scholarly journals A 10-year impact assessment of the Efficacy and Mechanism Evaluation (EME) programme: an independent mixed-method evaluation study

2021 ◽  
Vol 8 (20) ◽  
pp. 1-106
Author(s):  
Maike C Rentel ◽  
Kelly Simpson ◽  
Anoushka Davé ◽  
Scott Carter ◽  
Margaret Blake ◽  
...  
Keyword(s):  
Clinical Research ◽  
Economic Impact ◽  
Public Involvement ◽  
Secondary Data ◽  
Patient And Public Involvement ◽  
Health Needs ◽  
Representative Sampling ◽  
Stakeholder Consultation ◽  
Use Of Resources ◽  
Desk Research

Background The Efficacy and Mechanism Evaluation (EME) programme – a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership – funds trials that evaluate the efficacy of interventions with the potential to promote health and studies that improve our understanding of the mechanisms of underlying diseases and their treatments. Objective To conduct an independent review of the EME programme’s impact and identify opportunities for future improvement. Design A mixed-methods approach, including desk research, an analysis of secondary data, stakeholder consultation and the development of impact case studies. Participants Chief investigators of EME awards, unfunded applicants to the EME programme and key opinion leaders relevant to the programme and research ecosystem. Interventions No interventions were tested, as this was a retrospective programme evaluation. Main outcome measures The evaluation was guided by a set of 15 evaluation questions. Results The EME programme bridges the gap between proof-of-concept and effectiveness studies that are located among other MRC and NIHR schemes and grants from charities in the funding landscape. Mechanistic studies alongside EME trials add value by lending confidence to trial findings and providing insights into the underlying biology. Between 2009 and September 2018, £175.7M in funding was approved for 145 EME projects. EME programme-funded research has started to deliver value to the NHS and patients by improving treatments and providing more efficient use of resources. Of the 43 completed trials, 14% (n = 6) showed that the intervention had a positive effect, whereas 74% (n = 32) of trials did not. The remaining five (12%) trials were unable to recruit participants or did not proceed to the full-trial stage. Seven projects (i.e. 16% of completed trials) have informed clinical guidelines or regulatory approval decisions and another eight projects have the potential to do so in the future, given the nature of their findings. Projects in the EME programme portfolio address a range of UK health needs and government priority areas, but they do not fully align with the level of health needs present. Commissioned calls for applications steer applicants. However, many commissioned calls do not lead to funded awards, and a better understanding of the underlying reasons for this would enable targeted supported to address key health needs. The majority of EME projects investigate existing interventions of limited commercial interest, focusing on repurposing (67/136, 49%) and informing current practice (23/136, 17%). Although there is little evidence of wider economic impact from commercial benefits, the EME programme is important in funding research in which industry is unlikely to invest. Stronger co-ordination with other funders, such as charities, could lead to synergies, enhancing the potential for health impact and influence on other funders’ agendas. The main challenges identified for EME projects were ‘complex and slow contracting processes’ (35/46, 76%), ‘setting up of study sites’ (30/46, 65%) and patient recruitment (28/46, 61%). Enablers of research included a clinical research fellow position on the project and support from Clinical Research Networks and Biomedical Research Centres. Nearly all of the chief investigators consulted had engaged in patient and public involvement at some project stage, and a lack of patient and public involvement did not emerge as a barrier to research or impact. Research ideas stemming from patients were, however, over-represented among unfunded applications, but the reason for this is unclear. Limitations Only about one-third of all studies had been completed or had published their main findings, necessitating a purposive, rather than representative, sampling of the portfolio. The COVID-19 outbreak cut short the programme of interviews, limiting the depth to which some evaluation questions could be explored. Several data sources were based on self-reporting by chief investigators; whereas key self-reported aspects were verified through desk research, this was not possible for all findings. Conclusions The EME programme plays an important role in the UK research funding landscape and has started to deliver value to the NHS and patients. Based on the evidence gathered, seven recommendations were developed to enhance the EME programme’s health and economic impact and address challenges encountered by chief investigators in implementing research projects. Funding This project was funded by the EME programme, a MRC and NIHR partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 20. See the NIHR Journals Library website for further project information.

scholarly journals Fleshing out the data: when epidemiological researchers engage with patients and carers. Learning lessons from a patient involvement activity

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e036311
Author(s):  
Melanie Morris ◽  
Yuki Alencar ◽  
Bernard Rachet ◽  
Richard Stephens ◽  
Michel P Coleman
Keyword(s):  
Quantitative Research ◽  
Patient Involvement ◽  
Public Involvement ◽  
Cancer Survival ◽  
Essential Element ◽  
Secondary Data ◽  
Patient And Public Involvement ◽  
Survival Group ◽  
National Cancer Research Institute ◽  
Future Events

Patient and public involvement and engagement has become an essential element of health research, ensuring aims and outputs are worthwhile and relevant. However, research involving secondary data analyses does not present immediately obvious ways to involve patients and the public. Innovative approaches to ensure their involvement is meaningful and effective are required.The Cancer Survival Group cohosted a full-day meeting with the National Cancer Research Institute Consumer Forum—a group of patients and carers. This included the Forum’s ‘Dragons’ Den’: a small-group session in which their members provided insight, advice and ideas on current or planned research in the Cancer Survival Group.We investigated this activity as an example of effective patient involvement, with the aim of developing broad recommendations to improve epidemiological/quantitative research by involving patients and carers as directly as possible.In addition to quantitative data captured through evaluation forms completed after the event, we used semistructured interviews of a sample of participants to evaluate the effectiveness of the session and to learn lessons. The interviews were analysed to identify broad or recurrent themes and recommendations.Feedback was overwhelmingly positive, and some impacts on the research projects were identified. Interviewees commented on overall expectations and experiences, as well as specifics of room layout, timing of the session, composition of groups, effectiveness of the facilitation and content of discussions.We present a summary of our findings as a guide for other researchers, including recommendations for improvement gleaned from the interviews. The value to researchers of hosting and participating in such activities was clear. We developed recommendations that should help to improve future events for ourselves and for others who wish to conduct similar activities, which in turn may lead to more concrete benefits for research and patients.

scholarly journals Patient and public involvement in infection clinical research

2018 ◽  
Vol 24 (11) ◽  
pp. 1121-1122
Author(s):  
S. Grier ◽  
A. Gibson ◽  
A. Micciche ◽  
E. Berry ◽  
A. MacGowan
Keyword(s):  
Clinical Research ◽  
Public Involvement ◽  
Patient And Public Involvement

OP338 Involving Patients In Research: Early Consultation Of Women To Improve Study Design And Investigate Trial Acceptability

2021 ◽  
Vol 37 (S1) ◽  
pp. 14-14
Author(s):  
Jamie Erskine ◽  
Alejandra Castanon
Keyword(s):  
Data Collection ◽  
Clinical Research ◽  
Feasibility Study ◽  
Public Involvement ◽  
Research Output ◽  
Patient And Public Involvement ◽  
English Summary ◽  
Ongoing Research ◽  
Consultation Group ◽  
Funding Application

IntroductionGaining the perspective of patients is invaluable in the design, management and reporting of research. As part of the process of facilitating clinical research into the effectiveness of a digital colposcope in a cervical cancer pathway, patients were involved from the outset.MethodsUsing funding made available by a Public Involvement Fund, a patient consultation group was established. The group's initial discussions informed the design of a feasibility study and funding application, which was submitted to the UK National Institute of Health Research (NIHR). A Patient and Public Involvement (PPI) representative was recruited and along with the consultation group, contributed to the ethical approvals for the study. The Patient Information Sheet and Consent Form were reviewed by the patients, to ensure readability, understandability and accessibility. The patient questionnaires and interview topics that are part of the feasibility study were also developed in conjunction with the PPI group, to make sure that women's concerns are being addressed in the research design and protocols.ResultsThe PPI consultation group's contributions helped strengthen the funding application and funding for a feasibility study was granted as part of the NIHR's Research for Patient Benefit funding scheme. Part of the grant will be used for training and reimbursement for time spent for the PPI representative. Data collection for the study is due to commence in the summer of 2021. The PPI group will be consulted at the beginning and end of the data collection period and will contribute to the data analysis and dissemination of the research output, including a Plain English Summary.ConclusionsInvolving patients greatly amplified the quality of the funding and ethical applications and will continue to benefit the ongoing research. Resources were widely available within the researcher's University and also through UK-wide schemes. Such resources are crucial and should be encouraged as part of all clinical research.

scholarly journals Role of patient and public involvement in implementation research: a consensus study

2018 ◽  
Vol 27 (10) ◽  
pp. 858-864 ◽  
Author(s):  
Kara A Gray-Burrows ◽  
Thomas A Willis ◽  
Robbie Foy ◽  
Martin Rathfelder ◽  
Pauline Bland ◽  
...  
Keyword(s):  
Clinical Research ◽  
Implementation Research ◽  
Public Involvement ◽  
Good Practice ◽  
Strong Support ◽  
Research Process ◽  
Patient And Public Involvement ◽  
Consensus Process ◽  
Convenience Sample

BackgroundPatient and public involvement (PPI) is often an essential requirement for research funding. Distinctions can be drawn between clinical research, which generally focuses on patients, and implementation research, which generally focuses on health professional behaviour. There is uncertainty about the role of PPI in this latter field. We explored and defined the roles of PPI in implementation research to inform relevant good practice guidance.MethodsWe used a structured consensus process using a convenience sample panel of nine experienced PPI and two researcher members. We drew on available literature to identify 21 PPI research roles. The panel rated their agreement with roles independently online in relation to both implementation and clinical research. Disagreements were discussed at a face-to-face meeting prior to a second online rating of all roles. Median scores were calculated and a final meeting held to review findings and consider recommendations.ResultsTen panellists completed the consensus process. For clinical research, there was strong support and consensus for the role of PPI throughout most of the research process. For implementation research, there were eight roles with consensus and strong support, seven roles with consensus but weaker support and six roles with no consensus. There were more disagreements relating to PPI roles in implementation research compared with clinical research. PPI was rated as contributing less to the design and management of implementation research than for clinical research.ConclusionsThe roles of PPI need to be tailored according to the nature of research to ensure authentic and appropriate involvement. We provide a framework to guide the planning, conduct and reporting of PPI in implementation research, and encourage further research to evaluate its use.

scholarly journals PARE0007 PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIAL DESIGN

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1289.1-1290
Author(s):  
S. De Souza ◽  
R. Williams ◽  
E. Johansson ◽  
C. Zabalan ◽  
T. Esterine ◽  
...  
Keyword(s):  
At Risk ◽  
Lived Experience ◽  
Public Involvement ◽  
Clinical Trial Design ◽  
Patient And Public Involvement ◽  
Face To Face ◽  
Before And After ◽  
Extensive Consultation ◽  
New Perspective ◽  
The Eu

Background:Patient and public involvement (PPI) is gaining increasing recognition as important in ensuring research is relevant and acceptable to participants. Rheuma Tolerance for Cure (RTCure) is a 5 year international collaboration between academia and industry; focusing on earlier detection and prevention of rheumatoid arthritis (RA) through the use of immune-tolerising treatments.Objectives:To bring lived experience and insight into scientific discussions; and to evolve collaboration between lay representatives and academia/industry.Methods:9 Patient Research Partners (PRPs) from 5 European countries were recruited via the EULAR PARE Network and institutions within the RTCure Consortium (8 PRPs with RA and 1 ‘at risk’). They were asked to enter into a legal agreement with the Consortium. PRPs participated in teleconferences (TCs) and were invited to attend face-to-face (F2F) meetings at least annually. Requests for input/feedback were sent from researchers to PRPs via the project’s Patient Engagement Expert [SK].Results:PRP involvement has given researchers and industry partners a new perspective on patient priorities, and focused thought on the ethics of recruitment for and participation in clinical trials of people ‘at risk’ of developing RA. PRPs have helped define the target populations, given their thoughts on what types of treatments are acceptable to people ‘at risk’ and have aided the development of a survey (sent to EULAR PARE members) regarding the use of animal models in biomedical research. Positive informal feedback has been received from researchers and industry regarding the contribution of PRPs to the ongoing project (formal evaluation of PPI in RTCure will be carried out in 2020 and at the project end in 2022).Challenges:Legal agreements- Many PRPs refused to sign the Consortium’s complex PRP Agreement; feeling it unnecessary, incomprehensible and inequitable. After extensive consultation with various parties (including EULAR and the Innovative Medicines Initiative) no similar contract was found. Views for its requirement even varied between legal experts. After 2 years of intense discussion, a simple non-disclosure agreement was agreed upon. Ideally any contract, if required, should be approved prior to project onset.Meeting logistics- Other improvements identified were to locate the meeting venue and accommodation on the same site to minimise travel, and to make it easier for PRPs to take breaks when required. This also facilitates informal discussions and patient inclusivity. We now have agreed a policy to fund PRPs extra nights before and after meetings, and to bring a carer if needed.Enabling understanding– Future annual meetings will start with a F2F meeting between PRPs and Work Package Leads. Researchers will be encouraged to start presentations with a summary slide in lay language. Additionally, an RTCure Glossary is in development.Enabling participation– SK will provide monthly project updates and PRP TCs will be held in the evening (as some PRPs remain employed). PRPs will be invited to all project TCs and F2F meetings. Recruitment is underway to increase the number of ‘at risk’ PRPs as their viewpoint is vital to this study.Conclusion:Currently PPI in RTCure is an ongoing mutual learning process. Universal guidance regarding what types of contracts are needed for PPI would be useful. Communication, trust and fruitful discussions have evolved through F2F meetings (both formal and informal) between PRPs, academia and industry. It is important that all parties can be open with each other in order to make PPI more meaningful.Acknowledgments:This work has received support from the EU/EFPIA Innovative Medicines Initiative 2 Joint Undertaking RTCure grant number 777357.Disclosure of Interests:Savia de Souza: None declared, Ruth Williams: None declared, Eva Johansson: None declared, Codruta Zabalan: None declared, Tom Esterine: None declared, Margôt Bakkers: None declared, Wolfgang Roth: None declared, Neil Mc Carthy: None declared, Meryll Blake: None declared, Susanne Karlfeldt: None declared, Martina Johannesson: None declared, Karim Raza Grant/research support from: KR has received research funding from AbbVie and Pfizer, Consultant of: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai, Speakers bureau: KR has received honoraria and/or consultancy fees from AbbVie, Sanofi, Lilly, Bristol-Myers Squibb, UCB, Pfizer, Janssen and Roche Chugai

scholarly journals Household medication safety practices during the COVID-19 pandemic: a descriptive qualitative study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e044441
Author(s):  
Tamasine C Grimes ◽  
Sara Garfield ◽  
Dervla Kelly ◽  
Joan Cahill ◽  
Sam Cromie ◽  
...  
Keyword(s):  
Social Media ◽  
Qualitative Study ◽  
Medication Safety ◽  
Best Practice ◽  
Public Involvement ◽  
Comparative Method ◽  
Patient And Public Involvement ◽  
Safety Practices ◽  
Trinity College Dublin ◽  
Descriptive Qualitative

IntroductionThose who are staying at home and reducing contact with other people during the COVID-19 pandemic are likely to be at greater risk of medication-related problems than the general population. This study aims to explore household medication practices by and for this population, identify practices that benefit or jeopardise medication safety and develop best practice guidance about household medication safety practices during a pandemic, grounded in individual experiences.Methods and analysisThis is a descriptive qualitative study using semistructured interviews, by telephone or video call. People who have been advised to ‘cocoon’/‘shield’ and/or are aged 70 years or over and using at least one long-term medication, or their caregivers, will be eligible for inclusion. We will recruit 100 patient/carer participants: 50 from the UK and 50 from Ireland. Recruitment will be supported by our patient and public involvement (PPI) partners, personal networks and social media. Individual participant consent will be sought, and interviews audio/video recorded and/or detailed notes made. A constructivist interpretivist approach to data analysis will involve use of the constant comparative method to organise the data, along with inductive analysis. From this, we will iteratively develop best practice guidance about household medication safety practices during a pandemic from the patient’s/carer’s perspective.Ethics and disseminationThis study has Trinity College Dublin, University of Limerick and University College London ethics approvals. We plan to disseminate our findings via presentations at relevant patient/public, professional, academic and scientific meetings, and for publication in peer-reviewed journals. We will create a list of helpful strategies that participants have reported and share this with participants, PPI partners and on social media.

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