A METHOD FOR ASSESSING THE QUALITY OF A RANDOMIZED CONTROL TRIAL
A METHOD FOR ASSESSING THE QUALITY OF A RANDOMIZED CONTROL TRIAL
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DOI：
10.1016/0197-2456(81)90056-8
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发表时间：
1981-01-01
期刊：
影响因子：
--
通讯作者：
AMBROZ, A
中科院分区：
文献类型：
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作者：
CHALMERS, TC;SMITH, H;AMBROZ, A
构建了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判断、医生对持续结果的判断）被认为是任何试验中最重要的方面。分析技术的评分与研究规划和实施中的偏差控制相同。对患者和治疗材料的描述以及各种质量控制的测量的权重较小。提出了 RCT 的质量指标，并阐述了其优缺点。如果发表的论文接近这些原则，随机对照试验的质量将会显着提高。合理的标准设计和试验实施将有助于解释那些具有冲突结果的结果，并有助于对小规模试验进行有效组合。
A system was 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 trechniques 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. A resonable standard design and conduct of trials will facilitate the interpretation of those with conflicting results and help in making valid combinations of undersized trials.