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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Developing a core outcome set for people living with dementia at home in their neighbourhoods and communities: study protocol for use in the evaluation of non-pharmacological community-based health and social care interventions

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Andrew J. E. Harding, Hazel Morbey, Faraz Ahmed, Carol Opdebeeck, Ying-Ying Wang, Paula Williamson, Caroline Swarbrick, Iracema Leroi, David Challis, Linda Davies, David Reeves, Fiona Holland, Mark Hann, Ingrid Hellström, Lars-Christer Hydén, Alistair Burns, John Keady, Siobhan Reilly
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Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2584-9) contains supplementary material, which is available to authorized users.

Abstract

Background

The key aim of the study is to establish an agreed standardised core outcome set (COS) for use when evaluating non-pharmacological health and social care interventions for people living at home with dementia.

Methods/design

Drawing on the guidance and approaches of the Core Outcome Measures in Effectiveness Trials (COMET), this study uses a four-phase mixed-methods design:
1
Focus groups and interviews with key stakeholder groups (people living with dementia, care partners, relevant health and social care professionals, researchers and policymakers) and a review of the literature will be undertaken to build a long list of outcomes.
 
2
Two rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi surveys and participation processes will be developed and informed through substantial member involvement with people living with dementia and care partners. A consensus meeting will be convened with key participant groups to discuss the key findings and finalise the COS.
 
3
A systematic literature review will be undertaken to assess the properties of tools and instruments to assess components of the COS. Measurement properties, validity and reliability will be assessed using the Consensus-based Standards for the Selection of Health Measurement (COSMIN) and COMET guidance.
 
4
A stated preference survey will elicit the preferences of key stakeholders for the outcomes identified as important to measure in the COS.
 

Discussion

To the best of our knowledge, this study is the first to use a modified Delphi process to involve people living with dementia as a participant group. Though the study is confined to collecting data in the United Kingdom, use of the COS by researchers will enhance the comparability of studies evaluating non-pharmacological and community-based interventions.

Trial registration

The study is registered on the COMET initiative, registered in 2014 at comet-initiative.​org.
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