Patient-Reported Outcomes for Quality of Life Assessment in Atrial Fibrillation: A Systematic Review of Measurement Properties

Dipak Kotecha, Amar Ahmed, Melanie Calvert, Mauro Lencioni, Caroline B Terwee, Deirdre A Lane, Dipak Kotecha, Amar Ahmed, Melanie Calvert, Mauro Lencioni, Caroline B Terwee, Deirdre A Lane

Abstract

Background: Atrial fibrillation is a large and growing burden across all types of healthcare. Both incidence and prevalence are expected to double in the next 20 years, with huge impact on hospital admissions, costs and patient quality of life. Patient wellbeing determines the management strategy for atrial fibrillation, including the use of rhythm control therapy and the clinical success of heart rate control. Hence, evaluation of quality of life is an emerging and important part of the assessment of patients with atrial fibrillation. Although a number of questionnaires to assess quality of life in atrial fibrillation are available, a comprehensive overview of their measurement properties is lacking.

Methods and results: We performed a systematic review of the measurement properties of atrial fibrillation-specific health-related quality of life questionnaires. Methodological quality was assessed using the Consensus based Standards for selection of health Measurement Instruments (COSMIN) checklist, with measurement properties rated for quality against optimal criteria and levels of evidence. We screened 2,216 articles, of which eight articles describing five questionnaires were eligible for inclusion: Atrial Fibrillation 6 (AF6), Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT), Atrial Fibrillation Quality of Life Questionnaire (AFQLQ), Atrial Fibrillation Quality of Life (AFQoL), and Quality of Life in Atrial Fibrillation (QLAF). Good reliability (internal consistency and test-retest reliability) was demonstrated for AF6, AFEQT, AFQLQ and AFQoL. Content, construct and criterion validity were positively rated only in AFEQT. Responsiveness was positively rated only in AFEQT, but with limited evidence. Overall, AFEQT showed strong positive evidence for 2 of 9 measurement properties, compared to one for AFQoL and none for the remaining questionnaires.

Interpretation: Given the low ratings for many measurement properties, no single questionnaire can be recommended, although AFEQT performed strongest. Further studies to robustly assess reliability, validity and responsiveness of AF-specific quality of life questionnaires are required. This review consolidates the current evidence for quality of life assessment in patients with atrial fibrillation and identifies priority areas for future research.

Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form (www.icmje.org/coi_disclosure.pdf) and declare the following, all outside of the submitted work: DK is the lead for the Beta-blockers in Heart Failure Collaborative Group (BB-meta-HF) and the RATE-AF trial, and has received honoraria and research grants from Menarini, professional development support from Daiichi-Sankyo and speaker fees from AtriCure; AA none; MC has received personal fees from Astellas Pharma outside the submitted work, and has received travel awards from the European Society of Cardiology and the Atrial Fibrillation NETwork (AFNET) to attend conferences presenting on the use of PROMs in cardiovascular research and clinical practice; ML has received travel grants from Pfizer, Bayer and Biosense Webster and has been on the speaker bureau for Bayer and Pfizer; CT has not received any funding but is one of the founders of the COSMIN initiative; DAL has received investigator-initiated educational grants from Bayer Healthcare, Bristol Myers Squibb (BMS) and Boehringer Ingelheim, has been on the speaker bureau for Boehringer Ingelheim, Bayer, and BMS/Pfizer and is a consultant for BMS and Boehringer Ingelheim.

Figures

Fig 1. Selection of studies flowchart.
Fig 1. Selection of studies flowchart.
Study inclusion flowchart. See S1 Appendix for search strategy.
Fig 2. Summary of assessment.
Fig 2. Summary of assessment.
For each measurement property, the PROM is assessed for methodological quality of the study (excellent, good, fair or poor) and given an overall rating (positive [+], negative [-] or indeterminate/unknown [?]) for the results. A level of evidence was applied, combining the number and quality of the studies with the strength of findings. Studies that have poor quality are given an ‘indeterminate /unknown’ rating due to the limited level of evidence. For AFQoL, reliability was assessed differently in the two related studies. * Insufficient data were available to rate this criterion. See Table 1 for assessment criteria.

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