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

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 with dementia living at home. Methods: Drawing on the Core Outcome Measures in Effectiveness Trials (COMET) guidance and approaches this study uses a four phase mixed-methods design: 1 – Focus groups and interviews with key stakeholder groups (people living with dementia, care partners and relevant health and social care professionals, researchers, policy makers) and a review of literature will be undertaken in order to build a ‘long list’ of outcomes. 2 – Two rounds of Delphi surveys will be used with key stakeholder groups. Statements for the Delphi, 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 – Systematic literature reviews 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