JSM 2005 - Toronto

Abstract #304096

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Legend: = Applied Session, = Theme Session, = Presenter
Activity Number: 223
Type: Topic Contributed
Date/Time: Tuesday, August 9, 2005 : 8:30 AM to 10:20 AM
Sponsor: Biometrics Section
Abstract - #304096
Title: Use of Multiple Imputation and Other Techniques To Assess Impact of Censoring by Loss to Followup in Clinical Trials
Author(s): Barry Davis*+
Companies: The University of Texas Health Science Center at Houston
Address: 1200 Herman Pressler, Houston, TX, 77030, United States
Keywords: Multiple Imputation ; Censoring ; Survival Analysis
Abstract:

Large long-term trials are done to assess risks and benefits of treatments. The consequences of losses to followup can be great, especially if results are used for policy statements or treatment guidelines. Sensitivity analyses should assess the impact of losses.The following can be compared: hazard ratio (HR) estimates (and their significance) for treatment effects from intent to treat analyses, HRs obtained using multiple imputation, HRs from analyses excluding losses, and HRs excluding small subsets of data that maintain the randomization scheme. An example will be presented from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT), a randomized double-blind, active-controlled clinical trial in hypertensive patients designed to determine if treatment with newer Antihypertensive agents reduces coronary heart disease incidence compared to a diuretic. Randomization to treatment was stratified by center. Mean follow-up was 4.9 years, and 99% of expected person-years were observed. The suggested analyses were performed, and all were consistent with the trial's published conclusions. The results and their implications will be presented.


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Revised March 2005