THE EFFECT OF PARTIAL NONCOMPLIANCE ON THE POWER OF A CLINICAL-TRIAL

被引：31

作者：

FREEDMAN, LS

机构：

[1] Biometry Branch, Division of Cancer Prevention and Control, National Cancer Institute, Bethesda, MD

来源：

CONTROLLED CLINICAL TRIALS | 1990年 / 11卷 / 03期

关键词：

breast cancer; dietary fat; noncompliance; power; Prevention trials; sample size;

D O I：

10.1016/0197-2456(90)90010-Y

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：

Noncompliance is an important concern in randomized trials and must be taken into account when calculating sample sizes. The effect of noncompliance is usually assessed through a simple binary model that assumes that the patient either does or does not comply with the allocated treatment. In this article I present an example from cancer prevention, and show that different time courses of noncompliance can have different effects on the power, with widely varying estimates of the sample size required. The time course as well as the level of noncompliance should be considered when planning trials with long-term treatments. © 1990.

引用

收藏

页码：157 / 168

页数：12

相关论文

共 23 条

[1] THE RELATIVE EFFICIENCY OF ZELEN PRERANDOMIZATION DESIGN FOR CLINICAL-TRIALS [J].

ANBAR, D .

BIOMETRICS, 1983, 39 (03) :711-718

[2]

ARMSTRONG BK, 1983, MORTALITY CANCER MIG

[3] FACTORIAL-DESIGNS IN CLINICAL-TRIALS - THE EFFECTS OF NON-COMPLIANCE AND SUBADDITIVITY [J].

BRITTAIN, E ;

WITTES, J .

STATISTICS IN MEDICINE, 1989, 8 (02) :161-171

[4] CLINICAL-TRIALS IN DIET AND CANCER [J].

BYAR, DP ;

FREEDMAN, LS .

PREVENTIVE MEDICINE, 1989, 18 (02) :203-219

[5] EVALUATION OF POSSIBILITIES FOR MASS-SCREENING FOR COLORECTAL-CANCER WITH HEMOCCULT FECAL BLOOD-TEST [J].

CARLSSON, U ;

EKELUND, G ;

ERIKSSON, R ;

FORK, T ;

JANZON, L ;

LEANDOER, L ;

LINDSTROM, C ;

TRELL, E .

DISEASES OF THE COLON & RECTUM, 1986, 29 (09) :553-557

[6]

CARROLL K K, 1984, Nutrition and Cancer, V6, P254, DOI 10.1080/01635588509513831

[7] SAMPLE SIZES FOR MEDICAL TRIALS WITH SPECIAL REFERENCE TO LONG-TERM THERAPY [J].

HALPERIN, M ;

ROGOT, E ;

GURIAN, J ;

EDERER, F .

JOURNAL OF CHRONIC DISEASES, 1968, 21 (01) :13-&

[8] RESULTS OF A RANDOMIZED FEASIBILITY STUDY OF A LOW-FAT DIET [J].

INSULL, W ;

HENDERSON, MM ;

PRENTICE, RL ;

THOMPSON, DJ ;

CLIFFORD, C ;

GOLDMAN, S ;

GORBACH, S ;

MOSKOWITZ, M ;

THOMPSON, R ;

WOODS, M .

ARCHIVES OF INTERNAL MEDICINE, 1990, 150 (02) :421-427

[9] EVALUATION OF SAMPLE-SIZE AND POWER FOR ANALYSES OF SURVIVAL WITH ALLOWANCE FOR NONUNIFORM PATIENT ENTRY, LOSSES TO FOLLOW-UP, NONCOMPLIANCE, AND STRATIFICATION [J].

LACHIN, JM ;

FOULKES, MA .

BIOMETRICS, 1986, 42 (03) :507-519

[10] SAMPLE-SIZE DETERMINATION IN CLINICAL-TRIALS WITH TIME-DEPENDENT RATES OF LOSSES AND NONCOMPLIANCE [J].

LAKATOS, E .

CONTROLLED CLINICAL TRIALS, 1986, 7 (03) :189-199