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

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.

Contributors

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

Publication

Journal: Alzheimers Dement (N Y)
Volume: 11
Issue: 3
Pages: e70134 -
Year: 2025
DOI: 10.1002/trc2.70134

Further Study Information

Current Stage: Completed
Date:
Funding source(s): Health Research Board Ireland, Clinical Research Network grant, CTN-2021-003, Dementia Trials Ireland, lead, I Leroi; Health Research Board Ireland [CTN-2021-003] for Dementia Trials Ireland (lead: I Leroi)

Health Area

Disease Category: Neurology

Disease Name: Lewy Body Dementia (LBD)

Target Population

Age Range: Unknown

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Regulatory agency representatives
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Systematic review

This study will involve six distinct stages:
1. Identifying outcomes from a systematic review, and
developing a preliminary list
2. Reaching consensus on a preliminary DLB-COS from
the perspective of professional and lay stakeholders via
two rounds of Delphi surveys;
3. Building on the preliminary list of outcomes (Objective 2),
develop a final DLB-COS for use in future DLB
research and clinical practice, via an online consensus
meeting with professional and lay stakeholders;
4. Identifying and reaching consensus on the most appropriate instruments to measure outcomes in the final DLB-COS,
via an online consensus meeting attended by professional
stakeholders.
5. Disseminating and promoting the implementation of the
DLB-COS globally

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