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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
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Official URL: http://dx.doi.org/10.1371/journal.pone.0144658
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 Medicine > Warwick Medical School | ||||||||
| Journal or Publication Title: | PLoS One | ||||||||
| Publisher: | Public Library of Science | ||||||||
| ISSN: | 1932-6203 | ||||||||
| Official Date: | 19 January 2016 | ||||||||
| Dates: |
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| 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 |
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