Involving older people in the design and conduct of clinical trials

Power Struggle ◽

Research Strategies ◽

Academic Knowledge ◽

Key Points ◽

The Uk ◽

New Treatments ◽

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.

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

BMJ Open ◽

10.1136/bmjopen-2020-047995 ◽

2021 ◽

Vol 11 (8) ◽

pp. e047995

Author(s):

Rosamund Yu ◽

Bec Hanley ◽

Simon Denegri ◽

Jaber Ahmed ◽

Nicholas J McNally

Keyword(s):

Biomedical Research ◽

Public Involvement ◽

Good Practice ◽

Training Programme ◽

Research Centre ◽

Major Research ◽

The Public ◽

The Uk ◽

ObjectivesTo 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.DesignA bespoke programme of training workshops in PPI aimed at researchers.SettingA large National Institute for Health Research Biomedical Research Centre in London and several partner organisations.Participants721 scientists, clinicians and research managers attending dedicated training in PPI at a major London NHS (National Health Service)–university partnership.InterventionsA 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.ResultsTraining 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.ConclusionsWhen 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.

Patient and Public Involvement in doctoral research: Reflections and experiences of the PPI contributors and researcher

10.21203/rs.2.19778/v2 ◽

2020 ◽

Author(s):

Shoba Dawson ◽

Angela Ruddock ◽

Veena Parmar ◽

Rebecca Morris ◽

Sudeh Cheraghi-sohi ◽

...

Keyword(s):

Public Involvement ◽

Research Process ◽

Services Research ◽

Research Project ◽

Doctoral Research ◽

Research Cycle ◽

The Uk ◽

Personal Reflections ◽

Abstract Background: Patient and Public Involvement (PPI) has received considerable attention in the last two decades and working in partnership and co-design have now become a prerequisite in health services research in the UK. However, there is a lack of evidence and consistency in recording PPI and related activities. Researchers and PPI contributors are encouraged to record and reflect on the impact of PPI on research. There is significant variation in the way PPI contributors are involved, and it is often limited to some stages of the research cycle than others, without any reflections on the decision-making process for such involvement or any transferable learning. This has resulted in failure to provide a narrative of the research journey including researchers’ and PPI contributors’ personal reflections of involvement. Therefore, this paper provides an exemplar of what PPI in a doctoral research context should look like by providing a detailed account of how PPI was embedded in a doctoral research project, the PPI contributors and researcher’s reflections and key recommendations for involving people specifically in doctoral research.Methods: A reflective approach was taken using data from PPI contributor and researcher notes, e-mail correspondence, meeting notes. Data is presented narratively to reflect on the experiences of involvement throughout the research cycle. Results: Undertaking PPI enhanced the quality and relevance of the doctoral research, contributed to the recruitment of study participants, data analysis and dissemination. Building trust and relationships with PPI contributors was key to continued involvement throughout the life of the project and beyond. There is a need to adopt flexible approaches rather than a one-size-fits-all model when working with PPI contributors. Reflections by PPI contributors and the researcher emphasises that involvement was a rewarding experience. Conclusions: This paper contributes to the wider literature by providing an exemplar of how PPI can be embedded in doctoral research and demonstrates the value of PPI to the research process and the individuals involved. We also present recommendations on how PPI can be incorporated by doctoral and postdoctoral researchers when planning PPI in their research project.

Patient and Public Involvement in doctoral research: Reflections and experiences of the PPI contributors and researcher

10.21203/rs.2.19778/v1 ◽

2019 ◽

Author(s):

Shoba Dawson ◽

Angela Ruddock ◽

Veena Parmar ◽

Rebecca Morris ◽

Sudeh Cheraghi-sohi ◽

...

Keyword(s):

Health Services Research ◽

Health Services ◽

Public Involvement ◽

Research Process ◽

Services Research ◽

Research Project ◽

Doctoral Research ◽

The Uk ◽

Abstract Background Patient and Public Involvement (PPI) has received considerable attention in the last two decades and working in partnership and co-design have now become a prerequisite in health services research in the UK. However, there is a lack of evidence and consistency in recording PPI and related activities. Researchers and PPI contributors are encouraged to record and reflect on the impact of PPI on research. There is significant variation in the way PPI contributors are involved, and it is often limited to some stages of the research cycle than others, without any reflections on the decision-making process for such involvement or any transferable learning. This paper aims to highlight how PPI was embedded in a doctoral research project, the PPI contributors and researcher’s reflections and key recommendations for involving people in doctoral research specifically, but also health services research generally.Methods A reflective approach was taken using data from PPI contributor and researcher notes, e-mail correspondence, meeting notes. Data is presented narratively to reflect on the experiences of involvement throughout the research cycle.Results Undertaking PPI enhanced the quality and relevance of the doctoral research, contributed to the recruitment of study participants, data analysis and dissemination. Building trust and relationships with PPI contributors was key to continued involvement throughout the life of the project and beyond. There is a need to adopt flexible approaches rather than a one-size-fits-all model when working with PPI contributors. Reflections by PPI contributors and the researcher emphasises that involvement was a rewarding experience.Conclusions This paper contributes to the wider literature by providing an exemplar of how PPI can be embedded in doctoral research and demonstrates the value of PPI to the research process and the individuals involved. We also present recommendations on how PPI can be incorporated by doctoral and postdoctoral researchers when planning PPI in their research project.

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 ◽

Lessons Learned ◽

Reporting Guidelines ◽

Consensus Development ◽

Face To Face ◽

Three Phase ◽

Health And Social Care ◽

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.

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 ◽

Retention Rates ◽

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.

21. Applications: prisoners’ rights

10.1093/he/9780198871347.003.0021 ◽

2021 ◽

pp. 433-447

Author(s):

Howard Davis

Keyword(s):

Human Rights ◽

The State ◽

European Convention ◽

Legal Knowledge ◽

Key Points ◽

Self Test ◽

The Uk ◽

Article 5 ◽

The Impact ◽

Domestic Law

Without assuming prior legal knowledge, books in the Directions series introduce and guide readers through key points of law and legal debate. It discusses European Convention law and relates it to domestic law under the HRA. Questions, discussion points, and thinking points help readers to engage fully with each subject and check their understanding as they progress and knowledge can be tested by self-test questions and exam questions at the chapter end. This chapter considers the application of Convention rights in the field of prisoners’ rights; the impact of Convention rights on prisoners in the UK is considered. Prisoners remain within the protection of the European Convention on Human Rights, though the application of these rights will take their position into account. Prisoners’ rights include not only rights to the non-arbitrary loss of liberty (Article 5) and rights to fair procedures (Articles 5 and 6), but also not to be disproportionately denied the rights and freedoms in Articles 8–11. Imprisonment deprives individuals of their liberty and, therefore, is a public function for which the state is responsible under the Convention. The controversy over prisoners’ right to vote is discussed in Chapter 25.

General practitioners and emergency departments (GPED)—efficient models of care: a mixed-methods study protocol

BMJ Open ◽

10.1136/bmjopen-2018-024012 ◽

2018 ◽

Vol 8 (10) ◽

pp. e024012

Author(s):

Katherine Morton ◽

Sarah Voss ◽

Joy Adamson ◽

Helen Baxter ◽

Karen Bloor ◽

...

Keyword(s):

Emergency Department ◽

Case Studies ◽

General Practitioners ◽

Emergency Departments ◽

Quantitative Methods ◽

Public Involvement ◽

Clinical Care ◽

Urgent Care ◽

The Uk ◽

IntroductionPressure continues to grow on emergency departments in the UK and throughout the world, with declining performance and adverse effects on patient outcome, safety and experience. One proposed solution is to locate general practitioners to work in or alongside the emergency department (GPED). Several GPED models have been introduced, however, evidence of effectiveness is weak. This study aims to evaluate the impact of GPED on patient care, the primary care and acute hospital team and the wider urgent care system.Methods and analysisThe study will be divided into three work packages (WPs). WP-A; Mapping and Taxonomy: mapping, description and classification of current models of GPED in all emergency departments in England and interviews with key informants to examine the hypotheses that underpin GPED. WP-B; Quantitative Analysis of National Data: measurement of the effectiveness, costs and consequences of the GPED models identified in WP-A, compared with a no-GPED model, using retrospective analysis of Hospital Episode Statistics Data. WP-C; Case Studies: detailed case studies of different GPED models using a mixture of qualitative and quantitative methods including: non-participant observation of clinical care, semistructured interviews with staff, patients and carers; workforce surveys with emergency department staff and analysis of available local routinely collected hospital data. Prospective case study sites will be identified by completing telephone interviews with sites awarded capital funding by the UK government to implement GPED initiatives. The study has a strong patient and public involvement group that has contributed to study design and materials, and which will be closely involved in data interpretation and dissemination.Ethics and disseminationThe study has been approved by the National Health Service East Midlands—Leicester South Research Ethics Committee: 17/EM/0312. The results of the study will be disseminated through peer-reviewed journals, conferences and a planned programme of knowledge mobilisation.Trial registration numberISRCTN51780222.