Pilot Study

December 8, 2014

Questionnaire

Programming instructions are indicated in green font.

Notes to research team are indicated in red font.

[PROGRAMMER:

• Program progresses to the questioning in a “one-way” manner

• Record time in milliseconds spent on screen 1, screen 3, and screen 4. Record the start and end time for the total survey in seconds.

[PROGRAMMER: The OMB control number and Expiration Date should appear at the bottom of every screen (maybe above the privacy text).  It should be as unobtrusive as possible.

After the first screen (Consent Screen 1), we show:

DHHS research authorized by Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)). Confidentiality protected by 5 U.S.C. 552(a) and (b) and 21 CFR part 20. OMB Control #_0910-xxxx__ Expires xx/xx/xx

For every other screen we will show: OMB Control #_0910-xxxx____ Expires xx/xx/xx___]

PROG: (CUSTOM TERMINATION) For terminated 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. Thank you for your interest in this study and for taking the time to answer our questions today.

[Consent Screen 1]

You are being asked to participate in a survey about a new consumer product.  If you agree to take part in this research, you will be asked to watch a TV ad and to answer some questions about the ad.  The study will take about 30 minutes.

[Insert language about panel points/rewards]

[Insert language about panel privacy policy]

DHHS research authorized by Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)).  Confidentiality protected by 5 U.S.C. 552(a) and (b) and 21 CFR part 20.      

OMB Control #0910-xxxx____  Expires xx/xx/xx_____

[PROGRAMMER: Screen 1. TIME SPENT ON SCREEN IN MILLISECONDS]

[Next Page: Screen 2]

SCREENING QUESTIONS

S1. Are you at least 18 years old?

• Yes  continue

• No  terminate and show custom termination screen

S2. In what year were you born? ______

If Year is < or = 1996 [continue]

If Year is > 1996 [terminate and show custom termination screen]

S3a. Have you been diagnosed by a physician for any of the following conditions?

a. Asthma _____Yes _____No

b. Diabetes _____Yes _____No

c. Insomnia _____Yes _____No [If checked, go to S3b.1]

d. High cholesterol _____Yes _____No [If checked, go to S3b.2]

e. Acid reflux or GERD _____Yes _____No

f. Depression _____Yes _____No [If checked, go to S3b.3]

[PROGRAMMER: if Respondents check more than one condition, assign them to the lowest prevalence condition first. The prevalence order is depression < insomnia < high cholesterol]

S3b. Are your currently taking a prescription drug to treat your … ?

Yes No
1.Insomnia
2.High Cholesterol
3.Depression

S4. Are you trained or employed as a health care professional?

• Yes  terminate and show custom termination screen

• No  continue

S5. Do you work for a pharmaceutical company, an advertising agency, or a market research company?

• Yes  terminate and show custom termination screen

• No  continue

[Next page: Screen 3]

[SCRIPT] Thank you for agreeing to participate in this study today.

Make sure you are comfortable and can read the screen from where you sit. This study is about advertising for prescription medication. Your answers are private and will not be connected with your name. Your input is extremely valuable.

Let’s begin.

We will ask you questions about the ad after you have finished watching it. Do your best to remember details about the ad. We will ask you to explain your answers. Make sure your computer sound is turned on and set at a comfortable volume.

[PROGRAMMER: Screen 3. TIME SPENT ON EACH SCREEN IN MILLISECONDS]

[Next page: Screen 4]

[SCRIPT] Please click the link below to view the ad. It may take a minute or two for the video to begin. You should be able to see and hear the video when it begins to play.

[PROGRAMMER: Randomize order of clutter reel]

[PROGRAMMER: Screen 4. TIME SPENT ON EACH SCREEN IN MILLISECONDS]

[Next page: Screen 5]

[SCRIPT] Please answer the following questions based on the ad you saw.

Q1. Were you able to view the entire ad for [DRUG]?

• Yes

• No  [Skip back to ad]

• Not sure  [Skip back to ad]

[PROGRAMMER: If Q1a=No or Not sure, replay just the prescription drug ad.  If, after this, they still say No or Not sure to Q1a, then terminate.]

Q2a. Have you seen this exact ad before?

• Yes [Go to Q2b]

• No [Continue to Q2c]

• Not sure [Continue to Q2c]

Q2b. In the last 6 months, how often did you see this exact ad before?

• Never

• Rarely

• Sometimes

• Often

• Very often

Q2c. Have you seen other ads for this product before?

• Yes

• No

• Not sure

Q3. Please list the thoughts that were going through your mind as you viewed the ad for [DRUG] and list them below. Use one line for each thought.

[PROGRAMMER: Five separate text boxes]

[Next page: Screen 6]

Q4. What condition does [DRUG] treat? [PROGRAMMER: randomize responses]

• Seasonal allergies

• Insomnia

• Migraine headaches

• High Cholesterol

• Diabetes

• Acid Reflux/GERD

• Depression

• Don't know

Q5. What are the benefits of [DRUG]? Use one line for each benefit you list. [Open-ended]

[PROGRAMMER: Provide separate text boxes. The exact number of lines TBD]

Q6. What are the risks and side effects of [DRUG]? Use one line for each risk or side effect you list. [Open-ended]

[PROGRAMMER: Provide separate text boxes. The exact number of lines TBD]

[Next page: Screen 7]

[PROGRAMMER: MATCH VERSION OF Q7 TO DISEASE AD SHOWN]

(Memory for benefits and risks)

Q7_1. Based on the information in the ad, please check which of the following are benefits or risks of taking [DRUG]. [Depression version]

[PROGRAMMER: randomize a-l]

	Yes	No
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.

Q7_2. Based on the information in the ad, please check which of the following are benefits or risks of taking [DRUG]. [Insomnia version]

[PROGRAMMER: randomize a-k]

	Yes	No
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.

Q7_3. Based on the information in the ad, please check which of the following are benefits or risks of taking [DRUG]. [High cholesterol version]

[PROGRAMMER: randomize a-l]

	Yes	No
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
k.
l.

[Next page: Screen 8]

[PROGRAMMER: Randomize presentation order of the questions on screen 8]

(Perceived Benefit)

[SCRIPT] Please answer the following questions based on your impressions from the ad. Even though the ad didn’t tell you, please provide your best guess for the following questions

Q8. In your opinion, if 100 people take [DRUG], how many of the 100 would benefit from taking the drug?

[PROGRAMMER: Participants can slide an arrow to their answer.]

Q9. In your opinion, if [DRUG] did help a person’s [condition], how much would it help?

1	2	3	4	5
Would help [condition] a little				Would help [condition] a lot

(Perceived Risk)

Q10. In your opinion, if 100 people take [DRUG], how many of the 100 would have any side effects?

[PROGRAMMER: Participants can slide an arrow to their answer.]

Q11. In your opinion, if [DRUG] did cause a person with [condition] to have side effects, how serious would they be?

1	2	3	4	5
Not at all serious				Very serious

(Risk/benefit tradeoff)

Q12. Thinking overall about the risks and benefits of [DRUG], would you say it has:

1	2	3	4	5
Many more risks than benefits	Somewhat more risks than benefits	Equal risks and benefits	Somewhat more benefits than risks	Many more benefits than risks

(Perceptions of risk statement)

[PROGRAMMER: Randomize order of Q13a-g.]

Q13. Please rate your agreement or disagreement with each of the following statements.

	Strongly disagree	Somewhat disagree	Neither disagree nor agree	Somewhat agree	Strongly agree
The ad clearly communicated the benefits of [DRUG].
The ad clearly communicated the risks of [DRUG].
The ad evenly balanced the risks and benefits of [DRUG].
The ad did not give enough information about the possible benefits and positive effects of using the drug
The ad did not give enough information about the possible risks and side effects of using the drug.
The ad helped me learn about the drug’s benefits
The ad helped me learn about the drug’s risks and side effects

Q14. In my opinion, the prescription drug ad mentioned….

1	2	3	4	5
Not enough risks and side effects				Too many risks and side effects

Q15a. To what extent do you agree or disagree that the risks and side effects were:

[PROGRAMMER: Randomize order of Q15a.a-e.]

	Strongly disagree	Somewhat disagree	Neither disagree nor agree	Somewhat agree	Strongly agree
Informative
Actionable
Clear
Confusing
Important
Incomplete

Q16a. Overall, the risks and side effects mentioned in the prescription drug ad were….

1	2	3	4	5
Not at all serious				Very serious

Q16b. In your opinion, how serious are the following risks?

[PROGRAMMER: Randomize order of Q16b.a-f.]

	Not at all serious				Very serious

Q16c. In your opinion, how actionable are the following risks? We define ‘actionable’ as a symptom you would know you are at risk for (e.g., because of pre-existing condition or allergy) or recognize (e.g., because it is an observable physical or mental system) and can act upon to help lessen the risk (e.g., get immediate medical help to prevent a bad outcome).

[PROGRAMMER: Randomize order of Q16c.a-f.]

	Not at all actionable				Very actionable

Q16d. How likely is it that you would experience any of the following risks or side effects if you took [DRUG]?

[PROGRAMMER: Randomize order of Q16d.a-f.]

	Not at likely				Very likely

[Next page: Screen 9]

(Information seeking/intention items)

Q17. I am interested in trying [DRUG].

1	2	3	4	5
Strongly disagree	Somewhat disagree	Neither agree nor disagree	Somewhat agree	Strongly agree

[PROGRAMMER: counterbalance 18/19 and 20/21]

Q18. How likely are you to talk to your doctor about [DRUG]?

1	2	3	4	5
Very unlikely	Somewhat unlikely	Neither likely nor unlikely	Somewhat likely	Very likely

Q19. How likely are you to read the patient labeling for more information about [DRUG]?

1	2	3	4	5
Very unlikely	Somewhat unlikely	Neither likely nor unlikely	Somewhat likely	Very likely

Q20. How likely are you to look for more information about [DRUG]?

1	2	3	4	5
Very unlikely	Somewhat unlikely	Neither likely nor unlikely	Somewhat likely	Very likely

Q21. How likely are you to look for more information about [condition]?

1	2	3	4	5
Very unlikely	Somewhat unlikely	Neither likely nor unlikely	Somewhat likely	Very likely

Q22. If one of your family members or close friends had [condition], how likely would you be to mention [DRUG] to them?

1	2	3	4	5
Very unlikely	Somewhat unlikely	Neither likely nor unlikely	Somewhat likely	Very likely

[Next page: Screen 10]

[PROGRAMMER: Rotate order of Q22/Q22a and Q23/Q23a]

(Perceived Comparative Benefit and Risk)

[SCRIPT] For the next two questions, please think about other medicines you know of that treat [condition]. If you are not aware of other medicines that treat [condition], please choose the answer option “Neither disagree nor agree.”

When answering these questions, please base your impressions on the prescription drug ad you saw.

Q23. [DRUG] is more effective than other medicines that treat [condition].

• Strongly disagree

• Somewhat disagree

• Neither disagree nor agree

• Somewhat agree

• Strongly agree

Q23a. What other medicines were you thinking about?

[PROGRAMMER: Add fill space for write-ins]

Q24. [DRUG] is safer than other medicines that treat [condition].

• Strongly disagree

• Somewhat disagree

• Neither disagree nor agree

• Somewhat agree

• Strongly agree

Q24a. What other medicines were you thinking about?

[PROGRAMMER: Add fill space for write-ins]

(Perceived Quality)

Q25. Based on the information in the prescription drug ad, how would you rate the quality of [DRUG]?

1	2	3	4	5
Poor quality				Good quality

[PROGRAMMER: Randomize order of Q25a-d]

(Attitude toward Ad. From Bhutada et al., 2009, Shen & Chen, 2007, and MacKenzie & Lutz, 1989)

Q26. In my opinion, the ad for [DRUG] was:

a. 1 2 3 4 5

Good Bad

b. 1 2 3 4 5

Pleasant Unpleasant

c. 1 2 3 4 5

Favorable Unfavorable

d. 1 2 3 4 5

Very Not at all

persuasive persuasive

(Self-reported attention)

Q27. How much attention did you pay to the prescription drug ad when you were watching it?

1	2	3	4	5
A little				A lot

[Next page: Screen 11]

(Manipulation Checks)

Q28. Do you remember the prescription drug ad saying “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.”?

• Yes

• No

• Not sure

[PROGRAMMER: If “no” or “not sure” add to script “This ad did say that “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.”]

[SCRIPT]  Now we will show you the ad again.  This ad said “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.”   When answering the next few questions, please think only about that statement. 

[PROGRAMMER: Play prescription drug ad again for all conditions EXCEPT the Control conditions. For control condition, skip to Q30]

 

[Next page: Screen 12]

(Inferences about Statement)

Q29a. In your own words, list all your thoughts, reactions and ideas that went through your mind when the statement, “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.” was presented. Please use a separate line for each thought.

[PROGRAMMER: Five separate text boxes]

Q29b. For each of the thoughts, reactions and ideas you listed, indicate whether the thought was positive, negative or neutral.

[PROGRAMMER: Display responses from Q28a. 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 Q27a above in a separate box]	POSITIVE NEGATIVE NEUTRAL

(Peripheral Cue)

Q30. To what extent do you agree or disagree that the statement about the list of risks and side effects (“This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information”) was:

[PROGRAMMER: Randomize order of Q30a-f.]

	Strongly disagree	Somewhat disagree	Neither agree nor disagree	Somewhat agree	Strongly agree
Noticeable
Believable
Distracting
Important
Clear
Too long
Helpful

[Next page: Screen 13]

(FDA Perceptions/Knowledge)

Q31. Please rate your agreement or disagreement with each of the following statements.

[PROGRAMMER: Randomize order of Q31a-h]

	Strongly disagree	Somewhat disagree	Neither disagree nor agree	Somewhat agree	Strongly agree
The FDA only approves prescription drugs that have been found to be extremely effective
The FDA only approves prescription drugs that do not have serious side effects
Only prescription drugs that have been found to be extremely effective can be advertised to consumers
Prescription drugs that have serious side effects cannot be advertised to consumers
The FDA approves all prescription drug TV commercials before they can be shown to the public
All of the information in prescription drug TV commercials is true and accurate
I believe in all of the information provided in prescription drug TV commercials
Only the safest prescription drugs are allowed to be advertised to the public

[Next page: Screen 14]

[SCRIPT] Now we will ask a few questions to help us describe our sample of participants.

(Subjective Health Literacy)

Q32. How often do you have someone (like a family member or friend) help you read instructions, pamphlets, or other written material from your doctor or pharmacy?

1	2	3	4	5
Never	Occasionally	Sometimes	Often	Always

Q33. How confident are you filling out medical forms by yourself?

1	2	3	4	5
Not at all confident	A little bit	Somewhat	Quite a bit	Extremely confident

(Perceived illness knowledge)

Q34. In general, how much do you feel you know about [condition]?

1	2	3	4	5
Nothing at all	Only a slight amount	Some	A good bit	A lot

Q35. In general, how much do you feel you know about treatments for [condition]?

1	2	3	4	5
Nothing at all	Only a slight amount	Some	A good bit	A lot

[PROGRAMMER: If Respondent answered “no” to S3b, SKIP to Q37]

Q36. How long have you been taking prescription drugs for [condition]?

• Less than 2 weeks

• At least 2 weeks but less than 2 months

• At least 2 months but less than 6 months

• At least 6 months but less than 1 year

• At least 1 year but less than 5 years

• At least 5 years

Q37. In what year were you diagnosed with [medical condition]?

_______

Q38. Are you now covered by any form of health insurance or health plan? This includes any private insurance plan through your employer or a plan that you purchased yourself, as well as a government program like Medicare or Medicaid.

• Yes

• No [Skip to Q40]

• Don’t Know [Skip to Q40]

Q39. Does your current insurance plan help pay for prescription drugs?

• Yes

• No

• Don’t Know

Q40. What did you use to complete today’s survey?

• Desktop computer

• Laptop computer

• Tablet computer (e.g., Apple iPad, Samsung Galaxy Tab)

• Mobile phone or smartphone

• Other: ________________

Q41. Are you currently taking [DRUG]?

• Yes

• No

• Don’t Know

[Next page: Screen 15]

(Attitudes toward Disclosures; From Thomas et al., 2013)

[SCRIPT] We would now like to ask you some questions about how you feel about the use of disclosures.

A disclosure qualifies, clarifies, or otherwise limits a specific advertising claim.

Examples of disclosures include:

• “Certain rules and restrictions apply”

• “Results not typical”

• “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information”

• “Past performance is not necessarily indicative for future performances and transactions in financial products (including but not limited to securities, futures, options and other financial instruments) give rise to risks,”

• “This statement has not been evaluated by the Food and Drug Administration”

• “Prices include all cost to be paid by individual except for taxes, licensing, and registration”.

• “Pay no interest for one year. If you transfer a balance from another card, you will be charged a 3% fee.”

Q42. Please indicate your level of agreement with each of the following items.

[PROGRAMMER: Randomize order of Q42a-h]

	Strongly disagree			Neither disagree nor agree			Strongly agree
I think it should be illegal for companies to use disclosures. [R]
Disclosures are immoral. [R]
Disclosures are ethical.
Disclosures only trick consumers. [R]
Disclosures stand out from the background.
The size of disclosures is too small. [R]
In television advertising, companies do not provide consumers with enough time to read disclosures. [R]
Disclosures are easy to read.

(R indicates items that need to be reverse coded)

[Next page: Screen 16]

Q43. Would you like to receive the patient labeling for [DRUG] at the end of this survey to learn more about the complete list of risks and side effects?

• Yes

• No

Q44. What is your gender?

• Male

• Female

Q45. 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)

Q46. Are you:

• Hispanic or Latino

• Not Hispanic or Latino

Q47. 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

Q48. What is your household income?

• Less than $30,000 per year

• $30,001 - $75,000 per year

• $75,001 - $150,000 per year

• $150,001+ per year

[End time: ___________________ ]

[Next page: Screen 17]

[SCRIPT] The purpose of this research is to learn about consumer reactions to prescription drug advertising. In order to get your realistic reaction to this information, we used a real product; however the prescription drug ad was modified for the purpose of this study. Use of the brand name does not imply endorsement of the product by FDA. Please see your healthcare professional for questions about [condition].

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

[PROGRAMMER: If Respondent chooses “Yes” to Q43, at the end of the survey, after the debriefing, provide a link [or attach a PDF] to the patient labeling for the drug and include the following script: [SCRIPT] You indicated that you would like to receive the patient labeling for [DRUG] at the end of this survey to learn more about the complete list of risks and side effects. In the link below you will find the patient labeling for [DRUG]. Please see your healthcare professional for questions about [condition].

END

OMB Control # _____ Expires _____