Patient-reported outcome measures for atrial fibrillation: systematic review and evaluation of psychometric properties of symptom severity measures

Abstract Background The International Consortium for Health Outcome Measurement (ICHOM) and EHRA advocate collection of patient-reported outcomes (PROs) for benchmarking AF care. However, concerns over the robustness of available patient-reported outcome measures (PROMs) limits routine collection in clinical practice. Purpose This systematic review aimed to (1) identify PROMs used to evaluate seven PROs (health related quality-of-life (HRQoL), physical, emotional and cognitive function, symptom severity, exercise tolerance and ability to work) recognised as important quality indicators of care in patients with AF and (2) appraise measurement properties of identified symptom severity PROMs. Methods Six bibliographic databases were searched from inception until 2-February-2024. Full-text publications in all languages investigating ≥1 measurement property of PROMs in AF patients aged ≥18 years were eligible. The Consensus based Standards for the selection of health Measurement Instruments (COSMIN) recommendations appraised and synthesised measurement properties and risk-of-bias of symptom severity PROMs. Results 653 eligible publications identified 94 PROMs: 37 PROMs assessed HRQoL, 25 assessed emotional function, 9 physical function, eight exercise tolerance, seven on symptom severity, six for cognitive function and two assessed ability to work. Six symptom severity PROMs (AFSymp, AFS/B, AFSS, ASTA, AF6 and SCL) underwent psychometric property evaluation. ASTA, AFSymp and SCL demonstrated evidence of sufficient content validity and at least low-quality evidence for sufficient internal consistency. ASTA was the most validated PROM and exhibited the greatest level of certainty in evidence quality across assessed psychometric properties. COSMIN assessments revealed critical gaps in responsiveness, which was evaluated only for AF6. Cross-cultural validity was not assessed by any included study. Further, due to the paucity of robust methodological studies for all included PROMs, measurement properties were often rated as indeterminate, with low certainty in the quality of evidence. Conclusions Although ASTA emerged as the most robust symptom severity PROM, evaluation of all its psychometric properties was constrained by limited study availability. Further validation of PROMs identified for other PROs by COSMIN guidelines is recommended prior to their routine integration in AF care. Future validation studies should address responsiveness, interpretability, feasibility and cross-cultural validity to ensure PROMs reliably reflect patients' experiences and detect meaningful clinical changes across diverse populations.