Pilot Study

SCREENER

S1. In which age group do you fall? [Recruit a mix across the study]

• Under 18  terminate [Closing for Ineligible Participants]

• 18-34

• 35-54

• 55 or older

S2. Do you currently have any of the following health problems?

a) Asthma

• Yes

• No

b) High cholesterol

• Yes

• No

c) You need to lose more than 30 pounds

• Yes  continue

• No  terminate [Closing for Ineligible Participants]

S3. Are you trained or employed as a health care professional?

• Yes  terminate [Closing for Ineligible Participants]

• No  continue

S4. Do you work for a pharmaceutical company, an advertising agency, or a market research company?

• Yes  terminate [Closing for Ineligible Participants]

• No  continue

S5. Do you wear corrective lenses while watching television? Please check all that apply.

No, I do not wear glasses or contacts

Yes, I wear regular glasses

Yes, I wear bifocals  terminate [Closing for Ineligible Participants]

Yes, I wear soft contact lenses

Yes, I wear hard contact lenses  terminate [Closing for Ineligible Participants]

S6. What is your gender?

• Male

• Female

S7. What is your date of birth?

_____month

_____year

S8. What is the highest level of school you have completed or the highest degree you have received? (Please select one.)

• 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)

[Closing for Ineligible Participants]

I’m sorry, but you are not eligible for this study. There are many possible reasons why people are not eligible. These reasons were decided earlier by the researchers. However, thank you for your interest in this study and for taking the time to answer our questions today.

QUESTIONNAIRE

Thank you for taking time from your busy schedule to take part in this research. Your answers will remain confidential – that is, your personal responses will not be traced to your name.

You will watch television and then will be asked to answer the questions that follow.

Make sure you are comfortable and can read the screen from where you sit. The study will take about [insert 30 for main study and 60 for pilot study] minutes to complete.

Please answer the following questions to the best of your ability, based on the information you have just seen.

[PROGRAMMER: Randomly assign participants to an experimental condition]

[PROGRAMMER: Show participants a television clip followed by three ads, one of which is the experimental ad. Randomize the order of the ads. After participant is done viewing the stimuli begin questionnaire]

[PROGRAMMER: New screen]

Now we are going to ask you specifically about the DRUG X prescription drug ad that you saw.

Q1. How noticeable was the information about DRUG X’s side effects and negative outcomes?

	Not at all noticeable						Very noticeable 7
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[Based on pilot study results, we will include either Q2a, Q2b, or Q2c in the main study questionnaire]

Q2a. Based only on the information in the ad …If 100 people take DRUG X, what percentage of people will have any side effects or negative outcomes?

• Absolutely No Idea

Q2b.	Based only on the information in the ad, what is your initial impression of how likely it is that you would experience any side effects or negative outcomes if you took DRUG X?
	Not at all Likely 1						Extremely Likely 7
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Q2c.	Based only on the information in the ad, my initial impression is that DRUG X has very few risks and side effects.
	Strongly Disagree 1						Strongly Agree 7
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[Based on pilot study results, we may include only Q3a or Q3b in the main study questionnaire]

Q3a. Based only on the information in the ad…If DRUG X did cause a person to have side effects or negative outcomes, what is your initial impression of how many of the side effects or negative outcomes would be serious?

	Most would not be serious 1						Most would be very serious 7
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Q3b.	Based only on the information in the ad, what is your initial impression of how bothersome the stated side effects of the medication would be?
	Not at all 1						Extremely 7
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Q4. What are the side effects and negative outcomes of DRUG X? [Open-Ended] Please use one line for each side effect or negative outcome.

[PROGRAMMER: Sixteen separate text boxes]

Q5.	Based only on the information in the ad, what is your initial impression of how often DRUG X works as it should for patients taking it?
	Never 1						Always 7
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[Based on pilot study results, we will include either Q6a or Q6b in the main study questionnaire]

Q6a.	Based on the information in the ad, I am completely certain that the good things about this medication outweigh the bad things.
	Strongly Disagree 1						Strongly Agree 7
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Q6b.	Thinking overall about the risks and benefits of DRUG X, 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
		○	○	○	○	○

Q7. Please check which of the following were mentioned in the ad as side effects and negative outcomes of taking DRUG X. Even if you think a statement is true, please select it only if it was mentioned in the ad.

[PROGRAMMER: Randomize Q7a thru Q7j]

According to the ad, Drug X may ….

	Mentioned in the ad	NOT mentioned in the ad	Don’t Know
a. increase heart rate	X
b. cause muscle spasms	X
c. cause a severe rash	X
d. cause hip and spine fractures	X
e. cause itching	X
f. increase insulin levels		X
g. cause kidney damage		X
h. cause severe nausea		X
i. cause joint pain		X
j. cause dizziness		X

Q8. Please check which of the following were mentioned in the ad. Even if you think a statement is true, please select it only if it was mentioned in the ad.

[PROGRAMMER: Randomize Q8a thru Q8j]

According to the ad, you should not take DRUG X if you ….

	Mentioned in the ad	NOT mentioned in the ad	Don’t Know
a. are pregnant	X
b. have glaucoma	X
c. have thyroid problems	X
d. have liver problems	X
e. are taking antidepressants	X
f. have ever had a heart attack		X
g. sometimes have blurry vision		X
h. have migraine headaches		X
i. just had a vaccination		X
j. have kidney problems		X

[PROGRAMMER: Randomize Q9a thru Q9g]

Q9. Which of the following were mentioned in the ad for Drug X?

	Mentioned in the ad	NOT mentioned in the ad	Don’t Know
a. Drug X is used to lose weight	X
b. Drug X is used to maintain weight loss	X
c. Drug X must be used with diet and exercise	X
e. Drug X is for anyone who is 30 pounds overweight		X
f. Drug X is a once-daily pill		X
g. Drug X speeds up metabolism		X

Q10a. Did you notice a statement about FDA in the ad for DRUG X?

• Yes

• No

[PROGRAMMER: IF Q10a = Yes, Then ask Q10b and Q10c]

[PROGRAMMER: IF Q10a = No, then skip to Q11]

Q10b. What did the statement say? [Open-Ended]

Q10c. Why should you contact FDA, according to the statement?

[PROGRAMMER: Randomize first 4 categories]

• 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

Q11. Which, if any, of the following statements appeared in the ad?

Please select all that apply.

[PROGRAMMER: randomize first 5 categories]

[PROGRAMMER: Allow for multiple responses unless “None” is selected]

• You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

• 877-DRUG X-RX (877-372-2579)

• Clinical trials involved men and women over the age of 18 and were

conducted up to12 months.

• For more information on reduced cost prescription drug programs, contact

FDA at 1-800-FDA-1088.

• www.DRUG X.com

• None of these statements appeared in the ad.

[PROGRAMMER: Randomize Q12a thru Q12e]

Q12a.	As I viewed the ad, I thought about whether I agreed or disagreed with what was being said.
	Strongly Disagree 1						Strongly Agree 7
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Q12b.	As I viewed the ad, I found myself making connections between the ad and what I’ve read or heard about elsewhere.
	Strongly Disagree 1						Strongly Agree 7
	○	○	○	○	○	○	○
Q12c.	As I viewed the ad, I thought about how what I saw related to other things I know.
	Strongly Disagree 1						Strongly Agree 7
	○	○	○	○	○	○	○
Q12d.	I didn’t spend much time thinking about the ad after I viewed it.
	Strongly Disagree 1						Strongly Agree 7
	○	○	○	○	○	○	○
Q12e.	The ad presented too many conflicting viewpoints.
	Strongly Disagree 1						Strongly Agree 7
	○	○	○	○	○	○	○

Q13. How distracting were the images while the side effects and negative outcomes were listed?

	Not at all distracting 1						Very distracting 7
	○	○	○	○	○	○	○

Q14. How distracting were the sounds while the side effects and negative outcomes were listed?

	Not at all distracting 1						Very distracting 7
	○	○	○	○	○	○	○

Q15. How often do you have trouble understanding instructions, pamphlets, or other written material from your doctor or pharmacy?

• Never

• Rarely

• Sometimes

• Often

• Always

Q16.

My current body weight is a threat to my health.

Strongly disagree 1

Strongly agree 7

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Q17.

The following items ask about information related to obesity. Please answer each of the questions to the best of your ability.

Which of these serious health problems has/have been linked to obesity?

Type 2 diabetes

Heart disease

High blood pressure

Stroke

All of the above

Don’t know

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In which area of the body does a high percentage of fat pose the greatest health risks?

Thighs and arms

The abdominal region

The buttocks

The chin and neck

Don’t know

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Which kind of fat is more likely to raise people’s blood cholesterol level?

Saturated fats

Poly-unsaturated fats

Both saturated and poly-unsaturated fats

None of the above

Don’t know

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Q18. When did a healthcare professional first tell you that you need to lose weight?

• Never

• 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

[Based on pilot study results, we will include either Q19a or Q19b in the main study questionnaire]

Q19a.	Thinking about your current weight, how much weight would you like to lose, if any? If you do not want to lose any weight, please enter 0 in the box below.
	I would like to lose ___ pounds

Q19b. How would you describe your current weight goal?

• I want to gain a lot of weight

• I want to gain a little weight

• I am happy with my current weight

• I want to lose a little weight

• I want to lose a lot of weight

Q20. Are you Hispanic or Latino?

• No

• Yes

Q21. What is your race? You may select one or more races.

[PROGRAMMER: For Q21, Allow for multiple responses]

• 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? Your best guess is okay.

___ feet ___ inches

Q23. What is your weight? Your best guess is okay.

____ pounds

[PROGRAMMER: New screen]

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 X is not a real product and it is not available for sale. Please see your healthcare professional for questions about weight loss.

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

ADDITIONAL PILOT STUDY QUESTIONS

We are interested in what you thought about the short television clip that you saw. There is no right or wrong answer.

P1. How much did you like the television clip that you saw?

Not at all										Very much
1										10
○	○	○	○	○	○	○	○	○	○	○

P2. How ______________ was the television clip that you saw?

	Not at all										Very much
	1										10
Funny	○	○	○	○	○	○	○	○	○	○	○
Annoying	○	○	○	○	○	○	○	○	○	○	○
Interesting	○	○	○	○	○	○	○	○	○	○	○
Boring	○	○	○	○	○	○	○	○	○	○	○
Depressing	○	○	○	○	○	○	○	○	○	○	○
Suspenseful	○	○	○	○	○	○	○	○	○	○	○
Exciting	○	○	○	○	○	○	○	○	○	○	○

We are now going to ask you some follow-up questions about the questionnaire and your answers. I’d also like you to point out any questions or answer choices that might be confusing.

Do you have any questions before we begin?

P3a. Were you able to pay attention to the information about side effects that appeared in the ad?

P3b. [If no] What, if anything, distracted you?

P3c. [If yes] What, if anything, helped you pay attention?

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

P5. Do you have any suggestions or recommendations for improving the questionnaire? [Review each question with the participant]

[Ask after Q2a-Q2c]

P6a. How did you choose your answer (what information did you base your answer on)?

P6b. Please take another look at questions Q2a, Q2b, and Q2c.Which version was easier to answer? Why?

[Ask after Q3a and Q3b]

P7a. How did you choose your answer (what information did you base your answer on)?

P7b. Please take another look at questions Q3a and Q3b.Which version was easier to answer? Why?

[Ask after Q6a and Q6b]

P8a. How did you choose your answer (what information did you base your answer on)?

P8b. Please take another look at questions Q6a and Q6b.Which version was easier to answer? Why?

[Ask after Q19a and Q19b]

P9. Please take another look at questions Q19a and Q19b.Which version was easier to answer? Why?

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