期刊
CURRENT CARDIOLOGY REPORTS
卷 16, 期 10, 页码 -出版社
SPRINGER
DOI: 10.1007/s11886-014-0531-2
关键词
Subgroup analyses; Post-randomization; Causal inference; Multiplicity; Tests of interaction; Bias; A priori hypotheses
资金
- Johnson Johnson
- Regeneron
- Cubist Pharmaceuticals
- Sanofi
- Baxter
- Roche Diagnostics
- Ikaria
- Amgen
- Regado
- Merck
- Glaxo Smith Kline
- Amylin
- Novartis
- AstraZeneca
- Portola
- Eli Lilly
- Edwards Lifesciences
- Boehringer Ingelheim
- National Institute of Health
- National Heart, Lung & Blood Institute
- National Institute of Allergy & Infectious Diseases
- Bayer
- Biotronik
- Daiichi Sankyo
- Gilead Sciences
- Medtronic
- Ortho/McNeill
- St. Jude
- ACC
- John Hopkins University
- South East Area Health Education Center
- Sun Pharma
- Bristol MyersSquibb
- Duke Center for Educational Excellence
- University of British Columbia
- WebMD
- Perdue Pharma
- Dialogues
- Springer Publishing
- Haemonetics
- Forest
- Elsevier
Subgroup analyses are commonly performed in the clinical trial setting with the purpose of illustrating that the treatment effect was consistent across different patient characteristics or identifying characteristics that should be targeted for treatment. There are statistical issues involved in performing subgroup analyses, however. These have been given considerable attention in the literature for analyses where subgroups are defined by a pre-randomization feature. Although subgroup analyses are often performed with subgroups defined by a post-randomization feature-including analyses that estimate the treatment effect among compliers-discussion of these analyses has been neglected in the clinical literature. Such analyses pose a high risk of presenting biased descriptions of treatment effects. We summarize the challenges of doing all types of subgroup analyses described in the literature. In particular, we emphasize issues with post-randomization subgroup analyses. Finally, we provide guidelines on how to proceed across the spectrum of subgroup analyses.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据