Psychometric Properties of the Kansas City Cardiomyopathy Questionnaire in a Surgical Population of Patients With Aortic Valve Stenosis.

The 12-item version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) was originally developed for patients with heart failure but has been used and tested among patients with severe aortic stenosis (AS) who underwent transcatheter aortic valve implantation. Whether the instrument is suitable for patients with AS who underwent surgical aortic valve replacement (SAVR) is currently unknown. Thus, we aimed to investigate the psychometric properties of the KCCQ-12 before and after SAVR among patients with severe AS. We conducted a prospective cohort of 184 patients with AS who completed the KCCQ-12 and the EuroQol 5 Dimension 5 Levels before and 4 weeks after surgery. Construct validity was investigated with hypothesis testing and an analysis of Spearman's correlation between the two instruments. Structural validity was investigated with explorative and confirmatory factor analyses and reliability with Cronbach's α. All analyses were conducted on data from the two time points (preoperatively and four weeks after surgery). The hypothesis testing revealed how the New York Heart Association class was significantly correlated with the preoperative KCCQ-12 total score (higher New York Heart Association class, worse score). A longer length of hospital stay and living alone were significantly associated with poorer postoperative KCCQ-12 total score. KCCQ-12 and EuroQol 5 Dimension 5 Levels were moderately correlated in most domains/the total score/Visual Analogue Scale score. Principal component analyses revealed two 3-factor structures. The confirmatory factor analyses did not support the original model at any time point. Cronbach's α ranged from 0.22 to 0.84 in three preoperative factors and from 0.39 to 0.76 in the postoperative factors. The total Cronbach's α was 0.83 for the suggested preoperative 3-factor model and 0.83 for the postoperative model. In conclusion, the Danish version of the KCCQ-12 tested in a population of patients with AS who underwent SAVR appears to have acceptable construct validity, whereas structural validity cannot be confirmed for the original four-factor model. Overall reliability is good.

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.

Physician-led in-hospital multidisciplinary team conferences with multiple medical specialities present - A scoping review.

Introduction: Multidisciplinary Team Conferences (MDTs) are complex interventions in the modern healthcare system and they promote a model of coordinated patient care and management. However, MDTs within chronic diseases are poorly defined. Therefore, the aim of this scoping review was to summarise the current literature on physician-led in-hospital MDTs in chronic non-malignant diseases. Method: Following the PRISMA-ScR guideline for scoping reviews, a search on MDT interventions in adult patients, with three or more medical specialties represented, was performed. Results: We identified 2790 studies, from which 8 studies were included. The majority of studies were non-randomised and focused on a single disease entity such as infective endocarditis, atrial fibrillation, IgG4-related disease, or arterial and venous thrombosis. The main reason for referral was confirmation or establishment of a diagnosis, and the MDT members were primarily from medical specialties gathered especially for the MDT. Outcomes of the included studies were grouped into process indicators and outcome indicators. Process indicators included changes in diagnostic confirmation as well as therapeutic strategy and management. All studies reporting process indicators demonstrated significant changes before and after the MDT. Conclusion: MDTs within chronic diseases appeared highly heterogeneous with respect to structure, reasons for referral, and choice of outcomes. While process indicators, such as change in diagnosis, and treatment management/plan seem improved, such have not been demonstrated through outcome indicators.

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.

Cardiac rehabilitation for patients with heart failure: association with readmission and mortality risk.

AIMS: To examine the temporal trends and factors associated with national cardiac rehabilitation (CR) referral and compare the risk of hospital readmission and mortality in those referred for CR versus no referral. METHODS AND RESULTS: This cohort study includes all adult patients alive 120 days from incident heart failure (HF) identified by the Danish Heart Failure Registry (n = 33 257) between 2010 and 2018. Multivariable logistic regression models were used to assess the association between CR referral and patient factors and acute all-cause hospital readmission and mortality at 1 year following HF admission. Overall, 46.7% of HF patients were referred to CR, increasing from 31.7% in 2010 to 52.2% in 2018. Several factors were associated with lower odds of CR referral: male sex [odds ratio (OR): 0.85; 95% confidence interval: 0.80-0.89], older age, unemployment, retirement, living alone, non-Danish ethnic origin, low educational level, New York Heart Association (NYHA) class IV vs. I (OR: 0.75; 0.60-0.95), left ventricular ejection fraction >40%, and comorbidity (stroke, chronic kidney disease, atrial fibrillation/flutter, and diabetes). Myocardial infarction, arthritis, coronary artery bypass grafting, percutaneous coronary intervention, valvular surgery, NYHA class II, and use of angiotensin-converting enzyme inhibitors were associated with higher odds of CR referral. CR referral was associated with lower risk of acute all-cause readmission (OR: 0.92; 0.87-0.97) and all-cause mortality (OR: 0.65; 0.58-0.72). CONCLUSION: Although increased over time, only one in two HF patients in Denmark were referred to CR in 2018. Strategies are needed to reduce referral disparities, focusing on subgroups of patients at highest risk of non-referral.

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.

Health-Related Quality of Life in Patients with Philadelphia-Negative Myeloproliferative Neoplasms: A Nationwide Population-Based Survey in Denmark.

Previous studies have clarified that many patients with Philadelphia-negative myeloproliferative neoplasms (MPNs) have burdensome symptom profiles and accordingly impaired functioning and quality of life (QoL). In Denmark, all MPN patients are affiliated with public hospitals and because of a healthcare system financed by taxpayers these patients do not have any financial costs related to the hematological disease. Diagnoses are recorded for all patients in hospitals, and diagnosis codes are communicated to the National Patient Register (NPR). Owing to this, it was possible to contribute to the elucidation of Philadelphia-negative MPN patients' health-related quality of life (HRQoL), by conducting a nationwide, population-based, cross-sectional HRQoL survey of these patients with cost-free access to the best available, suitable medical treatment. The survey contained validated questionnaires covering functioning, symptom burden, symptom profile, QoL, and additional questions on lifestyle. Information on comorbid diagnoses was obtained from the NPR. The participants' HRQoL was compared to the general population. Moreover, differences in HRQoL across essential thrombocythemia, polycythemia vera, myelofibrosis, and unclassifiable MPN participants were investigated, adjusted for age, sex, comorbidity, and lifestyle. To the best of our knowledge this is the first survey of HRQoL in patients with unclassifiable MPN. A total of 2228 Philadelphia-negative MPN patients participated. The participants reported their HRQoL to be inferior to the general population, but the difference was minor. The differences in HRQoL across groups of participants with different MPN subtypes were subtle. Fatigue and sexual problems were prevalent and burdensome. Overall, participants reported a slightly healthier lifestyle compared to the general population.

Nutrition screening and assessment tools for patients with cancer and survivors of cancer: a systematic review protocol.

INTRODUCTION: Nutritional challenges are common consequences of cancer, and they do not only occur in the hospital setting. They are also frequent after completion of treatment, and nutritional interventions in community-based post-treatment rehabilitation services are important. The first step towards initiating any nutritional intervention is to identify the individual in need hereof, but evidence is limited on the applicability of different nutrition screening and assessment tools in the post-treatment rehabilitation services. The aim is to systematically review and identify nutrition screening and assessment tools appropriate for use in patients with cancer and survivors of cancer in hospital or community-based healthcare settings. METHODS AND ANALYSIS: In this systematic review, the electronic databases PubMed, CINAHL Complete and Embase were searched systematically using comprehensive search strategies. Primary searches were carried out in August 2018 with updated searches performed in November 2019. Clinicaltrials.gov and PROSPERO International Prospective Register of Systematic Reviews will be searched for additional relevant studies. Studies will be included if they validate a nutrition screening or assessment tool in adult patients with cancer or survivors of cancer. No restriction on publication date will be applied, and full-text articles in English, Danish, Norwegian and Swedish are eligible for inclusion. Two reviewers will independently conduct screening of search results, study selection, data extraction and quality assessment. Data will be synthesised narratively. ETHICS AND DISSEMINATION: No ethical approval is required. Results will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement and published in an international peer-reviewed journal. Furthermore, results will be presented in relevant research and clinical fora to facilitate transfer of results to clinical practice in benefit of patients. PROSPERO REGISTRATION NUMBER: CRD42018096678.

The use of patient-reported outcomes to detect adverse events in metastatic melanoma patients receiving immunotherapy: a randomized controlled pilot trial.

BACKGROUND: A randomized controlled pilot trial was conducted to assess if melanoma patients treated with immunotherapy had the number of grade 3 or 4 adverse events during treatment reduced by 50% using a tailored electronic patient-reported outcomes tool in addition to standard toxicity monitoring compared to standard monitoring alone. Secondary endpoints were: if more AEs were reported in the intervention group, if there was a difference between the two groups in the number of telephone consultations, extra out-patient visits, number of days in the hospital, days in steroid treatment and the time patients experienced grade 2 or higher toxicity. PATIENTS AND METHODS: Melanoma patients receiving immunotherapy at the Department of Oncology, Odense University Hospital, Denmark participated. Standard care included assessment of AEs by a clinician before each treatment cycle using the Common Terminology Criteria for Adverse Events. In addition, patients randomized to the intervention reported their AEs weekly by an electronic PRO-tool based on the PRO-CTCAE platform. RESULTS: One hundred forty-six melanoma patients were randomized. In this study, we did not detect a difference between the two groups in the number of grade 3 or 4 AEs (P = 0.983), in the overall number of AEs (P = 0.560) or in the time the patients in the two groups experienced grade 2 or higher toxicity (0.516). The number of phone contacts was significantly higher in the intervention group (P = 0.009) and there was a tendency towards patients in the intervention group having more extra visits (P = 0.156). CONCLUSION: It has been examined if the number of severe AEs for melanoma patients receiving immunotherapy could be reduced by involving the patients in the reporting of symptoms. The results do not justify the expansion of the pilot study into a regular phase III study with this particular set-up. However, a significant difference in the number of phone contacts was found as patients in the intervention group called more frequently, indicating that their attention to AEs was increased. Even though the use of an electronic PRO tool could not reduce the number of severe AEs in this melanoma population, a positive impact on other endpoints such as QoL, communication, or treatment-planning, cannot be excluded. TRIAL REGISTRATION: Clinicaltrials.gov NCT03073031 Registered 8 March 2017, Retrospectively registered.

Risk of Inflammatory Bowel Disease in Patients with Chronic Myeloproliferative Neoplasms: A Danish Nationwide Cohort Study.

An association between hematological cancers and inflammatory bowel disease (IBD) has previously been suggested, but the risk of IBD in patients with myeloproliferative neoplasms (MPNs) is unknown. We conducted a nationwide population-based cohort study using Danish registries, to estimate the risk of IBD in individuals diagnosed with essential thrombocythemia, polycythemia vera, myelofibrosis or unclassifiable MPN during 1994-2013. MPN patients were matched 1:10 with sex- and age-matched comparisons. Everyone was followed until a diagnosis of IBD, death/emigration, or 31 December 2013. The risk of IBD overall and according to MPN subtype was calculated using Cox regression and presented as hazard ratios (HRs) with 95% confidence intervals (CI). Of 8207 MPN patients followed for 45,232 person-years, 80 were diagnosed with IBD (61 ulcerative colitis, 19 Crohn's disease). The rate of IBD per 1000 person-years was 1.8 (95% CI:1.4-2.2) in patients vs. 0.8 (95% CI:0.7-0.8) in comparisons, and the absolute 10-year risk of IBD was 0.8% (95% CI:0.6-1.0) in patients vs. 0.4% (95% CI:0.4-0.5) in comparisons. The HR of IBD was 2.4 (95% CI:2.1-2.9) with similar HRs for ulcerative colitis and Crohn's disease. MPN subtype risks varied from 2.1 (95% CI:1.6-2.7) to 2.8 (95% CI:2.1-3.7). Our unselected cohort study showed a more than 2-fold increased risk of IBD in MPN patients.

Effects of a Multidisciplinary Residential Nutritional Rehabilitation Program in Head and Neck Cancer Survivors-Results from the NUTRI-HAB Randomized Controlled Trial.

Head and neck cancer survivors frequently experience nutritional challenges, and proper rehabilitation should be offered. The trial objective was to test the effect of a multidisciplinary residential nutritional rehabilitation programme addressing physical, psychological, and social aspects of eating problems after treatment. In a randomized controlled trial, 71 head and neck cancer survivors recruited through a nationwide survey were randomized to the program or a wait-list control group. Inclusion was based on self-reported interest in participation. The primary outcome was change in body weight. Secondary outcomes included physical function, quality of life, and symptoms of anxiety and depression. Differences between groups at the 3-month follow-up were tested. No significant differences were seen in body weight change, but there were overall trends towards greater improvements in physical function (hand grip strength: p = 0.042; maximal mouth opening: p = 0.072) and quality of life ("Role functioning": p = 0.041; "Speech problems": p = 0.040; "Pain": p = 0.048) in the intervention group. To conclude, a multidisciplinary residential nutritional rehabilitation program had no effect on body weight in head and neck cancer survivors with self-reported interest in participation, but it may have effect on physical function and quality of life. Further research on relevant outcomes, inclusion criteria, and the program's effect in different subgroups is needed.

The First Steps Taken to Implement Palliative Care in Advanced Heart Disease: A Position Statement from Denmark.

According to the World Health Organization, palliative care must be available for everyone with life-threatening diseases. However, in daily practice the primary focus worldwide is on cancer patients. The aim of the article was to generate a national position statement as the first step in implementing palliative care in severe heart disease with focus on advanced heart failure, including tools to identify the need for and timing of palliative care and how palliative care could be organized in Denmark. A task force was formed in the Danish Society of Cardiology Heart Failure Working Group, and the position statement was prepared in collaboration with members from a broad group of specialties, including palliative medicine. Because of major gaps in evidence, the position statement was based on small and low-quality studies and clinical practice statements. This position statement was aligned with the European Society of Cardiology recommendation, focusing on relieving suffering from the early disease stages parallel to standard care and supplementing life-prolonging treatment. The statement delivers practical guidance on clinical aspects and managing symptoms during the three stages of advanced heart disease. Furthermore, the statement describes the importance of communication and topics to be broached, including deactivating implantable cardioverter defibrillators. The statement recommends a targeted effort on organizational strategies using high-quality assessment tools and emphasizes multidisciplinary and intersectoral collaboration. Danish cardiologists supported by allied professionals acknowledge the importance of palliative care in advanced heart disease. This national position statement intended to inform and influence policy and practice and can hopefully inspire other countries to take action toward implementing palliative care in advanced heart disease.

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.

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.

Risk of being granted disability pension among incident cancer patients before and after a structural pension reform: A Danish population-based, matched cohort study.

Objective This study aimed to examine the risk of being granted a disability pension (DP) among incident cancer patients up to five years after diagnosis compared to a match control group, before and after the structural reform of the Danish Disability Pension Act in 2013. Methods All 20-60-year-old incident cancer-diagnosed individuals from 2000 to 2015 were identified in the Danish Cancer Registry. A control group, not previously diagnosed with cancer, was identified in Statistics Denmark matched by gender, age, education, and household income. Risk differences (RD) in cumulative incidence proportions of being granted a DP between cancer patients and controls were analyzed before and after the reform. Results In total, 111 773 incident cancer patients and 506 904 controls were included in the study. Before reform 10 561 cancer patients and 11 231 controls were granted DP; and 2570 cancer patients and 2646 controls were granted DP after the reform. The adjusted RD of being granted DP was significantly higher for cancer patients versus controls at all time points before the reform. The RD increased the most during the first (RD 3.6, 95% CI 3.5-3.7) and second (RD 7.2, 95% CI 7.0-7.4) follow-up year and levelled off the remaining three years. After the reform, the adjusted RD were lower for all 1-5 follow-up years compared to before the reform (RD range 2.8-7.7, 95% CI 2.6-8.1). Conclusion The 2013 reform of the Disability Pension Act reduced the risk of cancer patients being granted DP. The impact on a personal level should be further explored.

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

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

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.

Effect of Home-Based Cardiac Rehabilitation in a Lower-Middle Income Country: RESULTS FROM A CONTROLLED TRIAL.

PURPOSE: Cardiovascular disease is the leading cause of mortality and morbidity in lower-middle income countries (LMICs), including Bangladesh. Cardiac rehabilitation (CR) as part of secondary prevention of cardiovascular disease has been shown to reduce mortality and morbidity and improve quality of life and exercise capacity. However, to date, very few controlled trials of CR have been conducted in LMICs. METHODS: A quasi-randomized controlled trial comparing home-based CR plus usual care with usual care alone was undertaken with patients following coronary artery bypass graft surgery. Participants in the CR group received an in-hospital CR class and were introduced to a locally developed educational booklet with details of a home-based exercise program and then received monthly telephone calls for 12 mo. Primary outcomes were coronary heart disease (CHD) risk factors, health-related quality of life (HRQOL), and mental well-being. Maximal oxygen uptake as a measure of exercise capacity was a secondary outcome. RESULTS: In total, 142 of 148 eligible participants took part in the trial (96%); 71 in each group. At 12-mo follow-up, 61 patients (86%) in the CR group and 40 (56%) in the usual care group provided complete outcome data. Greater reductions in CHD risk factors and improvements in HRQOL, mental well-being, and exercise capacity were seen for the CR group compared with the usual care group. CONCLUSIONS: In the context of a single-center LMIC setting, this study demonstrated the feasibility of home-based CR programs and offers a model of service delivery that could be replicated on a larger scale.

National survey of current practice and opinions on rehabilitation for intermittent claudication in the Danish Public Healthcare System.

Objective. International guidelines recommend rehabilitation including supervised exercise therapy in patients with Intermittent Claudication (IC), but knowledge of the implementation in clinical practice is limited. This study aims to investigate current practice and opinions on rehabilitation for patients with IC among vascular surgeons and rehabilitation departments in the municipalities and hospitals. Design. Three electronic cross-sectional surveys were distributed nationally to the Danish vascular surgeons (n = 131) and to rehabilitation departments in the municipalities (n = 92) and hospitals (n = 33). Results. The response rates were 70% among the vascular surgeons, 98% among the municipalities and 94% among the hospitals. Vascular surgeons utilize oral advice to exercise by self-administered walking, pharmacological treatment, and revascularization to improve walking distance in patients with IC. Currently, only 12% of the vascular surgeons referred to rehabilitation to improve walking distance, while almost all vascular surgeons (96%) would refer their patients to IC rehabilitation, if it was available. Only 14% of municipalities and none of the hospitals, who treat patients with IC, have a rehabilitation program designed specifically for patients with IC. However, 59% of the rehabilitation departments in the municipalities and 26% in the hospitals included patients with IC in rehabilitation program designed for other patient groups - mostly cardiac patients. There was consensus among the groups of respondents that future IC specific rehabilitation should include an initial conversation, supervised exercise therapy, smoking cessation, and patient education according to guidelines. Conclusion. Vascular surgeons support referral and participation in IC rehabilitation to improve walking distance in patients with IC. Despite some hospitals and municipalities included patients with IC in rehabilitation nearly all services fail to meet current guideline as specific services tailored to patient with IC is almost non-existent in Denmark. Our findings call for action for services to comply with current recommendations of structured, systematic rehabilitation for patients with IC.