Sentinel Initiative

In this report, we investigated counts of cutaneous small vessel vasculitis (CSVV) diagnoses in patients without prior autoimmune disease who had prior direct-acting oral anticoagulant (DOAC) exposure or diagnosis of atrial fibrillation. We additionally evaluated counts of acute kidney injury (AKI) diagnoses among patients with prior DOAC exposure in the Sentinel Distributed Database (SDD).

Transfusion-related acute lung injury (TRALI) is an adverse event, broadly defined as the onset of respiratory distress during or within 6 hours of blood transfusion and is a leading cause of transfusion-associated fatalities reported to the U.S. Food and Drug Administration (FDA).This project focused on data exploration and assessed the feasibility of utilizing Sentinel inpatient EMR data to capture exposure to blood components and TRALI.

Using Brilinta and Brintellix as a proof‐of‐concept feasibility use case, we assessed whether drug name confusion errors between the pair could be identified in electronic health care data via the combination of a claims‐based algorithm and limited manual claims data review.

This study identified higher rates of gadolinium-based contrast agent (GBCA) exposure during the first few weeks of pregnancy compared with the later weeks of pregnancy, suggesting inadvertent exposure to GBCAs might occur before pregnancy is recognized.

This analysis compares the rate of four neuropsychiatric events (inpatient depressive disorder, outpatient depressive disorder, self-harm, and suicide) and describes all-cause mortality in patients with asthma and without chronic obstructive pulmonary disorder (COPD) dispensed montelukast compared to patients dispensed inhaled corticosteroids (ICS).

The authors validated an algorithm to detect frequency errors in computerized healthcare data and estimated the incidence of these errors in an integrated healthcare system.

This analysis consists of two reports. Report 1 estimates background rates of higher dosage strength opioid analgesic users in the Sentinel Distributed Database (SDD). Report 2 calculates summary statistics on length of treatment episode among users of higher dosage strength opioid analgesics in the SDD.

Sentinel routine querying tools are SAS programs designed to run against the Sentinel Common Data Model (SCDM). They allow rapid implementation of standard queries across the Sentinel Distributed Database (SDD). The programs can be customized using various input parameters that define medical product exposures, outcomes, covariates, diagnoses, date ranges, age ranges, and other implementation details. Tools can perform simple cohort characterization and descriptive analyses, but may also be used to perform more complex adjustment for confounding and support prospective surveillance activities. 

The Cohort Identification and Descriptive Analysis (CIDA) program is the foundation of the routine querying system. CIDA is responsible for identifying, extracting, and characterizing cohorts of interest from the SDD based on the specification of a number of requester-defined options (e.g., continuous enrollment requirements, incidence criteria, inclusion/exclusion criteria). 

The Sentinel Data Quality Review and Characterization Programs are used by the Sentinel Operations Center (SOC) for data quality review and characterization of the Sentinel Distributed Database (SDD). To create the SDD, each Data Partner transformed local source data into the Sentinel Common Data Model (SCDM) format. The SOC created a set of data quality review and characterization programs to ensure that the SDD meets reasonable standards for data transformation consistency and quality and that the SDD data meets expectations needed for a distributed health data network.

The documentation, appendices, and SAS programs associated with version 5.0.1 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository. 

The Sentinel Operations Center (SOC) coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data.

Changes in this release from v6.0.2 to v7.0.0 include a new Mother-Infant Linkage table and are listed in the “History of Modifications” tab of the SCDM v7.0.0 document.