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IntroductionMethodological 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.MethodsWe 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.ResultsForty-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.DiscussionIf adopted, DLB COS can enhance the comparability of research findings and facilitate standardization and harmonization.HighlightsA 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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