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Protocol - Passive Exposures to Tobacco Products

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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 includes the National Adult Tobacco Survey (NATS) and the Population Assessment of Tobacco and Health (PATH) Survey. Collectively, the questions are used to assess a respondent’s exposure to smoke in different environments.

Protocol:

1. Not counting decks, porches, or garages, during the past 7 days, that is, since last [TODAY’S DAY OF WEEK], on how many days did someone other than you smoke tobacco inside your home while you were at home?

[ ] 0_ NUMBER OF DAYS

[ ] 88 NONE

[ ] 77 DON’T KNOW/NOT SURE

[ ] 99 REFUSED

2. Not counting decks, porches, or garages, inside your home, is smoking …?

[ ] 1 Always allowed

[ ] 2 Allowed only at some times or in some places

[ ] 3 Never allowed

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

Asked of respondents (who reported that no one else smoked tobacco in their home in the past 7 days and live in homes where smoking is never allowed) or (who reported that someone else smoked tobacco in their home in at least one of the past 7 days and live in homes where smoking is allowed at some times or in some places).

3. Not counting decks, porches, or garages, to your knowledge, during the past 7 days, that is, since last [TODAY’S DAY OF WEEK], has anyone, including yourself, smoked tobacco inside your home when he or she was not supposed to?

[ ] 1 YES

[ ] 2 NO

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

Now I am going to ask you about some questions about policies on tobacco use in the place where you work. But first, I need to know about your employment status.

4. Do you currently have one job or more than one job?

[ ] 1 ONE JOB

[ ] 2 MORE THAN ONE JOB

[ ] 7 DON’T KNOW

[ ] 9 REFUSED

Please answer the following questions for the job at which you spend the most time.

5. Most of the time, do you work…?

[ ] 01 Outdoors

[ ] 02 In a vehicle

[ ] 03 Indoors at home

[ ] 04 Indoors in a place like an office building, retail store, restaurant, or factory

[ ] 96 Somewhere else (Specify)

[ ] 77 DON’T KNOW/NOT SURE

[ ] 99 REFUSED

The next two questions refer to smoking in indoor areas. When answering the questions, please count your vehicle as an indoor area.

6. At your workplace, is smoking in indoor areas…?

[ ] 1 Always allowed

[ ] 2 Allowed only at some times or in some places

[ ] 3 Never allowed

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

7. At your workplace, is smoking in outdoor areas…?

[ ] 1 Always allowed

[ ] 2 Allowed only at some times or in some places

[ ] 3 Never allowed

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

8. At your workplace, is the use of chewing tobacco, snuff, dip, or snus …?

[ ] 1 Always allowed

[ ] 2 Allowed only at some times or in some places

[ ] 3 Never allowed

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

9. To your knowledge, during the past 30 days, that is, since [DATE FILL], has anyone, including yourself, used tobacco products of any kind, including electronic cigarettes, at your work when he or she was not supposed to?

[ ] 1 YES

[ ] 2 NO

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

Now we have two questions about smoking in vehicles.

10. During the past 7 days, that is, since last [TODAY’S DAY OF WEEK], on how many days did you ride in a vehicle where someone other than you was smoking tobacco?

[ ] 0_ NUMBER OF DAYS

[ ] 88 NONE

[ ] 77 DON’T KNOW/NOT SURE

[ ] 99 REFUSED

11. Not counting motorcycles, in the vehicles that you or family members who live with you own or lease, is smoking…

[ ] 1 Always allowed in all vehicles

[ ] 2 Sometimes allowed in at least one vehicle

[ ] 3 Never allowed in any vehicle

[DO NOT READ]

[ ] 8 RESPONDENT’S FAMILY DOES NOT OWN OR LEASE A VEHICLE

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

The next several questions ask about tobacco use in indoor and outdoor public places. Examples of indoor public places are the indoor areas of stores, restaurants, bars, casinos, clubs, and sports arenas. Examples of outdoor public places are stadiums and parks.

12. Not counting times while you were at work, during the past 7 days, that is, since last [TODAY’S DAY OF WEEK], on how many days did you breathe the smoke from someone else who was smoking in an indoor or outdoor public place?

[ ] 0_ NUMBER OF DAYS

[ ] 88 NONE

[ ] 77 DON’T KNOW/NOT SURE

[ ] 99 REFUSED

13. Not counting times while you were at work, to your knowledge, during the past 7 days, that is, since last [TODAY’S DAY OF WEEK], has anyone, including yourself, used tobacco of any kind in an indoor or outdoor public place when he or she was not supposed to?

[ ] 1 YES

[ ] 2 NO

[ ] 7 DON’T KNOW/NOT SURE

[ ] 9 REFUSED

Secondhand Smoke Exposure Section

The next questions ask about tobacco use at your workplace and your home.

14. Which best describes your current job or paid employment status?

[ ] 1

Work full-time at least 35 hours per week

[ ] 2

Work part-time 15 to 34 hours per week

[ ] 3

Work part-time less than 15 hours per week

[ ] 4

I don’t currently work for pay

[ ] -8

DON’T KNOW

[ ] -7

REFUSED

15. How recently did someone smoke around you while you were at work?

1 [ ] Never

2 [ ] Today

3 [ ] In the past week

4 [ ] In the past two weeks

5 [ ] In the past month

6 [ ] Longer than a month ago but within the past year

7 [ ] More than a year ago

[ ] -8 DON’T KNOW

[ ] -7 REFUSED

16. In your childhood, did you live with a regular smoker who smoked inside your home?

Please think about anyone who smoked cigarettes, cigars, a pipe, or hookah.

1 [ ] Yes

2 [ ] No

[ ] -8 DON’T KNOW

[ ] -7 REFUSED

The next questions ask about the rules of using tobacco inside your home.

17. Does anyone who lives with you now do any of the following? Choose all that apply.

1 [ ] Smoke cigarettes

2 [ ] Use smokeless tobacco, such as chewing tobacco, snuff, dip, or snus

3 [ ] Smoke cigars, cigarillos, or filtered cigars

4 [ ] Use any other form of tobacco, including electronic cigarettes

5 [ ] No one who lives with me now uses any form of tobacco

[ ] -8 DON’T KNOW

[ ] -7 REFUSED

18. During the past seven days, about how many hours were you around others who were smoking, whether or not you were smoking yourself?

Include time in your home, in a car, at school, or outdoors.

1 [ ] I I__I__I

[ ] -8 DON’T KNOW

[ ] -7 REFUSED

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e., tested by an expert) at the completion of personal interviews. The interviewer should be trained to prompt respondents further if a "don’t know" response is provided.

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:

For these protocols, "smoking" and/or "smoke tobacco" and/or "used tobacco" includes the following acts: smoking tobacco products that are burned (e.g., combustible cigarette, little cigar, cigarillo, and hookah/water pipe); but does NOT include vaping an electronic cigarette. In the Secondhand Smoke Exposure Section of the protocol, questions 17 & 19, vaping and electronic cigarette use is addressed by specifying it as a separate category of tobacco product.

In order to fully capture this measure, the Agent WG recommends that investigators also administer the questions from the Passive Smoke Exposure measure currently in the PhenX Toolkit.

Research Domain Information

Release Date:

June 24, 2015

Definition

Instrument used to assess a respondent’s exposure to smoke or exhaled electronic cigarette vapor/aerosol in different environments, including work, home, and social settings.

Purpose

This measure is necessary in estimating the physicochemical environmental exposures from tobacco products encountered by respondents and the population as a whole including users and nonusers of tobacco.

Selection Rationale

The combination of questions from different questionnaires is necessary because the Population Assessment of Tobacco and Health (PATH) extended interview asks respondents questions about burned (e.g., cigarettes) versus unburned (e.g., electronic cigarette) tobacco products. In addition, these measures have respondents:

  • specify the number of days there were exposed to smoke indoors, at work, at home, in transit, and in social settings during the last 7 days;
  • specify if indoor smoking is allowed and whether they think it should be allowed; and
  • specify where they work most of the time: outdoors, in a vehicle, indoors at home, indoors in places like an office building or store.

The National Adult Tobacco Survey (NATS) is a validated survey that yields data representative and comparable at both the national and state levels. The 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. PATH Study data will provide an evidence base for assessing and monitoring FDA’s current and future 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
Common Data Elements (CDE)Tobacco Use Passive Smoke Exposure Assessment Text4883591CDE Browser

Process and Review

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

Source

Office on Smoking and Health (OSH), National Center for Chronic Disease Promotion and Health Prevention, Centers for Disease Control and Prevention. (2009). Questions 73-75, 77-84, 87, and 90. In National Adult Tobacco Survey Questionnaire, 2009-2010. Atlanta, GA: Author.

National Institute on Drug Abuse, National Institutes of Health, Department of Health and Human Services & Food and Drug Administration, Department of Health and Human Services. (2013, June 18). Population Assessment of Tobacco and Health (PATH), 2013: PATH Adult Extended Questionnaire, Version 7.5 (PATH ID: AM0014, AX0065, AR0144, AX0066, AX0068). Washington, DC: Author.

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:

730401

Variables:

Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX730401_Days_Someone_Smoke_Inside_HomePX730401010100Not counting decks, porches, or garages, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did someone other than you smoke tobacco inside your home while you were at home?4N/A
PX730401_Days_Someone_Smoke_Inside_HomeDaysPX730401010200Not counting decks, porches, or garages, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did someone other than you smoke tobacco inside your home while you were at home?4N/A
PX730401_Inside_Home_Smoking_IsPX730401020000Not counting decks, porches, or garages, inside your home, is smoking ¿¿¿?4N/A
PX730401_Past7Days_Anyone_Smoked_Tobacco_InsideNotSupposeToPX730401030000Not counting decks, porches, or garages, to your knowledge, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], has anyone, including yourself, smoked tobacco inside your home when he or she was not supposed to?4N/A
PX730401_Currently_Have_OneorMore_JobPX730401040000Do you currently have one job or more than one job?4N/A
PX730401_Most_Of_Time_DoYou_WorkPX730401050000Most of the time, do you work¿¿¿?4N/A
PX730401_Workplace_Smoking_Indoor_AreasPX730401060000At your workplace, is smoking in indoor areas¿¿¿?4N/A
PX730401_Workplace_Smoking_Outdorr_AreasPX730401070000At your workplace, is smoking in outdoor areas¿¿¿?4N/A
PX730401_Workplace_Use_ChewingTobacco_Dip_SmokelessPX730401080000At your workplace, is the use of chewing tobacco, snuff, dip, or snus ¿¿¿?4N/A
PX730401_Pas30Days_HasAnyone_UsedTobacco_Work_NotSupposeTOPX730401090000To your knowledge, during the past 30 = days, that is, since [DATE FILL], has anyone, including yourself, used tobacco products of any kind, including electronic cigarettes, at your work when he or she was not supposed to?4N/A
PX730401_Pas7Days_Ride_Vehicle_SomeoneSmokingPX730401100100During the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did you ride in a vehicle where someone other than you was smoking tobacco?4N/A
PX730401_Pas7Days_Ride_Vehicle_SomeoneSmoking_DaysPX730401100200During the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did you ride in a vehicle where someone other than you was smoking tobacco?4N/A
PX730401_NotMotorcycles_Vehicles_Family_Smoking_AllowedPX730401110000Not counting motorcycles, in the vehicles that you or family members who live with you own or lease, is smoking¿¿¿4N/A
PX730401_NotWork_7Days_BreatheSmoke_SomeElse_SmokingPX730401120100Not counting times while you were at work, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did you breathe the smoke from someone else who was smoking in an indoor or outdoor public place?4N/A
PX730401_NotWork_7Days_BreatheSmoke_SomeElse_SmokingDaysPX730401120200Not counting times while you were at work, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], on how many days did you breathe the smoke from someone else who was smoking in an indoor or outdoor public place?4N/A
PX730401_NotWork_7Days_AnyoneTobacco_NotSupposedToPX730401130000Not counting times while you were at work, to your knowledge, during the past 7 days, that is, since last [TODAY¿¿¿S DAY OF WEEK], has anyone, including yourself, used tobacco of any kind in an indoor or outdoor public place when he or she was not supposed to?4N/A
PX730401_Best_Describes_CurrentJob_StatusPX730401140000Which best describes your current job or paid employment status?4N/A
PX730401_How_Recently_Someone_Smoke_AroundYouWorkPX730401150000How recently did someone smoke around you while you were at work?4N/A
PX730401_Your_Childhood_LiveWith_Smoker_InsidePX730401160000In your childhood, did you live with a regular smoker who smoked inside your home?4N/A
PX730401_Anyone_LivesWith_YouNow_DoFollowing_ChooseAllApplyPX730401170000Does anyone who lives with you now do any of the following? Choose all that apply.4N/A
PX730401_Past7Days_Hours_Around_Smoking_CarPX730401180101During the past seven days, about how many hours were you around others who were smoking, whether or not you were smoking yourself?4N/A
PX730401_Past7Days_Hours_Around_Smoking_SchoolPX730401180102During the past seven days, about how many hours were you around others who were smoking, whether or not you were smoking yourself?4N/A
PX730401_Past7Days_Hours_Around_Smoking_OutdoorsPX730401180103During the past seven days, about how many hours were you around others who were smoking, whether or not you were smoking yourself?4N/A
PX730401_Past7Days_Hours_Around_Smoking_EncodedPX730401180200During the past seven days, about how many hours were you around others who were smoking, whether or not you were smoking yourself?4N/A