Core Outcome Measures in Effectiveness Trials

The development of a Dementia core outcome set for dementia care in the community

General Information

Summary:
The key aim of this study focuses on dementia care and services, and is to establish an agreed standardised set of outcomes that should be included and measured when evaluating interventions or trials, as completed and on-going Cochrane reviews of interventions for people with dementia indicate a high degree of variation in outcome measures, with limited consistency between studies, leading to marked heterogeneity reporting biases. These hinder comparison of findings and meta-analysis and make interpretation of results difficult. The development of a standard core outcome set for dementia interventions/trials is one method proposed to address these issues with a focus on people with dementia living in the community. We also intend to involve a range of stakeholders including people with dementia, carers, healthcare professionals and policy makers to have their perspectives on what outcomes are important and meaningful.

Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2584-9

Contributors:
Principal investigator: Dr Siobhan Reilly, Lancaster University

Affiliations:
Andrew Harding, Lancaster University
Dr Hazel Morbey, Lancaster University
Faraz Ahmed, Lancaster University
Dr Iracema Leroi, University of Manchester
Professor Paula Williamson, University of Liverpool
Professor John Keady, University of Manchester
Professor Lara-Christer Hyden, Linköping University
Dr Caroline Swarbrick, University of Manchester
Dr David Reeves, University of Manchester
Professor Alistair Burns, University of Manchester
Professor Linda Davies, University of Manchester
Professor David Challis, University of Manchester

Further Study Information

Current Stage:
Ongoing
Date:
November 2014 - April 2019
Funding source(s):
Economic and Social Research Council (ESRC) National Institute for Health Research (NIHR)

Health Area

Disease Category
Neurology

Disease Name
Dementia

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Unknown

Method(s)

Delphi process
Focus group(s)
Literature review
Survey
Systematic review

Study design uses COMET guidance and includes a rigorous 4-phase study design of:
Phase 1: Focus group + literature review
Focus groups involve key stakeholder to identify outcomes that are important for dementia care and services in the community.
Reviewing evidence to identify outcomes that reported in current interventions/trials for dementia care.
Phase 2: Delphi Survey
A series of Delphi surveys to reduce the range of potential outcomes, and to reach consensus on the list of outcomes included in the core set.
Phase 3: Systematic review
A systematic review to identify and assess instrument/tools that are used to measure identified outcome in the core set.
Phase 4: Stated Preference survey
Stated preference survey to elicit the preference of key stakeholders for different types of outcomes identified in the core outcome set.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Policy makers

Study Type

COS for clinical trials or clinical research

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