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When assessing a patient with heart failure, which patient-reported outcome assessment (current score, prior score, or a change in score) is most prognostic of subsequent death and heart failure hospitalization?
In this study, while current, prior, or a change in the Kansas City Cardiomyopathy Questionnaire score were all significantly associated with mortality and heart failure hospitalization in isolation, when either prior and current Kansas City Cardiomyopathy Questionnaire score or change and current score were considered together, only the current Kansas City Cardiomyopathy Questionnaire score was significantly associated with the outcomes, irrespective of ejection fraction.
While interpreting current, prior, or a change in Kansas City Cardiomyopathy Questionnaire score, the most recent assessment provides the most important information about the risks for subsequent clinical events.
While there is increasing emphasis on incorporating patient-reported outcome measures in routine care for patients with heart failure (HF), how best to interpret longitudinally collected patient-reported outcome measures is unknown.
To examine the strength of association between prior, current, or a change in Kansas City Cardiomyopathy Questionnaire (KCCQ) scores with death and hospitalization in patients with HF with preserved (HFpEF) and reduced (HFrEF) ejection fractions.
Design, Setting, and Participants
Secondary analyses of the Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT) trial of 1372 patients with HFpEF, conducted between August 2006 and January 2012, and the HF-ACTION trial that included 1669 patients with HFrEF, conducted between April 2003 and February 2007.
Prior, current, and change in KCCQ Overall Summary scores (KCCQ-os) in 5-point increments (higher scores indicate better health status).
Main Outcomes and Measures
Time to cardiovascular death/first HF hospitalization (primary outcome) and all-cause death (secondary outcome).
Of 1767 eligible TOPCAT participants, 882 were women (49.9%), and the mean (SD) age was 71.5 (9.7) years. Of 2130 eligible HF-ACTION participants, 599 were women (28.1%), and the mean age was 58.6 (12.7) years. Each 5-point difference in prior or current KCCQ-os scores was associated with a 6% (95% CI, 4%-8%; P < .001) to 9% (95% CI, 7%-11%; P < .001) lower risk for subsequent cardiovascular death/first HF hospitalization in patients with HFpEF and 6% (95% CI, 4%-9%; P < .001) to 8% (95% CI, 5%-10%; P < .001) lower risk for subsequent cardiovascular death/first HF hospitalization in patients with HRpEF and HFrEF in unadjusted analyses. Results were similar for change in KCCQ-os. In models with the prior and current KCCQ-os, only the current KCCQ-os was significantly associated with 10% (95% CI, 7%-12%; P < .001) and 7% (95% CI, 3%-11%; P < .001) lower risk for subsequent cardiovascular death/first HF hospitalization in patients with HFpEF and HFrEF, respectively. Similar results were observed when the current and Δ KCCQ-os were considered together, when adjusted for important patient and treatment characteristics, when including 3 sequential KCCQ-os scores, and when examining all-cause death as the outcome.
Conclusions and Relevance
In serial health status evaluations of patients with HF, the most recent KCCQ score was most strongly associated with subsequent death and cardiovascular hospitalization in HFpEF and HFrEF. Measuring serial patient-reported outcome measures in the clinical care of patients with HF can provide an updated assessment of prognosis.
clinicaltrials.gov Identifier: NCT00094302 (TOPCAT) and NCT00047437 (HF-ACTION)
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Corresponding Author: John A. Spertus, MD, MPH, Saint Luke’s Mid America Heart Institute, 4401 Wornall Rd, Cardiovascular Research, 9th Floor, Kansas City, MO 64111 (firstname.lastname@example.org).
Accepted for Publication: September 12, 2017.
Correction: This article was corrected on December 20, 2017, to correct an error in the Abstract. The first sentence of the Results section of the Abstract should be replaced with 2 sentences that read “Of 1767 eligible TOPCAT participants, 882 were women (49.9%), and the mean (SD) age was 71.5 (9.7) years. Of 2130 eligible HF-ACTION participants, 599 were women (28.1%), and the mean age was 58.6 (12.7) years.”
Published Online: November 1, 2017. doi:10.1001/jamacardio.2017.3983
Author Contributions: Drs Pokharel and Tang had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Pokharel, Khariton, Tang, Nassif, Spertus.
Acquisition, analysis, or interpretation of data: Pokharel, Tang, Nassif, Chan, Arnold, Jones, Spertus.
Drafting of the manuscript: Pokharel.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Tang, Jones.
Obtained funding: Spertus.
Administrative, technical, or material support: Pokharel, Khariton, Spertus.
Supervision: Pokharel, Nassif, Spertus.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Spertus owns the copyright to KCCQ and has provided consultative services to Novartis, Bayer, Cytokinetics, and United Healthcare. No other disclosures were reported.
Funding/Support: Both TOPCAT and HF-ACTION trials were supported by the National Heart, Lung, and Blood Institute. Drs Pokharel, Khariton, and Nassif are supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under award T32HL110837. Dr Chan is supported by grant R01HL123980 from the National Heart, Lung, and Blood Institute.
Role of the Funder/Sponsor: The sponsor had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation; review, or approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimer: All information and materials in the article are original. The views expressed in this article are those of the authors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute.
Meeting Presentation: Presented as abstracts at the 2017 American College of Cardiology Annual Scientific Sessions; March 19, 2017; Washington, DC.
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