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1دورية أكاديمية
المؤلفون: Sonja Harkener, Ekkehart Jenetzky, Rüdiger Rupp, Jennifer Dell, Christoph Engel, Maximilian Ferry von Bargen, Robert Finger, Maximilian Glienke, Carsten Heinz, Patrick Jersch, David Martin, Rita Schmutzler, Martin Schönthaler, Barbara Suwelack, Jeannine Wegner, Jürgen Stausberg
المصدر: BMC Medical Informatics and Decision Making, Vol 24, Iss 1, Pp 1-9 (2024)
مصطلحات موضوعية: Data element, Health care, Health services research, Metadata, Registry, Computer applications to medicine. Medical informatics, R858-859.7
الوصف: Abstract 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.
وصف الملف: electronic resource
Relation: https://doaj.org/toc/1472-6947
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2دورية أكاديمية
المؤلفون: Jürgen Stausberg, Ulrich Vogel
المصدر: Healthcare, Vol 12, Iss 12, p 1214 (2024)
مصطلحات موضوعية: cause-of-death statistics, coding, death certificate, diagnosis, ICD-11, Medicine
الوصف: The 11th Revision of the International Statistical Classification of Diseases, Injuries, and Causes of Death (ICD-11) will replace its predecessor as international standard for cause-of death-statistics. The digitization of healthcare is a main motivation for its introduction. In parallel, the replacement of the paper-based death certificate with an electronic format is under evaluation. At the moment, the death certificate is used in paper-based format with ICD-10 for coding in Germany. To be prepared for the switch to ICD-11, the compatibility between ICD-11 and the electronic certificate should be assured. Objectives were to check the appropriateness of diagnosis-related information found on death certificates for an ICD-11 coding and to describe enhancements to the certificate’s structure needed to fully utilize the strengths of ICD-11. As part of an exploratory test of a respective application, information from 453 electronic death certificates were provided by one local health authority. From a sample of 200 certificates, 433 diagnosis texts were coded into the German version of ICD-11. The appropriateness of the results as well as the further requirements of ICD-11, particularly with regard to post-coordination, were checked. For 430 diagnosis texts, 649 ICD-11 codes were used. Three hundred and sixty two diagnosis texts were rated as appropriately represented through the coding result. Almost all certificates contained diagnosis texts that lacked details required by ICD-11 for a precise coding. The distribution of diseases was very similar between ICD-10 and ICD-11 coding. A few gaps in ICD-11 were identified. Information requested by ICD-11 for a mandatory post-coordination were almost entirely absent from the death certificates. The structure and content of the death certificate are currently not well prepared for an ICD-11 coding. Necessary information was frequently missing. The line-oriented structure of death certificates has to be supplemented with a more flexible approach. Then, the semantic knowledge base of ICD-11 should better guide the content related input fields of a future electronic death certificate.
وصف الملف: electronic resource
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3دورية أكاديمية
المؤلفون: Michael Czihal, Nasser Malyar, Jürgen Stausberg, Ulrich Hoffmann
المصدر: Journal of Cardiovascular Development and Disease, Vol 10, Iss 3, p 115 (2023)
مصطلحات موضوعية: peripheral arterial disease, critical limb threatening ischemia, endovascular revascularization, registry, randomized controlled trial, Diseases of the circulatory (Cardiovascular) system, RC666-701
الوصف: Background: To compare the characteristics of a “real world” population included in a prospective registry to patients enrolled in a randomized, controlled trial (RCT) after endovascular revascularization (EVR) for symptomatic peripheral artery disease (PAD). Methods: The RECcording COurses of vasculaR Diseases (RECCORD) registry is an observational registry prospectively recruiting patients undergoing EVR for symptomatic PAD in Germany. VOYAGER PAD was an RCT which demonstrated the superiority of rivaroxaban and aspirin versus aspirin to reduce major cardiac and ischemic limb events following infrainguinal revascularization for symptomatic PAD. For this exploratory analysis, the clinical characteristics of 2.498 patients enrolled in RECCORD and of 4.293 patients from VOYAGER PAD who underwent EVR were compared. Results: The rate of patients aged ≥ 75 years was considerably higher in the registry (37.7 vs. 22.5%). More patients in the registry had undergone previous EVR (50.7 vs. 38.7%) or suffered from critical limb threatening ischemia (24.3 vs. 19.5%). Registry patients were more commonly active smokers (51.8 vs. 33.6%), but less frequently suffered from diabetes mellitus (36.4 vs. 44.7%). While statins (70.5 vs. 81.7%) were less frequently used, antiproliferative catheter technologies (45.6 vs. 31.4%) and postinterventional dual antiplatelet therapy (64.5 vs. 53.6%) were more commonly applied in the registry. Conclusions: There were many similarities but some clinically meaningful differences in clinical characteristics between PAD patients who underwent EVR and were included in a nationwide registry and PAD patients from the VOYAGER PAD trial.
وصف الملف: electronic resource
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4دورية أكاديمية
المؤلفون: Carsten Oliver Schmidt, Stephan Struckmann, Cornelia Enzenbach, Achim Reineke, Jürgen Stausberg, Stefan Damerow, Marianne Huebner, Börge Schmidt, Willi Sauerbrei, Adrian Richter
المصدر: BMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-15 (2021)
مصطلحات موضوعية: Data quality, Observational health studies, Data quality indicators, Data quality monitoring, Initial data analysis, Medicine (General), R5-920
الوصف: Abstract 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.
وصف الملف: electronic resource
Relation: https://doaj.org/toc/1471-2288
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5دورية أكاديمية
المؤلفون: Jürgen Stausberg, Aykut Uslu
المصدر: Journal of Medical Internet Research, Vol 24, Iss 3, p e37419 (2022)
مصطلحات موضوعية: Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
وصف الملف: electronic resource
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6دورية أكاديمية
المؤلفون: Aykut Uslu, Jürgen Stausberg
المصدر: Journal of Medical Internet Research, Vol 23, Iss 12, p e26323 (2021)
مصطلحات موضوعية: Computer applications to medicine. Medical informatics, R858-859.7, Public aspects of medicine, RA1-1270
الوصف: BackgroundElectronic 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. ObjectiveThe 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. MethodsThe 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. ResultsThe 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. ConclusionsThis 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.
وصف الملف: electronic resource
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7دورية أكاديمية
المؤلفون: Nils Kuklik, Jürgen Stausberg, Marjan Amiri, Karl-Heinz Jöckel
المصدر: BMC Health Services Research, Vol 19, Iss 1, Pp 1-7 (2019)
مصطلحات موضوعية: Routine data, ICD-10, Adverse drug event, Medication error, Drug safety, Public aspects of medicine, RA1-1270
الوصف: Abstract 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.
وصف الملف: electronic resource
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8دورية أكاديمية
المؤلفون: Jacqueline Stella, Jürgen Stausberg, Michael Lichtenberg, Ulrich Hoffmann, Nasser M. Malyar
المصدر: Journal of Clinical Medicine, Vol 11, Iss 20, p 6074 (2022)
مصطلحات موضوعية: endovascular revascularization, lower extremity artery disease, aorto-iliac, femoropopliteal, infrapopliteal, Medicine
الوصف: Background: Endovascular revascularization (EVR) is a pillar of therapeutic management in patients with symptomatic lower extremity artery disease (LEAD). Due to lack of scientific evidence, the approach of EVR type and the devices used at the different anatomic vascular segments of the lower limbs vary substantially between operators and centers. We analyzed data from the RECcording COurses of vasculaR Diseases (RECCORD) registry to assess the current real-world EVR treatment patterns in relation to anatomic vascular segments in symptomatic LEAD patients in Germany. Patients and Methods: RECCORD is an ongoing, prospective, multicenter, all-comers and entirely web-based registry platform. Baseline demographic and periprocedural data of patients undergoing EVR for symptomatic LEAD were assessed and performed EVRs were grouped according to the intervened anatomic vascular segment. We analyzed four EVR groups comprising either the aorto-iliac, femoropopliteal, or infrapopliteal segments (all these EVRs with or without a further intervention in another anatomic segment) or the infrapopliteal segment alone. Results: A total of 2210 EVR segments (in 1639 patients) were analyzed. Of those 616 (27.9%) were aorto-iliacal, 1346 (60.9%) femoropopliteal, 248 (11.2%) infrapopliteal and 104 (4.7%) only infrapopliteal segments. Aorto-iliac EVR was associated with younger age, smoking, claudication and simple lesions, while the distal infrapopliteal EVRs were related to advanced age, diabetes, multiple comorbidities, limb threatening ischemia and complex lesions. The use of different EVR devices at the aorto-iliac, femoropopliteal, infrapopliteal and only infrapopliteal segments were: only ballon-angioplasty: 8.3%, 12.9%, 58.1% and 63.5%; stenting: 82.3%, 45.3%, 16.9% and 12.5%; drug-coated balloon: 11.2%, 55.0%, 19.4% and 19.2%. Conclusion: The RECCORD registry data demonstrate that in LEAD clinical and lesion characteristics are related to anatomic vascular segments. Despite the clear relationship between vascular segments and the current use of device types, prospective, segment-specific clinical studies are warranted to establish a consistent, evidence-based path for EVR in LEAD.
وصف الملف: electronic resource
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9دورية أكاديمية
المؤلفون: Nils Kuklik, Jürgen Stausberg, Karl-Heinz Jöckel
المصدر: PLoS ONE, Vol 12, Iss 11, p e0187510 (2017)
الوصف: 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.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.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.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.
وصف الملف: electronic resource
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10دورية أكاديمية
المؤلفون: Jürgen Stausberg, Stefan Hagn
المصدر: PLoS ONE, Vol 10, Iss 12, p e0143365 (2015)
الوصف: 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.
وصف الملف: electronic resource
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