Evidence map›Paper›PMID 33112874›Full record

ArticlePloS one2020

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

Ameeta Retzer, Ruth Sayers, Vanessa Pinfold, John Gibson, Thomas Keeley, Gemma Taylor, Humera Plappert, Bliss Gibbons, Peter Huxley, Jonathan Mathers and 2 more

Abstract read
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Collaborative care approaches for people with severe mental illness.The Cochrane database of systematic reviews · 2024
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  12. Exploring the impact of engagement in mental health and substance use research: A scoping review and thematic analysis.Health expectations : an international journal of public participation in health care and health policy · 2023
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Ameeta RetzerCentre for Patient Reported Outcomes Research (CPROR), Institute of Applied Health Research, and Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, United Kingdom.
Ruth SayersThe McPin Foundation, London, United Kingdom.
Vanessa PinfoldThe McPin Foundation, London, United Kingdom.
John GibsonThe McPin Foundation, London, United Kingdom.
Thomas KeeleyGlaxoSmithKline (formerly of CPROR, University of Birmingham), London, United Kingdom.
Gemma TaylorAddiction and Mental Health Group (AIM), Department of Psychology, University of Bath, Bath, United Kingdom.
Humera PlappertInstitute for Mental Health, School of Psychology, University of Birmingham, Birmingham, United Kingdom.
Bliss GibbonsCoventry and Warwickshire Partnership NHS Trust and Warwick Medical School, University of Warwick, Warwick, United Kingdom.ORCID 0000-0002-1310-6838
Peter HuxleyCentre for Mental Health and Society, Bangor University, Bangor, United Kingdom.
Jonathan MathersInstitute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
Maximillian BirchwoodMental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, United Kingdom.
Melanie CalvertCentre for Patient Reported Outcomes Research (CPROR), Institute of Applied Health Research, and Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, United Kingdom.ORCID 0000-0002-1856-837X

Funding

Cancer Research UK C56067/A21330Department of Health RP-PG-0611-20004
6 · The paper itself

Abstract

backgroundA 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.

methodsA 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.

resultsFifty 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.

conclusionsThis 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.

Indexed as

Bipolar DisorderClinical Trials as TopicDelphi TechniqueEndpoint DeterminationFocus GroupsHumansOutcome and Process Assessment, Health CareQualitative ResearchResearch DesignTreatment Outcome

Identifiers

PMID33112874
PMCPMC7592842

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.