期刊
AMERICAN JOURNAL OF EPIDEMIOLOGY
卷 184, 期 4, 页码 325-335出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/aje/kwv445
关键词
bias (epidemiology); confounding factors (epidemiology); epidemiologic methods; immortal time bias; longitudinal studies; models; survival analysis
资金
- MS [Multiple Sclerosis] Society of Canada (MSSOC)
- National Multiple Sclerosis Society (NMSS) [RG 4202-A-2]
- Canadian Institutes of Health Research (CIHR) [MOP-93646]
- NMSS [RG 4202-A-2]
- Natural Sciences and Engineering Research Council of Canada
- Canada Research Chair Program
- MSSOC Don Paty Career Development Award
- Michael Smith Foundation
- CIHR [MOP-93646]
- Multiple Sclerosis Trust (United Kingdom)
- MSSOC
- Michael Smith Foundation for Health Research
- CIHR HIV/AIDS Research Initiative
- Christopher Foundation
- University of British Columbia
- Pacific Institute for the Mathematical Sciences
- Biogen
- EMD Serono
- Myelin Research Foundation
- Novartis
- ERTN
- ECTRIMS
- Consortium of MS Centres
- Aventis
- Bayer
- Biogen Idec
- BioMS
- Corixa
- Genentech
- GlaxoSmithKlein
- Merck-Serono
- Serono
- Shering
- Talecris
- Teva Neuroscience
In time-to-event analyses of observational studies of drug effectiveness, incorrect handling of the period between cohort entry and first treatment exposure during follow-up may result in immortal time bias. This bias can be eliminated by acknowledging a change in treatment exposure status with time-dependent analyses, such as fitting a time-dependent Cox model. The prescription time-distribution matching (PTDM) method has been proposed as a simpler approach for controlling immortal time bias. Using simulation studies and theoretical quantification of bias, we compared the performance of the PTDM approach with that of the time-dependent Cox model in the presence of immortal time. Both assessments revealed that the PTDM approach did not adequately address immortal time bias. Based on our simulation results, another recently proposed observational data analysis technique, the sequential Cox approach, was found to be more useful than the PTDM approach (Cox: bias = -0.002, mean squared error = 0.025; PTDM: bias = -1.411, mean squared error = 2.011). We applied these approaches to investigate the association of beta-interferon treatment with delaying disability progression in a multiple sclerosis cohort in British Columbia, Canada (Long-Term Benefits and Adverse Effects of Beta-Interferon for Multiple Sclerosis (BeAMS) Study, 1995-2008).
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