Validating a new quality of life questionnaire for atrial fibrillation patients

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Abstract

Background

Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, and has major impact on health-related quality of life, thus, there is a need for a specific instrument to assess AF symptoms and quality of life.

Methods

We developed and validated a specific questionnaire for quality of life in AF patients (QLAF) based on clinical manifestations (palpitation, breathlessness, dizziness and chest pain), and the usual treatments (medication, cardioversion and ablation). For validation, the new questionnaire was compared with the generic SF-36 questionnaire. Reproducibility was tested using 40 questionnaires administered by two different observers at distinct times and places. Responsiveness was evaluated based on variation of the QLAF score over time.

Results

There were a total of 462 questionnaires (231 SF-36 and 231 QLAF) administered at baseline, 3, 6, 9 and 12 months. Construct validity was demonstrated by the negative correlation between QLAF and SF-36 scores that was observed over the follow-up period. Analysis of internal consistency for reproducibility showed excellent Cronbach's alpha coefficients (inter- and intraobserver coefficients of 0.98 and 0.96, respectively). QLAF was responsive as indicated by significant differences in mean domain scores from the beginning to the end of follow-up. It took much less time to administer the QLAF than the SF-36 (3:08 ± 0:33 min vs. 9:25 ± 1:14 min, p < 0.001).

Conclusion

The QLAF questionnaire is easy to understand and can be administered rapidly in the outpatient setting. Furthermore, the QLAF score is valid and reproducible and responsive to a change in clinical status.

Introduction

Atrial fibrillation (AF) is the most common sustained arrhythmia observed in clinical practice and is associated with increased mortality and morbidity [1], [2]. The clinical impact ranges from completely asymptomatic subjects to others living extremely limited lives, the first manifestation being an embolic event or exacerbated cardiac failure [3]. Common symptoms include palpitations, breathlessness, chest pain and dizziness or fatigue [4]. AF patients frequently report general discomfort, low exercise tolerance, irritability, concentration deficit and sleep disorder. The optimal clinical management for AF is still unclear. The therapeutic arsenal, which includes anticoagulation, rhythm control, rate control, surgical and catheter ablation, pacemakers and, defibrillators, appears to be insufficient [5], [6], [7]. As a consequence, symptom relief and improving quality of life are often the primary goals of treatment [8], [9].

The definition of quality of life is inherently subjective; however, accurate quantification of quality of life has been proposed based on the use of two basic types of questionnaires, generic and disease-specific [9], [10], [11]. An appropriate questionnaire must evaluate a specific situation adequately, and be easy to use and understand [12]. A basic prerequisite is analysis of its validity, reproducibility and responsiveness in terms of psychometric properties [9], [10], [13].

Since 2000, a number of studies have evaluated AF patient quality of life using both generic and disease-specific instruments, but the questionnaires are not fully satisfactory [6], [14], [15], [16], [17], [18], [19]. The generic SF-36 questionnaire has been extensively used in the literature, but does not cover AF-specific manifestations. Despite the importance of AF, the University of Toronto Atrial Fibrillation Scale is the only questionnaire specifically designed for this arrhythmia, but covers only the symptom of palpitations.

We sought to develop an instrument for assessing AF patient quality of life that covered the main clinical manifestations and treatments and had properly tested measurement properties.

Section snippets

Initial phase

Three meetings were held with eight specialists certified by the Brazilian Society of Electrophysiology. First, the specialists determined the most important clinical manifestations of atrial fibrillation. To design the questionnaire it is useful to understand the difference between items, questions and domains, because quality of life is generally measured by a complex collection of items, questions, domains, and instruments. An item is a single question, and the domain identifies a particular

Clinical outcomes

Patients' clinical characteristics are shown in Table 1. Beta-blockers were the drug most frequently used by patients at all times during the study, except at 12 months, followed by amiodarone, digoxin and calcium antagonists. The drugs less frequently used at all times were sotalol, propafenone, and quinidine. ECG determined heart rhythm on each visit and a rhythm other than AF or sinus were called “other”. Heart rate monitoring with a 24-h Holter system, valid when performed up to one month

Discussion

The aim in developing a disease-specific QLAF was to assess the full range of AF, so we formulated questions covering the main clinical manifestations and treatments. Equally important, we tested the instrument's psychometric properties to show its validity, reproducibility, and responsiveness.

The QLAF questionnaire that we developed to evaluate the quality of life of patients with AF showed good agreement with the SF-36. However, in addition to requiring less time for its application, this new

Acknowledgement

The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology [28].

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