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).

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.

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.

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.

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.

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.

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.

Increased Concentrations of Circulating Interleukins following Non-Invasive Vagus Nerve Stimulation: Results from a Randomized, Sham-Controlled, Crossover Study in Healthy Subjects.

OBJECTIVE: The vagus nerve constitutes the main component of the parasympathetic nervous system and plays an important role in the regulation of neuro-immune responses. Invasive stimulation of the vagus nerve produces anti-inflammatory effects; however, data on humoral immune responses of transcutaneous vagus nerve stimulation (tVNS) are rare. Therefore, the present study investigated changes in serum cytokine concentrations of interleukin-1ß (IL-1ß), IL-6, IL-8, and tumor necrosis factor α (TNFα) following a short-term, non-invasive stimulation of the vagus nerve. METHODS: Whole blood samples were collected before and after a short-lived application of active tVNS at the inner tragus as well as sham stimulation of the earlobe. Cytokine serum concentrations were determined in two healthy cohorts of younger (n = 20) and older participants (n = 19). Differences between active and sham conditions were analyzed using linear mixed models and post hoc F tests after applying Yeo-Johnson power transformations. This trial was part of a larger study registered on ClinicalTrials.gov (NCT05007743). RESULTS: In the young cohort, IL-6 and IL-1ß concentrations were significantly increased after active stimulation, whereas they were slightly decreased after sham stimulation (IL-6: p = 0.012; IL-1ß: p = 0.012). Likewise, in the older cohort, IL-1ß and IL-8 concentrations were significantly elevated after active stimulation and reduced after sham application (IL-8: p = 0.007; IL-1ß: p = 0.001). In contrast, circulating TNFα concentrations did not change significantly in either group. CONCLUSION: Our results show that active tVNS led to an immediate increase in the serum concentrations of certain pro-inflammatory cytokines such as IL-1ß, IL-6, and/or IL-8 in two independent cohorts of healthy study participants.

The association of general practitioners' awareness of depression and anxiety with change in quality of life in heart failure patients: results of the prospective observational RECODE-HF cohort study.

BACKGROUND: Depression and anxiety are more prevalent in patients with heart failure (HF) than in the general population and reduce quality of life (QoL); therefore, clinical guidelines recommend screening HF patients for depression/anxiety. OBJECTIVE: We investigated, whether the general practitioners' (GPs) awareness of patients' symptoms of depression and/or anxiety (psychosocial distress) was associated with a change in QoL. METHODS: In this prospective observational study, we recruited 3,129 primary care HF patients in Germany. Patients completed baseline and 12-month follow-up questionnaires. Their GPs were interviewed. We identified 666 patients with psychosocial distress and compared 2 groups by analysis of covariance: 235 patients with psychosocial distress whose GP was aware of the psychosocial distress and 431 patients with psychosocial distress whose GP was unaware of such distress. Primary outcome was the change in QoL, assessed by the EQ-5D visual analogue scale. RESULTS: Patients with psychosocial distress showed lower baseline QoL than those without (45.9 vs 64.1; P < 0.001). Within the patients with psychosocial distress, the GPs' awareness of psychosocial distress was not associated with improvement of QoL (F = 1.285; P = 0.258) or remission of psychosocial distress (odds ratio = 0.887; P = 0.608). CONCLUSION: We found no association between the GPs' awareness of psychosocial distress and change in QoL. Although data for effective treatments of depression in HF are currently insufficient, psychosocial distress strongly impairs the QoL in HF patients. These findings might influence the development of clinical practice guidelines in HF.

Smoking cessation by combined medication and counselling: a feasibility study in lung cancer patients.

PURPOSE: Smoking cessation in patients with diagnosed lung cancer has positive effects on cancer therapy and overall prognosis. Despite this, knowledge on smoking cessation in lung cancer patients is sparse. METHODS: This is an observational single centre, 12-week, prospective, single-arm trial at a tertiary lung cancer centre. Responsive patients were enrolled following confirmed lung cancer diagnosis. Smoking cessation intervention included counselling as well as pharmacotherapy. The primary endpoint was the point prevalence abstinence rate at week 12 based on biochemical verification. Secondary endpoints were the abstinence rate at week 26, quality of life and side effects. RESULTS: 80 patients were enrolled. Mean age was 62.6 ± 7.9 years. Most patients (63%) were treated with chemotherapy or radiochemotherapy. 39 patients used nicotine replacement therapy, 35 varenicline whereas six patients did not use pharmacotherapy. During the study period 13 patients died. Data were available in 72 patients after 12 weeks and 57 patients at week 24. Point prevalence abstinence rates were 37.5% (95% CI 26.4-49.7%) at week 12 and 32.8% (95% CI 21.8-45.4%) at week 26, respectively. Quality of life and side effects were not significantly affected by pharmacotherapy. CONCLUSION: In conclusion, our results suggest that smoking cessation is feasible in patients with newly diagnosed lung cancer. The observed abstinence rate is comparable to other patient cohorts. Furthermore, pharmacotherapy in addition to cancer therapy was safe and did not show novel side effects in these seriously ill patients. Thus, smoking cessation should be an integral part of lung cancer treatment. Trial registration The study was conducted in accordance with good clinical practice standards (GCP) and approved by the local ethics committee (16/3/14), the European PAS registry (EUPAS8748) and the German BfArM (NIS-Studien-Nr. 5508). All patients provided written informed consent before study enrollment.

Prognostic factors associated with quality of life in heart failure patients considering the use of the generic EQ-5D-5L™ in primary care: new follow-up results of the observational RECODE-HF study.

BACKGROUND: The implementation of care concepts fitting the needs of patients with chronic heart failure (HF) remains challenging. In this context, psycho-emotional well-being is not routinely assessed, and under-researched despite indications that it is of great relevance for, e.g., acceptance, adherence, and prognosis. The aim of this study was to observe clinical characteristics for their prognostic utility in HF patients, and to compare the patients' health-related quality of life (QoL) with German population norm values. METHODS: The current post-hoc analysis was performed on data collected amongst participants of the RECODE-HF study who had fully answered the EQ-5D-5L™ items at both baseline and 12 months (n = 2354). The status in the patients' self-assessment items, EQ-5D visual analog scale (VAS) and EQ-5D index was categorized into worse/unchanged/improved. General linear mixed models (GLMM) with logit link were applied. Subgroups included 630 patients (26.8%) screened positive and 1724 patients (73.2%) screened negative for psychosocial distress (PSD). RESULTS: The 12-months change in EQ-5D index, generally resulting from change in individual EQ-5D items, additionally associated not only with high NYHA class but sociodemographics (employment/living alone/GP practice years) (96.2% correctly classified in GLMM). The 12- months change in individual QoL aspects showed associations with age*NYHA, gender, body-mass index, and comorbidities dyslipidemia, myocardial infarction, asthma/chronic pulmonary disease. Important social roles were reflected in particular when HF patients lived alone or the doctor mentioned to the patient that the patient had HF. Patients with/without PSD differed in some sociodemographic and clinical parameters. However, no influence of PSD could be demonstrated in the 12-month follow-up of the EQ-5D-5L™. Nonetheless, comparison of the 12-months QoL with general German population norm values by age groups < 75 years and 75+ showed markedly health restrictions in HF patients in all EQ-5D-5L™ aspects. CONCLUSION: Our analysis revealed different prognostic factors primarily associated with change of burden in different QoL aspects in HF patients. In GP practice it is important to consider in addition to the overall day-related VAS all the individual health-related QoL aspects to take a holistic view of the patient, as well as to pay particular attention to the interrelation of individual characteristics.

Telephone-based peer support intervention to reduce depressive symptoms in women with coronary heart disease, a randomized controlled trial in Germany.

Depressive symptoms in patients with coronary heart disease (CHD) predict adverse outcomes regarding e.g. cardiovascular complications. We trained women with CHD to support female peers through telephone-based counseling and tested whether depressive symptoms can be reduced, and perceived social support can be improved by the intervention over six months. 108 women with CHD and self-reported depressive or anxiety symptoms were included in a randomized controlled trial. The intervention group was offered immediate telephone-based peer support for six months, while the waiting list control group received the intervention with a 6-months delay. Primary outcomes were depressive symptoms and perceived social support immediately after the intervention period and at 6-months-follow-up. 40% of the women made use of the peer support. During the first six months, both groups showed a reduction in depressive symptoms (IIG: t(169) = -1.79, p = .08; WCG: t(169) = -2.76, p = .007) and a significant improvement in social support (IIG: t(175) = 3.54, p < .001; WCG: t(175) = 3.36, p < .001). We found no significant group × time interactions. There was no influence of telephone-based peer support on depressive symptoms and social support. We discuss potential causes for both lack of specific treatment effects and the general improvement over time in both groups.

Efficacy of team-based collaborative care for distressed patients in secondary prevention of chronic coronary heart disease (TEACH): study protocol of a multicenter randomized controlled trial.

BACKGROUND: Coronary heart disease (CHD) is the leading cause of death and years of life lost worldwide. While effective treatments are available for both acute and chronic disease stages there are unmet needs for effective interventions to support patients in health behaviors required for secondary prevention. Psychosocial distress is a common comorbidity in patients with CHD and associated with substantially reduced health-related quality of life (HRQoL), poor health behavior, and low treatment adherence. METHODS: In a confirmatory, randomized, controlled, two-arm parallel group, multicenter behavioral intervention trial we will randomize 440 distressed CHD patients with at least one insufficiently controlled cardiac risk factor to either their physicians' usual care (UC) or UC plus 12-months of blended collaborative care (TeamCare = TC). Trained nurse care managers (NCM) will proactively support patients to identify individual sources of distress and risk behaviors, establish a stepwise treatment plan to improve self-help and healthy behavior, and actively monitor adherence and progress. Additional e-health resources are available to patients and their families. Intervention fidelity is ensured by a treatment manual, an electronic patient registry, and a specialist team regularly supervising NCM via videoconferences and recommending protocol and guideline-compliant treatment adjustments as indicated. Recommendations will be shared with patients and their physicians who remain in charge of patients' care. Since HRQoL is a recommended outcome by both, several guidelines and patient preference we chose a ≥ 50% improvement over baseline on the HeartQoL questionnaire at 12 months as primary outcome. Our primary hypothesis is that significantly more patients receiving TC will meet the primary outcome criterion compared to the UC group. Secondary hypotheses will evaluate improvements in risk factors, psychosocial variables, health care utilization, and durability of intervention effects over 18-30 months of follow-up. DISCUSSION: TEACH is the first study of a blended collaborative care intervention simultaneously addressing distress and medical CHD risk factors conducted in cardiac patients in a European health care setting. If proven effective, its results can improve long-term chronic care of this vulnerable patient group and may be adapted for patients with other chronic conditions. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00020824, registered on 4 June, 2020; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00020824.

Association of depression and anxiety with adherence in primary care patients with heart failure-cross-sectional results of the observational RECODE-HF cohort study.

BACKGROUND: Psychological distress has a negative impact on the prognosis and quality of life for patients with heart failure. We investigated the association between psychological distress and the patients' adherence to medical treatment (medication adherence) and self-care advice (lifestyle adherence) in heart failure. We further examined whether there are different factors associated with low medication compared to low lifestyle adherence. METHOD: This secondary analysis of the RECODE-HF cohort study analyzed baseline data of 3099 primary care heart failure patients aged 74 ± 10 years, 44.5 % female. Using multivariable regression, factors relating to medication and lifestyle adherence were investigated in order to estimate the extent to which these factors confound the association between psychological distress and adherence. RESULTS: Psychological distress was significantly associated with poorer medication adherence but not with lifestyle adherence after controlling for confounders. We identified different factors associated with medication compared to lifestyle adherence. A higher body mass index, a less developed social network, living alone, fewer chronic co-morbidities and unawareness of the heart failure diagnosis were only related to lower lifestyle adherence. Higher education was associated with poorer medication adherence. Male sex, younger age, lower self-efficacy and less familiar relation with the general practitioner were common factors associated with both lower medication and lifestyle adherence. CONCLUSION: Promising factors for increasing medication adherence (reduction of psychological distress) and lifestyle adherence (explaining the patient his/her heart failure diagnosis more than once and increase in the patients' self-efficacy), which were found in this cross-sectional study, must be further investigated in longitudinal studies.

Length Polymorphisms in the Angiotensin I-Converting Enzyme Gene and the Serotonin-Transporter-Linked Polymorphic Region Constitute a Risk Haplotype for Depression in Patients with Coronary Artery Disease.

Genetic variations affecting the course of depressive symptoms in patients with coronary artery disease (CAD) have not yet been well studied. Therefore, we set out to investigate whether distinct haplotypes of the two insertion/deletion polymorphisms in the serotonin-transporter-linked polymorphic region (5-HTTLPR) and the angiotensin I-converting enzyme (ACE) gene located on chromosome 17 can be identified as risk factors for trajectories of depression. Clinical and genotyping data were derived from 507 depressed CAD patients participating in the randomized, controlled, multicenter Stepwise Psychotherapy Intervention for Reducing Risk in Coronary Artery Disease (SPIRR-CAD) trial, of whom the majority had an acute cardiac event before study inclusion. Depression scores on the Hospital Anxiety and Depression Scale (HADS) were assessed at baseline and at five follow-up time points up to 2 years after study entrance. At baseline, depression scores did not significantly differ between patients carrying the risk haplotype ACE D/D, 5-HTTLPR I/I (n = 46) and the non-risk haplotypes (n = 461, 10.9 ± 2.7 versus 10.4 ± 2.5, p = 0.254). HADS-depression scores declined from study inclusion during the first year irrespective of the genotype. At each follow-up time point, HADS-depression scores were significantly higher in ACE D/D, 5-HTTLPR I/I carriers than in their counterparts. Two years after study inclusion, the mean HADS depression score remained 1.8 points higher in patients with the risk haplotype as compared to subjects not carrying this haplotype (9.9 ± 4.2 versus 8.1 ± 4.0, p = 0.009). In summary, the presence of the ACE D/D, 5-HTTLPR I/I haplotype may be a vulnerability factor for comorbid depressive symptoms in CAD patients.

Emotions, Bodily Changes, and the Social Environment: How Did Early Psychosomatic Medicine Consider the Social Dimension in Health and Disease?

OBJECTIVE: Social relationships play an important role in human health and disease processes, and the field of psychosomatic medicine currently integrates social factors in its theoretical models and clinical interventions. This article provides a historical perspective on the field of psychosomatic medicine in the United States and examines the extent to which early American psychosomatic medicine incorporated the impact of social relationships on health and disease outcomes. METHODS: We searched PubMed across all issues of Psychosomatic Medicine for key words related to emotions versus social processes. Article counts are compared for these key words. We then performed a narrative review to analyze how concepts of associations among emotional, interpersonal, and physiological variables evolved in early publications. RESULTS: Of 5023 articles found in Psychosomatic Medicine, 1453 contained an emotional, 936 a social search term, and 447 contained both. In the qualitative review, influences of the social environment on emotional states and physiology were recognized already in the 1930s but they only played a subordinate role in early Psychosomatic Medicine. Publications often lacked a clear working model how interpersonal events exert their impact on physiology. With increasing understanding of developmental and neural mechanisms, a more differentiated view evolved. CONCLUSIONS: Early publications in psychosomatic medicine mainly focused on associations between emotions and physiology. However, some highlighted the importance of interpersonal and social factors. Later, the understanding of emotions, social relationships, and physiology with their developmental and neurobiological correlates have led to a fuller "biopsychosociocultural" understanding of health and disease, although more research on and within these networks is urgently needed.

Somatic and sociodemographic predictors of depression outcome among depressed patients with coronary artery disease - a secondary analysis of the SPIRR-CAD study.

BACKGROUND: Depressive symptoms are common in patients with coronary artery disease (CAD) and are associated with an unfavourable outcome. Establishing prognostic patient profiles prior to the beginning of mental health care may facilitate higher efficacy of targeted interventions. The aim of the current study was to identify sociodemographic and somatic predictors of depression outcome among depressed patients with CAD. METHODS: Based on the dataset of the multicentre SPIRR-CAD randomised controlled trial (n = 570 patients with CAD and ≥ 8 points on the Hospital Anxiety and Depression Scale (HADS)), 141 potential sociodemographic and somatic predictors of the change in the HADS-D depression score from baseline to 18-month-follow-up were derived in two different ways. We screened for univariable association with response, using either analysis of (co)variance or logistic regression, respectively, both adjusted for baseline HADS-D value and treatment group. To guard against overfitting, multivariable association was evaluated by a linear or binomial (generalised) linear model with lasso regularisation, a machine learning approach. Outcome measures were the change in continuous HADS-D depression scores, as well as three established binary criteria. The Charlson Comorbidity Index (CCI) was calculated to assess possible influences of comorbidities on our results and was also entered in our machine learning approach. RESULTS: Higher age (p = 0.002), unknown previous myocardial infarction (p = 0.013), and a higher heart rate variability during numeracy tests (p = .020) were univariably associated with a favourable depression outcome, whereas hyperuricemia (p ≤ 0.003), higher triglycerides (p = 0.014), NYHA class III (p ≤ 0.028), state after resuscitation (p ≤ 0.042), intake of thyroid hormones (p = 0.007), antidiabetic drugs (p = 0.015), analgesic drugs (p = 0.027), beta blockers (p = 0.035), uric acid drugs (p ≤ 0.039), and anticholinergic drugs (p = 0.045) were associated with an adverse effect on the HADS-D depression score. In all analyses, no significant differences between study arms could be found and physical comorbidities also had no significant influence on our results. CONCLUSION: Our findings may contribute to identification of somatic and sociodemographic predictors of depression outcome in patients with CAD. The unexpected effects of specific medication require further clarification and further research is needed to establish a causal association between depression outcome and our predictors. TRIAL REGISTRATION: www.clinicaltrials.gov NCT00705965 (registered 27th of June, 2008). www.isrctn.com ISRCTN76240576 (registered 27th of March, 2008).

Exploring the Association of Hypertension With Risk for Depression: Evidence for Tamed Neurobehavioral Arousal Versus Central Emotional Dysregulation.

Depression is an established predictor of adverse cardiovascular disease outcomes. Less is known about cardiovascular risk factors as predictors of depression. In this issue of Psychosomatic Medicine (2018;80:508-514), Patel et al. report data indicating that pre-existing hypertension may be inversely associated with the atypical but not typical form of depression. We highlight here the strengths and limitations of the article and discuss the findings in light of research linking blood pressure and emotion regulation. In general, evidence suggests that higher blood pressure is associated with reduced expression of negative emotions and pain. Two prominent models of interaction have been proposed and supported by epidemiological and experimental research: one assumes that elevations in blood pressure lead to reduced arousal and pain sensitivity through baroreceptor activation and possibly additional afferent mechanisms. Operant conditioning may then result in (chronic) hypertension. The other one posits that impaired emotion processing as indicated by dampened emotion recognition may lead to disinhibition of hypothalamic centers and thereby result in sustained increases in blood pressure. These models are described in context of the current literature and open research questions are formulated.

Cross-Sectional and Longitudinal Associations of Systolic Blood Pressure With Quality of Life and Depressive Mood in Older Adults With Cardiovascular Risk Factors: Results From the Observational DIAST-CHF Study.

OBJECTIVE: Although diagnosed arterial hypertension and antihypertensive medication usually have an adverse impact on quality of life, recent studies suggest that actual blood pressure may be positively related to better well-being. However, data in older patients with cardiovascular risk factors are lacking, for whom such an association may be of particular relevance. METHODS: In 1300 adults aged 50 to 85 years with cardiovascular risk factors (51.5% men, mean age = 65.7 ± 8.2 years) participating in an observational study, we performed standardized measurements of blood pressure and assessed quality of life and depressive symptoms at baseline and 1-year follow-up using the Short Form-36 (SF-36) and the Hospital Anxiety and Depression Scale (HADS). RESULTS: Bivariate analysis demonstrated that systolic blood pressure was associated with higher SF-36 mental component summary scores (r = 0.100, p < .001) and reduced HADS depression (r = -0.082, p = .003). Multivariate regression models adjusting for age, sex, and disease severity confirmed that higher systolic blood pressure significantly predicted both better mental quality of life (ß = 0.070, p = .012) and less depressive mood (ß = -0.083, p = .003) at baseline, independently of antihypertensive medication and diagnosed hypertension. Moreover, the beneficial effects of baseline systolic blood pressure remained stable for both summary components of the SF-36 as well as HADS depression at 1-year follow-up. All results remained unchanged, when limiting the analyses to the 1072 patients with diagnosed hypertension. CONCLUSIONS: In older adults with cardiovascular risk factors, higher systolic blood pressure readings are independently related to better quality of life and fewer depressive symptoms in both cross-sectional and longitudinal settings, although the magnitude of the effect sizes is typically small.

Importance of comorbidities in the treatment of primary care patients with heart failure-Baseline results of the observational RECODE-HF Study.

Background: Both non-cardiac and cardiac comorbidities are related to the prognosis of chronic heart failure (HF), but so far little is known about the impact of comorbidities on treatment difficulties in routine care. Objectives: To investigate which comorbidities are associated with treatment difficulties in primary care. We hypothesized that somatic comorbidities as well as psychosocial distress are associated with treatment difficulties. Methods: In this baseline analysis of data of the observational RECODE-HF study, HF patients were recruited via primary care practices in two German sites. They received a questionnaire by mail to measure psychosocial distress. Each patient's GP was interviewed by phone regarding the patient's comorbidities and treatment difficulties. Logistic regression analyses controlled for GP cluster effects were calculated to investigate the association between comorbidities/psychosocial distress and treatment difficulties. Results: The 3282 patients of 285 GPs included in the analysis were aged 74.2 (±10.1) years and had a mean number of 4.6 (±2.4) comorbidities. GPs reported treatment difficulties in 32.5% of the patients. Allergies/drug intolerance [odds ratio (ORs)=2.0], asthma/chronic obstructive pulmonary disease (ORs=1.4), renal insufficiency (ORs=1.3), atherosclerosis/peripheral arterial occlusive disease (ORs=1.3) and cardiac arrhythmias (ORs=1.2) as well as patient-reported psychosocial distress (ORs=1.2), HF severity (ORs=3.7-1.6) and age (ORs=0.98) were associated with treatment difficulties. Conclusion: Five somatic comorbidity groups as well as patient-reported psychosocial distress were significantly associated with a higher risk of GP-reported treatment difficulties. Further efforts to address comorbidities in clinical guidelines could be built on these results.