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The Patient - Patient-Centered Outcomes Research

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01-10-2017 | Editorial

The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States

Authors: Bennett Levitan, A. Brett Hauber, Marina G. Damiano, Ross Jaffe, Stephanie Christopher

Published in: The Patient - Patient-Centered Outcomes Research | Issue 5/2017

Excerpt

There are many approaches to assessing the patient’s perspective on medical treatment [1, 2]. Among these approaches, patient preference studies have taken on an increasingly important role in assessing the benefits and risks of medical devices. Patient preference studies can provide a number of transparent and defensible measures of the patient perspective on treatment benefits, risks, and other characteristics, including an identification of what features of medical device treatments matter to patients, quantitative estimates of how much each feature matters, the tradeoffs patients are willing to make among the treatment features, and an estimate of the proportion of patients who would perceive the benefits of a medical technology to outweigh its risks [3, 4]. Therefore, patient preference information can inform medical device development strategy, development planning, regulatory submission, and post-approval assessment. …

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Title: The Ball is in Your Court: Agenda for Research to Advance the Science of Patient Preferences in the Regulatory Review of Medical Devices in the United States
Authors: Bennett Levitan
A. Brett Hauber
Marina G. Damiano
Ross Jaffe
Stephanie Christopher
Publication date: 01-10-2017
Publisher: Springer International Publishing
Published in: The Patient - Patient-Centered Outcomes Research / Issue 5/2017
Print ISSN: 1178-1653
Electronic ISSN: 1178-1661
DOI: https://doi.org/10.1007/s40271-017-0272-6

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