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摘要: 证据合成即使用系统、明确的方法对现有研究进行合成。目前的证据合成方法种类众多，应用领域广泛，如何选择和使用最佳的证据合成方法是研究人员、政策制定者和其他利益相关者普遍关注的问题。本文在归纳与总结证据合成方法发展现状和分类的基础上，阐述证据合成方法的定义、特点及应用中存在的问题，并就证据合成方法应用中面临的问题与挑战提出思考与建议。Abstract: Evidence synthesis is the synthesis of existing research using a systematic and appropriate method. Various types of evidence synthesis are currently in use. Correctly choosing and applying the best evidence synthesis method is crucial for researchers, policymakers, and stakeholders. Thus, based on summarizing the current situation, progress, and classification of evidence synthesis methods, we introduced the definition and characteristics of common evidence synthesis methods and problems in their application, and presented thoughts and suggestions for the problems in the application of evidence synthesis methods.
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Key words:
- evidence synthesis /
- methodology /
- current situation and progress
作者贡献：苏仁凤、玉炫负责资料搜集、整理分析并撰写论文初稿；史乾灵、罗旭飞、孙雅佳、兰慧、任梦娟、吴守媛、王平、王玲、赵俊贤负责论文初稿修订；陈耀龙负责论文选题、结构设计、团队组建、质量控制及审校。利益冲突：所有作者均声明不存在利益冲突 -
表 1 证据合成领域的重要事件
年份 重要事件 1753 Lind首次提出研究合成在减少偏倚中的重要性[5] 1904 Karl最早使用Meta分析对接种伤寒疫苗与死亡率的相关性进行分析[7] 1972 Cochrane发表《疗效与效益：健康服务中的随想》，提出应对随机对照试验进行系统评价[8] 1976 Glass正式提出Meta分析的概念及其统计分析方法[9] 1977 Glass和Smith最早在社会科学领域使用Meta分析[10] 1992 Chalmers在英国牛津成立首个Cochrane中心 1993 Cochrane协作网在英国牛津正式成立，旨在为临床治疗实践和医疗卫生决策提供科学依据 1999 Moher等最早提出QUOROM(Quality of Reporting of Meta-analyses)声明，旨在提高随机对照试验Meta分析的报告质量[11] 2000 Campbell协作网在宾西法尼亚大学正式成立，旨在为非医学领域提供系统评价证据 2004 GRADE工作组在BMJ发表《如何针对研究合成的结论进行分级》的方法学文章[12] 2009 Moher等更新了QUOROM声明，并将其更名为PRISMA(Preferred Reporting Items for Systematic Reviews and Meta-analyses)[13] 2010 Research Synthesis Methods创刊，是国际上首本关于研究合成方法的学术杂志 2011 英国国家健康研究所(National Institute for Health Research)下设的评价和传播中心(Centre for Reviews and Dissemination)建立PROSPERO注册平台，为全球系统评价提供免费注册 2011 美国医学科学院将系统评价写入指南新定义[14] 2012 Systematic Review创刊，是国际上首本专门发表系统评价及其研究方法的学术杂志 2020 证据合成国际网络发布立场声明，提出证据合成国际网络的9项核心原则和5个主要目标[6] 
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表 2 证据合成方法及其与系统评价的区别和联系
证据合成方法 其他术语 定义 特征及其与系统评价的区别和联系 系统评价 (systematic review) 系统综述 通过系统检索某一主题的所有相关研究，按照纳排标准进行文献筛选，对纳入研究进行严格的偏倚风险和证据质量评价，并对各研究结果进行定量合成或定性客观评价，以对拟解决的问题进行系统总结的方法[18] 相较于其他证据合成方法，系统评价在方法学上更具透明性、可重复性、系统性和可更新性，但在其制作的各步骤中均可能产生偏倚，如检索文献不全导致抽样偏倚、文献筛选出现选择偏倚等[19] 快速评价 (rapid review) 快速综述、快速评估 通过加速或简化系统评价的制作流程，以在短时间内为决策者作出紧急决策提供信息[20-21] 虽然快速评价与系统评价在制作流程上存在相似之处，但其制作周期更短，决策者常将其用于突发事件或需快速作出反应的决策中[22]。简化检索策略、限制灰色文献数量、仅提取关键变量，以及进行简单的质量评价等均可缩短快速评价的制作时间，但易增加偏倚风险，如限制检索时间导致发表偏倚、限制质量评价导致研究结果可信度降低等[23] 概况性评价 (scoping review) 范围综述、范围审查、概况性综述 通过系统检索初步评估文献的潜在规模和范围的方法[24]，倾向于关注研究的广度而非深度 与系统评价相似，概况性评价同样遵循系统的检索流程，但二者关注的研究目的不同。系统评价倾向于解决具体的研究问题，而概况性评价主要用于识别特定领域的证据类型、确定文献的关键概念或定义、识别研究差距，为系统评价提供依据等[24]。由于通常不对文献的方法学质量进行评价，其结果易存在偏倚，因此不建议用于政策制定[23] 证据地图 (evidence map/mapping review/systematic map) 证据图谱、证据图 通过对相关领域现有证据进行系统检索，以确定研究空白和未来研究需求，并以表格或图形直观呈现结果的方法[25]，有助于判断是否进一步开展系统评价 相较于系统评价，证据地图侧重于呈现某个领域研究的整体情况，而不进行深入分析。证据地图仅对纳入研究进行描述性分析，易导致结果过度简化，掩盖研究与结果间的异质性。由于其通常不对纳入研究进行质量评价，研究结论的可靠性较差[23] 系统评价再评价 (overview of review) 伞型评价、元评价 通过全面收集拟解决问题的多个相关系统评价进行综合研究的方法[26] 有助于解决多个系统评价结果或结论不一致的问题，可为决策者和使用者提供更为集中的高质量证据，但其结论可靠性受纳入研究质量的影响 动态系统评价 (living syste-matic review) / 通过定期更新以实时纳入最新相关研究的系统评价[27]，对提高结果的准确性、时效性与适用性发挥重要作用 相较于传统系统评价，动态系统评价的可持续性更新将带来额外的工作量，需要稳定的团队进行持续性制作。更新系统评价可能涉及数据的重新分析，易增加Ⅰ类错误(即假阳性错误)的发生风险[28]。其主要特点在于保证系统评价结果的时效性、准确性和临床适用性 元民族志 (meta-ethnography) Meta民族志、元人种学、元人种志 通过对比分析原始研究的核心概念以产生新知识、新理解和新发现的解释性方法[29] 与系统评价注重检索的全面性不同，元民族志采用目的性抽样进行资料收集，直至达到理论饱和。作为定性研究证据合成的常用方法，元民族志的特点在于不局限于既定框架，可根据纳入研究的主题进行合成，对发展理论体系、理论框架和高阶模型具有重要意义[30] 主题综合 (thematic synthesis) 主题合成、主题集成 是一种基于主题分析合成原始研究的解释性方法[31]。主题综合涉及三个阶段：第一阶段是对单个研究结果逐行自由编码；第二阶段是应用自由编码构建“描述性主题”；第三阶段是形成“分析性主题”[31] 相较于系统评价，主题综合更能反映定性研究结果的主题观点。主题综合结合了扎根理论和元民族志的方法，主要取决于研究人员的经验和理论知识，易受研究人员的主观影响，但也更易被理解和接受，在定性研究证据合成中较为常用 框架综合 (framework synthesis) 框架合成、框架集成 采用预先建立的框架提取和合成结果的高度结构化方法，其中预先框架由背景材料和团队讨论形成[32] 与系统评价及其他证据合成方法不同，框架综合采用预先建立的框架提取和合成结果，其在很大程度上是一种演绎方法。该方法最初仅用于定性研究，但有学者认为此方法适用于所有研究类型[33] 扎根理论 (grounded theory) / 通过系统收集、分析与归纳相关研究以产生更高层次理论的方法[34]，包括三种流派，分别为原始扎根理论、程序化扎根理论和建构型扎根理论[35] 与系统评价相对线性的过程不同，扎根理论需不断迭代和深入，对数据进行反复分析和解释。扎根理论能够从经验数据中建构新的概念和理论，而非仅对其进行描述[35]。比较是贯穿扎根理论整个研究过程的分析思路，其中常数比较法最为常见[36]。在扎根理论编码过程中，研究人员需警惕资料过度切割与碎片化，导致无法产生更高层次的理论 /：无其他术语
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表 3 证据合成方法研究报告规范汇总
序号 报告规范 发表年份 条目数量
(个)适用研究类型 适用范围 1 PRISMA 2009[45] 2009 27 系统评价和Meta分析 全文 2 PRISMA-Equity[46] 2012 27 公平性系统评价和Meta分析 全文 3 PRISMA-Abstracts[47] 2013 12 系统评价和Meta分析 摘要 4 PRISMA-NMA[48] 2015 27 网状Meta分析 全文 5 PRISMA-IPD[49] 2015 27 单个病例数据系统评价和Meta分析 全文 6 PRISMA-P[50] 2015 17 系统评价和Meta分析计划书 全文 7 PRISMA-Harms[51] 2016 27 系统评价和Meta分析 危害/不良反应/安全性数据 8 PRISMA-CI[52] 2017 33 复杂干预系统评价和Meta分析 全文 9 PRISMA-ScR[53] 2018 22 概况性评价 全文 10 PRISMA-DTA[54] 2018 27 诊断准确性试验系统评价和Meta分析 全文 11 PRISMA-A[55] 2019 27 针灸系统评价和Meta分析 全文 12 PRISMA-M[56] 2020 27 艾灸系统评价和Meta分析 全文 13 PRISMA-CHM[57] 2020 24 中草药系统评价和Meta分析 全文 14 PRISMA 2020[58] 2021 27 系统评价和Meta分析 全文 15 PRISMA-S[59] 2021 16 系统评价和Meta分析 方法 16 PRISMA-DTA for Abstracts[60] 2021 12 诊断准确性试验系统评价和Meta分析 摘要 17 PRISMA-EcoEvo[61] 2021 27 生态学和进化生物学系统评价和Meta分析 全文 18 PRISMA-ATCM[62] 2022 27 中医药领域动物实验系统评价和Meta分析 全文 19 RAMESES: meta-narrative reviews[63] 2013 20 元叙事 全文 20 RAMESES: realist syntheses[64] 2013 19 现实主义综合 全文 21 ENTREQ[65] 2012 21 定性合成研究 方法/讨论 22 PRIO-harms[66] 2018 27 系统评价再评价 危害/不良反应/安全性数据/全文 23 eMERGe[67] 2019 19 元民族志 全文 24 SwiM[68] 2020 9 无Meta分析的系统评价 方法/结果/讨论 25 PRIOR[69] 2022 27 系统评价再评价 全文 PRISMA：系统评价和Meta分析的优先报告条目；PRISMA-Equity：公平性系统评价和Meta分析的优先报告条目；PRISMA-NMA：网状Meta分析的优先报告条目；PRISMA-Abstracts：系统评价和Meta分析摘要的优先报告条目；PRISMA-IPD：单个病例数据系统评价和Meta分析的优先报告条目；PRISMA-P：系统评价和Meta分析研究计划书的优先报告条目；PRISMA-Harms：PRISMA危害报告清单：改进系统评价中危害的报告；PRISMA-CI：复杂干预系统评价和Meta分析报告规范；PRISMA-ScR：概况性评价的优先报告条目；PRISMA-DTA：诊断准确性试验系统评价和Meta分析的优先报告条目；PRISMA-A：针灸系统评价和Meta分析的优先报告条目；PRISMA-M：艾灸系统评价和Meta分析报告规范；PRISMA-CHM：中草药系统评价和Meta分析报告规范；PRISMA-S：系统评价和Meta分析文献检索的优先报告条目；PRISMA-DTA for Abstracts：诊断准确性试验系统评价和Meta分析摘要的优先报告条目；PRISMA-EcoEvo：生态学和进化生物学系统评价和Meta分析的优选报告条目；PRISMA-ATCM：中医药领域动物实验系统评价报告规范；RAMESES: meta-narrative reviews：元叙事报告规范；RAMESES：realist syntheses：现实主义综合报告规范；ENTREQ：提高定性合成研究报告透明度声明；PRIO-harms：系统评价再评价危害报告清单；eMERGe：元民族志报告规范；SwiM：无Meta分析的系统评价报告规范；PRIOR：系统评价再评价的优先报告条目
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