One in two cancer patients is significantly distressed: Prevalence and indicators of distress.

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 3724 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. 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 3 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 3 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.

Early detection and integrated care for adolescents and young adults with psychotic disorders: the ACCESS III study.

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 < 0.001); younger age predicted non-remission (OR = 1.1, CI: 1.01-1.19, P = 0.038). Linear regressions indicated a reduction of DUP in EDIC (P < 0.001), but not in SC (P = 0.41). MMRMs showed significantly larger improvements in PANSS positive (P < 0.001) and GAF (P < 0.01) scores in EDIC vs. SC, and in EDIC over time in CGI-Severity (P < 0.001) and numerically in Q-LES-Q-18 (P = 0.052). CONCLUSIONS: EDIC lead to significantly higher proportions of patients achieving combined remission. Moderating variables included a reduction of DUP and EDIC, offering psychotherapeutic interventions.

Fetoscopic laser coagulation in 1020 pregnancies with twin-twin transfusion syndrome demonstrates improvement in double-twin survival rate.

OBJECTIVE: To investigate the growing experience and learning curve of fetoscopic laser coagulation of the placental vascular anastomoses in severe mid-trimester twin-twin transfusion syndrome (TTTS) and its influence on perinatal outcome in a single-center setting. METHODS: Between January 1995 and March 2013 we performed laser therapy in 1020 consecutive pregnancies with TTTS between 15.1 and 27.4 weeks' gestation. We compared perinatal outcome in blocks of five sequential groups of 200 cases, taking into account several covariates in order to adjust for case mix and to demonstrate learning curves and success rates. RESULTS: The percentage of pregnancies with survival of both fetuses increased from 50.0% (n = 100) in the first 200 cases to 69.5% (n = 153) in the last 220 cases (P = 0.018 for trend) and the overall survival rate for both fetuses in the complete series of 1019 cases with known outcome was 63.3% (n = 645). The survival rate of at least one fetus increased from 80.5% (161/200) in the first group to 91.8% (202/220) in the last group (P = 0.072 for trend) and the overall survival rate of at least one fetus in the complete series was 86.7% (883/1019). In the total population, the mean gestational age at delivery of pregnancies with at least one liveborn neonate was 33.7 ± 3.2 weeks, with a mean interval of 12.9 ± 4.0 weeks between intervention and delivery. Among the first two groups, 124 pregnancies had anterior placentae and were treated with a 0° fetoscope. These cases had the poorest overall outcome, with a double-twin survival rate of 44.4% (55/124), which increased to 65.1% (207/318; P = 0.001) after the introduction of a 30° fetoscope for cases with anterior placenta. The success rate for double-twin survival reached a plateau of 69% at 600 procedures, a rate equalled by a new operator who was trained hands-on and performed 174 of the last 400 procedures. CONCLUSIONS: We report the largest single-center experience of laser coagulation in TTTS. We observed a continuous increase in double-twin survival rate owing to the growing experience based on the learning curve and refinements in fetoscopic instruments and techniques. These data provide strong arguments for the centralization of minimally invasive intrauterine surgery in specialized high-volume centers. Copyright © 2017 ISUOG. Published by John Wiley & Sons Ltd.

Effectiveness of one-to-one peer support for patients with severe mental illness - a randomised controlled trial.

BACKGROUND: One-to-one peer support is a resource-oriented approach for patients with severe mental illness. Existing trials provided inconsistent results and commonly have methodological shortcomings, such as poor training and role definition of peer supporters, small sample sizes, and lack of blinded outcome assessments. METHODS: This is a randomised controlled trial comparing one-to-one peer support with treatment as usual. Eligible were patients with severe mental illnesses: psychosis, major depression, bipolar disorder or borderline personality disorder of more than two years' duration. A total of 216 patients were recruited through in- and out-patient services from four hospitals in Hamburg, Germany, with 114 allocated to the intervention group and 102 to the control group. The intervention was one-to-one peer support, delivered by trained peers and according to a defined role specification, in addition to treatment as usual over the course of six months, as compared to treatment as usual alone. Primary outcome was self-efficacy measured on the General Self-Efficacy Scale at six-month follow-up. Secondary outcomes included quality of life, social functioning, and hospitalisations. RESULTS: Patients in the intervention group had significantly higher scores of self-efficacy at the six-month follow-up. There were no statistically significant differences on secondary outcomes in the intention to treat analyses. CONCLUSIONS: The findings suggest that one-to-one peer support delivered by trained peer supporters can improve self-efficacy of patients with severe mental disorders over a one-year period. One-to-one peer support may be regarded as an effective intervention. Future research should explore the impact of improved self-efficacy on clinical and social outcomes.

Collaborative stepped care for somatoform disorders: A pre-post-intervention study in primary care.

OBJECTIVE: The successful management of somatoform disorders in primary care is often limited due to low diagnostic accuracy, delayed referral to psychotherapy, and unstructured overuse of health care. This study aimed to investigate the feasibility of establishing a collaborative stepped health care network for somatoform disorders, and its impact on the diagnostic process and treatment recommendations in primary care. METHOD: The Network for Somatoform and Functional Disorders (Sofu-Net) was established to connect 41 primary care physicians (PCP), 35 psychotherapists, and 8 mental health clinics. To evaluate Sofu-Net, primary care patients at high risk of having a somatoform disorder were identified using the Patient Health Questionnaire, and were assessed in detail at the patient and PCP level. Discussion of psychosocial distress in the consultations, diagnostic detection rates and treatment recommendations were compared before and 12 months after establishing the network. RESULTS: Out of the pre- (n=1645) and 12-months-post Sofu-Net patient samples (n=1756), 267 (16.2%) and 269 (15.3%) high-risk patients were identified. From these, 156 and 123 patients were interviewed and information was assessed from their PCP. Twelve months after Sofu-Net establishment, high-risk patients more frequently discussed psychosocial distress with their PCP (63.3% vs. 79.2%, p<.001). PCPs prescribed more antidepressants (3.8% vs. 25.2%, p<.001) and less benzodiazepines (21.8% vs. 6.5%, p<.001). Sofu-Net did not affect PCP's diagnostic detection rates or recommendation to initiate psychotherapy. CONCLUSION: The study results indicate feasibility of an interdisciplinary network for somatoform disorders. Collaborative care networks for somatoform disorders have the potential to improve doctor-patient-communication and prescription behavior.

Variations of heart rate variability parameters prior to the onset of ventricular tachyarrhythmia and sinus tachycardia in ICD patients. Results from the heart rate variability analysis with automated ICDs (HAWAI) registry.

The HAWAI registry evaluated the role of heart rate variability in predicting the occurrence of ventricular tachycardia and fibrillation (VT/VF) and sinus tachycardia in patients with an implantable cardioverter-defibrillator (45 patients with 155 RR recordings). A significant decrease of the mean value of all RR intervals (MeanNN) was observed in the period starting 20 and 40 min prior to VT/VF and sinus tachycardia, respectively. The standard deviation of RR intervals (SDNN) and the power at low frequency (LF) were the only parameters with significant changes prior to VT/VF. For sinus tachycardia, the root mean square of successive differences of all successive RR intervals (r-MSSD) and the power at low and high frequency (HF) decreased, whereas SDNN and the power at very low frequency increased. Comparison of RR recordings preceding VT/VF and sinus tachycardia revealed significant differences of the MeanNN, SDNN, r-MSSD, LF and HF. Based on a classification and regression tree analysis, MeanNN, SDNN and r-MSSD showed a sensitivity of 94.4% and a specificity of 50.6% as predictors of VT/VF. Our results suggest that the temporal changes in heart rate before an arrhythmic event can be used to predict the occurrence of VT/VF. These parameters may be used to optimize pacing therapies designed to prevent VT/VF recurrences as well as for improving device-based discriminators for VT/VF and sinus tachycardia.

Quality of life one year post-Shiga toxin-producing Escherichia coli O104 infection--a prospective cohort study.

BACKGROUND: In 2011, a major outbreak of hemolytic-uremic syndrome (HUS) and bloody diarrhea related to infections from Shiga toxin-producing Escherichia coli O104 (STEC) occurred in Germany. While previous research has focused on the medical components of this disease, we aimed to investigate the course of health-related quality of life (HrQoL) over 12 months including somatic and psychosocial risk factors. Furthermore, the influence of chronic fatigue (CF) on HrQoL was examined. METHODS: A prospective cohort study with n = 389 patients completing self-report scales at baseline, after 6 months (participation rate: 79%) and after 12 months (participation rate: 77%). The courses of physical and mental HrQoL over the 12 month period were calculated by employing general linear mixed models. KEY RESULTS: While the physical component score of HrQoL reached a score comparable to the general population, the mental component score remained below average 12 months after STEC infection. Female gender, prior psychiatric disorder, and prior traumatic events were risk factors for a worse HrQoL course after 12 months, while social support was identified to be protective. CF was associated with low HrQoL. In addition, the somatic symptom burden remained persistently high. CONCLUSIONS & INFERENCES: Our results show high somatic and psychosocial burden in patients 12 months after STEC infection. We recommend considering the risk factors and protective factors of poor HrQoL early in the treatment of STEC or similar diseases. Patients who are suffering from persisting somatic symptoms, CF, and impaired HrQoL may require specific aftercare.

Target organ damage and control of cardiovascular risk factors in hypertensive patients. Evidence from the multicenter ESTher registry.

AIMS: This study investigated the incidence of hypertensive target organ damage (TOD), control of cardiovascular risk factors, and the short-term prognosis in hypertensive patients under contemporary guideline-oriented therapy. PATIENTS AND METHODS: A total of 1,377 consecutive patients (mean age 58.2 ± 9.9 years, 82.2 % male) with arterial hypertension were included in the ESTher (Endorganschäden, Therapie und Verlauf - target organ damage, therapy, and course) registry at 15 rehabilitation clinics within the framework of the National Genome Research Network. Cardiovascular risk factors, medication, comorbidities, and glomerular filtration rate (GFR) were assessed. Left ventricular hypertrophy (LVH), left ventricular mass (LVM), left ventricular mass index (LVMI), and left ventricular ejection fraction (LVEF) were determined by two-dimensional echocardiography. The mean follow-up was 513 ± 159 days. Changes in continuous parameters were tested by the t test, changes in discrete characteristics are presented by means of transition tables and tested with the McNemar test. RESULTS: The mean LVEF was 59.3 ± 9.9 %, both mean LVM (238.6 ± 101.5 g) and LVMI (54.0 ± 23.6 g/m(2.7)) were increased while relative wall thickness (RWT, 0.46 ± 0.18) indicated the presence of concentric LVH. Of the patients, 10.2 % displayed renal dysfunction (estimated GFR < 60 ml/min/1.73 m(2)). The 1.5-year overall mortality was 1.2 %. Compared with discharge, at follow-up the proportion of patients with blood pressure (BP) values < 140/90 mmHg decreased from 68.7 % to 55.0 % (p < 0.001) and with low-density lipoprotein (LDL) values < 100 mg/dl from 62.6 % to 38.1 % (p < 0.001). At follow-up significantly more patients displayed a GFR value of < 60 ml/min/1.73 m(2) (10.2 % vs. 16.0 %, p < 0.001). CONCLUSION: A significant proportion of hypertensive rehabilitation participants displayed TOD including LVH and renal dysfunction. Even after stringent BP reduction, a considerable increase in nephropathy could be found after 18 months.

The relationship between biogenetic attributions and desire for social distance from persons with schizophrenia and major depression revisited.

AIMS: Previous population-based studies did not support the view that biological and genetic causal models help increase social acceptance of people with mental illness. However, practically all these studies used un-labelled vignettes depicting symptoms of the disorders of interest. Thus, in these studies the public's reactions to pathological behaviour had been assessed rather than reactions to psychiatric disorders that had explicitly been labelled as such. The question arises as to whether results would have been similar if respondents had been confronted with vignettes with explicit mention of the respective diagnosis. METHODS: Analyses are based on data of a telephone survey in two German metropolises conducted in 2011. Case-vignettes with typical symptoms suggestive of depression or schizophrenia were presented to the respondents. After presentation of the vignette respondents were informed about the diagnosis. RESULTS: We found a statistically significant association of the endorsement of brain disease as a cause with greater desire for social distance from persons with schizophrenia. In major depression, this relation was absent. With both disorders, there was no statistically significant association between the endorsement of hereditary factors as a cause and social distance. CONCLUSIONS: Irrespective of whether unlabelled or labelled vignettes are employed, the ascription to biological or genetic causes seems not to be associated with a reduction of the public's desire for social distance from people with schizophrenia or depression. Our results corroborate the notion that promulgating biological and genetic causal models may not help decrease the stigma surrounding these illnesses.

[Use and potential risks of over-the-counter analgesics]. / Gebrauch und potenzielle Risiken durch nicht verschreibungspflichtige Schmerzmittel.

BACKGROUND AND AIM: We investigated the use of prescription and non-prescription (over-the-counter, OTC) analgesics and the associated risks in elderly patients with multiple morbidities. METHODS: Pain medication use was evaluated from the baseline data (2008/2009) of the MultiCare cohort enrolling elderly patients with multiple morbidities who were treated by primary care physicians (trial registration: ISRCTN89818205). We considered opioids (N02A), other analgesics, and antipyretics (N02B) as well as nonsteroidal anti-inflammatory drugs (NSAIDs; M01A). OTC use, duplicate prescription, dosages, and interactions were examined for acetylsalicylic acid, diclofenac, (dex)ibuprofen, naproxen, and acetaminophen. RESULTS: Of 3,189 patients with multiple morbidities aged 65-85 years, 1,170 patients reported to have taken at least one prescription or non-prescription analgesic within the last 3 months (36.7 %). Of these, 289 patients (24.7 % of 1,170) took at least one OTC analgesic. Duplicate prescription was observed in 86 cases; 15 of these cases took the analgesics regularly. In two cases, the maximum daily dose of diclofenac was exceeded due to duplicate prescription. In 235 cases, patients concurrently took a drug with a potentially clinically relevant interaction. In 43 cases (18.3 % of 235) an OTC analgesic, usually ibuprofen, was involved. DISCUSSION: About one third of the elderly patients took analgesics regularly or as needed. Despite the relatively high use of OTC analgesics, the proportions of duplicate prescription, medication overdoses, and adverse interactions due to OTC products was low.

Prognostic impact of the time interval between surgery and chemotherapy in advanced ovarian cancer: analysis of prospective randomised phase III trials.

BACKGROUND AND AIMS: Surgery followed by platinum-taxane chemotherapy is the current standard approach to treat advanced ovarian cancer. The impact of the time interval between surgery and initiation of chemotherapy for clinical outcome has not been clarified yet. METHODS: Individual patient data analysis of 3326 patients from three prospective randomised phase III trials conducted between 1995 and 2002 to investigate platinum-taxane based chemotherapy regimens in advanced ovarian cancer. Time to chemotherapy (TTC) was analysed and correlated with outcome. RESULTS: Median TTC was 19 days (range 1-56). The effect of TTC differed significantly for patients with or without residual disease for progression-free (PFS; interaction p=0.004) and for overall survival (OS; interaction p=0.028). A delayed start of chemotherapy was associated with earlier disease recurrence (HR 1.038, 95% CI 0.973; 1.106, p=0.257 per week delay) and a significantly decreased OS (HR 1.087, 95% CI 1.005; 1.176 p=0.038) in patients with no residual tumour after surgery. In contrast, in patients with residual disease, a longer TTC was significantly associated with later progression (HR 0.931, 95% CI 0.895; 0.969, p<0.001) and no effect towards OS (HR 0.983, 95% CI 0.940; 1.028, p=0.452). CONCLUSIONS: Our results provide evidence that early initiation of chemotherapy might result in slightly improved survival in patients with complete cytoreduction while patients with residual disease after surgery did not benefit from earlier chemotherapy. A prospective study randomising patients to different time intervals could clarify the definitive relevance of the time between surgery and chemotherapy.

[Health and competence: detection and decoding using comprehensive assessments in the Longitudinal Urban Cohort Ageing Study (LUCAS)]. / Grauzonen von Gesundheit und Handlungsfähigkeit: Erfassung und Aufschlüsselung durch erweiterte Assessments in der Longitudinalen Urbanen Cohorten-Alters-Studie (LUCAS).

PURPOSE: The goal of this work was to characterise and distinguish persons without (fit), with earliest signs (pre-frail) or accelerated functional decline (frail) during self-referral (geriatric centre) or preventive home visits. METHODS: After screening independently living older people in an urban longitudinal cohort (n = 1,995) using a self-administered questionnaire, they were functionally classified as fit, pre-frail or frail. In 10% randomly selected samples of these cohort parts a comprehensive extended gerontological-geriatric assessment (EGGA) was administered. RESULTS: Fit, pre-frail and frail samples are significantly different regarding comorbidity, medication, mobility, fall risk, instrumental activities of daily living and use of social support but not nutrition. The best indicator to discriminate fit versus frail was exhaustion (mobility tiredness). CONCLUSION: Competence is essential regarding health in old age. Identification of resources and risks by comprehensive assessment is useful before planning interventions to prevent frailty or its progression.

[Reliability of morbidity data reported by GPs. Results of a longitudinal study in primary care]. / Reliabilität ärztlicher Morbiditätsangaben zu chronischen Krankheiten. Ergebnisse einer Längsschnittstudie im hausärztlichen Bereich.

BACKGROUND: Data on prevalence of chronic diseases are important for planning health care services. Such prevalence data are mostly based on patient self-reports, claims data, or other research data-with limited validity and reliability partially due to their cross-sectional character. Currently, only claims data of statutory health insurance offer longitudinal information. In Germany, these data show a loss of diagnoses of chronic health conditions over time. This study investigated whether there is a similar tendency of loss in the documentation of chronic diseases in data specifically collected for a longitudinal cohort study by general practitioners. In addition, the explanatory power of patient or GP characteristics regarding these losses is investigated. PATIENTS AND METHODS: A total of 3,327 patients aged 75 years and older were recruited for the German Study on Ageing, Cognition and Dementia in Primary Care Patients (AgeCoDe). For 1,765 patients, GP diagnoses of four chronic conditions at three time points were available for a total period of 4.5 years. In order to explain the loss of chronic diagnoses, a multilevel mixed-effects logistic regression was performed. RESULTS: Over the course of 4.5 years, 18.6% of the diagnoses of diabetes mellitus, 34.5% of the diagnoses of coronary heart disease, and 44.9% of the diagnoses of stroke disappeared in the GP documentation for the longitudinal study. The diagnosis of coronary heart disease was less often lost in men than in women. The risk of losing the diagnosis of diabetes was higher in patients who were well known by the GP for a long time. An essential part of the variance of the losses can be explained by practice (owner) effects. CONCLUSION: Data on morbidity collected in epidemiological studies and reported by physicians should always be checked for validity and reliability. Appropriate options (e.g., an investigator collecting the data directly in the field or the comparison of the data with health insurance companies' claims data) are presented and discussed.

Comparable short-term prognosis in diabetic and non-diabetic patients with acute coronary syndrome after cardiac rehabilitation.

BACKGROUND: Patients with pathological glucometabolism are at increased risk of recurrent cardiovascular events after acute coronary syndrome (ACS). The goal of this study was to investigate the association of glucometabolism and the one-year outcome of cardiac rehabilitation patients. DESIGN: Prospective multicentre registry from four German rehabilitation clinics. METHODS: During 2005-2006, 1614 consecutive patients (85.9% male, mean age 55 ± 10.3 years) were included after the first ACS (mean 18.9 days) and classified into group 1 (apparent diabetes mellitus, n = 268), group 2 (no diabetes, impaired oral glucose tolerance [OGT], n = 185), and group 3 (normal fasting glucose and normal OGT, n = 1161). The mean follow-up was 13.4 months and the follow-up events were analysed by multivariate logistic regression models with backward elimination. RESULTS: The overall mortality was 1.3% (group 1: 1.2%; group 2: 1.8%; group 3: 1.5%; p(Trend) = NS). The target blood pressure values at discharge (<140/90 mmHg) were achieved by 88.7%, 89.1% and 90.8% of patients in groups 1, 2 and 3, respectively (p(Trend) = NS). The target value for LDL cholesterol (<100 mg/dl) was attained by 87.0%, 80.8% and 81.5% of the patients in groups 1, 2 and 3, respectively (p(Trend) = NS). There was a trend of a lower proportion of patients reaching the target values for HDL-C of 46.1%, 51.4% and 60.8% (p(Trend) < 0.001) and triglycerides of 65.1%, 79.9% and 74.6% (p(Trend) = 0.004) for groups 1, 2 and 3, respectively. The strongest multivariate predictors for overall mortality were patients experiencing a previous stroke (OR, 6.29 [95% CI: 1.06-37.19]; p = 0.042) and, with a trend, peripheral arterial disease (OR, 3.60 [95% CI: 0.95-13.68]; p = 0.061). In the multivariate analysis, the diabetic state had no association with poor outcomes (i.e. death or rehospitalization). CONCLUSION: The short-term prognosis for both diabetic and non-diabetic patients was good and was determined by end organ damage rather than by glucometabolic status. Diabetic patients received comparable (and not more aggressive) pharmacotherapy and therefore achieved target values for cardiovascular risk factors to a lesser extent than the non-diabetic and pre-diabetic patients.

Reduction of thyroid nodule volume by levothyroxine and iodine alone and in combination: a randomized, placebo-controlled trial.

CONTEXT: Nodular goiter is common worldwide, but there is still debate over the medical treatment. OBJECTIVE: The objective of the study was the measurement of the effect of a treatment with (nonsuppressive) T(4), iodine, or a combination of both compared with placebo on volume of thyroid nodules and thyroid. DESIGN: This was a multicenter, randomized, double-blind trial in patients with nodular goiter in Germany [LISA (Levothyroxin und Iodid in der Strumatherapie Als Mono-oder Kombinationstherapie) trial]. SETTING: The study was conducted in outpatient clinics in university hospitals and regional hospitals and private practices. PARTICIPANTS: One thousand twenty-four consecutively screened and centrally randomized euthyroid patients aged 18-65 yr with one or more thyroid nodules (minimal diameter 10 mm) participated in the study. INTERVENTION: Intervention included placebo, iodine (I), T(4), or T(4)+I for 1 yr. T(4) doses were adapted for a TSH target range of 0.2-0.8 mU/liter. OUTCOME MEASURES: The primary end point was percent volume reduction of all nodules measured by ultrasound, and the main secondary end point was a change in goiter volume. RESULTS: Nodule volume reductions were -17.3% [95% confidence interval (CI) -24.8/-9.0%, P < 0.001] in the T(4)+I group, -7.3% (95% CI -15.0/+1.2%, P = 0.201) in the T(4) group, and -4.0% (95% CI -11.4/+4.2%, P = 0.328) in the I group as compared with placebo. In direct comparison, the T(4)+I therapy was significantly superior to T(4) (P = 0.018) or I (P = 0.003). Thyroid volume reductions were -7.9% (95% CI -11.8/-3.9%, P < 0.001), -5.2% (95% CI -8.7/-1.6%, P = 0.024) and -2.5% (95% CI -6.2/+1.4%, P = 0.207), respectively. The T(4)+I therapy was significantly superior to I (P = 0.034) but not to T(4) (P = 0.190). CONCLUSION: In a region with a sufficient iodine supply, a 1-yr therapy with a combination of I and T(4) with incomplete suppression of thyrotropin reduced thyroid nodule volume further than either component alone or placebo.

Impact of the type of centre on management of AF patients: surprising evidence for differences in antithrombotic therapy decisions.

Atrial fibrillation (AF) patients may receive treatment from specialists or from general medicine physicians representing different levels of care within a structured health care system. This "choice" is influenced by patient flow within a health care system, patient preference, and individual access to health care resources. We analysed how the postgraduate training and work environment of treating physicians affects management decisions in AF patients. Patient characteristics and treatment decisions were analysed at the time of enrolment into the registry of the German Atrial Fibrillation NETwork (AFNET). A total of 9,577 patients were enrolled from 2004 to 2006 in 191 German centres that belonged to the following four levels of care: 13 tertiary care centres (TCC) enrolled 3,795 patients (39.6%), 58 district hospitals (DH) enrolled 2,339 patients (24.4%), 62 office-based cardiologists (OC) enrolled 2,640 patients (27.6%), and 58 general practitioners or internists (GP) enrolled 803 patients (8.4%). Patients with new-onset AF were often treated in DH. TCC treated younger patients who more often presented with paroxysmal AF. Older patients and patients in permanent AF more often received outpatient care. Consistent with recommendations, younger patients and patients with non-permanent AF received rhythm control therapy more often. In addition, the type of centre affected the decision for rhythm control. Stroke risk was similar between centre types (mean CHADS2 scores 1.6 -1.9). TCC (68.8%) and OC (73.6%) administered adequate antithrombotic therapy more often than DH (55.1%) or GP (52.0%, p<0.001 between groups). Upon multivariate analysis, enrolment by TCC or OC was associated with a 1.60 (1.20-2.12, p=0.001) fold chance for adequate antithrombotic treatment. This difference between centre types was consistent irrespective of the type of stroke risk estimation (ESC 2001 guidelines, CHADS2 score), and also consistent when the recently suggested CHA2DS2-VASc score was used to estimate stroke risk. In conclusion, management decisions in AF are influenced by the education and clinical background of treating physicians in Germany. Inpatients receive more rhythm control therapy. Adequate antithrombotic therapy is more often administered in specialist (cardiologist) centres.

[Clinical trial endpoints in alpha-1-antitrypsin deficiency: interdisciplinary aspects]. / Studienendpunkte beim Alpha-1-Antitrypsin-Mangel:Interdisziplinäre Aspekte.

Patients with alpha-1-antitrypsin deficiency (AAD) represent a small subgroup of subjects with chronic obstructive pulmonary disease (COPD). Only about 800 patients are registered in the German AAD registry, so that about 90 % of the estimated 8000 afflicted individuals have not yet been diagnosed. Clinical trials to demonstrate the efficacy of alpha-1-antitrypsin augmentation therapy are difficult not only due to the small number of potential participants. As in recent COPD trials, FEV (1) and other standard respiratory function parameters have failed to demonstrate statistically significant differences between treatment groups. The present article reviews and discusses both established and potentially new study endpoints. Novel parameters emerge within the field of diagnostic imaging. IT-supported analysis of lung density allows to quantify the extent of emphysema. The EXACTLE trial has shown that CT densitometry is able to document the progression of emphysema over 2 to 3 years. Magnetic resonance imaging (MRI) can serve as an adjunct to assess lung perfusion, ventilation, and breathing dynamics. In the future, prospective multi-centre studies will rather use imaging endpoints than classical respiratory function measurements such as FEV (1). In addition, diffusion capacity and combined endpoints such as the BODE index, which correlates with mortality in COPD, should be considered.