[AKTIN - The German Emergency Department Data Registry - real-time data from emergency medicine : Implementation and first results from 15 emergency departments with focus on Federal Joint Committee's guidelines on acuity assessment]. / Das AKTIN-Notaufnahmeregister ­ kontinuierlich aktuelle Daten aus der Akutmedizin : Ergebnisse des Registeraufbaus und erste Datenauswertungen aus 15 Notaufnahmen unter besonderer Berücksichtigung der Vorgaben des Gemeinsamen Bundesausschusses zur Ersteinschätzung.

BACKGROUND: Emergency care in Germany is in transition. Emergency departments (EDs) treat their patients based on symptoms and acuity. However, this perspective is not reflected in claims data. The aim of the AKTIN project was to establish an Emergency Department Data Registry as a data privacy-compliant infrastructure for the use of routine medical data. METHODS: Data from the respective documentation systems are continuously transmitted to local data warehouses using a standardized interface. They are available for several applications such as internal reports but also multicentre studies, in compliance with data privacy regulations. Based on a 12-months period we evaluate the population with focus on acuity assessment (triage) and vital parameters in combination with presenting complaints. RESULTS: For the period April 2018 to March 2019, 436,149 cases from 15 EDs were available. A triage level is documented in 86.0% of cases, and 70.5% were triaged within 10 min of arrival. Ten EDs collected a presenting complaint regularly (82.3%). The respective documentation of vital signs shows plausible patterns. CONCLUSIONS: The AKTIN registry provides an almost real-time insight into German EDs, regardless of the primary documentation system and health insurance claims data. The Federal Joint Committee's requirements are largely met. Standardized presenting complaints allow for symptom-based analyses as well as health surveillance.

[Memorandum registry for health services research]. / Memorandum Register für die Versorgungsforschung.

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by their member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. Registries in Health Services Research vary in their aims and research questions as well as in their designs, methods of data collection, and statistical analyses. This paper aims to provide both a methodological guideline for developers to ensure a high quality of a planned registry and, to provide an instrument for users of data from registries to assess their overall quality. First, the paper provides a definition of registries and presents an overview of objectives in Health Services Research where registries can be useful. Second, several areas of methodological importance for the development of registries are presented. This includes the different phases of a registry (i. e., conceptual and preliminary design, implementation), technical organisation of a registry, statistical analysis, reporting of results, data protection, and ethical/legal aspects. From these areas, several criteria are deduced to allow the assessment of the quality of a registry. Finally, a checklist to assess a registry's quality is presented.

CDISC standard-based electronic archiving of clinical trials.

OBJECTIVES: Our objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database. METHODS: Based on own experiences with CDISC, existing implementations and future developments, CDISC standards were evaluated concerning requirements for archiving clinical studies. Trial master files of a small, medium and large clinical study were analyzed to collect specifications for electronic archiving of records. RESULTS: Two different ways of long-term storage exist for the clinical trial archive: document-oriented archival and data archiving of the study database. The trial master file has a highly complex structure; its different parts can vary greatly in size, depending of the working style of investigators, number of patients recruited, the number of adverse event reports and the number of queries. The CDISC standard ODM is especially suited for archiving clinical trials, because among other features it contains the entire clinical trial data and full audit trail information. On the other hand SDTM is a content standard suited for data warehouses. Two recent developments in CDISC will affect the archival of studies: the further development of ODM in the area of "eCRF submission" and the use of "Electronic Source Data". CONCLUSIONS: The complexity and size of the trial master file requires new solutions. Though ODM provides effective means to archive the study database, it shows still deficiencies, especially for the joint archiving of data and the complex documentation of the trial master file. A concept was developed in which the ODM standard is part of an integrated archiving of the trial data and documents. ODM archiving of the study database enables long-term storage which is GCP-compliant. Archiving of documents of the trial master file in PDF/A, including links and electronic signatures, as well as the storage of selected study data in a data warehouse at the sponsor site in SDTM are the other components of the concept.