AMSTER-2是在其第一代AMSTER (A measurement tool for the ‘assessment of multiple systematic reviews’)基础上修订的系统评价/Meta分析方法学质量评价工具，适用于随机对照研究或非随机干预研究或两者都有的系统评价。本文着重介绍AMSTER-2的概述、使用方法、评价清单及清单详细内容。关于AMSTER-2清单内容解读详见Meta分析质量评价——AMSTER (A Measure Tool to Assess Systematic Reviews) - 2 (下)。
关键词：Meta分析; Meta分析质量评价; AMSTER-2
一、AMSTER-2概述
在循证医学中，高质量的RCTs系统综述/Meta分析被列为 I 级/A级证，可以为临床诊疗决策提供重要信息。但如何评价系统综述/Meta分析的质量，是证据使用者面临的难题。A Measure Tool to Assess Systematic Reviews (AMSTER)是目前国际上最为常用的系统综述/Meta分析质量评价工具。第一版的AMSTER于2007年制定并发表，2017年被修订和更新后发表AMSTER-2。
二、AMSTER-2使用方法
AMSTAR-2适用于随机对照研究(RCTs)或非随机干预研究(NRSI)或两者都有的系统综述，不包括诊断试验准确性研究系统评价、网状meta分析、单个病例数据的meta分析、概况性评价和现实主义评价。
AMSTER-2共有16个条目，主要涉及研究方法、文献筛选和偏倚风险等方面，评价选项分别为“是”“部分是”和“否”。AMSTAR-2并不是根据每个条目的评价结果计算一个总分，因为高得分可能会掩盖一些非常严重的方法学缺陷，如文献检索不全或未对纳入的研究进行偏倚风险评估。因此，AMSTAR-2推荐重点考虑关键条目是否存在方法学缺陷，并据此评价Meta分析的总体质量，并对总的评价结果进行“可信度(Overall Confidence)”分级(见下表)。关键条目包括：第2、4、7、9、11、13和15条。
表1 系统综述/Meta分析质量评价可信度分级
| Rating overall confidence 可信度分级 | Content 内容 |
| High 高 | No or one non-critical weakness: the systematic review provides an accurate and comprehensive summary of the results of the available studies that address the question of interest |
| 译文：无或仅1个非关键条目不合格：针对研究问题，系统评价基于可获取研究的结果提供了准确而全面的总结 | |
| Moderate 中 | More than one non-critical weakness*: the systematic review has more than one weakness but no critical flaws. It may provide an accurate summary of the results of the available studies that were included in the review |
| 译文：超过1个非关键条目不合格*：基于可获取研究的结果，系统评价可能提供了准确的总结 | |
| Low 低 | One critical flaw with or without non-critical weaknesses: the review has a critical flaw and may not provide an accurate and comprehensive summary of the available studies that address the question of interest |
| 译文：1个关键条目不合格并且有或没有非关键条目不合格：基于可获取研究的结果，系统评价可能难以提供准确而全面的总结 | |
| Critically low 极低 | More than one critical flaw with or without non-critical weaknesses: the review has more than one critical flaw and should not be relied on to provide an accurate and comprehensive summary of the available studies |
| 译文：超过1个关键条目不合格，有或没有非关键条目不合格：基于可获取研究的结果，系统评价不可能提供准确而全面的总结 |
*Multiple non-critical weaknesses may diminish confidence in the review and it may be appropriate to move the overall appraisal down from moderate to low confidence.
译文：*表示当多个非关键条目不合格时，会降低系统评价的可信度分级，可从中等降级至低等。
三、AMSTER-2评价清单
| Items 条目 | Evaluation options 评价选项 |
| 1. Did the research questions and inclusion criteria for the review include the components of PICO? | Yes No |
| 译文：1. 研究问题和纳入标准是否包括PICO部分？ | 是 否 |
| 2. Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol? | Yes Partial Yes No |
| 译文：2. 是否声明在系统评价实施前确定了系统评价的研究方法？对于与研究方案不一致之处是否进行了说明？ | 是 部分是 否 |
| 3. Did the review authors explain their selection of the study designs for inclusion in the review? | Yes No |
| 译文：3. 系统评价者是否说明了纳入文献的研究类型？ | 是 否 |
| 4. Did the review authors use a comprehensive literature search strategy? | Yes Partial Yes No |
| 译文：4. 系统评价者的文献检索策略是否全面？ | 是 部分是 否 |
| 5. Did the review authors perform study selection in duplicate? | Yes No |
| 译文：5. 系统评价者是否采取了双人重复筛选文献？ | 是 否 |
| 6. Did the review authors perform data extraction in duplicate? | Yes No |
| 译文：6. 系统评价者是否采取了双人重复提取数据？ | 是 否 |
| 7. Did the review authors provide a list of excluded studies and justify the exclusions? | Yes Partial Yes No |
| 译文：7. 系统评价者是否提供了排除文献的清单并说明理由？ | 是 部分是 否 |
| 8. Did the review authors describe the included studies in adequate detail? | Yes Partial Yes No |
| 译文：8. 系统评价者是否详细描述了纳入的研究？ | 是 部分是 否 |
| 9. Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review? | Yes Partial Yes No Includes only NRSI or RCTs |
| 译文：9. 系统评价者是否使用了合适的工具来评估每项纳入研究的偏倚风险(RoB)？ | 是 部分是 否 仅纳入NRSI或RCTs |
| 10. Did the review authors report on the sources of funding for the studies included in the review? | Yes No |
| 译文：10. 系统评价者是否报告了各项纳入研究的资助来源？ | 是 否 |
| 11. If meta-analysis was performed did the review authors use appropriate methods for statistical combination of results? | Yes No No meta-analysis conducted |
| 译文：11. 如果开展了Meta分析，系统评价者是否使用了合适的统计学方法合并研究结果？ | 是 否 未进行Meta分析 |
| 12. If meta-analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta-analysis or other evidence synthesis? | Yes No No meta-analysis conducted |
| 译文：12. 如果开展了Meta分析，系统评价者是否评估了每个研究的偏倚风险对Meta分析结果或其他证据综合结果的潜在影响？ | 是 否 未进行Meta分析 |
| 13. Did the review authors account for RoB in individual studies when interpreting/ discussing the results of the review? | Yes No |
| 译文：13. 系统评价者在解释/讨论研究结果时是否考虑了纳入研究的偏倚风险？ | 是 否 |
| 14. Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? | Yes No |
| 译文：14. 系统评价者是否对研究结果的异质性给出了合理的解释和讨论？ | 是 否 |
| 15. If they performed quantitative synthesis did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? | Yes No No meta-analysis conducted |
| 译文：15. 如果系统评价者进行了定量合并，是否对发表偏倚(小样本研究偏倚)进行了充分的调查，并讨论了其对结果可能产生的影响？ | 是 否 未进行Meta分析 |
| 16. Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review? | Yes No |
| 译文：16. 系统评价者是否报告了任何潜在的利益冲突来源，包括所接受的任何用于进行系统评价的资助？ | 是 否 |
四、AMSTER-2评价清单详细内容
| 1. Did the research questions and inclusion criteria for the review include the components of PICO? | ||
| For Yes: Population Intervention Comparator group Outcome | Optional (recommended) Timeframe for follow-up | Yes No |
| 译文：1. 研究问题和纳入标准是否包括PICO部分？ | ||
| “是”： 研究对象 干预措施 对照组 结局指标 | 备选(推荐)： 随访期限 | 是 否 |
| 2. Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol? | ||
| For Partial Yes: The authors state that they had a written protocol or guide that included ALL the following: review question(s) a search strategy inclusion/exclusion criteria a risk of bias assessment | For Yes: As for partial yes, plus the protocol should be registered and should also have specified: a meta-analysis/synthesis plan, if appropriate, and a plan for investigating causes of heterogeneity justification for any deviations from the protocol | Yes Partial Yes No |
| 译文：2. 是否声明在系统评价实施前确定了系统评价的研究方法？对于与研究方案不一致之处是否进行了说明？ | ||
| “部分是”： 作者声明有成文的研究方案或指导文件，包括以下内容： 研究问题 检索策略 纳入/排除标准 偏倚风险评估 | “是”： 在“部分是”的基础上，研究方案应已注册详细说明以下内容： 如果适合进行Meta分析/数据合并，要有相应方案 异质性原因分析方案 与研究方案不一致的理由 | 是 部分是 否 |
| 3. Did the review authors explain their selection of the study designs for inclusion in the review? | ||
| For Yes, the review should satisfy ONE of the following: Explanation for including only RCTs OR Explanation for including only NRSI OR Explanation for including both RCTs and NRSI | Yes No | |
| 译文：3. 系统评价者是否说明了纳入文献的研究类型？ | ||
| “是”，应满足以下一项： 说明仅纳入RCTs的理由 说明仅纳入NRSI的理由 说明RCTs和NRSI两者都纳入的理由 | 是 否 | |
| 4. Did the review authors use a comprehensive literature search strategy? | ||
| For Partial Yes (all the following): searched at least 2 databases (relevant to research question) provided key word and/or search strategy justified publication restrictions (e.g. language) | For Yes, should also have (all the following): searched the reference lists / bibliographies of included studies searched trial/study registries included/consulted content experts in the field where relevant, searched for grey literature conducted search within 24 months of completion of the review | Yes Partial Yes No |
| 译文：4. 系统评价者的文献检索策略是否全面？ | ||
| “部分是”(满足以下各项)： 至少检索2个与研究问题相关的数据库 提供关键词和/或检索策略 说明文献发表的限制情况，如语言限制 | “是”还应包括以下各项： 检索了纳入研究的参考文献列表/参考书目 检索试验/研究注册库 纳入/咨询该领域的专家 搜索相关灰色文献 在系统评价完成前24个月内进行检索 | 是 部分是 否 |
| 5. Did the review authors perform study selection in duplicate? | ||
| For Yes, either ONE of the following: at least two reviewers independently agreed on selection of eligible studies and achieved consensus on which studies to include OR two reviewers selected a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder selected by one reviewer. | Yes No | |
| 译文：5. 系统评价者是否采取了双人重复筛选文献？ | ||
| “是”，满足以下任一项即可： 至少两名评价员独立筛选文献，并就纳入的文献意见一致 或两名评价员选择的文献样本取得了良好的一致性(Kappa值≥80%)，余下部分由一名评价员完成 | 是 否 | |
| 6. Did the review authors perform data extraction in duplicate? | ||
| For Yes, either ONE of the following: at least two reviewers achieved consensus on which data to extract from included studies OR two reviewers extracted data from a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder extracted by one reviewer. | Yes No | |
| 译文：6. 系统评价者是否采取了双人重复提取数据？ | ||
| “是”，满足以下任一项即可： 至少有两名评价员就纳入研究的数据提取内容达成共识 或两名评价员就文献样本的数据提取取得了良好的一致性(Kappa值≥80%)，余下文献数据提取可由一名评价员完成 | 是 否 | |
| 7. Did the review authors provide a list of excluded studies and justify the exclusions? | ||
| For Partial Yes: provided a list of all potentially relevant studies that were read in full-text form but excluded from the review | For Yes, must also have: Justified the exclusion from the review of each potentially relevant study | Yes Partial Yes No |
| 译文：7. 系统评价者是否提供了排除文献的清单并说明理由？ | ||
| “部分是”： 提供了所有潜在相关研究列表，这些研究都通过阅读全文后排除 | “是”，还必须满足： 说明每项研究被排除的理由 | 是 部分是 否 |
| 8. Did the review authors describe the included studies in adequate detail? | ||
| For Partial Yes (ALL the following): described populations described interventions described comparators described outcomes described research designs | For Yes, should also have ALL the following: described population in detail described intervention in detail (including doses where relevant) described comparator in detail (including doses where relevant) described study’s setting timeframe for follow-up | Yes Partial Yes No |
| 译文：8. 系统评价者是否详细描述了纳入的研究？ | ||
| “部分是”(满足以下各项) 描述研究人群 描述干预措施 描述对照措施 描述结局指标 描述研究类型 | “是”，还应满足以下各项： 详细描述研究人群 详细描述干预措施(包括相关药物剂量) 详细描述对照措施(包括相关药物剂量) 描述研究场所 随访期限 | 是 部分是 否 |
| 9. Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review? | ||
| RCTs： | ||
| For Partial Yes, must have assessed RoB from: unconcealed allocation, and lack of blinding of patients and assessors when assessing outcomes (unnecessary for objective outcomes such as all-cause mortality) | For Yes, must also have assessed RoB from: allocation sequence that was not truly random, and selection of the reported result from among multiple measurements or analyses of a specified outcome | Yes Partial Yes No Includes only NRSI |
| NRSI： | ||
| For Partial Yes, must have assessed RoB: from confounding, and from selection bias | For Yes, must also have assessed RoB: methods used to ascertain exposures and outcomes, and selection of the reported result from among multiple measurements or analyses of a specified outcome | Yes Partial Yes No Includes only RCTs |
| 译文：9. 系统评价者是否使用了合适的工具来评估每项纳入研究的偏倚风险(RoB)？ | ||
| RCTs： | ||
| “部分是”，需评估以下偏倚风险： 未进行分配隐藏 在评估结局时，未对患者和评价人员设盲(对于全因死亡率等客观结局指标可不需要) | “是”，还需评估： 分配序列不是真随机，且 从多个测量结局指标中选择性报告，或只报告指定的结局指标 | 是 部分是 否 仅纳入NRSI |
| NRSI： | ||
| “部分是”，需评估以下偏倚风险： 混杂偏倚 选择偏倚 | “是”，还需评估： 用于确定暴露和结局指标的方法，且 从多个测量指标中选择性报告结果或只报告其中指定的结局指标 | 是 部分是 否 仅纳入RCTs |
| 10. Did the review authors report on the sources of funding for the studies included in the review? | ||
| For Yes： Must have reported on the sources of funding for individual studies included in the review. Note: Reporting that the reviewers looked for this information but it was not reported by study authors also qualifies | Yes No | |
| 译文：10. 系统评价者是否报告了各项纳入研究的资助来源？ | ||
| “是”： 必须报告各项纳入研究的资助来源。注意：评价员查找了这些信息，但研究原作者没有报告资助来源也为合格 | 是 否 | |
| 11. If meta-analysis was performed did the review authors use appropriate methods for statistical combination of results? | ||
| RCTs | ||
| For Yes: The authors justified combining the data in a meta-analysis AND they used an appropriate weighted technique to combine study results and adjusted for heterogeneity if present. AND investigated the causes of any heterogeneity | Yes No No meta-analysis conducted | |
| For NRSI | ||
| For Yes: The authors justified combining the data in a meta-analysis AND they used an appropriate weighted technique to combine study results, adjusting for heterogeneity if present AND they statistically combined effect estimates from NRSI that were adjusted for confounding, rather than combining raw data, or justified combining raw data when adjusted effect estimates were not available AND they reported separate summary estimates for RCTs and NRSI separately when both were included in the review | Yes No No meta-analysis conducted | |
| 译文：11. 如果开展了Meta分析，系统评价者是否使用了合适的统计学方法合并研究结果？ | ||
| RCTs | ||
| “是”： 开展Meta分析时，解释了合并数据的理由 使用合适的加权方法合并研究结果，存在异质性时进行了调整 分析了异质性的原因 | 是 否 未进行Meta分析 | |
| For NRSI | ||
| “是”： 开展Meta分析时，解释了为何合并数据 使用合适的加权方法合并研究结果，存在异质性时进行了调整 将混杂因素调整后再合并NRSI的估计效应量，而不是合并原始数据；当调整的估计效应量未提供时，解释合并原始数据的理由 当纳入RCTs和NRSI时，须分别单独报告RCTs和NRSI的合并估计效应量 | 是 否 未进行Meta分析 | |
| 12. If meta-analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta-analysis or other evidence synthesis? | ||
| For Yes: included only low risk of bias RCTs OR, if the pooled estimate was based on RCTs and/or NRSI at variable RoB, the authors performed analyses to investigate possible impact of RoB on summary estimates of effect. | Yes No No meta-analysis conducted | |
| 译文：12. 如果开展了Meta分析，系统评价者是否评估了每个研究的偏倚风险对Meta分析结果或其他证据综合结果的潜在影响？ | ||
| “是”： 仅纳入低偏倚风险的RCTs 或，当合并估计效应量是基于不同等级偏倚风险的RCTs和/或NRSI时，应分析偏倚风险对总估计效应量可能产生的影响 | 是 否 未进行Meta分析 | |
| 13. Did the review authors account for RoB in individual studies when interpreting/ discussing the results of the review? | ||
| For Yes: included only low risk of bias RCTs OR, if RCTs with moderate or high RoB, or NRSI were included the review provided a discussion of the likely impact of RoB on the results | Yes No | |
| 译文：13. 系统评价者在解释/讨论研究结果时是否考虑了纳入研究的偏倚风险？ | ||
| “是”： 仅纳入低偏倚风险的RCTs 或，如果纳入了中等或高偏倚风险的RCTs或纳入了NRSI，应讨论偏倚风险对结果可能产生的影响 | 是 否 | |
| 14. Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? | ||
| For Yes: There was no significant heterogeneity in the results OR if heterogeneity was present the authors performed an investigation of sources of any heterogeneity in the results and discussed the impact of this on the results of the review | Yes No | |
| 译文：14. 系统评价者是否对研究结果的异质性给出了合理的解释和讨论？ | ||
| “是”： 结果中没有显著的异质性 或，如果存在异质性，对异质性的来源进行讨论，并讨论了其对研究结果的影响 | 是 否 | |
| 15. If they performed quantitative synthesis did the review authors carry out an adequate investigation of publication bias (small study bias) and discuss its likely impact on the results of the review? | ||
| For Yes: performed graphical or statistical tests for publication bias and discussed the likelihood and magnitude of impact of publication bias | Yes No No meta-analysis conducted | |
| 译文：15. 如果系统评价者进行了定量合并，是否对发表偏倚(小样本研究偏倚)进行了充分的调查，并讨论了其对结果可能产生的影响？ | ||
| “是”： 对发表偏倚进行了图形检验或统计学检验，并讨论了发表偏倚存在的可能性和影响的严重程度 | 是 否 未进行Meta分析 | |
| 16. Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review? | ||
| For Yes: The authors reported no competing interests OR The authors described their funding sources and how they managed potential conflicts of interest | Yes No | |
| 译文：16. 系统评价者是否报告了任何潜在的利益冲突来源，包括所接受的任何用于进行系统评价的资助？ | ||
| “是”： 报告没有利益冲突 或，描述了资助来源以及如何处理潜在的利益冲突 | 是 否 | |
注：本文内容是参考相关文献后对AMSTER (A Measure Tool to Assess Systematic Reviews) - 2的概述，仅代表本网站观点。关于AMSTER-2的更多内容详见网站（https://amstar.ca/）或论文AMSTAR 2: a critical appraisal tool for systematic reviews that include randomised or non-randomised studies of healthcare interventions, or both。
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