| Inverse probability-of-censoring weights for the correction of time-varying noncompliance in the effect of randomized highly active antiretroviral therapy on incident AIDS or death. | |
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MedLine Citation:
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PMID: 19347843 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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In 1996-1997, the AIDS Clinical Trial Group 320 study randomized 1156 HIV-infected U.S. patients to combination antiretroviral therapy (ART) or highly active ART with equal probability. Ninety-six patients incurred AIDS or died, 51 (4 per cent) dropped out, and 290 (= 51 + 239, 25 per cent) dropped out or stopped their assigned therapy for reasons other than toxicity during a 52-week follow-up. Such noncompliance likely results in null-biased estimates of intent-to-treat hazard ratios (HR) of AIDS or death comparing highly active ART with combination ART, which were 0.75 (95 per cent confidence limits [CL]: 0.43, 1.31), 0.30 (95 per cent CL: 0.15, 0.60), and 0.51 (95 per cent CL: 0.33, 0.77) for follow-up within 15 weeks, beyond 15 weeks, and overall, respectively. Noncompliance correction using Robins and Finkelstein's (RF) inverse probability-of-censoring weights (where participants are censored at dropout or when first noncompliant) yielded estimated HR of 0.46 (95 per cent CL: 0.25, 0.85), 0.43 (95 per cent CL: 0.19, 0.96), and 0.45 (95 per cent CL: 0.27, 0.74) for follow-up within 15 weeks, beyond 15 weeks, and overall, respectively. Weights were estimated conditional on measured age, sex, race, ethnicity, prior Zidovudine use, randomized arm, baseline and time-varying CD4 cell count, and time-varying HIV-related symptoms. Noncompliance corrected results were 63 and 13 per cent farther from the null value of one than intent-to-treat results within 15 weeks and overall, respectively, and resolve the apparent non-proportionality in intent-to-treat results. Inverse probability-of-censoring weighted methods could help to resolve discrepancies between compliant and noncompliant randomized evidence, as well as between randomized and observational evidence, in a variety of biomedical fields. |
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Authors:
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Lauren E Cain; Stephen R Cole |
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Publication Detail:
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Type: Journal Article; Research Support, N.I.H., Extramural |
Journal Detail:
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Title: Statistics in medicine Volume: 28 ISSN: 0277-6715 ISO Abbreviation: Stat Med Publication Date: 2009 May |
Date Detail:
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Created Date: 2009-05-07 Completed Date: 2009-07-01 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8215016 Medline TA: Stat Med Country: England |
Other Details:
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Languages: eng Pagination: 1725-38 Citation Subset: IM |
Copyright Information:
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(c) 2009 John Wiley & Sons, Ltd. |
Affiliation:
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Department of Epidemiology, Harvard School of Public Health, Boston, MA, U.S.A. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Acquired Immunodeficiency Syndrome
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drug therapy,
mortality Antiretroviral Therapy, Highly Active Biometry Female HIV Infections / drug therapy*, mortality* Humans Male Patient Compliance / statistics & numerical data* Probability Randomized Controlled Trials as Topic / statistics & numerical data* Time Factors United States / epidemiology |
| Grant Support | |
ID/Acronym/Agency:
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R03-AI 071763/AI/NIAID NIH HHS |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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