Die COVID-19 Pandemie als Herausforderung und Chance für
                    Register in der Versorgungsforschung: Erfahrungen aus Lean European Open Survey
                    on SARS-CoV-2 Infected Patients (LEOSS)

Pilgram, Lisa; Schons, Maximilian; Jakob, Carolin E. M.; Claßen, Annika Y.; Franke, Bernd; Tscharntke, Lene; Schulze, Nick; Fuhrmann, Sandra; Sauer, Gabriel; Miranda, Susana M. Nunes de; Praßer, Fabian; Stecher, Melanie; Vehreschild, Jörg Janne

doi:10.1055/a-1655-8705

Cited by 14 publications

(8 citation statements)

References 23 publications

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“…Patients with IRD and SARS-CoV-2 infection were included in the ongoing IRD registry by their rheumatologists ( 13 ). The LEOSS cohort includes cases of SARS-CoV-2 infections in the general German population ( 14 ). Here data were entered by treating physicians, study nurses and other medical staff.…”

Section: Methodsmentioning

confidence: 99%

The protective effect of tumor necrosis factor-alpha inhibitors in COVID-19 in patients with inflammatory rheumatic diseases compared to the general population—A comparison of two German registries

Hasseli,

Hanses,

Stecher

et al. 2024

Front. Med.

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ObjectivesTo investigate, whether inflammatory rheumatic diseases (IRD) inpatients are at higher risk to develop a severe course of SARS-CoV-2 infections compared to the general population, data from the German COVID-19 registry for IRD patients and data from the Lean European Survey on SARS-CoV-2 (LEOSS) infected patients covering inpatients from the general population with SARS-CoV-2 infections were compared.Methods4310 (LEOSS registry) and 1139 cases (IRD registry) were collected in general. Data were matched for age and gender. From both registries, 732 matched inpatients (LEOSS registry: n = 366 and IRD registry: n = 366) were included for analyses in total.ResultsRegarding the COVID-19 associated lethality, no significant difference between both registries was observed. Age > 65°years, chronic obstructive pulmonary disease, diabetes mellitus, rheumatoid arthritis, spondyloarthritis and the use of rituximab were associated with more severe courses of COVID-19. Female gender and the use of tumor necrosis factor-alpha inhibitors (TNF-I) were associated with a better outcome of COVID-19.ConclusionInflammatory rheumatic diseases (IRD) patients have the same risk factors for severe COVID-19 regarding comorbidities compared to the general population without any immune-mediated disease or immunomodulation. The use of rituximab was associated with an increased risk for severe COVID-19. On the other hand, the use of TNF-I was associated with less severe COVID-19 compared to the general population, which might indicate a protective effect of TNF-I against severe COVID-19 disease.

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Section: Methodsmentioning

confidence: 99%

The protective effect of tumor necrosis factor-alpha inhibitors in COVID-19 in patients with inflammatory rheumatic diseases compared to the general population—A comparison of two German registries

Hasseli,

Hanses,

Stecher

et al. 2024

Front. Med.

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“…Next, a semiquantitative risk assessment was performed by studying the variables' availability (variables likely to be known to adversaries), replicability (variables that occur repeatedly in relationship to the individual), and distinguishability (variables that make, alone or in combination, individuals unique) [40]. This method has been successfully applied for several real-world data sets [41][42][43]. The scoring system was adapted to our real-world application according to literature and expert knowledge.…”

Section: Threat Modelmentioning

confidence: 99%

The Costs of Anonymization: Case Study Using Clinical Data

Pilgram,

Meurers,

Malin

et al. 2024

J Med Internet Res

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Background Sharing data from clinical studies can accelerate scientific progress, improve transparency, and increase the potential for innovation and collaboration. However, privacy concerns remain a barrier to data sharing. Certain concerns, such as reidentification risk, can be addressed through the application of anonymization algorithms, whereby data are altered so that it is no longer reasonably related to a person. Yet, such alterations have the potential to influence the data set’s statistical properties, such that the privacy-utility trade-off must be considered. This has been studied in theory, but evidence based on real-world individual-level clinical data is rare, and anonymization has not broadly been adopted in clinical practice. Objective The goal of this study is to contribute to a better understanding of anonymization in the real world by comprehensively evaluating the privacy-utility trade-off of differently anonymized data using data and scientific results from the German Chronic Kidney Disease (GCKD) study. Methods The GCKD data set extracted for this study consists of 5217 records and 70 variables. A 2-step procedure was followed to determine which variables constituted reidentification risks. To capture a large portion of the risk-utility space, we decided on risk thresholds ranging from 0.02 to 1. The data were then transformed via generalization and suppression, and the anonymization process was varied using a generic and a use case–specific configuration. To assess the utility of the anonymized GCKD data, general-purpose metrics (ie, data granularity and entropy), as well as use case–specific metrics (ie, reproducibility), were applied. Reproducibility was assessed by measuring the overlap of the 95% CI lengths between anonymized and original results. Results Reproducibility measured by 95% CI overlap was higher than utility obtained from general-purpose metrics. For example, granularity varied between 68.2% and 87.6%, and entropy varied between 25.5% and 46.2%, whereas the average 95% CI overlap was above 90% for all risk thresholds applied. A nonoverlapping 95% CI was detected in 6 estimates across all analyses, but the overwhelming majority of estimates exhibited an overlap over 50%. The use case–specific configuration outperformed the generic one in terms of actual utility (ie, reproducibility) at the same level of privacy. Conclusions Our results illustrate the challenges that anonymization faces when aiming to support multiple likely and possibly competing uses, while use case–specific anonymization can provide greater utility. This aspect should be taken into account when evaluating the associated costs of anonymized data and attempting to maintain sufficiently high levels of privacy for anonymized data. Trial Registration German Clinical Trials Register DRKS00003971; https://drks.de/search/en/trial/DRKS00003971 International Registered Report Identifier (IRRID) RR2-10.1093/ndt/gfr456

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“…Medizinische Registerdaten sind für eine optimale Patientenversorgung und wissenschaftliche Arbeit unverzichtbar 1 2 . Das deutsche Transplantationsregister (TxR) wurde daher als Meilenstein in der nationalen Entwicklung der Transplantationsmedizin bezeichnet 3 .…”

Section: Introductionunclassified

Das Deutsche Transplantationsregister – eine Analyse der Altdaten 2006–2016

Otto,

Budde,

Bara

et al. 2024

Gesundheitswesen

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Zusammenfassung Einleitung 2018 wurden transplantationsmedizinische Daten, die bei drei Institutionen vorliegen, zusammengeführt, um ein deutsches Transplantationsregister zu schaffen. Seit Juni 2021 besteht Zugriff auf Daten des Registers. Um Sonderregelungen der Organallokation mit Regelallokation bei Herz-, Leber-, Lungen- und Nierentransplantation zu vergleichen sollten die Registerdaten analysiert werden. Unser Vorgehen führte zu einer Qualitätsanalyse des Registers. Methoden Auf Antrag wurden Altdaten des Registers bereitgestellt. Die Daten sind in 61 Elemente gegliedert. Hieraus muss der Nutzer den benötigten Datensatz zusammenstellen. Es erfolgten Prüfungen auf Vollständigkeit, korrekte Zuordenbarkeit der Angaben und Übereinstimmung bei unterschiedlicher Datenherkunft. Hierzu wurden die Datensoftwares R, SQL und Excel verwendet. Ergebnisse Die Ausgangselemente (Elemente „Warteliste“) der 4 Transplantationsarten enthalten Daten von insgesamt 80.259 ursprünglich gelisteten Patienten. Diese Patienten sind in anderen Elementen nur unvollständig vorhanden, so dass sich für die Wartezeit nur in 23, 30, 50 und 96% sowie für den Verlauf nach Transplantation in 14, 11, 38 und 13% (Herz-, Leber-, Lungen- und Nierentransplantation) ein vollständiger Datensatz zusammenstellen lässt. Die Verknüpfung von Dringlichkeitsangaben mit klinischen Angaben gelingt nur bei einem geringen Anteil, 6% bei der Herztransplantation. Es finden sich regelwidrige und damit undenkbare Zuordnungen bei Allokations-Sonderregelungen, was nur durch falsche Einträge im Register erklärt werden kann. Daten unterschiedlicher Datenlieferanden sind widersprüchlich. Diskussion Unvollständigkeit und fehlerhafte Datenzuordnung stellen wissenschaftliche Studien anhand des Transplantationsregisters in Frage. Die komplexe Struktur behindert zudem die Zusammenstellung eines verlässlichen Datensatzes und ist international unüblich. Neudaten ab 2017 stehen erst seit Dezember 2023 zur Verfügung. Schlussfolgerung Das Transplantationsregister sollte dringend neu strukturiert werden. Fachkompetentes klinisches Datenmanagement, Einbeziehung transplantationsmedizinischer Expertise sowie kontinuierliche Qualitätskontrollen sind dabei essentiell.

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Die COVID-19 Pandemie als Herausforderung und Chance für Register in der Versorgungsforschung: Erfahrungen aus Lean European Open Survey on SARS-CoV-2 Infected Patients (LEOSS)

Cited by 14 publications

References 23 publications

The protective effect of tumor necrosis factor-alpha inhibitors in COVID-19 in patients with inflammatory rheumatic diseases compared to the general population—A comparison of two German registries

The protective effect of tumor necrosis factor-alpha inhibitors in COVID-19 in patients with inflammatory rheumatic diseases compared to the general population—A comparison of two German registries

The Costs of Anonymization: Case Study Using Clinical Data

Das Deutsche Transplantationsregister – eine Analyse der Altdaten 2006–2016

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