DESIGNING MEDICAL AND EDUCATIONAL INTERVENTION STUDIES - A REVIEW OF SOME ALTERNATIVES TO CONVENTIONAL RANDOMIZED CONTROLLED TRIALS
DESIGNING MEDICAL AND EDUCATIONAL INTERVENTION STUDIES - A REVIEW OF SOME ALTERNATIVES TO CONVENTIONAL RANDOMIZED CONTROLLED TRIALS
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DOI：
10.2337/diacare.16.2.509
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发表时间：
1993-02-01
期刊：
影响因子：
16.2
通讯作者：
BRADLEY, C
中科院分区：
文献类型：
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作者：
BRADLEY, C
随机对照试验设计的优点和局限性进行了讨论，并考虑了一系列替代设计的医疗和教育干预研究。选择的设计是那些解决被忽视的心理问题，涉及招募患者和分配患者的治疗试验。设计包括Zelen（18）随机同意设计，Brewin和布拉德利（20）部分随机以患者为中心的设计，以及Korn和Baumrind（21）部分随机以临床医生为中心的设计。从最后两个设计的功能相结合的可能性进行了说明，并讨论了采用更灵活和临床相关的方法来设计临床试验的优点。
The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partially randomized clinician-centered design. The possibilities of combining features from each of the last two designs are illustrated, and the advantages of adopting a more flexible and clinically relevant approach to the design of clinical trials are discussed.