Corrigendum: A critical reflection on using the Patient Engagement In Research Scale (PEIRS) to evaluate patient and family partners' engagement in dementia research.

[This corrects the article DOI: 10.3389/frdem.2024.1422820.].

Consequences of how third sector organisations are commissioned in the NHS and local authorities in England: a mixed-methods study.

Background: As a matter of policy, voluntary, community and social enterprises contribute substantially to the English health and care system. Few studies explain how the National Health Service and local authorities commission them, what outputs result, what contexts influence these outcomes and what differentiates this kind of commissioning. Objectives: To explain how voluntary, community and social enterprises are commissioned, the consequences, what barriers both parties face and what absorptive capacities they need. Design: Observational mixed-methods realist analysis: exploratory scoping, cross-sectional analysis of National Health Service Clinical Commissioning Group spending on voluntary, community and social enterprises, systematic comparison of case studies, action learning. Social prescribing, learning disability support and end-of-life care were tracers. Setting: Maximum-variety sample of six English local health and care economies, 2019-23. Participants: Commissioning staff; voluntary, community and social enterprise members. Interventions: None; observational study. Main outcome measures: How the consequences of commissioning compared with the original aims of the commissioners and the voluntary, community and social enterprises: predominantly qualitative (non-measurable) outcomes. Data sources: Data sources were: 189 interviews, 58 policy and position papers, 37 items of rapportage, 692,659 Clinical Commissioning Group invoices, 102 Freedom of Information enquiries, 131 survey responses, 18 local project group meetings, 4 national action learning set meetings. Data collected in England during 2019-23. Results: Two modes of commissioning operated in parallel. Commodified commissioning relied on creating a principal-agent relationship between commissioner and the voluntary, community and social enterprises, on formal competitive selection ('procurement') of providers. Collaborative commissioning relied on 'embedded' interorganisational relationships, mutual recognition of resource dependencies, a negotiated division of labour between organisations, and control through persuasion. Commissioners and voluntary, community and social enterprises often worked around the procurement regulations. Both modes were present everywhere but the balance depended inter alia on the number and size of voluntary, community and social enterprises in each locality, their past commissioning experience, the character of the tracer activity, and the level of deprivation and the geographic dispersal of the populations served. The COVID-19 pandemic produced a shift towards collaborative commissioning. Voluntary, community and social enterprises were not always funded at the full cost of their activity. Integrated Care System formation temporarily disrupted local co-commissioning networks but offered a longer-term prospect of greater voluntary, community and social enterprise influence on co-commissioning. To develop absorptive capacity, commissioners needed stronger managerial and communication capabilities, and voluntary, community and social enterprises needed greater capability to evidence what outcomes their proposals would deliver. Limitations: Published data quality limited the spending profile accuracy, which did not include local authority commissioning. Case studies did not cover London, and focused on three tracer activities. Absorptive capacity survey was not a random sample. Conclusions: The two modes of commissioning sometimes conflicted. Workarounds arose from organisations' embeddedness and collaboration, which the procurement regulations often disrupted. Commissioning activity at below its full cost appears unsustainable. Future work: Spending profiles of local authority commissioning; analysis of commissioning in London and of activities besides the present tracers. Analysis of absorptive capacity and its consequences, adjusting the concept for application to voluntary, community and social enterprises. Comparison with other health systems' commissioning of voluntary, community and social enterprises. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR128107) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 39. See the NIHR Funding and Awards website for further award information.

National Health Service commissioners and local councils often buy health and care services from voluntary, community and social enterprises. This study aimed to explore how commissioners and voluntary, community and social enterprises worked together and where improvements could be made. We talked to commissioners and voluntary, community and social enterprises in six areas across England and focused on services for learning disabilities, social prescribing and end-of-life care. We analysed National Health Service financial accounts to see how much the National Health Service was spending on services provided by voluntary, community and social enterprises. We surveyed how commissioners and voluntary, community and social enterprises were using information and knowledge to make decisions. We organised events bringing together commissioners and voluntary, community and social enterprises to share knowledge and experience. We found there were two ways commissioners bought services from voluntary, community and social enterprises. One was commodified (a buying-and-selling model), the other collaborative (based on working together). Both were happening at the same time in all the areas of the study, but usually one of them was more present than the other. We saw a general move towards collaboration, but some areas were further along with this than others. Various things helped commissioners and voluntary, community and social enterprises collaborate, such as: paying voluntary, community and social enterprises enough for their services; having people and networks that encouraged others to work with voluntary, community and social enterprises; and including voluntary, community and social enterprises in making decisions about health and care. Commissioners and voluntary, community and social enterprises might therefore lean further towards working together to see how collaborative commissioning can be further developed; how to make contract prices cover voluntary, community and social enterprises' costs; how to enable longer-term contracts; and how to enable less hurried, more considered ways of renewing contracts (e.g. by putting draft contract specifications out to pre-tender consultation). The new Integrated Care Systems in local areas could encourage all this to happen, but pressures elsewhere in the health and care sector might make it more difficult.

Inclusion of people with multiple long-term conditions in pregnancy research: patient, public and stakeholder involvement and engagement in a randomised controlled trial.

BACKGROUND: Both pregnant women and those with multiple long-term conditions are under-served groups in clinical research. Informing and improving research through patient and public involvement, including pregnant women with two or more long-term health conditions, is critical to increasing their inclusion in maternity research. Giant PANDA is a randomised controlled trial, evaluating the effect of a treatment initiation strategy with nifedipine versus labetalol on severe maternal hypertension and a composite outcome of fetal/neonatal death, or neonatal unit admission. We aimed to undertake a mixed methods study-within-a-project within the Giant PANDA trial to understand barriers and facilitators to participation, understand and optimise current representativeness of clinical trial delivery of those with multiple long-term conditions and co-create a checklist to support their inclusion in pregnancy research. METHODS: We undertook online workshops with women with lived experience and hybrid workshops with healthcare professionals who look after women with multiple long-term conditions. A site audit of Giant PANDA sites provided insights into research delivery capacity and health system set-up, and how this influences inclusion. An extension to the Giant PANDA screening log captured data on multiple long-term conditions enabling analysis of the impact of these health conditions on women's inclusion in the trial. We co-created a checklist of recommendations for those designing and recruiting to similar clinical trials. RESULTS: Five key recommendations were identified including a need to (1) involve women with multiple long-term conditions as partners in maternity research and (2) minimise barriers that stop them from taking part through (3) designing and delivering research that is flexible in time and place (4) consider research as part of care for everyone, including those with multiple long-term conditions and (5) measure and report inclusion of those with two or more health conditions in maternity research. Multiple long-term conditions were not a barrier to recruitment or randomisation in the Giant PANDA trial. CONCLUSION: Women with multiple long-term conditions would like opportunities to find out about and participate in research which accounts for their needs. Our checklist aims to support those designing and delivering maternity research to optimise inclusion of individuals with multiple-long term conditions. TRIAL REGISTRATION: Giant PANDA: EudraCT number: 2020-003410-12, ISRCTN: 12,792,616.

Pregnant women with two or more long-term health problems may be less likely to be included in research. Including them in research is important to ensure we give the best care. Giant PANDA is a study comparing two medicines (nifedipine or labetalol) to manage high blood pressure in pregnancy. As part of the study, we looked at the number of women with two or more long-term health conditions included. We talked to women with experience of two or more long-term health conditions in pregnancy, and healthcare staff who look after these women. Finally, we looked at how maternity research is set up in Giant PANDA study sites. We found that women with two or more health conditions were taking part in the Giant PANDA study. Women with two or more long-term conditions would like the choice to be included in research which considers their needs. This includes being involved in the planning and ongoing support for studies. Research needs to be part of routine care, flexible, and not time consuming to help those with two or more health conditions take part. Our findings have been used to make a checklist to help plan and support studies for women and birthing people with two or more long-term health conditions.

"I am there just to get on with it": a qualitative study on the labour of the patient and public involvement workforce.

BACKGROUND: Workers tasked with specific responsibilities around patient and public involvement (PPI) are now routinely part of the organizational landscape for applied health research in the United Kingdom. Even as the National Institute for Health and Care Research (NIHR) has had a pioneering role in developing a robust PPI infrastructure for publicly funded health research in the United Kingdom, considerable barriers remain to embedding substantive and sustainable public input in the design and delivery of research. Notably, researchers and clinicians report a tension between funders' orientation towards deliverables and the resources and labour required to embed public involvement in research. These and other tensions require further investigation. METHODS: This was a qualitative study with participatory elements. Using purposive and snowball sampling and attending to regional and institutional diversity, we conducted 21 semi-structured interviews with individuals holding NIHR-funded formal PPI roles across England. Interviews were analysed through reflexive thematic analysis with coding and framing presented and adjusted through two workshops with study participants. RESULTS: We generated five overarching themes which signal a growing tension between expectations put on staff in PPI roles and the structural limitations of these roles: (i) the instability of support; (ii) the production of invisible labour; (iii) PPI work as more than a job; (iv) accountability without control; and (v) delivering change without changing. CONCLUSIONS: The NIHR PPI workforce has enabled considerable progress in embedding patient and public input in research activities. However, the role has led not to a resolution of the tension between performance management priorities and the labour of PPI, but rather to its displacement and - potentially - its intensification. We suggest that the expectation to "deliver" PPI hinges on a paradoxical demand to deliver a transformational intervention that is fundamentally divorced from any labour of transformation. We conclude that ongoing efforts to transform health research ecologies so as to better respond to the needs of patients will need to grapple with the force and consequences of this paradoxical demand.

The active involvement of patients in oncology research.

The aim of this review is to provide an overview of the status of patient/public involvement (PPI) in oncology research, including definitions, regulatory aspects, ongoing clinical activities in different countries, achievements and difficulties. The 10-year activities of the Swiss Group for Clinical Cancer Research (SAKK) Patient Advisory Board are described, illustrating challenges faced and solutions in daily practice. Even though clinical data are still limited, it appears PPI has great potential for development in oncology. The drive for precision medicine, activities of patient organizations, pharmaceutical industry interest, and strong support from regulatory agencies, are facilitators to integration of PPI throughout the drug development process. Despite the availability of guidance documents providing recommendations for the implementation of PPI, lack of human and structural resources, training for patients / caregivers and healthcare personnel, and lack of collaboration among stakeholders are some of the main barriers reported. More rigorous reporting of PPI in clinical studies is needed, including the methods to evaluate the impact of PPI and in the representation of patients as partner.

Is this really Empowerment? Enhancing our understanding of empowerment in patient and public involvement within clinical research.

BACKGROUND: There has been a growing push to involve patients in clinical research, shifting from conducting research on, about, or for them to conducting it with them. Two arguments advocate for this approach, known as Patient and Public Involvement (PPI): to improve research quality, appropriateness, relevance, and credibility by including patients' diverse perspectives, and to use PPI to empower patients and democratize research for more equity in research and healthcare. However, while empowerment is a core objective, it is often not clear what is meant by empowerment in the context of PPI in clinical research. This vacancy can lead to insecurities for both patients and researchers and a disconnect between the rhetoric of empowerment in PPI and the reality of its practice in clinical trials. Thus, clarifying the understanding of empowerment within PPI in clinical research is essential to ensure that involvement does not become tokenistic and depletes patients' capacity to advocate for their rights and needs. METHODS: We explored the historical roots of empowerment, primarily emerging from mid-20th century social movements like feminism and civil rights and reflected the conceptual roots of empowerment from diverse fields to better understand the (potential) role of empowerment in PPI in clinical research including its possibilities and limitations. RESULTS: Common themes of empowerment in PPI and other fields are participation, challenging power structures, valuing diverse perspectives, and promoting collaboration. On the other hand, themes such as contextual differences in the empowerment objectives, the relationship between empowerment and scientific demands, research expertise, and power asymmetries mark a clear distinction from empowerment in other fields. CONCLUSION: PPI offers potential for patient empowerment in clinical trials, even when its primary goal may be research quality. Elements like participation, sharing opinions, and active engagement can contribute to patient empowerment. Nonetheless, some expectations tied to empowerment might not be met within the constraints of clinical research. To empower patients, stakeholders must be explicit about what empowerment means in their research, engage in transparent communication about its realistic scope, and continuously reflect on how empowerment can be fostered and sustained within the research process.

The academic impact of paediatric research agendas: a descriptive analysis.

BACKGROUND: Increasingly, researchers are involving children and young people in designing paediatric research agendas, but as far as we were able to determine, only one report exists on the academic impact of such an agenda. In our opinion, the importance of insight into the impact of research agendas designed together with children and young people cannot be overstated. The first aim of our study was therefore to develop a method to describe the academic impact of paediatric research agendas. Our second aim was to describe the academic impact of research agendas developed by involving children and young people. METHODS: We based our method on aspects of the Research Impact Framework developed by Kuruvilla and colleagues and the Payback Framework developed by Donovan and Hanney. We named it Descriptive Academic Impact Analysis of Paediatric Research Agendas, consisting of five steps: [1] Identification of paediatric research agendas, [2] Citation analysis, [3] Impact analysis, [4] Author assessment, and [5] Classification of the ease of determining traceability. RESULTS: We included 31 paediatric research agendas that were designed by involving children and young people. These agendas were cited 517 times, ranging from 0 to 71 citations. A total of 131 new studies (25%) were published, ranging from 0 to 23 per paediatric research agenda, based on at least one of the research priorities from the agenda. Sixty studies (46%) were developed by at least one of the first, second, or last authors of the paediatric research agenda on which the studies were based. Based on their accessibility and the ease with which we could identify the studies as being agenda-based, we categorised 44 studies (34%) as easy, 62 studies (47%) as medium, and 25 studies (19%) as difficult to identify. CONCLUSION: This study reports on the development of a method to describe the academic impact of paediatric research agendas and it offers insight into the impact of 31 such agendas. We recommend that our results be used as a guide for designing future paediatric research agendas, especially by including ways of tracing the academic impact of new studies concerning the agendas' research priorities.

Increasingly, researchers are involving children and young people in designing paediatric research agendas. However, few researchers have described the impact of these agendas on the research undertaken. We strongly believe that it is important to know how such agendas affect research, what their impact is. One of the reasons paediatric research agendas are being designed is to create a clear overview of what the research questions are that need to be investigated - if this question is left unanswered, why bother designing the agendas at all? Therefore, we developed a 5-step tool to identify these agendas and to describe their impact. We tested our tool on 31 paediatric research agendas that were designed together with children and young people. These agendas were mentioned 517 times, 131 new studies were based on these agendas, and 60 studies were performed by the same authors who had designed the agendas. Of the new studies, we found 44 that were easy to identify, 62 that were fairly easy, and 25 that were difficult to identify as being based on paediatric research agendas. We hope that our results will serve as a useful guide for future researchers who aim to involve children and young people in designing research agendas. Especially, if ways are included to trace the impact of new studies in relation to the most important questions stated in the original research agendas.

Reporting community involvement in autism research: Findings from the journal Autism.

LAY ABSTRACT: There has been a growing push for the Autistic and autism communities to be more actively involved in autism research. From January 2021, the journal Autism made it a rule for authors to report whether they involved community members in their work; and if they did, how they had done so. In this study, we wanted to see how this new rule has changed things. Our team of Autistic and non-autistic researchers read all 283 articles published in Autism in 2019, about 2 years before the rule was in place, and in 2022, about 1 year after. We recorded what each article was about and how the community was involved. We found there was an increase in how often articles talked about community involvement - from about 10% before the rule to over 50% after. Most of these studies, however, only involved community members giving advice, with the researchers making most decisions about the research. This was especially true for applied research (like wellbeing) rather than basic science (like causes of autism). Also, some of these articles were unclear or did not give enough information for us to understand how the community was involved. This tells us that while it is promising that more community involvement is reported, researchers need to describe this involvement more clearly. It is also important for community members to have a bigger say in research by sharing power with the researchers or even leading the research themselves.

Aripiprazole/Sertraline Combination: Clinical and Cost-Effectiveness in Comparison With Quetiapine for the Treatment of Bipolar Depression (ASCEnD Trial)-Protocol for a Nested Qualitative Study.

INTRODUCTION: Bipolar disorder is a recurrent mental health disorder with a prevalence rate of 1.4%. On average, there can be a delay of 9.5 years from the initial presentation of symptoms to a confirmed diagnosis. Individuals living with bipolar disorder have a reduced life expectancy. There is limited evidence regarding the effectiveness of antidepressants in treating bipolar disorder. The ASCEnD clinical trial will test the clinical and cost-effectiveness of the aripiprazole/sertraline combination in comparison with quetiapine for the treatment of bipolar depression (individuals who suffer from depressive episodes in bipolar disorder) and will include a nested qualitative study. METHODS: The qualitative study will use semi-structured interviews to explore pilot trial participants' and clinicians' perspectives on recruitment procedures, the acceptability of the intervention, the management of bipolar disorder and attitudes to medication combinations. CONCLUSION: Findings will inform recruitment strategies and optimise training for the participating sites in the ASCEnD full trial. They will also help to illuminate the lived experience of people with bipolar disorder and the clinicians who work with people with bipolar disorder. The discussion will explore perspectives on the delay in diagnosis, having a diagnosis, the impact of living with bipolar disorder and attitudes to treatment, including drug combinations. PATIENT OR PUBLIC CONTRIBUTION: A Lived Experience Advisory Panel (LEAP) has been convened with the support of the McPin Foundation, which will contribute to the ASCEnD trial and its nested qualitative study to provide input on the design and delivery of the trial and qualitative study, analysis of qualitative data and dissemination of findings.

Evaluating qualitative data analysis workshops from the perspective of public contributors.

BACKGROUND: The aim of this project is to evaluate public contributors' experiences of their involvement in qualitative data analysis workshops during an on-going research project titled 'Personalised Primary care for Patients with Multiple long-term conditions'. METHODS: Four qualitative data analysis workshops were designed and conducted between August and December 2023. We used the Cube evaluation framework (henceforth referred to as the Cube) to evaluate the workshops. The Cube suggests four domains for successful PPI (voice, agenda, change, contribute).Within Workshops One, Two and Three public contributors had to login to an account to access the Cube; this was modified in Workshop Four following feedback from public contributors. FINDINGS: Across the four workshops the Cube was completed 11 times. Across all four workshops, public contributors thought that their voice was heard, that there were diverse ways to contribute and that they led the agenda. Public contributors thought that researchers responded to their questions and issues, when necessary. CONCLUSION: This evaluation has shown that public contributors can gain new skills and lead qualitative data analysis discussions.

Why are we doing this project?Patient and public involvement (PPI) can enhance qualitative research methods, however, public contributors may need support in order to contribute. The aim of this project is to evaluate public contributors' experiences of qualitative data analysis workshops during an on-going research project titled 'Personalised Primary care for Patients with Multiple long-term conditions (PP4M)'.How did we do this project?Four qualitative data analysis workshops were co-designed and conducted between August and December 2023. The Cube evaluation framework (henceforth referred to as the Cube) was used to evaluate each workshop. The Cube suggests four domains for successful PPI (voice, agenda, change, contribute). Within Workshops One, Two and Three public contributors had to login to an account to access the Cube; this was modified in Workshop Four following feedback from public contributors.What did we learn?Across the four workshops the Cube was completed 11 times. Public contributors thought that their voice was heard, that there were diverse ways to contribute and that they led the agenda. Public contributors thought that researchers responded to their questions and issues, when necessary. This evaluation has shown that public contributors can gain new skills and lead qualitative data analysis discussions.

From Hospital to Home: Applying a Co-Design Approach to Determine the Key Components of an Intervention to Support Transition-To-Home After Stroke.

BACKGROUND: People with stroke and their families face numerous challenges as they leave hospital to return home, often experiencing multifaceted unmet needs and feelings of abandonment. The essential elements of an intervention intended to support transition-to-home after stroke are unclear. OBJECTIVE: The aim of the project was to engage in a co-design process to identify the key components of a pragmatic intervention to inform a transition-to-home support pathway following stroke. MATERIALS AND METHODS: The study was conducted using a co-design process engaging multiple stakeholders, including 12 people with stroke, 6 caregivers, 26 healthcare professionals and 6 individuals from stroke organisations in a series of three workshops, facilitated by the primary researcher, a wider team of researchers and an individual with lived experience of stroke. World Café methodology and Liberating Structures facilitation techniques were adapted to meet the aim of the workshops. Data collection involved observations during workshops, followed by summarising of findings and reaching group consensus agreement on outputs. Facilitated consensus on a prioritisation task resulted in the final output. RESULTS: The co-design group identified 10 key intervention components of a transition-to-home support pathway following stroke. These components focussed on enhancing collaboration, streamlining transition processes and facilitating post-discharge support. While a stroke coordinator was considered a top priority, increased cross-setting information sharing and community in-reach, where community-based healthcare staff extended their services into hospital settings to provide continuity care, were considered most feasible to implement. CONCLUSION: The co-design approach, involving a multi-stakeholder group and strengthened by patient and public involvement, ensured that the identified transition-to-home intervention components are meaningful and relevant for people with stroke and their families. Further co-design workshops are required to refine, and feasibility test the components for generalisability within the wider Irish healthcare setting. PATIENT OR PUBLIC CONTRIBUTION: Individuals who have experienced a stroke actively contributed to shaping the methodological design of this study and the ethics process. They engaged in the analysis of co-design outputs and provided input for the discussion and recommendations regarding future research. An individual who had experienced a stroke formed part of the research team, co-facilitating the co-design workshops and co-authoring this article.

The psychological effects of research participation on people with dementia: findings from a German exploratory interview study.

The German National Dementia Strategy aims to engage people with dementia in research projects. However, the effects of such research participation on experience and behavior have been insufficiently explored. This study aimed to investigate the psychological effect of research participation on people living with dementia. In a qualitative, exploratory approach, guideline-based interviews were conducted with four persons with dementia who had served as co-researchers on an advisory board in a health services research study for 8 months at that time. The analysis revealed predominantly positive effects of research participation at all levels of experience and behavior. Most effects were reported by the co-researchers on a cognitive level. Both the perception of being competent and of making a positive contribution to oneself and/or others are key effects of research participation. The main effects on an emotional level were joy and wellbeing and on a behavioral level were positive social contacts and social communication. Sadness and insecurity represent the sole negative effects. Nuanced focal points of effects among the individual interviews were found. The results align with existing research highlighting the positive effects of participation on people with dementia. Through advancing an interdisciplinary perspective on their research involvement, we advocate for heightened attention to this topic within the realm of psychology.

Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial.

INTRODUCTION: ASCEND PLUS is a randomised controlled trial assessing the effects of oral semaglutide on the primary prevention of cardiovascular events in around 20,000 individuals with type 2 diabetes in the UK. The trial's innovative design includes a decentralised direct-to-participant invitation, recruitment, and follow-up model, relying on self-completion of online forms or telephone or video calls with research nurses, with no physical sites. Extensive patient and public involvement and engagement (PPIE) was essential to the design and conduct of ASCEND PLUS. AIM: To report the process and conduct of PPIE activity in ASCEND PLUS, evaluate effects on trial design, reflect critically on successes and aspects that could have been improved, and identify themes and learning relevant to implementation of PPIE in future trials. METHODS: PPIE activity was coordinated centrally and included six PPIE focus groups and creation of an ASCEND PLUS public advisory group (PAG) during the design phase. Recruitment to these groups was carefully considered to ensure diversity and inclusion, largely consisting of adults living with type 2 diabetes from across the UK. Two members of the PAG also joined the trial Steering Committee. Steering Committee meetings, focus groups, and PAG meetings were conducted online, with two hybrid workshops to discuss PPIE activity and aspects of the trial. RESULTS: PPIE activity was critical to shaping the design and conduct of ASCEND PLUS. Key examples included supporting choice for participants to either complete the screening/consent process independently online, or during a telephone or video call interview with a research nurse. A concise 'initial information leaflet' was developed to be sent with the initial invitations, with the 'full' information leaflet sent later to those interested in joining the trial. The PAG reviewed the content and format of participant- and public-facing materials, including written documents, online screening forms, animated videos, and the trial website, to aid clarity and accessibility, and provided input into the choice of instruments to assess quality of life. CONCLUSIONS: PPIE is integral in ASCEND PLUS and will continue throughout the trial. This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial.

Perspectives of researchers and clinicians on patient and public involvement (PPI) in preclinical spinal cord research: An interview study.

INTRODUCTION: Patient and public involvement (PPI) in research is an embedded practice in clinical research, however, its role in preclinical or laboratory-based research is less well established and presents specific challenges. This study aimed to explore the perspectives of two key stakeholder groups, preclinical researchers and clinicians on PPI in preclinical research, using spinal cord research as a case study. METHODS: Semi-structured interviews were conducted online with 11 clinicians and 11 preclinical researchers all working in the area of spinal cord injury (SCI). Interviews were transcribed verbatim and analysed thematically. FINDINGS: Nine themes were developed through analysis. Participants' perspectives included that people living with SCI had a right to be involved, that PPI can improve the relevance of preclinical research, and that PPI can positively impact the experiences of researchers. They identified the distance between lab-based research and the daily experiences of living with SCI to be a barrier and proactive management of accessibility and the motivated and networked SCI community as key facilitators. To develop strong partnerships, participants suggested setting clear expectations, ensuring good communication, and demonstrating respect for the time of PPI contributors involved in the research. CONCLUSIONS: While traditionally PPI has been more commonly associated with clinical research, participants identified several potential benefits of PPI in preclinical spinal cord research that have applicability to preclinical researchers more broadly. Preclinical spinal researchers should explore how to include PPI in their work. PATIENT OR PUBLIC CONTRIBUTION: This study was conducted as part of a broader project aiming to develop an evidence base for preclinical PPI that draws on a 5-year preclinical research programme focused on the development of advanced biomaterials for spinal cord repair as a case study. A PPI Advisory Panel comprising seriously injured rugby players, clinicians, preclinical researchers, and PPI facilitators collaborated as co-authors on the conceptualisation, design of the interview protocol, data analysis and writing of this manuscript.

Patient and public involvement in preclinical and medical research: Evaluation of an established programme in a Discovery-Based Medical Research Institute.

BACKGROUND AND CONTEXT: Involving people with lived experience of health conditions and the public (consumers) in health research is supported by policy, practice and research funding schemes. However, consumer involvement programmes in discovery-based preclinical research settings are uncommon. Few formal evaluations of these programmes are reported in the literature. OBJECTIVE: This study aimed to evaluate an established patient and public involvement programme operating in a major Australian Discovery-Based Medical Research Institute (DBMRI) to inform programme development and the wider field. DESIGN AND PARTICIPANTS: A multimethods programme evaluation incorporating demographic, descriptive and qualitative data obtained through consumer/researcher co-developed online surveys and semistructured virtual interviews. Programme participants (n = 111) were invited to complete an online survey seeking feedback on their experience of involvement, programme processes and perceived impacts. A purposive sample of 25 participants was interviewed. Descriptive data were analysed using explanatory statistics and qualitative data from surveys and interviews were thematically analysed. RESULTS: This consumer involvement programme was found to be useful and meaningful for most participants, with specific examples of perceived added value. Consumers most commonly engaged with researchers to inform research development, prepare funding applications or strengthen lay communication of science. Genuine consumer-researcher interactions, relationship development and mutual respect were key elements in a positive experience for participants. Opportunities to 'give back', to learn and to ground research in lived experience were identified programme strengths and benefits. Developing researcher training in how to work with consumers, increasing the diversity of the consumer group membership and expanding the range of consumer activities were identified opportunities for improvement. Organisational support and adequate programme resourcing were identified as key enablers. CONCLUSION: Discovery-based preclinical research is often viewed as being distant from clinical application; therefore, consumer involvement may be considered less relevant. However this study identified value in bringing a strong consumer voice to the discovery-based research process through a coordinated, organisation-wide approach with the potential for application in similar preclinical research settings. PATIENT OR PUBLIC CONTRIBUTION: Four consumer partners from the DBMRI Consumer Advisory Panel were actively engaged in developing this programme evaluation. Specifically, these consumer partners co-developed and pilot-tested surveys and interview guides, reviewed and commented on project data analysis and reporting and also contributed as co-authors by editing the manuscript.

Patient and public involvement in international research: Perspectives of a team of researchers from six countries on collaborating with people with lived experiences of dementia and end-of-life.

BACKGROUND: Patient and public involvement (PPI) is a critical priority in research, policy, academia and advocacy organizations. PPI in dementia research is gaining momentum. However, these efforts are missing in international projects aimed at those living with advanced dementia in long-term care (LTC) homes. Additional complexities can arise in enacting PPI within the context of integration of a palliative approach to care and experiences around end-of-life in (EOL) dementia. The mySupport study involved implementing the Family Carer Decision Support (FCDS) intervention for care partners of those living with advanced dementia in LTC in six countries. RESEARCH DESIGN AND OBJECTIVE: An interpretive description study was conducted to explore the perspectives of international researchers from six countries on engaging people with lived experiences of dementia and EOL care in research processes. The findings from this study informed the development of a PPI strategy and a subsequent toolkit for the FCDS intervention. FINDINGS: Thirty-eight interviews were completed with project researchers: 12 from the United Kingdom, 8 from Canada, 7 from Ireland, 4 each from Italy and The Netherlands and 3 from the Czech Republic. Four broad themes describe international researchers' perspectives on advancing methods of engagement for people with lived experiences of dementia and EOL in international PPI activities: (1) Groundwork to engage in research; (2) planning for research activities is key; (3) focus on meaningful engagement and (4) having foresight for practical issues shaping PPI. DISCUSSION AND IMPLICATIONS: International projects that involve PPI can present many sources of challenges. The findings in this study highlight important considerations for foundational work for incorporating PPI in international projects. Learning from world leaders and those with lived experiences in various regions can be insightful and help share tools and resources. PATIENT OR PUBLIC CONTRIBUTION: PPI was envisioned as a critical part of conducting the mySupport study. The findings from this study informed the development of a PPI strategy and an international Strategic Guiding Council that included family carers of those living with advanced dementia in LTC homes in six countries. This manuscript focused on the perspectives of researchers on their engagement with people with lived experiences of dementia and EOL. The perspectives of persons with lived experiences on engaging in the mySupport research study will be reported in a forthcoming manuscript.

Participatory research with carers: A systematic review and narrative synthesis.

INTRODUCTION: As patient and public involvement (PPI) in research has become increasingly common, research-based recommendations on its principles and impacts have been established. The specifics of conducting PPI are likely to differ when involving different groups. Family/informal carers for those with health conditions or disabilities have a lot to contribute to research, but instances of their involvement have yet to be reviewed. OBJECTIVE: To systematically review and synthesize studies where family/informal carers have been involved in the research process, to develop an understanding of the benefits, barriers and facilitating factors. METHODS: A search of five electronic databases was conducted using a combination of terms relating to carers, involvement and research. A grey literature search, expert consultation and hand-searching were also used. Following screening, data extraction and quality assessment, a narrative synthesis incorporating thematic analysis was conducted. FINDINGS: A total of 55 studies met the inclusion criteria, with diverse design and participatory approaches. Four themes were identified, relating to the outcomes, challenges, and practicalities of involving carers: (re) building relationships with carers; carers as equals not afterthoughts; carers have unique experiences; carers create change. Full involvement throughout the research was not always possible, due to barriers from the research world and responsibilities of the caring role. The literature demonstrated ways for carers to contribute in ways that suited them, maximizing their impact, while attending to relationships and power imbalances. CONCLUSION: By summarizing the reported instances of carer involvement in research, this review brings together different examples of how successful research partnerships can be built with carers, despite various challenges. Carers are a heterogeneous group, and participatory approaches should be tailored to specific situations. Wider understanding of the challenges of conducting empowering research with carers, and the resources required to address these, are needed. PATIENT AND PUBLIC INVOLVEMENT: The initial findings and themes were presented to a group of carers who had been involved in research and whose reflections informed the final synthesis.

Co-Design Workshops to Develop a Psychosocial Support Service Model for Refugees in Sweden Affected by Gender-Based Violence.

BACKGROUND: Experiencing gender-based violence (GBV) is common among refugees. Intersecting systems of oppression can increase the risk of GBV and of suffering detrimental consequences, while concurrently creating barriers to meaningful support. Despite this, refugees with lived experience of GBV are rarely involved in the development, planning and adaptation of services and policies. METHODS: This article reports on a formative research process that aimed to involve public contributors (refugee victim-survivors of GBV) and relevant stakeholders in co-designing a service model aimed at improving psychosocial support in Sweden. Led by a partnership of public contributors and academic researchers, the research process consisted of iterative cycles of co-design workshops, complemented by scoping of existing literature. RESULTS: The co-design process resulted in a characterisation of the psychosocial service system needs, as perceived by the survivor co-researchers and stakeholders, and a two-level empowerment and support service model. The model included (i) a community-based intervention to promote help-seeking and (ii) psychosocial group support delivered in specialist clinics. Outcomes of the project included perceived benefits for those involved, service-led direct changes and acquisition of funding for continued research on the co-designed model. CONCLUSION: Improving psychosocial support for refugees in Sweden affected by GBV requires safe spaces to connect with peers and familiarise with available services, laws and rights in the society. Further, strengthened collaborations across sectors are necessary to meet the variety of needs. Co-design workshops were an effective way to initiate changes in the service delivery model for psychosocial support for refugees in Sweden affected by GBV. PATIENT OR PUBLIC CONTRIBUTIONS: This is a participatory reflection on a participatory process. The survivor co-researchers contributed to designing and carrying out the PPI process and have co-authored this manuscript.