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

Abstract

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.

Validity and reliability of three commonly used quality of life measures in a large European population of coronary heart disease patients

“…McNew, Seatle Angina Questionnaire) QoL measures, and not to restrict to the use of a single instrument. The integrated HeartQol, a coronary heart disease-specific, health-related QoL questionnaire, might be a good alternative (43).…”

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

“…The HeartQoL Project target was to enroll at least 1) 315 patients (105 with angina, 105 with MI and 105 with heart failure) in an international cross-sectional study and 2) 150 patients with IHD in each of the two arms in the prospective study 9 . The eligibility criteria are detailed elsewhere 12 and include patients with documented angina (Canadian Cardiovascular Society (CCS) functional status classification Class II, II, or IV) 13 , MI, or ischemic heart failure (New York Heart Association (NYHA) functional status classification Class II, III, and IV) 14 , ≥18 years old, and considered by the referring physician 1) to be able to complete the self-administered battery of HRQL instruments, 2) not have serious psychiatric disorder, and 3) not be a current substance abuser.…”

“…; generic, rather than specific, HRQL tools were used 10 , and continue to be used 11 , for making between-diagnosis HRQL comparisons in patients with IHD. The HeartQoL Project was designed to develop a single reliable and valid core IHDspecific, HRQL questionnaire, to be called the HeartQoL, for comparing HRQL outcomes in patients with angina pectoris, MI, or ischemic heart failure with left ventricular systolic dysfunction 9 .…”

Exercise Mediates the Association Between Positive Affect and 5-Year Mortality in Patients With Ischemic Heart Disease

“…The patient sample has been described previously. 24 In short, patients with documented angina (Canadian Cardiovascular Society functional classes II, III, or IV), myocardial infarction, and ischemic heart failure (New York Heart Association functional classes II, III, and IV), ≥18 years of age with sufficient understanding of the Danish language to complete the self-administered battery of health-related quality of life instruments were eligible for inclusion. Patients were identified in local databases, after which medical records were screened according to the inclusion and exclusion criteria by trained nurses.…”