Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review.
Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review.
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DOI：
10.1289/ehp.1206389
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发表时间：
2013-09
影响因子：
10.4
通讯作者：
Bero L
中科院分区：
文献类型：
--
作者：
Krauth D;Woodruff TJ;Bero L
背景资料：动物毒理学研究的结果对于在人体试验之前评估暴露于环境化学品的潜在危害或药物的安全性至关重要。然而，关于如何评估动物研究的方法学和潜在偏倚存在重大争议。没有商定的办法，也没有对目前的最佳做法进行系统评价。目的：我们进行了一项系统性综述，以识别和评价用于评估偏倚风险和/或动物研究其他方法学标准的工具。方法：我们检索Medline（1966年1月至2011年11月），以识别所有相关文章。我们提取了关于偏倚风险标准的数据（例如，随机化、盲法、分配隐藏）和每个评估工具中包括的其他研究设计特征。讨论内容：确定了30种不同的工具，评估的偏倚风险、方法和/或报告标准的总数范围为2 - 25。评估的最常见标准为随机化（25/30，83%）、研究者设盲（23/30，77%）和样本量计算（18/30，60%）。总的来说，作者未能从经验上证明为什么包括这些或其他标准。几乎所有的工具（28/30，93%）没有经过严格的有效性或可靠性测试。结论：我们的综述强调了一些偏倚风险评估标准，这些标准已经在动物研究中进行了经验性检验，包括随机化、隐藏分配、设盲和所有动物的核算。此外，有必要对其他方法学标准进行实证检验，并评估标准偏倚风险评估工具的有效性和可靠性。引文：Krauth D，Woodruff TJ，Bero L。2013.评估已发表动物研究偏倚风险和其他方法学标准的工具：系统性综述。环境健康展望121：985-992（2013）; http：dx.doi.org/10.1289/ehp.1206389
Background: Results from animal toxicology studies are critical to evaluating the potential harm from exposure to environmental chemicals or the safety of drugs prior to human testing. However, there is significant debate about how to evaluate the methodology and potential biases of the animal studies. There is no agreed-upon approach, and a systematic evaluation of current best practices is lacking. Objective: We performed a systematic review to identify and evaluate instruments for assessing the risk of bias and/or other methodological criteria of animal studies. Method: We searched Medline (January 1966–November 2011) to identify all relevant articles. We extracted data on risk of bias criteria (e.g., randomization, blinding, allocation concealment) and other study design features included in each assessment instrument. Discussion: Thirty distinct instruments were identified, with the total number of assessed risk of bias, methodological, and/or reporting criteria ranging from 2 to 25. The most common criteria assessed were randomization (25/30, 83%), investigator blinding (23/30, 77%), and sample size calculation (18/30, 60%). In general, authors failed to empirically justify why these or other criteria were included. Nearly all (28/30, 93%) of the instruments have not been rigorously tested for validity or reliability. Conclusion: Our review highlights a number of risk of bias assessment criteria that have been empirically tested for animal research, including randomization, concealment of allocation, blinding, and accounting for all animals. In addition, there is a need for empirically testing additional methodological criteria and assessing the validity and reliability of a standard risk of bias assessment instrument. Citation: Krauth D, Woodruff TJ, Bero L. 2013. Instruments for assessing risk of bias and other methodological criteria of published animal studies: a systematic review. Environ Health Perspect 121:985–992 (2013); http://dx.doi.org/10.1289/ehp.1206389
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