Integration of patient and public involvement in a doctoral research study using the research cycle.

BACKGROUND: Patient and public involvement (PPI) in research is widely acknowledged as essential to achieving successful and impactful research. Despite this acknowledgement, there are limited reports on how to approach and apply meaningful PPI throughout the research cycle and how to address challenges for researchers such as doctoral students, particularly when undertaking research on sensitive topics. This paper provides insights and examples for researchers new to PPI, on the impact of active PPI and recommendations for building and developing a PPI group in a paediatric focused doctoral research study with bereaved parents and carers. METHODS: PPI was informed by the research cycle. The GRIPP2 short-form checklist was used to report PPI. The research was funded by the National Institute for Health and Care Research. RESULTS: PPI enhanced the research through input into the study design, recruitment, co-design of the study website and branding; and ethics amendments to increase participation in response to the COVID-19 pandemic. The literature review was extended to incorporate a PPI consultation phase and members contributed to data analysis. A flexible approach enabled involvement to develop iteratively throughout the research study, resulting in changes being made to enhance the study design and outcomes. CONCLUSION: This paper contributes to the limited knowledge base on embedding PPI into a doctoral research study and within the paediatric setting specifically working in partnership with bereaved parents and carers. Employing an adaptive approach to meet individual PPI needs, building a trusting and respectful partnership, creating shared ownership and investment in the research, are essential components to successful PPI.

Involving patients and the public in research provides the opportunity to develop meaningful outcomes that are relevant to the population being studied. Despite the benefits of patient and public involvement in research, guidelines that support researchers in doing so, lack detail on how to do this effectively. This is particularly important for those new to research such as doctoral students, who have so much to learn in developing a research study. Different approaches and applications to involvement are also likely to be needed depending on the population being studied. There are limited published papers on examples of how doctoral students have engaged and involved patients and the public in the context of their studies, and specifically within the children's setting, working in partnership with bereaved parents and carers, or those with seriously ill children. This paper offers examples and insights for those new to research in how to involve patients and the public throughout the research cycle. Specifically undertaking research in a sensitive subject of a particular childhood cancer which has poor outcomes and how to incorporate and evaluate successful patient and public involvement in their research activities such as study design and analysis of the results. Parent and carer reflections on their experiences of being involved are also reported and researcher recommendations for approaching and working with a patient and public group are described.

Engaging a community to focus on upper limb function in people with multiple sclerosis: the ThinkHand campaign case study.

BACKGROUND: Solving complex research challenges requires innovative thinking and alternative approaches to traditional methods. One such example is the problem of arm and hand, or upper limb function in multiple sclerosis (MS), a neurological condition affecting approximately 2.9 million people worldwide and more than 150,000 in the United Kingdom. Historically, clinical trials and research have focused on mobility and walking ability. This excludes a large number of patients who are wheelchair users, limiting their quality of life and restricting access to possibly helpful medications. To address this issue, the ThinkHand campaign was launched in 2016, aiming to raise awareness about the importance of upper limb function in MS and develop alternative ways to measure, record, and account for hand and arm function changes. MAIN BODY: The campaign utilised innovative strategies at scientific conferences and online surveys to engage people affected by MS, healthcare professionals, charities, and researchers in discussing the importance of preserving upper limb function. Through co-design and interdisciplinary collaboration, the campaign developed new tools like the low-cost cardboard version of the Nine-Hole Peg Test, facilitating remote monitoring of hand function. Additionally, the campaign co-created the "Under & Over" rehabilitation tool, allowing individuals with advanced MS to participate in a remote rehabilitation program.The impact of the ThinkHand campaign has been significant, helping to shift the focus of both academic and industry-supported trials, including the O'HAND and ChariotMS trials, both using upper limb function as their primary end point. The campaign's patient-centred approach highlighted the importance of recognising patients' perspectives in research and challenged established assumptions and practices. It demonstrated the effectiveness of interdisciplinary collaboration, systems thinking, and co-creation with stakeholders in tackling complex problems. CONCLUSION: The ThinkHand campaign provides valuable insights for health research practices. By involving patients at all stages, researchers can gain a deeper understanding of the impact of disease on their lives, identify gaps and focus research on their needs. Experimentation and iteration can lead to innovative solutions, and openness to unconventional methods can drive widespread change. The ThinkHand campaign exemplifies the potential of patient-centred approaches to address complex research challenges and revolutionise the field of MS research and management. Embracing such approaches will contribute to more inclusive and impactful research in the future.

Solving complex research challenges requires creative thinking and new ways of doing things. One such challenge is understanding the problems with arm and hand function in multiple sclerosis (MS), a neurological condition that affects more than 150,000 in the United Kingdom. In the past, research focused mainly on walking ability, leaving out many people who use wheelchairs.To tackle this issue, we created the ThinkHand campaign in 2016. Its goal was to raise awareness about the importance of hand and arm function for people with MS (pwMS) and find better ways to measure changes in these functions such that they can become outcomes in clinical trials. This could provide a pathway to better treatments for pwMS who cannot walk.The campaign used various methods, including surveys, social media posts, exhibitions and music to involve pwMS, healthcare professionals, charities, and researchers in discussions about the issues. Working together, they created tools to support pwMS, particularly those at an advanced stage of the disease (pwAMS), to take part in research and measure their hand and arm function. Through our collaborative approach focusing on patients' perspectives, the campaign challenged old ideas and deeply embedded practices. It showed that collaboration between different areas of expertise involving pwMS at all stages of research can help solve complex problems. This campaign teaches us valuable lessons for health research. When researchers listen to patients and try new things, they can better understand how a disease affects people's lives and develop better solutions.In conclusion, we show how embracing a patient-centred approach can address complex research challenges and improve how we study and manage MS and other conditions in the future.

Negotiating pace, focus and identities: Patient/public involvement/engagement in a palliative care study.

Patient and public involvement and engagement (PPIE) is an increasingly important component of research conduct to enhance processes and potential for impact, yet is rarely critically interrogated. This paper draws on Foucauldian analysis to highlight the disciplinary powers and tensions arising in PPIE. The paper draws on a nested evaluation interview study with three PPIE members and eight academics, who had been involved in an implementation science study focused on palliative care. PPIE members were involved in the whole study and are co-authors of this article. Through shared values and commitments to the study, a team culture of equality was developed. Yet while power was dispersed and taken-up by all team members, in so doing a self-governance approach within the team was developed. The pace and focus of discussions was at times more subjugating than co-production. Identities and positions were porous; the simplistic division of 'academic' and 'PPIE' did not stand up to scrutiny, with an increasing blurring of boundaries as people's experiences and insights changed over time. Continual, subtle, negotiations of roles, inputs and identities were manifest throughout the project. PPIE in research involves subtle, complex and ongoing disciplinary practices enacted by all members of the team.

Co-producing an online patient public community research hub: a qualitative study exploring the perspectives of national institute for health research (NIHR) research champions in England.

BACKGROUND: Patient and Public Involvement and Engagement (PPIE) should be embedded as part of researchers' everyday practice. However, this can be challenging. Creating a digital presence for PPIE as part of Higher Education Institutes' (HEIs) infrastructure may be one way of supporting this. This can support how information is made available to patients and members of the public, but relatively little is known about how HEIs can best do this. Our aim was to develop a university website for patients and members of the public to learn about ways to get actively involved in research and be able to access the results of health and social care research. METHODS: This project involved working as partners with five National Institute for Health and Care Research (NIHR) Research Champions. NIHR Research Champions are volunteers who raise awareness and share experiences about health and social care research. Content of a prototype Patient Public Community Research Hub website was co-produced with the Research Champions, and then 15 NIHR Research Champions from across England were asked for their views about the website. FINDINGS: The information collected told us that the Patient Public Community Research Hub was viewed as being beneficial for increasing visibility of PPIE opportunities and sharing the findings of studies though needs further work: to make the information more user-friendly; to improve the methods for directing people to the site and to create new ways of connecting with people. It provides a foundation for further co-development and evaluation. A set of recommendations has been developed that may be of benefit to other HEIs and organisations who are committed to working with patients and members of the public.

Sharing the results of health and care research studies with patients and members of the public could be improved. In many cases, patients and members of the public do not receive the results of studies they have taken part in. As well, it should also be easy for patients and members of the public to find out about opportunities to get involved with researchers in the development of their research. Universities have an important role to play in providing opportunities for patients and members of the public to be involved in the development of research studies, as well as sharing the findings of their studies. Creating an online patient public community research hub for this purpose was co-produced with National Institute for Health and Care Research (NIHR) Research Champions. The aims of this research were to find out what research volunteers within the National Institute for Health Research (NIHR), in the UK, would like to find on a university website about health and care research. This research aimed to understand how best to raise awareness about how people can get involved in research. It also aimed to understand how best to share information about research, with patients and members of the public, from a university website. Five NIHR Research Champions from diverse ethnic and cultural backgrounds (including younger and older people) helped to develop a set of webpages on a university website, called the Patient Public Community Research Hub. Once the initial online hub was created, online interviews were held with another 15 NIHR Research Champions. The interviews were to help the researcher to understand what they thought about the Patient Public Community Research Hub. The results from the interviews were analysed and grouped into themes. The themes helped to tell us what NIHR Research Champions felt patients and members of the public would want to see on the Patient Public Community Research Hub and what areas needed improving. A co-produced set of recommendations was created with the NIHR Research Champions who helped to shape the Patient Public Community Research Hub. The recommendations are for researchers, other organisations, or services to use. These recommendations along with the findings may help to improve how information gets shared about the results of research and ways in which patients and members of the public can get involved.

Extracting the latent needs of dementia patients and caregivers from transcribed interviews in japanese: an initial assessment of the availability of morpheme selection as input data with Z-scores in machine learning.

BACKGROUND: Given the increasing number of dementia patients worldwide, a new method was developed for machine learning models to identify the 'latent needs' of patients and caregivers to facilitate patient/public involvement in societal decision making. METHODS: Japanese transcribed interviews with 53 dementia patients and caregivers were used. A new morpheme selection method using Z-scores was developed to identify trends in describing the latent needs. F-measures with and without the new method were compared using three machine learning models. RESULTS: The F-measures with the new method were higher for the support vector machine (SVM) (F-measure of 0.81 with the new method and F-measure of 0.79 without the new method for patients) and Naive Bayes (F-measure of 0.69 with the new method and F-measure of 0.67 without the new method for caregivers and F-measure of 0.75 with the new method and F-measure of 0.73 without the new method for patients). CONCLUSION: A new scheme based on Z-score adaptation for machine learning models was developed to predict the latent needs of dementia patients and their caregivers by extracting data from interviews in Japanese. However, this study alone cannot be used to assign significance to the adaptation of the new method because of no enough size of sample dataset. Such pre-selection with Z-score adaptation from text data in machine learning models should be considered with more modified suitable methods in the near future.

To summarise the approach to and findings of the PPIE undertaken as part of a programme of secondary research with a vulnerable, hard to reach population during the COVID-19 pandemic.

BACKGROUND: Public and patient involvement and engagement (PPIE) is an important part of research. The inclusion of PPIE in research is becoming more widespread, however, there are some areas where it is still uncommon. For example, undertaking PPIE in secondary analysis projects is uncommon and PPIE with difficult to reach populations and vulnerable groups can be seen as being too difficult to facilitate. The aim was to summarise the approach to and findings of the PPIE undertaken as part of a programme of secondary analysis with a vulnerable, hard to reach population; residents of residential care facilities (RCFs), during the COVID-19 pandemic. METHODS: As part of a project to develop a publically available database of statutory notifications of adverse events from RCFs in Ireland, residents (n = 9) from RCFs for older people and people with disability were telephone interviewed. Residents were engaged through gatekeepers and posted participant information and consent forms. Themes were identified using content analyses of interview notes. RESULTS: Three parent themes were identified, each with two subthemes: privacy concerns, enthusiasm and dissemination of research findings. Residents highlighted the importance that no personal information be shared in the database. Once data were anonymized, residents thought that the database should be published and shared. Residents reported being happy about research being undertaken using the data and thought that publishing the database would help inform the public about RCFs. Completing a PPIE project with a vulnerable group during the global COVID-19 pandemic required planning and resources. Resources included finances, time and expertise. CONCLUSIONS: The involvement of residents informed the data inclusion in the published database and the approach taken in the protection of personal data. Enthusiasm for publication and research using the database by residents encouraged the developers as it was considered something that was wanted by residents. The benefits of PPIE can be achieved with vulnerable groups during unprecedented times with the appropriate planning. It requires dedication of time, finances and expertise. Overcoming the obstacles was achievable and worthwhile. The approach outlined can be used as an example to support PPIE in secondary analysis projects and or with vulnerable groups.

When doing research, it is important to involve the people that the research is going to impact. Research projects are increasingly including this involvement, however, there are some areas of research where it is not yet commonplace. For example, when undertaking projects with existing data or when the people of interest are considered a difficult to reach or vulnerable group. The LENS project (LEarning from Notifications in Social care) is a research project that developed and published a database using existing data on safety incidents in care homes. We carried out a consultation with people living in care homes as part of this project. People were asked for their input on the development of the database and the research that was being carried out on it. This work was completed during the COVID-19 pandemic and, as such, the people giving input were considered a vulnerable group. The people living in care homes were concerned about personal details being included in the database. Once they were reassured that no personal information would be included they were supportive of the database being made public. They also offered ideas about how the research that used the database could teach people working and living in care homes. The article describes how the researchers engaged the people and what was needed to achieve this. The article shows that involving people from vulnerable groups and in research relating to existing data, adds value even though there are obstacles to overcome. It is summarised here as an example for researchers undertaking similar work.

Democratic Justifications for Patient Public Involvement and Engagement in Health Research: An Exploration of the Theoretical Debates and Practical Challenges.

The literature on patient public involvement and engagement (PPIE) in health research has grown significantly in the last decade, with a diverse range of definitions and topologies promulgated. This has led to disputes over what the central functions and purpose of PPIE in health research is, and this in turn makes it difficult to assess and evaluate PPIE in practice. This paper argues that the most important function of PPIE is the attempt to make health research more democratic. Bringing this function to the fore and locating PPIE in the wider context of changes in contemporary forms of democratic engagement provides greater conceptual clarity over what PPIE in research should be trying to achieve. Conceptualizing PPIE as a form of democratization has a number of benefits. First, theories of what are appropriate, normatively justifiable and workable criteria for PPIE practices can be developed, and this can provide tools to address the legitimacy and accountability questions that have troubled the PPIE community. Second, this work can be used to form the basis of a research agenda to investigate how PPIE in health research operates, and how it can facilitate and/or improve democratic processes in health research.

How social media can help to understand treatment experiences of survivors of rare cancers: Findings from the Granulosa Cell Tumor Survivor Sisters Facebook group member survey.

BACKGROUND: Engaging with online social media consumer groups for rare cancers may help to develop collaborations between consumers and researchers. This study, a collaboration with the Granulosa Cell Tumor-Survivor Sisters (GCT-SS) Facebook group, explores the results of their survey of member's treatment and follow-up experiences. METHODS: Members of the closed multinational GCT-SS Facebook group completed a 43-item survey covering symptoms, diagnosis, treatment, recurrence, follow-up, and possible risk factors for GCT. Group members could have adult (aGCT) or juvenile (jGCT) disease. Data was collected via an online survey between 2014 and 2019. RESULTS: A total of 743 members (average 4.4 years [SD = 5.9] post-diagnosis) participated including 52 with jGCT. A total of 67% had stage I disease and 8% had stage III-IV at diagnosis, although 30% of aGCT and 25% of jGCT reported recurrent disease at survey completion. A total of 48% of aGCT had laparoscopic surgery, tumor encapsulation was reported by 49%, and tumor bagging reported by 29% overall (37% laparoscopic; 8% open). Recurrence rates were higher when the tumor was cut or ruptured (ruptured: p < .001; cut: p = .01). A total of 19% of aGCT had chemotherapy with this most common for stage II-III disease. Bleomycin, etoposide, and cisplatin protocols became less common over time (diagnosed before 2015: 47% vs. diagnosed post-2015: 21%). CONCLUSIONS: This is one of the largest surveys of GCT treatment. Members of the GCT-SS group report treatment patterns generally in line with those found from clinical audits. Using naturally forming consumer groups may assist with developing the evidence base for care and supporting those living with GCT ovarian cancer. PLAIN LANGUAGE SUMMARY: This study is a collaboration between members of Granulosa Cell Tumor-Survivor Sisters (GCT-SS) Facebook group and researchers to assess members' experiences of treatment and follow-up. A total of 743 members (52 with juvenile GCT) completed an online survey. A total of 67% had stage I disease at diagnosis. Treatment patterns were generally in line with those found from clinical audits: 95% had surgery and 19% of those with adult GCT had chemotherapy. A total of 30% reported recurrent disease, with recurrence occurring within 5 years of diagnosis for 33%. Using naturally forming consumer groups may assist with developing the evidence base for care and supporting those living with GCT ovarian cancer.

Key stakeholder perspectives on expert-by-experience involvement in the values-based recruitment of student mental health nurses: A co-produced qualitative study.

BACKGROUND: Values-based recruitment is a mandatory process for nursing programmes within UK higher education, with the Nursing Midwifery Council expecting that experts-by-experience are engaged in these recruitment and selection processes. The wider involvement of experts-by-experience in healthcare education is gaining momentum internationally with calls for engagement in all aspects of design and delivery; however, the impact of such involvement in recruitment of nursing students has received little attention, particularly in mental health nursing. AIM: To understand the impact of expert-by-experience involvement in the values-based recruitment of mental health nursing students from the perspective of candidates, experts-by-experience, and academic staff. DESIGN AND METHODS: This qualitative approach was co-designed and implemented by a research team comprised of academics, experts-by-experience, and student mental health nurses. Focus groups and an on-line survey were used to collect data, with Burnard's thematic analysis providing a framework for data analysis. SETTING/PARTICIPANTS: This study took place at one UK university. Participants included nurse academics, experts-by-experience, and student nurses with experience of a values-based recruitment process. RESULTS: Thematic analysis identified four themes: starting out, collaboration, rich assessment, and stakeholder gains. Whilst not without its challenges, the involvement of experts-by-experience in the recruitment of mental health nursing students was identified as delivering a robust recruitment process, encompassing academic abilities alongside the personal qualities required to make a 'good nurse'. Personal benefits for experts-by-experience, candidates, and academics were also reported. CONCLUSION: This study provides insights into the impact of experts-by-experience in supporting values-based recruitment. The approach is identified as enhancing the selection process by drawing from academic and lived experience perspectives and highlights to potential candidates, at the outset of their career, the value of meaningful engagement. These findings support the Nursing Midwifery Council's position that experts-by-experience should be engaged in the recruitment and selection of student nurses.

Co-design of a Smartphone App for People Living With Dementia by Applying Agile, Iterative Co-design Principles: Development and Usability Study.

BACKGROUND: The benefits of involving those with lived experience in the design and development of health technology are well recognized, and the reporting of co-design best practices has increased over the past decade. However, it is important to recognize that the methods and protocols behind patient and public involvement and co-design vary depending on the patient population accessed. This is especially important when considering individuals living with cognitive impairments, such as dementia, who are likely to have needs and experiences unique to their cognitive capabilities. We worked alongside individuals living with dementia and their care partners to co-design a mobile health app. This app aimed to address a gap in our knowledge of how cognition fluctuates over short, microlongitudinal timescales. The app requires users to interact with built-in memory tests multiple times per day, meaning that co-designing a platform that is easy to use, accessible, and appealing is particularly important. Here, we discuss our use of Agile methodology to enable those living with dementia and their care partners to be actively involved in the co-design of a mobile health app. OBJECTIVE: The aim of this study is to explore the benefits of co-design in the development of smartphone apps. Here, we share our co-design methodology and reflections on how this benefited the completed product. METHODS: Our app was developed using Agile methodology, which allowed for patient and care partner input to be incorporated iteratively throughout the design and development process. Our co-design approach comprised 3 core elements, aligned with the values of patient co-design and adapted to meaningfully involve those living with cognitive impairments: end-user representation at research and software development meetings via a patient proxy; equal decision-making power for all stakeholders based on their expertise; and continuous user consultation, user-testing, and feedback. RESULTS: This co-design approach resulted in multiple patient and care partner-led software alterations, which, without consultation, would not have been anticipated by the research team. This included 13 software design alterations, renaming of the product, and removal of a cognitive test deemed to be too challenging for the target demographic. CONCLUSIONS: We found patient and care partner input to be critical throughout the development process for early identification of design and usability issues and for identifying solutions not previously considered by our research team. As issues addressed in early co-design workshops did not reoccur subsequently, we believe this process made our product more user-friendly and acceptable, and we will formally test this assumption through future pilot-testing.

Male prisoners' experiences of taking part in research about suicide and violence: a mixed methods study.

BACKGROUND: There is an apparent reluctance to engage 'vulnerable' participants in conversation about sensitive topics such as suicide and violence and this can often lead to a paucity of research in these areas. This study aimed to explore the experiences of male prisoners taking part in quantitative and qualitative research on suicide and violence. METHODS: Participants at four male prisons completed a visual analogue scale of mood before and after data collection for both a cross-sectional study and also a qualitative interview. Participants were also asked to give three words to describe their experience of participation. A paired samples T-test was conducted to explore the difference in pre- and post-mood ratings, and content analysis was conducted to explore the positive and negative comments on participants' experiences. RESULTS: Overall, participants' mood significantly improved after participating in a cross-sectional study about suicide and violence (from 4.8 out of 10 to 5.3, p = 0.016), and there was no significant change in mood following participation in a related qualitative study (5.1 to 5.0, p = 0.793). Participants primarily described their experiences as positive, stating that the process had been satisfying, calming, interesting, enlightening and beneficial. A smaller number of participants described their experiences as stressful, challenging, saddening, uncomfortable and bizarre. CONCLUSIONS: This study has found that researching sensitive topics such as suicide and violence with male prisoners did not have a negative impact on mood, rather that participants largely enjoyed the experience. These findings dispel the myth that research about sensitive topics with prisoners is too risky and could inform how future researchers assess levels of risk to participants.

Some topics of research are considered 'sensitive' or 'risky'. This includes topics such as suicide and violence. Some groups of people are also considered 'sensitive' or 'risky'. This includes prisoners. Because of this, there is little research done with prisoners on topics such as suicide and violence. This study aimed to explore the experiences of prisoners who took part in a study about suicide and violence. Eighty male prisoners took part in either a questionnaire study or an interview study (or both). At the beginning of the session people were asked to rate their mood from 0 to 10. Zero was the worst possible imaginable mood and 10 was the best possible imaginable mood. People were asked to do this again at the end of the session. People were also asked to give three words to describe their experience of the session. The people who took part in the questionnaire study had a significant improvement in mood after the session. The people who took part in the interview study had no difference in mood after the session. Most people gave positive words to describe the session. People said the session was satisfying, calming, interesting, enlightening and beneficial. A smaller number of people gave negative words. They described the session as stressful, challenging, saddening, uncomfortable and bizarre. This study therefore contrasts the idea that prisoners will become upset if they take part in research about suicide and violence. Therefore, we should continue to research this area.

Who should I involve in my research and why? Patients, carers or the public?

Patient and public involvement in research helps to make it more relevant and useful to the end-users. Involvement influences the design, delivery and dissemination of research, ultimately leading to better services, treatments and care. Researchers are therefore keen to involve patients, carers and public in their work, but are sometimes uncertain about who to involve. Some confusion may arise from the terms used. The UK's catch-all term 'patient and public involvement' suggests this is a single activity, that perhaps both 'patient' and 'public' input are needed, or that either will do. The terms 'patient', 'carer' and 'public' have been defined, but are not used consistently. In fact there are many different contexts for involvement and many different kinds of decisions made, which then determine whose input will be most valuable.Clarity about the 'why' can help answer the 'who' question. However, not all researchers are clear about the purpose of involvement. While it is often understood to have a moral purpose, or to improve research quality, this doesn't always identify who needs to be involved. When learning is understood to be the purpose of involvement, then the most appropriate people to involve are those with relevant experiential knowledge. In research projects, these are people with lived experience of the topic being investigated. This could be patients, carers, members of the public or health professionals.In this article we discuss how involving people who do not have the relevant experiential 'lived' knowledge may contribute to ineffective or tokenistic involvement. These people are as likely as researchers to make assumptions, risking missing key insights or resulting in outcomes that are off-putting or even harmful to research participants.We conclude that greater attention needs to be given to the question of who to involve. Raising awareness of the significance of experiential knowledge and the contextual factors that determine whose input will be most useful will help everyone to understand their roles and improve the quality of involvement. It will help to maximise the opportunities for learning, increasing the likelihood of impact, and helping to achieve the ultimate goal of improved health and services.

Patient and public involvement in research helps to make it more relevant and useful to the end-users. Researchers are therefore keen to involve people but are sometimes uncertain about who to involve. Some confusion comes from the terms used. The UK's term 'patient and public involvement' suggests there is only one activity and that both inputs are needed or either will do. The terms 'patient', 'carer' and 'public' are not used in the same way by everyone.Involvement happens in many different situations, influencing different kinds of decisions, which then determines whose input will be most valuable. Being clear about the 'why' can help answer the 'who' question. However, not all researchers are clear about the purpose of involvement. When learning is understood to be the purpose, the most appropriate people to involve are those with relevant experiential knowledge. They provide insights based on their lived experience. In research projects, this is experience of the topic being studied. This could be patients, carers, public or health professionals.We discuss how involving people who do not have relevant experiential knowledge may limit impact. These people may be as likely as researchers to make wrong assumptions. This risks missing key insights or making unhelpful decisions.We conclude that greater attention should be given to the question of who to involve. Raising awareness of the importance of relevant experiential knowledge and other factors that determine whose input will be most useful, will help maximise opportunities for learning and increase the potential for impact.

Using the United Kingdom standards for public involvement to evaluate the impact of public involvement in a multinational clinical study.

BACKGROUND: The publication of the United Kingdom (UK) Standards for Public Involvement (PI) (UK Standards) in research drew a clear line in the sand regarding the importance of utilising the unique experience, skills and expertise that lay people may offer to the development, conduct and dissemination of clinical research. The UK Standards provide a benchmark which researchers should aim to achieve, yet its implementation continues to be a step wise iterative process of change management. A recent evaluation by a regional research group has suggested that our understanding of PI is enhanced through reflection on the UK Standards. We report on the utility of PI in the design, conduct and dissemination of the HIDDen study, a national, multicentre clinical study based across three UK centres. METHODS: A retrospective review of PI within the HIDDen study was conducted using field notes taken by the lead author from interactions throughout their involvement as a lay representative on the study. Key members of the HIDDen study were interviewed and data analysed to explore adherence to the UK Standards. RESULTS: There was universal support for PI across the study management group with genuine inclusivity of lay members of the committee. All six of the UK Standards were met to varying degrees. The greatest opportunities lay in 'working together' and 'support and learning'. There were challenges meeting 'governance' with evidence of participation in decision making but less evidence of opportunities in management, regulation, leadership. CONCLUSION: This study concurs with previous research supporting the utility of the Standards in the conduct and evaluation of PI in clinical research. To our knowledge this is the first multi-national study to be evaluated against the UK Standards.

The past decade has seen a genuine increase in patient and public involvement (PI) in clinical research, far beyond a symbolic presence on a trial management committee or inclusion on a grant application. The United Kingdom (UK) Standards for Public Involvement provide a useful structure to support PI throughout a study as well as defining a benchmark that can be used to improve the involvement of patients and the public in studies.The importance of reflecting on and reporting on PI in specific studies has been recognised since it contributes to a stepwise change process which will eventually lead to PI becoming normal practice for clinical research. A recent review identified a myriad of frameworks by which PI may be evaluated, risking an inconsistent approach to PI evaluation and consequently slowing down its progression.The Hospice Inpatient Deep vein thrombosis Detection study (HIDDen) was a national multicentre study to explore the prevalence and associated variables of blood clots in patients with advanced cancer when they were admitted to the specialist palliative care unit.In this paper we will be considering the HIDDen research in terms of the UK Standards for Public Involvement.

Drug Information Association (DIA) Japan - 17th Annual Meeting (November 8-10, 2020 - Virtual Meeting).

As many other conferences held in 2020, the 17th Drug Information Association (DIA) Japan Annual Meeting 2020 was held virtually for the first time due to the COVID-19 crisis. The virtual platform delivered 64 sessions across 3 days and allowed participants to join the sessions flexibly, interactively participate in Q and A and connect with fellows without boundaries. The opening speech was addressed by Hajime Saijo (DIA Japan) to introduce the conference theme "Beyond Innovation" and key sessions featured discussions on future healthcare, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) 30-year anniversary, the Pharmaceuticals and Medical Devices Agency (PMDA) town hall, patient-focused drug development and global drug development. This meeting report covers the topics discussed from the programs featuring patient engagement, innovative drug development and new technologies.

Importance of involving patients and public in health research in Bangladesh and Nepal.

Patient and public involvement/engagement (PPI/E) in public health research and health technology assessment (HTA) in high-income countries (HICs) have significantly increased over the past decade. PPI/E helps to improve research and HTA, ultimately benefitting patients and service users. PPI/E is a very new concept in many low- and middle-income countries (LMICs). This paper considers the importance of PPI in public health research and HTA in the development and implementation of technology in the health sector in South Asia. Currently, in this region, health technology is frequently adopted from HICs without local research and HTA. It also discusses the importance of local co-creation of technology to reflect the needs of users within a culturally appropriate setting. It is important for LMIC-based researchers to understand the potential of PPI/E and how it can contribute to it to improve health care and research, especially perhaps in the era of COVID-19.

"Vicarious thinking" was a key driver of score change in Delphi surveys for COS development and is facilitated by feedback of results.

OBJECTIVE: The objectives of this nested study were to (1) assess whether changes in scores between rounds altered the final degree of consensus achieved in three Delphi surveys conducted as part of COS development projects (anal, gastric, and prostate cancer), and (2) explore participants' reasons for changing scores between rounds. STUDY DESIGN AND SETTING: All Delphi surveys were conducted online using DelphiManager software and included healthcare professionals and participating patients. Participants were invited to give a free-text reason whenever they changed their score across an important threshold on a 1-9 Likert scale (1-3 not important, 4-5 important, 7-9 critically important). Reasons for score change were coded by four researchers independently using an inductive-iterative approach. RESULTS: In all three Delphi surveys, the number of outcomes reaching criteria for consensus was greater in R2 than R1. Twelve themes and 23 subthemes emerged from 2298 discrete reasons given for score change. The most common reasons for the change were "time to reflect" (482 responses, 23%) and vicarious thinking (424, 21%), with 68% (291) of vicarious thinking attributed to seeing other participant's scores. CONCLUSION: Our findings support conducting a Delphi survey over the use of a single questionnaire where building consensus is the objective. Time to reflect and vicarious thinking, facilitated by seeing other participant's scores, were important drivers of score change. How results are presented to participants between rounds and the duration of and time between rounds in a Delphi survey may, therefore, influence the results and should be clearly reported.

Mapping epilepsy-specific patient-reported outcome measures for children to a proposed core outcome set for childhood epilepsy.

OBJECTIVE: The objectives of the study were to (1) map questions in epilepsy-specific patient-reported outcome measures (PROMs) of children's health-related quality of life (HRQoL) to a proposed core outcome set (COS) for childhood epilepsy research and (2) gain insight into the acceptability of two leading candidate PROMs. METHOD: We identified 11 epilepsy-specific PROMs of children's HRQoL (17 questionnaire versions) in a previous systematic review. Each item from the PROMs was mapped to 38 discrete outcomes across 10 domains of the COS: seizures, sleep, social functioning, mental health, cognition, physical functioning, behavior, adverse events, family life, and global quality of life. We consulted with three children with epilepsy and six parents of children with epilepsy in Patient Public Involvement and Engagement (PPIE) work to gain an understanding of the acceptability of the two leading PROMs from our review of measurement properties: Quality of Life in Childhood Epilepsy (QOLCE-55) and Health-Related Quality of Life Measure for Children with Epilepsy (CHEQOL). RESULTS: Social Functioning is covered by all PROMs except DISABKIDS and G-QOLCE and Mental Health is covered by all PROMs except G-QOLCE and Hague Restrictions in Childhood Epilepsy Scale (HARCES). Only two PROMs (Epilepsy and Learning Disability Quality of Life (ELDQOL) and Glasgow Epilepsy Outcome Scale (GEOS-YP)) have items that cover the Seizure domain. The QOLCE-55 includes items that cover the domains of Physical Functioning, Social Functioning, Behavior, Mental Health, and Cognition. The CHEQOL parent and child versions cover the same domains as QOLCE-55 except for Physical Functioning and Behavior, and the child version has one item that covers the discrete outcome of Overall Quality of Life and one item that covers the discrete outcome of Relationship with parents and siblings. The QOLCE-55 parent version was acceptable to the parents we consulted with, and CHEQOL parent and child versions were described as acceptable to our child and parent advisory panel members. SIGNIFICANCE: Mapping items from existing epilepsy-specific PROMs for children is an important step in operationalizing our COS for childhood epilepsy research, alongside evaluation of their measurement properties. Two leading PROMS, QOLCE-55 and CHEQOL, cover a wide range of domains from our COS and would likely be used in conjunction with assessment tools selected for specific study objectives. The PPIE work provided practical insights into the administration and acceptability of candidate PROMs in appropriate context. We promote our COS as a framework for selecting outcomes and PROMs for future childhood epilepsy evaluative research.

Impact of community engagement and social support on the outcomes of HIV-related meningitis clinical trials in a resource-limited setting.

BACKGROUND: Clinical trials remain the cornerstone of improving outcomes for HIV-infected individuals with cryptococcal meningitis. Community engagement aims at involving participants and their advocates as partners in research rather than merely trial subjects. Community engagement can help to build trust in communities where these trials are conducted and ensure lasting mutually beneficial relationships between researchers and the community. Similarly, different studies have reported the positive effects of social support on patient's outcomes. We aimed to describe our approach to community engagement in Uganda while highlighting the benefits of community engagement and social support in clinical trials managing patients co-infected with HIV and cryptococcal meningitis. METHODS: We carried out community engagement using home visits, health talks, posters, music and drama. In addition, social support was given through study staff individually contributing to provide funds for participants' food, wheel chairs, imaging studies, adult diapers, and other extra investigations or drugs that were not covered by the study budget or protocol. The benefits of this community engagement and social support were assessed during two multi-site, randomized cryptococcal meningitis clinical trials in Uganda. RESULTS: We screened 1739 HIV-infected adults and enrolled 934 with cryptococcal meningitis into the COAT and ASTRO-CM trials during the period October 2010 to July 2017. Lumbar puncture refusal rates decreased from 31% in 2010 to less than 1% in 2017. In our opinion, community engagement and social support played an important role in improving: drug adherence, acceptance of lumbar punctures, data completeness, rate of screening/referrals, reduction of missed visits, and loss to follow-up. CONCLUSIONS: Community engagement and social support are important aspects of clinical research and should be incorporated into clinical trial design and conduct. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT01075152 and NCT01802385.

Cost of non-alcoholic steatohepatitis in Europe and the USA: The GAIN study.

BACKGROUND & AIMS: Non-alcoholic steatohepatitis (NASH) leads to cirrhosis and is associated with a substantial socioeconomic burden, which, coupled with rising prevalence, is a growing public health challenge. However, there are few real-world data available describing the impact of NASH. METHODS: The Global Assessment of the Impact of NASH (GAIN) study is a prevalence-based burden of illness study across Europe (France, Germany, Italy, Spain, and the UK) and the USA. Physicians provided demographic, clinical, and economic patient information via an online survey. In total, 3,754 patients found to have NASH on liver biopsy were stratified by fibrosis score and by biomarkers as either early or advanced fibrosis. Per-patient costs were estimated using national unit price data and extrapolated to the population level to calculate the economic burden. Of the patients, 767 (20%) provided information on indirect costs and health-related quality of life using the EuroQOL 5-D (EQ-5D; n = 749) and Chronic Liver Disease Questionnaire - Non-Alcoholic Fatty Liver Disease (CLDQ-NAFLD) (n = 723). RESULTS: Mean EQ-5D and CLDQ-NAFLD index scores were 0.75 and 4.9, respectively. For 2018, the mean total annual per patient cost of NASH was €2,763, €4,917, and €5,509 for direct medical, direct non-medical, and indirect costs, respectively. National per-patient cost was highest in the USA and lowest in France. Costs increased with fibrosis and decompensation, driven by hospitalisation and comorbidities. Indirect costs were driven by work loss. CONCLUSIONS: The GAIN study provides real-world data on the direct medical, direct non-medical, and indirect costs associated with NASH, including patient-reported outcomes in Europe and the USA, showing a substantial burden on health services and individuals. LAY SUMMARY: There has been little research into the socioeconomic burden associated with non-alcoholic steatohepatitis (NASH). The GAIN study provides real-world data on the direct medical, direct non-medical, and indirect costs associated with NASH, including patient-reported outcomes in five European countries (UK, France, Germany, Spain, and Italy) and the USA. Mean total annual per patient cost of NASH was estimated at €2,763, €4,917, and €5,509 for the direct medical, direct non-medical, and indirect cost categories, respectively.