HEALTH SERVICES AND DELIVERY RESEARCH

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1 HEALTH SERVICES AND DELIVERY RESEARCH VOLUME 3 ISSUE 38 SEPTEMBER 2015 ISSN ReseArch with Patient and Public involvement: a RealisT evaluation the RAPPORT study Patricia Wilson, Elspeth Mathie, Julia Keenan, Elaine McNeilly, Claire Goodman, Amanda Howe, Fiona Poland, Sophie Staniszewska, Sally Kendall, Diane Munday, Marion Cowe and Stephen Peckham DOI /hsdr03380

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3 ReseArch with Patient and Public involvement: a RealisT evaluation the RAPPORT study Patricia Wilson, 1,2 * Elspeth Mathie, 1 Julia Keenan, 3,4 Elaine McNeilly, 1 Claire Goodman, 1 Amanda Howe, 3 Fiona Poland, 3,5 Sophie Staniszewska, 6 Sally Kendall, 1 Diane Munday, 7 Marion Cowe 7 and Stephen Peckham 2 1 Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK 2 Centre for Health Services Studies, University of Kent, Canterbury, UK 3 Norwich Medical School, University of East Anglia, Norwich, UK 4 School of Health Sciences, University of East Anglia, Norwich, UK 5 School of Rehabilitation Sciences, University of East Anglia, Norwich, UK 6 RCN Research Institute, University of Warwick, Coventry, UK 7 Public Involvement in Research Group, University of Hertfordshire, Hatfield, UK *Corresponding author Declared competing interests of authors: none Published September 2015 DOI: /hsdr03380 This report should be referenced as follows: Wilson P, Mathie E, Keenan J, McNeilly E, Goodman C, Howe A, et al. ReseArch with Patient and Public involvement: a RealisT evaluation the RAPPORT study. Health Serv Deliv Res 2015;3(38).

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5 Health Services and Delivery Research ISSN (Print) ISSN (Online) This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) ( Editorial contact: nihredit@southampton.ac.uk The full HS&DR archive is freely available to view online at Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: Criteria for inclusion in the Health Services and Delivery Research journal Reports are published in Health Services and Delivery Research (HS&DR) if (1) they have resulted from work for the HS&DR programme or programmes which preceded the HS&DR programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors. HS&DR programme The Health Services and Delivery Research (HS&DR) programme, part of the National Institute for Health Research (NIHR), was established to fund a broad range of research. It combines the strengths and contributions of two previous NIHR research programmes: the Health Services Research (HSR) programme and the Service Delivery and Organisation (SDO) programme, which were merged in January The HS&DR programme aims to produce rigorous and relevant evidence on the quality, access and organisation of health services including costs and outcomes, as well as research on implementation. The programme will enhance the strategic focus on research that matters to the NHS and is keen to support ambitious evaluative research to improve health services. For more information about the HS&DR programme please visit the website: This report The research reported in this issue of the journal was joint funded by the HS&DR programme or one of its preceeding programmes and INVOLVE as project number 10/2001/36. The contractual start date was in September The final report began editorial review in March 2014 and was accepted for publication in January The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HS&DR editors and production house have tried to ensure the accuracy of the authors report and would like to thank the reviewers for their constructive comments on the final report document. However, they do not accept liability for damages or losses arising from material published in this report. This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Health. Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Published by the NIHR Journals Library ( produced by Prepress Projects Ltd, Perth, Scotland (

6 Health Services and Delivery Research Editor-in-Chief Professor Ray Fitzpatrick Professor of Public Health and Primary Care, University of Oxford, UK NIHR Journals Library Editor-in-Chief Professor Tom Walley Director, NIHR Evaluation, Trials and Studies and Director of the HTA Programme, UK NIHR Journals Library Editors Professor Ken Stein Chair of HTA Editorial Board and Professor of Public Health, University of Exeter Medical School, UK Professor Andree Le May Chair of NIHR Journals Library Editorial Group (EME, HS&DR, PGfAR, PHR journals) Dr Martin Ashton-Key Consultant in Public Health Medicine/Consultant Advisor, NETSCC, UK Professor Matthias Beck Chair in Public Sector Management and Subject Leader (Management Group), Queen s University Management School, Queen s University Belfast, UK Professor Aileen Clarke Professor of Public Health and Health Services Research, Warwick Medical School, University of Warwick, UK Dr Tessa Crilly Director, Crystal Blue Consulting Ltd, UK Dr Peter Davidson Director of NETSCC, HTA, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Professor Elaine McColl Director, Newcastle Clinical Trials Unit, Institute of Health and Society, Newcastle University, UK Professor William McGuire Professor of Child Health, Hull York Medical School, University of York, UK Professor Geoffrey Meads Professor of Health Sciences Research, Faculty of Education, University of Winchester, UK Professor John Norrie Health Services Research Unit, University of Aberdeen, UK Professor John Powell Consultant Clinical Adviser, National Institute for Health and Care Excellence (NICE), UK Professor James Raftery Professor of Health Technology Assessment, Wessex Institute, Faculty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Kleijnen Systematic Reviews Ltd, UK Professor Helen Roberts Professor of Child Health Research, UCL Institute of Child Health, UK Professor Helen Snooks Professor of Health Services Research, Institute of Life Science, College of Medicine, Swansea University, UK Professor Jim Thornton Professor of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, University of Nottingham, UK Please visit the website for a list of members of the NIHR Journals Library Board: Editorial contact: nihredit@southampton.ac.uk NIHR Journals Library

7 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 Abstract ReseArch with Patient and Public involvement: a RealisT evaluation the RAPPORT study Patricia Wilson, 1,2* Elspeth Mathie, 1 Julia Keenan, 3,4 Elaine McNeilly, 1 Claire Goodman, 1 Amanda Howe, 3 Fiona Poland, 3,5 Sophie Staniszewska, 6 Sally Kendall, 1 Diane Munday, 7 Marion Cowe 7 and Stephen Peckham 2 1 Centre for Research in Primary and Community Care, University of Hertfordshire, Hatfield, UK 2 Centre for Health Services Studies, University of Kent, Canterbury, UK 3 Norwich Medical School, University of East Anglia, Norwich, UK 4 School of Health Sciences, University of East Anglia, Norwich, UK 5 School of Rehabilitation Sciences, University of East Anglia, Norwich, UK 6 RCN Research Institute, University of Warwick, Coventry, UK 7 Public Involvement in Research Group, University of Hertfordshire, Hatfield, UK *Corresponding author p.m.wilson@kent.ac.uk Background: Patient and public involvement (PPI) is a prerequisite for many funding bodies and NHS research ethics approval. PPI in research is defined as research carried out with or by the public rather than to, about or for them. While the benefits of PPI have been widely discussed, there is a lack of evidence on the impact and outcomes of PPI in research. Objectives: To determine the types of PPI in funded research, describe key processes, analyse the contextual and temporal dynamics of PPI and explore the experience of PPI in research for all those involved. Mechanisms contributing to the routine incorporation of PPI in the research process were assessed, the impact of PPI on research processes and outcomes evaluated, and barriers and enablers to effective PPI identified. Design: A three-staged realist evaluation drawing on Normalisation Process Theory to understand how far PPI was embedded within health-care research in six areas: diabetes mellitus, arthritis, cystic fibrosis, dementia, public health and learning disabilities. The first two stages comprised a scoping exercise and online survey to chief investigators to assess current PPI activity. The third stage consisted of case studies tracked over 18 months through interviews and document analysis. The research was conducted in four regions of England. Participants: Non-commercial studies currently running or completed within the previous 2 years eligible for adoption on the UK Clinical Research Network portfolio. A total of 129 case study participants included researchers and PPI representatives from 22 research studies, and representatives from funding bodies and PPI networks. Results: In the scoping 51% (n = 92) of studies had evidence of PPI and in the survey 79% (n = 80), with funder requirements and study design the strongest influence on the extent of PPI. There was little transparency about PPI in publicly accessible information. In case studies, context mechanism outcome configurations suggested that six salient actions were required for effective PPI. These were a clear purpose, role and structure for PPI; ensuring diversity; whole research team engagement with PPI; mutual understanding and trust between the researchers and lay representatives; ensuring opportunities for PPI throughout the research process; and reflecting on, appraising and evaluating PPI within a research study. Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. v

8 ABSTRACT PPI models included a one-off model with limited PPI, a fully intertwined model in which PPI was fully embedded and an outreach model with lay representatives linking to broader communities. Enabling contexts included funder, topic/design, resources, research host, organisation of PPI and, most importantly, relationships. In some case studies, lack of coherence in defining PPI persisted, with evidence of a dual role of PPI representative/study participant. Evidence of PPI outcomes included changes to study design, improvements to recruitment materials and rates, and dissemination. Conclusions: Six salient actions were required for effective PPI and were characterised by a shared understanding of moral and methodological purposes of PPI, a key individual co-ordinating PPI, ensuring diversity, a research team positive about PPI input and fully engaged with it, based on relationships that were established and maintained over time, and PPI being evaluated in a proactive and systematic approach. Future work recommendations include exploring the impact of virtual PPI, cost analysis and economic evaluation of the different models of PPI, and a longer-term follow-up study of the outcomes of PPI on research findings and impact on services and clinical practice. Funding: The National Institute for Health Research Health Services and Delivery Research programme. vi NIHR Journals Library

9 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 Contents List of tables List of figures List of boxes List of abbreviations Plain English summary Scientific summary xiii xv xvii xix xxi xxiii Chapter 1 Introduction 1 Definition of patient and public involvement within the RAPPORT study 1 Rationale for the study 2 Aims and objectives of the RAPPORT study 2 Structure of the report 2 Chapter 2 Background 3 Search strategy 3 Patient and public involvement: historical roots 4 Patient and public involvement: the moral argument 4 Patient and public involvement: the policy argument 4 The policy approach to patient and public involvement in research 5 Patient and public involvement: the methodological argument 5 The evidence base for patient and public involvement in research 6 Conclusion 9 Chapter 3 Research design and methods 11 Method of enquiry: realist evaluation with Normalisation Process Theory 12 Middle-range theories and hypotheses 14 Normalisation Process Theory 15 Research design and methods 16 Inclusion and exclusion criteria 18 Ethical approval 19 Ethical issues 19 Stage 1: national scoping of studies 19 Sample 19 Data collection 19 Scoping response 20 Analysis 22 Stage 2: survey of lead researchers 22 Sample 22 Data collection 22 Survey response and study characteristics 22 Analysis 23 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. vii

10 CONTENTS Stage 3: case studies 23 Sample 24 Data collection and recruitment 24 Overview of the analytic approach 27 Quality assurance during the analytic phase 29 Research data management 29 Dissemination 29 Presentation of data in subsequent chapters 30 Chapter 4 Patient and public involvement in the RAPPORT study 31 Background to the project 31 Patient and public involvement design 31 Coapplicants 31 Co-researchers 31 Reference groups and representation 31 Project advisory group 32 Patient and public involvement activities 32 Research design 32 Data collection and data analysis 32 Dissemination 33 Data sources for the analysis of patient and public involvement in the RAPPORT study 33 Impacts of patient and public involvement in the RAPPORT study 33 Study development and protocol 34 Data collection 34 Data analysis 35 Impact of patient and public involvement on representatives 35 Discussion of emergent findings 35 Enablers and challenges for patient and public involvement within the RAPPORT study 36 Coherence 36 Participation 36 Collective action 36 Reflexive monitoring 37 Summary 37 Chapter 5 Findings from scoping and survey 39 Summary of key findings 39 Studies without patient and public involvement 39 Differences in the reported presence of patient and public involvement 40 Organisation and resources for patient and public involvement 41 Funder requirements 43 Defining patient and public involvement 43 The challenges of patient and public involvement 44 Impact of patient and public involvement 45 Systematic evaluation of patient and public involvement 45 Conclusion 46 Coherence 46 Cognitive participation 46 Collective action 46 Reflexive monitoring 46 viii NIHR Journals Library

11 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 Chapter 6 Findings from the case studies 47 Normalisation Process Theory as the candidate programme theory being tested 47 Summary of key findings 48 Enabling contexts 49 Context mechanism outcome configurations 49 Purpose, structure and role of patient and public involvement 50 Funder requirements 50 Structures for patient and public involvement 53 Outsourcing patient and public involvement 53 Training 56 Recruiting lay representatives reflecting the diversity of a study population 58 Strategies for recruiting lay representatives 58 Challenges in ensuring diversity 66 The dual role 66 Whole research team is engaged with patient and public involvement 68 Relying on one person to lead patient and public involvement 68 Patient and public involvement as a collective action 71 Mutual understanding and trust 74 Coherence in understanding the contribution of patient and public involvement 74 Building relationships over time 78 Trust as the foundation for patient and public involvement 80 Enablers and barriers to trust 82 Virtual patient and public involvement 84 Reimbursement 87 Opportunities for patient and public involvement throughout the research process 88 Patient and public involvement and the research cycle 88 Patient and public involvement in different research designs 88 Levels of involvement 93 Reflection, appraisal and evaluation 94 Systematic appraisal of patient and public involvement 94 Enabling contexts for evaluating patient and public involvement 99 Modifying future work 101 Impact and outcomes of patient and public involvement 104 Research priority and question setting 105 Linking to the wider community 105 Marketing the study 106 Design of study 106 Safety of study 107 Design of intervention 107 Research ethics submission 108 Recruitment 108 Outcome measures 109 Data analysis and collection 109 Dissemination 110 Moral impact and outcomes 110 Longer-term outcomes 110 Conclusion 111 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. ix

12 CONTENTS Chapter 7 Discussion 113 How embedded is patient and public involvement within a national research infrastructure? 113 Coherence: how was patient and public involvement understood? 114 Engagement, feedback or involvement? 114 The dual role 115 Patient and public involvement: is it always needed? 115 Values shaping patient and public involvement approaches 116 Models and commitment to patient and public involvement 118 Dynamic framework for patient and public involvement 118 Models of patient and public involvement 120 Contextual enablers: organisation of patient and public involvement 122 Contextual enablers for patient and public involvement: resources 126 Contextual enablers for patient and public involvement: relationships 126 Impact and outcomes of patient and public involvement 128 Impact of patient and public involvement 128 Impact and outcomes of patient and public involvement in the RAPPORT study 129 Impact of involvement on patient and public representatives 130 Evaluating patient and public involvement in research studies 131 Summary 132 Chapter 8 Conclusions 133 What was the variation in types and extent of patient and public involvement across the topic areas? 133 What were the key processes and mechanisms of patient and public involvement in research? 134 What are the contextual and temporal dynamics of patient and public involvement in research? 135 How did researchers and lay representatives experience involvement? 135 What mechanisms were needed to routinely incorporate patient and public involvement into research? 136 What was the impact of patient and public involvement on research processes and outcomes? 137 What are the barriers and enablers to effective patient and public involvement in research? 137 Key conclusions 138 Reflections on and limitations of the research 138 Implications for patient and public involvement practice 139 Reflection, appraisal and evaluation 139 Implications for lay representatives 141 Recommendations for future development and research 141 Acknowledgements 143 References 145 Appendix 1 Online survey 159 Appendix 2 RAPPORT interview schedule 163 x NIHR Journals Library

13 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 Appendix 3 Participant information sheet 167 Appendix 4 Consent form 169 Appendix 5 Dissemination events 171 Appendix 6 Amander s Levels of Patient and Public Involvement Significance (ALPS), reproduced with permission [Amander Wellings, Norfolk and Suffolk Patient and Public Involvement in Research (PPIRes) panel, 2014, personal communication] 175 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xi

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15 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 List of tables TABLE 1 Search terms 3 TABLE 2 Realist framework of perspectives on PPI 14 TABLE 3 Normalisation Process Theory constructs and their components 16 TABLE 4 Search terms for topic areas accessed on UKCRN portfolio 20 TABLE 5 Search of UKCRN portfolio in six topic areas 20 TABLE 6 Scoping response rate by topic area 21 TABLE 7 Survey response by topic area 23 TABLE 8 Sample recruited 26 TABLE 9 Lay involvement in research studies by topic area and study design 40 TABLE 10 Patient and public activities in research 42 TABLE 11 Mechanisms to embed PPI 47 TABLE 12 Context, mechanism and outcome configuration: purpose, role and structure for PPI 51 TABLE 13 Context, mechanism and outcome configuration: diversity 59 TABLE 14 Context, mechanism and outcome configuration: whole research team engagement 69 TABLE 15 Context, mechanism and outcome configuration: mutual understanding and trust 75 TABLE 16 Context, mechanism and outcome configuration: opportunities for patient and public involvement throughout the research process 89 TABLE 17 Context, mechanism and outcome configuration: reflection, appraisal and evaluation 95 TABLE 18 Methodological impact of PPI by topic area 104 TABLE 19 Three aspects to the bridging role 124 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xiii

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17 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 List of figures FIGURE 1 Framework for PPI in research 8 FIGURE 2 Stages in the RE process (adapted from Pawson and Tilley and Hewitt et al.) 13 FIGURE 3 RAPPORT flow chart 17 FIGURE 4 Flow diagram of scoping and survey 21 FIGURE 5 Sampling frame 24 FIGURE 6 Levels of PPI embeddedness illustrated through NPT radar plots 28 FIGURE 7 Survey: box plot of number of activities for those studies with PPI by topic (showing range of the number of activities, 75th percentile, median and 25th percentile) 42 FIGURE 8 Insider/outsider perspective 77 FIGURE 9 Virtuous cycle of PPI triggered by policy 116 FIGURE 10 Pathways triggered by moral value set 117 FIGURE 11 Dynamic framework of PPI 118 FIGURE 12 Model 1: the one-off PPI 120 FIGURE 13 Model 2: fully intertwined PPI 121 FIGURE 14 Model 3: outreach PPI 122 FIGURE 15 Architecture for PPI (adapted from Brett et al.) 123 FIGURE 16 Components of PPI co-ordination work 124 FIGURE 17 Skills for PPI co-ordination (adapted from Williams) 125 FIGURE 18 Skills and traits for managing relationships in PPI (adapted from Williams) 128 FIGURE 19 Patient and public involvement processes and outcomes in study recruitment 129 FIGURE 20 Credibility versus understanding research 131 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xv

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19 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 List of boxes BOX 1 The RAPPORT study objectives 2 BOX 2 Definitions of terms of RE as applied to PPI in research (adapted from Pawson and Tilley and Jagosh et al.) 12 BOX 3 Definition of CMO configurations (adapted from Pawson and Tilley and Jagosh et al.) 13 BOX 4 Documentary analysis 35 BOX 5 Enabling contexts 49 BOX 6 Case study 21: IDDs 54 BOX 7 Case study 22: CF 55 BOX 8 Case study 01: dementia 57 BOX 9 Case study 18: arthritis 60 BOX 10 Case study 03: diabetes mellitus 62 BOX 11 Case study 02: diabetes mellitus 63 BOX 12 Case study 12: diabetes mellitus 65 BOX 13 Case study 08: arthritis 66 BOX 14 Case study 05: arthritis 70 BOX 15 Case study 11: IDD 71 BOX 16 Case study 13: public health 73 BOX 17 Case study 07: diabetes mellitus 76 BOX 18 Case study 19: public health 79 BOX 19 Case study 15: dementia 81 BOX 20 Case study 16: diabetes mellitus 83 BOX 21 Case study 23: diabetes mellitus 85 BOX 22 Case study 04: diabetes mellitus 90 BOX 23 Case study 17: diabetes mellitus 92 Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xvii

20 LIST OF BOXES BOX 24 Case study 06: public health 96 BOX 25 Case study 10: public health 98 BOX 26 Case study 14: arthritis 101 BOX 27 Case study 09: IDD 103 BOX 28 Documentary evidence: case study BOX 29 Documentary evidence: case study BOX 30 Documentary evidence: case study BOX 31 Documentary evidence: case study BOX 32 Documentary evidence: case study BOX 33 Documentary evidence: case study BOX 34 Key messages for lay representatives 141 xviii NIHR Journals Library

21 DOI: /hsdr03380 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 38 List of abbreviations AMRC Association of Medical Research Charities PIRG Public Involvement in Research Group BME CF CI black and minority ethnic cystic fibrosis chief investigator PIRICOM Patient and Public Involvement in Research: Impact, Conceptualisation, Outcomes and Measurement CLAHRC CMO CS Collaboration for Leadership in Applied Health Research and Care context, mechanism and outcome case study PIS PPI PPIRes participant information sheet patient and public involvement Norfolk and Suffolk Patient and Public Involvement in Research HEI HSDR higher education institution Health Services and Delivery Research RAPPORT RCT ReseArch with Patient and Public involvement: a RealisT evaluation randomised controlled trial IDD IRAS MRT NIHR NPT intellectual and developmental disability Integrated Research Application System middle-range theory National Institute for Health Research Normalisation Process Theory RDS RE rep. UKCRN YPD Research Design Service realist evaluation representative (also service user, lay representative) UK Clinical Research Network young people with diabetes mellitus Queen s Printer and Controller of HMSO This work was produced by Wilson et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xix