Key result
AF-PROMs questionnaire demonstrates excellent internal consistency, strong test-retest reliability, and responsiveness to clinical changes.
Why the study?
Existing tools lack AF-specific instruments that comprehensively assess health-related quality of life and are developed in collaboration with patients from the outset.
Is the AF-PROMs questionnaire a valid, reliable, and responsive tool for assessing health-related quality of life in patients with atrial fibrillation?
Observational (n=856)
Yes
Is the AF-PROMs questionnaire a valid, reliable, and responsive tool for assessing health-related quality of life in patients with atrial fibrillation?
Effect estimate: Cohen's d ≥1.0
p-value: p=<0.01
The newly developed AF-PROMs questionnaire is a highly reliable and responsive patient-reported outcome measure for evaluating quality of life in atrial fibrillation patients.
AF-PROMs supports reliable QoL assessment in AF; leaves open routine adoption pending prospective validation.
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.
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Kanthasamy et al. (2025) conducted an observational in Atrial fibrillation (n=856). AF-PROMs questionnaire was evaluated on Psychometric evaluations including internal consistency, reliability, responsiveness, and known-group validity (Cohen's d ≥1.0, p=<0.01). The AF-PROMs questionnaire demonstrated excellent internal consistency (Cronbach's alpha ≥0.89), strong test-retest reliability (ICC >0.97), and responsiveness to clinical changes (Cohen's d ≥1.0).
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