Translation and evaluation of the HeartQoL in patients with coronary heart disease in Iceland.

BACKGROUND: Health-related quality of life (HRQoL) reflects an individual's own perception of their symptom burden, functional limitations, prognosis, overall health and changes associated with treatment. The HeartQoL is a validated heart disease-specific questionnaire with a physical and an emotional subscale that is used internationally to assess HRQoL in patients with coronary heart disease (CHD). The aim of this study was to translate and evaluate the psychometric properties of the HeartQoL in patients with CHD in Iceland. METHODS: Patients ≥ 18 years (n = 396; mean age 64.4 ± 8.8 years; 79.6% male) admitted with CHD were recruited from two hospitals in Iceland and completed the Icelandic versions of the HeartQoL, Short-Form 12v2 Health Survey (SF-12v2), and Hospital Anxiety and Depression Scale (HADS). A subsample of 47 patients completed the HeartQoL 14 days later. Confirmatory factor analysis for ordinal data was used to evaluate the measurement model with a physical and an emotional subscale. Convergent and divergent validity, internal consistency, and test-retest reliability were evaluated. RESULTS: Overall, the hypothesized two-factor structure of the Icelandic version of the HeartQoL was supported. However, problems with cross-loadings and correlated error variances were identified. Convergent and divergent validity were supported in correlational analyses between HeartQoL, SF-12v2, and HADS. Internal consistency reliability, measured by ordinal alpha, was good for the physical (α = 0.96) and emotional (α = 0.90) subscale. According to intraclass correlations (ICC), acceptable test-retest reliability was demonstrated (ICC = 0.79-0.86). CONCLUSION: With the two-factor structure confirmed, the Icelandic HeartQoL demonstrated satisfactory psychometric properties in the sample of patients with CHD. Users of the instrument can use the original scoring.

Exercise-based cardiac rehabilitation for coronary heart disease: a meta-analysis.

AIMS: Coronary heart disease is the most common reason for referral to exercise-based cardiac rehabilitation (CR) globally. However, the generalizability of previous meta-analyses of randomized controlled trials (RCTs) is questioned. Therefore, a contemporary updated meta-analysis was undertaken. METHODS AND RESULTS: Database and trial registry searches were conducted to September 2020, seeking RCTs of exercise-based interventions with ≥6-month follow-up, compared with no-exercise control for adults with myocardial infarction, angina pectoris, or following coronary artery bypass graft, or percutaneous coronary intervention. The outcomes of mortality, recurrent clinical events, and health-related quality of life (HRQoL) were pooled using random-effects meta-analysis, and cost-effectiveness data were narratively synthesized. Meta-regression was used to examine effect modification. Study quality was assessed using the Cochrane risk of bias tool. A total of 85 RCTs involving 23 430 participants with a median 12-month follow-up were included. Overall, exercise-based CR was associated with significant risk reductions in cardiovascular mortality [risk ratio (RR): 0.74, 95% confidence interval (CI): 0.64-0.86, number needed to treat (NNT): 37], hospitalizations (RR: 0.77, 95% CI: 0.67-0.89, NNT: 37), and myocardial infarction (RR: 0.82, 95% CI: 0.70-0.96, NNT: 100). There was some evidence of significantly improved HRQoL with CR participation, and CR is cost-effective. There was no significant impact on overall mortality (RR: 0.96, 95% CI: 0.89-1.04), coronary artery bypass graft (RR: 0.96, 95% CI: 0.80-1.15), or percutaneous coronary intervention (RR: 0.84, 95% CI: 0.69-1.02). No significant difference in effects was found across different patient groups, CR delivery models, doses, follow-up, or risk of bias. CONCLUSION: This review confirms that participation in exercise-based CR by patients with coronary heart disease receiving contemporary medical management reduces cardiovascular mortality, recurrent cardiac events, and hospitalizations and provides additional evidence supporting the improvement in HRQoL and the cost-effectiveness of CR.

Psychometric Evaluation of the Mandarin HeartQoL Health-Related Quality of Life Questionnaire Among Patients With Ischemic Heart Disease in China.

OBJECTIVES: This study evaluated the psychometric properties of the Mandarin version of the HeartQoL questionnaire, a core ischemic heart disease (IHD) health-related quality of life (HRQL) instrument, in patients with angina, myocardial infarction (MI), and ischemic heart failure (IHF). METHODS: The English version of HeartQoL was translated into Mandarin. A cross-sectional study was then conducted in mainland China using the Mandarin HeartQoL, Short Form-12 Health Survey, and Hospital Anxiety and Depression Scale. Factor analysis was used to establish the HeartQoL structure and internal consistency reliability and construct validity were assessed. RESULTS: Patients with IHD (n = 412; angina = 112, MI = 151, and IHF = 149) were enrolled. Significantly higher HeartQoL HRQL scores were reported by patients with either angina or MI than by patients with IHF. The 2-factor structure was confirmed by Mokken scale analysis in the total group with strong H coefficients on the global scale (0.64) and both the physical (0.70) and emotional (0.80) subscales. Internal consistency reliability was strong with Cronbach's α ranging from 0.90 to 0.95. Convergent validity was confirmed with strong correlations between similar physical and mental HeartQoL and Short Form-12 Health Survey subscales ranging from 0.77 to 0.82 with divergent validity confirmed with significantly lower correlations between dissimilar constructs. Discriminative validity was confirmed for 72% of the a priori sociodemographic and clinical hypotheses. CONCLUSIONS: The Mandarin version of the HeartQoL HRQL questionnaire demonstrates acceptable internal consistency reliability and convergent, divergent, and discriminative validity in patients with IHD and in each diagnostic subgroup. The data support the use of the HeartQoL to assess and compare HRQL in Mandarin-speaking patients with IHD.

Validation of the Italian HeartQoL: a short health-related quality of life questionnaire for patients with ischemic heart disease.

The psychometric properties of the core disease-specific 14-item Italian HeartQoL health-related quality of life questionnaire have been evaluated in this study. The Italian version of the HeartQoL, the MacNew questionnaire, and the Hospital Anxiety and Depression Scale were completed by 472 patients (angina, N = 183; myocardial infarction, N = 167; or ischemic heart failure, N = 122) who were recruited in five Italian centers (Florence, Veruno, Turin, Udine, and Naples) between 2015 and 2017. Patients with myocardial infarction reported significantly higher HeartQoL scores than patients with angina or ischemic heart failure. Floor and ceiling effects were always minor on the HeartQoL global scale and physical subscale with moderate ceiling effects on the emotional subscale in the total group and in patients with myocardial infarction. The bifactorial structure of the original HeartQoL questionnaire was confirmed with strong physical, emotional, and global scale H coefficients (> 0.50). The HeartQoL scales demonstrated optimal internal consistency (Cronbach's alpha > 0.84). Convergent and divergent validity were confirmed. Discriminative validity was not confirmed for age, largely confirmed for sex, and fully confirmed for anxiety, depression, and distress. The Italian HeartQoL questionnaire demonstrated adequate key psychometric attributes of internal consistency reliability and validity in Italian-speaking patients with ischemic heart disease.

Exercise-based cardiac rehabilitation for coronary heart disease.

BACKGROUND: Coronary heart disease (CHD) is the most common cause of death globally. However, with falling CHD mortality rates, an increasing number of people living with CHD may need support to manage their symptoms and prognosis. Exercise-based cardiac rehabilitation (CR) aims to improve the health and outcomes of people with CHD. This is an update of a Cochrane Review previously published in 2016. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of exercise-based CR (exercise training alone or in combination with psychosocial or educational interventions) compared with 'no exercise' control, on mortality, morbidity and health-related quality of life (HRQoL) in people with CHD. SEARCH METHODS: We updated searches from the previous Cochrane Review, by searching CENTRAL, MEDLINE, Embase, and two other databases in September 2020. We also searched two clinical trials registers in June 2021. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of exercise-based interventions with at least six months' follow-up, compared with 'no exercise' control. The study population comprised adult men and women who have had a myocardial infarction (MI), coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI), or have angina pectoris, or coronary artery disease. DATA COLLECTION AND ANALYSIS: We screened all identified references, extracted data and assessed risk of bias according to Cochrane methods. We stratified meta-analysis by duration of follow-up: short-term (6 to 12 months); medium-term (> 12 to 36 months); and long-term ( > 3 years), and used meta-regression to explore potential treatment effect modifiers. We used GRADE for primary outcomes at 6 to 12 months (the most common follow-up time point).  MAIN RESULTS: This review included 85 trials which randomised 23,430 people with CHD. This latest update identified 22 new trials (7795 participants). The population included predominantly post-MI and post-revascularisation patients, with a mean age ranging from 47 to 77 years. In the last decade, the median percentage of women with CHD has increased from 11% to 17%, but females still account for a similarly small percentage of participants recruited overall ( < 15%). Twenty-one of the included trials were performed in low- and middle-income countries (LMICs). Overall trial reporting was poor, although there was evidence of an improvement in quality over the last decade. The median longest follow-up time was 12 months (range 6 months to 19 years). At short-term follow-up (6 to 12 months), exercise-based CR likely results in a slight reduction in all-cause mortality (risk ratio (RR) 0.87, 95% confidence interval (CI) 0.73 to 1.04; 25 trials; moderate certainty evidence), a large reduction in MI (RR 0.72, 95% CI 0.55 to 0.93; 22 trials; number needed to treat for an additional beneficial outcome (NNTB) 75, 95% CI 47 to 298; high certainty evidence), and a large reduction in all-cause hospitalisation (RR 0.58, 95% CI 0.43 to 0.77; 14 trials;  NNTB 12, 95% CI 9 to 21; moderate certainty evidence). Exercise-based CR likely results in little to no difference in risk of cardiovascular mortality (RR 0.88, 95% CI 0.68 to 1.14; 15 trials; moderate certainty evidence), CABG (RR 0.99, 95% CI 0.78 to 1.27; 20 trials; high certainty evidence), and PCI (RR 0.86, 95% CI 0.63 to 1.19; 13 trials; moderate certainty evidence) up to 12 months' follow-up. We are uncertain about the effects of exercise-based CR on cardiovascular hospitalisation, with a wide confidence interval including considerable benefit as well as harm (RR 0.80, 95% CI 0.41 to 1.59; low certainty evidence). There was evidence of substantial heterogeneity across trials for cardiovascular hospitalisations (I2 = 53%), and of small study bias for all-cause hospitalisation, but not for all other outcomes. At medium-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.90, 95% CI 0.80 to 1.02; 15 trials), MI (RR 1.07, 95% CI 0.91 to 1.27; 12 trials), PCI (RR 0.96, 95% CI 0.69 to 1.35; 6 trials), CABG (RR 0.97, 95% CI 0.77 to 1.23; 9 trials), and all-cause hospitalisation (RR 0.92, 95% CI 0.82 to 1.03; 9 trials), a large reduction in cardiovascular mortality was found (RR 0.77, 95% CI 0.63 to 0.93; 5 trials). Evidence is uncertain for difference in risk of cardiovascular hospitalisation (RR 0.92, 95% CI 0.76 to 1.12; 3 trials). At long-term follow-up, although there may be little to no difference in all-cause mortality (RR 0.91, 95% CI 0.75 to 1.10), exercise-based CR may result in a large reduction in cardiovascular mortality (RR 0.58, 95% CI 0.43 to 0.78; 8 trials) and MI (RR 0.67, 95% CI 0.50 to 0.90; 10 trials). Evidence is uncertain for CABG (RR 0.66, 95% CI 0.34 to 1.27; 4 trials), and PCI (RR 0.76, 95% CI 0.48 to 1.20; 3 trials). Meta-regression showed benefits in outcomes were independent of CHD case mix, type of CR, exercise dose, follow-up length, publication year, CR setting, study location, sample size or risk of bias. There was evidence that exercise-based CR may slightly increase HRQoL across several subscales (SF-36 mental component, physical functioning, physical performance, general health, vitality, social functioning and mental health scores) up to 12 months' follow-up; however, these may not be clinically important differences. The eight trial-based economic evaluation studies showed exercise-based CR to be a potentially cost-effective use of resources in terms of gain in quality-adjusted life years (QALYs). AUTHORS' CONCLUSIONS: This updated Cochrane Review supports the conclusions of the previous version, that exercise-based CR provides important benefits to people with CHD, including reduced risk of MI, a likely small reduction in all-cause mortality, and a large reduction in all-cause hospitalisation, along with associated healthcare costs, and improved HRQoL up to 12 months' follow-up. Over longer-term follow-up, benefits may include reductions in cardiovascular mortality and MI. In the last decade, trials were more likely to include females, and be undertaken in LMICs, increasing the generalisability of findings. Well-designed, adequately-reported RCTs of CR in people with CHD more representative of usual clinical practice are still needed. Trials should explicitly report clinical outcomes, including mortality and hospital admissions, and include validated HRQoL outcome measures, especially over longer-term follow-up, and assess costs and cost-effectiveness.

A little is better than none: the biggest gain of physical activity in patients with ischemic heart disease.

BACKGROUND: There is a relationship between physical activity and health-related quality of life (HRQL) in healthy people and in patients with ischemic heart disease (IHD). The purpose of this study was to determine whether this relationship between sports or recreational physical activity levels and HRQL has a dose-response gradient in patients with IHD. METHODS: Using one generic and three IHD-specific HRQL questionnaires, differences in HRQL scores (adjusted for confounders) were determined for physically a) inactive vs. active patients and b) inactive vs. patients being active 1-2, 3-5, or >5 times per week. RESULTS: Data were provided by 6143 IHD-patients (angina: N = 2033; myocardial infarction: N = 2266; ischemic heart failure: N = 1844). Regardless of diagnosis or instrument used, when patients were dichotomized as either inactive or active, the latter reported throughout higher physical and emotional HRQL (all p < 0.001; d = 0.25-0.70). When categorized by physical activity levels, there was a positive HRQL dose-response gradient by increasing levels of physical activity that was most marked between inactive patients and those being active 1-2 times per week (63 82%). CONCLUSIONS: Using generic and IHD-specific HRQL questionnaires, there seems to be an overall dose-dependent gradient betweenincreasing levels of sports or recreational physical activity and higher HRQL in patients with angina, myocardial infarction, and ischemic heart failure. The greatest bang for the public health buck still lies on putting all the effort in changing sedentary lifestyle to at least a moderate active one (1-2 times per week), in particular in cardiac rehabilitation settings.

Changes in Physical Performance and Their Association With Health-Related Quality of Life in a Mixed Nonischemic Cardiac Population That Participates in Rehabilitation.

PURPOSE: Exercise-based cardiac rehabilitation improves physical performance and health-related quality of life (HRQoL). However, whether improvements in physical performance are associated with changes in HRQoL has not been adequately investigated in a nonischemic cardiac population. METHODS: Patients who were ablated for atrial fibrillation, who underwent heart valve surgery or who were treated for infective endocarditis, and who participated in 1 of 3 randomized controlled rehabilitation trials were eligible for the current study. Change in physical performance and HRQoL were measured before and after a 12-wk exercise intervention. Physical performance was assessed using a cardiopulmonary exercise test, a 6-min walk test, and a sit-to-stand test. Health-related quality of life was assessed using the generic 36-Item Short Form Health Survey and the disease-specific HeartQoL questionnaire. Spearman correlation coefficient (ρ) and linear regressions quantified the association between changes in physical outcome measures and changes in HRQoL. RESULTS: A total of 344 patients were included (mean age: 60.8 ± 11.6 yr and 77% males). Associations between changes in physical outcome measures and HRQoL ranged from very weak to weak (ρ = -0.056 to 0.228). The observed associations were more dominant within physical dimensions of the HRQoL compared with mental or emotional dimensions. After adjusting for sex, age, and diagnosis, changes in physical performance explained no more than 20% of the variation in the HRQoL. CONCLUSION: The findings show that the positive improvement in HRQoL from exercise-based cardiac rehabilitation cannot simply be explained by an improvement in physical performance.

Validation of the German HeartQoL: a short health-related quality of life questionnaire for cardiac patients.

PURPOSE: The aim of this study was to evaluate psychometric properties of the core disease-specific 14-item German HeartQoL questionnaire. METHODS: As an extension of the international HeartQol Project, cross-sectional and longitudinal health-related quality of life (HRQL) data were collected from 305 patients with angina (N = 101), myocardial infarction (N = 123), or ischemic heart failure (N = 81) in Austria and Switzerland using German versions of the HeartQoL, the Short Form-36 Health Survey (SF-36), and the Hospital Anxiety and Depression Scale. The underlying factor structure was examined with Mokken Scaling analysis; then convergent, divergent, and discriminative validity, internal consistency reliability, and responsiveness were assessed. RESULTS: The highest HRQL scores were reported by patients with myocardial infarction followed by ischemic heart failure and then angina. The two-factor structure was confirmed with strong physical, emotional, and global scale H coefficients (> .50). Divergent and convergent validity (from r = .04 to .78) were shown for each diagnosis; discriminative validity was verified as well (partially: age, sex, and disease severity; largely: SF-36 health status/transition; totally: anxiety and depression). Internal consistency reliability was excellent (Cronbach's alpha = .91). In terms of responsiveness, physical and global scale scores improved significantly after percutaneous coronary intervention (p < .01) while after cardiac rehabilitation all scale scores improved significantly (p < .001). CONCLUSIONS: The German HeartQoL questionnaire is a valid and reliable HRQL instrument with these data supporting its potential use in clinical practice and research to assess and compare HRQL in German-speaking patients with ischemic heart disease. The shortness of the tool may prove to be helpful particularly in clinical practice.

Cost-effectiveness of exercise therapy in patients with coronary heart disease, chronic heart failure and associated risk factors: A systematic review of economic evaluations of randomized clinical trials.

AIMS: Prescribed exercise is effective in adults with coronary heart disease (CHD), chronic heart failure (CHF), intermittent claudication, body mass index (BMI) ≥25 kg/m2, hypertension or type 2 diabetes mellitus (T2DM), but the evidence for its cost-effectiveness is limited, shows large variations and is partly contradictory. Using World Health Organization and American Heart Association/American College of Cardiology value for money thresholds, we report the cost-effectiveness of exercise therapy, exercise training and exercise-based cardiac rehabilitation. METHODS: Electronic databases were searched for incremental cost-effectiveness and incremental cost-utility ratios and/or the probability of cost-effectiveness of exercise prescribed as therapy in economic evaluations conducted alongside randomized controlled trials (RCTs) published between 1 July 2008 and 28 October 2018. RESULTS: Of 19 incremental cost-utility ratios reported in 15 RCTs in patients with CHD, CHF, intermittent claudication or BMI ≥25 kg/m2, 63% met both value for money thresholds as 'highly cost-effective' or 'high value', with 26% 'not cost-effective' or of 'low value'. The probability of intervention cost-effectiveness ranged from 23 to 100%, probably due to the different populations, interventions and comparators reported in the individual RCTs. Confirmation with the Consolidated Health Economic Evaluation Reporting checklist varied widely across the included studies. CONCLUSIONS: The findings of this review support the cost-effectiveness of exercise therapy in patients with CHD, CHF, BMI ≥25 kg/m2 or intermittent claudication, but, with concerns about reporting standards, need further confirmation. No eligible economic evaluation based on RCTs was identified in patients with hypertension or T2DM.

A systematic review of recent cardiac rehabilitation meta-analyses in patients with coronary heart disease or heart failure.

Aim: The aim of the project was to conduct a systematic review of meta-analyses of supervised, home-based or telemedicine-based exercise cardiac rehabilitation (CR) published between July 2011 and April 2018. Materials & methods: Evidence on mortality, hospitalization, peak VO2, exercise capacity, muscle strength and health-related quality of life in patients with coronary heart disease or heart failure referred to CR was obtained by searching six electronic databases. Results: Of the 127 point estimates identified in the 30 CR meta-analyses identified (mortality, n = 12; hospitalization, n = 11; VO2, n = 40; exercise capacity, n = 20; strength, n = 18; health-related quality of life, n = 26), 60% were statistically significant and 35% clinically important. Conclusion: The statistical data are sufficiently robust to promote strategies to improve referral to and participation in CR although evidence for clinical importance needs to be further investigated.

Measuring HRQoL following heart valve surgery: the HeartQoL questionnaire is a valid and reliable core heart disease instrument.

PURPOSE: Patient-reported health-related quality of life is a complementary healthcare outcome and important when assessing treatment efficacy. Using COSMIN methodological recommendations, this study evaluates the validity and reliability of a core heart disease-specific health-related quality of life questionnaire, the HeartQoL questionnaire (Danish version) in a sample of patients following heart valve surgery. DESIGN: This project involved a cross-sectional validity study and a test-retest reliability study. METHODS: Eligible patients completed the HeartQoL, the SF-36 health survey questionnaire, and the Hospital Anxiety and Depression Scale following heart valve surgery. Construct validity was tested using a priori hypotheses. Internal consistency reliability was assessed with Cronbach's alpha. An independent sample of patients participated in the test-retest study and reproducibility was determined with relative [intra-class correlation coefficient (ICC)] and absolute reliability [standard error of measurement (SEM) and smallest detectable change (SDC)]. RESULTS: Internal consistency was high with Cronbach's alpha ≥ 0.87. ICC was 0.86-0.92. SEM ranged from 0.17 to 0.26 points and SDC ranged from 0.5 to 0.7 points. Construct validity was confirmed with 87% of all a priori hypotheses for predicted variables. CONCLUSIONS: The HeartQoL questionnaire demonstrates acceptable construct validity, internal consistency, and test-retest reproducibility in patients following heart valve surgery. Future studies should focus on assessing the responsiveness of the HeartQoL questionnaire over time and following heart valve surgery.

Validation of the English Version of the HeartQoL Health-Related Quality of Life Questionnaire in Patients With Coronary Heart Disease.

PURPOSE: The aim of this study was to validate the English version of the HeartQoL health-related quality of life questionnaire for use in patients with angina or myocardial infarction. METHODS: Patients living in the United States and referred, either for percutaneous coronary intervention or to cardiac rehabilitation, completed the HeartQoL, the Short Form-36 Health Survey, and the Hospital Anxiety and Depression Scale at baseline and 3-months later. The data were analyzed for validity, reliability, and responsiveness. RESULTS: Patients (n = 313 with angina and n = 97 with myocardial infarction) who were referred either for percutaneous coronary intervention (n = 164) or to cardiac rehabilitation (n = 246) completed baseline questionnaires. Patients with angina had significantly lower HeartQoL scores (poorer health-related quality of life) compared with patients with myocardial infarction. Exploratory factor analysis largely supported the 2-factor structure of the HeartQoL in both diagnoses, but further investigation is warranted. Internal consistency reliability was adequate, convergent validity correlations were significant, and discriminative validity was fully confirmed in patients with angina and largely confirmed in patients with myocardial infarction. Responsiveness was largely confirmed in patients who underwent percutaneous coronary intervention (n = 67) and those referred to cardiac rehabilitation (n = 167) with conventional statistical tests and clinically with the effect size, a standardized measure of change. CONCLUSIONS: The English HeartQoL health-related quality of life questionnaire is valid, reliable, and responsive in patients with angina and myocardial infarction allowing (1) assessment of baseline, (2) between-diagnosis comparisons, and (3) evaluation of change over time.

Psychometric properties of HeartQoL, a core heart disease-specific health-related quality of life questionnaire, in Danish implantable cardioverter defibrillator recipients.

Background Patient-reported health-related quality of life is increasingly used as an outcome measure in clinical trials and as a performance measure to evaluate quality of care. The objective of this study was to assess the psychometric properties of the Danish HeartQoL questionnaire, a core heart disease-specific health-related quality of life questionnaire, in implantable cardioverter defibrillator recipients. Design This study involved cross-sectional and test-retest study designs. Method Implantable cardioverter defibrillator recipients in the cross-sectional study completed the HeartQoL, the Short-Form 36 Health Survey, and the Hospital Anxiety and Depression Scale. The HeartQoL structure, construct-related validity (convergent and discriminative) and reliability (internal consistency) were assessed. HeartQoL reproducibility (test-retest) was assessed in an independent sample of implantable cardioverter defibrillator recipients. Results Mokken scale analysis supported the bi-dimensional structure of HeartQoL among 358 implantable cardioverter defibrillator recipients. Convergent ( r > 0.72) and discriminative validity were confirmed. The HeartQoL scales demonstrated satisfactory internal consistency (Cronbach's alpha > 0.90). Test-retest reliability (two weeks interval) was assessed in 89 implantable cardioverter defibrillator recipients and found to be acceptable for each scale (intra-class correlation > 0.90). Conclusion The Danish HeartQoL questionnaire demonstrated satisfactory key psychometric attributes of validity and reliability in this implantable cardioverter defibrillator population. This study adds support for the HeartQoL as a core heart-specific health-related quality of life questionnaire in a broad group of patients with heart disease including implantable cardioverter defibrillator recipients.

Cost-utility analysis of cardiac rehabilitation after conventional heart valve surgery versus usual care.

Background While cardiac rehabilitation in patients with ischaemic heart disease and heart failure is considered cost-effective, this evidence may not be transferable to heart valve surgery patients. The aim of this study was to investigate the cost-effectiveness of cardiac rehabilitation following heart valve surgery. Design We conducted a cost-utility analysis based on a randomised controlled trial of 147 patients who had undergone heart valve surgery and were followed for 6 months. Methods Patients were randomised to cardiac rehabilitation consisting of 12 weeks of physical exercise training and monthly psycho-educational consultations or to usual care. Costs were measured from a societal perspective and quality-adjusted life years were based on the EuroQol five-dimensional questionnaire (EQ-5D). Estimates were presented as means and 95% confidence intervals (CIs) based on bootstrapping. Costs and effect differences were presented in a cost-effectiveness plane and were transformed into net benefit and presented in cost-effectiveness acceptability curves. Results No statistically significant differences were found in total societal costs (-1609 Euros; 95% CI: -6162 to 2942 Euros) or in quality-adjusted life years (-0.000; 95% CI -0.021 to 0.020) between groups. However, approximately 70% of the cost and effect differences were located below the x-axis in the cost-effectiveness plane, and the cost-effectiveness acceptability curves showed that the probability for cost- effectiveness of cardiac rehabilitation compared to usual care is at minimum 75%, driven by a tendency towards costs savings. Conclusions Cardiac rehabilitation after heart valve surgery may not have improved health-related quality of life in this study, but is likely to be cost-effective for society, outweighing the extra costs of cardiac rehabilitation.

How Accurate Is the Prediction of Maximal Oxygen Uptake with Treadmill Testing?

BACKGROUND: Cardiorespiratory fitness measured by treadmill testing has prognostic significance in determining mortality with cardiovascular and other chronic disease states. The accuracy of a recently developed method for estimating maximal oxygen uptake (VO2peak), the heart rate index (HRI), is dependent only on heart rate (HR) and was tested against oxygen uptake (VO2), either measured or predicted from conventional treadmill parameters (speed, incline, protocol time). METHODS: The HRI equation, METs = 6 x HRI- 5, where HRI = maximal HR/resting HR, provides a surrogate measure of VO2peak. Forty large scale treadmill studies were identified through a systematic search using MEDLINE, Google Scholar and Web of Science in which VO2peak was either measured (TM-VO2meas; n = 20) or predicted (TM-VO2pred; n = 20) based on treadmill parameters. All studies were required to have reported group mean data of both resting and maximal HRs for determination of HR index-derived oxygen uptake (HRI-VO2). RESULTS: The 20 studies with measured VO2 (TM-VO2meas), involved 11,477 participants (median 337) with a total of 105,044 participants (median 3,736) in the 20 studies with predicted VO2 (TM-VO2pred). A difference of only 0.4% was seen between mean (±SD) VO2peak for TM- VO2meas and HRI-VO2 (6.51±2.25 METs and 6.54±2.28, respectively; p = 0.84). In contrast, there was a highly significant 21.1% difference between mean (±SD) TM-VO2pred and HRI-VO2 (8.12±1.85 METs and 6.71±1.92, respectively; p<0.001). CONCLUSION: Although mean TM-VO2meas and HRI-VO2 were almost identical, mean TM-VO2pred was more than 20% greater than mean HRI-VO2.

Association Between Cardiac Rehabilitation Participation and Health Status Outcomes After Acute Myocardial Infarction.

IMPORTANCE: Cardiac rehabilitation (CR) improves survival after acute myocardial infarction (AMI), and referral to CR has been introduced as a performance measure of high-quality care. The association of participation in CR with patients' health status (eg, quality of life, symptoms, and functional status) is poorly defined. OBJECTIVE: To examine the association of participation in CR with health status outcomes after AMI. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study was conducted of patients enrolled in 2 AMI registries: PREMIER, from January 1, 2003, to June 28, 2004, and TRIUMPH, from April 11, 2005, to December 31, 2008. The analytic cohort was restricted to 4929 patients with data available on baseline health status, 6- or 12- month follow-up health status, and participation in CR. Data analysis was performed from 2014 to 2015. EXPOSURES: Participation in at least 1 CR session within 6 months of hospital discharge. MAIN OUTCOMES AND MEASURES: Patient health status was quantified using the Seattle Angina Questionnaire (SAQ) and the 12-Item Short-Form Health Survey (SF-12). The primary outcomes of interest were the mean differences in SAQ domain scores during the 12 months after AMI between patients who did and did not participate in CR. Secondary outcomes were the mean differences in the SF-12 summary scores and all-cause mortality. RESULTS: After successfully matching the cohorts of the 4929 patients (3328 men and 1601 women; mean [SD] age, 60.0 [12.2] years) for the propensity to participate in CR and comparing the groups using linear, mixed-effects models, mean differences in the SAQ and SF-12 domain scores were similar at 6 and 12 months between the 2012 patients participating in CR (3 were unable to be matched) and the 2894 who did not participate (20 were unable to be matched). At 6 months, the mean difference was -0.76 (95% CI, -2.05 to 0.52) for the SAQ quality of life score, -1.53 (95% CI, -2.57 to -0.49) for the SAQ angina frequency score, 0.38 (95% CI, -0.51 to 1.27) for the SAQ treatment satisfaction score, -0.42 (95% CI, -1.65 to 0.79) for the SAQ physical limitation score, 0.50 (95% CI, -0.22 to 1.22) for the SF-12 physical component score, and 0.13 (95% CI, -0.53 to 0.79) for the SF-12 mental component score. At 12 months, the mean difference was -0.89 (95% CI, -2.20 to 0.43) for the SAQ quality of life score, -1.05 (95% CI, -2.12 to 0.02) for the SAQ angina frequency score, 0.38 (95% CI, -0.54 to 1.29) for the SAQ treatment satisfaction score, -0.14 (95% CI, -1.41 to 1.14) for the SAQ physical limitation score, 0.17 (95% CI, -0.57 to 0.92) for the SF-12 physical component score, and 0.12 (95% CI, -0.56 to 0.80) for the SF-12 mental component score. In contrast, the hazard rate of all-cause mortality (up to 7 years) associated with participating in CR was 0.59 (95% CI, 0.46-0.75). CONCLUSIONS AND RELEVANCE: In a cohort of 4929 patients with AMI, we found that those who did and did not participate in CR had similar reported health status during the year following AMI; however, participation in CR did confer a significant survival benefit. These findings underscore the need for increased use of validated patient-reported outcome measures to further examine if and how health status can be maximized for patients who participate in CR.

International SF-36 reference values in patients with ischemic heart disease.

PURPOSE: International reference data for the SF-36 health survey (version 1) are presented based on a sample of 5508 adult patients with ischemic heart disease. METHODS: Patients with angina, myocardial infarction and ischemic heart failure completed the SF-36. Data were analyzed by diagnosis, gender, age, region and country within region and presented as mean ± standard deviation (SD), minimum, maximum, 25th, 50th and 75th percentile of the physical (PCS) and mental component summary (MCS) measures. RESULTS: Mean PCS scores were reported as being more than one SD below the normal range (standardized mean of 50 ± 10) by more than half of the patient subgroups (59 %) with all of the mean MCS scores falling within the normal range. Patients with angina and patients with ischemic heart failure reported the poorest mean PCS scores with both diagnoses reporting scores more than one SD below the standardized mean. Females, older patients (especially >70 years) and patients from Eastern Europe reported significantly worse mean PCS scores than male, younger and non-Eastern European patients. The cardiac diagnosis had no effect on the mean MCS scores; however, females, younger patients (especially <51 years) and patients from Eastern Europe reported significantly worse mean MCS scores than male, older and non-Eastern European patients. CONCLUSIONS: These international reference SF-36 values for patients with IHD are useful for clinicians, researchers and health-policy makers when developing improved health services.