Research policy for people with multiple long-term conditions and their carers.

People with multiple long-term conditions (MLTC) are a growing population, not only in the United Kingdom but internationally. Health and care systems need to adapt to rise to this challenge. Policymakers need to better understand how medical education and training, and service configuration and delivery should change to meet the needs of people with MLTC and their carers. A series of workshops with people with MLTC and carers across the life-course identified areas of unmet need including the impact of stigma; poorly coordinated care designed around single conditions; inadequate communication and consultations that focus on clinical outcomes rather than patient-oriented goals and imperfectly integrate mental and physical wellbeing. Research which embeds the patient voice at its centre, from inception to implementation, can provide the evidence to drive the change to patient-centred, coordinated care. This should not only improve the lives of people living with MLTC and their carers but also create a health and care system which is more effective and efficient. The challenge of MLTC needs to be bought to the fore and it will require joint effort by policymakers, practitioners, systems leaders, educators, the third sector and those living with MLTC to design a health and care system from the perspective of patients and carers, and provide practitioners with the skills and tools needed to provide the highest quality care.

Evaluation of a patient and public involvement training programme for researchers at a large biomedical research centre in the UK.

OBJECTIVES: To design, deliver and evaluate a programme of training workshops for biomedical researchers aimed at building confidence and skills in actively involving patients and the public (PPI) in research. DESIGN: A bespoke programme of training workshops in PPI aimed at researchers. SETTING: A large National Institute for Health Research Biomedical Research Centre in London and several partner organisations. PARTICIPANTS: 721 scientists, clinicians and research managers attending dedicated training in PPI at a major London NHS (National Health Service)-university partnership. INTERVENTIONS: A programme of 72 training workshops, designed to build practical skills and confidence for researchers working with patients and the public in research, was delivered at a major research-active NHS:university partnership. An iterative approach was taken to the programme, with the content of the workshops continually reviewed and refreshed to respond to the needs of researchers. Surveys before, immediately following and 6 months after training investigated the impact on researchers' confidence and skills in PPI work, and the kind of PPI they subsequently carried out. RESULTS: Training brought about immediate marked increases in researchers' self-reported confidence to carry out PPI activities within their research, and in their knowledge of good practice. The evaluation indicates that workshop attendees were more likely to involve patients in their research following training. Researchers tended to involve patients and the public in a range of areas, including input to study design and patient information, in particular. CONCLUSIONS: When positioned within a broader organisational strategy for PPI in research, such training has an important role to play in progressing PPI in a major research partnership. Training appeared to provide the confidence needed to carry out PPI which enabled further development of confidence and skills. Involving researchers who have attended the training in the ongoing development of the programme and bringing in patients to the training programme are key next steps.

'All hands-on deck', working together to develop UK standards for public involvement in research.

BACKGROUND: Public involvement in research is an established part of the research process in the UK, however there remain questions about what good public involvement in research looks and feels like. Until now public involvement practitioners, researchers and members of the public have looked for answers in examples shared across networks, published case studies, guidance and research articles. Pulling these strands together, the UK Standards for Public Involvement provides six statements (standards) about public involvement in research. They were produced by a partnership of organisations from Scotland, Northern Ireland, Wales and England with contributions from involvement practitioners, public partners, researchers and research funders. MAIN BODY: Each standard has reflective questions, which are designed to encourage standard users to use approaches and behaviours that improve involvement, over time. The standards are designed to be used as a practical tool, and reflect the agreed hallmarks of good public involvement in research for example, flexibility in approaches used, shared learning, and mutual respect.The standards development process is described from the initial idea and scoping, via the appraisal of existing standard sets and integration of values and principles in public involvement in research. The collaborative writing process of and consultation on the draft standard set is described, together with what changed as a result of feedback. The initiation of a year-long testing programme with forty participating research organisations, the experiential feedback and the resulting changes to the standards is summarised. CONCLUSION: This commentary paper describes, in some detail, a process to develop a set of six standards for public involvement in research in the UK. Producing a complex, national public involvement initiative is not without its challenges, and in supplementary material partnership members reflect on and share their experiences of standards development. The next phase of integration and implementation is explored with concluding comments from those that tested and helped improve the standards.

Reviewing progress in public involvement in NIHR research: developing and implementing a new vision for the future.

OBJECTIVES: To review the progress of public involvement (PPI) in NIHR (National Institute for Health Research) research, identify barriers and enablers, reflect on the influence of PPI on the wider health research system in the UK and internationally and develop a vision for public involvement in research for 2025. The developing evidence base, growing institutional commitment and public involvement activity highlight its growth as a significant international social movement. DESIGN: The 'Breaking Boundaries Review' was commissioned by the Department of Health. An expert advisory panel was convened. Data sources included: an online survey, international evidence sessions, workshop events, open submission of documents and supporting materials and existing systematic reviews. Thematic analysis identified key themes. NVivo was used for data management. The themes informed the report's vision, mission and recommendations, published as 'Going the Extra Mile-Improving the health and the wealth of the nation through public involvement in research'. The Review is now being implemented across the NIHR. RESULTS: This paper reports the Review findings, the first of its type internationally. A range of barriers and enablers to progress were identified, including attitudes, resources, infrastructure, training and support and leadership. The importance of evidence to underpin practice and continuous improvement emerged. Co-production was identified as a concept central to strengthening public involvement in the future. The Vision and Mission are supported by four suggested measures of success, reach, refinement, relevance and relationships. CONCLUSIONS: The NIHR is the first funder of its size and importance globally to review its approach to public involvement. While significant progress has been made, there is a need to consolidate progress and accelerate the spread of effective practice, drawing on evidence. The outcomes of the Review are being implemented across the NIHR. The findings and recommendations have transferability for other organisations, countries and individuals.

Reaching consensus on reporting patient and public involvement (PPI) in research: methods and lessons learned from the development of reporting guidelines.

INTRODUCTION: Patient and public involvement (PPI) is inconsistently reported in health and social care research. Improving the quality of how PPI is reported is critical in developing a higher quality evidence base to gain a better insight into the methods and impact of PPI. This paper describes the methods used to develop and gain consensus on guidelines for reporting PPI in research studies (updated version of the Guidance for Reporting Patient and Public Involvement (GRIPP2)). METHODS: There were three key stages in the development of GRIPP2: identification of key items for the guideline from systematic review evidence of the impact of PPI on health research and health services, a three-phase online Delphi survey with a diverse sample of experts in PPI to gain consensus on included items and a face-to-face consensus meeting to finalise and reach definitive agreement on GRIPP2. Challenges and lessons learnt during the development of the reporting guidelines are reported. DISCUSSION: The process of reaching consensus is vital within the development of guidelines and policy directions, although debate around how best to reach consensus is still needed. This paper discusses the critical stages of consensus development as applied to the development of consensus for GRIPP2 and discusses the benefits and challenges of consensus development.

Priorities for methodological research on patient and public involvement in clinical trials: A modified Delphi process.

BACKGROUND: Despite increasing international interest, there is a lack of evidence about the most efficient, effective and acceptable ways to implement patient and public involvement (PPI) in clinical trials. OBJECTIVE: To identify the priorities of UK PPI stakeholders for methodological research to help resolve uncertainties about PPI in clinical trials. DESIGN: A modified Delphi process including a two round online survey and a stakeholder consensus meeting. PARTICIPANTS: In total, 237 people registered of whom 219 (92%) completed the first round. One hundred and eighty-seven of 219 (85%) completed the second; 25 stakeholders attended the consensus meeting. RESULTS: Round 1 of the survey comprised 36 topics; 42 topics were considered in round 2 and at the consensus meeting. Approximately 96% of meeting participants rated the top three topics as equally important. These were as follows: developing strong and productive working relationships between researchers and PPI contributors; exploring PPI practices in selecting trial outcomes of importance to patients; and a systematic review of PPI activity to improve the accessibility and usefulness of trial information (eg participant information sheets) for participants. CONCLUSIONS: The prioritized methodological research topics indicate important areas of uncertainty about PPI in trials. Addressing these uncertainties will be critical to enhancing PPI. Our findings should be used in the planning and funding of PPI in clinical trials to help focus research efforts and minimize waste.

Hospitals should be at the heart of Britain's world-beating partnership with patients in research.

The Royal College of Physicians Future Hospital Commission report and recommendations highlighted the importance of clinical research to its definition of the hospital of tomorrow. But why should hospitals put research at the centre of what they do and how can they make it happen in practice? This opinion piece sets out a vision of a 'research hospital' from a patient and public perspective. It argues that patients will increasingly value those hospitals that: visibly focus on research to improve quality of care and treatment; actively enable their patients to contribute to this endeavour; and help to make the results of this research more accessible to its public.

It's plain and simple: transparency is good for science and in the public interest.

In the past couple of years, there has been a growing focus on the need to make scientific output accessible to a greater number of people, especially in the field of clinical research. The public are being urged to become more well-informed and to ask their doctors about taking part in clinical trials. A key finding of a report from the Association of Medical Research Charities was that all published scientific papers would benefit from having a section in plain English. Researchers running a clinical trial are expected to provide a summary of their intended research at various stages of the research process. However, there is evidence that existing summaries are of variable length and quality and not always in plain English. As a result, the National Institute for Health Research (NIHR) commissioned a review of the guidance that is available to researchers. However, recent initiatives demonstrate that there are still a number of challenges in making current research both accessible and understandable by prospective participants. BioMed Central also has a number of ongoing initiatives involving trial registration services and journals.

A collaboratively-derived science-policy research agenda.

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.

"Natural ground" for medical research charities: public and patient involvement in research funding.

Improving patient and public involvement in research is now an established goal of UK science policy. With many medical research charities often representing distinct patient groups as part of their broader charitable role, or having strong patient groups allied to them, patient and public involvement would seem "natural ground" for them. The Association of Medical Research Charities Natural Ground project brought together a learning set of staff and volunteers from member organizations to discuss current activities and share best practice. This article identifies 5 areas where medical research charities involve patients and discusses some of the methods used.

Is what's mine my own?

This paper examines the key issues around privacy and the secondary use of data in health research from the perspective of patients and the public. It argues that there is low public awareness and understanding of the issues around medical privacy and deep public unease over the extent to which public and private bodies have access to personal information. Quoting a recent example from the field of dementia, it challenges the notion that all research is necessarily in the public interest. It argues that a socially sustainable system for the secondary use of data that preserves the gift relationship in research is dependent on there being strong systems to enforce privacy and confidentiality. Underpinning this is a need to involve patients and their representatives in the development of any new system.