[Epistaxis and anticoagulation therapy: an analysis based on health insurance data from Lower Saxony]. / Epistaxis und antithrombotische Medikation: eine Analyse der Daten einer gesetzlichen Krankenversicherung in Niedersachsen.

BACKGROUND: Epistaxis is a common symptom in the medical practice. It is associated with various comorbidities and the use of medications, especially anticoagulants. Despite the high lifetime prevalence, there is limited data on prevalence and possible risk factors. METHODS: The study examines epistaxis care in a large patient population (AOK Lower Saxony) over a ten-year period (2007-2016). Risk factors, age at diagnosis, concomitant medication and comorbidities were analysed and the prevalence in the study period calculated. RESULTS: 162,167 patients visited their doctors between 2007-2016 (308,947 cases). Most patients were treated as outpatients (96.6%) and 54% of patients were men. Over the study period, the prevalence of epistaxis rose by 21% (increase from 8.6 to 9.3 per 1000 insured persons per year) with a comparatively stable prevalence for the inpatient setting (0.2 per 1000 insured persons per year). In 54,105 of all epistaxis cases (17.5%), the use of antithrombotic drugs was recorded (oral anticoagulants: 9.5%). During the study period, increased prescribing of oral anticoagulants (from 7.7% of cases in 2007 to 11.8% in 2016), especially of NOAC was documented (from 0.1% of cases in 2011 to 5.1% in 2016). CONCLUSION: In addition to arterial hypertension, the predominant male sex and the typical age distribution, we found that cases of epistaxis often received anticoagulation therapy. This study showed an increase of epistaxis along with rising prescriptions of NOAC. In contrast, no increase of severe epistaxis cases leading to hospitalization was found.

Efficacy and safety of pharmacological treatments for acute Lyme neuroborreliosis - a systematic review.

BACKGROUND AND PURPOSE: Our aim was to evaluate the available evidence for pharmacological treatment of acute Lyme neuroborreliosis as a basis for evidence-based clinical recommendations in a systematic review. METHODS: A systematic literature search of Medline, EMBASE, the Cochrane Library and three trial registries was performed. Randomized controlled trials (RCTs) and non-randomized studies (NRS) were evaluated. Risk of bias was assessed using the Cochrane risk of bias tools. The primary outcome was 'residual neurological symptoms' whilst the secondary outcomes were disability, quality of life, pain, fatigue, depression, cognition, sleep, adverse events and cerebrospinal fluid pleocytosis. The quality of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS: After screening 5779 records, eight RCTs and eight NRS were included. Risk of bias was generally high. No statistically significant difference was found between doxycycline and beta-lactam antibiotics in a meta-analysis regarding residual neurological symptoms at 4-12 months [risk ratio (RR) 1.27, 95% confidence interval (CI) 0.98-1.63, P = 0.07] or adverse events (RR 0.82, 95% CI 0.54-1.25, P = 0.35). Significantly fewer neurological symptoms for cefotaxime compared with penicillin were found (RR 1.81, 95% CI 1.10-2.97, P = 0.02). Adverse events were significantly fewer for penicillin (RR 0.56, 95% CI 0.38-0.84, P = 0.005). CONCLUSIONS: Evidence regarding pharmacological treatment of acute Lyme neuroborreliosis is scarce and therefore insufficient to recommend preference of beta-lactam antibiotics over doxycycline or vice versa. However, due to considerable imprecision, relevant differences between treatments cannot be excluded. No evidence suggesting benefits of extended antibiotic treatments could be identified. Further well-designed trials are needed. Individual treatment decisions should address patients' preferences and individual conditions like prior allergic reactions.

[Pain medication in nursing home residents with and without cancer. Most frequently with metamizole]. / Schmerzmittelversorgung von Pflegeheimbewohnern mit und ohne Krebserkrankung. Am häufigsten mit Metamizol.

BACKGROUND: Pain is a highly prevalent symptom in nursing home residents. The analgesic pharmacotherapy of older adults is associated with challenges; however, studies from Germany examining the prescription pattern of analgesics in nursing home residents are rare. OBJECTIVES: This study was carried out to examine the prescription of analgesics in nursing home residents with and without the diagnosis of cancer. MATERIAL AND METHODS: Using health insurance claims data persons aged ≥ 65 years who were newly admitted to a nursing home between 2004 and 2009 and who survived at least the first 90 days after admission were included in the study. Cancer was identified by outpatient diagnoses of malignant neoplasms (ICD-10: C00-C97). Prescription drugs within the first 90 days after admission to a nursing home were analyzed which means that aspirin and acetaminophen were not taken into account. RESULTS: A total of 5549 nursing home residents were included, who were on average 81.5 years old (56.8 % females). More than half (53.5 %) were assigned to care level I and 781 (14.1 %) were diagnosed with cancer. The study cohort received on average 7.8 different medications (with vs. without cancer: 8.6 vs. 7.6, respectively) and 43.8 % had prescriptions for analgesics (with vs. without cancer: 52.5 vs. 42.3 %, respectively). A total of 37.1 % were taking WHO step 1 analgesics (step 2: 11.4 % and step 3: 9.2 %). The proportion of persons receiving metamizole (dipyrone) was 28.3 % (with vs. without cancer: 35.6 vs. 27.1 %, respectively). Regarding all prescriptions, metamizole was by far the most frequently prescribed medication in nursing homes followed by melperone and omeprazole. CONCLUSION: Approximately one third of nursing home residents received metamizole and most were long-term prescriptions. Considering that metamizole is associated with potentially life-threatening adverse effects, caution is indicated particularly when prescribed over long periods.

Who gets dipyrone (metamizole) in Germany? Prescribing by age, sex and region.

WHAT IS KNOWN AND OBJECTIVE: Metamizole (dipyrone) is an analgesic that has been the focus of considerable controversy regarding its safety. Because of potentially life-threatening blood disorders such as agranulocytosis, it has been withdrawn in many countries but not in Germany, where prescribing even increased over recent years. We aimed to evaluate prescribing of metamizole in Germany with respect to age, sex and regional variations. METHODS: Using data of a statutory health insurance, we analysed a cohort of 1·7 million persons who were insured at least 1 day in each quarter of 2009. Outcome of interest was the outpatient prescription prevalence, for example the proportion of persons receiving at least one prescription of metamizole. RESULTS AND DISCUSSION: A total of 6·8% received metamizole with a higher prescribing prevalence in females (7·8% vs. 6·0%). The prevalence increased with age up to 26·7% in persons ≥85 years (men: 21·1%; and women: 30·4%). We found large regional variations with higher prevalences in the northern part of Germany. Most of the prescriptions were issued by general practitioners (78·9%). 58·3% were liquid oral formulations with considerable regional variations ranging between 32·3% in Mecklenburg-West Pomerania and 67·3% in North Rhine-Westphalia. Overall, liquid oral forms are much more often prescribed in the western than in the eastern part of Germany. WHAT IS NEW AND CONCLUSION: Metamizole - a drug with a relatively narrow indication - is often prescribed in Germany with relevant differences by age, sex and region. Qualitative studies should clarify reasons for this. Further quantitative research should investigate small-area variations, indications and treatment durations.

Healthcare utilization of people with type 2 diabetes in Germany: an analysis based on health insurance data.

AIMS: This population-based study assesses the healthcare utilization of people with Type 2 diabetes by analysing routine data from Allgemeine Orts-Krankenkasse (AOK), the largest statutory health insurance provider in Germany. METHODS: Anonymized billing data from all AOK-insured persons with at least one day of insurance during the evaluation year 2010 were analysed. Treatment and cost data from all areas of inpatient and outpatient care were available, as was information regarding patient age and sex. International Classification of Diseases (ICD-10) diagnosis and Anatomical Therapeutic Chemical (ATC) classification were used to identify 2.7 million insured persons with diabetes. RESULTS: The age- and sex-standardized prevalence of Type 2 diabetes was 9.8%. Of those patients identified, 33.9% had at least one diabetes-related complication and 83.0% had a diagnosis of hypertension. Almost two-thirds (63.1%) received antihyperglycaemic medication. Metformin and sulfonylurea were prescribed most often; medications without proof of benefit in endpoint studies were prescribed much less frequently. People without diabetes were admitted to hospital only half as often as those with Type 2 diabetes. The projected total expenditure in Germany for all people with Type 2 diabetes amounted to approximately €33.3 billion in 2010. CONCLUSIONS: This study shows an increase in both the prevalence of diabetes and treatment costs. The majority of people with Type 2 diabetes were aged 70 years or older. One third of this group has diabetes-related complications. Antihyperglycaemic medications without proof of benefit in endpoint studies were prescribed much less frequently than drugs with proof of benefit.

General and abdominal obesity parameters and their combination in relation to mortality: a systematic review and meta-regression analysis.

Epidemiological studies assessing general and abdominal obesity measures or their combination for mortality prediction have shown inconsistent results. We aimed to systematically review the associations of body mass index (BMI), waist-to-hip ratio (WHR), waist circumference (WC) and waist-to-height ratio (WHtR) with all-cause mortality in prospective cohort studies. In this systematic review, which includes a meta-regression analysis, we analysed the associations with all-cause mortality of BMI, WHR, WC and WHtR in prospective cohort studies available in Medline, Embase, the Cochrane Database of Systematic Reviews and Esbiobase from inception through 7 May 2010. A total of 18 studies met the inclusion criteria, comprising 689, 465 participants and 48, 421 deaths during 5-24 years of follow-up. The studies were heterogeneous, mainly due to differences in categorization of anthropometric parameters (AP) and different approaches to statistical analysis. Both general and abdominal obesity measures were significantly associated with mortality. In analyses using categorical variables, BMI and WC showed predominantly U- or J-shaped associations with mortality, whereas WHR and WHtR demonstrated positive relationships with mortality. All measures showed similar risk patterns for upper quantiles in comparison to reference quantiles. The parameters of general and abdominal obesity each remained significantly associated with mortality when adjusted for the other. This evidence suggests that abdominal obesity measures such as WC or WHR, show information independent to measures of general obesity and should be used in clinical practice, in addition to BMI, to assess obesity-related mortality in adults.

Evaluating frequency, diagnostic quality, and cost of Lyme borreliosis testing in Germany: a retrospective model analysis.

BACKGROUND: Data on the economic impact of Lyme borreliosis (LB) on European health care systems is scarce. This project focused on the epidemiology and costs for laboratory testing in LB patients in Germany. MATERIALS AND METHODS: We performed a sentinel analysis of epidemiological and medicoeconomic data for 2007 and 2008. Data was provided by a German statutory health insurance (DAK) company covering approx. 6.04 million members. In addition, the quality of diagnostic testing for LB in Germany was studied. RESULTS: In 2007 and 2008, the incident diagnosis LB was coded on average for 15,742 out of 6.04 million insured members (0.26%). 20,986 EIAs and 12,558 immunoblots were ordered annually for these patients. For all insured members in the outpatient sector, a total of 174,820 EIAs and 52,280 immunoblots were reimbursed annually to health care providers (cost: 2,600,850€). For Germany, the overall expected cost is estimated at 51,215,105€. However, proficiency testing data questioned test quality and standardization of diagnostic assays used. CONCLUSION: Findings from this study suggest ongoing issues related to care for LB and may help to improve future LB disease management.

[Disease-specific Questionnaire for Quality of Life in Patients with Peripheral Arterial Occlusive Disease in the Stage of Critical Ischemia (FLeQKI): psychometric evaluation of its responsiveness and practicability (Part 2)]. / Fragebogen zur gesundheitsbezogenen Lebensqualität von Patienten mit peripherer arterieller Verschlusskrankheit (pAVK) im Stadium kritischer Ischämie (FLeQKI): Psychometrische Bestimmung von Veränderungssensitivität und Praktikabilität (Teil 2).

PURPOSE: To test the "Questionnaire for Life Quality in Patients with Peripheral Arterial Occlusive Disease at the Stage of Critical Ischemia" (FLeQKI) in a prospective study with respect to responsiveness and practicability. PATIENTS AND METHODS: The responsiveness of the FLeQKI for therapy-induced changes of health related quality of life was prospectively determined in 65 consecutive patients with peripheral occlusive arterial disease at the stage of critical ischemia prior to percutaneous transluminal angioplasty (PTA) or bypass operation, and 1 month and 6 months after. 40 healthy individuals who were matched for age and questioned with the FLeQKI twice within 6 months served as the control. Additionally, all patients and healthy volunteers were questioned with the "Medical Outcomes Study Group Short Form" (SF-36). In all patients, the ankle/brachial index (ABI) was measured along with each of the three interviews. To validate practicability, we measured the time needed to fill out the questionnaires and asked the patients to indicate on a visual analog scale (VAS) graduated from 0 - 10 how strenuous they found the questionnaires to be. For statistical analysis, two-sided paired t-tests were used. RESULTS: The treatment group consisted of 35 men and 30 women with an age of 75.1+/-7.0 years, and the control group was comprised of 21 men and 19 women with an age of 73.4+/-7.8 years. In the control group, none of the FLeQKI scales showed significant changes over time (p>0.05). In the pAVK group, all scales improved between the interviews before and 6 months after therapy. Changes were either significant (comorbidity, p<0.05) or highly significant (all other scales, p<0.005 or p<0.0001). ABI increased above 0.5 (p<0.05). With an average of 12 minutes, the FLeQKI required less time than the SF-36 with an average of 15.57 minutes (p<0.05). Both questionnaires were evaluated with a VAS value of less than 1 (p>0.05) as non-strenuous. CONCLUSION: Regarding responsiveness and practicability, the FLeQKI is well suited for determining the specific impairments of life quality in patients with peripheral arterial occlusive disease in the stage of critical ischemia. Compared with the SF-36, the FLeQKI reached similar or better psychometric values.

[Disease-specific Questionnaire for Quality of Life in Patients with Peripheral Arterial Occlusive Disease in the Stage of Critical Ischemia (FLeQKI)--methodical development of a specific measuring instrument and psychometric evaluation of its validity and reliability (Part 1)]. / Fragebogen zur gesundheitsbezogenen Lebensqualität von Patienten mit peripherer arterieller Verschlusskrankheit (pAVK) im Stadium kritischer Ischämie (FLeQKI)--methodische Entwicklung eines krankheitsspezifischen Messinstruments und psychometrische Bestimmung seiner Validität und Reliabilität (Teil 1).

PURPOSE: To develop a disease-specific measuring instrument for quality of life in German-speaking patients with peripheral arterial occlusive disease in the stage of critical ischemia and to test it in a prospective study for validity and reliability. MATERIALS AND METHODS: We developed a questionnaire compiling items representing subjective disease relevant health states. With 35 of these items, we designed the scales comorbidity (KO), physical pain (SZ), physical functioning (KF), physical state (KS), social functioning (SB), mental health (PB), and therapy-induced limitations (TE). Each item was to be valued as never, seldom, often or always. The scales were standardized with a control group of 40 individuals without peripheral arterial occlusive disease who were interviewed twice in an interval of 6 months using both the FLeQKI and the Medical Outcomes Study Group Short Form 36 (SF-36). Convergent and discriminative validity was determined in 65 consecutive in-patients with peripheral occlusive arterial disease in the stage of critical ischemia who were interviewed with FLeQKI and SF-36 prior to percutaneous transluminal angioplasty (PTA) or bypass operation and 1 month and 6 months after. The internal consistency and test-retest reliability of the FLeQKI were determined in the control group. For statistical analysis, Cronbach's alpha Test and Pearsons Product Moment Correlation were used. RESULTS: The control group consisted of 21 men and 19 women with an age of 73.4+/-7.8, and the treatment group was comprised of 35 men and 30 women with an age of 75.1+/-7.0. In the treatment group, convergent validity reached high values in the scales SB, KF, PB, and SZ (r=0.41-0.70). With their discriminative validity (r=-0.04-0.30), TE and KS were independent, specific dimensions of life quality. The control group showed good values for internal consistency (Cronbach's alpha=0.54-0.93) and for test-retest reliability (r=0.44-0.96). CONCLUSION: The FLeQKI is well suited for determining the specific impairments of life quality in patients with peripheral arterial occlusive disease at the stage of critical ischemia. Its psychometric scores for validity and reliability corresponded to those of the SF-36.

[Incidence of major amputations, bypass procedures and percutaneous transluminal angioplasties (PTA) in the treatment of peripheral arterial occlusive disease in a German referral center 1996-2003]. / Inzidenzen von Major-Amputationen, Bypass-Operationen und perkutanen transluminalen Angioplastien (PTA) zur Behandlung der peripheren arteriellen Verschlusskrankheit in einer deutschen Klinik der Maximalversorgung 1996-2003.

PURPOSE: To determine the current incidence of major amputations, bypass procedures and percutaneous transluminal angioplasties (PTA) in a study population of patients with peripheral arterial occlusive disease in a German referral center. MATERIALS AND METHODS: In a retrospective study, we recruited patients with peripheral arterial occlusive disease who underwent an amputation, bypass procedure, or PTA in the region of the pelvis or lower limbs between 1996 and 2003 at the Augsburg Medical Center. Patients were identified via the hospital database. This was performed with the help of the International Classification of Diseases (ICD 9 and 10), the operation code (OPS), and appropriate invoices. The incidence of PTAs was further estimated with 200 charts. RESULTS: Of 5379 patients, 627 underwent amputation, 1832 a bypass procedure, and 2920 a PTA. The incidence of PTAs increased during the study period from 51.3/100 000/year to 64.4/100 000/year (p < 0.01), while the number of amputations and bypass procedures remained stable. The incidence of PTAs was exceeded by that of bypass procedures only in patients older than 85 years. The age of the amputees decreased during the study period from 72.2 to 70.5 years (p < 0.01). The age of patients who underwent a bypass procedure increased from 67.2 to 69.4 years, and the age of patients who underwent PTA increased from 66.3 to 69.8 years (p < 0.01). Bypass procedures and PTAs were performed in men 6.3 years earlier than in women (p < 0.01). CONCLUSION: The result is a population-corrected need of 8.4/100 000/year major amputations, 23/100 000/year bypass procedures and 64.4/100 000/year PTAs for patients with peripheral arterial occlusive disease within the referral area of our hospital. The performance of major amputations and bypass procedures stagnates, while the incidence of PTAs is increasing.

[Goals of therapy]. / Therapieziele.

Relevant criteria to assess specific diseases have been heavily discussed since Rudolf Virchow when morphologic changes represented the center of interest. However, nowadays presence and severity of disease cannot exclusively depend on the mere absence or presence of morphologic criteria anymore. The progress in basic and clinical science, moral values and economic constraints imply to reflect, concretize and ultimately operationalize the goals of medical therapy. Recent advances in molecular biology and genetics have lead to further understanding of pathophysiological mechanisms of disease and opened new ways for sophisticated and individualized therapeutical approaches. It is important to reconsider the definition of health and appropriately address functional and quality of life aspects. The categorical classification of therapeutical options, i.e. curative versus palliative therapy, does not provide satisfying answers to several clinical scenarios such as early stage prostate cancer in older adults or functional limitations in patients with peripheral arterial disease. Clinical research does acknowledge increasingly that relevant outcomes extend well beyond the quantitative prolongation of life. The scientific field of health services research is supposed to increase the evidence base of these decisions. Lastly, the goals of therapy should not be defined by physicians alone. It is important to inform the patient appropriately and discuss individual prognosis, therapeutical options and goals. Ultimately, therapy should be based on a shared decision making process.