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

Da Juanicia N. Holmes, Jonathan P. Piccini, Larry A. Allen, Gregg C. Fonarow, Bernard J. Gersh, Peter R. Kowey, Emily C. O'Brien, James A. Reiffel, Gerald Naccarelli, Michael D. Ezekowitz, Paul S. Chan, Daniel E. Singer, John A. Spertus, Eric D. Peterson, Laine Thomas

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)e005358
JournalCirculation. Cardiovascular quality and outcomes
Volume12
Issue number5
DOIs
StatePublished - May 1 2019

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Atrial Fibrillation
Quality of Life
Registries
Activities of Daily Living
Outpatients
Therapeutics
Clinical Trials
Physicians

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Holmes, D. J. N., Piccini, J. P., Allen, L. A., Fonarow, G. C., Gersh, B. J., Kowey, P. R., ... Thomas, L. (2019). Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. Circulation. Cardiovascular quality and outcomes, 12(5), e005358. https://doi.org/10.1161/CIRCOUTCOMES.118.005358
Holmes, Da Juanicia N. ; Piccini, Jonathan P. ; Allen, Larry A. ; Fonarow, Gregg C. ; Gersh, Bernard J. ; Kowey, Peter R. ; O'Brien, Emily C. ; Reiffel, James A. ; Naccarelli, Gerald ; Ezekowitz, Michael D. ; Chan, Paul S. ; Singer, Daniel E. ; Spertus, John A. ; Peterson, Eric D. ; Thomas, Laine. / Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. In: Circulation. Cardiovascular quality and outcomes. 2019 ; Vol. 12, No. 5. pp. e005358.
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abstract = "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.",
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Holmes, DJN, Piccini, JP, Allen, LA, Fonarow, GC, Gersh, BJ, Kowey, PR, O'Brien, EC, Reiffel, JA, Naccarelli, G, Ezekowitz, MD, Chan, PS, Singer, DE, Spertus, JA, Peterson, ED & Thomas, L 2019, 'Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score', Circulation. Cardiovascular quality and outcomes, vol. 12, no. 5, pp. e005358. https://doi.org/10.1161/CIRCOUTCOMES.118.005358

Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score. / Holmes, Da Juanicia N.; Piccini, Jonathan P.; Allen, Larry A.; Fonarow, Gregg C.; Gersh, Bernard J.; Kowey, Peter R.; O'Brien, Emily C.; Reiffel, James A.; Naccarelli, Gerald; Ezekowitz, Michael D.; Chan, Paul S.; Singer, Daniel E.; Spertus, John A.; Peterson, Eric D.; Thomas, Laine.

In: Circulation. Cardiovascular quality and outcomes, Vol. 12, No. 5, 01.05.2019, p. e005358.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Defining Clinically Important Difference in the Atrial Fibrillation Effect on Quality-of-Life Score

AU - Holmes, Da Juanicia N.

AU - Piccini, Jonathan P.

AU - Allen, Larry A.

AU - Fonarow, Gregg C.

AU - Gersh, Bernard J.

AU - Kowey, Peter R.

AU - O'Brien, Emily C.

AU - Reiffel, James A.

AU - Naccarelli, Gerald

AU - Ezekowitz, Michael D.

AU - Chan, Paul S.

AU - Singer, Daniel E.

AU - Spertus, John A.

AU - Peterson, Eric D.

AU - Thomas, Laine

PY - 2019/5/1

Y1 - 2019/5/1

N2 - 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.

AB - 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.

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DO - 10.1161/CIRCOUTCOMES.118.005358

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