The evaluation of real-world data (RWD) enables insights to be gained from a wide range of patient data collected in routine clinical practice. In addition, multicenter analyses represent a broad and representative patient population and have the potential to capture the actual treatment situation. As a basis for this, the definition of datasets and an infrastructure for data exchange is necessary.
View Article and Find Full Text PDFIntroduction: In German and international research networks different approaches concerning patient consent are applied. So far it is time-consuming to find out to what extent data from these networks can be used for a specific research project. To make the contents of the consents queryable, we aimed for a permission-based approach (Opt-In) that can map both the permission and the withdrawal of consent contents as well as make it queryable beyond project boundaries.
View Article and Find Full Text PDFStud Health Technol Inform
May 2023
Availability and accessibility are important preconditions for using real-world patient data across organizations. To facilitate and enable the analysis of data collected at a large number of independent healthcare providers, syntactic- and semantic uniformity need to be achieved and verified. With this paper, we present a data transfer process implemented using the Data Sharing Framework to ensure only valid and pseudonymized data is transferred to a central research repository and feedback on success or failure is provided.
View Article and Find Full Text PDFBackground: The Federal Ministry of Education and Research of Germany (BMBF) funds a network of university medicines (NUM) to support COVID-19 and pandemic research at national level. The "COVID-19 Data Exchange Platform" (CODEX) as part of NUM establishes a harmonised infrastructure that supports research use of COVID-19 datasets. The broad consent (BC) of the Medical Informatics Initiative (MII) is agreed by all German federal states and forms the legal base for data processing.
View Article and Find Full Text PDFStud Health Technol Inform
May 2022
COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing approaches are inevitable. Though organizational clinical data are abundant, many of them are available only in isolated silos and largely inaccessible to external researchers.
View Article and Find Full Text PDFBackground: 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 aspects of clinical trials.
View Article and Find Full Text PDFBackground: The identity management is a central component in medical research. Patients are recruited from various sites, which requires an error tolerant record linkage method, to ensure that patients are registered only once. In large research projects or institutions, the identity management has to deal with several thousands or millions of patients.
View Article and Find Full Text PDFObjective: The age of modern microsurgery has made resection of glomus tumors with extensive skull base involvement possible. Resection of extensive lesions is not without risk of major complication or new cranial nerve deficit. Because glomus tumors are rare and slow growing, data reflecting recurrence risk after resection using modern skull base techniques are lacking.
View Article and Find Full Text PDFObjective: To evaluate intradural drilling as a mechanism for the development of postoperative headache after retrosigmoid craniectomy.
Study Design: A retrospective review of charts was performed on 565 retrosigmoid approaches to the cerebellopontine angle performed between January 1980 and January 1998. Patients treated with retrosigmoid vestibular nerve section without intradural drilling were compared with patients who underwent retrosigmoid removal of vestibular schwannomas in which intradural drilling was performed for exposure of the internal auditory canal.
Objective: To review the occurrence characteristics of and clinical repair experience with brain herniation in to the middle ear and mastoid from 1970-1995.
Study Design: Retrospective chart/case review.
Setting: Private Otology/Neurotology referral practice.
Intracranial extension (ICE) is the spread of tumor into the subarachnoid space through dura or along cranial nerve roots. The single-stage removal of the skull base tumor with its ICE has been confounded by cerebrospinal fluid management and defect reconstruction. The purpose of this report is to review a current protocol for managing the cranial base tumor and its ICE as a unit.
View Article and Find Full Text PDF