Klinische Register im 21. Jahrhundert

Behrendt, Christian‐Alexander; Pridöhl, Henning; Schaar, Katrin; Federrath, Hannes; Debus, Eike Sebastian

doi:10.1007/s00104-017-0542-9

Cited by 14 publications

(8 citation statements)

References 4 publications

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“…All analyses were carried out by GermanVasc, which is an interdisciplinary university working group that was founded in Hamburg in 2014 [4] and which is concerned with the data protection compliant [3] use of registry and routine data in vascular treatment research and quality development [6]. We would like to thank the German Association for the Promotion of Science and Humanities ( Stifterverband für die Deutsche Wissenschaft e.   V. ) for making this study possible.…”

Section: Acknowledgementsmentioning

confidence: 99%

Complex endovascular treatment of intact aortic aneurysms

et al. 2018

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BackgroundThe complex endovascular repair of aortic aneurysms and dissections with fenestrated or branched stent grafts (FB-EVAR) remains challenging for interventional vascular surgery. To date, the evidence regarding treatment patterns and outcome measures consists of single center studies; however, it might be reasonable to validate results with multicenter real-world evidence.MethodsHealth insurance claims data from Germany’s third largest insurance provider, DAK-Gesundheit, were used to determine outcomes following FB-EVAR of non-ruptured thoracic aorta (TA) or thoracoabdominal including pararenal abdominal (TAA) aorta. The study included patients operated between January 2008 and April 2017.ResultsIncluded were 984 patients (18.1% female) who underwent FB-EVAR. Patients with treatment of the TA were younger (71.7 vs. 73.2 years, p < 0.001) and more often female (38.5% vs. 17.0%, p < 0.001) as compared to patients with treatment of TAA. In the TA group peripheral arterial disease was less frequent compared to the TAA group (67.3% vs. 80.4%, p = 0.036). Mortality was significantly (p < 0.001) higher following repair of the TAA compared to the TA at discharge (17.3% vs. 4.6%), at 30 days (26.9% vs. 8.2%) and at 90 days (34.6% vs. 10.1%). Patients with treatment of the TAA suffered more often from stroke as compared to the TA group (7.7% vs. 1.2%, p = 0.002).ConclusionIn this large-scale German analysis of claims data, multicenter real-world evidence was different from single center studies regarding patient risk-factors and outcome measures. Validated multicenter registry studies could help to further investigate this topic in times of increasing procedures.

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Section: Acknowledgementsmentioning

confidence: 99%

Complex endovascular treatment of intact aortic aneurysms

et al. 2018

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“…Recently, 2 comprehensive reforms of the European Union regulatory framework with major impact on real-world evidence have been implemented. On the one side, the GDPR aims to modernise data protection and privacy in times of big data techniques and significantly strengthens informed consent of the data subjects [5,25]. On the other side, a new Medical Device Regulation promotes the utilisation of available real-world data for market access and surveillance of medical devices what actually affects a wide spectrum of multidisciplinary vascular medicine.…”

Section: Discussionmentioning

confidence: 99%

“…Firstly, to ensure the lawfulness of any processing of personal data in terms of record linkage, an explicit informed consent by the data subject is necessary until no other legal justification exists. This, however, requires a great deal of effort and costs and potentially introduces harms of individual privacy [5,17,25]. Secondly, the reference data (e. g., registry data) must have enough internal and external validity to be suitable for validation purposes.…”

Section: Discussionmentioning

confidence: 99%

Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach

et al. 2019

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Recently, health insurance claims have regained the attention of the scientific community as a source of real-world evidence in health care research and quality improvement. To date, very few studies are available which investigate the validity of health insurance claims; these may be affected by bias from several sources, such as possible upcoding of co-morbidities and complications for reimbursement advantages. The IDOMENEO study investigates the inpatient treatment of peripheral arterial disease (PAD) comprehensively using various data sources with a consortium involving experts from health care research and data privacy, a large health insurance fund, biostatisticians, jurists, and computer scientists. Prospective registry data were collected from 30–40 vascular centres in Germany using the GermanVasc registry. In addition, health insurance claims data were prospectively collected from BARMER, the second largest health insurance fund in Germany. The consortium is currently developing a data privacy compliant method of health insurance claims data validation, the methodological foundations of which are described here.

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“…For example, the German Centre for Cardiovascular Research (DZHK) generously provides access to the data they have collected for several studies. 5 The process to get access to that data involves at least eight parties and has a lower bound of 10 weeks processing time, some of which is spent on determining whether privacy-related preconditions are met. A more automated process arguably increases the trust placed in the software system by developers, authorities, and users.…”

Section: Introductionmentioning

confidence: 99%

Automatically Proving Purpose Limitation in Software Architectures

Bavendiek

Mueller

Wittner

et al. 2019

IFIP Advances in Information and Communication Technology

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The principle of purpose limitation is one of the corner stones in the European General Data Protection Regulation. Automatically verifying whether a software architecture is capable of collecting, storing, or otherwise processing data without a predefined, precise, and valid purpose, and more importantly, whether the software architecture allows for re-purposing the data, greatly helps designers, makers, auditors, and customers of software. In our case study, we model the architecture of an existing medical register that follows a rigid Privacy by Design approach and assess its capability to process data only for the defined purposes. We demonstrate the process by verifying one instance that satisfies purpose limitation and two that are at least critical cases. We detect a violation scenario where data belonging to a purpose-specific consent are passed on for a different and maybe even incompatible purpose.

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Klinische Register im 21. Jahrhundert

Cited by 14 publications

References 4 publications

Complex endovascular treatment of intact aortic aneurysms

Complex endovascular treatment of intact aortic aneurysms

Data Privacy Compliant Validation of Health Insurance Claims Data: the IDOMENEO Approach

Automatically Proving Purpose Limitation in Software Architectures

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