Minimally Clinically Important Difference in Health Status Scores in Patients With HFrEF vs HFpEF

Javed Butler1, Muhammad Shahzeb Khan2, JoAnn Lindenfeld3

  • 1Department of Medicine, University of Mississippi, Jackson, Mississippi, USA.

JACC. Heart Failure
|July 2, 2022
PubMed

Insights

Clinically meaningful improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ) is at least 9 points for heart failure with reduced ejection fraction (HFrEF) and 7 points for heart failure with preserved ejection fraction (HFpEF). These thresholds aid in evaluating treatment effectiveness in heart failure patients.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Patient-Reported Outcomes

Background:

  • Establishing clinically significant thresholds for patient-reported outcome measures like the Kansas City Cardiomyopathy Questionnaire (KCCQ) is crucial for differentiating between heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF).
  • Existing data on these thresholds are less defined for HFpEF compared to HFrEF.

Purpose of the Study:

  • To estimate meaningful thresholds for improvement or deterioration in the KCCQ-Total Symptom Score (TSS).
  • To compare these thresholds between patients with HFrEF and HFpEF.

Main Methods:

  • A secondary analysis of the EMPERIAL program data was conducted.
  • Anchor- and distribution-based approaches were utilized, with Patient Global Impression of Severity (PGIS) as the primary anchor.
  • Mean changes in KCCQ-TSS from baseline to week 12 were calculated based on PGIS categories.

Main Results:

  • The study included 312 HFrEF and 315 HFpEF patients.
  • A meaningful threshold for KCCQ-TSS improvement was identified as ≥9 points for HFrEF and ≥7 points for HFpEF.
  • These thresholds demonstrated acceptable sensitivity and specificity in distinguishing meaningful change.

Conclusions:

  • A change of ≥9 points in KCCQ-TSS signifies the minimal clinically important difference for improvement in HFrEF patients.
  • A change of ≥7 points in KCCQ-TSS signifies the minimal clinically important difference for improvement in HFpEF patients.
  • These findings confirm a broad range of 5-10 points as meaningful thresholds for KCCQ-TSS change in heart failure management.
Abstract

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