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Background: The World Health Organization (WHO) has been developing the 11th revision of the International Classification of Diseases (ICD) since 2007. ICD-11 is different from the ICD-10 in volume and structure. Therefore, the WHO planned field tests with a coding of diagnoses and cases., Objectives: To describe the background of the field tests and their implementation in Germany., Materials and Methods: Interested parties were invited to submit proposals through a call to the Association of the Scientific Medical Societies (AWMF). The Technology, Methods, and Infrastructure for Networked Medical Research (TMF) was responsible for the coordination, supported by the German Institute for Medical Documentation and Information (DIMDI). The target was a beta version of the ICD-11 for Mortality and Morbidity Statistics (ICD-11-MMS), denoted as "draft for quality assurance"., Results: Eleven field tests were maintained between March and September 2017. With the exception of one field test analyzing diagnoses terms from the thesaurus of the ICD-10-GM, all field tests focused on a specific medical field. Eight different quality criteria were investigated over the 11 field tests, and 22 of the 27 chapters of the ICD-11-MMS were at least partially covered., Conclusions: Despite the strict time frame, the field tests were successfully implemented and concluded in Germany. Mostly, the ICD-11 tools from the WHO were used. A high percentage of the ICD chapters were partially covered. In summary, it has been demonstrated for the first time that field tests are a valuable approach to evaluate the ICD in parallel to its development. However, a methodological framework integrating the field tests should be developed, taking into account all relevant requirements.

Background: Cohort studies are a longitudinal observational study type. They are firmly established within epidemiology to assess the course of diseases and risk factors. Yet, standards to describe and evaluate quality characteristics of cohort studies need further development., Objective: Within the TMF ("Technologie- und Methodenplattform für die vernetzte medizinische Forschung e. V.") project "Quality management standards in cohort studies", a catalogue of requirements was compiled and evaluated, focusing on the preparation and conduct of epidemiologic cohort studies., Materials and Methods: The catalogue of requirements was established based on a consensus process between representatives of seven German epidemiologic cohort studies. For this purpose, a set of expert meetings (telephone, face-to-face, web-based) was conducted and the importance of each element of the catalogue was assessed as well as its implementation., Results: A catalogue of requirements with 138 requirements was consented. It is structured into ten sections: 1. Study documentation; 2. Selection of instruments; 3. Study implementation, 4. Organizational structure; 5. Qualification and certification; 6. Participant recruitment; 7. Preparation, conduct and follow-up processing of examinations; 8. Study logistics and maintenance, 9. Data capture and data management; 10. Reporting and monitoring. In total, 41 elements were categorized as being essential, 91 as important, and 6 as less important., Conclusion: The catalogue of requirements provides a guideline to improve the preparation and operation of cohort studies. The evaluation of the importance and degree of implementation of requirements depended on the study design. With adaptations, the catalogue might be transferable to other study types.

Several dimensions of data quality are described in the literature. One overriding aspect is considered to be the extent to which data represent the truth which is captured by data validity. Unfortunately, a common terminology, well defined concepts, and approved measures are missing in regard to data validity. In particular, there is a need to discuss the gold standard as reference for the data at hand and respective measures. Ultimate gold standard would be the state of the patient which itself is subjected to human and personal interpretations. Usually, an often diverse form of source data is used as gold standard. Based on the concept of the measure, it might be inappropriate differentiating between present and absent while calculating precision and recall. Due to the complexity and uncertainty of many health care related issues, a more sophisticated comparison might be necessary in order to establish relevant and general figures of data quality. Unfortunately, a harmonization in this field is not visible. Further research is needed to establish validated standards to measure data quality.

Registries are increasingly implemented to record the practice of health care. Within a national funding scheme for registries, an accompanying project was launched to support the design of the registries' IT infrastructure amongst other tasks for 16 projects. A challenge of data management systems was organized by the accompanying project in order to enable the projects to define realistic expectations towards IT support in their research protocols. Twelve vendors participated in the challenge. They presented their solutions for selected use cases. In advance, the projects considered a sufficient authorization concept and the possibility to export data to be of highest importance. However, the systems covered mainly core processes of electronic data capture. The accompanying project will continue its support for the next stage of the funding scheme, which will be the implementation of the registries that win a competitive review of their research protocols prepared in the concept development stage.

Objective: Adverse drug events (ADEs) during hospital stays are a significant problem of healthcare systems. Established monitoring systems lack completeness or are cost intensive. Routinely assigned International Statistical Classification of Diseases and Related Health Problems (ICD) codes could complement existing systems for ADE identification. To analyze the potential of using routine data for ADE detection, the validity of a set of ICD codes was determined focusing on hospital-acquired events., Material and Methods: The study utilized routine data from four German hospitals covering the years 2014 and 2015. A set of ICD, 10th Revision, German Modification (ICD-10-GM) diagnoses coded most frequently in the routine data and identified as codes indicating ADEs was analyzed. Data from psychiatric and psychotherapeutic departments were excluded. Retrospective chart review was performed to calculate positive predictive values (PPV) and sensitivity., Results: Of 807 reviewed ADE codes, 91.2% (95%-confidence interval: 89.0, 93.1) were identified as disease in the medical records and 65.1% (61.7, 68.3) were confirmed as ADE. For code groups being predominantly hospital-acquired, 78.5% (73.7, 82.9) were confirmed as ADE, ranging from 68.5% to 94.4% dependent on the ICD code. However, sensitivity of inpatient ADEs was relatively low. 49.7% (45.2, 54.2) of 495 identified hospital-acquired ADEs were coded as disease in the routine data, from which a subgroup of 12.1% (9.4, 15.3) was coded as drug-associated disease., Conclusions: ICD codes from routine data can provide an important contribution to the development and improvement of ADE monitoring systems. Documentation quality is crucial to further increase the PPV, and actions against under-reporting of ADEs in routine data need to be taken.

The German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e.V. (DNVF)] fosters the methodological quality of health services research studies by memoranda and other initiatives. Quality of care and patient safety research (QCPSR) form core areas of health services research. The present memorandum explicates principal QCPSR questions and methods. Based on the issues' particular relevance for health policy, the memorandum exemplifies methods for developing and testing indicators, risk adjustment techniques, methods for collecting patient safety data, tools to analyse patient safety incidents and methods for evaluating often complex and multicomponent QCPS interventions. Furthermore, we point out urgent research topics., Competing Interests: Interessenkonflikt: Die Autoren geben an, dass kein Interessenkonflikt besteht., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: The prevalence of peripheral artery disease (PAD) is increasing worldwide. Revascularization procedures constitute a cornerstone of the therapy in PAD, not only in critical limb ischaemia but increasingly also in patients with intermittent claudication. The German Society of Angiology - Society for Vascular Medicine is establishing a nationwide, prospective, multicentre registry to address the lack of contemporary real life data regarding current practice of medical and interventional care in vascular patients and its subsequent long-term outcome., Patients and Methods: The RECording COurses of vasculaR Diseases registry (RECCORD registry) is an observational, prospective, multicentre, all-comers registry platform. In the initial phase, patients referred for endovascular revascularization of PAD of the lower limbs will be prospectively included and followed up for at least one year. At baseline, data on patients' demographic characteristics, comorbidities, previous peripheral interventions, medication, and clinical stage of PAD (Rutherford category), haemodynamic parameters, and procedural data including complications will be assessed. Major adverse cardiac and limb events will be recorded at planned (at six and 12 months) and at any unplanned visits. The therapeutic management will be exclusively left to the discretion of the vascular specialists., Results and Conclusions: The RECCORD registry will provide a comprehensive dataset depicting the current real life practice and outcome of vascular care. The seven predefined quality indicators will be used for benchmarking the participating centres. Moreover, identifying factors promoting a favourable outcome might pave the way for an evidence-based therapeutic strategy and a dedicated therapeutic pathway for patients with PAD including patient-oriented best interventional approaches. In the future, the RECCORD registry may provide a general platform to study the courses of various defined vascular diseases in order to get detailed insights into the real life current practice of health care provided to vascular patients.

Record linkage (RL) is the process of identifying pairs of records that correspond to the same entity, for example the same patient. The basic approach assigns to each pair of records a similarity weight, and then determines a certain threshold, above which the two records are considered to be a match. Three different RL methods were applied under privacy-preserving conditions on hospital admission data: deterministic RL (DRL), probabilistic RL (PRL), and Bloom filters. The patient characteristics like names were one-way encrypted (DRL, PRL) or transformed to a cryptographic longterm key (Bloom filters). Based on one year of hospital admissions, the data set was split randomly in 30 thousand new and 1,5 million known patients. With the combination of the three RL-methods, a positive predictive value of 83 % (95 %-confidence interval 65 %-94 %) was attained. Thus, the application of the presented combination of RL-methods seem to be suited for other applications of population-based research.

Introduction: Internationally, the hospital standardized mortality ratio is increasingly used as a risk-adjusted simple measure for quality control. Goodness of fit of different risk models in Germany and robustness of hospital comparisons were evaluated with a secondary data analysis. Methods: Anonymized routine data from the year 2012 of 37 hospitals of the association Quality Indicators for Ecclesiastical Hospitals were used. 2 independent risk models and the observed mortality were compared, the risk models considered both the original and the adapted forms. Results: The risk models showed an area under curve between 0.906 [95% CI 0.904-0.908] and 0.920 [0.918-0.922]. There was a significant correlation between the risk models and the observed mortality with a correlation coefficient between 0.388 (p<0.05) and 0.936 (p<0.01). 26 hospitals had an identical assessment in all risk models comparing their HSMR with the group. 2 hospitals achieved a positive and a negative assessment taking into account the observed mortality. Conclusion: The quality of the risk models is high and the hospital comparison with the HSMR remained stable. However, it is unclear whether the differences are caused by quality-related issues or by different structures and case-mix. Therefore, the HSMR is primarily intended for quality management purposes within German hospitals., (© Georg Thieme Verlag KG Stuttgart · New York.)

In addition to clinical trials, registries and cohort studies are the fundamental basis of patient-orientated research. The importance of registries is increasing because more questions involving patient care under routine conditions (real world data) need to be answered. This article supplies answers to the questions: what can be achieved with registries and what are the limitations? Starting with a consensus definition of a registry from the German Network of Health Services Research (DNVF), the question of existing registries was examined and it was concluded that there was a lack of transparency. Consequently, a registry of registries similar to clinical trials registries is urgently needed as well as an evaluation of the quality of existing registries. Criteria are deduced that allow an assessment of the quality of a registry and which comprehensive possibilities registries can provide are discussed in eight different areas of interest to clinicians. The limitations of registries compared to randomized clinical trials and cohort studies are emphasized and discussed in this article. In the future, the use of registry-based randomized clinical trials (RRCT) will allow data related to efficacy as well as to effectiveness to be collated.

Background: We analysed a potential association between the decrease in major amputations in Germany and the number of doctors, prescribed podologic foot care (PFC) and antidiabetic drugs, and performed percutaneous endoluminal angioplasties (PTA)., Patients and Methods: Data of all lower limb major amputations between 2007 and 2011, the cases hospitalised with an additional diagnosis of diabetes mellitus, and the numbers of PTAs, and the number of doctors in private practices and in hospitals were obtained from the Federal Statistical Office. Furthermore, the number of PFC treatments and prescribed antidiabetics for each of the five years were derived from the federal report of the statutory health insurance., Results: Within the 5 year time period, major amputations decreased by 19.0%, from 17,846 in 2007 to 14,463 in 2011. There is an inverse relation between the number of major amputations and the increasing number of prescribed PFC, of doctors working in hospital and of below-the-knee PTA in the multiple Poisson regression analysis. The number of prescribed antidiabetics and that of all PTA showed a positive relation. In the multiple linear regression analysis with the dependent variable ratio of amputations and the cases hospitalised with an additional diagnosis of diabetes mellitus, only numbers of prescribed PFC and below-the-knee PTA still showed an inverse relation that reached a level of significance., Conclusions: While substantial improvements in patients care by doctors, endovascular interventions, prescriptions of PFC and antidiabetic drugs are under discussion to reduce major amputation rates, in this approach including comprehensive data from Germany, only prescriptions of PFC and the number of below-the-knee PTA had an independent and significant impact on the reduction of major amputations. It has to be pointed out that such a statistical association does not prove any causality.

Effective detection of corresponding or duplicate records in medical data sets is vital for a high quality health care system. We evaluate the efficacy of several current and novel record linkage approaches by modeling a hospital-admission scenario, wherein an incoming patient may or may not have been previously treated. Our work is to develop recommendations for how an automated system could operate in such a scenario, especially regarding comparison and classification. By using a large, anonymous, real-world data set, we can gain insight into the robustness of these methods in a way that artificial data sets cannot provide. Preliminary results show that even minor confounders have deleterious effects on our ability to classify matches. We aim to evaluate and refine a semi-supervised classification technique to cope with these influences.

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.

Measures of morbidity and comorbidity are frequently used for the control of confounding, particularly in health services research. Several proposals for those measures are defined with ICD-coded diagnoses available in hospital routine data. However, a measure that makes use of the ICD structure is missing. Objective of this work was to elaborate the power of the ICD structure for defining morbidity and comorbidity measures. Routine data from three German hospitals with inpatients discharged 2008 were used for model development; routine data from 36 German hospitals with inpatients admitted and discharged 2010 were used for model evaluation. Two different risk models were developed, one based on ICD-10 chapters, the other based on ICD-10 groups. The models were transformed into sum scores using whole-number weights. Models and scores were compared with the Charlson Index and the Elixhauser Comorbidities using the receiver operating characteristic. Dependent variable was hospital death. Logistic regression was used to derive the new models. Charlson Index and Elixhauser Comorbidities were mapped to the German ICD-10. According to the receiver operating characteristic, the quality of the measures based on the structure of the ICD-10 was superior compared with the Charlson Index and the Elixhauser Comorbidities. The best result was achieved with the measure based on ICD-10-groups with an area under curve of 0.910 (95% confidence interval = 0.907-0.913). The sum scores showed a comparable performance. The developed new measures may be used to control for confounding.

We analysed time trends in the pulmonary embolism (PE) mortality rates in Germany from 2004 and assessed for an association between the use of anticoagulants and PE caused mortality. We extracted age-specific number of deaths due to PE (ICD-10 I26) from 2004 to 2011 as available from the WHO mortality databases. In addition we derived defined daily dosage (DDD) of prescribed anticoagulants and the low molecular heparin Enoxaparin for the years 2004-2011 from the statutory health insurance-drug-information system reports. Age-standardized PE mortality per 100,000 decreased from 5.9283 in year 2004 to 4.4876 in 2011 (-24.3 %). Amounts of prescribed anticoagulants increased in this period from 271,810.7 × 1000 DDD to 416,611.8 × 1000 DDD (+53.3 %), that of Enoxaparin increased from 27,071.1 × 1000 DDD in 2004 97,276.5 × 1000 DDD in 2011. The PE mortality is negatively correlated with anticoagulants (-0.9463, p = 0.0004) as well as with enoxaparin (-0.9740, p < 0.0001) and of DDD of Enoxaparin per 1000 insured (-0.9682, p < 0.0001). In univariate linear regression model, anticoagulants, Enoxaparin and Enoxaparin per 1000 insured all reach significance (p = 0.0004, p = 4.31 × 10(-5) and p = 0.0001 respectively). Multiple regression models show that Enoxaparin has the most robust effect. Including the time trend in the model does not alter the results. Our study shows that increasing number of prescribed Enoxaparin in an outpatient setting might be one determinant of decreasing PE mortality rate in Germany since 2004.

Background and Objectives: According to § 137 social code book (SGB) V, data from the national quality assurance are published annually. Objective of this study was to analyse the long-term development of the quality of hospital care., Methods: On the basis of national data and results of another study covering the years 2004-2008, quality indicators with comparable results of at least 3 subsequent years were included. 292 quality indicators of 26 service groups and 14 medical fields were included. We identified a trend with linear regression and continuous change., Results: 95 % of the performance measures showed either an improvement of quality (105 measures, 36 %) or a stable condition (173 measures, 59 %). Five percent of the quality indicators (14 measures) showed a deterioration. Eleven of the 14 measures assessed quality in coronary angiography and percutaneous coronary intervention., Conclusion: Evaluated with performance measures from the national quality assurance, the quality of hospital care improved from 2008-2011, as already from 2004-2008. The deterioration of quality in 5 % of measures shows the need for action in particular situations of care., (© Georg Thieme Verlag KG Stuttgart · New York.)

A literature review was done within a revision of a guideline concerned with data quality management in registries and cohort studies. The review focused on quality indicators, feedback, and source data verification. Thirty-nine relevant articles were selected in a stepwise selection process. The majority of the papers dealt with indicators. The papers presented concepts or data analyses. The leading indicators were related to case or data completeness, correctness, and accuracy. In the future, data pools as well as research reports from quantitative studies should be obligatory supplemented by information about their data quality, ideally picking up some indicators presented in this review.

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.)

In 2002, Haux, Ammenwerth, Herzog, and Knaup published a prognosis about health care in the information society. In contrast to other prognoses, they underpinned their 30 theses with 71 quantitative statements that could be easily checked. A citation analysis was performed to assess the perception of this work in the medical informatics community. The ISI Web of Science was used for the citation search. From 55 hits, 38 articles were finally included in the metadata analysis, 33 articles in the qualitative analysis. The most prominent statement citing the paper of Haux et al. was identified in each article, divided into statements about the present and those about the future. Each statement was tagged with one keyword out of a convenient list. One article provided a statement about the present and the future. Most of the references were published in English as journal articles between 2006 and 2009. The majority of the first authors were from Europe. Twenty-two articles offered a statement about the present, 12 about the future. There was a shift from the present emphasis on electronic medical records and information and communication technologies to challenges in the future because of an aging population and the advent of personalized medicine. The citing papers seemed to be representative of medical informatics in terms of journals and the authors' countries of origin. The statements relating the citing literature with the paper of Haux et al. corresponded well with current notions about medical informatics. However, there was no debate about the concrete theses and prognoses offered in the cited paper. Therefore, the medical informatics community needs to rethink its own citation strategy.

Health care and information technology in health care is advancing at tremendous speed. We analysed whether the prognoses by Haux et al. - first presented in 2000 and published in 2002 - have been fulfilled in 2013 and which might be the reasons for match or mismatch. Twenty international experts in biomedical and health informatics met in May 2013 in a workshop to discuss match or mismatch of each of the 71 prognoses. After this meeting a web-based survey among workshop participants took place. Thirty-three prognoses were assessed matching; they reflect e.g. that there is good progress in storing patient data electronically in health care institutions. Twenty-three prognoses were assessed mismatching; they reflect e.g. that telemedicine and home monitoring as well as electronic exchange of patient data between institutions is not established as widespread as expected. Fifteen prognoses were assessed neither matching nor mismatching. ICT tools have considerably influenced health care in the last decade, but in many cases not as far as it was expected by Haux et al. in 2002. In most cases this is not a matter of the availability of technical solutions but of organizational and ethical issues. We need innovative and modern information system architectures which support multiple use of data for patient care as well as for research and reporting and which are able to integrate data from home monitoring into a patient centered health record. Since innovative technology is available the efficient and wide-spread use in health care has to be enabled by systematic information management.

More than 10 years ago Haux et al. tried to answer the question how health care provision will look like in the year 2013. A follow-up workshop was held in Braunschweig, Germany, for 2 days in May, 2013, with 20 invited international experts in biomedical and health informatics. Among other things it had the objectives to discuss the suggested goals and measures of 2002 and how priorities on MI research in this context should be set from the viewpoint of today. The goals from 2002 are now as up-to-date as they were then. The experts stated that the three goals: "patient-centred recording and use of medical data for cooperative care"; "process-integrated decision support through current medical knowledge" and "comprehensive use of patient data for research and health care reporting" have not been reached yet and are still relevant. A new goal for ICT in health care should be the support of patient centred personalized (individual) medicine. MI as an academic discipline carries out research concerning tools that support health care professionals in their work. This research should be carried out without the pressure that it should lead to systems that are immediately and directly accepted in practice.

Background: Adverse drug events, the unintended and harmful effects of medications, are important outcome measures in health services research. Yet no universally accepted set of International Classification of Diseases (ICD) revision 10 codes or coding algorithms exists to ensure their consistent identification in administrative data. Our objective was to synthesize a comprehensive set of ICD-10 codes used to identify adverse drug events., Methods: We developed a systematic search strategy and applied it to five electronic reference databases. We searched relevant medical journals, conference proceedings, electronic grey literature and bibliographies of relevant studies, and contacted content experts for unpublished studies. One author reviewed the titles and abstracts for inclusion and exclusion criteria. Two authors reviewed eligible full-text articles and abstracted data in duplicate. Data were synthesized in a qualitative manner., Results: Of 4241 titles identified, 41 were included. We found a total of 827 ICD-10 codes that have been used in the medical literature to identify adverse drug events. The median number of codes used to search for adverse drug events was 190 (IQR 156-289) with a large degree of variability between studies in the numbers and types of codes used. Authors commonly used external injury (Y40.0-59.9) and disease manifestation codes. Only two papers reported on the sensitivity of their code set., Conclusions: Substantial variability exists in the methods used to identify adverse drug events in administrative data. Our work may serve as a point of reference for future research and consensus building in this area.

Background: Adverse drug events (ADEs) are frequent in hospitals, occurring either in patients before admission or as a nosocomial event, and either as a drug reaction or as a consequence of a medication error. Routine data primarily recorded for reimbursement purposes are increasingly being used on a national level both in pharmacoepidemiological studies and in trigger tools. The aim of this study was to compare the prevalence rates of coded ADEs in hospitals on a transnational level., Methods: Hospital data for England and the USA were obtained for the fiscal or calendar year 2006. German data for 2006 were accessed via teleprocessing with the Federal Statistical Office. The datasets from England and the USA were adapted to the German data. About 6 million (England), 7 million (USA), and 16 million (Germany) inpatients could be included. ADEs were identified through a list of codes used in the national diagnosis classifications., Results: The overall prevalence rate (and 95% confidence interval, CI) of coded ADEs was 3.22% (3.20-3.23%) for England, 4.78% (4.73-4.83%) for Germany, and 5.64% (5.63-5.66%) for the USA. Most of the English ADE cases occurred in patients admitted as emergency. A non-surgical status and a longer length of stay were consistently associated with the occurrence of an ADE. Enterocolitis caused by Clostridium difficile was the most frequent ADE in all countries., Conclusions: According to routine data, the overall ADE prevalence rates for England, Germany, and the USA are different. However, the differences are narrower than those determined from the rates of ADEs or adverse drug reactions inferred from prospective or retrospective pharmacoepidemiological studies. Since the ADEs in the countries examined in this study share several characteristics, the use of routine data for transnational research on ADEs is feasible.

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.

Confidentiality of patient data in the field of medical informatics is an important task. Leaked sensitive information within this data can be adverse to and being abused against a patient. Therefore, when working with medical data, appropriate and secure models which serve as guidelines for different applications are needed. Consequently, this work presents a model for performing a privacy preserving record linkage between study and registry data. The model takes into account seven requirements related to data privacy. Furthermore, this model is exemplified with a study on family based colorectal cancer in Germany. The model is very strict and excludes possible violations towards data privacy protection to a reasonable degree. It should be applicable to similar use cases which are in need of a mapping between medical data of a study and a registry database.

Background and Objectives: Introducing fixed fees for inpatient hospital care has raised fears of a negative influence on treatment quality. To address these concerns, an external quality assurance was implemented. The results of the quality indicators should indicate changes in the quality of inpatient care between 2004 and 2008., Methods: On the basis of the evaluation data delivered by the Federal Quality Assurance Agency, quality indicators with similar results of at least 3 subsequent years were included. A trend was identified with linear regression as well as with a constant change in the results. 204 quality indicators of 19 health care sectors of 6 diagnosis groups were included., Results: Half of the quality indicators showed a particularly striking quality improvement in the categories "indication" and "process". The lowest number of quality indicators with a quality improvement occurred in the cardiac surgery. To this diagnosis group also belong 13 of the 18 quality indicators with deterioration. Sixteen of the 18 quality indicators rank among the category "result"., Conclusion: The quality of inpatient care improved substantially from 2004 through 2008, measured against the quality indicators of the external comparable quality assurance. This corresponds to other analyses of a similar time period in Germany of the same or different data sources. Those analyses showed additionally that the subjective perceptions of clinicians and of nursing staff are significantly worse., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: Adverse drug events are a frequent cause of emergency department presentations. Administrative data could be used to identify patients presenting with adverse drug events for post-market surveillance, and to conduct research in patient safety and in drug safety and effectiveness. However, such data sources have not been evaluated for their completeness with regard to adverse drug event reporting. Our objective was to determine the proportion of adverse drug events to outpatient medications diagnosed at the point-of-care in emergency departments that were documented in administrative data., Methods: We linked the records of patients enrolled in a prospective observational cohort study on adverse drug events conducted in two Canadian tertiary care emergency departments to their administrative data. We compared the number of adverse drug events diagnosed and recorded at the point-of-care in the prospective study with the number of adverse drug events recorded in the administrative data., Results: Among 1574 emergency department visits, 221 were identified as adverse drug event-related in the prospective database. We found 15 adverse drug events documented in administrative records with ICD-10 codes clearly indicating an adverse drug event, indicating a sensitivity of 6.8% (95% CI 4.0-11.2%) of this code set. When the ICD-10 code categories were broadened to include codes indicating a very likely, likely or possible adverse event to a medication, 62 of 221 events were identifiable in administrative data, corresponding to a sensitivity of 28.1% (95% CI 22.3-34.6%)., Conclusions: Adverse drug events to outpatient medications were underreported in emergency department administrative data compared to the number of adverse drug events diagnosed and recorded at the point-of-care.

In order to support empirical medical research concerning reuse and improvement of the expressiveness of study data and hence promote syntactic as well as semantic interoperability, services are required for the maintenance of data element collections. As part of the project for the implementation of a German metadata repository for empirical research we assessed the ability of ISO/IEC 11179 "Information technology - Metadata registries (MDR)" part 3 edition 3 Final Committee Draft "Registry metamodel and basic attributes" to represent healthcare standards. First step of the evaluation was a reformulation of ISO's metamodel with the terms and structures of the different healthcare standards. In a second step, we imported instances of the healthcare standards into a prototypical database implementation representing ISO's metamodel. Whereas the flat structure of disease registries as well as some controlled vocabularies could be easily mapped to the ISO's metamodel, complex structures as used in reference models of electronic health records or classifications could be not exhaustively represented. A logical reconstruction of an application will be needed in order to represent them adequately. Moreover, the correct linkage between elements from ISO/IEC 11179 edition 3 and concepts of classifications remains unclear. We also observed some restrictions of ISO/IEC 11179 edition 3 concerning the representation of items of the Operational Data Model from the Clinical Data Interchange Standards Consortium, which might be outside the scope of a MDR. Thus, despite the obvious strength of the ISO/IEC 11179 edition 3 for metadata registries, some issues should be considered in its further development., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Anonymous or privacy preserving record linkage is the term for systems allowing the linkage of data from different sources while maintaining an individual's anonymity. This work displays the impact of variations in the process of generating weights in a probabilistic record linkage system on different datasets, the resulting set of weights of candidate pairs and consequently on the final classification process. Furthermore, the results give insight into general problems of current unsupervised classification methods.

The supplementation of documentation systems with controlled vocabularies is a prerequisite for improved and consistent communication, high data quality and efficient data exchange. To outline the requirements of an application system which supports the terminology-based development of documentation systems, existing documentation systems offering a terminological support in the definition of item collections were retrieved in the literature and analyzed. The analysis of four selected documentation systems caused us to define four main criteria for a terminology-based documentation system, which are: use of a controlled vocabulary, definition of a characteristic level, the definition of a value domain level and definition of roles and entities to combine vocabulary, characteristic and value domain levels together.

Background: The purpose of this study was to compare standard treatment of strokes with a complex form, defined by the German procedure classification., Patients and Methods: 3827 patients in 2005 were compared with 4315 patients in 2007 concerning mortality within hospital and 30, 90 and 360 days after hospital admission. Furthermore, the costs for the statutory health insurances were linked to the mortality rates. 2005 was set as proxy for the standard treatment and 2007 as proxy for the neurological complex treatment., Results: There were significant differences in the 1-year mortality with a 3.11 percentage point reduction (p < 0.0373). For the other periods, there were no significant deviations. The cost for the statutory health insurance per case rose with an average of 0.4809 cost weights., Conclusion: There are hints of an improvement in the long-term mortality after the introduction of complex neurological treatment. For the health insurance significant additional costs ensue, which are in an international published range. On the other hand, savings by improving the morbidity must be taken into account., (© Georg Thieme Verlag KG Stuttgart · New York.)

Background: In developed countries 1-5% of all hospital admissions are due to adverse drug events (ADE). An ADE is defined as an injury resulting from medical intervention related to a drug. The established reporting systems and study designs only capture selective data. The objective of the current analysis was to evaluate the rate, distribution and correlations of ADE related admissions by using German routine data., Methods: ADEs were identified by an array of 502 specified codes of the ICD-10-GM. The evaluation included only verified codes and was carried out by remote queries of the German DRG-Statistics 2006. Hospital admission due to an ADE was identified via the primary diagnosis., Results: Of all hospital admissions 0.92% were revealed to be certainly caused by an adverse drug event. The average age between affected and non-affected was nearly identical for women 53.48 vs. 53.67 years, for men it was reduced by 4 years (48.38 years). The average hospital stay was lower for cases with an ADE, being reduced by 1.3 days for women (6.26 days vs. 7.55 days) and 1.5 days for men (5.91 days vs. 7.42 days). While mortality with an odds ratio (OR) of 0.59 (95% CI 0.57-0.62) was lower in ADE cases, the rate of emergency admissions due to ADE was increased, the OR being 3.10 (95% CI 3.07-3.13). The wards with excess rates of ADE cases were internal medicine, paediatrics, dermatology, intensive care and neurology., Conclusions: Younger age, reduced hospital stay and lower mortality of ADE cases are contrary to findings in the relevant literature. The DRG-Statistics also comprise populations which often are excluded in established study designs, in particular, children and cases due to medication errors, overdose, poisoning and allergic reactions. As these cases respond easily to prevention and are of significant interest to pharmacovigilance, the use of routine data is valuable for more intense research of ADE., (© Georg Thieme Verlag KG Stuttgart · New York.)

Objective: In Germany, only limited data are available to quantify the attributable resource utilization associated with adverse drug events (ADEs). The aim of this study was twofold: first, to calculate the direct treatment costs associated with ADEs leading to hospitalization and, second, to derive the excess costs and extra hospital days attributable to ADEs of inpatient treatments in selected German hospitals., Methods: This was a retrospective and medical record-based study performed from the hospitals' perspective based on administrative accounting data from three hospitals (49,462 patients) in Germany. Total treatment costs ("analysis 1") and excess costs (i.e., incremental resource utilization) between patients suffering from an ADE and those without ADEs were calculated by means of a propensity score-based matching algorithm ("analysis 2")., Results: Mean treatment costs ("analysis 1") of ADEs leading to hospitalization (n = 564) were €1,978 ± 2,036 (range €191-18,147; median €1,446; €843-2,480 [Q1-Q3]). In analysis 2, the mean costs of inpatients suffering from an ADE (n = 1,891) as a concomitant disease or complication (€5,113 ± 10,059; range €179-246,288; median €2,701; €1,636-5,111 [Q1-Q3]) were significantly higher (€970; P < 0.0001) than those of non-ADE inpatients (€4,143 ± 6,968; range €154-148,479; median €2,387; €1,432-4,701 [Q1-Q3]). Mean inpatient length of stay of ADE patients (12.7 ± 17.2 days) and non-ADE patients (9.8 ± 11.6 days) differed by 2.9 days (P < 0.0001). A nationwide extrapolation resulted in annual total treatment costs of €1.058 billion., Conclusions: This is one of the first administrative data-based analyses calculating the economic consequences of ADEs in Germany. Further efforts are necessary to improve pharmacotherapy and relieve health care payers of preventable treatment costs., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

This paper describes the data mining method of association analysis within the framework of Knowledge Discovery in Databases (KDD) with the aim to identify standard patterns of nursing care. The approach is application-oriented and used on nursing routine data of the method LEP nursing 2. The increasing use of information technology in hospitals, especially of nursing information systems, requires the storage of large data sets, which hitherto have not always been analyzed adequately. Three association analyses for the days of admission, surgery and discharge, have been performed. The results of almost 1.5 million generated association rules indicate that it is valid to apply association analysis to nursing routine data. All rules are semantically trivial, since they reflect existing knowledge from the domain of nursing. This may be due either to the method LEP Nursing 2, or to the nursing activities themselves. Nonetheless, association analysis may in future become a useful analytical tool on the basis of structured nursing routine data.

The relevance of controlled vocabularies in promoting the standardized representation and exchange of clinical data is no longer to be proved. As part of a national project we evaluated the integration of classifications and terminologies in metadata registries based on the standard ISO/IEC 11179 Information technology - Metadata Registries (MDR). To overcome integration and maintenance tasks of monohierarchical classifications in the MDR, and to provide an exchange format between classifications publishers and the MDR, we implemented an import interface based on the Classification Markup Language (ClaML). The implementation transforms classifications from ClaML into a MDR conform structure using the Extensible Stylesheet Language Transformation (XSLT). Several XSLT-scripts were linked and successively executed. The national obliged classifications ICD-10-GM and OPS could be hence imported into the MDR. Problems arose with different interpretations and extensions of ClaML by WHO and the national publisher. We therefore advocate a unique interpretation of ClaML as prerequisite for a general use of the ClaML import interface.

Data quality significantly impacts the reliability and validity of empirical medical research. Specific measures can be used to check the quality of data during operation of a research project like a register. Furthermore these indicators allow an assessment of data quality independently from the institution responsible for data recording. A previously developed set of 24 data quality indicators was compared with measures of three research projects, each representing a specific view on the topic. The structure of the set was confirmed, being able to capture most of the projects' measures under the headings plausibility, organization, and correctness. Solely two indicators about metadata could not be appropriately mapped. However, several measures not considered so far were added to reach a number of 51 quality indicators in a first draft of a revised set. Most of the new indicators refine existing ones; e. g. the indicator "allowed values for missings" refines the existing indicator "allowed values for qualitative data elements". Seven projects' measures contribute supplementary aspects of data quality. The draft of the revised set of quality indicators will now be reviewed within and beyond the group.

Background: Mortality is widely used to assess quality of hospital care. Inpatient mortality is easily available in administrative data. The use of periods other than length of stay is questionable. We compared different overlapping and disjunctive periods for the calculation of mortality associated with hospital care., Subjects and Methods: Information from public quality reports covering insured from local sickness funds were retrospectively recorded. Nineteen thousand eight hundred thirteen patients from 69 hospitals were included for 5 tracers. The relationship between different periods, or time spans from admission to death or discharge, was assessed calculating the nonparametric correlation coefficient for mortality rates and standardized mortality ratios. The periods were hospital stay, 30, 90, and 365 days after admission, 31 to 90 days, and 91 to 365 days. The variation within each period was assessed with the coefficient of variation., Results: There is a strong relationship between overlapping periods for nonsurgical tracers with r > 0.559 (P < .001). The surgical tracers present a reverse relationship between 30-day and 91-day to 365-day mortality with r = -0.724 (P = .012) for colorectal carcinoma with operation and r = -0.490 (P = .028) for total hip replacement in case of femur fracture. Nonsurgical tracers show a decreasing variation of mortality rates with extending periods, whereas colorectal carcinoma shows a stable and small variation., Conclusions: For nonsurgical tracers, hospital stay is the best period to assess mortality associated with hospital stay. The courses (sequences of 4 mortality rates for one tracer in a hospital) for surgical tracers, in particular colorectal carcinoma, appear as a harvesting effect with an association of high in-hospital mortality with low mortality in the medium term.

Background: Adverse reactions and medication errors are complications of drug use. Spontaneous reporting systems and pharmacoepidemiological studies incompletely detect the occurrence of these events in daily hospital care. In this study, the frequency and type of drug-related admissions and hospital-acquired adverse drug events (ADE) in Germany were assessed using routinely collected hospital data., Methods: The study was based on aggregated hospital routine data covering the period 2003 to 2007 and annually recorded as part of the further development of the German Diagnosis-Related Groups. The 505 ICD-10-codes indicating an ADE were categorized in seven groups according to their certainty. Primary diagnoses were considered as a proxy for drug-related admissions, and secondary diagnoses as a proxy for hospital-acquired ADE., Results: Among all hospital admissions, 5% were found to be at least possibly drug-induced and 0.7% very likely drug-induced. There was a significant increase in the overall rate of drug-related admissions over time (p < 0.038). Enterocolitis due to Clostridium difficile infection was the most frequent cause of a drug-related admission. About 4.5% of in-patients had experienced a hospital-acquired ADE. In addition, over the course of the study period, the overall frequency of hospital-acquired ADEs significantly increased (p < 0.001)., Conclusions: In Germany, more than 5% of hospital episodes are either caused or complicated by an ADE. Between 2003 and 2007, there was a statistically significant increase in the overall rate and in some of the subcategories defined by the list of ICD-10-codes suspected to be indicative of an ADE. Before the use of routine data in pharmacovigilance and patient safety can be fully exploited, a further tailoring of both the ICD and the available variable set is needed.

Background: Hospitals are increasingly being evaluated with respect to the quality of provided care. In this setting, several indicator sets compete with one another for the assessment of effectiveness and safety. However, there have been few comparative investigations covering different sets. The objective of this study was to answer three questions: How concordant are different indicator sets on a hospital level? What is the effect of applying different reference values? How stable are the positions of a hospital ranking?, Methods: Routine data were made available to three companies offering the Patient Safety Indicators, an indicator set from the HELIOS Hospital Group, and measurements based on Disease Staging™. Ten hospitals from North Rhine-Westphalia, comprising a total of 151,960 inpatients in 2006, volunteered to participate in this study. The companies provided standard quality reports for the ten hospitals. Composite measures were defined for strengths and weaknesses. In addition to the different indicator sets, different reference values for one set allowed the construction of several comparison groups. Concordance and robustness were analyzed using the non-parametric correlation coefficient and Kendall's W., Results: Indicator sets differing only in the reference values of the indicators showed significant correlations in most of the pairs with respect to weaknesses (maximum r = 0.927, CI 0.714-0.983, p < 0.001). There were also significant correlations between different sets (maximum r = 0.829, CI 0.417-0.958, p = 0.003) having different indicators or when different methods for performance assessment were applied. The results were weaker measuring hospital strengths (maximum r = 0.669, CI 0.068-0.914, p = 0.034). In a hospital ranking, only two hospitals belonged consistently either to the superior or to the inferior half of the group. Even altering reference values or the supplier for the same indicator set changed the rank for nine out of ten hospitals., Conclusions: Our results reveal an unsettling lack of concordance in estimates of hospital performance when different quality indicator sets are used. These findings underline the lack of consensus regarding optimal validated measures for judging hospital quality. The indicator sets shared a common definition of quality, independent of their focus on patient safety, mortality, or length of stay. However, for most of the hospitals, changing the indicator set or the reference value resulted in a shift from the superior to the inferior half of the group or vice versa. Thus, while taken together the indicator sets offer the hospitals complementary pictures of their quality, on an individual basis they do not establish a reliable ranking.

Empirical medical research needs services for the maintenance of item collections. We evaluated the appropriateness of ISO/IEC 11179 "Information technology - Metadata Registries (MDR)" part 3 "Registry Metamodel and basic attributes" for a national MDR. In particular, possibilities of including classifications and terminologies (summarized as vocabularies) using the metamodel of this standard were assessed. The hierarchical structure of classifications and terminologies could be mapped easily to ISO's metamodel. The Classification Markup Language (ClaML) is attractive as interface standard for the import of classifications into the MDR. The correct linkage between data elements and vocabularies remained unclear however. An extension of the ISO 11179 metamodel might be necessary to satisfy the predefined needs of a national MDR.

Background: Several disease specific registers are operated by members of the 'TMF - Technology, Methods, and Infrastructure for Networked Medical Research', an umbrella organization of research networks in Germany., Objective: To describe the coverage and the current state as well as financial and organizational issues of registers operated by member networks of the TMF, to identify their requirements and needs, and to recommend best practice models., Methods: A survey with a self-completion questionnaire including all 55 TMF member networks was carried out in winter 2007/2008. Interviews focusing on technological issues were conducted and analyzed in summer 2009 with a convenience sample of 10 registers., Results: From 55 TMF member networks, 11 provided information about 14 registers. Six registers address diseases of the circulatory system with more than 150,000 registered patients. The interviews revealed a typical setting of "research registers". Research registers are an important mean to generate hypotheses for clinical research, to identify eligible patients, and to share data with clinical trials. Concerning technical solutions, we found a remarkable heterogeneity. The analysis of the most efficient registers revealed a structure with five levels as best practice model of register management: executive, operations, IT-management, software, hardware., Conclusion: In the last ten years, the TMF member networks established disease specific registers in Germany mainly to support clinical research. The heterogeneity of organizational and technical solutions as well as deficits in register planning motivated the development of respective recommendations. The TMF will continue to assist the registers in quality improvement.

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.)

This study analysed the outstanding homogeneity of the German Diagnosis-Related Groups (G-DRG) using the reduction in variance (R²) of costs. Arbitrary increase in case groups, definition of additional charges and combination of several case groups in one DRG were considered as potential confounders. In 2009, the G-DRG-system offers an outstanding homogeneity with R² of 83.5% in comparison to 2004 with R² of 70.2%. The effect of an arbitrary increase in case groups is negligible. However, a simulation of the other confounders explains three-fourth of the increase in R² between 2004 and 2009. The definition of additional charges attributes in particular to the outstanding homogeneity. The assessment of DRG-systems with R² should be complemented with measures that are independent from a trimming of costs, e.g. relating actual costs with prospective payment. The G-DRGs left medical ground in order to achieve optimal economical homogeneity.

Background and Objective: In-hospital mortality is a common criterion for evaluating the quality of medical care provided for inpatients. Besides general concerns, the call for a defined follow-up-period is the subject to be discussed. A project - abbreviated as QSR - covering insured from local health insurance funds now provides respective information. By this means, the relationship between in-hospital and peri-hospital mortality can be elaborated., Patients and Methods: Data regarding in-hospital mortality, mortality 30 days, 90 days as well as one year after admission was gathered from QSR quality reports covering 31 hospitals of the HELIOS hospital group. The relationship between the various periods was determined by the non-parametric correlation coefficient, whereas trends were analyzed based on linear regression., Results: There is a relevant (r between 0.552 and 0.908) and significant (p ≤ 0.006) relation between the various periods with respect to heart failure, cardiac infarction, and stroke or intracerebral haemorrhage. As to surgical fields, comparable results can be recognized. Fifteen out of 85 courses show a statistically significant trend. Only four courses are tangent to the threshold 1 applicable for the standard mortality ratio., Conclusion: The study revealed no imperative need to analyze mortality for longer follow-up-periods in order to assess quality of inpatient health care. Therefore, future efforts should concentrate on the identification of an adequate operand that supports best the hospitals in their internal quality management., (© Georg Thieme Verlag KG Stuttgart · New York.)

Aim: To evaluate the relation between pressure ulcers and delivery of care., Background: No decrease of pressure ulcer rates could be recognised in acute hospital care, despite intensive efforts in prevention. Furthermore, reports show increasing rates., Design: Retrospective analysis of hospital data., Methods: The study included all inpatients from year 1 (2003/2004) and 4 (2006/2007) of the interdisciplinary decubitus project. Information on ulcers was recorded at admission, discharge and in case of new events. We analysed the effect of age, length of stay, operation and intensive care episode. In logistic regression, we used the existence of ulcers and the appearance of new ulcers as dependent variables., Results: Parallel to a decrease in the number of inpatients, age, length of stay and operation frequency rose between 2003 and 2007. Higher age, longer length of stay, operation, intensive care episode and year 4 raise the odds for ulcers in univariate and with exception of operation in multivariate analyses. With exception of operation and year 4, the same variables raise the odds for new ulcers, too., Conclusions: The increase of pressure ulcer frequency could be related to changes in delivery of care. The adverse event pressure ulcer will become more important in hospital care., Relevance to Clinical Practice: There is no decrease in pressure ulcer rates, albeit enormous efforts in prevention. Hospital care has been facing changes in case mix. Age, length of stay and intensive care episodes are related to increasing ulcer rates at a University Clinic. Nursing management has to be aware of additional workload for pressure ulcer management in the future.

Background: Adverse drug events (ADE) are a common cause of hospital admission as well as a common complication of inpatient care. The current reporting systems in Germany are of only limited use for the identification of ADE. The aim of this study is to examine the potential usefulness of ICD-10 coded diagnoses in routine hospital data for the identification of ADE., Methods: The common, major manifestations of ADE were mapped to the ICD-10-GM, and categories in the ICD-10-GM for which a possible causal relationship with medications is explicitly mentioned were included as well. A total of 505 relevant ICD-10-GM codes were identified. An evaluation was carried out on the basis of an aggregated data set from eleven million inpatients treated in 2006., Results: 0.7% of hospital admissions were revealed by routine data to be causally related to the administration of a drug. In 5.3% of admissions, there was at least a reason to suspect such a causal relation. Furthermore, one of the 505 relevant codes was found to be present in 9.0% of the secondary diagnoses., Conclusions: The available ICD-10-GM codes for manifestations of ADE are used in routine hospital data in Germany. Their usefulness for the identification of ADE should be better exploited. Our results and other relevant published literature imply that this procedure will result in both false-positive and false-negative findings, which will have to be taken into account as well.