THE HEALTHY RESPONDER PHENOMENON IN NONRANDOMIZED CLINICAL-TRIALS

被引：11

作者：

HALLSTROM, AP

GREENE, HL

HUTHER, ML

机构：

[1] CAST Coordinating Center, Department of Biostatistics, University of Washington, 1107 NE 45th Street, Room 505, Seattle, Washington

来源：

STATISTICS IN MEDICINE | 1991年 / 10卷 / 10期

关键词：

D O I：

10.1002/sim.4780101013

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

An example from the Cardiac Arrhythmia Suppression Trial (CAST) illustrates what we term the 'healthy responder' phenomenon. The hypothesis is that patients who respond to a given treatment are healthier than patients who do not respond. In observational studies this results in an apparent but not real benefit for the treatment. The unique design of CAST, namely, titration before randomization, allows illustration of this phenomenon since we can view the study as both a non-randomized as well as a randomized trial of therapy. We conclude that, in demonstration of a drug effect, randomized trials are essential.

引用

页码：1621 / 1631

页数：11

共 8 条

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