Health Services Research In Germany Research Articles

Participant observation for inquiry-based learning: a document analysis of exam papers from an internship-course for master’s students in health services research in Germany

Inquiry-based learning (IBL) is a type of problem-based learning. While IBL aims at reflecting the work of practicing researchers, only some students will pursue an academic career. We therefore designed a course that provides opportunities for IBL by applying participant observation to internship work experience inside and outside academia. Using this internship course as an example, we investigated, how master’s students in health science executed an IBL assignment regarding the application of participant observation and presentation of findings. In addition, the understanding of occupational fields provided through the IBL assignment was examined.To determine whether learning objectives were met, a document analysis of IBL assignments comprising presentation slides and field protocols was performed. Within content analysis, a category grid was used examining (a) suitability of chosen research objectives, (b) execution of field protocols, (c) sufficiency of reporting and (d) extent of reflection.49 IBL assignments from the years 2020–2022 were included. Sides of IBL observations were: (a) organizations providing health care (n = 28); (b) administrations of health care (n = 8); and (c) research institutes (n = 13). Within students’ field protocols, the level of detail of descriptions differed. 30 assignments included reflection on the methods used and research experience. In about a third of IBL assignments, indication of observation type, theoretical background and data analysis was missing.Using participant observation of internship work-experience for IBL can serve as a teaching tool for students to develop methodological skills. For future courses, we developed a checklist to strengthen reporting, reflection and use of theory. As internships are often integrated in degree programs in health sciences similar courses could be implemented in different programs, given qualified methodological guidance.

Correction: Navigating the Future of Organisational Health Services Research in Germany and beyond: a Position Paper.

Correction: Navigating the Future of Organisational Health Services Research in Germany and beyond: a Position Paper.

Organisational Health Services Research in Germany: A Scoping Review of Conference Abstracts.

Health Services Research (HSR) is a growing field in Germany, in which Organisational Health Services Research (OHSR) has emerged as a subfield. The aim of this scoping review was to provide an overview of the field of OHSR within HSR in Germany and to map systematically original contributions by describing the organisational setting, the research design, the research objectives and the theoretical underpinning. A scoping review examined published abstracts from the 19th German Conference on Health Services Research 2020. Abstracts were included if (1) health care organisations, subunits or organisational processes were mentioned as research objects, and (2) if at least one out of five research perspectives from a recent German definition of OHSR was addressed. After intensive pilot screenings within a group of nine researchers, all abstracts were screened independently in three review teams with three researchers each, and data from included abstracts were extracted using content analysis based on a self-developed detailed coding scheme. Out of n=468 identified abstracts in German (84%) or English (16%) language, n=138 (29.5%) abstracts were included. The majority of included abstracts addressed acute care in hospitals (34.8%), reported results from observational studies (59.4%) and collected primary data (69.6%). There was a slightly higher use of quantitative (32.6%) than qualitative (24.6%) research methods with a considerable number of studies using more than one method (31.9%). An explicit reference to theory was made in 7.2% and 17.4% used the term 'organisation' or related terms explicitly in their abstract. This review provides a systematic but preliminary overview of the scope to which HSR in Germany addresses OHSR. The organisational perspective is considered extensively in HSR abstracts, but mostly implicitly. The research is reported largely free of theory which can reduce their explanatory power. Therefore, a research agenda, more awareness as well as education and better conceptualisation of OHSR topics within German HSR are needed.

Navigating the Future of Organisational Health Services Research in Germany and beyond: a Position Paper.

Recent analyses have shown that in health services research in Germany, healthcare organisations are often considered primarily as a study setting, without fully taking their complex organisational nature into account, neither theoretically nor methodologically. Therefore, an initiative was launched to analyse the state of Organisational Health Services Research (OHSR) in Germany and to develop a strategic framework and road map to guide future efforts in the field. This paper summarizes positions that have been jointly developed by consulting experts from the interdisciplinary and international scientific community. In July 2023, a scoping workshop over the course of three days was held with 32 (inter)national experts from different research fields centred around OHSR topics using interactive workshop methods. Participants discussed their perspectives on OHSR, analysed current challenges in OHSR in Germany and developed key positions for the field's development. The seven agreed-upon key positions addressed conceptual and strategic aspects. There was consensus that the field required the development of a research agenda that can guide future efforts. On a conceptual level, the need to address challenges in terms of interdisciplinarity, terminology, organisation(s) as research subjects, international comparative research and utilisation of organisational theory was recognized. On a strategic level, requirements with regard to teaching, promotion of interdisciplinary and international collaboration, suitable funding opportunities and participatory research were identified. This position paper seeks to serve as a framework to support further development of OHSR in Germany and as a guide for researchers and funding organisations on how to move OHSR forward. Some of the challenges discussed for German OHSR are equally present in other countries. Thus, this position paper can be used to initiate fruitful discussions in other countries.

Health Services research in Germany in Times of COVID-19: How Does the Pandemic Influence Research Processes, Methods and the Personal Situation of Researchers? An Online Survey

The COVID-19 pandemic has a massive impact on social life, the healthcare system, and also on health services research. However, the effects of the pandemic on research processes, methods, and the personal situation of researchers has not been investigated so far. Guided by the question of how research processes and methods are adapted to the challenges posed by COVID-19 and how researchers perceive the impact of the pandemic on their personal situation, an online survey of health services researchers was conducted from June to July 2021. The results showed that a large proportion of research projects have had delays due to recruitment and/or data collection issues. Two-thirds of the respondents who had already collected data since the beginning of the pandemic (March 2020) were unable to collect data in the originally planned form and relied primarily on digital data collection methods. The analysis of the open-ended survey responses showed that the pandemic had a massive impact on all phases of the research process: key challenges included difficult field access, problems in achieving planned sample sizes, and concerns about data quality. Regarding their personal situation, researchers perceived the reduction of personal contacts, and the resulting lack of visibility as negative, while at the same time they benefited from the easy digital contact possibilities. Overall, the study provides an initial assessment of how the COVID-19 pandemic affected health services research and researchers. It shows that after the initial "shock" of the first lockdown in March 2020, pragmatic and often innovative ways were found to carry out projects under the pandemic conditions. However, the increased use of digital communication forms and data collection methods brings numerous challenges, but also methodological impulses.

Anwendung und Darstellung qualitativer Methoden in der Versorgungsforschung in Deutschland: ein Scoping Review zu Primärstudien (2010–2019)

BackgroundQualitative research methods offer a unique perspective on health care services. However, little is known about the actual application of qualitative methods in health services research. Therefore, the aim of this study was to gain an overview of volume and variety of the use of qualitative research methods in health services research in Germany. MethodsBy means of a scoping review, a systematic literature search of the database PubMed was conducted in September 2020. We included (1) qualitative studies in (2) a health services setting (3) in Germany, (4) published in either German or English as (5) original research in a journal (6) between 2010 and 2019. After removing duplicates, tandem teams of researchers first performed a title and abstract screening, followed by a full text screening. Data was extracted by using a category grid considering research focus, study design and reporting. ResultsIn total, 759 articles were included in the title and abstract screening. After applying the exclusion criteria, 97 articles were included in the data extraction. The studies investigating mainly subjective perspectives of different stakeholders, especially physicians and patients, covered 13 areas of health care. Interviews were the dominant form of data collection (n=64). Data analysis was mainly conducted using content analysis (n=65). ConclusionA clear absolute increase in publications since the mid-2010s can be observed. At the same time, there has been a strong tendency towards certain methods being used for data collection and analysis. Compared to reporting standards and guidelines (e.g., COREQ), incomplete reporting of research methods has been noted. The results show that both an extension of the range of methods and the quality of reporting need to be discussed.

Educational Programmes in Health Services Research in Germany: Current State and Future Perspectives

ZusammenfassungZiel der Studie Ziel dieser Untersuchung war es, die derzeit akkreditierten Versorgungsforschungsstudiengänge in Deutschland im Hinblick auf ihre Strukturdaten und Inhalte zu analysieren. Methodik Im Rahmen eines deskriptiven qualitativen Designs wurden die aktuellen Studienverlaufspläne, die Modulhandbücher und die Steckbriefe akkreditierter Masterstudiengänge der Versorgungsforschung inhaltsanalytisch ausgewertet. Ergebnisse Die 6 analysierten Studiengänge zeigen sich hinsichtlich ihrer strukturellen Merkmale und lehr-lerninhaltlichen Ausrichtung in den wesentlichen Punkten als homogen. Ziel aller Studiengänge ist es, fach- und disziplinübergreifende personale und soziale Kompetenzen zu fördern, um Versorgungsbedarfe im Gesundheitswesen zu identifizieren, Innovationen der Versorgung zu entwickeln, zu initiieren, zu evaluieren und kritisch zu reflektieren. Schlussfolgerungen Trotz ähnlicher Lehr-Lerninhalte bestehen spezifische Ausrichtungen, für die sich die Studierenden vor dem Hintergrund ihrer individuellen Präferenzen entscheiden können. Diese Ergebnisse könnten unter Berücksichtigung aktueller Diskurse und weiterer Erkenntnisse als Grundlage für Empfehlungen zur Entwicklung eines Kerncurriculums dienen.

The Junior Research Academy 2017 of the German Research Foundation (DFG) - Promotion of Young Researchers in Health Services

The fourth Junior Research Academy in Health Services Research was once again funded by the German Research Foundation (DFG) in 2017. The academy was initiated by the Centre for Health and Society (chs) in Düsseldorf with the participation of the Centre for Health Services Research Cologne (ZVFK), the Research Centre for Health Communication and Health Services Research (CHSR) of the Clinic and Polyclinic for Psychosomatic Medicine and Psychotherapy of the University Hospital Bonn, the Interdisciplinary Centre for Health Services Research (IZVF) in Witten and the Institute for Health Services Research and Clinical Epidemiology (IVE) of the University Marburg. The aims of the Junior Research Academy are for imparting skills in the development and elaboration of innovative project ideas, to increase the number of proposals from the field of health services research to the DFG, to strengthen basic research within health services research in Germany and to network the scientific community. Young researchers from all over Germany were eligible to apply for participation by submitting an application in the form of a research proposal. A total of 83 applications were received. The 21 most promising applicants (14 women and 7 men) were selected in a 2-stage review process; 20 of these completed the Junior Research Academy program. After a one-day preparatory workshop, the preparation and review of a sample application, an academy week and a finalisation phase, all applications were submitted to the DFG on time. Of these proposals, 9 were funded. The first alumni meeting of the DFG Junior Research Academy took place in Düsseldorf in July 2019.

DNVF-Memorandum III - Methods for Health Services Research, Part 4 - Concept and Methods for Organizational Health Services Research: Short Version

Organizational health services research in Germany is of increasing relevance. Based on the guide on methods for organizational health services research of the Memorandum III, part 1 from the year 2009, the fundamentals and standards have now been refined. The memorandum captures the theoretical framework, basic methodological approaches and methods in health services research for the design, evaluation and implementation of complex interventions in healthcare organizations.

Versorgungsforschung

This overview article highlights the central role of health services research (HSR) for the further development of the healthcare system. As ayoung scientific discipline in Germany, HSR covers five important elements with different weighting in different definitions, which are elaborated in some detail in this article: patient orientation, results and outcome orientation at the patient and population levels, implementation perspectives and context relation, complex interventions and improvement, multidisciplinarity and multiprofessionalism. One of the fundamental pillars of HRS is related to the insufficient implementation of scientifically proven treatment methods and improvement strategies into routine patient care. Healthcare research is therefore the so-called second translation of clinical trials in the routine daily care (from bedside to practice) after the first translation from bench to bedside. The scientific methods used in HSR clearly extend beyond the spectrum of (clinical) epidemiology. The methodological standards are developed as consensus memoranda of members of the German network of HSR, which serve as orientation points for qualitatively good HSR. Finally, various perspectives for the long-term safeguarding and improvement of the quality of HSR in Germany are proposed.

Regional Differences in Thrombectomy Rates : Secondary use of Billing Codes in the MIRACUM (Medical Informatics for Research and Care in University Medicine) Consortium.

Mechanical thrombectomy, in addition to intravenous (i.v.) thrombolysis is recommended for treatment of acute stroke in patients with large vessel occlusions (LVO) in the anterior circulation up to 6 h after symptom onset. We compared thrombectomy rates of eight university hospitals of the MIRACUM consortium to analyze the implementation of this guideline in clinical routine. Anonymized billing data in a standardized format were loaded into a local i2b2 data warehouse by applying already existing extract, transform and load (ETL) routines. A locally executed uniform SQL (structured query language) query delivered aggregated site data for all inpatients with a discharge diagnosis of ischemic stroke (ICD-10 I63) containing counts for type of acute treatment, type of admission and age groups, which were centrally analyzed with R. From 2014 to 2016, the thrombectomy rate almost doubled from a mean of 4.7% to 9.6%, although significant differences between centers exist (range in 2016: 5.8-17%). The number of drip-and-ship procedures increased in 3 out of 8 centers. There was no evidence for a decrease in thrombectomy rates during weekends/holiday or among patients older than 80 years, but this age group is more likely to receive i.v. recombinant tissue plasminogen activator (rtPA). The observed increase of thrombectomy rates and drip-and-ship procedures without a significant difference between weekdays and weekends or patients of different ages is substantiating a rapid implementation of stroke guidelines within the analyzed neurovascular centers. The prototype of the MIRACUM Data Integration Center already contributes to health services research in Germany.

Multilevel Analysis in Health Services Research in Healthcare Organizations: Benefits, Requirements and Implementation

Multilevel Analysis (MLA) are still rarely used in Health Services Research in Germany, though hierarchical data, e. g. from patients clustered in hospitals, is often present. MLA provide the valuable opportunity to study the health care context in health care organizations and the associations between context and health care outcomes. This article's aims are to introduce this particular method of data analysis, to discuss its' benefits and its' applicability particularly for Health Services Research focusing on organizational characteristics and to provide a concise guideline for performing the analysis. First, the benefits and the necessity for MLA compared to ordinary correlation analyses in the case of hierarchical data are discussed. Furthermore, the statistical requirements and key decisions for the performance of MLA are illustrated.

Costs and treatment patterns of incident ADHD patients - a comparative analysis before and after the initial diagnosis.

Background and objectivesThe costs and treatment patterns of attention deficit hyperactivity disorder (ADHD) are subjects of health services research in Germany and worldwide. Previous publications focused mainly on prevalent patients and thus research gaps were identified regarding costs and treatment patterns of incident patients before and after the first diagnosis.MethodsAnalyses were conducted using claims data obtained from a large German sickness fund (Techniker Krankenkasse). Inclusion criteria consisted of patients with at least two secured outpatient or one inpatient ADHD diagnosis in 2007. Incidence was ensured by defining a baseline period without ADHD-diagnosis in 2006. In addition to diseaserelated cost analyses compared to a control group including age group comparisons, comorbidities, the proportion of multimodal treatment and medication treatment patterns were described.ResultsIn total, 9083 newly diagnosed ADHD patients were identified (73 % male; mean age: 12.9 years (SD: 10.3)). The mean total cost of ADHD patients during the year after the first diagnosis exceeded the mean total cost of the year before by 976 € (Differencein-Difference-estimator: 1006 €). Our analyses have shown that 10 % of ADHD patients have been treated with multimodal therapy. In addition, 11 % of the investigated ADHD population have received methylphenidate or atomoxetine preceeding the date of diagnosis in the relevant observation period.DiscussionThis study provides important insights into the costs as well as the treatment patterns of incident ADHD patients. ADHD-related costs and medications can be identified prior to the date of the first ADHD diagnosis. Although, multimodal therapy is presented as an optimal treatment option by many international guidelines and experts, its proportion for treatment is low (10 %).Further research is necessary to identify reasons for the low proportion of multimodal therapy and (cost-)effectiveness has to be evaluated in comparison to other treatment options. In addition, ADHD-related costs could be identified before the first diagnosis is documented. The reasons for medication prior to diagnosis have to be further investigated.

Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study

Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed.

Health services research for the public health service (PHS) and the public health system

There is a great need for health services research in the public health system and in the German public health service. However, the public health service is underrepresented in health services research in Germany. This has several structural, historical and disciplinary-related reasons. The public health service is characterised by a broad range of activities, high qualification requirements and changing framework conditions. The concept of health services research is similar to that of the public health service and public health system, because it includes the principles of multidisciplinarity, multiprofessionalism and daily routine orientation. This article focuses on a specified system theory based model of health services research for the public health system and public health service. The model is based on established models of the health services research and health system research, which are further developed according to specific requirements of the public health service. It provides a theoretical foundation for health services research on the macro-, meso- and microlevels in public health service and the public health system. Prospects for public health service are seen in the development from "old public health" to "new public health" as well as in the integration of health services research and health system research. There is a significant potential for development in a better linkage between university research and public health service as is the case for the "Pettenkofer School of Public Health Munich".

Qualitative Studien in der Versorgungsforschung - Diskus­sionspapier, Teil 2: Stand qualitativer Versorgungsforschung in Deutschland - ein exemplarischer Überblick

This is the second part of a 3-part discussion paper by the working group on "Qualitative Methods" in the German network of health services research (DNVF) that shall contribute to the development of a memorandum concerning qualitative health services research. It aims to depict the different types of qualitative research that are conducted in health services research in Germany. In addition, the authors present a specific set of qualitative data collection and analysis tools to demonstrate the potential of qualitative research for health services research. QUALITATIVE RESEARCH IN HEALTH SERVICES RESEARCH - AN OVERVIEW: To give an overview of the types of qualitative research conducted in German health services research, the abstracts of the 8th German Conference on Health Services Research were filtered to identify qualitative or mixed-methods studies. These were then analysed by looking at the context which was studied, who was studied, the aims of the studies, and what type of methods were used. Those methods that were mentioned most often for data collection and analysis are described in detail. QUALITATIVE RESEARCH AT THE CONFERENCE FOR HEALTH SERVICES RESEARCH 2009: Approximately a fifth of all abstracts (n=74) had a qualitative (n=47) or a mixed-methods approach combining quantitative and qualitative methods (n=27). Research aims included needs assessment (41%), survey development (36%), evaluation (22%), and theorizing (1%). Data collection mostly consisted of one-on-one interviews (n=45) and group discussions (n=29). Qualitative content analysis was named in 35 abstracts, 30 abstracts did not reference their method of analysis. In addition to a quantitative summary of the abstract findings, the diversity of fields addressed by qualitative methods is highlighted. Although drawing conclusions on the use of qualitative methods in German health services research from the analysis of conference abstracts is not possible, the overview we present demonstrates the diversity of methods used for data collection and analysis and showed that a few select methods are extensively used. One of the tasks a memorandum of qualitative health services research should accomplish is to highlight underutilized research methods, which may help to develop the potential of qualitative methodology in German health services research.

Regional and temporal variations in coding of hospital diagnoses referring to upper gastrointestinal and oesophageal bleeding in Germany

BackgroundHealth insurance claims data are increasingly used for health services research in Germany. Hospital diagnoses in these data are coded according to the International Classification of Diseases, German modification (ICD-10-GM). Due to the historical division into West and East Germany, different coding practices might persist in both former parts. Additionally, the introduction of Diagnosis Related Groups (DRGs) in Germany in 2003/2004 might have changed the coding. The aim of this study was to investigate regional and temporal variations in coding of hospitalisation diagnoses in Germany.MethodsWe analysed hospitalisation diagnoses for oesophageal bleeding (OB) and upper gastrointestinal bleeding (UGIB) from the official German Hospital Statistics provided by the Federal Statistical Office. Bleeding diagnoses were classified as "specific" (origin of bleeding provided) or "unspecific" (origin of bleeding not provided) coding. We studied regional (former East versus West Germany) differences in incidence of hospitalisations with specific or unspecific coding for OB and UGIB and temporal variations between 2000 and 2005. For each year, incidence ratios of hospitalisations for former East versus West Germany were estimated with log-linear regression models adjusting for age, gender and population density.ResultsSignificant differences in specific and unspecific coding between East and West Germany and over time were found for both, OB and UGIB hospitalisation diagnoses, respectively. For example in 2002, incidence ratios of hospitalisations for East versus West Germany were 1.24 (95% CI 1.16-1.32) for specific and 0.67 (95% CI 0.60-0.74) for unspecific OB diagnoses and 1.43 (95% CI 1.36-1.51) for specific and 0.83 (95% CI 0.80-0.87) for unspecific UGIB. Regional differences nearly disappeared and time trends were less marked when using combined specific and unspecific diagnoses of OB or UGIB, respectively.ConclusionsDuring the study period, there were substantial regional and temporal variations in the coding of OB and UGIB diagnoses in hospitalised patients. Possible explanations for the observed regional variations are different coding preferences, further influenced by changes in coding and reimbursement rules. Analysing groups of diagnoses including specific and unspecific codes reduces the influence of varying coding practices.

Grenzen der Versorgungsforschung

Current limitations in health services research (HRS) in Germany are caused by issues of research funding, interest-driven commissioning, and restricted research conditions due to the structural and organizational context of the German health system. Methodological challenges arise in the validation and generalizability of routine data. There are substantial risks of bias in non-controlled interventional studies. In order to overcome these limitations and to improve the standing and quality of HRS in Germany, political opinion leaders and stakeholders need to be provided with continuous information on the need and potential of HRS. Methodological standards are needed for the evaluation of routine data, and principles of evidence-based medicine must be applied in all research addressing the effectiveness of health care interventions.

DFG-Nachwuchsakademie Versorgungsforschung –Konzept – Ablauf - Teilnehmerrückmeldungen

In December 2010, the Institutes for Social Medicine and Cancer Epidemiology of the University of Lübeck hosted the first Workshop for Early Career Investigators in the area of Health Services Research. This workshop was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) with the aim to promote young scientists and researchers that wish to pursue research in the field of Health Services Research in an early phase of their career. The following report addresses the background, concept and progress of the initiative. All applicants had to submit a detailed project proposal and underwent a rigorous selection process. The projects presented at the workshop covered a wide range of topics, such as, for example, access to health care, common elements of mental illnesses and psychosomatic disorders, quality assurance in medical practices (i.e., evaluation of disease management programmes) and targets in rehabilitation. A major subject was migration as a challenge to Health Services Research. The 20 best applicants out of 121 were invited to attend the programme. During five days the participants had the opportunity to present their projects and discuss current issues as well as fundamental themes in study design. At the same time, national and international leading experts gave a series of lectures on current topics of Health Services Research. In numerous discussion groups and topical workshops participants and speakers explored and sought solutions to specific research issues. Following the programme participants are expected to finalise their research proposals and apply for funding to the DFG. To foster networking among early-career researchers, an alumni meeting is scheduled after 12 months. The DFG Workshop for Early Career Investigators was the first of its kind in the field of Health Services Research in Germany. However, evidence of its sustainability will have to be obtained from the future development of the German Health Services Research.

Hospitalization rates of generic metoprolol compared with the original beta‐blocker in an epidemiological database study

A less favourable galenic profile of generic formulations of the beta-blocker metoprolol raised the concern of a higher risk for serious cardiovascular (CV) events. We assessed hospital admission rates for CV diseases and prescription prevalences of various drugs using claims data of statutory health insurances (SHIs) to compare the incidence of serious CV events among users of original and generic metoprolol. Index events included hospitalization due to myocardial infarction, hypertensive crisis and stroke. Data files of three SHIs were linked with dispensing data of drug prescriptions from each pharmacy's electronic data processing centre on an individual basis. Incidences of hospital admissions among patients receiving original metoprolol and among patients treated with the generic equivalent were compared by logistic regression, stratified for Bremen and the rest of Northern Germany. Risk estimates and confidence intervals were adjusted for confounders. A total of 49,673 patients receiving metoprolol were identified within a cohort of 3,649,285 insurance members. While the crude analysis revealed a higher risk for index events in patients receiving the generic drug (Bremen: RR 1.45; Northern Germany: RR 1.14), no elevated risk remained after confounder adjustment (Bremen: OR 1.06; Northern Germany: OR 1.04). Among co-morbid conditions considered as confounders, a previous CV event and an elevated thromboembolic risk exerted the strongest effect on index events. SHI data are a valuable source for pharmacoepidemiology and health services research in Germany. Incidence rates of serious CV events did not reveal any noticeable differences between the original and the generic group after confounder adjustment.