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Activity Number: 113 - Clinical Outcome Assessments: Measurement, Evaluation, and Interpretation
Type: Topic Contributed
Date/Time: Monday, July 31, 2017 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #322716 View Presentation
Title: Generalizability Theory for Clinician-Rated Outcomes
Author(s): Joseph Cappelleri*
Companies: Pfizer Inc
Keywords: generalizability theory ; reliability ; clinician-reported outcomes ; clinical outcome assessments ; measurement ; dependability
Abstract:

Generalizability (G) theory is a statistical theory about the dependability or reliability of behavioral or other measurements. The strength of G theory is that multiple sources of variance (such as from persons, raters, and time) in a measurement can be estimated separately in a single analysis. In the process, G theory provides a summary coefficient reflecting the level of dependability in measurement. Originating in the behavioral and educational sciences, G theory also has merit in the reliability assessment of clinical outcome assessments in the health sciences, in particular, for clinician-rated outcomes. Yet it has been underused there. With the advent of a published guidance on clinician-rated assessments of treatment benefit by an ISPOR Task Force, however, the application of G theory in this area is both timely and relevant. In this manuscript, the fundamentals and a pedagogical example of G theory in the context of clinician-rated outcomes are described and illustrated.


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