Smoking Cessation Product History Example 2

Modelling of this information needs discussion at ISMT.

Should this be related to SU using FASU,

Should the NRT be recorded in CM, or SU.

How to represent in SUCAT Should SUCAT always be TOBACCO... can Nicotine be used.

Types of tobacco use Cigarette,Cigars,Smokeless Tobacco,Pipe Tobacco,Nicotine Vaping Collected with Check all that appy in CDASH.

Current type of smokeless tobacco used, Snuff, Chewing tobacco. Amount Used : Cans/pouches per week, Dips per day Dipping tobacco is a type of finely ground or shredded, moistened smokeless tobacco product. It is commonly and idiomatically known as "dip". Dipping tobacco is used by placing a pinch, or "dip", of tobacco between the lip and the gum (sublabial administration). The act of using it is called dipping.

Other users of tobacco in household

Years of regular smokeless tobacco use

Fagerstrom Test for Nicotine Dependence (FND) The Fagerström Tolerance Questionnaire was developed by Karl-Olov Fagerström. This instrument was modified to the Fagerström Test for Nicotine Dependence by Todd Heatherton, et al. in 1991. The FTND is copyrighted by Taylor and Francis Ltd., but may be reproduced without permission, as available from the source reference (Heatherton, et al., 1991).

Smoking status (self-reported and biochemically validated)

SMOKING CESSATION PRODUCT

	What is the category of the substance used? SUCAT Pre-populated	SMOKING CESSATION PRODUCT
Indicate if the subject had used any products to attempted to quit smoking.	Did the subject previously use any products to attempted to quit smoking? SUYN SUOCCUR where SUTRT=Smoking Cessation Product"	Yes No <NY codelist>
	How many times did the subject attempt to quit smoking using a smocking cessation product? FAORRES FAORRES where FAOBJ ="SMOKING CESSATION PRODUCT" and FATEST= NUMBER OF ATTEMPTS"	_________________

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

SUCAT

1

What is the category of the substance used?

Text

SUCAT

SMOKING CESSATION PRODUCT

SUYN

2

Did the subject previously use any products to attempted to quit smoking?

Indicate if the subject had used any products to attempted to quit smoking.

Text

SUOCCUR

SUOCCUR where SUTRT=Smoking Cessation Product"

(NY)

Yes; No

FAORRES

3

How many times did the subject attempt to quit smoking using a smocking cessation product?

Text

FAORRES

FAORRES where FAOBJ ="SMOKING CESSATION PRODUCT" and FATEST= NUMBER OF ATTEMPTS"

SMOKING CESSATION PRODUCT

	What is the category of the substance used? Not Collected Not Submitted Pre-populated	SMOKING CESSATION PRODUCT
Record the type of product the subject used to attempted to quit smoking.	What is the type of product the subject used to attempted to quit smoking? Not Collected SUSCAT	Nicotine Replacement Therapy (NRT Pharmaceuticals other than NRTs Other Smoking Cessation aids
	What was the name of the product the subject used to attempted to quit smoking? Not Collected SUTRT	_________________
Indicate the amount of amount of tobacco product used to quit smoking?	Amount Not Collected SUDOSE SUDOSTXT	_________________
Provide the duration of the substance use	Duration Not Collected SUDOSFRQ	QD EVERY WEEK QM PA
Select the appropriate duration unit of the tobacco product used	Unit Not Collected SUDUR	DAYS MONTHS YEARS
	Frequency Not Collected Not Submitted	QD EVERY WEEK QM PA <FREQ codelist>

RECORD THE INFORMATION FOR THE LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED

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

SUCAT

1

What is the category of the substance used?

SMOKING CESSATION PRODUCT

SUSCAT

3

What is the type of product the subject used to attempted to quit smoking?

Substance Use Category

Record the type of product the subject used to attempted to quit smoking.

Text

SUSCAT

Nicotine Replacement
Therapy (NRT

Pharmaceuticals
other than NRTs

Other
Smoking Cessation aids

SUTRT

4

What was the name of the product the subject used to attempted to quit smoking?

Text

SUTRT

SUDSTXT

5

What was the amount of product used to quit smoking?

Amount

Indicate the amount of amount of tobacco product used to quit smoking?

Text

SUDOSE; SUDOSTXT

Prompt

SUDUR

6

What was the duration of the product usage to quit smoking?

Duration

Provide the duration of the substance use

Text

SUDOSFRQ

QD; EVERY WEEK; QM; PA

Prompt

SUCDURU

7

What was the duration unit of the product used to quit smoking?

Unit

Select the appropriate duration unit of the tobacco product used

Text

SUDUR

DAYS; MONTHS; YEARS

Prompt

SUDOSFRQ

8

What was the frequency of of the product used to quit smoking

Frequency

(FREQ)

QD; EVERY WEEK; QM; PA

Prompt

Row 1:
Row 2:
Row 3:
Row 4:
Row 5:
Row 6:
Row 7:

Row Captions Debug Message

Please provide a caption for every row caption label.

su.xpt

xx.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUSCAT	SUPRESP	SUOCCUR	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTTPT	SUSTRTPT	SUENTPT	SUENRTPT
1	1234	SU	1234005	1	SMOKING CESSATION PRODUCT	SMOKING CESSATION PRODUCT		Y	Y	2	PACK	QD			2006-01-01	BEFORE	2006-01-01	ONGOING
2	1234	SU	1234005	2	Nicotine patch	SMOKING CESSATION PRODUCT	NICOTINE REPLACEMENT THERAPY	Y	Y	3	CUP	QD	2006-01-01	2006-01-01
3	1234	SU	1234006	1	Nicotine gum	SMOKING CESSATION PRODUCT	NICOTINE REPLACEMENT THERAPY	Y	Y	1	PACK	QD		2003	2006-03-15	BEFORE
4	1234	SU	1234006	2	Nicotine lozenges:	SMOKING CESSATION PRODUCT	NICOTINE REPLACEMENT THERAPY	Y	Y	1	CUP	QD	2006-03-15	2006-03-15
5	1234	SU	1234006	3	bupropion	SMOKING CESSATION PRODUCT	Pharmaceuticals other than NRTs	Y	Y	2	CUP	QD	2006-03-15	2006-03-15
6	1234	SU	1234007	1	Chantix	SMOKING CESSATION PRODUCT	Pharmaceuticals other than NRTsY	Y

Dataset Debug Messages

There are 14 leading, trailing, or non-breaking spaces in the dataset.
Please remove all formatting (see How to Clear Formatting).
Please remove all paragraph and/or line breaks.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Rows 1, 6, 11:
Rows 2-5, 7-10, 12-15:

Row Captions Debug Message

Please provide a caption for every row caption label.

fa.xpt

fasu.xpt

Row	STUDYID	DOMAIN	USUBJID	FASEQ	FASPID	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC	FATPT	FATPTNUM	FAELTM	FATPTREF
1	ABC	FA	ABC-123	1	90567		NUMBER	NRT	TOBACCO CESSATION ATTEMPTS	10	10	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
2	ABC	FA	ABC-123	2	90567	OCCUR	AGE STARTED SMOKING ( Or Tobacco Product) DAILY			16	16	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
3	ABC	FA	ABC-123	3	90567	OCCUR	NUMBER	PHARMACUETIAL	TOBACCO CESSATION ATTEMPTS	N	N	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
4	ABC	FA	ABC-123	4	90567	OCCUR	Occurrence Indicator			Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING
5	ABC	FA	ABC-123	5	90567	OCCUR	Occurrence Indicator			Y	Y	2007-05-16	5M PRE-DOSE	1	-PT5M	DOSING

Dataset Debug Messages

There are two leading, trailing, or non-breaking spaces in the dataset.
Please remove all hyperlinks from the dataset.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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Smoking Cessation Product History Example 2

Chantix