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; The DLB COS Delphi Group; Annette Hand

doi:10.1002/trc2.70134

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, The DLB COS Delphi Group, Annette Hand

^*Corresponding author for this work

School of Healthcare and Nursing Sciences

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

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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.

Original language	English
Article number	e70134
Number of pages	12
Journal	Alzheimer's and Dementia: Translational Research and Clinical Interventions
Volume	11
Issue number	3
Early online date	11 Jul 2025
DOIs	https://doi.org/10.1002/trc2.70134
Publication status	Published - 11 Jul 2025

Keywords

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

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TRCI-D-25-00068_R1 Authors acceptedAccepted author manuscript, 3.55 MB
A D Transl Res Clin Interv - 2025 - Kane - A common outcome set for trials in dementia with Lewy bodies DLB COSFinal published version, 1.9 MBLicence: CC BY

Cite this

Kane, J. P. M., Fitzpatrick, R. L., Betzhold, S., Daly, G., Kalfas, E., Kinchin, I., Aarsland, D., Greaney, K., Grycuk, E., Folkerts, A.-K., Kalbe, E., Rodriguez-Porcel, F., Saldanha, I. J., Smith, V., Taylor, J.-P., Thompson, R., Wyman-Chick, K., Leroi, I., The DLB COS Delphi Group, & Hand, A. (2025). A common outcome set for trials in dementia with Lewy bodies (DLB COS). Alzheimer's and Dementia: Translational Research and Clinical Interventions, 11(3), Article e70134. https://doi.org/10.1002/trc2.70134

@article{339ce2a3f56c4542ba1d41f7a21d8fef,

title = "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.",

keywords = "Alzheimer's disease and related dementias, Delphi, consensus, core outcome set, dementia, dementia with Lewy bodies, outcome measures, trial methods",

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

note = "Annette Hand is part of the The DLB COS Delphi Group.",

year = "2025",

month = jul,

day = "11",

doi = "10.1002/trc2.70134",

language = "English",

volume = "11",

journal = "Alzheimer's and Dementia: Translational Research and Clinical Interventions",

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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, The DLB COS Delphi Group & Hand, A 2025, 'A common outcome set for trials in dementia with Lewy bodies (DLB COS)', Alzheimer's and Dementia: Translational Research and Clinical Interventions, vol. 11, no. 3, e70134. https://doi.org/10.1002/trc2.70134

TY - JOUR

T1 - A common outcome set for trials in dementia with Lewy bodies (DLB COS)

AU - Kane, Joseph P. M.

AU - Fitzpatrick, Rachel L.

AU - Betzhold, Sara

AU - Daly, Gillian

AU - Kalfas, Emily

AU - Kinchin, Irina

AU - Aarsland, Dag

AU - Greaney, Ken

AU - Grycuk, Emilia

AU - Folkerts, Ann-Kristin

AU - Kalbe, Elke

AU - Rodriguez-Porcel, Federico

AU - Saldanha, Ian J.

AU - Smith, Valerie

AU - Taylor, John-Paul

AU - Thompson, Rachel

AU - Wyman-Chick, Kathryn

AU - Leroi, Iracema

AU - The DLB COS Delphi Group

AU - Hand, Annette

N1 - Annette Hand is part of the The DLB COS Delphi Group.

PY - 2025/7/11

Y1 - 2025/7/11

N2 - 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.

AB - 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.

KW - Alzheimer's disease and related dementias

KW - Delphi

KW - consensus

KW - core outcome set

KW - dementia

KW - dementia with Lewy bodies

KW - outcome measures

KW - trial methods

UR - https://www.scopus.com/pages/publications/105013793728

U2 - 10.1002/trc2.70134

DO - 10.1002/trc2.70134

M3 - Article

SN - 2352-8737

VL - 11

JO - Alzheimer's and Dementia: Translational Research and Clinical Interventions

JF - Alzheimer's and Dementia: Translational Research and Clinical Interventions

IS - 3

M1 - e70134

ER -

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

Abstract

Keywords

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