The Ottawa Statement implementation guidance document for cluster randomized trials in the hemodialysis setting.

Research teams are increasingly interested in using cluster randomized trial (CRT) designs to generate practice-guiding evidence for in-center maintenance hemodialysis. However, CRTs raise complex ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials, published in 2012, provides 15 recommendations to address ethical issues arising within 7 domains: justifying the CRT design, research ethics committee review, identifying research participants, obtaining informed consent, gatekeepers, assessing benefits and harms, and protecting vulnerable participants. But applying the Ottawa Statement recommendations to CRTs in the hemodialysis setting is complicated by the unique features of the setting and population. Here, with the help of content experts and patient partners, we co-developed this implementation guidance document to provide research teams, research ethics committees, and other stakeholders with detailed guidance on how to apply the Ottawa Statement recommendations to CRTs in the hemodialysis setting, the result of a 4-year research project. Thus, our work demonstrates how the voices of patients, caregivers, and all stakeholders may be included in the development of research ethics guidance.

Parental Engagement in Identifying Information Needs After Newborn Screening for Families of Infants with Suspected Athymia.

Congenital athymia is a rare T-lymphocytopaenic condition, which requires early corrective treatment with thymus transplantation (TT). Athymic patients are increasingly identified through newborn screening (NBS) for severe combined immunodeficiency (SCID). Lack of relatable information resources contributes to challenging patient and family journeys during the diagnostic period following abnormal NBS results. Patient and Public Involvement and Engagement (PPIE) activities, including parental involvement in paediatrics, are valuable initiatives to improve clinical communication and parental information strategies. Parents of infants with suspected athymia were therefore invited to discuss the information they received during the diagnostic period following NBS with the aim to identify parental information needs and targeted strategies to address these adequately. Parents reported that athymia was not considered with them as a possible differential diagnosis until weeks after initial NBS results. Whilst appropriate clinical information about athymia and TT was available upon referral to specialist immunology services, improved access to easy-to-understand information from reliable sources, including from clinical nurse specialists and peer support systems, remained desirable. A roadmap concept, with written or digital information, addressing parental needs in real time during a potentially complex diagnostic journey, was proposed and is transferrable to other inborn errors of immunity (IEI) and rare diseases. This PPIE activity provides insight into the information needs of parents of infants with suspected athymia who are identified through SCID NBS, and highlights the role for PPIE in promoting patient- and family-centred strategies to improve IEI care.

Optimising the implementation of evidence-based osteoarthritis guidelines in primary care: Development of a Knowledge Mobilisation Toolkit.

OBJECTIVE: Implementing clinical guidelines for osteoarthritis (OA) in primary care is complex. Whilst international guidelines detail what best practice for OA looks like, little is known about how this is best implemented. Limited resources are available to guideline developers, practitioners, researchers, or the public to facilitate implementation. Set in the context of a larger research project which sought to understand the factors that influence knowledge mobilisation (KM) in implementation for OA guidelines, this study reports the development of a toolkit to optimise KM for the implementation of evidence-based OA guidelines in primary care. DESIGN: Triangulation of three qualitative data sets was conducted, followed by a stakeholder consensus exercise. Public contributors were involved in dedicated meetings (n = 3) to inform the content, design, and KM plans for the toolkit. RESULTS: From data triangulation, 53 key findings were identified, which were refined into 30 draft recommendation statements, within six domains: approaches to KM; the knowledge mobiliser role; understanding context; implementation planning; the nature of the intervention; and appealing to a range of priorities. Stakeholder voting (n = 27) demonstrated consensus with the recommendations and informed the wording of the final toolkit. CONCLUSIONS: Factors that optimise KM for OA guideline implementation in primary care were identified. Empirical data, practice-based evidence, implementation practice, and stakeholder (including patient and public) engagement have informed a toolkit comprising several overarching principles of KM, which are suitable for use in primary care. Consideration of equitable access when implementing evidence-based OA care among diverse populations is recommended when using the toolkit. Further research is needed to evaluate the toolkit's utility and transferability.

Embedding Patient Input in Outcome Measures for Long-Term Disease-Modifying Parkinson Disease Trials.

BACKGROUND: Clinical trials of disease-modifying therapies in PD require valid and responsive primary outcome measures that are relevant to patients. OBJECTIVES: The objective is to select a patient-centered primary outcome measure for disease-modification trials over three or more years. METHODS: Experts in Parkinson's disease (PD), statistics, and health economics and patient and public involvement and engagement (PPIE) representatives reviewed and discussed potential outcome measures. A larger PPIE group provided input on their key considerations for such an endpoint. Feasibility, clinimetric properties, and relevance to patients were assessed and synthesized. RESULTS: Although initial considerations favored the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III in Off, feasibility, PPIE input, and clinimetric properties supported the MDS-UPDRS Part II. However, PPIE input also highlighted the importance of nonmotor symptoms, especially in the longer term, leading to the selection of the MDS-UPDRS Parts I + II sum score. CONCLUSIONS: The MDS-UPDRS Parts I + II sum score was chosen as the primary outcome for large 3-year disease-modification trials. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Participatory translational science of neurodivergence: model for attention-deficit/hyperactivity disorder and autism research.

BACKGROUND: There are increasing calls for neurodivergent peoples' involvement in research into neurodevelopmental conditions. So far, however, this has tended to be achieved only through membership of external patient and public involvement (PPI) panels. The Regulating Emotions - Strengthening Adolescent Resilience (RE-STAR) programme is building a new participatory model of translational research that places young people with diagnoses of attention-deficit hyperactivity disorder (ADHD) and autism at the heart of the research team so that they can contribute to shaping and delivering its research plan. AIMS: To outline the principles on which the RE-STAR participatory model is based and describe its practical implementation and benefits, especially concerning the central role of members of the Youth Researcher Panel (Y-RPers). METHOD: The model presented is a culmination of a 24-month process during which Y-RPers moved from advisors to co-researchers integrated within RE-STAR. It is shaped by the principles of co-intentionality. The account here was agreed following multiple iterative cycles of collaborative discussion between academic researchers, Y-RPers and other stakeholders. RESULTS: Based on our collective reflections we offer general guidance on how to effectively integrate young people with diagnoses of ADHD and/or autism into the core of the translational research process. We also describe the specific theoretical, methodological and analytical benefits of Y-RPer involvement in RE-STAR. CONCLUSIONS: Although in its infancy, RE-STAR has demonstrated the model's potential to enrich translational science in a way that can change our understanding of the relationship between autism, ADHD and mental health. When appropriately adapted we believe the model can be applied to other types of neurodivergence and/or mental health conditions.

A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair.

OBJECTIVE: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets (COS) has been developed. COS, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact AAA repair. METHODS: Following COMET methodology, potential outcomes were identified from a systematic review of published outcomes and focus groups involving patients, carers, and nurses. A 38 question Delphi consensus survey in lay language was developed (with translation to local languages); this included 35 themes identified from the findings of the systematic review and three themes from the focus groups. All three of the themes identified by the focus groups (cognitive, physical, and social functioning) can be evaluated from quality of life instruments, with overall quality of life being identified from the systematic review. The survey was completed by patients, carers or family members, vascular nurses, vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners from six European countries. After two rounds of the survey, the top outcomes were discussed at a face to face multistakeholder consensus meeting. RESULTS: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents) 15 questions were eliminated, and 11 further questions were eliminated after round 2 (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: death at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, five year survival, and continued sac growth. CONCLUSION: Six core outcomes are recommended for use as a minimum framework in all future studies and registries of intact open and endovascular AAA repair. Further work to select instruments for quality of life and to define instruments for cognitive functioning is needed.

Older people's goals of care in relation to frailty status-the COOP-study.

BACKGROUND: Literature relating older people's goals of care to their varying frailty status is scarce. OBJECTIVE: To investigate goals of care in case of acute and/or severe disease in relationship to frailty status among the general older population. METHOD: Older people aged ≥70 in the Netherlands completed a questionnaire. They were divided into three subgroups based on a self-reported Clinical Frailty Scale: fit (CFS 1-3), mildly frail (CFS 4-5) and severely frail (CFS 6-8). Seven goals were graded as unimportant (1-5), somewhat important (6-7) or very important (8-10): extending life, preserving quality of life (QoL), staying independent, relieving symptoms, supporting others, preventing hospital admission and preventing nursing home admission. RESULTS: Of the 1,278 participants (median age 76 years, 63% female), 57% was fit, 32% mildly frail and 12% severely frail. Overall, participants most frequently considered preventing nursing home admission as very important (87%), followed by staying independent (84%) and preserving QoL (83%), and least frequently considered extending life as very important (31%). All frailty subgroups reported similar preferences out of the surveyed goals as the overall study population. However, participants with a higher frailty status attached slightly less importance to each individual goal compared with fit participants (Ptrend-values ≤ 0.037). CONCLUSION: Preferred goals of care are not related to frailty status, while the importance ascribed to individual goals is slightly lower with higher frailty status. Future research should prioritise outcomes related to the shared goals of fit, mildly frail and severely frail older people to improve personalised medicine for older patients.

Long COVID quality of life and healthcare experiences in the UK: a mixed method online survey.

PURPOSE: The complexity of long COVID and its diverse symptom profile contributes to unprecedented challenges for patients, clinicians, and healthcare services. The threat of long COVID remains ignored by Governments, the media and public health messaging, and patients' experiences must be heard through understanding of the lived experience. This study aimed to understand the lived experience of those living with long COVID. METHODS: An online web-based survey was designed using Patient and Public Involvement and Engagement (PPIE) to increase understanding of the lived experiences of long COVID, and was distributed through PPIE groups, social media, and word of mouth. The survey used closed and open questions relating to demographics, pre- and post-COVID-19 health quality of life, daily activities and long COVID experiences. RESULTS: Within our sample of 132 people living with long COVID, the findings highlight that individuals are being severely impacted by their symptoms and are unable to or limited in participating in their daily activities, reducing quality of life. Long COVID places strain on relationships, the ability to live life fully and is detrimental to mental health. Varying health care experiences are described by participants, with reports of medical gaslighting and inadequate support received. CONCLUSIONS: Long COVID has a severe impact on the ability to live life fully, and strains mental health. The appropriate mechanisms and support services are needed to support those living with long COVID and manage symptoms.

Evaluating parent and public involvement activities within a paediatric palliative care research centre: Route map to impactful and meaningful engagement.

BACKGROUND: Patient and Public Involvement (PPI) is an important component of healthcare research. Conducting PPI within paediatric palliative care research requires specific ethical and practical considerations. Regular reviews of PPI activity are important. AIM: To evaluate a paediatric palliative care research centre's PPI activity to determine what went well, or less well; and how future activities can be improved. DESIGN: Two stage evaluation: first a review of PPI study logs; second a qualitative exploration using a survey, structured interviews and a focus group. Data were analysed thematically. SETTINGS/PARTICIPANTS: Parents of children with life-limiting conditions, bereaved parents and researchers, all engaged in PPI activity within a paediatric palliative care research centre. FINDINGS: The review of PPI logs for 15 studies highlighted the crucial role of funding in enabling PPI throughout the research. Eight parents completed the survey, 4 parents were interviewed and 12 researchers participated in a focus group. Three themes were developed: Clarity of processes and purpose; balanced relationships created a safe space; and mutual respect and value for PPI. These themes highlight what is working well within the Centre's approach to PPI and the opportunities to improve. CONCLUSIONS: To undertake meaningful PPI in paediatric palliative care research, adequate time and resources are required. Roles, processes and expectations must be explicitly agreed. Establishing relationships ensures trust and enables authenticity and vulnerability. In addition to improving research, PPI has personal benefits for researchers and parents. The evaluation led to the development of a 'route map' for establishing an impactful PPI group for paediatric palliative care research.

Power to the people? A co-produced critical review of service user involvement in mental health professions education.

Meaningful service user involvement in health professions education requires integrating knowledge held by "lay" people affected by health challenges into professional theories and practices. Involving service users redefines whose knowledge "counts" and implies a shift in power. Such a shift is especially significant in the mental health field, where power imbalances between health professionals and service users are magnified. However, reviews of the literature on service user involvement in mental health professional education do little to explore how power manifests in this work. Meanwhile critical and Mad studies scholars have highlighted that without real shifts in power, inclusion practices can lead to harmful consequences. We conducted a critical review to explore how power is addressed in the literature that describes service user involvement in mental health professions education. Our team used a co-produced approach and critical theories to identify how power implicitly and explicitly operates in this work to unearth the inequities and power structures that service user involvement may inadvertently perpetuate. We demonstrate that power permeates service user involvement in mental health professional education but is rarely made visible. We also argue that by missing the opportunity to locate power, the literature contributes to a series of epistemic injustices that reveal the contours of legitimate knowledge in mental health professions education and its neoliberal underpinnings. Ultimately, we call for a critical turn that foregrounds power relations to unlock the social justice-oriented transformative potential of service user involvement in mental health professions education and health professions education more broadly.

What really is nontokenistic fully inclusive patient and public involvement/engagement in research?

Patient and public involvement and engagement (PPIE) is critically important in healthcare research. A useful starting point for researchers to understand the scope of PPIE is to review the definition from the National Institute for Health and Care Research (NIHR) as, 'research being carried out "with" or "by" members of the public rather than "to", "about" or "for" them'. PPIE does not refer to participation in research, but to actively shaping its direction. The 'Effectiveness of a decision support tool to optimise community-based tailored management of sleep for people living with dementia or mild cognitive impairment (TIMES)' study is funded through the NIHR programme grant for applied research. TIMES has thoroughly embraced PPIE by ensuring the person's voice is heard, understood, and valued. This editorial showcases how the TIMES project maximised inclusivity, and we share our experiences and top tips for other researchers. We base our reflections on the six key UK standards for public involvement; Inclusive Opportunities, Working Together, Support and Learning, Communications, Impact and Governance. We present our work, which had been co-led by our PPIE leads, academics and partners including, together in dementia everyday, Innovations in Dementia, The UK Network of Dementia Voices (Dementia Engagement & Empowerment Project) and Liverpool Chinese Wellbeing. We have a Lived Experience Advisory Forum on Sleep, which includes people with dementia, family carers, representatives of the South Asian Community and the Chinese community.

Emotion in public involvement: A conceptual review.

BACKGROUND: Experiential knowledge can aid in designing research by highlighting what an idea looks like from a patient and carer perspective. Experiential knowledge can be emotional, and this can create challenges at formal research meetings. OBJECTIVE: The aim of this study was to consider the role of emotions in public involvement. METHODS: This is a conceptual review informed by relevant literature and reflection within the author team. A structured Scopus search was conducted in November 2021 and December 2022, identifying 18 articles that presented findings from patient and public involvement (PPI) research related to 'emotion'. We complemented the search with theory-generating articles related to the role of emotion and emotional labour in human life. FINDINGS: Study findings from the structured search were tabulated to identify recurring themes; these were as follows: emotional connections to the research topic can cause stressful as well as cathartic experiences of PPI, 'emotional work' is part of PPI when people are contributing with their experiential knowledge and the emotional aspect of 'lived experience' needs to be recognised in how PPI is planned and facilitated. These points were considered in relation to theoretical works and experiences within the author team. DISCUSSION: 'Emotion work' is often required of public collaborators when they contribute to research. They are asked to contribute to research alongside researchers, with knowledge that often contains emotions or feelings. This can be both upsetting and cathartic, and the environment of the research study can make the experience worse or better. CONCLUSIONS: The emotional component of experiential knowledge can be challenging to those invited to share this knowledge. It is imperative that researchers, research institutions and health and care professionals adjust research meeting spaces to show an awareness of the emotional labour that is involved in PPI. PATIENT OR PUBLIC CONTRIBUTION: This review was initiated after a meeting between carers and family members of residents in care homes and researchers. The review is co-written by a group of three researchers and three carers and family members. Regular online meetings were held during the draft stages to incorporate people's views and ideas. Data extracted from the review were presented to the group of public collaborators in a variety of formats (e.g., posters, slideshows, text and verbally) to facilitate shared sense-making and synthesis of the literature.

#DryByChristmas: A patient and public involvement study on women's engagement with humorous pelvic floor muscle training digital nudges on social media.

INTRODUCTION: Patient and public involvement (PPI) is essential for women's health research. Little is known about how women engage with humorous social media and behavioural health messaging targeting pelvic floor muscle training (PFMT). This PPI aimed to understand how women engage with a humorous social media campaign encouraging PFMT. The study findings will influence the co-design of a digital intervention to support women's adherence to PFMT. METHODS: The Guidance for Reporting Involvement of Patients and the Public Version 2 short form was used to report the study's findings. The study examined public engagement with a humorous social media campaign encouraging PFMT in women. A healthcare professional and comedian ran the campaign following the national guidelines for engagement in PFMT. Instagram analytics gave insight into the demographics of the public who engaged, how they engaged and the most popular content. The behaviour change techniques (BCTs) used in the digital nudges that generated the highest levels of engagement were analysed using the Capability Opportunity Motivation Behaviour Change Wheel. RESULTS: The majority (96%) of the population showing the highest levels of engagement were women aged 35-44 years and were based in the United Kingdom (77%). The Instagram account saw an increase in engagement by 12% over the 3-month campaign, with 22,032 users seeing digital nudges and 2645 engaging with the digital nudges. The preferred way of engaging was using Likes (9723). The common themes in the digital nudges that generated the highest levels of engagement were BCTs associated with the 'social influences' theoretical domain framework that targeted the core behaviour opportunity. CONCLUSION: The study findings suggest humour may improve women's engagement with online PFMT programmes; however, more rigorous research is required to better understand diverse women's experiences of humorous online PFMT nudges. Future studies may use PFMT mobile apps instead of social media to capture true user engagement and adherence to PFMT more accurately. The insights gained from the study will be taken forward to co-design a digital behavioural intervention as part of a larger study. PUBLIC CONTRIBUTION: Members of the public were involved in the co-design of a digital health intervention that will be trialled as part of a larger research study. The public was involved using the social media platform Instagram. Public engagement with a humorous social media campaign to encourage women to engage with pelvic floor exercises was captured using Instagram analytics, for example, the timing of engagement.

Patient and public involvement in the development of health services: Engagement of underserved populations in a quality improvement programme for inflammatory bowel disease using a community-based participatory approach.

INTRODUCTION: Involving people with lived experience is fundamental to healthcare development and delivery. This is especially true for inflammatory bowel disease (IBD) services, where holistic and personalised models of care are becoming increasingly important. There is, however, a significant lack of representation of underserved and diverse groups in IBD research, and there are significant barriers to healthcare access and utilisation among minority groups in IBD. IBD centres need to be aware of these experiences to address barriers via service changes, improve interactions with local communities and promote meaningful engagement for improved health outcomes. METHODS: A pragmatic community-based approach was taken to engage with leaders and members of underserved groups across 11 workshops representing Roma, Afro-Caribbean, people of African descent and the wider black, Asian and minority ethnic (BAME) communities, Muslim women, refugee community members, deprived areas of South Yorkshire, LGBTQ+ and deaf populations. Thematic analysis of field notes identified patterns of attention across the community groups and where improvements to services were most frequently suggested. RESULTS: Findings demonstrated several barriers experienced to healthcare access and utilisation, including language accessibility, staff attitudes and awareness, mental health and stigma, continuity of support, and practical factors such as ease of service use and safe spaces. These barriers acted as a lever to co-producing service changes that are responsive to the health and social care needs of these groups. CONCLUSIONS: Engaging with people from a range of communities is imperative for ensuring that service improvements in IBD are accessible and representative of individual needs and values. PATIENT OR PUBLIC CONTRIBUTION: Local community leaders and members of community groups actively participated in the co-design and development of improvements to the IBD service for a local hospital. Their contributions further informed a pilot process for quality improvement programmes in IBD centres.

Development and Evaluation of a Framework for Authentic Online Co-Design: Partnership-Focussed Principles-Driven Online Co-Design.

INTRODUCTION: Co-design in health research involves patient and public involvement and engagement (PPIE) in intervention or service design. Traditionally, co-design is undertaken in-person; however, exploring online delivery is warranted. PPIE in co-design must be considered carefully, and assumptions that in-person approaches will transition automatically to an online environment should be avoided. Currently, there are a lack of evidence-informed approaches to facilitating co-design online. This study aimed to develop and evaluate a framework for authentically adapting health research co-design into an online environment. MATERIALS AND METHODS: The initial framework was developed through a literature review, synthesis of in-person co-design principles, and alignment of online strategies. The framework was then applied to a co-design project with 10 participants across relevant PPIE groups (end-users [n = 4], clinicians [n = 2], coaches [n = 2] and clinician-researchers [n = 2]). Participants' experiences of the online co-design process were evaluated via a mixed-methods design using surveys and semi-structured interviews. Evaluation data were analysed using descriptive statistics and reflexive thematic analysis to inform a revised framework. RESULTS: The developed framework, Partnership-focussed Principles-driven Online co-Design (P-POD) was used to design eight 90 min online co-design workshops. Evaluation data involved 46 survey responses, and eight participants were interviewed on project completion. Survey data indicated that the process was satisfying, engaging and adhered to the P-POD framework. Themes derived from interview data describe a respectful and collaborative online culture, valuing of diverse perspectives and space for healthy debate, how power was perceived as being shared but not equal and multiple definitions of success within and beyond the process. A final, refined P-POD framework is presented. CONCLUSION: With evaluation of the initial P-POD framework showing evidence of adherence to co-design principles, positive participant experiences and goal achievement for both the project and the participants, the refined P-POD framework may be used and evaluated within future intervention or service design. PATIENT OR PUBLIC CONTRIBUTION: This study involved the participants (end-users, clinicians and service providers) in the co-design process described, interpretation of the results through member-checking interview responses, assisting in development of the final framework and as co-authors for this manuscript.

Engaging women to set the research agenda for assisted vaginal birth.

INTRODUCTION: Public and patient involvement can provide crucial insights to optimise research by enhancing relevance and appropriateness of studies. The World Health Organization (WHO) engaged in an inclusive process to ensure that both technical experts and women had a voice in defining the research gaps and needs to increase or reintroduce the use of assisted vaginal birth (AVB) in settings where this intervention is needed but unavailable or underused. METHODS: We describe the methods and outcomes of online workshops led by WHO to obtain women representatives' perspectives about AVB research gaps and needs. RESULTS: After technical experts created a list of research questions based on various evidence syntheses, WHO organised four online workshops with 31 women's representatives from 27 mostly low- and middle-income (LMIC) countries. Women rated the importance and priority of the research questions proposed by the technical experts, improving and broadening some of them, added new questions, and voiced their main concerns and views about AVB. Women helped to put the research questions into context in their communities, highlighted neglected factors/dimensions that influence practices and affect women's experience during labour and childbirth, underscored less salient consequences of AVB, and highlighted the main concerns of women about research on AVB. The consolidated vision of technical experts and women's representatives resulted in a technical brief published by WHO. The technical brief is expected to stimulate global research and action closely aligned with women's priorities. CONCLUSIONS: We describe a successful experience of engaging women, mostly from LMICs, in the identification of research gaps and needs to reintroduce AVB use. This process contributed to better aligning research questions with women's views, concerns, and priorities. Given the scarcity of reports about engaging women from LMICs to optimise research, this successful experience can serve as an inspiration for future work. PATIENT OR PUBLIC CONTRIBUTION: Women representatives were involved at every stage of the workshops described in full in this manuscript.

Exploring the Experiences of Living With the Post-COVID Syndrome: A Qualitative Study.

INTRODUCTION: Many people experience persistent symptoms for more than 12 weeks following SARS-CoV-2 infection, which is known as post-COVID-19 condition (PCS) or Long COVID (LC). PCS can impair people's quality of life and daily functioning. However, there is a lack of in-depth research exploring the PCS patient journey, as well as gendered aspects of patients' experiences. METHODS: Nineteen semi-structured qualitative interviews were conducted with people living with PCS in the United Kingdom (13 women, 6 men). Interviews were transcribed verbatim and analysed inductively using reflexive thematic analysis. RESULTS: Five main themes were identified: 'Symptom dismissal', 'Lack of information and support', 'Life before and after Long COVID', 'Psychological impact' and 'Acceptance'. A shift overtime to self-management of symptoms was evident. These themes represent different stages of patients' PCS journey. Narratives indicated that women highlighted dismissal by healthcare professionals (HCPs), which was not as prominent in men's narratives. In addition, women went into more detail about the psychological impact of PCS compared to men. CONCLUSION: Women with PCS reported symptom dismissal by HCPs, which may have delayed their diagnosis and negatively affected their well-being. We were not able to explore the experiences of people from non-conforming gender groups. Raising awareness of these issues among HCPs, particularly general practitioners, could improve patient care in PCS. PATIENT OR PUBLIC CONTRIBUTION: Patient and public involvement consisted of people who took part in the interviews and commented on the themes' interpretation and study conclusions.

Understanding and Defining Young People's Involvement and Under-Representation in Mental Health Research: A Delphi Study.

INTRODUCTION: The mental health of young people (aged 16-25 years) is a growing public health concern in the United Kingdom due to the increasing numbers of young people experiencing mental health difficulties, with many not in contact with mental health services. To design services that meet the needs of all young people, a diversity of young people must be involved in mental health research, beyond being participants. This Delphi study aimed to identify different types of 'involvement' and to define and describe 'under-representation' in young people's involvement in mental health research. METHODS: Twenty-seven experts in young people's mental health research completed a series of online questionnaires. The experts were academic researchers, patient and public involvement (PPI) professionals and young 'experts by experience'. Round 1 generated panellists' views on 'involvement' and 'under-representation'. Round 2 summarised panellists' responses from Round 1 and sought consensus (minimum 70% agreement) in nine question areas. Round 3 validated the findings of the previous rounds. RESULTS: Consensus was achieved in eight out of nine areas, resulting in a matrix (with definitions) of the different types of young people's involvement in mental health research, from being advisors to involvement ambassadors. The findings generated an agreed-upon definition of under-representation, an identification of when in the research process there is under-representation and the characteristics of the young people who are under-represented. Experts further agreed on demographic data that should be collected to improve reporting on involvement. CONCLUSIONS: This study adds to our understanding of involvement and under-representation in the context of young people's mental health research through expert consensus. It provides a practical resource for researchers considering involving young people in the research process and suggests the data that should be collected to improve reporting on the diversity of the young people involved. PATIENT AND PUBLIC CONTRIBUTION: A research oversight group of five young people advised on this study. They contributed throughout the project-from endorsing the research question to commenting on the findings and dissemination. Two of the group reviewed all participant materials and piloted the initial questionnaire.

Coproducing Health Information Materials With Young People: Reflections and Lessons Learned.

BACKGROUND: This paper describes and critically reflects on how children and young people (CYP) acted as public advisors to coproduce health information materials about Long Covid for younger audiences. This work was underpinned by the Lundy model, a framework which provides guidance on facilitating CYP to actively contribute to matters which affect them. METHODS: Coproduction activity sessions took place with CYP in schools as well as video conferences with a CYP stakeholder group and CYP with Long Covid. Activities encouraged CYP to focus on the content, format, and design of materials and used problem-based and collaborative learning to encourage engagement with the project. Using a range of methods and open discussion, CYP codesigned a series of Long Covid health information materials for younger audiences. RESULTS: Sixty-six CYP (aged 10-18), and two young adults were involved. CYP codesigned specifications for the final materials and provided feedback on early designs. The project led to the development of a series of health information materials targeted at CYP: a short social media campaign with six short videos and a 12-page illustrated leaflet about Long Covid; released on social media and distributed in local area. All the CYP were positive about the project and their involvement. DISCUSSION: Involving CYP led to the development of innovative and engaging information materials (influence). Developing rapport was important when working with CYP and this was facilitated by using approaches and activities to establish an environment (space) where the CYP felt comfortable sharing their views (voice) and being listened to (audience) by the adults in the project. Working with external groups who are willing to share their expertise can help the meaningful involvement of voices 'less heard'. PUBLIC CONTRIBUTION: One CYP coapplicant contributed to the project design and facilitation of PPIE sessions, 64 CYP were involved in the PPIE sessions to design and feedback on materials. Two young adult media producers worked with CYP to produce these materials, another CYP supported this process. Three public contributors were involved in the preparation 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.