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Development of a Standardised stroke risk assessment for patients with MigraAinous symptoms Reviewed as suspected TIA (SMART): study protocol for a mixed methods study

Lookup NU author(s): Dr Lisa ShawORCiD, Jemma IsaacORCiD, Professor Linda SharpORCiD, Lisa Stuart, Professor Christopher PriceORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© Author(s) (or their employer(s)) 2025. Re-use permitted under CC BY. Published by BMJ Group. BACKGROUND: Transient ischaemic attack (TIA) and migraine can generate identical symptoms but have very different short-term risks of stroke. Uncertainty about the diagnosis may lead to missed opportunities to prevent stroke if TIA is treated as migraine, or overtreatment if migraine is treated as TIA. This project aims to define the risk of stroke for people with migrainous symptoms reviewed as suspected TIA and develop a risk assessment tool that could promote standardisation of care. METHODS AND ANALYSIS: The project involves two interlinked studies:(1) Study A: prospective observational cohort study. SETTING: NHS TIA and stroke services. POPULATION: adults with migrainous symptoms undergoing review for suspected TIA by a TIA/stroke service and the initial specialist clinician symptom-based diagnosis is either possible migraine or possible TIA with migrainous symptoms. DATA COLLECTION: baseline clinical characteristics, investigations and treatments. Stroke, TIA and migraine events within 90 days. SAMPLE SIZE: 2709 participants.Main analyses: analysis of stroke risk, development of stroke risk prediction model, preparation of visual tools to represent the risk model.(2) Study B: qualitative co-design study. SETTING AND POPULATION: clinicians from NHS TIA and stroke services. DATA COLLECTION: focus groups/interviews exploring views about the potential role for a risk assessment tool, the most appropriate visualisation for the risk tool and barriers/facilitators for implementation. SAMPLE SIZE: approximately 16 clinicians. ANALYSES: framework approach using the Implementation Research Logic Model. ETHICS AND DISSEMINATION: This study has ethical, Health Research Authority and participating NHS Trust approvals. Dissemination of study results will include presentations at national and international conferences and events, publication in peer-reviewed journals, and plain English summaries for patient/public engagement activities. TRIAL REGISTRATION NUMBER: ISRCTN16775533.


Publication metadata

Author(s): Shaw L, Isaac J, Scott J, Sharp L, Smyth E, Stuart L, Werring DJ, Price C

Publication type: Article

Publication status: Published

Journal: BMJ Open

Year: 2025

Volume: 15

Issue: 12

Online publication date: 24/12/2025

Acceptance date: 25/11/2025

Date deposited: 05/01/2026

ISSN (print): 2044-6055

ISSN (electronic): 2044-6055

Publisher: BMJ Publishing Group

DOI: 10.1136/bmjopen-2025-113253

PubMed id: 41448715


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Funding

Funder referenceFunder name
National Institute for Health and Care Research (NIHR): Research for Patient Benefit Programme (reference: NIHR206779)
NIHR Newcastle Patient Safety Research Collaboration

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