Search

Background Patients with atopic dermatitis (AD) frequently use acupuncture (ACU) and osteopathic medicine (OM), although their therapeutic benefits are unclear. Aim To investigate the effectiveness of ACU and OM in patients with AD. Methods In a three-armed, single-centre, randomized controlled open explorative clinical trial, adult patients with AD received ACU, OM or no study intervention (control group; CG) plus routine care. Outcomes included disease severity (SCORing Atopic Dermatitis; SCORAD), itching intensity (visual analogue scale; VAS), frequency of topical corticosteroid (TCS) use over 7 days and cost-effectiveness. Endpoints were analysed by analysis of covariance adjusted for the respective baseline value and TCS use. Results Overall, 121 patients (92 women, 29 men) with a mean ± SD age of 31.4 ± 10.5 years were randomized. After 12 weeks, the adjusted means (95% CI) for ACU, OM and control were, respectively, 22.3 (18.3–26.3), 26.4 (22.6–30.2) and 23.7 (19.9–27.5) for SCORAD (P = 0.32); 27.9 (19.5–36.4), 35.0 (26.9–43.0) and 42.3 (34.7–50.0) for VAS itching (P < 0.05); and 2.3 (0.8–3.9), 1.9 (0.4–3.5) and 4.3 (2.6–6.0), for TCS use (P = 0.10). ACU and OM were not cost-effective compared with the CG. Conclusion Although no differences in disease severity were found, our findings indicate that ACU might reduce itching in patients with AD. Furthermore, ACU and OM showed a trend towards reducing TCS use.

During the COVID-19 pandemic, rehearsal and concert activities of professional orchestras and choirs were severely restricted based on the assumption of particularly high infection risks associated with wind instruments and singing. Therefore, our primary objective was to determine the incidence of SARS-CoV-2 infections in orchestra and choir musicians compared to controls. We also assessed influenza, flu, upper respiratory tract infections, and course of illness. Musicians from professional orchestras and choirs and controls from 23 institutions throughout Germany were included in a prospective cohort study. Data were collected from October 2020 to June 2021 by weekly online surveys. A mixed-effects cox proportional hazards model was used to assess the effect of exposure by professional activity on SARS-CoV-2 infection. In 1,097 participants (46.7 years (SD 10.3); 46.8% female; 705 orchestra, 154 choir, and 238 control subjects) 40 SARS-CoV-2 infections occurred. Cases per person-years were 0.06 in orchestras, 0.11 in choirs, and 0.03 in controls. Hazard ratios compared to controls were 1.74 (95% CI 0.58 to 5.25, p = 0.320) for orchestra musicians and 2.97 (0.87 to 10.28, p = 0.087) for choir singers. Infection source was suspected predominantly in private contexts. Disease courses were mild to moderate. Other respiratory infections were reported in 6.1% of study weeks in orchestras, 10.1% in choirs, and 8.0% in controls. Sick leave days of total study days were 0.5, 2.1 and 1.3%, respectively. This epidemiologic study during the pandemic in professional musicians indicates no increased risk of SARS-CoV-2 infections in orchestra musicians and a trend towards increased risk in choir singers compared to controls. However, the exact routes of infection could not be validated. If appropriate hygiene concepts are adhered to, safe orchestra and choir activity appears possible in pandemic times.

Purpose Musicians’ practice and performance routines reportedly lead to musculoskeletal complaints and disorders (MCD) that impact their wellbeing and performance abilities. This systematic review aims to assess the prevalence, risk factors, prevention and effectiveness of treatments for MCD in professional musicians and consider the methodological quality of the included studies. Methods A systematic literature search was performed in December 2017 using electronic databases and supplemented by a hand search. Case–control studies, cohort studies, cross-sectional studies, interventional studies and case reports investigating the prevalence, risk factors, prevention or treatment effects of MCD in professional musicians or music students (age ≥ 16 years) were included. Quality assessments of the included studies were performed using an adapted version of the “Study Quality Assessment Tools” from the National Heart, Lung, and Blood Institute. Results One case–control study, 6 cohort studies, 62 cross-sectional studies, 12 interventional studies and 28 case reports were included and assessed for methodological quality. The study designs, terminology, and outcomes were heterogeneous, as the analyses mostly did not control for major confounders, and the definition of exposure was often vague. Therefore, evidence that being a professional musician is a risk factor for MCD as well as the causal relationship between these factors remains low despite the fact that a large number of studies have been performed. Conclusions Studies with high internal and external validity regarding the prevalence, risk factors and effectiveness of the prevention or treatment of MCD in professional musicians are still missing. Further high-quality observational and interventional studies are required. Electronic supplementary material The online version of this article (10.1007/s00420-019-01467-8) contains supplementary material, which is available to authorized users.

The study aims to evaluate the prevalence of depression and the severity of depressive symptoms among primary care patients, who are high utilizers (HU) of health care resources. A cross-sectional, two-stage design was applied to screen for depression using the Brief Psychiatric Health Questionnaire and the Diagnostic Expert System for Psychiatric Disorders. A total of 38 primary care physicians accredited to practice in Berlin and Potsdam in Germany participated in the study. A total of 1,775 patients participated, 507 were identified as HU, 182 (36%) of these were depressed compared to 81 (11%) of the typical utilizers (p < 0.001). The depression score was higher and acute suicidality was more prevalent in HU than in typical utilizers (p < 0.001). Our results suggest that HU represent a population with a high prevalence of depression in primary care and should be considered for routine depression screening.

Physical activity (PA) behavior is increasingly described as trajectories taking changes over a longer period into account. Little is known, however, about predictors of those trajectories among migrant populations. Therefore, the aim of the present cohort study was to describe changes of PA over six years and to explore migration-related and other predictors for different PA trajectories in adults of Turkish descent living in Berlin. At baseline (2011/2012) and after six years, sociodemographics, health behavior, and medical information were assessed. Four PA trajectories were defined using data of weekly PA from baseline and follow-up: &ldquo, inactive&rdquo, &ldquo, decreasing&rdquo, increasing&rdquo, and &ldquo, stable active&rdquo, Multivariable regression analyses were performed in order to determine predictors for the &ldquo, trajectory, and results were presented as adjusted odds ratios (aOR) with 95% confidence intervals (95%CI). In this analysis, 197 people (60.9% women, mean age &plusmn, standard deviation 49.9 &plusmn, 12.8 years) were included. A total of 77.7% were first-generation migrants, and 50.5% had Turkish citizenship. The four PA trajectories differed regarding citizenship, preferred questionnaire language, and marital status. &ldquo, Stable active&rdquo, trajectory membership was predicted by educational level (high vs. low: aOR 4.20, 95%CI [1.10, 16.00]), citizenship (German or dual vs. Turkish only: 3.60 [1.20, 10.86]), preferred questionnaire language (German vs. Turkish: 3.35 [1.05, 10.66]), and BMI (overweight vs. normal weight: 0.28 [0.08, 0.99]). In our study, migration-related factors only partially predicted trajectory membership, however, persons with citizenship of their country of origin and/or with poor language skills should be particularly considered when planning PA prevention programs.

Data on cognitive testing in migrants in Germany are scarce. We aimed to evaluate the Montreal Cognitive Assessment (MoCA) in Turkish migrants in Berlin and its association with demographics and health-related variables.For this cross-sectional study, a random sample of persons with Turkish names was drawn from the registration-office. Cognitive function was assessed using the MoCA; 0 = worst, 30 = best total score. Multivariable linear regression models were calculated to determine associated factors with the total MoCA-score.In our analyses we included 282 participants (50% female), mean age 42.3 ± 11.9 years (mean ± standard deviation (SD)). The mean ± SD MoCA score was 23.3 ± 4.3. In the multivariable analysis, higher education (ß = 2.68; p0.001), and chosing the German version of the MoCA (ß = -1.13; p = 0.026), were associated with higher MoCA-scores, whereas higher age (ß = -0.08; p = 0.002) was associated with lower MoCA scores.In our study, a higher educational level, lower age, and German as the preferred test language (as compared to Turkish) were positively associated with the cognitive performance of Berliners with Turkish roots. To examine neurocognitive health of migrants, longitudinal population-based and clinical cohort studies that specifically compare migrants and their descendants with the original population of their home countries are required.

Introduction The appropriate strategy for initiating oral anticoagulant (OAC) therapy after an acute venous thromboembolism (VTE) depends on the intermediate-term anticoagulant to be used. While heparin bridging to vitamin K antagonists (VKA) is required, the direct oral anticoagulants (DOAC) rivaroxaban (30 mg/day) and apixaban (10 mg/day) can be initiated directly without parenteral anticoagulation. The objective was to evaluate OAC initiation patterns in clinical practice. Materials and methods PREFER in VTE was an international, non-interventional registry conducted between January 2013 and August 2015. Consecutive acute VTE patients were grouped based on their OAC treatment at 1 month after the index event (VKA or DOAC). Results At 1 month, 825 patients were receiving a VKA and 687 a DOAC (rivaroxaban in 685/687 cases). DOAC patients were significantly younger, less comorbid, at a lower bleeding risk, and less frequently diagnosed with pulmonary embolism (34.4% vs. 44.7%). During the first month after VTE, the most common treatment pattern was heparin-OAC overlap for VKA patents (69.6%), and OAC only for DOAC patients (49.1%). However, 28.8% of DOAC patients received a heparin-OAC overlap (median heparin duration: 3 days; IQR: 2–6) and 14.8% were switched from heparin to DOAC. For those on rivaroxaban at 1 month, only 29.7% had received the initial 30 mg/day recommended dose. Clinical event rates were comparable between the DOAC only, heparin-DOAC switch, and heparin-DOAC overlap subgroups at 1 and 6 months. Conclusions Guidelines for DOAC/rivaroxaban initiation after VTE are often not adhered to in clinical practice. This could result in adverse outcomes or suboptimal anticoagulation. Intervention programs to raise awareness amongst physicians may be merited.

Although the available evidence is insufficient, acupuncture is used in patients suffering from chronic asthma. The aim of this pragmatic study was to investigate the effectiveness of acupuncture in addition to routine care in patients with allergic asthma compared to treatment with routine care alone.Patients with allergic asthma were included in a randomized controlled trial and randomized to receive up to 15 acupuncture sessions over 3 months or to a control group receiving routine care alone. Patients who did not consent to randomization received acupuncture treatment for the first 3 months and were followed as a cohort. All trial patients were allowed to receive routine care in addition to study treatment. The primary endpoint was the asthma quality of life questionnaire (AQLQ, range: 1-7) at 3 months. Secondary endpoints included general health related to quality of life (Short-Form-36, SF-36, range 0-100). Outcome parameters were assessed at baseline and at 3 and 6 months.A total of 1,445 patients (mean age 43.8 [SD 13.5] years, 58.7% female) were randomized and included in the analysis (184 patients randomized to acupuncture and 173 to control, and 1,088 in the nonrandomized acupuncture group). In the randomized part, acupuncture was associated with an improvement in the AQLQ score compared to the control group (difference acupuncture vs. control group 0.7 [95% confidence interval (CI) 0.5-1.0]) as well as in the physical component scale and the mental component scale of the SF-36 (physical: 2.5 [1.0-4.0]; mental 4.0 [2.1-6.0]) after 3 months. Treatment success was maintained throughout 6 months. Patients not consenting to randomization showed similar improvements as the randomized acupuncture group.In patients with allergic asthma, additional acupuncture treatment to routine care was associated with increased disease-specific and health-related quality of life compared to treatment with routine care alone.

Perfluoroalkyl substances (PFASs) are a complex group of man-made chemicals with high stability and mobility leading to ubiquitous environmental contamination and accumulation in the food chain. In human serum/plasma samples, perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) are the lead compounds. They are immunotoxic in experimental animals, and epidemiological studies provided evidence of a diminished production of vaccine antibodies in young children. However, information on children of the first year of age is missing but relevant, as they have a relatively high exposure if breastfed, and may have a higher susceptibility as their immune system is developing. In a cross-sectional study with 101 healthy 1-year-old children, internal levels of persistent organic pollutants and a broad panel of biological parameters were investigated at the end of the 1990s. Additional analysis of PFASs resulted in plasma levels (mean ± SD) of PFOA and PFOS of 3.8 ± 1.1 and 6.8 ± 3.4 µg/L, respectively, in the 21 formula-fed children, and of 16.8 ± 6.6 and 15.2 ± 6.9 µg/L in the 80 children exclusively breastfed for at least 4 months. The study revealed significant associations between levels of PFOA, but not of PFOS, and adjusted levels of vaccine antibodies against Haemophilus influenza type b (Hib, r = 0.32), tetanus (r = 0.25) and diphtheria (r = 0.23), with no observed adverse effect concentrations (NOAECs) determined by fitting a ‘knee’ function of 12.2, 16.9 and 16.2 µg/L, respectively. The effect size (means for PFOA quintiles Q1 vs. Q5) was quantified to be − 86, − 54 and − 53%, respectively. Furthermore, levels of PFOA were inversely associated with the interferon gamma (IFNɣ) production of ex-vivo lymphocytes after stimulation with tetanus and diphtheria toxoid, with an effect size of − 64 and − 59% (means Q1 vs. Q5), respectively. The study revealed no influence of PFOA and PFOS on infections during the first year of life and on levels of cholesterol. Our results confirmed the negative associations of PFAS levels and parameters of immune response observed in other epidemiological studies, with high consistency as well as comparable NOAECs and effects sizes for the three vaccine antibodies investigated, but for PFOA only. Due to reduction of background levels of PFASs during the last 20 years, children in Germany nowadays breastfed for a long duration are for the most part not expected to reach PFOA levels at the end of the breastfeeding period above the NOAECs determined. Electronic supplementary material The online version of this article (10.1007/s00204-020-02715-4) contains supplementary material, which is available to authorized users.

Background: Due to demographic transition, multimorbidity and high numbers of medicinal products, polypharmacy rates will presumably further increase. This could lead to higher risks of potentially inappropriate medications with potential drug-drug interactions (PDDI). PDDI has already been investigated by several studies, but not for patients with indication for prophylactic implantation of a cardioverter defibrillator (ICD). Thus, the objective of this analysis was to examine the frequency of PDDI in that specific group of patients and compare patients with or without PDDI regarding potential underlying factors.Methods: Cross-sectional data analyses were performed using data of the prospective EU-CERT-ICD study that primarily aimed to assess ICD effectiveness in Europe. Self-reported baseline medication data of patients from Germany and Switzerland were used. Patients who reported to take at least two drugs simultaneously for at least 80 days were defined as population at risk. By means of a publicly available interaction checker, we analyzed the medication data regarding occurrence and characteristics of PDDI categorized as minor, moderate, and major PDDI. The analyses were done using descriptive methods and chi square testing.Results: The total population (n = 524) and the population at risk (n = 383) were rather similar with an average age of 64 years and about 80% male. PDDIs were found for 296 patients (in 57% of total population vs. 77% of population at risk). The moderate PDDI category was most frequently with 268 affected patients. Comparing patients with and without any PDDI, the proportion of patients with place of residence in Germany varied distinctly (93% vs. 78%). The frequency of any PDDI for the total population was twice as high in Germany as in Switzerland (p value Conclusions: PDDIs were frequently observed in this selected patient population and differed markedly between German and Swiss patients. The results should lead to higher awareness of polypharmacy and PDDIs. Adequate cooperation between health care providers should be promoted and new technologies such as drug interaction information systems or digital patient files used.Trial registration: The EU-CERT-ICD study is registered at www.clinicaltrials.gov ( NCT02064192).

Physical activity (PA) in youth tends to decline with increasing age, while sedentary behaviour including screen time (ST) increases. There are adolescents, however, whose PA and ST do not follow this pattern. The aim of this study is (i) to examine trajectories in PA and ST from grade 7&ndash, 9 among students in Berlin, and (ii) to investigate the relationship of these trajectories with individual factors and school type. For the present analyses, changes in students&rsquo, PA and ST across three time points from 7th to 9th grade were assessed via self-report questionnaires. Positive and negative trajectories were defined for both PA (positive: increasing or consistently high, negative: decreasing or consistently low) and ST (vice versa). Multivariable logistic regression analyses were performed to identify possible predictors of PA and ST trajectories. In total, 2122 students were included (50.2% girls, mean age 12.5 (standard deviation 0.7) years). Compared to grade 7, less students of grade 9 fulfilled PA and ST recommendations (PA: 9.4% vs. 13.2%, ST: 19.4% vs. 25.0%). The positive PA trajectory included 44% of all students (63% boys), while the positive ST trajectory included 21% of all students (30% boys). Being a boy was significantly associated with a positive PA trajectory, while being a girl, having a high socioeconomic status, and attending a high school, were significantly associated with a positive ST trajectory. Different PA and ST trajectories among adolescents should be taken into account when implementing prevention programs for this target group.

Objectives: Deep vein thrombosis (DVT) is a major health-care burden in Europe, but exact estimates are lacking. This study reports results from the PREFER venous thromboembolism (VTE) study concerning health-related quality of life (HrQoL) and mortality of patients with DVT. Methods: PREFER VTE was a prospective, observational study, conducted in 7 European countries, designed to provide data concerning treatment patterns, resource utilization, mortality, and QoL. First-time or recurrent patients with DVT were followed at 1, 3, 6, and 12 months. Health-related QoL—as measured by the EuroQoL 5-Dimension 5-Level instrument ( EQ-5D-5L)—was analyzed using Tobit regression with repeated measures, assessing the impact of baseline characteristics stratified by cancer activity. Mortality was analyzed using logistic regression. Results: At baseline, patients with DVT had a 0.14 lower EQ-5D-5L index score (0.72 for total sample) compared to the reference UK population (0.85). The EQ-5D-5L index score improved from baseline to 12 months in patients with active cancer (from 0.70 to 0.79) and those without (0.72-0.87); 7.3% died within a year, a 5.2% excess mortality compared to the age- and gender-adfjusted general population. The 12-month mortality rate of DVT varied between 2.9% in the pooled data from Germany, Switzerland, or Austria and 15.4% in Italy. Furthermore, the mortality rate differed between patients with active cancer and those without (42.9% vs 4.7%). Conclusions: Deep vein thrombosis is associated with a substantial burden of illness in terms of HrQoL at baseline, which following treatment normalizes after 12 months and has a significant mortality rate. In addition, active cancer has a significant impact on mortality and the HrQoL of patients with DVT.

BACKGROUND: A small proportion of patients undergoing primary prophylactic implantation of implantable cardioverter defibrillators (ICDs) experiences malignant arrhythmias. We postulated that periodic repolarisation dynamics, a novel marker of sympathetic-activity-associated repolarisation instability, could be used to identify electrically vulnerable patients who would benefit from prophylactic implantation of ICDs by way of a reduction in mortality. METHODS: We did a prespecified substudy of EUropean Comparative Effectiveness Research to Assess the Use of Primary ProphylacTic Implantable Cardioverter Defibrillators (EU-CERT-ICD), a prospective, investigator-initiated, non-randomised, controlled cohort study done at 44 centres in 15 EU countries. Patients aged 18 years or older with ischaemic or non-ischaemic cardiomyopathy and reduced left ventricular ejection fraction (≤35%) were eligible for inclusion if they met guideline-based criteria for primary prophylactic implantation of ICDs. Periodic repolarisation dynamics from 24-h Holter recordings were assessed blindly in patients the day before ICD implantation or on the day of study enrolment in patients who were conservatively managed. The primary endpoint was all-cause mortality. Propensity scoring and multivariable models were used to assess the interaction between periodic repolarisation dynamics and the treatment effect of ICDs on mortality. FINDINGS: Between May 12, 2014, and Sept 7, 2018, 1371 patients were enrolled in our study. 968 of these patients underwent ICD implantation, and 403 were treated conservatively. During follow-up (median 2·7 years [IQR 2·0-3·3] in the ICD group and 1·2 years [0·8-2·7] in the control group), 138 (14%) patients died in the ICD group and 64 (16%) patients died in the control group. We noted a 43% reduction in mortality in the ICD group compared with the control group (adjusted hazard ratio [HR] 0·57 [95% CI 0·41-0·79]; p=0·0008). Periodic repolarisation dynamics significantly predicted the treatment effect of ICDs on mortality (adjusted p=0·0307). The mortality benefits associated with ICD implantation were greater in patients with periodic repolarisation dynamics of 7·5 deg or higher (n=199; adjusted HR 0·25 [95% CI 0·13-0·47] for the ICD group vs the control group; p

BACKGROUND The individual and societal burden of Alzheimer's disease (AD) is substantial. Identifying relevant factors deteriorating AD and inducing need for nursing care would be of high relevance for healthcare planning. OBJECTIVE The main objective of this study was the identification of predictors of first assignment of a level of long-term care in AD, used as an approximation for disease progression. METHODS In a retrospective cohort study using data from a large German statutory health and long-term care insurance (SHI) company, co-morbidities and drug exposure were evaluated with respect to their predictive value for disease progression (first day the amount of daily nursing care exceeded 1.5 hours). Time to disease progression was modeled using COX-proportional hazard regression with stepwise selection of predictor variables. RESULTS The risk of nursing care need increased substantially with increasing age. Number of hospitalizations and number of different drugs used were significant indicators for progression, whereas outpatient visits were associated with a reduced need for care. Gender did not indicate significant influence on progression. Malignant neoplasms of ill-defined, secondary, and unspecified sites, malnutrition, renal failure, and injuries increased the risk of need for nursing care most significantly. Among prescribed drugs, significant increased risks were associated with drugs used in diabetes, preparations for treatment of wounds and ulcers, antiseptics and disinfectants, and analgesics. CONCLUSIONS Physical comorbidities are relevant contributors to an increase in need for nursing care. Some medical predicting conditions may be linked to cognition, while others may be directly linked to demand for care. AD patients with these comorbidities should be monitored with special attention, as they may be under an increased risk of care dependency.

Introduction There is a lack of performance comparisons of the generic quality of life tool EQ-5D-5L against disease- and treatment-specific measures in venous thromboembolism (VTE). The aim of this study was to compare EQ-5D-5L against the pulmonary embolism (PE)-specific PEmb-QoL and the deep vein thrombosis (DVT)-specific VEINES-QOL/Sym, and PACT-Q2 (treatment-specific) questionnaires in five language settings. Methods PREFER in VTE was a non-interventional disease registry conducted between 2013 and 2014 in primary and secondary care across seven European countries with five languages, including English, French, German, Italian and Spanish. Consecutive patients with acute PE/DVT were enrolled and followed over 12months. Only patients who completed all three questionnaires at baseline were included in the study sample. The psychometric properties examined included acceptability (missing, ceiling and floor effects), validity (convergent and known-groups validity), and responsiveness. Known groups validity and responsiveness were assessed using both effect size (Cohen's d) and relative efficiency (F-statistic). All analyses were conducted in each language version and the total sample across all languages. Results A total of 1054 PE and 1537 DVT patients were included. 14% of PE and 10% of DVT patients had the maximum EQ-5D-5L index score. EQ-5D-5L was low to moderately correlated with other measures (r

Venous thromboembolism (VTE) is often accompanied by co-morbidities, which complicate and confound data interpretation concerning VTE-related mortality, costs and quality of life. We aimed to assess the contribution of co-morbidities to the burden of VTE. The PREFER in VTE registry, across seven European countries, documented and followed acute VTE patients over 12 months. Patients with co-morbidities were grouped in major co-morbidity groups: cancer, cardiovascular (CV) comorbidity (other than VTE), CV risks, venous, renal, liver, respiratory, bone and joint diseases, and lower extremity paralysis. Mortality rates and health-related quality of life (HrQoL) utility values grouped per co-morbidity were compared to the UK general population. Regression analyses were performed to determine the impact of co-morbidities on mortality and HrQoL. VTE were analyzed together and separately as pulmonary embolism (PE) and deep vein thrombosis (DVT). In total, 3455 patients were included, 40.5% with PE and 59.5% with DVT. 13% and 16% of the PE and DVT patients had no co-morbidities and had a 12-month mortality rate of 1.8% and 1.7%, respectively. Frequency and severity of co-morbidities increased mortality rates up to 30%. The EQ-5D-5L index in patients without co-morbidities were 0.826 and 0.838 for PE and DVT. These scores decreased to 0.638 and 0.555 in the presence of co-morbidities. Co-morbidities in VTE patients are common. VTE had an impact on mortality and HrQoL, and additional impact of co-morbidities was seen. Awareness of the presence of co-morbidities is important when making VTE-related treatment decisions. The presence of co-morbidities in PE and DVT patients is common and their frequency and severity in VTE patients have a substantial impact on mortality rates and HrQoL. When adjusting for co-morbidities, the impact of VTE on mortality as well as health-related quality of life remains present. Assessing patients without consideration of co-morbidities might lead to misinterpretations of the disease burden of PE and DVT.

There is only a limited number of studies on associations between musical activity and health issues. It seems that musical activity has physiological and psychological benefits, as well as effects on the mental capacity, but this has been studied only in a few clinical and epidemiological studies. One reason might be that no appropriate survey instrument assessing musical activity is available.Here we provide an overview of survey instruments that assess musicality and musical activity. One focus is the presentation of a newly developed German questionnaire (MusA), which assesses musical activity (active music making and music reception) and was specifically developed for the "German National Cohort", a German health study.Through literature research, questionnaires were identified that assess musicality and / or musical activity. A new German questionnaire was developed from a panel of experts and tested in a small study (n=121, women and men age 18-70 years).In the literature research, 3 questionnaires were identified which focus on musicality and musical activity with different aspects (Gold-MSI, MUSE, MEQ). All 3 instruments may be characterized as large psychometric scales, which especially assess aspects of musicality in the English language. The Gold-MSI is additionally available in German. None of the existing questionnaires covers musical activities in detail. A new short German questionnaire consisting of 9 questions with a maximum filling time of 3-5 min has been developed.There are few questionnaires available for assessing musicality and musical activity with different aspects. The newly developed MusA in the German language focuses on the assessment of musical activity and is intended to be used in larger, population-based as well as clinical studies, to examine music activities and listening to music as independent factors in connection with prevention and therapy of chronic diseases.Zusammenhänge zwischen musikalischer Aktivität und dem Auftreten von Erkrankungen sind bisher nur in wenigen Studien untersucht, obgleich es viele Hinweise gibt, dass musikalische Aktivität einen Einfluss auf physiologische, pathophysiologische, psychische und kognitive Prozesse hat. Eine Ursache für die geringe Anzahl größerer Studien könnte das Fehlen eines geeigneten Erhebungsinstrumentes sein. ZIEL: Ziel der vorliegenden Arbeit ist es, einen Überblick über Erhebungsinstrumente zur Erfassung von Musikalität und musikalischer Aktivität zu geben. Ein Schwerpunkt liegt dabei in der Vorstellung eines neu entwickelten Fragebogens (MusA), der die musikalische Aktivität (aktives Musizieren und Musikrezeption) erfasst und derzeit bereits in der NAKO Gesundheitsstudie eingesetzt wird.Mittels Literaturrecherche wurden Fragebögen identifiziert, die Musikalität und/ oder musikalische Aktivität erfassen. Von einer Expertenrunde wurde ein neuer deutschsprachiger Fragebogen entwickelt und in einer kleinen Studie hinsichtlich seiner Reliabilität getestet (n=121, Männer und Frauen im Alter von 18 bis 70 Jahren).Bei der Literaturrecherche wurden 3 Fragebögen (Gold-MSI, MUSE, MEQ) identifiziert, die sich mit Aspekten der Musikalität und musikalischen Aktivität mit jeweils unterschiedlicher Schwerpunktsetzung befassen. Alle 3 Instrumente sind als umfangreiche psychometrische Skalen zu bewerten, die sich insbesondere der Musikalität widmen. Bisher steht nur der Gold-MSI in einer deutschen Übersetzung zur Verfügung. Keiner der 3 bestehenden Fragebögen erfasst die musikalische Aktivität differenziert. Der neu entwickelte, kurze MusA-Fragebogen, bestehend aus 9 Fragen mit einer maximalen Ausfülldauer von 3 bis 5 Min, schließt diese Lücke.Es stehen nur wenige Fragebögen zur Erfassung von Musikalität und musikalischer Aktivität mit unterschiedlicher Schwerpunktsetzung zur Verfügung. Der neu entwickelte deutschsprachige MusA dient der differenzierten Erfassung von musikalischer Aktivität und soll eingesetzt werden, um in größeren populationsbasierten aber auch klinischen Studien wie z. B. der NAKO Gesundheitsstudie aktives Musizieren und Musikhören als eigenständige Faktoren im Zusammenhang mit Prävention und Therapie chronischer Erkrankungen untersuchen zu können.

The main objective of this analysis was to assess the medical and economic differences between patients with and without diagnosed Alzheimer's Disease (AD). Analysis included co-morbidities, patterns of drug use, and clinical course, as well as the magnitude of these differences attributable to AD.This evaluation is based on retrospective analyses of anonymized claims data from 2005-2008 provided by a large German Statutory Health Insurance (SHI). Cross-sectional analyses were performed with the following data: demographics, number of hospitalizations, number of in-patient days, number of ambulatory physician visits, number of drugs used, total number of defined daily doses (DDD) of prescribed drugs, and costs. A propensity score model was used to assess costs attributable to AD.Patients with AD caused substantially higher costs from the perspective of a SHI. The differences in long-term care costs explained 70-75% of the total cost difference, with being responsible for about half of the total costs in AD patients. Comparing matched AD patients with controls resulted in 2.2-2.4-fold higher costs in the cross-sectional analysis, €7413-€9207 for AD patients vs €3378-€3850 for controls. The propensity score model resulted in a difference of €3771 attributable to AD. These costs are mainly caused by differences in hospitalization and long-term care costs.This analysis is one of the largest health economic studies of AD in Germany. The limitations of this study include the fact that reported diagnosis couldn't be validated and disease severity was not taken into account. Despite these methodological constraints, it can be concluded that AD is a substantial cost driver from the SHI payer perspective in Germany.

ObjectivesFew studies have explored the impact of neighbourhood socioeconomic status (SES) on health behaviours in youths in Germany. Our aim was to investigate the association of individual and neighbourhood SES with physical activity (PA) and screen time (ST) in students aged 12–13 years in Berlin.DesignCross-sectional study.SettingSecondary schools (high schools and integrated secondary schools) in Berlin, Germany.ParticipantsA total of 2586 students aged 12–13 years (seventh grade).Main outcome measuresSociodemographics, anthropometric data and health behaviours were assessed by self-report during classes. Primary outcome was the association of individual and neighbourhood SES with meeting daily PA and exceeding daily ST recommendations. Students’ characteristics were described with means or percentages. Comparisons were performed using generalised linear mixed model yielding ORs with 95% CIs.ResultsMean (±SD) age was 12.5±0.5 years, 50.5% were girls and 34.1% had a migrant background. When adjusting for individual covariates, associations of low versus high individual SES were 0.85 (0.48; 1.52) for PA and 2.08 (1.26; 3.43) for ST. Associations of low versus high neighbourhood SES were 1.76 (1.12; 2.75) for PA and 1.54 (1.10; 2.17) for ST. After additional adjustment for school type and school neighbourhood SES, associations comparing low versus high individual and neighbourhood SES were attenuated for PA (individual SES 0.74 (0.41; 1.33) and neighbourhood SES 1.51 (0.93; 2.46)) and ST (individual SES 1.88 (1.12; 3.14) and neighbourhood SES 1.40(0.98; 2.00).ConclusionsLower individual and neighbourhood SES were associated with higher ST. Lower neighbourhood but not individual SES was associated with higher PA. After consideration of school type and school neighbourhood SES associations were attenuated and became insignificant for the relationship between neighbourhood SES, PA and ST. Further research is warranted to unravel the complex relationships between individual SES, neighbourhood SES and school environment to develop more targeted health promotion strategies in the future.

Objectives\ud Pulmonary embolism (PE) is associated with a substantial economic burden. However evidence from patients in Europe is scarce. The aim of this study was to report the impacts of PE on healthcare resource utilization (HCRU) and return to work using the PREFER in VTE registry.\ud \ud Methods\ud The PREFER in VTE registry was a prospective, observational, multicenter study in seven European countries, aiming to provide data concerning treatment patterns, HCRU, mortality, quality of life and work-loss. Patients with a first-time or recurrent PE were included and followed up at 1, 3, 6 and 12 months. Treatment patterns, re-hospitalization rates, length of hospital stays (LOS), and ambulatory/office visits, as well as proportion of patients returning to work, were assessed. Subgroups by country and with/without active cancer were examined separately. Zero-inflated negative binomial and Cox regression were applied to investigate the relationship between baseline characteristics and LOS and return to work, respectively.\ud \ud Results\ud Amongst 1399 patients with PE, 53.2% were male and the average age was 62.3 ± 17.1 years old. Overall, patients were treated with combinations of heparin, vitamin K antagonists (VKA) and the non-VKA oral anticoagulants (NOACs) (50.0% treated with the combination of heparin with VKA). Patients with active cancer were primarily treated with heparin (84.9%). NOACs were used more frequently in DACH (Germany, Austria and Switzerland) and France (55.2% and 32.6%) compared to Italy and Spain (4.5% and 6.1%). The VTE-related re-hospitalization rate within 12 months and the average LOS varied substantially between countries, from 26.2% in UK to 12.3% in France, and from 12.9 days in Italy to 3.9 days in France. PE patients were often co-managed by general practitioners in France and DACH (>84%), and less frequently in other countries (

Background and aims Implantable cardioverter defibrillator (ICD) remote follow-up and ICD remote monitoring (RM) are established means of ICD follow-up. The reduction of the number of in-office visits and the time to decision is proven, but the true clinical benefit is still unknown. Cost and cost-effectiveness of RM remain leading issues for its dissemination. The MONITOR-ICD study has been designed to assess costs, cost-effectiveness, and clinical benefits of RM versus standard-care follow-up in a prospective multicenter randomized controlled trial. Methods and results Patients indicated for single- or dual-chamber ICD are eligible for the study and are implanted an RM-capable Biotronik ICD (Lumax VR-T or Lumax DR-T; Biotronik SE & Co KG, Berlin, Germany). Implantable cardioverter defibrillator programming and alert-based clinical responses in the RM group are highly standardized by protocol. As of December 2011, recruitment has been completed, and 416 patients have been enrolled. Subjects are followed-up for a minimum of 12months and a maximum of 24months, ending in January 2013. Disease-specific costs from a societal perspective have been defined as primary end point and will be compared between RM and standard-care groups. Secondary end points include ICD shocks (including appropriate and inappropriate shocks), cardiovascular hospitalizations and cardiovascular mortality, and additional health economic end points. Conclusions The MONITOR-ICD study will be an important randomized RM study to report data on a primary economic end point in 2014. Its results on ICD shocks will add to the currently available evidence on clinical benefit of RM.

Acupuncture is increasingly used in patients with allergic asthma, but there is a lack of evidence on the cost-benefit relationship of this treatment. The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone. DESIGN, SUBJECTS, INTERVENTION, OUTCOME MEASURES: In a randomized controlled trial, patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group. Both groups were free to use routine care treatment. The resource consumption, costs, and health-related quality of life were evaluated at baseline, and after 3 and 6 months by using statutory health insurance information and standardized questionnaires. Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio (ICER) of acupuncture treatment.Three hundred and six (306) patients (159 acupuncture; 147 controls) were included (mean age 46.5±13.11 years, female 57.2%) and were comparable at baseline. Acupuncture treatment was associated with significantly higher costs compared to control patients (overall costs: €860.76 [95% confidence interval (CI) 705.04-1016.47] versus €518.80 [95% CI 356.66-680.93]; p=0.003; asthma-related costs: €517.52 [95% CI 485.63-549.40] versus €144.87 [95% CI 111.70-178.05]; p0.001). These additional costs seem essentially driven by acupuncture costs themselves (€378.40 [95% CI 367.10-389.69]). However, acupuncture was associated with superior effectiveness in terms of quality-adjusted life years (QALYs). Resulting ICER lay between €23,231 (overall) and €25,315 (diagnosis-specific) per additional QALY. When using German acupuncture prices of year 2012, the ICER would improve to €12.810 (overall) versus €14,911 (diagnosis-specific) per QALY gained.Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients' quality of life. Acupuncture therefore seems to be a useful and cost-effective add-on treatment.

Background We aimed to describe the current management of patients with atrial fibrillation (AF) by cardiologists, and to identify predicting factors for a stable disease course. Methods 2753 consecutive patients with ECG-confirmed AF in the previous 12months were documented in a 1-year observational (non-interventional) study from 616 centers. Stable disease was defined as having neither AF related intervention nor change in antiarrhythmic therapy in the previous 12months. Stepwise selection of parameters for multivariate regression was used to identify factors for stable AF. Results At baseline, paroxysmal AF was reported in 33.5%, persistent in 26.7%, and permanent in 39.7%; rate control alone was the prevailing antiarrhythmic strategy (64.2%). Drugs for thromboembolic prevention were administered in 93.8%, with a clear predominance of oral anticoagulants (OAC), alone or in combination with antiplatelet drugs. Electrical or pharmacological conversions were reported in 23.6%. A total of 96 (3.5%) patients in the total cohort experienced stroke, 72 patients (2.6%) TIA, and 24 (0.9%) arterial embolism. 26% were hospitalized during follow-up (0.4 events per patient), and 9.4% developed incident heart failure (42% prevalence at follow-up). The rate of stable patients was 43.4%. In the multivariate model male gender, history of stroke, and permanent (vs. persistent) AF were associated with stable disease. Conversely, the factors chronic heart failure, impaired left ventricular function, rhythm-control (vs. other), OAC and antiplatelet therapy were significantly correlated with unstable disease. Conclusions The relatively low proportion of stable patients and in particular, the high hospitalization and stroke rate indicate difficulties in everyday management of patients with AF.

Background Allergic rhinitis (AR) is a frequent allergic disorder with a significant economic effect on health care costs and productivity. Objective To assess the cost-effectiveness of acupuncture for patients with seasonal AR (SAR) in Germany. Methods The present analysis was part of the Acupuncture in Seasonal Allergic Rhinitis (ACUSAR) trial, a 3-arm randomized, controlled, multicenter trial in patients with SAR, comparing acupuncture plus rescue medication (RM), penetrating sham acupuncture plus RM, and a control group receiving RM alone. Measures for health economic analyses were costs and health-related quality of life. Incremental cost-effectiveness ratio was calculated for different scenarios on the duration of acupuncture effects and was expressed as costs per quality-adjusted life-year gained. The study was conducted from society's and from a third-party payer's perspective. Results From 422 initially randomized patients, a total of 364 patients with complete data on costs and quality of life were included in the health economic evaluation. Patients receiving acupuncture or sham acupuncture caused higher costs than patients in the RM group. Patients in the acupuncture group gained significantly more quality-adjusted life-years compared with the RM group. Depending on different scenarios, the incremental cost-effectiveness ratio for acupuncture patients was between €31,241 (approximately US $38.569) and €118,889 (approximately US $146,777) from society's perspective and between €20,807 (approximately US $25,688) and €74,585 (approximately US $92.080) from a third-party payer's perspective. Conclusion Acupuncture is an effective intervention that results in improved quality of life in patients with SAR. However, in times of limited resources for health care, acupuncture for AR may not be a cost-effective intervention. Trial Registration clinicaltrials.gov Identifier: NCT00610584

Background Cardiovascular disease continues to be the single most common cause of death and to account for the largest single portion of treatment costs in Germany. Reliable data on regional differences in the frequency of cardio - vascular disease are important for the planning of targeted care structures and preventive measures. Methods Pooled data from the German Health Update (GEDA), a nationwide telephone health survey conducted in 2009, 2010 and 2012 (n = 62 214) were used to estimate the lifetime prevalence of major cardiovascular disease (self-reported medical diagnosis of myocardial infarction, other coronary heart disease, stroke, or congestive heart failure) in each of the German federal states. The influence of sociodemographic factors on regional prevalence differences was examined in adjusted logistic regression analyses. Prevalences were compared with mortality rates from cardiovascular disease that were obtained from cause-of-death statistics. Results The lifetime prevalence of cardiovascular disease in Germany ranged from 10.0% in Baden-W¨rttemberg to 15.8% in Saxony-Anhalt. After adjustment for age, sex, socioeconomic status, and size of the communities of residence, nine of the other 15 states had significantly higher prevalences than Baden-W¨rttemberg, with odds ratios ranging from 1.26 (Hesse) to 1.55 (Saxony-Anhalt). Four of the five states that previously constituted the German Democratic Republic (East Germany) had above-average figures for prevalence and mortality. Conclusion There are relevant differences among the German federal states in the lifetime prevalence of major cardiovascular disease, which are only partly accounted for by differences in age and sex distribution, socioeconomic status, and community size.

Histological Barrett's esophagus, defined as specialized intestinal metaplasia (SIM+) at the cardia without endoscopic suspicion of columnar epithelium, is found frequently in biopsies at the gastro-esophageal junction although its clinical relevance is unknown. The authors aim was to evaluate prospectively the progression of SIM+ to macroscopically evident Barrett's esophagus (BE/SIM+), and to identify risk factors for this progression.Data were obtained from a sub-group of patients (no visible BE at presentation, but SIM+) included in the ProGERD study, a prospective evaluation of the clinical course of GERD under routine clinical care. They had esomeprazole 20-40 mg/day for 2-8 weeks. Symptom assessment was performed annually, and endoscopy with biopsy was planned at baseline, after healing treatment and after 2 and/or 5 years.128 of 171 (74.8%) patients with unequivocal SIM at the z-line after healing were biopsied again after 2 and/or 5 years. At follow-up, 33 (25.8%) of these patients showed progression to BE/SIM+. Factors significantly associated with progression were smoking, a long history of GERD and severe esophagitis at baseline. Patients who had progressed to BE/SIM+ already at 2 years showed consistent findings at 5 years.More than 20% of GERD patients with SIM+ in this study were found to have BE/SIM+ within 2-5 years. This finding supports the hypothesis that SIM+ at the cardia could be the missing link explaining increased cancer risk in GERD patients without overt BE and merits further investigation in a prospective study.

Heart failure is an increasing burden for all healthcare systems with prevalence reaching over 20 million patients worldwide and direct costs of disease requiring ∼1% of healthcare budget expenditures. Beyond traditional pharmaceutical treatment, medical devices and remote monitoring tools were introduced to ensure a closely managed control of patients. In this context, a decision-maker needs to know whether the new technology provides clinical benefit towards patients and what resource use is attached to them.Health services research is a complementary approach to clinical trials providing results to the impact of the technology in real life settings. As an example this study reports of a secondary data analysis of one of the largest health insurance companies in Germany, comparing resource use of heart failure patients receiving a cardiac resynchronization therapy (CRT) device coupled with a fluid status monitoring and alert function with patients receiving conventional CRT, ICD (implantable cardioverter defibrillator), or no intervention.Disease-associated expenses can be attributed to far more than 50% to heart failure. Although implementation of the CRT device with alert function was most expensive (31,794 Euros compared to 27,659 Euros in the conventional CRT group, 24,128 Euros in the ICD group, and 3735 Euros in the no intervention group) in the first year after implementation, the least costs have been caused in this group (7000 Euros compared to more than 11,000 Euros in all other groups).This article highlights potential health services research approaches focusing on the example of a CRT device coupled with a pulmonary diagnostic and alert function. Although this retrospective analysis holds a number of limitations (e.g., small number of patients in intervention group, cost calculations only from the payer perspective), and despite the need for randomized controlled trials, it was shown that secondary data research in this field is a valuable approach.

To determine the cost-effectiveness of adding eptifibatide to the standard treatment for selected high-risk patients undergoing coronary stenting in Germany. Furthermore, to investigate the impact of several extrapolation methods on the results. A Markov model was developed to reflect the clinical events in this specific patient population, including target vessel revascularization, myocardial infarction, and death. To extrapolate clinical data beyond 1 year, a linear, an exponential, and a Weibull survival curves were estimated. Patient characteristics and transition probabilities were derived from a high-risk subgroup of the ESPRIT trial; patient-level utility data came from a published Dutch study. Costs were calculated from a hospital and from a third-party payer perspective. For both perspectives, the additional treatment with eptifibatide is the considered dominant alternative. The incremental net benefit of its use exceeds €10,000 for both perspectives. Results proved stable in probabilistic sensitivity analysis as well as under the different extrapolation scenarios. Eptifibatide is likely to be dominant strategy with 77.7 and 96.7% of the simulations leading to QALYs gained and generating cost savings from both the hospital and the third-party payer perspective. Eptifibatide offsets its additional treatment costs by avoiding costly repeat procedures and leads to positive QALY gains by preventing cardiovascular events lending themselves to transient or permanent lower quality of life. The method used to extrapolate the short-term risks did not impact on results, mainly due to similar clinical risk profiles between the two treatment groups in the long term.

Observational studies from the USA have demonstrated that off-label use of drug-eluting stents (DES) is common. Data on off-label use in Western Europe are limited.We analyzed the data of consecutive patients receiving DES prospectively enrolled in the multicenter German DES.DE registry (Deutsches Drug-Eluting Stent Register) between October 2005 and October 2006. Off-label use was defined in the presence of one of the following criteria: ST-elevation myocardial infarction, in-stent stenosis, chronic total occlusion, lesions in a bypass graft, in bifurcation or left main stem, stent length per lesion ≥32 mm, and vessel diameter 2.5 or 3.5 mm.Overall, 4,295 patients were included in this analysis and divided into two groups: 2,366 (55.1%) received DES for off-label and 1,929 (44.9%) for on-label indications. There were substantial differences in the rates of off-label use at the participating hospitals. Patients with off-label DES more often presented with high-risk features such as acute coronary syndrome, cardiogenic shock, congestive heart failure, and more complex coronary anatomy. Among hospital survivors, the incidence of the composite endpoint of death, myocardial infarction and stroke (MACCE) (9.2 vs. 7.4%, p 0.05), and target vessel revascularization (TVR) (11.3 vs. 9.1%, p 0.05) was increased in the off-label group at the 1-year follow-up. However, in the multivariate analysis off-label use was not linked with an elevated risk for MACCE (hazard ratio 0.86, 95% confidence interval 0.62-1.18) and TVR (hazard ratio 1.05, 95% confidence interval 0.78-1.42).In clinical practice, DES was very frequently used off-label. After adjustment for confounding variables, off-label use was not associated with an increase of adverse events.

Complementary and alternative medicine (CAM) is frequently used in patients in industrialised countries. Despite this popularity, there remains a considerable deficit of discourse and cooperation between physicians practicing CAM and conventional medicine. The aim is to present the methodology and results of the first international case conference on integrative medicine (IM) dealing with a patient with low back pain. In this paper the methodological tool "case conference on IM" is also described.The interactive case conference took place on November 20th, 2009 as part of the "2nd European Congress of IM" in Berlin, Germany. An experienced expert panel from both conventional medicine and CAM developed integrative medical diagnoses and therapeutic strategies using as their starting point an individual patient case on chronic low back pain (LBP). The case was selected because LBP is a common diagnosis with considerable economic impact and a problem which is often treated with CAM.In this case conference, the expert panel agreed on a diagnosis of "chronic non-specific LBP with somatic and psychological factors" and proposed multi-modal short- and long-term treatment including of CAM. The importance of the patient-physician-relationship and the consultation process with appropriate consultation time for treatment success was highlighted. There was consensus that the diagnostic process and resulting treatment plan should be individualised and focussed on the patient as a complete person, identifying the significance the disease has for the patient and not just on the disease for itself. Considerable differences were found amongst the experts regarding the first steps of treatment and each expert saw possibilities of "effective and adequate treatment" being met by their own individual treatment method.The case conference on integrative medicine stimulated an intensive exchange between the approaches used by conventional medicine and CAM clarifying different treatment possibilities for low back pain. Therefore, case conferences on integrative medicine could serve as a model for evaluating similar activities in academic hospitals and establishing such approaches in routine medical care. This strategy has the potential to improve patient centred care.

The aim was to investigate the frequency of adverse effects due to acupuncture treatment, the need for treatment and the costs in patients with chronic low back or neck pain. This prospective observational study included patients who received acupuncture for chronic low back pain or chronic neck pain. After treatment all patients documented adverse events associated with acupuncture (defined as adverse effects) and provided details e.g. on treatment. Cost data was provided by the health insurance companies. We used a societal perspective including direct health care costs related to the acupuncture and the indirect costs caused through lost workdays. From 73,406 patients, 5440 patients (7.4% [95% CI 7.2%; 7.6%] reported experiencing at least one adverse effect and 1422 patients (1.9% [1.8%; 2.0%]) required treatment. The subsequent treatments reported were either self-treatment (1.2% [1.09%; 1.25%]), treatment with medication and/or by a physician (0.6% [0.57%; 0.68%]), or treatment in a hospital (0.03% [0.02%; 0.04%]). Patients reporting adverse effects that required treatment had higher costs compared to patients without adverse effects (at 3 months €1265 [1179; 1351] vs. €1140 [1128; 1153] and at 12 months € 3534 [3256; 3812] vs. € 3249 [3209; 3289]. The difference was caused through the expense of visiting physicians and higher indirect costs (difference at 3 months: €125 [38; 211], p = 0.005 and at 12 months: €285 [4; 566], p = 0.047). Adverse effects from acupuncture occur in about 7% of patients and were mainly treated by themselves. When these effects needed treatment by a health professional additional expenses were the consequence.

Objective: To compare the efficacy of applying hot dry air versus dry air at room temperature to the throat of patients with a newly acquired common cold using a symptom severity score. Design, setting and participants: A randomised single-blind controlled trial with a treatment duration of 3 days and a follow-up period of 4 days was conducted at a sauna in Berlin, Germany. Between November 2007 and March 2008 and between September 2008 and April 2009, 157 patients with symptoms of the common cold were randomly assigned to an intervention group (n = 80) and a control group (n =7 7). Interventions: Participants in the intervention group inhaled hot dry air within a hot sauna, dressed in a winter coat, whereas participants in the control group inhaled dry air at room temperature within a hot sauna, also dressed in a winter coat. Main outcome measures: Area under the curve (AUC) summarising symptom severity over time (Days 2, 3, 5 and 7), symptom severity scores for individual days, intake of medication for the common cold and general ill feeling. Results: No significant difference between groups was observed for AUC representing symptom severity over time (intervention group mean, 31.2 [SEM, 1.8]; control group mean, 35.1 [SEM, 2.3]; group difference, − 3.9 [95% CI, − 9.7 to 1.9]; P = 0.19). However, significant differences between groups were found for medication use on Day 1 (P = 0.01), symptom severity score on Day 2 (P = 0.04), and participants’ ratings of the effectiveness of the therapy on Day 7 (P =0 .03). Conclusion: Inhaling hot air while in a sauna has no significant impact on overall symptom severity of the common cold. Trial registration

ObjectiveThe prevalence of overweight and obesity is increasing in most countries, including Germany. The idea of estimating the population-wide energy gap that is likely responsible for the epidemic has recently been introduced and discussed.DesignUsing published estimates of body weight from population-based data of national health surveys (1985–2002), the energy gap was calculated by estimating the distribution of the rate of weight gain within the German population (25–69 years of age) and the amount of excess energy storage that is responsible for this population-wide pattern of weight gain.SettingGermany.SubjectsA representative sample of 26 614 participants (12 984 men, 13 630 women).ResultsThe average annual weight gain was 0·22 kg for men and 0·32 kg for women over the 17-year period. An estimated 90 % of the population gained < 0·54 kg/year. Assuming that each kilogram of weight gained represents 32238 kJ (7700 kcal), the estimated energy accumulation was 19 kJ (4·64 kcal)/d in men and 28 kJ (6·75 kcal)/d in women aged 25–69 years. The distribution of estimated energy accumulation for 90 % of the German population was < 50 kJ (12 kcal)/d.ConclusionsWith an assumed energy efficiency of 50 %, the findings suggest that weight gain could be prevented in 90 % of the German population with < 100 kJ (24 kcal) reduction in energy intake or increase in energy expenditure per day. Theoretically, further weight gain might be prevented using a small-changes approach that emphasizes the importance of making small changes in physical activity and food intake.

Previous research revealed substantial differences in mortality due to ischemic heart disease (IHD) between the 16 German states. As variation may also be present within these states, analyses with higher geographical resolution are necessary to characterize changes in the magnitude of variation over time.To describe regional differences of IHD mortality in Germany over a period of 10 years (1998 and 2007) on a county level and to investigate whether variation in mortality can be explained by region.Data on deaths due to IHD (ICD 10 I20-I25) and the number of inhabitants were obtained from the State Offices for Statistics to calculate age-standardized rates. Poisson regression models with and without random effects and measures of absolute variability (standard deviation) and relative variability (coefficient of variation) were used to analyze mortality due to IHD.Regional differences in IHD mortality were observed (p0.001) with the highest burden in the northeast and the lowest in the southwest. From 1998 to 2007, age-standardized mortality rates due to IHD decreased by35% in men and women (p0.001). While measure of absolute variability between German regions also decreased by35% (p0.001), measures of relative geographical differences did not change in men (-2.5%, p = 0.618) and decreased only slightly in women (-10.2%, p = 0.044).There is a marked regional variation of IHD mortality in Germany. The relative variability changed little during the last 10 years and provides a unique chance to characterize the impact of important IHD risk factors on the population level and improve preventive strategies.

Recent evidence suggests that gallstones and kidney stones are associated with insulin resistance, but the relation between stone diseases and the risk of developing type 2 diabetes mellitus is not clear. Participants in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam Study (Potsdam, Germany) provided information about the presence of gallstones and kidney stones at recruitment between 1994 and 1998. On biennial questionnaires, participants reported newly diagnosed type 2 diabetes mellitus, and confirmation was obtained from treating physicians. During a mean follow-up period of 7.0 years between 1994 and 2005, 849 incident cases of type 2 diabetes were identified among 25,166 participants. After adjustment for sex, age, waist circumference, and lifestyle risk factors, persons with reported gallstones (n = 3,293) had an increased risk of type 2 diabetes (relative risk = 1.42, 95% confidence interval: 1.21, 1.68). Among the 23,817 participants with information on reported kidney stones (784 cases of incident diabetes), those who developed kidney stones (n = 2,468) were not at increased risk of diabetes in multivariable-adjusted models (relative risk = 1.05, 95% confidence interval: 0.86, 1.27). These findings suggest that gallstones, but not kidney stones, may predict the risk of developing type 2 diabetes, providing physicians with an interventional opportunity to implement adequate prevention measures.

We studied costs of healthcare and productivity loss in 487 German outpatients starting anthroposophic treatment: Group 1 was treated for depression, Group 2 had depressive symptoms but were treated for another chronic disorder, while Group 3 did not have depressive symptoms. Costs were adjusted for socio-demographics, comorbidity, and baseline health status. Total costs in groups 1-3 averaged euro7,129, euro4,371, and euro3,532 in the pre-study year (P = 0.008); euro6,029, euro3,522, and euro3,353 in the first year (P = 0.083); and euro4,929, euro3,792, and euro4,031 in the second year (P = 0.460). In the 2nd year, costs were significantly reduced in Group 1. This study underlines the importance of depression for health costs, and suggests that treatment of depression could be associated with long-term cost reductions.

The prospective multicenter German Drug-Eluting Stent (DES.DE) registry is an observational study to analyze and evaluate the therapeutic principle of the differential drug-eluting stents (sirolimus- and paclitaxel-eluting stents) and bare metal stents under real world conditions in the context of the German healthcare system. The baseline clinical and angiographic characteristics and follow-up events for 1 year were recorded for all enrolled patients. In addition, a health economics assessment was performed at 3, 6, 9, and 12 months after initial stent placement. The composite of death, myocardial infarction, and stroke, defined as major adverse cardiac and cerebrovascular events, and target vessel revascularization were used as the primary objectives. From October 2005 to October 2006, 6,384 patients were enrolled (sirolimus-eluting stents, n = 2,137; paclitaxel-eluting stents, n = 2,740; bare metal stents, n = 485) at 98 Deutsches Drug-Eluting Stent Register sites. With similar baseline clinical and descriptive morphology of coronary artery disease between both drug-eluting stent groups, no differences were present at 1 year of follow-up in the rates of overall mortality (3.8% vs 4.1%), target vessel revascularization (10.4% vs 10.4%), overall stent thrombosis (3.6% vs 3.8%), and major adverse cardiac and cerebrovascular events (8.1% vs 8.0%). Compared with the bare metal stent group, patients treated with drug-eluting stents had significantly lower rates of myocardial infarction (3.2% vs 6.0%; p

Background: The use of complementary therapies by patients has increased over the past 20 years, both in terms of self-medication and physician prescriptions. Among herbal medicines, those containing extracts of Asteraceae (Compositae), such as Echinacea spp., Arnica montana, Matricaria recutita and Calendula officinalis, are especially popular in the primary-care setting. However, there remains a gap between the growing acceptance of these remedies and the lack of data on their safety. Objective: The aim of this study was to analyse prescribing patterns and adverse drug reactions (ADRs) for Asteraceae-containing remedies in Germany. Methods: Primary-care physicians, all of whom were members of the German National Association of Anthroposophic Physicians were invited to participate in this prospective, multicentre, observational study. During the study period (September 2004 to September 2006), all prescriptions and suspected ADRs for both conventional and complementary therapies were documented using a web-based system. The study centre monitored all ADR reports and conducted a causality assessment according to Uppsala Monitoring Centre guidelines. Relative risks (RRs) and proportional reporting ratios (PRRs) were calculated. Results: Thirty-eight physicians, 55% of whom were general practitioners and 45% were specialists, fulfilled the technical requirements and were included in the investigation. Because documenting all ADRs (i.e. serious and non-serious) was time consuming, only a subgroup consisting of seven physicians agreed to report nonserious in addition to serious ADRs. During the study period, a total of 50 115 patients were evaluated and 344 ADRs for conventional and complementary remedies were reported. Altogether, 18 830 patients (58.0% female, 60.3% children) received 42 378 Asteraceae-containing remedies. The most frequently prescribed Asteraceae was Matricaria recutita (23%), followed by Calendula officinalis (20%) and Arnica montana (20%). No serious ADRs for Asteraceae-containing remedies were reported. In the analysis of the subgroup of seven physicians who also documented nonserious ADRs, 11 nonserious ADRs for Asteraceae-containing remedies occurred in 6961 patients, resulting in an RR of 0.13 (95% CI 0.07, 0.23). The majority of reported ADRs for Asteraceae-containing remedies were classified as uncommon. A subgroup analysis comparing phytotherapeutic and homoeopathic preparations did not reveal any relevant differences. The PRR for Asteraceae-containing remedies with respect to all other prescriptions was 1.7 (95% CI 1.0, 2.0) for the system organ class ‘skin and subcutaneous tissue disorders’ (six ADRs) and 1.0 (95% CI 0.3, 3.6) for ‘gastrointestinal disorders’ (three ADRs). Neither result was significant according to the PRR criteria developed by Evans et al. Conclusion: This is the first study to provide a systematic overview of prescribing patterns and ADRs for Asteraceae-containing remedies in the German primary-care sector. Asteraceae-containing remedies were used frequently in this context, especially among children. Our results indicate that treatment with Asteraceae-containing remedies is not associated with a high risk of ADRs.

Background and purpose: Educating the public to screen for vascular risk factors and have them treated is a major public health issue. We assessed the vascular risk factor awareness and frequency of treatment in a cohort of patients with cerebral ischaemia. Methods: Data on awareness and pharmacological treatment of vascular risk factors before hospital admission of patients with confirmed ischaemic stroke/transient ischaemic attack (TIA) were analyzed. A follow-up questionnaire assessed the frequency of treatment 1 year after discharge and assessed non-adherence to antithrombotic medication. Results: At time of stroke/TIA, individual awareness regarding existing hypertension, diabetes, hyperlipidemia and atrial fibrillation (AF) was 83%, 87%, 73% and 69% respectively (n = 558). Pharmacological treatment for hypertension, diabetes, hyperlipidemia and AF was being administered in 80%, 77%, 37% and 62% of patients aware of their conditions. The follow-up was completed by 383 patients (80% recall rate): of the patients with hypertension, diabetes, hyperlipidemia and AF, 89%, 78%, 45% and 86% were receiving risk factor targeted medication. This represents a significant increase concerning AF and hyperlipidemia. Non-adherence to recommended antithrombotics (15%) was higher in patients who had had a TIA. Conclusions: All risk factors leave room for improvement in screening and treatment efforts. Adherence to treatment is higher for hypertension and diabetes than for hyperlipidemia. Education efforts should bear in mind less well recognized risk factors.

Background The prevalence of allergic airway diseases in childhood is higher in boys than in girls but switches toward a female predominance in adolescents and adults. The sex-specific prevalence of allergic sensitization to 1 of the most common allergens worldwide, house dust mite (HDM), has not been examined systematically by age group and species. Objective To systematically review the literature to examine sex-specific differences in the prevalence of allergic sensitization to HDM. Methods On the basis of a systematic MEDLINE search for population-based studies published between 1990 and 2007, we conducted meta-analyses of male to female ratios for sensitization to 2 different species of HDMs ( Dermatophagoides pteronyssinus and Dermatophagoides farinae ) separately for children and adults. Results We included data from 7,822 children and 18,522 adults from 15 studies. The prevalence of sensitization to D pteronyssinus was significantly higher in boys vs girls (male to female ratio, 1.39; 95% confidence interval [CI], 1.13-1.71) and in men vs women (male to female ratio, 1.40; 95% CI, 1.22-1.61). For sensitization to D farinae, the significant male predominance in adults was even more pronounced (male to female ratio, 1.95; 95% CI, 1.37-2.79), but there were no sex-specific differences in children (male to female ratio, 0.90; 95% CI, 0.56-1.46). Conclusions In adults, the male predominance in sensitization to HDM seems to be contrary to the prevalence of allergic airway symptoms, which has a female predominance. The male predominance is even higher in allergic sensitization to D farinae than to D pteronyssinus . Further research is necessary regarding sex-specific differences in allergy and asthma.

Atrial fibrillation (AF) is an increasing burden on health-care systems because of an aging population. This study aimed to estimate health-care resource use and costs of treating AF in Germany.A 6-month multicenter prospective observational cohort study with additional 3-month retrospective clinical data collection was performed in physician practices. AF-related resource use was documented by 3-month retrospective and 6-month prospective clinical data from physician charts and prospectively by patient questionnaires at 3 and 6 months. Cost calculation was from the health-care payer perspective.A total of 361 patients (mean age 71 +/- 9 years, 61% male) were recruited from 45 physician practices. Of 311 (86.1%) patients with complete data, 75% had persistent AF; oral anticoagulation and/or aspirin were prescribed in 98%. A rhythm-control strategy was applied in 27%, rate control in 58%, and 15% received neither antiarrhythmic medication nor cardioversion. A higher proportion of rhythm-control patients had paroxysmal AF (P0.001). Mean annual AF-related per-patient cost was 827 Euro +/- 1476 (median 386 Euro). 50% of total costs were incurred by 11% of patients, driven by AF-related hospitalizations (44%). Antiarrhythmics and stroke prophylaxis accounted for 20% and 15% of expenditures, respectively. Mean annualized costs were higher for rhythm-control patients than for rate-control patients or those without antiarrhythmic treatment (1572 vs. 780 vs. 544 Euro, P0.001).This evaluation provides an overview of current treatment modalities and cost of AF management in Germany. Efforts to reduce the economic burden of AF should focus on avoidance of AF hospital admissions and optimization of stroke prevention and rhythm control.

Although anthroposophic medicine has been used for more than 80 years and global interest in complementary treatments is increasing, a comprehensive and long-term description of everyday anthroposophic care is still lacking. Our study aims to evaluate how anthroposophic medicine is practised under everyday conditions.A total of 38 primary-care physicians in Germany participated in this prospective, multi-centre observational study. Prescriptions, diagnoses, and non-pharmacological therapies were reported for each consecutive patient.In 2005, 95,116 prescriptions for 32,839 patients (56.2% children, 57.3% female) were recorded. The median duration of consultation depended on physician specialization (general practitioners: 9.5 min; paediatricians: 8.1 min). The most frequent single diagnoses were acute upper respiratory tract infections (URTI), otitis media, and bronchitis in children; hypertension, breast cancer, and depressive episodes in adult females; and hypertension, URTI, and asthma in adult males. Anthroposophic remedies accounted for 41.8% of all drugs prescribed. The odds ratio (OR) for receiving an anthroposophic remedy was very high for cancer (OR = 4.5; 95% CI: 4.2-4.8) and1 for dorsopathies (OR = 1.5; CI: 1.3-1.6), otitis media (OR = 1.3; CI: 1.2-1.3), and URTI (OR = 1.1; CI: 1.1-1.2). Of the 5,289 therapeutic procedures prescribed, 27% were anthroposophic.A broad range of anthroposophic remedies and non-pharmacological therapies are prescribed for a specific set of diseases in everyday anthroposophic practice. Particularly, patients60 years received anthroposophic care. Our findings will help in the planning and implementation of further studies.

To assess quality of life and cost-effectiveness of additional acupuncture treatment for allergic rhinitis, patients were randomly allocated to 2 groups; both received usual care, but one group received an additional 10 acupuncture sessions. Quality of life (according to the SF-36 Health Survey), and direct and indirect costs, were assessed at baseline and after 3 months, and the incremental cost-effectiveness ratio of acupuncture treatment was calculated. This German study (December 2000-June 2004) involved 981 patients (64% women, mean age 40.9 years (standard deviation, 11.2); 36% men, mean age 43.2 years (standard deviation, 13.0)). At 3 months, quality of life was higher in the acupuncture group than in the control group (mean Physical Component Score 51.99 (standard error (SE), 0.33) vs. 48.25 (SE, 0.33), P < 0.001; mean Mental Component Score 48.55 (SE, 0.42) vs. 45.35 (SE, 0.42), respectively, P < 0.001). Overall costs in the acupuncture group were significantly higher than those in the control group (Euro (euro; 1 euro = US $1.27) 763, 95% confidence interval: 683, 844 vs. 332 euro, 95% confidence interval: 252, 412; mean difference 432 euro, 95% confidence interval: 318, 545). The incremental cost-effectiveness ratio was 17,377 euro per quality-adjusted life year (women, 10,155 euro; men, 44,871 euro) and was robust in sensitivity analyses. Acupuncture, supplementary to routine care, was beneficial and, according to international benchmarks, cost-effective. However, because of the study design, it remains unclear whether the effects are acupuncture specific.

Neuroendocrine tumours (NET) of the gastroenteropancreatic system comprise a malignant entity with a low incidence. Only limited information is available on long-term clinical outcome and clinically applicable prognostic factors. We performed a retrospective analysis of a large, well-characterized centre-based patient cohort of 399 patients with histologically proven NET. Data were analysed according to epidemiological, clinical and histopathological characteristics. Detailed survival analyses using the Kaplan-Meier method were performed. Prognostic factors were tested by log-rank testing and independent risk factors were analysed using a Cox regression model. In the studied cohort, primary tumours originated in the fore-, mid- and hindgut in 46.1, 37.1 and 4.5% respectively. Extra-intestinal or unknown primary tumours were present in 8.4 and 10.5% respectively. Distant metastasis was present at initial diagnosis in 69.4%. Most frequent metastatic sites were liver (85%), peritoneal cavity (18%), bones (8%), other intra-abdominal sites (6%) and lungs (4%). Overall, 5- and 10-year survival rates were 78 and 63% respectively. Time to progression after initial diagnosis was significantly shorter in pancreatic as compared with ileal NET. Survival analysis revealed significantly better clinical outcome for primary tumours smaller than 25 mm, absence of metastasis, absence of any clinical symptoms, positive immunohistochemical staining for chromogranin A and a lower Ki67 index. These results were confirmed as independent by multivariate analysis. Therefore, this large retrospective analysis of a well-documented cohort of patients with NET demonstrates several prognostic factors of clinical relevance and wide availability, which should be considered for risk stratification in the management of NET.

BACKGROUND. Neuroendocrine tumors (NETs) of the gastroenteropancreatic (GEP) system comprise a rare but challenging group of malignant neoplasms and occur at virtually any site of the GEP system. In 2006, a new TNM classification system was proposed for the staging and grading of upper GEP NETs. METHODS. The prognostic relevance of the TNM classification system was analyzed retrospectively in 202 patients from a referral center with histologically proven foregut NET. Patients were classified according to previous classification systems and the TNM classification. Survival data were acquired and statistical analyses were performed by using log-rank and Cox regression testing. RESULTS. Primary tumors were gastric (n = 48), duodenal (n = 23), and pancreatic (n = 131). During the observation period, 21% of patients died. The overall 5- and 10-year survival rates were 75% and 64%, respectively. Previous classification systems discriminated between low-grade and high-grade malignant NETs but did not allow further prognostic differentiation. In contrast, the proposed TNM classification was able to differentiate significantly between different tumor stages (stages I-III vs stage IV; P < .01) and cellular proliferation rates according to Ki-67 labeling (grade 1 vs grade 2, P = .04; grade 1 vs grade 3 and grade 2 vs grade 3, P < .01). Cox regression analysis confirmed an increased risk of reduced survival for patients with stage III or IV NET and grade 2 or 3 NET. CONCLUSIONS. The current results demonstrated the prognostic relevance of the newly proposed TNM classification system for foregut NETs with statistical significance for the subgroups of both the staging classification and the grading system. Thus, the new classification system provides a valid and powerful tool for prognostic stratification of GEP NETs in clinical practice and research. Cancer 2008. © 2008 American Cancer Society.

Context: Resistin is a hormone that has been linked to insulin resistance, inflammatory processes, and coronary heart disease in case-control studies; however, prospective data on the association between plasma resistin levels and future risk of cardiovascular disease are lacking. Objective: The objective of the study was to investigate the association between plasma resistin levels and risk of future myocardial infarction (MI) and ischemic stroke (IS) in a large prospective cohort. Methods: We investigated the association between plasma resistin levels and risk of MI and IS in a case-cohort design among 26,490 middle-aged subjects from the European Investigation into Cancer and Nutrition-Potsdam Study without history of MI or stroke at time of blood draw. Plasma resistin levels were measured in baseline blood samples of 139 individuals who developed MI, 97 who developed IS, and 817 individuals who remained free of cardiovascular events during a mean follow-up of 6 yr. Results: After multivariable adjustment for established cardiovascular risk factors including C-reactive protein, individuals in the highest compared with the lowest quartile of plasma resistin levels had a significantly increased risk of MI (relative risk 2.09; 95% confidence interval 1.01–4.31; P for trend = 0.01). In contrast, plasma resistin levels were not significantly associated with risk of IS (relative risk 0.94; 95% confidence interval 0.51–1.73; P for trend = 0.88). Conclusion: Our data suggest that high plasma resistin levels are associated with an increased risk of MI but not with risk of IS. Further studies are needed to evaluate the predictive value of plasma resistin levels for cardiovascular disease.

Over the past several decades, numerous large cohort studies have attempted to quantify the protective effect of physical activity on cardiovascular and all-cause mortality. The aim of the authors' review was to provide an up-to-date overview of the study results.In a systematic MEDLINE search conducted in May 2007, the authors included cohort studies that assessed the primary preventive impact of physical activity on all-cause and cardiovascular mortality. The authors reported risk reductions on the basis of comparison between the least active and the most active population subgroups, with the least active population subgroup as the reference group. Random-effect models were used for meta-analysis.A total of 33 studies with 883,372 participants were included. Follow-up ranged from 4 years to over 20 years. The majority of studies reported significant risk reductions for physically active participants. Concerning cardiovascular mortality, physical activity was associated with a risk reduction of 35% (95% confidence interval, 30-40%). All-cause mortality was reduced by 33% (95% confidence interval, 28-37%). Studies that used patient questionnaires to assess physical activity reported lower risk reductions than studies that used more objective measures of fitness.Physical activity is associated with a marked decrease in cardiovascular and all-cause mortality in both men and women, even after adjusting for other relevant risk factors.

There is evidence that stress increases the risk of asthma. Chronic noise exposure is known to act as an unspecific stressor, but little is known about its effect on the risk of asthma in children. The aim of this study was to compare subjectively reported noise annoyance in 12-year-old asthmatic and non-asthmatic children with special regard to sex-specific differences.In a German multi-center birth cohort study we assessed the annoyance by different sources of environmental noise, doctor-diagnosed asthma, and potential confounders by questionnaire. The comparisons between asthmatic and non-asthmatic children were stratified by sex.A total of 336 boys and 316 girls were included in the analysis. Prevalence of doctor-diagnosed asthma was 13% in boys and 5% in girls; 73% of the boys and 74% of the girls reported at least some degree of noise annoyance during the day and night time. In girls, asthma was associated with a significantly increased total noise annoyance at night (adjusted odds ratio aOR 1.5, 95%CI 1.1;2.1), for noise within the home/apartment (aOR 3.5, 95%CI 1.5;8.0), and in or around the house (aOR 3.3, 95%CI 1.7;6.3). No statistical significant effects were seen in boys.Noise annoyance, particularly at night or caused by domestic sources, is associated with increased asthma prevalence in girls but not boys. Further research is needed to identify underlying mechanisms of these sex-specific differences.

Background: Gastroesophageal reflux disease (GERD) is a common disorder. The aim of our study was to describe the prevalence of nighttime heartburn and its associations with esophagitis, Barrett’s esophagus, and extra-esophageal symptoms. Methods: Data were collected as part of the ongoing Progression of Gastroesophageal Reflux Disease (ProGERD) study. Based on endoscopy results, patients were categorized as having nonerosive GERD, erosive GERD, or Barrett’s esophagus. ORs and 95% CIs derived from logistic regression analysis were calculated for the association between nighttime heartburn and GERD complications. Results: The overall prevalence of nighttime heartburn for at least 1 of 3 years was 49%, and 21% of patients reported nighttime heartburn in all 3 years. According to multivariate analysis, chronic nighttime heartburn was associated with globus sensation (OR 1.79, 95% CI 1.29–2.47) and erosive GERD (OR 1.67, 95% CI 1.29–2.15). Compared to continuous proton pump inhibitor (PPI) intake, noncontinuous PPI therapy (OR 2.26, 95% CI 1.73–2.96) and medication other than PPIs (OR 2.46, 95% CI 1.67–3.62) were also associated with chronic nighttime heartburn. Conclusions: The prevalence of nighttime heartburn in GERD patients under routine care was high, even in patients on continuous PPI therapy. Nighttime heartburn was not associated with Barrett’s esophagus or most extra-esophageal symptoms.

The GERSHWIN study (German Stent Health Outcome and Economics Within Normal Practice) was designed to evaluate long-term effects of treatment of coronary artery disease (CAD) with sirolimus-eluting stents (SES), as compared to bare-metal stents (BMS). Within a multicenter, prospective intervention study in 35 hospitals throughout Germany, CAD patients with coronary stenosis and elective percutaneous coronary intervention (PCI) indication were treated either with SES or BMS (sequential control design with a case-to-control ratio of 2 : 1). Standardized questionnaires were completed by patients and their physicians at baseline, 3, 6, 12, and 18 months following PCI to document re-PCI for restenosis, myocardial infarction (MI), coronary bypass surgery (CABG), and death. Angiographic PCI documentation was evaluated by an independent expert. From April 2003 until June 2005, 658 patients were treated with SES (mean age 63 ± 9 years, 87% male) and 294 patients with BMS (mean age 64 ± 10 years, 79% male). Significant baseline differences were found by age, gender, household status, threevessel disease, and number of implanted stents. After 18 months, 8% of the SES versus 17% of the BMS group had undergone target vessel revascularization (p adjusted < 0.0001). There were no significant differences between BMS and SES regarding MI, CABG, or death. Re-PCI of target and new non-target vessel lesions was performed at a significantly lower degree of stenosis in SES than in BMS. Compared to patients with BMS, patients with implantation of SES experienced considerably fewer target vessel revascularizations. The threshold to perform re-PCI appeared lower in SES than in BMS. An extended evaluation of the effects of SES will be available from the 3-year follow-up of the GERSHWIN study.