Tobacco Usage History Example 2

This data may be Puff topraphy for smokless products- Self-reported tobacco use information was elicited from each subject. Subjects were required to keep daily paper diaries of their tobacco use. In each diary, subjects were required to write down when they put a dip into their mouth, when they removed a dip from their mouth, and when a new tin of ST was opened

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 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
Record the brand name of the tobacco product used.	What was the name of the tobacco product? SUTRT	BRAND X:BRAND Y BRAND Z
Indicate if this is the subject usual brand of tobacco product used	Is this the subject usual brand of tobacco product? SUSCAT	Yes No <USUAL, BRAND, NOT, USUAL, or BRAND codelist>
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	_ _ / _ _ _ / _ _ _ _

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SUSCAT

1

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

4

What was the name of the tobacco product?

Substance Treatment

Record the brand name of the tobacco product used.

Text

SUTRT

BRAND X:BRAND Y; BRAND Z;

SUSCAT

5

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

Yes; No

FAORRES

5

What was the duration of use of the tobacco product ?

Duration

Provide the duration of the tobacco product used

Text

FAORRES

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SUCDURU

6

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	SUOCCUR	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT
1	TB901	SU	TB901005	BAND XYZ	1	BRAND XYZ CIGARTTES	SMOKED TOBACCO PRODUCT	USUAL BRAND	Y			2	PACK	QD			2006-01-01	BEFORE	2006-01-01	ONGOING
2	TB901	SU	TB901006	BRAND ZZZ	1	CHEWING TOBACCO BRAND ZZZ	SMOKELESS TOBACCO PRODUCT	NOT USUAL BRAND	Y						2002	2006-01-01

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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. A sponsor may only collect details on the usual brand of tobacco used.

Row 1:	The subject
Row 2:

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Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOTESTCD	TOTEST	TOCAT	TOORRES	TOORRESU
1	TB901	TO	BRAND XYZ	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	CIGARTTES
2	TB901	TO	BRAND XYZ	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER
3	TB901	TO	BRAND XYZ	3	MANUF	Manufacturer	PRODUCT IDENTIFIER	BRAND XYZ COMPANY
1	TB901	TO	BRAND ZZZ	1	TBPRDCAT	Tobacco Product Category	PRODUCT IDENTIFIER	SNUFF	Everyday Rich Tobacco
2	TB901	TO	BRAND ZZZ	2	TBPRSCAT	Tobacco Product Subcategory	PRODUCT IDENTIFIER
3	TB901	TO	BRAND ZZZ	3	MANUF	Manufacturer	PRODUCT IDENTIFIER

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Tobacco Usage History Example 2