- Vaccines, Blood & Biologics
- Devices and Radiologic Health
The goals of this request were to 1) estimate the rate of multiple sclerosis (MS) relapses among Copaxone, Glatopa, Gilenya, and glatiramer users and 2) compare MS relapse algorithms in the Sentinel Distributed Database (SDD). Data from September 21, 2010 to January 31, 2018 from 17 Data Partners contributing to the SDD were included in this report.
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).
The goal of this request was to investigate the occurrence of non-melanoma skin cancer (NMSC) diagnoses among incident users of thiazide diuretics or comparator drugs of interest and to observe follow-up time after incident drug dispensing 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.
The 35th International Conference on Pharmacoepidemiology & Therapeutic Risk Management (ICPE) took place August 24-28, 2019, in Philadelphia, PA where a variety of Sentinel-related work was featured, including presentations, posters, and more.
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.
The purpose of these reports was to compare the frequency of diagnoses for several selected health outcomes using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) versus International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. These health outcomes include atrial fibrillation, deep vein thrombosis, gastrointestinal hemorrhage, intracranial hemorrhage, ischemic stroke, mitral stenosis, and pulmonary embolism.
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.
The goal of this request was to estimate the number of prevalent users and dispensings of angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs) among pediatric populations in the Sentinel Distributed Database (SDD).
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 Sentinel Query Builder is a web application which allows users to visualize, draft, and create medical product utilization queries with a user-friendly interface from a set of pre-defined parameters and convert them into Sentinel query request packages. The Sentinel Query Builder application can now be downloaded onto users' computers.
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.
The goal of this request was to estimate the number of incident users of Qsymia (combination product of phentermine and topiramate), phentermine, topiramate, and concomitant phentermine and topiramate in the Sentinel Distributed Database (SDD).
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.
This analysis investigates whether children with centralized precocious puberty (CPP) who are exposed to Lupron Depot-PED are at higher risk for fractures compared to children who are unexposed to Lupron Depot-PED in the Sentinel Distributed Database. The Level 2 analytic package for this analysis is now publicly available in the Sentinel Git repository.
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 Operations Center (SOC) has transformed the Medicare Claims Synthetic Public Use Files (SynPUFs) into the Sentinel Common Data Model (SCDM) format as part of an ongoing effort to make Sentinel resources available to external investigators, with the goal of creating a community of investigators who can understand, utilize, and contribute to the Sentinel enterprise.
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 and IBM Watson Health have partnered to make SAS® code available for transforming the IBM MarketScan® Commercial and Medicare Supplemental Databases into the Sentinel Common Data Model.
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.
The goal of this request was to explore the association between sinus stent implants with mometasone and subsequent development of diminished visual acuity in the Sentinel Distributed Database (SDD). This request contains two reports: