Use of intravenous iron and risk of anaphylaxis: A multinational observational post-authorisation safety study in Europe.

PURPOSE: This post-authorisation safety study estimated the risk of anaphylaxis in patients receiving intravenous (IV) iron in Europe, with interest in iron dextran and iron non-dextrans. Studies conducted in the United States have reported risk of anaphylaxis to IV iron ranging from 2.0 to 6.8 per 10 000 first treatments. METHODS: Cohort study of IV iron new users, captured mostly through pharmacy ambulatory dispensing, from populations covered by health and administrative data sources in five European countries from 1999 to 2017. Anaphylaxis events were identified through an algorithm that used parenteral penicillin as a positive control. RESULTS: A total of 304 210 patients with a first IV iron treatment (6367 iron dextran), among whom 13-16 anaphylaxis cases were identified and reported as a range to comply with data protection regulations. The pooled unadjusted incidence proportion (IP) ranged from 0.4 (95% confidence interval [CI], 0.2-0.9) to 0.5 (95% CI, 0.3-1.0) per 10 000 first treatments. No events were identified at first dextran treatments. There were 231 294 first penicillin treatments with 30 potential cases of anaphylaxis (IP = 1.2; 95% CI, 0.8-1.7 per 10 000 treatments). CONCLUSION: We found an IP of anaphylaxis from 0.4 to 0.5 per 10 000 first IV iron treatments. The study captured only a fraction of IV iron treatments administered in hospitals, where most first treatments are likely to happen. Due to this limitation, the study could not exclude a differential risk of anaphylaxis between iron dextran and iron non-dextrans. The IP of anaphylaxis in users of penicillin was consistent with incidences reported in the literature.

[Prevalence and incidence of documented diabetes based on health claims data-reference analysis for diabetes surveillance in Germany]. / Prävalenz und Inzidenz des dokumentierten Diabetes mellitus ­ Referenzauswertung für die Diabetes-Surveillance auf Basis von Daten aller gesetzlich Krankenversicherten.

BACKGROUND: The prevalence and incidence of documented diabetes are two essential indicators intended to be reported on a periodic basis within the framework of diabetes surveillance in Germany. METHODOLOGY: Data provided based on the Data Transparency Act were analyzed. The data contain information on outpatient and inpatient care for all approximately 70 million persons with statutory health insurance. The case definition for the prevalence of documented diabetes comprises a confirmed outpatient diagnosis in at least two quarters of a year or an inpatient diagnosis in at least one quarter of a year in accordance with ICD-10 codes E10.- to E14.-. The incidence was calculated based on the same definition and with one year of diagnosis-free lead time. RESULTS: In 2011, a prevalence of 9.7% (women: 9.4%, men: 10.1%) was observed for persons with statutory health insurance. There are considerable differences in prevalence between the federal states and the maximum gap is 7.1 percentage points (age standardized: 4.0 percentage points). Type 2 and type 1 diabetes show a documented prevalence of 7.5% and 0.28%, respectively. Unspecified diabetes is documented relatively frequently with 1.9%. In 0.21% of persons, the diagnosis diabetes is documented via one inpatient secondary diagnosis. In addition, 0.17% of people without documented diabetes have at least one prescription of an antidiabetic drug. In 2012, 565,040 insured persons were newly diagnosed with diabetes; this corresponds to 1.0% of the insured persons (women: 1.0%, men: 1.1%). DISCUSSION: The developed reference analysis is suitable for reporting the prevalence and incidence of documented diabetes within the framework of diabetes surveillance. The differentiation of diabetes types is difficult due to coding practice.

Secondary data in diabetes surveillance - co-operation projects and definition of references on the documented prevalence of diabetes.

In addition to the Robert Koch Institute's health surveys, analyses of secondary data are essential to successfully developing a regular and comprehensive description of the progression of diabetes as part of the Robert Koch Institute's diabetes surveillance. Mainly, this is due to the large sample size and the fact that secondary data are routinely collected, which allows for highly stratified analyses in short time intervals. The fragmented availability of data means that various sources of secondary data are required in order to provide data for the indicators in the four fields of action for diabetes surveillance. Thus, a milestone in the project was to check the suitability of different data sources for their usability and to carry out analyses. Against this backdrop, co-operation projects were specifically funded in the context of diabetes surveillance. This article presents the results that were achieved in co-operation projects between 2016 and 2018 that focused on a range of topics: from evaluating the usability of secondary data to statistically modelling the development of epidemiological indices. Moreover, based on the data of the around 70 million people covered by statutory health insurance, an initial estimate was calculated for the documented prevalence of type 2 diabetes for the years 2010 and 2011. To comparably integrate these prevalences over the years in diabetes surveillance, a reference definition was established with external expertise.

[Integration of secondary data into national diabetes surveillance : Background, aims and results of the secondary data workshop at the Robert Koch Institute]. / Integration von Sekundärdaten in die Nationale Diabetes-Surveillance : Hintergrund, Ziele und Ergebnisse des Sekundärdaten-Workshops am Robert Koch-Institut.

Epidemiological data provide evidence that diabetes mellitus is a highly relevant public health issue in Germany as in many other countries. The Robert Koch Institute (RKI) is in the process of building a national diabetes surveillance system that is aimed at establishing indicator-based public health monitoring of diabetes population dynamics using primary and secondary data. The purpose of the workshop was to conduct an inventory of available secondary data sources and to discuss data contents, data access, data analysis examples in addition to the options for ongoing data use for diabetes surveillance.

Modeling Requirements for Cohort and Register IT.

BACKGROUND: The project KoRegIT (funded by TMF e.V.) aimed to develop a generic catalog of requirements for research networks like cohort studies and registers (KoReg). The catalog supports such kind of research networks to build up and to manage their organizational and IT infrastructure. OBJECTIVES: To make transparent the complex relationships between requirements, which are described in use cases from a given text catalog. By analyzing and modeling the requirements a better understanding and optimizations of the catalog are intended. There are two subgoals: a) to investigate one cohort study and two registers and to model the current state of their IT infrastructure; b) to analyze the current state models and to find simplifications within the generic catalog. METHODS: Processing the generic catalog was performed by means of text extraction, conceptualization and concept mapping. Then methods of enterprise architecture planning (EAP) are used to model the extracted information. To work on objective a) questionnaires are developed by utilizing the model. They are used for semi-structured interviews, whose results are evaluated via qualitative content analysis. Afterwards the current state was modeled. Objective b) was done by model analysis. RESULTS: A given generic text catalog of requirements was transferred into a model. As result of objective a) current state models of one existing cohort study and two registers are created and analyzed. An optimized model called KoReg-reference-model is the result of objective b). CONCLUSION: It is possible to use methods of EAP to model requirements. This enables a better overview of the partly connected requirements by means of visualization. The model based approach also enables the analysis and comparison of the empirical data from the current state models. Information managers could reduce the effort of planning the IT infrastructure utilizing the KoReg-reference-model. Modeling the current state and the generation of reports from the model, which could be used as requirements specification for bids, is supported, too.

Requirements and tasks of cohorts and registers, the German KoRegIT project.

Epidemiological cohorts and registers (KoReg) are long lasting and complex research projects, which need systematic and extensive planning and steering. The aim of the KoRegIT project was to develop a generic catalogue of requirements to support the organisational- and IT-structure of KoReg. The catalogue of requirements comprises the top level (TL) tasks of the core processes. All TL were classified into the following project phases: 1. Development, 2. Operation, 3. Completion. According to the defined TL tasks, the appropriate use cases (UC) were identified. The catalogue currently specifies 45 TL tasks and 207 UC. The UC were elaborated by a short and standardized description of the task, the involved actors (human or external systems), the preconditions, which have to be fulfilled in order to realize this task, the normal flow of the task and the post conditions. The developed catalogue was reviewed by representatives of different KoReg in Germany. The draft catalogue of requirements was revised according to the reviewer's feedback and discussion. The revised and complete catalogue with all elaborated UC was reviewed again by further experts. The developed KoRegIT catalogue of requirements offers a supporting tool to set-up the organisational structures and processes of KoReg as well as the definition of the needed IT-infrastructure. In addition it can be used to optimize or to expand these structures.

Revising the ECRIN standard requirements for information technology and data management in clinical trials.

The pilot phase of the ECRIN (European Clinical Research Infrastructure Network) certification programme for European data centres, in late 2011, led to a substantial revision of the original ECRIN standards, completed by June 2012. The pilot phase, the conclusions drawn from it and the revised set of standards are described. Issues concerning the further development of standards and related material are discussed, as are the methods available to best support that development. A strategy is outlined based on short-lived specific task groups, established as necessary by a steering group drawn from ECRIN-ERIC. A final section discusses possible future developments.