ID

19544

Description

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

Keywords

Versions (5)
  1. 1/8/17 1/8/17 -
  2. 1/29/17 1/29/17 -
  3. 1/29/17 1/29/17 -
  4. 8/25/19 8/25/19 -
  5. 8/25/19 8/25/19 -
Uploaded on

January 8, 2017

DOI

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License

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

English

Sentinel Common Data Model Diagnosis

1 forms  
Diagnosis
Description

Diagnosis

Unique member identifier
Description

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.

Data type

text

Alias
UMLS CUI [1]
C2348585
Unique encounter identifier
Description

Arbitrary encounter-level identifier. Used to link the Encounter, Diagnosis, and Procedure tables. Note: For efficiency medical utilization data is captured in 3 tables: Encounter: the encounter record that characterizes the outpatient visit or hospital stay Diagnosis: the diagnosis code(s) associated with the encounter record Procedure: the procedure code(s) associated with the encounter record These 3 tables and the Inpatient Pharmacy, Inpatient Transfusion, and Vital Signs are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID. It is allowable to have "orphan" diagnosis or procedure records with EncounterIDs that do not have a match in the Encounter table.

Data type

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1300638
Admission Date
Description

Encounter or admission date.

Data type

date

Alias
UMLS CUI [1]
C1302393
Unique provider identifier
Description

Provider code for the provider who is most responsible for this encounter. For encounters with multiple providers choose one so the encounter can be linked to the diagnosis and procedure tables. As with the PatID, the provider code is a pseudoidentifier with a consistent crosswalk to the real identifier.

Data type

text

Alias
UMLS CUI [1,1]
C1138603
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.

Data type

integer

Alias
UMLS CUI [1]
C0545082
Diagnosis Code
Description

For ICD codes this variable can include decimal points or not. Remove site specific suffixes and prefixes. Other codes should be listed as recorded in the source data. Note: For ICD codes, some Data Partners will have a decimal point in the DX variable and others will not. We recommend that users of the data strip the decimal point during data analyses.

Data type

text

Alias
UMLS CUI [1]
C1550350
Diagnosis Code Type
Description

Diagnosis code type. This field combined with the DX field should be used to capture any type of diagnosis or clinical concept available in the source data. We provide values for ICD and SNOMED code types. Other code types will be added as new terminologies are used. Note For those who collect SNOMED CT codes as part of routine care, those codes can be stored in this table, using the "SM" DX_CodeType

Data type

integer

Alias
UMLS CUI [1,1]
C1550350
UMLS CUI [1,2]
C0449913
Original diagnosis from source table, if different
Description

Used if Data Partner has to map internal codes to standard codes.

Data type

text

Alias
UMLS CUI [1]
C3874295
Admission diagnosis
Description

Indicates whether the diagnosis code is indicative of a condition present at admission. Note: Only one Sentinel Data Partner is expected to populate the PAdmit field

Data type

boolean

Alias
UMLS CUI [1]
C1628992
Principal Discharge Diagnosis
Description

Principal discharge diagnosis flag. Relevant only on IP and IS encounters. For ED, AV, and OA encounter types, mark as missing. One principal diagnosis is expected, although in some instances more than one diagnosis may be flagged as principal.

Data type

integer

Alias
UMLS CUI [1,1]
C1555319
UMLS CUI [1,2]
C1542147
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Similar models

Sentinel Common Data Model Diagnosis

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Diagnosis
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])
Admission Date
Item
Admission Date
date
C1302393 (UMLS CUI [1])
Provider ID
Item
Unique provider identifier
text
C1138603 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item
Encounter Type
integer
C0545082 (UMLS CUI [1])
Visit Type
Code List
Encounter Type
CL Item
Ambulatory Visit (1 )
CL Item
Emergency Department (2 )
CL Item
Inpatient Hospital Stay (3 )
CL Item
Non-Acute Institutional Stay (4 )
CL Item
Other Ambulatory Visit (5 )
Diagnosis Code
Item
Diagnosis Code
text
C1550350 (UMLS CUI [1])
Item
Diagnosis Code Type
integer
C1550350 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Diagnosis Code Type
Code List
Diagnosis Code Type
CL Item
ICD-9-CM (9 )
CL Item
ICD-10-CM (10 )
CL Item
ICD-11-CM (11 )
CL Item
SNOMED CT (12 )
CL Item
Other (13 )
Original Code System
Item
Original diagnosis from source table, if different
text
C3874295 (UMLS CUI [1])
Admission diagnosis
Item
Admission diagnosis
boolean
C1628992 (UMLS CUI [1])
Item
Principal Discharge Diagnosis
integer
C1555319 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Principal Discharge Diagnosis
Code List
Principal Discharge Diagnosis
CL Item
Principal (1 )
CL Item
Secondary (2 )
CL Item
Unable to Classify (3 )
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