Evidence map›Paper›PMID 39506862›Full record

ArticleResearch involvement and engagement2024

Patient and public involvement in the design of an international clinical trial: real world experience.

Gwenda Simons, Helen Jones, Ian Clarke, Firoza Davies, Stacey Grealis, Elspeth Insch, Hameed Kahn, Joanne Lloyd, Al Richards, Hayley Rose and 7 more

Abstract read
In one paragraph

Article in Research involvement and engagement, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Gwenda SimonsDepartment of Inflammation and Ageing, College of Medicine and Health, Rheumatology Research Group, University of Birmingham, Queen Elizabeth Hospital, Birmingham, UK. g.simons@bham.ac.uk.
Helen JonesPPI Partner, Patient and public Involvement and engagement in Musculoskeletal reSearch (PIMS) group, Newcastle upon Tyne Hospitals, Newcastle, UK.
Ian ClarkePPI Partner, Muscle Health PPI Group, NIHR Birmingham Biomedical Research Centre (BRC), Birmingham, UK.
Firoza DaviesPPI Partner, Birmingham Rheumatology Research Patient Partnership (R2P2), University of Birmingham, Birmingham, UK.
Stacey GrealisPPI Partner, University College Dublin (UCD) Centre for Arthritis Research, Dublin, Ireland.
Elspeth InschPPI Partner, Birmingham Rheumatology Research Patient Partnership (R2P2), University of Birmingham, Birmingham, UK.
Hameed KahnPPI Partner, Muscle Health PPI Group, NIHR Birmingham Biomedical Research Centre (BRC), Birmingham, UK.
Joanne LloydPPI Partner, Patient and public Involvement and engagement in Musculoskeletal reSearch (PIMS) group, Newcastle upon Tyne Hospitals, Newcastle, UK.
Al RichardsIndependent PPI Partner, London, UK.
Hayley RoseIndependent PPI Partner, Amsterdam, The Netherlands.
Ruth WilliamsCentre for Rheumatic Diseases, Department of inflammation Biology, PPI partner, Kings College London, London, UK.
Maarten de WitIndependent PPI Partner, Zaltbommel, The Netherlands.
Clarissa WoodcockPPI Partner, Birmingham Rheumatology Research Patient Partnership (R2P2), University of Birmingham, Birmingham, UK.
Leigh RomaniukRheumatology Clinical Research Team, Education Centre - Freeman Hospital, Newcastle upon Tyne, UK.
Michelle BardgettNewcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK.
Arthur G Pratt *Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK. arthur.pratt@newcastle.ac.uk.
Marie Falahee *Department of Inflammation and Ageing, College of Medicine and Health, Rheumatology Research Group, University of Birmingham, Queen Elizabeth Hospital, Birmingham, UK.

Funding

NIHR Efficacy and Mechanism Evaluation (EME) Accelerator Award NIHR158397
6 · The paper itself

Abstract

backgroundThe value of patient and public involvement (PPI) during the earliest stages of clinical trial development, and prior to the award of substantive funding, is widely recognised. However, it is often under-resourced and PPI processes during this phase are rarely reported in detail. Having benefitted from seed funding to develop an international clinical trial proposal, we sought to describe and appraise PPI activities and processes that support pre-award co-development.

methodsA 12-month "accelerator" award facilitated development of a substantive funding application to deliver the Rheumatoid Arthritis Prevention PlatfORm Trial (RAPPORT), conceived to prioritise preventative interventions for people at risk of RA. PPI partners, including individuals at risk of rheumatoid arthritis (RA), RA patients, relatives and members of the public, provided feedback on key trial design issues through online meetings, a feedback form and emails. PPI processes employed during the one-year accelerator project were thereafter evaluated by PPI partners using an anonymous online feedback form with reference to National Institute of Health and Care Research (NIHR) UK standards for public involvement in research.

resultsSixteen out of the 25-strong PPI partner panel completed an online feedback form (64%). Respondents perceived PPI processes positively in relation to all NIHR standard domains. Several key facilitators and challenges were identified, including the need for adequate PPI funding during pre-award phases of research, strategies for creating an inclusive environment, flexibility around levels of involvement, and challenges in achieving representatively diverse participation, and the importance of communicating transparent processes for role-assignment and time-reimbursement.

conclusionsIn general, RAPPORT was considered an example of PPI well done, and in line with UK standards for public involvement in research. Facilitators and challenges of relevance for the development of future translational and clinical trial funding applications are highlighted.

Indexed as

Clinical trialsEvaluationPatient and public involvement and engagementPre-award

Identifiers

PMID39506862
PMCPMC11539688

What Socratic holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.