Developing a core outcome set (COS) for Dementia with Lewy bodies (DLB)

Emilia Grycuk; Emily Eichenholtz; Dag Aarsland; Sara Betzhold; Gillian Daly; Rachel Fitzpatrick; Ann-Kristin Folkerts; Elke Kalbe; Joseph Pm Kane; Irina Kinchin; Ian J Saldanha; Valerie Smith; John-Paul Taylor; Rachel Thompson; Iracema Leroi

doi:10.12688/hrbopenres.13590.2

Developing a core outcome set (COS) for Dementia with Lewy bodies (DLB)

HRB Open Res. 2023 Oct 10:5:57. doi: 10.12688/hrbopenres.13590.2. eCollection 2022.

Authors

Affiliations

¹ Department of Psychiatry, School of Medicine, Trinity College Dublin, Ireland.
² Trinity College Institute of Neuroscience, Trinity College Dublin, Ireland.
³ Institute of Psychiatry, Psychology and Neuroscience, King's College, London, UK.
⁴ School of Medicine, Trinity College Dublin, Ireland.
⁵ Medical Psychology | Neuropsychology and Gender Studies & Centre for Neuropsychological Diagnostics and Intervention (CeNDI), Faculty of Medicine and University Hospital Cologne, University of Cologne, Germany.
⁶ Centre for Public Health, Queens University Belfast, Northern Ireland, UK.
⁷ Global Brain Health Institute, and Centre for Health Policy and Management, Trinity College, Dublin, Ireland.
⁸ Brown School of Public Health, Brown University, USA.
⁹ School of Nursing and Midwifery, Trinity College, Dublin, Ireland.
¹⁰ Translational and Clinical Research Institute, Newcastle University, UK.
¹¹ Dementia U.K., Aldgate, UK.
¹² Lewy Body Society U.K., Wigan, UK.
¹³ Global Brain Health Institute, and Department of Psychiatry, Trinity College Dublin, Ireland.

Abstract

Background: Dementia with Lewy bodies (DLB) is an important cause of dementia with a range of clinical manifestations, including motor, neuropsychiatric, and autonomic symptoms. Compared with more common forms of dementia such as Alzheimer's disease, DLB has been the focus of significantly fewer treatment studies, often with diverse outcome measures, making comparison and clinical implementation difficult. A core outcome set (COS) can address this by ensuring that data are comparable, relevant, useful, and usable for making the best healthcare decisions. Methods: Using a multi-stage approach, development of the DLB-COS will include the following stages: (1) A systematic review, following PRISMA guidelines to create an initial long list of outcomes; (2) A two-round online Delphi including clinicians, scientists, policymakers, and individuals with lived experience of DLB and their representatives; (3) An online consensus meeting to agree on the final core list of outcomes (the final DLB-COS) for use in research and clinical practice; (4) A systematic review to identify appropriate measurement instruments for the DLB-COS outcomes; (5) A final consensus meeting of the professional stakeholders who attended the online consensus meeting to agree on the instruments that should be used to measure the outcomes in the DLB-COS; and (6) Global dissemination. Discussion: This is a multi-stage project to develop a COS to be used in treatment trials for DLB. A DLB-COS will ensure the selection of relevant outcomes and will identify the instruments to be used to measure DLB globally. Keywords: Dementia, Dementia with Lewy Bodies, Core Outcome Set, Delphi, Systematic Review, Ageing, Cognition, Memory.

Keywords: Ageing; Cognition; Core Outcome Set; Delphi; Dementia; Dementia with Lewy Bodies; Memory; Systematic Review.

Grants and funding

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)