Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for medicines management interventions for people with dementia in primary care

General Information

Summary:
Over two-thirds of people with dementia (PWD) currently live in the community setting, and many are often supported by carers. Medicines management, encompassing the whole process from prescribing and dispensing through to adherence and review of medication, is complex and this complexity increases in those with cognitive impairment. The importance of appropriate medicines management for PWD has been acknowledged by the literature. The development of a COS for medicines management in dementia is part of a larger study to develop a comprehensive medicines management intervention for PWD in primary care. The COS will be used in a feasibility study to test this intervention, and will be applicable to other studies assessing the effectiveness of medicines management interventions in PWD.

The aim of this study is to develop a COS for medicines management interventions for PWD in primary care.

The objectives of the study are to:
1.Conduct a systematic review to identify outcomes currently used in randomised controlled trials assessing the effectiveness of medicines management interventions in PWD.
2.Identify outcomes of importance to key stakeholders in dementia care by means of semi-structured interviews with healthcare professionals, patients and carers.
3.Condense the outcomes identified through the systematic review and interviews with stakeholders through a Delphi exercise completed by a panel of experts.

Contributors:
Professor Carmel Hughes, School of Pharmacy, Queen's University Belfast (QUB)
Mairead McGrattan, School of Pharmacy, QUB
Dr Cristín Ryan, School of Pharmacy, Royal College of Surgeons in Ireland
Dr Heather Barry, School of Pharmacy, QUB
Professor A. Peter Passmore, QUB & Belfast Health and Social Care Trust
Professor A. Louise Robinson, University of Newcastle and Institute for Ageing
Dr Gerard Molloy, National University of Ireland, Galway
Dr Janine A. Cooper, Ulster University
Ms. Carmel Darcy, Western Health and Social Care Trust
Dr Hilary Buchanan, Alzheimer’s Society


Further Study Information

Current Stage:
Planning
Date:
October 2015 - April 2017
Funding source(s):
Department for Education and Learning

Health Area

Disease Category
Health care of older people

Disease Name
Dementia

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Medicines Management Interventions

Method(s)

Delphi process
Interview
Systematic review

Outcomes will be identified through a review of the current literature, and through interviews with people with dementia, their carers, community pharmacists, and general practitioners (GPs).

These outcomes will be presented to a panel of experts, via three sequential web-based questionnaires. Participants will be asked to rate each outcome using the scale proposed by the GRADE group (www.gradeworkinggroup.org) in which 1 to 3 rates an outcome ‘of limited importance’, 4 to 6 ‘important but not critical’ and 7 to 9 ‘critical’. Participants will also be given the opportunity to suggest any additional outcomes, during the first round of the questionnaire.

Consensus regarding whether an outcome should be in the COS will be defined as 70% or more of the participants scoring it 7 to 9, and fewer than 15% scoring it as 1 to 3. Exclusion of an outcome will be based on 70% or more scoring it as a 1 to 3, and fewer than 15% scoring it as 7 to 9. All other score distributions will be taken to indicate lack of consensus for inclusion in the COS.

A final agreed list of outcomes to be included in the COS for medicines management interventions for people with dementia living in primary care will be reported.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Researchers

Study Type

COS for clinical trials or clinical research

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