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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Autores principales:	Melanie Calvert, Derek Kyte, Helen Duffy, Adrian Gheorghe, Rebecca Mercieca-Bebber, Jonathan Ives, Heather Draper, Michael Brundage, Jane Blazeby, Madeleine King
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/5de183d937d248fba457a8d4b2e02241
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spelling	oai:doaj.org-article:5de183d937d248fba457a8d4b2e022412021-11-25T05:56:25ZPatient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.1932-620310.1371/journal.pone.0110216https://doaj.org/article/5de183d937d248fba457a8d4b2e022412014-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0110216https://doaj.org/toc/1932-6203<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 protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.<h4>Methods and findings</h4>We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.<h4>Conclusions</h4>PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.Melanie CalvertDerek KyteHelen DuffyAdrian GheorgheRebecca Mercieca-BebberJonathan IvesHeather DraperMichael BrundageJane BlazebyMadeleine KingPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 10, p e110216 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Melanie Calvert Derek Kyte Helen Duffy Adrian Gheorghe Rebecca Mercieca-Bebber Jonathan Ives Heather Draper Michael Brundage Jane Blazeby Madeleine King Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
description	<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 protocol may help improve trial conduct and the reporting and appraisal of PRO results; however, it is currently unclear exactly what PRO-specific information should be included. The aim of this review was to summarize the current PRO-specific guidance for clinical trial protocol developers.<h4>Methods and findings</h4>We searched the MEDLINE, EMBASE, CINHAL and Cochrane Library databases (inception to February 2013) for PRO-specific guidance regarding trial protocol development. Further guidance documents were identified via Google, Google scholar, requests to members of the UK Clinical Research Collaboration registered clinical trials units and international experts. Two independent investigators undertook title/abstract screening, full text review and data extraction, with a third involved in the event of disagreement. 21,175 citations were screened and 54 met the inclusion criteria. Guidance documents were difficult to access: electronic database searches identified just 8 documents, with the remaining 46 sourced elsewhere (5 from citation tracking, 27 from hand searching, 7 from the grey literature review and 7 from experts). 162 unique PRO-specific protocol recommendations were extracted from included documents. A further 10 PRO recommendations were identified relating to supporting trial documentation. Only 5/162 (3%) recommendations appeared in ≥50% of guidance documents reviewed, indicating a lack of consistency.<h4>Conclusions</h4>PRO-specific protocol guidelines were difficult to access, lacked consistency and may be challenging to implement in practice. There is a need to develop easily accessible consensus-driven PRO protocol guidance. Guidance should be aimed at ensuring key PRO information is routinely included in appropriate trial protocols, in order to facilitate rigorous collection/reporting of PRO data, to effectively inform patient care.
format	article
author	Melanie Calvert Derek Kyte Helen Duffy Adrian Gheorghe Rebecca Mercieca-Bebber Jonathan Ives Heather Draper Michael Brundage Jane Blazeby Madeleine King
author_facet	Melanie Calvert Derek Kyte Helen Duffy Adrian Gheorghe Rebecca Mercieca-Bebber Jonathan Ives Heather Draper Michael Brundage Jane Blazeby Madeleine King
author_sort	Melanie Calvert
title	Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
title_short	Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
title_full	Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
title_fullStr	Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
title_full_unstemmed	Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
title_sort	patient-reported outcome (pro) assessment in clinical trials: a systematic review of guidance for trial protocol writers.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/5de183d937d248fba457a8d4b2e02241
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Patient-reported outcome (PRO) assessment in clinical trials: a systematic review of guidance for trial protocol writers.

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