Elsevier

American Heart Journal

Volume 150, Issue 4, October 2005, Pages 707-715
American Heart Journal

Clinical Investigation
Congestive Heart Failure
Monitoring clinical changes in patients with heart failure: A comparison of methods

https://doi.org/10.1016/j.ahj.2004.12.010Get rights and content

Background

Although monitoring the clinical status of patients with heart failure rests at the core of clinical medicine, the ability of different techniques to reflect clinical change has not been evaluated. This study sought to describe changes in various measures of disease status associated with gradations of clinical change.

Methods

A prospective, 14-center cohort of 476 outpatients was assessed at baseline and 6 ± 2 weeks to compare changes in 7 heart failure measures with clinically observed change. Measures included health status instruments (the Kansas City Cardiomyopathy Questionnaire [KCCQ], Short Form-12, and EQ-5D), physician-assessed functional class (New York Heart Association [NYHA]), an exercise test (6-minute walk), patient weight, and a biomarker (B-type natriuretic peptide). Cardiologists, blinded to all measures except weight and NYHA, categorized clinical change ranging from large deterioration to large improvement.

Results

The KCCQ, NYHA, and 6-minute walk test were most sensitive to clinical change. For patients with large, moderate, and small deteriorations, the KCCQ decreased by 25 ± 16, 17 ± 14, and 5.3 ± 11 points, respectively. For patients with small, moderate, and large improvements, the KCCQ increased by 5.7 ± 16, 10.5 ± 16, and 22.3 ± 16 points, respectively (P < .01 for all compared with the no change group). New York Heart Association and 6-minute walk distance were significantly different for those with moderate and large changes (P < .05) but neither revealed a difference between those with small versus no clinical deterioration. The KCCQ had the highest c statistic for monitoring individual patients, followed by NYHA and 6-minute walk.

Conclusion

The KCCQ, followed by the NYHA and the 6-minute walk test, most accurately reflected clinical change in patients with heart failure.

Section snippets

Study population

Patients were recruited through the Cardiovascular Outcomes Research Consortium, a collaborative of 14 North American centers (Appendix). Outpatients with the diagnosis of heart failure in their outpatient medical record, or a hospitalization for decompensated heart failure within the past 3 years, were screened for participation. Patients with documented left ventricular systolic dysfunction (left ventricular ejection fraction <0.40) and who were >30 years of age were asked to participate and

Patient population

A total of 547 patients were enrolled in the study; complete 6-week follow-up data were available on 476 (87%). There were 5 deaths during the study. Baseline demographic, clinical, and health status characteristics of the study population are summarized in Table II. Of 120 baseline demographic, clinical, and health status variables collected, only a few differed significantly between those with and without follow-up. Those without follow-up were less likely to be white (57% vs 70%, P = .04),

Discussion

This study compared the ability of multiple different measures to monitor the clinical status of patients with heart failure over time. We compared the sensitivity of several health status questionnaires (the KCCQ, SF-12, and the EQ-5D), a physician-assessed measure of patient function (the NYHA), a physiological test of exercise capacity (6-minute walk test), patient weight, and a biomarker of disease severity (BNP) to reflect clinical change over 6 weeks in a multicenter cohort of outpatients

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    Supported by an unrestricted research grant from Pharmacia with some supplies donated by Biosite.

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