Protocol Overview

June 24, 2015

This section will be completed when reviewed by an Expert Review Panel.

This protocol includes questions from the Wave 1 Adult Population Assessment of Tobacco and Health (PATH) Survey instrument. These specific questions are used to measure the price paid for smokeless tobacco such as snus pouches, loose snus, moist snuff, dip, spit, and chewing tobacco. Common brands include Redman^®, Levi Garrett^®, Beechnut^®, Skoal^®, Grizzly®, Nordic Ice^®, and Copenhagen^®.

To answer these questions, investigators will need to determine whether or not the respondent is a current smokeless tobacco user. To do so, the Working Group is recommending that investigators add the Use of Tobacco Products Toolkit measure.

[SMKLSSFILL] = smokeless tobacco; snus

1. How much do you usually pay for a container of [SMKLSSFILL]?

ASK: Current users

2. How many pouches are in the container of snus that you usually buy?

ASK: Current users snus

PROGRAM: This is only asked of snus users where SMKLSSFILL[2] = 2 {uses snus - Skoal Bandits and other brands or no Skoal Bandits}; this is not asked of smokeless tobacco users where SMKLSSFILL[1] = 1 {uses snus - Skoal Bandits and other brands}.

Export Variables

Variable Name	Variable ID	Variable Description	Version	Mapping
PX740804_TobaccoPrice_Smokeless_Tobacco_HowMuchPaid	PX740804010100	How much do you usually pay for a container of [SMKLSSFILL] = smokeless tobacco; snus?	4	N/A
PX740804_TobaccoPrice_Smokeless_Tobacco_HowMuchPaid_Coded	PX740804010200	How much do you usually pay for a container of [SMKLSSFILL] = smokeless tobacco; snus?	4	N/A
PX740804_TobaccoPrice_Smokeless_Tobacco_Howmanypouch	PX740804020100	How many pouches are in the container of snus that you usually buy?	4	N/A
PX740804_TobaccoPrice_Smokeless_Tobacco_Howmanypouch_Coded	PX740804020200	How many pouches are in the container of snus that you usually buy?	4	N/A

The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, in-person longitudinal cohort study of nonusers and users of tobacco products and those at risk for tobacco use across the United States. Respondents 12 years old and up are asked questions on tobacco use, attitudes, and health, and biospecimens (buccal cell, urine, and blood) are collected from adults. The PATH Study was implemented to provide an evidence base for assessing and monitoring the Food and Drug Administration’s regulatory actions in meeting its mandate under the Family Smoking Prevention and Tobacco Control Act. Regulatory domains include product standards, new and modified risk products, health warnings, and health education campaigns.

National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA), Population Assessment of Tobacco and Health (PATH) Study, PATH Wave 1 Adult Extended Interview 7.5, 2013, Items AS1042, AU9001.

Adult

English, Spanish

Adult (18+ years of age)

None.

None.

Standard	Name	ID	Source
Common Data Elements (CDE)	Smokeless Tobacco Cost Assessment Text	4884687	CDE Browser

National Institutes of Health, U.S. Food and Drug Administration. (2013). Population Assessment of Tobacco and Health (PATH) Study: Final Adult Baseline (Wave 1) Questionnaire. Bethesda, MD: National Institutes of Health.

Interviewer-administered questionnaire

None

Requirement Category	Required
Average time of greater than 15 minutes in an unaffected individual	No
Major equipment	No
Specialized requirements for biospecimen collection	No
Specialized training	No

This section will be completed when reviewed by an Expert Review Panel.