Sichere und datenschutzgerechte Umsetzung medizinischer Register

Petersen, Tom; Blochberger, Maximilian; Mueller, Tobias; Federrath, Hannes; Behrendt, Christian‐Alexander

doi:10.1007/s11623-019-1153-z

Cited by 7 publications

(3 citation statements)

References 6 publications

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“…The study was approved by the ethical committee at the medical association in Hamburg, Germany (PV5691) as well as 18 additional ethical committees in Germany. The European Union (EU) General Data Protection Regulation (GDPR) compliant GermanVasc registry platform was developed to follow the principles of privacy by design while collecting the personal and medical data relevant for the current study [ 23 , 24 , 25 ]. Results were reported using the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement [ 26 ].…”

Section: Methodsmentioning

confidence: 99%

The Impact of Chronic Kidney Disease on Mid-Term Outcomes after Revascularisation of Peripheral Arterial Occlusive Disease: Results from a Prospective Cohort Study

Kotov

Blasche

Peters

et al. 2022

JCM

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Objective: The current study aimed to determine the relationship between chronic kidney disease (CKD) and major 12-month outcomes for patients with in-hospital treatment for symptomatic peripheral arterial occlusive disease (PAOD). Methods: An analysis of the prospective longitudinal multicentric cohort study with 12-month follow-up was conducted including patients who underwent endovascular or open surgery for symptomatic PAOD at 35 German vascular centres (initial study protocol: NCT03098290). Severity of CKD was grouped into four stages combining information about the estimated glomerular filtration rate (eGFR) at baseline and dialysis dependency. Outcomes included overall mortality as well as the two composite endpoints of amputation or death, and of major cardiovascular events (MACE). 12-month incidences and adjusted hazard ratios were estimated using the Kaplan–Meier function and Cox proportional hazard models. Results: A total of 4354 patients (32% female, 69 years mean age, 68% intermittent claudication, 69% percutaneous endovascular revascularisation) were included and followed for 244 days in median. Thereof, 22% had any CKD and 5% had end stage kidney disease (ESKD) at baseline. The 12-month overall mortality rate was 3.6% (95% CI 2.3–4.9) with 96 events in the entire cohort: 147 were amputated or died (5.3%, 95% CI 5.2–5.3), and 277 had a MACE (9.5%, 95% CI 9.4–9.5). When compared with patients without kidney disease, ESKD was significantly associated with overall mortality (HR 1.9; 95% CI 1.1–3.5), amputation or death (HR 2.4; 95% CI 1.4–4.1), and MACE (HR 2.0; 95% CI 1.3–3.2). Conclusions: In the current study on mid-term outcomes after invasive revascularisation for symptomatic PAOD, one out of five patients suffered from any CKD while those few with ESKD had twice the odds of death, of amputation or death, and of major adverse cardiovascular events after twelve months. These results emphasise that concomitant CKD and its impact on outcomes should be considered by severity while mild and moderate grades should not lead to ineffectual treatment strategies.

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Section: Methodsmentioning

confidence: 99%

The Impact of Chronic Kidney Disease on Mid-Term Outcomes after Revascularisation of Peripheral Arterial Occlusive Disease: Results from a Prospective Cohort Study

Kotov

Blasche

Peters

et al. 2022

JCM

Self Cite

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“…A total of 18 ethical committees in affected German federal states confirmed the initial approval by the leading ethical committee at the medical association in Hamburg, Germany (PV5691). The European Union (EU) General Data Protection Regulation (GDPR) compliant GermanVasc registry platform was developed to follow the principles of privacy by design while collecting the personal and medical data relevant for the current study [11,15,16]. Results were reported using the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement [17].…”

Section: Methodsmentioning

confidence: 99%

The prospective GermanVasc cohort study

Kotov

Peters

Debus

et al. 2021

Vasa

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Summary: Background: Previous observational studies reported a wide variation and possible room for improvement in the treatment of patients suffering from symptomatic peripheral artery disease (PAD). Yet, systematic assessment of everyday clinical practice is lacking. A General Data Protection Regulation (GDPR) compliant registry was developed and used to collect comprehensive data on clinical treatment and outcomes regarding PAD in Germany. Here, we report baseline characteristics of patients prospectively enrolled until the end of 2020. Methods: The GermanVasc registry study is a prospective longitudinal multicentre cohort study. Between 1st May 2018 and 31st December 2020, invasive endovascular, open-surgical, and hybrid revascularisations of patients suffering from chronic symptomatic PAD were prospectively included after explicit informed consent (NCT03098290). For ensuring high quality of the data, we performed comprehensive risk-based and random-sample external and internal validation. Results: In total, 5608 patients from 31 study centres were included (34% females, median 69 years). On-site monitoring visits were performed at least once in all centres. The proportion of chronic limb-threatening ischaemia was 30% and 13% were emergent admissions. 55% exhibited a previous revascularisation. Endovascular techniques made 69% among all documented invasive procedures (n=6449). Thirty-five percent were classified as patients with severe systemic disease, and 3% exhibited a constant threat to life according to the American Society of Anaesthesiologists classification. The risk profile comprised of 75% former or current smokers, 36% diabetes mellitus, and in 30% a current ischemic heart disease was present. At discharge, 93% of the patients received antiplatelets and 77% received statins. Conclusions: The GermanVasc registry study provides insights into real-world practice of treatment and outcomes of 5,608 patients with symptomatic PAD in Germany. The cohort covers a broader range of disease severity and types of interventions than usually found in trials. In future studies, comparative outcomes will be analysed in more detail.

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“…Fasst man die Entwicklungen der letzten zwei Jahrzehnte zusammen, ergibt sich eine große Chance, aber auch Herausforderung für wissenschaftsorientierte Registerinitiativen: die datenschutzkonforme und privatsphärefreundliche Sammlung von unverzerrten sowie validen Langzeitdaten zur Medizinprodukteevaluation [12][13][14][15]. Dabei sind über die beiden Reformen hinaus weitere Anpassungen des EU-Rechts zu berücksichtigen, die sich teilweise erst in den nächsten Jahren auswirken werden.…”

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