Sentinel Initiative

  • Description:

    Public Sentinel Training at FDA 

    The 2019 Sentinel Public Training, Day 2 of the Eleventh Annual Sentinel Initiative Public Workshop will be held on April 4, 2019. The Training will focus on enabling expanded use of Sentinel tools among the public and will consist of a series of presentations and exercises on the Cohort Identification and Descriptive Analysis (CIDA) tool.

    In addition to the on-site registration options, organizers will be webcasting the joint morning session and the Applications in Medical Product Safety afternoon session. For those unable to attend on-site, please register to attend via webinar, and the link with be sent to you with your registration confirmation.

    Published Date:
    Tue, 03/19/2019
  • Description:

    This request examines utilization patterns of nine obesity drugs in the Sentinel Distributed Database (SDD) between January 1, 2008 and December 31, 2017.

    Published Date:
    Tue, 03/19/2019
  • Description:

    The U.S. Food and Drug Administration's Sentinel Initiative “modular programs” have been shown to replicate findings from conventional protocol‐driven, custom‐programmed studies. One such parallel assessment—dabigatran and warfarin and selected outcomes—produced concordant findings for three of four study outcomes. The effect estimates and confidence intervals for the fourth—acute myocardial infarction—had more variability as compared with other outcomes. This paper evaluates the potential sources of that variability that led to unexpected divergence in findings.

    Published Date:
    Wed, 03/06/2019
  • Description:

    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 5.0.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository. 

    Published Date:
    Mon, 03/04/2019
  • Description:

    The purpose of this report was to compare the frequency of diagnoses for intracranial hemorrhage in the inpatient care setting 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. 

    Published Date:
    Fri, 03/01/2019
  • Description:

    The purpose of this report was to compare the frequency of diagnoses for intracranial hemorrhage in any care setting 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.

    Published Date:
    Fri, 03/01/2019
  • Description:

    This purpose of this report was to compare the frequency of diagnoses for gestational diabetes mellitus 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.

    Published Date:
    Fri, 03/01/2019
  • Description:

    The purpose of this report was to compare the frequency of diagnoses for lower limb amputation 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. 

    Published Date:
    Fri, 03/01/2019
  • Description:

    Sentinel Initiative Public Workshop

    The Eleventh Annual Sentinel Initiative Public Workshop will be held on Wednesday, April 3, 2019. Convened by the Duke-Margolis Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this annual workshop serves as a forum to bring together leading experts and interested stakeholders to discuss the ongoing development of the Sentinel Initiative.

    Public Sentinel Training at FDA 

    The 2019 Sentinel Public Training, Day 2 of the Eleventh Annual Sentinel Initiative Public Workshop will be held on April 4, 2019. The Training will focus on enabling expanded use of Sentinel tools among the public and will consist of a series of presentations and exercises on the Cohort Identification and Descriptive Analysis (CIDA) tool.

    International Regulator’s Forum

    The U.S. Food and Drug Administration (FDA) will be hosting a forum on April 5, 2019 on the Sentinel System for other regulatory agencies immediately following the two-day Sentinel Annual Meeting. This is a forum designed for staff from regulatory agencies worldwide: it is a meeting by regulators, for fellow regulators. 

    Published Date:
    Fri, 02/01/2019
  • Description:

    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). 

    Published Date:
    Mon, 03/11/2019
  • Description:

    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.

    Published Date:
    Wed, 10/31/2018
  • Description:

    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. 

    Published Date:
    Wed, 04/25/2018