Lifestyle intervention reduces risk score for cardiovascular mortality in company employees with pre-diabetes or diabetes mellitus - A secondary analysis of the PreFord randomized controlled trial with 3 years of follow-up.

Aim: To evaluate the effects of a multimodal intervention (including exercise training, psychosocial interventions, nutrition coaching, smoking cessation program, medical care) on the health and long-term cardiovascular disease (CVD) mortality risk of company employees with pre-diabetes or diabetes mellitus (DM) at high CVD risk. Methods: In the PreFord study, German company employees (n=4196) participated in a free-of-charge CVD mortality risk screening at their workplace. Based on their European Society of Cardiology - Systematic Coronary Risk Evaluation score (ESC-SCORE), they were subdivided into three risk groups. High-risk patients (ESC-SCORE≥5%) were randomly assigned to a 15-week lifestyle intervention or usual care control group. Data from patients with pre-DM/DM were analyzed intention-to-treat (ITT: n=110 versus n=96) and per protocol (PP: n=60 versus n=52). Results: Body mass index, glycated hemoglobin, total cholesterol, low-density lipoprotein, triglyceride levels as well as systolic and diastolic blood pressure improved through the intervention (ITT, PP: p<0.001). The ESC-SCORE markedly decreased from pre- to post-intervention (ITT, PP: p<0.001). ESC-SCORE changes from baseline differed significantly between the groups, with the intervention group achieving more favorable results in all follow-up visits 6, 12, 24 and 36 months later (at each time point: ITT: p<0.001; PP: p ≤ 0.010). Conclusion: The study demonstrates the feasibility of attracting employees with pre-DM/DM at high CVD mortality risk to participate in a multimodal lifestyle program following a free CVD mortality risk screening at their workplace. The lifestyle intervention used in the PreFord study shows high potential for improving health of company employees with pre-DM/DM in the long term. ISRCTN23536103.

Typology of drug discontinuation trials - Methodological recommendations.

OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation. STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels. RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type. CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

Risk and associated factors of depression and anxiety in men with prostate cancer: Results from a German multicenter study.

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.

Patient-reported outcomes predict return to work and health-related quality of life six months after cardiac rehabilitation: Results from a German multi-centre registry (OutCaRe).

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).

Cancer patients' preferred and perceived level of involvement in treatment decision-making: an epidemiological study.

Background: We aimed to analyze preferred and perceived levels of patients' involvement in treatment decision-making in a representative sample of cancer patients.Material and Methods: We conducted a multicenter, epidemiological cross-sectional study with a stratified random sample based on the incidence of cancer diagnoses in Germany. Data were collected between January 2008 and December 2010. Analyses were undertaken between 2017 and 2019. We included 5889 adult cancer patients across all cancer entities and disease stages from 30 acute care hospitals, outpatient facilities, and cancer rehabilitation clinics in five regions in Germany. We used the Control Preferences Scale to assess the preferred level of involvement and the nine-item Shared Decision-Making Questionnaire to assess the perceived level of involvement.Results: About 4020 patients (mean age of 58 years, 51% female) completed the survey. Response rate was 68.3%. About a third each preferred patient-led, shared, or physician-led decision-making. About 50.7% perceived high levels, about a quarter each reported moderate (26.0%) or low (24.3%) levels of shared decision-making. Sex, age, relationship status, education, health care setting, and tumor entity were linked to preferred and/or perceived decision-making. Of those patients who preferred active involvement, about 50% perceived high levels of shared decision-making.Conclusion: The majority of patients with cancer wanted to be involved in medical decisions. Many patients perceived a high level of shared decision-making. However, many patients' level of involvement did not fit their preference. This study provides a solid basis for efforts to improve shared decision-making in German cancer care.

Biomarkers in patients with heart failure and central sleep apnoea: findings from the SERVE-HF trial.

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).

Age and gender differences in anxiety and depression in cancer patients compared with the general population.

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.

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.

AIMS: To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF). METHODS AND RESULTS: Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations. CONCLUSIONS: The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

Determinants of Return to Work After Multicomponent Cardiac Rehabilitation.

OBJECTIVES: To explore predictors of return to work in patients after acute coronary syndrome and coronary artery bypass grafting, taking into account cognitive performance, depression, physical capacity, and self-assessment of the occupational prognosis. DESIGN: Observational, prospective, bicentric. SETTING: Postacute 3-week inpatient cardiac rehabilitation (CR). PARTICIPANTS: Patients (N=401) <65 years of age (mean 54.5±6.3y), 80% men. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Status of return to work (RTW) 6 months after discharge from CR. RESULTS: The regression model for RTW showed negative associations for depression (odds ratio 0.52 per SD, 95% confidence interval 0.36-0.76, P=.001), age (odds ratio 0.72, 95% confidence interval 0.52-1.00, P=.047), and in particular for a negative subjective occupational prognosis (expected incapacity for work odds ratio 0.19, 95% confidence interval 0.06-0.59, P=.004; unemployment odds ratio 0.08, 95% confidence interval 0.01-0.72, P=.024; retirement odds ratio 0.07, 95% confidence interval 0.01-0.067, P=.021). Positive predictors were employment before the cardiac event (odds ratio 9.66, 95% confidence interval 3.10-30.12, P<.001), capacity to work (fit vs unfit) at discharge from CR (odds ratio 3.15, 95% confidence interval 1.35-7.35, P=.008), and maximum exercise capacity (odds ratio 1.49, 95% confidence interval 1.06-2.11, P=.022). Cognitive performance had no effect. CONCLUSIONS: The patient's perception and expectation regarding the occupational prognosis play a crucial role in predicting return to work 6 months after an acute cardiac event and CR. These findings highlight the importance of the multimodal approach, in particular psychosocial components, of CR.

Posttraumatic stress disorder among cancer patients-Findings from a large and representative interview-based study in Germany.

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.

Impact of cognitive performance on disease-related knowledge six months after multi-component rehabilitation in patients after an acute cardiac event.

BACKGROUND: Although associations between cardiovascular diseases and cognitive impairment are well known, the impact of cognitive performance on the success of patient education as a core component of cardiac rehabilitation remains insufficiently investigated so far. DESIGN: Prospective observational study in two inpatient cardiac rehabilitation centres between September 2014 and August 2015 with a follow-up six months after cardiac rehabilitation. METHOD: At admission to and discharge from cardiac rehabilitation, the cognitive performance of 401 patients (54.5 ± 6.3 years, 80% men) following an acute coronary syndrome and/or coronary artery bypass graft was tested using the Montreal Cognitive Assessment. Patients' disease-related knowledge was determined using a quiz (22 items for medical knowledge and 12 items for healthy lifestyle and behaviour) at both times and at follow-up. The change in knowledge after cardiac rehabilitation was analysed in multivariable regression models. Potentially influencing parameters (e.g. level of education, medication, cardiovascular risk factors, coronary artery bypass graft, comorbidities, exercise capacity) were considered. RESULTS: During cardiac rehabilitation, disease-related knowledge was significantly enhanced in both scales. At follow-up, the average level of medical knowledge was significantly reduced, while lifestyle knowledge remained at a stable level. The maintenance of knowledge after cardiac rehabilitation was predominantly predicted by prior knowledge, cognitive performance at discharge from cardiac rehabilitation and, in the case of medical knowledge, by coronary artery bypass graft. CONCLUSION: Patient education in cardiac rehabilitation led to enhanced disease-related knowledge, but the maintenance of this essentially depended on patients' cognitive performance, especially after coronary artery bypass graft. Therefore, patient education concepts in cardiac rehabilitation should be reconsidered and adjusted as needed.

Risk of Malignancy in Adenomas Detected During Screening Colonoscopy.

BACKGROUND & AIMS: 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. METHODS: 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. RESULTS: 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 vs <1 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). CONCLUSIONS: 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.

Quality of life in cancer patients-a comparison of inpatient, outpatient, and rehabilitation settings.

PURPOSE: 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. METHODS: A sample of 4020 German cancer patients (1735 inpatients, 1324 outpatients, 961 participants in rehabilitation treatment) was tested with the EORTC QLQ-C30. RESULTS: 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. CONCLUSION: 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.

The Generalized Anxiety Disorder Screener (GAD-7) and the anxiety module of the Hospital and Depression Scale (HADS-A) as screening tools for generalized anxiety disorder among cancer patients.

OBJECTIVE: Anxiety in cancer patients may represent a normal psychological reaction. To detect patients with pathological levels, appropriate screeners with established cut-offs are needed. Given that previous research is sparse, we investigated the diagnostic accuracy of 2 frequently used screening tools in detecting generalized anxiety disorder (GAD). METHODS: We used data of a multicenter study including 2141 cancer patients. Diagnostic accuracy was investigated for the Generalized Anxiety Disorder Screener (GAD-7) and the anxiety module of the Hospital Anxiety and Depression Scale (HADS-A). GAD, assessed with the Composite International Diagnostic Interview for Oncology, served as a reference standard. Overall accuracy was measured with the area under the receiver operating characteristics curve (AUC). The AUC of the 2 screeners were statistically compared. We also calculated accuracy measures for selected cut-offs. RESULTS: Diagnostic accuracy could be interpreted as adequate for both screeners, with an identical AUC of .81 (95% CI: .79-.82). Consequently, the 2 screeners did not differ in their performance (P = .86). The best balance between sensitivity and specificity was found for cut-offs ≥7 (GAD-7) and ≥8 (HADS-A). The officially recommended thresholds for the GAD-7 (≥ 10) and the HADS-A (≥11) showed low sensitivities of 55% and 48%, respectively. CONCLUSIONS: The GAD-7 and HADS-A showed AUC of adequate diagnostic accuracy and hence are applicable for GAD screening in cancer patients. Nevertheless, the choice of optimal cut-offs should be carefully evaluated.

Return to work in heart failure patients with suspected viral myocarditis.

BACKGROUND: Endomyocardial biopsy is considered as the gold standard in patients with suspected myocarditis. We aimed to evaluate the impact of bioptic findings on prediction of successful return to work. METHODS: In 1153 patients (48.9 ± 12.4 years, 66.2% male), who were hospitalized due to symptoms of left heart failure between 2005 and 2012, an endomyocardial biopsy was performed. Routine clinical and laboratory data, sociodemographic parameters, and noninvasive and invasive cardiac variables including endomyocardial biopsy were registered. Data were linked with return to work data from the German statutory pension insurance program and analyzed by Cox regression. RESULTS: A total of 220 patients had a complete data set of hospital and insurance information. Three quarters of patients were virus-positive (54.2% parvovirus B19, other or mixed infection 16.7%). Mean invasive left ventricular ejection fraction was 47.1% ± 18.6% (left ventricular ejection fraction <45% in 46.3%). Return to work was achieved after a mean interval of 168.8 ± 347.7 days in 220 patients (after 6, 12, and 24 months in 61.3%, 72.2%, and 76.4%). In multivariate regression analysis, only age (per 10 years, hazard ratio, 1.27; 95% confidence interval, 1.10-1.46; p = 0.001) and left ventricular ejection fraction (per 5% increase, hazard ratio, 1.07; 95% confidence interval, 1.03-1.12; p = 0.002) were associated with increased, elevated work intensity (heavy vs light, congestive heart failure, 0.58; 95% confidence interval, 0.34-0.99; p < 0.049) with decreased probability of return to work. None of the endomyocardial biopsy-derived parameters was significantly associated with return to work in the total group as well as in the subgroup of patients with biopsy-proven myocarditis. CONCLUSION: Added to established predictors, bioptic data demonstrated no additional impact for return to work probability. Thus, socio-medical evaluation of patients with suspected myocarditis furthermore remains an individually oriented process based primarily on clinical and functional parameters.

Unmet needs for information and psychosocial support in relation to quality of life and emotional distress: A comparison between gynecological and breast cancer patients.

OBJECTIVE: We compared gynecological and breast cancer patients regarding their needs for information and psychosocial support, quality of life (QoL), and emotional distress and the relationship among these constructs. METHODS: In a multicenter, cross-sectional study in Germany, we evaluated 1214 female cancer patients (317 with gynecological cancer, 897 with breast cancer). We obtained self-reports of unmet needs, using a self-developed measure. We measured QoL with the EORTC QLQ-C30, symptoms of depression with the Patient Health Questionnaire (PHQ-9), and symptoms of anxiety with the Generalized Anxiety Disorder Scale (GAD-7). RESULTS: Compared to breast cancer patients, gynecological cancer patients felt less informed about several aspects of their disease, particularly regarding psychological support (p<0.001), tended to have more unmet information needs, and reported lower QoL levels. Lower emotional functioning, but higher physical functioning were independent correlates of the level of unmet information needs. Depressive symptoms and higher physical functioning (only in breast cancer) were independent correlates of higher needs for psychosocial support. CONCLUSION: Compared to breast cancer, gynecological cancer patients were less satisfied with the information received and reported lower levels of QoL. PRACTICE IMPLICATIONS: Both clinicians and policy makers should take efforts to address the higher needs of gynecological cancer patients.

The Hospital Anxiety and Depression Scale (HADS) and the 9-item Patient Health Questionnaire (PHQ-9) as screening instruments for depression in patients with cancer.

BACKGROUND: Depression screening in patients with cancer is recommended by major clinical guidelines, although the evidence on individual screening tools is limited for this population. Here, the authors assess and compare the diagnostic accuracy of 2 established screening instruments: the depression modules of the 9-item Patient Health Questionnaire (PHQ-9) and the Hospital Anxiety and Depression Scale (HADS-D), in a representative sample of patients with cancer. METHODS: This multicenter study was conducted with a proportional, stratified, random sample of 2141 patients with cancer across all major tumor sites and treatment settings. The PHQ-9 and HADS-D were assessed and compared in terms of diagnostic accuracy and receiver operating characteristic (ROC) curves for Diagnostic and Statistical Manual of Mental Disorders, 4th edition diagnosis of major depressive disorder using the Composite International Diagnostic Interview for Oncology as the criterion standard. RESULTS: The diagnostic accuracy of the PHQ-9 and HADS-D was fair for diagnosing major depressive disorder, with areas under the ROC curves of 0.78 (95% confidence interval, 0.76-0.79) and 0.75 (95% confidence interval, 0.74-0.77), respectively. The 2 questionnaires did not differ significantly in their areas under the ROC curves (P = .15). The PHQ-9 with a cutoff score ≥7 had the best screening performance, with a sensitivity of 83% (95% confidence interval, 78%-89%) and a specificity of 61% (95% confidence interval, 59%-63%). The American Society of Clinical Oncology guideline screening algorithm had a sensitivity of 44% (95% confidence interval, 36%-51%) and a specificity of 84% (95% confidence interval, 83%-85%). CONCLUSIONS: In patients with cancer, the screening performance of both the PHQ-9 and the HADS-D was limited compared with a standardized diagnostic interview. Costs and benefits of routinely screening all patients with cancer should be weighed carefully. Cancer 2017;123:4236-4243. © 2017 American Cancer Society.

Two-year outcome and risk factors for mortality in patients with coronary artery disease and renal failure: The prospective, observational CAD-REF Registry.

BACKGROUND: Chronic kidney disease (CKD) and coronary artery disease (CAD) are strongly associated. CAD is the most frequent cause of cardiovascular death in patients with CKD. METHODS: The prospective observational nationwide multicenter Coronary Artery Disease and REnal Failure (CAD-REF) Registry enrolled 3352 patients with angiographically documented CAD classified according to their baseline estimated glomerular filtration rate (eGFR) into 5 groups according to the K/DOQI-guidelines. Patients were followed for two years. The aim of this study was the analysis of outcome and the identification of risk factors for two-year mortality in patients with both CKD and CAD. RESULTS: With decreasing renal function, patients had more often diabetes mellitus, hypertension, peripheral artery disease, and previous cardiovascular events and interventions. The amount of diseased vessels increased with decreasing renal function. For the whole cohort, two-year mortality was 6.5%. Kaplan-Meier-curves showed highest mortality in patients with CKD stages 4 and 5 (22.4%). In multivariate Cox-regression analyses, significant risk factors for two-year all-cause mortality were lower eGFR, current smoking, left ventricular ejection fraction, diabetes mellitus treated with oral medication or insulin, age, and peripheral artery disease. Coronary status missed the level of statistical significance as a risk factor for mortality in multivariable regression analysis. An eGFR reduction of 10ml/min/1.73m2 increased the risk of mortality by 19% regardless of other risk factors. CONCLUSIONS: Two-year morbidity and mortality increased with the degree of renal impairment. To improve survival of patients with CAD and CKD, nephroprotection is urgently needed especially for patients with atherosclerotic burden. CLINICAL TRIAL REGISTRATION NUMBER: NCT00679419, http://clinicaltrials.gov/.

Prevalence of mild cognitive impairment in employable patients after acute coronary event in cardiac rehabilitation.

INTRODUCTION: Adequate cognitive function in patients is a prerequisite for successful implementation of patient education and lifestyle coping in comprehensive cardiac rehabilitation (CR) programs. Although the association between cardiovascular diseases and cognitive impairments (CIs) is well known, the prevalence particularly of mild CI in CR and the characteristics of affected patients have been insufficiently investigated so far. METHODS: In this prospective observational study, 496 patients (54.5 ± 6.2 years, 79.8% men) with coronary artery disease following an acute coronary event (ACE) were analyzed. Patients were enrolled within 14 days of discharge from the hospital in a 3-week inpatient CR program. Patients were tested for CI using the Montreal Cognitive Assessment (MoCA) upon admission to and discharge from CR. Additionally, sociodemographic, clinical, and physiological variables were documented. The data were analyzed descriptively and in a multivariate stepwise backward elimination regression model with respect to CI. RESULTS: At admission to CR, the CI (MoCA score < 26) was determined in 182 patients (36.7%). Significant differences between CI and no CI groups were identified, and CI group was associated with high prevalence of smoking (65.9 vs 56.7%, P = 0.046), heavy (physically demanding) workloads (26.4 vs 17.8%, P < 0.001), sick leave longer than 1 month prior to CR (28.6 vs 18.5%, P = 0.026), reduced exercise capacity (102.5 vs 118.8 W, P = 0.006), and a shorter 6-min walking distance (401.7 vs 421.3 m, P = 0.021) compared to no CI group. The age- and education-adjusted model showed positive associations with CI only for sick leave more than 1 month prior to ACE (odds ratio [OR] 1.673, 95% confidence interval 1.07-2.79; P = 0.03) and heavy workloads (OR 2.18, 95% confidence interval 1.42-3.36; P < 0.01). CONCLUSION: The prevalence of CI in CR was considerably high, affecting more than one-third of cardiac patients. Besides age and education level, CI was associated with heavy workloads and a longer sick leave before ACE.