- Vaccines, Blood & Biologics
- Devices and Radiologic Health
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 6.1.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository.
The goals of this methods project are to evaluate the performance of TreeScan to assess maternal and infant outcomes, test signal identification methods in a pregnancy setting, and evaluate methods performance using older drugs with relatively well-characterized safety profiles. A Propensity Score-Based TreeScan approach will be the primary analysis for this project.
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The goal of this query was to examine utilization of metoclopramide among female members without evidence of liveborn delivery with type 2 diabetes. We also examined female members without evidence of liveborn delivery with a combination of type 2 diabetes and diabetic gastroparesis in the Sentinel Distributed Database (SDD). Data from January 1, 2008 - September 30, 2015 from 17 Data Partners who contributed to the SDD were included in this report. This request was distributed on May 24, 2018.
The purpose of this request was to characterize hydroxyurea use among members with sickle cell anemia (SCA). Data from January 1, 2000 to September 30, 2015 from 17 Data Partners contributing to the Sentinel Distributed Database (SDD) were included in these reports. This request was distributed on February 28, 2018. This request contains two reports.
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) module 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).
FDA’s Sentinel System was used to characterize the epidemiology of respiratory syncytial virus-associated illness (RSV-AI) in U.S. children between 1 month and 5 years of age from January 2008 through June 2016. Greater than 80% of cases were managed as outpatients and >50% of hospitalized children, including those requiring intensive care, had no traditional risk factors besides young chronologic age.
As the prevalence of diabetes mellitus increases in the population, the exposure to antidiabetic drugs (ADDs) during pregnancies is expected to grow, as has been seen over the last decade. The objective of this study was to estimate the prevalence of ADD use during pregnancy among women in the Mini-Sentinel Distributed Database (MSDD) who delivered a liveborn infant. We identified qualifying livebirth pregnancies among women aged 10 to 54 years in the MSDD from 2001 to 2013. ADD use was estimated using outpatient pharmacy dispensing claims and days-supplied among three cohorts: all livebirth pregnancies, pregnancies among women with pre-existing diabetes, and pregnancies among women without prior ADD use.
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 adult-onset Still's disease, alveolar proteinosis, interstitial lung disease, macrophage activation syndrome, non-Hodgkin's lymphoma, pulmonary arterial hypertension, and systemic juvenile idiopathic arthritis.
The purpose of this request was to estimate the number of pediatric patients with respiratory syncytial virus (RSV) and RSV-related events and related preventative services in the Sentinel Distributed Database (SDD).
Epidemiological study reporting is improving but is not transparent enough for easy evaluation or replication. One barrier is insufficient details about design elements in published studies. Using a previously conducted drug safety evaluation in claims as a test case, we investigated the impact of small changes in five key design elements on risk estimation. These elements are index day of incident exposure's determination of look-back or follow-up periods, exposure duration algorithms, heparin exposure exclusion, propensity score model variables, and Cox proportional hazard model stratification. We covaried these elements using a fractional factorial design, resulting in 24 risk estimates for one outcome. We repeated eight of these combinations for two additional outcomes. We measured design effects on cohort sizes, follow-up time, and risk estimates.
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).
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 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.
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.