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This subanalysis of the CASTLE-AF (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF) trial aimed to address the association between atrial fibrillation (AF) recurrence, AF burden, and hard clinical outcomes in heart failure (HF) patients with AF.The CASTLE-AF trial demonstrated the benefit of CA compared to pharmacological treatment in decreasing mortality and CV hospitalizations in patients with AF and HFrEF. However, the impact of AF recurrence and AF burden after ablation on long-term treatment benefit remains unknown.The CASTLE-AF protocol randomized 363 patients with coexisting HF and AF in a multicenter prospective controlled fashion to catheter ablation (n = 179) versus pharmacological therapy (n = 184). Two hundred eighty patients were included in this subanalysis (as-treated), 128 of them underwent ablation and 152 received pharmacological treatment. All patients had implanted dual chamber or biventricular implantable defibrillators with activated home monitoring capabilities. The individual AF burden was calculated as the percentage of the atrial arrhythmia time per day.AF burden at baseline was not predictive of the primary endpoint (p = 0.473) or all-cause mortality (p = 0.446). AF recurrence (defined as any episode30 s) did not show any relationship with the primary endpoints of mortality and occurrence of HF, irrespective of the treatment arm. An AF burden below 50% after 6 months of catheter ablation, was associated with a significant decrease in primary composite outcome (hazard ratio [HR]: 0.33; 95% confidence interval [CI]: 0.15 to 0.71; p = 0.014) and all-cause mortality (HR: 0.23; 95% CI: 0.07 to 0.71; p = 0.031). The risk of the primary endpoint or mortality was directly related to a low (50%) or high (≥50%) AF burden at 6 months post-ablation.AF burden at 6 months was predictive of hard clinical outcomes in HF patients with AF. The first recurrent atrial tachyarrhythmia episode30 s after ablation was not associated with improvement in mortality and hospitalization for HF. (Catheter Ablation vs. Standard Conventional Treatment in Patients With LV Dysfunction and AF [CASTLE-AF]; NCT00643188).

The value of antiarrhythmics to maintain normal sinus rhythm in patients with atrial fibrillation (AF) and heart failure (HF) is still being debated. We aimed to determine whether rhythm control using antiarrhythmic drugs (AADs) is more effective than rate control in improving outcomes in this population. In this sub-analysis of the CASTLE-AF study, we included patients that were treated pharmacologically either to maintain sinus rhythm or to achieve rate control. The primary endpoint was defined as a composite of death from any cause or worsening of HF that led to an unplanned overnight hospitalization. Among 210 patients (mean age of 64.1 ± 10.8 years, 83.3% male) treated pharmacologically, 60 patients were in the rhythm control group and 150 were in the rate control group. Patients in the rhythm control group were less likely to be assigned a beta-blocker (53 (88.3%) vs 141 (97.9%), P = 0.004) and digitalis (8 (13.3%) vs 53 (36.8%), P

Background The impact of ECG presentations of acute myocardial infarction (AMI) in cardiogenic shock is unknown. Research Question In myocardial infarction with cardiogenic shock, is there a difference in the outcomes and effect of revascularization strategies between non-ST-segment elevation myocardial infarction (NSTEMI) and left bundle branch block myocardial infarction (LBBBMI) vs ST-segment elevation myocardial infarction (STEMI)? Study Design and Methods Cardiogenic shock patients from the CULPRIT-SHOCK trial with NSTEMI or LBBBMI were compared with STEMI patients for 30-day and 1-year all-cause mortality. The interaction between ECG presentation and the effect of revascularization strategies on outcomes was evaluated. Results Of 665 cardiogenic shock patients analyzed, 55.9% demonstrated STEMI, 29.3% demonstrated NSTEMI, and 14.7% demonstrated LBBBMI. Patients differed in mean age (68.0 years in STEMI patients, 71.0 years in NSTEMI patients, and 73.5 years in LBBBMI patients; P = .015), cardiovascular risk factors, and angiographic severity. No difference was found in the 30-day risk of death between NSTEMI and STEMI patients (48.7% vs 43.0%; adjusted OR [aOR], 1.05; 95% CI, 0.66-1.67; P = .85), nor between LBBBMI and STEMI patients (59.2% vs 43.0%; aOR, 1.31; 95% CI, 0.73-2.34; P = .36). Although the univariate risk of death by 1 year was higher in NSTEMI and LBBBMI patients compared with STEMI patients, ECG presentation was not an independent risk factor of mortality after adjustment (NSTEMI vs STEMI: 56.4% vs 46.8%; aOR, 1.21; 95% CI, 0.76-1.92; P = .42; LBBBMI vs STEMI: 69.4% vs 46.8%; aOR, 1.59; 95% CI, 0.89-2.84; P = .12). ECG presentation did not modify the effect of the revascularization strategy on 30-day and 1-year mortality (P = .91 and P = .97 for interaction). Interpretation In patients with cardiogenic shock, NSTEMI and LBBBMI presentations reflect higher-risk profiles than STEMI presentations, but are not independent risk factors of mortality. ECG presentations did not modify the treatment effect, supporting culprit-lesion-only percutaneous coronary intervention as the preferred strategy across the AMI spectrum.

IntroductionHealthcare systems around the world are looking for solutions to the growing problem of mental disorders. RECOVER is the synonym for an evidence-based, stepped and cross-sectoral coordinated care service model for mental disorders. RECOVER implements a cross-sectoral network with managed care, comprehensive psychological, somatic and social diagnostics, crisis resolution and a general structure of four severity levels, each with assigned evidence-based therapy models (eg, assertive community treatment) and therapies (eg, psychotherapy). The study rationale is the investigation of the effectiveness and efficiency of stepped and integrated care in comparison to standard care.Methods and analysisThe trial is conducted in accordance to the Standard Protocol Items: Recommendations for Interventional Trials Statement. The study aims to compare the RECOVER model with treatment as usual (TAU). The following questions are examined: Does RECOVER reduce healthcare costs compared with TAU? Does RECOVER improve patient-relevant outcomes? Is RECOVER cost-effective compared with TAU? A total sample of 890 patients with mental disorders will be assessed at baseline and individually randomised into RECOVER or TAU. Follow-up assessments are conducted after 6 and 12 months. As primary outcomes, cost reduction, improvement in symptoms, daily functioning and quality of life as well as cost-effectiveness ratios will be measured. In addition, several secondary outcomes will be assessed. Primary and secondary outcomes are evaluated according to the intention-to-treat principle. Mixed linear or logistic regression models are used with the direct maximum likelihood estimation procedure which results in unbiassed estimators under the missing-at-random assumption. Costs due to healthcare utilisation and productivity losses are evaluated using difference-in-difference regressions.Ethics and disseminationEthical approval from the ethics committee of the Hamburg Medical Association has been obtained (PV5672). The results will be disseminated to service users and their families via the media, to healthcare professionals via professional training and meetings and to researchers via conferences and publications.Trial registration number and registry nameClinicalTrials.gov (NCT03459664), RECOVERProtocol version19 March 2020 (V.3.0)

Objective: In order to optimize psycho-oncological care, studies that quantify the extent of distress and identify certain risk groups are needed. Among patients with prostate cancer (PCa), findings on depression and anxiety are limited. Methods: We analyzed data of PCa patients selected from a German multi-center study. Depression and anxiety were assessed with the PHQ-9 and the GAD-7 (cut-off ≥7). We provided physical symptom burden, calculated absolute and relative risk (AR and RR) of depression and anxiety across patient subsets and between patients and the general population (GP) and tested age as a moderator within the relationship of disease-specific symptoms with depression and anxiety. Results: Among 636 participants, the majority reported disease-specific problems (sexuality: 60%; urination: 52%). AR for depression and anxiety was 23% and 22%, respectively. Significant RR were small, with higher risks of distress in patients who are younger (eg, RRdepression = 1.15; 95%-CI: 1.06-1.26), treated with chemotherapy (RRdepression = 1.46; 95%-CI: 1.09-1.96) or having metastases (RRdepression = 1.30; 95%-CI: 1.02-1.65). Risk of distress was slightly elevated compared to GP (eg, RRdepression = 1.13; 95%-CI: 1.07-1.19). Age moderated the relationship between symptoms and anxiety (Burination = −0.10, P =.02; Bsexuality = −0.11, P =.01). Conclusions: Younger patients, those with metastases or treatment with chemotherapy seem to be at elevated risk for distress and should be closely monitored. Many patients suffer from disease-specific symptom burden, by which younger patients seem to be particularly distressed. Support of coping mechanisms associated with disease-specific symptom burden seems warranted.

Background The emergence and increased spread of microbial resistance is a major challenge to all health care systems worldwide. In primary care, acute respiratory tract infection (ARTI) is the health condition most strongly related to antibiotic overuse. Objective The RESIST program aims at optimizing antibiotic prescribing for ARTI in German primary care. By completing a problem-orientated online training course, physicians are motivated and empowered to utilize patient-centered doctor-patient communication strategies, including shared decision making, in the treatment of patients with ARTI. Methods RESIST will be evaluated in the form of a nonrandomized controlled trial. Approximately 3000 physicians of 8 (out of 16) German federal states can participate in the program. Patient and physician data are retrieved from routine health care data. Physicians not participating in the program serve as controls, either among the 8 participating regional Associations of Statutory Health Insurance Physicians (control group 1) or among the remaining associations not participating in RESIST (control group 2). Antibiotic prescription rates before the intervention (T0: 2016, 1st and 2nd quarters of 2017) and after the intervention (T1: 3rd quarter of 2017 until 1st quarter of 2019) will be compared. The primary outcome measure is the overall antibiotic prescription rate for all patients insured with German statutory health insurance before and after provision of the online course. The secondary outcome is the antibiotic prescription rate for coded ARTI before and after the intervention. Results RESIST is publicly funded by the Innovations funds of the Federal Joint Committee in Germany and was approved in December 2016. Recruitment of physicians is now completed, and a total of 2460 physicians participated in the intervention. Data analysis started in February 2020. Conclusions With approximately 3000 physicians participating in the program, RESIST is among the largest real-world interventions aiming at reducing inadequate antibiotic prescribing for ARTI in primary care. Long-term follow up of up to 21 months will allow for investigating the sustainability of the intervention. Trial Registration ISRCTN Registry ISRCTN13934505; http://www.isrctn.com/ISRCTN13934505 International Registered Report Identifier (IRRID) RR1-10.2196/18648

BACKGROUND The emergence and increased spread of microbial resistance is a major challenge to all health care systems worldwide. In primary care, acute respiratory tract infection (ARTI) is the health condition most strongly related to antibiotic overuse. OBJECTIVE The RESIST program aims at optimizing antibiotic prescribing for ARTI in German primary care. By completing a problem-orientated online training course, physicians are motivated and empowered to utilize patient-centered doctor-patient communication strategies, including shared decision making, in the treatment of patients with ARTI. METHODS RESIST will be evaluated in the form of a nonrandomized controlled trial. Approximately 3000 physicians of 8 (out of 16) German federal states can participate in the program. Patient and physician data are retrieved from routine health care data. Physicians not participating in the program serve as controls, either among the 8 participating regional Associations of Statutory Health Insurance Physicians (control group 1) or among the remaining associations not participating in RESIST (control group 2). Antibiotic prescription rates before the intervention (T0: 2016, 1st and 2nd quarters of 2017) and after the intervention (T1: 3rd quarter of 2017 until 1st quarter of 2019) will be compared. The primary outcome measure is the overall antibiotic prescription rate for all patients insured with German statutory health insurance before and after provision of the online course. The secondary outcome is the antibiotic prescription rate for coded ARTI before and after the intervention. RESULTS RESIST is publicly funded by the Innovations funds of the Federal Joint Committee in Germany and was approved in December 2016. Recruitment of physicians is now completed, and a total of 2460 physicians participated in the intervention. Data analysis started in February 2020. CONCLUSIONS With approximately 3000 physicians participating in the program, RESIST is among the largest real-world interventions aiming at reducing inadequate antibiotic prescribing for ARTI in primary care. Long-term follow up of up to 21 months will allow for investigating the sustainability of the intervention. CLINICALTRIAL ISRCTN Registry ISRCTN13934505; http://www.isrctn.com/ISRCTN13934505 INTERNATIONAL REGISTERED REPORT RR1-10.2196/18648

Background An ageing population worldwide needs to investigate quality of life (QoL) and level of functioning (LoF) in the elderly and its associated variables. We aimed to study the relationship between Quality of Life (QoL) and Level of Functioning (LoF) in an elderly population in Europe. Method As part of the Ment_Dis65+ European Project, 3142 community-dwelling adults aged 65–84 years in six countries were assessed by using the adaptation for the elderly of the Composite International Diagnostic Interview (CIDI65+) to provide psychiatric diagnosis according to the International Classification of Diseases (10th edition) (ICD-10 Classification of Mental and Behavioural Disorders). Socio-demographic and clinical interviews, and two self-report tools, the World Health Organization QoL assessment (WHO QoL BREF), to assess QoL, and the WHO Disability Assessment Schedule -II (WHODAS-II), to assess LoF, were also administered. Results Most subjects reported good levels of QoL (56.6%) and self-rated health (62%), with no or mild disability (58.8%). There was a linear decrease of the QoL and the LoF by increase of age. Elderly with ICD-10 mental disorder (e.g. somatoform, affective and anxiety disorders) had poorer QoL and lower LoF. There were a number of predictors of lower levels of QoL and disability, including both socio-demographic variables (e.g. male gender, increase in age, poor financial situation, retirement, reduced number of close significant others), ICD-10 psychiatric diagnosis (mainly anxiety, somatoform disorders) and presence of medical disorders (mainly heart and respiratory diseases). Conclusions The study indicates that QoL and LoF were quite acceptable in European elderly people. A series of variables, including psychiatric and somatic disorders, as well as socio-demographic factor influenced in a negative way both QoL and LoF. More specific links between mental health, social and health services dedicated to this segment of the population, should be implemented in order to provide better care for elderly people with conditions impacting their QoL and functioning.

We investigated the differential effectiveness of a stepped and collaborative care model (SCM) vs. treatment as usual (TAU) for primary care patients with various depression severity degrees and explored whether subgroups received distinct evidence-based treatments.Subgroup analyses of a RCT were calculated applying a multiple linear mixed model with the factors 1. group (SCM; TAU), 2. severity ((mild-moderate (MMD); severe depression (SD)) and their interaction, with PHQ-9 as primary outcome. Utilization of treatments was analyzed descriptively.For the 737 participating patients (SCM: n = 569; TAU: n = 168), availability of data substantially varies between subgroups at 12-month follow-up ranging between 37% and 70%. ITT-analysis (Last-observation-carried-forward) revealed a significant interaction for group x severity [p = 0.036] and a significant difference between groups in symptom reduction for MMD (-3.9; [95% CI: -5.1 to -2.6, p0.001; d = 0.64] but not for SD (-1.6; [95% CI: -3.4 to 0.2, p = 0.093; d = 0.27]. Sensitivity analyses (multiple imputation, completer analysis, pattern mixture model) didn`t confirm the interaction effect and showed significant effects for both severity groups with slightly higher effect sizes for MMD. Differences between SCM and TAU in the percentage of patients utilizing depression-specific treatments are larger for MMD.There was a high proportion of missing values among severely depressed patients, especially in SCM.SCM is effective for both MMD and SD. Utilization patterns might help explain the higher effects for MMD. Various strategies of replacement of missing values lead to slightly divergent results due to selective drop out between severity groups.

International audience; Aims: The Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients with Heart Failure trial investigated the effects of adaptive servo-ventilation (ASV) (vs. control) on outcomes of 1325 patients with heart failure and reduced ejection fraction (HFrEF) and central sleep apnoea (CSA). The primary outcome (a composite of all-cause death or unplanned HF hospitalization) did not differ between the two groups. However, all-cause and cardiovascular (CV) mortality were higher in the ASV group. Circulating biomarkers may help in better ascertain patients’ risk, and this is the first study applying a large set of circulating biomarkers in patients with both HFrEF and CSA.Methods and results: Circulating protein-biomarkers (n = 276) ontologically involved in CV pathways, were studied in 749 (57% of the trial population) patients (biomarker substudy), to investigate their association with the study outcomes (primary outcome, CV death and all-cause death). The mean age was 69 ± 10 years, and > 90% were male. The groups (ASV vs. control and biomarker substudy vs. no biomarker) were well balanced. The “best” clinical prognostic model included male sex, systolic blood pressure < 120 mmHg, diabetes, loop diuretic, cardiac device, 6-min walking test distance, and N-terminal pro BNP as the strongest prognosticators. On top of the “best” clinical prognostic model, the biomarkers that significantly improved both the discrimination (c-index) and the net reclassification index (NRI) of the model were soluble suppression of tumorigenicity 2 for the primary outcome; neurogenic locus notch homolog protein 3 (Notch-3) for CV-death and all-cause death; and growth differentiation factor 15 (GDF-15) for all-cause death only.Conclusions: We studied 276 circulating biomarkers in patients with HFrEF and central sleep apnoea; of these biomarkers, three added significant prognostic information on top of the best clinical model: soluble suppression of tumorigenicity 2 (primary outcome), Notch-3 (CV and all-cause death), and GDF-15 (all-cause death).

The Lufthansa Prevention Study (LUPS) study is a prospective observation of a healthy worker cohort to identify early changes in metabolism leading to the Metabolic Syndrome (MetS) and to analyze their relation to behavioral factors like nutrition, physical activity, psychological status, and to underlying genetic conditions. The LUPS study recruited a sample of 1.962 non-diabetic healthy adults between 25–60 years, employed at a flight base of Lufthansa Technik GmbH in Hamburg, Germany. Baseline assessments included anthropometric measures, blood and urine samples and medical history. Psychosocial variables, dietary habits and life-style risk factors were assessed via self-reported questionnaires.In this report we describe the study design and present baseline parameters including the prevalence of the MetS using different classification criteria. The MetS was present in 20% of male and 12% of female subjects according to the ‘Harmonizing the metabolic syndrome’ definition. The prevalence varies between 2.6% in male and 2.3% in female subjects up to 48% in male and 41% in female subjects according to different classification criteria of MetS.In conclusion, this first cross-sectional view on the LUPS data confirms the expectation that this cohort is rather healthy and thus provides the opportunity to analyze early changes associated with the development of the MetS. The LUPS study is registered as a clinical trial NCT01313156.

A higher incidence of proximal interval cancers after colonoscopy has been reported in several follow-up studies. One possible explanation for this might be that proximally located adenomas have greater malignant potential. The aim of the present study was to assess the risk of malignancy in proximal versus distal adenomas in patients included in a large screening colonoscopy database; adenoma shape and the patients' age and sex distribution were also analyzed.Data for 2007-2012 from the German National Screening Colonoscopy Registry, including 594,614 adenomas identified during 2,532,298 screening colonoscopies, were analyzed retrospectively. The main outcome measure was the rate of high-grade dysplasia (HGD) in adenomas, used as a surrogate marker for the risk of malignancy. Odds ratios (ORs) for the rate of HGD found in adenomas were analyzed in relation to patient- and adenoma-related factors using multivariate analysis.HGD histology was noted in 20,873 adenomas (3.5%). Proximal adenoma locations were not associated with a higher HGD rate. The most significant risk factor for HGD was adenoma size (OR 10.36 ≥1 cm vs1 cm), followed by patient age (OR 1.26 and 1.46 for age groups 65-74 and 75-84 vs 55-64 years) and sex (OR 1.15 male vs female). In comparison with flat adenomas as a reference lesion, sessile lesions had a similar HGD rate (OR 1.02) and pedunculated adenomas had a higher rate (OR 1.23). All associations were statistically significant (P ≤ .05).In this large screening database, it was found that the rates of adenomas with HGD are similar in the proximal and distal colon. The presence of HGD as a risk marker alone does not explain higher rates of proximal interval colorectal cancer. We suggest that certain lesions (flat, serrated lesions) may be missed in the proximal colon and may acquire a more aggressive biology over time. A combination of endoscopy-related factors and biology may therefore account for higher rates of proximal versus distal interval colorectal cancer.

Summary Background Remote patient management in patients with heart failure might help to detect early signs and symptoms of cardiac decompensation, thus enabling a prompt initiation of the appropriate treatment and care before a full manifestation of a heart failure decompensation. We aimed to investigate the efficacy of our remote patient management intervention on mortality and morbidity in a well defined heart failure population. Methods The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial was a prospective, randomised, controlled, parallel-group, unmasked (with randomisation concealment), multicentre trial with pragmatic elements introduced for data collection. The trial was done in Germany, and patients were recruited from hospitals and cardiology practices. Eligible patients had heart failure, were in New York Heart Association class II or III, had been admitted to hospital for heart failure within 12 months before randomisation, and had a left ventricular ejection fraction (LVEF) of 45% or lower (or if higher than 45%, oral diuretics were being prescribed). Patients with major depression were excluded. Patients were randomly assigned (1:1) using a secure web-based system to either remote patient management plus usual care or to usual care only and were followed up for a maximum of 393 days. The primary outcome was percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death, analysed in the full analysis set. Key secondary outcomes were all-cause and cardiovascular mortality. This study is registered with ClinicalTrials.gov, number NCT01878630, and has now been completed. Findings Between Aug 13, 2013, and May 12, 2017, 1571 patients were randomly assigned to remote patient management (n=796) or usual care (n=775). Of these 1571 patients, 765 in the remote patient management group and 773 in the usual care group started their assigned care, and were included in the full analysis set. The percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause death was 4·88% (95% CI 4·55–5·23) in the remote patient management group and 6·64% (6·19–7·13) in the usual care group (ratio 0·80, 95% CI 0·65–1·00; p=0·0460). Patients assigned to remote patient management lost a mean of 17·8 days (95% CI 16·6–19·1) per year compared with 24·2 days (22·6–26·0) per year for patients assigned to usual care. The all-cause death rate was 7·86 (95% CI 6·14–10·10) per 100 person-years of follow-up in the remote patient management group compared with 11·34 (9·21–13·95) per 100 person-years of follow-up in the usual care group (hazard ratio [HR] 0·70, 95% CI 0·50–0·96; p=0·0280). Cardiovascular mortality was not significantly different between the two groups (HR 0·671, 95% CI 0·45–1·01; p=0·0560). Interpretation The TIM-HF2 trial suggests that a structured remote patient management intervention, when used in a well defined heart failure population, could reduce the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality. Funding German Federal Ministry of Education and Research.

Background Advance Care Planning (ACP) has been shown to increase prevalence of advance directives in German nursing homes (n/h) and therefore been introduced by recent legislation for n/h residents covered by sickness funds. However, clinical benefits and costs of ACP for n/h residents have not been studied in German speaking countries yet. Methods cRCT in 4 study centres, each comprising 11 n/h (3.520 n/h residents altogether). 22 n/h will be randomised to the ACP intervention, the other half continue with usual care. The complex ACP intervention consists of comprehensive qualification of ACP facilitators and family physicians, education of all regional health care actors relevant for the care of n/h residents, and coordination within and between participating institutions. Primary hypothesis is a reduced rate of unwanted hospital admissions. Secondary hypotheses include increased rates of residents whose preferences are known and followed in pre-defined critical treatment decisions, residents dying in the n/h (versus in hospital) according to their preference, and residents, their families, and their caregivers who appreciate congruence between treatment wanted and delivered. Additionally, we plan a comprehensive process evaluation and a health economic analysis. Conclusion While ACP has been repeatedly shown to be clinically effective in n/h, recent data from the Netherlands indicate it may not. Our trial, funded by the Innovation Fund of the Federal Joint Commission, will provide elaborate, 8 days facilitator qualification involving 24 hours of role plays with simulated patients, and it will be the first to study hospitalisation rate in all residents of participating n/h.

Women have been reported to suffer from impaired outcome after acute myocardial infarction (AMI). The aim of our study was to determine the impact of sex and age on utilization of inpatient healthcare and outcome in patients with AMI (STEMI and NSTEMI) in a real‐life setting. We performed a routine‐data‐based analysis of 203 106 nationwide inpatients hospitalized with STEMI and NSTEMI, focusing on sex differences regarding risk constellation, treatments, and in‐hospital outcome. A logistic regression model was designed to evaluate the use of coronary angiography and interventions and their sex‐related impact on mortality (within 30 days). Compared with males, female STEMI patients (25 146, vs 52 965 males) were older and had a higher incidence of diabetes mellitus (27.4% vs 20.6%), heart failure (32.8% vs 26.2%), and chronic kidney disease (19.1% vs 13.5%, respectively; all P < 0.05), and had higher observed in‐hospital mortality (STEMI, 16.9% vs 9.9%; NSTEMI, 11.7% vs 8.7%). Females were less likely to receive coronary angiography in STEMI in the age groups

The aim of this study was to compare quality of life (QoL) data from cancer patients in different clinical settings with data from the general population. A sample of 4020 German cancer patients (1735 inpatients, 1324 outpatients, 961 participants in rehabilitation treatment) was tested with the EORTC QLQ-C30. Compared with the general population, cancer patients reported markedly worse QoL. There were clinically significant differences on all 15 scales of the EORTC QLQ-C30 (except one). For the sum score, averaging across 13 scales, the effect size of the difference between cancer patients and the general population was d = 1.16. Inpatients reported the greatest detriments to QoL, followed by the rehabilitation patients and the outpatients (mean sum scores 68.6, 71.0, and 72.3, respectively, compared with 89.2 in the general population). Mean scores for different groups of cancer sites are given separately for the three settings. The detriments to QoL were stronger than in comparable studies conducted on data from clinical trials. Since these detriments were found in all three settings to a similar degree, health care providers should offer their services not only to inpatients but to outpatients and patients treated in rehabilitation clinics as well. The data can be used for QoL comparisons of assessments from different settings.

Composite endpoints combine several events within a single variable, which increases the number of expected events and is thereby meant to increase the power. However, the interpretation of results can be difficult as the observed effect for the composite does not necessarily reflect the effects for the components, which may be of different magnitude or even point in adverse directions. Moreover, in clinical applications, the event types are often of different clinical relevance, which also complicates the interpretation of the composite effect. The common effect measure for composite endpoints is the all-cause hazard ratio, which gives equal weight to all events irrespective of their type and clinical relevance. Thereby, the all-cause hazard within each group is given by the sum of the cause-specific hazards corresponding to the individual components. A natural extension of the standard all-cause hazard ratio can be defined by a weighted all-cause hazard ratio where the individual hazards for each component are multiplied with predefined relevance weighting factors. For the special case of equal weights across the components, the weighted all-cause hazard ratio then corresponds to the standard all-cause hazard ratio. To identify the cause-specific hazard of the individual components, any parametric survival model might be applied. The new weighted effect measure can be tested for deviations from the null hypothesis by means of a permutation test. In this work, we systematically compare the new weighted approach to the standard all-cause hazard ratio by theoretical considerations, Monte-Carlo simulations, and by means of a real clinical trial example.

Aims The SERVE-HF trial investigated the impact of treating central sleep apnoea (CSA) with adaptive servo-ventilation (ASV) in patients with systolic heart failure. A preplanned substudy was conducted to provide insight into mechanistic changes underlying the observed effects of ASV, including assessment of changes in left ventricular function, ventricular remodelling, and cardiac, renal and inflammatory biomarkers. Methods and results In a subset of the 1325 randomised patients, echocardiography, cardiac magnetic resonance imaging (cMRI) and biomarker analysis were performed at baseline, and 3 and 12 months. In secondary analyses, data for patients with baseline and 12-month values were evaluated; 312 patients participated in the substudy. The primary endpoint, change in echocardiographically determined left ventricular ejection fraction from baseline to 12 months, did not differ significantly between the ASV and the control groups. There were also no significant between-group differences for changes in left ventricular dimensions, wall thickness, diastolic function or right ventricular dimensions and ejection fraction (echocardiography), and on cMRI (in small patient numbers). Plasma N-terminal pro B-type natriuretic peptide concentration decreased in both groups, and values were similar at 12 months. There were no significant between-group differences in changes in cardiac, renal and systemic inflammation biomarkers. Conclusion In patients with systolic heart failure and CSA, addition of ASV to guideline-based medical management had no statistically significant effect on cardiac structure and function, or on cardiac biomarkers, renal function and systemic inflammation over 12 months. The increased cardiovascular mortality reported in SERVE-HF may not be related to adverse remodelling or worsening heart failure.

The Need for Psychosocial Support in Parents of Chronically Ill Children Chronic illness in childhood and adolescence is associated with special requirements and demands on affected families. In particular, severe chronic diseases and rare diseases with a high level of health care needs or with progressive medical diagnoses permanently challenge the families' resources. The aim of this study was to assess the need for psychological, nursing, legal and organisational support from a parent's perspective. Using qualitative content analysis according to Mayring, data from 96 parents of 68 chronically ill children were evaluated. The findings suggest an increased need for psychosocial support, but, the ideas, needs, and goals of parents are very versatile. However, family-based psychosocial support programs, which are adapted to the specific family situations, are unanimously judged to be useful. Interventions should be flexible as well as tailored to the affected families' individual needs.

Effects of early and permanent footwear use are not well understood. The aim of this study was to investigate the effects of habituation to footwear on foot strike patterns of children and adolescents. Healthy habitually barefoot and shod participants (aged 6–18 years) from South Africa (n=288) and Germany (n=390) performed multiple 20-m jogging and running trials with and without shoes. Each foot strike was captured using a high-speed camera to determine a rearfoot or non-rearfoot strike. The probability of a rearfoot strike in both cohorts and each age was analyzed by using a mixed-effects logistic regression adjusted for possible confounders. Habitually barefoot children showed a higher probability of using rearfoot strikes than habitually shod children (p

Objective Stepped, collaborative, and coordinated approaches have been proposed as the optimal treatment strategy for somatic symptom and related disorders, but evidence supporting this strategy is lacking. The aim of this study was to assess the effectiveness of a guideline-based health care network for patients who are at high risk of somatoform disorder (Sofu-Net). Methods In a controlled, prospective, observer-blinded cluster cohort study, patients who were at high risk of somatoform disorder were recruited at 18 primary care practices in the Sofu-Net and at 15 primary care practices that provided care as usual (CAU). The primary outcome at 6-month follow-up was the rate at which the patients received mental health treatment since the establishment of Sofu-Net. The secondary outcomes included the patients' clinical symptom severity. Results A total of 119 patients in the Sofu-Net intervention group and 100 patients in the CAU control group who were at high risk of somatoform disorder were followed for 6 months. A significantly greater proportion of Sofu-Net patients than CAU patients received mental health treatment (47.9% versus 31.0%; odds ratio = 1.96; 95% confidence interval, 1.07–3.58). However, the Sofu-Net group did not show greater reductions in clinical symptom burden compared with the CAU group. Conclusions The treatment of somatoform disorders within a guideline-based health care network resulted in increased rates of mental health treatment but failed to improve patient clinical outcomes. Future investigations are needed to investigate the combined value of health care networks with specialized psychotherapy interventions in patients at high risk of somatic symptom and related disorders. Conclusions Trial Registration: ISRCTN55870770.

Trial design Prospective randomized multicentre interventional study. Methods Individual cardiovascular risk assessment in Ford Company, Germany employees (n = 4.196), using the European Society of Cardiology-Systematic Coronary Risk Evaluation (ESC-SCORE) for classification into three risk groups. Subjects assigned to ESC high-risk group (ESC-SCORE ≥ 5%), without a history of cardiovascular disease were eligible for randomization to a multimodal 15-week intervention programme (INT) or to usual care and followed up for 36 months. Objectives Evaluation of the long-term effects of a risk-adjusted multimodal intervention in high-risk subjects. Primary endpoint: reduction of ESC-SCORE in INT versus usual care. Secondary endpoints: composite of fatal and non-fatal cardiovascular events and time to first cardiovascular event. Statistical analysis: intention-to-treat and per-protocol analysis. Results Four hundred and forty-seven subjects were randomized to INT (n = 224) or to usual care (n = 223). After 36 months ESC-SCORE development favouring INT was observed (INT: 8.70% to 10.03% vs. usual care: 8.49% to 12.09%; p = 0.005; net difference: 18.50%). Moreover, a significant reduction in the composite cardiovascular events was observed: (INT: n = 11 vs. usual care: n = 27). Hazard ratio of intervention versus control was 0.51 (95% confidence interval 0.25–1.03; p = 0.062) in the intention-to-treat analysis and 0.41 (95% confidence interval 0.18–0.90; p = 0.026) in the per-protocol analysis, respectively. No intervention-related adverse events or side-effects were observed. Conclusions Our results demonstrate the efficiency of identifying cardiovascular high-risk subjects by the ESC-SCORE in order to enrol them to a risk adjusted primary prevention programme. This strategy resulted in a significant improvement of ESC-SCORE, as well as a reduction in predefined cardiovascular endpoints in the INT within 36 months. (ISRCTN 23536103.)

AimThis non-randomized pre–post-intervention study investigated the effect of a systemic public health intervention on the length of time between anorexia nervosa symptom onset and contact with the health care system as well as the initiation of treatment.BackgroundAlthough systemic public health interventions have successfully been implemented in physical and mental health fields, their effect on the early treatment of patients with anorexia nervosa remains unclear.MethodsIn total, 59 anorexia nervosa patients (mean age=21.5 years, SD=7.2) were recruited before a systemic public health intervention, and 18 patients (mean age=22.2 years, SD=8.9) were recruited afterwards. Using validated self-report measures and a semi-structured interview, the duration of untreated anorexia nervosa and the duration until first contact with the health care system were investigated.FindingsAt the beginning of the individual treatment initiation process, participants in both samples most frequently consulted their general practitioner or paediatrician about their eating disorder-related symptoms. Neither the mean duration of untreated anorexia nervosa, that is, the time between illness onset and the initiation of a recommended treatment, nor the duration until first contact with the health care system significantly decreased after the implementation of the systemic public health intervention. The mean duration of untreated anorexia nervosa was 36.5 months (SD=68.2) before the systemic public health intervention and 40.1 months (SD=89.4) after the implementation of the systemic public health intervention. The mean duration until first contact with the health care system was 25.0 months (SD=53.0) before the intervention and 32.8 months (SD=86.5) after the intervention.ConclusionPrimary care providers are crucial to the treatment initiation process and should be involved in future interventions to improve early detection and treatment commencement amongst patients with anorexia nervosa.

The development of the human foot is crucial for motor learning in children and adolescents as it ensures the basic requirements for bipedal locomotion and stable standing. Although there is an ongoing debate of the advantages and disadvantages of early and permanent footwear use, the influence of regular barefootness on foot characteristics in different stages of child development has not been extensively evaluated. A multicenter epidemiological study was conducted to compare the foot morphology between habitually barefoot children and adolescents (N = 810) to age-, sex- and ethnicity-matched counterparts that are used to wearing shoes. While controlling for confounders, we found that habitual footwear use has significant effects on foot-related outcomes in all age groups, such as a reduction in foot arch and hallux angles. The results indicate an impact of habitual footwear use on the development of the feet of children and adolescents. Therefore, growing up barefoot or shod may play an important role for childhood foot development, implying long-term consequences for motor learning and health later in life.

BACKGROUND: Reduced left ventricular ejection fraction (LVEF) ≤30% is the most powerful prognostic indicator for sudden cardiac death (SCD) in patients after myocardial infarction (MI), but there are little data about long-term changes of LVEF after revascularization and the following implantation of a cardioverter defibrillator (ICD). METHODS: We performed a retrospective analysis of 277 patients with reduced LVEF at least 1month after MI and complete revascularization. Patients (median time post-MI 23.4months; 74.3% after PCI, 25.7% after CABG were assigned either to group 1 (LVEF, Postprints der Universität Potsdam : Mathematisch-Naturwissenschaftliche Reihe, 882

Objective Psychological distress is common in cancer patients and awareness of its indicators is essential. We aimed to assess the prevalence of psychological distress and to identify problems indicative of high distress. Methods We used the Distress Thermometer (DT) and its 34-item Problem List to measure psychological distress in 3,724 cancer patients (mean age 58 years; 57% women) across major tumor entities, enrolled in an epidemiological multicenter study. To identify distress-related problems, we conducted monothetic analyses (MONA). Results We found high levels of psychological distress (DT≥5) in 52% of patients. The most prevalent problems were fatigue (56%), sleep problems (51%), and problems getting around (47%). Sadness, fatigue and sleep problems were most strongly associated with the presence of other problems. High distress was present in 81.4% of patients reporting all three of these problems (DT M=6.4). When analyzing only the subset of physical problems, fatigue, problems getting around and indigestion showed the strongest association with the remaining problems and 76.3% of patients with all three problems were highly distressed (DT M=6.1). Conclusions Our results show a high prevalence of psychological distress in cancer patients, as well as a set of problems that indicate the likely presence of other problems and high distress and can help clinicians identify distressed patients even if no routine distress screening is available.

Objective The objective of the study was to investigate whether a combined intervention composed of early detection plus integrated care (EDIC) enhances outcomes in patients with early psychosis compared to standard care (SC). Methods ACCESS III is a prospective non-randomized historical control design 1-year study examining the efficacy of EDIC (n = 120) vs. SC (n = 105) in patients aged 12–29 years. Primary outcome was the rate of ≥6 months combined symptomatic and functional remission. Additional outcomes comprised the reduction of DUP and course of psychopathology, functioning, quality of life, and satisfaction with care. Results In observed cases, 48.9% in the EDIC and 15.2% in the SC group reached the primary endpoint. Remission was predicted by EDIC (OR = 6.8, CI: 3.15–14.53, P

Confidentiality and informed consent are important concepts enabling the sharing of sensitive data. In a paper on this topic of this issue, Williams and Pigeot (2017) discuss that these have to be balanced with openness to ensure research standards. In this opinion paper, we give some background on how the paper by Williams and Pigeot evolved, reflect on their concepts, and provide some examples of the application of these concepts in various settings relevant to biostatisticians working in health research.

Background Multi-component cardiac rehabilitation (CR) is performed to achieve an improved prognosis, superior health-related quality of life (HRQL) and occupational resumption through the management of cardiovascular risk factors, as well as improvement of physical performance and patients’ subjective health. Out of a multitude of variables gathered at CR admission and discharge, we aimed to identify predictors of returning to work (RTW) and HRQL 6 months after CR. Design Prospective observational multi-centre study, enrolment in CR between 05/2017 and 05/2018. Method Besides general data (e.g. age, sex, diagnoses), parameters of risk factor management (e.g. smoking, hypertension), physical performance (e.g. maximum exercise capacity, endurance training load, 6-min walking distance) and patient-reported outcome measures (e.g. depression, anxiety, HRQL, subjective well-being, somatic and mental health, pain, lifestyle change motivation, general self-efficacy, pension desire and self-assessment of the occupational prognosis using several questionnaires) were documented at CR admission and discharge. These variables (at both measurement times and as changes during CR) were analysed using multiple linear regression models regarding their predictive value for RTW status and HRQL (SF-12) six months after CR. Results Out of 1262 patients (54±7 years, 77% men), 864 patients (69%) returned to work. Predictors of failed RTW were primarily the desire to receive pension (OR = 0.33, 95% CI: 0.22–0.50) and negative self-assessed occupational prognosis (OR = 0.34, 95% CI: 0.24–0.48) at CR discharge, acute coronary syndrome (OR = 0.64, 95% CI: 0.47–0.88) and comorbid heart failure (OR = 0.51, 95% CI: 0.30–0.87). High educational level, stress at work and physical and mental HRQL were associated with successful RTW. HRQL was determined predominantly by patient-reported outcome measures (e.g. pension desire, self-assessed health prognosis, anxiety, physical/mental HRQL/health, stress, well-being and self-efficacy) rather than by clinical parameters or physical performance. Conclusion Patient-reported outcome measures predominantly influenced return to work and HRQL in patients with heart disease. Therefore, the multi-component CR approach focussing on psychosocial support is crucial for subjective health prognosis and occupational resumption. Trial registration The study was registered at the German Clinical Trial Registry and the International Clinical Trials Registry Platform (ICTRP) of the World Health Organization (DRKS00011418; http://www.drks.de/DRKS00011418, http://apps.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00011418).

Summary Background The Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial showed that, compared with usual care, a structured remote patient management (RPM) intervention done over 12-months reduced the percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause death. The aim of the study was to evaluate whether this clinical benefit seen for the RPM group during the initial 12 month follow-up of the TIM-HF2 trial would be sustained 1 year after stopping the RPM intervention. Methods TIM-HF2 was a prospective, randomised, multicentre trial done in 43 hospitals, 60 cardiology practices, and 87 general practitioners in Germany. Patients with heart failure, New York Heart Association functional class II or III, and who had been hospitalised for heart failure within 12 months before randomisation were randomly assigned to either the RPM intervention or usual care. At the final study visit (main trial), the RPM intervention was stopped and the 1 year extended follow-up period started, which lasted 1 year. The primary outcome was percentage of days lost due to unplanned cardiovascular hospitalisations and all-cause mortality. Analyses were done using the intention-to-treat principle. This trial is registered with ClinicalTrials.gov , number NCT01878630 . Findings Between Aug 13, 2013, and May 12, 2017, 1538 patients were enrolled (765 to the remote patient management group and 773 to the usual care group) in the main trial. 671 of 765 patients in the remote patient management group and 673 of 773 in the usual care group completed the main trial and started the extended follow-up period up to 1 year later. In the extended follow-up period, the percentage of days lost due to unplanned cardiovascular hospital admissions and all-cause mortality did not differ significantly between groups weighted mean 5·95% [95% CI 4·59–7·31] in the RPM group vs 6·64% [95% CI 5·19–8·08] in the usual care group [rate ratio 0·79; 95% CI 0·78–1·21]). However, when data from the main trial and the extended follow-up period were combined, the percentage of days lost due to unplanned cardiovascular hospitalisation or all-cause death was significantly less in patients allocated to the RPM group (382 [50%] of 765; weighted mean 9·28%; 95% CI 7·76–10·81) than in the UC group (398 [51%] of 773; 11·78%; 95% CI 10·08–13·49; ratio of weighted average 0·79; 95% CI 0·62–1·00; p=0·0486). Interpretation The positive effect of our RPM intervention on morbidity and mortality over the course of the main trial was no longer observed 1 year after stopping the RPM intervention. However, because the TIM-HF2 trial was not powered to show significance during the extended follow-up period, our results are exploratory and require further research. Funding German Federal Ministry of Education and Research.

The Hamburg City Health Study (HCHS) is a large, prospective, long-term, population-based cohort study and a unique research platform and network to obtain substantial knowledge about several important risk and prognostic factors in major chronic diseases. A random sample of 45,000 participants between 45 and 74 years of age from the general population of Hamburg, Germany, are taking part in an extensive baseline assessment at one dedicated study center. Participants undergo 13 validated and 5 novel examinations primarily targeting major organ system function and structures including extensive imaging examinations. The protocol includes validate self-reports via questionnaires regarding lifestyle and environmental conditions, dietary habits, physical condition and activity, sexual dysfunction, professional life, psychosocial context and burden, quality of life, digital media use, occupational, medical and family history as well as healthcare utilization. The assessment is completed by genomic and proteomic characterization. Beyond the identification of classical risk factors for major chronic diseases and survivorship, the core intention is to gather valid prevalence and incidence, and to develop complex models predicting health outcomes based on a multitude of examination data, imaging, biomarker, psychosocial and behavioral assessments. Participants at risk for coronary artery disease, atrial fibrillation, heart failure, stroke and dementia are invited for a visit to conduct an additional MRI examination of either heart or brain. Endpoint assessment of the overall sample will be completed through repeated follow-up examinations and surveys as well as related individual routine data from involved health and pension insurances. The study is targeting the complex relationship between biologic and psychosocial risk and resilience factors, chronic disease, health care use, survivorship and health as well as favorable and bad prognosis within a unique, large-scale long-term assessment with the perspective of further examinations after 6 years in a representative European metropolitan population. Electronic supplementary material The online version of this article (10.1007/s10654-019-00577-4) contains supplementary material, which is available to authorized users.

Background Does an intervention designed to foster patient-centered communication and shared decision making among GPs and their patients with poorly controlled type 2 diabetes mellitus reduce the level of HbA1c. Methods The DEBATE trial is a cluster-randomized controlled trial conducted in German primary care and including patients with type 2 diabetes mellitus having an HbA1c level of 8.0% (64 mmol/mol) or above at the time of recruitment. Data was measured before intervention (baseline, T0), 6–8 months (T1), 12–14 months (T2), 18–20 months (T3), and 24–26 months (T4) after baseline. Main outcome measure is the level of HbA1c. Results In both, the intervention and the control group the decline of the HbA1c level from T0 to T4 was statistically significant (− 0.67% (95% CI: − 0.80,-0.54%; p

Background Telerehabilitation can contribute to the maintenance of successful rehabilitation regardless of location and time. The aim of this study was to investigate a specific three-month interactive telerehabilitation routine regarding its effectiveness in assisting patients with physical functionality and with returning to work compared to typical aftercare. Objective The aim of the study was to investigate a specific three-month interactive telerehabilitation with regard to effectiveness in functioning and return to work compared to usual aftercare. Methods From August 2016 to December 2017, 111 patients (mean 54.9 years old; SD 6.8; 54.3% female) with hip or knee replacement were enrolled in the randomized controlled trial. At discharge from inpatient rehabilitation and after three months, their distance in the 6-minute walk test was assessed as the primary endpoint. Other functional parameters, including health related quality of life, pain, and time to return to work, were secondary endpoints. Results Patients in the intervention group performed telerehabilitation for an average of 55.0 minutes (SD 9.2) per week. Adherence was high, at over 75%, until the 7th week of the three-month intervention phase. Almost all the patients and therapists used the communication options. Both the intervention group (average difference 88.3 m; SD 57.7; P=.95) and the control group (average difference 79.6 m; SD 48.7; P=.95) increased their distance in the 6-minute-walk-test. Improvements in other functional parameters, as well as in quality of life and pain, were achieved in both groups. The higher proportion of working patients in the intervention group (64.6%; P=.01) versus the control group (46.2%) is of note. Conclusions The effect of the investigated telerehabilitation therapy in patients following knee or hip replacement was equivalent to the usual aftercare in terms of functional testing, quality of life, and pain. Since a significantly higher return-to-work rate could be achieved, this therapy might be a promising supplement to established aftercare. Trial Registration German Clinical Trials Register DRKS00010009; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010009

Objective The aim of this study was to compare the levels of anxiety and depression in cancer patients with those of the general population, to examine age and gender differences in anxiety and depression, to analyse the impact of several socio-demographic and clinical parameters on anxiety and depression, and to test the age and gender measurement invariance of the Hospital Anxiety and Depression Scale (HADS). Methods A sample of 3,785 German patients with cancer and a sample of 2,747 people of the German general population were examined using the HADS. Results Patients with cancer were more anxious but slightly less depressed than age- and gender-matched individuals of the general population. Young patients with cancer were particularly affected by anxiety. Measurement invariance across gender and age could be established. For all analysed clinical variables, including tumour site, tumour stage, metastases, setting and Eastern Cooperative Oncology Group (ECOG) performance status we found no significant interaction effects with gender that exceeded the 5% significance criterion. Conclusion The HADS provides fair comparisons between age and gender groups. Gender differences in anxiety and depression can be generalised across the cancer sites and clinical subgroups. Young patients with cancer deserve special attention by the healthcare system.

Healthcare for mental disorders is a big challenge for the German healthcare system. In cases of comorbid mental diseases, patients suffer from an especially high burden of disease. So far, innovative care models for collaborative and stepped care have only been investigated with respect to their effectiveness for single mental disorders.The project "Collaborative and Stepped Care in Mental Health by Overcoming Treatment Sector Barriers" (COMET), which is being carried out by the Hamburg Network for Health Services Research (HAM-NET) from 2017 until 2020, examines an innovative, guideline-based healthcare model for the improvement of healthcare for patients with mental illnesses and their potential comorbidities. In this article this new stepped and collaborative care model for patients in primary care that integrates general practitioners, psychiatrists, psychotherapists, and hospitals is presented. For the implementation and facilitation of the model, guideline-based treatment pathways, a tablet-based computer program for screening, diagnostic and guideline-based treatment recommendations, as well as a web-based transferal platform were developed.The results of this project on the effectiveness and efficacy of the model can help determine if the model can be implemented in routine healthcare. This could represent a major step towards more integrated and cross-sectoral healthcare for patients with mental illnesses.

Recent innovations have the potential to improve rhythm control therapy in patients with atrial fibrillation (AF). Controlled trials provide new evidence on the effectiveness and safety of rhythm control therapy, particularly in patients with AF and heart failure. This review summarizes evidence supporting the use of rhythm control therapy in patients with AF for different outcomes, discusses implications for indications, and highlights remaining clinical gaps in evidence. Rhythm control therapy improves symptoms and quality of life in patients with symptomatic AF and can be safely delivered in elderly patients with comorbidities (mean age 70 years, 3–7% complications at 1 year). Atrial fibrillation ablation maintains sinus rhythm more effectively than antiarrhythmic drug therapy, but recurrent AF remains common, highlighting the need for better patient selection (precision medicine). Antiarrhythmic drugs remain effective after AF ablation, underpinning the synergistic mechanisms of action of AF ablation and antiarrhythmic drugs. Atrial fibrillation ablation appears to improve left ventricular function in a subset of patients with AF and heart failure. Data on the prognostic effect of rhythm control therapy are heterogeneous without a clear signal for either benefit or harm. Rhythm control therapy has acceptable safety and improves quality of life in patients with symptomatic AF, including in elderly populations with stroke risk factors. There is a clinical need to better stratify patients for rhythm control therapy. Further studies are needed to determine whether rhythm control therapy, and particularly AF ablation, improves left ventricular function and reduces AF-related complications.

OBJECTIVE In order to optimize psycho-oncologic care for patients with severe stressor-related symptomatology, we aimed to provide (a) valid and generalizable prevalence rates of posttraumatic stress disorder (PTSD) in oncological patients and (b) the percentage of PTSD cases elicited by cancer-related events. METHODS This multi-center study was based on a representative sample of patients across cancer types. A diagnostic interview (CIDI-O) was used to assess PTSD according to DSM-IV. We first describe type and frequency of potentially traumatic events (A1-events) and the degree to which they meet the trauma criteria (A2-events). Subsequently, we present adjusted prevalence rates of PTSD and explore the proportion of patients with cancer-related PTSD. RESULTS Four thousand twenty patients participated (response rate: 68 %), and 2141 completed the diagnostic interview; 1641 patients reported at least one A1-event, of whom 16% (n = 257) reported cancer-related events. Ninety-one percent (n = 232) of theses cancer-related events qualified as A2-events. Across cancer types, the adjusted 4-week prevalence of PTSD was 2.0% (95% CI, 1.5-2.7); 9% (n = 5) of the 4-week PTSD cases were cancer-related. CONCLUSIONS Across cancer types and treatment settings, few cancer patients fulfilled diagnostic criteria for PTSD. Of those, a mere fraction was attributable to cancer-related events. These robust findings should be taken into account in both research and practice to develop and provide adequate care for cancer patients with severe stressor-related symptomatology.

Guidelines recommend stepped and collaborative care models (SCM) for depression. We aimed to evaluate the effectiveness of a complex guideline-based SCM for depressed patients. German primary care units were cluster-randomised into intervention (IG) or control group (CG) (3:1 ratio). Adult routine care patients with PHQ-9 ≥ 5 points could participate and received SCM in IG and treatment as usual (TAU) in CG. Primary outcome was change in PHQ-9 from baseline to 12 months (hypothesis: greater reduction in IG). A linear mixed model was calculated with group as fixed effect and practice as random effect, controlling for baseline PHQ-9 (intention-to-treat). 36 primary care units were randomised to IG and 13 to CG. 36 psychotherapists, 6 psychiatrists and 7 clinics participated in SCM. 737 patients were included (IG: n = 569 vs. CG: n = 168); data were available for 60% (IG) and 64% (CG) after 12 months. IG showed 2.4 points greater reduction [95% confidence interval (CI): −3.4 to −1.5, p

(1) Background: Health-related quality of life (HRQoL) is frequently reduced in children of parents with a mental illness (COPMI). Child self- and parent proxy-ratings vary with raters&rsquo, characteristics and facets of HRQoL. This study aimed at analyzing risk and protective factors associated with HRQoL in COPMI, and at examining the magnitude, direction, and predictors of child&ndash, parent agreement. (2) Methods: Analyses were based on baseline data of the German CHIMPS (children of parents with a mental illness) project with n = 134 parents diagnosed with mental illness and n = 198 children and adolescents aged 8 to 18 years. (3) Results: Both children and parents reported significantly lower HRQoL than the reference population, particularly for the child&rsquo, s physical and psychological well-being. Parents&rsquo, proxy-report indicated a lower HRQoL than the children&rsquo, s self-report. Child and parental psychopathology, social support, and the child&rsquo, s age significantly predicted HRQoL. Interrater agreement was satisfactory and better for observable aspects like physical well-being and school environment. The child&rsquo, s gender-identity and mental health significantly predicted child&ndash, parent agreement. (4) Conclusions: Parental psychopathology significantly reduces children&rsquo, s HRQoL. Interventions should promote resilience in children by targeting risk and protective factors. Child&ndash, parent agreement emphasizes the need to obtain both self- and proxy-reports, whenever possible.

Background In the last decade, transcatheter aortic valve implantation has become a promising treatment modality for patients with aortic stenosis and a high surgical risk. Little is known about influencing factors of function and quality of life during multicomponent cardiac rehabilitation. Methods From October 2013 to July 2015, patients with elective transcatheter aortic valve implantation and a subsequent inpatient cardiac rehabilitation were enrolled in the prospective cohort multicentre study. Frailty-Index (including cognition, nutrition, autonomy and mobility), Short Form-12 (SF-12), six-minute walk distance (6MWD) and maximum work load in bicycle ergometry were performed at admission and discharge of cardiac rehabilitation. The relation between patient characteristics and improvements in 6MWD, maximum work load or SF-12 scales were studied univariately and multivariately using regression models. Results One hundred and thirty-six patients (80.6 ± 5.0 years, 47.8% male) were enrolled. 6MWD and maximum work load increased by 56.3 ± 65.3 m ( p 0.001) and 8.0 ± 14.9 watts ( p 0.001), respectively. An improvement in SF-12 (physical 2.5 ± 8.7, p = 0.001, mental 3.4 ± 10.2, p = 0.003) could be observed. In multivariate analysis, age and higher education were significantly associated with a reduced 6MWD, whereas cognition and obesity showed a positive predictive value. Higher cognition, nutrition and autonomy positively influenced the physical scale of SF-12. Additionally, the baseline values of SF-12 had an inverse impact on the change during cardiac rehabilitation. Conclusions Cardiac rehabilitation can improve functional capacity as well as quality of life and reduce frailty in patients after transcatheter aortic valve implantation. An individually tailored therapy with special consideration of cognition and nutrition is needed to maintain autonomy and empower octogenarians in coping with challenges of everyday life.

Aim The Integrated Care in Early Psychosis (ACCESS III) Study examined the efficacy and cost-effectiveness of a combined intervention consisting of strategies to improve early detection and quality of care (integrated care including therapeutic assertive community treatment) in adolescents and young adults in the early phase of a severe psychotic disorder from 2011 to 2014. Methods This is a prospective, single-centre, 1-year cohort study comparing an intervention condition (early detection plus integrated care, n = 120) to the historical control condition (standard care, SC, n = 105) for adolescents and young adults aged 12–29 years suffering from a severe, early-phase psychotic disorder (i.e. within 2 years of treatment). Results Primary outcome is the rate of combined symptomatic (i.e. Positive and Negative Syndrome Scale (PANSS) criteria) and functional (i.e. Global Assessment of Functioning scale (GAF) ≥ 60 points criterion) remission over at least 6 months at study endpoint. Secondary outcome comprises the comparison of the reduction in the duration of untreated psychosis within the 4-year study duration between integrated care and SC, course of psychopathology, functioning, quality of life, satisfaction with care, cost and quality-adjusted life years (QALYs) in comparison to a historical control group. Conclusion To the authors’ knowledge, this is the first study assessing the efficacy and cost-effectiveness of a combined intervention consisting of early detection strategies and strategies to improve quality of care in both adolescents and young adults with early-phase psychosis. The results will be published in 2016.

RATIONALE: Obstructive sleep apnea (OSA) is common in patients with coronary artery disease (CAD), many of whom do not report daytime sleepiness. First-line treatment for symptomatic OSA is continu ...

Objective Although one-third of cancer patients are perceived to have a need for psychological support based on the percentage of mental disorders, little is known about the actual utilization of psychological care in cancer. We aimed to assess cancer patients' reported use of psychological care and its correlates in a large, representative sample. Methods In a multicenter, cross-sectional study in Germany, 4020 cancer patients (mean age 58 years, 51% women) were evaluated. We obtained self-reports of use of psychotherapy and psychological counseling. We measured distress with the Distress Thermometer, symptoms of depression with the Patient Health Questionnaire, anxiety with the Generalized Anxiety Disorder Scale, and social support with the Illness-specific Social Support Scale. In a subsample of 2141, we evaluated the presence of a mental disorder using the Composite International Diagnostic Interview. Results In total, 28.9% (95% confidence interval 27.4%-30.4%) reported having used psychotherapy or psychological counseling or both because of distress due to cancer. Independent correlates of utilization included age (odds ratio [OR] = 0.97 per year], sex (male, OR = 0.55), social support (OR = 0.96), symptoms of depression (OR = 1.04) and anxiety (OR = 1.08), the diagnosis of a mental disorder (OR = 1.68), and a positive attitude toward psychosocial support (OR = 1.27). Less than half of those currently diagnosed with a mental disorder reported having taken up psychological support offers. Conclusion Special efforts should be made to reach populations that report low utilization of psychological care in spite of having a need for support.

Articular cartilage calcification is considered a pathological albeit incompletely understood process which is known to be associated with osteoarthritis of the knee and hip. The goal of this study was to determine the prevalence of articular cartilage calcification of the shoulder as a non-weight-bearing joint and to analyze the interrelationship of calcification with age and histological severity of shoulder osteoarthritis in the general population. In a cross-sectional study of 180 humeral heads from 90 donors (n = 49 male, n = 41 female; mean age 62.7 years [20-93]), cartilage calcification of the humeral head was quantified by digital contact radiography (DCR). Histological OA grade (OARSI) was determined and structural equation modeling (SEM) was used to analyze the interrelationship of cartilage calcification, OARSI and age. The prevalence of articular cartilage calcification was 98.9% (95%CI: [93.96%, 99.97%]) and was independent of gender (p = 0.55). Cartilage calcification of one shoulder correlated significantly with that of the contralateral side (r = 0.61, 95%CI: [0.46, 0.73], p

Objectives This prospective study investigated the prevalence of sleep-disordered breathing (SDB) and its predictors in patients with stable chronic heart failure (HF). Background SDB is increasingly recognized as being important in patients with HF. Methods The multicenter SchlaHF (Sleep-Disordered Breathing in Heart Failure) registry provides demographic and clinical data on chronic, stable, symptomatic patients with HF (New York Heart Association functional class ≥II; left ventricular rejection fraction ≤45%). Moderate-to-severe SDB (apnea-hypopnea index ≥15/h) was determined by a 2-channel screening device (ApneaLink, ResMed, Sydney, Australia). Results Data from 6,876 patients were analyzed. The prevalence of moderate-to-severe SDB was 46%, with a significant sex difference: 36% in women (n = 1,448) versus 49% in men (n = 5,428). Prevalence of SDB rose with increasing age (31%, 39%, 45%, 52%, and 59% in those age ≤50, >50 to 60, >60 to 70, >70 to 80, and >80 years, respectively). Risk factors for SDB were body mass index (per 5 units; odds ratio [OR]: 1.29; 95% confidence interval [CI]: 1.22 to 1.36), left ventricular rejection fraction (per 5% decrement from 45%; OR: 1.10; 95% CI: 1.06 to 1.14), age (per 10-year difference to 60 years; OR: 1.41; 95% CI: 1.34 to 1.49), atrial fibrillation (OR: 1.19; 95% CI: 1.06 to 1.34), and male sex (OR: 1.90; 95% CI: 1.67 to 2.17). Conclusions SchlaHF registry data demonstrate a high prevalence of SDB in a representative population of stable patients with chronic HF receiving contemporary medical management. Male sex, age, body mass index, and the severity of both symptoms and left ventricular dysfunction were clinical predictors for prevalent SDB. (Prevalence, Clinical Characteristics and Type of Sleep-disordered Breathing in Patients With Chronic, Symptomatic, Systolic Heart Failure; NCT01500759)

In May/June 2011, the new Shiga-like toxin-producing Escherichia coli (STEC) strain O104:H4 caused the severest outbreak ever recorded of hemorrhagic enterocolitis in 3842 patients in Germany.As bacterial enterocolitis is an established risk factor of subsequent irritable bowel syndrome (IBS), we aimed to estimate prevalence and incidence of post-infectious (PI)-IBS after six and 12 months in a cohort of STEC O104:H4 patients and to prospectively identify associated somatic and psychometric risk factors.A total of 389 patients were studied prospectively at baseline and at six and 12 months after STEC infection using STEC disease-related questionnaires and validated instruments for IBS (Rome III) and psychological factors. Frequencies and logistic regression models using multiple imputations were applied to assess predictor variables.Prevalence of IBS increased from 9.8% prior to STEC infection to 23.6% at six and 25.3% at 12 months after STEC infection. In patients without IBS symptoms prior to STEC infection, incidence of new IBS was 16.9%. Logistic regression models indicated higher somatization and anxiety scores as risk factors for, and mesalazine treatment during, STEC infection as the only significant protective factor against IBS. No other factor analyzed, including disease severity, showed an association.PI-IBS rates following this unusually severe STEC outbreak were similar to what has been observed after other infectious gastroenteritis outbreaks. Our findings suggest that mesalazine may have reduced the risk of subsequent PI-IBS. As altered mucosal immune activity is a pivotal pathogenic factor in PI-IBS, our observation of a potential protective effect of mesalazine might be explained by its known modulatory action on mucosal immunity, and may warrant further investigation.

Background The aim of the study was to determine pre-interventional predictors for all-cause mortality in patients after transcatheter aortic valve implantation (TAVI) with a 12-month follow-up. Methods From 10/2013 to 07/2015, 344 patients (80.9 ± 5.0 years, 44.5% male) with an elective TAVI were consecutively enrolled prospectively in a multicentre cohort study. Prior to the intervention, sociodemographic parameters, echocardiographic data and comorbidities were documented. All patients performed a 6-min walk test, Short Form 12 and a Frailty Index (score consisting of activities of daily living, cognition, nutrition and mobility). Peri-interventional complications were documented. Vital status was assessed over telephone 12 months after TAVI. Predictors for all-cause mortality were identified using a multivariate regression model. Results At discharge, 333 patients were alive (in-hospital mortality 3.2%; n = 11). During a follow-up of 381.0 ± 41.9 days, 46 patients (13.8%) died. The non-survivors were older (82.3 ± 5.0 vs. 80.6 ± 5.1 years; p = 0.035), had a higher number of comorbidities (2.6 ± 1.3 vs. 2.1 ± 1.3; p = 0.026) and a lower left ventricular ejection fraction (51.0 ± 13.6 vs. 54.6 ± 10.6%; p = 0.048). Additionally, more suffered from diabetes mellitus (60.9 vs. 44.6%; p = 0.040). While the global Frailty Index had no predictive power, its individual components, particularly nutrition (OR 0.83 per 1 pt., CI 0.72–0.95; p = 0.006) and mobility (OR 5.12, CI 1.64–16.01; p = 0.005) had a prognostic impact. Likewise, diabetes mellitus (OR 2.18, CI 1.10–4.32; p = 0.026) and EuroSCORE (OR 1.21 per 5%, CI 1.07–1.36; p = 0.002) were associated with a higher risk of all-cause mortality. Conclusions Besides EuroSCORE and diabetes mellitus, nutrition status and mobility of patients scheduled for TAVI offer prognostic information for 1-year all-cause mortality and should be advocated in the creation of contemporary TAVI risk scores.

BACKGROUND AND OBJECTIVE Increases in Cheyne-Stokes respiration (CSR) cycle length (CL), lung-to-periphery circulation time (LPCT) and time to peak flow (TTPF) may reflect impaired cardiac function. This retrospective analysis used an automatic algorithm to evaluate baseline CSR-related features and then determined whether these could be used to identify patients with systolic heart failure (HF) who experienced serious adverse events in the Treatment of Sleep-Disordered Breathing with Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients with Heart Failure (SERVE-HF) substudy. METHODS A total of 280 patients had overnight diagnostic polysomnography data available; an automated algorithm was applied to quantify CSR-related features. RESULTS Median baseline CL, LPCT and TTPF were similar in the control (n = 152) and adaptive servo-ventilation (ASV, n = 156) groups. In both groups, CSR-related features were significantly longer in patients who did (n = 129) versus did not (n = 140) experience a primary endpoint event (all-cause death, life-saving cardiovascular intervention or unplanned hospitalization for worsening HF): CL, 61.1 versus 55.1 s (P = 0.002); LPCT, 36.5 versus 31.5 s (P