Recommended data elements for health registries: a survey from a German funding initiative.

BACKGROUND: The selection of data elements is a decisive task within the development of a health registry. Having the right metadata is crucial for answering the particular research questions. Furthermore, the set of data elements determines the registries' readiness of interoperability and data reusability to a major extent. Six health registries shared and published their metadata within a German funding initiative. As one step in the direction of a common set of data elements, a selection of those metadata was evaluated with regard to their appropriateness for a broader usage. METHODS: Each registry was asked to contribute a 10%-selection of their data elements to an evaluation sample. The survey was set up with the online survey tool "LimeSurvey Cloud". The registries and an accompanying project participated in the survey with one vote for each project. The data elements were offered in content groups along with the question of whether the data element is appropriate for health registries on a broader scale. The question could be answered using a Likert scale with five options. Furthermore, "no answer" was allowed. The level of agreement was assessed using weighted Cohen's kappa and Kendall's coefficient of concordance. RESULTS: The evaluation sample consisted of 269 data elements. With a grade of "perhaps recommendable" or higher in the mean, 169 data elements were selected. These data elements belong preferably to groups' demography, education/occupation, medication, and nutrition. Half of the registries lost significance compared with their percentage of data elements in the evaluation sample, one remained stable. The level of concordance was adequate. CONCLUSIONS: The survey revealed a set of 169 data elements recommended for health registries. When developing a registry, this set could be valuable help in selecting the metadata appropriate to answer the registry's research questions. However, due to the high specificity of research questions, data elements beyond this set will be needed to cover the whole range of interests of a register. A broader discussion and subsequent surveys are needed to establish a common set of data elements on an international scale.

Understanding the Nature of Metadata: Systematic Review.

BACKGROUND: Metadata are created to describe the corresponding data in a detailed and unambiguous way and is used for various applications in different research areas, for example, data identification and classification. However, a clear definition of metadata is crucial for further use. Unfortunately, extensive experience with the processing and management of metadata has shown that the term "metadata" and its use is not always unambiguous. OBJECTIVE: This study aimed to understand the definition of metadata and the challenges resulting from metadata reuse. METHODS: A systematic literature search was performed in this study following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines for reporting on systematic reviews. Five research questions were identified to streamline the review process, addressing metadata characteristics, metadata standards, use cases, and problems encountered. This review was preceded by a harmonization process to achieve a general understanding of the terms used. RESULTS: The harmonization process resulted in a clear set of definitions for metadata processing focusing on data integration. The following literature review was conducted by 10 reviewers with different backgrounds and using the harmonized definitions. This study included 81 peer-reviewed papers from the last decade after applying various filtering steps to identify the most relevant papers. The 5 research questions could be answered, resulting in a broad overview of the standards, use cases, problems, and corresponding solutions for the application of metadata in different research areas. CONCLUSIONS: Metadata can be a powerful tool for identifying, describing, and processing information, but its meaningful creation is costly and challenging. This review process uncovered many standards, use cases, problems, and solutions for dealing with metadata. The presented harmonized definitions and the new schema have the potential to improve the classification and generation of metadata by creating a shared understanding of metadata and its context.

Facilitating harmonized data quality assessments. A data quality framework for observational health research data collections with software implementations in R.

BACKGROUND: No standards exist for the handling and reporting of data quality in health research. This work introduces a data quality framework for observational health research data collections with supporting software implementations to facilitate harmonized data quality assessments. METHODS: Developments were guided by the evaluation of an existing data quality framework and literature reviews. Functions for the computation of data quality indicators were written in R. The concept and implementations are illustrated based on data from the population-based Study of Health in Pomerania (SHIP). RESULTS: The data quality framework comprises 34 data quality indicators. These target four aspects of data quality: compliance with pre-specified structural and technical requirements (integrity); presence of data values (completeness); inadmissible or uncertain data values and contradictions (consistency); unexpected distributions and associations (accuracy). R functions calculate data quality metrics based on the provided study data and metadata and R Markdown reports are generated. Guidance on the concept and tools is available through a dedicated website. CONCLUSIONS: The presented data quality framework is the first of its kind for observational health research data collections that links a formal concept to implementations in R. The framework and tools facilitate harmonized data quality assessments in pursue of transparent and reproducible research. Application scenarios comprise data quality monitoring while a study is carried out as well as performing an initial data analysis before starting substantive scientific analyses but the developments are also of relevance beyond research.

Value of the Electronic Medical Record for Hospital Care: Update From the Literature.

BACKGROUND: Electronic records could improve quality and efficiency of health care. National and international bodies propagate this belief worldwide. However, the evidence base concerning the effects and advantages of electronic records is questionable. The outcome of health care systems is influenced by many components, making assertions about specific types of interventions difficult. Moreover, electronic records itself constitute a complex intervention offering several functions with possibly positive as well as negative effects on the outcome of health care systems. OBJECTIVE: The aim of this review is to summarize empirical studies about the value of electronic medical records (EMRs) for hospital care published between 2010 and spring 2019. METHODS: The authors adopted their method from a series of literature reviews. The literature search was performed on MEDLINE with "Medical Record System, Computerized" as the essential keyword. The selection process comprised 2 phases looking for a consent of both authors. Starting with 1345 references, 23 were finally included in the review. The evaluation combined a scoring of the studies' quality, a description of data sources in case of secondary data analyses, and a qualitative assessment of the publications' conclusions concerning the medical record's impact on quality and efficiency of health care. RESULTS: The majority of the studies stemmed from the United States (19/23, 83%). Mostly, the studies used publicly available data ("secondary data studies"; 17/23, 74%). A total of 18 studies analyzed the effect of an EMR on the quality of health care (78%), 16 the effect on the efficiency of health care (70%). The primary data studies achieved a mean score of 4.3 (SD 1.37; theoretical maximum 10); the secondary data studies a mean score of 7.1 (SD 1.26; theoretical maximum 9). From the primary data studies, 2 demonstrated a reduction of costs. There was not one study that failed to demonstrate a positive effect on the quality of health care. Overall, 9/16 respective studies showed a reduction of costs (56%); 14/18 studies showed an increase of health care quality (78%); the remaining 4 studies missed explicit information about the proposed positive effect. CONCLUSIONS: This review revealed a clear evidence about the value of EMRs. In addition to an awesome majority of economic advantages, the review also showed improvements in quality of care by all respective studies. The use of secondary data studies has prevailed over primary data studies in the meantime. Future work could focus on specific aspects of electronic records to guide their implementation and operation.

[Cross-Project Support of Registries in Development, Implementation and Operation]. / Projektübergreifende Unterstützung von Registern in Entwicklung, Umsetzung und Betrieb.

OBJECTIVE: The German Federal Ministry of Education and Research funded a project accompanying a funding initiative for registries in health services research. The aim was to provide cross-registry support initially for 16 and later 6 projects with regard to methodological, technical and structural standards. METHODS: The 16 projects were initially guided in concept development, e. g., providing a template for a registry protocol. Furthermore, an expert consultation was organized and carried out. To assist in the selection of an IT solution, a challenge workshop was hosted where different vendors presented their software for registries. The catalogs of data elements of the projects were migrated into a metadata catalog and transferred to the standard model of ISO/IEC 11179. A set of quality indicators was defined for a cross-registry quality management approach to be implemented during the operational phase. To improve data quality, the indicators were to be transmitted and evaluated on a regular basis. RESULTS: The template for a registry protocol was used by the majority of projects when applying for funding of their operational phase. At the workshop on IT solutions, 12 products for registry software were presented; however, the projects opted for other solutions for different reasons. Transferring the catalogs of data elements into a standard model enabled a comparison of attributes and value sets, which in turn enabled formulation of recommendations for important elements. A set of five quality indicators was defined for quality management, for which an initial evaluation was carried out for 2020. CONCLUSION: The template of a registry protocol serves a systematic development of a concept. The use of a uniformly structured catalog of data elements supports compliance with the FAIR principles. Monitoring of data quality can be achieved by regularly identifying quality indicators across registries.

[Position paper of the German Network for Health Services Research (DNVF) on application-related data collection according to Social Code Book V]. / Positionspapier des Deutschen Netzwerk Versorgungsforschung (DNVF) zur anwendungsbegleitenden Datenerhebung nach Sozialgesetzbuch V.

Within the framework of the early benefit assessment, the Federal Joint Committee (G-BA) has been authorised since 2019 by the law for more safety in the supply of pharmaceuticals GSAV to request additional application-related data capture for certain pharmaceutical drugs. This results in certain challenges, especially in the area of conflict between methodological requirements and practical feasibility. The position paper provides an overview and takes up the general regulations defined by the Federal Ministry of Health (BMG) as well as the process defined by the G-BA. Subsequently, possible solutions are discussed and recommendations for implementation are given from the perspective of health care research.

Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry - the first 1000 patients.

Background: The RECcording COurses of vasculaR Diseases (RECCORD) registry established by the German Society of Angiology - Society for Vascular Medicine aimed to address the lack in contemporary real-world data regarding current practice of medical and interventional care in vascular patients. We herein report the demographic and procedural characteristics of the first 1000 patients undergoing endovascular revascularization (EVR) for symptomatic peripheral artery disease (PAD). Patients and methods: RECCORD is an observational, prospective, multicenter, all-comers registry. Only patients undergoing EVR for symptomatic PAD are included and followed up for at least 1 year. Demographic characteristics, comorbidities, previous peripheral vascular interventions, medication, clinical stage of lower extremity artery disease (Rutherford category), hemodynamic parameters, and procedural data including complications are recorded via an entirely web-based platform. Results: Of the first 1000 patients (mean age 70 ± 10 years, 35% female) with 1096 EVR at 1477 vascular segments of the lower extremities, 25.0% were at the stage of chronic limb threatening ischemia (CLTI) and 75.0% at non-CLTI. The femoropopliteal segment was the dominant target lesion site (61.0%), followed by iliac (26.4%) and below-the-knee EVR (10.3%). Only angioplasty was performed in 130 EVR (11.9%), adjunctive drug coated balloons (DCB) in 498 (45.4%), additional stenting in 633 (57.8%). Debulking devices were used in 106 (9.7%) EVR. Clinical (Rutherford categories) and hemodynamic parameters (ankle-brachial-index) as well as secondary preventive medication were significantly improved post EVR. Periprocedural complications occurred in 63 (5.7%) EVR with pseudoaneurysm as the leading complication type in 26 (2.4%) EVR. Conclusions: The baseline data of the first 1000 patients from the RECCORD registry representing the real-world setting illustrate that the majority of EVR are performed in patients with claudication. Adjunctive use of DCB and stenting are the dominant types of EVR, while periprocedural complications are at an acceptable low rate.

[Memorandum Registry for Health Services Research: Update 2019]. / Memorandum Register für die Versorgungsforschung: Update 2019.

Health registries could be used to analyze questions concerning routine practice in healthcare. Therefore, registries are a core method in health services research. The German Network for Health Services Research (Deutsches Netzwerk Versorgungsforschung, DNVF) promotes the quality of registries by scientific exchange, organization of advanced training, and recommendations in the form of a memorandum "Registry for Health Services Research". The current recommendations are an update of the memorandum's first version of 2010. The update describes the capabilities and aims of registries in health services research. Furthermore, it illustrates the state-of-the-art in designing and implementing health registries. The memorandum provides developers the methodological basis to ensure high quality health registries. It further provides users of health registries with insights that enable assessing the quality of data and results of health registries. Finally, funding agencies and health policy actors can use the quality criteria to establish a framework for the financing and legislative requirements for health registries. The memorandum provides first a definition of health registries and presents an overview of their utility in health services research and health care improvement. Second, several areas of methodological importance for the development and operation of health registries are presented. This includes the conceptual and preliminary design, implementation, technical organization of a health registry, statistical analysis, reporting of results, and data protection. From these areas, criteria are deduced to allow the assessment of the quality of a health registry. Finally, a checklist is presented.

[Patient registries for rare diseases in Germany: concept paper of the NAMSE strategy group]. / Patientenregister für Seltene Erkrankungen in Deutschland: Konzeptpapier der Strategiegruppe "Register" des Nationalen Aktionsbündnisses für Menschen mit Seltenen Erkrankungen (NAMSE).

The National Action Plan for People with Rare Diseases contains 52 concrete actions, including in the fields of care, research, diagnosis, and information management. With the aim of improving the quality and interoperability of national registries in the long term, action 28 proposed the establishment of a "Rare Diseases Registry" strategy group. The strategy group began its work in 2016. In this report, the group takes into account developments at the national and international level in order to develop recommendations for national initiatives.In addition to this, the group reports on consent and implementation as well as on the adaptation of a minimal dataset for use in rare disease registries and mapping the used data elements and schemata in a metadata repository. This position paper was created by the strategy group together with additional authors. The paper reached a consensus within the strategy group and can be seen as a concept paper of the Rare Diseases Registry strategy group.

Improving drug safety in hospitals: a retrospective study on the potential of adverse drug events coded in routine data.

BACKGROUND: Adverse drug events (ADEs) that occur during hospitalization are an ongoing medical concern. Systematic strategies for ADE identification are lacking. The aim of this study was to evaluate the potential to identify adverse drug events caused by medication errors (preventable ADEs, pADEs), and previously unknown adverse drug reactions (ADRs or non-preventable ADEs, npADEs) in inpatients by combining diagnosis codes in routine data with a chart review. METHODS: Diagnoses of inpatients are routinely coded using the International Classification of Diseases, 10th Revision (ICD-10). A total of 2326 cases were sampled from routine data of four hospitals using a set of ICD-10 German Modification ADE codes. Following a chart review, cases were evaluated in a standardized process with regard to drug relation and preventability of events. RESULTS: By chart review, 1302 cases were classified as hospital-acquired and included in the evaluation. This yielded 1285 cases indicating an ADE. 96.8% of ADEs (1244 ADEs) were classified as known npADEs, only three cases as suspected previously unknown npADEs, one case as event after drug abuse. A total of 37 ADEs were classified as preventable (2.9% of all ADEs) by identifying a medication error as probable cause. The prevalence of pADEs varied considerably between included ADE codes, with hemorrhagic diathesis due to coumarins and localized skin eruptions showing the highest rates (8.7 and 9.1%, respectively). Most frequent medication errors were non-compliance to a known allergy, and improper dose. CONCLUSIONS: When focusing on specific ADE codes, routine data can be used as markers for npADEs and medication errors, thus providing a meaningful complement to existing drug surveillance systems. However, the prevalence of medication errors is lower than in former studies on the frequency of pADEs.

[Diagnosis Coding in German Medical Practices: A Retrospective Study Using Routine Data]. / Diagnosenkodierung in deutschen Arztpraxen aus klassifikatorischer Sicht: Eine retrospektive Studie mit Routinedaten.

OBJECTIVES: Primary care physicians and specialists deal with a wide range of diseases. The diagnoses are coded by using the annual version of the International Statistical Classification of Diseases and Related Health Problems, 10th revised version, German modification (ICD-10-GM). The aim of this study was to describe the current spectrum of documented diagnoses by physicians. Based on the underlying conditions, a broad variety of ICD-10-GM codes could be expected, which in many cases would not be coded to the final character (terminal). METHODS: 22,287,583 data sets of 900 medical practices of 13 various physician groups were included in this retrospective study. The data originate from the regions Brandenburg and North Rhine and the accounting period October 2014 - September 2015. The normalized Gini coefficient was applied as a measure for inequality. RESULTS: 97.6 % of the total data set were coded to the final character using the ICD-10-GM. ENT physicians used the highest rate of terminal codes (99.6 %), whereas orthopedists and cardiologists used the lowest rate (94.0 %). The broadest variety of different ICD-10-GM codes was used by primary care physicians (71.1 % of all possible terminal codes), the smallest variety was used by ophthalmologists (22.9 %). The lowest inequality of using ICD-10-GM codes could be detected for primary care physicians (Gini coefficient: 0.56), the highest inequality could be shown for ophthalmologists (Gini coefficient: 0.93). CONCLUSIONS: The specialists mainly use a circumscribed set of ICD-10-GM codes, whereas primary care physicians not only use a broad variety of different ICD-10-GM codes, but very often code them to their final character. This indicates a high quality of coding.

[Field tests for the beta version of the ICD-11-MMS in Germany: background and methods]. / Feldtests zur Betaversion der ICD-11-MMS in Deutschland: Hintergrund und Methodik.

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.

[Quality standards for epidemiologic cohort studies : An evaluated catalogue of requirements for the conduct and preparation of cohort studies]. / Qualitätsstandards für epidemiologische Kohortenstudien : Ein bewerteter Anforderungskatalog zur Studienvorbereitung und Studiendurchführung.

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.

Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry).

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.

[Memorandum III, Part 3: Quality of Care and Patient Safety Research Methods]. / DNVF-Memorandum III "Methoden für die Versorgungsforschung", Teil 3: Methoden der Qualitäts- und Patientensicherheitsforschung.

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.

Determinants of decreasing major amputation rates in Germany.

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.