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

Abstract

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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ORCID for Jay Amin: orcid.org/0000-0003-3792-0428

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