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dc.contributor.authorZeissler, M-L
dc.contributor.authorMcFarthing, K
dc.contributor.authorRaphael, KG
dc.contributor.authorRafaloff, G
dc.contributor.authorWindle, R
dc.contributor.authorCarroll, CB
dc.date.accessioned2023-12-18T11:07:16Z
dc.date.available2023-12-18T11:07:16Z
dc.date.issued2023-11-18
dc.identifier.issn1877-7171
dc.identifier.issn1877-718X
dc.identifier.urihttps://pearl.plymouth.ac.uk/handle/10026.1/21801
dc.description.abstract

Background: Design of disease modification (DM) trials for Parkinson’s disease (PD) is challenging. Successful delivery requires a shared understanding of priorities and practicalities. Objective: To seek stakeholder consensus on phase 3 trials’ overall goals and structure, inclusion criteria, outcome measures, and trial delivery and understand where perspectives differ. Methods: An international expert panel comprising people with Parkinson’s (PwP), care partners (CP), clinical scientists, representatives from industry, funders and regulators participated in a survey-based Delphi study. Survey items were informed by a scoping review of DM trials and PwP input. Respondents scored item agreement over 3 rounds. Scores and reasoning were summarized by participant group each round until consensus, defined as≥70% of at least 3 participant groups falling within the same 3-point region of a 9-point Likert scale. Results: 92/121 individuals from 13 countries (46/69 PwP, 13/18 CP, 20/20 clinical scientists, representatives from 8/8 companies, 4/5 funders, and 1/1 regulator) completed the study. Consensus was reached on 14/31 survey items: 5/8 overall goals and structure, 1/8 Eligibility criteria, 7/13 outcome measures, and 1/2 trial delivery items. Extent of stakeholder endorsement for 428 reasons for scores was collated across items. Conclusions: This is the first systematic multi-stakeholder consultation generating a unique repository of perspectives on pivotal aspects of DM trial design including those of PwP and CP. The panel endorsed outcomes that holistically measure PD and the importance of inclusive trials with hybrid delivery models. Areas of disagreement will inform mitigating strategies of researchers to ensure successful delivery of future trials.

dc.format.extent1-14
dc.format.mediumPrint
dc.languageeng
dc.publisherIOS Press
dc.subjectParkinson's disease
dc.subjectdisease modification
dc.subjectclinical trial
dc.subjectDelphi survey
dc.titleAn International Multi-Stakeholder Delphi Survey Study on the Design of Disease Modifying Parkinson’s Disease Trials
dc.typejournal-article
dc.typeArticle
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/38007672
plymouth.issue8
plymouth.volume13
plymouth.publisher-urlhttp://dx.doi.org/10.3233/jpd-230109
plymouth.publication-statusPublished
plymouth.journalJournal of Parkinson's Disease
dc.identifier.doi10.3233/jpd-230109
plymouth.organisational-group|Plymouth
plymouth.organisational-group|Plymouth|Research Groups
plymouth.organisational-group|Plymouth|Faculty of Health
plymouth.organisational-group|Plymouth|Research Groups|Institute of Translational and Stratified Medicine (ITSMED)
plymouth.organisational-group|Plymouth|Research Groups|Institute of Translational and Stratified Medicine (ITSMED)|CCT&PS
plymouth.organisational-group|Plymouth|REF 2021 Researchers by UoA
plymouth.organisational-group|Plymouth|Users by role
plymouth.organisational-group|Plymouth|Users by role|Academics
plymouth.organisational-group|Plymouth|REF 2021 Researchers by UoA|UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy
plymouth.organisational-group|Plymouth|Faculty of Health|Peninsula Medical School
plymouth.organisational-group|Plymouth|Research Groups|FoH - Community and Primary Care
plymouth.organisational-group|Plymouth|Research Groups|FoH - Applied Parkinson's Research
plymouth.organisational-group|Plymouth|Research Groups|Plymouth Institute of Health and Care Research (PIHR)
plymouth.organisational-group|Plymouth|REF 2028 Researchers by UoA
plymouth.organisational-group|Plymouth|REF 2028 Researchers by UoA|UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy
dc.publisher.placeNetherlands
dcterms.dateAccepted2023-10-23
dc.date.updated2023-12-18T11:07:15Z
dc.rights.embargodate2023-12-19
dc.identifier.eissn1877-718X
rioxxterms.versionofrecord10.3233/jpd-230109


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