Developing a core outcome set for intervention studies in post stroke cognitive impairment (COS-PSCI): a protocol

Introduction: Post-stroke cognitive impairment (PSCI) negatively impacts peoples’ quality of life and functional independence. Its complexity poses challenges for both clinical management and intervention research. Despite global guidelines recommending cognitive assessment for all stroke survivors, there is no consensus on what, when or how to measure PSCI. Intervention studies use varied outcome measures, limiting comparability and clinical translation. Developing a core outcome set (COS) for PSCI could address these challenges by standardising outcome measurement, enhancing comparability across studies and facilitating the translation of research into clinical practice. This study aims to develop a COS for intervention research in PSCI. Methods and analysis: 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 in the published literature. Third, qualitative focus groups with stroke survivors, support persons, and healthcare professionals will further identify outcomes of importance. Fourth, findings from the preceding stages will be synthesised to generate a comprehensive list of candidate outcomes. Fifth, a real-time modified eDelphi survey with key stakeholders will prioritise outcomes and identify those meeting predefined consensus criteria for inclusion in a Core Outcome Set for Post-Stroke Cognitive Impairment (COS-PSCI). Finally, international consensus meetings will be held to 1) finalise the COS-PSCI and 2) select appropriate outcome measurement instruments, guided by the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). Patient and public involvement (PPI) will be embedded throughout all stages of the study. Ethics and dissemination: Ethical approval has been obtained from the University of Limerick Education and Health Sciences Research Ethics Committee (2025_03_18_EHS) and the Health Service Executive Mid-West Research Ethics Committee (REC ref: 0296). Findings will be disseminated via peer-reviewed publications, international stroke conferences, social media platforms and public engagement events. Registration: This study is registered in the Core Outcome Measures for Effectiveness database and is available at https://www.comet-initiative.org/Studies/Details/3508.