DEVELOPMENT AND VALIDATION OF A NEW DISEASE SPECIFIC QUALITY OF LIFE MEASURE FOR ATRIAL FIBRILLATION DERIVED FROM PATIENT PERSPECTIVES: THE ATRIAL FIBRILLATION PATIENT-REPORTED OUTCOME MEASURES (AF-PROMS) QUESTIONNAIRE

Abstract Background Atrial Fibrillation (AF) is the most common cardiac arrhythmia, significantly impacting patients’ quality of life (QoL) by affecting their physical, psychological, and social well-being. Existing tools lack a comprehensive, AF-specific approach to health-related QoL (HRQoL) that involves patients in the development process from the outset. Purpose This study aimed to develop and validate a novel, AF-specific patient-reported outcome measure (PROM) designed to assess HRQoL in patients with AF. Methods A prospective, observational study was conducted at two centres in the UK, with 895 participants enrolled. Extensive patient and public involvement (PPI), conducted through focus groups and qualitative interviews, played a key role in guiding item generation and domain selection to ensure content validity, as outlined in Fig. 1. Results Tool development involved focus groups for item generation, followed by expert review and qualitative interviews for content and face validity, resulting in a draft questionnaire with 28 items. Statistical item reduction was applied during the pilot (n = 265) and field validation (n = 550). Exploratory factor analysis identified 5 optimal factors explaining 65.15% of the variance, with excellent sampling adequacy (KMO = 0.923) and significant Bartlett’s Test of Sphericity (P < 0.001), confirming data suitability (Fig. 2). Clinical review refined this into a 3-factor model: Physical Symptoms [F1], Social Wellbeing and Activities of Daily Living [F2], and Psychological/Treatment Concerns [F3] (Table 1). Confirmatory factor analysis demonstrated excellent internal consistency (Cronbach’s alpha F1 = 0.89, F2 = 0.92, F3 = 0.9) and strong test–retest reliability (Inter class correlation >0.97). The tool was highly responsive to clinical changes, especially post-catheter ablation, with moderate to large effect sizes (Cohen’s d ≥ 1.0 for overall score) (Fig. 3). Known-group validity was supported by significant score differences (P < 0.01) between healthy volunteers and AF patients across all domains (Table 2). Conclusion AF-PROMs is the first AF-specific QoL tool developed with the largest participant cohort to date and patient collaboration from the outset. Its strengths include extensive PPI, high reliability, and sensitivity to clinical interventions, making it a valuable and practical tool for improving patient-centred outcomes in both clinical practice and research.