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.
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.
Aims During this presentation we will share learning from a Wellcome Trust Engagement Fellowship. We will present examples of artsbased public involvement activities, including a sculpture project with young people and a play about dementia. We aim to raise awareness of what public involvement can gain from the arts; stimulate discussion about the pros and cons of different approaches; and discuss how to encourage more creativity within public involvement. Why is it important and to whom? Public involvement has been criticised for a lack of diversity and inclusivity. By diversifying the involvement activities which we offer, we may attract a wider variety of people. Arts based activities also have the potential to facilitate discussion in an accessible, safe and fun way. This session may be of particular interest to people who are planning or facilitating public involvement activities (members of the public and researchers). What difference has, or could, this project make? Throughout the project, both researchers and members of the public have found arts activities stimulating and useful. However people have encountered some practical challenges when running these projects. Specifically, people do not feel they have the necessary skills to plan and facilitate arts activities. I will discuss how we might address that skills gap and invite the audience to suggest what support is needed. What will people take away from session? An understanding of what arts/health collaborations can offer public involvement Access to resources and contacts to support future projects Acknowledgments This work is funded by the Wellcome Trust
Background Individuals living with severe mental illness can have significant emotional, physical and social challenges. Collaborative care combines clinical and organisational components. Aims We tested whether a primary care-based collaborative care model (PARTNERS) would improve quality of life for people with diagnoses of schizophrenia, bipolar disorder or other psychoses, compared with usual care. Method We conducted a general practice-based, cluster randomised controlled superiority trial. Practices were recruited from four English regions and allocated (1:1) to intervention or control. Individuals receiving limited input in secondary care or who were under primary care only were eligible. The 12-month PARTNERS intervention incorporated person-centred coaching support and liaison work. The primary outcome was quality of life as measured by the Manchester Short Assessment of Quality of Life (MANSA). Results We allocated 39 general practices, with 198 participants, to the PARTNERS intervention (20 practices, 116 participants) or control (19 practices, 82 participants). Primary outcome data were available for 99 (85.3%) intervention and 71 (86.6%) control participants. Mean change in overall MANSA score did not differ between the groups (intervention: 0.25, s.d. 0.73; control: 0.21, s.d. 0.86; estimated fully adjusted between-group difference 0.03, 95% CI −0.25 to 0.31; P = 0.819). Acute mental health episodes (safety outcome) included three crises in the intervention group and four in the control group. Conclusions There was no evidence of a difference in quality of life, as measured with the MANSA, between those receiving the PARTNERS intervention and usual care. Shifting care to primary care was not associated with increased adverse outcomes.
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