Protocol - Tobacco Warning Label Exposure and Recall
- Cigarette Smoking Status - Adolescent
- Cigarette Smoking Status - Adult
- Smoking Quit Attempts
- Tobacco - Age of Offset of Cigarette Use - Adolescent
- Tobacco - Age of Offset of Cigarette Use - Adult
Description
This protocol uses a combination of questions from the Population Assessment of Tobacco and Health (PATH) Study and the 2015 International Tobacco Control (ITC) 4-Country Survey instruments. Collectively, the questions are used to assess the effectiveness of health warnings on tobacco packages, which have been associated with perceptions of risk and may promote smoking cessation and reduce uptake among young people.
Specific Instructions
This protocol was systematically updated to reflect the Wave 7 data collection of the Population Assessment of Tobacco and Health (PATH) Study. This protocol will be formally reviewed by a TRR Content Expert Panel early in 2024.
The Population Assessment of Tobacco and Health (PATH) Study is an interviewer-administered survey, but the PhenX Working Group (WG) acknowledges that these questions can also be self-administered.
The WG recommends that for questions 2 through 4, the investigator should note the following:
- Do not read out list of labels. Select the codes for as many warning labels as respondent is able to describe.
- If respondent does not remember any warning labels, select 9 (Don’t know).
Continue to show prompt until respondent chooses "Don’t know." If response = 8 or 9, end questionnaire.
Availability
Protocol
Tobacco Warning Label Exposure and Recall
1. In the past 30 days, how often, if at all, have you read or looked closely at the health warnings on cigarette packages?…(1-5 scale, "Never" to "Very often")
1[ ]Never
2[ ]Rarely
3[ ]Sometimes
4[ ]Often
5[ ]Very often
-8[ ]DON’T KNOW
-7[ ]REFUSED
2. I want you to think about the health warnings that currently appear on the exterior of CIGARETTE PACKS. I’d like you to describe the first warning that comes to mind, if any.
[After first response, prompt:]
3. Please describe the next health warning that comes to mind.
[After second and any subsequent response, prompt:]
4. Do any others come to mind?
[Pre-coded checklist]
SURGEON GENERAL’S WARNING: Cigarette Smoke Contains Carbon Monoxide.
1[ ]Mentioned
2[ ]Not mentioned
7[ ]Not applicable
8[ ]Refused
9[ ]Don’t know
SURGEON GENERAL’S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
1[ ]Mentioned
2[ ]Not mentioned
7[ ]Not applicable
8[ ]Refused
9[ ]Don’t know
SURGEON GENERAL’S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
1[ ]Mentioned
2[ ]Not mentioned
7[ ]Not applicable
8[ ]Refused
9[ ]Don’t know
Personnel and Training Required
None
Equipment Needs
None
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
Self-administered or interviewer-administered questionnaire
Lifestage
Child, Adolescent, Adult
Participants
Adults and adolescents 12-17 years old
Selection Rationale
The Population Assessment of Tobacco and Health (PATH) Study is a nationally representative, longitudinal cohort study of nonusers and users of tobacco products and of 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. 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.
The health warning measures used in PATH are very similar to measures used in other countries, such as the International Tobacco Control (ITC) Survey.
The 2015 ITC 4-Country Survey is an international cohort study of tobacco use whose overall objective is to measure the psychosocial and behavioral impact of key national-level policies. This survey is being used in more than 20 countries.
Language
English, Other languages available at source
Standards
| Standard | Name | ID | Source |
|---|
Derived Variables
None
Process and Review
Not applicable.
Protocol Name from Source
Population Assessment of Tobacco and Health (PATH) Study: Final Adult Interview, Wave 7 (January 2022 - December 2022) & International Tobacco Control 4-Country Survey, 2015
Source
National Institutes of Health, U.S. Food and Drug Administration. (2023). Population Assessment of Tobacco and Health (PATH) Study: Final Adult Interview, Wave 7 (January 2022 – December 2022), English Data Collection Instrument. Bethesda, MD: National Institutes of Health.
PATH ID: R07_AR0095
Final_PATH_Wave_7_English_Adult_Questionnaire.pdf
International Tobacco Control Policy Evaluation Project. (2015). International Tobacco Control 4-Country Survey 2015, Wave 9, Items 154a, 154b, 154c and 154d.
General References
National Institutes of Health, U.S. Food and Drug Administration. (2023). Population Assessment of Tobacco and Health (PATH) Study: Final Adult Interview, Wave 7 (January 2022 – December 2022), English Data Collection Instrument. Bethesda, MD: National Institutes of Health. Final_PATH_Wave_7_English_Adult_Questionnaire.pdf
Protocol ID
730902
Variables
Export Variables| Variable Name | Variable ID | Variable Description | dbGaP Mapping |
|---|
Measure Name
Tobacco Warning Label Exposure and Recall
Release Date
December 22, 2023
Definition
Questions assessing exposure to health warnings and ability to recall message content.
Purpose
These questions help to assess the effectiveness of health warnings on tobacco packages, which have been associated with perceptions of risk and may promote smoking cessation and reduce uptake among young people.
Keywords
nicotine, agent, Tobacco Regulatory Research, TRR, health warning, health knowledge, Perceived risk, product labeling, Population Assessment of Tobacco and Health, PATH, label, warning, warning label, cigarette, cigarettes, behavior modification
Measure Protocols
| Protocol ID | Protocol Name |
|---|---|
| 730902 | Tobacco Warning Label Exposure and Recall |
Publications
There are no publications listed for this protocol.