The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.
The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.
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临床前和临床研究的方法学质量评估工具、系统评价和荟萃分析以及临床实践指南：系统评价。
DOI：
10.1111/jebm.12141
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发表时间：
2015-02-01
影响因子：
--
通讯作者：
Du, Liang
中科院分区：
文献类型：
--
作者：
Zeng, Xiantao;Zhang, Yonggang;Du, Liang
目的：系统评价临床前和临床研究的方法学评估工具、系统评价和荟萃分析以及临床实践指南。 方法：我们检索了 PubMed、干预系统评价 Cochrane 手册、Joanna Briggs Institute (JBI) 审稿人手册、评价和传播中心、批判性评估技能计划 (CASP)、苏格兰校际指南网络 (SIGN) 和国家临床卓越研究所 (NICE) 截至 2014 年 5 月 20 日。两位作者选择了研究并提取了数据；进行定量分析，总结纳入工具的特点。结果：我们总共纳入了21个评估工具进行分析。许多工具是由学术组织开发的，有些工具仅由一小群研究人员开发。 JBI 开发的方法评估工具数量最多，CASP 位居第二。用于评估随机对照研究的方法学质量的工具是最丰富的。 Cochrane 协作组织用于评估偏倚风险的工具是评估 RCT 的最佳可用工具。对于队列和病例对照研究，我们建议使用纽卡斯尔-渥太华量表。非随机研究方法学指数 (MINORS) 是评估非随机干预研究的绝佳工具，医疗保健研究和质量局 (ARHQ) 方法清单适用于横断面研究。对于诊断准确性测试研究，建议使用诊断准确性研究质量评估-2 (QUADAS-2) 工具；实验动物实验系统审查中心 (SYRCLE) 偏倚风险工具可用于评估动物研究；多重系统评价评估（AMSTAR）是系统评价/荟萃分析的测量工具；已开发出用于评估病例系列研究的 18 项工具，指南、研究和评估评估 (AGREE)-II 工具被广泛用于评估临床实践指南。结论：我们已成功确定了适用于不同类型研究设计的多种方法学评估工具。然而，由于目前其他领域缺乏此类工具，因此有必要进一步努力开发关键评估工具。遗传学研究和一些现有工具（例如巢式病例对照研究和病例报告）需要更新，以符合当前的研究实践和严谨性。此外，非常重要的是，所有关键评估工具都保持主观性，并有效避免绩效偏差。
OBJECTIVE: To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline.METHODS: We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools.RESULTS: We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines.CONCLUSIONS: We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided.