Study: Adults (Ages 26+)

Investigation of Consumer Perceptions of Expressed Modified Risk Claims

6. Expressed Claims Questionnaire_OMB

Study: Adults (Ages 26+)

OMB: 0910-0873

Document [docx]
Download: docx | pdf

OMB#0910-XXXX

Exp:xx/xx/xxxx


ATTACHMENT 6. EXPRESSED CLAIMS QUESTIONNAIRE

Contents

Section Page



FDA Expressed Claims Questionnaire

[PROGRAMMING NOTES:

  • Response numbers in parentheses should be programmed but not shown on the screen. Response numbers without parenthesis should be shown on the screen.

  • All questions should appear on separate pages. When instructions should be on a separate page from the questions that come before and after the instructions, this is noted with “next page”

  • Participants may refuse to answer any question by clicking to the next page. When participants refuse to answer a question, show “Prefer not to answer” as an additional response option and provide a prompt to check that option if they want to skip the question.

  • Prompt: Please answer the question or click “Prefer not to answer” if you need to skip it.

  • EC‑Q#=ONLY ASK FOR E‑CIGARETTE CONDITION (Conditions 1-6 and 31-36)

  • ST‑Q#=ONLY ASK FOR SNUFF CONDITION (Conditions 7-30 and 37-60)

  • S# or Q# (no prefix) = ADMINISTERED TO ALL PARTICIPANTS UNLESS OTHERWISE NOTED

  • Don’t display question numbers

  • For “product name” and “BRAND NAME PRODUCT,” display brand and product type

  • blu e-cigarettes

  • MarkTen e-cigarettes

  • Vuse e-cigarettes

  • Copenhagen snuff

  • Grizzly snuff

  • Skoal snuff

  • For “package/ad” or “a package of/an advertisement for” display “package” or “a package of” for conditions 1-30. Display “ad” or “an advertisement for” for conditions 31-60. For “it” or “them”, display “it” for conditions 7-30 and 37-60. Display “them” for conditions 1-6 and 31-36.

  • For questions specifying FILL “snuff” OR “e-cigarettes”, fill “snuff” for conditions 7-30 AND 37-60. Fill “e-cigarettes” for conditions 1-6 AND 31-36.

  • For questions specifying “cancer/ lung disease” display “cancer” for conditions 1-6 and 31-36. Display “lung disease” for conditions 7-30 and 37-60.

  • **Add 5 screen timing variables (in milliseconds):

  • First stimuli exposure screen

  • Second stimuli exposure screen

  • Debriefing information screen

  • Add a Survey Start time variable and a survey End time variable.











  1. Random Assignment

[IF S3=3 OR 99 (not current e‑cigarette user) AND S4=3 OR 99 (not current snuff user),

RANDOMLY ASSIGN TO VIEW ONE of the E‑CIGARETTE OR SNUFF conditions 1-60]

[IF S3=3 OR 99 (not current e‑cigarette user) AND S4=1 OR 2 (current snuff user),

RANDOMLY ASSIGN TO VIEW ONE of the SNUFF conditions 7-30 AND 37-60]

[IF S3=1 OR 2 (current e‑cigarette user) AND S4=3 OR 99 (not current snuff user),

RANDOMLY ASSIGN TO VIEW ONE of the E‑CIGARETTE conditions 1-6 AND 31-36]

[IF S3=1 OR 2 (current e‑cigarette user) AND S4=1 OR 2 (current snuff user) AND QUOTA

NOT MET FOR SNUFF CONDITION, RANDOMLY ASSIGN TO VIEW ONE of the SNUFF conditions; OTHERWISE, RANDOMLY ASSIGN TO VIEW ONE of the E‑CIGARETTE conditions]

[IF S2 = 1 OR 2 (current cigarette user) AND S3=1 OR 2 (current e‑cigarette user) AND S4=1 OR 2 (current snuff user) AND QUOTA NOT MET FOR SNUFF CONDITION, RANDOMLY ASSIGN TO VIEW ONE of the SNUFF conditions (7-30 AND 37-60); OTHERWISE, RANDOMLY ASSIGN TO VIEW ONE of the E‑CIGARETTE conditions (1-6 AND 31-36)]




  1. Identification of Susceptible Populations

[Ever Tobacco Use]

[INTRO PAGE, STATING]:

Now, we will ask you a few more questions about your use of tobacco products.

[NEXT PAGE]

[Smoking]

[If S2=3, ASK Q1; OTHERWISE, GO TO Q2]

Q1. Have you ever smoked a cigarette, even one or two puffs?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: Adapted from PATH)

[IF S2=1 OR 2 OR Q1=1, ASK Q2; OTHERWISE GO TO Q6]

Q2. On how many of the past 30 days did you smoke a cigarette?

(1) |__|__| Days [allow 0-30]

(99) Prefer not to answer

(Source: NHIS)

[IF Q2=0, GO TO Q6; OTHERWISE, ASK Q3]

Q3. Not counting today, how many cigarettes did you smoke on the last day you smoked? A pack usually has 20 cigarettes in it. Your best estimate is fine.

(1) |__|__| Number of cigarettes [allow 1-99]

(99) Prefer not to answer

(Source: Adapted from PATH)

[IF S2=1 OR 2, ASK Q4; OTHERWISE GO TO Q6]

Q4. On the days that you smoke cigarettes, would you say you smoke your first cigarette of the day within the first 30 minutes after you wake up?

(1) Yes

(2) Sometimes

(3) No

(99) Prefer not to answer

(Source: Adapted from PATH)

Q5. Which of the following describes you?

(1) I don’t want to stop smoking cigarettes.

(2) I think I should stop smoking cigarettes but don’t really want to.

(3) I want to stop smoking cigarettes but haven’t thought about when.

(4) I REALLY want to stop smoking cigarettes but I don’t know when I will.

(5) I want to stop smoking cigarettes and hope to soon.

(6) I REALLY want to stop smoking cigarettes and intend to in the next 3 months.

(7) I REALLY want to stop smoking cigarettes and intend to in the next month.

(99) Prefer not to answer.

(Source: Kotz et al., 2013)

[E‑cigarette Use]

[INTRO PAGE, STATING]:

We will now ask you about using e‑cigarettes (including vape pens, e‑hookahs, hookah pens, personal vaporizers, mods, tanks, e‑pipes, and e‑cigars). Please do not include using e‑cigarettes to vape marijuana or hash oil in your answers.


[NEXT PAGE]

[If S3=3, ASK Q6; OTHERWISE, GO TO Q7]

Q6. Have you ever used an e‑cigarette [EC ROLLOVER: E‑cigarettes include vape pens, e‑hookahs, hookah pens, personal vaporizers, mods, tanks, e‑pipes, and e‑cigars], even one or two times?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: Adapted from PATH)

[IF S3=1 OR 2 OR Q6=1, ASK Q7; OTHERWISE GO TO Q15]

Q7. On how many of the past 30 days did you use an e‑cigarette [EC ROLLOVER]?

(1) |__|__| Days [allow 0-30]


(99) Prefer not to answer

(Source: NHIS)

[IF Q7=0, GO TO Q15; OTHERWISE, ASK Q8]

Q8. How many times per day do you usually use your e‑cigarette [EC ROLLOVER]?

(1) 0-4 times per day

(2) 5-9 times per day

(3) 10-14 times per day

(4) 15-19 times per day

(5) 20-29 times per day

(6) 30 or more times per day

(99) Prefer not to answer

(Source: RTI internal e‑cig survey)

(FDA rating: 2, maybe cut)

[IF S3=1 OR 2, ASK Q9; OTHERWISE GO TO Q15]

Q9. On the days that you use an e‑cigarette [EC ROLLOVER], would you say you use it within the first 30 minutes after you wake up?

(1) Yes

(2) Sometimes

(3) No

(99) Prefer not to answer

(Source: Adapted from PATH)

Q10. Which of the following describes you?

(1) I don’t want to stop using e‑cigarettes.

(2) I think I should stop using e‑cigarettes but don’t really want to.

(3) I want to stop using e‑cigarettes but haven’t thought about when.

(4) I REALLY want to stop using e‑cigarettes but I don’t know when I will.

(5) I want to stop using e‑cigarettes and hope to soon.

(6) I REALLY want to stop using e‑cigarettes and intend to in the next 3 months.

(7) I REALLY want to stop using e‑cigarettes and intend to in the next month.

(99) Prefer not to answer.

(Source: Kotz et al., 2013)

Q12. When you use an e-cigarette [EC ROLLOVER], how often do you use it with nicotine?

(1) Always

(2) Sometimes

(3) Never

(4) Don’t Know

(99) Prefer not to answer

(Source: Adapted from PATH)

Q13. Do you have a regular e‑cigarette [EC ROLLOVER] brand that you use most?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: FDA Peer Reviewers)

[If Q13=1, ASK Q14; otherwise, go to Q15]

Q14. What e‑cigarette [EC ROLLOVER] brand do you use most?

  1. blu

  2. JUUL

(2) Logic

(3) MarkTen

(4) NJOY

(5) Vuse

(6) Something else (please specify): [allow fill-in]

(7) Don’t know

(99) Prefer not to answer

(Source: FDA Peer Reviewers)

Q14_N. Do you now use any e-liquid that is flavored to taste like tobacco?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: FDA Peer Reviewers)

[snuff]

[INTRO PAGE, STATING]:

Next, we will ask you about using snuff (also called smokeless tobacco, dip, and snus).

[NEXT PAGE]

[If S4=3, ASK Q15; OTHERWISE, GO TO Q16]

Q15. Have you ever used snuff [ST ROLLOVER: also called smokeless tobacco, dip, and snus], even one or two times?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: Adapted from PATH)

[If S4=1 OR 2 or Q15=1, ASK Q16; otherwise, go to Q23]

Q16. On how many of the past 30 days did you use snuff [ST ROLLOVER]?

(1) |__|__| Days [allow 0-30]

(99) Prefer not to answer

(Source: NHIS)

[IF Q16=0, GO TO Q23; OTHERWISE, ASK Q17]

Q17. Not counting today, how many times did you use snuff [ST ROLLOVER] on the last day that you used it?

(1) |__|__| Number of occasions [allow 01-99]

(99) Prefer not to answer

(Source: Adapted from PATH)

(FDA rating: 2, maybe cut)

[If S4=1 OR 2, ASK Q18; otherwise, go to Q23]

Q18. On the days that you use snuff [ST ROLLOVER], would you say you use it within the first 30 minutes after you wake up?

(1) Yes

(2) Sometimes

(3) No

(99) Prefer not to answer

(Source: Adapted from PATH)

Q19. Which of the following describes you?

(1) I don’t want to stop using snuff.

(2) I think I should stop using snuff but don’t really want to.

(3) I want to stop using snuff but haven’t thought about when.

(4) I REALLY want to stop using snuff but I don’t know when I will.

(5) I want to stop using snuff and hope to soon.

(6) I REALLY want to stop using snuff and intend to in the next 3 months.

(7) I REALLY want to stop using snuff and intend to in the next month.

(99) Prefer not to answer.

(Source: Kotz et al., 2013)

Q20. Do you have a regular brand of snuff [ST ROLLOVER] that you use most?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: FDA Peer Reviewers)

[If Q20=1, ASK Q21; otherwise, go to Q23]

Q21. What brand of snuff [ST ROLLOVER] do you use most?

(1) Camel snus

(2) Copenhagen

(3) Grizzly

(4) Skoal

(5) Skoal X-tra

(6) Something else (please specify): [allow fill-in]

(7) Don’t know

(99) Prefer not to answer

(Source: FDA Peer Reviewers)

[Do not allow selection of 1-5 and 6]

Q22. Do you now use any snuff [ST ROLLOVER] that is flavored to taste like wintergreen or mint (including, for example, spearmint, ice, or menthol)?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: Adapted from PATH)

[IF S5=3, ASK Q23; OTHERWISE, GO TO Q24]

Q23 INTRO: Next, we are going to ask you a question about a few other tobacco products.

[NEXT PAGE]

Q23. Have you ever smoked a cigar, cigarillo, or little cigar, even one or two puffs?

(1) Yes

(2) No

(99) Prefer not to answer (offer for each item)

(Source: Adapted from PATH)

[IF S6=3, ASK Q24; OTHERWISE, GO TO Q25]

Q24. Have you ever smoked tobacco in a hookah or water pipe, even one or two puffs?

(1) Yes

(2) No

(99) Prefer not to answer (offer for each item)

(Source: Adapted from PATH)





  1. Perceived Relative Risk of Product Type

[Perceived Relative Risk Versus Cigarettes]

Q25 INTRO: Now, we will ask you about the harms of [FILL snuff or e‑cigarettes] compared to cigarettes.

[NEXT PAGE]

Q25. Compared to smoking cigarettes, how harmful is using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)]?

Much less harmful
1

Less harmful
2

Just as harmful
3

More harmful
4

Much more harmful
5


(99) Prefer not to answer

(Source: Adapted from HINTS-FDA to match wording for specific products)

  1. Certainty/Skepticism

[Certainty]

Q26. How certain are you of your belief that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is [FILL IN RESPONSE FROM EC‑Q25: more harmful than/ less harmful than/ just as harmful as] smoking cigarettes?

Not at all certain
1

Not very certain
2

Somewhat certain
3

Very certain
4

Extremely certain
5

(99) Prefer not to answer

(Source: Adapted from Tormala et al., 2009)

Q27. How sure are you that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is [FILL IN RESPONSE FROM Q25: more harmful than/ less harmful than/ just as harmful as] smoking cigarettes?

Not at all sure
1

Not very sure
2

Somewhat sure
3

Very sure
4

Extremely sure
5

(99) Prefer not to answer

(Source: Adapted from Tormala et al., 2009)

Q28. How firm are your beliefs that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is [FILL IN RESPONSE FROM Q25: more harmful than/ less harmful than/ just as harmful as] smoking cigarettes?

Not at all firm
1

Not very firm
2

Somewhat firm
3

Very firm
4

Extremely firm
5

(99) Prefer not to answer

(Source: Adapted from Tormala et al., 2009)

Q29. Overall, how confident are you in your belief that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is [FILL IN RESPONSE FROM Q25: more harmful than/ less harmful than/ just as harmful as] smoking cigarettes?

Not at all confident
1

Not very confident
2

Somewhat confident
3

Very confident
4

Extremely confident
5

(99) Prefer not to answer

(Source: Adapted from Tormala et al., 2009)

Q30. How hard would it be for someone to change your current belief that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is [FILL IN RESPONSE FROM Q25: more harmful than/ less harmful than/ just as harmful as] smoking cigarettes?

Not at all hard
1

Not very hard
2

Somewhat hard
3

Very hard
4

Extremely hard
5

(99) Prefer not to answer

(Source: Adapted from Tormala et al., 2009)

[Skepticism]

Q32 INTRO: Please indicate how much you disagree or agree with the following statements:

Q32. The medical evidence that using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] is harmful is exaggerated.

Strongly disagree
1

Somewhat disagree
2

Neither agree nor disagree
3

Somewhat agree
4

Strongly agree
5

(99) Prefer not to answer

(Source: Adapted from Oakes et al., 2004)

Q33. Using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] cannot be all that bad for you because many people who use [FILL it or them] live healthy lives.

Strongly disagree
1

Somewhat disagree
2

Neither agree nor disagree
3

Somewhat agree
4

Strongly agree
5

(99) Prefer not to answer

(Source: Adapted from Oakes et al., 2004)

Q34. Using [FILL snuff (ST ROLLOVER) or e‑cigarettes (EC ROLLOVER)] cannot be that bad because top sports people use [FILL it or them] and still perform well.

Strongly disagree
1

Somewhat disagree
2

Neither agree nor disagree
3

Somewhat agree
4

Strongly agree
5

(99) Prefer not to answer

(Source: Adapted from Oakes et al., 2004)





  1. First Stimuli Exposure

The rest of this survey is about a specific brand of [e-cigarettes/snuff]. You will see the specific brand on the next page.


Please look at the image on the next page very carefully, as the rest of the survey is based on this image. Please take as much time as you need to look at it. You will be able to move to the next page in 10 seconds.


[NEXT PAGE]



[Display stand-alone image of package/advertisement for product that matches participant’s condition (assigned on page 6). Display stimuli for 10 seconds before a “Next” button appears on the screen.]



[NEXT PAGE]





  1. Perceived Absolute Risk of Product

[Display image of product pack only. No condition will show an ad.]



We will now ask you to rate the risk of getting different health problems from using [PRODUCT NAME]. This is not a test of your scientific knowledge. We just want to know your opinions. If you aren't sure how to answer, give your best guess.



[NEXT PAGE]



[Display image of product pack only. No condition will show an ad.]

Q36. If you were to use [product name] every day, how likely is it that you would…

[Randomize presentation of items in matrix]

#



Not at all likely

1


Slightly likely

2


Somewhat likely

3


Very likely

4


Extremely likely

5

Q36_1

Harm your overall health

Q36_2

Have a shorter life

Q36_3

Get sick often

Q36_4

Get lung cancer

Q36_5

Get mouth cancer

Q36_6

Get a life-threatening disease

Q36_7

Have heart problems

Q36_8

Get addicted

Q36_9

Have breathing problems

Q36_10

Damage your teeth

(99) Prefer not to answer (offer for each item)

(Source: FDA-CTP)





  1. Second Stimuli Exposure



On the next page, we’re going to show you the [e-cigarette/snuff] [ad/package] you first saw again to remind you of what specific product we’re asking you questions about. Please look at it carefully. The rest of the questions are about this image.

[NEXT PAGE]



[Display stand-alone image of package/advertisement for product that matches participant’s condition (assigned on page 7). Display stimuli for 5 seconds before a “Next” button appears on the screen. NOTE THAT PARTIPANTS WHO FIRST SAW AN AD WILL SEE THE SAME AD AGAIN HERE.]



[NEXT PAGE]





  1. Perceived Relative Risk of Product

[Compared to Cigarettes]

[INTRO PAGE, STATING]:

We will now ask you to compare different products or situations.


For the next questions, imagine you use one of these products every day:

[display image of product pack VS image of pack of cigarettes]


We will ask you to pick the product that you think would make it more likely that you would get each health problem.


[NEXT PAGE]



[Present Q37-Q41 in randomized order.]



[display image of product pack VS image of pack of cigarettes with question]

Q37. If you either used [product name] OR cigarettes every day, which product would make it more likely that you would…

[Randomize presentation of items in matrix]

#


MUCH more likely with [product name]

1

More likely with [product name]

2

Equally likely

3

More likely with cigarettes

4

MUCH more likely with cigarettes

5

Q37_1

Damage your teeth

Q37_2

Get mouth sores

Q37_3

Get tooth decay

Q37_4

Get gum disease

Q37_5

Get stomach ulcers

Q37_6

Get mouth irritation

Q37_7

Get mouth cancer

Q38_1

Get the common cold or flu

Q38_2

Damage your lungs

Q38_3

Get pain in your lungs

Q38_4

Get lung disease

Q38_5

Get asthma

Q38_6

Get emphysema (A disease where the air sacs in your lungs are damaged, making it hard to breathe)

Q38_7

Get bronchitis

Q39_1

Crave the product all the time

Q39_2

Get lung cancer

Q39_3

Get stomach cancer

Q39_4

Get pancreatic cancer

Q39_5

Cough often

Q39_6

Get hooked

Q39_7

Irritate your throat

Q39_8

Get shortness of breath

Q40_1

Get high blood pressure

Q40_2

Have a heart attack

Q40_3

Have a stroke

Q40_4

Get heart disease

Q40_5

Have trouble stopping using the product

Q40_7

Get diabetes

Q41_1

Harm your overall health

Q41_2

Have a shorter life

Q41_3

Get sick often

Q41_4

Get cancer

Q41_5

Get a life-threatening disease

Q41_6

Have heart problems

Q41_7

Get addicted

Q41_8

Have breathing problems

(99) Prefer not to answer (offer for each item)

(Source: CTP)







Q42 INTRO: We will now ask you to do something new.


[new line] For the next questions, imagine a woman who is pregnant and uses one of these products every day:


[display image of product pack VS image of pack of cigarettes]


We will ask you to pick the product that you think would make the pregnant woman more likely to have the following health problems.


[NEXT PAGE]




[display image of product pack VS image of pack of cigarettes with question]


Q42. Imagine that a woman was pregnant and either used [product name] OR cigarettes every day. Which product would make it more likely that…

[Randomize presentation of items in matrix]

#



MUCH
more likely with [product name]

1


More likely with [product name]

2


Equally likely

3


More likely with cigarettes

4


MUCH more likely with cigarettes

5

Q42_1

The baby would be harmed before it is born

Q42_2

The woman would have a miscarriage

Q42_3

The baby would be born too early

Q42_4

The baby would be born too small

Q42_5

The baby would have a birth defect

(99) Prefer not to answer (offer for each item)

(Source: CTP)





[Compared to NRT]


Q43 INTRO: Now we are going to ask you to make a different comparison.


Imagine that you use one of these products every day, and it is the only tobacco or nicotine product that you use:

[display image of product pack VS image of nicotine replacement products]

On the next page, we will ask you to pick the product that you think would make it more likely that you get each health problem.


We know these questions might have started to feel repetitive, but we appreciate you continuing with the survey!

[NEXT PAGE]



[display image of product pack VS image of nicotine replacement products with question]


Q43. Imagine you used either [product name] OR nicotine replacement therapy (NRT) every day, and no other nicotine or tobacco products. Which product would make it more likely that you would…

[Randomize presentation of items in matrix]

#



MUCH
more likely with [product name]

1


More likely with [product name]

2


Equally likely

3


More likely with NRT

4


MUCH more likely with NRT

5

Q43_1

Harm your overall health

Q43_2

Have a shorter life

Q43_3

Get sick often

Q43_4

Get cancer

Q43_5

Get a life-threatening disease

Q43_6

Have heart problems

Q43_7

Get addicted

Q43_8

Have breathing problems

Q43_9

Damage your teeth

(99) Prefer not to answer (offer for each item)

(Source: CTP)



[Compared to Quitting all Tobacco]

Q44 INTRO: Now, we are going to ask you to compare two different situations.


Imagine that you either use only the product below or that you stop using all nicotine and tobacco products completely.


[display image of text box containing product image pack with “Completely switch to:” written above product pack image VS no tobacco image]



[NEXT PAGE]

Q44. Imagine that you either:

[display image of text box containing product image pack with “Completely switch to:” written above product image VS no tobacco image with question]

Which situation would make it more likely that you would…

[Randomize presentation of items in matrix]

#



MUCH
more likely with
[product name]

1


More likely with
[product name]

2


Equally likely

3


More likely with quitting all tobacco

4


MUCH more likely with quitting all tobacco

5

Q44_1

Harm your overall health

Q44_2

Have a shorter life

Q44_3

Get sick often

Q44_4

Get cancer

Q44_5

Get a life-threatening disease

Q44_6

Have heart problems

Q44_7

Have breathing problems

Q44_8

Damage your teeth

(99) Prefer not to answer (offer for each item)

(Source: CTP)



  1. Intention to Use Specific Products

Q45 INTRO: Now we will ask you just a few more questions about the [product name] that you saw.

[NEXT PAGE]

Q45. If one of your best friends were to offer you [product name], would you use it?

Definitely not
1

Probably not
2

Probably yes
3

Definitely yes
4

(99) Prefer not to answer

(Source: Adapted from PATH, originally Pierce et al., 1996)

Q46. Do you think you will buy [product name]?

Definitely not
1

Probably not
2

Probably yes
3

Definitely yes
4

(99) Prefer not to answer

(Source: Adapted from PATH, originally Pierce et al., 1996)

Q47. Do you think you will use [product name] soon?

Definitely not
1

Probably not
2

Probably yes
3

Definitely yes
4

(99) Prefer not to answer

(Source: Adapted from PATH, originally Pierce et al., 1996)

Q48. Do you think you will use [product name] any time in the next year?

Definitely not
1

Probably not
2

Probably yes
3

Definitely yes
4

(99) Prefer not to answer

(Source: Adapted from PATH, originally Pierce et al., 1996)

  1. Manipulation Check

[CLAIM RECALL – AIDED]

M1. Which of the following, if any, appeared on the [e-cigarette/snuff] [package/ad] that you saw?



[RANDOMIZE ORDER BUT KEEP ‘None of these statements…’ AT THE END OF THE LIST.]

(1) [CORRECT] If cigarette smokers switch completely to this product, they can lower their risk of [cancer/lung disease].

(2) [FOIL] This product is safer than cigarettes.

(3) [FOIL] This product contains fewer harmful chemicals than cigarettes.

(4) [FOIL] If cigarette smokers switch completely to this product, they can reduce their exposure to harmful chemicals.

(5) [FOIL] None of these statements were on the [package/ad].

(99) Prefer not to answer



(Source: Created by RTI based on instructions from CTP)

[NEXT PAGE]

M2. Imagine that [an e-cigarette/a snuff] [ad/package] said,



“If cigarette smokers switch completely to this product, they can lower their risk of [cancer/lung disease].”



Describe what this statement means to you in your own words.

[allow fill-in]

(99) Prefer not to answer

(Source: Created by RTI based on instructions from CTP)





  1. Demographics

Q49 Intro: Next, we are going to ask you a few more questions about yourself.

[NEXT PAGE]

Q49. How many children under the age of 12 live in your household?

(1) |__|__| Number of children under 12

(99) Prefer not to answer

(Source: Adapted from HINTS)

Q51. What category best describes you? Choose all that apply.

(1) White

(2) Hispanic, Latino, or Spanish

(3) Black or African American

(4) Asian

(5) American Indian or Alaska Native

(6) Middle Eastern or North African

(7) Native Hawaiian or other Pacific Islander



(Source: FDA CTP Peer Reviewers)

Q52. Are you currently serving in the U.S. Armed Forces?

(1) Yes

(2) No

(99) Prefer not to answer

(Source: FDA CTP Peer Reviewers)





[Sexual Identity]

Q55. Which of the following best describes you?

(1) Female

(2) Male

(3) Additional category

(99) Prefer not to answer

(Source: Adapted from RTI marijuana survey)



Q56. Do you think of yourself as…

(1) Straight

(2) Lesbian or gay

(3) Bisexual

(4) Queer

(5) Something else

(99) Prefer not to answer

(Source: PATH)

[NEXT PAGE]

  1. Administer Debriefing

[RANDOMIZE PARTICIPANTS TO ONE OF FOUR DEBRIEFING CONDITIONS:

1 SIMPLE TEXT,

2 STANDARD TEXT,

3 SIMPLE BUBBLES, OR

4 STANDARD BUBBLES


THE BUBBLES VERSION WILL INCLUDE THE SAME TEXT AS THE TEXT VERSION BUT WILL DISPLAY CONTENT IN DISTINCT BUBBLES]



[SIMPLE TEXT]:


Thank you for taking this survey. This survey was done for the Food and Drug Administration (FDA). FDA studies people’s beliefs about tobacco and nicotine products. This study looked at what people thought of different tobacco product labels and ads.


We wanted to know what you thought about a [BRAND NAME PRODUCT] [package/ ad].


[Continue with the following text for claim conditions only]:


The [package/ ad] claimed that smokers can lower their [cancer/ lung disease] risk if they switch to [product name]. This claim was made up for this study. The makers of [BRAND NAME PRODUCT] do not say this. This claim is not written on [BRAND NAME PRODUCT]s sold in stores. We showed you this claim to see how it might change your beliefs about [BRAND NAME PRODUCT]. We also wanted to know if it would make you want to use [BRAND NAME PRODUCT]. We picked [BRAND NAME PRODUCT] to study because a lot of people use it.


[Continue with the following text for e‑cigarette conditions only]:


For smokers, completely switching from cigarettes to e‑cigarettes can lower their risk of getting a disease from tobacco. Using e‑cigarettes still has risks. As e‑cigarette warning labels state, the product contains nicotine, which is addictive.


[Continue with the following text for snuff conditions only]:


For smokers, completely switching from cigarettes to snuff can lower their risk of getting a disease from tobacco. Using snuff still has risks. As snuff warning labels state, smokeless tobacco (snuff) is addictive and can cause mouth cancer, gum disease, and tooth loss.


If you have concerns about this study, please contact FDA at 301‑796‑9605 or RIHSC@fda.hhs.gov.


The best thing for your health is to quit using all tobacco products. This includes cigarettes, snuff, and e‑cigarettes.


Quitting can be hard, but you should still try. Quitting takes practice. You are more likely to succeed if you keep trying, use medication, get help from a doctor, and get support from loved ones. Setting a quit date can also help.


If you or a loved one wants to quit tobacco or learn more about its harms, you can call your state’s quitline at 1-800-QUIT-NOW (1-800-784-8669).



[STANDARD TEXT]:


Your participation in this study has been very valuable, and we greatly appreciate you taking the time to complete this survey. This research study was funded by the United States Food and Drug Administration’s (FDA’s) Center for Tobacco Products. One of the topics that the FDA Center for Tobacco studies is people’s beliefs about tobacco and nicotine products, and the goal of this study was to determine what tobacco product labels and advertising communicate to people about the product.


We wanted to know what you thought about a [BRAND NAME PRODUCT] [package/ ad].


[Continue with the following text for claim conditions only]:


The package or advertisement claimed “if cigarette smokers switch completely to [BRAND NAME PRODUCT], they can lower their risk of [cancer/ lung disease].” It is important for you to know that the claim on the package or advertisement you viewed was made up for the sake of this study. In other words, the claim that the product had a lower risk of [cancer/ lung disease] was made up. The manufacturer of [BRAND NAME PRODUCT] does not make this claim about this product, and does not include this claim on its products in the marketplace. The pack or advertisement you viewed may have been a brand you’re familiar with, but this claim was made up for the purpose of this study. We showed you the package or advertisement with the claim to see how the claim might have influenced your perceptions, attitudes, beliefs, and likelihood of using [BRAND NAME PRODUCT]. The [BRAND NAME PRODUCT] brand was selected by the study researchers because it is one of the most popular brands in the marketplace and was used only for the sake of the research study.


[E‑cigarette version]:


For cigarette smokers, completely switching from using cigarettes to using e‑cigarettes can reduce their risk of getting tobacco-related diseases. However, using e‑cigarettes still has negative consequences. As e‑cigarette warning labels state, the product contains nicotine, which is addictive.


[Snuff version]:


For cigarette smokers, completely switching from using cigarettes to using snuff can reduce their risk of getting a tobacco-related disease. However, using snuff still has negative consequences. As snuff warning labels state, smokeless tobacco (snuff) is addictive and can cause mouth cancer, gum disease, and tooth loss.


The Research Involving Human Subjects Committee (RIHSC) at FDA has reviewed this research. RIHSC is an institutional review board, a group of people who are responsible for assuring that the rights of research study participants are protected. RIHSC may review the records of your participation in this research to ensure that proper study procedures were followed.

If you have any questions, comments, or concerns about how you are treated in the study, you may call RIHSC at 301-796-9605, or email at RIHSC@fda.hhs.gov.

The best way to improve your health is to quit using all tobacco products, including cigarettes, snuff, and e‑cigarettes.

It can be very difficult to quit using products that contain nicotine, but this should not discourage you from attempting to do so. Successful quitting takes practice, and you are more likely to be successful in quitting if you keep trying, use medication, seek assistance from a health care provider, and seek social support. Setting a date when you plan to quit can also help.


If you or a loved one currently use a tobacco or nicotine product and are interested in quitting or want to learn more about the negative consequences of using these products, a useful resource is your state’s quitline, which you can reach at 1-800-QUIT-NOW (1-800-784-8669).



[SIMPLE BUBBLES]:


Shape1

Thank you for taking this survey. This survey was done for the Food and Drug Administration (FDA). FDA studies people’s beliefs about tobacco and nicotine products. This study looked at what people thought of different tobacco product labels and ads.










Shape2

We wanted to know what you thought about a [BRAND NAME PRODUCT] [package/ ad].







Shape3

[Claim Conditions only]:[Continue with the following text for experimental/claim conditions only]:

The [package/ ad] claimed that smokers can lower their [cancer/ lung disease] risk if they switch to [product name]. This claim was made up for this study. The makers of [BRAND NAME PRODUCT] do not say this. This claim is not written on [BRAND NAME PRODUCT] sold in stores. We showed you this claim to see how it might change your beliefs about [BRAND NAME PRODUCT]. We also wanted to know if it would make you want to use [BRAND NAME PRODUCT]. We picked [BRAND NAME PRODUCT] to study because a lot of people use it.














Shape4

[E‑cigarette version]:


For smokers, completely switching from cigarettes to e‑cigarettes can lower their risk of getting a disease from tobacco. Using e‑cigarettes still has risks. As e‑cigarette warning labels state, the product contains nicotine, which is addictive.


[Snuff version]:


For smokers, completely switching from cigarettes to snuff can lower their risk of getting a disease from tobacco. Using snuff still has risks. As snuff warning labels state, smokeless tobacco (snuff) is addictive and can cause mouth cancer, gum disease, and tooth loss.

















Shape5

If you have concerns about this study, please contact FDA at 301‑796‑9605 or RIHSC@fda.hhs.gov.









Shape6

The best thing for your health is to quit using all tobacco products. This includes cigarettes, snuff, and e‑cigarettes.


Quitting can be hard, but you should still try. Quitting takes practice. You are more likely to succeed if you keep trying, use medication, get help from a doctor, and get support from loved ones. Setting a quit date can also help.


If you or a loved one wants to quit tobacco or learn more about its harms, you can call your state’s quitline at 1-800-QUIT-NOW (1-800-784-8669).





















[STANDARD BUBBLES]:


Shape7

Your participation in this study has been very valuable, and we greatly appreciate you taking the time to complete this survey. This research study was funded by the United States Food and Drug Administration’s (FDA’s) Center for Tobacco Products. One of the topics that the FDA Center for Tobacco studies is people’s beliefs about tobacco and nicotine products, and the goal of this study was to determine what tobacco product labels and advertising communicate to people about the product.










Shape8

In today’s survey, we wanted to know what you thought about a [BRAND NAME PRODUCT ] [package/ ad].









Shape9

[Claim Conditions only]:[Continue with the following text for experimental/claim conditions only]:

The package or advertisement claimed “if cigarette smokers switch completely to [BRAND NAME PRODUCT], they can lower their risk of [cancer/ lung disease].” It is important for you to know that the claim on the package or advertisement you viewed was made up for the sake of this study. In other words, the claim that the product had a lower risk of [cancer/ lung disease] was made up. The manufacturer of [BRAND NAME PRODUCT] does not make this claim about this product, and does not include this claim on its products in the marketplace. The pack or advertisement you viewed may have been a brand you’re familiar with, but this claim was made up for the purpose of this study. We showed you the package or advertisement with the claim to see how the claim might have influenced your perceptions, attitudes, beliefs, and likelihood of using [BRAND NAME PRODUCT]. The [BRAND NAME PRODUCT] brand was selected by the study researchers because it is one of the most popular brands in the marketplace and was used only for the sake of the research study.

























Shape10

[E‑cigarette version]:


For cigarette smokers, completely switching from using cigarettes to using e‑cigarettes can reduce their risk of getting tobacco-related diseases. However, using e‑cigarettes still has negative consequences. As e‑cigarette warning labels state, the product contains nicotine, which is addictive.


[Snuff version]:


For cigarette smokers, completely switching from using cigarettes to using snuff can reduce their risk of getting a tobacco-related disease. However, using snuff still has negative consequences. As snuff warning labels state, smokeless tobacco (snuff) is addictive and can cause mouth cancer, gum disease, and tooth loss.






















Shape11

The Research Involving Human Subjects Committee (RIHSC) at FDA has reviewed this research. RIHSC is an institutional review board, a group of people who are responsible for assuring that the rights of research study participants are protected. RIHSC may review the records of your participation in this research to ensure that proper study procedures were followed.

If you have any questions, comments, or concerns about how you are treated in the study, you may call RIHSC at 301-796-9605, or email at RIHSC@fda.hhs.gov.













Shape12

The best way to improve your health is to quit using all tobacco products including cigarettes, snuff, and e‑cigarettes.

It can be very difficult to quit using products that contain nicotine, but this should not discourage you from attempting to do so. Successful quitting takes practice, and you are more likely to be successful in quitting if you keep trying, use medication, seek assistance from a health care provider, and seek social support. Setting a date when you plan to quit can also help.


If you or a loved one currently use a tobacco or nicotine product and are interested in quitting or want to learn more about the negative consequences of using these products, a useful resource is your state’s quitline, which you can reach at 1-800-QUIT-NOW (1-800-784-8669).



















[NEXT PAGE]


  1. Post-Debriefing Questions

Please answer a few questions based on what you just read.


[ASK OF THOSE IN CLAIM CONDITIONS ONLY]

#



Yes

1


No

2


Unsure

3



D1

What you just read said that this study made up the claim that [product name] [have/has] lower risk of [cancer/lung disease] than cigarettes.



(99) Prefer not to answer



[ASK OF ALL RESPONDENTS]

#



Yes

1


No

2


Unsure

3



D2

What you just read said that [product name] currently sold in stores claim to be lower risk for [cancer/ lung disease]compared to cigarettes.



D3

What you just read said that there are health risks to using [E‑CIGARETTES/SNUFF].



D4

What you just read said that cigarette smokers could reduce their risk of tobacco-related disease if they completely switch to [E‑CIGARETTES/SNUFF].



(99) Prefer not to answer

(Source: CTP)


D5. Who was this study done for?

a. [An/A] [E‑CIGARETTE/SNUFF] company

b. A group of university researchers

c. The Food and Drug Administration (FDA)

d. The Centers for Disease Control and Prevention (CDC)

(Source: CTP)



D6. What was the purpose of this study?

  1. To see how much smokers and nonsmokers wanted to use [E‑CIGARETTES/SNUFF].

  2. To see how worried you are about health consequences of [E‑CIGARETTES/SNUFF].

  3. To develop new packages and advertisements for [BRAND/PRODUCT].

  4. To see how a claim about the risk of using [BRAND/PRODUCT] affects people’s beliefs.

(Source: CTP)



D7. Which one of the following is TRUE about quitting tobacco?

a. People who successfully quit using tobacco usually do it on their first try.

b. Setting a “quit date” doesn’t really help people quit.

c. Doctors can help people successfully quit using tobacco.

d. The people who ran this study recommend using certain tobacco products.

(Source: CTP)


D8. What phone number can you call to learn more about quitting tobacco?

a. 1-800-YOU-QUIT

b. 1-800-QUIT-NOW

c. 1-800-STOP-SMK

d. 1-800-CAN-QUIT

(Source: CTP)


[NEXT PAGE]

[DISPLAY TO ALL RESPONDENTS]


Thank you.


FDA conducted this survey.


[DISPLAY TO THOSE IN CLAIM CONDITIONS ONLY]


We showed you a claim about the [cancer/lung disease] risk of using [product name]. The maker of [product name] does not make this claim about its products.



[DISPLAY TO ALL RESPONDENTS]


If cigarette smokers switch completely to [e‑cigarettes/snuff], they can lower their risk of getting a disease from tobacco. However, using [e‑cigarettes/snuff] still has risks.


We recommend quitting all tobacco products.


Quitting can be hard. It might help to use medication, set a quit date, and get help from a doctor and loved ones.


For help quitting, call 1-800-QUIT-NOW (1-800-784-8669).


If you have concerns about this study, please contact FDA at 301‑796‑9605 or RIHSC@fda.hhs.gov.


D9. If there is anything you would like to tell us about this survey, please write it here.

Note: This is optional.

_______________________________________________________________

_______________________________________________________________

_______________________________________________________________


_______________________________________________________________



Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 20 minutes per response to complete the questionnaire (the time estimated to read, review, respond). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.


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