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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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WRAP-development-core-outcome-set-use-community-based bipolar-trials-Birchwood-2020.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1145Kb) | Preview |
Official URL: http://dx.doi.org/10.1371/journal.pone.0240518
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 | ||||||
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| 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 |
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| 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: |
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| 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: |
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| Is Part Of: | 1 |
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