列出并说明所有资料相关的条目（如PICOS和资金来源）,以及作出的任何推断和简化形式
单个研究存在
的偏倚		 12 描述用于评价单个研究偏倚的方法（包括该方法是否用于研究层面或结局层面）,以及在资料综合中该信息如何被利用
概括效应指标 13 说明主要的综合结局指标,如危险度比值（risk ratio）、均值差（difference in means）
结果综合 14 描述结果综合的方法,如果进行了meta分析,则说明异质性检验的方法
研究偏倚 15 详细评估可能影响数据综合结果的可能存在的偏倚（如发表偏倚和研究中的选择性报告偏倚）
其他分析 16 对研究中其他的分析方法进行描述（如敏感性分析或亚组分析,meta回归分析）,并说明哪些分析是预先制定的
结果
研究选择 17 报告初筛的文献数,评价符合纳入标准的文献数以及最终纳入研究的文献数,同时给出每一步排除文献的原因,最好提供流程图
研究特征 18 说明每一个被提取资料的文献的特征（如样本含量、PICOS和随访时间）并提供引文出处
研究内部偏倚
风险		 19 说明每个研究中可能存在偏倚的相关数据,如果条件允许,还需要说明结局层面的评估（见条目12）
单个研究的结果 20 针对所有结局指标（有效性或有害性）,说明每个研究的各干预组结果的简单合并（a）,以及综合效应值及其可信区间（b）,最好以森林图形式报告
结果的综合 21 说明每个meta分析的结果,包括可信区间和异质性检验的结果
研究间偏倚 22 说明研究间可能存在偏倚的评价结果（见条目15）
其他分析 23 如果有,给出其他分析的结果（如敏感性分析或亚组分析,meta-回归分析,见条目16）
讨论
证据总结 24 总结研究的主要发现,包括每一个主要结局的证据强度;分析它们与主要利益集团的关联性（如医疗保健的提供者、使用者及政策决策者）
局限性 25 探讨研究层面和结局层面的局限性（如偏倚的风险）,以及系统综述的局限性（如检索不全面,报告偏倚等）
结论 26 给出对结果的概要性的解析,并提出对未来研究的提示
资金支持
资金 27 描述本系统综述的资金来源和其他支持（如提供资料）以及资助者在完成系统综述中所起的作用

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项目 条目 QUOROM PRISMA 解释
摘要 √ √ QUOROM和PRISMA都要求作者报告摘要,然而PRISMA并未在格式上作特殊要求。
前言 目的 √ 这个新的条目（4）要求针对PICOS列出详细的问题（包括对系统综述的研究对象、干预措施、对照和结局的描述）,再结合研究的设计类型;本条目与条目6、11和18均有关联。
方法 方案 √ 这个新条目（5）要求作者报告本系统综述是否已发表研究方案,并要求告知获取该发表方案的途径。
方法 检索 √ √ 尽管QUOROM和PRISMA都包含报告检索方法的条目,但在PRISMA中要求作者至少提供对一个检索库的详细检索策略（条目8）,使得作者的检索结果可以被重复实现。
方法 评价纳入研究
的偏倚		 √ √ 对QUOROM中的“质量评价”作了重命名。该条目（12）与报告结果（条目19）相关。对新的概念“结局层面”的分析评估前面已经提及了。
方法 评价研究间
的偏倚		 √ 这个新条目（15）要求作者描述系统综述中任何可能存在的偏倚风险,例如对于纳入研究的选择性报告偏倚。这个条目也与结果报告（条目22）相关。
讨论 √ √ 尽管QUOROM和PRISMA的条目中都包含了讨论部分,但是在PRISMA条目中讨论部分占了3条（条目24~26）。其中局限性是被特别强调要求详细说明的。
资金 √ 这个新条目（27）要求作者提供本系统综述所有资金支持的详细信息。

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完成一个系统综述是一个反复的过程 一项系统综述的实施与所纳入研究的规模和质量息息相关,因此在操作的过程中,有可能需要对原有的方案进行调整。系统综述报告指南则应该建议上述更改可以进行报告和解释,而不用认为它们是不合理的。《PRISMA声明》（条目5、11、16和23）体现了这个反复的过程。除Cochrane系统综述要求所有的综述都要首先提交方案外,其余的系统综述只有10%是从制定方案开始的[22]。如果没有公开发布的方案,将各种各样的修订在合理与不合理之间做出界定是十分困难的。
实施和报告研究是两个不同的概念 虽说两者是不同的概念,对系统综述来说,其差异并不像单个研究报告的实施和报告之间的差异那么直接,这是因为系统综述的本质决定了其实施与报告必须是彼此紧密联系的。例如,系统综述未能报告对纳入的研究进行偏倚风险的评估,则意味着该系统综述的实施质量较差,表明对纳入研究的质量进行评估对系统综述过程来说十分重要[37]。
在研究层面以及结局层面对偏倚的风险作出评估 在一个系统综述中对纳入研究可能存在的偏倚进行深入的风险评估,不仅要求“研究层面”（study level）的评估（例如随机分配方案的隐藏是否充分）,针对某些特点,还需要一种新的方法,称为“结局层面”（outcome level）的评估。其过程涉及每一项单个研究中通过判断它们各自对重要结局的测量方法来评价这些重要结局相关数据的可靠性与真实性[38]。对于不同的结局,证据的质量也可能有所不同,甚至在同一个研究中也会如此。比如对一个主要疗效结局的评估和一个严重危害的评估[39]就有可能很不一样,因为前者的测量往往非常细致并且系统,后者却未必。这样的信息应该进行报告,从而对正确评价疗效的范围进行明确而详细的评估[38]。
报告偏倚的重要性 不同类型的报告偏倚有可能削弱系统综述的实施和解读。当进行一项系统综述并报告结果时,研究者应该考虑到对于完整研究的选择性报告（例如发表偏倚）[28]以及新近基于经验得到验证的单个研究中的“结局报告偏倚”[40, 41]。虽然这些偏倚对系统综述的实施和报告可能产生的影响还不清楚,先前的一些研究已经显示选择性结局报告同样有可能存在于系统综述中[42]。
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