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.
Vijayabharathy Kanthasamy, Richard J Schilling, Sarah Horan, Victoria Baker, Nikhil Ahluwalia, Ross J Hunter, Shohreh Honarbakhsh, Malcolm Finlay
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引用次数: 0
Abstract
Background: Atrial fibrillation (AF) significantly affects patients' health-related quality of life (HRQoL), influencing physical, psychological, and social wellbeing. Despite existing tools, there is a notable lack of AF-specific instruments that comprehensively assess HRQoL and are developed in collaboration with patients from the outset.
Objective: This study aimed to develop and validate the AF specific Patient Reported Outcome Measures questionnaire (AF-PROMs), a novel, patient-centered tool designed to measure HRQoL in patients with AF.
Methods: A prospective, observational study was conducted across 2 centers in the United Kingdom, enrolling 856 participants (265 in the pilot phase, 550 in the field-validation phase). Item generation and domain selection were guided by extensive patient and public involvement (PPI), through focus groups and qualitative interviews with patients, ensuring content validity. Psychometric evaluations included exploratory (EFA) and confirmatory factor analyses (CFA), along with assessments of reliability, responsiveness, and known-group validity.
Results: The AF-PROMs tool demonstrated excellent internal consistency across all domains (Cronbach's alpha ≥0.89) and strong test-retest reliability (intraclass correlation coefficient [ICC] >0.97), highlighting its stability. The tool showed robust responsiveness to clinical changes, particularly post-catheter ablation, with moderate to large effect sizes (Cohen's d ≥1.0 for overall score), underscoring its sensitivity to meaningful treatment effects. The 3-factor model achieved a satisfactory fit. Known-group validity was confirmed by significant score differences (P < .01) between healthy volunteers and patients with AF across all domains.
Conclusion: AF-PROMs is a validated, patient-centered instrument, developed with the largest participant group to date, offering a comprehensive assessment of HRQoL in patients with AF. Its unique strengths include extensive patient involvement, high reliability, and sensitivity to clinical interventions, making it a valuable tool for both clinical practice and research in enhancing the measurement of HRQoL in AF.
期刊介绍：
HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability.
HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community.
The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.
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