Background: Post-stroke cognitive impairment (PSCI) affects up to 60% of stroke survivors within the first year, significantly impacting quality of life and independence. It commonly affects attention, memory, processing speed, executive function, language, apraxia, neglect, and visual perception. Despite international guidelines recommending cognitive outcome measurement for all stroke survivors, there is no consensus on what, when, or how to measure PSCI in intervention studies. The use of varied outcome measures limits comparability and clinical translation. This study aims to develop a Core Outcome Set (COS) for PSCI to standardise outcome measurement, improve comparability across studies, and support clinical application.
Rationale for New PSCI COS: Several COS registered with the COMET Initiative relate to stroke or cognitive outcomes, but none fully address the complexity of PSCI. For example, Crocker et al. (2018) planned a Life After Stroke Set of Outcomes (LASSO), which is broad and does not capture PSCI-specific constructs. Trépel et al. (2020) proposed a COS for acquired brain injury, but it is not stroke or cognition-specific. Rowe et al. (2019) focused on visual impairment in stroke, but their COS does not include visual perceptual deficits, which are common to PSCI. Wallace et al. (2019) addressed aphasia through the ROMA consensus, offering partial overlap, but PSCI encompasses a wider range of cognitive domains and impacts to consider. Turner et al. (2023) are developing a COS for mild cognitive impairment (MCI), which differs in aetiology and symptom profile from PSCI. These gaps highlight the need for a dedicated COS to capture the complexity of PSCI, ensure consistent measurement, and enhance the impact of intervention research.
To develop a core outcome set for intervention research with adults experiencing post-stroke cognitive impairment.
Associate Prof. Sara Hayes, Principal Investigator and Supervisor, School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Limerick, Ireland V94t9PX
Sinead Purcell, phD candidate, School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Limerick, Ireland V94t9PX
Prof. Katie Robinson, Supervisor, School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Limerick, Ireland V94t9PX. Health Research Board, Trials Methodology Network, University of Limerick
Prof. Jon Salsberg, Supervisor, School of Medicine, Faculty of Education and Health Sciences, Health Research Institute, University of Limerick, Limerick, Ireland V94t9PX.
Prof. Margeret O’Connor, Consultant Geriatrician, Department of Ageing and Therapeutics, University of Limerick Hospital Group, Limerick, Ireland.
Associate Prof. Annmarie Morrissy, School of Allied Health, Faculty of Education and Health Sciences, Ageing Research Centre, Health Research Institute, University of Limerick, Limerick, Ireland V94t9PX
Disease Category: Heart & circulation, Neurology
Disease Name: Stroke, Post-stroke cognitive impairment
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Charities
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service commissioners
- Service providers
- Service users
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Literature review
This study will follow the Core Outcome Set–STAndards for Development (COS-STAD) framework and will be conducted in six stages. First, a scoping review of intervention studies will identify commonly measured outcomes. Second, a rapid qualitative evidence synthesis will explore outcomes valued by stakeholders as reported in the literature. Third, qualitative focus groups with stroke survivors, support persons, and healthcare professionals will further identify outcomes of importance. In the fourth stage, findings from the previous stages will be synthesised to generate a comprehensive list of candidate outcomes. The fifth stage will involve a real-time modified eDelphi survey with key stakeholders to prioritise outcomes and reach consensus on a Core Outcome Set for Post-Stroke Cognitive Impairment (COS-PSCI). Finally, international consensus meetings will be held to finalise the COS-PSCI and, guided by COSMIN standards, select appropriate outcome measurement instruments. Patient and Public Involvement (PPI) will be embedded throughout all stages of the study. Findings will be disseminated via peer-reviewed publications, international stroke conferences, social media platforms and public engagement events.