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Activity Number: 459
Type: Roundtables
Date/Time: Wednesday, August 3, 2016 : 7:00 AM to 8:15 AM
Sponsor: Health Policy Statistics Section
Abstract #319608
Title: Navigating the Long and Winding Road to Validly Interpreting Patient-Reported Outcomes
Author(s): Joseph Cappelleri*
Companies: Pfizer
Keywords: patient-reported outcomes ; interpretation ; clinical meaningful difference ; meaningful change ; effect size ; anchors

A patient-reported outcome is any report on the status of a patient's health condition that comes directly from the patient. Clear and meaningful interpretation of patient-reported outcome scores are fundamental to their use as they can be valuable in designing studies, evaluating interventions, educating consumers, and informing health policy makers involved with regulatory, reimbursement, and advisory agencies. Interpretation of patient-reported outcome scores, however, is often not well understood because of insufficient data or lack of experience or clinical understanding to draw from. This roundtable involves a discussion of approaches to enrich interpretation of patient-reported outcomes. I will provide an updated review on two broad approaches-anchor-based and distributed-based-aimed at enhancing the understanding and meaning of patient-reported outcome scores. Anchor-based approaches include percentages based on thresholds, criterion-group interpretation, statistical significance and clinical equivalence, content-based interpretation, and clinical important difference. Distributed-based approaches include effect size, probability of relative benefit, and cumulative proportions. What are the advantages and limitations of these approaches? What other methods may be considered? What can be said about the minimal clinically important difference?

Authors who are presenting talks have a * after their name.

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