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A common outcome set for trials in dementia with Lewy bodies (DLB COS)

Lookup NU author(s): Professor John-Paul TaylorORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2025 The Author(s). Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals LLC on behalf of Alzheimer's Association.INTRODUCTION: Methodological heterogeneity in dementia with Lewy bodies (DLB) trials contributes to publication bias and makes evidence synthesis and meta-analysis challenging. We aimed to develop a core outcome set for DLB (DLB COS) trials to improve consistency and comparability in DLB research. METHODS: We conducted a systematic review to identify outcomes and administered a two-stage Delphi survey to a diverse panel of lay and professional stakeholders. We asked respondents which outcomes should be prioritized and included in DLB COS. RESULTS: Forty-nine outcomes were presented to survey respondents. Consensus was reached regarding eight outcomes for the final DLB COS: delusions/paranoia; fluctuations in cognition, attention, and arousal; functioning; global cognition; hallucinations; quality of life; motor parkinsonism; and rapid eye movement sleep behavior disorder. DISCUSSION: If adopted, DLB COS can enhance the comparability of research findings and facilitate standardization and harmonization. Highlights: A systematic review revealed heterogeneity in dementia with Lewy bodies (DLB) study outcomes. Our study produced a DLB Core Outcome Set (DLB COS) comprising eight outcomes. DLB COS sets the minimum reporting standards for future trials. DLB-specific rating scales incorporating these outcomes are needed. Addressing this gap is a strategic priority in DLB research.

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Author(s): Kane JPM, Fitzpatrick RL, Betzhold S, Daly G, Kalfas E, Kinchin I, Aarsland D, Greaney K, Grycuk E, Folkerts A-K, Kalbe E, Rodriguez-Porcel F, Saldanha IJ, Smith V, Taylor J-P, Thompson R, Wyman-Chick K, Leroi I

Publication type: Article

Publication status: Published

Journal: Alzheimer's and Dementia: Translational Research and Clinical Interventions

Year: 2025

Volume: 11

Issue: 3

Print publication date: 01/09/2025

Online publication date: 11/07/2025

Acceptance date: 30/05/2025

Date deposited: 01/09/2025

ISSN (print): 2352-8737

ISSN (electronic): 2352-8737

Publisher: John Wiley and Sons Inc

URL: https://doi.org/10.1002/trc2.70134

DOI: 10.1002/trc2.70134

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