ID

43808

Beschreibung

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. 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 Description: The SCDM Incident Drug Category Summary Table1 provides a count of unique members with an incident dispensing for each drug category of interest stratified by age group, sex, and year. Incidence is defined as a member with a dispensing with the drug category of interest (i.e., the index date), in the year of interest with no evidence of a dispensing for that drug category in the 90, 180 and 270 days (i.e., the lookback periods) before the index date. Both medical and drug coverage are required during the three possible lookback periods, allowing for eligibility gaps of <=45 days. In addition to reporting the number of members with an incident dispensing, for each such incident user a treatment episode starting on the index date is created, and the total number of dispensings with the drug category, days supplied and length of treatment episodes (in days) in the 90, 180, 270 days after the index date are reported. Treatment gaps of <= 15 days are allowed when building treatment episodes and no restriction on the length of treatment episodes is applied. Although a member can have multiple index events in a given calendar year the first one only is counted and used for reporting. This table also reports a count of members with index dates in each quarter which sum up to total number of members for that year.

Link

www.sentinelsystem.org

Stichworte

Versionen (2)
  1. 02.02.17 02.02.17 -
  2. 20.09.21 20.09.21 -
Hochgeladen am

20. September 2021

DOI

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Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model Incident Drug Category

Englisch

Sentinel Common Data Model Incident Drug Category

1 Formulare  
Incident Drug Category
Beschreibung

Incident Drug Category

Alias
UMLS CUI-1
C0596463
UMLS CUI-2
C1551358
Age Group
Beschreibung

Age is defined as age at initial cohort eligibility during the period (e.g., age as of the start of coverage).

Datentyp

text

Alias
UMLS CUI [1]
C0001779
Sex
Beschreibung

Any individual not designated as male or female is categorized as unknown.

Datentyp

text

Year of dispensing
Beschreibung

4 digit year

Datentyp

integer

Alias
UMLS CUI [1]
C0456586
Drug class
Beschreibung

Drug class, also referred to as drug category. Note: The drug category is standardized using a look-up table provided by the SOC.

Datentyp

text

Alias
UMLS CUI [1]
C0596463
Age Group Id
Beschreibung

The unique ID for the Age_Group from the Age Groups Table.

Datentyp

text

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C1300638
Drug Category - Details
Beschreibung

Drug Category - Details

Alias
UMLS CUI-1
C0596463
UMLS CUI-2
C1522508
Members during 90/ 180/ 270 date.
Beschreibung

Count of members who had a dispensing with the drug class during the period with no evidence of another dispensing with that drug class in the 90/ 180/ 270 days before the index date. Only the first incident event/index date within each year is considered.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
Dispensings during 90/ 180/ 270 days before the index date.
Beschreibung

For members who satisfy the Members90/180/270 criteria, count of dispensings with the drug class 90/ 180/ 270 days after the index date (including the index event).

Datentyp

integer

Alias
UMLS CUI [1]
C1880359
Days supply during 90/ 180/ 270 days before the index date.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, count of days supply on the dispensings with the drug class 90/ 180/ 270 days after the index date (including the index event).

Datentyp

integer

Alias
UMLS CUI [1,1]
C0243163
UMLS CUI [1,2]
C1948053
Length of Treatment during 90/ 180/ 270 days before the index date.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, length of treatment episodes (in days) of the dispensings with the drug class 90/ 180/ 270 days after the index date (including the index event). Treatment gaps of <= 15 days are allowed when building treatment episodes and no restriction on the length of treatment episodes is applied.

Datentyp

integer

Alias
UMLS CUI [1]
C0444921
Members during 90/ 180/ 270 days before the index date with an index date in Q1.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q1 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205435
Members during 90/ 180/ 270 days before the index date with an index date in Q2.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q2 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205436
Members during 90/ 180/ 270 days before the index date with an index date in Q3.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q3 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205437
Members during 90/ 180/ 270 days before the index date with an index date in Q4.
Beschreibung

For members who satisfy the Members90/ 180/ 270 criteria, count of members with an index date in Q4 of the year. The sum of Members90/ 180/ 270Q1 through Members90/ 180/ 270Q4 equals Members90/ 180/ 270.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0680022
UMLS CUI [1,2]
C0449788
UMLS CUI [2,1]
C2825406
UMLS CUI [2,2]
C0205438
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Ähnliche Modelle

Sentinel Common Data Model Incident Drug Category

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Incident Drug Category
C0596463 (UMLS CUI-1)
C1551358 (UMLS CUI-2)
Item
Age Group
text
C0001779 (UMLS CUI [1])
Age
Code List
Age Group
CL Item
0-1 (0-1)
CL Item
2-4 (2-4)
CL Item
5-9 (5-9)
CL Item
10-14 (10-14)
CL Item
15-18 (15-18)
CL Item
19-21 (19-21)
CL Item
22-44 (22-44)
CL Item
45-64 (45-64)
CL Item
65-74 (65-74)
CL Item
75+ (75+)
Item
Sex
text
Gender
Code List
Sex
CL Item
Female (F )
CL Item
Male (M )
CL Item
Unknown (U )
Calendar Year
Item
Year of dispensing
integer
C0456586 (UMLS CUI [1])
Drug class
Item
Drug class
text
C0596463 (UMLS CUI [1])
Age ID
Item
Age Group Id
text
C0001779 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
Item Group
Drug Category - Details
C0596463 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Count of Members
Item
Members during 90/ 180/ 270 date.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Dispensings
Item
Dispensings during 90/ 180/ 270 days before the index date.
integer
C1880359 (UMLS CUI [1])
Days supply
Item
Days supply during 90/ 180/ 270 days before the index date.
integer
C0243163 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
Length of Treatment
Item
Length of Treatment during 90/ 180/ 270 days before the index date.
integer
C0444921 (UMLS CUI [1])
Count of Members: Q1
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q1.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205435 (UMLS CUI [2,2])
Count of Members: Q2
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q2.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
Count of Members: Q3
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q3.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205437 (UMLS CUI [2,2])
Count of Members: Q4
Item
Members during 90/ 180/ 270 days before the index date with an index date in Q4.
integer
C0680022 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
C2825406 (UMLS CUI [2,1])
C0205438 (UMLS CUI [2,2])
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