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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Aims Infective endocarditis is a complex and highly mortal disease requiring lengthy treatment. Physical and mental deconditioning is common. Nonetheless, rehabilitation is virtually unexplored in this population. The aim of this trial was therefore to investigate the effects of cardiac rehabilitation in patients following endocarditis. Methods and results In a randomized trial, adults with left-sided or cardiac device endocarditis were randomized 1:1 to 12 weeks of physical exercise training and five psycho-educational consultations (cardiac rehabilitation) vs. usual care without rehabilitation (control). Primary outcome was mental health measured by SF-36 Mental Component Summary (MCS) at 6 months. Secondary outcome was physical capacity measured by peak oxygen uptake (VO2) at 4 months. Exploratory outcomes were investigated. Low inclusion rate resulted in trial termination before reaching the target sample size. A total of 117 participants (mean age: 60 years, 81% male) were randomized to cardiac rehabilitation (n  = 58) or to control (n  = 59). Mental health and physical capacity at baseline were generally poor (MCS: 38.9–42.2 points, VO2 peak: 16.1–16.6 mL/kg/min). Cardiac rehabilitation compared with control showed no effect on mental health (MCS: 44.6 points vs. 48.8 points, P  = 0.41) or physical capacity (VO2 peak: 19.9 mL/kg/min vs. 18.0 mL/kg/min, P  = 0.09). Effects favouring the intervention were identified in exploratory outcomes including general fatigue (P  = 0.005), and physical capacity as maximal power (W) (P  = 0.005). Adherence to the intervention was 28%. Conclusions Results indicate no effect of cardiac rehabilitation in patients following endocarditis; however, lack of statistical power and poor adherence render findings inconclusive. Valuable insight into patients' capabilities and safety was gained, and further investigations into rehabilitation needs and modes of delivery in this high-need population should be a future priority. Registration The trial is registered at ClinicalTrials.gov, NCT01512615 [ABSTRACT FROM AUTHOR]

Aim To quantify the provision of standard cardiac rehabilitation to Danish survivors of cardiac arrest at a programme level, and to analyse whether organizational factors influenced the provision. Method We mapped the provision of cardiac rehabilitation core components to survivors of cardiac arrest and compared this with a reference group of patients after acute myocardial infarction using data from a cross-sectional programme-level survey among all hospitals (n = 34) and municipalities (n = 98) in Denmark. Organizational factors of potential importance to service provision were considered: health care region, size of catchment area/population, type of department/municipality and socioeconomic index. Results Response rates for the provision of each core component of cardiac rehabilitation ranged from 64% to 98%. All hospitals and municipalities provided some aspect of cardiac rehabilitation to survivors of cardiac arrest. Across hospitals, provision of four core components of cardiac rehabilitation to survivors of cardiac arrest was lower compared with post acute myocardial infarction patients: patient education (relative risk (RR) = 0.45 (95% confidence interval (CI) 0.27 to 0.75)), exercise training (RR = 0.69 (95% CI 0.49 to 0.98)), screening for anxiety and depression (RR = 0.64 (95% CI 0.46 to 0.90) and nutritional counselling RR = 0.76 (95% CI 0.62 to 0.93)). No difference was found in the provision of core components across municipalities. Overall, the provision of cardiac rehabilitation to survivors of cardiac arrest was not affected by organizational factors. Conclusion This study indicates a need for future research to inform the development, adoption and implementation of equal access to all components of cardiac rehabilitation for survivors of cardiac arrest in Denmark. [ABSTRACT FROM AUTHOR]

Aims and objectives: To explore the advantages and disadvantages of using video consultations, as experienced by specialised palliative care healthcare professionals, who are involved in palliative care at home. Background: One challenge in the work of specialised palliative care teams is the substantial resources used in terms of time and transport to and from the patient's home. Video consultations may be a solution for real‐time specialised palliative home care. Designs: Hermeneutic, postphenomenology. Methods: An explorative qualitative study utilising data from field notes of an autobiographical diary, participant observations and semi‐structured interviews with healthcare professionals. The COREQ guideline was used for reporting the study. See Appendix S1. The data collection took place in patients' homes and at the Department of Oncology, Odense University Hospital, Denmark. Results: Eight participants (n = 8); five community nurses; and three specialised palliative care team members—a head physician, a physiotherapist and a nurse—participated in the study. The healthcare professionals' knowledge was based on n = 82 video consultations with 11 patients. The range of video consultations was 3–18 per patient. The use of tablets in video consultations facilitated direct palliative care and led the community nurses and the specialised palliative care team nurse to co‐operate. Potential barriers against using video consultations are the discussions about personal, and private issues regarding the illness, while family members are present. Conclusions: Video consultations in specialised palliative home care are feasible, and the technology can facilitate multidisciplinary participation and co‐operation among healthcare professionals. The continuous use of video consultations over time may increase the quality of specialised palliative home care. Relevance to clinical practice: The use of video consultations can provide direct specialised palliative care over distance involving healthcare professionals, patients and their relatives. [ABSTRACT FROM AUTHOR]

Abstract: The aim of the study was to determine the impact of an interdisciplinary exercise‐based rehabilitation intervention on fatigue and quality of life (QOL) in patients with Philadelphia‐negative myeloproliferative neoplasms (MPNs). At the Danish Knowledge Centre for Rehabilitation and Palliative Care, a 5‐day interdisciplinary exercise‐based rehabilitation intervention was carried out on 48 patients with MPN. It was followed by 12 weeks of self‐exercising prior to follow‐up. Initially and at follow‐up, participants filled out validated questionnaires; Brief Fatigue Inventory, Multidimensional Fatigue Inventory, European Organization for Research and Treatment of Cancer Quality‐of‐Life questionnaire, Myeloproliferative Neoplasm Symptom Assessment Form and Hospital Anxiety and Depression Scale. Maximal oxygen uptake and muscular strength were tested as well. Paired t test was used to compare scores between baseline and follow‐up. In total, 45 participants (94%) completed the follow‐up. No significant differences were observed on fatigue or QOL when comparing baseline and follow‐up. Mean maximal oxygen uptake increased from 27.2 to 33.6 ml O2 · kg−1 ·min−1 (p < 0.001). Handgrip strength (p = 0.01) and the 30‐s chair‐stand test (p < 0.001) improved as well. No changes were found regarding levels of fatigue and QOL. However, we observed a significant increase in the physical capacity. Our observations call for further studies investigating the effects of non‐pharmacological approaches in patients with MPN. [ABSTRACT FROM AUTHOR]

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

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

Introduction: The cardiopulmonary exercise test (CPET) assesses maximal oxygen uptake (VO2max) and is commonly performed on a leg cycle ergometer (LC). However, some individuals would rather perform the CPET on an arm cycle ergometer (AC). Objective: The objectives of this study were to undertake a systematic review and meta-analysis of the difference in VO2max achieved by AC compared to LC in healthy adults and to explore factors that may be predictive of this difference. Methods: MEDLINE, EMBASE, CINAHL, and PEDro were searched in April 2015. The differences in VO2max (ACLCdiff) were pooled across studies using random effects meta-analysis and three different methods were used to estimate the ratio between the values obtained from the tests (ACLCratio). Results: This paper included 41 studies with a total of 581 participants. The mean ACLCdiff across studies was 12.5 ml/kg/min and 0.89 1/min with a mean ACLCratio of 0.70. The ACLCdiff was lower in studies with higher mean age and lower aerobic capacity. Conclusion: There is linear association between the AC and LC values in healthy adults. The AC values were on average 70% of the LC values. The magnitude of this difference appeared to be reduced in studies on older and less active populations. [ABSTRACT FROM AUTHOR]

Aims To explore the structure and content of narratives about the recovery process among patients undergoing heart valve surgery participating in cardiac rehabilitation. Background Several studies with short-term follow-up have shown that recovering from cardiac surgery can be challenging, but evidence on the long-term recovery process is very limited, especially following heart valve surgery. Furthermore, few studies have explored the recovery process among cardiac rehabilitation participants. Design A qualitative study with serial interviews analysed using narrative methods. Methods We collected data over 18 months (April 2013-October 2014). We recruited nine patients undergoing heart valve surgery from a randomized trial, CopenHeart VR and conducted 27 individual narrative interviews at 2-3 weeks, 3-4 months and 8-9 months after surgery. Findings Following heart valve surgery, the participants expected to return to normality. The analysis identified four courses of recovery, with three non-linear complex pathways deviating from the classic restitution narrative: the frustrated struggle to resume normality, the challenged expectation of normality - being in a limbo and becoming a heart patient. These deviating pathways were characterized by physical, existential and mental challenges even up to 9 months after surgery. Conclusion The recovery processes of participants' in cardiac rehabilitation were often more complicated than anticipated. Patients undergoing heart valve surgery may benefit from more extensive medical follow-up immediately after discharge, individual psychological assessment and individualized, realistic information about the recovery trajectory. [ABSTRACT FROM AUTHOR]

Background: The Copenhagen Outpatient ProgrammE-Implantable Cardioverter Defibrillator trial was a randomized clinical trial that compared a complex rehabilitation intervention including exercise training and psychoeducational interventions with usual care. A significant difference between rehabilitation and usual care was found in physical capacity and general and mental health. However, the clinical effect sizes of these findings were not investigated, and the findings from the quantitative and qualitative analyses were not triangulated to address the issue of whether the qualitative results could help explain the quantitative results and bring forward additional information. Objectives: The objectives are to (a) determine the clinical effect sizes of the primary outcomes and (b) triangulate the quantitative and qualitative findings. Methods: A total of 196 patients with first-time implantable cardioverter defibrillator implantation were randomized (1:1) to comprehensive cardiac rehabilitation (12 weeks of exercise training and 1 year of psychoeducational follow-up) versus treatment as usual. Two primary outcomes, perceived health (Short Form-36) and peak oxygen uptake, were used. Cohen d was calculated. Qualitative interviews were conducted with 10 patients representing the rehabilitation group. Triangulation was carried out by integrating the findings from the quantitative and qualitative results in light of each other. Results: Clinically meaningful effects were found between groups in peak oxygen uptake, general health, and mental health in favor of the rehabilitation group. Within groups, we found medium/high effect sizes on the mental component score in the rehabilitation group over time and only a small effect in the usual care group. The mechanisms of these effects were further explained by the qualitative findings. Patients with better physical health learned how to interpret body signals and adjust exercise behavior and experienced increased physical capacity. Those with better mental health received support that assisted them to cope with the possibility of shock and death and regain trust in their bodies. Conclusion: The program has a clinical effect and is perceived as beneficial through supportive coping. [ABSTRACT FROM AUTHOR]

Objective. To evaluate how municipality-based post-discharge follow-up visits including a general practitioner and municipal nurse affect early readmission among high-risk older people discharged from a hospital department of internal medicine. Design and setting. Centrally randomized single-centre pragmatic controlled trial comparing intervention and usual care with investigator-blinded outcome assessment. Intervention. The intervention was home visits with a general practitioner and municipal nurse within seven days of discharge focusing on medication, rehabilitation plan, functional level, and need for further health care initiatives. The visit was concluded by planning one or two further visits. Controls received standard health care services. Patients. People aged 65  years discharged from Holbæk University Hospital, Denmark, in 2012 considered at high risk of readmission. Main outcome measures. The primary outcome was readmission within 30 days. Secondary outcomes at 30 and 180 days included readmission, primary health care, and municipal services. Outcomes were register-based and analysis used the intention-to-treat principle. Results. A total of 270 and 261 patients were randomized to intervention and control groups, respectively. The groups were similar in baseline characteristics. In all 149 planned discharge follow-up visits were carried out (55%). Within 30 days, 24% of the intervention group and 23% of the control group were readmitted (p  0.93). No significant differences were found for any other secondary outcomes except that the intervention group received more municipal nursing services. Conclusion. This municipality-based follow-up intervention was only feasible in half the planned visits. The intervention as delivered had no effect on readmission or subsequent use of primary or secondary health care services. [ABSTRACT FROM AUTHOR]

Background: Serious illness will inevitably lead to a fundamental emotional reaction. Traditionally, in interventional treatment or rehabilitation trials, the psychological status of patients with implantable cardioverter defibrillators has been evaluated with anxiety and depression as outcome measures. In caring for these patients, the aim of nursing is to help patients manage life with complex heart disease. The early detection and management of negative emotional response might prevent the development of pathological conditions such as depression. Objective: The aims of this study were to (a) describe the trajectory of primary emotions over time in patients with implantable cardioverter defibrillators and (b) examine the potential effects of psychoeducational nursing on primary emotions. Methods: During the inclusion period (October 2007 to November 2009), 196 patients with implantable cardioverter defibrillator were randomized (1:1) to rehabilitation versus usual care. Rehabilitation consisted of a psychoeducational nursing component and an exercise training component. This article concerns phase 1, psychoeducational nursing, guided by a theory of nursing, Rosemary Rizzo Parses Human Becoming Practice Methodologies. The outcome measure is the Emotions and Health Scale. The scale consists of 8 primary emotions: joy, agreeableness, surprise, fear, sadness, disgust, anger, and anticipation. Results: Mean (SD) age was 58 (13) years, and 79% of the participants were men. Significant improvements were found in primary emotional responses over time (P < .05) when combining groups. However, no difference in emotional intensity was found between the groups after 3 months of psychoeducational nursing intervention (P > .05). Conclusions: Primary emotions are affected after implantable cardioverter defibrillator implantation. Improvements over time were found. However, it was not possible to detect any effect of a short-term psychoeducational nursing intervention. Evaluating the primary emotions might be a good way for nurses to monitor patients' psychological outcomes because the instrument is sensitive to changes over a short period. Further development of early psychoeducational nursing interventions for patients with implantable cardioverter defibrillators is needed. [ABSTRACT FROM AUTHOR]

Background The COPE-ICD (Copenhagen Outpatient ProgrammE-implantable cardioverter defibrillator) trial studied comprehensive cardiac rehabilitation for patients with ICDs. The purpose of this paper was to explore: (1) gender differences in self-rated health and quality of life (QoL) at hospital discharge after ICD implantation, (2) gender differences in effect of cardiac rehabilitation, and (3) predictors of effect of cardiac rehabilitation. Methods Patients with first-time ICD implantation were randomized to comprehensive cardiac rehabilitation versus usual care. Gender differences in self-rated health and QoL and effect of rehabilitation were tested using t-tests. Predictors of effect of rehabilitation were tested using logistic regression. Results A total of 196 patients (mean age 58 ± 13 years; 155 men, 41 women) were included. At hospital discharge, significant differences were found in physical component scale, mental component scale, social functioning, physical functioning, bodily pain, vitality, mental health, and QoL with men having higher scores. Among men only, significant differences were found in VO2 (rehabilitation: 20.9 mL/min/kg [standard deviation (SD) 8.1] vs 23.4 mL/min/kg [SD 9.5] and usual care: 22.1 mL/min/kg [SD 8.1] vs 21.8 mL/min/kg [SD 8.3], P = 0.01), total exercise time (rehabilitation: 587.0 seconds [SD 249.6] vs 650.7 seconds [SD 279.8] and usual care: 613.8 seconds [SD 264.7] vs 606.1 seconds [SD 277.3], P = 0.01), and the mental component scale (rehabilitation: 47.7 points [SD 10.1] vs 54.8 points [7.1] and usual care: 48.1 points [SD 10.9] vs 51.9 points [SD 9.6], P = 0.05). Conclusions After ICD implantation, significant gender differences were found in physical health, mental health, and QoL. Effects of rehabilitation were found among men only and gender predicted effect of rehabilitation on the mental component scale. [ABSTRACT FROM AUTHOR]

Background Although highly effective in preventing arrhythmic death, patients receiving an implantable cardioverter defibrillator (ICD) may still experience psychological difficulties such as anxiety, depression, and reduced quality of life. The objectives of this study were to describe patient-reported outcomes among ICD patients: (1) compared to a matched healthy population, (2) compared by ICD indication, (3) factors predicting patient-reported outcomes, and (4) if patient-reported outcomes predicted mortality. Methods The study was a mailed survey to an unselected group of patients 18+ years old receiving ICD between January 1, 2011 and June 30, 2011 (n = 499). The following instruments were used: SF-36, Hospital Anxiety and Depression Scale, HeartQoL, EQ-5D, and the Multidimensional Fatigue Inventory. Results The response rate was 72%. Mean age was 65.5 years and 82% patients were males. Fifty-three percent of patients had primary prevention indication ICD. Compared to an age- and gender-matched population without disease, the ICD population had worse mental health (55.0 vs 51.7 points) and physical health (52.6 vs 41.9 points). Patients with primary prevention indication had lower levels of perceived health, quality of life, and fatigue; for example, physical health 39.8 versus 44.3 points, compared to secondary prevention indication. Anxiety, poor perceived health, fatigue, and low quality of life were all predictors of mortality, anxiety being the strongest with an adjusted odds ratio of 4.17 (1.49; 11.66). Conclusions Patients with primary prevention ICD had lower levels of perceived health, quality of life, and more fatigue. Anxiety, poor perceived health, fatigue, and low quality of life were all predictors of mortality. [ABSTRACT FROM AUTHOR]

Background: Heart valve disease is becoming a public health problem due to increasing life expectancy and new treatment methods. Patients are at risk of developing depression, anxiety or post-traumatic stress disorder after heart valve surgery. To better plan proper care, describing and understanding patients' perception of recovery after heart valve replacement is essential. The objective was to describe the experience of recovery at home after heart valve replacement. Methods: Qualitative interviews were conducted with 10 patients representing the population and these were later transcribed. The analysis was inspired by Ricoeur's theory of interpretation, which consists of three levels: naive reading, structured analysis, and critical interpretation and discussion. Results: The overall concept that emerged was suffering weakness and struggling to resume normality. Patients all struggled to resume normal living, both in regaining physical strength and in reestablishing balance in overall living. The overall concept can be interpreted in terms of the following themes: Disturbed network: Invaluable relatives, Contact with healthcare staff, Rehabilitation. Disturbed body: Stressful complications, Bodily attention, Physically affected, Physical capability. Recovery: Interrupted living, Suffering weakness, Gradual recovery, Achieving normality. Reflections: Thoughts about the procedure and Feeling sad and fragile. Conclusion: The study presents the main themes of network, body, recovery and reflection for ten patients after heart valve replacement. These main themes can overall be summarized as suffering weakness and struggling to resume normality. Patients felt weak with a changed body, but after a long recovery process regained vitality and returned to their daily life. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Simple Summary: We wanted to investigate the risk of inflammatory bowel disease (IBD) in patients with Philadelphia-negative chronic myeloproliferative neoplasms (MPNs), since up to 50% of these patients experience gastrointestinal symptoms and several studies have suggested an association between hematological cancers and IBD. We included ∼8000 patients and ∼80,000 sex- and age-matched, non-MPN comparisons from the general population, and found that MPN patients were two to three times more likely to develop IBD, but the absolute risk of IBD was modest. In addition, MPN patients were also 40% more likely to have a prior diagnosis of IBD. Our results pose intriguing questions about the causal pathways linking MPN and IBD, which may include genetic, treatment-related and immune-mediated factors. Moreover, it shows that abdominal symptoms in MPN patients may not only be caused by an enlarged spleen or treatment side-effects. Conversely, persistent leucocytosis and/or increased platelets in IBD patients may reflect concomitant MPN. 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. [ABSTRACT FROM AUTHOR]