The association between health-related quality of life, self-reported characteristics and 1- and 3-year mortality amongst cardiac patients with and without type 2 diabetes.

PURPOSE: The objectives amongst cardiac patients with and without type 2 diabetes were to (i) describe self-reported characteristics as health-related quality of life (HRQoL), health behaviour, body mass index (BMI) and physical shape and to (ii) investigate the association between self-reported characteristics and 1- and 3-year mortality. METHODS: Adult patients (≥ 18 years) discharged with a cardiac diagnosis were invited to participate in a national survey, DenHeart. Self-reported characteristics included HRQoL (EQ-5D-5L and HeartQol), health behaviour (alcohol and smoking), BMI and physical shape. Data were linked to national registries. The association between self-reported characteristics and 1- and 3-year mortality were investigated using the Cox Proportional Hazard Regression model, reported as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: In total, 16,659 cardiac responders were included (n = 2,205 with type 2 diabetes, n = 14,454 without type 2 diabetes). Self-reported characteristics were worse amongst cardiac patients with type 2 diabetes compared to those without. After three years, the mortality rate was 14% amongst responders with diabetes and 7% amongst responders without type 2 diabetes (p ≤ 0.001). Better HRQoL was associated with a reduced risk of mortality amongst both groups. "Never been smoking" significantly reduced the risk of 1- and 3-year mortality amongst cardiac patients without diabetes, whereas good physical shape was associated with a reduced risk across both groups. CONCLUSION: HRQoL, health behaviour, BMI and physical shape are significantly worse amongst cardiac patients with type 2 diabetes. Better HRQoL was associated with a reduced risk of mortality amongst both groups, whereas other self-reported characteristics and the mortality risk varied.

Long-term effects of cardiac rehabilitation after heart valve surgery - results from the randomised CopenHeartVR trial.

Aims. The CopenHeartVR trial found positive effects of cardiac rehabilitation (CR) on physical capacity at 4 months. The long-term effects of CR following valve surgery remains unclear, especially regarding readmission and mortality. Using data from he CopenHeartVR Trial we investigated long-term effects on physical capacity, mental and physical health and effect on mortality and readmission rates as prespecified in the original protocol. Methods. A total of 147 participants were included after heart valve surgery and randomly allocated 1:1 to 12-weeks exercise-based CR including a psycho-educational programme (intervention group) or control. Physical capacity was assessed as peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing, mental and physical health by Short Form-36 questionnaire, Hospital Anxiety and Depression Scale, and HeartQol. Mortality and readmission were obtained from hospital records and registers. Groups were compared using mixed regression model analysis and log rank test. Results. No differences in VO2 peak at 12 months or in self-assessed mental and physical health at 24 months (68% vs 75%, p = .120) was found. However, our data demonstrated reduction in readmissions in the intervention group at intermediate time points; after 3, 6 (43% vs 59%, p = .03), and 12 (53% vs 67%, p = .04) months, respectively, but no significant effect at 24 months. Conclusions. Exercise-based CR after heart valve surgery reduces combined readmissions and mortality up to 12 months despite lack of improvement in exercise capacity, physical and mental health long-term. Exercise-based CR can ensure short-term benefits in terms of physical capacity, and lower readmission within a year, but more research is needed to sustain these effects over a longer time period. These considerations should be included in the management of patients after heart valve surgery.

Illness Perception After Heart Valve Surgery: Differences Among Men and Women.

BACKGROUND: Illness perception is composed of thoughts, ideas, and beliefs about illness, and a negative illness perception is known to be associated with poor outcomes. Among men and women, clinical outcomes after heart valve surgery are known to differ, but knowledge about differences in illness perception is sparse. OBJECTIVES: The aim of this study is to describe the differences in illness perception among men and women after open heart valve surgery and to identify sociodemographic and clinical characteristics associated with worse illness perception in men and women. METHODS: In a national cross-sectional study combined with register-based clinical and sociodemographic information, data on illness perception were collected with the Brief Illness Perception Questionnaire.Worse illness perception was defined as the worst quartile of each item of the Brief Illness Perception Questionnaire. Multiple logistic regression analyses were conducted to explore characteristics associated with worse illness perception. RESULTS: Of 1084 eligible patients, 32% (n = 349) completed the questionnaire (67% men; mean age, 68 years). Compared with men, women reported significantly worse scores of illness perception in 6 of 8 items. Furthermore, being female, age, length of stay, and comorbidity were associated with worse illness perception (worse quartile of scores). Age, higher educational level, and comorbidity were found to be associated with worse illness perception for men and length of stay for women. CONCLUSION: After open heart valve surgery, illness perception differs among men and women, with women having worse illness perception. Among the total population, being female, age, a longer length of stay, and comorbidity were also associated with worse illness perception.

The association between self-reported health status and adverse events: a comparison among coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI).

PURPOSE: While several studies have investigated clinical outcomes following coronary artery bypass grafting (CABG) vs. percutaneous coronary intervention (PCI), studies investigating self-reported health and the association with adverse outcomes are limited. Thus, the aim was to investigate differences in health-related quality of life (HRQoL), anxiety and depression at discharge and the association with a composite endpoint of the first event of acute cardiac readmission, revascularisation or 1-year mortality among patients undergoing CABG vs. PCI. METHODS: Data from the national cohort study, DenHeart, were used, including measures of HRQoL; EuroQoL-5D-5L (EQ-5D Index Score and VAS) and HeartQoL (Global, Physical and Emotional), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and register-based follow-up. A total of 7000 patients were included (CABG n = 652, PCI n = 6348) (median age 65, 75% men). Cox Proportional Hazard models were performed among a propensity-matched population of responders (n = 520). RESULTS: HRQoL was significantly better among patients undergoing PCI vs. CABG, but with no differences in time to readmission or revascularisation. HRQoL, anxiety and depression were significantly associated with the risk of the composite endpoint among the PCI group (Hazard Ratio, HR (95% confidence intervals, CI) [EQ-5D index score 3.07 (1.67-5.67), EQ-5D VAS 0.97 (0.96-0.99), HeartQol Global 0.61 (0.38-0.95), HeartQol Emotional 0.56 (0.39-0.80), HADS-D ≥ 8 3.12 (1.61-6.01), HADS-A ≥ 8 2.08 (1.14-3.80)]. CONCLUSION: Patients undergoing PCI reported better HRQoL at discharge compared with patients undergoing CABG, whereas readmission rates were similar. Self-reported health was associated with the risk of adverse events among patients undergoing PCI, but not among patients undergoing CABG. CLINICAL TRIAL REGISTRATION: NCT01926145.

Questionnaire measuring patient participation in health care: Scale development and psychometric evaluation.

BACKGROUND: Patient participation in treatment and care is often encouraged and is desirable because of its proven positive impact on treatment, quality of care and patient safety. AIMS: To develop an instrument to measure patient participation in health care and to investigate the measurement properties of the Patient Participation Questionnaire (PPQ). METHODS: A literature review was conducted to develop a model of patient participation. The PPQ was constructed consisting of 17 items organized into four subscales. Psychometric evaluation of factor structure, convergent construct validity by hypothesis testing and analyses of internal consistency using Cronbach's alpha were performed on data from a hospitalised mixed group of patients with cardiac disease, pulmonary disease and cancer (N=378 patients). RESULTS: Confirmatory factor analysis did not show a clear model fit, which is why an exploratory factor analysis was performed, suggesting a different four subscale structure consisting of a total of 16 items. The four subscales were labelled Shared decision power, Adapted and individualized knowledge, Collaboration and Human approach. There were strong ceiling effects on all items. Analysis of convergent construct validity showed a moderate correlation (0.59) between the PPQ and another instrument measuring patient participation. Internal consistency for the total PPQ score was high: 0.89. CONCLUSION: In a mixed group of patients with cardiac disease, pulmonary disease and cancer, the PPQ showed promising psychometric properties in terms of factor structure, convergent construct validity and internal consistency. The PPQ may be used to shed light on the experience of patient participation and guide quality improvements.

Patient-reported outcomes predict high readmission rates among patients with cardiac diagnoses. Findings from the DenHeart study.

BACKGROUND: High rates of readmission after myocardial infarction and cardiac surgery have been reported, indicating a heavy burden for both patients and society. Patient-reported outcomes are predictors of adverse outcomes such as morbidity and mortality and may also be useful in preventive risk assessment as predictors of readmission. AIM: To describe (i) the prevalence of cardiac readmissions one year after hospital discharge among cardiac patients, (ii) patient-reported outcomes at hospital discharge as predictors of readmission. METHODS: The following patient-reported outcomes were measured across cardiac diagnoses at hospital discharge from the five heart centres, cardiology and thoracic surgery units, as a part of the national, cross-sectional DenHeart Study: Short-Form 12 (SF-12), Hospital Anxiety and Depression Scale (HADS), EuroQoL (EQ-5D-5L), HeartQoL and the Edmonton Symptom Assessment Scale (ESAS). One year readmissions were obtained from national registers. RESULTS: A total of 34,564 cardiac patients were discharged of whom 16,712 patients completed the questionnaire. A total of 11,693 (36%) patients were readmitted for cardiac reasons at least once during the first year after index admission. The risk of readmission was predicted by anxiety (HR = 1.36 (CI:1.26-1.46)) and depression (HR = 1.42 (CI:1.31-1.55)). Higher scores reflected lower readmission risk on the physical (HR = 0.98 (CI:0.98-0.98)) health component of the SF-12. CONCLUSION: A total of 36% of cardiac patients admitted to a national heart center were readmitted during the first year. Readmission was predicted by patient-reported anxiety, depression, perceived health, quality of life and symptom distress, which may be used in risk assessment in clinical practice.

Mental health is a risk factor for poor outcomes in cardiac patients: Findings from the national DenHeart survey.

OBJECTIVE: To explore (i) the prevalence of cardiac risk factors (obesity, smoking, excessive alcohol consumption and medication non-adherence) among cardiac patients with depression and anxiety, (ii) associations between depression and anxiety scores and cardiac risk factors and (iii) the association of depression and anxiety and cardiac risk factors with mortality, and their population attributable risk. METHODS: A national cross-sectional study using patient-reported outcomes at discharge and national register data. For one year (April 15th 2013 to April 15th 2014) all patients discharged or transferred from the five Danish Heart Centres were included in the study. A total of 14,239 patients answered the HADS questionnaire, response rate 51%. RESULTS: Mean age was 64.8 years and 69% were male. Patients with depression or anxiety (HADS-D or HADS-A score ≥ 8) had 30% and 45%, respectively, higher odds of being current smokers; 19% and 37% higher odds of being obese and 31% and 24% higher odds of excessive alcohol consumption. Depressive patients had 34% higher odds of being non-adherent to their medication. At one-year follow-up, patients with depression (HADS-D score ≥ 11) had the highest attributable risk associated with mortality followed by: smoking, ischemic heart disease, anxiety, diabetes, hypertension chronic obstructive pulmonary disease and excessive alcohol consumption. CONCLUSION: Depression and anxiety in patients with cardiac disease is associated with cardiac risk behaviour such as smoking, obesity, excessive alcohol consumption and medication non-adherence. Depression and anxiety have an attributable risk associated with mortality that is comparable to other well-known risk factors such as smoking.

High readmission rates and mental distress after infective endocarditis - Results from the national population-based CopenHeart IE survey.

BACKGROUND: Infective endocarditis (IE) is a severe disease requiring lengthy hospitalisation. Little is known about patients' recovery after IE. The aims of this study in IE patients were; (i) to describe mortality, readmission, self-reported health and rehabilitation up to 1year post-discharge, (ii) to examine associations between self-reported health and readmission, and (iii) to investigate predictors of readmission and mortality. METHODS: All adults treated for IE in Denmark, January-June 2011 (N=347), were followed in registers. Eligible individuals (n=209) were invited to participate in a questionnaire survey (responders n=122). Responses were compared with those of a background reference population and a heart valve surgery population. Mortality and readmission data from registers 12months post-discharge were investigated. RESULTS: Patients discharged after treatment for IE had a mortality of 18% (95% confidence interval (CI): 14%-23%) one year post-discharge and 65% (95% CI: 59%-71%) had been readmitted, the majority (82%) acutely. Patients had lower self-reported health compared to the background population (physical component scale (PCS); mean (standard deviation (SD)): 42.2 (11.1) vs. 47.1 (12.1), (p=0.0004), mental component scale (MCS); 50.1 (11.7) vs. 53.8 (9.2), (p=0.006), and more were sedentary (29 vs. 15%), (p=0.002). Large proportions had clinical signs of anxiety and depression, 25% and 22% respectively, exceeding a hospital anxiety and depression scale (HADS) cut-off score of 8. Almost half (47%) had not been offered cardiac rehabilitation (CR). CONCLUSIONS: After IE, mortality and readmission rates were high and self-reported physical and mental health poor. These findings call for changes in in-hospital and post-discharge management.

Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control: the CopenHeartVR trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising because of an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. The secondary outcome is self-assessed mental health measured by the standardized questionnaire Short Form-36. Long-term healthcare utilization and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether cardiac rehabilitation should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 ).

Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial.

BACKGROUND: Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery. METHODS: A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. DISCUSSION: The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: ClinicalTrials.gov (http://NCT01558765).

A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol.

INTRODUCTION: Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalisation, high-dosage antibiotic therapy and possible valve replacement surgery. Despite advances in treatment, the 1-year mortality remains at 20-40%. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work up to a year postdischarge. No studies investigating the effects of rehabilitation have been published. We present the rationale and design of the CopenHeart(IE) trial, which investigates the effect of comprehensive cardiac rehabilitation versus usual care for patients treated for IE. METHODS AND ANALYSIS: We will conduct a randomised clinical trial to investigate the effects of comprehensive cardiac rehabilitation versus usual care on the physical and psychosocial functioning of patients treated for IE. The trial is a multicentre, parallel design trial with 1 : 1 individual randomisation to either the intervention or control group. The intervention consists of five psychoeducational consultations provided by specialised nurses and a 12-week exercise training programme. The primary outcome is mental health (MH) measured by the standardised Short Form 36 (SF-36). The secondary outcome is peak oxygen uptake measured by the bicycle ergospirometry test. Furthermore, a number of exploratory analyses will be performed. Based on sample size calculation, 150 patients treated for left-sided (native or prosthetic valve) or cardiac device endocarditis will be included in the trial. A qualitative and a survey-based complementary study will be undertaken, to investigate postdischarge experiences of the patients. A qualitative postintervention study will explore rehabilitation participation experiences. ETHICS AND DISSEMINATION: The study complies with the Declaration of Helsinki and was approved by the regional research ethics committee (no H-1-2011-129) and the Danish Data Protection Agency (no 2007-58-0015). Study findings will be disseminated widely through peer-reviewed publications and conference presentations. REGISTRATION: Clinicaltrials.gov identifier: NCT01512615.