JSM 2004 - Toronto

Abstract #301062

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Activity Number: 368
Type: Topic Contributed
Date/Time: Wednesday, August 11, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #301062
Title: Issues Scoring Radiographs and the Use of Multiple Readers
Author(s): Ronald D. Pedersen*+
Companies: Wyeth Pharmaceuticals
Address: 500 Arcola Road, Collegeville, PA, 19426,
Keywords: intraclass correlation ; radiograph
Abstract:

When radiographs are used in clinical trials multiple readers are often used with the intent of both saving time and improving the precision of estimation. A design objective of clinical trials including radiographic endpoints is to find the right balance of the number of readers and the number of patients to maximize statistical power while minimizing completion time and managing costs. Increasing the number of replicate readings to achieve greater precision increases both costs and time required. Methods to help decide the number of replicates will be reviewed. With multiple readers, inter-reader variability must be controlled, as well as intra-reader variability. Statistical methods to guide training using intraclass and interclass correlation evaluation will be reviewed. Approaches to minimize reader bias through designed distribution of radiographs to readers will be reviewed and statistical models to address reader effect will be discussed.

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Revised March 2004