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Item Response Model Adaptation for Analyzing Data from Different Versions of Parkinson's Disease Rating Scales
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
GlaxoSmithKline, London, England;AstraZeneca, IMED Biotech Unit, Early Clin Dev, Quantitat Clin Pharmacol, Cambridge, England.
GlaxoSmithKline, London, England.
GlaxoSmithKline, London, England.
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2019 (English)In: Pharmaceutical research, ISSN 0724-8741, E-ISSN 1573-904X, Vol. 36, no 9, article id 135Article in journal (Refereed) Published
Abstract [en]

Purpose: The aim of this work was to allow combination of information from recent and historical trials in Parkinson's Disease (PD) by developing bridging methodology between two versions of the clinical endpoint.

Methods: A previously developed Item Response Model (IRM), that described longitudinal changes in Movement Disorder Society (MDS) sponsored revision of Unified Parkinson's Disease Rating Scale (UPDRS) [MDS-UPDRS] data from the De Novo PD cohort in Parkinson's Progression Markers Initiative, was first adapted to describe baseline UPDRS data from two clinical trials, one in subjects with early PD and another in subjects with advanced PD. Assuming similar IRM structure, items of the UPDRS version were mapped to those in the MDS-UPDRS version. Subsequently, the longitudinal changes in the placebo arm of the advanced PD study were characterized.

Results: The parameters reflecting differences in the shared items between endpoints were successfully estimated, and the model diagnostics indicated that mapping was better for early PD subjects (closer to De Novo cohort) than for advanced PD subjects. Disease progression for placebo in advanced PD patients was relatively shallow.

Conclusion: An IRM able to handle two variants of clinical PD endpoints was developed; it can improve the utilization of data from diverse sources and diverse disease populations.

Place, publisher, year, edition, pages
SPRINGER/PLENUM PUBLISHERS , 2019. Vol. 36, no 9, article id 135
Keywords [en]
Data integration, disease progression, item response theory, movement disorder society (sponsored revision) - Unified parkinson's disease rating scale, parkinson's disease
National Category
Neurology
Identifiers
URN: urn:nbn:se:uu:diva-390377DOI: 10.1007/s11095-019-2668-6ISI: 000475976900001PubMedID: 31317279OAI: oai:DiVA.org:uu-390377DiVA, id: diva2:1341797
Available from: 2019-08-12 Created: 2019-08-12 Last updated: 2019-08-12Bibliographically approved

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Gottipati, GopichandKarlsson, MatsPlan, Elodie L.

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