Prospective study validating a multidimensional treatment decision score predicting the 24-month outcome in untreated patients with clinically isolated syndrome and early relapsing-remitting multiple sclerosis, the ProVal-MS study.

Introduction: In Multiple Sclerosis (MS), patients´ characteristics and (bio)markers that reliably predict the individual disease prognosis at disease onset are lacking. Cohort studies allow a close follow-up of MS histories and a thorough phenotyping of patients. Therefore, a multicenter cohort study was initiated to implement a wide spectrum of data and (bio)markers in newly diagnosed patients.

Retrospective cohort study to devise a treatment decision score predicting adverse 24-month radiological activity in early multiple sclerosis.

Background: Multiple sclerosis (MS) is a chronic neuroinflammatory disease affecting about 2.8 million people worldwide. Disease course after the most common diagnoses of relapsing-remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS) is highly variable and cannot be reliably predicted.

Towards Harmonized Data Quality in the Medical Informatics Initiative - Current State and Future Directions.

Health data from hospital information systems are valuable sources for medical research but have known issues in terms of data quality. In a nationwide data integration project in Germany, health care data from all participating university hospitals are being pooled and refined in local centers. As there is currently no overarching agreement on how to deal with errors and implausibilities, meetings were held to discuss the current status and the need to develop consensual measures at the organizational and technical levels.

Enabling Agile Clinical and Translational Data Warehousing: Platform Development and Evaluation.

Background: Modern data-driven medical research provides new insights into the development and course of diseases and enables novel methods of clinical decision support. Clinical and translational data warehouses, such as Informatics for Integrating Biology and the Bedside (i2b2) and tranSMART, are important infrastructure components that provide users with unified access to the large heterogeneous data sets needed to realize this and support use cases such as cohort selection, hypothesis generation, and ad hoc data analysis.

Objective: Often, different warehousing platforms are needed to support different use cases and different types of data.

A comprehensive tool for creating and evaluating privacy-preserving biomedical prediction models.

Background: Modern data driven medical research promises to provide new insights into the development and course of disease and to enable novel methods of clinical decision support. To realize this, machine learning models can be trained to make predictions from clinical, paraclinical and biomolecular data. In this process, privacy protection and regulatory requirements need careful consideration, as the resulting models may leak sensitive personal information.

Protecting Biomedical Data Against Attribute Disclosure.

Modern medical research requires access to patient-level data of significant detail and volume. In this context, privacy concerns and legal requirements demand careful consideration. Data anonymization, which means that data is transformed to reduce privacy risks, is an important building block of data protection concepts.

Privacy-enhancing ETL-processes for biomedical data.

Background: Modern data-driven approaches to medical research require patient-level information at comprehensive depth and breadth. To create the required big datasets, information from disparate sources can be integrated into clinical and translational warehouses. This is typically implemented with Extract, Transform, Load (ETL) processes, which access, harmonize and upload data into the analytics platform.

A Scalable and Pragmatic Method for the Safe Sharing of High-Quality Health Data.

The sharing of sensitive personal health data is an important aspect of biomedical research. Methods of data de-identification are often used in this process to trade the granularity of data off against privacy risks. However, traditional approaches, such as HIPAA safe harbor or -anonymization, often fail to provide data with sufficient quality.

Orchestrating differential data access for translational research: a pilot implementation.

Background: Translational researchers need robust IT solutions to access a range of data types, varying from public data sets to pseudonymised patient information with restricted access, provided on a case by case basis. The reason for this complication is that managing access policies to sensitive human data must consider issues of data confidentiality, identifiability, extent of consent, and data usage agreements. All these ethical, social and legal aspects must be incorporated into a differential management of restricted access to sensitive data.