Background: Current evidence on the effect of nutritional interventions in delaying or preventing cognitive impairment and dementia remains limited and heterogeneous due to a lack of standardized outcome measures. To address this gap, we aim to develop a Core Outcome Set (COS) for nutritional interventions aimed at delaying or preventing cognitive impairment and dementia among adults (aged 18 years and older) across the cognitive health spectrum (from cognitively healthy individuals to those with mild cognitive impairment or dementia), and to identify the most appropriate instruments for measuring those outcomes.
Objectives: 1) To identify potential outcomes for nutritional interventions aimed at delaying or preventing cognitive impairment and dementia in adults. 2) To prioritize outcomes for inclusion in the final COS. 3) To identify existing measurement instruments and recommend the most appropriate instrument for each outcome included in the COS.
Methods: The development of our COS project will be guided by the Core Outcome Measures in Effectiveness Trials (COMET) Initiative Handbook and the COS–STAndards for Development (COS-STAD) recommendations. This study will combine scoping reviews, qualitative interviews with healthcare providers and people with lived experience, Delphi process, and face-to-face consensus meetings.
Potentially relevant COS: Core Outcome Set for Non-Pharmacological Community-Based Health and Social Care Interventions for Dementia (https://www.comet-initiative.org/Studies/Details/1518). The scope of these interventions includes psycho-social interventions; psychological interventions; social programmes (e.g., a memory café); case management/care coordination interventions; assistive technology; arts-based activities; and educational programmes (https://doi.org/10.1093/ageing/afaa015). This non-pharmacological COS does not include nutritional interventions. Therefore, our proposed COS remains unique, relevant, and necessary.
Leticia Radin Pereira. Department of Community Health Sciences, Cumming School of Medicine. University of Calgary, Canada (Principal Investigator).
Mario Siervo. Curtin School of Population Health, Faculty of Health Sciences. Curtin Medical Research Institute. Curtin University, Australia.
Alexandra Johnstone. The Rowett Institute, School of Medicine. University of Aberdeen, Scotland.
Disease Category: Neurology
Disease Name: Dementia
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Diet and nutrition
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Literature review
The COMET Initiative Handbook and the COS-STAD recommendations will guide the study. A scoping review and qualitative interviews with key knowledge users—including healthcare providers and people with lived experience of dementia (i.e., patients and family members or caregivers)—will be conducted to generate a list of outcomes. A modified Delphi process will then be used to prioritize the outcomes. This will be followed by a face-to-face consensus meeting with key knowledge users to define the final Core Outcome Set. Finally, we will identify existing instruments for measuring each outcome and evaluate their measurement properties and feasibility through a literature review and a subsequent consensus meeting to recommend the most appropriate instruments.