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Abstract:
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A PRO (patient-reported outcome) is a measurement of any aspect of a patient's health that comes directly from a patient. In the usual controlled clinical trials, PROs can be considered the primary, secondary, or tertiary endpoints. Within PROs, subjects may provide responses including continuous, categorical, and open-ended responses over time. Frequently, PROs contain repeated measures categorical response data from each subject. These PROs will be the subject of discussion. Data collected may be analyzed using statistically valid categorical data analysis methodologies. The proper design and use of PROs present considerable challenge to statisticians. Using the PRO guidance to stimulate dialogue, we will explore issues related to the reliability, sensitivity, and analysis of categorical response PROs in clinical trials.
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