Health economic evaluation of blended collaborative care for older multimorbid heart failure patients: study protocol.

BACKGROUND: Integrated care, in particular the 'Blended Collaborative Care (BCC)' strategy, may have the potential to improve health-related quality of life (HRQoL) in multimorbid patients with heart failure (HF) and psychosocial burden at no or low additional cost. The ESCAPE trial is a randomised controlled trial for the evaluation of a BCC approach in five European countries. For the economic evaluation of alongside this trial, the four main objectives were: (i) to document the costs of delivering the intervention, (ii) to assess the running costs across study sites, (iii) to evaluate short-term cost-effectiveness and cost-utility compared to providers' usual care, and (iv) to examine the budgetary implications. METHODS: The trial-based economic analyses will include cross-country cost-effectiveness and cost-utility assessments from a payer perspective. The cost-utility analysis will calculate quality-adjusted life years (QALYs) using the EQ-5D-5L and national value sets. Cost-effectiveness will include the cost per hospital admission avoided and the cost per depression-free days (DFD). Resource use will be measured from different sources, including electronic medical health records, standardised questionnaires, patient receipts and a care manager survey. Uncertainty will be addressed using bootstrapping. DISCUSSION: The various methods and approaches used for data acquisition should provide insights into the potential benefits and cost-effectiveness of a BCC intervention. Providing the economic evaluation of ESCAPE will contribute to a country-based structural and organisational planning of BCC (e.g., the number of patients that may benefit, how many care managers are needed). Improved care is expected to enhance health-related quality of life at little or no extra cost. TRIAL REGISTRATION: The study follows CHEERS2022 and is registered at the German Clinical Trials Register (DRKS00025120).

Generalized anxiety is a predictor of impaired quality of life in patients with atrial fibrillation: Findings from the prospective observational ARENA study.

OBJECTIVE: Atrial fibrillation (AF) is associated with impaired health-related quality of life (HRQoL), an increased risk of morbidity, and mortality. Traditional AF-related outcomes (e.g., AF recurrence) primarily demonstrate the physiological benefits of AF management but do not focus on the benefits experienced subjectively by the patient (i.e., patient-reported outcomes), which have been suggested as optimal endpoints in AF intervention studies. The aim of this study is to identify medical and psychological factors associated with impaired HRQoL at 1-year follow-up. METHODS: Using data from the prospective observational multicenter ARENA study in patients with AF, we analyzed associations between medical factors, anxiety, and HRQoL at 1-year follow-up assessed using 5-level EuroQoL-5D. RESULTS: In 1353 AF patients (mean age 71.4 ± 10.3 years, 33.8% female), none of the medical predictors (e.g., heart disease) or history of cardioversion were associated with HRQoL at the 1-year follow-up. Higher generalized anxiety (ß = -0.114, p < .001) but not cardiac anxiety (ß = -0.006, p = .809) at baseline predicted decreased HRQoL, independent of confounding variables and patients' medical status. Furthermore, the worsening of patients' generalized anxiety was associated with decreased HRQoL (ß = -0.091, p < .001). In contrast, the improvement of generalized anxiety over time predicted higher HRQoL (ß = 0.097, p < .001). Finally, the worsening of patients' cardiac anxiety over time was associated with decreased HRQoL (ß = -0.081, p < .001). CONCLUSION: Our results highlight the importance of anxiety as a predictor of future HRQoL in patients with AF. Additional studies to examine the impact of anxiety treatment on HRQoL in this population are needed. CLINICAL TRIAL REGISTRATION: The investigators registered on ClinicalTrials.gov (NCT02978248) on November 30, 2016 https://clinicaltrials.gov/ct2/show/NCT02978248.

Needs of multimorbid heart failure patients and their carers: a qualitative interview study and the creation of personas as a basis for a blended collaborative care intervention.

Introduction: Involving patients and carers in the development of blended collaborative care (BCC) interventions for multimorbid heart failure (HF) patients is recommended but rarely practised, and research on the patient perspective is scarce. The aim of this study is to investigate patients' and carers' care-related needs and preferences to better customize a novel international BCC intervention. Methods: A qualitative study design using framework analysis was employed. The study was performed in accordance with the EQUATOR standards for reporting qualitative research (SRQR). Patients aged at least 65 years with HF and at least two other physical diseases as well as their carers completed semistructured interviews in Germany, Italy, and Denmark. Based on these interviews, personas (prototype profiles of patients and carers) were created. Results: Data from interviews with 25 patients and 17 carers were analysed. Initially, seven country-specific personas were identified, which were iteratively narrowed down to a final set of 3 personas: (a) the one who needs and wants support, (b) the one who has accepted their situation with HF and reaches out when necessary, and (c) the one who feels neglected by the health care system. Carers identifying with the last persona showed high levels of psychological stress and a high need for support. Discussion: This is the first international qualitative study on patients' and carers' needs regarding a BCC intervention using the creation of personas. Across three European countries, data from interviews were used to develop three contrasting personas. Instead of providing "one size fits all" interventions, the results indicate that BCC interventions should offer different approaches based on the needs of individual patients and carers. The personas will serve as a basis for the development of a novel BCC intervention as part of the EU project ESCAPE (Evaluation of a patient-centred biopSychosocial blended collaborative CAre Pathway for the treatment of multimorbid Elderly patients).

Health-Related Quality of Life in Patients With Ventricular Assist Device: Psychometric Evaluation of the German Version of the Quality of Life With a Ventricular Assist Device Questionnaire.

BACKGROUND: Ventricular assist device (VAD) implantation has become an alternative treatment for patients with end-stage heart failure. In Germany, valid and reliable instruments to assess health-related quality of life in patients with VAD are lacking. OBJECTIVE: The aim of this study was to present the psychometric validation of the German version of the Quality of Life with a Ventricular Assist Device questionnaire. METHODS: In a multicenter, cross-sectional study, 393 participants (mean age, 58.3 years; 85.8% male, 60.3% bridge to transplant, and 72.8% living with VAD for ≤2 years) completed the German Quality of Life with a Ventricular Assist Device questionnaire of physical, emotional, social, cognitive, and meaning/spiritual domains. Item and confirmatory factor analyses were conducted to test item difficulty and discrimination and the underlying structure, respectively. To examine internal consistency, Cronbach α was assessed. Convergent construct validity was tested using the Kansas City Cardiomyopathy Questionnaire and the Patient Health Questionnaire-9. Readability was examined using Flesch Reading Ease index and Vienna Factual Text Formula. RESULTS: The Quality of Life with a Ventricular Assist Device showed reasonable item difficulty (Ptotal = .67) and mostly moderate to high discriminatory power (rit > 0.30). In confirmatory factor analysis, root-mean-square error of approximation (0.07) was acceptable for model fit, but no other indices. Acceptable internal consistency was found (α ≥ 0.79), with the exception of the cognitive domain (α = 0.58). The overall questionnaire and single domains demonstrated convergent validity (r ≥ 0.45, P < .001). The questionnaire showed adequate readability (Flesch Reading Ease, 64.11; Vienna Factual Text Formula, 6.91). CONCLUSION: Findings indicate a promising standardized clinical instrument to assess health-related quality of life in patients with VAD.

Supervised exercise training in patients with advanced heart failure and left ventricular assist device: A multicentre randomized controlled trial (Ex-VAD trial).

AIMS: Small studies and observations suggested that exercise training may improve peak oxygen consumption (peakVO2 ) in patients with advanced heart failure and left ventricular assist device (LVAD). We investigated whether in this patient group a supervised exercise training can improve exercise capacity. METHODS AND RESULTS: In this multicentre, prospective, randomized, controlled trial, patients with stable heart failure and LVAD were randomly assigned (2:1) to 12 weeks of supervised exercise training or usual care, with 12 weeks of follow-up. The primary endpoint was the change in peakVO2 after 12 weeks (51 patients provided a power of 90% with an expected group difference in peakVO2 of 3 ml/kg/min). Secondary endpoints included changes in submaximal exercise capacity and quality of life. Among 64 patients enrolled (97% male, mean age 56 years), 54 were included in the analysis. Mean difference in the change of peakVO2 after 12 weeks was 0.826 ml/min/kg (95% confidence interval [CI] -0.37, 2.03; p = 0.183). There was a positive effect of exercise training on 6-min walk distance with a mean increase in the intervention group by 43.4 m (95% CI 16.9, 69.9; p = 0.0024), and on the Kansas City Cardiomyopathy Questionnaire physical domain score (mean 14.3, 95% CI 3.7, 24.9; p = 0.0124), both after 12 weeks. The overall adherence was high (71%), and there were no differences in adverse events between groups. CONCLUSION: In patients with advanced heart failure and LVAD, 12 weeks of exercise training did not improve peakVO2 but demonstrated positive effects on submaximal exercise capacity and physical quality of life.

The multicenter effectiveness study of inpatient and day hospital treatment in departments of psychosomatic medicine and psychotherapy in Germany.

Background: Reliable outcome data of psychosomatic inpatient and day hospital treatment with a focus on psychotherapy are important to strengthen ecological validity by assessing the reality of mental health care in the field. This study aims to evaluate the effectiveness of inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy in a prospective, naturalistic, multicenter design including structured assessments. Methods: Structured interviews were used to diagnose mental disorders according to ICD-10 and DSM-IV at baseline. Depression, anxiety, somatization, eating disorder and posttraumatic stress disorder (PTSD) symptoms, as well as personality functioning were assessed by means of questionnaires on admission and at discharge. Results: 2,094 patients recruited by 19 participating university hospitals consented to participation in the study. Effect sizes for each of the outcome criteria were calculated for 4-5 sub-groups per outcome domain with differing severity at baseline. Pre-post effect sizes for patients with moderate and high symptom severity at baseline ranged from d = 0.78 to d = 3.61 with symptoms of PTSD, depression, and anxiety showing the largest and somatization as well as personality functioning showing somewhat smaller effects. Conclusions: Inpatient and day hospital treatment in German university departments of Psychosomatic Medicine and Psychotherapy is effective under field conditions. Clinical trial registration: https://drks.de/search/de/trial/DRKS00016412, identifier: DRKS00016412.

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Previous studies have demonstrated the efficacy of rehabilitation after a cardiovascular procedure. Especially older and multimorbid patients benefit from rehabilitation after a cardiac procedure. Prehabilitation prior to cardiac procedures may also have positive effects on patients' pre- and postoperative outcomes. Results of a current meta-analysis show that prehabilitation prior to cardiac procedures can improve perioperative outcomes and alleviate adverse effects. Germany currently lacks a structured cardiac prehabilitation program for older patients, which is coordinated across healthcare sectors. METHODS: In a randomized, controlled, two-arm parallel group, assessor-blinded multicenter intervention trial (PRECOVERY), we will randomize 422 patients aged 75 years or older scheduled for an elective cardiac procedure (e.g., coronary artery bypass graft surgery or transcatheter aortic valve replacement). In PRECOVERY, patients randomized to the intervention group participate in a 2-week multimodal prehabilitation intervention conducted in selected cardiac-specific rehabilitation facilities. The multimodal prehabilitation includes seven modules: exercise therapy, occupational therapy, cognitive training, psychosocial intervention, disease-specific education, education with relatives, and nutritional intervention. Participants in the control group receive standard medical care. The co-primary outcomes are quality of life (QoL) and mortality after 12 months. QoL will be measured by the EuroQol 5-dimensional questionnaire (EQ-5D-5L). A health economic evaluation using health insurance data will measure cost-effectiveness. A mixed-methods process evaluation will accompany the randomized, controlled trial to evaluate dose, reach, fidelity and adaptions of the intervention. DISCUSSION: In this study, we investigate whether a tailored prehabilitation program can improve long-term survival, QoL and functional capacity. Additionally, we will analyze whether the intervention is cost-effective. This is the largest cardiac prehabilitation trial targeting the wide implementation of a new form of care for geriatric cardiac patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS; http://www.drks.de ; DRKS00030526). Registered on 30 January 2023.

A randomized vagus nerve stimulation study demonstrates that serum aldosterone levels decrease with age in women, but not in men.

In this randomized, sham-controlled study, we explored the effects of acute transcutaneous vagus nerve stimulation (tVNS) on serum aldosterone in 20 younger (21-26 years) and 19 older (40-70 years) healthy participants. Blood samples were collected on two different days before and after a 20-min application of active tVNS at the inner tragus or sham stimulation of the earlobe. Irrespective of the stimulation mode, aldosterone levels decreased from pre- to post-stimulation in both the young (active: ß = - 1.610 (- 2.855, - 0.365), p = 0.022; sham: ß = - 0.857 (- 2.102, 0.388), p = 0.257) and the old cohort (active: ß = - 1.969 (- 3.234, - 0.703), p = 0.005; sham: ß = - 1.334 (- 2.600, - 0.069), p = 0.063). Although this decline was significant during active tVNS, the difference in estimated ß-coefficients between active and sham stimulation was not statistically significant in either cohort. Nevertheless, aldosterone concentrations showed a significant interaction effect between sex and age (p = 0.001). Among all study participants, younger women (23.3 ± 1.6 years) had the highest mineralocorticoid levels (pre active: 172.1 ± 102.0 pg/ml, pre sham: 214.3 ± 82.3 pg/ml), whereas the lowest were observed in older females (59.4 ± 9.4 years) (pre active: 104.9 ± 85.8 pg/ml, pre sham: 81.1 ± 53.8 pg/ml). This post hoc analysis did not suggest that active auricular tVNS reduces serum aldosterone levels compared to sham stimulation in healthy subjects. However, serum aldosterone levels differed among subjects depending on their age and sex, irrespective of tVNS.

Coping styles as predictors for quality of life and prognosis in patients at risk for or with a diagnosis of heart failure: Results from the observational DIAST-CHF study.

OBJECTIVE: Patients with heart failure often experience impaired health-related quality of life (HRQOL) and have an increased risk of cardiovascular and cerebrovascular events. The aim of this study was to investigate the predictive role of different coping styles on outcome. METHODS: This longitudinal study included 1536 participants who either had cardiovascular risk factors or were diagnosed with heart failure. Follow-ups took place one, two, five and ten years after recruitment. Coping and HRQOL were investigated using self-assessment questionnaires (Freiburg Questionnaire for Coping with Illness, Short Form-36 Health Survey). Somatic outcome was quantified by incidence of major adverse cardiac and cerebrovascular events (MACCE) and 6-min-walking-distance. RESULTS: Pearson correlation and multiple linear regression analysis showed significant associations between the coping styles used at the first three time points and HRQOL after five years. After adjusting for baseline HRQOL, minimization and wishful thinking predicted worse mental HRQOL (ß = -0.106; p = 0.006), while depressive coping predicted worse mental (ß = -0.197; p < 0.001) and physical HRQOL (ß = -0.085; p = 0.03; n = 613). Active problem-oriented coping could not significantly predict HRQOL. Only minimization and wishful thinking was significantly associated with an increased 10-year-risk for MACCE (hazard ratio = 1.06; 95% confidence interval: 1.01-1.11; p = 0.02; n = 1444) and reduction in 6-min-walking-distance at 5 years (ß = -0.119; p = 0.004; n = 817) in adjusted analyses. CONCLUSIONS: Depressive coping and minimization and wishful thinking were associated with worse quality of life in patients at risk for or with diagnosed heart failure. Minimization and wishful thinking also predicted worse somatic outcome. Therefore, patients using those coping styles might benefit from early psychosocial interventions.

Longitudinal association between N-terminal B-type natriuretic peptide, anxiety and social support in patients with HFpEF: results from the multicentre randomized controlled Aldo-DHF trial.

BACKGROUND: Higher plasma levels of natriuretic peptides (NPs) have been associated with reduced anxiety in experimental research and a number of patient samples. As NP levels are elevated in heart failure patients, we investigate whether this elevation is related to anxiety in patients with heart failure with preserved ejection fraction (HFpEF). METHODS: Post-hoc regression and mediation analyses were conducted, using data of 422 patients with HFpEF from the randomized, placebo-controlled, double-blinded, two-armed, multicentre aldosterone in diastolic heart failure trial, testing associations and their mediators between the N-terminal B-type natriuretic peptide (NT-proBNP) and anxiety at baseline and over 12-month follow-up. Anxiety was measured by the Hospital Anxiety and Depression Scale (HADS), social support by the ENRICHD Social Support Inventory and physical functioning by the Short Form 36 Health Survey. RESULTS: The mean age of the study population was 66.8 ± 7.6 years, 47.6% were male and 86.0% had NYHA class II. NT-proBNP showed a weak negative correlation with HADS anxiety scores at baseline (r = - 0.087; p = 0.092), which was significant (r = - 0.165; p = 0.028) in men but not in women. NT-proBNP also tended to predict lower anxiety at 12-months in men. On the other hand, higher anxiety at baseline was associated with lower NT-proBNP scores 12 months later (r = - 0.116; p = 0.026). All associations lost significance in multivariate regression for age, perceived social support (ESSI), physical function (SF-36) and study arm. Mediation analyses revealed that social support acts as a full mediator for the link between NT-proBNP levels and anxiety. CONCLUSION: The mechanisms linking NT-proBNP to anxiety may be more complex than originally assumed. While effects of NT-proBNP on anxiety may be mediated by perceived social support, there may be an additional negative effect of anxiety on NT-proBNP. Future research should consider this possible bi-directionality of the association and assess the potential influence of gender, social support, oxytocin and vagal tone on the interaction of anxiety and natriuretic peptide levels. Trial Registration http://www.controlled-trials.com  (ISRCTN94726526) on 07/11/2006. Eudra-CT-number: 2006-002,605-31.

Integrated care for older multimorbid heart failure patients: protocol for the ESCAPE randomized trial and cohort study.

ESCAPE: Evaluation of a patient-centred biopsychosocial blended collaborative care pathway for the treatment of multimorbid elderly patients. THERAPEUTIC AREA: Healthcare interventions for the management of older patients with multiple morbidities. AIMS: Multi-morbidity treatment is an increasing challenge for healthcare systems in ageing societies. This comprehensive cohort study with embedded randomized controlled trial tests an integrated biopsychosocial care model for multimorbid elderly patients. HYPOTHESIS: A holistic, patient-centred pro-active 9-month intervention based on the blended collaborative care (BCC) approach and enhanced by information and communication technologies can improve health-related quality of life (HRQoL) and disease outcomes as compared with usual care at 9 months. METHODS: Across six European countries, ESCAPE is recruiting patients with heart failure, mental distress/disorder plus ≥2 medical co-morbidities into an observational cohort study. Within the cohort study, 300 patients will be included in a randomized controlled assessor-blinded two-arm parallel group interventional clinical trial (RCT). In the intervention, trained care managers (CMs) regularly support patients and informal carers in managing their multiple health problems. Supervised by a clinical specialist team, CMs remotely support patients in implementing the treatment plan-customized to the patients' individual needs and preferences-into their daily lives and liaise with patients' healthcare providers. An eHealth platform with an integrated patient registry guides the intervention and helps to empower patients and informal carers. HRQoL measured with the EQ-5D-5L as primary endpoint, and secondary outcomes, that is, medical and patient-reported outcomes, healthcare costs, cost-effectiveness, and informal carer burden, will be assessed at 9 and ≥18 months. CONCLUSIONS: If proven effective, the ESCAPE BCC intervention can be implemented in routine care for older patients with multiple morbidities across the participating countries and beyond.

Does Anxiety Affect Survival in Patients with Coronary Heart Disease?

INTRODUCTION: Behavioral and physiological risk factors worsen the prognosis of coronary heart disease (CHD). Anxiety is known to be a psychological predictor of CHD. In this study, we investigated whether this factor is associated with all-cause mortality in CHD patients in the long term. METHODS: We studied 180 patients (mean age 60.6 SD 9.2 years, 26% women) with CHD from the Berlin Anxiety Trial (BAT) and the Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD) study. Their cardiac and psychological risk profile was represented by standardized procedures, including the Hospital Anxiety and Depression Scale (HADS) questionnaire. Mortality outcomes were assessed using a community-based registry. RESULTS: Of 180 patients, we obtained information on all-cause mortality in 175 (96.7%) after a mean follow-up of 12.2 years (range 10.4-16.6 years). Of all participants, 54.4% had prior myocardial infarction, 95.3% had percutaneous transluminal coronary angioplasty and 22.2% had prior coronary artery bypass graft. Most of the patients (98.4%) had New York Heart Association class I and II, 25.6% had diabetes and 38.2% were smokers. Patients had a mean HADS anxiety score of 9.7 SD 4.1 at study entrance. We found the highest HADS anxiety quartile all-cause mortality in 14%, 30.2% in the middle quartiles and 58.7% in the lowest quartile (chi2 20.8, p = 0.001). Related to psychological mechanisms, a low level of anxiety, seemed to be a significant predictor of all-cause mortality. We found no advantage for patients who had received psychosocial therapy in terms of survival. CONCLUSION: These first data confirmed our hypothesis about the association of psychological risk factors with the long-term outcome of CAD patients. Future studies will clarify whether the severity of disease, age or a particular type of coping or denial mechanism are associated with the presented outcome in low-anxious patients.

Validity of a German Comprehensive Psychosocial Screening Instrument based on the ESC Cardiovascular Prevention Guidelines.

Background: Following guidelines for cardiovascular disease prevention of the European Society for Cardiology (ESC), the current study validated the German Comprehensive Psychosocial Screening Instrument in participants who underwent coronary angiography. Methods: 314 participants (Mage = 69.7 ± 12.0; 69 % male) completed the German Comprehensive Psychosocial Screening Instrument and validated comparison scales to measure depression (PHQ-9), anxiety (GAD-7), Type D personality (DS14), work stress (ERI), family stress (SMSS), trauma (PC-PTSD), and anger and hostility (Z-scale of MMPI-2). Results: Confirmatory factor analysis (CFA) confirmed that the psychosocial risk factors were separate entities rather than a signs or symptoms of a single broad indication of distress (CFI = .872, RMSEA = .056, SRMR = .058). Intraclass coefficients (ICC), kappa and diagnostic accuracy indicators (receiver operator characteristic [ROC] curves, sensitivity, specificity, and the positive and negative predictive values [PPV; NPV]) indicated that most screener scales were sufficient to good. We also compared patients with established coronary heart disease (CHD; n = 213) to those with no current CHD (n = 100) and found overall similar results. Discussion: The German version of the Comprehensive Psychosocial Screening Instrument has an acceptable performance. Aside from minor improvements, the screening instrument could be implemented in the cardiological practice to screen patients on multidimensional psychosocial risk.

Type D Personality as a Risk Factor for Adverse Outcome in Patients With Cardiovascular Disease: An Individual Patient-Data Meta-analysis.

OBJECTIVE: Type D personality, a joint tendency toward negative affectivity and social inhibition, has been linked to adverse events in patients with heart disease, although with inconsistent findings. Here, we apply an individual patient-data meta-analysis to data from 19 prospective cohort studies ( N = 11,151) to investigate the prediction of adverse outcomes by type D personality in patients with acquired cardiovascular disease. METHOD: For each outcome (all-cause mortality, cardiac mortality, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention, major adverse cardiac event, any adverse event), we estimated type D's prognostic influence and the moderation by age, sex, and disease type. RESULTS: In patients with cardiovascular disease, evidence for a type D effect in terms of the Bayes factor (BF) was strong for major adverse cardiac event (BF = 42.5; odds ratio [OR] = 1.14) and any adverse event (BF = 129.4; OR = 1.15). Evidence for the null hypothesis was found for all-cause mortality (BF = 45.9; OR = 1.03), cardiac mortality (BF = 23.7; OR = 0.99), and myocardial infarction (BF = 16.9; OR = 1.12), suggesting that type D had no effect on these outcomes. This evidence was similar in the subset of patients with coronary artery disease (CAD), but inconclusive for patients with heart failure (HF). Positive effects were found for negative affectivity on cardiac and all-cause mortality, with the latter being more pronounced in male than female patients. CONCLUSION: Across 19 prospective cohort studies, type D predicts adverse events in patients with CAD, whereas evidence in patients with HF was inconclusive. In both patients with CAD and HF, we found evidence for a null effect of type D on cardiac and all-cause mortality.

Is only-child status associated with a higher blood pressure in adolescence? An observational study.

Growing up with siblings may affect quality of life as well as hemodynamic parameters including blood pressure. Using weighted data from the nationwide and representative German KiGGs study, we assessed the relationship between only-child status, birth order, and arterial blood pressure in a cohort of 7311 adolescents aged between 11 and 17 years. Our data showed that only-children had the highest mean arterial blood pressure (87.3 ± 8.4 mmHg) as compared to first-born (86.3 ± 8.0), middle-born (86.4 ± 8.7), and youngest-born siblings (86.6 ± 8.2; p = 0.012). The two groups of only-children and first-borns differed significantly with respect to their age- and sex-specific, z-scored data for systolic (p = 0.047), diastolic (p = 0.012), and mean arterial blood pressure (p = 0.005). Linear regression models with blood pressure recordings as dependent variable adjusted to age, migration background, and age- and sex-specific z-scores of body-mass index confirmed that only-child status was an independent predictor of a higher diastolic blood pressure (p = 0.037). A similar result was observed for mean arterial blood pressure (p = 0.033), whereas systolic blood pressure was not associated with only-children status (p = 0.258).   Conclusion: In summary, we found a significant and positive relationship between only-child status and blood pressure, with the highest recordings in only-children and the lowest in first-borns. Models adjusted for relevant clinical confounders demonstrated slightly higher blood pressure in only-children compared to first-borns, who are both in an alpha birth order. Although these blood pressure differences were statistically significant, they have limited, if any, clinical meaning in this age group. What is Known: • In children and adults, blood pressure is significantly higher in only-children compared to children with siblings. However, it is unclear whether there are also similar blood pressure differences in adolescents and between only-children and first-borns. What is New: • Among adolescents in the alpha birth order, growing up as an only-child is associated with significantly higher mean blood pressure than among first-borns living with younger siblings.

Anxiety and Depression Levels in Parents after Counselling for Fetal Heart Disease.

The progress in fetal cardiology allows for the early diagnosis of congenital heart defects, but there is still a lack of data on the psychological situation of parents expecting a child with a congenital heart defect. In this cross-sectional study, 77 parents (45 women and 32 men) expecting a child with a heart defect were interviewed with different questionnaires. The standardized Hospital Anxiety and Depression Scale (HADS) questionnaire was used to assess the psychological state of the parents. Various statistical procedures were performed to determine the prevalence, risk factors, and predictors of anxiety and depression. The prevalence for prenatal anxiety was 11.8% and for depressed mood 6.6%, whereas the postnatal prevalence was 25% for anxiety and 16.7% for depressed mood. The mother is influential in protecting against depression as a contact person (p = 0.035). Women were more affected by anxiety and depression than men (p = 0.036). A significant and positive correlation was observed between anxiety and depression before birth (ρ = 0.649, p < 0.001) and after birth (ρ = 0.808, p < 0.001). The level of education correlated negatively with depression (p = 0.016) and anxiety (p = 0.017) before birth. Significantly higher anxiety and depression scores were not observed among health and social workers (p = 0.084), first-time mothers (p = 0.190), and parents whose pregnancies were due to medical assistance (p = 0.051). Close collaboration between maternal-fetal care units, pediatric cardiologists and psychiatric/psychosomatic disciplines is a possible strategy to reduce stress in parents. Therefore, an expert team of professionals, educating with understandable terms and sufficient knowledge about fetal heart disease in parenting counseling, is required. The support of affected parents can positively impact the treatment of the child and should be integrated into the daily routine of the clinic.

What Kind of Patients Receive Inpatient and Day-Hospital Treatment in Departments of Psychosomatic Medicine and Psychotherapy in Germany?

INTRODUCTION: Germany is one of the few countries with a medical specialty of psychosomatic medicine and psychotherapy and many treatment resources of this kind. OBJECTIVE: This observational study describes the psychosomatic treatment programs as well as a large sample of day-hospital and inpatients in great detail using structured diagnostic interviews. METHODS: Mental disorders were diagnosed according to ICD-10 and DSM-IV by means of Mini-DIPS and SCID-II. In addition to the case records, a modified version of the CSSRI was employed to collect demographic data and service use. The PHQ-D was used to assess depression, anxiety, and somatization. RESULTS: 2,094 patients from 19 departments participated in the study after giving informed consent. The sample consisted of a high proportion of "complex patients" with high comorbidity of mental and somatic diseases, severe psychopathology, and considerable social and occupational dysfunction including more than 50 days of sick leave per year in half of the sample. The most frequent diagnoses were depression, somatoform and anxiety disorders, eating disorders, personality disorders, and somato-psychic conditions. CONCLUSIONS: Inpatient and day-hospital treatment in German university departments of psychosomatic medicine and psychotherapy is an intensive multimodal treatment for complex patients with high comorbidity and social as well as occupational dysfunction.

Assessment of health-related quality of life in individuals with depressive symptoms: validity and responsiveness of the EQ-5D-3L and the SF-6D.

BACKGROUND: The EQ-5D and the SF-6D are examples of commonly used generic preference-based instruments for assessing health-related quality of life (HRQoL). However, their suitability for mental disorders has been repeatedly questioned. OBJECTIVE: To assess the responsiveness and convergent validity of the EQ-5D-3L and SF-6D in patients with depressive symptoms. METHODS: The data analyzed were from cardiac patients with depressive symptoms and were collected as part of the SPIRR-CAD (Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease) trial. The EQ-5D-3L and SF-6D were compared with the HADS (Hospital Anxiety and Depression Scale) and PHQ-9 (Patient Health Questionnaire) as disease-specific instruments. Convergent validity was assessed using Spearman's rank correlation. Effect sizes were calculated and ROC analysis was performed to determine responsiveness. RESULTS: Data from 566 patients were analysed. The SF-6D correlated considerably better with the disease-specific instruments (|rs|= 0.63-0.68) than the EQ-5D-3L (|rs|= 0.51-0.56). The internal responsiveness of the SF-6D was in the upper range of a small effect (ES: - 0.44 and - 0.47), while no effect could be determined for the EQ-5D-3L. Neither the SF-6D nor the EQ-5D-3L showed acceptable external responsiveness for classifying patients' depressive symptoms as improved or not improved. The ability to detect patients whose condition has deteriorated was only acceptable for the EQ-5D-3L. CONCLUSION: Overall, both the convergent validity and responsiveness of the SF-6D are better than those of the EQ-5D-3L in patients with depressive symptoms. The SF-6D appears, therefore, more recommendable for use in studies to evaluate interventions for this population.