Publications by authors named "D S Carrell"
The FDA Sentinel Real World Evidence Data Enterprise (RWE-DE).
Pharmacoepidemiol Drug Saf
October 2024
Article Synopsis
- - The FDA's Sentinel Innovation Center created a quality-checked network using electronic health records (EHRs) and insurance claims data from over 10 million individuals to enhance regulatory decision-making with real-world data.
- - The resulting network, called the Real-World Evidence Data Enterprise (RWE-DE), includes data from two commercial sources covering 21 million lives and four academic partners covering 4.5 million lives.
- - The report details data completeness, patient populations, and a process for managing free-text notes, while also highlighting potential use cases for RWE-DE to address broader questions in healthcare regulation.
Article Synopsis
- Post-marketing safety surveillance can be improved by detecting clinical events through spontaneous reporting, but it requires healthcare professionals to be well-informed and aware of the reporting process.
- The study introduces a new method for identifying incidents using unstructured clinical data and natural language processing, validated against traditional methods for two specific health concerns: suicide attempts and sleep-related behaviors.
- Results showed that while the new approach effectively identified suicide attempts with decent precision, it struggled more with sleep-related behaviors; additionally, performance varied by race, highlighting the need for careful monitoring and bias reduction in healthcare AI applications.
Introduction: Rapid identification of individuals developing a psychotic spectrum disorder (PSD) is crucial because untreated psychosis is associated with poor outcomes and decreased treatment response. Lack of recognition of early psychotic symptoms often delays diagnosis, further worsening these outcomes.
Methods: The proposed study is a cross-sectional, retrospective analysis of electronic health record data including clinician documentation and patient-clinician secure messages for patients aged 15-29 years with ≥ 1 primary care encounter between 2017 and 2019 within 2 Kaiser Permanente regions.
Context: Dyslipidemia is common, and resultant endothelial dysfunction may impact reproductive outcomes. No prospective study has examined the effect of preconception lipid parameters in both female and male partners or their interaction on live birth.
Objective: To determine whether live birth is associated with preconception lipids in both partners by planned fertility treatment.