The rise and fall of a social support intervention feasibility trial targeting loneliness in patients with cardiac disease - lessons learned and future perspectives.

BACKGROUND: One of the psychosocial factors recognized for its positive impact on health outcomes among patients with heart disease, is social support provided by network members. However, an increasing number of patients report to experience loneliness. This study addresses the gap in research on the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness. METHOD: A feasibility trial of a 6-month social support intervention targeted patients treated for cardiac disease who experienced loneliness. The intervention involved providing the patient with an informal caregiver, either a person from the patient's social network or a peer, in the long-term rehabilitation phase. Furthermore, the intervention included nurse consultations and motivational text messages. Feasibility was assessed in terms of acceptability and adherence. RESULTS: During October 2022-July 2023, n = 464 patients were screened for loneliness and 28 (6.0%) screened positive of which 17 (60.7%) accepted to be contacted and receive additional information about the social support intervention. Of these, 2 (11.8%) accepted participation. The low recruitment rate did not meet the predetermined acceptability criterion of 25%. CONCLUSION: This individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness was non-feasible. The study highlights the complexities of engaging lonely patients in a social support intervention program and contributes with valuable insights for future research aiming to develop effective social support interventions tailored to the needs of cardiac patients who experience loneliness. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.

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

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

Association Between Risk Factors and Readmission for Patients With Atrial Fibrillation Treated With Catheter Ablation: Results From the Nationwide DenHeart Study.

BACKGROUND: Because of high readmission rates for patients treated with ablation for atrial fibrillation (AF), there is great value in nurses knowing which risk factors make the largest contribution to readmission. OBJECTIVE: The aims of this study were to (1) describe potential risk factors at discharge and (2) describe the associations of risk factors with readmission from 60 days to 1 year after discharge. METHODS: Data from a national cross-sectional survey exploring patient-reported outcomes were used in conjunction with data from national health registers. This study included patients who had an ablation for AF during a single calendar year. The Hospital Anxiety and Depression Scale and questions on risk factors were included. Sociodemographic and clinical data were collected through registers, and readmissions were examined at 1 year. RESULTS: In total, 929 of 1320 (response rate, 70%) eligible patients treated with ablation for AF completed the survey. One year after ablation, there were 333 (36%) acute readmissions for AF and 401 (43%) planned readmissions for AF. Readmissions were associated with ischemic heart disease, anxiety, and depression. CONCLUSION: High observed readmission rates were associated with risk factors that included anxiety and depression. Postablation care should address these risk factors.

Sex Differences in Patient-Reported Outcomes in the Immediate Recovery Period After Resuscitation: Findings From the Cross-sectional DenHeart Survey.

BACKGROUND: A paucity of resuscitation studies have examined sex differences in patient-reported outcomes upon hospital discharge. It remains unclear whether male and female patients differ in health outcomes in their immediate responses to trauma and treatment after resuscitation. OBJECTIVES: The aim of this study was to examine sex differences in patient-reported outcomes in the immediate recovery period after resuscitation. METHODS: In a national cross-sectional survey, patient-reported outcomes were measured by 5 instruments: symptoms of anxiety and depression (Hospital Anxiety and Depression Scale), illness perception (Brief Illness Perception Questionnaire [B-IPQ]), symptom burden (Edmonton Symptom Assessment Scale [ESAS]), quality of life (Heart Quality of Life Questionnaire), and perceived health status (12-Item Short Form Survey). RESULTS: Of 491 eligible survivors of cardiac arrest, 176 (80% male) participated. Compared with male, resuscitated female reported worse symptoms of anxiety (Hospital Anxiety and Depression Scale-Anxiety score ≥8) (43% vs 23%; P = .04), emotional responses (B-IPQ) (mean [SD], 4.9 [3.12] vs 3.7 [2.99]; P = .05), identity (B-IPQ) (mean [SD], 4.3 [3.10] vs 4.0 [2.85]; P = .04), fatigue (ESAS) (mean [SD], 5.26 [2.48] vs 3.92 [2.93]; P = .01), and depressive symptoms (ESAS) (mean [SD], 2.60 [2.68] vs 1.67 [2.19]; P = .05). CONCLUSIONS: Between sexes, female survivors of cardiac arrest reported worse psychological distress and illness perception and higher symptom burden in the immediate recovery period after resuscitation. Attention should focus on early symptom screening at hospital discharge to identify those in need of targeted psychological support and rehabilitation.

The association between cardiac drug therapy and anxiety among cardiac patients: results from the national DenHeart survey.

BACKGROUND: Neuropsychiatric side effects of cardiac drugs such as nervousness, mood swings and agitation may be misinterpreted as symptoms of anxiety. Anxiety in cardiac patients is highly prevalent and associated with poor outcomes, thus an accurate identification is essential. The objectives were to: (I) describe the possible neuropsychiatric side effects of common cardiac drug therapies, (II) describe the use of cardiac drug therapy in cardiac patients with self-reported symptoms of anxiety compared to those with no symptoms of anxiety, and (III) investigate the association between the use of cardiac drug therapy and self-reported symptoms of anxiety. METHODS: DenHeart is a large national cross-sectional survey combined with national register data. Symptoms of anxiety were measured by the Hospital Anxiety and Depression Scale (HADS-A) on patients with ischemic heart disease, arrhythmia, heart failure and heart valve disease. Side effects were obtained from 'product summaries', and data on redeemed prescriptions obtained from the Danish National Prescription Registry. Multivariate logistic regression analyses explored the association between cardiac drug therapies and symptoms of anxiety (HADS-A ≥ 8). RESULTS: Among 8998 respondents 2891 (32%) reported symptoms of anxiety (HADS-A ≥ 8). Neuropsychiatric side effects were reported from digoxin, antiarrhythmics, beta-blockers, ACE-inhibitors and angiotensin receptor antagonists. Statistically significant higher odds of reporting HADS ≥ 8 was found in users of diuretics, lipid-lowering agents, nitrates, antiarrhythmics and beta-blockers compared to patients with no prescription. CONCLUSION: Some cardiac drugs were associated with self-reported symptoms of anxiety among patients with cardiac disease. Of these drugs neuropsychiatric side effects were only reported for antiarrhythmics and beta-blockers. Increased awareness about the possible adverse effects from these drugs are important.

Patient-reported outcomes, sociodemographic and clinical factors are associated with 1-year mortality in patients with ischemic heart disease-findings from the DenHeart cohort study.

PURPOSE: In patients with ischemic heart disease, the objectives were (1) to explore associations between patient-reported outcomes, sociodemographic, and clinical factors at discharge and 1-year all-cause mortality and (2) to investigate the discriminant predictive performance of the applied patient-reported outcome instruments on 1-year all-cause mortality. METHODS: Data from the Danish national DenHeart cohort study were used. Eligible patients (n = 13,476) were invited to complete a questionnaire-package, of which 7167 (53%) responded. Questionnaires included the 12-item Short form health survey (SF-12), Hospital anxiety and depression scale (HADS), EQ-5D, HeartQoL, Edmonton symptom assessment scale (ESAS), and ancillary questions on, e.g., social support. Clinical and demographic characteristics were obtained from registers, as were data on mortality. Comparative analyses were used to investigate differences in patient-reported outcomes. Mortality associations were explored using multifactorially adjusted Cox regression analyses. Predictive performance was analyzed using receiver operating characteristics (ROC). RESULTS: Patient-reported outcomes at discharge differed among those alive versus those deceased at one year, e.g., depression (HADS-Depression ≥ 8) 19% vs. 44% (p < 0.001). Associations with 1-year mortality included feeling unsafe about returning home from the hospital; hazard ratio (HR) 2.07 (95% CI 1.2-3.61); high comorbidity level, HR 3.6 (95% CI 2.7-4.8); and being unmarried, HR 1.60 (95% CI 1.33-1.93). Best predictive performance was observed for SF-12 physical component summary (Area under the curve (AUC) 0.706). CONCLUSION: Patient-reported health, sociodemographic, and clinical factors are associated with 1-year mortality. We propose systematic screening with robust predictive tools to identify patients at risk and healthcare initiatives to explore and offer effective treatment to modify patient-reported health indicators.

Cause of Death Among Cardiac Patients With and Without Anxiety.

BACKGROUND: Mental distress is reported internationally among patients with cardiac disease. A Danish survey found that 25% of patients with cardiac disease experienced symptoms indicating anxiety and that anxiety was associated with an increased risk of death. AIM: The aims of this study were to (1) compare cause of death patterns among deceased cardiac patients with anxiety to those without anxiety and (2) examine the association between anxiety symptoms and specific causes of death. METHODS: We used data from the DenHeart survey to evaluate symptoms of anxiety at discharge by using the Hospital Anxiety and Depression Scale. Data on mortality in the 3 years after discharge and cause of death according to International Classification of Diseases-10 classification came from national registers. Cause of death was compared between patients with and without anxiety using χ2 tests. The association between symptoms of anxiety and cause of death was investigated using logistic regression. RESULTS: Of 12 913 patients included, a total of 1030 (8%) died within 3 years. After 1 year, 4% of patients with anxiety symptoms had died versus 2% of patients without; after 3 years, the proportions were 9% versus 8%, respectively. Almost all died of natural causes irrespective of anxiety symptoms. No statistically significant differences were found regarding the cause of death between patients with and without anxiety. CONCLUSION: Despite higher mortality rates in patients with cardiac disease with anxiety symptoms, the pattern of cause of death was identical for patients with cardiac disease with and without anxiety symptoms. It seems that an acceleration of morbid processes leading to mortality is more likely than a difference in cause of death. However, further research is needed to better understand the behavioral and pathophysiological processes that cause the higher mortality seen among patients reporting symptoms of anxiety.

Prognostic value of a brief loneliness questionnaire for patients with coronary heart disease: Proposal for a prediction model.

BACKGROUND: In patients with coronary heart disease (CHD), loneliness is associated with increased risk of morbidity and mortality. No predictive tool is available to detect patients who are influenced by loneliness to a degree that impacts mortality. AIM: To: (i) propose a prediction model that detects patients influenced by loneliness to a degree that increases one-year all-cause mortality, (ii) evaluate model classification performance of the prediction model, and (iii) investigate potential questionnaire response errors. METHOD: A cohort of patients with CHD (n = 7169) responded to a national cross-sectional survey, including two questions on loneliness. Information on cohabitation and follow-up information on one-year all-cause mortality were obtained from national registers. Prediction model development was based on the prognostic values of item responses in the questionnaire on loneliness and of cohabitation, evaluated with Cox-proportional Hazards Ratio (HR). Item responses which significantly predicted one-year mortality were included in the high-risk loneliness (HiRL) prediction model. Sensitivity, specificity and likelihood ratio were calculated to evaluate model classification performance. Sources of response errors were evaluated using verbal probing technique in an additional cohort (n = 7). The TRIPOD checklist has been used to ensure transparent reporting. RESULTS: Two item responses significantly predicted one-year mortality HR = 2.24 (95%CI = 1.24-4.03) and HR = 2.65 (95%CI = 1.32-5.32) and were thus included in the model. Model classification performance showed a likelihood ratio of 1.89. Response error was evaluated as low. CONCLUSION: Based on the prognostic value in a loneliness questionnaire, a prediction model suitable to screen patients with CHD for high-risk loneliness was suggested. RELEVANCE TO CLINICAL PRACTICE: The HiRL prediction model is a short and easy-to-use screening tool that offers clinical staff to identify patients with CHD who are influenced by loneliness to a degree that impacts mortality. However, further evaluation of model performance and questionnaire validation is recommended before integrating the model into clinical practice.

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

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

Psychometric properties of the Danish Hospital Anxiety and Depression Scale in patients with cardiac disease: results from the DenHeart survey.

BACKGROUND: Anxiety and depression symptoms are common among cardiac patients. The Hospital Anxiety and Depression Scale (HADS) is frequently used to measure symptoms of anxiety and depression; however, no study on the validity and reliability of the scale in Danish cardiac patients has been done. The aim, therefore, was to evaluate the psychometric properties of HADS in a large sample of Danish patients with the four most common cardiac diagnoses: ischemic heart disease, arrhythmias, heart failure and heart valve disease. METHODS: The DenHeart study was designed as a national cross-sectional survey including the HADS, SF-12 and HeartQoL and combined with data from national registers. Psychometric evaluation included analyses of floor and ceiling effects, structural validity using both exploratory and confirmatory factor analysis and hypotheses testing of convergent and divergent validity by relating the HADS scores to the SF-12 and HeartQoL. Internal consistency reliability was evaluated by Cronbach's alpha, and differential item functioning by gender was examined using ordinal logistic regression. RESULTS: A total of 12,806 patients (response rate 51%) answered the HADS. Exploratory factor analysis supported the original two-factor structure of the HADS, while confirmatory factor analysis supported a three-factor structure consisting of the original depression subscale and two anxiety subscales as suggested in a previous study. There were floor effects on all items and ceiling effect on item 8. The hypotheses regarding convergent validity were confirmed but those regarding divergent validity for HADS-D were not. Internal consistency was good with a Cronbach's alpha of 0.87 for HADS-A and 0.82 for HADS-D. There were no indications of noticeable differential item functioning by gender for any items. CONCLUSIONS: The present study supported the evidence of convergent validity and high internal consistency for both HADS outcomes in a large sample of Danish patients with cardiac disease. There are, however, conflicting results regarding the factor structure of the scale consistent with previous research. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01926145.

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

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

Subgroup Differences and Determinants of Patient-Reported Mental and Physical Health in Patients With Ischemic Heart Disease: Results From the DenHeart Study.

BACKGROUND: A growing population is living with ischemic heart disease (IHD). Patient-reported outcomes (PROs) are reliable prognostic tools. Studies exploring PROs are needed to identify vulnerable patients and guide targeted healthcare strategies. OBJECTIVES: The aims of this study were to (i) describe PROs at hospital discharge across 3 diagnostic subgroups: (1) chronic IHD/stable angina, (2) non-ST-elevation myocardial infarction (non-STEMI)/unstable angina, and (3) ST-elevation myocardial infarction (STEMI), and (ii) examine determinants for PROs at hospital discharge in patients with IHD. METHODS: This study included a national cohort with register-data linkage including 14 115 adults with IHD discharged from Danish heart centers. Eligible patients (n = 13 476) were invited to complete a questionnaire, and 7 167 (53%) responded. Questionnaires included the Medical Outcome Study Short-Form 12, the Hospital Anxiety and Depression Scale, EuroQoL, HeartQoL, the Edmonton Symptom Assessment Scale, and ancillary questions. Sociodemographic and clinical characteristics were obtained from national registers. Student t test, χ test, and adjusted linear and logistic regression analyses were conducted to investigate subgroup differences, and adjusted linear and logistic regression analyses were conducted to explore determinants for PROs. RESULTS: Statistically significant subgroup differences were found, with groups reporting worst to best scores for most of PROs being as follows: chronic IHD/stable angina, non-STEMI/unstable angina, and STEMI. Symptoms of anxiety were highly prevalent in the non-STEMI/unstable angina group, with 33.8% exceeding a Hospital Anxiety and Depression Scale-Anxiety cutoff score indicating a possible anxiety disorder. Determinants for worse PROs included female sex, lower educational level, obesity, and poor physical fitness. CONCLUSIONS: Significant differences in PROs across IHD subgroups were observed and determinants for poor outcomes suggested. Results may guide differentiated care initiatives and resource allocation for preventative strategies.

Employment Status and Sick Leave After First-Time Implantable Cardioverter Defibrillator Implantation: Results From the COPE-ICD Trial.

BACKGROUND: In the Copenhagen Outpatient Programme-Implantable Cardioverter Defibrillator (COPE-ICD) Trial, a positive effect from a cost-saving, comprehensive cardiac rehabilitation program was found on physical and mental health in patients with ICDs. OBJECTIVE: In the context of the COPE-ICD Trial, the aims of this study is to investigate (a) employment status after ICD implantation, (b) the number of sick days related to ICD implantation, (c) differences in employment status and sick days between rehabilitation and usual care groups, and (d) predictors of employment status and sick leave. METHOD: Patients with first-time ICD implantation were randomized to comprehensive cardiac rehabilitation or usual care. One year after ICD implantation, patients answered questions about employment status and sick leave. Differences were tested using the Student t test and the χ test. Predictors of employment status and sick leave were tested using logistic regression and linear regression models. RESULT: A total of 196 patients were randomized. The questionnaire was completed by 138 patients (70%). In total, 47% had worked before ICD implantation. After 1 year, 81% were still working and their mean (SD) number of sick days was 33.8 (58.3). Age 60 years or younger and secondary ICD indication were predictors of working after 1 year. Patients with secondary ICD indication had more sick days and patients who were not married had fewer sick days. CONCLUSION: Most patients who worked before ICD implantation returned to work after the ICD was placed. Those who were married and had an ICD for secondary prevention took more sick days after the ICD than did those without these characteristics. Those who were younger and have a secondary indication ICD were more likely to be working 1 year after ICD implantation.

Effect of cardiac rehabilitation in patients with ICD: are gender differences present? Results from the COPE-ICD trial.

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.

Physical activity in primary versus secondary prevention indication implantable cardioverter defibrillator recipients 6-12 months after implantation - a cross-sectional study with register follow up.

OBJECTIVES: To describe physical activity status among patients with implantable cardioverter defibrillators (ICDs) according to the indication for ICD implant compared with international guidelines and compared with a matched healthy reference population to detect potential for improved physical outcomes; to describe patients' beliefs regarding participation in physical exercise by ICD indication; to describe factors predicting low physical activity; and to describe physical activity as a predictor of mortality. DESIGN: National survey with register follow-up. Comparisons were made to a matched healthy reference population, and patients were followed in registers for 15 months. SETTING: Patients are identified from national registers and questionnaires are distributed by postal mail. PARTICIPANTS: All diagnostic profiles and indications were included as were both single-chamber ICD and biventricular ICD (N=499). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Questions regarding physical activity and the International Physical Activity Questionnaire-Short Form were used to assess physical activity. RESULTS: The response rate was 71.7%. The mean age of participants was 65.5 years, with 82% of participants being men. Of the participants, 37% participated in a rehabilitation program, and 21% were sedentary compared with 8% in the reference population (P<.0001). Only 13% of patients followed physical exercise guidelines. Low physical activity was predicted by primary prevention indication (odds ratio [OR]=2.5; 95% confidence interval [CI], 1.3-4.7) and higher comorbidity (OR=2.1; 95% CI, 1.0-4.1; P<.05). Finally, low physical activity was associated with increased mortality (OR=3.9; 95% CI, 1.11-13.71; P<.05); however, it was not statistically significant when adjusted for age, sex, marital status, and comorbidity. CONCLUSIONS: Guidelines for exercise and participation in rehabilitation are not met for this population, leaving a great potential for future interventions to improve the clinical outcomes, which are modifiable by exercise.

Self-reported mental and physical health is associated with not returning to work in patients with ischemic heart disease.

BACKGROUND: Ischemic Heart Disease (IHD) can lead to prolonged sick leave and loss of ability to work. This study aimed to describe non-return to work (non-RTW) across three IHD subgroups at 3 and at 12 months post discharge, and explore whether baseline characteristics, and patient-reported mental and physical health were associated with work detachment. METHODS: Data from the national cohort study DenHeart were used, including the patient-reported outcomes (PROs) Short-Form 12, Hospital Anxiety and Depression Scale, Edmonton Symptom Assessment Scale and HeartQoL measured at discharge and register-based follow-up at 3 and at 12 months. A total of 3873 patients with IHD ≤ 63 years old and part of the workforce prior to hospitalisation, were included in the analyses and divided into three groups: chronic IHD/stable angina, non-STEMI (non-ST-Elevation Myocardial Infarction)/unstable angina and STEMI (ST-Elevation Myocardial Infarction). A composite outcome of 'prolonged sick leave' and/or 'left the workforce' was defined as non-return to work (non-RTW). Adjusted logistic regression models were performed. RESULTS: Overall, the frequency of non-RTW was 37.7% and 38.0% at 3 and 12 months, respectively, thus not improving with time. The largest proportion of non-RTW was found in STEMI patients, followed by non-STEMI/unstable angina and IHD/stable angina patients. Several clinical and socio-demographic factors, as well as patient-reported mental and physical health were associated with non-RTW among the subgroups. CONCLUSION: The findings demonstrate a need for identifying IHD patients at risk of non-RTW after discharge based on their mental and physical health and a need for initiatives to minimize unwanted non-RTW.

Faced with a dilemma: Danish midwives' experiences with and attitudes towards late termination of pregnancy.

BACKGROUND: The introduction of prenatal screening for all pregnant women in Denmark in 2004 has lead to an increase in the number of late terminations of pregnancy after the 12th week of pregnancy. Midwives' experiences with late termination of pregnancy (TOP) are still poorly described in the scientific literature. AIM: To explore Danish midwives' experiences with and attitudes towards late TOP. Focus was on how midwives perceive their own role in late TOP, and how their professional identity is influenced by working with late TOP in a time where prenatal screening is rapidly developing. METHOD: A qualitative study consisting of ten individual interviews with Danish midwives, all of whom had taken part in late TOP. RESULTS: Current practice of late TOP resembles the practice of normal deliveries and is influenced by a growing personalisation of the aborted foetus. The midwives strongly supported women's legal right to choose TOP and considerations about the foetus' right to live were suppressed. Midwives experienced a dilemma when faced with aborted foetuses that looked like newborns and when aborted foetuses showed signs of life after a termination. Furthermore, they were critical of how physicians counsel women/couples after prenatal diagnosis. CONCLUSIONS: The midwives' practice in relation to late TOP was characterised by an acknowledgement of the growing ethical status of the foetus and the emotional reactions of the women/couples going through late TOP. Other professions as well as structural factors at the hospital highly influenced the midwives' ability to organize their work with late terminations. There is a need for more thorough investigation of how to secure the best possible working conditions for midwives, and how to optimise the care for women/couples going through late TOP.

Protocol for a feasibility randomized trial of a social support intervention plus usual care versus usual care, targeting patients treated for cardiac disease who experience loneliness.

INTRODUCTION: In patients treated for cardiac disease, loneliness is known to contribute negatively to health behavior, health outcome, and increase risk of cardiac and all-cause mortality. Even so, in health care research, social support interventional studies targeting patients who experience loneliness are lacking. AIM: To determine the feasibility of an individually structured social support intervention targeting patients treated for cardiac disease who experience loneliness. DESIGN: A feasibility study based on randomized clinical trial design with 1:1 randomization to a 6-month social support program, plus usual care (intervention) versus usual care, (i.e., regular guidelines-based follow-up). INTERVENTION: Patients classified as high risk lonely according to the High Risk Loneliness tool will be provided with an informal caregiver in the 6 months rehabilitation phase following cardiac disease treatment. The informal caregiver will be designated by the patient from the existing social network or a peer, depending on patients' preferences. The core content of the intervention is through nurse consultations at baseline and 1, 3, and 6 months, to enhance and reinforce the informal caregiver's competences to be a social support resource. The theoretical framework of the nurse consultations will be based on middle-range theory of self-care. OUTCOME: Feasibility will be evaluated in terms of acceptability and adherence according to predefined feasibility criteria. The preliminary effect of the intervention on patient-reported outcomes, health behaviors, and health outcomes will be evaluated in the intervention and the control group at baseline and 1, 3, 6, and 12 months. DISCUSSION: The present study will contribute with knowledge on how to implement a feasible social support intervention targeting patients treated for cardiac disease who experience loneliness and, furthermore, investigate the preliminary effect on health behavior and health outcome in the early rehabilitation period. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT05503810) 18.08.2022.

Infection with SARS-CoV-2 following Second Dose Pfizer-BioNTech mRNA COVID-19 Vaccine BNT162b2 in Danish Adolescents Aged 12-18 Years: A Real-World Nationwide Danish Cohort Study.

In this real-world cohort study based on Danish nationwide registers, the cumulated proportion, relative risk (RR) of SARS-CoV-2 breakthrough infections, and vaccine effectiveness (VE) were investigated in adolescents aged 12-18 years following vaccination with the BNT162b2 vaccine compared to unvaccinated controls. Adolescents with and without vaccination with the first dose of BNT162b2 between 1 May and 30 September 2021 were included. Effect estimates include proportions with a positive SARS-CoV-2 RT-PCR test among vaccinated and unvaccinated, RR, and VE at three different time points. During Delta-dominance, VE was first 97.6% (95% CI 96.3-98.4), then 96.2% (95% CI 95.4-96.9) in the age group 12-15 and 95.1% (95% CI 94.1-96.0) followed by 95.5% (95% CI 94.8-96.1) in the age group 16-18 years, respectively. During Omicron dominance, VE was 5.8% (95% CI 4.6-7.0) in ages 12-15 years and 9.2% (95% CI 7.7-10.6) in ages 16-18 years. Thus, BNT162b2-vaccine protection was limited during the Omicron era.

Risk of New-onset Type 1 Diabetes in Danish Children and Adolescents After SARS-CoV-2 Infection: A Nationwide, Matched Cohort Study.

We investigated the association between SARS-CoV-2 infection and new-onset type 1 diabetes (T1D) in children and adolescents in a nationwide, matched cohort study. The hazard ratio of new-onset T1D within 6 months after SARS-CoV-2 infection was 1.22 (0.58-2.58). The risk of new-onset T1D in children and adolescents was not significantly increased after SARS-CoV-2 infection.