Understanding who is and isn't involved and engaged in health research: capturing and analysing demographic data to diversify patient and public involvement and engagement.

BACKGROUND: Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK. The aim of this study was to develop to capture and analyse the characteristics of who does and doesn't take part in patient and public involvement and engagement (PPIE) activities. METHODS: As part of its strategic focus on diversity and inclusion, Vocal developed a questionnaire to assess the demographics of people taking part in its PPIE activities. Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. The questionnaire was implemented across Vocal activities between December 2018 and March 2022. In that time. Vocal was working with approximately 935 public contributors. 329 responses were received: a return rate of 29.3%. Analysis of findings and comparison against local population demographic data, and available national data related to public contributors to health research, was performed. RESULTS: Results show that it is feasible to assess the demographics of people who take part in PPIE activities, through a questionnaire system. Further, our emerging data indicate that Vocal are involving people from a wider range of ages and with a greater diversity of ethnic backgrounds in health research, as compared to available national data. Specifically, Vocal involves more people of Asian, African and Caribbean heritage, and includes a wider range of ages in its PPIE activities. More women than men are involved in Vocal's work. CONCLUSION: Our 'learn by doing' approach to assessing who does and doesn't take part in Vocal's PPIE activities has informed our practice and continues influence our strategic priorities for PPIE. Our system and learning reported here may be applicable and transferable to other similar settings in which PPIE is carried out. We attribute the greater diversity of our public contributors to our strategic priority and activities to promote more inclusive research since 2018.

Patient and public involvement and engagement (PPIE) can improve the relevance, quality, ethics and impact of research thus contributing to high quality research. Currently in the UK, people who get involved in research tend to be aged 61 years or above, White and female. Calls for greater diversity and inclusion in PPIE have become more urgent especially since the COVID-19 pandemic, so that research can better address health inequalities and be relevant for all sectors of society. Yet, there are currently no routine systems or requirements to collect or analyse the demographics of people who get involved in health research in the UK. Vocal is a non-profit organisation which supports PPIE in health research across the region of Greater Manchester in England. Since 2018, one of Vocal's strategic priorities has been to promote inclusive research by diversifying those who are engaged and involved in research, through the development of more inclusive ways of working together, including methods to understand who is (and isn't) currently involved in Vocal's PPIE activities. We find that it's feasible to capture and analyse demographic data related to PPIE. Further, our emerging data indicate that we are involving people from a wider range of ages and with a greater diversity of ethnic backgrounds in PPIE for health research, as compared to available national data. However, similarly to national trends, more women than men are involved in PPIE work.

Patient and public involvement in hearing research: opportunities, impact and reflections with case studies from the Manchester Centre for Audiology and Deafness.

OBJECTIVE: Patient and public involvement (PPI) in research improves relevance to end users and improves processes including recruitment participants. PPI in our research has gone from being non-existent to ubiquitous over a few years. We provide critical reflections on the benefits and challenges of PPI. DESIGN: Case studies are reported according to a modified GRIP2 framework; the aims, methodology, impact of PPI and critical reflections on each case and our experiences with PPI in general. STUDY SAMPLE: We report five UK projects that included PPI from teenagers, families, people living with dementia, autistic people, and people from South Asian and d/Deaf communities. RESULTS: Our experience has progressed from understanding the rationale to grappling methodologies and integrating PPI in our research. PPI took place at all stages of research, although commonly involved input to design including recruitment and development of study materials. Methodologies varied between projects, including PPI co-investigators, advisory panels and online surveys. CONCLUSION: On-going challenges include addressing social exclusion from research for people that lack digital access following increasing on-line PPI and involvement from underserved communities. PPI was initially motivated by funders; however the benefits have driven widespread PPI, ensuring our research is relevant to people living with hearing loss.

"We are not hard to reach, but we may find it hard to trust" . Involving and engaging 'seldom listened to' community voices in clinical translational health research: a social innovation approach.

BACKGROUND: Public involvement in clinical translational research is increasingly recognised as essential for relevant and reliable research. Public involvement must be diverse and inclusive to enable research that has the potential to reach those that stand to benefit from it the most, and thus address issues of health equity. Several recent reports, however, indicate that public involvement is exclusive, including in its interactions with ethnic groups. This paper outlines a novel community-led methodology - a community sandpit - to address the inclusion of ethnic groups in public involvement in research, reports on its evaluation, findings, legacy and impact. METHODS: Through detailed planning - thinking through and taking into account all stakeholders perspectives in the planning and design of the sandpit, relationship-building, co-design and co-delivery between the Public Programmes team based at Manchester University NHS Foundation Trust and the Greater Manchester Black and Minority Ethnic Network - the community sandpit was held in July 2018. RESULTS: Fifteen community organisations took part in the two-day event, as well as six researchers, and six creative practitioners. Six community-based partnership projects were seed-funded; four of these received additional funding from other sources also. CONCLUSIONS: Evaluation of the sandpit showed the format to be well-received by all: it levelled power relationships between community organisations, health researchers and research infrastructure; it developed capacity amongst researchers about the accessibility, role and potential of community organisations. Described as "not another community seed fund" by community partners, the sandpit offered community partners, equitable avenues for collaboration within Greater Manchester translational research and led to the formation of the Black, Asian and Minority Ethnic Research Advisory Group (BRAG Vocal Website information, - https://www.wearevocal.org/opportunities/black-asian-and-minority-ethnic-research-advisory-group-brag/ , 2021). The method has the potential to be replicated elsewhere to support inclusive public involvement in research and inclusive research.

Public involvement in "bench to bedside" research (from laboratory-based research to clinical practice) is increasingly recognised as essential for relevant and reliable research. To enable the findings from health research to meet the needs of those who stand to benefit from it the most and to ensure that differences in health and disease are reduced as much as possible, public involvement must be diverse and inclusive. Recent reports, however, indicate that public involvement is exclusive, including in its interactions with racially minoritised groups. This paper outlines a novel community-led methodology ­ a community sandpit ­ to address the inclusion of ethnic groups in public involvement in research, reports on its evaluation, findings, legacy and impact.Through detailed planning ­ thinking through and taking into account all stakeholders perspectives in the planning and design of the sandpit, relationship-building, co-design and co-delivery between the Public Programmes Team (now Vocal) based at Manchester University NHS Foundation Trust worked with the Greater Manchester Black and Minority Ethnic Network - the community sandpit was held in July 2018. Fifteen community organisations took part in the two-day event, as well as six researchers, and six creative practitioners (artists with experience of working with the public on socially engaged projects to engage them in areas such as science). Six community-based partnership projects were seed-funded; four of these received additional funding from other sources. Evaluation of the sandpit showed the format to be well-received by all: it levelled power relationships between community organisations, health researchers and research infrastructure; it increased researchers knowledge and insights about the accessibility of community organisations and of how they might work effectively with them. Described as "not another community seed fund" by community partners, the sandpit began the process of levelling the playing field for collaboration between Greater Manchester translational research and local community organisations and led to the formation of the Black, Asian and Minority Ethnic Research Advisory Group (BRAG) (Vocal Website information, - https://www.wearevocal.org/opportunities/black-asian-and-minority-ethnic-research-advisory-group-brag/ , 2021). The method has the potential to be repeated elsewhere to support inclusive public involvement in research and inclusive research.

Patient and Public Involvement Refines the Design of ProtOeus: A Proposed Phase II Trial of Proton Beam Therapy in Oesophageal Cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy for oesophageal cancer significantly improves overall survival but is associated with severe post-operative complications. Proton beam therapy may reduce these toxicities by sparing normal tissues compared with standard radiotherapy. ProtOeus is a proposed randomised phase II study of neoadjuvant chemoradiotherapy in oesophageal cancer that compares proton beam therapy to standard radiotherapy techniques. As proton beam therapy services are often centralised in academic centres in major cities, proton beam therapy trials raise distinct challenges including patient acceptance of travelling for proton beam therapy, coordination of treatments with local centres and ensuring equity of access for patients. METHODS: Focus groups were held early in the trial development process to establish patients' views on the trial proposal. Topics discussed include perception of proton beam therapy, patient acceptability of the trial pathway and design, patient-facing materials, and common clinical scenarios. Focus groups were led by the investigators and facilitated by patient involvement teams from the institutions who are involved in this research. Responses for each topic were analysed, and fed back to the trial's development group. RESULTS: Three focus groups were held in separate locations in the UK (Manchester, Cardiff, Wigan). Proton beam therapy was perceived as superior to standard radiotherapy making the trial attractive. Patients felt strongly that travel costs should be reimbursed to ensure equity of access to proton beam therapy. They were very supportive of a shorter treatment schedule and felt that toxicity reduction was the most important endpoint. DISCUSSION AND CONCLUSIONS: Incorporating patient views early in the trial development process resulted in significant trial design refinements including travel/accommodation provisions, choice of primary endpoint, randomisation ratio and fractionation schedule. Focus groups are a reproducible and efficient method of incorporating the patient and public voice into research.

Innovating public engagement and patient involvement through strategic collaboration and practice.

BACKGROUND: Patient and public involvement and engagement is an important and expected component of health-related research activity in the UK. Specifically within the health research sphere, public engagement (usually defined as raising awareness of research) and patient involvement (usually defined as actively involving people in research) have traditionally been seen as separate but have much to gain from working together towards a common goal of better health outcomes for all. METHODS: This paper describes a unique approach taken by the Public Programmes Team: a small interdisciplinary team of public engagement specialists, with backgrounds in science, community development, public engagement and involvement, policy, ethics, communications, industry, museums and creative practice, embedded within translational research infrastructure and delivery in Manchester in the North West of England. We propose a new model of professional practice - a 'cycle' of engagement and involvement - innovating across the complementary fields of public engagement and patient involvement, and working inclusively and in partnership with people in health research. Further, our approach capitalises on strategic collaboration offering economies of scale and a joined up way of working. Our ambition is to boldly experiment, learn and reflect, responsibly and based on evidence and partnerships, using methods of engagement that address issues of social justice. RESULTS: Here, we report on preliminary case studies exemplifying the impact of our approach, and data relating to achievements and learning between April 2017 and March 2018. Informed by our findings, we propose that our approach has the potential to be replicated elsewhere. CONCLUSIONS: Our practice and the beginning of its evaluation lead us to believe that our way of working and model of professional practice - the 'cycle' of engagement and involvement - is effective in: addressing our vision of making health research relevant and inclusive for everyone; and embedding and joining up public involvement in a busy and fertile translational health research ecosystem.