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Registries and cohort studies play a central role in patient-oriented medical research, in particular in health services research. In order to increase the transparency about ongoing registries and cohort studies in Germany, and to promote communication and cooperation between the drivers in the field a so-called register portal should be established. Metadata are characteristics that are used to describe registries and cohort studies in the register portal. A limited set of characteristics, the core set, should correctly describe the projects on the one hand while reducing workload for data capture and data administration on the other hand. The core set consists of 26 data elements that had been defined in a Delphi-consensus process involving experts from the working group registries of the German Network for Health Services Research (DNVF) and the working group IT infrastructure and quality management of the Technology, Methods, and Infrastructure for Networked Medical Research (TMF). Transparent policies are required to guarantee traceability and reliability of the portal's services. Six so-called top-level-tasks and 37 use cases were defined in an interim report so far. The metadata have been agreed upon by most of the member associations of the DNVF. Metadata and rules of procedures are the starting point for the practical implementation of the register portal in the next future., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Assessment of the quality of medical care plays an increasingly important role in the German healthcare system. Requirements for quality indicators include validity, reliability, responsiveness, interpretability and feasibility. Because of the high impact of guidelines, quality indicators that are recommended in such guidelines are of special relevance., Methods: We conducted a systematic review of all German S3 guidelines (actual as of November 30(th), 2013) to investigate the proportion of guidelines recommending quality indicators, which categories to classify quality indicators were used, and whether quality indicators in German S3 guidelines were developed following evidence-based methods., Results: In 34 from 87 S3 guidelines (39%) a total of 394 quality indicators were defined. The vast majority of the recommended quality indicators focused on process quality. Outcome indicators were only recommended in 9 S3 guidelines (10%). None of the guidelines analysed reported the properties of the recommended quality indicators., Conclusion: Despite the increasing relevance of quality assessment for all stakeholders in the German healthcare system only approximately 40% of the S3 guidelines define indicators to measure the quality of care. Recommendations to assess outcome indicators are only provided in 10% of S3 guidelines. The process of the development and recommendation of quality indicators is heterogeneous and frequently not transparently reported. The current practice for the recommendation and validation of quality indicators in German S3 guidelines does not meet the requirements of evidence-based healthcare., (© Georg Thieme Verlag KG Stuttgart · New York.)

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., (© Georg Thieme Verlag KG Stuttgart · New York.)

The methodical quality of health services research studies is often subject to criticism. Common standards in the field of health services research have been lacking so far. Hence, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] decided to contribute to an improvement of this situation. The DNVF e. V. has already published part 1 of the Memorandum III"Methods for Health Services Research" for the 3 subject areas "Epidemiological Methods for Health Services Research", "Methods for Organisational Health Services Research" and "Methods for Quality of Life Research". The herewith published Part 2 of the Memorandum extends the spectrum by describing the methodological principles and minimum standards of "Methods of Health Economic Evaluations" and "Registries for Health Services Research". On 30 (th) August 2010, the member societies, mentioned as authors, approved this second part of the Memorandum III. 2 in-depth publications focussing on the 2 mentioned topics will be published in the next issues of this journal. This memorandum is intended for health services researchers who are planning, conducting and publishing studies as well as for reviewers who evaluate research proposals and publications on health services research studies. In accord with the expected advances in knowledge in health services research, it is planned to update the 2 parts of Memorandum III at appropriate intervals and to publish further parts from the huge spectrum of methods relevant to this field in the near future. Thus, the Memorandum has to be considered as work in progress., (© Georg Thieme Verlag KG Stuttgart · New York.)

On July 1, 2009, 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 the member societies mentioned as authors and published in this Journal [Gesundheitswesen 2009; 71: 505-510]. This is an in-depth publication on "quality-of-life assessment in health services research". Within the context of the health sciences, quality of life (QL) encompasses the subjective well-being and functioning in the physical, psychological and social domains. QL informs about the aspects of health care that "actually get to the patient". QL is what patients primarily experience, what they talk about and what to a large degree affects the acceptance of health-care services and processes in the society. Therefore, QL can be considered as a highly important endpoint within health services research. The importance of the construct quality of life is also emphasised in German treaties on social law and utility analyses. This paper is the first account on the relations between health services research and the concept and assessment of QL. Our working group has specified key criteria for QL assessment within studies on health services research. (1) Assessment instruments need to comply with standard quality criteria (reliability, validity, sensitivity, interpretability) and the decision for a particular instrument has to be reasonably justified. (2) Study design and study population have to match with the scientific research question and the sample size has to be biometrically sound. (3) QL assessment including time points over the course of the study has to follow a standardized protocol. (4) Criteria for analysis and interpretation have to be prospectively specified. (5) Studies focusing on diagnostic/therapeutic issues need to specify standards for diagnostic criteria and related therapeutic interventions., (Copyright Georg Thieme Verlag KG Stuttgart . New York.)

The methodical quality of health services research studies is often subject to criticism. Common standards in the field of health services research have been lacking so far. Hence, the German Network Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF e.V.)] decided to contribute to improve this situation. On 1 July 2009, the DNVF e.V. approved the Memorandum III "Methods for Health Services Research", supported by the member societies mentioned as authors. For the three subject areas "Epidemiological Methods for Health Services Research", "Methods for Organisational Health Services Research" and "Methods for Quality of Life Research", this Memorandum describes the methodological principles and minimum standards which should be adhered to when conducting and publishing health services research studies. Three in-depth publications focussing on the three mentioned topics will be published in the next issues of this journal. This memorandum is intended for health services researchers who are planning, conducting and publishing studies as well as for reviewers who evaluate research proposals and publications on health services research studies. In accord with the expected advances in knowledge in health services research, it is planned to update the Memorandum III (part 1) at appropriate intervals and to publish part 2 in the near future. Thus, the Memorandum has to be considered as work in progress., ((c) Georg Thieme Verlag KG Stuttgart-New York.)