Completes, Pilot

Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads

Appendix B Questionnaires

Completes, Pilot

OMB: 0910-0861

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49


APPENDIX B: QUESTIONNAIRES


RHEUMATOID ARTHRITIS QUESTIONNAIRE



We are going to ask you specifically about the Mytrozen prescription drug ad that you saw.

Please answer the following questions based on the information you have just seen.





Q1.


Thinking overall about the risks and benefits of Mytrozen, would you say it has…



Many more risks than benefits

1

Somewhat more risks than benefits

2

Equal risks and benefits

3

Somewhat more benefits than risks

4

Many more benefits than risks

5







Q2. How noticeable was the information about Mytrozen’s side effects?


Not at all noticeable

1

2


3

4



5

Very noticeable

6




Q3. How noticeable was the information about Mytrozen’s benefits?


Not at all noticeable

1

2


3

4



5

Very noticeable

6






The next three questions ask about taking Mytrozen, in this order:

  • 4a: The most serious risks of taking it.

  • 4b: Other side effects that might occur from taking it.

  • 4c: Other reasons why people should not take it.








Q4a. Based strictly on the information in the ad, what are the most serious risks of taking Mytrozen?

(Please use one box for each serious risk.)










Q4b. Based strictly on the information in the ad, what are the other side effects of taking Mytrozen?

(Please use one box for each side effect.)

























Q4c. Based strictly on the information in the ad, for what other reasons should people not take Mytrozen?

(Please use one line for each reason.)























Q5. In reviewing the Mytrozen ad, did you see any of the drug risks more than once?


  • Yes

  • No


Q6. Thinking of the drug risks, how repetitive was this information in the Mytrozen ad?


Not at all repetitive

1

2

3

4



5

Very repetitive

6





Q7. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as a risk of taking Mytrozen.




Mentioned in the ad

Not mentioned in the ad

a. Can affect your immune system

b. Can increase risk of certain cancers

c. Can cause serious infections

d. Can cause perforations (tears) in the stomach or intestines

e. Can raise your cholesterol levels

f. Can cause heart failure



Q8. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as reasons you should not take Mytrozen.



Mentioned

in the ad

Not mentioned

in the ad

a. Have or have had cancer

b. Have tuberculosis (TB)

c. Have signs of or are prone to infection

d. Are under 18 years old

e. Have lung problems

f. Have heart problems



Q9. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as benefits of taking Mytrozen.




Mentioned

in the ad

Not mentioned

in the ad

a. Mytrozen is used to lessen the signs and symptoms of RA

b. Mytrozen can reduce the progression of joint damage

c. Mytrozen can make corticosteroids more effective

d. Mytrozen is a once-daily capsule

e. Mytrozen can be taken with or without methotrexate




The next questions ask for your opinions based on reading the ad.


Q10. How likely is it that you would experience at least one side effect if you took Mytrozen?



Not at all likely

1

2

3

4



5

Extremely likely

6



Q11. How serious are Mytrozen’s side effects?



Not at all serious

1

2

3


4




5

Extremely serious

6



Q12. How likely is it that Mytrozen would lessen the signs and symptoms of rheumatoid arthritis if you took it?



Not at all likely

1

2

3

4



5

Extremely likely

6



Q13. How much would Mytrozen improve your rheumatoid arthritis?


No improvement

1

2

3

4



5

Substantial improvement

6



The next questions ask about the different parts of the ad.


Q14. Based on the image below, which of the following areas got your attention?



Got my attention

Did not get my attention

a. AREA A

b. AREA B

c. AREA C

d. AREA D



Q15. Overall, how much, if any, of the advertisement did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know



Q16. Refer to the area marked on the image to the right. How much, if any, of that risk information did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know



Q17. Refer to the area marked on the image to the right. How much, if any, of that risk information did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know




Q18. To me, this ad for Mytrozen is:


a.

Unimportant






Important

1

2

3

4

5

6

7


b.

Boring






Interesting

1

2

3

4

5

6

7


c.

Irrelevant






Relevant

1

2

3

4

5

6

7


d.

Unexciting






Exciting

1

2

3

4

5

6

7


e.

Means nothing







Means a lot to me

1

2

3

4

5

6

7


f.

Unappealing






Appealing

1

2

3

4

5

6

7


g.

Mundane






Fascinating

1

2

3

4

5

6

7


h.

Worthless






Valuable

1

2

3

4

5

6

7


i.

Uninvolving






Involving

1


2

3

4

5

6

7





j.

Not needed






Needed

1


2

3

4

5

6

7



Q19. Based on your reading of the ad, how confident are you that you could do the following tasks?


  1. Recognize side effects.


Not at all confident

1

2

3

4




5


Completely confident

6




  1. Identify which drugs interact with Mytrozen.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Remember the risk information.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know when to stop taking the drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know what condition is treated by this drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Tell the difference between a common side effect and a severe reaction.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Identify who should not take this drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know when you should ask a doctor or health professional about a side effect you might have.


Not at all confident

1

2

3

4




5


Completely confident

6




  1. Feel confident you can discuss the side effect with your doctor.


Not at all confident

1

2

3

4




5


Completely confident

6




Q20. The benefits of Mytrozen outweigh all the things I have to do to obtain it (appointments, prescriptions, leave).



Strongly disagree

1

2

3

4




5


Strongly agree

6



Q21. The benefits of Mytrozen outweigh any side effects it may have.



Strongly disagree

1

2

3

4




5


Strongly agree

6


Q22. In general, how much do you feel you know about rheumatoid arthritis? Would you say you are...

Not at all knowledgeable

1

Slightly knowledgeable

2

Somewhat knowledgeable

3

Moderately knowledgeable

4


Very knowledgeable

5


Extremely knowledgeable

6



Q23. How familiar are you with prescription drugs that treat rheumatoid arthritis condition?

Not at all familiar

1

Slightly familiar

2

Somewhat familiar

3

Moderately familiar

4



Very familiar

5


Extremely familiar

6



Q24. In general, how severe is your rheumatoid arthritis?


Not at all severe

1

Slightly severe

2

Somewhat severe

3

Moderately severe

4

Very severe

5

Extremely severe

6



Q25. How concerned are you about the impact of rheumatoid arthritis on your life?



Not at all concerned

1

Slightly concerned

2

Somewhat

concerned

3

Moderately concerned

4

Very concerned

5

Extremely concerned

6



Q26. How likely are you to…




Very unlikely

1

Somewhat unlikely

2

Neither likely or unlikely

3

Somewhat likely

4

Very likely

5

a. Talk to your doctor about Mytrozen?







b. Look for more information about Mytrozen?







Q27. Do you have any health conditions that would prevent you from taking Mytrozen?


  • Yes

  • No

  • Don’t know



Q28. How often do you have a problem understanding the written materials about your medical condition?



Never

1

Occasionally

2

Sometimes

3

Often

4

Always

5




Q29. How often do you have a problem understanding what is told to you about your medical condition?



Never

1

Occasionally

2

Sometimes

3

Often

4

Always

5




Q30. How confident are you filling out medical forms by yourself?


Not at all

1

A little bit

2

Somewhat

3

Quite a bit

4

Extremely

5







Next are a few questions about the ice cream label from the back of a container of a pint of ice cream, shown here.




Q31. If you eat the entire container, how many calories will you eat?


|___|___|___|___| Number of calories


  • Don’t know


Q32. If you are allowed to eat 60 grams of carbohydrates as a snack, how much ice cream could you have?


|___| Number of cup(s) or |___| Number of serving(s)


  • Don’t know



Q33. Your doctor advises you to reduce the amount of saturated fat in your diet. You usually have 42 g of saturated fat each day, which includes one serving of ice cream. If you stop eating ice cream, how many grams of saturated fat would you be consuming each day?


|___|___| Number of grams


  • Don’t know



Q34. If you usually eat 2,500 calories in a day, what percentage of your daily value of calories will you be eating if you eat one serving?

|___|___|___| %


  • Don’t know



Q35. Pretend that you are allergic to the following substances: penicillin, eggs, latex gloves, and bee stings. Is it safe for you to eat this ice cream?


  • Yes

  • No

  • Don’t know

[If answer to Q35 is “No.”]


Q36. Why not?


_________________________________




Finally, we would like to ask you a few questions about yourself. This section will help us determine how representative the participants are who complete this questionnaire.

Q37. Are you Hispanic or Latino?


  • Yes

  • No


Q38. What is your race? You may select one or more races.

  • American Indian or Alaska Native

  • Asian

  • Black or African American

  • Native Hawaiian or other Pacific Islander

  • White

  • Some Other Race



Q39. What is your date of birth?


_____Month


_____Year




Q40. Of these income groups, which category best represents your total combined family income during 2017?

  • Less than $20,000

  • $20,000–$39,999

  • $40,000–$59,999

  • $60,000–$79,999

  • $80,000–$99,999

  • $100,000 or more





Q41. For how many years have you taken prescription drug(s) for rheumatoid arthritis (RA)?


  • Years


  • Check here if you have never taken prescription drug(s) for rheumatoid arthritis.



Q42. Would you like to see more information about Mytrozen?


  • Yes, I would like to see more information now.

  • No, I do not wish to see more information now.





---------------------------------------------------



PRETEST STUDY PROBES

(For Pretest Only)


We are interested in what you thought about the ad that you saw. We’ll look at a playback of your eye information while you looked at the drug ad. We just want to learn a little more about what drew your attention and why. There are no right or wrong answers.


Do you have any questions before we begin?



[Start gaze replay; stop and probe based on participant’s ad viewing.]


[For participants whose eye tracking information shows they did not look at the ISI at all, or any specific area within the ISI, i.e. contraindications, most severe side effects.]


P1. Your vision (eye tracking) information shows that you spent less time looking at [fill with ad element(s) within the ISI that participant spent either no or relatively little time looking at]. Can you tell me about that?


[IF NEEDED]:


  • Why did that draw your attention?


[For participants whose eye tracking information shows they spent time looking at ad elements unrelated to risks.]


P2. Your vision (eye tracking information) shows that you looked at [FILL WITH DESCRIPTION OF WHAT P LOOKED AT]. Can you tell me more about that? Why did that get your attention more than [fill with ISI description]?


[IF NEEDED]:


  • Why did that draw your attention?


[For participants in a brief summary condition, if their eye tracking information shows they did not look at the brief summary.]


P3. Your vision (eye tracking) information shows that you spent {less/only a very brief time} time looking at this page. Can you tell me about that?




P4. Thinking about the questions that were presented following the ad, was there anything that stood out to you as confusing or anything that you did not understand?



Debriefing


Mytrozen is not a real product and it is not available for sale. The purpose of this research is to understand how people think about prescription drug information. In order to get an unbiased reaction to this information, we created a brand for this study. Please see your healthcare professional for questions about rheumatoid arthritis (RA).


You have been very helpful. Thank you very much for your participation!



OVERACTIVE BLADDER QUESTIONNAIRE



We are going to ask you specifically about the Serenin prescription drug ad that you saw.


Please answer the following questions based on the information you have just seen.





Q1.


Thinking overall about the risks and benefits of Serenin, would you say it has…



Many more risks than benefits

1

Somewhat more risks than benefits

2

Equal risks and benefits

3

Somewhat more benefits than risks

4

Many more benefits than risks

5








Q2. How noticeable was the information about Serenin’s side effects?


Not at all noticeable

1

2


3

4



5

Very noticeable

6




Q3. How noticeable was the information about Serenin’s benefits?


Not at all noticeable

1

2


3

4



5

Very noticeable

6




The next three questions ask about taking Serenin, in this order:

  • 4a: The most serious risks of taking it.

  • 4b: Other side effects that might occur from taking it.

  • 4c: Other reasons why people should not take it.





Q4a. Based strictly on the information in the ad, what are the most serious risks of taking Serenin?

(Please use one box for each serious risk.)












Q4b. Based strictly on the information in the ad, what are the other side effects of taking Serenin?

(Please use one box for each side effect.)




























Q4c. Based strictly on the information in the ad, for what other reasons should people not take Serenin?

(Please use one line for each reason.)

























Q5. In reviewing the Serenin ad, did you see any of the drug risks more than once?


  • Yes

  • No


Q6. Thinking of the drug risks, how repetitive was this information in the Serenin ad?


Not at all repetitive

1

2

3

4



5

Very repetitive

6







Q7. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as a risk of taking Serenin.



Mentioned in the ad

Not mentioned in the ad

a. Can cause sleepiness

b. Can change the way other prescription medications work

c. Can cause serious allergic reactions

d. Can cause dizziness

e. Can increase heart rate

f. Can cause muscle pain




Q8. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as reasons you should not take Serenin.



Mentioned

in the ad

Not mentioned

in the ad

a. Have kidney disease

b. Have uncontrolled narrow-angle glaucoma

c. Have stomach or intestinal problems

d. Have liver disease

e. Are taking antidepressants

f. Have heart problems



Q9. Based strictly on the information in the ad, please indicate whether any of the following were mentioned in the ad as benefits of taking Serenin.



Mentioned

in the ad

Not mentioned

in the ad

a. Serenin is used for treating symptoms of urinary leakage

b. Serenin is used for treating symptoms of urinary urgency.

c. Serenin is available as a once-daily pill

d. Serenin is available as a medicated adhesive patch

e. Serenin can provide round-the-clock relief from OAB symptoms




The next questions ask for your opinions based on reading the ad.


Q10. How likely is it that you would experience at least one side effect if you took Serenin?



Not at all likely

1

2

3

4



5

Extremely likely

6




Q11. How serious are Serenin’s side effects?



Not at all serious

1

2

3


4




5

Extremely serious

6



Q12. How likely is it that Serenin would help manage your overactive bladder symptoms if you took it?



Not at all likely

1

2

3

4



5

Extremely likely

6





Q13. How much would Serenin improve your overactive bladder condition?


No improvement

1

2

3

4



5

Substantial improvement

6



The next questions ask about the different parts of the ad.



Q14. Based on the image to the right, which of the following areas got your attention?




Got my attention

Did not get my attention

a. AREA A

b. AREA B

c. AREA C

e. AREA D



Q15. Overall, how much, if any, of the advertisement did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know



Q16. Refer to the area marked on the image to the right. How much, if any, of that risk information did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know


Q17. Refer to the area marked on the image to the right. How much, if any, of that risk information did you read?


__ None of the information

__ Only a little of the information

__ About half of the information

__ Almost all of the information

__ All of the information

__ Don't know




Q18. To me, this ad for overactive bladder is:

a.

Unimportant






Important

1

2

3

4

5

6

7


b.

Boring






Interesting

1

2

3

4

5

6


7


c.

Irrelevant






Relevant

1

2

3

4

5

6

7




d.

Unexciting






Exciting

1

2

3

4

5

6

7


e.

Means nothing







Means a lot to me

1

2

3

4

5

6

7


f.

Unappealing






Appealing

1

2

3

4

5

6

7


g.

Mundane






Fascinating

1

2

3

4

5

6

7


h.

Worthless






Valuable

1

2

3

4

5

6

7


i.

Uninvolving






Involving

1


2

3

4

5

6

7



j.

Not needed






Needed

1


2

3

4

5

6

7




Q19. Based on your reading of the ad, how confident are you that you could do the following tasks?


  1. Recognize side effects.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Identify which drugs interact with Serenin.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Remember the risk information.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know when to stop taking the drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know what condition is treated by this drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Tell the difference between a common side effect and a serious reaction.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Identify who should not take this drug.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Know when you should ask a doctor or health professional about a side effect you might have.


Not at all confident

1

2

3

4




5


Completely confident

6



  1. Feel confident you can discuss the side effect with your doctor.


Not at all confident

1

2

3

4




5


Completely confident

6




Q20. The benefits of Serenin outweigh all the things I have to do to obtain it (appointments, prescriptions, leave).



Strongly disagree

1

2

3

4




5


Strongly agree

6



Q21. The benefits of Serenin outweigh any side effects it may have.



Strongly disagree

1

2

3

4




5


Strongly agree

6



Q22. In general, how much do you feel you know about overactive bladder? Would you say you are...

Not at all knowledgeable

1

Slightly knowledgeable

2

Somewhat knowledgeable

3

Moderately knowledgeable

4


Very knowledgeable

5


Extremely knowledgeable

6



Q23. How familiar are you with prescription drugs that treat overactive bladder?

Not at all familiar

1

Slightly familiar

2

Somewhat familiar

3

Moderately familiar

4



Very familiar

5


Extremely familiar

6


Q24. In general, how severe is your overactive bladder condition?


Not at all severe

1

Slightly severe

2

Somewhat severe

3

Moderately severe

4

Very severe

5

Extremely severe

6




Q25. How concerned are you about the impact of overactive bladder on your life?



Not at all concerned

1

Slightly concerned

2

Somewhat

concerned

3

Moderately concerned

3

Very concerned

4

Extremely concerned

5



Q26. How likely are you to…



Very unlikely

1

Somewhat unlikely

2

Neither likely or unlikely

3

Somewhat likely

4

Very likely

5

a. Talk to your doctor about Serenin?







b. Look for more information about Serenin?









Q27. Do you have any health conditions that would prevent you from taking Serenin?


  • Yes

  • No

  • Don’t know


Q28. How often do you have a problem understanding the written materials about your medical condition?



Never

1

Occasionally

2

Sometimes

3

Often

4

Always

5



Q29. How often do you have a problem understanding what is told to you about your medical condition?



Never

1

Occasionally

2

Sometimes

3

Often

4

Always

5



Q30. How confident are you filling out medical forms by yourself?


Not at all

1

A little bit

2

Somewhat

3

Quite a bit

4

Extremely

5





Next are a few questions about the ice cream label from the back of a container of a pint of ice cream, shown here.



Q31. If you eat the entire container, how many calories will you eat?


|___|___|___|___| Number of calories


  • Don’t know




Q32. If you are allowed to eat 60 grams of carbohydrates as a snack, how much ice cream could you have?


|___| Number of cup(s) or |___| Number of serving(s)


  • Don’t know



Q33. Your doctor advises you to reduce the amount of saturated fat in your diet. You usually have 42 g of saturated fat each day, which includes one serving of ice cream. If you stop eating ice cream, how many grams of saturated fat would you be consuming each day?


|___|___| Number of grams


  • Don’t know


Q34. If you usually eat 2,500 calories in a day, what percentage of your daily value of calories will you be eating if you eat one serving?

|___|___|___| %


  • Don’t know



Q35. Pretend that you are allergic to the following substances: penicillin, eggs, latex gloves, and bee stings. Is it safe for you to eat this ice cream?


  • Yes

  • No

  • Don’t know

[If answer to Q35 is “No.”]



Q36. Why not?


_________________________________


[Demographics]


Finally, we would like to ask you a few questions about yourself. This section will help us determine how representative the participants are who complete this questionnaire.

Q37. Are you Hispanic or Latino?


  • Yes

  • No



Q38. What is your race? You may select one or more races.

  • American Indian or Alaska Native

  • Asian

  • Black or African American

  • Native Hawaiian or other Pacific Islander

  • White

  • Some Other Race



Q39. What is your date of birth?


_____Month


_____Year



Q40. Of these income groups, which category best represents your total combined family income during 2017?

  • Less than $20,000

  • $20,000–$39,999

  • $40,000–$59,999

  • $60,000–$79,999

  • $80,000–$99,999

  • $100,000 or more






Q41. For how many years have you taken prescription drug(s) for overactive bladder (OAB)?

  • Years


  • Check here if you have never taken prescription drug(s) for overactive bladder.


Q42. Would you like to see more information about Serenin?


  • Yes, I would like to see more information now.

  • No, I would not like to see more information now.




PRETEST STUDY PROBES

(For Pretest Only)


We are interested in what you thought about the ad that you saw. We’ll look at a playback of your eye information while you looked at the drug ad. We just want to learn a little more about what drew your attention and why. There are no right or wrong answers.


Do you have any questions before we begin?



[Start gaze replay; stop and probe based on participant’s ad viewing.]


[For participants whose eye tracking information shows they did not look at the ISI at all, or any specific area within the ISI, i.e. contraindications, most severe side effects.]


P1. Your vision (eye tracking) information shows that you spent less time looking at [fill with ad element(s) within the ISI that participant spent either no or relatively little time looking at]. Can you tell me about that?


[IF NEEDED]:


  • Why did that draw your attention?


[For participants whose eye tracking information shows they spent time looking at ad elements unrelated to risks.]


P2. Your vision (eye tracking information) shows that you looked at [FILL WITH DESCRIPTION OF WHAT P LOOKED AT]. Can you tell me more about that? Why did that get your attention more than [fill with ISI description]?


[IF NEEDED]:


  • Why did that draw your attention?


[For participants in a brief summary condition, if their eye tracking information shows they did not look at the brief summary.]


P3. Your vision (eye tracking) information shows that you spent {less/only a very brief time} time looking at this page. Can you tell me about that?




P4. Thinking about the questions that were presented following the ad, was there anything that stood out to you as confusing or anything that you did not understand?


Debriefing


Serenin is not a real product and it is not available for sale. The purpose of this research is to understand how people think about prescription drug information. In order to get an unbiased reaction to this information, we created a brand for this study. Please see your healthcare professional for questions about overactive bladder (OAB).


You have been very helpful. Thank you very much for your participation!




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