ID

19621

Beschrijving

Sentinel: Overview and Description of the Common Data Model v6.0 "The primary goal of the Sentinel pilot 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." Sentinel Collaborating Institutions maintain data resources and provide technical, scientific, and methodological expertise as needed to meet the public health surveillance requirements of Sentinel. The Collaborating Institutions also participate as members of the Planning Board, the Safety Science Committee, the Sentinel Operations Center (SOC), and various Sentinel workgroups. Sentinel Common Data Model "The SOC Data Core 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. The SOC Scientific Systems Division manages creation of the Sentinel Distributed Database (SDD) using the SCDM, and maintains complete documentation of the implementation and characteristics of the SDD. The SDD refers to the data held and maintained by the Data Partners in the SCDM format. The SCDM was developed in accordance with the SCDM Guiding Principles and was modeled after the HMO Research Network Virtual Data Warehouse. The SCDM currently includes 13 tables that represent information for the data elements needed for Sentinel activities. Records are linked across tables by a unique person identifier, PatID. Details of the 13 tables are provided in this document. An additional 13 Summary Tables are created from the ""parent tables"" and are also described in this document. Revisions and enhancements to the SCDM are expected, including the addition of clinical information, incorporation of other data types and sources, and revisions based on lessons learned from use of the SDD. This may include adopting variables and formats developed by other programs." This data model is freely available to all. For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org

Link

www.sentinelsystem.org

Trefwoorden

Versies (4)
  1. 16-01-17 16-01-17 -
  2. 29-01-17 29-01-17 -
  3. 25-08-19 25-08-19 -
  4. 25-08-19 25-08-19 -
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16 januari 2017

DOI

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

Engels

Sentinel Common Data Model Vital Signs

1 Formulieren  
Vital signs
Beschrijving

Vital signs

Alias
UMLS CUI-1
C0518766
Unique member identifier
Beschrijving

Arbitrary person-level identifier. Used to link across tables. Note: 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.

Datatype

text

Alias
UMLS CUI [1]
C2348585
Unique encounter identifier
Beschrijving

A unique combination of PatID, ADate, Provider and EncType. Used to link the Encounter, Diagnosis, Procedure, Inpatient Pharmacy, Inpatient Transfusion, and Vital Signs tables. Note: The Encounter, Diagnosis, Procedure, Inpatient Transfusion, Inpatient Pharmacy, and Vital Signs tables are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID.

Datatype

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1300638
Vital signs date
Beschrijving

Date the vital signs were measured. Note: The Encounter, Diagnosis, Procedure, Inpatient Transfusion, Inpatient Pharmacy, and Vital Signs tables are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID.

Datatype

date

Alias
UMLS CUI [1]
C2826644
Vital signs time
Beschrijving

Time associated with the vital signs record. This may be the time an actual blood pressure measurement was taken or it may be a check-in time from encounter.

Datatype

time

Alias
UMLS CUI [1]
C2826762
Height
Beschrijving

If HT can be represented in inches. Only populated

Datatype

float

Maateenheden
  • inches
Alias
UMLS CUI [1]
C0005890
inches
Weight
Beschrijving

If WT can be represented in pounds. Only populated if weight was taken on this date. If missing, leave blank.

Datatype

float

Maateenheden
  • lbs
Alias
UMLS CUI [1]
C0005910
lbs
Diastolic blood pressure
Beschrijving

If Diastolic can be represented in mmHg. Only populated if diastolic blood pressure was taken on this date. If missing, leave blank.

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0428883
mmHg
Systolic blood pressure
Beschrijving

If Systolic can be represented in mmHg. Only populated if systolic blood pressure was taken on this date. If missing, leave blank.

Datatype

float

Maateenheden
  • mmHg
Alias
UMLS CUI [1]
C0871470
mmHg
Blood Pressure Method
Beschrijving

Type of blood pressure taken.

Datatype

integer

Alias
UMLS CUI [1]
C0489446
Blood Pressure Position
Beschrijving

Position for orthostatic blood pressure. If unknown, leave blank.

Datatype

integer

Alias
UMLS CUI [1]
C1828063
Tobacco use
Beschrijving

Tobacco status as of the visit date. Unknown values should be left blank. The "Not asked" value should be used only when it is a valid response from your system (e.g. this is a valid value for EPIC). The "Conflicting" value should be used when you receive tobacco information from multiple sources that disagree.

Datatype

integer

Alias
UMLS CUI [1]
C0543414
Tobacco type
Beschrijving

Tobacco status as of the visit date. Unknown values should be left blank. The "Not asked" value should be used only when it is a valid response from your system (e.g. this is a valid value for EPIC). The "Conflicting" value should be used when you receive tobacco information from multiple sources that disagree.

Datatype

integer

Alias
UMLS CUI [1]
C3166496
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Similar models

Sentinel Common Data Model Vital Signs

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Vital signs
C0518766 (UMLS CUI-1)
Patient ID
Item
Unique member identifier
text
C2348585 (UMLS CUI [1])
Encounter ID
Item
Unique encounter identifier
text
C1512346 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Vital signs date
Item
Vital signs date
date
C2826644 (UMLS CUI [1])
Vital signs time
Item
Vital signs time
time
C2826762 (UMLS CUI [1])
Height
Item
Height
float
C0005890 (UMLS CUI [1])
Weight
Item
Weight
float
C0005910 (UMLS CUI [1])
Diastolic Blood Pressure
Item
Diastolic blood pressure
float
C0428883 (UMLS CUI [1])
Systolic Blood Pressure
Item
Systolic blood pressure
float
C0871470 (UMLS CUI [1])
Item
Blood Pressure Method
integer
C0489446 (UMLS CUI [1])
Blood Pressure Method
Code List
Blood Pressure Method
CL Item
Extended (1 )
CL Item
Multiple (2 )
CL Item
Orthostatic (3 )
CL Item
Rooming (4 )
Item
Blood Pressure Position
integer
C1828063 (UMLS CUI [1])
Blood Pressure Position
Code List
Blood Pressure Position
CL Item
Sitting (1 )
CL Item
Standing (2 )
CL Item
Supine (3 )
Item
Tobacco use
integer
C0543414 (UMLS CUI [1])
Tobacco use
Code List
Tobacco use
CL Item
Current user (1 )
CL Item
Never (2 )
CL Item
Quit/former user (3 )
CL Item
Passive (4 )
CL Item
Environmental exposure (5 )
CL Item
Not asked (6 )
CL Item
Conflicting (7 )
Item
Tobacco type
integer
C3166496 (UMLS CUI [1])
Tobacco type
Code List
Tobacco type
CL Item
Cigarettes only (1 )
CL Item
Other tobacco only (2 )
CL Item
Cigarettes and other tobacco (3 )
CL Item
None (4 )
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