ID

37806

Description

Sentinel: Overview and Description of the Common Data Model v7.0.0 "The primary goal of Sentinel 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." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org Description: The SCDM Diagnosis Table contains one record per unique combination of PatID, EncounterID, DX, and DX_CodeType. This table should capture all uniquely recorded diagnoses for all encounters.

Lien

www.sentinelsystem.org

Mots-clés

  1. 08/01/2017 08/01/2017 -
  2. 29/01/2017 29/01/2017 -
  3. 29/01/2017 29/01/2017 -
  4. 25/08/2019 25/08/2019 -
  5. 25/08/2019 25/08/2019 -
Détendeur de droits

FDA's Sentinel Initiative

Téléchargé le

25 août 2019

DOI

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Licence

Creative Commons BY-NC-ND 3.0

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Sentinel Common Data Model Diagnosis

Sentinel Common Data Model Diagnosis

Diagnosis
Description

Diagnosis

Patient ID
Description

Unique member identifier. 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.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Encounter ID
Description

Unique encounter identifier. 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.

Type de données

text

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

Encounter or admission date.

Type de données

date

Alias
UMLS CUI [1]
C1302393
Provider ID
Description

Unique provider identifier. 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.

Type de données

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.

Type de données

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
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.

Type de données

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.

Type de données

text

Alias
UMLS CUI [1,1]
C1550350
UMLS CUI [1,2]
C0449913
Original Code System
Description

Original diagnosis from source table, if different. Used if Data Partner has to map internal codes to standard codes.

Type de données

text

Alias
UMLS CUI [1]
C3874295
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.

Type de données

text

Alias
UMLS CUI [1,1]
C1555319
UMLS CUI [1,2]
C1542147
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.

Type de données

text

Alias
UMLS CUI [1]
C1628992

Similar models

Sentinel Common Data Model Diagnosis

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Diagnosis
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
EncounterID
Item
Encounter ID
text
C1512346 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
ADate
Item
Admission Date
date
C1302393 (UMLS CUI [1])
Provider
Item
Provider ID
text
C1138603 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item
Encounter Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
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)
DX
Item
Diagnosis Code
text
C1550350 (UMLS CUI [1])
Item
Diagnosis Code Type
text
C1550350 (UMLS CUI [1,1])
C0449913 (UMLS CUI [1,2])
Code List
Diagnosis Code Type
CL Item
ICD-10-CM (10)
CL Item
ICD-11-CM (11)
CL Item
ICD-9-CM (09)
CL Item
SNOMED CT (SM)
CL Item
Other (OT)
OrigDX
Item
Original Code System
text
C3874295 (UMLS CUI [1])
Item
Principal Discharge Diagnosis
text
C1555319 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Code List
Principal Discharge Diagnosis
CL Item
Principal (P)
CL Item
Secondary (S)
CL Item
Unable to Classify (X)
Item
Admission diagnosis
text
C1628992 (UMLS CUI [1])
Code List
Admission diagnosis
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Unknown or unable to determine (U)
CL Item
Unreported/not used (X)

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