Completes, Pretests Phase 1

[PROGRAMMER:

• The OMB control number and Expiration Date [OMB Control # 0910-0791 Expires 05/31/2018] should appear at the bottom of every screen. It should be as unobtrusive as possible.

[Consent Screen 1]

[DISPLAY]

You are one of about 1,000 people in the United States who are being asked to take a survey about a new medication. First, we will show you a few ads. Second, we will ask you to complete a survey that will take approximately 30 minutes.

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 #0910-0791 Expires 05/31/2018

[Screener]

S1. Have you ever been diagnosed by a physician or other qualified medical professional with any of the following conditions? Select all that apply.

• Asthma

• Cancer

• Depression

• Diabetes [Respondent needs to check Diabetes to Continue]

• Heart attack

• None of the above

PROG: For terminated participants:

Thank you for your interest in our survey. Unfortunately, you do not meet the qualifications. Thank you for your time.

[Consent Screen 2]

[DISPLAY]

This survey is being conducted by RTI International (RTI), an independent nonprofit research organization, on behalf of a public health agency. RTI is working with Research Now to conduct this survey but is not affiliated with Research Now in any way. If you have questions about this survey, please contact Dr. Brian Southwell, the project director. He can be reached between 9 AM and 5 PM Eastern Standard Time Monday – Friday at 1-800-334-8571 ext. 8037.

Possible Risks or Discomforts

We do not expect that any of the survey questions will make you uncomfortable or upset. Still, there is a chance that you may feel discomfort about some of the questions we ask. Your participation in this study is voluntary. You can refuse to answer any question or you may take a break at any time during the survey. There is also a potential risk of loss of confidentiality. Every effort will be made to protect your information, but this cannot be guaranteed.

Benefits

Your responses are very important because they will help researchers understand how people make decisions about medications.

Incentive

In appreciation for your time, you will receive e-Rewards Currency for completing this survey as outlined in the invitation.

Rights as a Participant

If you have any questions about your rights as a participant, you may wish to contact RTI’s Office of Research Protection at 1-866-214-2043.

Privacy and Confidentiality

As with other surveys you receive from Research Now, the privacy and confidentiality of your information is of the highest importance, and we are committed to maintaining a secure environment in which you can participate. All information collected in this survey will be kept confidential to the extent provided by law. Your name and your e‑mail address will not be shared outside of Research Now, and they will not be associated with your answers or used in any report.

[Consent Screen 3]

[RADIO]

Consent1. If you have read the previous screens and agree to participate, please click the Yes button. If not, click the No button.

• Yes, I agree to participate. [Randomly assign to condition and continue with next section]

• No, I do not agree to participate. [Go on to next question]

[RADIO]

[IF COSNENT1 = NO]

Consent2. Are you sure you don't want to participate? Your opinions are important to us. Please select the Yes button to continue this survey. Select the No button to exit.

• Yes, I agree to participate. [Randomly assign to condition and continue with next section]

• No, I do not agree to participate [end survey].

SCRIPT for txtIntro page:

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 advertisements (ads) that appear in magazines and newspapers.

You will view two ads and then we will ask you to complete a couple of short, open-ended questions and a number of multiple-choice and multiple-response questions.

We greatly appreciate your time. You may skip any item you do not want to answer. If you do skip an item, red text will appear to let you know that an item was skipped, but that you may leave that item blank if you’d like. If that question was accidentally left blank, then you can provide an answer before moving to the next page.

The study will take about 30 minutes to complete. We ask you to complete the study in one sitting (without taking any breaks) to avoid distractions.

Your answers are private, and no one will ever connect your name with your answers.

SCRIPT:

On the next screen, you will see some ads for new and existing products. Even though they are on a computer screen, please read the ads as if they were in a magazine.

Imagine that the ads are for products in which you might be interested.

Please pay close attention to the ads because we will ask you questions about them afterward.

[PROGRAMMER: Display ad correspondent to the participant’s experimental condition. Record duration of time spent watching ad and also time spent on each screen answering questions. Time spent on instruction screens will be used as baseline reading speed measure. Participants are allowed to page back and forth between the display page and the brief summary, but once they move beyond the final screen, do not allow participants to look back at the ad.]

[AD VIEWING ABILITY CHECK]

We would now like to ask you some questions specifically about the prescription drug ad that you saw.

1. Were you able to view the prescription drug ad?

• Yes [Continue]

• No [Terminate; Link to screening responses and keep data, though]

PROG: For terminated participants: Thank you for your interest in our survey. Unfortunately, you do not meet the qualifications. Thank you for your time.

[BRAND RECOGNITION]

2. Which of the following drugs did you see advertised?

[PROGRAMMER: Randomize response options. Allow respondents to check more than one box]

• Veridan

• Lyrica

• Cymbalta

• Carmitet

• None of the above

[INTENTION FOR DRUG USE AND INFORMATION SEEKING]

SCRIPT: For the following questions, we are interested in your initial impression and honest opinions. There are no right or wrong answers.

3. Based on the prescription drug ad, please rate how likely or unlikely you are to do each of the following behaviors.

	Not at all likely 1	2	3	4	5	Very likely 6
Look for information about Veridan.
Talk with a friend or family member about Veridan.
Ask your doctor for more information about Veridan.
Ask your doctor to prescribe Veridan.
Take Veridan if your doctor prescribed it.

[RECALL OF BENEFITS AND RISKS]

[PROGRAMMER: Randomize order of Q5 and Q6 (counterbalance). Include thirteen separate text boxes. Do not force response, but please suggest response: if a participant leaves the question blank display the following message, “You did not enter an answer to this question. Your answer to this question is important to us if you have one to offer. You can enter “none””]

SCRIPT: The advertisement you saw included messages about a prescription drug named Veridan.

4. Based on the prescription drug advertisement, what are the benefits of Veridan? Please list as many benefits as you can remember. Use one line for each benefit you list.

5. Based on the prescription drug advertisement, what are the risks and side effects of Veridan? Please list as many risks and side effects as you can remember. Use one line for each risk or side effect you list.

[PRICE COMPARISON CLAIM AND DISCLOSURE RECOGNITION]

SCRIPT: This question asks about information that may or may not have been in the prescription drug ad.

6. Which of the following statements, if any, were in the prescription drug ad you saw? Check all that apply.

[PROGRAMMER: RANDOMIZE ORDER. Do not show the letter before each item, that is only for programming/data preparation purposes]

☐ a. If you take Lyrica, switching to Veridan could save you up to $560.00 a year.

☐ b. If you take Lyrica, switching to Veridan could cause you to spend $210.00 more a year.

☐ c. Veridan is an FDA-approved prescription medicine used to treat diabetes-related nerve pain (neuropathy).

☐ d. Only Veridan is designed to treat two of the most common types of nerve pain, diabetic nerve pain and pain after shingles.

☐ e. Taken once a day, it works by interfering with chemical processes in the brain that cause you to feel pain, providing significant relief.

☐ f. The price savings presented may not reflect the actual savings by consumers or third-party payers. The products in this price comparison may or may not be equally effective or safe.

☐ g. Veridan is the first and only pain reliever that is FDA-approved to treat some forms of pain caused by general inflammation.

☐ h. None of the above.

[PROGRAMMER: On a new screen please include the following message:]

SCRIPT: For the following questions, we are interested in your initial impression and honest opinions. There are no right or wrong answers.

[PERCEIVED EFFICACY – Likelihood and magnitude]

SCRIPT: Please answer the following questions based on the impression that you got from the prescription drug ad.

Please do not use your personal experience when answering.

7. How likely is it that taking Veridan provides significant relief from diabetic nerve pain?

   1	2	3	4	5	6
   Not at all likely					Very likely

8. Veridan will help relieve most people’s diabetic nerve pain.

1	2	3	4	5	6
Strongly disagree					Strongly agree

9. How much relief does Veridan give people from their diabetic nerve pain?

1	2	3	4	5	6
Very little relief					Complete relief

[PERCEIVED COMPARATIVE EFFICACY]

SCRIPT: Please answer the following questions based on the impression that you got from the prescription drug ad.

Please do not use your personal experience when answering. Do your best to answer each question, even if you have never taken Lyrica.

10. Compared to Lyrica, is Veridan better or worse at relieving diabetic nerve pain?

1	2	3	4	5	6	7
Veridan is much worse			They are the same			Veridan is much better

☐ I don’t know based on the ad

11. Compared to Lyrica, how much relief does Veridan give people from their diabetic nerve pain?

1	2	3	4	5	6	7
Veridan gives much less relief			They are the same			Veridan gives much more relief

☐ I don’t know based on the ad

12. Compared to Lyrica, how many people get relief from diabetic nerve pain by taking Veridan?

1	2	3	4	5	6	7
Far fewer people get relief with Veridan			They are the same			Many more people get relief with Veridan

☐ I don’t know based on the ad

[PERCEIVED RISK – Likelihood and magnitude]

SCRIPT: Please answer the following questions based on the impression that you got from the prescription drug ad.

Please do not use your personal experience when answering.

13. How likely is it that people taking Veridan will have minor side effects?

    1	2	3	4	5	6
    Not at all likely					Very likely

14. How likely is it that people taking Veridan will have serious side effects?

1	2	3	4	5	6
Not at all likely					Very likely

15. People taking Veridan will have at least one side effect.

1	2	3	4	5	6
Strongly disagree					Strongly agree

16. Overall, Veridan’s side effects are:

1	2	3	4	5	6
Not at all serious					Very serious

[PERCEIVED COMPARATIVE RISK]

SCRIPT: Please answer the following questions based on the impression that you got from the prescription drug ad.

Please do not use your personal experience when answering. Do your best to answer each question, even if you have never taken Lyrica.

17. Compared to Lyrica, how risky or safe is Veridan?

1	2	3	4	5	6	7
Veridan is much safer			They are the same			Veridan is much riskier

☐ I don’t know based on the ad

18. Compared to Lyrica, what is your impression about Veridan’s side effects?

1	2	3	4	5	6	7
Veridan’s side effects are much less serious			They are the same			Veridan’s side effects are much more serious

☐ I don’t know based on the ad

19. Compared to Lyrica, is it more or less common that people taking Veridan will have minor side effects?

1	2	3	4	5	6	7
Minor side effects are much less common with Veridan			They are the same			Minor side effects are much more common with Veridan

☐ I don’t know based on the ad

20. Compared to Lyrica, is it more or less common that people taking Veridan will have serious side effects?

1	2	3	4	5	6	7
Serious side effects are much less common with Veridan			They are the same			Serious side effects are much more common with Veridan

☐ I don’t know based on the ad

21. Aside from price, Veridan and Lyrica are interchangeable.

    1	2	3	4	5	6
    Strongly disagree					Strongly agree

22. The ad does not provide enough information for me to know if Veridan and Lyrica are interchangeable.

1	2	3	4	5	6
Strongly disagree					Strongly agree

[BENEFIT AND RISK RECOGNITION]

[PROGRAMMER: Randomize Q23and Q24]

23. Based on the prescription drug ad, please indicate whether each of the following was mentioned as a benefit of taking Veridan. Even if you think a statement is true, please select “Yes” only if it was mentioned in the ad.

[PROGRAMMER: RANDOMIZE ORDER]	Yes, claim is in the ad	No, claim is not in the ad
a. relieves diabetic nerve pain
b. only needs to be taken once a day
c. relieves problems with urination
d. reduces indigestion, nausea, or vomiting
e. works better than Lyrica

24. Based on the prescription drug ad, please indicate whether each of the following was mentioned as a side effect or risk of taking Veridan. Even if you think a statement is true, please select “Yes” only if it was mentioned in the ad.

[PROGRAMMER: RANDOMIZE ORDER]	Yes, claim is in the ad	No, claim is not in the ad
a. blurred vision
b. headache
c. insomnia
d. diarrhea
e. skin sores
f. dry mouth
g. thoughts of suicide
h. difficulty breathing
i. paralysis
j. hallucinations

[SPECIFIC CLAIM BELIEF – PRICE COMPARISON]

[PROGRAMMER: If in CONTROL condition  SKIP to Q26.]

Q25. The following statement appeared in the ad:

“If you take Lyrica, switching to Veridan could save you up to $560.00 a year.”

How accurate do you believe that statement is?

1	2	3	4	5	6
Not at all accurate					Very accurate

[IMPORTANCE OF PRICE COMPARISON CLAIM]

26. How important would the following statement be if you were deciding whether Veridan is a good option for you?

“If you take Lyrica, switching to Veridan could save you up to $560.00 a year.”

1	2	3	4	5	6
Not at all important					Very important

[SPECIFIC CLAIM BELIEF – PRICE COMPARISON DISCLOSURE]

[PROGRAMMER: If in CONTROL condition OR COMPARISON_NO CONTEXT condition  SKIP to Q28.]

26. The following statement appeared in the ad:

“The price savings presented may not reflect the actual savings by consumers or third-party payers. The products in this price comparison may or may not be equally effective or safe.”

How accurate do you believe that statement is?

1	2	3	4	5	6
Not at all accurate					Very accurate

[IMPORTANCE OF PRICE COMPARISON DISCLOSURE CLAIM]

Q28. How important would the following statement be if you were deciding whether Veridan is a good option for you?

“The price savings presented may not reflect the actual savings by consumers or third-party payers. The products in this price comparison may or may not be equally effective or safe.”

1	2	3	4	5	6
Not at all important					Very important

[Price disclosure comprehension]

SCRIPT: Please answer the following question to the best of your ability.

29. Imagine you wanted to explain to a friend what the statement displayed below means. Please explain the statement in your own words.

“The price savings presented may not reflect the actual savings by consumers or third-party payers. The products in this price comparison may or may not be equally effective or safe.”

[OPEN-ENDED RESPONSE]

[SUBJECTIVE HEALTH LITERACY]

SCRIPT: Next, we’d like to ask you a few questions about yourself.

Q30. 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	Rarely	Sometimes	Often	Always

31. 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	Very confident

[PERCEIVED Medical condition knowledge]

31. In general, how much do you feel you know about diabetes? Would you say you know:

    1	2	3	4	5	6
    Nothing					A lot

32. How familiar are you with prescription drugs that treat diabetes?

1	2	3	4	5	6
Very unfamiliar					Very familiar

[price-quality perception]

31. Please indicate your level of agreement with the following statements. Please note that these questions refer to any product and not just prescription drugs.

	1 Strongly disagree	2	3	4	5	6 Strongly agree
Generally speaking, the higher the price of a product, the higher the quality.
The old saying "you get what you pay for" is generally true.
The price of the product is a good indicator of its quality.
You always have to pay a bit more for the best.

[value consciousness]

35. Please indicate your level of agreement with the following statements. Please note that these questions refer to any product and not just prescription drugs.

	1 Strongly disagree	2	3	4	5	6 Strongly agree
I generally shop around for lower prices on products, but they still must meet quality requirements before I buy them.
When shopping, I compare the prices of different brands to be sure I get the best value for the money.

[COST CONCERNS]

35. Did you do any of the following in the past year to help ease the costs of prescription medication? Check all that apply.

• Skipped doses

• Cut pills in half

• Stopped taking the medication

• Switched to a generic

• Tried to get financial assistance

• Delayed filling a prescription

• Asked your doctor for a lower-priced medication

• Bought prescription drugs from another country

• Used alternative therapies

• Shared medication with friends or family

• None of the above [PROGRAMMER: If this is checked, do not allow other boxes to be checked off as well]

[CURRENT PRESCRIPTION STATUS]

35. Are you currently taking, or have you ever taken, any prescription drug(s) for diabetes?

• Currently taking

• Have taken in the past but not currently taking

• Have never taken

Q38. In what year were you diagnosed with diabetes?

______ (enter a number)

Q39. Have you ever been diagnosed with diabetic neuropathy?

• Yes

• No

• Don’t know

[APPRAISAL OF DIABETES]

40. How upsetting is having diabetes for you?

• Not at all

• Slightly upsetting

• Moderately upsetting

• Very upsetting

• Extremely upsetting

40. How much control over your diabetes do you have?

• None at all

• Slight amount

• Moderate amount

• Large amount

• Total amount

40. How much uncertainty do you currently experience in your life as a result of being diabetic?

• None at all

• Slight amount

• Moderate amount

• Large amount

• Extremely large amount

[Objective numeracy]

40. Please answer the following questions to the best of your ability.

Imagine that you flip a fair coin 1,000 times. What is your best guess about how many times the coin would come up heads in 1,000 flips?	Enter a number between 0 and 1,000 _____ [PROGRAMMER: Allow only numbers or symbols]
In the BIG BUCKS LOTTERY, the chance of winning a $10 prize is 1%. What is your best guess about how many people would win a $10 prize if 1,000 people each buy a single ticket to the BIG BUCKS LOTTERY?	Enter a number between 0 and 1,000 _____ [PROGRAMMER: Allow only numbers or symbols]
In ACME PUBLISHING SWEEPSTAKES, the chance of winning a car is 1 in 1,000. What percent of tickets to ACME PUBLISHING SWEEPSTAKES will win a car?	_____ % [PROGRAMMER: Allow only numbers or symbols]

[HEALTH INSURANCE]

40. 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 Q53]

• Don’t know

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

• Yes

• No

• Don’t know

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

[AGE]

Q46. Please tell us your age. ___ years old.

[Ethnicity]

Q47. Are you Hispanic or Latino?

• Yes

• No

[Race]

Q48. 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

• Refuse to answer

[GENDER]

Q49. What is your gender?

• Male

• Female

[Household income]

Q50. Of these income groups, which category best represents your total combined family income during 2014?

• Less than $20,000

• $20,000–$39,999

• $40,000–$59,999

• $60,000–$79,999

• $80,000–$99,999

• $100,000 or more

[Level of educational attainment]

Q51. 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)

[PRIOR EXPOSURE TO LYRICA AD]

52. Have you ever seen any advertising for Lyrica before today?

• Yes

• No

• Unsure

52. Have you ever taken Lyrica?

• Yes

• No

• Unsure

[DEBRIEFING]

SCRIPT: You have been very helpful. Thank you very much for taking part in this survey!

The purpose of this research is to learn about how people feel about information provided in direct-to-consumer prescription drug ads and to learn how people use this information to understand how well prescription drugs work. Veridan is a fictitious drug and is not a product currently for sale. Please see your healthcare professional for questions about your health and your medical conditions. We used Lyrica in this study as an example comparison only.  Use of the brand name does not imply endorsement of the product by FDA.

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