Protocol - Perception of Tobacco Product Harm - E-Cigarettes

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 harm 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.

Availability

Available

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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.
²Fontem Holdings 4 B.V.
³Smoking Everywhere LLC

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 Category	Required
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

Lifestage

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 U.S. 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

Standard	Name	ID	Source
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 ID	Variable Description	dbGaP 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 Harm

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 of the relative harm 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 harms associated with using tobacco products. Perceptions of harm of tobacco products are important in predicting first use and continued use.

Keywords

Perceived harm, product harm, 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

Measure Protocols

Protocol ID	Protocol Name
330501	Perception of Tobacco Product Harm - Cigarettes
330502	Perception of Tobacco Product Harm - E-Cigarettes
330503	Perception of Tobacco Product Harm - Cigars
330504	Perception of Tobacco Product Harm - Pipe Tobacco
330505	Perception of Tobacco Product Harm - Smokeless Tobacco

Publications

There are no publications listed for this protocol.