Mapping and Harmonising Outcomes in Post-Stroke Cognitive Impairment Intervention Trials to Inform Core Outcome Set Development: A Scoping Review Protocol

<ns5:p>Background Post-stroke cognitive impairment (PSCI) affects up to 70% of individuals within the first year after stroke and includes deficits in memory, attention, executive function, processing speed, language, and visuospatial abilities. PSCI significantly reduces independence, quality of life, and participation, making it a key priority for rehabilitation. However, intervention trials in PSCI report highly heterogeneous outcomes and measurement instruments, limiting comparability, hindering evidence synthesis, and impeding the development of a robust evidence base to inform clinical practice. A Core Outcome Set for PSCI (COS-PSCI) is being developed to standardise outcome selection and reporting through a multistage consensus process. This scoping review forms Phase 1 of that programme. Methods This scoping review will systematically map and characterise outcomes reported in PSCI intervention studies published between 2020 and 2025, in accordance with PRISMA-ScR guidance. Searches will be conducted in CINAHL, PsycINFO, PubMed, Scopus, Cochrane CENTRAL, and ClinicalTrials.gov. Eligible studies will include randomised controlled trials, quasi-randomised trials, and trial protocols or registry records evaluating interventions targeting PSCI in adults. Two reviewers will independently screen studies and extract data, with disagreements resolved by consensus. Outcomes will be extracted verbatim and harmonised using a six-stage workflow, including construct-level grouping and mapping to the Core Outcome Measures in Effectiveness Trials (COMET) taxonomy. Conclusions This review will generate a comprehensive, structured, and fully traceable long list of harmonised outcomes to inform COS-PSCI development and underpin a subsequent Delphi consensus study involving people with stroke, carers, clinicians, and researchers.</ns5:p>