Cognitive Interviews for Risk and Benefit Perception Scale Development Study

Appendix C – Questionnaire

Note: The amount of distraction during the major statement will vary (no, low, high) among ads. In all conditions the ads will have dual-modality SUPERs and the toll-free statement.

[PROGRAMMER: We need to record the total time in milliseconds for the interview protocol. Participants should not be able to return to questions after they have answered them.]

Interview Protocol.

(Present Informed Consent Form)

Thank you for agreeing to participate in this study today. This study is about advertising for a new product.

Even though it is on a computer screen, please watch this ad as if you saw it on television. Please try to remember as much about the ad as possible. We will ask you questions about the ad later in the study.

[PROGRAMMER: New screen]

Please sure make your speakers are turned on and the volume adjusted to a comfortable level.

Please note that the commercial will play twice. Please allow some time for the commercial to load on your computer.

[PROGRAMMER: Randomize to show Ad 1 twice OR Ad 2 twice OR Ad 3 twice.]

Now please answer the following questions based on the ad you saw.

S5. Were you able to view the ad for [DRUG NAME]?

Yes

No (terminate)

Not sure (terminate)

Q1. (Main reaction, Open-ended) In your own words, list all your thoughts, reactions and ideas that went through your mind while you were watching the part of the ad that talks about the drugs’ side effects and negative outcomes. Please use a separate line for each thought.

[PROGRAMMER: Five separate text boxes]

Distracting in general

Distracting visuals

Distracting words

Distracting music

Distracting voice

Clear

Couldn’t understand risks

Could understand risks

Too much risk information

Too little risk information

Code any specific risks mentioned

(codes to be determined)

Q2. For each of the thoughts, reactions and ideas you listed, indicate whether the thought was positive, negative or neutral.

[PROGRAMMER: Display responses from Q_. For each response, include a drop-down choice box or other appropriate choice box with the choices POSITIVE, NEGATIVE, NEUTRAL]

You said…	Is it…
[insert each response from Q_ above in a separate box]	POSITIVE NEGATIVE NEUTRAL

Q3. (Risk Notice-ability) How noticeable was the information about [DRUG NAME]’s side effects or negative outcomes?

1 2 3 4 5 6 7

Not at all Very

noticeable noticeable

Q4. Recall of Risks, Open-ended) What are the side effects and negative outcomes of [DRUG NAME]? (one code per correct risk; create count of correct risks listed)

Q5. (Recall of Risks) Please check which of the following were mentioned in the ad as side effects and negative outcomes of taking [DRUG NAME]. Even if you think a statement is true, please select it only if it was mentioned in the ad.

[PROGRAMMER: randomize Q8a-h]

[Placeholders]	Mentioned in the ad	NOT mentioned in the ad
a. [DRUG NAME] may cause abdominal pain.	x
b. A serious side effect of [DRUG NAME] is bone loss.	x
c. Women who are pregnant should not take [DRUG NAME].	x
d. [DRUG NAME] may cause headaches.	x
e. [DRUG NAME] may cause nausea.		x
f. [DRUG NAME] may cause dizziness.		x
g. People with kidney problems should not take [DRUG NAME].		x
h. A serious side effect of [DRUG NAME] is joint pain.		x

(Perceived Risk)

Q6. In your opinion…If 100 people take [DRUG NAME], how many will have any side effects or negative outcomes? Please enter a number in the box below.

__ people

Q7. In your opinion…If [DRUG NAME] did cause a person to have side effects or negative outcomes, how serious would they be?

1 2 3 4 5 6 7

Not at all Very

serious serious

(Distraction)

Q8. How distracting were the images while the side effects and negative outcomes were listed?

1 2 3 4 5 6 7

Not at all Very

distracting distracting

(IF Q8 >= 5, ask Q8a)

Q8a. What about the images did you find distracting? (open-ended)

(codes to be determined)

Q9. How distracting were the sounds while the side effects and negative outcomes were listed?

1 2 3 4 5 6 7

Not at all Very

distracting distracting

(IF Q9 >= 5, ask Q9a)

Q9a. What about the sounds did you find distracting? (open-ended)

(codes to be determined)

(Ad Impression)

Q10a – Q10e. In your opinion, was the ad for DRUG X:

1 2 3 4 5 6 7

Bad Good

1 2 3 4 5 6 7

Unpleasant Pleasant

1 2 3 4 5 6 7

Unfavorable Favorable

1 2 3 4 5 6 7

Unbelievable Believable

1 2 3 4 5 6 7

Uninteresting Interesting

Q11. Was this ad less believable or more believable than the ads you have seen on television for other prescription medications?

1 2 3 4 5 6 7

Less More

Believable Believable

Q12. How similar or different was this ad compared to ads that you have seen on television for other prescription medications?

1 2 3 4 5 6 7

Nothing like Just like

ads on TV ads on TV

Q13. Please rate your impressions of this ad:

[PROGRAMMER: randomize questions and rotate responses top-to-bottom; bottom-to-top]

1. How would you rate the audio quality of this ad?

1 2 3 4 5 6 7

Very Very

low high

(b) How would you rate the visual quality of the ad?

1 2 3 4 5 6 7

Very Very

low high

(Toll-Free Statement Recall)

Q14a. Did you notice a statement about FDA in the ad for Drug X?

▪ Yes (ask Q14b and Q14c, do not ask Q14d)

▪ No (skip to Q15)

▪ Don‘t know (skip to Q14d)

Q14b. What did the statement say? (open-ended)

▪ Participate in a study/clinical trial

▪ Seek medical advice

▪ Get more information

▪ Report side effects

▪ Contact drug company

▪ Call FDA

▪ Other

Q14c. Why should you contact FDA, according to the statement?

▪ To participate in a clinical trial

▪ To seek medical advice

▪ To get more information about the drug

▪ To report side effects

▪ None of the above

▪ Don‘t know

Q14d. Did you notice a statement about reporting side effects in the ad?

▪ Yes

▪ No

Q15. Which, if any, of the following statements appeared in the ad? You may select more than one.

[PROGRAMMER: randomize]

a. You are encouraged to report negative side effects of prescription drugs to the

FDA.Visit www.fda.gov/, or call 1-800-FDA-1088.

b. 800-555-DrugX [placeholder]

c. Clinical trials involved men and women over the age of 18 and were conducted

up to12 months.

d. For more information on reduced cost prescription drug programs, contact

FDA at 1-800-FDA-1088.

e. www.drugx.com [placeholder]

f. None of these statements appeared in the ad.

Q16. How distracting did you think this ad was? Please be specific about what you thought was distracting, if anything. (open-ended)

(codes to be determined)

Q17. Gender

• Male

• Female

Q18. What is your date of birth?

_____month [pull down menu]

_____year [pull down menu]

Q19. What is the highest level of school you have completed or the highest degree you have received?

Less than high school

High school graduate—high school diploma or the equivalent (for example: GED)

Some college but no degree

Associate degree in college

Bachelor’s degree (for example: BA, AB, BS)

Advanced or post-graduate degree (for example: Master’s degree, MD, DDS,

JD, PhD, EdD)

Q20. Are you Hispanic or Latino?

􀂉 No

􀂉 Yes

Q21. 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

Q22. What is your height?

___ feet ___ inches

Q23. What is your weight?

____ pounds

(Debriefing)

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. [DRUG NAME] is not a real product and it is not available for sale. Please see your healthcare professional for questions about [medical condition].

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

8

OMB Control #0910-0695 Expiration Date 10/31/14