The prevalence and impact of dementia is increasing rapidly, and it has been recognised as a major public health issue in many developed countries. Evidence seems to highlight positive effects of exercise/physical activity interventions for this population, however caution is still needed in the interpretation of the available evidence due to the heterogeneity of methodologies and diverse outcome measures used in the studies. The most recent Cochrane review concluded that it was not possible to establish the impact of exercise on outcomes such as quality of life, mortality and health care costs, as data on these outcomes were either not available or there were no trials assessing these outcomes that met the inclusion criteria.
The development of a core outcome set (COS), aiming to standardise a minimum set of outcomes to be assessed in clinical trials, may be key to minimise reporting bias and allow data synthesis across studies. We propose the development of a COS to evaluate physical activity in people with dementia. This COS will cover exercise/physical activity interventions in all stages of the disease progression and be applicable across settings. This project aims to i) inform the design of clinical trials of exercise/physical activity including people with dementia and ii) provide guidance for health care professionals, assessing exercise/physical activity interventions for people with dementia, regarding the most appropriate outcomes and outcome measures.
Protocol: https://www.magonlinelibrary.com/doi/10.12968/ijtr.2018.25.7.346
PhD student:
Ana Carolina Vieira Goncalves, Clinical Doctoral Research Fellow and Physiotherapist, University of Southampton & Solent NHS Trust, UK.
Supervisory team:
Dinesh Samuel, Acting Programme Leader, Faculty of Health Sciences, University of Southampton, UK.
Sara Demain, Associate Professor, Faculty of Health Sciences, University of Southampton; NIHR Wessex Collaboration for Leadership and Research in Health Care, Southampton, UK.
Alda Marques, Senior Lecturer at School of Health Sciences (ESSUA), University of Aveiro, and Center for Health Technology and Services Research (CINTESIS), University of Aveiro, Aveiro Portugal.
Other collaborators:
Joana Cruz, PhD Student - School of Health Sciences of the University of Aveiro, Portugal.
Disease Category: Neurology
Disease Name: Dementia
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Exercise, Physical
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Delphi process
- Focus group(s)
- Interview
- Systematic review
This COS will be developed in 4 phases and will generate distinct recommendations for the selection of outcomes and outcome measures to be used with people with i) mild to moderate and ii) severe dementia.
Phase 1: A systematic literature review. This literature review will synthesise the outcomes of exercise/physical activity interventions used in primary quantitative, qualitative and mixed methods studies.
Phase 2: A qualitative study using interviews and/or focus groups with different stakeholders.
The two phases described above will generate a comprehensive list of important outcomes of physical activity for people with i) mild to moderate and ii) severe dementia.
Phase 3: A Delphi survey, followed by a consensus meeting, involving different stakeholders aiming to reach consensus on what outcomes should be assessed in exercise/physical activity interventions for people living with dementia (distinctly mild to moderate and severe stages).
Phase 4: A systematic literature review, linking the outcomes agreed in the Delphi survey to the most appropriate outcome measures. This last step will generate recommendations about the suitability of the selected outcome measures based on their psychometric properties.
The final step of a preference survey which determines the preference weightings of the different outcomes/outcome measures will not be achieved during this research project. However it will be suggested as a recommendation for future research, using the COS developed in the present study.