Challenges and benefits of using the HeartDiet food frequency questionnaire in cardiac rehabilitation practice.

BACKGROUND AND AIMS: A heart-healthy diet is an important component of secondary prevention in ischemic heart disease. The Danish Health Authority recommends using the validated 19-item food frequency questionnaire HeartDiet in cardiac rehabilitation practice to assess patients' need for dietary interventions, and HeartDiet has been included in national electronic patient-reported outcome instruments for cardiac rehabilitation. This study aims to evaluate challenges and benefits of its use. The objectives are to: 1) describe HeartDiet responses of patients with ischemic heart disease and discuss HeartDiet's suitability as a screening tool, 2) discuss whether an abridged version should replace HeartDiet. METHODS AND RESULTS: A cross-sectional study using data from a national feasibility test. HeartDiet was sent electronically to 223 patients with ischemic heart disease prior to cardiac rehabilitation. Data were summarised with descriptive statistics, and Spearman's rank correlations, explorative factor analysis, and Cohen's kappa coefficient were used to derive and evaluate abridged versions. The response rate was 68 % (n = 151). Evaluated with HeartDiet, no respondents had a heart-healthy diet. There was substantial agreement between HeartDiet and an abridged 9-item version (kappa = 0.6926 for Fat Score, 0.6625 for FishFruitVegetable Score), but the abridged version omits information on milk products, wholegrain, nuts, and sugary snacks. CONCLUSION: With the predefined cut-offs, HeartDiet's suitability as a screening tool to assess needs for dietary interventions was limited, since no respondents were categorised as having a heart-healthy diet. An abridged version can replace HeartDiet, but the tool's educational potential will be compromised, since important items will be omitted.

Cardiac rehabilitation for heart failure: 'Cinderella' or evidence-based pillar of care?

Cardiac rehabilitation remains the 'Cinderella' of treatments for heart failure. This state-of-the-art review provides a contemporary update on the evidence base, clinical guidance, and status of cardiac rehabilitation delivery for patients with heart failure. Given that cardiac rehabilitation participation results in important improvements in patient outcomes, including health-related quality of life, this review argues that an exercise-based rehabilitation is a key pillar of heart failure management alongside drug and medical device provision. To drive future improvements in access and uptake, health services should offer heart failure patients a choice of evidence-based modes of rehabilitation delivery, including home, supported by digital technology, alongside traditional centre-based programmes (or combinations of modes, 'hybrid') and according to stage of disease and patient preference.

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.

Placing patient-reported outcomes at the centre of cardiovascular clinical practice: implications for quality of care and management.

Patient-reported outcomes (PROs) provide important insights into patients' own perspectives about their health and medical condition, and there is evidence that their use can lead to improvements in the quality of care and to better-informed clinical decisions. Their application in cardiovascular populations has grown over the past decades. This statement describes what PROs are, and it provides an inventory of disease-specific and domain-specific PROs that have been developed for cardiovascular populations. International standards and quality indices have been published, which can guide the selection of PROs for clinical practice and in clinical trials and research; patients as well as experts in psychometrics should be involved in choosing which are most appropriate. Collaborations are needed to define criteria for using PROs to guide regulatory decisions, and the utility of PROs for comparing and monitoring the quality of care and for allocating resources should be evaluated. New sources for recording PROs include wearable digital health devices, medical registries, and electronic health record. Advice is given for the optimal use of PROs in shared clinical decision-making in cardiovascular medicine, and concerning future directions for their wider application.

Return to work: does cardiac rehabilitation make a difference? Danish nationwide register-based study.

AIM: to assess whether participation in cardiac rehabilitation affects the probability of returning to work after ischaemic heart disease. METHODS: the study population consisted of 24,509 patients (18-70 years of age) discharged from an inpatient admission at a Danish hospital during 2014-2018 and who were working before their admission. Only patients with a percutaneous coronary intervention or coronary artery bypass grafting surgery procedure and ICD-10 codes I20-I25 as their main diagnosis or ICD-10 codes I21, I240, I248 or I249 as secondary diagnosis during an emergency admission were included. Exposure was defined as participation in cardiac rehabilitation (N = 15,742), and binary indicator of being at work in the last week of a given month were used as primary outcomes. Coarsened exact matching (CEM) of exposed and unexposed patients was used to reduce selection bias. Logistic regression models were applied on the matched population (N = 15,762). RESULTS: Less deprived and less comorbid patients were more likely to receive cardiac rehabilitation. CEM succeeded in arriving at a population where this selection was reduced and in this population we found that patients who received cardiac rehabilitation had a lower probability of returning to work after 3 months (OR 0.81, 95%CI: 0.77-0.84), a higher but insignificant probability after 6 (OR 1.02, 95%CI: 0.97-1.08), and a higher probability after 9 (OR 1.08, 95%CI: 1.02-1.15) and 12 months (OR 1.20, 95%CI: 1.13-1.28). CONCLUSIONS: Deprived and comorbid patients have lower use of cardiac rehabilitation. In a matched population where this bias is reduced, cardiac rehabilitation will increase the probability of returning to work.

Effects of screening for anxiety and depression in patients with ischaemic heart disease - a nationwide Danish register study.

AIM: To investigate the effect of screening for anxiety and depression (AD) in patients with ischaemic heart disease (IHD) on the likelihood of receiving treatment for AD. METHODS: We used a nationwide dataset of all Danish patients with an incident IHD diagnosis in the period 2015-2018 (N = 80,701) of which 20,461 (25%) were exposed to screening for AD as part of cardiac rehabilitation. A binary composite indicator for the use of any AD treatment (prescriptions of AD drugs, general practitioner (GP) counselling or referral to a psychologist), was modelled as the dependent variable. The probability of receiving AD treatment was estimated using linear probability and instrumental variable regression models. RESULTS: Exposure to AD screening was lower for patients with low income (change in probability -0.67, 95% CI -0.76; -0.59), low education (change in probability -0.16, 95% CI -0.20; -0.13), and a high comorbidity burden (change in probability -0.09, 95% CI -0.10; -0.07). Screened patients had a lower conditional probability of AD treatment (change in probability -0.0061, p < 0.001) than non-screened patients. The patient's GP also had an impact on the probability of being referred for AD treatment. Using an instrumental variable approach did not affect the results. CONCLUSIONS: Screening for AD was subject to selection at the patient level; patients at lower risk of AD had a higher probability of being screened. Hence, extending systematic screening to cover a larger population may not achieve a noticeable increase in the uptake of AD treatment if it is not supported by appropriate measures to reduce reverse selection into screening.

Considerable gaps and differences in rehabilitation after major lower extremity amputations across regions and municipalities in Denmark - A national survey.

INTRODUCTION: Equal access to healthcare is a fundamental principle in the fully tax-financed Danish healthcare system. This study reveals whether this system lives up to the principle of equal access when it comes to the rehabilitation of patients who have major lower extremity amputations. METHODS: With the aim of exploring possible inequality in rehabilitation for patients having major lower extremity amputation in Denmark, a nationwide electronic survey was conducted in the autumn of 2020, which included all hospitals and municipalities in Denmark. RESULTS: Eighty six percent of hospitals (n = 19) and 97% (n = 95) of municipalities responded. Of the 32% (n = 6) of hospitals and 78% (n = 74) of municipalities that provided prosthesis rehabilitation, the majority (hospitals 50% /municipalities 91%) provided prostheses for <10 patients in 2019, and 36% reported having competencies at only a general level among physiotherapists performing prosthetic training. Psychosocial rehabilitation modalities were lacking overall. CONCLUSIONS: This national study documents pronounced geographic inequality in access to qualified rehabilitation services for the relatively few patients undergoing lower extremity amputations in Denmark. The decentralised organisation of amputation rehabilitation makes it difficult to build and maintain specialist competencies among healthcare professionals. Inconsistent availability of psychosocial rehabilitation modalities of all kinds found in this study points to a need for action particularly among patients not in prosthetic rehabilitation where palliative needs should also be considered.

The patient education strategy "learning and coping" improves adherence to cardiac rehabilitation in primary healthcare settings: a pragmatic cluster-controlled trial.

BACKGROUND: Adherence and completion of programmes in educational and physical exercise sessions is essential in cardiac rehabilitation (CR) to obtain the known benefits on morbidity, mortality, risk factors, lifestyle, and quality of life. The patient education strategy "Learning and Coping" (LC) has been reported to positively impact adherence and completion in a hospital setting. It is unknown if LC has impact on adherence in primary healthcare settings, and whether LC improves self-management. The aim of this pragmatic primary healthcare-based study was to examine whether patients attending CR based on LC had a better adherence to patient education and physical exercise, higher program completion rate, and better self-management compared to patients attending CR based on a consultation program Empowerment, Motivation and Medical Adherence (EMMA). METHOD: A pragmatic cluster-controlled trial of two types of patient education LC and EMMA including ten primary healthcare settings and 514 patients (LC, n = 266; EMMA, n = 248) diagnosed with ischaemic heart disease discharged from hospital and referred to CR between August 1, 2018 and July 31, 2019. Adherence was defined as participation in ≥ 75% of provided sessions. Completion was defined as patients attended the final interview at the end of the 12-weeks programme. Patient Activation Measure (PAM) was used to obtain information on a person's knowledge, skills and confidence for self-management. PAM questionnaire was completed at baseline and 12-weeks follow-up. Multiple and Linear regression analyses adjusted for potential confounder variables and cluster effect were performed. RESULT: Patients who followed CR based on LC had a higher adherence rate to educational and physical exercise sessions compared to patients who followed CR based on EMMA (p < 0.01). High-level of completion was found at the end of CR with no statistically significant between clusters (78.9% vs. 78.2%, p > 0.05). At 12-weeks, there was no statistical differences in PAM-score between clusters (p > 0.05). CONCLUSION: This study indicates that the LC positively impacts adherence in CR compared to EMMA. We found non-significant difference in completing CR and in patient self-management between the two types of patient education. Future studies are needed to investigate if the higher adherence rate achieved by LC in primary healthcare settings translates into better health outcomes.

Benefits of cardiac rehabilitation following acute coronary syndrome for patients with and without diabetes: a systematic review and meta-analysis.

AIM: The benefits of cardiac rehabilitation (CR) after acute coronary syndrome (ACS) are well established. However, the relative benefit of CR in those with comorbidities, including diabetes, is not well understood. This systematic review and meta-analysis examined the benefit of CR on exercise capacity and secondary outcomes in ACS patients with a co-diagnosis of diabetes compared to those without. METHODS: Five databases were searched in May 2021 for randomised controlled trials (RCTs) and observational studies reporting CR outcomes in ACS patients with and without diabetes. The primary outcome of this study was exercise capacity expressed as metabolic equivalents (METs) at the end of CR and ≥ 12-month follow-up. Secondary outcomes included health-related quality of life, cardiovascular- and diabetes-related outcomes, lifestyle-related outcomes, psychological wellbeing, and return to work. If relevant/possible, studies were pooled using random-effects meta-analysis. RESULTS: A total of 28 studies were included, of which 20 reported exercise capacity and 18 reported secondary outcomes. Overall, the studies were judged to have a high risk of bias. Meta-analysis of exercise capacity was undertaken based on 18 studies (no RCTs) including 15,288 patients, of whom 3369 had diabetes. This analysis showed a statistically significant smaller difference in the change in METs in ACS patients with diabetes (standardised mean difference (SMD) from baseline to end of CR: - 0.15 (95% CI: - 0.24 to - 0.06); SMD at the ≥ 12-month follow-up: - 0.16 (95% CI: - 0.23 to - 0.10, four studies)). CONCLUSION: The benefit of CR on exercise capacity in ACS patients was lower in those with diabetes than in those without diabetes. Given the small magnitude of this difference and the substantial heterogeneity in the results of the study caused by diverse study designs and methodologies, further research is needed to confirm our findings. Future work should seek to eliminate bias in observational studies and evaluate CR based on comprehensive outcomes.

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.

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.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

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.

Exercise-based cardiac rehabilitation for adults after heart valve surgery.

BACKGROUND: The impact of exercise-based cardiac rehabilitation (CR) following heart valve surgery is uncertain. We conducted an update of this systematic review and a meta-analysis to assess randomised controlled trial evidence for the use of exercise-based CR following heart valve surgery. OBJECTIVES: To assess the benefits and harms of exercise-based CR compared with no exercise training in adults following heart valve surgery or repair, including both percutaneous and surgical procedures. We considered CR programmes consisting of exercise training with or without another intervention (such as an intervention with a psycho-educational component). SEARCH METHODS: We searched the Cochrane Central Register of Clinical Trials (CENTRAL), in the Cochrane Library; MEDLINE (Ovid); Embase (Ovid); the Cumulative Index to Nursing and Allied Health Literature (CINAHL; EBSCO); PsycINFO (Ovid); Latin American Caribbean Health Sciences Literature (LILACS; Bireme); and Conference Proceedings Citation Index-Science (CPCI-S) on the Web of Science (Clarivate Analytics) on 10 January 2020. We searched for ongoing trials from ClinicalTrials.gov, Clinical-trials.com, and the World Health Organization International Clinical Trials Registry Platform on 15 May 2020. SELECTION CRITERIA: We included randomised controlled trials that compared exercise-based CR interventions with no exercise training. Trial participants comprised adults aged 18 years or older who had undergone heart valve surgery for heart valve disease (from any cause) and had received heart valve replacement or heart valve repair. Both percutaneous and surgical procedures were included. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. We assessed the risk of systematic errors ('bias') by evaluating risk domains using the 'Risk of bias' (RoB2) tool. We assessed clinical and statistical heterogeneity. We performed meta-analyses using both fixed-effect and random-effects models. We used the GRADE approach to assess the quality of evidence for primary outcomes (all-cause mortality, all-cause hospitalisation, and health-related quality of life). MAIN RESULTS: We included six trials with a total of 364 participants who have had open or percutaneous heart valve surgery. For this updated review, we identified four additional trials (216 participants). One trial had an overall low risk of bias, and we classified the remaining five trials as having some concerns. Follow-up ranged across included trials from 3 to 24 months. Based on data at longest follow-up, a total of nine participants died: 4 CR versus 5 control (relative risk (RR) 0.83, 95% confidence interval (CI) 0.26 to 2.68; 2 trials, 131 participants; GRADE quality of evidence very low). No trials reported on cardiovascular mortality. One trial reported one cardiac-related hospitalisation in the CR group and none in the control group (RR 2.72, 95% CI 0.11 to 65.56; 1 trial, 122 participants; GRADE quality of evidence very low). We are uncertain about health-related quality of life at completion of the intervention in CR compared to control (Short Form (SF)-12/36 mental component: mean difference (MD) 1.28, 95% CI -1.60 to 4.16; 2 trials, 150 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD 2.99, 95% CI -5.24 to 11.21; 2 trials, 150 participants; GRADE quality of evidence very low), or at longest follow-up (SF-12/36 mental component: MD -1.45, 95% CI -4.70 to 1.80; 2 trials, 139 participants; GRADE quality of evidence very low; and SF-12/36 physical component: MD -0.87, 95% CI -3.57 to 1.83; 2 trials, 139 participants; GRADE quality of evidence very low).  AUTHORS' CONCLUSIONS: Due to lack of evidence and the very low quality of available evidence, this updated review is uncertain about the impact of exercise-CR in this population in terms of mortality, hospitalisation, and health-related quality of life. High-quality (low risk of bias) evidence on the impact of CR is needed to inform clinical guidelines and routine practice.

Municipality-based pragmatic rehabilitation stratified in accordance with individual needs-results from a longitudinal survey study.

OBJECTIVE: Evidence on municipality-based cancer rehabilitation is sparse. This longitudinal study explores the following: (1) Rehabilitation needs, (2) effectiveness of municipality-based rehabilitation, and (3) whether rehabilitative services are stratified according to individual needs in breast cancer patients. METHODS: We collected data from a longitudinal survey among 82 breast cancer patients referred to municipality-based rehabilitation at the Copenhagen Centre for Cancer and Health. Rehabilitation needs, health-related quality of life (HRQoL), and functional status were collected using patient-reported outcomes (PROs) including distress thermometer, problem list, Functional Assessment of Cancer Therapy-Breast questionnaire (FACT-B), and upper body function with the abbreviated disability of the arm, shoulder, and hand (Quick-DASH) questionnaire. Data collection time points are as follows: entry, follow-up, and end of intervention. RESULTS: At referral, scores were (mean (range)) distress 4.0 (0-10), problems 9.5 (0-24), and FACT-B 103.0 (49.8-135.5). HRQoL increased during rehabilitation (FACT-B ∆ mean 8.1 points (> MID, p < 0.0001)); 56% had a positive change, 34% no difference, and 11% a decline. Those with the lowest FACT-B entry score had significantly longer duration of rehabilitation (10.9 vs 8.7 months, p < 0.001), higher number of services (7.0 vs 5.3, p < 0.003), and participated more in group-based exercise (+3 sessions: 57% vs 8%, p < 0.001). CONCLUSION: This is the first study to report on pragmatic municipality-based cancer rehabilitation. The results suggest that services are aimed at patients with rehabilitation needs, improve HRQoL, and are properly stratified to those who need it the most. We suggest future monitoring of municipality-based rehabilitation services to ensure quality of care.

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.

Rationale and design of a randomised controlled trial investigating the effect of multidisciplinary nutritional rehabilitation for patients treated for head and neck cancer (the NUTRI-HAB trial).

BACKGROUND: Eating problems frequently affect quality of life and physical, psychological and social function in patients treated for head and neck cancer (HNC). Residential rehabilitation programmes may ameliorate these adverse effects but are not indicated for all individuals. Systematic assessment of rehabilitation needs may optimise the use of resources while ensuring referral to rehabilitation for those in need. Yet, evidence lacks on which nutrition screening and assessment tools to use. The trial objectives are: 1) To test the effect of a multidisciplinary residential nutritional rehabilitation programme compared to standard care on the primary outcome body weight and secondary outcomes health-related quality of life, physical function and symptoms of anxiety and depression in patients curatively treated for HNC and 2) To test for correlations between participants' development in outcome scores during their participation in the programme and their baseline scores in Nutritional Risk Screening 2002 (NRS 2002), the Scored Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF), and M. D. Anderson Dysphagia Inventory (MDADI) and to assess sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores. METHODS: In a randomised controlled trial, 72 patients treated for HNC recruited through a nationwide survey will be randomised to a multidisciplinary residential nutritional rehabilitation programme or to a wait-list control group. Data are collected at baseline, three and six months. Primary outcome is change in body weight, and secondary outcomes include changes in quality of life, physical function and symptoms of anxiety and depression. Potential correlations between intervention effect and baseline scores in NRS 2002, PG-SGA-SF and MDADI will be tested, and sensitivity, specificity and predictive values of the three tools in relation to a clinically relevant improvement in outcome scores will be assessed. DISCUSSION: This is the first randomised controlled trial to test the effect of a multidisciplinary residential nutritional rehabilitation programme in patients treated for HNC. Recruitment through a nationwide survey gives a unique possibility to describe the trial population and to identify potential selection bias. As the trial will explore the potential of different nutrition screening and assessment tools in the assessment of rehabilitation needs in patients treated for HNC, the trial will create knowledge about how selection and prioritisation of nutritional rehabilitation aimed at patients treated for HNC should be offered. The results may contribute to a better organisation and use of existing resources in benefit of patients treated for HNC. TRIAL REGISTRATION: The trial is registered by The Danish Data Protection Agency (registration 2012-58-0018, approval number 18/14847) and the Regional Committees on Health Research Ethics for Southern Denmark (journal number 20182000-165). ClinicalTrials.gov Identifier: NCT03909256. Registered April 9, 2019.

Cardiac Rehabilitation for Patients Treated for Atrial Fibrillation With Ablation Has Long-Term Effects: 12-and 24-Month Follow-up Results From the Randomized CopenHeartRFA Trial.

OBJECTIVE: To assess outcomes at 12 and 24 months after participation in a multidisciplinary cardiac rehabilitation program plus usual care compared with usual care alone for patients treated for atrial fibrillation with catheter ablation. DESIGN: Long-term follow-up on the randomized CopenHeartRFA trial. SETTING: Patients were enrolled and outcome assessed at the hospital and the intervention were carried out at the hospital or at local rehabilitation centers. PARTICIPANTS: Patients (N=210) treated for atrial fibrillation with catheter ablation included in the CopenHeartRFA trial. INTERVENTIONS: A 6-month cardiac rehabilitation program consisting of physical exercise and psychoeducational consultations plus usual care or usual care alone. MAIN OUTCOME MEASURES: Physical capacity was measured by peak oxygen uptake (Vo2peak) at 12 months, and patient-reported outcomes on perceived health, anxiety, and depression were collected by validated questionnaires at 12 and 24 months. Information on hospital admissions and mortality was collected through national registers up to 24 months. RESULTS: Mean Vo2peak was higher at 12 months in the cardiac rehabilitation group (cardiac rehabilitation group: 25.82 mL/kg/min vs usual care group, 22.43 mL/kg/min, P=.003). A lower proportion of patients had high levels of anxiety at 24 months in the cardiac rehabilitation group compared to usual care (12% vs 24%, P=.004). There was no difference in mortality or hospital admissions at 24 months between groups. CONCLUSIONS: This long-term follow-up of a comprehensive multidisciplinary cardiac rehabilitation program for patients treated for atrial fibrillation with catheter ablation found sustained improvements with respect to physical capacity and anxiety compared to usual care but no difference on mortality or hospital admission.

Patient-Reported Outcomes During Immunotherapy for Metastatic Melanoma: Mixed Methods Study of Patients' and Clinicians' Experiences.

BACKGROUND: The benefits of electronic patient reported outcomes (PRO) questionnaires have been demonstrated in many settings, including in hospitals and patient homes. However, it remains to be investigated how melanoma patients and their treating clinicians experience the electronic self-reporting of side effects and the derived communication. OBJECTIVE: The primary objective of this study was to examine patients' and clinicians' experiences with an eHealth intervention for weekly monitoring of side effects during treatment with immunotherapy. METHODS: An eHealth intervention based on questions from the PRO-Common Terminology Criteria for Adverse Events (CTCAE) library was used and tested in a randomized clinical trial with patients receiving immunotherapy for malignant melanoma and clinicians at a university hospital in Denmark. On a weekly basis, patients reported their symptoms from home during the treatment via a provided tablet. The electronic patient reports were available to clinicians in the outpatient clinic. A mixed methods approach was applied to investigate the patients' and clinicians' experiences with the intervention. Data from patient experiences were collected in a short survey, the Patient Feedback Form. Moreover, a subset of the patients participating in the survey was interviewed about their experience. Furthermore, one focus group interview with clinicians was carried out to elucidate their views. RESULTS: A total of 57 patients completed the Patient Feedback Form, and 14 patients were interviewed. The focus group interview included 5 clinicians. Overall, patients and clinicians were satisfied with the tool. They believed it enhanced patients' awareness of side effects and increased their feeling of involvement. The patients reported that it was easy to fill out the questionnaire and that it made sense to do so. However, a minority of the patients expressed in the interviews that they did not believe that the health care professionals had seen their reports when they came to the clinic, and that the reporting did not lead to increased contact with the department. CONCLUSIONS: Overall, satisfaction with the eHealth intervention was high among patients and their treating clinicians. The tool was easy to use and contributed to greater symptom awareness and patient involvement. Thus, in terms of patient and clinician satisfaction with the tool, it makes sense to continue using the tool beyond the project period. TRIAL REGISTRATION: ClinicalTrials.gov NCT03073031; https://tinyurl.com/tjx3gtu.

A place of understanding: Patients' lived experiences of participating in a sexual rehabilitation programme after heart disease.

AIMS AND OBJECTIVES: The aim of this project was to explore the lived experience of participating in a nonpharmacological sexual rehabilitation programme. BACKGROUND: In the healthcare system, patients are important stakeholders, and their experience and knowledge are essential to include when evaluating rehabilitation programmes. Patient experiences with participating in sexual rehabilitation for cardiovascular patients have not yet been investigated. METHODS: Ten qualitative interviews were conducted with male patients from a randomised controlled trial investigating the effect of a 12-week rehabilitation programme focusing on sexuality. The analysis was inspired by Paul Ricoeur's theory of interpretation. Analysis consisted of three levels: (i) naive reading, (ii) structural analysis and (iii) critical interpretation and discussion. The theoretical framework reflects aspects of behavioural theory of social cognitive theory developed by Albert Bandura and his concept of self-efficacy. RESULTS: The findings are presented as themes extracted from the structural analysis and interpreted in the critical interpretation and express the way in which cardiovascular patients experience participating in a sexual rehabilitation programme. Three themes were identified reflecting the intervention to be a special place of understanding, describing the intervention as a supporting atmosphere and finally expressing the intervention as empowering sexuality. CONCLUSIONS: Participating in the sexual rehabilitation programme was experienced as efficient, valuable, motivating and safe, but dependent on a professional setting. The intervention developed participants' self-efficacy with regard to their sexual performance and relationship. RELEVANCE TO CLINICAL PRACTICE: The findings highlight the importance of a professional setting including certain competencies such as humour and professional skills when handling the after-care of cardiovascular patients with sexual problems.