Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2018

Open Access 01-12-2018 | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2018

Login to get access

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.
Appendix
Available only for authorised users
Footnotes
1
Care partners is the term selected by involvement groups in work programme 1 of the Neighbourhoods and Dementia study to refer to those who look after, support and care for someone living with dementia, in a non-professional unpaid capacity. This may be a family member, friend or neighbour.
 
Literature
1.
Alzheimer’s Society. Support. Stay. Save. Care and Support of People with Dementia in Their Own Homes. London: Alzheimer's Society; 2011.
2.
3.
Department of Health. Living Well with Dementia: A National Dementia Strategy. Leeds: Department of Health; 2009.
4.
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.
5.
Department of Health. Quality Outcomes for People with Dementia: Building on the Work of the National Dementia Strategy. 2010.
6.
Katona C, Livingston G, Cooper C, Ames D, Brodaty H, Chiu E. International Psychogeriatric Association consensus statement on defining and measuring treatment benefit in dementia. Int Psychogeriatr. 2007;19(3):345–54.
7.
Webster L, Groskreutz D, Grinbergs-Saull A, Howard R, Brien J, Mountain G, et al. Core outcome measures for interventions to prevent or slow the progress of dementia for people living with mild to moderate dementia: systematic review and consensus recommendations. PLoS One. 2017;12(6):e0179521.
8.
Nishant Verma S, Beretvas N, Pascual B, Masdeu JC, Markey MK. The Alzheimer's disease neuroimaging initiative. New Scoring methodology improves the sensitivity of the Alzheimer's Disease Assessment Scale – Cognitive subscale (ADAS-Cog) in clinical trials. Alzheimers Res Ther. 2015;7:1–17.CrossRef
9.
10.
Bonifacio G, Zamboni G. Brain imaging in dementia. Postgrad Med J. 2015;92:333–40.CrossRef
11.
Jekel K, Damian M, Wattmo C, Hausner L, Bullock R, Connelly PJ, et al. Mild cognitive impairment and deficits in instrumental activities of daily living: a systematic review. Alzheimers Res Ther. 2015;7:1–20.CrossRef
12.
Saxton J, Snitz BE, Lopez OL, Ives DG, Dunn LO, Fitzpatrick A, et al. Functional and cognitive criteria produce different rates of MCI and conversion to dementia. J Neurol Neurosurg Psychiatry. 2009;80:737–43.CrossRefPubMedPubMedCentral
13.
Cummings J. The Neuropsychiatric Inventory Questionnaire: background and administration. Mary S. Easton Center for Alzheimer's Disease Research: Los Angeles; 1994.
14.
Banerjee S. DEMQOL a patient reported outcome measure for use in dementia – development to address the need for evaluations of cost effectiveness as well as clinical effectiveness. J Ment Health Policy Econ. 2012;15:S1.
15.
Moniz-Cook E, Vernooij-dassen M, Woods R, Verhey F, Chattat R, Vugt MD, et al. A European consensus on outcome measures for psychosocial intervention research in dementia care. Aging Ment Health. 2008;12:14–29.CrossRefPubMed
16.
17.
Sansoni J, Marosszeky N, Jeon Y-H, Chenoweth L, Hawthorne G, King M, et al. Final Report: Dementia Outcomes Measurement Suite Project. Wollongong: University of Wollongong; 2007.
18.
Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13:132–9.CrossRefPubMedPubMedCentral
19.
Bamford C, Bruce E. Defining the outcomes of community care: the perspectives of older people with dementia and their carers. Ageing Soc. 2000;20:543–70.CrossRef
20.
Corbett J, d'Angelo C, Gangitano L, Freeman J. Future of Health. Findings from a Survey of Stakeholders on the Future of Health and Healthcare in England. Cambridge: RAND Europe; 2017.CrossRef
21.
Gorst SL, Gargon E, Clarke M, Smith V, Williamson PR. Choosing important health outcomes for comparative effectiveness research: an updated review and identification of gaps. PLoS One. 2016;11:e0168403.CrossRefPubMedPubMedCentral
22.
Sinha I, Smyth R, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trial: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393.
23.
Healthcare at Home. Dementia Care: Understanding Out-of-hospital Dementia Care. 2011.
24.
Keady J. Neighbourhoods and dementia: an introduction to the study. J Dementia Care. 2014;22(6):12–13.
25.
Morgan D, Krueger R. When to use focus groups and why. In: Morgan D, editor. Successful focus groups. London: Sage Publications; 1993.
26.
27.
Hellström I, Nolan M, Nordenfelt L, Lundh U. Ethical and methodological issues in interviewing persons with dementia. Nurs Ethics. 2007;14:608–19.CrossRefPubMed
28.
Ritchie J, Lewis J, Elam G. Designing and selecting samples. In: Ritchie J, Lewis J, editors. Qualitative research practice. London: Sage; 2009.
29.
McNair AGK, Whistance RN, Forsythe RO, Macefield R, Rees J, Pullyblank AM, et al. Core outcomes for colorectal cancer surgery: a consensus study. PLoS Med. 2016;13:e1002071.CrossRefPubMedPubMedCentral
30.
Colucci E. Focus groups can be fun. The use of activity-oriented questions in focus group discussions. Qual Health Res. 2007;17:1422–33.CrossRefPubMed
31.
Stewart DW, Shamdasani PN, Rook DW. Focus groups. Thousand Oaks: Sage Publications; 2007.CrossRef
32.
Wood C. Co-produced and patient reported experience outcomes for dementia: a report. London: Health Innovation Network South London; 2014.
33.
Keeley T, Williamson P, Callery P, Jones LL, Mathers J, Jones J, et al. The use of qualitative methods to inform Delphi surveys in core outcome set development. Trials. 2016;17:230.CrossRefPubMedPubMedCentral
34.
Jones JE, Jones LL, Keeley TJH, Calvert MJ, Mathers J. A review of patient and carer participation and the use of qualitative research in the development of core outcome sets. PLoS One. 2017;12:e0172937.CrossRefPubMedPubMedCentral
35.
36.
37.
Scottish Dementia Working Group Research Sub-Group UK. Core principles for involving people with dementia in research: innovative practice. Dementia (London). 2014;13:680–5.CrossRef
38.
39.
Keeley T, Khan H, Pinfold V, Williamson P, Mathers J, Davies L. Core outcome sets for use in effectiveness trials involving people with bipolar and schizophrenia in a community-based setting (PARTNERS2): study protocol for the development of two core outcome sets. Trials. 2015;16:47. https://​doi.​org/​10.​1186/​s13063-015-0553-0.
40.
41.
Mokkink L, Terwee C, Patrick D, ALsonso J, Knol D, Bouter L, et al. COSMIN checklist manual. Netherlands: VU University Medical Center; 2012.
42.
Burr J, Kilonzo M, Vale L, Ryan M. Developing a preference-based glaucoma utility index using a discrete choice experiment. Optom Vis Sci. 2007;84(8):797–808
43.
Bowen A, Hesketh A, Patchick E, Young A, Davies LM, Vail A, et al. Clinical effectiveness, cost-effectiveness and service users’ perceptions of early, well-resourced communication therapy following a stroke: a randomised controlled trial (the ACT NoW study). Health Technol Assess. 2012;16:1–160.CrossRefPubMed
Metadata
Title
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
Authors
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
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Trials / Issue 1/2018
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-2584-9

Other articles of this Issue 1/2018

Trials 1/2018 Go to the issue

Research

Patients’ reasoning regarding the decision to participate in clinical cancer trials: an interview study

Study protocol

Effects of transcranial direct current stimulation on gait in people with Parkinson’s disease: study protocol for a randomized, controlled clinical trial

Study protocol

High-intensity versus low-intensity noninvasive positive pressure ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease (HAPPEN): study protocol for a multicenter randomized controlled trial

Study protocol

Baby Steps – a structured group education programme with accompanying mobile web application designed to promote physical activity in women with a history of gestational diabetes: study protocol for a randomised controlled trial

Study protocol

Operative Treatment of Intra-Articular Distal Radius Fractures With versus Without Arthroscopy: study protocol for a randomised controlled trial

Study protocol

The effects of Kinesiotape on acute lateral ankle sprain: study protocol for a randomized controlled trial