Background: Paradoxical reactions (PRs) are defined as the occurrence during biologic therapy of a pathological condition that usually responds to these drugs.
Objectives: To estimate the incidence of PRs and identify risk factors.
Methods: Multicentre study of the database for the Greater Paris University Hospitals, including biologic-naive patients receiving anti-tumour necrosis factor-α, anti-interleukin-12/23, anti-interleukin-17 or anti-α4β7-integrin agents for psoriasis, inflammatory rheumatism or inflammatory bowel disease (IBD).
Stud Health Technol Inform
May 2022
Information systems used by platform trials should handle changes that are not predefined. Unfortunately, the technical architecture of most existing clinical data management systems (CDMS) do not support changes to be incorporated into an ongoing trial. Adaptive clinical trials need advanced architectural solutions setup to enable biomarker stratification and enrichment strategy necessary for the adaptive clinical trial operation.
View Article and Find Full Text PDFStud Health Technol Inform
May 2022
Unlabelled: Sharing observational and interventional health data within a common data space enables university hospitals to leverage such data for biomedical discovery and moving towards a learning health system.
Objective: To describe the AP-HP Health Data Space (AHDS) and the IT services supporting piloting, research, innovation and patient care.
Methods: Built on three pillars - governance and ethics, technology and valorization - the AHDS and its major component, the Clinical Data Warehouse (CDW) have been developed since 2015.
We leveraged the largely untapped resource of electronic health record data to address critical clinical and epidemiological questions about Coronavirus Disease 2019 (COVID-19). To do this, we formed an international consortium (4CE) of 96 hospitals across five countries (www.covidclinical.
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