Non-adherence in non-inferiority trials: pitfalls and recommendations

被引：54

作者：

Mo, Yin ^{[1
,2
,3
,4
]}

Lim, Cherry ^{[1
,4
]}

Watson, James A. ^{[1
,4
]}

White, Nicholas J. ^{[1
,4
]}

Cooper, Ben S. ^{[1
,4
]}

机构：

[1] Mahidol Univ, Fac Trop Med, Mahidol Oxford Trop Med Res Unit, Bangkok, Thailand

[2] Natl Univ Singapore Hosp, Univ Med Cluster, Singapore, Singapore

[3] Natl Univ Singapore, Dept Med, Singapore, Singapore

[4] Univ Oxford, Nuffield Dept Med, Ctr Trop Med, Oxford OX3 7BN, England

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2020年 / 370卷

基金：

英国惠康基金; 英国医学研究理事会;

关键词：

CAUSAL; DURATION; EFFICACY; CARE;

D O I：

10.1136/bmj.m2215

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Non-adherence in non-inferiority trials can affect treatment effect estimates and often increases the chance of claiming non-inferiority under the standard intention-to-treat analysis. This article discusses the implications of different patterns of non-adherence in non-inferiority trials and offers practical recommendations for trial design, alternative analysis strategies, and outcome reporting to reduce bias in treatment estimates and improve transparency in reporting.

引用

页数：10

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