Department of Health Services Research and Policy, Research School of Population Health, Australian National University, 62 Mills Road, Acton, ACT 2601, Australia; Department for Health Evidence, SYRCLE, Radboud University Medical Center, Nijmegen, The Netherlands.
National Centre for Epidemiology and Population Health, Research School of Population Health, Australian National University, Canberra, ACT, Australia.
J Clin Epidemiol. 2021 Jun;134:52-64. doi: 10.1016/j.jclinepi.2021.01.012. Epub 2021 Jan 21.
OBJECTIVE: This paper presents a unified framework for assessment of the methodological quality of analytic study designs. STUDY DESIGN AND SETTING: A systematic review of 393 methodological quality assessment tools that updated a previous assessment with 100 tools. Tool items were extracted, examined and reworded. Bias domains and finally methodological standards to be fulfilled were defined. RESULTS: There were 36 unique methodological safeguards that were categorized into seven methodological standards to be fulfilled in the MASTER scale. These methodological standards reflect initial and ongoing equivalence in particular areas, including equal recruitment, equal retention, equal ascertainment, equal implementation, equal prognosis, sufficient analysis, and temporal precedence. CONCLUSION: This approach unifies existing methods for methodological quality assessment and will be useful for (1) clinical researchers when a bias assessment of clinical research studies is required across analytical designs, (2) promoting a unified framework for bias assessment.
目的:本文提出了一种用于评估分析性研究设计方法学质量的统一框架。
研究设计和设置:对 393 种方法学质量评估工具进行了系统回顾,其中更新了先前的评估,纳入了 100 种工具。提取、检查和改写了工具项目。定义了偏倚域和最终需要满足的方法学标准。
结果:共有 36 个独特的方法学保障措施,这些措施被归类为 MASTER 量表中需要满足的七个方法学标准。这些方法学标准反映了特定领域的初始和持续等同性,包括平等招募、平等保留、平等确定、平等实施、平等预后、充分分析和时间优先。
结论:这种方法统一了现有的方法学质量评估方法,将有助于(1)临床研究人员在需要跨分析设计评估临床研究偏倚时,(2)促进偏倚评估的统一框架。
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