Cardiac late events in German breast cancer patients: a validation study on the agreement between patient self-reports and information from physicians.

BACKGROUND: Self-administered health-status questionnaires are important tools in epidemiology. The objective of the presented validation study is to measure the agreement between breast cancer patients' self-reports and their physicians' information on late cardiac events, and to investigate determinants of agreement. To estimate possible misclassification is an important requirement for observational studies on cardiovascular endpoints. METHODS: A retrospective, multi-center cohort study included 11,982 women diagnosed with breast cancer in Germany in 1998-2008. In 2014, a questionnaire survey assessed cardiovascular risk factors and incident cardiac events after therapy. A validation study was conducted, based on a sample of 3091 breast cancer patients from two university hospitals. Among them, 2261 women (73%) sent back the questionnaire on cardiovascular events, and 1316 women gave consent to request medical records from their general practitioners. A total of 1212/1316 (92.1%) medical records could be obtained for validation. Cohen's kappa coefficient was calculated, and multivariate regression was applied to study the influence of patient characteristics on agreement between both data sources. RESULTS: Overall agreement for the composite endpoint of any cardiac event was 84.5% (kappa 0.35). Of 1055 breast cancer patients reporting no cardiac event, 950 (90%) had no such diagnosis in physicians' medical records. A total of 157 breast cancer survivors indicated a cardiac event, and the same diagnosis was confirmed by GPs for 74 (47%) women. For specific diagnoses, moderate to substantial agreement of self-reports was found for myocardial infarction (kappa 0.54) and stroke (kappa 0.61). Poor to fair agreement was present for angina pectoris, valvular heart disease, arrhythmia, and congestive heart failure. Younger age, higher education and a more recent cancer diagnosis were found to be associated with greater total agreement. CONCLUSIONS: For the composite endpoint, survivors of breast cancer report the absence of cardiac disease accurately. However, for specific diagnoses, self-reported morbidity data from breast cancer patients may not fully agree with information from physicians. The agreement is moderate for acute events like myocardial infarction and stroke, but poor to fair for chronic diseases.

Loneliness in the elderly is associated with the use of psychotropic drugs.

OBJECTIVE: The aim of this study was to evaluate the association between loneliness in elderly people with the use of psychotropic drugs. METHODS: A subsample of 3111 participants (ages 55-85) of the large population-based German ESTHER study was included in the study. Loneliness was measured by using a three-item questionnaire. Two subgroups were defined according to their degrees of loneliness. Psychotropic drugs were categorized by study doctors. Logistic regression analyses were conducted to determine the association between loneliness subgroups and the use of psychotropic drugs adjusted for psychosocial variables, multimorbidity, depression, anxiety, and somatic symptom severity. RESULTS: Of the participants 14.1% (95%-CI = [12.9; 15.4]) were estimated to have a high degree of loneliness (women > men); 19% (95%-CI = [17.6; 20.4]) of the participants used psychotropic drugs, 8.4% (95%-CI = [7.5; 9.5]) antidepressants. Logistic regression analysis showed that more lonely participants had significantly higher odds for using psychotropic drugs (OR: 1.495; 95%-CI = [1.121; 1.993]). Depression severity, somatic symptom severity, and female gender were also positively associated with the use of psychotropic drugs. CONCLUSION: A high degree of subjective loneliness in the elderly is associated with the use of psychotropic drugs, even after adjustment for somatic and psychological comorbidities and psychosocial variables.

Significance and costs of complex biopsychosocial health care needs in elderly people: results of a population-based study.

OBJECTIVE: To improve health care for the elderly, a consideration of biopsychosocial health care needs may be of particular importance-especially because of the prevalence of multiple conditions, mental disorders, and social challenges facing elderly people. The aim of the study was to investigate significance and costs of biopsychosocial health care needs in elderly people. METHODS: Data were derived from the 8-year follow-up of the ESTHER study-a German epidemiological study in the elderly population. A total of 3124 participants aged 57 to 84 years were visited at home by trained medical doctors. Biopsychosocial health care needs were assessed using the INTERMED for the Elderly (IM-E) interview. Health-related quality of life (HRQOL) was measured by the 12-Item Short-Form Health Survey, and psychosomatic burden was measured by the Patient Health Questionnaire. RESULTS: The IM-E correlated with decreased mental (mental component score: r = -0.38, p < .0001) and physical HRQOL (physical component score: r = -0.45, p < .0001), increased depression severity (r = 0.53, p < .0001), and costs (R = 0.41, p < .0001). The proportion of the participants who had an IM-E score of at least 21 was 8.2%; according to previous studies, they were classified as complex patients (having complex biopsychosocial health care needs). Complex patients showed a highly reduced HRQOL compared with participants without complex health care needs (mental component score: 37.0 [10.8] versus 48.7 [8.8]; physical component score: 33.0 [9.1] versus 41.6 [9.5]). Mean health care costs per 3 months of complex patients were strongly increased (1651.1 &OV0556; [3192.2] versus 764.5 &OV0556; [1868.4]). CONCLUSIONS: Complex biopsychosocial health care needs are strongly associated with adverse health outcomes in elderly people. It should be evaluated if interdisciplinary treatment plans would improve the health outcomes for complex patients.

Assessing generalized anxiety disorder in elderly people using the GAD-7 and GAD-2 scales: results of a validation study.

OBJECTIVE: The aim of this study was to evaluate the validity of the seven-item Generalized Anxiety Disorder scale (GAD-7) and its two core items (GAD-2) for detecting GAD in elderly people. METHODS: A criterion-standard study was performed between May and December of 2010 on a general elderly population living at home. A subsample of 438 elderly persons (ages 58-82) of the large population-based German ESTHER study was included in the study. The GAD-7 was administered to participants as part of a home visit. A telephone-administered structured clinical interview was subsequently conducted by a blinded interviewer. The structured clinical (SCID) interview diagnosis of GAD constituted the criterion standard to determine sensitivity and specificity of the GAD-7 and the GAD-2 scales. RESULTS: Twenty-seven participants met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for current GAD according to the SCID interview (6.2%; 95% confidence interval [CI]: 3.9%-8.2%). For the GAD-7, a cut point of five or greater appeared to be optimal for detecting GAD. At this cut point the sensitivity of the GAD-7 was 0.63 and the specificity was 0.9. Correspondingly, the optimal cut point for the GAD-2 was two or greater with a sensitivity of 0.67 and a specificity of 0.90. The areas under the curve were 0.88 (95% CI: 0.83-0.93) for the GAD-7 and 0.87 (95% CI: 0.80-0.94) for the GAD-2. The increased scores on both GAD scales were strongly associated with mental health related quality of life (p <0.0001). CONCLUSION: Our results establish the validity of both the GAD-7 and the GAD-2 in elderly persons. Results of this study show that the recommended cut points of the GAD-7 and the GAD-2 for detecting GAD should be lowered for the elderly general population.

[Patients' perspectives on behavioral and cognitive changes after hospitalization: a 3-month follow-up cohort study using qualitative and quantitative research methods]. / Verhaltens- und Einstellungsänderungen nach Behandlung auf einer internistichen beziehungsweise internistisch-psychosomatischen Akutstation - eine qualitative und quantitative naturalistische Katamnesestudie.

OBJECTIVES: To describe patients' subjective perspectives on hospitalization at time of admission, to prospectively investigate patients' views on changes actually achieved after discharge, and to identify predictors of subjective changes 3 months after hospitalization. METHODS: We conducted a 3-month follow-up cohort study using qualitative and quantitative research methods. Consecutive adult inpatients of an internal medicine ward and a ward integrating internal and psychosomatic medicine were included. They answered open-ended questions concerning their motivation for change at the time of admission (N = 639) using self-report questionnaires and 3 months post hospitalization via a telephone interview (N = 389). Qualitative content analysis was performed. Predictors of subjective change 3 months after hospitalization were identified using multivariate logistic regression analyses. RESULTS: At admission, more psychosomatic patients than internal-medicine ward patients wanted to achieve change (58% vs. 44 %). Patients expressed desires that were assigned to three main categories: to pay more attention to one's physical health (40 %), to change one's perceptions (32 %), and to change one's way of life (16 %). Three months after discharge, 52 % of patients had experienced cognitive and behavioral changes they attributed to their hospitalization. 31 % of the patients reported continuing to implement changes that had begun during hospitalization. Predictors of subjective change 3 months after hospitalization included high educational level (OR = 2.04, 95 %-CI 1.27-3.26), young age (OR = 0.98, 95 %-CI 0.97-1.00), and length of hospitalization (OR = 1.03, 95 %-CI 1.00-1.05). CONCLUSIONS: There is considerable motivation for behavioral and cognitive change among inpatients following admission; this deserves the attention of healthcare professionals. An integrated psychosomatic setting would appear to support cognitive and behavioral changes more effectively than a classical internal medicine ward.

[Outcome of simultaneous psychosomatic/internal-medicine inpatient care--a naturalistic follow-up study]. / Behandlungsverlauf stationär-internistisch-psychosomatischer Versorgung--eine prospektive, naturalistische Studie.

OBJECTIVES: The effectiveness of simultaneous psychosomatic and internal-medicine inpatient care has not yet been satisfyingly investigated. What outcome is found in patients treated in a psychosomatic/internal medicine setting? Can we predict a reduction in depression and symptom severity? METHODS: The study design is prospective and naturalistic. Patients from a psychosomatic/internal-medicine setting and a solely internal-medicine ward filled in self-report questionnaires on the day of admission, five days thereafter, and three months after discharge. RESULTS: A total of 221 patients from a psychosomatic/internal-medicine setting and 418 patients from a solely internal-medicine ward were included. Patient characteristics differed significantly between the two wards. Treatment was associated with a reduction of depression and somatic symptom severity over time. Depression severity improved more in the psychosomatic/internal-medicine setting than in the internal-medicine ward (ES = 0.37 vs. ES = 0.65). The strongest predictor of improvement of depression and somatic symptom severity was the patients' belief that their physical well-being was influenced by psychological factors (B = 1.44 and 1 = 0.65). CONCLUSIONS: The results document a differential approach to admission in an integrated psychosomatic/internal medicine setting and underline the favourable course for psychological and somatic symptoms.

Effectiveness of a 1-year resident training program in clinical research: a controlled before-and-after study.

BACKGROUND: To increase the number of clinician scientists and to improve research skills, a number of clinical research training programs have been recently established. However, controlled studies assessing their effectiveness are lacking. OBJECTIVE: To investigate the effectiveness of a 1-year resident training program in clinical research. DESIGN: Controlled before-and-after study. The training program included a weekly class in clinical research methods, completion of a research project, and mentorship. PARTICIPANTS: Intervention subjects were 15 residents participating in the 1-year training program in clinical research. Control subjects were 22 residents not participating in the training program. MEASUREMENTS AND MAIN RESULTS: Assessments were performed at the beginning and end of the program. Outcomes included methodological research knowledge (multiple-choice progress test), self-assessed research competence, progress on publications and grant applications, and evaluation of the program using quantitative and qualitative methods. RESULTS: Intervention subjects and controls were well matched with respect to research experience (5.1 +/- 2.2 vs 5.6 +/- 5.8 years; p = .69). Methodological knowledge improved significantly more in the intervention group compared to the control group (effect size = 2.5; p < .001). Similarly, self-assessed research competence increased significantly more in the intervention group (effect size = 1.1; p = .01). At the end of the program, significantly more intervention subjects compared to controls were currently writing journal articles (87% vs 36%; p = .003). The intervention subjects evaluated the training program as highly valuable for becoming independent researchers. CONCLUSIONS: A 1-year training program in clinical research can substantially increase research knowledge and productivity. The program design makes it feasible to implement in other academic settings.

Risk factors of symptom underestimation by physicians.

OBJECTIVE: The aims of this study were to characterize patient-physician agreement on various psychological and somatic symptoms in internal medicine inpatients and to identify predictors of symptom severity underestimation by physicians. METHODS: Consecutive adult inpatients of two internal medicine wards of a university hospital completed visual analogue scales (VASs) for severity of disability, anxiety, depression, somatic symptoms, and pain at the time of admission (n=639, participation rate=70%) and 5 days thereafter (n=401, participation rate=82%). In addition, the Patient Health Questionnaire 9 (PHQ-9) depression scale and the Clinical Global Impression Scale--Revised were used. At the same time, the six treating physicians independently rated the complaints of their patients using the same VAS. Rates of overestimation, concordance, and underestimation of symptom severity were analyzed. Logistic regression analyses were used to identify predictors of symptom underestimation by physicians. RESULTS: Concordance between patients and physicians regarding disability, anxiety, depression, somatic symptom severity, and pain reached 50-60%. Symptom severity of patients suffering from major depressive episode was significantly more often underestimated than that of nondepressed patients (all P<.01). Of all the variables, greater depression on the PHQ depression score was the most important risk factor for symptom underestimation by physicians (OR ranging from 1.29 to 1.57; all P<.05, except underestimation of disability). Symptom underestimation of pain severity was also associated with panic disorder symptoms (odds ratio, 2.44; P=.01). CONCLUSION: Depressed patients seem to be at greater risk of symptom underestimation by their physicians--a finding bearing implications for avoidance of underdiagnosis and insufficient treatment. Mutual understanding could be improved by better doctor-patient communication skills. Brief self-report depression screeners might help to reliably identify patients at risk for symptom underestimation by physicians.

Gender specific temporal and cross-sectional associations between BMI-class and symptoms of depression in the elderly.

OBJECTIVE: The aim of the study was the gender specific analysis of cross-sectional and longitudinal associations between body mass index class (BMI-class) and symptoms of depression in a representative sample of elderly German people. METHODS: At the baseline of the ESTHER study (2000-2002), 9953 participants completed a comprehensive questionnaire including items regarding weight, height, and depression history. After five years, 7808 participants again completed the questionnaire and the 15-item geriatric depression scale (GDS-15). BMI was classified into five classes: normal weight, 18.5≤BMI<25; overweight, 25≤BMI<30; obesity class I, 30≤BMI<35; obesity class II, 35≤BMI<40; obesity class III, BMI≥40. RESULTS: Logistic regression analysis for the cross-sectional data at five-year follow-up, adjusted for age, education, marital status, smoking, multimorbidity, physical activity, self-perceived cognitive impairment, and use of antidepressants, showed that the odds for depression were significantly elevated for women in obesity class II and significantly decreased for overweight men. The longitudinal analysis showed a similar pattern: Women in obesity classes II and III at baseline had significantly higher odds for being depressive five years later than women with normal weight at baseline (class II: OR=1.67; 95%CI=[1.06; 2.64]; class III: OR=2.93; 95%CI=[1.37; 6.26]; overweight men had lower odds than normal-weight men (OR=0.69; 95%CI=[0.51;0.92]). CONCLUSION: The relationship between obesity and symptoms of depression appears to be heterogeneous across BMI-classes. Women are more affected than men by obesity class II and III; overweight appears to be associated with reduced risk of depression in elderly men.

Development of a group therapy to enhance treatment motivation and decision making in severely obese patients with a comorbid mental disorder.

BACKGROUND: The prevalence rate of mental disorders in severely obese patients appears to be high. In the Department of Psychosomatic Medicine, Heidelberg, we established a short outpatient group intervention for severely obese patients with an affective, anxiety, and/or eating disorder who either are not able to make a clear decision for an intensive weight loss program or who have already decided to undergo bariatric surgery but are advised to attend a support group before surgery. The aim of the group intervention was to reduce depressive symptoms and, in indecisive patients, to enhance the motivation of the patients for engagement in further intensive treatment programs, including bariatric surgery. METHODS: Descriptive data of the first two intervention groups are provided. The treatment program and topics of the group sessions are explained. Time series analysis methods are used to investigate the development of a single patient during the intervention program. RESULTS: Initially, 16 patients joined the group program; ten of these attended the group therapy to completion. The remaining ten patients showed clinically relevant reduction in depression levels and improvement in mental quality of life. Results of the single-case time series analysis indicate that the temporal relationship between eating behavior and depression changed during treatment. CONCLUSIONS: The group program, as outlined, could be a useful intervention for severely obese patients with comorbid depression, anxiety, or eating disorder. A gap in the health care system is thus bridged by this short intervention that can encourage further treatment decisions such as bariatric surgery.

Psychiatric comorbidity in cardiovascular inpatients: costs, net gain, and length of hospitalization.

OBJECTIVE: Although psychiatric comorbidity often goes undetected and untreated in cardiovascular patients, it is not clear whether the costs for a special treatment of psychiatric comorbidity are appropriately reflected in the reimbursement system. To investigate the economic impact of psychiatric comorbidity, we compared costs, returns, net gain, and duration of hospitalization in cardiovascular inpatients with and without psychiatric comorbidity. METHODS: For a period of 2 years, we analyzed costs, net gain, and other outcome variables according to the diagnosis-related group (DRG) system for cardiovascular inpatients of a German university department (n = 940). Psychiatric disorders were diagnosed by the treating physicians based on clinical criteria and results from the Patient Health Questionnaire (PHQ). With respect to the outcome variables, we compared patients with and without a psychiatric disorder, controlling for sociodemographic characteristics. RESULTS: The average total costs of hospitalization (mean ± S.E.) for cardiovascular patients without psychiatric comorbidity and for patients with psychiatric comorbidity differed significantly (€5142 ± 210 vs. €7663 ± 571; d = 0.39). The increased costs for patients with psychiatric comorbidity were related to elevated returns, but the net gain for patients without psychiatric comorbidity was €277 ± 119. In contrast, the treatment of internal medicine patients with psychiatric disorders resulted in a net loss of -€624 ± 324 (overall group difference, d = -0.25). CONCLUSION: Psychiatric comorbidity in cardiovascular inpatients leads to higher costs that are not reflected in the current reimbursement system in Germany. The inappropriate reimbursement of psychiatric comorbidity in cardiovascular inpatients may result in a serious undertreatment of these patients.

[Elevated costs of treatment in medical inpatients with psychiatric comorbidity are not reflected in the German DRG-system]. / Höhere Kosten bei internistischen Krankenhauspatienten mit psychischer Komorbidität: Fehlende Abbildung im DRG-System.

OBJECTIVE: So far, it remains unclear whether treatment of psychiatric comorbidity in medical inpatients is appropriately reflected in the German Diagnosis-Related Groups (DRG) system. Therefore, we investigated the relationship of psychiatric disorders and costs, returns, net gain, and duration of hospitalization in internal medicine inpatients. METHODS: For a period of 1 year, we analyzed costs, net gain and other outcome variables according to the DRG system for all inpatients of a university department of internal and psychosomatic medicine (n = 697). Psychiatric disorders were diagnosed by the treating physicians based on clinical criteria and results from the Patient Health Questionnaire (PHQ). With respect to the outcome variables, we compared three groups of patients with none, one, and more than one psychiatric disorder controlling for sociodemographic characteristics. RESULTS: The average total costs of the hospitalization (M +/- SD) for internal medicine patients without psychiatric comorbidity (4357 +/- 5312 euro), for patients with one psychiatric disorder, (4733 +/- 5389 euro), and for patients with more than one psychiatric disorder (7163 +/- 8277 euro) differed significantly (p = 0.0003). However, the increased costs for patients with psychiatric comorbidity were not related to elevated returns: the net gain for patients without psychiatric comorbidity was 457 +/- 2884 euro; in contrast, the treatment of internal medicine patients with one and more than one psychiatric disorder resulted in a net loss of - 260 +/- 2389 euro and - 348 +/- 3370 euro, respectively (overall group difference, p = 0.03). CONCLUSIONS: Additional work and expenses caused by patients with psychiatric comorbidity should be documented and reflected in the revenue systems. Practical self-report screening questionnaires may help to detect and treat psychiatric disorders in internal medicine inpatients as early as possible.

[Crash course "clinical research in psychosocial medicine": changes in research knowledge and subjective research competence]. / Intensivkurs Klinische Forschung in der Psychosozialen Medizin": Veränderungen von Forschungswissen und subjektiver Forschungskompetenz.

In the field of psychosocial medicine, there is a lack of structured training programs in clinical research methodology for young investigators. This study investigates changes in research knowledge and subjective research competence during a one-day crash course in clinical research. In addition, the participants evaluated the quality of the course. The crash course, held at the 2007 meeting of the German Council of Psychosomatic Medicine, consisted of 10 lessons regarding clinical study design, biostatistics, and publication of study results. Changes in research knowledge and subjective research competence were measured with multiple-choice and open-ended questions using a one-group pre-post-test-design. All 11 participants (73 % male, mean age 37.0 +/- 9.5 years) completed the evaluations at the beginning and at the end of the course. The crash course was associated with a significant increase in research knowledge (effect size = 1.3; p < 0.001), but no significant change was found with respect to subjective research competence (effect size = 0.2; p = 0.52). Overall, the quality of the course was rated as excellent; 10 of the 11 participants (91 %) would participate again in a similar crash course. The substantial increase in research knowledge suggests that structured courses in clinical research methodology should regularly be offered to young investigators, e. g. within the scope of research meetings or other national structures.