Sentinel Initiative

  • Description:

    This request has two components. Part 1 (cder_mpl2r_wp008) includes a replication of a protocol-based assessment (PBA) of an investigation on acute myocardial infarction (AMI) and heart failure following saxagliptin or sitagliptin use in comparison to long-acting insulin, pioglitazone, and second-generation sulfonylureas in the Sentinel Distributed Database (SDD). Part 2 (cder_mpl2r_wp011) includes an analysis with data that were unavailable at the time of the PBA and accounted for present-day drugs and analysis tool capabilities.

    Published Date:
    Wed, 09/16/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    This analysis investigates the risk of stroke, gastrointestinal bleeding, and intracranial hemorrhage for patients with non-valvular atrial fibrillation treated with apixaban compared to warfarin in the Sentinel Distributed Database.

    The study period included data from December 28, 2012 to June 30, 2018. We distributed this request to 8 Data Partners on January 22, 2019. This request includes two reports:

    • Report 1: In this report, analyses were restricted to Data Partners 1-7 of 8.
    • Report 2: In this report, analyses were restricted to Data Partner 8 of 8.
    Published Date:
    Wed, 09/16/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The objective of this request was to estimate the number of new users of methotrexate and the number of dispensings that had potential errors in dosing frequency in the Sentinel Distributed Database (SDD). We included data from January 1, 2010 to May 30, 2015 from 17 Data Partners contributing to the SDD in this request. This request was distributed on September 19, 2018.

    Published Date:
    Wed, 09/16/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The goal of this request was to identify and count percutaneous transluminal septal myocardial ablation (PTSMA) procedures, and estimate incidence rates of post-PTSMA cardiovascular outcomes in the Sentinel Distributed Database (SDD). Only aggregate level data was returned. Two runs of the program were required.

    Published Date:
    Wed, 09/16/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    This analysis investigates the risk of severe uterine bleed for patients treated with Novel Oral Anticoagulants (NOACs) (including Rivaroxaban, Dabigatran, Apixaban), and Warfarin in the Sentinel Distributed Database. This request includes two reports:

    • Report 1: This request was distributed to Data Partners on October 11, 2017.
    • Report 2: This analysis is an update to the previous request, including new indication covariates, redefined age groups, and revisions to the propensity score stratification analysis. This request was distributed to Data Partners on December 30, 2019.
    Published Date:
    Wed, 09/16/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    In this report we compared risk of stroke, intracranial hemorrhage, and bleeding outcomes associated
    with use of dabigatran, rivaroxaban, and apixaban in those aged 65 years or older in the Sentinel Distributed Database (SDD).

    Published Date:
    Tue, 09/15/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The purpose of this request was to calculate the number of treated patients and time to treatment among patients exposed to either non‐vitamin K antagonist oral anticoagulants (NOACs), warfarin, or allopurinol who had a prior diagnosis of atrial fibrillation in the Sentinel Distributed Database (SDD). The outcomes of interest were cutaneous small‐vessel vasculitis (CSVV) followed by a treatment of prednisone or prednisolone or steroid medication within 90 days.

    Published Date:
    Tue, 09/15/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    We use simulated data to examine the consequences of depletion of susceptibles for hazard ratio (HR) estimators based on a propensity score (PS).

    Published Date:
    Tue, 09/15/2020
    Category:
    Publications and Presentations
  • Description:

    This project supports FDA’s COVID-19 response through: 

    1. Adding COVID-19 laboratory results data to the Sentinel Common Data Model for routine querying in the Active Risk Identification and Analysis (ARIA) system
    2. Developing access to the “freshest feasible” rapid COVID-19 data from Sentinel data partners in the distributed data network 
    Published Date:
    Mon, 09/14/2020
    Category:
    Ongoing Projects
  • Description:

    This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Vincent Lo Re from the University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes updates to the specific aims previously presented on the June 5, 2020 and July 15, 2020 meetings such as the evaluation of arterial and venous thrombotic events separately and study outcomes considerations.

    Published Date:
    Fri, 09/11/2020
    Category:
    Publications and Presentations
  • Description:

    This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Jeffrey Brown from Sentinel Operations Center. It addresses the issue of a lack of standard metrics for describing data across systems and the utilization of data quality management (DQM) as a potential solution. 

    Published Date:
    Fri, 09/11/2020
    Category:
    Publications and Presentations
  • Description:

    This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Vincent Lo Re from the University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes updates to the study design previously presented on the June 5, 2020 meeting such as priority data sources, inclusions and exclusions within the cohort, and planned data elements.

    Published Date:
    Fri, 09/11/2020
    Category:
    Publications and Presentations
  • Description:

    This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Vincent Lo Re from the University of Pennsylvania on behalf of the FDA Sentinel COVID-19 Coagulopathy workgroup. It includes the potential aims and methodology for “Descriptive Assessment of Coagulopathy Among COVID-19 Patients in the Inpatient Setting: A Sentinel Feasibility Study,” with a focus on thrombotic complications such as venous and arterial thromboses.

    Published Date:
    Thu, 09/10/2020
    Category:
    Publications and Presentations
  • Description:

    This presentation was given at the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Diagnostics Evidence Accelerator Parallel Analysis meeting by Noelle Cocoros, Judith C. Maro, and Jeff Brown from Sentinel Operations Center. The presentation includes both “Defining COVID-19 cohorts in real-world data” and “Data Type Considerations in Data Networks”. 

    Published Date:
    Thu, 09/10/2020
    Category:
    Publications and Presentations
  • Description:

    Registration is now open for the 2020 Sentinel Public Training, which will be held virtually on Monday, November 2, 2020 at 9:00 AM ET.

    Published Date:
    Mon, 11/02/2020
    Category:
    Sentinel Initiative Events
  • Description:

    In this request we assessed the use patterns of ranitidine and a comparator agent, famotidine, within the Sentinel Distributed Database (SDD).

    Published Date:
    Thu, 09/03/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    In this report we estimated intravenous (IV) iron utilization among women with live-birth delivery, stillbirth, or pre-eclampsia/eclampsia event in the Sentinel Distributed Database (SDD).

    Published Date:
    Wed, 09/02/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    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. 

    The Sentinel Operations Center posted this final draft protocol for public comment from June 19, 2020 through July 6, 2020. The public comment period is now closed. A revised version was approved for implementation by FDA on August 17, 2020. A log of changes is included in the revised protocol (v2).

    Published Date:
    Tue, 09/01/2020
    Category:
    Ongoing Projects
  • 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) 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).

    Published Date:
    Tue, 09/01/2020
    Category:
    Data and Tools
  • Description:

    In this analysis we estimated start of pregnancy using in-vitro fertilization (IVF), intrauterine insemination (IUI), and select prenatal tests among pregnancies resulting in a live-born delivery in the Sentinel Distributed Database (SDD). This request includes two reports.

    Published Date:
    Mon, 08/31/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    Sacubitril/valsartan (SV), an angiotensin-receptor-neprilysin inhibitor (ARNI) and angiotensin-receptor blocker (ARB), was approved on July 7, 2015 for the treatment of patients with New York Heart Association (NYHA) class II–IV heart failure (HF) with reduced ejection fraction (HFrEF). The pivotal trial for new drug approval concluded early because of overwhelming benefts and reported a 20% reduction in death from cardiovascular causes or HF hospitalization compared with enalapril. In 2016, the American College of Cardiology/American Heart Association (ACC/AHA) Task Force on clinical practice guidelines recommended that angiotensin-converting enzyme inhibitors (ACEIs) or ARBs be replaced with an ARNI for patients with chronic symptomatic NYHA class II or III HFrEF to further reduce morbidity or mortality. We examined SV use, duration, and patterns of switching from existing treatments to understand its uptake in the real world.

    Published Date:
    Mon, 08/31/2020
    Category:
    Publications and Presentations
  • Description:

    These reports examined the availability of International Normalized Ratio (INR) laboratory test values and INR test procedures among new warfarin users in the Mini-Sentinel Distributed Database (MSDD).

    The study period included data from January 1, 2008 to December 31, 2014. We distributed the request to 11 Data Partners contributing to the MSDD on March 10, 2015.

    Published Date:
    Thu, 08/27/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    Prospective sequential surveillance of medical products is a core component of FDA’s Active Risk Identification and Analysis System (ARIA). However, FDA has had limited experience using these sequential tools and their capabilities have evolved quickly over time. To prepare for implementing sequential analyses, Sentinel will conduct a “live” pilot test of the new sequential surveillance modes associated with sequential propensity score matched (PSM) analyses using a “known positive” association that has already been studied in a protocol-based assessment. 

    Published Date:
    Wed, 08/26/2020
    Category:
    Final Results and Reports
  • Description:

    In this analysis we examined counts of new users of sacubitril/valsartan, angiotensin-converting enzyme (ACE) inhibitors, and other angiotensin II receptor blockers (ARBs) with heart failure in the Sentinel Distributed Database (SDD). We also captured switching between products.

    This analysis include two reports containing data from 16 Data Partners contributing to the SDD. Data from January 1, 2015 to July 31, 2019 were included in Report 1, which was distributed on December 6, 2019. Data from January 1, 2015 to July 31, 2019 were included in Report 2, which was distributed on February 27, 2020.

    Published Date:
    Wed, 08/26/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    In this report we examined the number of individuals with reduced ejection fraction heart failure (HFrEF) or preserved ejection fraction heart failure (HFpEF) in the Sentinel Distributed Database (SDD) and described the utilization of spironolactone among these individuals.

    Published Date:
    Wed, 08/26/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The objective of this request was to investigated severe uterine bleeding (SUB) among new users of oral anticoagulants (rivaroxaban, apixaban, dabigatran, and warfarin) in the Sentinel Distributed Database (SDD). We included new users between October 19, 2010 and September 30, 2015 from 17 Data Partners contributing to the Sentinel Distributed Database (SDD) in this report. This request was distributed on September 17, 2019.

    Published Date:
    Mon, 09/14/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    IMPACT-AFib was an 80,000-patient randomized clinical trial implemented by five US insurance companies (health plans) aimed at increasing the use of oral anticoagulants by individuals with atrial fibrillation who were at high risk of stroke and not on treatment. The underlying thesis was that patients could be change agents to initiate prescribing discussions with their providers. We tested the effect of mailing information to both patients and their providers. We used administrative medical claims and pharmacy dispensing data to identify eligible patients, to randomize them to an early or delayed intervention, and to assess clinical outcomes.

    Published Date:
    Tue, 08/18/2020
    Category:
    Publications and Presentations
  • Description:

    The purpose of this international descriptive study is to examine changes in ARB utilization suspected to have resulted from the July 2018 recall of N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) contaminated angiotensin receptor blockers (ARBs) initiated by FDA and international regulatory agencies. The project seeks to query several data sources using the Sentinel Common Data Model (SCDM). The FDA will conduct US based analyses in their Sentinel System.  The international participants will conduct the same analyses in their data sources which include: United Kingdom (Clinical Practice Research Datalink (CPRD)), Canada (Canadian Network for Observational Drug Effect Studies (CNODES)), Denmark (Danish National Prescription Database (DNPR)).  

    Published Date:
    Tue, 08/18/2020
    Category:
    Ongoing Projects
  • Description:

    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.

    Published Date:
    Mon, 08/17/2020
    Category:
    Data and Tools
  • Description:

    There have been conflicting results from observational studies regarding the risk of psychiatric adverse events (PAEs) with montelukast use. The objective of this study was to determine if there are associations of depressive disorders, self-harm and suicide with use of montelukast compared to inhaled corticosteroid (ICS) use.

    Published Date:
    Mon, 08/17/2020
    Category:
    Publications and Presentations
  • Description:

    In this analysis we examined ocular events and nasal septal perforations in single and repeat mometasone sinus implant users with nasal polyposis in the Sentinel Distributed Database (SDD).

    These reports contain data from 16 Data Partners contributing to the SDD. Data from January 1, 2016 to April 30, 2019 were included in Report 1; Data from January 1, 2016 to September 30, 2019 were included in Reports 2 and 3.

    Published Date:
    Wed, 08/05/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The Sentinel Innovation Center seeks to leverage machine learning approaches to efficiently identify health outcomes. Computable phenotypes developed from electronic health record data could improve efficiency within the Sentinel System. A scalable approach to computable phenotyping requires that algorithms are transportable across different health care systems. This webinar will describe efforts to evaluating and ensuring transportability of computable phenotypes across multiple sites.

    This webinar is scheduled on Monday, August 24, 2020 from 2:00-3:00 PM ET.

    Published Date:
    Mon, 08/03/2020
    Category:
    Sentinel Initiative Events
  • Description:

    The proposed goal of this project is to pilot, via two use cases, the ability to more routinely and broadly understand how FDA might conduct “on-demand quality assurance” for selected vital signs and laboratory results in a within cohort fashion. The first use case will evaluate a cohort of pediatric patients with hypertension. The second use case will evaluate a cohort of new adult users of SGLT-2 inhibitors.

    Vital signs and laboratory measures will be evaluated for each use case. Measures will include blood pressure as well as smoking use/status, height, and weight. Laboratory tests will include Hemoglobin A1c and creatinine.

    A final report will be prepared with the results from the two use cases. Additionally, a comparison of the identification using a claims-only phenotype versus a clinical data (e.g., electronic health record based) phenotype will be conducted.

    Published Date:
    Thu, 07/30/2020
    Category:
    Ongoing Projects
  • Description:

    This analysis executed the Cohort Identification and Descriptive Analysis (CIDA) Pregnancy Episodes tool to assess risk of congenital cardiac malformations following armodafinil or modafinil use during the first trimester of pregnancy in the Sentinel Distributed Database (SDD). The Level 2 analytic package for this analysis is now publicly available in the Sentinel Git repository.

    Published Date:
    Thu, 07/30/2020
    Category:
    Data and Tools
  • Description:

    Many studies showing underuse of oral anticoagulants (OACs) in patients with atrial fibrillation (AF) predated the advent of the non-vitamin K antagonist OACs. We retrospectively examined use of OACs in a large commercially insured population.

    Published Date:
    Mon, 07/27/2020
    Category:
    Publications and Presentations
  • Description:

    Current causal inference approaches implemented in the Sentinel System include methods based on propensity scores for control of confounding. Targeted Learning, which incorporates machine learning (ML) methods for causal inference, has been proposed as an alternative and potentially better approach.

    The goal of this project is to evaluate the potential use of Targeted Learning methods within the Sentinel System compared to existing approaches. 

    Published Date:
    Fri, 07/24/2020
    Category:
    Ongoing Projects
  • Description:

    This activity encompasses two aims that are using inpatient electronic health record data from HCA Healthcare:

    Aim 1: The objective for Aim 1 is to describe the natural history of disease among hospitalized COVID-19 patients as identified based on diagnosis codes and/or laboratory results. This project will describe patients’ clinical characteristics, healthcare utilization, disease progression, and outcomes.  Queries will be updated periodically to understand trends in the disease course and patient care over time.

    Aim 2: The objective for Aim 2 is to establish the capacity to monitor critical drugs used in the care of hospitalized COVID-19 patients, and to sequentially monitor utilization through repeated data updates.

    Published Date:
    Thu, 07/23/2020
    Category:
    Ongoing Projects
  • Description:

    In this request, we estimated rates of hypertension in a pediatric population within the Sentinel Distributed Database (SDD). 

    The study period included data from January 1, 2008 to April 30, 2019. We distributed the request to 15 Data Partners on September 26, 2019.

    Published Date:
    Thu, 07/23/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The Sentinel Innovation Center webinar series features presentations by leading experts and innovators on topics relevant to the Innovation Center’s master plan. 

    Published Date:
    Wed, 07/29/2020
    Category:
    Sentinel Initiative Events
  • Description:

    The Sentinel Operations Center posted this final draft protocol for public comment from June 19, 2020 through July 6, 2020. Any revisions done to this protocol following the public comment period will be noted in the change log document included in the amended protocol. Posting of the revised document will be listed on the Sentinel homepage, on the relevant assessments project details page, and in the Sentinel RSS feed.

    Published Date:
    Fri, 06/19/2020
    Category:
    Study Protocols and Surveillance Plans
  • Description:

    This presentation, Hydrochlorothiazide Use and Risk of Non-Melanoma Skin Cancer, was delivered at the Department of Biostatistics, Epidemiology, and Informatics, Perelman School of Medicine, University of Pennsylvania.

    Published Date:
    Tue, 06/16/2020
    Category:
    Publications and Presentations
  • Description:

    The purpose of this project is to describe the natural history of coagulopathy among COVID-19 patients in the inpatient setting. Activities will include development of a study synopsis for a descriptive study of coagulopathy among hospitalized COVID-19 patients, as well as assessment of feasibility of study implementation within inpatient settings. SOC is partnering with leading infectious disease and hematology specialists on this activity.

    Published Date:
    Wed, 06/17/2020
    Category:
    Spotlight
  • Description:

    A distributed data network approach combined with distributed regression analysis (DRA) can reduce the risk of disclosing sensitive individual and institutional information in multicenter studies. However, software that facilitates large-scale and efficient implementation of DRA is limited. This study aimed to assess the precision and operational performance of a DRA application comprising a SAS-based DRA package and a file transfer workflow developed within the open-source distributed networking software PopMedNet in a horizontally partitioned distributed data network.

    Published Date:
    Wed, 06/10/2020
    Category:
    Publications and Presentations
  • Description:

    The purpose of this project is to design and implement a system that enables rapid querying of electronic health record (EHR) data to support FDA's COVID-19 response. The project will partner with TriNetX to provide access to the TriNetX querying platform and TriNetX Live™ data network. On average 85% of the 60 U.S. healthcare organizations (HCOs) in the TriNetX Live™ data network refresh their data every two-to-four weeks.

    Published Date:
    Fri, 06/05/2020
    Category:
    Ongoing Projects
  • Description:

    The COVID-19 Natural History Master Protocol effort involves the development of a protocol designed to identify multiple COVID-19 cohorts to support a variety of on-demand queries and subsequent inferential studies. The protocol will be adaptable to various data sources with clinically rich data and will include specific populations of interest, such as the pediatric population, pregnant women, and other vulnerable populations identified by FDA.

    Published Date:
    Thu, 06/04/2020
    Category:
    Ongoing Projects
  • Description:

    The FDA is interested in identifying other International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes in the patient episode profile retrieval (PEPR) claims profiles from the Stillbirth Validation project and evaluate whether they can inform further refinement of the algorithm used in that project.

    Published Date:
    Wed, 06/03/2020
    Category:
    Ongoing Projects
  • Description:

    This activity supports investigators of COVID-19 related drug trials that need a digital platform for patient informed consent when face to face contact is not possible or practical. The COVID MyStudies application allows for secure and remote electronic consent. The end product is a signed consent form emailed to the patient or legally authorized representative and a copy which the investigator can access in a secure and compliant manner through the platform. The investigator can print the form or transfer an electronic copy into another electronic system. Under the FDA-Catalyst program, the Sentinel Operations Center will coordinate the branding and administration of this application.

    Published Date:
    Mon, 06/01/2020
    Category:
    Spotlight
  • Description:

    The goal of this project is to conduct algorithm validation using diagnosis codes to identify potential hospitalized COVID-19 cases and validate the algorithm(s) using laboratory test results.

    Published Date:
    Mon, 06/01/2020
    Category:
    Ongoing Projects
  • Description:

    This presentation was delivered to the Reagan-Udall Foundation by representatives from the FDA, TriNetX, and Sentinel Operations Center. 

    Published Date:
    Tue, 05/26/2020
    Category:
    Publications and Presentations
  • Description:

    FDA’s Sentinel System is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic, ranging from monitoring the use of drugs, describing the course of illness among hospitalized patients, and evaluating the treatment impact of therapies actively being used under real-world conditions. Descriptions of efforts led by the Center for Drug Evaluation and Research are detailed in the link below.

    Published Date:
    Thu, 07/23/2020
    Category:
    Spotlight
  • 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 6.2.0 of the Sentinel Data Quality Review and Characterization Programs can be found externally in Sentinel's Git Repository. 

    Published Date:
    Fri, 04/03/2020
    Category:
    Data and Tools
  • Description:

    This presentation was delivered at the Use of Real World Data / Evidence to Inform Regulatory Decision Making Workshop hosted by the Canadian Society for Pharmaceutical Sciences. It was delivered during a session on Data Sources and Data Quality – Meeting the Bar for “Fit for Purpose” in Regulatory Decision Making.

    Published Date:
    Fri, 02/28/2020
    Category:
    Publications and Presentations
  • Description:

    This presentation was delivered at the Canadian Mother-Child Cohort (CAMCCO) Active Surveillance 1st Team and Stakeholders Symposium. Topics covered include an overview of the Sentinel system and routine querying tools, an introduction to Cohort Identification and Analysis (CIDA), and the steps involved in conducting pregnancy analyses.

    Published Date:
    Mon, 02/24/2020
    Category:
    Publications and Presentations
  • Description:

    This report presents counts of individuals with medical and drug coverage and number of days covered in the Sentinel Distributed Database (SDD). Results were generated using the Sentinel Distributed Query Tool from 2012-2018. The query was distributed on January 2, 2019 and includes data from 17 Data Partners.

    Published Date:
    Wed, 02/19/2020
    Category:
    Modular Programs and Summary Tables
  • Description:

    The CHA2DS2‐VaSc and HAS‐BLED risk scores are commonly used in the studies of oral anticoagulants (OACs). The best ways to map these scores to the International Classification of Diseases, 10th Revision, Clinical Modification (ICD‐10‐CM) codes is unclear, as is how they perform in various types of OAC users. We aimed to assess the distributions of CHA2DS2‐VaSc and HAS‐BLED scores and C‐statistics for outcome prediction in the ICD‐10‐CM era using different mapping strategies.

    Published Date:
    Tue, 02/18/2020
    Category:
    Publications and Presentations
  • Description:

    Evidence on the risk of febrile seizures after inactivated influenza vaccine (IIV) and 13-valent pneumococcal conjugate vaccine (PCV13) is mixed. In the FDA-sponsored Sentinel Initiative, we examined risk of febrile seizures after IIV and PCV13 in children 6-23 months of age during the 2013-14 and 2014-15 influenza seasons.

    Published Date:
    Thu, 02/13/2020
    Category:
    Publications and Presentations
  • 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, 03/27/2019
    Category:
    Data and Tools
  • Description:

    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.

    Published Date:
    Wed, 01/30/2019
    Category:
    Data and Tools
  • 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
    Category:
    Data and Tools
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