A systematic review found that deviations from intention-to-treat are common in randomized trials and systematic reviews

被引：38

作者：

Abraha, Iosief ^{[1
]}

Cozzolino, Francesco ^{[1
]}

Orso, Massimiliano ^{[1
]}

Marchesi, Mauro ^{[2
]}

Germani, Antonella ^{[2
]}

Lombardo, Guido ^{[3
]}

Eusebi, Paolo ^{[1
]}

De Florio, Rita ^{[4
]}

Luchetta, Maria Laura ^{[5
]}

Iorio, Alfonso ^{[6
]}

Montedori, Alessandro ^{[1
]}

机构：

[1] Reg Hlth Author Umbria, Hlth Planning Serv, Via Mario Angeloni 61, I-06124 Perugia, Italy

[2] Azienda Osped Perugia, Transfus Med Serv, Piazzale Menghini 1, I-06129 Perugia, Italy

[3] Univ Perugia, Surg & Biomed Sci, Piazzale Gambuli 1, I-06129 Perugia, Italy

[4] Azienda USL Umbria 1, Gen Med, Via Guerriero Guerra 21, I-06127 Perugia, Italy

[5] Azienda USL Umbria 2, Gen Med, Viale Donato Bramante 37, I-05100 Terni, Italy

[6] McMaster Univ, Dept Clin Epidemiol & Biostat, CRL 140,1280 Main St West, Hamilton, ON, Canada

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2017年 / 84卷

关键词：

Deviation from intention-to-treat; Modified intention-to-treat; Bias; Epidemiology; Randomized trials; Meta-analysis; MISSING DATA; PRINCIPLE; EXCLUSIONS; PROTOCOL; OUTCOMES;

D O I：

10.1016/j.jclinepi.2016.11.012

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objectives: To describe the characteristics, and estimate the incidence, of trials included in systematic reviews deviating from the intention-to-treat (ITT) principle. Study Design and Setting: A 5% random sample of reviews were selected (Medline 2006-2010). Trials from reviews were classified based on the ITT: (1) ITT trials (trials reporting standard ITT analyses); (2) modified ITT (mITT) trials (modified ITT; trials deviating from standard ITT); or (3) no ITT trials. Results: Of 222 reviews, 81 (36%) included at least one mITT trial. Reviews with mITT trials were more likely to contain trials that used placebo, that investigated drugs, and that reported favorable results. The incidence of reviews with mITT trial ranged from 29% (17/58) to 48% (23/48). Of the 2,349 trials, 597 (25.4%) were classified as ITT trials, 323 (13.8%) as mITT trials, and 1,429 (60.8%) as no ITT trials. The mITT trials were more likely to have reported exclusions compared to studies classified as ITT trials and to have received funding. Conclusion: The reporting of the type of ITT may differ according to the clinical area and the type of intervention. Deviation from ITT in randomized controlled trials is a widespread phenomenon that significantly affects systematic reviews. (C) 2017 Elsevier Inc. All rights reserved.

引用

页码：37 / 46

页数：10

共 30 条

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