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Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients.

ABSTRACT: BACKGROUND: While generic health status measures quantify the impact of all patients' diseases on their health-related quality of life, disease specific measures focus on only one of the many conditions that a patient may have. If a patient has two diseases with similar clinical manifestations, they may respond differently to a disease-specific instrument if one of their conditions improves while the other worsens or remains stable, thus undermining the instruments in that patient population. We sought empirical evidence of the reliability and validity (including responsiveness) of the Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure for heart failure (HF), among HF patients with and without anemia, a condition that has similar symptoms to HF. METHODS: This work used a prospective cohort study of 811 HF outpatients from 58 U.S. centers with a baseline assessment of anemia of whom 698 were followed for 3 months with serial health status measures. RESULTS: Among participants, 268 (33%) were anemic. The construct validity of the KCCQ was supported by showing similar correlations with the New York Heart Association (NYHA) classification in patients with and without anemia (P value for interaction = 0.38). The internal consistency (Cronbach's alpha = 0.92 and 0.93 for anemic and non-anemic patients, respectively) and test-retest reliability (mean 3-month change scores in stable patients = -2.8 [SD = 1.4] and -0.5 [SD = 0.8], P = 0.14) were similar. Estimates of responsiveness were also similar. CONCLUSION: This study provides empirical evidence that the psychometric properties of the KCCQ are similar in patients with or without anemia, a potentially confounding clinical condition in patients with heart failure.

SUBMITTER: Spertus JA

PROVIDER: S-EPMC2238779 | biostudies-other | 2008 Mar

REPOSITORIES: biostudies-other

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Project description:Patient-reported outcome measures (PROMs) are relevant independent outcomes in heart failure (HF) care and are predictive of subsequent hospitalization and death in HF. The Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ) are the 2 most widely adopted PROMs specific to HF. We compared their prognostic abilities in a prospective cohort of HF patients. A prospective cohort of subjects from a single-center registry was analyzed with regard to baseline KCCQ and MLHFQ scores and the outcomes of death, transplant, or left ventricular assist device implantation and hospitalization. A total of 516 subjects with reduced left ventricular ejection fraction (HFrEF) and 151 subjects with preserved left ventricular ejection fraction (HFpEF) were included. Discrimination was assessed using c-statistics based on time-to-event analyses and receiver-operator curves. The additive contribution of MLHFQ was assessed through the change in c-statistic, incremental discrimination index, and category-free net reclassification index. Overall, KCCQ was superior to MLHFQ for predicting death/transplant/ventricular assist device (c-statistic 0.702 [0.666 to 0.738] and 0.658 [0.621 to 0.695] respectively, p value for difference <0.001) and hospitalization (c-statistic 0.640 [0.613 to 0.666] and 0.624 [0.597 to 0.651], respectively, p value for difference 0.022). However, this difference was statistically nonsignificant in the HFpEF group alone. When analyzing the additional prognostic information afforded by adding MLHFQ to KCCQ in the overall, HFrEF, and HFpEF groups there was no significant improvement, although adding KCCQ to MLHFQ did significantly improve risk stratification. Scoring based upon the abbreviated KCCQ-12 did not reduce the prognostic accuracy of KCCQ. In conclusion, KCCQ is more prognostic of death/transplant/left ventricular assist device and hospitalization than MLHFQ in a combined cohort of patients with HFrEF and HFpEF, although the effect in HFpEF was less pronounced. KCCQ should be the preferred PROM for patients with HF if prognostication is a desired goal of using the PROMs.

Project description:BackgroundHeart failure is a worldwide health problem that significantly affects patients' physical function and health state. The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a disease-specific patient-reported outcome measure commonly used for the assessment of health states of patients with heart failure. This study aimed to evaluate the psychometric properties of the Japanese version of the KCCQ.MethodsUsing pooled data of 141 Japanese patients with chronic heart failure from three clinical trials, the Japanese version of the KCCQ was evaluated for validity and reliability, with a focus on the clinical summary score (CSS) and its component domains. For construct validity, the associations of baseline KCCQ scores with New York Heart Association (NYHA) class and the EuroQol five-dimension, three-level (EQ-5D-3L) scores at baseline were analyzed. For reliability, internal consistency was assessed using Cronbach's α, and test-retest reliability (reproducibility) was assessed among stable patients. Responsiveness to changes in patients' clinical status was assessed by analyzing score changes between two timepoints among patients whose health states improved.ResultsAmong 141 patients (mean age, 73.7 ± 10.9 years), 76.6% were NYHA class II at baseline. For CSS and its component domains (physical limitations, symptom frequency, and symptom severity), baseline scores were all significantly lower in patients with a higher NYHA class (p < 0.001 for all, Jonckheere-Terpstra test). The physical limitations domain and CSS showed a moderate correlation (Spearman's ρ = - 0.40 to - 0.54) with three functional status-related EQ-5D dimensions (mobility, self-care, and usual activities). The Cronbach's standardized α was high (> 0.70) for all KCCQ domain/summary scores. In the test-retest analysis among 58 stable patients, all domain/summary scores minimally changed by 0.3-4.2 points with intraclass correlation coefficients of 0.65-0.84, demonstrating moderate to good reproducibility, except for the symptom stability domain. Among 44 patients with improved health states, all domain/summary scores except for the symptom stability and self-efficacy domains substantially improved from baseline with a medium to large effect size of 0.62-0.88.ConclusionsThe Japanese version of the KCCQ was demonstrated to be a valid and reliable tool for the assessment of symptoms and physical function of Japanese patients with chronic heart failure.

Project description:BackgroundThe Eye Allergy Patient Impact Questionnaire (EAPIQ) was developed based on a pilot study conducted in the US and focus groups with eye allergy sufferers in Europe. The purpose of this study was to present the results of the psychometric validation of the EAPIQ.MethodsOne hundred forty six patients from two allergy clinics completed the EAPIQ twice over a two-week period during the fall and winter allergy seasons, along with concurrent measures of health status, work productivity, and utility. Construct validity, reliability (internal consistency and test-retest), concurrent, known-group, and clinical validities, and responsiveness of the EAPIQ were assessed. Known-group validity was assessed by comparing EAPIQ scale scores between patients grouped according to their self-rating of ocular allergy severity (no symptoms, very mild, mild, moderate, severe, very severe). Clinical validity was assessed by assessing differences in EAPIQ scores between groups of patients rated by their clinician as non-symptomatic, mild, moderate, and severe.Results and discussionResults from the validation study suggested the deletion of 14 of 43 items (including embedded questions) that required patients to complete the percentage of time they were troubled by something (daily activity limitations/emotional troubles). These items yielded a significant amount of missing or inconsistent data (50%). The resulting factor analysis suggested four domains: symptoms, daily life impact, psychosocial impact, and treatment satisfaction. When included as separate scales, the symptom-bother and symptom-frequency scales were highly correlated (> 0.9). As a consequence, and due to superior discriminative validity, the symptom bother and frequency items were summed. All items met the tests for item convergent validity (item-scale correlation = 0.4). The success rate for item discriminant validity testing was 97% (item-scale correlation greater with own scale than with any other). The criterion for internal consistency reliability (alpha coefficient > or = 0.70) was met for all EAPIQ scales (range 0.89-0.93), as was the criterion for test-retest reliability (intraclass correlation [ICC] > or = 0.70). Largely moderate correlations between the scales of the EAPIQ and the mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ) and low correlations with the Health Utilities Index 2/3 (HUI2/3) were indicative of satisfactory concurrent validity. The EAPIQ symptoms, Daily Life Impact, and Psychosocial Impact scales were able to distinguish between patients differing in eye allergy symptom severity, as rated by patients and clinicians, providing evidence of satisfactory known-group and clinical validities, respectively. Preliminary analyses indicated the EAPIQ Symptoms, Daily Life Impact, and Psychosocial Impact scales to be responsive to changes in eye allergies.ConclusionFollowing item reduction, construct validity, reliability, concurrent validity, known-group validity, and preliminary responsiveness were satisfactory for the EAPIQ in this population of ocular allergy patients.

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Validity, reliability, and responsiveness of the Kansas City Cardiomyopathy Questionnaire in anemic heart failure patients.

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