Hermann Faller

Four-Week Prevalence of Mental Disorders in Patients With Cancer Across Major Tumor Entities

PURPOSE To provide the 4-week prevalence estimates of mental disorders in cancer populations. PATIENTS AND METHODS We enrolled adult patients with cancer from in- and outpatient care facilities, using a proportional stratified random sample based on the nationwide cancer incidence in Germany. Patients who scored 9 or above on the Patient Health Questionnaire (PHQ-9) were administered to the standardized computer-assisted Composite International Diagnostic Interview for mental disorders adapted for cancer patients (CIDI-O). A random sample of those with a PHQ-9 score that was less than 9 were selected for a CIDI-O. RESULTS A total of 5,889 patients were identified, which led to 4,020 participants (a 68.3% response rate); of those, 2,141 patients were interviewed. The 4-week total prevalence for any mental disorder was 31.8% (95% CI, 29.8% to 33.8%); this included any anxiety disorder (11.5%; 95% CI, 10.2% to 12.9%), any adjustment disorder (11.1%; 95% CI, 9.7% to 12.4%), any mood disorder (6.5%; 95% CI, 5.5% to 7.5%), any somatoform/conversion disorder (5.3%; 95% CI, 4.3% to 6.2%), nicotine dependence (4.5%; 95% CI, 3.6% to 5.4%), alcohol abuse/dependence (0.3%; 95% CI, 0.1% to 0.6%), any mental disorder resulting from general medical condition (2.3%; 95% CI, 1.7% to 2.9%), and any eating disorder (0%). The highest prevalence for any mental disorder was found in patients with breast cancer (41.6%; 95% CI, 36.8% to 46.4%), followed by patients with head and neck cancer (40.8%; 95% CI, 28.5% to 53.0%). The lowest prevalence was found in patients with pancreatic cancer (20.3%; 95% CI, 8.9% to 31.6%) and stomach/esophagus cancers (21.2%; 95% CI, 12.8% to 29.6%). CONCLUSION Our findings provide evidence for the strong need for psycho-oncological interventions.

Paroxetine for the treatment of interferon-α-induced depression in chronic hepatitis C

Background : Psychiatric side‐effects may require dose reduction or premature discontinuation of interferon therapy in chronic hepatitis C. New strategies are needed in order to prevent the premature termination of interferon therapy.

Mode of Action and Effects of Standardized Collaborative Disease Management on Mortality and Morbidity in Patients With Systolic Heart Failure The Interdisciplinary Network for Heart Failure (INH) Study

Background— Trials investigating efficacy of disease management programs (DMP) in heart failure reported contradictory results. Features rendering specific interventions successful are often ill defined. We evaluated the mode of action and effects of a nurse-coordinated DMP (HeartNetCare-HF, HNC). Methods and Results— Patients hospitalized for systolic heart failure were randomly assigned to HNC or usual care (UC). Besides telephone-based monitoring and education, HNC addressed individual problems raised by patients, pursued networking of health care providers and provided training for caregivers. End points were time to death or rehospitalization (combined primary), heart failure symptoms, and quality of life (SF-36). Of 1007 consecutive patients, 715 were randomly assigned (HNC: n=352; UC: n=363; age, 69±12 years; 29% female; 40% New York Heart Association class III-IV). Within 180 days, 130 HNC and 137 UC patients reached the primary end point (hazard ratio, 1.02; 95% confidence interval, 0.81–1.30; P=0.89), since more HNC patients were readmitted. Overall, 32 HNC and 52 UC patients died (1 UC patient and 4 HNC patients after dropout); thus, uncensored hazard ratio was 0.62 (0.40–0.96; P=0.03). HNC patients improved more regarding New York Heart Association class (P=0.05), physical functioning (P=0.03), and physical health component (P=0.03). Except for HNC, health care utilization was comparable between groups. However, HNC patients requested counseling for noncardiac problems even more frequently than for cardiovascular or heart-failure–related issues. Conclusions— The primary end point of this study was neutral. However, mortality risk and surrogates of well-being improved significantly. Quantitative assessment of patient requirements suggested that besides (tele)monitoring individualized care considering also noncardiac problems should be integrated in efforts to achieve more sustainable improvement in heart failure outcomes. Clinical Trial Registration— URL: http://www.controlled-trials.com. Unique identifier: ISRCTN23325295.

Rationale and design of a randomised, controlled, multicenter trial investigating the effects of selective serotonin re‐uptake inhibition on morbidity, mortality and mood in depressed heart failure patients (MOOD‐HF)

Depression and chronic heart failure (CHF) are common conditions, both of which are clinically and economically highly relevant. Major depression affects 20–40% of CHF patients and predicts adverse outcomes in terms of quality of life, morbidity and mortality as well as health care expenditure, independent of other factors of prognostic relevance.

Depression and survival in chronic heart failure: Does gender play a role?

Data regarding the influence of depression on outcome in chronic heart failure are conflicting and neglect possible gender differences.

Compliance with Therapy in Patients with Chronic Hepatitis C: Associations with Psychiatric Symptoms, Interpersonal Problems, and Mode of Acquisition

Tolerance of interferon-α therapy for hepatitis C is often poor and medication is expensive. Compliance with diagnostic procedures and, even more important, with medical treatment is obviously critical to minimize the rate of dropouts and to maximize cost efficiency. Moreover, a good concordance with scheduled follow-ups is important for early recognition and treatment of interferon-associated side effects. Therefore, we investigated psychiatric symptoms, interpersonal problems, different modes of acquisition, and sociodemographic factors in HCV-infected patients as possible predictor variables of good versus poor compliance. In a longitudinal study, 74 patients with chronic hepatitis C (CHC) who fulfilled the criteria for treatment with interferon (IFN)-α-2b with or without ribavirin were investigated prospectively to identify those at risk for poor compliance during IFN medication. To assess predictive factors, we used both IIP-C (Inventory of Interpersonal Problems) and SCL-90-R (Symptom Check List 90 Items Revised) as psychometric instruments. Sociodemographic and somatic variables as well as compliance during IFN therapy were also evaluated. Poor compliance before or during medication was demonstrated by 23% (N = 17) of HCV patients. Sociodemographic factors and mode of acquisition, particularly former intravenous drug (IVD) abuse were not significantly linked with compliance. Logistic regression analysis demonstrated that the subgroup of patients with compliance problems was best identified by both pretherapeutic psychiatric symptoms and interpersonal problems. Predictive value was best and significant for anger-hostility (P = 0.009), intrusive (P = 0.014), depression (P = 0.015), and phobic anxiety (P = 0.049). Adopting this statistical prediction model, sensitivity was 47.1%, but specificity reached 98.3%. In total, 86.5% of cases were classified correctly. In situations of unclear indication for IFN therapy, psychological variables assessment of before the beginning of treatment may represent an additional decision-making factor.

Effect of Escitalopram on All-Cause Mortality and Hospitalization in Patients With Heart Failure and Depression: The MOOD-HF Randomized Clinical Trial.

IMPORTANCE Depression is frequent in patients with heart failure and is associated with adverse clinical outcomes. Long-term efficacy and safety of selective serotonin reuptake inhibitors in these patients are unknown. OBJECTIVE To determine whether 24 months of treatment with escitalopram improves mortality, morbidity, and mood in patients with chronic systolic heart failure and depression. DESIGN, SETTING, AND PARTICIPANTS The Effects of Selective Serotonin Re-Uptake Inhibition on Morbidity, Mortality, and Mood in Depressed Heart Failure Patients (MOOD-HF) study was a double-blind, placebo-controlled randomized clinical trial conducted at 16 tertiary medical centers in Germany. Between March 2009 and February 2014, patients at outpatient clinics with New York Heart Association class II-IV heart failure and reduced left ventricular ejection fraction (<45%) were screened for depression using the 9-item Patient Health Questionnaire. Patients with suspected depression were then invited to undergo a Structured Clinical Interview based on the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) to establish the diagnosis. INTERVENTIONS Patients were randomized 1:1 to receive escitalopram (10-20 mg) or matching placebo in addition to optimal heart failure therapy. Study duration was 24 months. MAIN OUTCOMES AND MEASURES The composite primary outcome was time to all-cause death or hospitalization. Prespecified secondary outcomes included safety and depression severity at 12 weeks of treatment (including the titration period), which were determined using the 10-item Montgomery-Åsberg Depression Rating Scale (total possible score, 0 to 60; higher scores indicate more severe depression). RESULTS A total of 372 patients (mean age, 62 years; 24% female) were randomized and had taken at least 1 dose of study medication when the data and safety monitoring committee recommended the trial be stopped early. During a median participation time of 18.4 months (n = 185) for the escitalopram group and 18.7 months (n = 187) for the placebo group, the primary outcome of death or hospitalization occurred in 116 (63%) patients and 119 (64%) patients, respectively (hazard ratio, 0.99 [95% CI, 0.76 to 1.27]; P = .92). The mean Montgomery-Åsberg Depression Rating Scale sum score changed from 20.2 at baseline to 11.2 at 12 weeks in the escitalopram group and from 21.4 to 12.5 in the placebo group (between-group difference, -0.9 [95% CI,-2.6 to 0.7]; P = .26). Safety parameters were comparable between groups. CONCLUSIONS AND RELEVANCE In patients with chronic heart failure with reduced ejection fraction and depression, 18 months of treatment with escitalopram compared with placebo did not significantly reduce all-cause mortality or hospitalization, and there was no significant improvement in depression. These findings do not support the use of escitalopram in patients with chronic systolic heart failure and depression. TRIAL REGISTRATION isrctn.com Identifier: ISRCTN33128015.

Prevalence of mental disorders, psychosocial distress and need for psychosocial support in cancer patients – study protocol of an epidemiological multi-center study

BackgroundEmpirical studies investigating the prevalence of mental disorders and psychological distress in cancer patients have gained increasing importance during recent years, particularly with the objective to develop and implement psychosocial interventions within the cancer care system. Primary purpose of this epidemiological cross-sectional multi-center study is to detect the 4-week-, 12-month-, and lifetime prevalence rates of comorbid mental disorders and to further assess psychological distress and psychosocial support needs in cancer patients across all major tumor entities within the in- and outpatient oncological health care and rehabilitation settings in Germany.Methods/DesignIn this multicenter, epidemiological cross-sectional study, cancer patients across all major tumor entities will be enrolled from acute care hospitals, outpatient cancer care facilities, and rehabilitation centers in five major study centers in Germany: Freiburg, Hamburg, Heidelberg, Leipzig and Würzburg. A proportional stratified random sample based on the nationwide incidence of all cancer diagnoses in Germany is used. Patients are consecutively recruited in all centers. On the basis of a depression screener (PHQ-9) 50% of the participants that score below the cutoff point of 9 and all patients scoring above are assessed using the Composite International Diagnostic Interview for Oncology (CIDI-O). In addition, all patients complete validated questionnaires measuring emotional distress, information and psychosocial support needs as well as quality of life.DiscussionEpidemiological data on the prevalence of mental disorders and distress provide detailed and valid information for the estimation of the demands for the type and extent of psychosocial support interventions. The data will provide information about specific demographic, functional, cancer- and treatment-related risk factors for mental comorbidity and psychosocial distress, specific supportive care needs and use of psychosocial support offers.

German short musculoskeletal function assessment questionnaire (SMFA-D): comparison with the SF-36 and WOMAC in a prospective evaluation in patients with primary osteoarthritis undergoing total knee arthroplasty

Abstract. In a prospective clinical trial, the German short musculoskeletal function assessment (SMFA-D), the short form (SF)-36, and the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) were evaluated in 63 patients with primary osteoarthritis undergoing total knee arthroplasty. All instruments were sensitive to change, demonstrating the effect of total knee arthroplasty at 1-year follow-up. The SMFA-D effect sizes in comparable scales were bigger than in the SF-36 and similar to those of the WOMAC. Significant correlations of the SMFA-D indices with the SF-36 and WOMAC scales preoperatively could be shown. After 1-year follow-up, all correlations between the SMFA-D indices and SF-36 scales were significant. In other comparison, only the correlation between the SMFA-D function index and the WOMAC function scales remained significant. The correlation of the SMFA-D function index with external validation criteria was higher than that using the other instruments. We recommend the SMFA-D for assessing change in functional status of patients with primary osteoarthritis of the knee following arthroplasty.

Somatic correlates of comorbid major depression in patients with systolic heart failure

BACKGROUND Major depression is 4-5 times more common in heart failure than in the general population, and associated with adverse outcomes. This prospective study investigated somatic correlates of comorbid depression in patients with heart failure aiming to better understand the interrelation of both conditions. METHODS We enrolled 702 consecutive patients hospitalized for heart failure with a left ventricular ejection fraction (LVEF) ≤ 40% (mean age 67 years, 71% male). Suspected episodes of depression were identified using the Patient Health Questionnaire (PHQ-9). A score >11 (9-11) was defined as suspected major (minor) depression. RESULTS The prevalence of major (minor) depression was 24% (15%). Major depression was more common in women (30%) than men (22%, p = 0.02). In multivariable analysis, history of depression, (OR 3.09, 95%CI 1.98-4.82, p < 0.001), New York Heart Association class (OR 2.07 per class, 95%CI 1.52-2.81, p<0.001), leukocyte count >8000/mm(3) (OR 1.50, 95%CI 1.03-2.17, p = 0.032), and obstructive pulmonary disease (OR 1.61, 95%CI 1.04-2.50, p = 0.033) correlated independently with higher prevalence rates of major depression. Hemoglobin (OR 0.87 per g/dL, 95%CI 0.79-0.96, p = 0.005), and treatment with 3-hydroxy-3-methylglutaryl-coenzyme-A-reductase inhibitors (OR 0.66, 95%CI 0.45-0.98, p = 0.039) correlated independently with lower prevalence rates. Female sex, diabetes, peripheral edema, hyperuricemia, cholesterol <150 mg/dL, LVEF <30%, peripheral vascular disease, diuretics, and renal dysfunction were predictive only in univariable models. CONCLUSIONS The high prevalence of major depression in patients with heart failure seems closely linked to various typical clinical features of this syndrome. Whether this implicates differential therapeutic needs in patients with comorbid compared with primary depression requires further investigation.