Contemp Clin Trials Commun
December 2024
Background: eSource software that transfers patient electronic health record data into a clinical trial electronic case report form holds promise for increasing data quality while reducing data collection, monitoring and source document verification costs. Integrating eSource into multicenter clinical trial start-up procedures could facilitate the use of eSource technologies in clinical trials.
Methods: We conducted a qualitative integrative analysis to identify eSource site start-up key steps, challenges that might occur in executing those steps, and potential solutions to those challenges.
Observational health research often relies on accurate and complete race and ethnicity (RE) patient information, such as characterizing cohorts, assessing quality/performance metrics of hospitals and health systems, and identifying health disparities. While the electronic health record contains structured data such as accessible patient-level RE data, it is often missing, inaccurate, or lacking granular details. Natural language processing models can be trained to identify RE in clinical text which can supplement missing RE data in clinical data repositories.
View Article and Find Full Text PDFIdiopathic Intracranial Hypertension (IIH) is a condition in which patients have elevated intracranial pressure which does not have an apparent cause. To diagnose IIH, evaluation excluding other causes of elevated pressure must be performed. This typically includes magnetic resonance imaging (MRI) of the brain and venous sinuses.
View Article and Find Full Text PDFBackground: Prophylactic total gastrectomy (PTG) is performed in carriers of CDH1 pathogenic and likely pathogenic (P/LP) variants and is becoming more frequent with broader use of germline genetic testing. There is an unmet need to standardize care and enhance outcomes among patients undergoing surgery for the prevention of gastric cancer.
Methods: This was a retrospective analysis of 150 individuals with germline CDH1 P/LP variants who underwent PTG as part of a prospective natural history study from October 2017 to May 2023.