Application of Machine Learning in Multimorbidity Research: Protocol for a Scoping Review.

BACKGROUND: Multimorbidity, defined as the coexistence of multiple chronic conditions, poses significant challenges to health care systems on a global scale. It is associated with increased mortality, reduced quality of life, and increased health care costs. The burden of multimorbidity is expected to worsen if no effective intervention is taken. Machine learning has the potential to assist in addressing these challenges since it offers advanced analysis and decision-making capabilities, such as disease prediction, treatment development, and clinical strategies. OBJECTIVE: This paper represents the protocol of a scoping review that aims to identify and explore the current literature concerning the use of machine learning for patients with multimorbidity. More precisely, the objective is to recognize various machine learning models, the patient groups involved, features considered, types of input data, the maturity of the machine learning algorithms, and the outcomes from these machine learning models. METHODS: The scoping review will be based on the guidelines of the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews). Five databases (PubMed, Embase, IEEE, Web of Science, and Scopus) are chosen to conduct a literature search. Two reviewers will independently screen the titles, abstracts, and full texts of identified studies based on predefined eligibility criteria. Covidence (Veritas Health Innovation Ltd) will be used as a tool for managing and screening papers. Only studies that examine more than 1 chronic disease or individuals with a single chronic condition at risk of developing another will be included in the scoping review. Data from the included studies will be collected using Microsoft Excel (Microsoft Corp). The focus of the data extraction will be on bibliographical information, objectives, study populations, types of input data, types of algorithm, performance, maturity of the algorithms, and outcome. RESULTS: The screening process will be presented in a PRISMA-ScR flow diagram. The findings of the scoping review will be conveyed through a narrative synthesis. Additionally, data extracted from the studies will be presented in more comprehensive formats, such as charts or tables. The results will be presented in a forthcoming scoping review, which will be published in a peer-reviewed journal. CONCLUSIONS: To our knowledge, this may be the first scoping review to investigate the use of machine learning in multimorbidity research. The goal of the scoping review is to summarize the field of literature on machine learning in patients with multiple chronic conditions, highlight different approaches, and potentially discover research gaps. The results will offer insights for future research within this field, contributing to developments that can enhance patient outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/53761.

Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.

Importance: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care tailored to individual needs. However, several ethical issues have been raised in relation to PRO use. Objective: To develop international, consensus-based, PRO-specific ethical guidelines for clinical research. Evidence Review: The PRO ethics guidelines were developed following the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network's guideline development framework. This included a systematic review of the ethical implications of PROs in clinical research. The databases MEDLINE (Ovid), Embase, AMED, and CINAHL were searched from inception until March 2020. The keywords patient reported outcome* and ethic* were used to search the databases. Two reviewers independently conducted title and abstract screening before full-text screening to determine eligibility. The review was supplemented by the SPIRIT-PRO Extension recommendations for trial protocol. Subsequently, a 2-round international Delphi process (n = 96 participants; May and August 2021) and a consensus meeting (n = 25 international participants; October 2021) were held. Prior to voting, consensus meeting participants were provided with a summary of the Delphi process results and information on whether the items aligned with existing ethical guidance. Findings: Twenty-three items were considered in the first round of the Delphi process: 6 relevant candidate items from the systematic review and 17 additional items drawn from the SPIRIT-PRO Extension. Ninety-six international participants voted on the relevant importance of each item for inclusion in ethical guidelines and 12 additional items were recommended for inclusion in round 2 of the Delphi (35 items in total). Fourteen items were recommended for inclusion at the consensus meeting (n = 25 participants). The final wording of the PRO ethical guidelines was agreed on by consensus meeting participants with input from 6 additional individuals. Included items focused on PRO-specific ethical issues relating to research rationale, objectives, eligibility requirements, PRO concepts and domains, PRO assessment schedules, sample size, PRO data monitoring, barriers to PRO completion, participant acceptability and burden, administration of PRO questionnaires for participants who are unable to self-report PRO data, input on PRO strategy by patient partners or members of the public, avoiding missing data, and dissemination plans. Conclusions and Relevance: The PRO ethics guidelines provide recommendations for ethical issues that should be addressed in PRO clinical research. Addressing ethical issues of PRO clinical research has the potential to ensure high-quality PRO data while minimizing participant risk, burden, and harm and protecting participant and researcher welfare.

External validity of randomized clinical trial studying preventing depressive symptoms following acute coronary syndrome.

OBJECTIVE: The objective of the current study was to quantitatively explore aspects of external validity, both researcher's choices (eligibility) and patient's choices (consent), of a recently conducted clinical trial. METHODS: A cohesive comparison between the MEDACIS trial (NCT02451293) database and a national quality and research database was conducted. Comparisons between both participants and nonconsenting patients (patient consent) and participants and noneligible patients (researcher selection) were performed. Comparisons of outcomes were depressive and anxiety symptoms, demographics, and somatic or psychiatric comorbidity. RESULTS: Noneligible patients had significantly higher levels of depressive symptoms and anxiety and were older and more likely to suffer from unstable angina pectoris. Furthermore, noneligible patients were less likely to be married, had a lower educational level, used more medication, and had a higher frequency of comorbidity. Nonconsenting patients had significantly higher levels of depressive symptoms and anxiety and were older and more likely to be females compared to participants. CONCLUSION: Significant differences were present between noneligible patients and participants; however, more troublingly significant differences were shown between nonconsenting patients and participants. The presence of depressive symptoms and anxiety has a significant impact on patients' willingness to give informed consent in clinical trials in cardiology with a focus on psychological outcomes.

Secondary prevention through comprehensive cardiovascular rehabilitation: From knowledge to implementation. 2020 update. A position paper from the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiology.

Secondary prevention through comprehensive cardiac rehabilitation has been recognized as the most cost-effective intervention to ensure favourable outcomes across a wide spectrum of cardiovascular disease, reducing cardiovascular mortality, morbidity and disability, and to increase quality of life. The delivery of a comprehensive and 'modern' cardiac rehabilitation programme is mandatory both in the residential and the out-patient setting to ensure expected outcomes. The present position paper aims to update the practical recommendations on the core components and goals of cardiac rehabilitation intervention in different cardiovascular conditions, in order to assist the whole cardiac rehabilitation staff in the design and development of the programmes, and to support healthcare providers, insurers, policy makers and patients in the recognition of the positive nature of cardiac rehabilitation. Starting from the previous position paper published in 2010, this updated document maintains a disease-oriented approach, presenting both well-established and more controversial aspects. Particularly for implementation of the exercise programme, advances in different training modalities were added and new challenging populations were considered. A general table applicable to all cardiovascular conditions and specific tables for each clinical condition have been created for routine practice.

Physical activity and serious adverse events in patients with atrial fibrillation and/or atrial flutter treated with catheter ablation.

BACKGROUND: Atrial fibrillation (AF) and atrial flutter (AFL) are cardiac arrhythmias associated with cardiovascular morbidity. Physical activity (PA) can trigger AF and AFL recurrence, but can also improve physical functional capacity in this patient group. Guidelines do not include concrete recommendations regarding PA for this patient group. OBJECTIVE: To assess the impact of the level of PA on risk of serious adverse events (SAEs) in patients with AF and/or AFL treated with catheter ablation. METHODS: A prospective cohort study including 462 patients with AF and/or AFL treated with catheter ablation from the CopenHeart Survey. The International Physical Activity Questionnaire (IPAQ) was used to explore patients' self-reported level of PA. SAEs were identified in the Danish National Patient Register and the Danish Civil Registration System one year after study onset. Cox regression analysis was carried out to assess the risks of SAE. RESULTS: During the one-year follow-up period, 98 patients (21.8%) experienced at least one SAE. Patients with a moderate-high PA level had a 36% lower risk of experiencing SAEs during the follow-up period, compared to patients in the low PA group, after adjusting for confounders. CONCLUSION: A moderate-high vs. low level of PA was found to be associated with a lower incidence of SAEs in patients undergoing AF and/or AFL ablation.

What to expect after open heart valve surgery? Changes in health-related quality of life.

PURPOSE: To (i) describe changes in health-related quality of life (HRQoL) pre-operatively, at discharge, and 4 weeks after discharge following open heart surgery, (ii) compare the performance of the EuroQol Questionnaire (EQ-5D 5L) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) against an anchor-based approach, and to (iii) investigate the association between HRQoL and 180-day readmission. METHODS: A prospective, consecutive cohort (single-center study) of 291 patients completed the EQ-5D 5L and KCCQ pre-operatively, at discharge and 4 weeks post-discharge. Changes in HRQoL over time were evaluated, and the performance of the instruments was investigated. The association between HRQoL and readmission were investigated with Cox Proportional Hazard models. RESULTS: Scores of the EQ-5D Index and VAS decreased significantly from the pre-operative assessment to discharge and improved from discharge to 4 weeks after. The KCCQ scores significantly improved from baseline to 4 weeks after. Minimal clinically important improvements from before surgery to 4 weeks after were seen among 24% (EQ-5D Index), 45% (EQ-5D VAS), and 57% (KCCQ). More than one-third experienced worse HRQoL 1 month after discharge. Area under the curve (AUC) (performance of the instruments) demonstrated the following: EQ-5D Index AUC 0.622 (95% CI 0.540-0.704), VAS AUC 0.674 (95% CI 0.598-0.750), and KCCQ AUC 0.722 (95% CI 0.65-0.792). None of the HRQoL measurements were associated with 180-day readmission. CONCLUSIONS: This study revealed that HRQoL measured with the EQ-5D is significantly worse at discharge compared to before surgery, but scores increases within the first month measured with the EQ-5D and the KCCQ. The EQ-5D and KCCQ have a moderate correlation with an anchor-based approach but were not associated with readmission.

Sleep Disturbances in Patients With Coronary Heart Disease: A Systematic Review.

STUDY OBJECTIVES: Investigation into sleep and coronary heart disease (CHD) has predominantly been focused on sleep disturbances as a risk factor for developing CHD. Objectively measured and self-reported sleep at a patient level has only been sparsely and not systematically reported. Therefore, we set out to review the literature for studies using objectively measured and self-reported sleep in patients with CHD. The review focuses on patients with acute coronary syndrome (ACS) and stable CHD. METHODS: A systematic review performed in four databases adhering to the PRISMA guidelines applying a qualitative synthesis of evidence. RESULTS: Following ACS, we found sleep architecture to be significantly disturbed with changes normalizing over a period of up to 6 months. With increasing severity of CHD, sleep disturbances were more pronounced; however, the modulating effects of sleep-disordered breathing and ejection fraction on sleep in patients with CHD are conflicting. Overall, studies were predominantly cross-sectional in design and of low methodological quality. Polysomnography was the predominant outcome assessment tool and validated self-reported assessment tools were limited. CONCLUSIONS: Future investigations in sleep and CHD applying both a longitudinal design and investigating objective and self-reported sleep assessments are warranted. SYSTEMATIC REVIEW REGISTRATION: Registry: PROSPERO, Title: Sleep measures in relation to coronary heart disease: a systematic review, Identifier: CRD42017056377, URL: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=56377.

Sexual rehabilitation for cardiac patients with erectile dysfunction: a randomised clinical trial.

BACKGROUND: Sexual dysfunction is common in patients with either ischaemic heart disease (IHD) or implantable cardioverter defibrillator (ICD) and has a negative impact on quality of life. Non-pharmacological treatment options are lacking. The purpose of this trial was to assess the effect of sexual rehabilitation versus usual care for males with erectile dysfunction and either IHD and/or ICD. METHODS: Participants with erectile dysfunction and IHD and/or ICD were randomised to 12 weeks of sexual rehabilitation consisting of physical exercise training, pelvic floor exercise and psychoeducation, or usual care. PRIMARY OUTCOME: sexual function by the International Index of Erectile Function (IIEF). Secondary outcome: sexual function by the Psychosocial Adjustment to Illness Scale. Exploratory outcomes: exercise capacity, pelvic floor strength/endurance, self-reported health and mental health. RESULTS: 154 participants were included, mean age 61.6 years (SD 6.1). Sexual rehabilitation compared with usual care improved sexual function with a mean difference IIEF score of 6.7 (95% CI 3.1 to 10.4, p<0.0003) at 4 months between groups (unadjusted IIEF mean scores 36.4 vs 31.3) and a mean difference of 6.7, 95% CI 3.2 to 10.1 (p<0.0002) at 6 months between groups (unadjusted mean scores IIEF 37.1 vs 32.2). No effects were seen on the secondary outcome. Sexual rehabilitation improved exercise capacity on cycle ergometer measured by Watt max with a mean difference of 10.3, 95% CI 3.6 to 16.9 (p<0.003) and pelvic floor strength (p<0.01). No differences were seen on self-reported health and mental health. CONCLUSION: Sexual rehabilitation compared with usual care improves sexual function and exercise capacity. TRIAL REGISTRATION: NCT01796353; Results.

Resistance to change: Role of relationship and communal coping for coronary heart disease patients and their partners in making lifestyle changes.

BACKGROUND: Lifestyle behaviours are important risk factors for coronary heart disease (CHD) and, hence, motivation for lifestyle changes is suggested to be a key factor in the success of cardiac rehabilitation and secondary prevention programmes. The motivation for changing lifestyle among people with CHD may be influenced by those with whom they have long-term, intimate relationships. AIMS: This study explores the role of the relationship between people with CHD and those closest to them in making lifestyle changes. This includes investigating if patients and partners experience autonomy, competence, and relatedness, and what role communal, i.e. relationship-centred coping serves in relation to patients' health behaviour. METHODS: The study is based on semi-structured, in-depth interviews with 10 couples; people who have experienced acute coronary syndrome, and their partners. Participants had diverse histories of disease and social backgrounds. A three-stage interview process was undertaken including focus group interviews, couple interviews and individual interviews. A thematic analysis, inspired by the self-determination theory and the interdependence theory, was conducted. RESULTS: Communal coping is evident in various forms, and at different levels, among people with CHD and their partners. Satisfaction with new lifestyle, ownership of change, confidence in ability to change, and emotional distress are all factors that affect how couples deal with lifestyle changes in the aftermath of CHD. CONCLUSIONS: Rehabilitation efforts, aimed at lifestyle changes, need to address each individual, as well as the dyadic interaction within couples. Incorporating a dyadic perspective in the rehabilitation process may lead to a reduction in motivational barriers to lifestyle changes.

Sex differences in health status and rehabilitation outcomes in patients with atrial fibrillation treated with ablation: Results from the CopenHeartRFA trial.

BACKGROUND: Increased physical capacity after comprehensive rehabilitation in patients with atrial fibrillation (AF) undergoing ablation has been found in the CopenHeartRFA trial. The purpose of this study was to investigate: (a) sex differences in health status, psychological distress and quality of life, (b) sex differences in rehabilitation outcomes and (c) predictors of effect of rehabilitation. METHODS: We conducted an exploratory analysis of data from the randomized CopenHeartRFA trial, where patients treated with ablation were randomized with 1:1 to comprehensive rehabilitation consisting of a physical exercise program and psycho-educational consultations versus usual care. Sex disparities in health status were tested using Chi-square and t-tests. RESULTS: Included were: 151 men (median age 59.25 years) and 59 women (median age 62.5 years). At hospital discharge, women reported lower physical health status compared with men. Among women, significant differences were found in the 6-min walk test [rehabilitation: 496.8 meters (SD 98.5) versus 559.3meters (SD 55.5) and usual care: 521.9 meters (SD 97.8) versus 530.9 meters (SD 102.2), p = 0.01] and exercise time [rehabilitation: 387.6 s (SD 126.0) versus 463.2 s (SD 121.8) and usual care: 353.4 s (SD 145.2) versus 355.8 s (SD 154.8), p < 0.004] and among men in the sit-to-stand test. Significant differences were found in mental health outcomes among men and in quality of life scores among women. Patients with a European Heart Rhythm Association (EHRA) score I-II had a positive effect of rehabilitation. CONCLUSION: The results suggest that sex differences exist in self-reported health after rehabilitation in patients ablated for AF. Patients with an I-II EHRA score seem more likely to gain from the rehabilitation programme compared with those with a III-IV score.

How to measure experiences of healthcare quality in Denmark among patients with heart disease? The development and psychometric evaluation of a patient-reported instrument.

OBJECTIVE: Measuring the quality of care as experienced by patients is increasingly recognised as a way of improving healthcare services. However, disease-specific measures that take the patient journey into account are needed. This paper presents the development of such a measure for patients with heart disease and details the psychometric evaluation. DESIGN: The questionnaire was developed based on a literature review, qualitative interviews and a pilot-test. The psychometric evaluation of the measure was assessed using exploratory factor analysis (EFA) and confirmatory factor analysis (CFA), Cronbach's alpha coefficient and differential item functioning analysis with data from a population-based survey. SETTING: Denmark in 2013-2014. STUDY PARTICIPANTS: Nineteen heart patients, four relatives and eight health professionals participated in qualitative interviews in the development phase, and 15 patients participated in the pilot-test. The questionnaire was subsequently sent to a random sample of 5000 heart patients who were diagnosed in 2013. RESULTS: The comprehensive development phase and pilot-testing contributed to high content validity of the questionnaire. Eligible questionnaire responses were received from 2496 patients. EFA indicated a nine-factor model: communication at the hospital, communication with the general practitioner, information on disease and treatment, information on psychosocial aspects, rehabilitation/support, organisation, medication, involvement of relatives and consideration of comorbidity. CFA confirmed the proposed factor structure (eg, goodness-of-fit index=0.88, adjusted goodness-of-fit index=0.86, root mean square error of approximation=0.05), and Cronbach's alpha coefficient revealed good internal consistency of the factors (range: 0.69-0.93). CONCLUSIONS: The results suggest that this disease-specific patient-reported experience measure is of good quality when measuring the quality of care among heart patients. The inclusion of patients in the development phase contributed to high content validity, and subsequent psychometric evaluation found high construct validity and internal consistency. This measure may be especially relevant when seeking information about which aspects of care require improvement and the impact on health outcomes.

The association between supportive relatives and lower occurrence of anxiety and depression in heart patients: Results from a nationwide survey.

BACKGROUND: Approximately 30-40% of heart patients develop anxiety and/or depression, which might influence recovery and long-term survival. Research has suggested that support from relatives may decrease anxiety and depression among heart patients; however, the results are inconsistent and often based on small study populations. AIM: The paper aimed to investigate the association between having supportive relatives and the occurrence of anxiety and depression in heart patients. METHODS: A population-based cross-sectional study among Danish patients diagnosed with ischemic heart disease, atrial fibrillation, heart failure, or heart valve disease. Presence of supportive relatives was measured as the degree to which the patients felt that they had relatives they could count on, while symptoms of anxiety and depression were measured by the Hospital Anxiety and Depression Scale (HADS). Multiple logistic regression analyses accounting for confounders were used to examine the association between supportive relatives and anxiety/depression. RESULTS: The questionnaire was answered by 2496 heart patients, corresponding to 50% of the invited population. Patients with low or some degree of supportive relatives had a higher odds ratio (OR) of anxiety than patients with a high degree (OR = 2.20, 95% confidence interval (CI): 1.28-2.37; OR = 1.75, 95% CI: 1.57-3.08, respectively). Likewise, patients with low or some degree of supportive relatives had a higher OR of depression than patients with a high degree (OR = 1.96, 95% CI: 1.40-2.66; OR = 1.93, 95% CI: 1.37-2.60, respectively). CONCLUSIONS: The presence of supportive relatives was found to be associated with lower occurrence of anxiety and depression. Health professionals should focus on including relatives in the treatment and rehabilitation of heart patients.

The MacNew Heart Disease Health-Related Quality of Life Questionnaire: A Scandinavian Validation Study.

The aim of this study is to validate the Danish, Norwegian and Swedish versions of the self-administered MacNew Heart Disease Health-related Quality of Life questionnaire in patients with ischemic heart disease. The MacNew questionnaire, the Short Form SF-36, and the Hospital Anxiety and Depression Scale were completed at baseline by 976 patients (Denmark n = 353, Norway n = 328, Sweden n = 295) with a diagnosis of angina (n = 335), myocardial infarction (n = 352), or heart failure (n = 289). Each language version of the MacNew satisfied reliability criteria with Cronbach's α values for the total group data (0.90-0.94) as well as the diagnostic group data (0.91-0.96). The test-retest correlations exceeded the criteria for group comparison (r ≥ 0.70) in Danish and Norwegian patients. The multidimensionality of the MacNew was confirmed although the original three-factor solution did not fully meet the criteria for good fit. Convergent and discriminative validity were confirmed in each language and diagnosis group with the exception of discriminative validity in Swedish angina patients. The psychometric properties of the Danish, Norwegian, and Swedish versions of the MacNew are largely confirmed. The MacNew can be recommended as a specific instrument for assessing and evaluating HRQL in Danish, Norwegian, and Swedish patients with angina, MI, and heart failure. However, the MacNew factor structure needs to be revisited in future studies.

Trends in time to invasive examination and treatment from 2001 to 2009 in patients admitted first time with non-ST elevation myocardial infarction or unstable angina in Denmark.

OBJECTIVE: To investigate trends in time to invasive examination and treatment for patient with first time diagnosis of non-ST elevation myocardial infarction (NSTEMI) and unstable angina during the period from 2001 to 2009 in Denmark. DESIGN: From 1 January 2001 to 31 December 2009 all first time hospitalisations with NSTEMI and unstable angina were identified in the National Patient Registry (n=65 909). Time from admission to initiation of coronary angiography (CAG), percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) was calculated. We described the development in invasive examination and treatment probability (CAG, PCI and CABG at 3, 7, 10, 30 and 60 days) for the years 2001-2009, taking the competing risk of death into account using Aalen-Johansen estimators and a Fine-Gray model. SETTING: Nationwide Danish cohort. RESULTS: The proportion of patients receiving a CAG and PCI increased substantially over time while the proportion receiving a CABG decreased for both NSTEMI and unstable angina. For both NSTEMI and unstable angina, a significant increase in invasive examination and treatment probability at 3 days for CAG and PCI were seen especially from 2007 through to 2009. For NSTEMI, the CAG examination probability at 3 days leaped from 20% in 2007 to 32% in 2008 and 39% in 2009, and for PCI the same was true with a leap in treatment probability from 19% to 28% from 2008 to 2009. CONCLUSIONS: In Denmark the use of CAG and PCI in treatment of NSTEMI and unstable angina has increased from 2001 to 2009, while the use of CABG has decreased. During the same period, there was a marked increase in invasive examination and treatment probability at 3 days, that is, more patients were treated faster which is in line with the political aim of reducing time to treatment.

No association between anxiety and depression and adverse clinical outcome among patients with cardiovascular disease: findings from the DANREHAB trial.

OBJECTIVE: Anxiety and depression have been linked to adverse prognostic outcome in patients with cardiovascular disease (CVD) with mixed results. The timing of anxiety and depression measurement has received little attention so far. METHODS: The study sample consisted of 536 patients admitted to hospital for CVD and followed in a rehabilitation trial. Symptoms were assessed using the Hospital Anxiety and Depression Scale at baseline and after 1 year. Cox proportional hazards model was used to describe the association between anxiety and depression and adverse outcome (myocardial infarction (MI), heart failure (HF), stroke, death and a combined endpoint) after 5 years. RESULTS: Prevalence of anxiety and depression at baseline was 32% and 13%, respectively. There were 303 combined events; 140 deaths, 60 patients had MI, 177 patients were admitted to hospital with HF and 60 patients had a stroke. Neither anxiety nor depression at any time was associated with mortality or the combined endpoint. Anxiety in IHD patients at baseline and at 1 year was associated with increased risk of MI (HR 2.74; 95% CI: 1.10-6.83) but was attenuated after adjusting for other risk factors (HR 1.18; 95% CI: 0.39-3.55). Both anxiety and depression at 1 year were associated with increased risk of stroke: HR 2.25 (95% CI: 1.05-4.82) and 2.34 (95% CI: 0.99-5.50), respectively, but risk associated with anxiety was attenuated after adjustment. There were no gender differences. CONCLUSIONS: Contrary to conclusions from recent meta-analyses, anxiety and depression measured at baseline and after 1 year were not associated with adverse outcome in CVD patients after multivariable adjustment.

Secondary prevention through cardiac rehabilitation: physical activity counselling and exercise training: key components of the position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation.

Cardiac patients after an acute event and/or with chronic heart disease deserve special attention to restore their quality of life and to maintain or improve functional capacity. They require counselling to avoid recurrence through a combination of adherence to a medication plan and adoption of a healthy lifestyle. These secondary prevention targets are included in the overall goal of cardiac rehabilitation (CR). Cardiac rehabilitation can be viewed as the clinical application of preventive care by means of a professional multi-disciplinary integrated approach for comprehensive risk reduction and global long-term care of cardiac patients. The CR approach is delivered in tandem with a flexible follow-up strategy and easy access to a specialized team. To promote implementation of cardiac prevention and rehabilitation, the CR Section of the EACPR (European Association of Cardiovascular Prevention and Rehabilitation) has recently completed a Position Paper, entitled 'Secondary prevention through cardiac rehabilitation: A condition-oriented approach'. Components of multidisciplinary CR for seven clinical presentations have been addressed. Components include patient assessment, physical activity counselling, exercise training, diet/nutritional counselling, weight control management, lipid management, blood pressure monitoring, smoking cessation, and psychosocial management. Cardiac rehabilitation services are by definition multi-factorial and comprehensive, with physical activity counselling and exercise training as central components in all rehabilitation and preventive interventions. Many of the risk factor improvements occurring in CR can be mediated through exercise training programmes. This call-for-action paper presents the key components of a CR programme: physical activity counselling and exercise training. It summarizes current evidence-based best practice for the wide range of patient presentations of interest to the general cardiology community.

Secondary prevention through cardiac rehabilitation: from knowledge to implementation. A position paper from the Cardiac Rehabilitation Section of the European Association of Cardiovascular Prevention and Rehabilitation.

Increasing awareness of the importance of cardiovascular prevention is not yet matched by the resources and actions within health care systems. Recent publication of the European Commission's European Heart Health Charter in 2008 prompts a review of the role of cardiac rehabilitation (CR) to cardiovascular health outcomes. Secondary prevention through exercise-based CR is the intervention with the best scientific evidence to contribute to decrease morbidity and mortality in coronary artery disease, in particular after myocardial infarction but also incorporating cardiac interventions and chronic stable heart failure. The present position paper aims to provide the practical recommendations on the core components and goals of CR intervention in different cardiovascular conditions, to assist in the design and development of the programmes, and to support healthcare providers, insurers, policy makers and consumers in the recognition of the comprehensive nature of CR. Those charged with responsibility for secondary prevention of cardiovascular disease, whether at European, national or individual centre level, need to consider where and how structured programmes of CR can be delivered to all patients eligible. Thus a novel, disease-oriented document has been generated, where all components of CR for cardiovascular conditions have been revised, presenting both well-established and controversial aspects. A general table applicable to all cardiovascular conditions and specific tables for each clinical disease have been created and commented.

Hospital-based comprehensive cardiac rehabilitation versus usual care among patients with congestive heart failure, ischemic heart disease, or high risk of ischemic heart disease: 12-month results of a randomized clinical trial.

BACKGROUND: Current guidelines broadly recommend comprehensive cardiac rehabilitation (CCR), although evidence for this is still limited. We investigated the 12-month effect of hospital-based CCR versus usual care (UC) for a broadly defined group of cardiac patients within the modern therapeutic era of cardiology. METHODS: We conducted a centrally randomized single-center clinical trial with blinded assessment of the primary outcome: registry-based composite of total mortality, myocardial infarction, or acute first-time readmission due to heart disease. Other outcomes were hospitalization, risk profile, and quality of life. The trial included 770 participants (20-94 years) with congestive heart failure (12%), ischemic heart disease (58%), or high risk of ischemic heart disease (30%). Comprehensive cardiac rehabilitation is composed of 6 weeks of intensive intervention and systematic follow-up for 10.5 months. RESULTS: We randomized 380 patients to CCR versus 390 to UC. Randomization was well balanced. The primary outcome occurred in 31% of both groups (relative risk 0.96, 95% confidence interval 0.78-1.26). Compared with the UC group, CCR significantly reduced length of stay by 15% (95% confidence interval 1.1%-27.1%, P = .04), mean number of cardiac risk factors above target (4.5 vs 4.1, P = .01), patients with systolic blood pressure below target (P = .003), physically inactivity (P = .01), and unhealthy dietary habits (P = .0003). Short-Form-36 and Hospital Anxiety and Depression Scale did not differ significantly. CONCLUSION: At 12 months, the CCR and UC groups did not differ regarding the primary composite outcome. Comprehensive cardiac rehabilitation significantly reduced length of hospital stay and improved cardiac risk factors.

Use of intensified comprehensive cardiac rehabilitation to improve risk factor control in patients with type 2 diabetes mellitus or impaired glucose tolerance--the randomized DANish StUdy of impaired glucose metabolism in the settings of cardiac rehabilitation (DANSUK) study.

BACKGROUND: The DANish StUdy of impaired glucose metabolism in the settings of cardiac rehabilitation (DANSUK) examined the effect of an intensified multifactorial intervention on risk factor profile in 104 patients with type 2 diabetes mellitus (T2DM) or impaired glucose tolerance (IGT) attending hospital-based outpatient comprehensive cardiac rehabilitation (CCR) compared to usual care (UC). METHODS: Patients with ischemic heart disease (67%), congestive heart failure (7%), or at least 3 risk factors for ischemic heart disease (26%) discharged from 1 coronary care unit were referred to CCR. Of 473 eligible individuals, 201 agreed to participate in the study, and 52% had T2DM or IGT. Patients randomized to CCR received a stepwise implementation of behavioral modification and pharmacotherapy. RESULTS: After 1 year, patients with T2DM in the CCR group experienced a mean change in HbA1c of -0.65% +/- 0.9% compared with a mean change of -0.08% +/- 0.7% in the UC group (P < .05). Mean change in systolic and diastolic blood pressures was -8 +/- 15 and -5 +/- 9 mm Hg in the CCR group compared with a mean change of -0.8 +/- 15 and -0.2 +/- 7 mm Hg in the UC group (P < .05). Patients with IGT attending CCR obtained a significantly higher exercise capacity compared with patients in the UC group (P < .05). CONCLUSIONS: In a group of patients with impaired glucose metabolism attending CCR, an intensified multifactorial intervention with an integrated diabetes module was more efficient in improving risk factor control than UC. Besides the improvement in the exercise capacity of patients with IGT, in patients with T2DM, both HbA1c and blood pressure were lowered to a level that has been shown to reduce both cardiac and diabetic complications. These findings have important implications for patients with impaired glucose metabolism in the future settings of CCR.