Recreational and Tobacco Product Usage

The Interventions domains in SDTM capture investigational, therapeutic, and other treatments that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product  coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).

Recreational drugs are chemical substances taken for enjoyment, or leisure purposes, rather than for medical reasons. They are often drugs that are misused or abused or drugs self-administered by the subject.  To support standardization, CDISC defined a Substance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions used for non-medical purposes and often maybe harmful to the individual or others. These include alcohol, marijuana and tobacco.  

Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as concomitant medications and represented in the SDTM Concomitant/Prior Medications (CM) domain and interventions administered as protocol-specified study products are represented  in the Exposure (EX) and Exposure as Collected (EC) domains..

In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.  

Example

There are 2 sections of this example CRF: The questions in the first section focus on the whether any recreational products were used, and the questions in the second section are for each recreational product used. The applicant did not include subjects that did not use recreational products in the SDTM dataset. In order to save space, some of the permissible values are only shown in the metadata specifications. 

CDASH SU Metadata Specifications

Section 1 The metadata/specification in the first section focus on the whether any recreational products were used. 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What is the category of the substance used?	Substance Use Category	Record the recreational product category, if not pre-printed on the CRF.	Text	SUCAT				RECREATIONAL PRODUCT
2	Were any recreational products used?	Any Recreational Product Used	Indicate if the subject had used any recreational products.	Text	SUYN		SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT"  where SUYN = "Not Done"	(NY)	Yes; No; Not Done
3	What was the reason the recreational product use was not done?	Reason Not Done	Record the reason recreational  product use was not done.	Text	SUREASND	SUREASND

 

Section 2 The metadata/specification in the second section focus on each recreational product used. 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
4	What was the recreational product used?	Type of Recreational Product Used	Record each recreational product used on a new line.	Text	SUTRT				Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
5	Does the subject currently use or formerly used recreational products?	Usage	Check the appropriate box to indicate if the subject currently or formerly used recreational products.	Text	SUNCF	SUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP			(NCF)	FORMERLY:CURRENT;
6	What was the amount of the recreational product used?	Amount	Indicate the amount of recreational drug the subject consumes on a regular basis.	Text	SUDOSE; SUDOSTXT
7	SUDOSU	What was the unit?	Record the unit. See the protocol for a list of units.	Text	SUDOSU	SUDOSU	(UNIT)
8	SUDOSFRQ	What was the frequency of recreational product use?	Record how often the subject regularly uses the recreational product.	Text	SUDOSFRQ		(FREQ)		Occasionally; Intermittent; Daily; PRN; Unknown

This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.   

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Row 1:	Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF.
Row 2:	Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. SUPRESP is used to indicate that the use of marijuana was solicited on the CRF.
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:	Shows the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.

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Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUPRESP	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT
1	1234	SU	1234005	1	CIGARETTES	RECREATIONAL PRODUCT	Y			2	PACK	QD			BEFORE	2006-01-01	ONGOING	2006-01-01
2	1234	SU	1234005	2	MARIJUNA	RECREATIONAL PRODUCT	Y						2002	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	RECREATIONAL PRODUCT	Y			1	PACK	QD		2003	BEFORE	2006-03-15
4	1234	SU	1234007	1	RECREATIONAL PRODUCT	RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed

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Dataset Wrapper Debug Message

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Example

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications. 

CDASH CM Metadata Specifications

Section 1 

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT					SMOKING CESSATION PRODUCT
2	Were any smoking cessation products taken?	Any Smoking Cessation Products Taken	Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR;		(NY)	No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT	CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.		NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4	Did the subject previously use the selected medication/product for smoking cessation?	Smoking Cessation Product Used	Indicate if the subject had used the selected smoking cessation product	Text	CMOCCUR	CMOCCUR		(NY)	No; Yes
5	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of product previously used.	Text	CMTRTO	CMTRT
6	Was the smoking cessation product discontinued due to an adverse experience?	Reason Smoking Cessation Product Discontinued	Indicate if the product was discontinued due to an Adverse Experience	Text	CMRSDISC	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	No:Yes:
7	What was the last date the product was used?	Last Date Smoking Cessation Product Used	Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded.	Date	CMENDAT	CMENDTC

These example SDTM datasets represent the data collected on the above CRF.

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Rows 1, 3, 7, 9:

Show whether the subject has used any medications to help with nicotine dependence. This was prespecified on the CRF, hence CMPRESP="Y". The applicant assigned CMTRT to "DRUG USED IN NICOTINE DEPENDENCE" which was the category name in an external dictionary.

Rows 2, 4, 5, 6, 8:

Show the various medications that were used by subjects. CMSCAT is used to indicate that these data are associated with the last attempted use. CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation. CMPRESP is null since the specific medication used is not prespecified.

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Row	STUDYID	DOMAIN	USUBJID	CMSEQ	CMTRT	CMCAT	CMSCAT	CMPRESP	CMOCCUR	CMDTC	CMDUR
1	1234	CM	1234005	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-08-08
2	1234	CM	1234005	2	NICOTINE PATCH XYZ	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2M
3	1234	CM	1234006	1	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-11-12
4	1234	CM	1234006	2	NICOTINE GUM ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P3M
5	1234	CM	1234006	3	NICOTINE LOZENGES ABC	NICOTINE REPLACEMENT THERAPY	LAST ATTEMPTED USE WITH THIS MEDICATION				P2W
6	1234	CM	1234006	1	BUPROPION	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P1M
7	1234	CM	1234007	2	DRUG USED IN NICOTINE DEPENDENCE			Y	Y	2008-06-12
8	1234	CM	1234007	3	VARENICLINE	DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS	LAST ATTEMPTED USE WITH THIS MEDICATION				P40D
9	1234	CM	1234012	1	DRUG USED IN NICOTINE DEPENDENCE			Y	N	2008-03-05

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Dataset Wrapper Debug Message

Please add a row column to your dataset.

FACM was used to represent the total number of times the subject attempted to reduce nicotine dependency using a medically acceptable product. Only subjects who had attempted to reduce nicotine dependence are included in the FACM dataset.  

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Row	STUDYID	DOMAIN	USUBJID	FASEQ	FATESTCD	FATEST	FAOBJ	FACAT	FAORRES	FASTRESC	FADTC
1	1234	FA	1234005	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	4	4	2008-08-08
2	1234	FA	1234006	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	5	5	2008-11-12
3	1234	FA	1234007	1	TOTNUM	Total Number	DRUG USED IN NICOTINE DEPENDENCE	ATTEMPTS TO REDUCE NICOTINE DEPENDENCE	3	3	2008-06-12

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