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

IF 4.9 Q1 CLINICAL NEUROLOGY

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Pub Date : 2025-07-11 DOI:10.1002/trc2.70134

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

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引用次数: 0

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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路易体痴呆（DLB COS）试验的常见结果集

路易体痴呆（DLB）试验的方法学异质性导致发表偏倚，并使证据合成和荟萃分析具有挑战性。我们旨在为DLB （DLB COS）试验制定一个核心结局集，以提高DLB研究的一致性和可比性。方法：我们进行了系统评价，以确定结果，并对不同的非专业利益相关者和专业利益相关者进行了两阶段的德尔菲调查。我们询问受访者哪些结果应该优先考虑并包括在DLB COS中。结果向调查对象提供了49项结果。就最终DLB COS的八种结果达成共识：妄想/偏执；认知、注意力和觉醒的波动；功能;全球认知;幻觉;生活质量；电动机震颤麻痹;以及快速眼动睡眠行为障碍。如果采用DLB COS，可以增强研究成果的可比性，促进标准化和协调。一项系统综述揭示了路易体痴呆（DLB）研究结果的异质性。我们的研究产生了包括8个结果的DLB核心结果集（DLB COS）。DLB COS为未来的试验设定了最低报告标准。需要包含这些结果的dlb特定评分量表。解决这一差距是DLB研究的战略重点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Alzheimer''s and Dementia: Translational Research and Clinical Interventions Medicine-Psychiatry and Mental Health

CiteScore

10.10

自引率

2.10%

发文量

134

审稿时长

10 weeks

期刊介绍： Alzheimer''s & Dementia: Translational Research & Clinical Interventions (TRCI) is a peer-reviewed, open access,journal from the Alzheimer''s Association®. The journal seeks to bridge the full scope of explorations between basic research on drug discovery and clinical studies, validating putative therapies for aging-related chronic brain conditions that affect cognition, motor functions, and other behavioral or clinical symptoms associated with all forms dementia and Alzheimer''s disease. The journal will publish findings from diverse domains of research and disciplines to accelerate the conversion of abstract facts into practical knowledge: specifically, to translate what is learned at the bench into bedside applications. The journal seeks to publish articles that go beyond a singular emphasis on either basic drug discovery research or clinical research. Rather, an important theme of articles will be the linkages between and among the various discrete steps in the complex continuum of therapy development. For rapid communication among a multidisciplinary research audience involving the range of therapeutic interventions, TRCI will consider only original contributions that include feature length research articles, systematic reviews, meta-analyses, brief reports, narrative reviews, commentaries, letters, perspectives, and research news that would advance wide range of interventions to ameliorate symptoms or alter the progression of chronic neurocognitive disorders such as dementia and Alzheimer''s disease. The journal will publish on topics related to medicine, geriatrics, neuroscience, neurophysiology, neurology, psychiatry, clinical psychology, bioinformatics, pharmaco-genetics, regulatory issues, health economics, pharmacoeconomics, and public health policy as these apply to preclinical and clinical research on therapeutics.