Romina Blasini
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View article: Building a Research Infrastructure with REDCap and FHIR
Building a Research Infrastructure with REDCap and FHIR Open
At the university hospital of Giessen since 2018 a research infrastructure has been implemented as part of the German Medical Informatics Initiative. A central FHIR repository acts as the core part of this architecture where clinical data …
View article: Transforming Data from a Commercial Hospital Information System into FHIR
Transforming Data from a Commercial Hospital Information System into FHIR Open
The expanded use of hospital information systems in recent decades offers possibilities to use data collected in the clinical routine not only for individual patient care, but also for medical research. For this purpose, it is important us…
View article: Design and Implementation of a FHIR-Based Data Infrastructure from Hospital Information Systems to the German Emergency Department Data Admission Registry AKTIN
Design and Implementation of a FHIR-Based Data Infrastructure from Hospital Information Systems to the German Emergency Department Data Admission Registry AKTIN Open
In the course of this research, we discerned the potential for the secondary utilization of medical data within the context of the German national emergency department data registry AKTIN. We identified all obligatory data to participate w…
View article: Measuring the State of Information Security and Data Protection in Healthcare Web Applications
Measuring the State of Information Security and Data Protection in Healthcare Web Applications Open
The digitalization of healthcare requires robust information security and data protection measures. This work outlines a methodology for assessing these aspects using the Technical Guideline TR-03161-2 from the German Federal Office for In…
View article: User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals
User Requirements for an Electronic Patient Recruitment System: Semistructured Interview Analysis After First Implementation in 3 German University Hospitals Open
Background Clinical trials are essential for medical research and medical progress. Nevertheless, trials often fail to reach their recruitment goals. Patient recruitment systems aim to support clinical trials by providing an automated sear…
View article: recruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM)
recruIT: A cloud-native clinical trial recruitment support system based on Health Level 7 Fast Healthcare Interoperability Resources (HL7 FHIR) and the Observational Medical Outcomes Partnership Common Data Model (OMOP CDM) Open
We contribute a novel, open-source implementation to support the patient recruitment process in clinical trials that can be deployed using state-of-the art technologies. According to the SUS score, the system provides good usability.
View article: Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals
Effectiveness of IT-supported patient recruitment: study protocol for an interrupted time series study at ten German university hospitals Open
Background As part of the German Medical Informatics Initiative, the MIRACUM project establishes data integration centers across ten German university hospitals. The embedded MIRACUM Use Case “Alerting in Care - IT Support for Patient Recr…
View article: Implementation of inclusion and exclusion criteria in clinical studies in OHDSI ATLAS software
Implementation of inclusion and exclusion criteria in clinical studies in OHDSI ATLAS software Open
Clinical trials are essential parts of a medical study process, but studies are often cancelled due to a lack of participants. Clinical Trial Recruitment Support Systems are systems that help to increase the number of participants by seeki…
View article: Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis
Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis Open
Background Clinical trials (CTs) are crucial for medical research; however, they frequently fall short of the requisite number of participants who meet all eligibility criteria (EC). A clinical trial recruitment support system (CTRSS) is d…
View article: Implementation of inclusion and exclusion criteria of clinical studies in the software OHDSI ATLAS
Implementation of inclusion and exclusion criteria of clinical studies in the software OHDSI ATLAS Open
Background Clinical trials are an essential part of the medical research process, but trials are often canceled due to lack of enrollment. Clinical trial recruitment support systems can help increase the number of participants by finding m…
View article: Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis (Preprint)
Evaluation of Eligibility Criteria Relevance for the Purpose of IT-Supported Trial Recruitment: Descriptive Quantitative Analysis (Preprint) Open
BACKGROUND Clinical trials (CTs) are crucial for medical research; however, they frequently fall short of the requisite number of participants who meet all eligibility criteria (EC). A clinical trial recruitment support system (CTRSS) is …
View article: RD-MON – Building a Rare Disease Monitor to Enhance Awareness for Patients with Rare Diseases in Intensive Care
RD-MON – Building a Rare Disease Monitor to Enhance Awareness for Patients with Rare Diseases in Intensive Care Open
Rare diseases are commonly defined by an incidence of less than 5/10000 inhabitants. There are some 8000 different rare diseases known. So even if a single rare disease is seldom, together they pose a relevant problem for diagnosis and tre…
View article: recruIT: A Cloud-Native Clinical Trial Recruitment Support System based on HL7 FHIR and the OMOP CDM - Design and Implementation Study (Preprint)
recruIT: A Cloud-Native Clinical Trial Recruitment Support System based on HL7 FHIR and the OMOP CDM - Design and Implementation Study (Preprint) Open
BACKGROUND Randomized clinical trials (RCTs) are foundational to the advancement of evidence-based medicine and recruiting a sufficient number of participants is one of the crucial steps to their successful conduct. Yet, poor recruitment …
View article: Building a Comprehensive Clinical Data Repository Using FHIR, LOINC and SNOMED
Building a Comprehensive Clinical Data Repository Using FHIR, LOINC and SNOMED Open
In 2018 the University Hospital of Giessen (UHG) moved its hospital information system from an in-house solution to commercial software. The introduction of MEONA and Synedra-AIM allowed for the successful migration of clinical documents. …
View article: Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals
Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals Open
Background Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challenging…
View article: Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals (Preprint)
Patient Recruitment System for Clinical Trials: Mixed Methods Study About Requirements at Ten University Hospitals (Preprint) Open
BACKGROUND Clinical trials are the gold standard for advancing medical knowledge and improving patient outcomes. For their success, an appropriately sized cohort is required. However, patient recruitment remains one of the most challengin…
View article: A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative
A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative Open
View article: Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study
Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study Open
Background Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-con…
View article: Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study (Preprint)
Prototypical Clinical Trial Registry Based on Fast Healthcare Interoperability Resources (FHIR): Design and Implementation Study (Preprint) Open
BACKGROUND Clinical trial registries increase transparency in medical research by making information and results of planned, ongoing, and completed studies publicly available. However, the registration of clinical trials remains a time-co…
View article: Design for a Modular Clinical Trial Recruitment Support System Based on FHIR and OMOP
Design for a Modular Clinical Trial Recruitment Support System Based on FHIR and OMOP Open
The MIRACUM consortium is developing a Clinical Trials Recruitment Support System to support the data-driven recruitment of patients for clinical trials. The design of the prototype includes both open source solutions (OMOP CDM, Atlas) and…