TY - JOUR
T1 - Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease
T2 - An Evaluation Protocol
AU - Zeissler, Marie Louise
AU - Bakshi, Nikul
AU - Bartlett, Michèle
AU - Batla, Amit
AU - Byrom, David
AU - Chapman, Rebecca
AU - Collins, Sally
AU - Cowd, Elaine
AU - Deeson, Eric
AU - Ellis-Doyle, Romy
AU - Forbes, Jodie
AU - Gonzalez-Robles, Cristina
AU - Jewell, Anna
AU - Lane, Emma L.
AU - Lapelle, Nancy R.
AU - Martin, Keith
AU - Matthews, Helen
AU - Miller, Laurel
AU - Mills, Georgia
AU - Morgan, Antony
AU - Parry, Miriam
AU - Pushparatnam, Kuhan
AU - Ratcliffe, Natasha
AU - Salathiel, Dorothy
AU - Scurfield, Paula
AU - Siu, Carroll
AU - Whipps, Sue
AU - Wonnacott, Sheila
AU - Foltynie, Thomas
AU - Carroll, Camille B.
AU - McFarthing, Kevin
N1 - Publisher Copyright:
© 2024-The authors. Published by IOS Press.
PY - 2024/6/4
Y1 - 2024/6/4
N2 - 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.
AB - 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.
KW - clinical trial protocol
KW - Evaluation study
KW - Parkinson's disease
KW - patient and public involvement
UR - http://www.scopus.com/inward/record.url?scp=85195530104&partnerID=8YFLogxK
UR - https://pearl.plymouth.ac.uk/context/pms-research/article/2665/viewcontent/jpd_2024_14_4_jpd_14_4_jpd230444_jpd_14_jpd230444.pdf
U2 - 10.3233/JPD-230444
DO - 10.3233/JPD-230444
M3 - Article
C2 - 38701161
AN - SCOPUS:85195530104
SN - 1877-7171
VL - 14
SP - 809
EP - 821
JO - Journal of Parkinson's Disease
JF - Journal of Parkinson's Disease
IS - 4
ER -
