JSM 2004 - Toronto

Abstract #301840

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Activity Number: 439
Type: Contributed
Date/Time: Thursday, August 12, 2004 : 10:30 AM to 12:20 PM
Sponsor: Section on Statistics in Epidemiology
Abstract - #301840
Title: Composite Outcomes in Cluster-randomized Clinical Trials: Experiences from the Community Hypertension Assessment Trial
Author(s): Lehana Thabane*+ and Keith O'Rourke and Janusz Kaczorowsk and Larry Chambers and Tina Karwalajtys and Cheryl Levitt and William Hogg and Lisa Dolovich
Companies: McMaster University and Ottawa Health Research Institute and McMaster University and University of Ottawa and McMaster University and McMaster University and University of Ottawa and McMaster University
Address: Centre for Evaluation of Medicines, Hamilton, ON, L8N 1G6, Canada
Keywords: composite outcomes ; controlled clinical trials ; hypertenstion ; community-based intervention ; blood pressure ; cluster-randomization
Abstract:

The choice of appropriate primary and secondary endpoints is one of the many crucial elements in designing a clinical trial. This presentation will examine the use of composite endpoint(s), created by combining several endpoints, in a community-based cluster-randomized clinical trial. We will use our experiences from the CHAT study to examine the challenges of choosing a composite endpoint. The CHAT study is a paired cluster-randomized trial to assess the effectiveness of community pharmacy blood pressure (BP) sessions, with feedback to physicians, patients and pharmacists, on monitoring and management of BP among older adults. It is a pragmatic trial intended to assess the effectiveness of the intervention in real-life setting and therefore relies on health record review as the primary source of data. There are no standardized BP measurements at the start and end of the trial. As a result, there are several methodological challenges that include choice of (preferably one) primary composite (or individual) endpoint that is valid, reliable, and sensitive to change based on chart audits.

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