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Joseph C. Cappelleri

Pfizer Inc



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113 – Clinical Outcome Assessments: Measurement, Evaluation, and Interpretation

Generalizability Theory for Clinician-Rated Outcomes

Sponsor: Biopharmaceutical Section
Keywords: generalizability theory, reliability, clinician-reported outcomes, clinical outcome assessments, measurement, dependability

Joseph C. Cappelleri

Pfizer Inc

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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