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. 2018 Apr 24;19(1):247.
doi: 10.1186/s13063-018-2584-9.

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

Andrew J E Harding  1 , Hazel Morbey  1 , Faraz Ahmed  1 , Carol Opdebeeck  2 , Ying-Ying Wang  1 , Paula Williamson  3 , Caroline Swarbrick  4 , Iracema Leroi  4 , David Challis  4 , Linda Davies  4 , David Reeves  4 , Fiona Holland  4 , Mark Hann  4 , Ingrid Hellström  5 , Lars-Christer Hydén  5 , Alistair Burns  4 , John Keady  4   6 , Siobhan Reilly  7
Affiliations

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

Andrew J E Harding et al. Trials. .

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 .

Keywords: Community-based programmes; Core outcome set; Delphi method; Dementia; Neighbourhood; Non-pharmacological interventions; Public involvement.

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Conflict of interest statement

Ethics approval and consent to participate

Ethics approval has been obtained from Lancaster University Research Ethics Committee and NHS Research Ethics Committee (Bangor), number 15/WA/0260.

In the phase 1 interviews and focus groups, all participants provided informed consent. For the phase 2 Delphi survey and phase 3 stated preference survey, all participants will be provided with study information and consent will be implied upon submission of the completed surveys.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study design of the development of a core outcome set for evaluating community health and social care interventions for people who live at home with dementia
See this image and copyright information in PMC

References

    1. Alzheimer’s Society. Support. Stay. Save. Care and Support of People with Dementia in Their Own Homes. London: Alzheimer's Society; 2011.
    1. Facts for the media. https://www.alzheimers.org.uk/info/20027/news_and_media/541/facts_for_th.... Accessed 19 Sept 2017.
    1. Department of Health . Living Well with Dementia: A National Dementia Strategy. Leeds: Department of Health; 2009.
    1. Minghella E. Transforming Models of Care for People Living with Dementia. Improving Experiences and Outcomes for People with Dementia and their Carers and Families. Manchester: Dementia Partnerships; 2012.
    1. Department of Health . Quality Outcomes for People with Dementia: Building on the Work of the National Dementia Strategy. 2010.

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