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 dayDipping tobaccois a type of finely ground or shredded, moistenedsmokelesstobacco 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 calleddipping.
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)
SUCAT
Pre-populated
Recreational Drugs
Indicate if the subject had used any recreational drugs.
Age subject began smoking daily
SUYNNot Submitted
<NY codelist>
Record the name of the recreational drug used.
SUTRT
_________________
Check the appropriate box to indicate if the subject currently or formerly used recreational drugs.
Usage
SUNCFSUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER".
<NCF codelist>
Indicate the amount of recreational drugs the subject consumes on a regular basis.
SUDSTXTSUDOSESUDOSTXT
_________________
Record how often the subject regularly uses recreational drugs.
Frequency
SUDOSFRQ
<FREQ codelist>
Provide the duration of the substance use (e.g., how long the subject has smoked).
SUCDURSUDUR
_________________
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?
Substance Use Category
Record the Substance Used category, if not pre-printed on the CRF.
Text
SUCAT
Recreational Drugs
SUYN
2
Age subject began smoking daily
Any Recreational Drugs Used
Indicate if the subject had used any recreational drugs.
Text
N/A
(NY)
Yes; No
SUTRT
3
Average number of cigarettes smoked per day over the past year
Type of Recreational Drug Used
Record the name of the recreational drug used.
Text
SUTRT
SUNCF
4
Has the subject attempted to quit with the use of Nicotine Replacement Therapy (NRT)? List details of NRT products used in Comments section
Usage
Check the appropriate box to indicate if the subject currently or formerly used recreational drugs.
Text
SUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRF
SUOCCUR = "Y" WHEN SUNCF = "CURRENT". SUOCCUR = "Y" WHEN SUNCF = "FORMER".
(NCF)
Current; Former
Prompt
SUDSTXT
5
Has the subject attempted to quit with the use of pharmaceuticals other than NRTs? List details of other pharmaceuticals used in the Comments section.
Amount
Indicate the amount of recreational drugs the subject consumes on a regular basis.
Text
SUDOSE; SUDOSTXT
SUDOSFRQ
6
Has the subject attempted to quit with the use of other smoking cessation aids? List details of other smoking cessation aids used in the Comments section.
Frequency
Record how often the subject regularly uses recreational drugs.
Text
SUDOSFRQ
(FREQ)
QD; EVERY WEEK; QM; PA
Prompt
SUCDUR
7
Has the subject made any other attempts to quit smoking? List details of other quit attempts in the Comments section.
Duration
Provide the duration of the substance use (e.g., how long the subject has smoked).
Text
SUDUR
Prompt
Row 1:
Subject 1234005 is a 2-pack/day current smoker. “Current” implies that smoking started sometime before the time the question was asked (SUSTTPT = "2006-01-01", SUSTRTPT = "BEFORE") and had not ended as of that date (SUENTTP = "2006-01-01", SUENRTPT = "ONGOING"). See Section 4.4.7, Use of Relative Timing Variables for the use of these variables. Both the beginning and ending reference time points for this question are the date of the assessment.
Row 2:
Subject 1234005 drank 3 cups of coffee on the day of the assessment.
Row 3:
Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:
Subject 1234006 drank tea on the day of the assessment.
Row 5:
Subject 1234006 drank coffee on the day of the assessment.
Row 6:
Subject 1234007 had missing data for the smoking questions; this is indicated by SUOCCUR null and SUSTAT = "NOT DONE". The reason is in SUREASND.
Row 7:
Subject 1234007 also had missing data for all of the caffeine questions.
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Row
STUDYID
DOMAIN
USUBJID
SUSEQ
SUTRT
SUCAT
SUPRESP
SUOCCUR
SUSTAT
SUREASND
SUDOSE
SUDOSU
SUDOSFRQ
SUSTDTC
SUENDTC
SUSTTPT
SUSTRTPT
SUENTPT
SUENRTPT
1
1234
SU
1234005
1
CIGARETTES
TOBACCO
Y
Y
2
PACK
QD
2006-01-01
BEFORE
2006-01-01
ONGOING
2
1234
SU
1234005
2
COFFEE
CAFFEINE
Y
Y
3
CUP
QD
2006-01-01
2006-01-01
3
1234
SU
1234006
1
CIGARETTES
TOBACCO
Y
Y
1
PACK
QD
2003
2006-03-15
BEFORE
4
1234
SU
1234006
2
TEA
CAFFEINE
Y
Y
1
CUP
QD
2006-03-15
2006-03-15
5
1234
SU
1234006
3
COFFEE
CAFFEINE
Y
Y
2
CUP
QD
2006-03-15
2006-03-15
6
1234
SU
1234007
1
CIGARETTES
TOBACCO
Y
NOT DONE
Subject left office before CRF was completed
7
1234
SU
1234007
2
CAFFEINE
CAFFEINE
Y
NOT DONE
Subject left office before CRF was completed
NICOTINE REPLACEMENT THERAPY
NICOTINE
Y OR N
SMOKELESS CIGARETTES
Y or N
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Rows 1, 6, 11:
Rows 2-5, 7-10, 12-15:
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