A core outcome set (COS) for dementia with Lewy bodies

Abstract

AbstractBackgroundMethodological heterogeneity in the outcome measurements adopted in DLB trials impedes effective evidence synthesis, rigorous meta‐analysis, and clinical translation. We aimed to develop a Core Outcome Set (COS), an agreed standardised set of outcomes that should be measured and reported, as a minimum, in all clinical DLB trials.MethodWe adopted a multi‐faceted approach to COS development, adopting the principles of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. We conducted systematic reviews of outcomes used in intervention trials, qualitative studies, and health economic studies in DLB. A resulting shortlist of outcome measures formed the basis of an e‐Delphi consensus process, piloted among members of the study group, before it was administered in two rounds to clinicians, scientists, policy and third sector leads. Lay stakeholders, including people with DLB and their caregivers, also contributed to the e‐Delphi process. Consensus on inclusion was determined by at least 70% of respondents grading an outcome measure as “critical for inclusion” and less than 15% grading as “not important”. After appraisal of each outcome using Consensus‐based Standards for the selection of health Measurement Instruments (COSMIN) guidelines, a consensus meeting was conducted, in which all participants were invited to agree on final outcomes and rate each outcome on impact, relevance and clinical feasibility.ResultsThrough validated mechanisms we constructed a COS including measurements of motor, cognitive, neuropsychiatric, autonomic, health economic, health provision, and quality of life. A diverse group of international and intersectional stakeholders have lent approval to its use.ConclusionWe propose a COS; a benchmark which all DLB trials should meet. This standardised approach will could optimise research resources, facilitate multicentre collaboration, and minimize methodological bias.