Risk Adjustment Model for Preserved Health Status in Patients With Heart Failure and Reduced Ejection Fraction: The CHAMP-HF Registry

2021 ◽  
Author(s):  
Andy T. Tran ◽  
Gregg C. Fonarow ◽  
Suzanne V. Arnold ◽  
Philip G. Jones ◽  
Laine E. Thomas ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Risk Adjustment ◽  
Kansas City ◽  
Performance Measure ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Reduced Ejection Fraction ◽  
Adjustment Model ◽  
Risk Adjustment Model

Background: Health status outcomes are increasingly being promoted as measures of health care quality, given their importance to patients. In heart failure (HF), an American College of Cardiology/American Heart Association Task Force proposed using the proportion of patients with preserved health status as a quality measure but not as a performance measure because risk adjustment methods were not available. Methods: We built risk adjustment models for alive with preserved health status and for preserved health status alone in a prospective registry of outpatients with HF with reduced ejection fraction across 146 US centers between December 2015 and October 2017. Preserved health status was defined as not having a ≥5-point decrease in the Kansas City Cardiomyopathy Questionnaire Overall Summary score at 1 year. Using only patient-level characteristics, hierarchical multivariable logistic regression models were developed for 1-year outcomes and validated using data from 1 to 2 years. We examined model calibration, discrimination, and variability in sites’ unadjusted and adjusted rates. Results: Among 3932 participants (median age [interquartile range] 68 years [59–75], 29.7% female, 75.4% White), 2703 (68.7%) were alive with preserved health status, 902 (22.9%) were alive without preserved health status, and 327 (8.3%) had died by 1 year. The final risk adjustment model for alive with preserved health status included baseline Kansas City Cardiomyopathy Questionnaire Overall Summary, age, race, employment status, annual income, body mass index, depression, atrial fibrillation, renal function, number of hospitalizations in the past 1 year, and duration of HF (optimism-corrected C statistic=0.62 with excellent calibration). Similar results were observed when deaths were ignored. The risk standardized proportion of patients alive with preserved health status across the 146 sites ranged from 62% at the 10th percentile to 75% at the 90th percentile. Variability across sites was modest and changed minimally with risk adjustment. Conclusions: Through leveraging data from a large, outpatient, observational registry, we identified key factors to risk adjust sites’ proportions of patients with preserved health status. These data lay the foundation for building quality measures that quantify treatment outcomes from patients’ perspectives.

scholarly journals Quality of life and disease experience in patients with heart failure with reduced ejection fraction in Spain: a mixed-methods study

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e053216
Author(s):  
Raül Rubio ◽  
Beatriz Palacios ◽  
Luis Varela ◽  
Raquel Fernández ◽  
Selene Camargo Correa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Ejection Fraction ◽  
Kansas City ◽  
Mixed Methods Study ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Reduced Ejection Fraction ◽  
Patients With Heart Failure ◽  
Disease Experience

ObjectivesTo gather insights on the disease experience of patients with heart failure (HF) with reduced ejection fraction (HFrEF), and assess how patients’ experiences and narratives related to the disease complement data collected through standardised patient-reported outcome measures (PROMs). Also, to explore new ways of evaluating the burden experienced by patients and caregivers.DesignObservational, descriptive, multicentre, cross-sectional, mixed-methods study.SettingSecondary care, patient’s homes.ParticipantsTwenty patients with HFrEF (New York Heart Association (NYHA) classification I–III) aged 38–85 years.MeasuresPROMs EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire and patient interview and observation.ResultsA total of 20 patients with HFrEF participated in the study. The patients’ mean (SD) age was 72.5 (11.4) years, 65% were male and were classified inNYHA functional classes I (n=4), II (n=7) and III (n=9). The study showed a strong impact of HF in the patients’ quality of life (QoL) and disease experience, as revealed by the standardised PROMs (EQ-5D-5L global index=0.64 (0.36); Kansas City Cardiomyopathy Questionnaire total symptom score=71.56 (20.55)) and the in-depth interviews. Patients and caregivers often disagreed describing and evaluating perceived QoL, as patients downplayed their limitations and caregivers overemphasised the poor QoL of the patients. Patients related current QoL to distant life experiences or to critical moments in their disease, such as hospitalisations. Anxiety over the disease progression is apparent in both patients and caregivers, suggesting that caregiver-specific tools should be developed.ConclusionsPROMs are an effective way of assessing symptoms over the most recent time period. However, especially in chronic diseases such as HFrEF, PROM scores could be complemented with additional tools to gain a better understanding of the patient’s status. New PROMs designed to evaluate and compare specific points in the life of the patient could be clinically more useful to assess changes in health status.

scholarly journals Psychometric Evaluation of the Kansas City Cardiomyopathy Questionnaire in Men and Women With Heart Failure

2021 ◽  
Author(s):  
Vittal Hejjaji ◽  
Yuanyuan Tang ◽  
Theresa Coles ◽  
Philip G. Jones ◽  
Bryce B. Reeve ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Construct Validity ◽  
Psychometric Properties ◽  
Kansas City ◽  
Preserved Ejection Fraction ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Men And Women ◽  
Reduced Ejection Fraction ◽  
Test Retest Reliability

Background: The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been psychometrically evaluated in multiple heart failure (HF) populations, but the comparability of its psychometric properties between men and women is unknown. Methods: Data from 3 clinical trials (1 in stable HF with preserved ejection fraction, 1 each in stable and acute HF with reduced ejection fraction) and 1 prospective cohort study (stable HF with reduced ejection fraction), incorporating 6773 men and 3612 women with HF, were used to compare the construct validity, internal and test-retest reliability, ability to detect change, predict mortality and hospitalizations and minimally important differences between the 2 sexes. Interactions of the KCCQ overall summary and subdomain scores by sex were independently examined. Results: The KCCQ-Overall Summary score correlated well with New York Heart Association functional class in both sexes across patients with stable (correlation coefficient: −0.40 in men versus −0.49 in women) and acute (−0.37 in men versus −0.34 in women) HF. All KCCQ subdomains demonstrated concordant relationships with relevant comparison standards with no significant interactions by sex in 19 of 21 of these construct validity analyses. All KCCQ scores were equally predictive and other psychometric evaluations showed similar results by sex: test-retest reliability (intraclass correlation coefficient 0.94 in men versus 0.92 in women), responsive to change (standardized response mean 1.01 in both sexes), as were the minimally important differences and internal reliability. Conclusions: The psychometric properties of the KCCQ, in terms of validity, prognosis, reliability, and sensitivity to change, are comparable in men and women with HF with preserved ejection fraction and HF with reduced ejection fraction.

scholarly journals Novel Trial Design: CHIEF-HF

2021 ◽  
Vol 14 (3) ◽  
Author(s):  
John A. Spertus ◽  
Mary C. Birmingham ◽  
Javed Butler ◽  
Ildiko Lingvay ◽  
David E. Lanfear ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Randomized Clinical Trial ◽  
Kansas City ◽  
Mobile Technologies ◽  
Patient Centered ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Diabetes Status ◽  
Patient Reported

Background: The expense of clinical trials mandates new strategies to efficiently generate evidence and test novel therapies. In this context, we designed a decentralized, patient-centered randomized clinical trial leveraging mobile technologies, rather than in-person site visits, to test the efficacy of 12 weeks of canagliflozin for the treatment of heart failure, regardless of ejection fraction or diabetes status, on the reduction of heart failure symptoms. Methods: One thousand nine hundred patients will be enrolled with a medical record-confirmed diagnosis of heart failure, stratified by reduced (≤40%) or preserved (>40%) ejection fraction and randomized 1:1 to 100 mg daily of canagliflozin or matching placebo. The primary outcome will be the 12-week change in the total symptom score of the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes will be daily step count and other scales of the Kansas City Cardiomyopathy Questionnaire. Results: The trial is currently enrolling, even in the era of the coronavirus disease 2019 (COVID-19) pandemic. Conclusions: CHIEF-HF (Canagliflozin: Impact on Health Status, Quality of Life and Functional Status in Heart Failure) is deploying a novel model of conducting a decentralized, patient-centered, randomized clinical trial for a new indication for canagliflozin to improve the symptoms of patients with heart failure. It can model a new method for more cost-effectively testing the efficacy of treatments using mobile technologies with patient-reported outcomes as the primary clinical end point of the trial. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04252287.

scholarly journals Association of Cardiac Biomarkers With the Kansas City Cardiomyopathy Questionnaire in Patients With Chronic Kidney Disease Without Heart Failure

2020 ◽  
Vol 9 (13) ◽  
Author(s):  
Sri Lekha Tummalapalli ◽  
Leila R. Zelnick ◽  
Amanda H. Andersen ◽  
Robert H. Christenson ◽  
Christopher R. deFilippi ◽  
...  
Keyword(s):  
Heart Failure ◽  
Chronic Kidney Disease ◽  
Health Status ◽  
Kidney Disease ◽  
Kansas City ◽  
Troponin T ◽  
Cardiac Biomarkers ◽  
Kansas City Cardiomyopathy Questionnaire ◽  
Galectin 3 ◽  
Multivariable Adjustment

Background The Kansas City Cardiomyopathy Questionnaire ( KCCQ ) is a measure of heart failure ( HF ) health status. Worse KCCQ scores are common in patients with chronic kidney disease ( CKD ), even without diagnosed heart failure ( HF ). Elevations in the cardiac biomarkers GDF‐15 (growth differentiation factor‐15), galectin‐3, sST2 (soluble suppression of tumorigenesis‐2), hsTnT (high‐sensitivity troponin T), and NT ‐pro BNP (N‐terminal pro‐B‐type natriuretic peptide) likely reflect subclinical HF in CKD . Whether cardiac biomarkers are associated with low KCCQ scores is not known. Methods and Results We studied participants with CKD without HF in the multicenter prospective CRIC (Chronic Renal Insufficiency Cohort) Study. Outcomes included (1) low KCCQ score <75 at year 1 and (2) incident decline in KCCQ score to <75. We used multivariable logistic regression and Cox regression models to evaluate the associations between baseline cardiac biomarkers and cross‐sectional and longitudinal KCCQ scores. Among 2873 participants, GDF‐15 (adjusted odds ratio 1.42 per SD ; 99% CI , 1.19–1.68) and galectin‐3 (1.28; 1.12–1.48) were significantly associated with KCCQ scores <75, whereas sST2, hsTnT, and NT ‐pro BNP were not significantly associated with KCCQ scores <75 after multivariable adjustment. Of the 2132 participants with KCCQ ≥75 at year 1, GDF‐15 (adjusted hazard ratio, 1.36 per SD ; 99% CI , 1.12–1.65), hsTnT (1.20; 1.01–1.44), and NT ‐pro BNP (1.30; 1.08–1.56) were associated with incident decline in KCCQ to <75 after multivariable adjustment, whereas galectin‐3 and sST2 did not have significant associations with KCCQ decline. Conclusions Among participants with CKD without clinical HF , GDF‐15, galectin‐3, NT ‐pro BNP , and hsTnT were associated with low KCCQ either at baseline or during follow‐up. Our findings show that elevations in cardiac biomarkers reflect early symptomatic changes in HF health status in CKD patients.

Association Between Sacubitril/valsartan Initiation And Real-world Health Status Trajectories Over 1 Year In Heart Failure With Reduced Ejection Fraction

2020 ◽  
Vol 26 (10) ◽  
pp. S38-S39
Author(s):  
Merrill Thomas ◽  
Yevgeniy Khariton ◽  
Gregg C. Fonarow ◽  
C. Larry Hill ◽  
Laine Thomas ◽  
...  
Keyword(s):  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Real World ◽  
World Health ◽  
Reduced Ejection Fraction

scholarly journals Empagliflozin, Health Status, and Quality of Life in Patients with Heart Failure and Preserved Ejection Fraction: The EMPEROR-Preserved Trial

Circulation ◽  
2021 ◽  
Author(s):  
Javed Butler ◽  
Gerasimos Filippatos ◽  
Tariq Jamal Siddiqi ◽  
Martina Brueckmann ◽  
Michael Böhm ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Heart Failure ◽  
Health Status ◽  
Ejection Fraction ◽  
Kansas City ◽  
Cardiovascular Death ◽  
Summary Score ◽  
Preserved Ejection Fraction ◽  
Patients With Heart Failure

Background: Patients with heart failure and preserved ejection fraction (HFpEF) have significant impairment in health-related quality of life (HRQoL). In EMPEROR-Preserved, we evaluated the efficacy of empagliflozin on HRQoL in patients with HFpEF and whether the clinical benefit observed with empagliflozin varies according to baseline health status. Methods: HRQoL was measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline, 12, 32 and 52 weeks. Patients were divided by baseline KCCQ Clinical Summary Score (CSS) tertiles and the effect of empagliflozin on outcomes were examined. The effect of empagliflozin on KCCQ-CSS, Total Symptom Score (TSS) and Overall Summary Score (OSS) were evaluated. Responder analyses were performed to compare the odds of improvement and deterioration in KCCQ related to treatment with empagliflozin. Results: The effect of empagliflozin on reducing the risk of time to cardiovascular death or HF hospitalization was consistent across baseline KCCQ-CSS tertiles (HR 0.83 [0.69-1.00], HR 0.70 [0.55-0.88] and HR 0.82 [0.62-1.08] for scores <62.5, 62.5-83.3 and ≥83.3, respectively; P trend=0.77). Similar results were seen for total HF hospitalizations. Patients treated with empagliflozin had significant improvement in KCCQ-CSS versus placebo (+1.03, +1.24 and +1.50 at 12, 32 and 52 weeks, respectively P<0.01); similar results were seen for TSS and OSS. At 12 weeks, patients on empagliflozin had higher odds of improvement ≥5 points (OR 1.23; 95%CI 1.10, 1.37), ≥10 points (1.15; 95%CI 1.03, 1.27), and ≥15 points (1.13; 95%CI 1.02, 1.26) and lower odds of deterioration ≥5 points in KCCQ-CSS (0.85; 95%CI 0.75, 0.97). A similar pattern was seen at 32 and 52 weeks, and results were consistent for TSS and OSS. Conclusions: In patients with HFpEF, empagliflozin reduced the risk for major HF outcomes across the range of baseline KCCQ scores. Empagliflozin improved HRQoL, an effect that appeared early and was sustained for at least one year.

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