Atrial Fibrillation Effect On Quality-of-Life Scores Research Articles

Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score

Background The Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire has recently been validated to measure the impact of atrial fibrillation on quality of life, but a clinically important difference in AFEQT score has not been well defined. Methods and Results To determine the clinically important difference in overall AFEQT (score range= 0 [worst] to 100 [best]) and selected subscales, we analyzed data in the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF) registry, a United States-based outpatient atrial fibrillation registry. AFEQT was assessed at baseline and 1 year in a subset of 1347 ORBIT-AF patients from 80 US sites participating in ORBIT-AF from June 2010 to August 2011. The mean change method was used to relate changes in 1-year AFEQT scores to clinically important changes in the physician assessment of European Heart Rhythm Association functional status (1 class improvement and separately 1 class deterioration). Clinically important differences and 95% CI corresponding to either a 1 European Heart Rhythm Association class improvement or deterioration were 5.4 (3.6-7.2) and -4.2 (-6.9 to -1.5) AFEQT points, respectively. Similarly, clinically important difference values were seen for a 1 European Heart Rhythm Association class improvement for the AFEQT subscales Activities of Daily Living and Symptoms: 5.1 (2.5-7.6) and 7.1 (5.3-9.0) AFEQT points, respectively. Conclusions Based on the anchor of 1 European Heart Rhythm Association class change, changes in AFEQT score of + or -5 points are clinically important changes in patients' health. Clinical Trial Registration URL: https://clinicaltrials.gov . Unique identifier: NCT01165710.

Improvement in the quality of life of patients with persistent or long-standing persistent atrial fibrillation after hybrid ablation.

Hybrid ablation (i.e., a combination of a thoracoscopic surgical ablation followed by a catheter ablation) is a treatment option for patients with non-paroxysmal atrial fibrillation (AF). Despite its promising efficacy, it is a surgical procedure with a relatively high risk of complications that could affect the quality of life (QoL) of patients, even when sinus rhythm is restored. To describe changes in the QoL of patients with non-paroxysmal AF before and after a hybrid ablation. Patients after hybrid ablation for persistent or long-standing persistent AF were prospectively studied. Follow-up visits were scheduled at 1, 3, 6, 9, and 12months. The maintenance of SR was assessed using 1-week Holter recordings at 6 and 12months and 24-h Holter recordings at 3 and 9months, or via an implantable loop recorder. QoL was assessed using the Atrial Fibrillation Effect on Quality-of-life (AFEQT) and the EuroQoL-5Dimensions (EQ-5D) questionnaires before and 12months after ablation. Seventy-five patients (49 men, age 62.9 ± 8.45years, 48 (64%) with long-standing persistent AF) were enrolled. Fifty-two (69.3%, SR group) were AF-free during the 12-month follow-up, 16 (21.3%, PAROX group) had only paroxysms of AF after ablation, and 7 (9.3%, PERM group) were on rate control due to permanent AF reoccurrence. The AFEQT score increased significantly in the SR group from 59.9 ± 19.4 to 91.4 ± 10.8 (p < 0.001), and in the PAROX group from 58.8 ± 19.0 to 81.5 ± 14.1 (p = 0.002) but remained unchanged in the PERM group (44.6 ± 7.5 vs. 47.4 ± 5.5, p = 0.24). The EQ-5D score significantly decreased in the descriptive part (from 7.90 ± 2.61 to 6.64 ± 1.90, p = 0.0001) and increased on the visual analog scale (from 63.56 ± 19.11 to 79.30 ± 16.9, p < 0.0001) in the SR group. In the PAROX group, no significant change was present on either the descriptive part (p = 0.3) or in the visual analog scale (p = 0.48). Similarly, no significant changes were present on either the descriptive part (p = 0.93) or the visual analog scale (p = 0.4) in the PERM group. The QoL of patients with non-paroxysmal AF and patients with AF paroxysms, after successful hybrid ablation, improved significantly in patients with SR. No significant improvement was present in patients on rate control after an unsuccessful ablation.

Abstract 130: Clinically Important Difference in the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Score: Results from the ORBIT-AF Registry

Background: The Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) survey has recently been validated to measure the impact of atrial fibrillation on patients’ quality of life, but a clinically important difference (CID) in AFEQT score has not been defined. Knowing the CID is needed to interpret the meaningfulness of differences between treatments in clinical trials; or patient populations for quality assessment. Objectives: To calculate CID values in AFEQT in the ORBIT registry. Methods: ORBIT-AF is a US-based outpatient AF registry that measured disease-specific QoL with the AFEQT tool (score range= 0 (worst) to 100) at baseline and at 1 year follow-up. Two anchor-based methods were used to relate changes in AFEQT to clinically important differences in the more established European Heart Rhythm Association (EHRA) measure of functional status. Ranging from 1 (no symptoms) to 4 (disabling), a change of 1 EHRA class was defined as an important change in the anchor. Both the mean change and receiver operating characteristics (ROC) methods were then used to identify CIDs in AFEQT at 1 year follow-up. This was done for both improvement and worsening on the anchor. The mean change method defines a CID as the mean change in AFEQT score among patients with a 1 EHRA class change. The ROC method identifies a CID as the point on the ROC curve that best discriminates patients who experienced an important change in the anchor (≥ 1 EHRA class change) from those who experienced no change. Results: AFEQT was assessed in 2008 AF patients at baseline and 1347 patients at 1 year from 99 US sites participating in ORBIT-AF. CIDs and 95% confidence intervals (CI) corresponding to an improvement in EHRA for the mean change method were 5.4 (3.6, 7.2) AFEQT points and 1.9 (0.4, 9.3) AFEQT points for the ROC method. CIDs corresponding to worsening in EHRA for the mean change method were -4.2 (-6.9,-1.5) AFEQT points and -7.4 (-13.9,-4.6) AFEQT points for the ROC method. Conclusions: Changes in AFEQT as small as 2 points may be clinically relevant, although CIDs vary depending on the method of calculation. The variability suggests identifying a single universal CID to assess improvement in quality of life in AF patients may not be ideal and improvement may relate to the nature of a patient’s symptoms and their baseline level of activity.

Association Between Atrial Fibrillation Symptoms, Quality of Life, and Patient Outcomes: Results From the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT-AF).

Instruments to assess symptom burden and quality of life among patients with atrial fibrillation (AF) have not been well evaluated in community practice or associated with patient outcomes. Using data from 10 087 AF patients in the Outcomes Registry for Better Informed Treatment of AF (ORBIT-AF), symptom severity was evaluated using the European Heart Rhythm Association (EHRA) classification system, and quality of life was assessed using the Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaire. The association between AF-related symptoms, quality of life, and outcomes was assessed using Cox regression. The majority of AF patients (61.8%) were symptomatic (EHRA >2) and 16.5% had severe or disabling symptoms (EHRA 3-4). EHRA symptom class was well correlated with the AFEQT score (Spearman correlation coefficient -0.39). Over 1.8 years of follow-up, AF symptoms were associated with a higher risk of hospitalization (adjusted hazard ratio for EHRA ≥2 versus EHRA 1 1.23, 95% confidence interval, 1.15-1.31) and a borderline higher risk of major bleeding. Lower quality of life was associated with a higher risk of hospitalization (adjusted hazard ratio for lowest quartile of AFEQT versus highest 1.49, 95% confidence interval, 1.2-1.84), but not other major adverse events, including death. In a community-based study, most patients with AF were symptomatic and had impaired quality of life. Quality of life measured by the AFEQT correlated closely with symptom severity measured by the EHRA class. AF symptoms and lower quality of life were associated with higher risk of hospitalization but not mortality during follow-up.

COMPARISON OF SYMPTOMS AND QUALITY OF LIFE IN ATRIAL FIBRILLATION: RESULTS FROM THE ORBIT-AF REGISTRY

In addition to stroke prevention, improvement of symptoms and quality of life (QoL) is a primary goal in the treatment of atrial fibrillation (AF). The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) is a recently developed disease-specific QOL tool for AF. AFEQT scores were compared across

Development and Validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in Patients With Atrial Fibrillation

Atrial fibrillation (AF) has a deleterious impact on health-related quality-of-life (HRQoL), but measuring this outcome is difficult. A comprehensive, validated, disease-specific questionnaire to measure the spectrum of QoL domains affected by AF and its treatment is not available. We developed and validated a 20-item questionnaire, Atrial Fibrillation Effect on QualiTy-of-life (AFEQT), in a 6-center, prospective, observational study. Factor analyses established 4 conceptual domains (Symptoms, Daily Activities, Treatment Concern, and Treatment Satisfaction) from which individual domain and global scores were calculated. Participants from 6 centers completed the AFEQT at baseline, at month 1, and at month 3. Psychometric analyses included internal consistency and known-group validity. Test-retest reliability was assessed by comparing 1-month changes in scores among those with no change in therapy. Effect size was used to assess responsiveness after intervention. Among 219 patients age 62±11.9 years, 94% completed the AFEQT at baseline and 3 months; 66% had paroxysmal, 24% persistent, 5% longstanding persistent, and 5% permanent AF. Internal consistency was >0.88 for all scales. Lower AFEQT scores were observed with increased AF severity, categorized as asymptomatic, mild, moderate and severe, respectively: 71.2±20.6, 71.3±19.2, 57.9±19.0, and 42.0±21.2. Intraclass correlations for Overall, Symptoms, Daily Activities, Treatment Concern, and Satisfaction scores were 0.8, 0.5, 0.8, 0.7, and 0.7, respectively. Changes in 3-month scores were larger after ablation than with pharmacological adjustments, and both were greater than those observed in stable patients. This initial validation of AFEQT supports its use as an outcome in studies and a means to clinically follow patients with AF.