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

Retzer, Ameeta; Sayers, Ruth; Pinfold, Vanessa; Gibson, John; Keeley, Thomas; Taylor, Gemma; Plappert, Humera; Gibbons, Bliss; Huxley, Peter; Mathers, Jonathan; Birchwood, Max; Calvert, Melanie

doi:10.1371/journal.pone.0240518

Cited by 22 publications

(23 citation statements)

References 31 publications

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“…A topic guide will be developed based on previous literature, and with the guidance of qualitative experts and patient representatives in the SAG and our PPI advisory group. 33 34 The focus group will be facilitated by a researcher with qualitative methodology training. The focus group discussion will be recorded using the virtual meeting platform, the recordings will be transcribed and imported to NVivo.…”

Section: Methodsmentioning

confidence: 99%

Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Lee

Eastwood

Moss³

et al. 2021

BMJ Open

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IntroductionIncreasingly more pregnant women are living with pre-existing multimorbidity (≥two long-term physical or mental health conditions). This may adversely affect maternal and offspring outcomes. This study aims to develop a core outcome set (COS) for maternal and offspring outcomes in pregnant women with pre-existing multimorbidity. It is intended for use in observational and interventional studies in all pregnancy settings.Methods and analysisWe propose a four stage study design: (1) systematic literature search, (2) focus groups, (3) Delphi surveys and (4) consensus group meeting. The study will be conducted from June 2021 to August 2022. First, an initial list of outcomes will be identified through a systematic literature search of reported outcomes in studies of pregnant women with multimorbidity. We will search the Cochrane library, Medline, EMBASE and CINAHL. This will be supplemented with relevant outcomes from published COS for pregnancies and childbirth in general, and multimorbidity. Second, focus groups will be conducted among (1) women with lived experience of managing pre-existing multimorbidity in pregnancy (and/or their partners) and (2) their healthcare/social care professionals to identify outcomes important to them. Third, these initial lists of outcomes will be prioritised through a three-round online Delphi survey using predefined score criteria for consensus. Participants will be invited to suggest additional outcomes that were not included in the initial list. Finally, a consensus meeting using the nominal group technique will be held to agree on the final COS. The stakeholders will include (1) women (and/or their partners) with lived experience of managing multimorbidity in pregnancy, (2) healthcare/social care professionals involved in their care and (3) researchers in this field.Ethics and disseminationThis study has been approved by the University of Birmingham’s ethical review committee. The final COS will be disseminated through peer-reviewed publication and conferences and to all stakeholders.

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Section: Methodsmentioning

confidence: 99%

Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Lee

Eastwood

Moss³

et al. 2021

BMJ Open

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“…Approaches to recruitment were tested iteratively involving flexibility for non-responders and support from NHS employed researchers for pre-consent work (initial identification and approach by letter and telephone) in primary care. A core outcome set for use in bipolar trials was developed (9). To account for the wider psychosis target population in PARTNERS2, and the nature of the intervention, an additional stakeholder consultation was undertaken to select outcomes and measures.…”

Section: Feasibility and Piloting In The Partners2 Programmementioning

confidence: 99%

“…A core outcome set for use in bipolar disorder trials was developed. 9 To account for the wider psychosis target population in PARTNERS2 and the nature of the intervention, an additional stakeholder consultation was undertaken to select outcomes and measures. QoL was selected as the most important outcome domain.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial

et al. 2021

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BackgroundCurrent NHS policy encourages an integrated approach to provision of mental and physical care for individuals with long term mental health problems. The ‘PARTNERS2’ complex intervention is designed to support individuals with psychosis in a primary care setting.AimsThe trial will evaluate the clinical and cost-effectiveness of the PARTNERS2 intervention.Design & settingThis is a cluster randomised controlled superiority trial comparing collaborative care (PARTNERS2) with care as usual, with an internal pilot to assess feasibility. The setting will be primary care within four trial recruitment areas: Birmingham & Solihull, Cornwall, Plymouth and Somerset. GP practices are randomised 1:1 to either (a) the PARTNERS2 intervention plus modified standard care (intervention) or (b) standard care only (control).Methods and analysisPARTNERS2 is a flexible general practice based person-centred coaching based intervention aimed at addressing mental health, physical health and social care needs. Two hundred eligible individuals from 39 GP practices are taking part. They were recruited through identification from secondary and primary care databases. The primary hypothesis is quality of life. Secondary outcomes include: mental wellbeing, time use, recovery and process of physical care. A process evaluation will assess fidelity of intervention delivery, test hypothesised mechanisms of action and look for unintended consequences. An economic evaluation will estimate the cost-effectiveness. Intervention delivery and follow up have been modified during the COVID-19 pandemic.ConclusionThe overarching aim is to establish the clinical and cost effectiveness of the model for adults with a diagnosis of schizophrenia, bipolar, or other types of psychosis.

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“…Measuring identical outcomes in clinical trials has become important internationally to synthesise evidence and achieve better health and social care [1,2]. This global trend has accelerated the development of core outcome sets (COSs) in the eld of mental health [3][4][5]. Currently, there are no consensus outcome sets for evaluating community-based psychosocial interventions for people with severe mental illness, including schizophrenia.…”

Section: Introductionmentioning

confidence: 99%

Outcomes Frequently Specified in Cochrane Reviews of Community-based Psychosocial Interventions for Adults with Severe Mental Illness: A Systematic Search and Narrative Synthesis

Igarashi

Yamaguchi

Kawaguchi

et al. 2021

Preprint

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Background: Outcome selection in intervention studies is a critical issue for synthesising evidence. This study is aimed to investigate outcomes used in Cochrane reviews assessing community-based psychosocial interventions for adults with severe mental illness.Methods: Cochrane reviews that evaluated a community-based psychosocial intervention for adults with severe mental illness were searched electronically and manually. We extracted all outcomes specified in the Methods section in each Cochrane review. Outcomes that represent the same concept and context were synthesised into an outcome term. Outcome terms were categorised according to the existing taxonomy.Results: We included 31 Cochrane reviews. Of the 214 outcome terms identified, 13 were used in more than half of the reviews: quality of life, mental state, economic outcome, admission to hospital, leaving the study early, social functioning, satisfaction, global state, relapse, adverse events/effects, carer satisfaction, employment, duration of admission. Most outcome terms were categorised into the life impact core area (57%), followed by the resource use area (21%).Conclusions: Our study provides a candidate outcome list for developing a core outcome set for severe mental illness and offers a basis for comparison for future outcome investigation on mental health research.

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

Cited by 22 publications

References 31 publications

Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Protocol for the development of a core outcome set for studies of pregnant women with pre-existing multimorbidity

Evaluation of a primary care-based collaborative care model (PARTNERS2) for people with diagnoses of schizophrenia, bipolar, or other psychoses: study protocol for a cluster randomised controlled trial

Outcomes Frequently Specified in Cochrane Reviews of Community-based Psychosocial Interventions for Adults with Severe Mental Illness: A Systematic Search and Narrative Synthesis

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