HeartQoL Questionnaire Research Articles

EEduHeart I: A Multicenter, Randomized, Controlled Trial Investigating the Effectiveness of a Cardiac Web-Based eLearning Platform - Rationale and Study Design

Objectives: Cardiac telerehabilitation includes, in its most comprehensive format, telemonitoring, telecoaching, social interaction, and eLearning. The specific role of eLearning, however, was seldom assessed. The aim of eEduHeart I is to investigate the medium-term effectiveness of the addition of a cardiac web-based eLearing platform to conventional cardiac care. Methods: In this prospective, multicenter randomized, controlled trial, 1,000 patients with coronary artery disease will be randomized 1:1 to an intervention group (receiving 1-month unrestricted access to the cardiac eLearning platform in addition to conventional cardiac care) or to conventional cardiac care alone. The primary endpoint is health-related quality of life, assessed by the HeartQoL questionnaire at the 1- and 3-month follow-ups. Secondary endpoints include pathology-specific knowledge and self-reported eLearning platform user experience. Data on the eLearning platform usage will be gathered through web logging during the study period. Results: eEduHeart I will be one of the first studies to report on the added value of eLearning. Conclusions: If the intervention is proven effective, current cardiac telerehabilitation programs can be augmented by including eLearning, too. The platform can then be used as a model for other chronic diseases in which patient education plays a key role.

The New European Questionnaire for Assessment of Quality of Life of Patients With Ischemic Heart Disease: HeartQoL

Quality of life (QL) of patients with ischemic heart disease (IHD) is a combination symptoms of the disease, physical state, emotional status, and social-laboring functioning. Until recently there were no universal questionnaire allowing to perform comparative analysis of QL of patients with effort angina (EF), survivors of myocardial infarction (MI) and chronic heart failure (CHF). Therefore, European Association of Cardiovascular Prevention and Rehabilitation conducted a study with the aim of developing universal questionnaire for assessment of QL in patients with IHD - HeartQol. The study enrolled 6384 patients with angina, MI, or CHF across 22 countries (315 in Russia). Patients completed a battery of questionnaires and Mokken scaling analysis was used to identify most important guestions for assessment of QL questions to be included into the HeartQoL questionnaire.

Validating the HeartQoL questionnaire in patients with atrial fibrillation.

Atrial fibrillation (AF) is associated with impaired health-related quality-of-life (HRQL). When assessing HRQL, disease-specific and generic instruments are used, which may hinder outcome comparisons across studies. A newly developed core ischaemic heart disease-specific HRQL questionnaire, the HeartQoL, offers a single measurement instrument which may allow outcome comparisons across cardiac diseases. The aim of the study was to evaluate the psychometric properties of HeartQoL in an AF population treated with ablation by assessing its factor structure, construct validity, internal consistency, and test-retest reliability. Data were collected in two phases: (a) a cross-sectional study including 462 patients with AF/atrial flutter who completed the HeartQoL and the Short-Form 36 (SF-36), allowing for the evaluation of internal consistency, factor structure and construct validity; and (b) a longitudinal study including 55 patients completing HeartQoL twice to evaluate test-retest reliability. The two-factor structure of HeartQoL was largely confirmed in patients with AF. Internal consistency was high (Cronbach's alpha (α) ≥ 0.90) and test-retest reliability good (intra-class correlation ≥ 0.90). The construct validity was supported, as subscales of HeartQoL correlated strongly with similar (r ≥ 0.78) and weakly (r ≤ 0.47) with dissimilar subscales of SF-36. The HeartQoL demonstrated ability to distinguish between different clinical subgroups of patients, indicating sensitivity. The HeartQoL showed overall satisfactory psychometric properties, demonstrating it to be a valid instrument in the evaluation of HRQL in patients with AF treated with ablation. This suggests that HeartQoL may be a valuable instrument for making HRQL comparisons across the spectrum of cardiac diseases.

The use of HeartQoL in patients with coronary heart disease: Association with risk factors and European reference values. The EUROASPIRE IV study of the European Society of Cardiology.

HeartQoL is a recently developed core health-related quality of life instrument for patients with coronary heart disease. The current study aims to investigate its association with patients' coronary risk profile and to provide reference values for patients with coronary heart disease across Europe. Analyses are based on the EUROASPIRE IV (EUROpean Action on Secondary and Primary prevention through Intervention to Reduce Events) cross-sectional survey. Patients with a diagnosis of coronary heart disease were examined and interviewed six months to three years after their coronary event. The HeartQoL questionnaire was completed by 7261 coronary heart disease patients. Reference values were calculated and the association with the coronary risk profile was assessed. Significantly worse outcomes were observed in higher-risk patient groups. Both metabolic and behavioural risk factors were associated with worse HeartQoL outcomes. Further, the HeartQoL scores decreased as the number of risk factors increased. The mean global reference values in males were 2.27 ± 0.65 (<60 years), 2.30 ± 0.61 (between 60 and 69 years) and 2.19 ± 0.64 (≥70 years). Likewise, in females, the respective global HeartQoL reference values were 2.02 ± 0.67, 2.01 ± 0.66 and 1.83 ± 0.70. The ceiling effect in males was 11.4%, 10.4% and 7.4% for the three age classes respectively, whereas in females the ceiling effect was 5.2%, 3.5% and 1.9%, respectively. HeartQoL scores were associated with patients' coronary risk profile. The reference values may help other researchers to interpret HeartQoL scores. Further research should focus on the minimal important difference needed to evaluate the effect of therapies and lifestyle changes.

Validity and reliability of the HeartQoL questionnaire based on the EUROASPIRE IV study

Coronary heart disease (CHD) is associated with a substantial physical and mental burden. Recently, HeartQoL, a core Health-related-quality-of-life (HRQL) instrument in patients with CHD, was developed. HeartQoL consists of 14 items; 10 items focusing on physical HRQL and 4 items on emotional HRQL together providing a global scale. The aim of the current study was to assess the reliability and validity of the instrument in a European sample of patients with CHD. Analyses are based on the recently performed EUROASPIRE IV (EUROpean Action on Secondary and Primary Prevention through Intervention to Reduce Events) survey (2012-2013). 7449 patients between 18 and 80 years old, with stable CHD who had been hospitalised for a first or recurrent coronary event completed the HeartQoL questionnaire. Psychometric analyses assessing the reliability and validity of the HeartQoL instrument were performed. The mean global score was 2.18 (0.66), the mean physical and emotional subscale scores were 2.13 (0.72) and 2.30 (0.72) respectively. Overall, excellent internal consistency was found on the global scale (a=0.92) and the physical subscale (a=0.91), and good internal consistency was seen on the emotional scale (a=0.87). Factor analyses confirmed the two-dimensional construct with factor loadings >0.5, with potential allocation problems on one item and fit indices which resulted in inconsistent outcomes. On country specific level, Bosnia scored poorly, probably due to a mistranslation of the questionnaire. Discriminative validity was confirmed with females reporting poorer global, physical and emotional scores, older patients reporting poorer global and physical scores and lower educated patients reporting poorer global, physical and emotional scores. Likewise convergent validity was confirmed with moderate to strong correlations among hypothesized constructs. Overall, psychometric analyses of the HeartQoL instrument in a population of patients with stable CHD showed good reliability and validity both at the European as well as on country-specific level.

Validity and reliability of the HeartQoL questionnaire in a large sample of stable coronary patients: The EUROASPIRE IV Study of the European Society of Cardiology.

The aim of this study was to investigate the validity and reliability of the HeartQoL instrument in a population of stable coronary patients. Analyses are based on the cross-sectional EUROASPIRE IV (EUROpean Action on Secondary and Primary prevention through Intervention to Reduce Events) survey. Patients with a diagnosis of coronary heart disease were examined and interviewed 6 months to 3 years after their coronary event. During the interview patients were asked to fill out the HeartQoL health-related quality of life questionnaire as well as the EQ-5D and the hospital anxiety and depression scale questionnaire. Psychometric analyses assessing the reliability and validity of the HeartQoL instrument were performed. A total of 7449 patients completed the HeartQoL instrument. Cronbach's alpha indicated excellent internal consistency for the global HeartQoL scale (α = 0.92) and the physical subscale (α = 0.91) and good internal consistency for the emotional subscale (α = 0.87). Factor analysis confirmed the two-dimensional construct although mixed results were found regarding the model fit. Discriminative validity analysis confirmed better HeartQoL results in men, younger patients and higher educated persons. Likewise, convergent validity was confirmed with moderate to strong correlations among hypothesised constructs. Overall, psychometric analyses of the HeartQoL instrument in a population of patients with stable coronary heart disease showed good reliability and validity both at the European as well as the country-specific level. However, further research should focus on the responsiveness of the HeartQoL, the possible ceiling effect of the emotional subscale, construct validity and the minimal clinically important difference.

Self-reported health-related quality of life predicts 5-year mortality and hospital readmissions in patients with ischaemic heart disease.

Patient health-related quality of life (HRQL) is an important health outcome with lower HRQL associated with adverse events in patients with ischaemic heart disease (IHD). Baseline health-related quality of life was investigated as a predictor of 5-year all-cause mortality and cardiac readmissions in Danish patients with IHD. The international HeartQoL Project survey was designed to develop a core HRQL questionnaire for patients with IHD. Baseline scores on each of the 14 items ultimately included in the HeartQoL questionnaire were linked to Danish national health registries and hazard ratios for mortality and readmissions were estimated using Cox regression models. Among 938 eligible Danish patients with IHD, 662 (70.6%) participated in the international HeartQoL Project. During the 5-year follow-up, 83 patients died and 196 patients were readmitted. Adjusted analyses showed a significant linear association between all-cause mortality and both lower global HRQL (HR = 1.67, 95% CI: 1.26-2.23; p<0.001) and physical scores (HR=1.71, 1.33-2.21; p<0.001) and between readmission and both lower global (HR=1.73, 1.41-2.12; p < 0.001) and physical scores (HR = 1.63, 1.35-1.96; p < 0.001). A significant, but non-linear, effect was found for emotional HRQL score on outcomes. This study shows a significant and linear relationship between lower global and physical HRQL scores in patients with IHD and 5-year all-cause mortality and cardiac readmission.

The HeartQoL: Part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease

Evaluation of health-related quality of life (HRQL) is important in improving the quality of patient care. The aim of this study was to determine the psychometric properties of the HeartQoL in patients with ischemic heart disease (IHD), specifically angina, myocardial infarction (MI), or ischemic heart failure. Data for the interim validation of the HeartQoL questionnaire were collected in (a) a cross-sectional survey and (b) a prospective substudy of patients undergoing either a percutaneous coronary intervention (PCI) or referred to cardiac rehabilitation (CR) and were then analyzed to determine the reliability, validity, and responsiveness of the HeartQoL questionnaire. We enrolled 6384 patients (angina, n = 2111, 33.1%; MI, n = 2351, 36.8%; heart failure, n = 1922, 30.1%) across 22 countries speaking 15 languages in the cross-sectional study and 730 patients with IHD in the prospective substudy. The HeartQoL questionnaire comprises 14-items with physical and emotional subscales and a global score (range 0-3 (poor to better HRQL). Cronbach's α was consistently ≥0.80; convergent validity correlations between similar HeartQoL and SF-36 subscales were significant (r ≥ 0.60, p < 0.001); discriminative validity was confirmed with predictor variables: health transition, anxiety, depression, and functional status. HeartQoL score changes following either PCI or CR were significant (p < 0.001) with effect sizes ranging from 0.37-0.64. The HeartQoL questionnaire is reliable, valid, and responsive to change allowing clinicians and researchers to (a) assess baseline HRQL, (b) make between-diagnosis comparisons of HRQL, and (c) evaluate change in HRQL in patients with angina, MI, or heart failure with a single IHD-specific HRQL instrument.

The HeartQoL: Part I. Development of a new core health-related quality of life questionnaire for patients with ischemic heart disease

Evaluation of health-related quality of life (HRQL) is important in improving the quality of patient care. The HeartQoL Project, with cross-sectional and longitudinal phases, was designed to develop a core ischemic heart disease (IHD) specific HRQL questionnaire, to be called the HeartQoL, for patients with angina, myocardial infarction (MI), or ischemic heart failure. Patients completed a battery of questionnaires and Mokken scaling analysis was used to identify items in the HeartQoL questionnaire. We enrolled 6384 patients (angina, n = 2111, 33.1%; MI, n = 2351, 36.8%; heart failure, n = 1922, 30.1%) across 22 countries and 15 languages. The HeartQoL questionnaire comprises 14-items with 10-item physical and 4-item emotional subscales which are scored from 0 (poor HRQL) to 3 (better HRQL) with a global score if needed. The mean baseline HeartQoL global score was 2.2 (±0.5) in the total group and was different (p < 0.001) by diagnosis (MI, 2.4 ± 0.5; angina, 2.2 ± 0.6; and heart failure, 2.1 ± 0.6). The HeartQoL questionnaire, with global and subscale scores, has the potential to allow clinicians and researchers to (a) assess baseline HRQL, (b) make between-diagnosis comparisons of HRQL, and (c) evaluate change in HRQL in patients with angina, MI, or heart failure with a single IHD-specific HRQL instrument.

The Euro Cardio-QoL Project. An international study to develop a core heart disease health-related quality of life questionnaire, the HeartQoL

Cardiovascular diseases, which include coronary heart disease, account for 48% of deaths in Europe and many developed countries have specifically targeted significant reductions in coronary heart disease deaths as major health care objectives. Reduction in the death rate and morbidity from coronary heart disease can be accomplished through three primary interventions: (1) modification of lifestyle behaviors; (2) use of medications; and (3) surgical procedures. In order to prescribe a specific intervention, patients with heart disease are typically diagnosed by physicians with one or more of three inter-related (but clinically distinct) conditions: myocardial infarction, angina pectoris, or heart failure. This diagnostic conceptualization of coronary heart disease has led to important improvements in specific treatments and researchers have increasingly focused their attention on comparing the efficacy of one intervention versus another. Patients, providers, and researchers have increasingly become interested in identifying those interventions that not only improve mortality but also improve symptoms, function, and health-related quality of life. Thus, researchers have developed specific symptom scales and health-related quality of life instruments for each of these three coronary heart disease conditions for use in clinical trials. As part of the Euro Cardio-QoL Project, the HeartQoL study is designed to develop a single reliable and valid core coronary heart disease-specific, health-related quality of life questionnaire, to be called the HeartQoL, in order to compare outcomes with the same or across different treatments among pure or mixed populations of patients with myocardial infarction, angina pectoris, and/or heart failure. To be of value in international studies, health-related quality of life instruments must be available in a range of languages as many important clinical studies require multi-national and multi-language site collaboration. The project will recruit a total of 4200 patients with myocardial infarction (n=1400), angina (n=1400), and heart failure (n=1400) in 40 sites located in 15 countries where 13 different languages are spoken. Data will be collected using a battery of three valid self-administered, health-related quality of life instruments at baseline and again within 2 to 4 weeks to develop the core HeartQoL questionnaire and to establish its reliability. Anxiety, depression, mood, personality, and generic health-related quality of life will also be assessed at baseline to provide preliminary evidence of validity.