ANALYSIS OF RANDOMIZED AND NONRANDOMIZED PATIENTS IN CLINICAL-TRIALS USING THE COMPREHENSIVE COHORT FOLLOW-UP-STUDY DESIGN

被引:77
作者
OLSCHEWSKI, M [1 ]
SCHUMACHER, M [1 ]
DAVIS, KB [1 ]
机构
[1] UNIV WASHINGTON,CASS COORDINATING CTR,SEATTLE,WA 98195
来源
CONTROLLED CLINICAL TRIALS | 1992年 / 13卷 / 03期
关键词
CLINICAL TRIALS; EXTERNAL VALIDITY; COMPREHENSIVE COHORT FOLLOW-UP STUDY; COX PROPORTIONAL HAZARDS REGRESSION MODEL;
D O I
10.1016/0197-2456(92)90005-K
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
In clinical research, randomized trials are widely accepted as the definitive method of evaluating the efficacy of therapies. The random assignment of patients to their treatment ensures the internal validity of the comparison of new treatments with controls. An assessment of the external validity of trial results can best be achieved by comparing the study population to the population of patients who met the eligibility criteria but did not consent to randomization. A part of the data of the Coronary Artery Surgery Study (CASS), in which coronary artery bypass surgery is compared to conventional medical therapy in patients with coronary artery disease, is used to illustrate a strategy of multivariate analysis of randomized and nonrandomized patients which allows an investigation of both internal and external validity. The method used Cox's proportional hazards regression model with inclusion of covariates for randomization status and corresponding interactions in addition to the usual covariates for treatment and the important prognostic factors.
引用
收藏
页码:226 / 239
页数:14
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