Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
Assessing the quality of reports of randomized clinical trials: Is blinding necessary?
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DOI：
10.1016/0197-2456(95)00134-4
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发表时间：
1996-02-01
期刊：
影响因子：
--
通讯作者：
McQuay, HJ
中科院分区：
文献类型：
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作者：
Jadad, AR;Moore, RA;McQuay, HJ
有人建议，临床试验的质量应由盲态评估者进行评估，以限制在荟萃分析、系统综述以及同行评审过程中引入偏倚的风险。文献中几乎没有证据能证实这一点。本研究描述了一种用于评估疼痛研究中随机临床试验（RCT）报告质量的工具的开发过程，以及使用该工具确定评估者盲态对质量评估的影响。一个由6名评委组成的多学科小组制定了该工具的初始版本。来自3种不同背景的14名评估者对从3个不同样本中选取的36份疼痛研究报告的质量进行了评估。其中7名被随机分配在盲态条件下进行评估。该工具的最终版本包括3个条目。所有评估者，无论其背景如何，对这些条目的评分都一致，并且能够区分不同样本的报告。盲态评估得出的分数明显低于开放评估，且更具一致性。本文讨论了这一发现对系统综述、荟萃分析研究以及同行评审过程的影响。
It has been suggested that the quality of clinical trials should be assessed by blinded raters to limit the risk of introducing bias into meta-analyses and systematic reviews, and into the peer-review process. There is very little evidence in the literature to substantiate this. This study describes the development of an instrument to assess the quality of reports of randomized clinical trials (RCTs) in pain research and its use to determine the effect of rater blinding on the assessments of quality. A multidisciplinary panel of six judges produced an initial version of the instrument. Fourteen raters from three different backgrounds assessed the quality of 36 research reports in pain research, selected from three different samples. Seven were allocated randomly to perform the assessments under blind conditions. The final version of the instrument included three items. These items were scored consistently by all the raters regardless of background and could discriminate between reports from the different samples. Blind assessments produced significantly lower and more consistent scores than open assessments. The implications of this finding for systematic reviews, meta-analytic research and the peer-review process are discussed.