Marie-Louise Zeissler, Nikul Bakshi, Michèle Bartlett, Amit Batla, David Byrom, Rebecca Chapman, Sally Collins, Elaine Cowd, Eric Deeson, Romy Ellis-Doyle, Jodie Forbes, Cristina Gonzalez-Robles, Anna Jewell, Emma L Lane, Nancy R LaPelle, Keith Martin, Helen Matthews, Laurel Miller, Georgia Mills, Antony Morgan, Miriam Parry, Kuhan Pushparatnam, Natasha Ratcliffe, Dorothy Salathiel, Paula Scurfield, Carroll Siu, Sue Whipps, Sheila Wonnacott, Thomas Foltynie, Camille B Carroll, Kevin McFarthing
{"title":"Patient and Public Involvement and Engagement in the Development of a Platform Clinical Trial for Parkinson's Disease: An Evaluation Protocol.","authors":"Marie-Louise Zeissler, Nikul Bakshi, Michèle Bartlett, Amit Batla, David Byrom, Rebecca Chapman, Sally Collins, Elaine Cowd, Eric Deeson, Romy Ellis-Doyle, Jodie Forbes, Cristina Gonzalez-Robles, Anna Jewell, Emma L Lane, Nancy R LaPelle, Keith Martin, Helen Matthews, Laurel Miller, Georgia Mills, Antony Morgan, Miriam Parry, Kuhan Pushparatnam, Natasha Ratcliffe, Dorothy Salathiel, Paula Scurfield, Carroll Siu, Sue Whipps, Sheila Wonnacott, Thomas Foltynie, Camille B Carroll, Kevin McFarthing","doi":"10.3233/JPD-230444","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Objective: </strong>The integration of PPIE in all aspects of trial design and its evaluation throughout the project.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":16660,"journal":{"name":"Journal of Parkinson's disease","volume":" ","pages":"809-821"},"PeriodicalIF":4.0000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191543/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Parkinson's disease","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3233/JPD-230444","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
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.
期刊介绍：
The Journal of Parkinson''s Disease (JPD) publishes original research in basic science, translational research and clinical medicine in Parkinson’s disease in cooperation with the Journal of Alzheimer''s Disease. It features a first class Editorial Board and provides rigorous peer review and rapid online publication.
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