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Management of patient-reported outcome (PRO) alerts in clinical trials : a cross sectional survey

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Kyte, Derek, Ives, Jonathan, Draper, Heather and Calvert, Melanie (2016) Management of patient-reported outcome (PRO) alerts in clinical trials : a cross sectional survey. PLoS One, 11 (1). e0144658. doi:10.1371/journal.pone.0144658 ISSN 1932-6203.

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Official URL: http://dx.doi.org/10.1371/journal.pone.0144658

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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.

Item Type: Journal Article
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title: PLoS One
Publisher: Public Library of Science
ISSN: 1932-6203
Official Date: 19 January 2016
Dates:
DateEvent
19 January 2016Published
20 November 2015Accepted
10 July 2015Submitted
Volume: 11
Number: 1
Article Number: e0144658
DOI: 10.1371/journal.pone.0144658
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)

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