Category: Parkinson’s Disease: Clinical Trials
Objective: To maximally involve people with the lived experience of Parkinson’s in the design of the first multi-arm multi-stage (MAMS) trial for disease modifying therapies in Parkinson’s and evaluate the impact of co-design on the project.
Background: Involving people with lived experience of Parkinson’s in trial design and oversight is essential for patient-centred clinical research. Their perspectives are vital to ensure trials address patient relevant questions, have protocols that maximise recruitment and retention, and implement effective communication strategies. In the Edmond J Safra ACT-PD initiative we are developing the first MAMS trial for disease modifying Parkinson’s treatments. This innovative approach investigates multiple treatments in parallel allowing for early stopping and replacement of treatments that are ineffective at interim stages. Here we present our patient-centred approach.
Method: Eight people with Parkinson’s (PwP) and three care partners (CP) (3 male, 8 female) were recruited nationally and two allocated to each of five working groups (WG) developing the trial. Together they form a Patient and Public Involvement and Engagement (PPIE) WG chaired by a PwP (KMcF). The group iteratively developed processes for supporting their input into WG decisions with an impact evaluation plan involving semi-structured interviews and a revised Patient Engagement in Research Scale.
Results: The PPIE team meets every four to six weeks online. Standard Reporting Forms facilitate communication between WGs and PPIE members, supporting group input into issues arising. PPIE feedback is an early agenda item at all WG meetings. Post-WG PPIE debriefs with the WG chairs ensure a shared understanding of discussions and clear objectives for wider PPIE consultation as they arise. Monthly PPIE forums provide opportunity for informal, education and themed, in-depth discussions with PwP/CP. Post forum feedback surveys allow for session evaluation as well as identification of future topics. A PwP/CP WhatsApp group creates a safe space for sharing experiences and ideas. Mechanisms have been created to evaluate the impact of PPIE within the overall success of the project.
Conclusion: We have developed a process by which PwP/CP can meaningfully co-design our MAMS trial, ensuring it is truly patient-centred.
This abstract may also be presented at Association of British neurologists Annual Meeting (May 2022).
To cite this abstract in AMA style:
M-L. Zeissler, N. Bakshi, M. Bartlett, A. Batla, D. Byrom, R. Chapman, E. Deeson, R. Ellis-Doyle, C. Gonzales-Robles, A. Jewell, H. Matthews, L. Miller, G. Mills, L. Mooney, A. Morgan, J. Rudiger, D. Salathiel, P. Scurfield, C. Siu, S. Whipps, S. Wonnacott, T. Foltynie, C. Carroll, K. Mcfarthing. Involving people with lived experience of Parkinson’s in trial design: the EJS ACT-PD initiative [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/involving-people-with-lived-experience-of-parkinsons-in-trial-design-the-ejs-act-pd-initiative/. Accessed May 13, 2025.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/involving-people-with-lived-experience-of-parkinsons-in-trial-design-the-ejs-act-pd-initiative/