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dc.contributor.authorZeissler, M-L
dc.contributor.authorBoey, T
dc.contributor.authorChapman, D
dc.contributor.authorRafaloff, G
dc.contributor.authorDominey, T
dc.contributor.authorRaphael, KG
dc.contributor.authorBuff, S
dc.contributor.authorPai, HV
dc.contributor.authorKing, E
dc.contributor.authorSharpe, P
dc.contributor.authorO’Brien, F
dc.contributor.authorCarroll, CB
dc.date.accessioned2024-04-24T11:57:27Z
dc.date.available2024-04-24T11:57:27Z
dc.date.issued2023-12-09
dc.identifier.issn2044-6055
dc.identifier.issn2044-6055
dc.identifier.othere071641
dc.identifier.urihttps://pearl.plymouth.ac.uk/handle/10026.1/22311
dc.description.abstract

Introduction Parkinson’s disease (PD) is a debilitating neurological disorder for which the identification of disease-modifying interventions represents a major unmet need. Diverse trial designs have attempted to mitigate challenges of population heterogeneity, efficacious symptomatic therapy and lack of outcome measures that are objective and sensitive to change in a disease modification setting. It is not clear whether consensus is emerging regarding trial design choices. Here, we report the protocol of a scoping review that will provide a contemporary update on trial design variability for disease-modifying interventions in PD.

Methods and analysis The Population, Intervention, Comparator, Outcome and Study design (PICOS) framework will be used to structure the review, inform study selection and analysis. The databases MEDLINE, Web of Science, Cochrane and the trial registry ClinicalTrials.gov will be systematically searched to identify published studies and registry entries in English. Two independent reviewers will screen study titles, abstracts and full text for eligibility, with disagreements being resolved through discussion or by a third reviewer where necessary. Data on general study information, eligibility criteria, outcome measures, trial design, retention and statistically significant findings will be extracted into a standardised form. Extracted data will be presented in a descriptive analysis. We will report our findings using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Scoping Review extension.

Ethics and dissemination This work will provide an overview of variation and emerging trends in trial design choices for disease-modifying trials of PD. Due to the nature of this study, there are no ethical or safety considerations. We plan to publish our findings in a peer-reviewed journal.

dc.format.extente071641-e071641
dc.format.mediumElectronic
dc.languageen
dc.publisherBMJ
dc.subjectParkinson-s disease
dc.subjectclinical trials
dc.subjectsystematic review
dc.titleInvestigating trial design variability in trials of disease-modifying therapies in Parkinson’s disease: a scoping review protocol
dc.typejournal-article
dc.typeArticle
plymouth.author-urlhttps://www.ncbi.nlm.nih.gov/pubmed/38070893
plymouth.issue12
plymouth.volume13
plymouth.publisher-urlhttp://dx.doi.org/10.1136/bmjopen-2023-071641
plymouth.publication-statusPublished
plymouth.journalBMJ Open
dc.identifier.doi10.1136/bmjopen-2023-071641
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|Current Academic staff
plymouth.organisational-group|Plymouth|REF 2021 Researchers by UoA|UoA01 Clinical Medicine
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 2029 Researchers by UoA
plymouth.organisational-group|Plymouth|REF 2029 Researchers by UoA|UoA01 Clinical Medicine
plymouth.organisational-group|Plymouth|REF 2029 Researchers by UoA|UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy
dc.publisher.placeEngland
dcterms.dateAccepted2023-11-05
dc.date.updated2024-04-24T11:57:26Z
dc.rights.embargodate2024-4-26
dc.identifier.eissn2044-6055
rioxxterms.versionofrecord10.1136/bmjopen-2023-071641


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