Best (but oft-forgotten) practices: intention-to-treat, treatment adherence, and missing participant outcome data in the nutrition literature

被引：27

作者：

Johnston, Bradley C. ^{[1
,2
,3
]}

Guyatt, Gordon H. ^{[4
,5
]}

机构：

[1] Hosp Sick Children, Prevent Lab, Toronto, ON, Canada

[2] Hosp Sick Children, Systemat Overviews Advancing Res Technol, Child Hlth Evaluat Sci, Toronto, ON, Canada

[3] Univ Toronto, Dalla Lana Sch Publ Hlth, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada

[4] McMaster Univ, Dept Clin Epidemiol & Biostat, Hamilton, ON, Canada

[5] McMaster Univ, Dept Med, Hamilton, ON, Canada

来源：

AMERICAN JOURNAL OF CLINICAL NUTRITION | 2016年 / 104卷 / 05期

关键词：

clinical trials; patient dropouts; randomization; adherence; intention to treat; missing outcome data; per protocol; RANDOMIZED CLINICAL-TRIALS; WEIGHT-LOSS; FOLLOW-UP;

D O I：

10.3945/ajcn.115.123315

中图分类号：

R15 [营养卫生、食品卫生]; TS201 [基础科学];

学科分类号：

100403 ;

摘要：

Among clinical trials of adequate size, randomization balances both known and unknown prognostic factors between trial arms, thus allowing an unbiased comparison of intervention and control. To preserve this benefit, all randomly assigned participants should be followed to study termination and analyzed in the arm to which they were allocated. There are 2 potential limitations in study implementation: 1) patients are nonadherent and continue with follow-up visits, or 2) patients are lost to follow-up and their outcome data are missing. Herein, we address these issues with an emphasis on binary outcomes, and discuss how authors of randomized trials should address issues of both noncompliance and missing data.

引用

页码：1197 / 1201

页数：5

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