- Vaccines, Blood & Biologics
- Devices and Radiologic Health
In these reports, we present incident and prevalent use of sodium-glucose cotransporter-2 (SGLT-2) inhibitors and obesity drugs dispensed in the Sentinel Distributed Database (SDD).
In 2012, a U.S. Institute of Medicine report called for a different approach to health care: “Left unchanged, health care will continue to underperform; cause unnecessary harm; and strain national, state, and family budgets.” The answer, they suggested, would be a “continuously learning” health system. Ethicists and researchers urged the creation of “learning health organizations” that would integrate knowledge from patient‐care data to continuously improve the quality of care. Our experience with an ongoing research study on atrial fibrillation—a trial known as IMPACT‐AFib—gave us some insight into one of the challenges that will have to be dealt with in creating these organizations. Although the proposed educational intervention study placed no restrictions on what providers and health plans could do, the oversight team argued that the ethical principle of beneficence did not allow the researchers to be “bystanders” in relation to a control group receiving suboptimal care. In response, the researchers designed a “workaround” that allowed the project to go forward. We believe the experience suggests that what we call “bystander ethics” will create challenges for the kinds of quality improvement research that LHOs are designed to do.
Healthcare databases are very useful sources of post-marketing real-world information, generating evidence on drug use, safety and effectiveness, particularly in populations where such information may be lacking in pre-clinical studies, such as paediatric and geriatric populations. However, healthcare databases can also provide pre-marketing information by measuring the burden of disease, identifying unmet clinical needs and estimating the number of patients potentially eligible for innovative and costly treatment. Whether in a pre- or post-marketing setting, these data sources can provide regulatory agencies with evidence that can inform the development/implementation of regulatory interventions and answer questions of high, and often urgent, public health interest. In April 2019, the Italian Drug Agency (Agenzia Italiana del Farmaco) organised a workshop on the role of healthcare databases in supporting drug regulatory agencies in their pre- and post-marketing regulatory activities. The experiences of the USA, Canada, Spain and Italy in this context were presented.
Our objective was to estimate use of hydroxyprogesterone caproate and progesterone during the second or third trimesters among pregnancies that ended with a live-birth delivery in the Sentinel Distributed Database (SDD). We identified live-birth deliveries occurring between January 1, 2008 to April 30, 2019. We distributed this request on August 5, 2019 to 15 Data Partners contributing to the SDD.
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 6.0.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository.
This study was designed to estimate real-world off-label use of sodium–glucose cotransporter 2 (SGLT2) inhibitors in patients with type 1 diabetes, estimate rates of diabetic ketoacidosis (DKA), and compare them with DKA rates observed in sotagliflozin clinical trials. This study identified initiators of SGLT2 inhibitors in the Sentinel system from March 2013 to June 2018, determined the prevalence of type 1 diabetes using a narrow and a broad definition, and measured rates of DKA using administrative claims data. Standardized incidence ratios (SIRs) were calculated using age- and sex-specific follow-up time in Sentinel and age- and sex-specific DKA rates from sotagliflozin trials 309, 310, and 312.
Sentinel has created the Sentinel CMS DataMart, containing 100% Medicare FFS administrative claims data housed in the Center for Medicare and Medicaid Services' CMS Virtual Research Data Center (VRDC). Duke University Department of Population Health Sciences (DPHS) serves as the Sentinel Data Partner in accessing the source data in the VRDC, transforming it into a Sentinel Common Data Model (SCDM) compliant database, executing queries, and returning results to the Sentinel Operations Center (SOC). There are three components made available to the public: (1) Program Specifications; (2) Code pack; and (3) User Guide.
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).
In this request, we identified individuals with asthma and without chronic obstructive pulmonary disease (COPD) who were dispensed either montelukast or inhaled corticosteroids (ICS) in the Sentinel Distributed Database (SDD), and examined the association between montelukast versus ICS use and neuropsychiatric events. Data between January 1, 2000 to September 30, 2015 from 17 Data Partners contributing to the SDD were included in this report.
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.
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.
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.
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.
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 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.