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.
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
Disease Category: Health care of older people, Neurology
Disease Name: Lewy Body Dementia (LBD)
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Drug, Nonpharmacological
- Clinical experts
- Consumers (caregivers)
- Economists
- Journal editors
- Methodologists
- Patient/ support group representatives
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
- Survey
- Systematic review
- Interview
Using a multi-stage approach, we first undertook a narrative review of the LBD intervention literature to inform a more rigorous systematic review, following PRISMA guideline. Next, using the intervention study outcomes, we created a long list of outcomes that are subjected to a consensus process (an e-Delphi with multiple waves) to create a shortlist of outcome options for research and clinical practice. Input is sought from stakeholders with lived experience of LBD and a range of professionals, including clinicians, scientists, policy and third sector leads. Finally, through a consensus meeting, we will select appropriate instruments to measure the construct outcomes in the COS for use in research and clinical practice.