Abstract
AIM: This study aimed to develop a tool for assessing the willingness of patients with acute ischemic stroke (AIS) and high-risk populations to undergo intravenous thrombolysis, and to evaluate its validity and reliability. DESIGN: The study aimed to validate an instrument for assessing intent and was conducted in three phases. Initially, items were generated through a comprehensive literature review, qualitative interviews, and brainstorming sessions. In Phase 1, two rounds of Delphi correspondence consultation and a preliminary survey were conducted to refine the items and evaluate their readability, involving 16 experts and 64 patients. In Phase 2, a cross-sectional survey was administered in Zhengzhou, Henan Province, from March to April 2024, to screen items and assess the instrument's reliability and validity. Approximately 166 subjects participated, with 40 participants completing the questionnaire again after 2 weeks to verify the scale's test-retest reliability. In Phase 3, data were collected from approximately 217 participants at the same location to perform CFA and criterion-related validity analysis during May and June 2024. RESULTS: A 12-item thrombolytic intention assessment scale was developed, consisting of one overall evaluation item and three dimensions. The scale showed strong internal consistency, with a Cronbach's α coefficient of 0.915, and demonstrated high reliability, as evidenced by split-half and test-retest reliability coefficients of 0.905 and 0.872, respectively. Exploratory Factor Analysis (EFA) identified three common factors that, after rotation, accounted for 53.601% of the variance. Confirmatory Factor Analysis (CFA) confirmed the scale's satisfactory convergent and discriminant validity. The correlation coefficients between the AISPITIS and both the TCDHLS and the perceived risk of hemorrhagic complications following thrombolysis were 0.447 (p < 0.001) and -0.302 (p < 0.001), respectively. The scale proved to be user-friendly and efficient in evaluating the intent for IVT in patients with AIS and those at elevated risk for AIS. PATIENT OR PUBLIC CONTRIBUTION: Patients with AIS and high-risk populations participated in qualitative interviews and questionnaire surveys to support the development and validation of the scale. No further involvement in study design or result interpretation was conducted.