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253 – Contributed Oral Poster Presentations: Biometrics

Sample Size Calculation for Survival Time Data in Cluster Randomized Trials Using NIATx 200 as an Example

Sponsor: Biometrics Section
Keywords: sample size, cluster randomized, survival, time to event

Antje Jahn-Eimermacher

University Medical Center, Mainz

Dennis McCarty

Oregon Health and Science University

Andrew Quanbeck

University of Wisconsin-Madison

Jim Robinson

University of Wisconsin-Madison

In several trials with a time to event endpoint, the interventions to be compared are randomized not to individuals but to groups of individuals (clusters), which might be patients of the same hospital. One example is the NIATx 200 trial, a cluster randomized trial investigating methods of disseminating quality improvement to addiction treatment centers in the U.S.. One of the primary endpoints to be compared between the different interventions is the time patients have to wait for their first treatment. Members of the same cluster tend to be more similar than members of different clusters causing intra-cluster correlation. Correlation affects the power of a trial and thus has to be considered when planning the sample size. We illustrate how to plan the sample size for clustered time to event data using the NIATx 200 trial as an example.

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