Die Bedeutung von Sentinels für die Implementierung und Evaluation von Impfstrategien

In sentinel surveillance a prearranged sample of reporting sources-often healthcare providers-agrees to report all cases of defined conditions. The German "Protection Against Infection Act" (IfSG) provides a mandate to the Robert Koch-Institute (RKI) to establish sentinel surveillance of not notifiable diseases relevant to public health. Sentinel systems with RKI involvement include two networks of private practitioners reporting cases of influenza and measles (within the Working Groups on Influenza and Measles, respectively). In addition a laboratory-based sentinel system reports cases of certain bacterial infections in children. Results from these systems serve as a basis for framing vaccination recommendations and goals as well as for the evaluation, adjustment and promotion of vaccination strategies. The data indicate time trends (e. g. number of cases by season, age and region) and supply specific information (e. g. for determination of risk factors, distribution of pathogens). Methodological problems of sentinel surveys (e. g. selection of appropriate samples, population-based estimates) can be accounted for with appropriate methods of analysis. More effective implementation of sentinel surveillance in Germany could be achieved through better coordination of existing structures. This would make more effective use of limited resources and better enable timely and flexible investigation of conceptual and organisational questions.     

Die Bedeutung der selektiven Angio- und Bronchographie für die Beurteilung der Silikose

Zusammenfassung Die aufgeführten bronchographischen und angiographischen Untersuchungsergebnisse vermitteln einen Einblick in die mannigfaltigen Veränderungen am Bronchial- und Gefäßsystem bei der Silikose. Ganz allgemein läßt sich sagen, daß die morphologischen Veränderungen im Bereiche der Luft- und Blutwege nach Art, Häufigkeit und Ausdehnung mit der Schwere der Silikose und ihrer Begleiterscheinungen zunehmen. Wir waren bei unseren Untersuchungen immer wieder überrascht, welche schwerwiegenden morphologischen und funktionellen Störungen im Luftröhren- und Blutgefäßsystem der Lungen sich hinter einem großen silikotischen Schwielenschatten auf dem Thoraxbild oder der Schichtaufnahme verbergen können. Bei dem großen diagnostischen und therapeutischen Interesse, das die primären und sekundären, durch eine Staubeinwirkung verursachten Bronchial- und Gefäßveränderungen beanspruchen, müssen die selektive Angiographie und Bronchographie als wertvolle zusätzliche diagnostische Hilfsmittel angesehen werden. Manche Diskrepanz zwischen klinischem und sonst üblichem Röntgenbefund kann durch ihre Anwendung aufgeklärt werden. Unter klarer Indikationsstellung sind somit die gezielte Broncho- und Angiographie eine wertvolle Ergänzung in der Reihe klinischer, röntgenologischer und funktioneller Untersuchungsmethoden, indem sie allein oft den Nachweis schwerwiegender Komplikationen verschiedener Stadien und Formen der Silikose erbringen.Besonders aber eröffnen diese neueren Untersuchungsmethoden dem Kliniker die Morphologie der Hauptstrombahnen von Blut und Atemluft und damit auch wertvolle Rückschlüsse auf die komplexen pathophysiologischen Wechselbeziehungen zwischen Atmung und Kreislauf. Nicht nur die Störungen der Ventilation und Zirkulation mit der Verschlechterung der normalen Luft-Blutverteilung, sondern auch die hämodynamischen Rückwirkungen des silikosebedingten Emphysems einschließlich des Cor pulmonale chronicum erfahren durch diese Befunde eine weitere Stütze und ergänzen unsere Funktionsdiagnostik zur Bestimmung der Leistungsfähigkeit des kardio-pulmonalen Systems in sehr anschaulicher Weise.Mit 17 Textabbildungen.     

Die Bedeutung von Biomarkern für eine personalisierte Medizin

In this paper the relevance of biomarkers for the benefit/risk assessment of pharmaceuticals and the validation of biomarkers within clinical trials is presented. For this purpose the most important study designs for validation are described and discussed. Using the example of the development of rosuvastatin and the validation of hs-CRP (JUPITER study), aspects that are necessary for the planning of a joint development program for a pharmaceutical drug and a biomarker are discussed. In addition, alternatives considering how the validation of the biomarker could be involved in the entire development program of the pharmaceutical drug are presented.     

Die Bedeutung von Biobanken für die klinische Entwicklung

Access to samples in biobanks and collection of samples for evaluation of biomarkers in clinical trials are an essential basis for the identification and development of biomarkers. From the perspective of a research-based pharmaceutical company identification of biomarkers and the accompanying diagnostics are an essential prerequisite for the further evolution of personalised healthcare—and the key to more effective and efficient healthcare. Research-based pharmaceutical companies can basically use four types of biobanks: biobanks of university hospitals, commercial providers, collaborative groups and company-owned biobanks. Areas of application, arising from the use of biobanks in the context of clinical development, are collection of prevalence data, evaluation of biomarker stability in different disease stages, technical validation of assays, an optimized course of clinical studies by focusing on defined, biomarker-stratified groups of patients and pharmacogenetic research. Challenges are, in particular, the availability of clinically annotated samples and tissue matching blood samples, in addition to sample quality, number and amount. An acceptable legal and regulatory framework, as well as the positive perception of biomarker data by politicians and the public, are important prerequisites for translational research for identification of biomarkers in clinical studies. Also, the early establishment of research alliances between academia and the pharmaceutical industry are required to transfer research results in new strategies for prevention, diagnosis and treatment of patients.     

Survivorship-Care-Programme für Krebspatienten: die Bedeutung von Risikostratifizierung,Selbstmanagement- und Gesundheitskompetenzen im Zeitalter digitaler Versorgung

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - In Deutschland wie allen anderen Industrieländern weltweit nimmt mit einer älter werdenden Bevölkerung und einer...     

Bedeutung der ICD für Vergleiche von Indikatorensätzen

Classifications and compliance with definitions and rules are necessary requirements for the construction of indicator sets. Many classification rules are included in the regulatory framework of the ICD and serve as a basis for the indicator sets of the federal states, the Federal Republic of Germany, WHO, the EU and OECD. Based on selected examples of population and mortality data, the authors of the following article analyse the compliance with and/or deviations from coding rules which make the comparability of indicator sets possible, sometimes however more difficult. All of analysed indicator sets adhere to international classification rules. The calculation of the average population data or of infant mortality in the WHO, EU and OECD indicator sets leads to deviating results of the country values. The calculation of the average population deviates from that in Germany or in the EU. Slight numeric deviations finally lead to differences in country data, both with regard to population and infant mortality data. Perinatal mortality on the country level is calculated based on criteria which differ from international indicator sets. Not to be underestimated are non-valid mortality data which are used for international studies. The comparability of indicators is not yet satisfactory; partly, uniform criteria are missing.     

Die Bedeutung der beweglichen Aeromonaden als Krankheitserreger für den Menschen

The genus Aeromonas belongs to the family Aeromonadaceae of the order Aeromonadales and consists of 14 phenospecies and 17 genomospecies. They are gram-negative, oxidase-positive, facultatively anaerobic and glucose-fermenting rods. Members of the mesophilic genus Aeromonas spp. are ubiquitous in the aquatic environment and can be isolated from fresh, brackish and marine water. In nutrient-enriched waters they can attain large populations, particularly in the warm seasons at higher temperatures. Sewage effluents are also a major allochthonous source of the mesophilic aeromonads in the aquatic environment. Organisms of the mesophilic aeromonads also occur in fresh and processed foods, often in very high numbers. They have been isolated from a wide range of both animal and plant food, including raw red meat, fish, seafood or vegetables. This reflects undoubtedly the contact of that food with contaminated water. Species of Aeromonas (A. hydrophila, A. caviae, A. veronii) have been shown to be associated with food borne gastroenteritis, with wound infections acquired via water or with sepsis, peritonitis or meningitis. Unlike gastroenteritis, these infections can have fatal or serious debilitating outcomes. Aeromonas sepsis generally arises secondary to gastroenteritis or wound infection and is associated with high mortality rates. Underlying diseases, particularly liver cirrhosis, or immunsuppressive states also play a major role in the acquisition and outcome of these infections.     

Bedeutung des Stillens für das Kind

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Muttermilch ist die natürliche Ernährung für Säuglinge. Neben Nährstoffen enthält Muttermilch eine...     

Richtwerte für Glykolether und Glykolester in der Innenraumluft

The German Ad-hoc Working Group on Indoor Guidelines of the Indoor Air Hygiene Committee and of the Supreme State Health Authorities is issuing indoor air guide values to protect public health. For health evaluation of glycol ethers and glycol esters in air, the entire group of substances with data for 47 compounds was analysed in order to gain a unique assessment. For some glycol ethers reproductive and haematological effects are of central interest, whereas for others effects on liver and kidneys are crucial. Moreover, some glycol ethers were also shown to cause irritation of the respiratory tract. Fourteen compounds could be characterized either by relevant inhalation studies or by analogies drawn to strongly related substances. For these compounds individual guide values were derived, the respective guide value I ranging from 0.02–2 mg/m³ (Tab. 2). The derivation of guide values considered the time exposure of the population as compared to working people or animal studies. The duration of the respective study, the interindividual variability—by a factor of 10—and the enhanced respiratory rate in children as compared to adults—by a factor of 2—were further taken into account. To allow for extrapolation from animal to human exposure differences in toxicodynamics were considered by a factor of usually 2.5. For compounds with insufficient data a default guide value II and I of 0.05 and 0.005 ppm, respectively, was recommended based on the statistical analysis of the available data of all glycol ethers. In order to achieve a total evaluation of all glycol ethers and glycol esters found in indoor air the proportional concentrations of each compound divided by the respective guide value were aggregated to give a total guide value. The total guide values are regarded to be complied with if their respective value falls below 1.     

Die bedeutung von primärtuberkulose und anderen lungeninfektionen für die entstehung der silikose

Zusammenfassung Nachuntersuchungen an 1060 Bergleuten, die mindestens 10000 Std in schwedischen Sulfiderzgruben staubexponiert waren, haben folgendes ergeben:Die Silikosehäufigkeit steigt nicht parallel mit der Expositionszeit an. Dies läßt darauf schließen, daß neben dem Staub auch noch andere Faktoren bei der Entstehung der Silikose eine Rolle spielen können. Als wesentliche Faktoren sind hier Lungeninfektionen zu nennen, die während der Staubexposition durchgemacht werden. Es wird gezeigt, daß das Silikoserisiko bei jenen Bergleuten, die während der Staubexposition keine Lungeninfektionen durchmachten, sehr gering war (1,5––3,5%), während es bei Bergleuten, die während der Staubexposition an Lungeninfektionen erkrankten, erheblich anstieg (55–58%).Daraus wird geschlossen, daß jene Personen am wenigsten silikose-tgefährdet sind, die niemals mit dem Tuberkelbacillus infiziert wurden oder die längere Zeit vor Beginn der Staubexposition eine Primär tuberkulose durchmachten oder BCG-geimpft wurden. Auch eine vor der Staubexposition durchgemachte Pleuritis and sogar ausgeheilte Lungentuberkulose und andere Lungeninfektionen scheinen die Empfänglichkeit für die Silikose nicht wesentlich zu erhöhen.Hingegen sind Personen, die während oder kurz vor der Exposition entweder eine Primärtuberkulose erwerben, BCG-geimpft werden oder an anderen Lungeninfektionen erkranken, die das Lymphsystem der Lunge belasten, sehr gefährdet.Diese Beobachtungen eröffnen die Möglichkeit einer medizinischen Prophylaxe der Silikose. Praktische Richtlinien für die medizinische Verhütung der Silikose werden gegeben, wobei die Konrolle der tuberkulösen Infektion von besonderer Bedeutung ist.

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Summary An examination of 1,060 mine workers who, for at least 10,000 hours had been exposed to dust in Swedish sulphide mines, gave the following result:The frequency of silicosis cases shows no correlation to length of exposure to mine dust. This phenomenon cannot alone be explained by normal variations in constitutional factors. Thus, besides dust there must be other factors which have a concial influence on the development of silicosis.The author considers that these other factors must primarily be looked for in lung infections contracted by persons during the period they were exposed to dust. He has studied his material in connection with this hypothesis and found a very low silicosis frequency (1.5–3.5%) amongst mine workers with absence from lung infections during exposure. On the other hand the frequency was high (55—58%) amongst those who have suffered various lung infections during exposure to dust.The author has drawn the conclusion that the least susceptible to silicosis are persons who have never been infected by tuberculosis or have received, a sufficiently long time before exposure to dust commenced, primary tuberculosis or BCG vaccination. Even pleurisy and pulmonary tuberculosis cured before the commencement of exposure does not in any degree worth mentioning increase susceptibility to silicosis. Silicosis is most imminent for these who during, or a short time before exposure to dust, incure either primary tuberculosis, or are BCG vaccinated, or suffer pneumonia or other lung infections which influence the lymphatic system.This discovery presents us with new possibilities to prevent silicosis by medical means. The principles of the medical provisions for providing against silicosis are given, of which control of primary tubercular infection is the most important.

     

Bedeutung von Klima- und Umweltschutz für die Gesundheit mit besonderer Berücksichtigung von Schädigungen der Hautbarriere und allergischen Folgeerkrankungen

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Die menschliche Haut erfüllt neben der Lunge und dem Darm eine zentrale Barrierefunktion hinsichtlich der Interaktion des...     

Nutzungskonzepte für Proben und Daten aus humanen Biobanken für die Forschung

It is accepted worldwide that biospecimen and data sharing (BDS) play an essential role for the future of medical research to improve diagnostics and prognostics, e.g. by validated biomarkers. BDS is also pivotal to the development of new therapeutic treatments and for the improvement of population health. Human biobanks can generate an added value to this need by providing biospecimens and/or associated data to researchers. An inspection of several examples of epidemiological as well as clinical/disease-oriented biobanks in Germany shows that best practice procedures (BPP) that are internationally agreed on are being installed for biospecimen and/or data access. In general, fair access is aimed at requiring a written application by the requesting scientist, which is then peer-reviewed for scientific and ethical validity by the Biobank. Applied BPP take into account (i) patient education/agreement according to the informed consent model, (ii) privacy protection, (iii) intellectual property rights, the (iv) notification obligation of health-related findings (including incidental findings), the (v) use of material (MTA) and data transfer agreements (DTA) for mutual legal security, the avoidance of conflicts of interests, as well as for cost recovery/fee for service as a basis for sustainability of the biobank. BPP are rooted in the self-regulation efforts of life sciences and are supported by parent ethics committees in Germany. Central biobank registries displaying aggregated information on biospecimens stored and the research foci constitute an important tool to make biobanks that are scattered across the country visible to each other, and, can thus promote access to hitherto unknown biospecimen and data resources.     

Die Potenziale von Patientenbefragungen für die Qualitätssicherung in der medizinischen Versorgung

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Was „Qualität“ in der medizinischen Versorgung ausmacht und mit welchen Mitteln sie kontrolliert, gesichert oder...