Objective: To demonstrate the direct impact patient input had on the study design and execution of the Epitome study (NCT06055725).

Background: It is increasingly accepted that people living with long-term conditions should be involved in the design, conduct and dissemination of research that affects them. EPITOME is a prospective, observational, epidemiological study (7 countries) designed to evaluate the proportion of stroke survivors with paresis who, within 1 year of their stroke, develop ‘problematic’ post-stroke spasticity (PSS) that would benefit from pharmacological therapy.

Method: Expert patient society representatives (patients and caregivers) from the US and Europe provided feedback on the study protocol in order to optimize patient recruitment and engagement during the study.

Results: The study will follow participants (18-85y) presenting with paresis within 2 weeks of a first-ever stroke. Based on patient feedback, the recruitment period was extended from 2 weeks to ≤4 weeks after the stroke event to offer patients and their caregivers more time to consider whether participation in the study was right for them. Participants are monitored remotely at 2 weeks, 1-, 2-, 3-, 6-, 9- and 12-months post stroke to detect the onset of PSS using the Post-stroke Spasticity Monitoring Questionnaire (PSMQ). The PSMQ was edited for plain language and the methods for remote data collection were broadened to allow participants the choice of remote monitoring by telephone calls or electronic questionnaire completion (by themselves or with caregiver assistance, depending on their ability to use equipment and personal preferences). For patients with confirmed PSS, the investigator will assess whether the patient has problematic spasticity that could benefit from pharmacological therapy. Patients endorsed the study definition of problematic spasticity “Spasticity that causes patient impairment, impact on daily functioning, and/or impact on participation” as meaningful.

Conclusion: Patient input on the protocol will aid recruitment and make study participation easier for patients living with PSS.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-patient-input-on-the-study-execution-of-a-prospective-epidemiological-study/