Omar F AbouEzzeddine1, Yee Weng Wong2, Robert J Mentz2, Sadi S Raza3, Jose Nativi-Nicolau4, Robb D Kociol5, Steven E McNulty6, Kevin J Anstrom6, Adrian F Hernandez6, Margaret M Redfield7. 1. Department of Cardiology, Mayo Clinic, Rochester, Minnesota. Electronic address: abouezzeddine.omar@mayo.edu. 2. Division of Cardiology, Department of Medicine, Duke University Medical Center and Duke Heart Center, Durham, North Carolina; Duke Clinical Research Institute, Durham, North Carolina. 3. Department of Medicine, Cardiology Unit, Cardiovascular Research Institute, University of Vermont, Burlington, Vermont. 4. Department of Medicine, University of Utah Health Care, Salt Lake City, Utah. 5. Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. 6. Duke Clinical Research Institute, Durham, North Carolina. 7. Department of Cardiology, Mayo Clinic, Rochester, Minnesota.
Abstract
OBJECTIVE: To characterize a novel "worst"-symptom visual analogue scale (WS-VAS) versus the traditional dyspnea visual analogue scale (DVAS) in an acute heart failure (AHF) trial. BACKGROUND: AHF trials assess symptom relief as a pivotal endpoint with the use of dyspnea scores. However, many AHF patients' worst presenting symptom (WS) may not be dyspnea. We hypothesized that a WS-VAS may reflect clinical improvement better than DVAS in AHF. METHODS AND RESULTS: AHF patients (n = 232) enrolled in the Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE-AHF) Trial indicated their WS at enrollment and completed DVAS and WS-VAS at enrollment and 24, 48, and 72 hours. Dyspnea was the WS in 61%, body swelling in 29%, and fatigue in 10% of patients. Clinical characteristics differed by WS. In all patients, DVAS scores were higher (less severe symptoms) than WS-VAS and the change in WS-VAS over 72 hours was greater than the change in DVAS (P < .001). Changes in DVAS were smaller in patients with body swelling and fatigue than in patients with dyspnea as their WS (P = .002), whereas changes in the WS-VAS were similar regardless of patients' WS. Neither score, nor its change, was associated with available decongestion markers (change in N-terminal pro-B-type natriuretic peptide, weight or cumulative 72-hour urine volume). CONCLUSIONS: Many AHF patients have symptoms other than dyspnea as their most bothersome symptom. The WS-VAS better reflects symptom improvement across the spectrum of AHF phenotypes. Symptom relief and decongestion were not correlated in this AHF study.
OBJECTIVE: To characterize a novel "worst"-symptom visual analogue scale (WS-VAS) versus the traditional dyspnea visual analogue scale (DVAS) in an acute heart failure (AHF) trial. BACKGROUND: AHF trials assess symptom relief as a pivotal endpoint with the use of dyspnea scores. However, many AHF patients' worst presenting symptom (WS) may not be dyspnea. We hypothesized that a WS-VAS may reflect clinical improvement better than DVAS in AHF. METHODS AND RESULTS: AHF patients (n = 232) enrolled in the Renal Optimization Strategies Evaluation in Acute Heart Failure (ROSE-AHF) Trial indicated their WS at enrollment and completed DVAS and WS-VAS at enrollment and 24, 48, and 72 hours. Dyspnea was the WS in 61%, body swelling in 29%, and fatigue in 10% of patients. Clinical characteristics differed by WS. In all patients, DVAS scores were higher (less severe symptoms) than WS-VAS and the change in WS-VAS over 72 hours was greater than the change in DVAS (P < .001). Changes in DVAS were smaller in patients with body swelling and fatigue than in patients with dyspnea as their WS (P = .002), whereas changes in the WS-VAS were similar regardless of patients' WS. Neither score, nor its change, was associated with available decongestion markers (change in N-terminal pro-B-type natriuretic peptide, weight or cumulative 72-hour urine volume). CONCLUSIONS: Many AHF patients have symptoms other than dyspnea as their most bothersome symptom. The WS-VAS better reflects symptom improvement across the spectrum of AHF phenotypes. Symptom relief and decongestion were not correlated in this AHF study.
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