Development and validation of the Life after Stroke questionnaire as a patient-reported outcome measure for stroke survivors living at home

Cerebrovascular disease is a leading cause of death and permanent neurological impairment worldwide. The goal of this study is to develop and validate a patient-reported outcome measure (PROM) that evaluates the daily lives of stroke survivors living at home. The questionnaire was developed using a four-phase procedure based on guidelines from the European Organization for Research and Treatment of Cancer Quality of Life Group. The phases included a literature review, semi-structured interviews with stroke patients, construction of the questionnaire, pre-testing with 20 patients, and validation with 216 patients. The statistical analyses included descriptive statistics, the intraclass correlation coefficient (ICC), Cronbach’s alpha, and Spearman’s rank correlation coefficients. The questionnaire demonstrated high test-retest reliability and strong correlations with established measures (SIS and EQ-5D-3L). The final questionnaire covered topics such as independence in daily activities, psychological and social well-being, and quality of life. The developed PROM “Life after Stroke” is a comprehensive and practical tool for evaluating the lives of stroke survivors who live at home. Its validity and reliability make it suitable for research and routine assessments (initial assessment and documentation of progress in long-term care) by healthcare providers. Trial registration: The study was registered in the German Clinical Trials Register (DRKS Deutsches Register Klinischer Studien) on September 1st, 2022 (DRKSID DRKS00029484).