The association of six autoimmune bullous diseases with thyroid disorders: a population-based study.

BACKGROUND: The association of autoimmune bullous diseases (AIBDs) with thyroid disorders remains to be profoundly investigated. OBJECTIVE: To evaluate the epidemiological association between six AIBDs and thyroid disorders. METHODS: A population-based cross-sectional study enrolled patients with bullous pemphigoid (BP), mucous membrane pemphigoid (MMP), epidermolysis bullosa acquisita (EBA), pemphigoid gestationis (PG), pemphigus vulgaris (PV) and pemphigus foliaceus (PF). Patients with these six AIBDs were compared with six age- and sex-matched control groups regarding the prevalence of thyroiditis and hyperthyroidism. Logistic regression was used to calculate the odds ratio (OR) and 95% confidence interval (CI) for thyroid disorders. RESULTS: The study population included 1,743, 251, 106, 126, 860 and 103 patients with BP, MMP, EBA, PG, PV and PF respectively. The corresponding control groups consisted of 10,141, 1,386, 606, 933, 5,142 and 588 matched controls respectively. A significant association was found between thyroiditis and BP (OR, 1.98; 95% CI, 1.18-3.35; P = 0.010), MMP (OR, 7.02; 95% CI, 1.87-26.33; P = 0.004) and PV (OR, 2.73; 95% CI, 1.45-5.15; P = 0.002). With regards to hyperthyroidism, PF was the only AIBD to demonstrate significant comorbidity (OR, 2.42; 95% CI, 1.13-5.21; P = 0.024). EBA and PG were not found to cluster with any of the investigated thyroid conditions. CONCLUSION: Patients with BP, MMP, PV and PF experience an elevated burden of thyroid disorders. Patients with these AIBDs presenting with suggestive symptoms may be carefully screened for comorbid thyroid disorders.

The burden of neurological comorbidities in six autoimmune bullous diseases: a population-based study.

BACKGROUND: Apart from bullous pemphigoid (BP), the association of other autoimmune bullous diseases (AIBDs) with neurological conditions is poorly understood. OBJECTIVE: To estimate the association between a wide array of AIBDs and neurological conditions. METHODS: A retrospective cross-sectional study recruited patients with BP, mucous membrane pemphigoid (MMP), epidermolysis bullosa acquisita (EBA), pemphigoid gestationis (PG), pemphigus vulgaris (PV) and pemphigus foliaceus (PF). These patients were compared with their age- and sex-matched control subjects with regard to the lifetime prevalence of Parkinson's disease (PD), Alzheimer's disease (AD), stroke, epilepsy and multiple sclerosis (MS). Logistic regression was used to calculate OR for specified neurological disorders. RESULTS: The current study included 1743, 251, 106, 126, 860 and 103 patients diagnosed with BP, MMP, EBA, PG, PV and PF, respectively. These patients were compared with 10 141, 1386, 606, 933, 5142 and 588 matched controls, respectively. Out of the investigated neurological conditions, PD associated with BP (OR, 2.71; 95% CI, 2.19-3.35); AD with BP (OR, 2.11; 95% CI, 1.73-2.57), MMP (OR, 2.37; 95% CI, 1.03-5.47), EBA (OR, 6.00; 95% CI, 1.90-18.97) and PV (OR, 2.24; 95% CI, 1.40-3.60); stroke with BP (OR, 1.84; 95% CI, 1.55-2.19) and EBA (OR, 2.79; 95% CI, 1.11-7.01); and epilepsy with BP (OR, 2.18; 95% CI, 1.72-2.77) and PV (OR, 1.80; 95% CI, 1.19-2.73). MS did not significantly cluster with any of the six AIBDs. CONCLUSION: In addition to BP, EBA and PV were found to cluster with neurological comorbidities. Patients with these AIBDs with compatible symptoms may be carefully assessed for comorbid neurological disorders.

Prevalence and age distribution of pemphigus and pemphigoid diseases among paediatric patients in Germany.

BACKGROUND: Autoimmune bullous diseases are rare and mostly occur in adults. Several cases and small case series have been described in children, but no systematic study about the prevalence of autoimmune bullous diseases (AIBD) in children is available. PATIENTS AND METHODS: We analysed data of 1.7 million children insured in the largest German health insurance company based on the ICD-10-GM classification for the year 2015. Data were adjusted to the general German population based on the data of the Federal Statistical Office for the year 2015. RESULTS: The prevalence of AIBD was calculated to 101.1/million children in 2015, resulting in about 1351 patients below the age of 18 years in Germany. The highest prevalence of all AIBD was seen for pemphigus vulgaris (30.5/million children) followed by linear IgA disease (24.5/million children) and bullous pemphigoid (4.9/million children). CONCLUSION: Autoimmune bullous diseases in minors are scarce but should be taken into consideration in patients with pruritus and/or blisters and erosions on the skin and/or mucous membranes. Treatment is challenging, and due to the rarity of AIBD in minors, the management of these disorders in this patient population is best performed in specialized centres in a multidisciplinary approach, including paediatric dermatologists or dermatologists and paediatricians.

Recent Canadian efforts to develop population-level pregnancy intervention studies to mitigate effects of natural disasters and other tragedies.

The preconception, pregnancy and immediate postpartum and newborn periods are times for mothers and their offspring when they are especially vulnerable to major stressors - those that are sudden and unexpected and those that are chronic. Their adverse effects can transcend generations. Stressors can include natural disasters or political stressors such as conflict and/or migration. Considerable evidence has accumulated demonstrating the adverse effects of natural disasters on pregnancy outcomes and developmental trajectories. However, beyond tracking outcomes, the time has arrived for gathering more information related to identifying mechanisms, predicting risk and developing stress-reducing and resilience-building interventions to improve outcomes. Further, we need to learn how to encapsulate both the quantitative and qualitative information available and share it with communities and authorities to mitigate the adverse developmental effects of future disasters, conflicts and migrations. This article briefly reviews prenatal maternal stress and identifies three contemporary situations (wildfire in Fort McMurray, Alberta, Canada; hurricane Harvey in Houston, USA and transgenerational and migrant stress in Pforzheim, Germany) where current studies are being established by Canadian investigators to test an intervention. The experiences from these efforts are related along with attempts to involve communities in the studies and share the new knowledge to plan for future disasters or tragedies.

Sex-related response to bivalirudin and unfractionated heparin in patients with acute myocardial infarction undergoing percutaneous coronary intervention: A subgroup analysis of the VALIDATE-SWEDEHEART trial.

AIMS: Our aim was to study the impact of sex on anticoagulant treatment outcomes during percutaneous coronary intervention in acute myocardial infarction patients. METHODS: This study was a prespecified analysis of the Bivalirudin versus Heparin in ST-Segment and Non ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART) trial, in which patients with myocardial infarction were randomised to bivalirudin or unfractionated heparin during percutaneous coronary intervention. The primary outcome was the composite of death, myocardial infarction or major bleeding at 180 days. RESULTS: There was a lower risk of the primary outcome in women assigned to bivalirudin than to unfractionated heparin (13.6% vs 17.1%, hazard ratio 0.78, 95% confidence interval (0.60-1.00)) with no significant difference in men (11.8% vs 11.2%, hazard ratio 1.06 (0.89-1.26), p for interaction 0.05). The observed difference was primarily due to lower risk of major bleeding (Bleeding Academic Research Consortium definition 2, 3 or 5) associated with bivalirudin in women (8.9% vs 11.8%, hazard ratio 0.74 (0.54-1.01)) but not in men (8.5% vs 7.3%, hazard ratio 1.16 (0.94-1.43) in men, p for interaction 0.02). Conversely, no significant difference in the risk of Bleeding Academic Research Consortium 3 or 5 bleeding, associated with bivalirudin, was found in women 4.5% vs 5.4% (hazard ratio 0.84 (0.54-1.31)) or men 2.9% vs 2.1% (hazard ratio 1.36 (0.93-1.99)). Bleeding Academic Research Consortium 2 bleeding occurred significantly less often in women assigned to bivalirudin than to unfractionated heparin. The risk of death or myocardial infarction did not significantly differ between randomised treatments in men or women. CONCLUSION: In women, bivalirudin was associated with a lower risk of adverse outcomes, compared to unfractionated heparin, primarily due to a significant reduction in Bleeding Academic Research Consortium 2 bleeds.

[Quality Assurance using routine data: Overdiagnosis by radiological imaging for back pain]. / Überdiagnostik mit Bildgebung bei Rückenschmerzen.

UNLABELLED: Background and Problem: Acute nonspecific back pain disorders are typically self-limiting. According to the national guideline low back pain, only in case of clinical suspicion of a serious course radiological imaging should take place immediately. Otherwise, the guideline recommends waiting at least six weeks. PATIENTS AND METHODOLOGY: Using Statutory Health Insurance (SHI) routine data of the Techniker Krankenkasse we analyzed how many of the insured persons suffering from acute back pain for the first time with no indication of a serious outcome received a non-indicated diagnostic imaging. RESULTS: In about 10 % diagnostic imaging is conducted after initial diagnosis. If an imaging is carried out, roughly one third of these cases takes place ahead of time or is completely unnecessary. Methodically this is a very conservative estimation, thus it seems likely that the extent of overdiagnosis in actual medical care situation is even larger. CONCLUSIONS: Every third patient who received radiological diagnostics due to first acute nonspecific back pain underwent the procedure more quickly than recommended (less than six weeks). Overdiagnosis is not only economically problematic but also with respect to patient orientation and patient safety. It may cause substantial damage to patients - either by the use of diagnostics itself or by means of therapies initiated after diagnostics.

Suitability and Usability of Claims Data for Review of Guidelines for the Treatment of Chronic Heart Failure.

Background: Guidelines have special importance in medicine, however, it is questionable to what extent these recommendations are applied in daily care, and under which conditions claims data can be used for verification of guideline adherence. Method: Advantages and limitations of claims data for verification of guidelines compliance in the therapeutic area as well as the guidelines themselves were analysed and critically assessed. To substantiate these results, claims data of a major German health insurance fund (Techniker Krankenkasse) were analysed. Results: 104 236 patients were identified. With certain limitations, claims data are useful for verifying guideline adherence; it could be shown that in pharmacotherapy the beta-adrenergic receptor blocker was used to the highest extent (70.5%). In contrast, only 56.4% of patients were treated with pure ACE inhibitors and ACE combined preparation. Conclusion: In order to validate guideline adherence by means of claims data analyses, a number of conditions relating to the database, the therapeutic area and the guidelines themselves have to be considered. Guideline recommendations, which, for example, are based on clinical data, cannot be reviewed by using claims data. Despite these limitations, claims data provide a suitable tool for reviewing selected guideline recommendations. They show that the current use of pharmacotherapy as well as clinical and diagnostic interventions might be increased in accordance with the guideline recommendations.

[Impact of guideline adherence on mortality in treatment of left heart failure]. / Auswirkung einer leitliniengerechten Behandlung auf die Mortalität bei Linksherzinsuffizienz.

BACKGROUND: The German national guidelines on chronic heart failure provide treatment recommendations to physicians and reflect the current level of evidence; however, it is questionable to what extent these recommendations are applied in the routine practice and what the effect of guideline adherence on mortality is. METHODS: In this study the claims data of a major German health insurance fund collected over a period of 4 years were analyzed. Using binary logistic regression and Cox regression analyses the influence of drug prescriptions, diagnostic measures, influenza vaccination, the New York Heart Association (NYHA) status, the age and gender on mortality were examined. RESULTS: The study population consisted of 85,465 heart failure patients. Approximately 60 % of the drugs were prescribed according to the guidelines. There was a positive correlation between a higher NYHA status and mortality with an odds ratio (OR) of 3.264. Especially pharmacotherapy with angiotensin-converting enzyme (ACE) inhibitors and beta blockers according to the guidelines was associated with a lower mortality rate (OR 0.448 resp. 0.444). Also patients diagnosed using echocardiography at regular intervals showed a lower risk of dying (OR 0.314). CONCLUSION: The results of this large sample could confirm the results of clinical trials that a therapy according to the guidelines has a significant impact on mortality. By analyzing the claims data evidence was found that in the treatment of heart failure patients the medical results could be improved by adherence to guideline recommendations.

[Age- and Gender-specific Costs as Well as Drug Therapies of ADHD Patients]. / Alters- und geschlechtsspezifische Kosten sowie die Versorgung mit medikamentösen Therapien von ADHS-Patienten.

UNLABELLED: Backround and Objectives: Attention deficit hyperactivity disorder (ADHD) is one of the most commonly diagnosed mental disorders in children and adolescents. The rate of persistence into adulthood varies up to 60% and shows the importance of the disease. Here we present age-stratified cost information on adult patients, as well as data on occupational therapy, medication and multimodal treatment. Furthermore, we also investigated retrospectively if methylphenidate was prescribed for adults already before its approval in 2011. METHODS: Claims data of a major German insurance fund (Techniker Krankenkasse) was available. Inclusion criteria were patients with ADHD diagnosis, either hospitalized or treated on an outpatient basis in 2006, 2007 and 2008 and insured over this period. This enabled identifying this disease as chronic. The data were analyzed as part of a control group design (1:3). Cost differences were examined as also the odds ratios for the burden of comorbidities and use of atomoxetine and methylphenidate. RESULTS: 77.9% of the identified ADHD patients were male (mean age: 16.5 years ±11.1). The mean total costs of patient treatment were € 2,032 (±4,112). The odds ratio was highest for the indication developmental disorders of scholastic skills (15.4) and differed between the sexes (female: 24.0 vs. male: 14.2). Drug prescription was higher in male than in female patients (atomoxetine: 7.2 vs. 5.9% and methylphenidate 59.1 vs. 48.4%). CONCLUSIONS: This study provides important insights into the importance of the adult ADHD collective. There were increasing resource consumption identified in adult ADHD patients. In addition, methylphenidate was used off-label for treating adults already before 2011 and its approval in 2011 provided increased certainty for physicians regarding prescription of this drug.

[Brachytherapy for Prostate Cancer: Potentials and Limitations of Social Health Insurance Data for Benefit Assessment]. / Brachytherapie beim Prostata-Ca: Möglichkeiten und Limitationen von GKV-Routinedaten für eine Nutzenbewertung.

BACKGROUND: Due to the insufficient data base the Federal Joint Committee (G-BA) had in 2009 after 7 years of deliberation decided to initiate consultation regarding ambulatory brachytherapy for localised prostate cancer for 10 years from social health insurance (SHI) benefits. The aim is to gain more findings by means of comparative studies. PROBLEM: Based on the non-availability of clinical primary data of a methodologically acceptable level, it was analysed to what extent secondary data of the SHI may be used in order to arrive at valid conclusions for benefit aspects. METHODS: As base approx. 8 million insured of TK with their data of cost reimbursement between 2006 and 2011 were considered. In SHI secondary data no clinical information regarding tumour stage and other prognostic factors are available. Therefore, a novel method with therapy-specific multisectoral inclusion and exclusion criteria, respectively, was developed in order to differentiate between localised and advanced tumours of the prostate. Overall survival, relapse-free survival, event-free survival and side-effects associated to prostate cancer were analysed. RESULTS: Out of 87 822 insured persons with the diagnosis prostate cancer, 795 with PBT, 10 936 with RP and 1 925 with EBRT were investigated in detail. The 4-year event-free survival rate was 73% for RP, 77% for PBT and 71% for EBRT. Many prostate cancer-specific side effects appeared already before intervention. Side effects of the intestinal tract (23.8%) and sexual impairments (26.5%) were more frequent for EBRT than for RP (17.1%/14.8%) and PBT (16.4%/13.2%). CONCLUSION: By means of SHI secondary data and adequate operationalisation important findings regarding relevant aspects of prostate cancer in healthcare research can be generated. However, these hold methodological limitations and are not suited to draw valid conclusions for benefit assessment. Based solely on SHI routine data valid statements regarding comparative benefit assessment are limited. Limitations could be reduced by applying a record linkage with clinical data. Such primary data should include information on tumour stages as well as therapy assignment and observation of survival time.

[Additional Costs for Care of Patients with Multi-Resistant Pathogens--An Analysis from the Perspective of a Statutory Health Insurance]. / Mehrkosten bei der Versorgung von Patienten mit multiresistenten Erregern--Eine Analyse aus Sicht einer gesetzlichen Krankenversicherung.

Aim of this study was to determine the additional expenditures for a German statutory health insurance which are induced by patients with multi-resistant bacteria. Therefore a nationwide cross-sectional data analysis using routine data of the health insurance "Techniker Krankenkasse" was conducted. In the consideration of costs we included expenditures for inpatient and outpatient care and on drugs in a time period of 12 months. A control group was matched by age, gender, basic disease, quarterly period and region. On average additional costs of 17,500 Euro per insured were calculated due to the presence of multi-resistant bacteria. The hypothesis was corroborated in that the level of these costs differ widely by age, gender and basic disease.

Evaluating methods for intersectoral comparison of quality of care. A routine data analysis of elective percutaneous coronary interventions.

OBJECTIVES: To compare the quality of care regarding the use of elective percutaneous coronary interventions (PCIs) in the inpatient and outpatient setting and to evaluate different methods of confounder control in this context. METHODS: Based on data of three statutory health insurances including more than nine million insurance members, a retrospective cohort study between 2005 and 2009 was conducted. The occurrence of myocardial infarction, stroke, further coronary intervention and death was ascertained following the first PCI in the study period, which was preceded by a one-year period without a PCI. A Cox proportional hazard model was used to assess the influence of the setting of the elective PCI on the risk for complications after the PCI for each outcome separately. Age, sex, the number of diseases of the Elixhauser comorbidity measure, past acute coronary syndrome, coronary artery disease, dyslipidemia, past stroke, past coronary artery bypass surgery and the year of the PCI were included as covariables. The analyses were repeated in a propensity score matched cohort as well as in inverse probability of treatment weighted analyses. RESULTS: The cohort comprised 4,269 patients with an outpatient PCI and 26,044 patients with an inpatient PCI. The majority of the analyses revealed no statistically significant effect of the setting of the PCI on the risk of myocardial infarction, stroke and further coronary interventions, whereas a reduced mortality risk was observed for outpatient PCIs. Similar results were obtained in the propensity score analyses. CONCLUSIONS: The analysis revealed that the adjusted risk for complications following an elective PCI is similar between the inpatient and the outpatient setting. For mortality the risk differed but this might be explained by residual or unmeasured confounding. The different methods applied in this study revealed mostly similar results. Since our study only covered one aspect of quality of care in the field of PCI and did not consider drug treatment in hospital or in the outpatient setting, further studies are needed which include these aspects.

[Physicians' prescription behavior of potentially inappropriate medications for elderly people: an analysis using the PRISCUS list based on TK routine data]. / Ärztliches Verordnungsverhalten von potenziell inadäquaten Medikamenten für ältere Menschen: Eine Potenzialanalyse anhand der PRISCUS-Liste auf Basis von TK-Routinedaten.

BACKGROUND: Referring to the German PRISCUS list, the paper analyzes differences in the prescription of potentially inadequate medication (PIM) between older and younger patients. We account for changes in the development over time and for the influence of the publication of the PRISCUS list. METHODS: The retrospective study analyzes pharmaceutical prescriptions based on data from the Techniker Krankenkasse for the years 2008-20012. Age groups are compared regarding PIM prescriptions as share of total prescriptions within therapeutic areas (based on ATC codes). For a comparison of prescribed daily doses between age groups the median of those younger than 65 was indexed to the value 100. RESULTS: The share of older insured with at least one PRISCUS prescription declined from 21,7 % in 2008 to 18,9 % in 2012. Moreover, the total share of PIM prescriptions is steadily higher for elderly persons. Comparing major therapeutic areas shows a heterogeneous picture. An influence of the PRISCUS list on the prescription behavior is not observable. CONCLUSION: The share of PIM prescriptions in the TK sample is slightly declining over time. Unexpectedly, the total share is higher for the elderly than for those below 65. With regard to different therapeutic areas, results are less clear. For future research, our findings emphasize the need to rely on the applied methods.

Economic burden of neural tube defects in Germany.

OBJECTIVE: Failure of closure of the neural tube often leads to serious malformations, including spina bifida, anencephaly and encephalocoele. Despite improvements in medical and surgical treatment, the burden associated with spina bifida is substantial but country-specific data are lacking outside North America. This study aims to improve understanding of the economic implications and burden associated with the morbidity of children and adults with neural tube defects (NTDs) in Germany. STUDY DESIGN: Retrospective data analysis. METHODS: 2006-2009 German health insurance data of persons with NTDs (spina bifida and encephalocoele) were analysed to determine the economic burden of illness associated with NTDs in Germany. Cases were identified using ICD-10 codes; data included outpatient and inpatient care, rehabilitation, remedies and medical aids, pharmacotherapy use, long-term care and information on sick leave. The analysis was stratified by age group to provide a burden estimate specific to a person's age. To obtain an indicator of incremental burden to the Statutory Health Insurance (SHI), results were compared to the standardized healthcare expenditures according to the German Risk Compensation Scheme (RSA). RESULTS: Overall, 4141 persons with an ICD code related to NTDs were identified (out of a population of 7.28 million persons screened). The administrative prevalence ranged from 0.54 to 0.58 per 1000 enrollees. Of those, 3952 (95.4%) were diagnosed with spina bifida. The average annual mean healthcare expenditure of persons with spina bifida was €4532 (95% CI = 4375-4689, SD = 9590, Median = 1000), with inpatient care contributing €1358 (30.0%), outpatient care €644 (14.2%), rehabilitation €29 (0.6%), pharmacotherapy €562 (12.4%), and remedies and medical aids €1939 (42.8%). The incremental cost due to spina bifida was substantially higher than the standardized SHI expenditures for all age groups. The difference was highest for persons ≤ 10 years old (€10,971 vs €2360 for the age group ≤ 1, €8599 vs €833 for the age group 2-5 years and €10,601 vs €863 for the age group 6-10 years). The difference was smallest for the age group 41-50 years (€2524 vs €1101) and for 71 years and over (€5278 vs €4389). CONCLUSION: Expenditures of persons with spina bifida exceeded the standardized SHI expenditures, indicating a considerable economic burden. The economic burden is continuous throughout the person's life, with high monetary impact and exposure to the healthcare system (especially in early years of life). Efforts should be devoted to improve the prevention of NTDs and provide appropriate support for persons with NTDs, parents, and caregivers--especially in early years.

[Disease management programs in Germany: Validity of the medical documentation]. / Validität der ärztlichen Dokumentation von Disease Management Programmen.

BACKGROUND AND AIM: The specific documentation for disease management programs (DMP) in Germany with respect to §â€Š137 Social Code Book V is the basis for evaluating the DMP. DMP run up costs of the order of a billion euro without assessing evidence-based benefit so far. Aim of this study was to question if and to which extent this documentation may be suitable for reliable quality assurance in its present form. METHODS: Data of nearly 300000 insured persons of a German Statutory Health Insurance (Techniker Krankenkasse, TK) which were continuously registered from July 1st 2009 until December 31st 2010 in a DMP were analyzed. We analyzed how items which were components of claims data and of DMP documentation were matched. RESULTS: With regard to prescriptions there were some considerable differences. Prescription of glibenclamid was documented twice as frequently in the DMP documentation compared to prescriptions filled in pharmacies. Only a fraction of emergency hospitalizations documented in the claims data were found in the DMP documentation. Investigations of the fundus oculi for diabetics are mentioned three times more frequently in the DMP documentation than they are accounted by ophthalmologists. CONCLUSION: There are considerable differences between claims data and DMP specific documentation. The latter shows a plainly reduced validity for investigated fields in the documentation forms. Reasons for this are manifold. Former evaluations of DM Ps carried out just on the basis of DMP documentation are thus highly questionable. Therefore, the DMPs themselves and their documentation have to be reformed.

[Calculation of disease-related costs in claims data analyses with the example of attention-deficit hyperactivity disorder. Comparison of methods]. / Die Berechnung indikationsspezifischer Kosten bei GKV-Routinedatenanalysen am Beispiel von ADHS. Ein Methodenvergleich.

Claims data have proven useful for carrying out cost-of-illness studies. To avoid overestimating disease-related costs, only those costs that are related to a specific disease should be considered. The present study demonstrates two basic approaches for identifying disease-related costs. Using the example of attention-deficit hyperactivity disorder (ADHD), the advantages and drawbacks of expert-based approaches and those based on control groups are compared. Anonymized data from the "Techniker Krankenkasse" for 2008 were available for the study. The study population encompassed all ADHD patients and a control group that was five times bigger. Additionally, a systematic literature review was carried out on 65 relevant studies. Compared with the control group, disease-related costs were EUR 2,902 per ADHD patient on average. However, using the expert-based approach, costs were established to be EUR 923 lower. This is mainly because a comparison with an appropriate control group incorporates all costs for possible comorbidities and concomitant diseases. Both approaches have specific advantages and drawbacks, and when planning studies the respective limitations need to be considered.

[Incidence and prevalence of type 2 diabetes mellitus in Germany: an analysis based on 5.43 million patients]. / Inzidenz und Prävalenz von Diabetes mellitus Typ 2 in Deutschland.

BACKGROUND AND OBJECTIVE: Based on claims-data of 5.43 million members of a large German statutory health insurance fund in 2008 (Techniker Krankenkasse), the aim of this contribution is to update and more precisely quantify age- and gender-specific prevalence and incidence of type 2 diabetes mellitus (T2DM) in a German setting. METHODS: A patient was classified as T2DM prevalent if he or she had received at least two outpatient diagnoses of T2DM in two different quarters of the year and/or had received at least one T2DM diagnosis during inpatient treatment between 01/01/2006 and 12/31/2008. A patient was considered to have had new onset T2DM in 2008 under one of three conditions: 1. no diagnosis of T2DM in 2006 and 2007, 2. no presripction of oral antidiabetics in 2006 and 2007, 3. either one inpatient or two outpatient diagnoses of T2DM conducted in two different quarters of 2008 or one outpatient T2DM diagnosis in 2006/07 when the second diagnosis was made in 2008. RESULTS: A total of 254,524 patients had T2DM. Compared to the total membership of the medical insurance fund, the prevalence of T2DM was 4.69 %. The average age was 64.8 years, and 66.37 % were male. The incidence of T2DM in our sample was 2.814 cases per 1,000 person-years in men and 1.690 cases in 1,000 person-years in women. Based on our sample and on official population data, 4,704,585 patients (5.75 %) in Germany would be T2DM prevalent in 2009. The number of incident T2DM cases would amount to 215,746 patients (0.264 %). CONCLUSIONS: T2DM is one of the most common chronic diseases in Germany. The expected demographic changes in Germany will increase the burden on the German health system caused by T2DM.

Navigation in femoral-shaft fractures--from lab tests to clinical routine.

INTRODUCTION: This study evaluates the use of a navigation system (BrainLAB, Feldkirchen, Germany) to intra-operatively check for correct length, axis and rotation in intramedullary nailing of femoral-shaft fractures in an experimental setting and in clinical routine. MATERIALS AND METHODS: We tested the navigation system in two experimental settings before introducing it into clinical routine. In the first experiment, 10 osteotomised model femora were fixed with intramedullary nails by using a navigation system. The goal was a locking fixation in predefined values for length and rotation. In the second experiment, eight examiners assessed values for rotation and length of one femur 10 times to examine the accuracy and reproducibility of that determination. Following this, we navigated 40 femoral nailing procedures in our department. Preoperatively, we assessed values of femur geometry on the contralateral side in a computed tomography (CT) scan and reproduced these values intra-operatively on the fractured side, guided by the navigation system. During the intervention, we recorded the length of the procedure steps and the fluoroscopy time. We verified the intra-operative values achieved with the navigation system in a postoperative CT scan and documented differences in rotation and length. After the assessment, we analysed the data for different findings on femur geometry, fluoroscopy time and procedure duration. RESULTS: The experimental evaluation showed a range of ±5° for anteversion differences and ±2.3 mm for length differences. We estimated this accuracy as sufficient to use the system in clinical routine. The navigation system was used for 40 fracture fixations. All our criteria for restoring femoral geometry could be achieved by navigation guidance in these procedures. Setting up the system took on average 33±11.5 min. An additional fluoroscopy time of 36±22 s was needed to acquire the reference X-rays and to verify pin placement. The differences between anteversion values assessed in intra-operative planning steps on the navigation system and values assessed with a postoperative CT were on average 5.4±3.5°, whilst femur length differed on average by 4±4 mm. DISCUSSION: Many authors judge intra-operative control of anteversion in femoral-shaft fracture fixation as problematic. Neither our experimental navigation assessment nor our clinical navigated evaluation showed relevant anteversion differences to a postoperative CT assessment of femur geometry. After initial training, guidance by a navigation system achieves consistent results in a clinical situation. CONCLUSIONS: The use of a navigation system to align axis, length and rotation led to a secure way of avoiding any relevant malalignment in complex femur-shaft fractures whilst exposing patients to an acceptable amount of additional procedure sequences. Malalignment can be avoided by using a navigation system in the operative treatment of femoral-shaft fractures and may be integrated into clinical routine in specialised centres.