Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.

<h4>Background</h4>Evidence suggests there are inconsistencies in patient-reported outcome (PRO) assessment and reporting in clinical trials, which may limit the use of these data to inform patient care. For trials with a PRO endpoint, routine inclusion of key PRO information in the prot...

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Main Authors: Melanie Calvert, Derek Kyte, Helen Duffy, Adrian Gheorghe, Rebecca Mercieca-Bebber, Jonathan Ives, Heather Draper, Michael Brundage, Jane Blazeby, Madeleine King
Format: article
Language:EN
Published: Public Library of Science (PLoS) 2014
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Online Access:https://doaj.org/article/5de183d937d248fba457a8d4b2e02241
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