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Protocol - Perception of Tobacco Product Risk - E-Cigarettes

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Description

This protocol includes questions from Wave 1 of the Adult Population Assessment of Tobacco and Health Study survey instrument. These specific questions are used to measure a respondent’s perception about the perceived risk of smoking e-cigarettes. The three response categories range from less harmful to more harmful.

Specific Instructions

The Smoking Cessation, Harm Reduction, and Biomarkers Working Group recommends categorizing respondents based on the following reported use characteristics: (1) ever user versus never user; (2) current established user, defined as everyday user or some-day user; and (3) former established user according to the Use of Tobacco Products protocol. Polyuse with other tobacco products should be considered as well.

Current and former users might also be categorized based on type of e-cigarette product used; for instance, closed systems such as disposable versus cartridge/pod devices or open-system refillable products that are modifiable or not. Investigators may also want to classify products based on nicotine content, salt or freebase nicotine, and e-liquid flavor characteristics. As new vaping products emerge (e.g., heat tobacco products), investigators should consider their inclusion as well.  

Protocol

Electronic Cigarettes (E-cigarettes)

The next questions are about electronic cigarettes, often called e-cigarettes. E-cigarettes look like regular cigarettes, but are battery-powered and produce vapor instead of smoke. There are many types of e-cigarettes. Some common brands include NJOY®1, Blu™2, and Smoking Everywhere3.

[SHOW GENERIC IMAGE OF E-CIGARETTES]

1. Have you ever seen or heard of an electronic cigarette or e-cigarette before this study?

1[ ]Yes

2[ ]No

-8[ ]DONT KNOW

-7[ ]REFUSED

ASK: All respondents

[SHOW GENERIC IMAGE OF E-CIGARETTES]

2. Is using e-cigarettes less harmful, about the same, or more harmful than smoking cigarettes? [SHOW IMAGE OF E-CIGARETTES]

1[ ]Less harmful

2[ ]About the same

3[ ]More harmful

-8[ ]DONT KNOW

-7[ ]REFUSED

ASK: Respondents who have seen or heard of e-cigarettes (Q1=1).

1 NJOY, Inc.
2 Fontem Holdings 4 B.V.
3 Smoking Everywhere LLC

Availability

Available

Personnel and Training Required

None

Equipment Needs

The PhenX Working Group acknowledges that these questions can be administered in a computerized or noncomputerized format (i.e., paper-and-pencil instrument). Computer software is necessary to develop computer-assisted instruments. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Life Stage

Adolescent, Adult

Participants

Adult (aged 18 or older)

Adolescent (aged 12-17)

Selection Rationale

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 aged 12 years or older 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.

Language

English, Spanish

Standards
StandardNameIDSource
caDSR Common Data Elements (CDE) Smoking PATH Electronic Cigarette Risk Perception Questionnaire 1 Seen Yes No Unknown Refused Indicator   7582530 CDE Browser
caDSR Common Data Elements (CDE) Smoking PATH Electronic Cigarette Risk Perception Questionnaire 2 Use Harmfulness Category   7582534 CDE Browser
Human Phenotype Ontology Addictive behavior HP:0030858 HPO
Derived Variables

None

Process and Review

Not Applicable

Protocol Name from Source

Population Assessment of Tobacco and Health (PATH) Study, PATH Wave 1 Adult Annotated Instrument, 2016

Source

U.S. Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse; and U.S. Department of Health and Human Services, Food and Drug Administration, Center for Tobacco Products, Population Assessment of Tobacco and Health (PATH) Study, 2016, Wave 1 Adult Annotated Instrument, items AE1001, AE1099. Distributed October 21, 2020, by Inter-university Consortium for Political and Social Research, Ann Arbor, MI.

General References

Elton-Marshall, T., Driezen, P., Fong, G. T., Cummings, K. M., Persoskie, A., Wackowski, O., Choi, K., Kaufman, A., Strong, D., Gravely, S., Taylor, K., Kwan, J., Bansal-Travers, M., Travers, M., & Hyland, A. (2020). Adult perceptions of the relative harm of tobacco products and subsequent tobacco product use: Longitudinal findings from waves 1 and 2 of the Population Assessment of Tobacco and Health (PATH) Study. Addictive Behaviors, 106, 106337.

Fong, G. T., Elton-Marshall, T., Driezen, P., Kaufman, A. R., Cummings, K. M., Choi, K., Kwan, J., Koblitz, A., Hyland, A., Bansal-Travers, M., Carusi, C., & Thompson, M. E. (2019). U.S. adult perceptions of the harmfulness of tobacco products: descriptive findings from the 2013-14 baseline wave 1 of the PATH Study. Addictive Behaviors, 91, 180-187.

Protocol ID

330502

Variables
Export Variables
Variable Name Variable IDVariable DescriptiondbGaP Mapping
PX330502_Perception_Risk_Electronic_Cigarettes_Ever
PX330502010000 Have you ever seen or heard of an electronic more
cigarette or e-cigarette before this study? show less
N/A
PX330502_Perception_Risk_Electronic_Cigarettes_Harmful
PX330502020000 Is using e-cigarettes less harmful, about more
the same, or more harmful than smoking cigarettes? show less
N/A
Smoking Cessation, Harm Reduction and Biomarkers
Measure Name

Perception of Tobacco Product Risk

Release Date

February 23, 2021

Definition

Instrument used to assess respondents’ perception of how much they think people risk harming themselves by using tobacco products and the relative health risk between low-risk products and combustible cigarettes.

Purpose

The purpose of this measure is to collect information from respondents on their thoughts about the physical and health risk associated with using tobacco products. Perceptions of risk of tobacco products are important in predicting first use and continued use.

Keywords

Perceived harm, perceived risk, product risk, Population Assessment of Tobacco and Health, PATH, National Institutes of Health, NIH, U.S. Food and Drug Administration, FDA, Smoking Cessation, Harm Reduction, and Biomarkers, cigarettes, tobacco, e-cigarettes, cigars, pipe tobacco, smokeless tobacco