Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: Reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan

Thomas S. Rector, Jay N Cohn

Research output: Contribution to journalArticle

648 Citations (Scopus)

Abstract

To determine the reliability and validity of a patient outcome questionnaire for chronic heart failure, a randomized, double-blind, placebo-controlled, 3-month trial of pimobendan, an investigational medication with inotropic and vasodilator activities, was performed. Evaluated were 198 ambulatory patients with primarily New York Heart Association (NYHA) class III heart failure from 20 referral centers. Baseline therapy included digoxin, diuretics and, in 80%, a converting enzyme inhibitor. Oral pimobendan at 2.5 (n = 49), 5.0 (n = 51), or 10 (n = 49) mg daily or matching placebo (n = 49) was administered. The Minnesota Living with Heart Failure (LIhFE) questionnaire was a primary outcome measure, along with an exercise test. Interitem correlations identified subgroups of questions representing physical and emotional dimensions. Repeated baseline scores were highly correlated (r = 0.93), as were the physical (r = 0.89) and emotional (r = 0.88) dimension scores. Placebo did not have a significant effect with median (25th, 75th percentile) changes from baseline scores of 1 (-3, 5), 1 (-2, 3), and 0 (-1, 2), respectively (all p values > 0.10). The 5 mg dose significantly improved the total score, 7.5 (0, 18; p = 0.01) and the physical dimension, 4 (0, 8; p = 0.01), compared with placebo. Changes in the total (r = 0.33; p < 0.01) and physical (r = 0.35; p < 0.01) scores were weakly related to changes in exercise times, but corresponded well with changes in patients' ratings of dyspnea and fatigue. These data suggest that the LIhFE questionnaire was a reliable and valid patient self-assessment of the therapeutic benefit from pimobendan.

Original languageEnglish (US)
Pages (from-to)1017-1025
Number of pages9
JournalAmerican Heart Journal
Volume124
Issue number4
DOIs
StatePublished - Oct 1992

Fingerprint

Patient Outcome Assessment
Reproducibility of Results
Heart Failure
Placebos
Digoxin
Enzyme Inhibitors
Vasodilator Agents
Exercise Test
Diuretics
Dyspnea
Fatigue
Referral and Consultation
Outcome Assessment (Health Care)
Exercise
pimobendan
Surveys and Questionnaires
Therapeutics

Cite this

@article{be2cd9ae435945ddadc095a7c0f0c54e,
title = "Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: Reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan",
abstract = "To determine the reliability and validity of a patient outcome questionnaire for chronic heart failure, a randomized, double-blind, placebo-controlled, 3-month trial of pimobendan, an investigational medication with inotropic and vasodilator activities, was performed. Evaluated were 198 ambulatory patients with primarily New York Heart Association (NYHA) class III heart failure from 20 referral centers. Baseline therapy included digoxin, diuretics and, in 80{\%}, a converting enzyme inhibitor. Oral pimobendan at 2.5 (n = 49), 5.0 (n = 51), or 10 (n = 49) mg daily or matching placebo (n = 49) was administered. The Minnesota Living with Heart Failure (LIhFE) questionnaire was a primary outcome measure, along with an exercise test. Interitem correlations identified subgroups of questions representing physical and emotional dimensions. Repeated baseline scores were highly correlated (r = 0.93), as were the physical (r = 0.89) and emotional (r = 0.88) dimension scores. Placebo did not have a significant effect with median (25th, 75th percentile) changes from baseline scores of 1 (-3, 5), 1 (-2, 3), and 0 (-1, 2), respectively (all p values > 0.10). The 5 mg dose significantly improved the total score, 7.5 (0, 18; p = 0.01) and the physical dimension, 4 (0, 8; p = 0.01), compared with placebo. Changes in the total (r = 0.33; p < 0.01) and physical (r = 0.35; p < 0.01) scores were weakly related to changes in exercise times, but corresponded well with changes in patients' ratings of dyspnea and fatigue. These data suggest that the LIhFE questionnaire was a reliable and valid patient self-assessment of the therapeutic benefit from pimobendan.",
author = "Rector, {Thomas S.} and Cohn, {Jay N}",
year = "1992",
month = "10",
doi = "10.1016/0002-8703(92)90986-6",
language = "English (US)",
volume = "124",
pages = "1017--1025",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "4",

}

TY - JOUR

T1 - Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire

T2 - Reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan

AU - Rector, Thomas S.

AU - Cohn, Jay N

PY - 1992/10

Y1 - 1992/10

N2 - To determine the reliability and validity of a patient outcome questionnaire for chronic heart failure, a randomized, double-blind, placebo-controlled, 3-month trial of pimobendan, an investigational medication with inotropic and vasodilator activities, was performed. Evaluated were 198 ambulatory patients with primarily New York Heart Association (NYHA) class III heart failure from 20 referral centers. Baseline therapy included digoxin, diuretics and, in 80%, a converting enzyme inhibitor. Oral pimobendan at 2.5 (n = 49), 5.0 (n = 51), or 10 (n = 49) mg daily or matching placebo (n = 49) was administered. The Minnesota Living with Heart Failure (LIhFE) questionnaire was a primary outcome measure, along with an exercise test. Interitem correlations identified subgroups of questions representing physical and emotional dimensions. Repeated baseline scores were highly correlated (r = 0.93), as were the physical (r = 0.89) and emotional (r = 0.88) dimension scores. Placebo did not have a significant effect with median (25th, 75th percentile) changes from baseline scores of 1 (-3, 5), 1 (-2, 3), and 0 (-1, 2), respectively (all p values > 0.10). The 5 mg dose significantly improved the total score, 7.5 (0, 18; p = 0.01) and the physical dimension, 4 (0, 8; p = 0.01), compared with placebo. Changes in the total (r = 0.33; p < 0.01) and physical (r = 0.35; p < 0.01) scores were weakly related to changes in exercise times, but corresponded well with changes in patients' ratings of dyspnea and fatigue. These data suggest that the LIhFE questionnaire was a reliable and valid patient self-assessment of the therapeutic benefit from pimobendan.

AB - To determine the reliability and validity of a patient outcome questionnaire for chronic heart failure, a randomized, double-blind, placebo-controlled, 3-month trial of pimobendan, an investigational medication with inotropic and vasodilator activities, was performed. Evaluated were 198 ambulatory patients with primarily New York Heart Association (NYHA) class III heart failure from 20 referral centers. Baseline therapy included digoxin, diuretics and, in 80%, a converting enzyme inhibitor. Oral pimobendan at 2.5 (n = 49), 5.0 (n = 51), or 10 (n = 49) mg daily or matching placebo (n = 49) was administered. The Minnesota Living with Heart Failure (LIhFE) questionnaire was a primary outcome measure, along with an exercise test. Interitem correlations identified subgroups of questions representing physical and emotional dimensions. Repeated baseline scores were highly correlated (r = 0.93), as were the physical (r = 0.89) and emotional (r = 0.88) dimension scores. Placebo did not have a significant effect with median (25th, 75th percentile) changes from baseline scores of 1 (-3, 5), 1 (-2, 3), and 0 (-1, 2), respectively (all p values > 0.10). The 5 mg dose significantly improved the total score, 7.5 (0, 18; p = 0.01) and the physical dimension, 4 (0, 8; p = 0.01), compared with placebo. Changes in the total (r = 0.33; p < 0.01) and physical (r = 0.35; p < 0.01) scores were weakly related to changes in exercise times, but corresponded well with changes in patients' ratings of dyspnea and fatigue. These data suggest that the LIhFE questionnaire was a reliable and valid patient self-assessment of the therapeutic benefit from pimobendan.

UR - http://www.scopus.com/inward/record.url?scp=0026699989&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0026699989&partnerID=8YFLogxK

U2 - 10.1016/0002-8703(92)90986-6

DO - 10.1016/0002-8703(92)90986-6

M3 - Article

C2 - 1529875

AN - SCOPUS:0026699989

VL - 124

SP - 1017

EP - 1025

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 4

ER -