Taiwan Post-Stroke Disability Study

Study Design T-PODS follows a prospective cohort study design to achieve its objectives. A total of 2,000 patients will be recruited across 14 medical centers, with competitive enrollment. Data will be collected at baseline, 3 months, and 12 months post-enrollment through questionnaires, assessment scales, and imaging analyses to comprehensively determine the prevalence, risk factors, and long-term trends of various dimensions of post-stroke disability in the Taiwanese population. Eligible patients will be screened at each participating hospital. Enrollment will occur either during hospitalization for acute stroke or during follow-up outpatient visits after discharge. However, enrollment will not take place in the emergency department. While there is no strict minimum time required before enrollment after an acute stroke, patients should be recruited within one month of stroke onset, as soon as their general medical and neurological conditions have stabilized. The preferred baseline visit is between 7 and 30 days post-stroke, depending on the severity of the stroke. Follow-up evaluations will be conducted during outpatient clinic visits at 3 and 12 months post-stroke, with a permissible window of ±14 days for scheduling.

Assessment module The study assessment involves three primary module, questionnaires and scales assessment, brain MRI, and blood sample collection (Figure 1). Of them, questionnaires and scales assessment and blood sample collection will take place at baseline, 3 months, and 12 months visit, while brain MRI is arranged at baseline and 12 month visit. Questionnaires and Scales Assessment encompasses six domains, including motor, swallowing, cognition, depression, epilepsy, and quality of life. Each session of assessment takes approximately 40 minutes. Specific items include the following (Table 2).

If the participant has undergone a brain MRI at baseline, a follow-up brain MRI will be scheduled at one year post-enrollment (within a three-month window) to evaluate the impact of stroke on brain structure. Of note, all patients with diagnosis of ischemic stroke will require a baseline MRI before enrollment, while patients with diagnosis of ICH may only have CT at baseline. The MRI procedure will take approximately 40 minutes. The MRI scanning protocol is not strictly mandated and can be conducted according to the clinical routine of each hospital. However, it must include an iron-sensitive sequence (e.g., susceptibility-weighted imaging, T2\* or gradient echo). At baseline, a single 10 mL blood sample will be collected from a peripheral vein to conduct genetic and molecular biomarker studies related to stroke.

Besides the above disability assessment, brain MRI, and blood samples, the research team will complete a case report form for each participant at baseline, 3 months, and 12 months post-enrollment through medical record review to collect key relevant clinical information. The following paragraph will briefly introduce each assessment tool.