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Development of a core outcome set for use in community-based bipolar trials — a qualitative study and modified Delphi

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Frey, Rosemary, Retzer, Ameeta, Sayers, Ruth, Pinfold, Vanessa, Gibson, John, Keeley, Thomas, Taylor, Gemma, Plappert, Humera, Gibbons, Bliss, Huxley, Peter, Mathers, Jonathan M., Birchwood, M. J. and Calvert, Melanie J. (2020) Development of a core outcome set for use in community-based bipolar trials — a qualitative study and modified Delphi. PLoS One, 15 (10). e0240518. doi:10.1371/journal.pone.0240518 ISSN 1932-6203.

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Official URL: http://dx.doi.org/10.1371/journal.pone.0240518

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Abstract

Background:
A core outcome set (COS) is a standardised collection of outcomes to be collected and reported in all trials within a research area. A COS can reduce reporting bias and facilitate evidence synthesis. This is currently unavailable for use in community-based bipolar trials. This research aimed to develop such a COS, with input from a full range of stakeholders.

Methods:
A co-production approach was used throughout. A longlist of outcomes was derived from focus groups with people with a bipolar diagnosis and carers, interviews with healthcare professionals and a rapid review of outcomes listed in bipolar trials on the Cochrane database. An expert panel with personal and/or professional experience of bipolar participated in a modified Delphi process and the COS was finalised at a consensus meeting.

Results:
Fifty participants rated the importance of each outcome. Sixty-six outcomes were included in Round 1 of the questionnaire; 13 outcomes were added by Round 1 participants and were rated in Round 2. Seventy-six percent of participants (n = 38) returned to Round 2 and 60 outcomes, including 4 outcomes added by participants in Round 1, received a rating of 7–9 by >70% and 1–3 by <25% of the sample. Fourteen participants finalised a COS containing 11 outcomes at the consensus meeting: personal recovery; connectedness; clinical recovery of bipolar symptoms; mental health and wellbeing; physical health; self-monitoring and management; medication effects; quality of life; service outcomes; experience of care; and use of coercion.

Conclusions:
This COS is recommended for use in community-based bipolar trials to ensure stakeholder-relevant outcomes, facilitate data synthesis, and transparent reporting. The COS includes guidance notes for each outcome to allow the identification of suitable measurement instruments. Further validation is recommended for use with a wide range of communities and to achieve standardised measurement.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Mental Health and Wellbeing
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Manic-depressive illness , Manic-depressive illness -- Treatment, Manic-depressive persons
Journal or Publication Title: PLoS One
Publisher: Public Library of Science
ISSN: 1932-6203
Official Date: 28 October 2020
Dates:
DateEvent
28 October 2020Published
28 September 2020Accepted
Volume: 15
Number: 10
Article Number: e0240518
DOI: 10.1371/journal.pone.0240518
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Date of first compliant deposit: 19 January 2021
Date of first compliant Open Access: 19 January 2021
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
RP-PG-0611-20004[NIHR] National Institute for Health Researchhttp://dx.doi.org/10.13039/501100000272
Is Part Of: 1

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