Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for oral health services research involving dependent older adults

General Information

Summary:
Background
Older people (defined as those over sixty-five years of age) are now retaining most of their natural teeth. As this population group were not exposed to the preventive effects of fluoride toothpaste when they were young, dental decay is becoming a major public health issue, with up to 40% experiencing new and active disease. As older people become increasingly dependent, their diet can deteriorate and access to services becomes problematic. Research shows poor oral health impacts on older people’s quality of life, their self-esteem, general health and nutritional status. The majority of dental diseases can be prevented; however, there is currently a lack of provision for the prevention of oral disease in dependent older people.

The World Health Organisation’s report on healthy aging, calls for the design of systems of care that are fit-for-purpose and evidence-based. People’s emotional and practical response to challenges in health and well-being and the responsiveness of systems to their need is crucial to improve the quality of service provision. Furthermore, the selection of appropriate outcomes is essential when designing clinical trials to directly compare the effects of different health service models.

The aim of this study is to develop a set of core outcomes for oral health services research involving dependent older adults.

Method
To identify potentially relevant outcomes, a systematic review of previous studies examining the effect of prevention interventions to improve the oral health of dependent older adults is being undertaken (Brocklehurst et al., 2016). A consensus process involving panel meetings, a Delphi survey, Nominal Group Techniques and individual interviews will then be conducted with key stakeholders, to generate a set of agreed standardised core outcomes. To facilitate this, the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist will be used, and the scale proposed by GRADE will be employed at the final consensus stage when stakeholders will be asked to score each of the outcomes gleaned from previous stages of the process. Stakeholders involved in the development will include dependent older adults, patients, carers, care-home managers, clinical researchers, Dentists, Dental Commissioners, Consultants in Dental Public Health and Restorative Dentistry, Geriatricians, Dieticians and policy makers.

Discussion
The consensus approach will provide a set of agreed standardised core outcomes for oral health service research involving dependent older adults. Ultimately the core outcome set identified will improve the design, conduct and reporting of clinical trials, and help strengthen the evidence base for the provision of high quality oral health care services for dependent older adults.

Contributors:
Dr Gerald McKenna (PI), Centre for Public Health, Queen's University Belfast
Professor Paul Brocklehurst, NWORTH Clinical Trials Unit, Bangor University
Dr Sinead Watson, Centre for Public Health, Queen's University Belfast

Further Study Information

Current Stage:
Ongoing
Date:
January 2018 - 2019
Funding source(s):
None

Health Area

Disease Category
Dentistry & oral health

Disease Name
N/A

Target Population

Age Range
65 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus meeting
Delphi process
Interview
Nominal group technique (NGT)
Systematic review

To identify potentially relevant outcomes, a systematic review of previous studies examining the effect of prevention interventions to improve the oral health of dependent older adults is being undertaken (Brocklehurst et al., 2016). A consensus process involving panel meetings, a Delphi survey, Nominal Group Techniques and individual interviews will then be conducted with key stakeholders, to generate a set of agreed standardised core outcomes. To facilitate this, the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist will be used, and the scale proposed by GRADE will be employed at the final consensus stage when stakeholders will be asked to score each of the outcomes gleaned from previous stages of the process. Stakeholders involved in the development will include dependent older adults, patients, carers, care-home managers, clinical researchers, Dentists, Dental Commissioners, Consultants in Dental Public Health and Restorative Dentistry, Geriatricians, Dieticians and policy makers.


Stakeholders Involved

Clinical experts
Consumers (caregivers)
Consumers (patients)
Policy makers
Researchers
Service commissioners
Service providers
Service users

Study Type

COS for clinical trials or clinical research

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