Evaluation of a provocative dyspnea severity score in acute heart failure

Abstract

Background: The acute heart failure (AHF) Syndromes International Working Group proposed that dyspnea be assessed under standardized, incrementally provocative maneuvers and called for studies to assess the feasibility of this approach. We sought to assess the feasibility and statistical characteristics of a novel provocative dyspnea severity score (pDS) versus the traditional dyspnea visual analog scale (DVAS) in an AHF trial.

Methods: At enrollment, 24, 48 and 72hours, 230 ROSE-AHF patients completed a DVAS. Dyspnea was then assessed with 5-point Likert dyspnea scales administered during 4 stages (A: upright-with O2, B: upright-without O2, C: supine-without O2 and D: exercise-without O2). Patients with moderate or less dyspnea were eligible for the next stage.

Results: At enrollment, oxygen withdrawal and supine provocation were highly feasible (≥97%), provoking more severe dyspnea (≥1 Likert point) in 24% and 42% of eligible patients, respectively. Exercise provocation had low feasibility with 38% of eligible patients unable to exercise due to factors other than dyspnea. A pDS was constructed from Likert scales during the 3 feasible assessment conditions (A-C). Relative to DVAS, the distribution of the pDS was more skewed with a high "ceiling effect" at enrollment (23%) limiting sensitivity to change. Change in pDS was not related to decongestion or 60-day outcomes.

Conclusions: Although oxygen withdrawal and supine provocation are feasible and elicit more severe dyspnea, exercise provocation had unacceptable feasibility in this AHF cohort. The statistical characteristics of a pDS based on feasible provocation measures do not support its potential as a robust dyspnea assessment tool in AHF.

Trial registration: ClinicalTrials.gov NCT01927549.

Conflict of interest statement

HHC has no specific COI related to this work; however, he reports that he and Mayo Clinic have patented and licensed designer natriuretic peptides to Anexon Inc and Capricor Therapeutics. PSP has no specific COI related to this work; however, he has or has had the following relationships with the following entities over the last 3 years where a conflict of interest might be perceived given dyspnea is a common endpoint in clinical trials. AFH has no specific COI related to this work.

Copyright © 2015 Elsevier Inc. All rights reserved.

Figures

Figure 1. Impact of provocative measures on dyspnea severity at enrollment and 72 hours

The percent of patients who had less severe (“better”, improvement by ≥ 1 point on Likert dyspnea scale), “unchanged”, or “worse” (worsening by ≥ 1 point on Likert dyspnea scale) dyspnea or who were eligible for but did perform the stage due to mechanical limitations, hypotension or refusal (unable) is shown for each provocative maneuver (oxygen withdrawal (O2 WD), supine position or bedside step test).

Figure 2. Provocative dyspnea score (pDS)

The proposed structure of the pDS was a nine-point score that incorporated 1) the severity of dyspnea on the Likert scale at three progressively more provocative stages (A: upright with O2, B: upright without O2, C: supine), 2) the eligibility for different stages and 3) the final stage tolerated.

Figure 3. Distribution of dyspnea scores at enrollment

The frequency distribution of the provocative dyspnea severity score (pDS, A) and the dyspnea visual analogue scale (DVAS, B) for patients with paired pDS and DVAS both at enrollment (“baseline”) and 72 hours (n=203) are shown. Distributions were similar when all patients with pDS or DVAS at baseline or 72 hours were included.

Figure 4. Distribution of the dyspnea visual analogue scale (DVAS) score relative to the provocative dyspnea score (pDS)

Scatter dot plot of DVAS with medians (red bar) according to the pDS scores for patients with paired pDS and DVAS both at baseline (A) and 72 hours (B)(n=203) are shown. DVAS increased with increasing pDS (p