ID

37788

Beschreibung

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)

Stichworte

Versionen (1)
  1. 25.08.19 25.08.19 -
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FDA's Sentinel Initiative

Hochgeladen am

25. August 2019

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Sentinel Common Data Model

Englisch

Mother-Infant Linkage

1 Formulare  
  1. StudyEvent: ODM
    1. Mother-Infant Linkage
Mother-Infant-Linkage
Beschreibung

Mother-Infant-Linkage

Mother Patient ID
Beschreibung

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.

Datentyp

text

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

Mother Birth_Date value from SCDM Demographic table.

Datentyp

date

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

Mother’s age as of ADate

Datentyp

integer

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

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

Datentyp

text

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

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.

Datentyp

text

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

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

Datentyp

date

Alias
UMLS CUI [1]
C1302393
Delivery Date
Beschreibung

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

Datentyp

date

Alias
UMLS CUI [1]
C2053594
Child Patient ID
Beschreibung

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.

Datentyp

text

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

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

Datentyp

date

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

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

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Child Enrollment Start
Beschreibung

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

Datentyp

date

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

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

Datentyp

integer

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

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.

Datentyp

integer

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

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

Datentyp

text

Alias
UMLS CUI [1,1]
C1708943
UMLS CUI [1,2]
C0025663
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Ähnliche Modelle

Mother-Infant Linkage

1 Formulare
  1. StudyEvent: ODM
    1. Mother-Infant Linkage
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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)
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