Adult Pretest and Main data collection

OMB #0910-XXXX

Expires XX/XX/XXXX

Appendix F: Questionnaire

PHASE 1: PROCEDURE

WITHIN EACH AGE GROUP (YOUTH, YOUNG ADULT, ADULT), RANDOMLY ASSIGN PARTICIPANTS INTO A CONTROL CONDITION OR ONE OF 16 EXPERIMENTAL CONDITIONS.

IN EACH CONDITION, RESPONDENTS WILL VIEW 9 OF 26 WARNING STATEMENT STIMULI (TABLE 1), WITH VARIATION IN THE STIMULI INCLUDED ACCORDING TO THE STUDY CONDITION (TABLE 2).

TABLE 1. WARNING STATEMENTS

#	STATEMENT
ORIGINAL
S1	WARNING: Cigarettes are addictive.
S2	WARNING: Tobacco smoke can harm your children.
S3	WARNING: Cigarettes cause fatal lung disease.
S4	WARNING: Cigarettes cause cancer.
S5	WARNING: Cigarettes cause strokes and heart disease.
S6	WARNING: Smoking during pregnancy can harm your baby.
S7	WARNING: Smoking can kill you.
S8	WARNING: Tobacco smoke causes fatal lung disease in nonsmokers.
S9	WARNING: Quitting smoking now greatly reduces serious risks to your health.
REVISED
R1A	WARNING: Smoking causes mouth and throat cancer.
R1B	WARNING: Smoking causes head and neck cancer.
R1C	WARNING: Smoking causes bladder cancer, which can lead to bloody urine.
R2A	WARNING: Smoking during pregnancy causes premature birth.
R2B	WARNING: Smoking during pregnancy stunts fetal growth.
R2C	WARNING: Smoking during pregnancy causes premature birth and low birth weight.
R3A	WARNING: Secondhand smoke causes respiratory illnesses in children like pneumonia.
R4A	WARNING: Smoking can cause heart disease and strokes by clogging arteries.
R5A	WARNING: Smoking causes COPD, a lung disease that can be fatal.
R5B	WARNING: Smoking causes serious lung diseases like emphysema and chronic bronchitis.
R6A	WARNING: Smoking reduces blood flow, which can cause erectile dysfunction.
R6B	WARNING: Smoking reduces blood flow to the limbs, which can require amputation.
R7A	WARNING: Smoking causes type 2 diabetes, which raises blood sugar.
R8A	WARNING: Smoking causes age-related macular degeneration, which can lead to blindness.
R8B	WARNING: Smoking causes cataracts, which can lead to blindness.

TABLE 2. STUDY CONDITIONS

CONDITION	STIMULI SLOT (RANDOMIZE ORDER)
	1	2	3	4	5	6	7	8	9
0 (CONTROL)	S1	S2	S3	S4	S5	S6	S7	S8	S9
1	S1	S2	S3	R1A	S5	S6	S7	S8	S9
2	S1	S2	S3	R1B	S5	S6	S7	S8	S9
3	S1	S2	S3	R1C	S5	S6	S7	S8	S9
4	S1	S2	S3	S4	S5	R2A	S7	S8	S9
5	S1	S2	S3	S4	S5	R2B	S7	S8	S9
6	S1	S2	S3	S4	S5	R2C	S7	S8	S9
7	S1	R3A	S3	S4	S5	S6	S7	S8	S9
8	S1	S2	S3	S4	R4A	S6	S7	S8	S9
9	S1	S2	S3	S4	S5	S6	S7	R5A	S9
10	S1	S2	R5A	S4	S5	S6	S7	S8	S9
11	S1	S2	R5B	S4	S5	S6	S7	S8	S9
12	RANDOM SELECTION OF 8 OF 9 ORIGINAL (“S”) STATEMENTS								R6A
13	RANDOM SELECTION OF 8 OF 9 ORIGINAL (“S”) STATEMENTS								R6B
14	RANDOM SELECTION OF 8 OF 9 ORIGINAL (“S”) STATEMENTS								R7A
15	RANDOM SELECTION OF 8 OF 9 ORIGINAL (“S”) STATEMENTS								R8A
16	RANDOM SELECTION OF 8 OF 9 ORIGINAL (“S”) STATEMENTS								R8B

SURVEY INSTRUMENT

Paperwork Reduction Act Statement: The public reporting burden for this information collection has been estimated to average 15 minutes per response to complete this survey (the time estimated to read and complete). Send comments regarding this burden estimate or any other aspects of this information collection, including suggestions for reducing burden, to PRAStaff@fda.hhs.gov.

SECTION A: WARNING STATEMENT PERCEPTIONS

INTRO_TEXT_1. In this survey, we are going to ask you to read some warning statements that might someday be placed with an image showing that health effect of smoking on a pack of cigarettes and on advertisements for cigarettes. Please read each statement carefully and answer the questions that follow to the best of your ability.

[FOR EACH OF 9 STATEMENTS, DISPLAY INTRO_TEXT_2 WITH THE WARNING STATEMENT BELOW ON A SINGLE SCREEN. KEEP WARNING STATEMENT VISIBLE THROUGH SECTION A. ASK SECTION A ITEMS ON FOLLOWING SCREENS. REPEAT SECTION A FOR EACH OF 9 STATEMENTS ACCORDING TO RESPONDENT’S ASSIGNED CONDITION. RANDOMIZE ORDER OF STATEMENTS PRESENTED.]

INTRO_TEXT_2. Please read the warning statement below. After reading the statement, you will be asked a few questions about the warning statement.

[DISPLAY STATEMENT X]

A1. Before today, had you heard about the specific smoking-related health effect described in the warning statement?

1. Yes

2. No

3. I’m not sure

A2. To what extent did you learn something new from this warning statement that you did not know before?

Not at all [1]	[2]	[3]	[4]	[5]	[6]	Very much [7]

A3. How much does this warning statement make you think about the health risks of smoking?

1. Not at all

2. A little

3. Somewhat

4. A lot

A4. This statement is…

A4_1. Not at all believable [1]	[2]	[3]	[4]	[5]	[6]	Very believable [7]
A4_2. Not at all informative [1]	[2]	[3]	[4]	[5]	[6]	Very informative [7]

A5_INTRO. Next, we would like to know whether you think this warning statement is an opinion or a fact. Opinions are judgements or feelings that cannot be proven true or false. Facts are statements that can be proven true or false.

A5_1. Would you say that this warning statement is an opinion or a fact?

1. Opinion

2. Fact

SECTION B: POST-TEST OUTCOMES

Next, we would like to ask you some questions about your beliefs about smoking-related health effects.

How much do you agree or disagree with the following statements?

[RANDOMIZE ORDER OF ITEM “BLOCKS” ACCORDING TO ITEM PREFIX (I.E. RANDOMIZE B1_, B2_, B3_ SERIES, ETC.]

[WARNING: Smoking causes mouth and throat cancer]

B1_1. Smoking causes mouth cancer

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B1_2. Smoking causes throat cancer

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes head and neck cancer]

B2_1. Smoking causes head cancer

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B2_2. Smoking causes neck cancer

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes bladder cancer, which can lead to bloody urine]

B3_1. Smoking causes bladder cancer, which can lead to bloody urine

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B3_2. Smoking causes bladder cancer

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B3_3. Smoking can lead to bloody urine

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking during pregnancy causes premature birth]

B4_1. Smoking during pregnancy causes premature birth

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking during pregnancy stunts fetal growth]

B5_1. Smoking during pregnancy stunts fetal growth

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking during pregnancy causes premature birth and low birth weight]

B6_1. Smoking during pregnancy causes low birth weight

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Secondhand smoke causes respiratory illnesses in children, like pneumonia]

B7_1. Secondhand smoke causes respiratory illnesses in children, like pneumonia

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B7_2. Secondhand smoke causes respiratory illnesses in children

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B7_3. Secondhand smoke causes pneumonia in children

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking can cause heart disease and strokes by clogging arteries]

B8_1. Smoking causes heart disease

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B8_2. Smoking causes strokes

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B8_3. Smoking clogs arteries

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B8_4. Smoking clogs arteries, which causes heart disease

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B8_5. Smoking clogs arteries, which causes strokes

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes COPD, a lung disease that can be fatal]

B9_1. Smoking causes COPD, a lung disease that can be fatal

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B9_2. Smoking causes COPD

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B9_3. Smoking causes a lung disease that can be fatal

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes serious lung diseases like emphysema and chronic bronchitis]

B10_1. Smoking causes serious lung diseases

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B10_2. Smoking causes emphysema

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B10_3. Smoking causes chronic bronchitis

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking reduces blood flow, which can cause erectile dysfunction]

B11_1. Smoking reduces blood flow, which can cause erectile dysfunction

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B11_2. Smoking reduces blood flow

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B11_3. Smoking can cause erectile dysfunction

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking reduces blood flow to the limbs, which can require amputation]

B12_1. Smoking reduces blood flow to the limbs, which can require amputation

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B12_2. Smoking reduces blood flow to the limbs

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B12_3. Smoking can lead to amputation

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes type 2 diabetes, which raises blood sugar]

B13_1. Smoking causes type 2 diabetes, which raises blood sugar.

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B13_3. Smoking can cause Type 2 Diabetes

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes age-related macular degeneration, which can lead to blindness]

B14_1. Smoking causes age-related macular degeneration, which can lead to blindness

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B14_2. Smoking causes age-related macular degeneration

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B14_3. Smoking can lead to blindness

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[WARNING: Smoking causes cataracts, which can lead to blindness]

B15_1. Smoking causes cataracts, which can lead to blindness

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

B15_2. Smoking causes cataracts

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]

BCONT1_1. Smoking causes migraines

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]

BCONT2_1. Secondhand smoke causes sleep disorders like insomnia in children

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

[CONTROL STATEMENT – NO ASSOCIATED WARNING LABEL]

BCONT3_1. Smoking during pregnancy causes hearing loss in babies

1. Strongly disagree

2. Disagree

3. Neither agree nor disagree

4. Agree

5. Strongly agree

SECTION C: COMBINED STIMULI OUTCOMES

PHASE 2: PROCEDURE

RESPONDENTS IN CONDITION 0 (CONTROL) OF PHASE 1 WILL VIEW ALL 9 ORIGINAL (“S”) STATEMENTS ON A SINGLE PAGE (TABLE 3). RESPONDENTS IN CONDITIONS 1-16 OF PHASE 1 WILL VIEW A SELECTION OF 9 OF THE 16 REVISED STATEMENTS ON A SINGLE PAGE, ACCORDING TO THE PROTOCOL IN TABLE 4. FORCE 10 SECOND VIEWING FOR THIS SCREEN. ASK SECTION E QUESTIONS ONCE FOLLOWING EXPOSURE.

TABLE 3. PHASE 2 CONTROL GROUP STIMULI SELECTION (SINGLE PAGE EXPOSURE)

STIMULI SLOT	SELECTION
1	S1
2	S2
3	S3
4	S4
5	S5
6	S6
7	S7
8	S8
9	S9

TABLE 4. PHASE 2 TREATMENT GROUP STIMULI SELECTION (SINGLE PAGE EXPOSURE)

STIMULI SLOT	SELECTION
1-2	RANDOM SELECTION OF 2 OF: R1A; R1B; R1C
3	RANDOM SELECTION OF 1 OF: R2A; R2B; R2C
4	R3A
5	R4A
6	RANDOM SELECTION OF 1 OF: R5A; R5B
7	RANDOM SELECTION OF 1 OF: R6A; R6B
8	R7A
9	RANDOM SELECTION OF 1 OF: R8A; R8B

INTRO_TEXT_3. Please read the set of warning statements below. After reading the statements, you will be asked a few questions.

[DISPLAY STATEMENT SET X; FORCE 10 SECOND VIEWING]

Next, we would like to ask you some questions about your beliefs about the health effects of smoking.

C1. Which, if any, of the following conditions do you think smoking can cause? (Select all that apply) [RANDOMIZE ORDER OF QUESTIONS]

C1_1. Mouth cancer

C1_2. Throat cancer

C1_3. Head cancer

C1_4. Neck cancer

C1_5. Bladder cancer

C1_6. Bloody urine

C1_7. Heart disease

C1_8. Strokes

C1_9. Clogged arteries

C1_10. COPD

C1_11. Emphysema

C1_12. Chronic bronchitis

C1_13. Reduced blood flow

C1_14. Erectile dysfunction

C1_15. Reduced blood flow to the limbs

C1_16. Amputation

C1_17. Type 2 Diabetes

C1_18. Age-related macular degeneration

C1_19. Blindness

C1_20. Cataracts

C1_CONT. Migraines

C2. Which, if any, of the following conditions do you think secondhand smoke can cause? (Select all that apply) [RANDOMIZE ORDER OF QUESTIONS]

C2_1. Respiratory illnesses in children

C2_2. Pneumonia in children

C2_CONT. Sleep disorders like insomnia in children

C3. Which, if any, of the following conditions do you think smoking during pregnancy can cause? (Select all that apply) [RANDOMIZE ORDER OF QUESTIONS]

C3_1. Premature birth

C3_2. Stunted fetal growth

C3_3. Low birth weight

C3_CONT. Hearing loss in babies

SECTION D: DEMOGRAPHICS

D1_INTRO. Now we are going to ask you a few questions that are not about cigarettes or smoking.

[ASK IF SA1 ≥ 18]

D1. Thinking about members of your family living in this household, what is your combined annual income, meaning the total pre-tax income from all sources earned in the past year?

1. $0 to $9,999

2. $10,000 to $14,999

3. $15,000 to $19,999

4. $20,000 to $34,999

5. $35,000 to $49,999

6. $50,000 to $74,999

7. $75,000 to $99,999

8. $100,000 or more

D2. How many adults (age 18 or older) and children (aged 17 or younger), including yourself, live in your household?

D2_1. Adults (age 18 or older):__________[DROP-DOWN MENU, RANGE 1-20]

D2_2. Children (age 17 or younger):__________[DROP-DOWN MENU, RANGE 1-20]

D3. Please indicate your state of residence.

[INSERT DROP DOWN MENU WITH STATES]

[ASK IF SA1 ≥ 18]

D4. Do you think of yourself as…

1. Heterosexual or straight

2. Homosexual, or gay or lesbian

3. Bisexual

4. Something else (Other)

[ASK IF SA1 ≥ 18]

D5. Please answer the following question based on the information in the text above.

If a person is at high risk for heart disease, which of the following levels of low density lipoprotein (LDL) cholesterol is best?

1. 102

2. 86

3. 129

4. 155

5. Not sure

ENDSCREEN: You’ve reached the end of the survey. Thank you for your participation.

Paperwork Reduction Act Statement: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The public reporting burden for this information collection has been estimated to average 15 minutes per response to complete the Survey (the time estimated to read, review, and 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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