Development and validation of a new patient-centred quality of life measure for atrial fibrillation: the AF-PROM questionnaire

Abstract Background Atrial fibrillation (AF) has a significant impact on patients' quality of life (QoL), affecting 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 sought to develop and validate the AF-specific Patient Reported Outcome Measures questionnaire (AF-PROMs), a new, patient-centred tool for assessing HRQoL in individuals with AF. Methods A prospective, observational study was conducted at two centres in the United Kingdom, with 895 participants enrolled. Extensive patient and public involvement (PPI) through focus groups and qualitative interviews guided item generation and domain selection to ensure content validity. Psychometric evaluations encompassed exploratory (EFA) and confirmatory factor analyses (CFA), as well as assessments of reliability, responsiveness, and known-group validity (Figure 1). Ethical approval was obtained from the Nottingham 1 Research Ethics Review Sub-Committee (reference 12/EM/0164), and the study was conducted in compliance with Good Clinical Practice and the Declaration of Helsinki. Results Tool development involved 41 participants in 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 (down from 31). Statistical item reduction was applied during the pilot phase (n=265) and field validation (n=550), with 39 participants excluded due to withdrawal or incomplete responses. EFA identified five optimal factors explaining 65.15% of the variance, with excellent sampling adequacy (KMO = 0.923) and significant Bartlett’s Test of Sphericity (χ² = 5057, p < .001), confirming data suitability. Clinical review refined this into a three-factor model: Physical Symptoms [F1], Social Wellbeing and Activities of Daily Living [F2], and Psychological/Treatment Concerns[F3]. CFA 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). Known-group validity was supported by significant score differences (p < 0.01) between healthy volunteers and AF patients across all domains. Conclusion AF-PROMs is a thoroughly validated, patient-centred tool developed with the largest cohort to date, delivering an in-depth assessment of HRQoL for AF patients. Its distinct advantages, grounded in significant patient involvement, high reliability, and sensitivity to treatment effects, make it an invaluable resource for clinical practice and research focused on improving quality of life in AF.