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37788

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Sentinel: Overview and Description of the Common Data Model v7.0: The primary goal ofSentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes. The SCDM Mother-Infant Linkage Table contains one record per MPatID, CPatID, and ADate. This table is created following identification of mothers (via evidence of live delivery by women aged 10-54 inclusive) and infants (via date of birth) in the Sentinel Distributed Database (SDD)

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  1. 25/08/2019 25/08/2019 -
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FDA's Sentinel Initiative

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25 août 2019

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Creative Commons BY-NC-ND 3.0
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    Sentinel Common Data Model

    Anglais

    Mother-Infant Linkage

    1 Formulaires  
    1. StudyEvent: ODM
      1. Mother-Infant Linkage
    Mother-Infant-Linkage
    Description

    Mother-Infant-Linkage

    Mother Patient ID
    Description

    Unique member identifier. Arbitrary person-level identifier. Used to link across tables. Length is DP specific. Must match mom “PatID” value in all other SCDM tables.Blank for child-only records. PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0600091
    Mother Birth Date
    Description

    Mother Birth_Date value from SCDM Demographic table.

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0421451
    Mother Age
    Description

    Mother’s age as of ADate

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0026591
    UMLS CUI [1,2]
    C0001779
    Encounter ID
    Description

    Unique encounter identifier. EncounterID value from SCDM Encounter table, for mother’s delivery encounter.Blank for child-only records. The Encounter, Diagnosis, Procedure, Inpatient Transfusion, Inpatient Pharmacy, Vital Signs, and Mother-Infant Linkage tables are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID. If more than 1 delivery encounter occur on the same ADate, then the values are based on the encounter selected from the following hierarchy: IP > ED > AV > IS > OA

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1512346
    UMLS CUI [1,2]
    C1300638
    Encounter Type
    Description

    Ambulatory Visit = Includes visits at outpatient clinics, same day surgeries, urgent care visits, and other same-day ambulatory hospital encounters, but excludes emergency department encounters. Emergency Department = Includes ED encounters that become inpatient stays (in which case inpatient stays would be a separate encounter). Excludes urgent care visits. ED claims should be pulled before hospitalization claims to ensure that ED with subsequent admission won't be rolled up in the hospital event. Inpatient Hospital Stay = Includes all inpatient stays, same-day hospital discharges, hospital transfers, and acute hospital care where the discharge is after the admission date. Non-Acute Institutional Stay = Includes hospice, skilled nursing facility (SNF), rehab center, nursing home, residential, overnight non-hospital dialysis and other non-hospital stays. Other Ambulatory Visit = Includes other non overnight AV encounters such as hospice visits, home health visits, skilled nursing facility visits, other non-hospital visits, as well as telemedicine, telephone and email consultations.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0545082
    UMLS CUI [1,2]
    C0332307
    Admission Date
    Description

    ADate value from SCDM Encounter table, for mother’s delivery encounter. Blank for child-only records.

    Type de données

    date

    Alias
    UMLS CUI [1]
    C1302393
    Delivery Date
    Description

    DDate value from SCDM Encounter table, for mother’s delivery encounter. Blank for child-only records.

    Type de données

    date

    Alias
    UMLS CUI [1]
    C2053594
    Child Patient ID
    Description

    Unique member identifier. Arbitrary person-level identifier. Used to link across tables. Length is DP specific. Must match child “PatID” value in all other SCDM tables.

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C0600091
    Child Birth Date
    Description

    Child Birth_Date value from SCDM Demographic table. Blank for mother/delivery-only records.

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C0421451
    Sex
    Description

    Child Sex value from SCDM Demographic table.Blank for mother/delivery-only records.

    Type de données

    text

    Alias
    UMLS CUI [1]
    C0079399
    Child Enrollment Start
    Description

    Earliest Enr_Start from Enrollment table. Blank for mother/delivery-only records.

    Type de données

    date

    Alias
    UMLS CUI [1,1]
    C0008059
    UMLS CUI [1,2]
    C1516879
    UMLS CUI [1,3]
    C0439659
    Birth Type
    Description

    Based upon ICD-9-CM/ICD-10-CM codes in the health plan data for the delivery admission. Blank for child-only records.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0005615
    UMLS CUI [1,2]
    C0332307
    Birth Type Primes
    Description

    Multiplication of all prime numbers assigned to all Birth_Types found in delivery codes within the selected encounter. This provides a record of all values of Birth_Type for the selected encounter. Missing/null for child-only records.

    Type de données

    integer

    Alias
    UMLS CUI [1,1]
    C0005615
    UMLS CUI [1,2]
    C0332307
    UMLS CUI [1,3]
    C0805701
    Match Method
    Description

    Prioritized method of linkage for mom-baby match, or reason for unlinked record.For linked records, prioritize so that only one method is listed:RE > SI > LA > BC > OT. For cases where a mother/delivery is not linked to a child OR a child is not linked to a mother/delivery, the value of this variable should be one of N1, N2, N3, or NA only

    Type de données

    text

    Alias
    UMLS CUI [1,1]
    C1708943
    UMLS CUI [1,2]
    C0025663
    Retour au début de la page

    Similar models

    Mother-Infant Linkage

    1 Formulaires
    1. StudyEvent: ODM
      1. Mother-Infant Linkage
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    Mother-Infant-Linkage
    MPatID
    Item
    Mother Patient ID
    text
    C0026591 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    MBirth_Date
    Item
    Mother Birth Date
    date
    C0026591 (UMLS CUI [1,1])
    C0421451 (UMLS CUI [1,2])
    Age
    Item
    Mother Age
    integer
    C0026591 (UMLS CUI [1,1])
    C0001779 (UMLS CUI [1,2])
    EncounterID
    Item
    Encounter ID
    text
    C1512346 (UMLS CUI [1,1])
    C1300638 (UMLS CUI [1,2])
    Item
    Encounter Type
    text
    C0545082 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Encounter Type
    Code List
    Encounter Type
    CL Item
    Ambulatory Visit (AV)
    CL Item
    Emergency Department (ED)
    CL Item
    Inpatient Hospital Stay (IP)
    CL Item
    Non-Acute Institutional Stay (IS)
    CL Item
    Other Ambulatory Visit (OA)
    ADate
    Item
    Admission Date
    date
    C1302393 (UMLS CUI [1])
    DDate
    Item
    Delivery Date
    date
    C2053594 (UMLS CUI [1])
    CPatID
    Item
    Child Patient ID
    text
    C0008059 (UMLS CUI [1,1])
    C0600091 (UMLS CUI [1,2])
    CBirth_Date
    Item
    Child Birth Date
    date
    C0008059 (UMLS CUI [1,1])
    C0421451 (UMLS CUI [1,2])
    Item
    Sex
    text
    C0079399 (UMLS CUI [1])
    Sex
    Code List
    Sex
    CL Item
    Ambiguous (e.g., transgender/hermaphrodite) (A)
    CL Item
    Female (F)
    CL Item
    Male (M)
    CL Item
    Unknown (U)
    CEnr_Start
    Item
    Child Enrollment Start
    date
    C0008059 (UMLS CUI [1,1])
    C1516879 (UMLS CUI [1,2])
    C0439659 (UMLS CUI [1,3])
    Item
    Birth Type
    integer
    C0005615 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    Birth Type
    Code List
    Birth Type
    CL Item
    Unspecified # of live births (0)
    CL Item
    1 live birth (1)
    CL Item
    2 live births (2)
    CL Item
    3 live births (3)
    CL Item
    4 live births (4)
    CL Item
    5 live births (5)
    CL Item
    Multiple live births, unspecified number (8)
    CL Item
    Conflicting code(s) for number of live births (9)
    Item
    Birth Type Primes
    integer
    C0005615 (UMLS CUI [1,1])
    C0332307 (UMLS CUI [1,2])
    C0805701 (UMLS CUI [1,3])
    Birth Type Primes
    Code List
    Birth Type Primes
    CL Item
    Birth Type of 0 (2)
    CL Item
    Birth Type of 1 (3)
    CL Item
    Birth Type of 2 (5)
    CL Item
    Birth Type of 3 (7)
    CL Item
    Birth Type of 4 (11)
    CL Item
    Birth Type of 5 (13)
    CL Item
    Birth Type of 8 (17)
    Item
    Match Method
    text
    C1708943 (UMLS CUI [1,1])
    C0025663 (UMLS CUI [1,2])
    Match Method
    Code List
    Match Method
    CL Item
    Birth Certificate (BC)
    CL Item
    DP maintained birth registry (RE)
    CL Item
    health plan subscriber or family number (SI)
    CL Item
    exact or probabilistic last name and address match based upon health plan administrative data (LA)
    CL Item
    other (OT)
    CL Item
    No subscriber/family IDs available for linkage (N1)
    CL Item
    No name/address available for linkage (N2)
    CL Item
    Neither subscriber/family IDs nor name/address available for linkage (N3)
    CL Item
    no linkage made; any other reason (NA)
    Retour au début de la page 

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