一种评估随机对照试验质量的方法。

A method for assessing the quality of a randomized control trial.

作者信息

Chalmers T C, Smith H, Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A

出版信息

Control Clin Trials. 1981 May;2(1):31-49. doi: 10.1016/0197-2456(81)90056-8.

Abstract

A system has been constructed to evaluate the design, implementation, and analysis of randomized control trials (RCT). The degree of quadruple blinding (the randomization process, the physicians and patients as to therapy, and the physicians as to ongoing results) is considered to be the most important aspect of any trial. The analytic techniques are scored with the same emphasis as is placed on the control of bias in the planning and implementation of the studies. Description of the patient and treatment materials and the measurement of various controls of quality have less weight. An index of quality of a RCT is proposed with its pros and cons. If published papers were to approximate these principles, there would be a marked improvement in the quality of randomized control trials. Finally, a reasonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.

摘要

已构建一个系统来评估随机对照试验(RCT)的设计、实施和分析。四重盲法的程度(随机化过程、医生和患者对治疗的不知情、医生对研究结果的不知情)被认为是任何试验最重要的方面。分析技术的评分与研究规划和实施中对偏倚控制的重视程度相同。患者和治疗材料的描述以及各种质量控制的测量权重较小。提出了随机对照试验质量指数及其优缺点。如果发表的论文能接近这些原则,随机对照试验的质量将有显著提高。最后,合理的标准试验设计和实施将有助于解释结果相互矛盾的试验,并有助于对规模较小的试验进行有效合并。

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