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Protocol - Tobacco Warning Label Exposure and Recall

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Protocol Name from Source:

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

Availability:

Publicly available

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.

Protocol:

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

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

Interviewers must be trained and found competent to conduct personal interviews with individuals from the general population.

Equipment Needs

None.

Requirements

Requirement CategoryRequired
Average time of greater than 15 minutes in an unaffected individualNo
Major equipmentNo
Specialized requirements for biospecimen collectionNo
Specialized trainingNo

Mode of Administration

Self-administered

Life Stage:

Child, Adolescent, Adult

Specific Instructions:

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.

Research Domain Information

Release Date:

June 24, 2015

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.

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, Spanish

Standards

StandardNameIDSource
Common Data Elements (CDE)Tobacco Use Warning Label Exposure Assessment Scale4883794CDE Browser
Common Data Elements (CDE)Tobacco Use Warning Label Recall Assessment Text4883878CDE Browser

Process and Review

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

Source

Department of Health and Human Services, National Institutes of Health, National Institute on Drug Abuse, Food and Drug Administration. (2013). Population Assessment of Tobacco and Health (PATH). PATH Adult Extended Questionnaire, Version 7.5. (PATH ID: AR0202)

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

Protocol ID:

730901

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX730901_HealthWarnings_Past30Days_CigarettePackagesPX730901010000In 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¿¿¿)4N/A
PX730901_HealthWarnings_CigarettePacks_Exterior_Describe_FirstPX730901020000I 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.4N/A
PX730901_HealthWarnings_CigarettePacks_Exterior_Describe_NextPX730901030000Please describe the next health warning that comes to mind.4N/A
PX730901_HealthWarnings_CigarettePacks_Exterior_Describe_OthersPX730901040000Do any others come to mind?4N/A
PX730901_HealthWarnings_SurgeonGenerals_Warning_CarbonMonoxidePX730901050000SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide.4N/A
PX730901_HealthWarnings_SurgeonGenerals_Warning_QuittingPX730901060000SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.4N/A
PX730901_HealthWarnings_SurgeonGenerals_Warning_CancerEtcPX730901070000SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.4N/A