Tobacco Usage History Example 2

This example illustrates how typical tobacco use history data could be collected. This example only includes tobacco products that are not being used as a medically acceptable therapies for smoke cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco strips. Usage of these products are represented in the SU domain.

Tobacco Usage History

Record the Age Category when the subject started smoking	What was the age of the subject when they started smoking? AGESTSMK__FAORRES FAORRES WHERE FATESTCD = "AGESTSMK"	16-24 years 25-34 years 45–64 years 65 years and older
Indicate whether the subject had previous tobacco cessation counseling.	Did the subject have any tobacco cessation counseling? TBCESSCO__FAORRES FAORRES WHERE FATESTCD = "TBCESSCO"	Yes No <NY codelist>
Record the longest duration of tobacco abstinence	What is the longest duration of previous abstinence from tobacco use? LDURABS__FAORRES FAORRES WHERE FATESTCD = "LDURABS"	≤7 days 8–28 days 1–6 months >6 months

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

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AGESTSMK__FAORRES

1

What was the age of the subject when they started smoking?

Age Started Smoking

Record the Age Category when the subject started smoking

FAORRES;FATEST;FATESTCD

FAORRES WHERE FATESTCD = "AGESTSMK"

16-24 years; 25-34 years; 45–64 years; 65 years and older

radio

TBCESSCO__FAORRES

2

Did the subject have any tobacco cessation counseling?

Tobacco Cessation Counseling

Indicate whether the subject had previous tobacco cessation counseling.

FAORRES;FATEST;FATESTCD

FAORRES WHERE FATESTCD = "TBCESSCO"

(NY)

Yes; No

LDURABS__FAORRES

3

What is the longest duration of previous abstinence from tobacco use?

Longest Duration of Abstinence

Record the longest duration of tobacco abstinence

FAORRES;FATEST;FATESTCD where FASCAT= "TOBACCO"

FAORRES WHERE FATESTCD = "LDURABS"

≤7 days; 8–28 days;1–6 months; >6 months

Tobacco Product Used

For each Tobacco product used, Complete the following

Record the type of tobacco product used	What is the type of tobacco product used by the subject? SUSCAT	Smoked tobacco product Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product
For each product used, record the brand name of the tobacco product used.	What was the name of the tobacco product? SUTRT	BRAND X BRAND BRAND Z
Indicate if this is the subject usual brand of tobacco product used	Is this the subject usual brand of tobacco product? SUSCAT	USUAL BRAND NOT USUAL BRAND
Provide the duration of the tobacco product used	Duration FAORRES	_________________
Select the appropriate duration unit of the tobacco product used	Unit SUCDURU FAORRESU	DAYS MONTHS YEARS
Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection and the end date should be left blank.	Is the tobacco use ongoing? SUONGO SUENRF or SUENRTPT	Yes <NY codelist>
Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank.	End Date SUENDAT SUENDTC	_ _ / _ _ _ / _ _ _ _

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTMIG Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-Populated Value

Query Display

List Style

Hidden

SUSCAT

4

What is the type of tobacco product used by the subject?

Substance Use Subcategory

Record the type of tobacco product used

Text

SUSCAT

Smoked tobacco product;

Smokeless tobacco (e.g., chewing tobacco, snuff, dip, snus, or dissolvable tobacco) product

SUTRT

5

What was the name of the tobacco product?

Substance Treatment

For each product used, record the brand name of the tobacco product used.

Text

SUTRT

BRAND X;BRAND; BRAND Z;

SUSCAT

6

Is this the subject usual brand of tobacco product?

Substance Use Subcategory

Indicate if this is the subject usual brand of tobacco product used

Text

SUSCAT

USUAL BRAND;

NOT USUAL BRAND

FAORRES

7

What was the duration of use of the tobacco product ?

Duration

Provide the duration of the tobacco product used

Text

FAORRES

Prompt

SUCDURU

8

What was the unit of duration of use of the tobacco product?

Unit

Select the appropriate duration unit of the tobacco product used

Text

FAORRESU

DAYS; MONTHS; YEARS;

Prompt

SUONGO

9

Is the tobacco use ongoing?

Ongoing

Record the tobacco product used as ongoing if the subject has not stopped taking the tobacco product used at the time of data collection and the end date should be left blank.

Text

SUENRF; SUENRTPT

SUENRF or SUENRTPT

(NY)

Yes

checkbox

SUENDAT

10

What was the end date?

End Date

Record the date the tobacco product used was stopped using this format (DD-MON-YYYY). If the subject has not stopped taking the tobacco product used leave this field blank.

Date

SUENDTC

prompt

Row 1:	Shows that the subject used this tobacco product. SUCAT and SUSCAT categorize the product used. The dates of use were not know, but SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT indicate that the use started before the visit and was still ongoing,
Row 2:	Shows that the subject used this smokeless tobacco product. This was not the subject usual brand of smokeless tobacco product.

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Row	STUDYID	DOMAIN	USUBJID	SPTOBID	SUSEQ	SUTRT	SUCAT	SUSCAT	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT
1	TB901	SU	TB901005	BAND XYZ	1	BRAND XYZ CIGARTTES	SMOKED TOBACCO PRODUCT	USUAL BRAND	2	PACK	QD			2006-01-01	BEFORE	2006-01-01	ONGOING
2	TB901	SU	TB901006	BRAND ZZZ	1	SNUS TOBACCO BRAND ZZZ	SMOKELESS TOBACCO PRODUCT	NOT USUAL BRAND	1	CAN	EVERY WEEK	2002	2006-01-01

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

In this situation, the sponsor maintained an in-house dictionary of tobacco brands. This allowed this sponsor to study products across studies using the same tobacco product code for each brand of tobacco product. These codes were used to create a TO domain. This domain provided details on the brand of tobacco product used by the subject. Data for two brands of tobacco are shown.

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Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOSTRESC
1	TB901	TO	BRAND XYZ	1	TBPRDCAT	Tobacco Product Category	BRAND IDENTIFIER	Cigarette	Cigarette
2	TB901	TO	BRAND XYZ	2	TBPRSCAT	Tobacco Product Subcategory	BRAND IDENTIFIER	Filtered,Combusted	Filtered, Combusted
3	TB901	TO	BRAND XYZ	3	MANUF	Manufacturer	BRAND IDENTIFIER	Brand XYZ Company	Brand XYZ Company
4	TB901	TO	BRAND XYZ	4	TRADENAM	Trade Name	BRAND IDENTIFIER	XYZ Menthol King Size	XYZ Menthol King Size
1	TB901	TO	BRAND ZZZ	1	TBPRDCAT	Tobacco Product Category	BRAND IDENTIFIER	Smokeless Tobacco Product	Smokeless Tobacco Product
2	TB901	TO	BRAND ZZZ	2	TBPRSCAT	Tobacco Product Subcategory	BRAND IDENTIFIER	Snus,portioned	Snus, portioned
3	TB901	TO	BRAND ZZZ	3	MANUF	Manufacturer	BRAND IDENTIFIER	ZZZ Smokeless	ZZZ Smokeless
			UPC 111	1	TBPRDCAT	Tobacco Product Category	BRAND IDENTIFIER	Cigarette

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Tobacco Usage History Example 2