Patient and public involvement and engagement in the development of a platform clinical trial for Parkinson's Disease: An evaluation protocol

Zeissler, Marie-Louise, Bakshi, Nikul, Bartlett, Michèle, Batla, Amit, Byrom, David, Chapman, Rebecca, Collins, Sally, Cowd, Elaine, Deeson, Eric, Ellis-Doyle, Romy, Forbes, Jodie, Gonzalez-Robles, Cristina, Jewell, Anna, Lane, Emma L. ORCID: https://orcid.org/0000-0001-8800-3764, LaPelle, Nancy R., Martin, Keith, Matthews, Helen, Miller, Laurel, Mills, Georgia, Morgan, Antony, Parry, Miriam, Pushparatnam, Kuhan, Ratcliffe, Natasha, Salathiel, Dorothy, Scurfield, Paula, Siu, Carroll, Whipps, Sue, Wonnacott, Sheila, Foltynie, Thomas, Carroll, Camille B. and McFarthing, Kevin 2024. Patient and public involvement and engagement in the development of a platform clinical trial for Parkinson's Disease: An evaluation protocol. Journal of Parkinson's Disease 14 (4) , pp. 809-821. 10.3233/JPD-230444

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Abstract

Background: Patient and public involvement and engagement (PPIE) in the design of trials is important, as participant experience critically impacts delivery. The Edmond J Safra Accelerating Clinical Trials in PD (EJS ACT-PD) initiative is a UK consortium designing a platform trial for disease modifying therapies in PD. Objective: The integration of PPIE in all aspects of trial design and its evaluation throughout the project. Methods: PwP and care partners were recruited to a PPIE working group (WG) via UK Parkinson’s charities, investigator patient groups and participants of a Delphi study on trial design. They are supported by charity representatives, trial delivery experts, researchers and core project team members. PPIE is fully embedded within the consortium’s five other WGs and steering group. The group’s terms of reference, processes for effective working and PPIE evaluation were co-developed with PPIE contributors. Results: 11 PwP and 4 care partners have supported the PPIE WG and contributed to the development of processes for effective working. A mixed methods research-in-action study is ongoing to evaluate PPIE within the consortium. This includes the Patient Engagement in Research Scale -a quantitative PPIE quality measure; semi-structured interviews -identifying areas for improvement and overall impressions of involvement; process fidelity- recording adherence; project documentation review – identifying impact of PPIE on project outputs. Conclusions: We provide a practical example of PPIE in complex projects. Evaluating feasibility, experiences and impact of PPIE involvement in EJS ACT-PD will inform similar programs on effective strategies. This will help enable future patient-centered research.

Item Type:	Article
Date Type:	Publication
Status:	Published
Schools:	Pharmacy
Publisher:	IOS Press
ISSN:	1877-7171
Date of First Compliant Deposit:	12 August 2024
Date of Acceptance:	27 March 2024
Last Modified:	16 Aug 2024 09:30
URI:	https://orca.cardiff.ac.uk/id/eprint/171317

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