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

Joseph P M Kane; Rachel L Fitzpatrick; Sara Betzhold; Gillian Daly; Emily Kalfas; Irina Kinchin; Dag Aarsland; Ken Greaney; Emilia Grycuk; Ann-Kristin Folkerts; Elke Kalbe; Federico Rodriguez-Porcel; Ian J Saldanha; Valerie Smith; John-Paul Taylor; Rachel Thompson; Kathryn Wyman-Chick; Iracema Leroi; and The DLB COS Delphi Group

doi:10.1002/trc2.70134

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

Alzheimers Dement (N Y). 2025 Jul 11;11(3):e70134. doi: 10.1002/trc2.70134. eCollection 2025 Jul-Sep.

Authors

Joseph P M Kane¹, Rachel L Fitzpatrick², Sara Betzhold², Gillian Daly³, Emily Kalfas^{4

5}, Irina Kinchin⁶, Dag Aarsland^{7

8}, Ken Greaney⁶, Emilia Grycuk², Ann-Kristin Folkerts⁹, Elke Kalbe¹⁰, Federico Rodriguez-Porcel¹¹, Ian J Saldanha¹², Valerie Smith¹³, John-Paul Taylor¹⁴, Rachel Thompson^{15

16}, Kathryn Wyman-Chick¹⁷, Iracema Leroi^{2

18}; and The DLB COS Delphi Group

Affiliations

¹ Centre for Public Health Queen's University Belfast Institute of Clinical Sciences B Royal Victoria Hospital Belfast UK.
² School of Medicine Trinity College Dublin Dublin UK.
³ Trinity College Institute of Neuroscience Trinity College Dublin Dublin UK.
⁴ Department of Neuroscience Columbia University New York New York USA.
⁵ Department of Biological and Biomedical Science Trinity College Dublin Dublin UK.
⁶ Centre for Health Policy and Management Trinity College Dublin Dublin UK.
⁷ Department of Psychological Medicine Centre for Healthy Brain Aging Institute of Psychiatry Psychology & Neuroscience King's College London London UK.
⁸ Centre for Age-Related Diseases Stavanger University Hospital Stavanger Norway.
⁹ Medical Psychology Neuropsychology and Gender Studies Faculty of Medicine and University Hospital Cologne University of Cologne Cologne Germany.
¹⁰ Medical Faculty and University Hospital University of Cologne Medical Psychology Neuropsychology and Gender Studies Cologne Germany.
¹¹ Department of Neurology Medical University of South Carolina Charleston South Carolina USA.
¹² Department of Epidemiology Center for Clinical Trials and Evidence Synthesis Johns Hopkins Bloomberg School of Public Health Baltimore Maryland USA.
¹³ School of Nursing Midwifery and Health Systems University College Dublin Dublin UK.
¹⁴ Translational and Clinical Research Institute and NIHR Newcastle Biomedical Research Centre Newcastle University Newcastle upon Tyne UK.
¹⁵ Dementia UK London UK.
¹⁶ The Lewy Body Society Wigan UK.
¹⁷ HealthPartners Struthers Parkinson's Center Minneapolis Minnesota USA.
¹⁸ Global Brain Health Institute Trinity College Dublin Dublin UK.

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.

Keywords: Alzheimer's disease and related dementias; Delphi; consensus; core outcome set; dementia; dementia with Lewy bodies; outcome measures; trial methods.