Animation in DTC Promotion

Data to Support Drug Product Communications as Used by the FDA

FDA Animation_Cog Int_Attachment B_Guide

Animation in DTC Promotion

OMB: 0910-0695

Document [pdf]
Download: pdf | pdf
Attachment B:
Animation in DTC Advertising
Main Study Questionnaire
Cognitive Testing Interview Guide
INTRODUCTION
Thank you for agreeing to participate in this study today. The goal of this study is to test a
survey that will be used to evaluate advertisements about prescription drugs. During today’s
interview, we will show you a brief TV ad for a new drug and ask you to complete a survey
about it. Your feedback will help us to strengthen the survey.
First, I’d like to provide an informed consent form that describes the study—and your
responsibilities—in more detail. [REVIEW INFORMED CONSENT]
[Note: Participants will be blind to FDA’s sponsorship]
COGNITIVE TESTING INSTRUCTIONS
As you review the survey, I’d like you to read the instructions and questions aloud and then
“think aloud” as you answer each question. This may feel a little unnatural, but it will help us to
understand how you think about and answer each question. Here’s an example:
Question: How many times did you go to a doctor’s office for a scheduled
appointment in the past three months?
Answer: Well, I see my heart doctor every month, so that’s three visits. I see my
primary care doctor twice a year, but I didn’t go in the last three months. I also had to
go to urgent care last week for a sinus infection…but that wasn’t a scheduled
appointment. I guess my answer is three visits.
After each survey question, I also may ask you some follow-up questions. We are interested in your
first impressions and honest opinions. There are no right or wrong answers, and it is ok to have strong
opinions. Please feel free to use the entire range of response options.

Let’s begin…

1

[PROGRAMMER: Informed consent to be recorded first.]
[QUOTA REQUIREMENT: Highest education level for 20% of sample must be high school
graduate or less]

On the next screen, you will see the television advertisement. The ad may take 15-30 seconds to
start playing.
[PROGRAMMER: Display ad correspondent to the participant’s experimental condition.
Each ad should run twice. Also, please disable the “Next” button while each ad is playing to
prevent participant from skipping ahead.]
We would like you to watch the ad a second time. Please click the Next button to view the ad.
[PROGRAMMER: Show ad second time on next screen.]

2

[GENERAL AD FEEDBACK]
Cognitive Testing Probes
[All Ads]
•

What were your general impressions of that ad?

•

How did it compare to other ads you have seen for prescription medications?

•

o

Was it similar or different?

o

Is the ad believable?

o

Is there anything about the ad that you would change?

What do you think of the scenario portrayed in this ad?
o

How relevant is this ad to you personally? Why is that?

•

Who was the main character in the ad?

•

What do you think of the main character in the ad?

•

o

Relatable? Relevant?

o

What words would you use to describe how the character makes you feel?

How does your own experience with [CONDITION] compare to the experience of the character
in the ad?

[Human Ad]
•

How relevant is the actor who plays the main character to you personally?

[Rotoscoped Ad]
•

How do you feel about the special effects used in this ad?
o

Is it distracting?

o

Visually appealing?

[Animated Ad]
•

How do you feel about the main character used in this ad?
o

Is the character distracting?

o

Funny?

3

[PROGRAMMER: SHOW EACH QUESTION ON A SEPARATE SCREEN.]
[BRAND RECOGNITION]
Q2.
Which of the following drugs did you see advertised?
[PROGRAMMER: RANDOMIZE RESPONSE OPTIONS, BUT KEEP “NONE OF THE
ABOVE” AT THE END OF THE LIST.]
1
2
3
4

[CORRECT] [XERAVAST/OCUZEL]
[FOIL]
[FOIL]
[FOIL] None of the above

[RECALL OF BENEFITS AND RISKS – OPEN ENDED]
[PROGRAMMER: RANDOMIZE ORDER OF NEXT TWO QUESTIONS]
Q3. What are the benefits of [XERAVAST/OCUZEL]? Please list as many benefits as you can
remember from the ad.
[TEXT BOXE(S): Will include as many response fields as there are benefits or risks
mentioned in the ad, whichever number is greater]
Cognitive Testing Probes
•

In your own words, what is this question asking?

•

What does this question mean by “benefits”?

•

How easy or difficult was this question to answer?

Q4. What are the side effects or risks of [XERAVAST/OCUZEL]? Please list as many side
effects or risks as you can remember from the ad.
[TEXT BOX(ES): Will include as many response fields as there are benefits or risks
mentioned in the ad, whichever number is greater]
Cognitive Testing Probes
•
•

Can you repeat the question back to me in your own words?
What does this question mean by “side effects or risks”?

•

How easy or difficult was this question to answer?

4

[ELABORATE PROCESSING]
Q5. Overall, how much did the [XERAVAST/OCUZEL] ad make you do the following?

a. Think about the risks of using
[XERAVAST/OCUZEL]
b. Think rather than feel
c. Think about how using
[XERAVAST/OCUZEL]
might affect your life
d. Think about the benefits of
using
[XERAVAST/OCUZEL]

Not at
all
1

2

3

4

5

6

Very
much
7

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

○

Cognitive Testing Probes
•
•
•

•

How easy or difficult were these questions to answer?
How would you answer these questions differently if it did not have an answer choice right in
the middle (4)?
Can you repeat question B back to me in your own words?
a. What does the word “Think” mean to you in this question?
b. What does the word “Feel” mean to you in this question?
Can you repeat question C back to me in your own words?
a. What do you think this question means by “affect your life”?

[PERCEIVED RISK – LIKELIHOOD AND MAGNITUDE]
Please answer the following questions to the best of your ability, even if you have never taken
the drug.
Q6. In your opinion, if 100 people take [XERAVAST/OCUZEL], how many will have any side
effects? Please enter a number in the box below.
__ people
Cognitive Testing Probes – Only ask these probes if there is enough time in the interview.
•
•

•

[How would you have answered this question if it had a “Don’t know” option?]
[If you were to answer “most people”, how many would that be? How many is “some people”?
How many is “a few people”?]
[If this question asked you about “any side effect” instead of “at least one side effect”, how
would you answer it?]

5

Q7. In your opinion, if [XERAVAST/OCUZEL] did cause you to have side effects, how serious
would they be?
Not at all
serious
1
○

2
○

3
○

4
○

5
○

6
○

Very
serious
7
○

Cognitive Testing Probes – Only ask the bracketed probes if there is enough time in the
interview.
•
•
•

How does this question differ from the previous one? [read the previous question if participant
can’t remember it]?
[What does the word “serious” mean to you in this question?]
[How would you answer this question if it asked “how serious could they be” instead of “how
serious would they be”?]

[PERCEIVED EFFICACY – LIKELIHOOD AND MAGNITUDE]
Please answer the following questions to the best of your ability, even if you have never taken
the drug.
Q8. In your opinion, if 100 people take [XERAVAST/OCUZEL], for how many will the drug
work? Please enter a number in the box below.
__ people

Q9. In your opinion, if you took [XERAVAST/OCUZEL], how effective do you think
[XERAVAST/OCUZEL] would be in helping to relieve your [psoriasis/chronic dry eye]?
Not at all
effective
1
○

2
○

3
○

4
○

5
○

6
○

Very
effective
7
○

Cognitive Testing Probes – Only ask the bracketed probes if there is enough time in the
interview.
•
•
•

How does this question differ from the previous one? [Read the previous question if the
participant can’t remember it.]
[How would you answer this question if it read “treat” instead of “relieve”?]
[What do you think this question means by “not at all effective”? And “very effective”?]

6

[PERCEIVED BALANCE OF RISKS AND BENEFITS]
Q10. Thinking about all the risks and benefits, would you say that [XERAVAST/OCUZEL]
has:
1
Many more risks than benefits
2
Somewhat more risks than benefits
3
Equal risks and benefits
4
Somewhat more benefits than risks
5
Many more benefits than risks
Cognitive Testing Probes
•
•

In your own words, what is this question asking?
Walk me through how you selected your answer to this question.

[CLAIM RECOGNITION]
The next few questions ask about information that may or may not have been in the advertising.
Please answer each question, even if you do not remember the information.
[PROGRAMMER: IF CONDITION = PSORIASIS, ASK Q11_PSO. IF CONDITION =
CHRONIC DRY EYE, ASK Q12_CDE.]

7

[MULTIPLE PUNCH]
Q11_PSO. Which of the following claims, if any, were in the ad you saw? Check all that apply.
[PROGRAMMER: RANDOMIZE ORDER, BUT KEEP “NONE OF THE ABOVE” AT THE
END OF THE LIST. IF “NONE OF THE ABOVE” DO NOT ALLOW MULTIPLE PUNCH.]
[CORRECT] XERAVAST is a prescription medication that provides relief from
moderate to severe plaque psoriasis.
[CORRECT] XERAVAST does not suppress the immune system.
[CORRECT] XERAVAST has been associated with an increase in depression.
[CORRECT] Women should not plan to become pregnant or breastfeed while taking
XERAVAST.
[FOIL] Tiredness is a common side effect of taking XERAVAST.
[FOIL] XERAVAST has not been studied in children.
[FOIL] XERAVAST should be taken three times a day.
[FOIL] None of the above.
Cognitive Testing Probes
•

What does this question mean by “claims”?

•
•
•

How easy or difficult was this question to answer?
Did you guess on any of the choices that you selected?
[If respondent doesn’t choose or has a hard time with any of the option, ask them if those
options were tricky or clear. If tricky, why?]

Note takers should pay attention to whether participants pause or look confused when selecting
response options.

8

[MULTIPLE PUNCH]
Q12_CDE. Which of the following claims, if any, were in the ad you saw? Check all that apply.
[PROGRAMMER: RANDOMIZE ORDER, BUT KEEP “NONE OF THE ABOVE” AT THE
END OF THE LIST. IF “NONE OF THE ABOVE” DO NOT ALLOW MULTIPLE PUNCH.]
[CORRECT] OCUZEL provides relief from the stinging and burning associated with
dry eyes.
[CORRECT] OCUZEL eliminates eye redness and swelling around the edge of the
eyelid.
[CORRECT] OCUZEL can cause a severe, life-threatening allergic reaction.
[CORRECT] Contact lens wearers should wait for 30 minutes before putting contacts in
after using OCUZEL.
[FOIL] Overactive tear ducts is a common side effect of taking OCUZEL.
[FOIL] OCUZEL has not been studied in children.
[FOIL] OCUZEL should be applied three times a day.
[FOIL] None of the above.
Cognitive Testing Probes
•

What does this question mean by “claims”?

•
•
•

How easy or difficult was this question to answer?
Did you guess on any of the choices that you selected?
[If respondent doesn’t choose or has a hard time with any of the option, ask them if those
options were tricky or clear. If tricky, why?]

Note takers should pay attention to whether participants pause or look confused when selecting
response options.
[PROGRAMMER: IF CONDITION = PSORIASIS, ASK Q13_PSO. IF CONDITION =
CHRONIC DRY EYE, ASK Q14_CDE.]

9

[OVERALL AD COMPREHENSION]
Q13_PSO. Which of the following choices best summarizes the information from the ad?
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] XERAVAST is a treatment for psoriasis but not all people with psoriasis
should take XERAVAST. XERAVAST has both common and uncommon side effects.
[FOIL] XERAVAST is a treatment for psoriasis, but serious side effects from taking
XERAVAST are common. If you are taking XERAVAST, it is necessary to see your
doctor regularly to monitor the serious side effects.
[FOIL] XERAVAST is a treatment for psoriasis, but if you have liver disease, you
should get blood tests to check your liver while taking XERAVAST.
[FOIL] XERAVAST is a treatment for psoriasis and is appropriate for all adults with
plaque psoriasis.
Cognitive Testing Probes
•
•

Why did you select [insert answer]?
How easy or difficult was this question to answer?

Q14_CDE. Which of the following choices best summarizes the information from the ad?
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] OCUZEL is a treatment for chronic dry eye but not all people with chronic
dry eye should take OCUZEL. OCUZEL has both common and uncommon side effects.
[FOIL] OCUZEL is a treatment for chronic dry eye, but serious side effects from taking
OCUZEL are common. If you are taking OCUZEL, it is necessary to see your doctor
regularly to monitor the serious side effects.
[FOIL] OCUZEL is a treatment for chronic dry eye. OCUZEL has some side effects, but
none of the side effects are life threatening.
[FOIL] OCUZEL is a treatment for chronic dry eye and is appropriate for all adults with
chronic dry eye OCUZEL.
Cognitive Testing Probes
•
•

Why did you select [insert answer]?
How easy or difficult was this question to answer?

10

[SPECIFIC CLAIM COMPREHENSION]
[PROGRAMMER: IF CONDITION = PSORIASIS, ASK Q15_PSO. IF CONDITION =
CHRONIC DRY EYE, ASK Q16_CDE.]
[PROGRAMMER: RANDOMIZE ORDER OF PSO BENEFIT AND RISK CLAIM
QUESTIONS.]
[PSO BENEFIT CLAIM #1 COMPREHENSION]
Q15a_PSO. Which of the following choices best summarizes what the statement displayed
below means?
XERAVAST is a prescription medication that provides relief from moderate to
severe plaque psoriasis in people who are healthy enough for systemic therapy or
UV-therapy.
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] XERAVAST is an appropriate treatment for certain people with
psoriasis.
[FOIL] XERAVAST is appropriate for all people with psoriasis.
[FOIL] XERAVAST works for all forms of psoriasis.
[FOIL] XERAVAST can be taken along with other psoriasis treatments.
Cognitive Testing Probes
•
•

How easy or difficult was this question to answer?
What does this question mean by “appropriate”?

11

[PSO BENEFIT CLAIM #2 COMPREHENSION]
Q15b_PSO. Which of the following choices best summarizes what the statement displayed
below means?
Because it is not a biologic, XERAVAST does not suppress the immune system,
while still providing significant relief from the most common form of psoriasis.
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] XERAVAST can improve psoriasis symptoms without harming the
immune system.
[FOIL] XERAVAST works with the immune system to treat psoriasis symptoms.
[FOIL] XERAVAST is designed to lower the immune responses that affect psoriasis.
[FOIL] XERAVAST uses a non-biological process to eliminate psoriasis.

Cognitive Testing Probes
•
•

Why do you think [insert answer choice]?
What does the word “summarize” mean?
o Is there a better term than “summarize” to describe that idea?

[PSO RISK CLAIM #1 COMPREHENSION]
Q15c_PSO. Which of the following choices best summarizes what the statement displayed
below means?
XERAVAST has been associated with an increase in depression and suicidal
thoughts. Tell your doctor if mood changes develop or worsen.
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] XERAVAST may cause depression, so it is important to monitor your
mood and tell your doctor if you feel depressed.
[FOIL] XERAVAST causes depressive symptoms, so your doctor will need to
monitor those symptoms as they develop.
[FOIL] Mood changes are common and should be monitored when taking
XERAVAST.
[FOIL] People who have a history of depression should not take XERAVAST.
Cognitive Testing Probes
•
•

How did you choose your answer to this question?
How easy or difficult was this question to answer?

12

[PSO RISK CLAIM #2 COMPREHENSION]
Q15d_PSO. Which of the following choices best summarizes what the statement displayed
below means?
Common risks and side effects of XERAVAST include dryness of skin and eyes,
headaches, nausea, and diarrhea.
[PROGRAMMER: RANDOM ORDER OF RESPONSES]
[CORRECT] It is likely that people who take XERAVAST will experience one or
more side effects that are not life-threatening.
[FOIL] XERAVAST causes multiple side effects that occur together.
[FOIL] Dryness of skin and eyes, headaches, nausea, and diarrhea may occur after
taking XERAVAST, but these risks and side effects are unlikely.
[FOIL] People who take XERAVAST will experience at least one risk or side effect
because these are common.
Cognitive Testing Probes
•
•

Why do you think [insert answer]?
How easy or difficult was this question to answer?

[PROGRAMMER: RANDOMIZE ORDER OF CDE BENEFIT AND RISK CLAIM
QUESTIONS.]
[CDE BENEFIT CLAIM #1 COMPREHENSION]
Q16a_CDE. Which of the following choices best summarizes what the statement displayed
below means?
OCUZEL provides relief from the stinging and burning associated with dry eyes
and improves or eliminates eye redness and swelling around the edge of the eyelid.
[PROGRAMMER: RANDOM ORDER OF RESPONSES]
[CORRECT] OCUZEL treats the symptoms that people experience when they have
chronic dye eye.
[FOIL] OCUZEL provides a cure for chronic dye eye by ensuring that the symptoms
do not return.
[FOIL] OCUZEL heals chronic dry eye symptoms without harming eye function.
[FOIL] OCUZEL eliminates or improves all chronic dry eye symptoms.
Cognitive Testing Probes
•
•

Why do you think [insert answer choice]?
What does the word “summarize” mean?
o Is there a better term than “summarize” to describe that idea?

13

[CDE RISK CLAIM #1 COMPREHENSION]
Q16c_CDE. Which of the following choices best summarizes what the statement displayed
below means?
OCUZEL can cause a severe, life-threatening allergic reaction. Do not take Ocuzel if
you are sensitive to any components of this product or have severe food allergies.
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] Some of the ingredients in OCUZEL may be harmful for certain
groups of people.
[FOIL] OCUZEL can cause people to develop life-threatening allergies to food.
[FOIL] For people with allergies, it is safest to avoid using OCUZEL.
[FOIL] Allergic reactions are common and should be monitored while taking
OCUZEL.
Cognitive Testing Probes
•
•

How did you choose your answer to this question?
How easy or difficult was this question to answer?

[CDE RISK CLAIM #2 COMPREHENSION]
Q16d_CDE. Which of the following choices best summarizes what the statement displayed
below means?
The most common side effects of OCUZEL are eye irritation and blurred vision
upon application.
[PROGRAMMER: RANDOMIZE ORDER OF RESPONSE OPTIONS]
[CORRECT] It is likely that people who use OCUZEL will experience one or more
side effects that are not life-threatening.
[FOIL] OCUZEL causes multiple side effects that occur together.
[FOIL] Eye irritation and blurred vision may occur after using OCUZEL, but these
side effects are unlikely.
[FOIL] People who use OCUZEL will experience at least one side effect because
these are common.
Cognitive Testing Probes
•
•

Why do you think [insert answer]?
How easy or difficult was this question to answer?

14

[INTENTION FOR DRUG USE]
Q17. Based on the [XERAVAST/OCUZEL] ad, please rate how likely or unlikely you are to do
each of the following...
Not at all
likely
1

2

3

4

5

6

a. Look for more
information about
[XERAVAST/
OCUZEL]
b. Ask your doctor to
prescribe [XERAVAST/
OCUZEL]
e. Take [XERAVAST/
OCUZEL] if your doctor
prescribed it

[ATTITUDE TOWARD PRODUCT]
Q18. Please rate how you feel about [XERAVAST/OCUZEL].
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS.]
a. Unpleasant
○ ○ ○ ○
○ ○
○
b. Bad
○ ○ ○ ○
○ ○
○
c. Dislike
○ ○ ○ ○
○ ○
○

Pleasant
Good
Like

Cognitive Testing Probes
•
•
•

How would you answer these questions if there wasn’t a middle option?
What do you think of the word pairings?
o Do any of them not make sense to you?
Do the answer options make sense to you? Do you think they need numbers?

[ATTITUDE TOWARD AD]
Q19. Please rate how you feel about the ad for [XERAVAST/OCUZEL].
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS.]
a. Unfavorable
○ ○ ○ ○
○ ○
○ Favorable
b. Bad
○ ○ ○ ○
○ ○
○ Good
c. Unpleasant
○ ○ ○ ○
○ ○
○ Pleasant
Cognitive Testing Probes
•

Did you notice the difference between this question and the previous question?

15

Extremely
likely
7

•

Do the answer options need numbers?

[ATTITUDE TOWARD CHARACTER]
Q20. Please rate how you feel about the main character in the ad for [XERAVAST/OCUZEL].
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS.]
a. I dislike the main character ○ ○ ○ ○
○ ○
○ I like the main character
b. The main character is bad
○ ○ ○ ○
○ ○
○ The main character is good
c. The main character is
○ ○ ○ ○
○ ○
○ The main character is
unpleasant
pleasant
Cognitive Testing Probes
•
•
•

How easy or difficult was this question to answer? Is it difficult to remember the character so far
along into this questionnaire?
Who is the question referring to by “the main character”?
What do you think of the choices at each end of the scale?
o Do any of them not make sense to you?

[IDENTIFICATION WITH CHARACTER]
Q21. How similar to the main character in the ad do you think you are?
Not at all
similar
1
○

2
○

3
○

4
○

5
○

6
○

Extremely
similar
7
○

Cognitive Testing Probes
•
•

How did you select your answer to this question?
How would you have answered this question if instead the answer choices were “not at all”
“somewhat” and “extremely”?

16

Q22. Please rate how much you agree or disagree with the following statements.
Strongly
disagree
1
a. I can identify with the
main character in the ad.
b. I can easily put myself
in the shoes of the main
character in the ad.

2

3

4

5

Strongly
agree
7

6

○

○

○

○

○

○

○

○

○

○

○

○

○

○

Cognitive Testing Probes
•
•
•

How did you select your answers to these questions?
What does this question mean by “identify with”?
o Is there a better phrase than “identify with” to describe that idea?
What does this question mean by “put myself in the shoes of the main character”?
o Is there a better phrase than “put myself in the shoes of the main character” to describe
that idea?

[TRUST IN THE AD]
Q23. How much do you think the ad is:
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS AND SPLIT THE ITEMS ACROSS 2
SCREENS.]
Not at all
Very much
1
2
3
4
5
6
7
a. Exaggerated
o
o
o
o
o
o
o
b. Dishonest
o
o
o
o
o
o
o
c. Manipulative
o
o
o
o
o
o
o
d. Suspicious
o
o
o
o
o
o
o
e. Relevant
o
o
o
o
o
o
o
f. Trustworthy
o
o
o
o
o
o
o
g. Ethical
o
o
o
o
o
o
o
h. Credible
o
o
o
o
o
o
o

Cognitive Testing Probes
•
•

How would you answer these questions differently if it did not have an answer choice right in
the middle (4)?
What words would you add to this list?

17

[EMOTIONAL REACTION TOWARD AD]
Q24. How did the ad make you feel?
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS AND SPLIT THE ITEMS ACROSS
TWO SCREENS, 5 ITEMS ON FIRST SCREEN AND 4 ITEMS ON SECOND SCREEN.]
Did not
Felt this
feel this
way very
way at all
strongly
1
2
3
4
5
6
7
Angry
○
○
○
○
○
○
○
Annoyed
○
○
○
○
○
○
○
Worried
○
○
○
○
○
○
○
Sad
○
○
○
○
○
○
○
Ashamed
○
○
○
○
○
○
○
Content
○
○
○
○
○
○
○
Optimistic
○
○
○
○
○
○
○
Happy
○
○
○
○
○
○
○
Cheerful
○
○
○
○
○
○
○
Cognitive Testing Probes
•
•
•

How easy or difficult was this question to answer?
Are there any other words you would use to describe how this ad made you feel that are not
listed here?
What did you think of the order of the words?

18

[EMOTIONAL REACTION TOWARD MAIN CHARACTER]
Q25. How did the main character in the ad make you feel?
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS AND SPLIT THE ITEMS ACROSS
TWO SCREENS.]
Did not
Felt this
feel this
way very
way at all
strongly
1
2
3
4
5
6
7
a. Disgusted
○
○
○
○
○
○
○
b. Nervous
○
○
○
○
○
○
○
c. Fearful
○
○
○
○
○
○
○
d. Happy
e. Relaxed
f. Cheerful
Cognitive Testing Probes
•
•

How easy or difficult was this question to answer?
Are there any other words you would use to describe how the main character made you feel?

[PERCEIVED MAIN CHARACTER EERINESS]
Q26. Please rate the extent to which you feel that the main character in the ad was eerie.
Not at all
eerie
1
○

2
○

3
○

4
○

5
○

6
○

Totally
eerie
7
○

Cognitive Testing Probes
•
•
•

In your own words, what is this question asking?
Why do you think [insert answer choice]?
[Ask if needed depending on response to first probe] [What do you think the word “eerie”
means in this question?]

[PERCEIVED ATTENTION TO AD]
Q27. How much attention did you pay to the ad you saw about [XERAVAST/OCUZEL]?
o None
o Very little
o Some
o Quite a bit
19

o A great deal
[PERCEIVED MESSAGE EFFECTIVENESS]
Q28. How much to you agree or disagree with the following statements about the ad you just
saw?
[PROGRAMMER: RANDOMIZE ORDER OF ITEMS AND SPLIT THE ITEMS ACROSS
TWO SCREENS, 3 ITEMS ON FIRST SCREEN AND 2 ITEMS ON SECOND SCREEN.]
Strongly
Strongly
disagree
agree
1
2
3
4
5
6
7
a. The ad is
o
o
o
o
o
o
o
worth remembering
b. The ad is
o
o
o
o
o
o
o
informative
c. The ad is
o
o
o
o
o
o
o
meaningful
d. The ad is
o
o
o
o
o
o
o
convincing
e. The ad is
o
o
o
o
o
o
o
believable

Cognitive Testing Probes
•

How would you answer these questions differently if it did not have an answer choice right in
the middle (4)?

[NEW SCREEN]
Thank you for answering questions about the ad. Now we have some other questions for you.
[NEW SCREEN]

20

[ANTHROPOMORPHISM]
[PROGRAMMER: RANDOMIZE ORDER OF Q29a, Q29b, Q29c.]
Q29a. To what extent does the average insect have a mind of its own?
Not at all
1
○

2
○

3
○

4
○

5
○

6
○

Very much
7
○

Cognitive Testing Probes
•
•
•
•

What are your initial thoughts when you read this question?
In your own words, what is this question asking?
Tell me how you chose your answer to this question.
What does this question mean by “a mind of its own”?
o Is there a better phrase than “a mind of its own” to describe that idea?

Q29b. To what extent does a cheetah experience emotions?
Not at all
1
○

2
○

3
○

4
○

5
○

6
○

Very much
7
○

Cognitive Testing Probes
•
•
•

What comes to mind when you first read this question?
Tell me why you answered [selected answer].
What does this question mean by “experience emotions”?
o Is there a better phrase than “experience emotions” to describe that idea?

Q29c. To what extent does technology (devices and machines for manufacturing, cars,
computers, and television sets) have intentions?
Not at all
1
○

2
○

3
○

4
○

5
○

6
○

Very much
7
○

Cognitive Testing Probes
•
•
•
•

Can you repeat the question back to me in your own words?
Why do you think [insert answer choice]?
What does this question mean by “have intentions”?
o Is there a better phrase than “have intentions” to describe that idea?
What did you think of the last three questions? Do they seem out of place? Did you have any
difficulty answering them?

21

[TIME SINCE TARGETED CONDITION DIAGNOSIS]
Q30. When did a health care professional first tell you that you had [psoriasis/chronic dry eye]?
Six months ago or less
More than six months ago but less than a year ago
A year ago or more but less than 5 years
Five years ago or longer
[PERCEIVED IMPACT OF ILLNESS]
Q31. How much does having [psoriasis/chronic dry eye] affect your daily activities?
Not at all
1
○

2
○

3
○

4
○

5
○

6
○

A great deal
7
○

Cognitive Testing Probes
•
•

How did you choose your answer to this question?
What does this question mean by “affect your daily activities”?
o Is there a better phrase than “affect your daily activities” to describe that idea?

[CURRENT PRESCRIPTION STATUS]
Q32. Are you currently taking, or have you ever taken, any prescription drugs to manage your
[psoriasis/chronic dry eye]?
Currently taking
Have taken in the past, but not currently taking
Have never taken

22

[GENERAL PERCEPTION OF DRUG ADVERTISING]
Q33. In general, how do you feel about ads on television for prescription drugs? Would you say
the ads are…
Not at all
useful
1
○

2
○

3
○

4
○

5
○

Cognitive Testing Probes
•
•
•

In your own words, what is this question asking?
Tell me why you answered [selected answer].
What does the word “useful” mean to you in this question?
o Is there a better word than “useful” to describe that idea?

[SEX]
Q34. What is your sex?
1. Male
2. Female
[AGE]
[NUMERICAL FIELD, VALID RANGE 0 - 116]
Q35. Please tell us your age.
___ years old.
[RACE/ETHNICITY]
[ETHNICITY]
Q36. Are you Hispanic or Latino?
1. Yes
2. No
[RACE]
Q37. What is your race? (Select all that apply)
1. American Indian or Alaska Native
2. Asian
3. Black or African-American
4. Native Hawaiian or Other Pacific Islander
5. White
6. Some other race

23

6
○

Very
useful
7
○

[DRUG INFORMATION SEARCH BEHAVIOR]
Q38. Would you like to see more information about [XERAVAST/OCUZEL]?
Yes, provide me with more information
No, do not provide me with more information

24

[AD COMPARISON ACTIVITY – COGNITIVE INTERVIEWS ONLY]
Now you will watch the same television ad that you saw at the beginning of the survey. Then
you’ll watch a different ad, and then I will ask you some questions about these ads.
[INTERVIEWER: Show the first assigned ad again, and then show the second assigned ad. Ad
pairs are in the table below.]
First assigned ad
Second assigned ad
1. Human
Rotoscoped
2. Human
Animated Sufferer
3. Rotoscoped
Animated Sufferer
4. Animated Sufferer
Animated Disease
5. Animated Sufferer
Animated Benefit
6. Animated Disease
Animated Benefit
Cognitive Testing Probes
•

If they cost the same, which drug would you choose:
The one in the first ad you saw or the second ad you saw?
Why?

•

What was the difference between these two ads?

•

[For all conditions except human/rotoscoped] Can you describe what happens to the main
character in the second ad compared to what happened to the main character in the first ad?
(If clarification is needed: In other words, what do the characters do in each ad?)

•

Which ad do you like better? Why?
o

What specifically about [PREFERRED AD] do you like better?

o

What specifically about [NON-PREFERRED AD] do you not like?

•

[If the second ad is an animated ad] In the second ad, which character was the main
character?

•

What do you think of the character used in the second ad?

•

o

Is the character distracting?

o

Funny?

Of the two ads, which main character do you prefer? Why?
o

What specifically about [PREFERRED CHARACTER] do you like better?

25

o

What specifically about [NON-PREFERRED CHARACTER] do you not like?

•

[If at least one of the ads is animated] Do the main characters in either of the animated ads
remind you of people? Or: Does the main character in the animated ad remind you of a
person?

•

Have you seen any drug ads on TV that include animated characters?
o

Which ones?

o

What are your thoughts about those characters in general?

o

Are there any you particularly like/dislike? Why?

[DEBRIEFING]
This concludes the survey. Our goal was to gather people’s reactions to information about
prescription drugs. To get your true reaction to this information, we used a fake drug brand in
this study.
XERAVAST/OCUZEL is not a real drug and it is not available for use or sale. Please see your
healthcare professional for questions about your health and your medical conditions.
Thank you very much for your time.

26


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File TitleMicrosoft Word - FDA Animation_Cognitive Interview OMB Memo_Appendix B.doc
Authorrpaquin
File Modified2016-02-29
File Created2016-02-29

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