This protocol is designed to conduct surveillance of influenza vaccines during the 2017-2018 influenza season, from October 2017 through May 2018; the last analysis will be performed at the beginning of June with the available data up to that time. Because influenza vaccines are administered during a relatively short period, the Sentinel Operations Center will work with select PRISM Data Partners to access sources of fresher data.
The purpose of this project is to develop an approach to using quantitative bias analysis methods to adaptively determine whether and when medical chart validation can be stopped early within the context of Sentinel assessments.
The newly developed approach will be applied to one or more completed Sentinel assessments in which medical record review for outcome validation was performed to test the empirical and practical performance of the method.
CBER has requested execution of the pregnancy tool to determine the number of pregnant women/episodes with a Tdap vaccination. This a feasibility assessment to determine if Sentinel data can provide enough sample size/power to be used to resolve regulatory concerns, such as the investigation of the impact of Tdap vaccination of pregnant women on the rates of pertussis in children in a full PBA.
This report contains estimates of the number of cases of pertussis among infants under six months of age.
Modular program-based assessment of severe hypoglycemia events following new use of glyburide versus glipizide.
FDA required a pregnancy registry for Actemra (tocilizumab) when it was approved for RA. The sponsor is citing recruitment challenges given the limited use of Actemra in pregnant women.
Modular program-based one-time assessment of incidence rates of angioedema among new users of oral levetiracetam and four other oral anti-epileptic drugs (AEDs).
Project to assess the risk of thromboembolic events after immunoglobulin administration using a self-controlled risk interval design. Potential post intravenous immunoglobulin and thromboembolic event cases were identified in the Sentinel Distributed Database and underwent medical record review.
This workgroup will develop a propensity score matched design compatible with the Bernoulli tree-based scan statistic, and pilot test it using simulated data derived from an empirical example.
This workgroup will test existing infrastructure and internal processes to help ensure a smooth transition from ICD-9-CM to ICD-10-CM codes. In addition, this workgroup will contribute to planning validation activities focused on ICD-10-CM algorithms for a selection of health outcomes.
The objective of this workgroup is to design and implement hybrid empirical/simulated experiments to compare the performance of methods for (1) disease risk score (DRS) development; and (2) incorporating DRSs for multiple outcomes into the analysis to improve inference. The workgroup will evaluate different approaches for developing DRSs and use a novel ‘dry run’ analysis approach to compare multiple analytic methods. Understanding the optimal approaches to DRS development and application in the distributed data and multiple outcome setting is critical for moving forward with DRS analyses in Sentinel.
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) 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.