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BACKGROUND: Data on self-reported cardiovascular and metabolic diseases are available for the first 100,000 participants of the population-based German National Cohort (GNC, NAKO Gesundheitsstudie). OBJECTIVES: To describe assessment methods and the frequency of self-reported cardiovascular and metabolic diseases in the German National Cohort. MATERIALS AND METHODS: Using a computer-based, standardized personal interview, 101,806 participants (20–75 years, 46% men) from 18 nationwide study centres were asked to use a predefined list to report medical conditions ever diagnosed by a physician, including cardiovascular or metabolic diseases. For the latter, we calculated sex-stratified relative frequencies and compared these with reference data. RESULTS: With regard to cardiovascular diseases, 3.5% of men and 0.8% of women reported to have ever been diagnosed with a myocardial infarction, 4.8% and 1.5% with angina pectoris, 3.5% and 2.5% with heart failure, 10.1% and 10.4% with cardiac arrhythmia, 2.7% and 1.8% with claudicatio intermittens, and 34.6% and 27.0% with arterial hypertension. The frequencies of self-reported diagnosed metabolic diseases were 8.1% and 5.8% for diabetes mellitus, 28.6% and 24.5% for hyperlipidaemia, 7.9% and 2.4% for gout, and 10.1% and 34.3% for thyroid diseases. Observed disease frequencies were lower than reference data for Germany. CONCLUSIONS: In the German National Cohort, self-reported cardiovascular and metabolic diseases diagnosed by a physician are assessed from all participants, therefore representing a data source for future cardio-metabolic research in this cohort. HINTERGRUND: Aus der NAKO Gesundheitsstudie, der größten deutschen bevölkerungsbasierten Studie zur Gesundheit, liegen die Daten zu selbst berichteten kardiovaskulären und metabolischen Erkrankungen der ersten ca. 100.000 Teilnehmenden vor. ZIEL: Beschreibung der Methoden zur Erhebung sowie Berechnung der Häufigkeit kardiovaskulärer und metabolischer Erkrankungen in der NAKO. MATERIAL UND METHODEN: 101.806 Teilnehmende (20–75 Jahre, 46 % Männer) aus 18 bundesweiten Studienzentren wurden in einem computergestützten, standardisierten persönlichen Interview gebeten, anhand einer vorgegebenen Liste anzugeben, welche Erkrankungen bei ihnen jemals ärztlich diagnostiziert wurden, darunter auch kardiovaskuläre und metabolische Erkrankungen. Für Letztere wurden deren geschlechtsspezifische relative Häufigkeiten berechnet und diese mit Referenzzahlen verglichen. ERGEBNISSE: Bezogen auf die kardiovaskulären Erkrankungen berichteten 3,5 % der Männer und 0,8 % der Frauen, jemals einen Herzinfarkt diagnostiziert bekommen zu haben, 4,8 % bzw. 1,5 % eine Angina pectoris, 3,5 % bzw. 2,5 % eine Herzinsuffizienz, 10,1 % bzw. 10,4 % Herzrhythmusstörungen, 2,7 % bzw. 1,8 % eine Claudicatio intermittens und 34,6 % bzw. 27,0 % eine arterielle Hypertonie. Die Häufigkeit berichteter diagnostizierter metabolischer Erkrankungen lag bei 8,1 % bzw. 5,8 % für Diabetes mellitus, bei 28,6 % bzw. 24,5 % für Hyperlipidämie, bei 7,9 % bzw. 2,4 % für Gicht und bei 10,1 % bzw. 34,3 % für Schilddrüsenerkrankungen. Die beobachteten Häufigkeiten lagen insgesamt etwas niedriger als Vergleichsdaten für Deutschland. DISKUSSION: Die NAKO erhebt von allen Teilnehmenden selbst berichtete, ärztlich diagnostizierte kardiovaskuläre und metabolische Erkrankungen und stellt damit eine Datenressource für weitergehende kardiometabolische Forschungsfragestellungen dar.

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

Zusammenfassung Hintergrund 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. Methode 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). Ergebnisse 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. Zusammenfassung 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.

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.

Background Until now, there has been little discussion of the costs of the deep infiltrating endometriosis (DIE) of the bowel or the bladder. The aim of the present secondary data analysis was to describe the population affected by this disease and to determine the economic burden in Germany from a payer's perspective. Methods Health claims data of women diagnosed with DIE of the bladder or bowel, who were surgically treated as inpatients between Jan 1, 2008 and Dec 31, 2012, were evaluated retrospectively. All data were extrapolated on a national statutory health insurance (SHI) level and normalized based on the year of surgery (index year). Case-individual information on age, comorbidities and prescribed drugs were presented for the index year. Direct medical cost data were analysed before and after the index year, differentiated by cost sector and age group. Results The data of 825 women with DIE were analysed. Sample size for different time points varied depending on insurance eligibility and continuous case information. The average age at surgery was 39 years. Besides DIE, 41 % of the women had at least one additional disease of the peritoneum. The mean annual total healthcare costs per DIE case were 12,868 Euros in the index year. Before surgery, mean annual costs varied between 548 and 2,475 Euros per case and after surgery between 1,739 and 2,818 Euros per case. In total, mean costs were higher in younger women as compared to older women, with a cost difference of 616 Euros over all time points. Conclusion Direct costs are highest during the year of surgical treatment, but DIE of the bowel and bladder places a substantial burden on the SHI also before and after surgery. Further studies on indirect costs would be desirable to complete the knowledge on the economic burden of DIE.

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.

Background Web portals providing health information online have the potential to reach large numbers of people. Yet few studies have assessed usage and costs of health portals, especially over an extended period of time. Objectives First, to assess the usage of a web portal on prevention and health promotion that was initiated by the German states of Berlin and Brandenburg. Second, to estimate average cost per pageview over the full web portal life-cycle. Methods Usage data were gathered through Google Analytics. The main usage metric assessed was pageviews originating from an IP address in Berlin or Brandenburg. Project cost data were reported by the local government and from own records. Descriptive and regression analyses were used to determine time trends in pageviews. Results The redesigned web portal Praeventionsatlas.de launched August 2011 and was discontinued March 2018. Analyzing the full calendar years only, the annual pageview number increased from 2012 (8492) to its peak in 2014 (11,876) and steadily decreased to its minimum in 2017 (7232). Pages of the web portal were most often viewed around lunchtime (12 to 1 p.m.), in the middle of the week (Wed to Thu), and at the beginning of the year (Jan to Feb). Adjusting for year, month, and weekday, the number of daily pageviews dropped on major public holidays (Easter −9, Pentecost −12, Christmas −12 and New Year’s Eve and Day −20; p Conclusion Usage of the web portal showed temporal variation and peaked before the middle of its 6.5 year life-cycle. Development and need for updates may require substantial investment in a web portal, such that a pageview can come at a considerable expense, even in small-scale projects. Assessing and discussing the cost-effectiveness of a web portal is therefore desirable.

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

BACKGROUND AND AIMS In Germany, the smoking prevalence among adolescents is among the highest in Europe. Our aim was to evaluate the long-term effectiveness of a combined student-parent and a student-only smoking prevention programme to reduce the smoking prevalence among 7th grade students in Berlin. DESIGN Three-armed cluster-randomized controlled trial (RCT). Schools as cluster units were randomized into (i) student intervention, (ii) combined student-parent intervention or (iii) control group, with follow-up after 12 and 24 months. SETTING High schools and integrated secondary schools in Berlin, Germany. PARTICIPANTS Seventh grade students aged 11-16 years. We included 47 schools, 161 classes and 2801 students [50.1% girls, mean age ± standard deviation (SD) = 13.0 ± 0.6 years]. MEASUREMENTS The primary outcome was self-reported regular smoking (at least one cigarette per day) after 24 months (point prevalence). Further self-reported outcomes were other smoking behaviours as well as parental rules and attitudes towards smoking. Comparisons were calculated as odds ratios (OR) with 95% confidence intervals (CI). FINDINGS At baseline, 2.3% of the students reported that they smoked regularly. After 24 months, 7.8% and 7.0% were regular smokers in the student-only intervention and the student-parent intervention, respectively, compared with 10.1% in the control group. The OR for being a regular smoker was 0.81 (0.34-1.92) for the student-parent intervention versus control, 0.95 (CI = 0.41-2.22) for the student-only intervention versus control and 0.85 (0.38-1.89) for student-parent intervention versus student-only intervention. CONCLUSION A combined student-parent smoking prevention intervention delivered via secondary schools in Berlin, Germany did not result in a statistically significant reduction in regular smoking compared with a control group or a student-only intervention. The student-only intervention did not result in a significant reduction in regular smoking compared with the control group.

Purpose This retrospective study aimed to describe patient characteristics of women with deep infiltrating endometriosis [DIE] affecting the bowel and bladder treated in a referral center in Germany, and to calculate direct costs during inpatient stay for surgery. Methods Patient characteristics and cost-relevant factors of women with DIE of the bladder or bowel surgically treated during 2008-2012 in a referral center were gathered from medical records. Patient economic data were retrieved from the hospital's finance and accounts department. Results One hundred and forty-eight cases with clinical information and cost data were analyzed retrospectively. Most cases had bowel endometriosis (91%) and were classified as severe (66%). The women analyzed were in their reproductive peak years (34 years; SD 6.3 years), of normal weight (body mass index [BMI] 23; SD 4.0) and most of them were employed (80%). Nearly all women (95%) were affected by multiple symptoms at hospital admission and the majority had a prior diagnosis of endometriosis (76%). Mean total costs per case were €11,458 (95% CI: €10,589-€12,326). Forty-four percent of the total costs were mean staff costs (€5,039), 30% were mean infrastructure costs (€3,425) and 26% mean material costs (€2,993). Conclusions This study is the first to estimate the surgery-related direct costs of DIE in Germany from a hospital's perspective based on data from a specialized center. Resource utilization and total costs of DIE are substantial.

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.

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 (

A modern urban lifestyle can be a risk factor for developing non-communicable diseases and mental health problems (Eckert S, Kohler S. Urbanization and health in developing countries: A systematic review. World Health Popul. 2014;15:7–20; Penkalla AM, Kohler S. Urbanicity and mental health in Europe: a systematic review. Eur J Ment Health 2014;9:163–77). Two non-commercial, state-funded web portals in the German states of Berlin and Brandenburg are attempting to support the residents in realizing a healthier lifestyle. The initial portal is named Präventionsatlas [Atlas of Prevention] and has existed since 2008. The second portal, called Stadtplan Gesundheitsförderung [Health Promotion Map], went online in 2014 and has become the successor to the former. Both web portals provide health information as well as searchable databases with locally available health promotion courses and projects. Since internet portals and knowledge management through Internet portals have become more and more frequently used as public health tools (see, e.g. Quinn E, Huckel-Schneider C, Campbell D, Seale H, Milat AJ. How can knowledge exchange portals assist in knowledge management for evidence-informed decision making in public health? BMC Public Health 2014;14:443), we share our lessons learned during the development and revision of the health portal www.praeventionsatlas.de in this article.

Hintergrund und Fragestellung | Vorhofflimmern (VHF) ist die haufigste anhaltende Herzrhythmusstorung in der klinischen Praxis und mit einem hohen Risiko fur Schlaganfall, Herzinsuffizienz und Hospitalisierung verbunden. Die vorliegende Krankheitskostenstudie untersucht die indikationsspezifischen direkten Kosten von gesetzlich versicherten VHF-Patienten in Deutschland. Methodik | Die Erhebung erfolgte bundesweit bei 54 niedergelassenen Allgemeinmedizinern, Praktikern und hausarztlich tatigen Internisten sowie bei 12 niedergelassenen Kardiologen. Der Beobachtungszeitraum pro Patient betrug ein Jahr. Die Kostenanalyse wurde aus der Perspektive der Gesetzlichen Krankenkasse (GKV) durchgefuhrt. In der Studienpopulation wurden die jahrlichen indikationsspezifischen direkten Kosten sowie weitere patientenrelevante Parameter erhoben. Ergebnisse | Die von den Hausarzten dokumentierten indikationsspezifischen Leistungen von 361 Patienten (Alter: 75 Jahre, mannlich: 55 %) verursachen durchschnittliche Kosten in Hohe von 582 € pro Patient. Den grosten Kostenblock stellen die Klinikkosten mit 289 €, gefolgt von den ambulanten Behandlungskosten mit 151 € und den Kosten fur Antikoagulation mit 52 € pro Patient. Ein zusatzlicher Besuch bei einem Kardiologen verursacht durchschnittlich Kosten in Hohe von 82 €. Die durchschnittlichen Gesamtkosten belaufen sich demnach auf 664 €. Folgerungen | Die Ergebnisse dieser prospektiv erhobenen Krankheitskostenanalyse zum VHF in der Alltagsversorgung in Deutschland zeigen eine hohe soziookonomische Belastung durch VHF.

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.

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 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.

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

Atrial fibrillation (AF), a supraventricular tachycardia disorder, is the most common sustained cardiac arrhythmia affecting 1-2 % of the general population. Prevalence is highly related to age, with every fourth individual older than 40 years old developing AF during his lifetime. Due to an aging population, the prevalence of AF is estimated to at least double within the next 50 years. This article presents AF-related cost-of-illness studies and reviews 19 cost-effectiveness studies and six cost studies published roughly over the past decade, which have compared different antiarrhythmic medications for AF. A systematic literature search for studies published between June 2000 and December 2011 was conducted in PubMed using the combination of keywords ((atrial fibrillation OR atrial flutter) AND cost). Current cost-effectiveness analyses of dronedarone and the pill-in-the-pocket strategy are subject to substantial uncertainties with regard to clinical benefit. Comparing rate control with rhythm control, a cost-effectiveness advantage for rate control was shown in several but not all studies. Within antiarrhythmic drug treatments, magnesium added onto ibutilide was shown to be more cost effective than ibutilide alone. Comparing chemical and electrical cardioversion, the latter was recommended as more cost effective from the healthcare system perspective in all reviewed studies but one. Catheter ablation appeared more cost effective than antiarrhythmic drugs in the medium to long run after 3.2-63.9 years. Admissions to hospital, inpatient care and interventional procedures as well as mortality benefit are key drivers for the cost effectiveness of AF medications. No clear cost-effectiveness advantage emerged for one specific antiarrhythmic drug from the studies that compared antiarrhythmic agents. Rate control as well as catheter ablation appear more cost effective than rhythm control in the treatment of AF. Rate control treatment also seems more cost effective than electrical cardioversion in AF patients.

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.

The present study investigated the association of dietary sodium intake and blood pressure (BP) based on existing data from the German National Health Interview and Examination Survey (GNHIES) and the associated German Nutrition Survey (GeNuS). After exclusion of participants with known hypertension and/or anti-hypertensive medication use, complete data of the GeNuS subsample of the 1998 GNHIES were analysed for 1,539 men and 1,553 women aged 18–79 years. The survey included a health and lifestyle questionnaire, a medical examination and a comprehensive diet history interview. Sodium density (g/1,000 kcal) was examined in quartiles of systolic and diastolic BP (SBP and DBP). Multiple linear regression models were used to investigate associations of sodium density and SBP or DBP. Adjustments were made for sex, age and socio- and health-behavioral risk factors previously found to be related to BP in univariate analysis. Participants with a high SBP and DBP (fourth quartile of SBP: ≥ 142 mmHg in men; ≥ 139 mmHg in women) had a significantly higher dietary sodium intake than individuals with a lower BP. In the multiple models, both SBP and DBP were significantly associated with sodium density when adjusted for other factors such as sex, age, body mass index and alcohol consumption. An association of dietary sodium intake and BP in the German population could be found. Further research using sodium data collected via 24-h urine samples is urgently needed for evidence-based public health policy reducing risk of BP associated morbidities and mortalities in Germany.

In Germany, the smoking prevalence among adolescents is among the highest in Europe. Our aim was to evaluate the long-term effectiveness of a combined student-parent and a student-only smoking prevention programme to reduce the smoking prevalence among 7th grade students in Berlin.Three-armed cluster-randomized controlled trial (RCT). Schools as cluster units were randomized into (i) student intervention, (ii) combined student-parent intervention or (iii) control group, with follow-up after 12 and 24 months.High schools and integrated secondary schools in Berlin, Germany.Seventh grade students aged 11-16 years. We included 47 schools, 161 classes and 2801 students [50.1% girls, mean age ± standard deviation (SD) = 13.0 ± 0.6 years].The primary outcome was self-reported regular smoking (at least one cigarette per day) after 24 months (point prevalence). Further self-reported outcomes were other smoking behaviours as well as parental rules and attitudes towards smoking. Comparisons were calculated as odds ratios (OR) with 95% confidence intervals (CI).At baseline, 2.3% of the students reported that they smoked regularly. After 24 months, 7.8% and 7.0% were regular smokers in the student-only intervention and the student-parent intervention, respectively, compared with 10.1% in the control group. The OR for being a regular smoker was 0.81 (0.34-1.92) for the student-parent intervention versus control, 0.95 (CI = 0.41-2.22) for the student-only intervention versus control and 0.85 (0.38-1.89) for student-parent intervention versus student-only intervention.A combined student-parent smoking prevention intervention delivered via secondary schools in Berlin, Germany did not result in a statistically significant reduction in regular smoking compared with a control group or a student-only intervention. The student-only intervention did not result in a significant reduction in regular smoking compared with the control group.

Despite the indisputable mortality advantages of implantable cardioverter defibrillators (ICDs), no consensus exists regarding their impact on quality of life (QoL). This systematic review investigates differences in QoL between patients with ICDs and controls. We systematically searched the MEDLINE, EMBASE, Cochrane, Web of Science and PsychINFO databases. Articles were included if they were published after the year 2000 and reported on original studies with a control group. Five randomized controlled trials with a total of 5,138 patients and ten observational studies with a total of 1,513 patients met the inclusion criteria. Nine studies found comparable QoL for ICD recipients and patients in the control groups, three studies found an increased QoL for ICD patients, and three studies found a decreased QoL for ICD patients. The question of whether QoL relates to ICD therapy cannot be answered conclusively due to the heterogeneity of the existing studies. Lower QoL was apparent among patients with an ICD who experienced several device discharges. Medical staff should be particularly aware of the signs of both psychological and physical disorders in these patients. Further investigations on QoL in ICD patients are desirable, but ethical reasons restrict the conduct of randomized trials.

Cardiovascular diseases are a major health problem in the industrialised world. The aim of the study was to measure the course of costs after a myocardial infarction. We undertook a retrospective review of the medical, hospital and drug claims data in the database of a German statutory health insurance company covering about 5 million insured persons. The data of patients suffering from myocardial infarction were extracted by using the documented hospital ICD-10 codes during 2004 and 2005. For these patients we reviewed and summarised all the charges incurred over a 1-year period after the initial index event on the basis of weekly costs and from the third party payer's perspective. We included 15,185 patients with a primary diagnosis of MI-DRG (57.43% male patients, mean age of 71.1 ± 12.6 years). The average weekly total first-year cost of a first myocardial infarction was calculated at about 251 ± 1,077 Euros per patient. The cumulative total cost was about 13,061 ± 1,162 Euros per patient for the first year. The largest burden of the first year after myocardial infarction is due to in-patient stays. This represents approximately 80% of the total costs (about 10,505 ± 1,107 Euros per year and patient). Myocardial infarction is associated with significant economic costs from the perspective of statutory health insurance. This cost burden particularly occurs within the first 2 weeks following a first myocardial infarction. For this reason, efficient management of the acute event is outstandingly important.

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.