Antimicrobial resistance of Helicobacter pylori in Germany, 2015 to 2018.

OBJECTIVES: National and international guidelines recommend empiric first-line treatments of individuals infected with Helicobacter pylori without prior antimicrobial susceptibility testing. For this reason, knowledge of primary resistance to first-line antibiotics such as clarithromycin is essential. We assessed the primary resistance of H. pylori in Germany to key antibiotics by molecular genetic methods and evaluated risk factors for the development of resistance. METHODS: Gastric tissue samples of 1851 yet treatment-naïve H. pylori-positive patients were examined with real-time PCR or PCR and Sanger sequencing for mutations conferring resistance to clarithromycin, levofloxacin and tetracycline. Clinical and epidemiological data were documented and univariable and multivariable logistic regression analyses were conducted. RESULTS: Overall primary resistances were 11.3% (210/1851) to clarithromycin, and 13.4% (201/1497) to levofloxacin; resistance to tetracycline (2.5%, 38/1497) was as low as combined resistance to clarithromycin/levofloxacin (2.6%, 39/1497). Female sex and prior antimicrobial therapies owing to unrelated bacterial infections were risk factors for clarithromycin resistance (adjusted OR (aOR) 2.3, 95% CI 1.6-3.4; and 2.6, 95% CI 1.5-4.5, respectively); older age was associated with levofloxacin resistance (aOR for those ≥65 years compared with those 18-35 years: 6.6, 95% CI 3.1-14.2). CONCLUSIONS: Clarithromycin might still be recommended in first-line eradication therapies in yet untreated patients, but as nearly every tenth patient may carry clarithromycin-resistant H. pylori it may be advisable to rule out resistance ahead of treatment by carrying out susceptibility testing or prescribing an alternative therapy.

Resource costing for multinational neurologic clinical trials: methods and results.

We present the results of a multinational resource costing study for a prospective economic evaluation of a new medical technology for treatment of subarachnoid hemorrhage within a clinical trial. The study describes a framework for the collection and analysis of international resource cost data that can contribute to a consistent and accurate intercountry estimation of cost. Of the 15 countries that participated in the clinical trial, we collected cost information in the following seven: Australia, France, Germany, the UK, Italy, Spain, and Sweden. The collection of cost data in these countries was structured through the use of worksheets to provide accurate and efficient cost reporting. We converted total average costs to average variable costs and then aggregated the data to develop study unit costs. When unit costs were unavailable, we developed an index table, based on a market-basket approach, to estimate unit costs. To estimate the cost of a given procedure, the market-basket estimation process required that cost information be available for at least one country. When cost information was unavailable in all countries for a given procedure, we estimated costs using a method based on physician-work and practice-expense resource-based relative value units. Finally, we converted study unit costs to a common currency using purchasing power parity measures. Through this costing exercise we developed a set of unit costs for patient services and per diem hospital services. We conclude by discussing the implications of our costing exercise and suggest guidelines to facilitate more effective multinational costing exercises.

[MORBUS: the Sentinel Practice Network. Report on a study in South Oldenbury]. / MORBUS: Beobachtungspraxen in Niedersachsen Bericht zur Erhebung in Süd-Oldenburg.

There has been considerable public concern that emissions from intensive livestock farming may have hazardous effects on human health, particularly on the respiratory system. From October 1991 to September 1992, data on consultations of asthmatic children (up to 8 years) were obtained by a network of 25 GP and paediatric practices in South Oldenburg, a region with one of the highest livestock densities in Germany. Comparable data from a similar network of 75 practices in 3 adjacent regions (Brunswick, Hanover, Verden) with average livestock density served as a reference. In South Oldenberg, 2084 consultations of 542 asthmatic children were observed, with asthma being the reason for visit in 734 of the contacts (36%). The boy-girl ratio was 2.1:1 among index patients and 1.9:1 among consultations. Consultation rate was 25.2 contacts by asthmatic children per 1,000 total consultations of children up to 8 years in South Oldenburg, compared to 17.8 per 1,000 in Hanover, 15.7 per 1,000 in Brunswick and 13.6 per 1,000 in Verden. Consultations due to asthma scored 11.2/1,000 in South Oldenburg, 10.8/1,000 in Hanover, 7.2/1,000 in Brunswick and 6.5/1,000 in Verden. Asthmatic patients in South Oldenburg were younger (mean age 38 vs. 42 months) than those observed in the reference regions. There were no regional patterns in sex ratio, severity of asthma, respiratory allergies or atopic dermatitis. As this is an ecological study design, inferences concerning the cause of the observed regional differences can only be weak. We therefore propose a case-control study in order to obtain exposure and health data on an individual level.

Economic evaluation of antiviral therapy for the treatment of herpes zoster in immunocompetent adults.

Shingles (herpes zoster) affects 20% of the population at some stage during their lives. The economic consequences can be significant. For example, in the UK, the costs of post-herpetic neuralgia, a complication that affects between 10 and 14% of patients with shingles, have been estimated between 4.8 million and 17.9 million pounds sterling (Pounds). This study is the first formal assessment of the cost-effectiveness of the 2 most commonly used oral antiviral treatments that have proven efficacy in patients with shingles: famciclovir and aciclovir (acyclovir). It shows that the clinical advantages of famciclovir over aciclovir are accompanied by potential economic advantages in the form of savings in direct costs to the UK National Health Service of between 2.04 pounds and 16.85 pounds per patient treated. Future economic research to validate the benefits of antiviral treatment should focus on prospective assessments alongside controlled trials incorporating resource use analysis, quality-of-life appraisal, assessments of pain severity, and long term follow-up with continuation protocols.

[Estimating the denominator of a sentinel practice using accounting data of the federal physicians association]. / Schätzung des Nenners einer Beobachtungspraxis mit Hilfe der Abrechnungsdaten der Kassenärztlichen Vereinigung.

In order to interpret the regional and temporal variation in the number of cases reported for sentinel topics, rates have to be calculated which relate these figures to a common denominator. For this denominator different definitions are possible, where this paper focuses on the contact denominator, counting all contacts between the patient and the doctor in a specified period of time and a specified population (i.e. children between 2 and 3 years of age by sex for the first MORBUS topic). One patient may produce different contacts. Due to work load considerations contact denominators could not be directly recorded in sentinel practices in the MORBUS-project. A method was developed which combined minimal denominator information obtained from sentinel practices with routine (accounting) data from the doctor's associations, in order to estimate denominators with a high degree of precision. Data elements in the accounting data base include number of personal patient-doctor-contacts by type of treatment (screening/cure/emergency/referral) and insurance status (ordinary member, family member, retired) itemized list of actions that were reimbursed through the insurance company structural data about the doctor/practice (specialty, accreditation date) etc. For a first assessment of the degree of accuracy with which denominators can be estimated by such data, a pilot test was scheduled for April 1991. Doctors recorded the number of contacts with children between two and three years of age (by sex) for one week on a simple checklist. A linear model which included specialty, region, number of vouchers per quarter, number of infant health assessments and date of accreditation as predictors, was fitted to the data.(ABSTRACT TRUNCATED AT 250 WORDS)

The validity of inferences based on incomplete observations in disease state models.

In many survival time studies or studies on the progression of a disease, information is often incomplete in the sense that it is known only that a patient has been in certain disease states at several time points. In this paper, conditions concerning the interrelationship between the disease process and the examination scheme (i.e., the pattern of examination times) are derived under which a valid statistical inference is possible. These conditions are confronted with examination schemes that are of practical importance in clinical research. A cancer marker study is used as an example to estimate the magnitude of the potential bias when the conditions derived are violated.