Research priorities in pernicious anaemia: James Lind Alliance Priority Setting Partnership.

OBJECTIVES: To form a James Lind Alliance (JLA) Priority Setting Partnership (PSP) to determine research priorities related to the cause, diagnosis, treatment and management of pernicious anaemia (PA) from the perspectives of patients, carers and clinicians. DESIGN: The PSP conducted two surveys and a workshop to identify the Top 10 questions for research. A first survey identified questions relating to the cause, diagnosis, treatment and management of PA. A literature search checked whether any of these questions had already been answered. A second survey asked respondents to identify and rank their top 10 questions from the list of questions from the first survey. An online workshop used an adapted nominal group technique to agree a final Top 10. RESULTS: In the first survey, 933 people submitted 3480 responses that were categorised and summarised to generate a long list of 40 questions. None had been answered by previous research. The combined rankings from the 1068 patients, carers and clinicians who took part in the second survey identified a short list of 16 questions. These were discussed at the final workshop to agree the final Top 10. The number one question was about an accurate and reliable diagnostic test for PA. The other nine questions were about making treatment safe and effective, understanding why people with PA vary in their need for treatment, links to other conditions, and how to encourage clinicians to take PA seriously and provide long-term care. CONCLUSIONS: This JLA PSP enabled patients, carers and clinicians to work together to agree the Top 10 uncertainties relating to the cause, diagnosis, management and treatment of PA. Addressing any of these questions will greatly benefit the end-users of research, the people whose daily lives and decisions will be directly affected by generating high quality research evidence.

Research priorities for mitochondrial disorders: Current landscape and patient and professional views.

Primary mitochondrial disorders encompass a wide range of clinical presentations and a spectrum of severity. They currently lack effective disease-modifying therapies and have a high mortality and morbidity rate. It is therefore essential to know that competitively funded research designed by academics meets the core needs of people with mitochondrial disorders and their clinicians. Priority setting partnerships are an established collaborative methodology that brings patients, carers and families, charity representatives and clinicians together to try to establish the most pressing and unanswered research priorities for a particular disease. We developed a web-based questionnaire, requesting all patients affected by primary mitochondrial disease, their carers and clinicians to pose their research questions. This yielded 709 questions from 147 participants. These were grouped into overarching themes including basic biology, causation, health services, clinical management, social impacts, prognosis, prevention, symptoms, treatment and psychological impact. Following the removal of "answered questions", the process resulted in a list of 42 discrete, answerable questions. This was further refined by web-based ranking by the community to 24 questions. These were debated at a face-to-face workshop attended by a diverse range of patients, carers, charity representatives and clinicians to create a definitive "Top 10 of unanswered research questions for primary mitochondrial disorders". These Top 10 questions related to understanding biological processes, including triggers of disease onset, mechanisms underlying progression and reasons for differential symptoms between individuals with identical genetic mutations; new treatments; biomarker discovery; psychological support and optimal management of stroke-like episodes and fatigue.

Do patients and family carers have different concerns about the use of medicines compared with healthcare professionals? A quantitative secondary analysis of healthcare concerns relating to adults with complex needs.

OBJECTIVE: To identify concerns related to the use of medicines for adults with complex needs and explore whether these differed between healthcare professionals and patients/carers, in order to inform development of interventions to increase medication adherence. METHODS: A quantitative secondary analysis of a database of healthcare professionals' and patients'/carers' healthcare concerns, related to adults with complex needs. Categories of concerns related to medicines use were identified and concerns related to medication use coded against these. Data were analysed descriptively, and a Chi-square test conducted to test for differences in responses from healthcare professionals versus patients/carers. RESULTS: There was a significant difference in the types of medication concern raised by healthcare professionals versus those raised by patients/carers. Patients/carers expressed more concerns about side effects and interactions; healthcare professionals identified more concerns related to patient support and carers' knowledge/training. CONCLUSION: Healthcare professionals had significantly different concerns about medicines to patients; this may be a potential barrier to medication adherence. PRACTICE IMPLICATIONS: Healthcare professionals may need to adopt an approach to non-adherence that goes beyond education and counselling and adopts a wider patient perspective. Findings suggest that a greater focus on addressing side effects and interactions may be beneficial in increasing medication adherence.

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.

What happens after James Lind Alliance Priority Setting Partnerships? A qualitative study of contexts, processes and impacts.

BACKGROUND: The James Lind Alliance (JLA) supports priority setting partnerships (PSPs) in which patients, carers and health professionals collaborate to identify a Top 10 list of research priorities. Few studies have examined how partnerships plan for the post-prioritisation phase, or how context and post-PSP processes influence the fortunes of priorities. This evaluation aimed to explore these questions. METHODS: We selected a diverse sample of 20 interviewees who had knowledge of 25 PSPs. Thirteen interviewees had led a PSP, either from a university, patient organisation or charity. Three were patients who had taken part in a PSP workshop. Four others, three researchers and one funder, had worked with JLA PSP priorities to develop research proposals. We analysed the data thematically, exploring how success was understood and achieved. RESULTS: The JLA PSPs had different histories, funding sources, goals and stakeholders. Whilst their focus was on generating priority research topics, PSPs' wider impacts included enhanced status and greater confidence for individuals, as well as relationship-building and network strengthening for the organisations involved. To follow through on a Top 10, additional work was needed to refine broad priority topics into research questions and match them with appropriate funding sources. Commitment to post-PSP action from partners appeared to increase the chance that priority topics would be followed through to funded studies. Academic publications could alert researchers to a PSP's outputs, but not all PSPs had the capacity to produce them. A Top 10 list potentially influences funding decisions through direct funding, themed calls or as a prompt in open calls. Influence on funders appears to depend on alignment between a priority and the funder's remit, culture and values. CONCLUSION: The history and context of a JLA PSP have a major influence on its impact. Our findings suggest that there is no universal formula for success, but that greater resource and attention should be given to what happens after prioritisation. Further research is needed on what works best in what circumstances. Overall, we conclude that a wider cultural change in the research world is needed for JLA PSPs to achieve their goal of shaping the research agenda.

Rare musculoskeletal diseases in adults: a research priority setting partnership with the James Lind Alliance.

BACKGROUND: Osteogenesis imperfecta, fibrous dysplasia/McCune-Albright syndrome and X-linked hypophosphatemia are three rare musculoskeletal diseases characterised by bone deformities, frequent fractures and pain. Little high-quality research exists on appropriate treatment and long-term management of these conditions in adults. This is further worsened by limited research funding in rare diseases and a general mismatch between the existing research priorities and those of the patients. This partnership adopted the James Lind Alliance approach to identify the top 10 research priorities for rare musculoskeletal diseases in adults through joint patient, carer and healthcare professional collaboration. RESULTS: The initial survey for question collection recruited 198 respondents, submitting a total of 988 questions. 77% of the respondents were patients with a rare musculoskeletal disease. Following out-of-scope question exclusion, repeating query grouping and scientific literature check for answers, 39 questions on treatment and long-term management remained. In the second public survey, 220 respondents, of whom 85% were patients with a rare musculoskeletal disease, their carers, relatives or friends, prioritised these uncertainties, which allowed selection of the top 25. In the last stage, patients, carers and healthcare professionals gathered for a priority setting workshop to reach a consensus on the final top 10 research priorities. These focus on the uncertainties surrounding appropriate treatment and holistic long-term disease management, highlighting several aspects indirect to abnormal bone metabolism, such as extra-skeletal symptoms, psychological care of both patients and their families and disease course through ageing. CONCLUSIONS: This James Lind Alliance priority setting partnership is the first to investigate rare bone diseases. The priorities identified here were developed jointly by patients, carers and healthcare professionals. We encourage researchers, funding bodies and other stakeholders to use these priorities in guiding future research for those affected by rare musculoskeletal disorders.

Learning as an outcome of involvement in research: what are the implications for practice, reporting and evaluation?

Public involvement in research has evolved over the last two decades in a culture dominated by the principles of evidence-based medicine. It is therefore unsurprising that some researchers have applied the same thinking to involvement, particularly to involvement in research projects. This may explain why they tend to conceptualise involvement as an intervention, seek to evaluate its impact in the same way that treatments are tested, highlight the need for an evidence-base for involvement, and use the language of research to describe its practice and report its outcomes. In this article we explore why this thinking may be unhelpful. We suggest an alternative approach that conceptualises involvement as 'conversations that support two-way learning'. With this framing, there is no 'method' for involvement, but a wide range of approaches that need to be tailored to the context and the needs of the individuals involved. The quality of the interaction between researchers and the public becomes more important than the process. All parties need to be better prepared to offer and receive constructive criticism and to engage in constructive conflict that leads to the best ideas and decisions. The immediate outcomes of involvement in terms of what researchers learn are subjective (specific to the researcher) and unpredictable (because researchers don't know what they don't know at the start). This makes it challenging to quantify such outcomes, and to carry out comparisons of different approaches. On this basis, we believe obtaining 'robust evidence' of the outcomes of involvement in ways that are consistent with the values of evidence-based medicine, may not be possible or appropriate. We argue that researchers' subjective accounts of what they learnt through involvement represent an equally valid way of knowing whether involvement has made a difference. Different approaches to evaluating and reporting involvement need to be adopted, which describe the details of what was said and learnt by whom (short term outcomes), what changes were made as a result (medium term outcomes), and the long-term, wider impacts on the research culture and agenda. Sharing researchers' personal accounts may support wider learning about how involvement works, for whom and when.

'What can I do that will most help researchers?' A different approach to training the public at the start of their involvement in research.

For patients and the public to work collaboratively with researchers, they need support and opportunities to engage in learning that builds on their skills and grows their confidence. In this article, we argue for a different approach to this learning, which starts with the expertise patients/ the public arrive with, and helps them identify and develop the soft skills required to influence researchers effectively. Much of the current training for patients and the public focuses on addressing the gaps in their knowledge and awareness about how research works and how public involvement adds value. Our training complements this by exploring the concept of 'experiential knowledge' in more depth. Patients and the public possess experiential knowledge (knowledge gained through lived experience) that researchers may not have. In the training we explore the nature of this expertise and other skills that patients/ the public bring, as well as how to identify who has the most relevant experiential knowledge in any given situation, and how best to share experiential knowledge to benefit researchers and maximise the impact of involvement. We co-produced this training with a patient member of the project team, and through feedback from patients and carers in an initial pilot. Our approach adds another dimension to preparing people for involvement and in particular for taking part in conversations with researchers that support mutual learning. We suggest this approach should be supported by separate, mirror training for researchers, that also develops their soft skills in preparation for learning from involvement.

Public involvement could usefully inform ethical review, but rarely does: what are the implications?

PLAIN ENGLISH SUMMARY: Researchers carrying out research in the NHS in England have to obtain approval for their study from an NHS Research Ethics Committee (REC). Involving the public in research helps to ensure studies are ethically acceptable to the people taking part, and therefore supports the REC review. The form used by RECs asks researchers to describe any involvement that has taken place before the review or any planned for the future. We analysed researchers' reports of involvement in 2748 applications to RECs in 2014, to assess how well their approaches to involvement are informing the review process. We found that researchers rarely describe involvement in enough detail to help REC members. It is difficult to judge whether previous involvement has shaped the research design in any way, and whether plans for future involvement are meaningful. It also seems that some researchers remain unclear about involvement and its purpose at different stages. This may be severely limiting its impact.So that public involvement can usefully inform REC reviews in future, the Health Research Authority, which oversees RECs, will carry out further work to find out what information RECS need about involvement. This information will be used to change the application form and to develop guidance and training for REC members and the wider research community. Researchers may also benefit from clearer guidance on the value and purpose of involvement at key research stages: early design, data collection and the dissemination of results. ABSTRACT: Background Researchers conducting research in the NHS in England are required to submit their study for approval by an NHS Research Ethics Committee (REC). Public involvement in research prior to REC review helps to ensure studies are ethically acceptable to participants, thus informing the review process. The Integrated Research Application System (IRAS) used by RECs, asks researchers to describe any involvement in the development of their project, and in its delivery and dissemination. We analysed researchers' reports of involvement to assess how well current approaches to involvement are supporting REC review. Methods We used a mixed methods approach. The anonymised free-text data from all 2748 non-educational applications submitted to RECs in 2014 were analysed using NVivo. Themes were developed from the data and used to summarise and categorise the different types of reports of involvement. The frequency of common types of report was analysed using simple statistics. Results In general, researchers rarely describe any prior involvement in sufficient detail to know what was done and what difference this made. This makes it difficult to judge whether the involvement shaped the research design in any way to make it more ethically acceptable. Similarly, researchers' plans for future involvement are not clear enough to enable RECs to make a proper assessment of whether this involvement will be meaningful, or whether potential ethical concerns raised by involvement have been addressed. This analysis also shows there is still considerable misunderstanding amongst researchers around what involvement means, and its purpose at different stages of a project. This may be severely limiting the potential for impact. Conclusions So that public involvement can usefully inform REC review in future, the HRA is undertaking a collaborative exercise to understand what information RECS need about involvement, and what changes need to be made to the IRAS form. At the same time it will develop guidance and training for REC members and the wider research community about how public involvement can support ethical review. Researchers may also benefit from guidance on the value and purpose of involvement at the research stages: design, data collection and dissemination of results.

The impact of involvement on researchers: a learning experience.

PLAIN ENGLISH SUMMARY: The impacts of involvement in research are often described in terms of the difference made to the research, the people involved and less frequently the researchers. This paper focuses on the researchers' experiences of involvement, based on an evaluation of a pilot project supporting patient/carer involvement in research at Parkinson's UK. Telephone interviews were conducted with researchers from eight different research projects with involvement. The researchers reported gaining new knowledge from patients and carers. They used this knowledge to change their project designs, interventions and new devices. They also gained new skills in communicating with the public. Meeting patients for the first time had a profound impact on some researchers, causing a change in their professional values. Face-to-face contact seemed particularly important to gain a sense of the 'people behind the data', which suggests such meetings may result in impacts beyond those typically achieved through an exchange of documents. Involvement also influenced one researcher's choices and preferences, in terms of who to ask to take part in their study In summary, researchers often learn something new from talking to patients and carers. Facilitating this conversation seems important to maximise the impact of this learning. In future, it might be helpful for evaluations of involvement to ask researchers in more detail about what they learnt from patients/carers and how they applied their new skills and knowledge. This may help to understand how involvement can influence researchers' thinking to have an impact on research. ABSTRACT: Background The impacts of patient/public involvement are often described in terms of the difference made to the research, the researchers and the people involved. Involvement often impacts on research by influencing the design, delivery and dissemination. Patients/the public report gaining new skills and knowledge, increased self-confidence, and satisfaction from making a difference. There are fewer reports of the impacts on researchers. This paper discusses the findings from an evaluation of a pilot project supporting patient/carer involvement in research at Parkinson's UK, focusing on the researchers' experiences. Methods Semi-structured telephone interviews were conducted with one researcher from each of the eight research projects which involved patients/carers in the pilot. The findings were analysed using theoretical thematic analysis. Results and discussion Learning can be described as acquiring new knowledge, behaviours, skills, values, or preferences. The researchers' reports reflected these different types of learning. They reported gaining new knowledge from patients and carers, which they recognised as distinct from their textbook knowledge of the condition. They used this learning to change their project designs and their new interventions and devices. They also gained new skills in communicating with patients and carers about the aims and significance of their research. Meeting patients for the first time had a profound impact on some researchers causing them to change their professional values. Face-to-face contact seemed particularly important to gain a sense of the 'people behind the data', which suggests such meetings may result in impacts beyond those typically achieved through an exchange of documents. The involvement also influenced one researchers' priorities and preferences, in terms of what questions to ask and of whom, in their project. Conclusions Researchers learn from an exchange of knowledge with patients/ carers, which influences their plans and actions. This seems to be one way that involvement subsequently has an impact on research. Facilitating this exchange seems important to support mutual learning and to enhance the impact on researchers. Future evaluations of involvement might benefit from exploring what researchers learnt from patients/carers and how they applied their new skills and knowledge.

It's not evidence, it's insight: bringing patients' perspectives into health technology appraisal at NICE.

PLAIN ENGLISH SUMMARY: Health technology appraisal involves reviewing the findings from clinical trials and economic data to produce guidance on how health technology should be used. This task is carried out by appraisal committees in NICE. One of the several ways in which patients can feed their views into these committees is via a written patient statement. We asked nine committee members about what difference the information from patients makes to their decision-making. The Committee members reported that written patient statements offer a different perspective when reviewing the clinical and economic data. This can have a profound impact when a committee draws conclusions based solely on the data, which may not reflect the reality of patients' lives. The patients' and carers' input provides meaning to the data, 'bringing the numbers to life'. It identifies if the technology has any wider impacts than what's been reported in the clinical trial, and also if the trial has measured what's important to patients. We conclude that the written patient statement adds value to the decision-making process by helping Committee members to make sense of the clinical and economic data-it makes them look at the evidence 'in a different light'. Patients' stories are very effective in this context, because they have the power to communicate and to challenge Committee members' assumptions. Understanding this difference between analysing research evidence and drawing on patients' insights is important in thinking about what's needed in a written patient statement and the best way to obtain it. ABSTRACT: Background Health technology appraisal involves reviewing clinical and economic data to inform guidance on the use of technology. In England this task is carried out by appraisal committees within the National Institute for Health and Care Excellence (NICE). Patients are not committee members as they have a vested interest in the outcome, but one of the several ways they are involved is through submitting a written patient statement, which is considered by the committee during its deliberations. We aimed to find out how the written patient statement adds value to the decision-making process by exploring how it is used in practice. Methods Semi-structured interviews were conducted with nine members of NICE appraisal committees. The interviews were transcribed and analysed thematically. We drew on published evidence of the impact of patient involvement on clinical research and our experience of supporting organisations to produce written patient statements to analyse the findings. Results Committee members reported that written patient statements offer a different perspective when evaluating clinical and economic data. This can have a profound impact when a committee draws conclusions based on data that may not reflect the reality of the patient experience. Information from patients and carers also provides context and meaning to the data, by explaining its real-life implications. It identifies wider impacts of a technology that may not have been assessed in a clinical trial, as well as commenting on whether what has been measured in a trial is relevant to patients. The main barrier to using the written patient statement is the misperception that it is a form of research 'evidence', when in fact it takes the form of experiential knowledge - or insight. Conclusions The written patient statement adds value by aiding Committee members in their interpretation of existing evidence - it enables them to consider this evidence 'in a different light'. In this context, patients' experiential knowledge is effective because it is subjective, emotional and anecdotal. It then has the power to communicate and to challenge assumptions based on the data alone. Understanding this difference between using evidence and insights has implications for the content of a written patient statement and the approaches used to obtain it.

'Is it worth doing?' Measuring the impact of patient and public involvement in research.

ABSTRACT: Much of the current debate around the impact of patient/public involvement on research focuses on the lack of empirical data. While a number of systematic literature reviews have reported the various ways in which involvement makes a difference to research and the people involved, this evidence has been criticised as being weak and anecdotal. It is argued that robust evidence is still required. This review reflects on the use of quantitative approaches to evaluating impact. It concludes that the statistical evidence is weakened by not paying sufficient attention to the context in which involvement takes place and the way it is carried out. However, if scientific (systematic, quantitative, empirical) approaches are designed in a way to take these factors into account, they might not generate knowledge that is useful beyond the original context. Such approaches might not therefore enhance our understanding of when, why and how involvement makes a difference. In the context of individual research projects where researchers collaborate with patients/the public, researchers often acquire 'new' knowledge about life with a health condition. This new understanding can be described as experiential knowledge-'knowledge in context'-that researchers gain through direct experience of working with patients/the public. On this basis, researchers' accounts of their experience potentially provide a source of insight and learning to influence others, in the same way that the patient experience helps to shape research. These accounts could be improved by increasing the detail provided about context and mechanism. One of the most important contextual factors that influence the outcome of involvement is the researchers themselves and the skills, assumptions, values and priorities they start with. At the beginning of any research project, the researchers 'don't know what they don't know' until they involve patients/the public. This means that the impact of involvement within any particular project is somewhat unpredictable. The answer to the question 'Is involvement worth doing?' will always be 'It depends'. Further exploration of the contextual and mechanistic factors which influence outcomes could give a stronger steer to researchers but may never accurately predict any specific impact. PLAIN ENGLISH SUMMARY: In recent years, there has been considerable interest in finding out what difference patient and public involvement makes to research projects. The evidence published so far has been criticised for being weak and anecdotal. Some people argue we need robust evidence of impact from scientific studies of involvement. In this review, I consider examples of where impact has been measured using statistical methods. I conclude that the statistical evidence is weak, if the studies do not consider the context in which involvement takes place and the way that it is done. Studies designed to take this into account give us more confidence that the involvement did make a difference to that particular project. They do not tell us whether the same impact will occur in the same way in other projects and therefore have limited value. Researchers gain an understanding of involvement through their direct experience of working with patients and the public. This is 'knowledge in context' or 'insight' gained in the same way that patients gain expertise through their direct experience of a health condition. This means that detailed accounts of involvement from researchers already provide valuable learning to others, in the same way that patients' insights help shape research. However, the impact of involvement will always be somewhat unpredictable, because at the start of any project researchers 'don't know what they don't know'-they do not know precisely what problems they might anticipate, until the patients/public tell them.

'The missing links': understanding how context and mechanism influence the impact of public involvement in research.

INTRODUCTION: It is now more widely recognized that public involvement in research increases the quality and relevance of the research. However, there are also more questions as to exactly how and when involvement brings added value. THE NATURE OF THE CURRENT EVIDENCE OF IMPACT: Based on the findings of recent literature reviews, most reports of public involvement that discuss impact are based on observational evaluations. These usefully describe the context, the type of involvement and the impact. However, the links between these factors are rarely considered. The findings are therefore limited to identifying the range of impacts and general lessons for good practice. Reflecting on the links between context, mechanism and outcome in these observational evaluations identifies which aspects of the context and mechanism could be significant to the outcome. Studies that are more in line with the principles of realistic evaluation can test these links more rigorously. Building on the evidence from observational evaluations to design research that explores the 'missing links' will help to address the question 'what works best, for whom and when'. CONCLUSIONS: We conclude that a more intentional and explicit exploration of the links between context, mechanism and outcome, applying the principles of realistic evaluation to public involvement in research, should lead to a more sophisticated understanding of the factors that increase or decrease the likelihood of positive outcomes. This will support the development of more strategic approaches to involvement maximizing the benefits for all involved.

Lay REC members: patient or public?

In practice, the role of lay members of research ethics committees (RECs) often involves checking the accessibility of written materials, checking that the practical needs of participants have been considered and ensuring that a lay summary of the research will be produced. In this brief report, I argue that all these tasks would be more effectively carried out through a process of patient involvement (PI) in research projects prior to ethical review. Involving patients with direct experience of the topic under investigation brings added value beyond the contributions typically made by lay REC members, who are often not patients themselves. This is because PI tailors the design and conduct of research to the specific interests and concerns of the people who will actually take part in a project and make use of its findings. If a project has PI in its early stages, then a similar input from lay REC members could at best result in duplication of effort and at worst create the potential for conflict. The rationale for lay REC membership will therefore need to change from 'contributing a patient perspective' to 'ensuring transparency and public accountability in REC decisions'. This has implications for addressing more strategic questions about lay REC membership, including who is best recruited to the role and how they should be expected to contribute in practice.

Service user involvement in cancer care: the impact on service users.

BACKGROUND: Service user involvement is embedded in the United Kingdom's National Health Service, but knowledge about the impact of involvement on service users, such as the benefits and challenges of involvement, is scant. Our research addresses this gap. OBJECTIVE: To explore the personal impact of involvement on the lives of service users affected by cancer. DESIGN: We conducted eight focus groups with user groups supplemented by nine face-to-face interviews with involved individuals active at a local, regional and national level. Thematic analysis was conducted both independently and collectively. SETTING AND PARTICIPANTS: Sixty-four participants, engaged in involvement activities in cancer services, palliative care and research, were recruited across Great Britain. RESULTS: We identified three main themes: (i) 'Expectations and motivations for involvement'- the desire to improve services and the need for user groups to have a clear purpose, (ii) 'Positive aspects of involvement'- support provided by user groups and assistance to live well with cancer and (iii) 'Challenging aspects of involvement'- insensitivities and undervaluing of involvement by staff. CONCLUSIONS: This study identified that involvement has the capacity to produce varied and significant personal impacts for involved people. Involvement can be planned and implemented in ways that increase these impacts and that mediates challenges for those involved. Key aspects to increase positive impact for service users include the value service providers attach to involvement activities, the centrality with which involvement is embedded in providers' activities, and the capacity of involvement to influence policy, planning, service delivery, research and/or practice.

Developing a model to enhance the capacity of statutory organisations to engage with lay communities.

OBJECTIVE: To understand the processes that constrain the capacity of statutory organisations to work effectively with lay communities and to develop a model to enhance their capacity to do so. METHODS: The research consisted of three elements: a review of relevant literature; in-depth interviews with a purposive sample of people who had recently been involved in community-statutory sector partnership; and a deliberative workshop involving ten expert witnesses, selected to reflect a range of sectors and levels within organisations. RESULTS: Many factors contribute to a lack of effective strategic partnerships between lay communities and statutory organisations. These factors fall into five domains: the community's capacity to engage; the skills and competencies of organisational staff; the dominant professional service culture; the overall organisational ethos and culture; and the dynamics of the local and national political systems. A model of the relationships and/or interaction between these domains is postulated. There is potential for testing this model with statutory organisations to see whether it concurs with their reality and whether it is enhancing their organisational capacity. CONCLUSIONS: Commonly occurring constraints to effective partnerships between statutory organisations and lay communities need to be identified and addressed by applying a dynamic model of the type presented here.