Involving Research Participants in a Pan-European Research Initiative: The EPAD Participant Panel Experience

Abstract Background: Including participants in patient and public involvement activities is increasingly acknowledged as a key pillar of successful research activity. Such activities can influence recruitment and retention, as well as researcher experience and contribute to decision making in research studies. However, there are few established methodologies of how to set up and manage participant involvement activities. Further, there is little discussion of how to do so when dealing with collaborative projects that run across countries and operate in multiple linguistic and regulatory contexts. Methods: In this paper we describe the set-up, running and experiences of the EPAD participant panel. The EPAD study was a pan-European cohort study with the aim to understand risks for developing Alzheimer’s disease and build a readiness cohort for Phase 2 clinical trials. Due to the longitudinal nature of this study, combined with the enrolment of healthy volunteers and those with mild cognitive impairments, the EPAD team highlighted participant involvement as crucial to the success of this project. The EPAD project employed a nested model, with local panels meeting in England, France, Scotland, Spain and The Netherlands, and feeding into a central study panel. The local panels were governed by terms of reference which were adaptable to local needs. Results: The impact of the panels has been widespread, and varies from feedback on documentation, to supporting with design of media materials and representation of the project at national and international meetings. Conclusions: The EPAD panels have contributed to the success of the project and the model established is easily transferable to other disease areas investigating healthy or at-risk populations.

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Involving research participants in a pan-European research initiative: the EPAD participant panel experience

Research Involvement and Engagement ◽

10.1186/s40900-020-00236-z ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

S. Gregory ◽

E. M. Bunnik ◽

A. B. Callado ◽

I. Carrie ◽

C. De Boer ◽

...

Keyword(s):

Public Involvement ◽

Patient And Public Involvement ◽

Phase 2 ◽

Research Activity ◽

Research Initiative ◽

At Risk Populations ◽

Set Up ◽

The Impact ◽

Study Panel ◽

Do So

Abstract Background Including participants in patient and public involvement activities is increasingly acknowledged as a key pillar of successful research activity. Such activities can influence recruitment and retention, as well as researcher experience and contribute to decision making in research studies. However, there are few established methodologies of how to set up and manage participant involvement activities. Further, there is little discussion of how to do so when dealing with collaborative projects that run across countries and operate in multiple linguistic and regulatory contexts. Methods In this paper we describe the set-up, running and experiences of the EPAD participant panel. The EPAD study was a pan-European cohort study with the aim to understand risks for developing Alzheimer’s disease and build a readiness cohort for Phase 2 clinical trials. Due to the longitudinal nature of this study, combined with the enrolment of healthy volunteers and those with mild cognitive impairments, the EPAD team highlighted participant involvement as crucial to the success of this project. The EPAD project employed a nested model, with local panels meeting in England, France, Scotland, Spain and The Netherlands, and feeding into a central study panel. The local panels were governed by terms of reference which were adaptable to local needs. Results The impact of the panels has been widespread, and varies from feedback on documentation, to supporting with design of media materials and representation of the project at national and international meetings. Conclusions The EPAD panels have contributed to the success of the project and the model established is easily transferable to other disease areas investigating healthy or at-risk populations.

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Involving Research Participants in a Pan-European Research Initiative: The EPAD Participant Panel Experience

10.21203/rs.3.rs-23355/v1 ◽

2020 ◽

Author(s):

Sarah Gregory ◽

Eline M Bunnick ◽

Ana Belén Callado ◽

Isabelle Carrie ◽

Casper De Boer ◽

...

Keyword(s):

Cognitive Impairments ◽

General Assembly ◽

Phase 2 ◽

European Research ◽

Research Activity ◽

Research Initiative ◽

At Risk Populations ◽

Set Up ◽

Central Panel ◽

Phase 2 Clinical Trials

Abstract Background Patient, public and participant involvement (PPPI) is increasingly acknowledged as a key pillar of successful research activity. PPPI can influence recruitment and retention, as well as researcher experience and contribute to decision making in research studies. However, there are few established methodologies of how to set up and manage PPPI activities. Methods In this paper we describe the set-up, running and experiences of the EPAD participant panel. The EPAD study was established as a pan-European cohort study aiming at understanding risks for developing Alzheimer’s disease and building a readiness cohort for Phase 2 clinical trials. Due to the longitudinal nature of this study, combined with the enrolment of healthy volunteers and those with mild cognitive impairments, the EPAD team highlighted PPPI involvement as crucial to the success of this project. The EPAD project employed a nested model, with local panels meeting at least twice a year established in England, France, Scotland, Spain and The Netherlands, feeding into a central panel who met once a year at the project’s General Assembly. The local panels were governed by terms of reference which were adaptable to meet local needs. We discuss the recruitment opportunities employed by the centres and the set-up of the panels. Results Impact of the panels has been widespread, and varies from feedback on documentation, to supporting with design of media materials and representation of the project at national and international meetings. Conclusions The EPAD panels have contributed to the success of the project and the model established is easily transferable to other disease areas investigating healthy or at-risk populations.

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Innovating public engagement and patient involvement through strategic collaboration and practice

Research Involvement and Engagement ◽

10.1186/s40900-019-0160-4 ◽

2019 ◽

Vol 5 (1) ◽

Cited By ~ 5

Author(s):

Leah Holmes ◽

Katharine Cresswell ◽

Susannah Williams ◽

Suzanne Parsons ◽

Annie Keane ◽

...

Keyword(s):

Professional Practice ◽

Public Engagement ◽

Health Research ◽

Patient Involvement ◽

Economies Of Scale ◽

Public Involvement ◽

Patient And Public Involvement ◽

Research Activity ◽

North West ◽

The Impact

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

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Shifting research culture to address the mismatch between where trials recruit and where populations with the most disease live: a qualitative study

BMC Medical Research Methodology ◽

10.1186/s12874-021-01268-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Tanvi Rai ◽

Sharon Dixon ◽

Sue Ziebland

Keyword(s):

Capacity Building ◽

Health Research ◽

Active Sites ◽

Public Involvement ◽

Research Participation ◽

Healthcare Services ◽

Patient And Public Involvement ◽

Research Activity ◽

Set Up ◽

The Uk

Abstract Background Research participation is beneficial to patients, clinicians and healthcare services. There is currently poor alignment between UK clinical research activity and local prevalence of disease. The National Institute of Health Research is keen to encourage chief investigators (CIs) to base their research activity in areas of high patient need, to support equity, efficiency and capacity building. We explored how CIs choose sites for their trials and suggest ways to encourage them to recruit from areas with the heaviest burden of disease. Methods Qualitative, semi-structured telephone interviews with a purposive sample of 30 CIs of ongoing or recently completed multi-centre trials, all of which were funded by the UK National Institute of Health Research. Results CIs want to deliver world-class trials to time and budget. Approaching newer, less research-active sites appears risky, potentially compromising trial success. CIs fear that funders may close the trial if recruitment (or retention) is low, with potential damage to their research reputation. We consider what might support a shift in CI behaviour. The availability of ‘heat maps’ showing the disparity between disease prevalence and current research activity will help to inform site selection. Embedded qualitative research during trial set up and early, appropriate patient and public involvement and engagement can provide useful insights for a more nuanced and inclusive approach to recruitment. Public sector funders could request more granularity in recruitment reports and incentivise research activity in areas of greater patient need. Accounts from the few CIs who had ‘broken the mould’ suggest that nurturing new sites can be very successful in terms of efficient recruitment and retention. Conclusion While improvements in equity and capacity building certainly matter to CIs, most are primarily motivated by their commitment to delivering successful trials. Highlighting the benefits to trial delivery is therefore likely to be the best way to encourage CIs to focus their research activity in areas of greatest need.

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

BMJ Open ◽

10.1136/bmjopen-2017-016948 ◽

2017 ◽

Vol 7 (10) ◽

pp. e016948 ◽

Cited By ~ 12

Author(s):

Jo Brett ◽

Sophie Staniszewska ◽

Iveta Simera ◽

Kate Seers ◽

Carole Mockford ◽

...

Keyword(s):

Public Involvement ◽

Evidence Base ◽

Patient And Public Involvement ◽

Lessons Learned ◽

Reporting Guidelines ◽

Consensus Development ◽

Face To Face ◽

Three Phase ◽

Health And Social Care ◽

The Impact

IntroductionPatient 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)).MethodsThere 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.DiscussionThe 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.

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Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽

10.1136/bmj.k4738 ◽

2018 ◽

pp. k4738 ◽

Cited By ~ 67

Author(s):

Joanna C Crocker ◽

Ignacio Ricci-Cabello ◽

Adwoa Parker ◽

Jennifer A Hirst ◽

Alan Chant ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trial ◽

Clinical Trials ◽

Lived Experience ◽

Odds Ratio ◽

Public Involvement ◽

Meta Analysis ◽

Patient And Public Involvement ◽

Retention Rates ◽

The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

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Involving older people in the design and conduct of clinical trials

10.1093/med/9780199689644.003.0015 ◽

2015 ◽

Author(s):

Kate Wilde ◽

Zena Jones

Keyword(s):

Personal Experience ◽

Public Involvement ◽

Patient And Public Involvement ◽

Power Struggle ◽

Research Strategies ◽

Academic Knowledge ◽

Key Points ◽

The Uk ◽

New Treatments ◽

The Impact

Key points• There are strong policy drivers in the UK to involve patients not only as participants in research, but also as members of the research team.• Patient and public involvement (PPI) can have significant benefits to the patient as well as to the research project.• Many research funders require PPI explicitly described and evaluated in research proposals.• Researchers need increased awareness of PPI, guidance, and a framework of how best to implement PPI within their research strategies.• There is a risk of ‘tokenistic’ involvement of service users.• There is the potential for a power struggle between the PPI representative with personal experience and the lead researcher with academic knowledge of the condition studied.• There is a need to formally evaluate the impact of PPI on the effectiveness of research to bring new treatments to patients.

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