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Public Library of Science, PLoS ONE, 1(11), p. e0144658, 2016

DOI: 10.1371/journal.pone.0144658

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Management of Patient-Reported Outcome (PRO) Alerts in Clinical Trials: A Cross Sectional Survey

Journal article published in 2016 by Derek Kyte, Jonathan Ives ORCID, Heather Draper, Melanie Calvert
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Assessment of patient-reported outcomes (PROs) provides valuable information to inform patient-centered care, but may also reveal ‘PRO alerts’: psychological distress or physical symptoms that may require an immediate response. Ad-hoc management of PRO alerts in clinical trials may result in suboptimal patient care or potentially bias trial results. To gain greater understanding of current practice in PRO alert management we conducted a national survey of personnel involved in clinical trials with a PRO endpoint.