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Development and Validation of the AFSymp™: An Atrial Fibrillation-Specific Measure of Patient-Reported Symptoms

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Abstract

Background

Patients with atrial fibrillation (AF) can be severely incapacitated by symptoms, but validated symptom measures are lacking. The aim of this study was to develop an AF-specific symptom questionnaire (AFSymp™).

Methods

Following a literature review, qualitative interviews with 91 patients (United States [US], n = 30; United Kingdom [UK], n = 16; France, n = 15; Germany, n = 15; Japan, n = 15) with paroxysmal, persistent, and permanent AF were conducted to identify emergent concepts and to develop the items and response options for the AFSymp™. Clinical experts (n = 21) in the US, the UK, France, Germany, and Japan provided feedback on the most clinically relevant symptoms via an email survey. Cognitive interviews with 30 patients were conducted to evaluate content validity. A prospective, observational, psychometric evaluation study (n = 313) consisting of two study visits was performed at 32 sites across the US.

Results

After item reduction, the AFSymp™ consisted of 11 items with a 1-week recall period. Exploratory and confirmatory factor analysis resulted in three subscales (heart symptoms, tiredness, chest discomfort) and two items: dizziness and shortness of breath. Internal consistency was strong across subscales (Cronbach’s α 0.82–0.91). The test–retest reliability of items and subscales was acceptable (intra-class correlation [ICC] 0.58–0.78). The reproducibility of the single global score was strong (ICC 0.78). The construct and known-groups validity was acceptable.

Conclusion

The AFSymp™ demonstrates evidence of reliability and validity as a comprehensive measure of AF symptoms that can be used to assess patient outcomes in clinical and research settings. More research is needed to evaluate the instrument’s responsiveness.

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Acknowledgments

We would like to acknowledge Anders Ingelgård and Daniel Eek, PRO scientists at AstraZeneca, who contributed to conception and design of the studies. Edits and review of the manuscript were provided by Chris Sexton, PhD, research scientist at Evidera.

Competing interest

Conflicts of interest: JM, KH, and KK are or were at the time of this work employees of AstraZeneca; RA and LA were employees of Mapi Values (now known as Adelphi Values), a health outcomes consultancy, and were contracted as consultants to AstraZeneca to conduct the research; and KC is an employee of Evidera (formerly United BioSource Corporation) and a scientific consultant to AstraZeneca in connection with the development of this measure.

Financial support: The study was funded by AstraZeneca.

Authors’ Contribution

JM drafted the manuscript and performed analysis and interpretation of the data. RA, LA, KH, KK, NE, and KC all participated in the design and delivery of the studies and questionnaire, performed analysis, and interpreted data. KC will act as the guarantor on behalf of all authors. All authors read and approved the final manuscript.

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Authors and Affiliations

  1. AstraZeneca R&D, Mölndal, Sweden

    Jennie Medin, Katarina Halling & Karoly Kulich

  2. Adelphi Values (known as Mapi Values at the time the work was conducted), Manchester, UK

    Rob Arbuckle & Linda Abetz

  3. Sahlgrenska Academy at Sahlgrenska University Hospital, Göteborg, Sweden

    Nils Edvardsson

  4. Evidera, 7101 Wisconsin Ave, Suite 600, Bethesda, MD, 20814, USA

    Karin S. Coyne

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  1. Jennie Medin
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  2. Rob Arbuckle
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Corresponding author

Correspondence to Karin S. Coyne.

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Medin, J., Arbuckle, R., Abetz, L. et al. Development and Validation of the AFSymp™: An Atrial Fibrillation-Specific Measure of Patient-Reported Symptoms. Patient 7, 319–327 (2014). https://doi.org/10.1007/s40271-014-0058-z

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  • DOI: https://doi.org/10.1007/s40271-014-0058-z

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