Document Detail


Intention-to-treat analyses for incomplete repeated measures data.
MedLine Citation:
PMID:  8805765     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
In a randomized longitudinal clinical trial designed to evaluate two or more rival treatments, an intent-to-treat analysis requires inclusion of all randomized patients, regardless of whether they remain on protocol for the duration of the study. We propose a piecewise linear random effects model for analyzing longitudinal data where the multivariate outcome can depend upon time spent on treatment. The model assumes that data are available on a random sample of subjects after treatment is terminated, and allows either a pragmatic or explanatory analysis (as defined by Schwartz and Lellouch, 1967, Journal of Chronic Diseases 20, 637-648). Full maximum likelihood estimation of the model parameters is carried out using widely available statistical software for repeated measures with missing data and for nonparametric survival curve estimation. Data from a national, multicenter pediatric AIDS clinical trial are analyzed to illustrate implementation and interpretation of the model.
Authors:
J W Hogan; N M Laird
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Publication Detail:
Type:  Journal Article; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Biometrics     Volume:  52     ISSN:  0006-341X     ISO Abbreviation:  Biometrics     Publication Date:  1996 Sep 
Date Detail:
Created Date:  1996-11-06     Completed Date:  1996-11-06     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  0370625     Medline TA:  Biometrics     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1002-17     Citation Subset:  IM; X    
Affiliation:
Center for Statistical Sciences, Brown University, Providence, Rhode Island 02912, USA.
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MeSH Terms
Descriptor/Qualifier:
Acquired Immunodeficiency Syndrome / drug therapy
Antiviral Agents / administration & dosage
Biometry
Child
Clinical Protocols
Data Interpretation, Statistical
Humans
Likelihood Functions
Longitudinal Studies
Models, Statistical
Patient Dropouts
Randomized Controlled Trials as Topic / statistics & numerical data*
Therapeutics*
Zidovudine / administration & dosage
Grant Support
ID/Acronym/Agency:
GM29745/GM/NIGMS NIH HHS; MH17119/MH/NIMH NIH HHS
Chemical
Reg. No./Substance:
0/Antiviral Agents; 30516-87-1/Zidovudine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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