Evaluating the usefulness of a wordless picture book for adults with intellectual disabilities about the COVID-19 vaccination programme using co-production: The CAREVIS study.

AIM: To explore the usefulness of a co-designed wordless book showing processes of receiving COVID-19 vaccines designed by, and for, adults with intellectual disabilities. METHODS: A qualitative evaluation of the resource using mixed methods. Semi-structured interviews were conducted with people with intellectual disabilities, carers and health professionals about resource content, and use. This was analysed thematically. A survey was circulated to intellectual disabilities networks to understand resource need, use, sharing and content. RESULTS: Understanding the COVID-19 vaccine was a process, not a single event using one resource. A visual resource had a place in facilitating conversations about vaccines between people with intellectual disabilities and carers. Differing perspectives were expressed regarding personal needs, existing awareness of vaccine programmes and communication preferences. Changes were suggested to improve the suggested storyline and relevance around COVID-19 restrictions changing. CONCLUSION: A visual resource may help conversations about the COVID-19 vaccine for people with intellectual disabilities.

Adaptations to research within the intellectual disability population during the COVID-19 pandemic: Lessons learned from the CAREVIS study.

The COVID-19 pandemic resulted in changes in all areas of clinical practice, including clinical research and within the intellectual disability population. While there have been some benefits from this rapid adoption of change, those involved in research have had to overcome a number of additional challenges. These adaptive changes, which have included the use of technology, closure of social spaces, working with specific groups who are more vulnerable to COVID-19, and mask use impairing communication, have had both positive and negative impacts on research. As the pandemic and related restrictions evolve, it is important to examine the changes that have occurred. In the future, the adoption of a hybrid model in research is likely to be a common approach, establishing a balance between technology and in-person interaction.

Reciprocal relationships and the importance of feedback in patient and public involvement: A mixed methods study.

BACKGROUND: Reciprocal relationships between researchers and patient and public involvement (PPI) contributors can enable successful PPI in research. However, research and anecdotal evidence suggest that researchers do not commonly provide feedback to PPI contributors thus preventing them from knowing whether, how or where their contributions were useful to researchers and research overall. AIMS: The aim of this study was to explore the variation, types, importance of, and satisfaction with feedback given by researchers to PPI contributors in six PPI groups in England, and identify the barriers to the process of feedback. METHODS: An explanatory mixed methods sequential study design with a questionnaire survey followed by semi-structured interviews with researchers and PPI contributors in six PPI groups. PPI contributors were involved in all stages of the research process. RESULTS: Researchers do not routinely give feedback to PPI contributors. Feedback was found to have different meanings: an acknowledgement, impact and study success and progress. PPI contributors who receive feedback are motivated for further involvement; it supports their learning and development and prompts researchers to reflect on PPI impact. The importance of the role of a PPI lead or coordinator to facilitate the process of providing feedback was also highlighted. CONCLUSION: This study found no generic way to give feedback indicating that mutual feedback expectations should be discussed at the outset. PPI feedback needs to become integral to the research process with appropriate time and resources allocated. PPI feedback can be seen as a key indicator of mature, embedded PPI in research.

Reporting on patient and public involvement (PPI) in research publications: using the GRIPP2 checklists with lay co-researchers.

BACKGROUND: Patient and public involvement (PPI) in health and social care research is considered important internationally, with increasing evidence that PPI improves the quality, relevance and outcomes of research. There has been a growth in research publications that describe PPI in the research process, but the frequency and detail of PPI reporting varies considerably. This paper reports on a collaborative study that aimed to describe the extent of PPI in publications from research funded by the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) in the East of England (EoE), part of the National Institute of Health Research (NIHR) in England (2014-2019). METHODS: A descriptive study of all research publications (1st January 2014 to 31st October 2017) funded by the NIHR CLAHRC EoE. Members of the Public Involvement in Research group (PIRg), at the University of Hertfordshire, were actively involved, with four PIRg co-researchers. We used an internationally recognised reporting checklist for PPI called the GRIPP2 (Guidance for Reporting Involvement of Patients and the Public, Version 2) to guide the reviewing process. RESULTS: Out of 148 research papers identified, 16 (14%) reported some aspect of PPI activity and were included for review. Ten of the publications (63%) acknowledged the contributions of PPI individuals and/or groups and five had PPI co-authors. There was considerable variation in the PPI reported in the publications, with some 'missed opportunities' to provide detail of PPI undertaken. The perspectives of the co-researchers shaped the reporting of the results from this study. The co-researchers found the GRIPP2-SF (short form) to be useful, but the GRIPP2-LF (long form) was considered over complicated and not user-friendly. CONCLUSIONS: This is one of the first studies to involve lay co-researchers in the review of PPI reporting using the GRIPP2 reporting checklists (GRIPP2-SF and GRIPP2-LF). We make recommendations for a revised version of the GRIPP2-SF, with clearer instructions and three additional sections to record whether PPI is reported in the abstract or key words, in the acknowledgements section, and whether there are PPI co-authors. We also recommend the provision of training and support for patient and public peer reviewers.

Involving patients, family carers and members of the public in research is known as patient and public involvement, or PPI. In health and social care research, PPI is considered important by many, including patients and research funders. Increasingly, research publications include an account of how members of the public have been involved in research being reported. But often there is not much detail regarding who was involved, what they did, and what difference their involvement made.In our study, we reviewed publications from research funded by an organisation called the Collaboration for Leadership in Applied Health Research and Care (CLAHRC) in the East of England (EoE), to understand how members of the public had been involved. We also wanted to see how lay co-researchers found the use of a checklist developed to assess the reporting of PPI: the 'Guidance for Reporting Involvement of Patients and the Public, Version 2' (GRIPP2).Members of a Public Involvement in Research group (PIRg), based at the University of Hertfordshire, were actively involved in the study, with four PIRg members becoming co-researchers. The GRIPP2 has a long form and short form, and we used these to review 16 research publications.We found great variation in the PPI activities reported in the publications. The lay co-researchers thought the GRIPP2 short form was useful, but the long form was considered over complicated and not user-friendly. We recommend a revised version of the GRIPP2 short form, with clearer instructions, additional sections and training and support for patient and public reviewers.

The role of patient and public involvement leads in facilitating feedback: "invisible work".

BACKGROUND: Health research in the UK requires patients, those with lived experience and members of the public to be involved in designing and shaping research: many of them have reported that their comments and suggestions are not always acknowledged, and they do not know if their input has been used or is useful. The benefits of feedback from researchers not only create motivation for further involvement but aids learning and development, as well as recording impact. The aims of this study were to improve the feedback experience of Patient and Public Involvement (PPI) contributors. Co-produced feedback processes were designed and implemented in order to change feedback from researchers to PPI contributors in six PPI groups in England. METHODS: An explanatory mixed methods sequential study design was utilised with a comparative questionnaire survey (administered 20 months apart), interviews and a focus group with PPI leads, researchers and PPI contributors. Patient and Public Involvement contributors were involved from initial idea, study design, data analysis through to dissemination. RESULTS: Co-designed feedback processes were introduced in five of the six PPI groups and there was an overall increase in the frequency of feedback over the period studied. The enablers and barriers to implementing feedback processes were identified, which included the importance of wider institutional level support. PPI leads need to have dedicated time and acknowledge feedback as part of their role. The importance of individual feedback processes designed by, and for each PPI group, rather than a generic one, was also identified as key to successful implementation. CONCLUSION: The role of the PPI lead is an important facilitator in improving feedback but can easily be overlooked and has been described as invisible. PPI leads can perform an essential bridging role between researchers and members of the public. This study has shown that PPI feedback processes can be implemented if they are part of embedded PPI with explicit expectations, facilitated by a dedicated PPI lead role with sufficient support and resources. The findings have implications beyond this particular study, particularly for those involved in undertaking and funding health and social care research.

'We're passengers sailing in the same ship, but we have our own berths to sleep in': Evaluating patient and public involvement within a regional research programme: An action research project informed by Normalisation Process Theory.

BACKGROUND: Patient and public involvement (PPI) is a requirement for UK health and social care research funding. Evidence for how best to implement PPI in research programmes, such as National Institute for Health Research (NIHR) Collaborations for Applied Health Research and Care (CLAHRCs), remains limited. This paper reports findings from an action research (AR) project called IMPRESS, which aims to strengthen PPI within CLAHRC East of England (EoE). IMPRESS combines AR with Normalisation Process Theory (NPT) to explore PPI within diverse case study projects, identifying actions to implement, test and refine to further embed PPI. METHODS: We purposively selected CLAHRC EoE case study projects for in-depth analysis of PPI using NPT. Data were generated from project PPI documentation, semi-structured qualitative interviews with researchers and PPI contributors and focus groups. Transcripts and documents were subjected to abductive thematic analysis and triangulation within case. Systematic across case comparison of themes was undertaken with findings and implications refined through stakeholder consultation. RESULTS: We interviewed 24 researchers and 13 PPI contributors and analysed 28 documents from 10 case studies. Three focus groups were held: two with researchers (n = 4 and n = 6) and one with PPI contributors (n = 5). Findings detail to what extent projects made sense of PPI, bought in to PPI, operationalised PPI and appraised it, thus identifying barriers and enablers to fully embedded PPI. CONCLUSION: Combining NPT with AR allows us to assess the embeddedness of PPI within projects and programme, to inform specific local action and report broader conceptual lessons for PPI knowledge and practice informing the development of an action framework for embedding PPI in research programmes. To embed PPI within similar programmes teams, professionals, disciplines and institutions should be recognised as variably networked into existing PPI support. Further focus and research is needed on sharing PPI learning and supporting innovation in PPI.

Regional working in the East of England: using the UK National Standards for Public Involvement.

PLAIN ENGLISH SUMMARY: Involving patients and members of the public to help shape and carry out research is recommended in health research in the United Kingdom (UK). There are a number of regional networks of Patient and Public Involvement (PPI) groups, which support the collaboration between researchers, patients and public members. We are a group of researchers, patients and public members who came together via a PPI regional network in the East of England to collaborate on a research study about the extent of feedback from researchers to PPI contributors.The aim of this paper is to use the recently developed UK National Standards for Public Involvement to structure our thinking about what worked well and what did not, within our recently completed study. We believe this paper is one of the first to use the National Standards to structure a retrospective reflection on PPI within a study.Our findings showed that there are benefits of regional working, including easier access to public members and bringing together researchers, public members and those who run PPI groups for research collaboration. The main challenges included involvement of people before studies are funded and working across organisations with different payment processes.The National Standards for Public Involvement has provided a useful framework to consider how best to involve patients and members of the public in research and could be a helpful structure to reflect on successes and challenges in individual projects and also regional, national or international comparisons of PPI in research. ABSTRACT: Background Regional networks of Patient and Public Involvement (PPI) organisations, including academic institutions, health and social care services, charities, patient and public groups and individuals, can play an important part in carrying out health research. In the UK, recommendations by the National Institute of Health Research (NIHR) encourage the use of regional, collaborative networks with shared resources and training. Methods The newly developed UK National Standards for Public Involvement were used as a framework for a retrospective reflection of PPI within a recently completed research study which focused on feedback from researchers to PPI contributors. PPI contributors, those running PPI groups (PPI leads) and researchers involved in the study have contributed to this reflection by completing evaluation forms throughout the research alongside notes of meetings and co-authors' final reflections. Results Results revealed a number of successes where the regional network was particularly useful in bringing together PPI contributors, those who lead PPI groups and researchers. The regional network helped researchers to get in touch with patients and members of the public. Challenges included involving people before funding and bureaucratic and financial barriers when working across different organisations in the region. The importance of working together in flexible, informal ways was key and on-going support for the PPI contributors was vital for continued involvement, including emotional support not just monetary. The first four National Standards of inclusive opportunities, working together, support and learning and communications were particularly useful as means of structuring our reflections. Conclusions To our knowledge, this is one of the first research studies to use the UK National Standards for Public Involvement as a framework to identify what worked well and the challenges of PPI processes. It is suggested that as more reflective papers are published and the National Standards are more widely used in the UK, many lessons can be learnt and shared on how to improve our Patient and Public Involvement within research studies. Evaluations or reflections such as these can further enhance our understanding of PPI with implications for regional, national and international comparisons.

Correction to: Abstracts from the NIHR INVOLVE Conference 2017.

[This corrects the article DOI: 10.1186/s40900-017-0075-x.].

Open label phase II trial of single, ascending doses of MRA in Caucasian children with severe systemic juvenile idiopathic arthritis: proof of principle of the efficacy of IL-6 receptor blockade in this type of arthritis and demonstration of prolonged clinical improvement.

Eighteen Caucasian (white, Middle East and Asian) children diagnosed by paediatric rheumatologists in the UK and France as having systemic juvenile idiopathic arthritis (sJIA) were enrolled in this open label, single dose trial. All patients had evidence of continued symptoms and disease activity for at least three months while receiving >0.2 mg/kg/day of prednisolone, or its equivalent, prior to recruitment. Twelve patients also received methotrexate (< or =20 mg/m2/week). The patients were divided into three groups receiving 2, 4 or 8 mg/kg of MRA (tocilizumab) by intravenous infusion. No evidence of dose-limiting toxicity was observed and there were no dose-limiting safety issues. MRA appeared to be dramatically effective, with clinical and laboratory responses observed by 48 h post infusion, and these improvements continued well after serum MRA was undetectable. Eleven patients achieved the JIA definition of improvement (at least 3 of 6 core set criteria with a 30% improvement and no more than one worsened by 30%) and eight achieved > or =50% improvement. There were no observable differences with age. Clinical improvement in these children was observed for up to eight weeks, supporting the hypothesis that IL-6 is a key cytokine in the upregulation of genes crucial in the inflammation processes of sJIA, and the possibility of sequestration of MRA in the extra-vascular compartment needs to be considered.