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

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

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

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

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

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

Impact of involving people with dementia and their care partners in research: a qualitative study.

OBJECTIVES: We aimed to evaluate the impact of patient and public involvement (PPI) at each stage of the research cycle in a dementia research programme. DESIGN: We used monitoring forms to record the impact of the research programme's PPI at different stages of research and qualitative interviews with all participants to evaluate the impact of PPI. SETTING: We evaluated Research User Groups (RUGs-older people with dementia and care partners) which were established to provide PPI support for the research programme in multiple European sites. PARTICIPANTS: We purposively sampled RUG members (n=34) and researchers (n=13) who had participated in PPI activities. Inclusion criteria for the study were: (a) RUG members who had participated in the research awareness training and in PPI activities and had the capacity to consent; (b) researchers who involved RUGs in their work. RESULTS: Impact on the research: changes to the study conduct were made as a result of the feedback from RUGs. These included prioritisation of clinical recommendations, the wording of study information and recruitment materials, the content and layout of the user interface for a computerised memory test, interpretation of intervention results and advice on dissemination avenues. Impact on RUG members: they reported that involvement had given them a sense of purpose and satisfaction. Their perception of health research changed from being an exclusive activity to one, which lay people, could have meaningful involvement. Impact on researchers: PPI was a new way of working and interacting with PPI members had given them insight into the impact of their work on people living with dementia. CONCLUSIONS: PPI can have a substantial impact on dementia research and the people involved in the research. To justify the time and expense of PPI, the advantageous practical impacts of PPI should be systematically recorded and consistently reported.

Evaluation of a research awareness training programme to support research involvement of older people with dementia and their care partners.

BACKGROUND: Best-practice guidelines recommend that appropriate support be provided to public contributors to facilitate their involvement in research. One form of support is research awareness training. Older people with dementia and care partners were involved in four Research User Groups (RUGs) in the UK, France, Cyprus and Greece. We delivered research awareness training (RAT) to the RUGs. The aim of this study was to evaluate the acceptability and perceived outcomes of the training from the perspective of RUG members. METHODS: At the end of each research training session, participants completed the Training Acceptability Rating Scale-section 2, which records the respondent's impressions of the training process and the outcomes of training. Participants were also invited to take part in semi-structured interviews at the end of the programme. RESULTS: Thirty-four RUG members completed the TARS-section 2 with 23 completing semi-structured interviews. Over two-thirds (67%) of participants rated their overall satisfaction with the RAT 'a great deal'. Qualitative responses indicated that participants found group work to be beneficial for learning, the structure of training activities and topics covered appropriate. The type and format of the training materials were viewed as helpful, and they valued the new knowledge gained. CONCLUSIONS: The training contents were applicable, useful and relevant to the participants' role within the research. We highlight the importance of facilitating participation by (a) fostering awareness of relevant research issues and (b) tailoring delivery of training according to the needs of the participants.

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

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

Patient and public involvement in dementia research in the European Union: a scoping review.

BACKGROUND: Internationally, there is a drive to involve patients and the public in health research, due to recognition that patient and public involvement (PPI) may increase the impact and relevance of health research. This scoping review describes the extent and nature of PPI in dementia research in the European Union (EU) and summarises: (i) how PPI is carried out; and (ii) the impact of PPI on people living with dementia and the public, researchers, and the research process. METHODS: Relevant studies were identified by searches in electronic reference databases and then filtered by two reviewers independently. Eligibility criteria for included studies were: (i) people living with dementia and/or care partners; (ii) PPI activity in dementia research conducted in the European Union (EU); and (iii) published between 2000 and 2018. An adapted version of the Guidance for Reporting Involvement of Patients and the Public (GRIPP2 SF) was used to collate the data. There was no language restriction other than the abstract needed to be available in English. RESULTS: We found 19 studies from the UK and one from the Netherlands meeting inclusion criteria. No studies from other EU countries met inclusion criteria. Studies reported various methods of PPI including workshops, drop-in sessions, meetings, consensus conference, reader consultation and participatory approach. The reported aims of PPI included identifying and prioritising research questions (n = 4), research design (n = 5), undertaking and managing research (n = 8), and data analysis and interpretation (n = 3). All PPI related to design and implementation of non-pharmacological studies. One study described two pharmacological studies as case studies incorporating PPI. Seventeen studies reported anecdotal impacts of PPI. CONCLUSIONS: Further development of PPI in dementia research in the EU and in pharmacological dementia research is required. Given the wide range of objectives of PPI in dementia research, PPI methods should be flexible and appropriate for the research context. Researchers should also formally evaluate and report the impacts of PPI for researchers, patients and the general public using good quality research designs to foster development of the field and enable the benefits and challenges of PPI to be better understood. TRIAL REGISTRATION: PROSPERO 2017: CRD42017053260 .

A protocol to evaluate the impact of involvement of older people with dementia and age-related hearing and/or vision impairment in a multi-site European research study.

PLAIN ENGLISH SUMMARY: Involving older people with dementia in research is increasingly recognised as important to ensure that research is relevant and beneficial for older people with dementia. But researchers need to know how best to involve older people with dementia and to be able to show the benefits of involving older people with dementia in dementia research.This paper describes a research plan to explore the involvement of older people with dementia and age-related hearing and/or vision impairment in a European research project investigating the combined impact of dementia with hearing and/or vision impairment. We set up four Research User Groups (RUGs) of older people with dementia with age-related hearing and/or vision impairment and their carers based in the UK, France, Cyprus and Greece to advise our researchers. We provided training to group members to support their input to the research.We will use a questionnaire and interview people in our RUGs to understand what they thought of the training and their experiences of being part of the RUG. We will also interview researchers to understand if they thought the advice from the groups was useful.This study will help us to understand how to effectively involve older people with dementia and age-related hearing and/or vision impairment in research and what the benefits of involving older people with dementia in research are. ABSTRACT: Background Research to prevent and treat dementia is an international priority. Involvement of older people with dementia in the research is important to ensure the relevance and utility of the research outcomes in clinical practice to them. Efforts to involve such people in research are growing due to increased recognition of the usefulness of incorporating the views of older people with dementia into the research process. Research User Groups (RUGs) of older people with dementia and carers for people with dementia were set up in UK (Manchester), France (Nice), Cyprus (Nicosia) and Greece (Athens) to advise on the research. We report a protocol for a study which aims to evaluate i) the perceptions of RUG members of the usefulness of Research Awareness Training that was provided to support their involvement in the research and ii) perceived impacts of the involvement of older people with dementia and age-related hearing and/or vision impairment on research from the point of view of RUG members and researchers. Methods Both qualitative and quantitative methods will be used to evaluate the acceptability, appropriateness and satisfaction with Research Awareness Training and the perceived impact of involvement of RUGs on research. Focus groups interviews with RUG members and one to one interviews with both RUG members (n = 24) and researchers (n = 6) will be conducted to understand the perceived impacts of patient and public involvement on research from the point of view of older people with dementia, carers and researchers. Any comparative differences in cultural, attitudinal and environmental differences between RUGs in outcomes of training and impact across the four European sites will be reported. Discussion This study is unique in its exploration of the impact of the involvement of older people with dementia and age-related hearing and/or vision impairment in a large multi-site European dementia research study. This work will be crucial in informing understanding of how to effectively involve older people with dementia and age-related hearing and/or vision impairment and carers in dementia research to ensure research addresses the needs and priorities of older people with dementia and age-related hearing and/or vision impairment.

What do young people with rheumatic conditions in the UK think about research involvement? A qualitative study.

BACKGROUND: Involving people of all ages in health research is now widely advocated. To date, no studies have explored whether and how young people with chronic rheumatic conditions want to be involved in influencing health research. This study aimed to explore amongst young people with rheumatic conditions, 1) their experiences of research participation and involvement 2) their beliefs about research involvement and 3) beliefs about how young people's involvement should be organized in the future. METHODS: Focus groups discussions with young people aged 11-24 years with rheumatic conditions across the UK. Data was analysed using a qualitative Framework approach. RESULTS: Thirteen focus groups were held involving 63 participants (45 F: 18 M, mean age 16, range 10 to 24 years) across the UK. All believed that young people had a right to be involved in influencing research and to be consulted by researchers. However, experience of research involvement varied greatly. For many, the current project was the first time they had been involved. Amongst those with experience of research involvement, awareness of what they had been involved in and why was often low. Those who had previously participated in research appeared more positive and confident about influencing research in the future. However, all felt that there were limited opportunities for them to be both research participants and to get involved in research as public contributors. CONCLUSIONS: These findings suggest that there is an on-going need to both increase awareness of research involvement and participation of young people in rheumatology as well as amongst young people themselves.

Working with public contributors to improve the patient experience at the Manchester Clinical Research Facility: an evaluation of the Experience Based Design approach.

PLAIN ENGLISH SUMMARY: The Experience Based Design (EBD) approach involves patients, staff and members of the public working together to improve a service. This paper evaluates the methods that are used to involve patients and members of the public in a project that aimed to improve the patient experience at Manchester Clinical Research Facility (MCRF). The aim was to explore what helps staff and members of the public to work well together. An evaluation questionnaire was used to get feedback from staff and public contributors. Questions included whether each person felt that they were able to shape the project; if they received enough training; whether they had enough time to complete each task; how well they thought the group worked together; and what could be improved. The findings showed that both staff and public contributors felt valued and that they were able to shape the project from the beginning. Training in EBD and research methodology, and providing enough time to complete each task helped to build relationships and increase confidence when contributing to the project. Personal benefits included a feeling of ownership over a worthwhile and rewarding project, increased awareness of public involvement and gaining new skills. The recommendations for successful involvement of patients and the public in EBD projects will hopefully be helpful for similar projects in the future. ABSTRACT: Background The Experience Based Design (EBD) approach promotes the effective involvement of patients and public contributors by enabling patients, public contributors and staff to co-design projects that aim to improve the patient experience. This approach allows patients and members of the public to have a role in shaping and improving current services. This paper aims to evaluate the EBD process from a public involvement perspective, exploring the barriers and facilitators to building successful working relationships. Methods An open-ended evaluation questionnaire was developed to gain feedback from staff and public contributors who co-produced an EBD project that aimed to improve the patient experience at Manchester CRF. Questions explored what worked well, how the project could be improved, and the benefits of being involved. Results Our findings highlight the importance of providing opportunities for staff, patients and members of the public to build relationships in order to feel confident in voicing their opinions. This can be achieved by training both staff and public contributors in EBD methodology to reduce any power imbalance that may exist. Negotiating adequate time to complete tasks and debate the best way forward also allows everyone to fully contribute to the project. Each individual felt that their contribution was valued and that they shaped the final action plan. Both public contributors and staff listed a number of personal benefits from their involvement in the project. This included a feeling of ownership over a worthwhile and rewarding project, increased awareness of public involvement in EBD projects and gaining new skills. Conclusion This evaluation provides recommendations for best practice for effectively involving public contributors in an EBD methodology. These findings aim to encourage a more consistent approach to EBD across organisations.

Research protocol for a complex intervention to support hearing and vision function to improve the lives of people with dementia.

BACKGROUND: Hearing and vision impairments are among the most common and disabling comorbidities in people living with dementia. Intervening to improve sensory function could be a means by which the lives of people living with dementia may be improved. However, very few studies have tried to ameliorate outcomes in dementia by improving sensory function. This paper describes the multi-step development of a new intervention designed to support hearing and vision function in people living with dementia in their own homes. At the end of the development programme, it is anticipated that a 'sensory support' package will be ready for testing in a full scale randomised controlled trial. METHODS: This programme is based on the process of 'intervention mapping' and comprises four integrated steps, designed to address the following: (1) scoping the gaps in understanding, awareness and service provision for the hearing and/or vision impairment care needs of people with dementia using a systematic literature review and Expert Reference Group; (2) investigating the support care needs through a literature search, stakeholder surveys, focus groups, semi-structured interviews and an Expert Reference Group, leading to a prototype sensory support package; (3) refining the prototype by additional input from stakeholders using focus groups and semi-structured interviews; and (4) field testing the draft intervention using an open-labelled, non-randomised feasibility study, integrating feedback from people with dementia and their significant others to develop the final intervention ready for full scale definitive trialling. Input from the 'patient and public voice' is a cornerstone of the work and will interlink with each step of the development process. The programme will take place in study centres in Manchester, Nicosia and Bordeaux. DISCUSSION: Quantitative and qualitative data analyses will be employed, dependent upon the sub-studies in question. Data from the steps will be integrated with consideration given to weighting of evidence for each step of the programme. This programme represents the logical development of a complex intervention to fulfil an unmet need. It is based on a theoretical framework and will lead to a subsequent full scale efficacy trial. The challenges in integrating the data and addressing the contextual issues across study sites will be scrutinised.

What do young people with rheumatic disease believe to be important to research about their condition? A UK-wide study.

BACKGROUND: The involvement of people of all ages including young people in research is now widely advocated but prioritisation of research topics is still driven largely by professional agendas. Evidence from adult literature has reported a mismatch between a researcher and patient generated list of research topics. There have been no studies to date exploring the priorities of young people with long term conditions other than in SLE. The study aimed to explore the research priorities of young people across the UK with respect to rheumatic conditions. METHODS: Focus groups were undertaken with young people aged 11-24 years with rheumatic conditions recruited across the UK via members of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR and relevant national charities. Data was analysed using a Framework approach. Participants discussed their beliefs about what should be researched in: Basic Science; Clinical Medicine; Health Services, Psychosocial, and Public Health. They were then invited to prioritize these areas in terms of how much funding they should receive. RESULTS: Thirteen focus groups were held involving 63 participants (18 males: 45 females, mean age 16 years, range 10 to 24) in all four nations of the UK. Young people's research priorities were influenced by whether they felt research would achieve benefits for all or just some patients and long or short term goals. Another influence was whether participants felt that research areas were already well funded. Across all groups, Basic Science was a key priority and participants felt that psychosocial research should be prioritized more. Health Services Research was a lower priority, as the majority of participants were happy with their care. Clinical medicine was not a high priority as young people were happy with their medication or uncomfortable with trying new ones. Finally, for nearly all groups, Public Health was a low priority. Differences were also observed between the two age groups and across the geographically diverse focus groups. CONCLUSION: Understanding young people's research priorities is important to develop research that is in tune with their needs. The results highlight the importance of considering the whole age range of adolescence and young adulthood as well as geographical diversity. The findings from this work will inform the future research of the Barbara Ansell National Network for Adolescent Rheumatology BANNAR in the UK.

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

OBJECTIVES: To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). SETTING: Pharmaceutical companies in the UK, Poland and Spain. PARTICIPANTS: 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. METHOD: Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. RESULTS: 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. CONCLUSIONS: Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships.

Study protocol: Determining what young people with rheumatic disease consider important to research (the Young People's Opinions Underpinning Rheumatology Research - YOURR project).

PLAIN ENGLISH SUMMARY: Involving young people in research about their health is increasingly recognized as being important to make sure that research is focused more on the needs of young people. However, at present, ideas about what should be researched and found out mainly come from researchers and health professionals like doctors and nurses rather than young people. Therefore, in the past, young people's ideas about what should be researched in terms of rheumatic problems have not been explored. In this study, we will talk with groups of young people with rheumatic problems across the UK to explore what they think research into their health should focus on. We will also discuss with young people, if and how, they would like to be involved in shaping research into rheumatic problems. The findings from this work will help make sure that the views of young people with rheumatic problems influence the work of a group of researchers and health professionals who concentrate on rheumatology research. This group is called the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR). A national young person's advisory group will be set up to make sure that the beliefs and ideas of young people with rheumatic disease inform the work of the BANNAR. ABSTRACT: Background The involvement of people of all ages (including young people) in health-related research is now widely advocated but research priorities are still largely driven by professional agendas, with evidence from the adult literature reporting a mismatch between researcher and patient generated lists of research topics. To date, there have been no studies exploring the research priorities of young people with long term conditions including rheumatic disease. In this study, we will explore young people's beliefs about their research priorities for rheumatic conditions and whether and how young people would like to become involved in the research process. Methods/Design We will hold up to 16 focus group discussions with young people (11-24 years) across England, Northern Ireland, Scotland and Wales. Two age groups will be recruited to the study, 11-15 year olds to represent early and mid-adolescence and 16-24 year olds to reflect late adolescence and emerging adulthood. Focus groups will be as interactive and engaging as possible, using a mixture of statement sorting and a research prioritization exercise to stimulate the discussion. Young people will be recruited via members of the Barbara Ansell National Network for Adolescent Rheumatology (BANNAR) and relevant national charities. Focus groups will be audiotaped and transcribed for analysis. Discussion This project will help ensure full representation from young people with rheumatic diseases in the development of a research strategy for BANNAR and will ultimately inform a young person's led involvement strategy to facilitate the future ethical and meaningful involvement of young people in BANNAR members' future research programmes. In addition, a national young persons' advisory group will be established, the constitution and format of which will be determined by the young people themselves.

What the public knows and wants to know about medicines research and development: a survey of the general public in six European countries.

OBJECTIVES: To explore public knowledge of, and interest in, learning more about medicines R&D in six European countries. DESIGN: Online survey of 6931 members of the public across Europe. METHODS: The survey formed part of a public omnibus survey. A quota sampling approach was used with quotas set according to national census data on age, gender and government region. The survey explored the public's knowledge and awareness of medicines R&D, their interest in learning more and the perceived influences on this. RESULTS: The survey was completed by 6931 members of the public, over 75% of whom reported having no or less than good knowledge of medicines R&D. Males were more likely than females to report good knowledge (17% vs 15%), and knowledge appeared to decrease with age. Those who were currently or had previously been involved in medical research were almost five times more likely to report good knowledge of medicines R&D overall (43% vs 13%). Participants reported good knowledge of medicines safety and clinical trials but little knowledge of pharmacoeconomics. They were most interested in learning more about medicines safety and personalised and predictive medicine and least interested in pharmacoeconomics. Older people, women and respondents with current good knowledge of medicines R&D were most interested in learning more about medicines R&D. CONCLUSIONS: Experience of medical research appears to play a key role in increasing public awareness of and future interest in medicines R&D. Some groups may need to be specifically targeted to increase their awareness of medicines R&D, for example, women expressed great interest in learning more but reported less knowledge than men. It may be useful to explore further the views of those who are currently uninterested in learning more.

Prevalence and impact of chronic widespread pain in the Bangladeshi and White populations of Tower Hamlets, East London.

The prevalence and impact of chronic pain differ between ethnic groups. We report a study of the comparative prevalence and impact of chronic pain in Bangladeshi, British Bangladeshi and White British/Irish people. We posted a short questionnaire to a random sample of 4,480 patients registered with 16 general practices in the London Borough of Tower Hamlets and conducted a longer questionnaire with patients in the waiting areas at those practices. We distinguished between Bangladeshi participants who were born in the UK or had arrived in the UK at the age of 14 or under (British Bangladeshi) and those who arrived in UK at the age of over 14 (Bangladeshi). We obtained 1,223/4,480 (27 %) responses to the short survey and 600/637 (94 %) to the long survey. From the former, the prevalence of chronic pain in the White, British Bangladeshi and Bangladeshi groups was 55, 54 and 72 %, respectively. The corresponding figures from the long survey were 49, 45 and 70 %. Chronic widespread pain was commoner in the Bangladeshi (16 %) than in the White (10 %) or British Bangladeshi (9 %) groups. People with chronic pain experienced poorer quality of life (odds ratio for scoring best possible health vs. good health (or good vs. poor health) 5.6 (95 % confidence interval 3.4 to 9.8)), but we found no evidence of differences between ethnic groups in the impact of chronic pain on the quality of life. Chronic pain is commoner and, of greater severity, in Bangladeshis than in Whites. On most measures in this study, British Bangladeshis resembled the Whites more than the Bangladeshis.

Methodological challenges and approaches to improving response rates in population surveys in areas of extreme deprivation.

BACKGROUND: Achieving good response rates to population surveys from hard to reach groups in deprived areas can be challenging. AIM: To explore and compare different approaches to improving response rates in an economically deprived multicultural area. METHOD: Following a lower than anticipated response rate in a pilot study for a postal questionnaire survey of chronic pain (79/653 (12%)), we conducted a second pilot involving a shorter postal survey and separate collection of more detailed information in a waiting room survey. The second postal survey used a shorter questionnaire, telephone data collection from non-responders by study team members rather than telephone reminders from practice receptionists, and involved a nested randomised-controlled trial (RCT) of hand-addressed versus printed-address envelopes. Both pilots involved subjects randomly selected from the practice registers. RESULTS: The second pilot postal survey using shorter questionnaires yielded considerably more responses (240/642 (37%)). Our RCT showed that hand-addressed envelopes achieved a slightly higher response rate although not large enough to justify its use in our main study. The waiting room survey was successful in collecting more detailed data from lengthy questionnaires. CONCLUSION: A range of methods of questionnaire administration may be required when conducting a survey with a hard to reach group in a deprived and ethnically diverse population. Postal and telephone administration can be used to collect a small amount of data. Face-to-face administration and recruitment can be successful for longer questionnaires.

The OPERA trial: a protocol for the process evaluation of a randomised trial of an exercise intervention for older people in residential and nursing accommodation.

BACKGROUND: The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. METHODS/DESIGN: Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control). DISCUSSION: Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. TRIAL REGISTRATION: ISRCTN No: ISRCTN43769277.

British pain clinic practitioners' recognition and use of the bio-psychosocial pain management model for patients when physical interventions are ineffective or inappropriate: results of a qualitative study.

BACKGROUND: To explore how chronic musculoskeletal pain is managed in multidisciplinary pain clinics for patients for whom physical interventions are inappropriate or ineffective. METHODS: A qualitative study was undertaken using semi-structured interviews with twenty five members of the pain management team drawn from seven pain clinics and one pain management unit located across the UK. RESULTS: All clinics reported using a multidisciplinary bio-psychosocial model. However the chronic pain management strategy actually focussed on psychological approaches in preference to physical approaches. These approaches were utilised by all practitioners irrespective of their discipline. Consideration of social elements such as access to social support networks to support patients in managing their chronic pain was conspicuously absent from the approaches used. CONCLUSION: Pain clinic practitioners readily embraced cognitive/behavioural based management strategies but relatively little consideration to the impact social factors played in managing chronic pain was reported. Consequently multidisciplinary pain clinics espousing a bio-psychosocial model of pain management may not be achieving their maximum potential.

Influences on older people's decision making regarding choice of topical or oral NSAIDs for knee pain: qualitative study.

OBJECTIVE: To explore the factors that influence older people's decision making regarding use of topical or oral ibuprofen for their knee pain. DESIGN: Qualitative interview study nested within a randomised controlled trial and a patient preference study that compared advice to use oral or topical non-steroidal anti-inflammatory drugs (NSAIDs) for knee pain in older people. SETTING: 11 general practices. PARTICIPANTS: 30 people aged > or =50 with knee pain. RESULTS: Participants' decision making was influenced by their perceptions of the associated risk of adverse effects, presence of other illness, nature of their pain, advice received, and practicality. Although participants' understanding of how the medications worked was sometimes poor their decision making about the use of NSAIDs seemed logical and appropriate. Participants' model for treatment was to use topical NSAIDs for mild, local, and transient pain and oral NSAIDs for moderate to severe, generalised, and constant pain (in the absence of other more serious illness or risk of adverse effects). Participants showed marked tolerance and normalisation of adverse effects. CONCLUSION: Participants had clear ideas about the appropriate use of oral and topical NSAIDs. Taking such views into account when prescribing may improve adherence, judgment of efficacy, and the doctor-patient relationship. Tolerance and normalisation of adverse effects in these patients indicate that closer monitoring of older people who use NSAIDs might be needed.