Completes, Pretest Phase 2

[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 1,440 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

[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 an honorarium 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]

[PROMPT IF SKIP]

[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.

This study is about advertisements (ads) that appear in academic journals and trade magazines that could be sent to providers.

You will view two ads and 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 will not be linked to your name.

SCRIPT:

On the next screen, you will see some ads. Even though they are on a computer screen, please read the ads as though you had received it in the mail or in print.

Please pay close attention to the advertisements 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.]

[BROCHURE 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 advertisement?

• 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 in the advertisement?

[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 advertisement, please rate how likely or unlikely you are to do each of the following behaviors.

	1 Not at all likely	2	3	4	5	6 Very likely
Look for more information about Veridan.
Direct your patients to, or provide them with, additional information about Veridan.
Talk with patients about Veridan.
Write a prescription for Veridan.
Write a prescription for another drug that treats diabetic peripheral neuropathy.

[RECALL OF BENEFITS AND RISKS]

[PROGRAMMER: Randomize order of Q4 and Q5 (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 PRICE DISCLOSURE RECOGNITION]

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

6. Which of the following statements, if any, were in the prescription drug advertisement 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 currently prescribe Lyrica to treat diabetic peripheral neuropathy, switching your patients to Veridan could save them up to $560.00 a year.

☐ b. If you currently prescribe Lyrica to treat diabetic peripheral neuropathy, switching your patients to Veridan could cause them to spend $210.00 more a year.

☐ c. Veridan is an FDA-approved prescription medicine used to treat diabetic peripheral 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 sufferers 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.

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 information in the advertisement.

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 information in the advertisement.

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

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

[PROGRAMMER: Randomize order of Q23 and Q24]

23. Based on the prescription drug advertisement, 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 advertisement.

[PROGRAMMER: RANDOMIZE ORDER]	Yes, claim is in the advertisement	No, claim is not in the advertisement
a. relieves pain from diabetic peripheral neuropathy
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 advertisement, please indicate whether each of the following was mentioned as a risk or side effect of taking Veridan. Even if you think a statement is true, please select “Yes” only if it was mentioned in the advertisement.

[PROGRAMMER: RANDOMIZE ORDER]	Yes, claim is in the advertisement	No, claim is not in the advertisement
a. blurred vision
b. headache
c. insomnia
d. diarrhea
e. skin sores
f. dry mouth
g. suicidal ideation
h. angioedema
i. paralysis
j. hallucinations

[SPECIFIC CLAIM BELIEF – PRICE COMPARISON]

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

25. The following statement appeared in the ad:

“If you currently prescribe Lyrica to treat diabetic peripheral neuropathy, switching your patients to Veridan could save them 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 your patients?

“If you currently prescribe Lyrica to treat diabetic peripheral neuropathy, switching your patients to Veridan could save them 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.]

27. 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]

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

“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 questions to the best of your ability.

29. Imagine you wanted to explain to a patient 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]

[PERCEIVED Medical condition knowledge]

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

Q30. 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

Q31. How familiar are you with prescription drugs that treat diabetes?

1	2	3	4	5	6
Very unfamiliar					Very familiar

[price-quality perception]

Q32. 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]

Q33. 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.

[PATIENT PRICE CONCERNS]

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

34. How frequently do your patients initiate conversations or ask questions about the price of prescription drugs?

1	2	3	4
Never	Seldom	Often	Almost every visit or every visit

[Objective numeracy]

Q35. 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]

36. Roughly, what percent of your patients are insured by any form of health insurance or health plan?

Insured ____%

Uninsured ____%

Roughly, the total should sum to 100%

[YEARS IN PRACTICE]

36. Since completing your residency, how many years have you been a health care provider?

_____ years

36. Do you consider yourself a primary care provider or specialist?

• Primary care provider (family practice, general practice, and internal medicine) [Skip to Q47]

• Specialist

36. What is your primary area of specialization?

[OPEN-ENDED RESPONSE]

[SIZE OF PATIENT LOAD/WEEK]

SCRIPT: The next set of questions asks about a normal week. We define a normal week as a week with a normal case load, with no holidays, vacations, or conferences.

36. In a normal week, about how many patients do you see? This includes both walk-in and continuous care patients. If you are not sure, please provide your best guess.

_____ patients in a normal week

36. In a normal week, about how many patients with diabetes do you see? If you are not sure, please provide your best guess.

_____ patients in a normal week

[# OF PRESCRIPTIONS/WEEK]

36. In a normal week, about how many prescriptions do you write? This includes both refills and new prescriptions. If you are not sure, please provide your best guess.

_____ prescriptions in a normal week

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]

Q43. Please tell us your age. ___ years old.

[Ethnicity]

Q44. Are you Hispanic or Latino?

• Yes

• No

[Race]

Q45. 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]

Q50. What is your gender?

• Male

• Female

[PRIOR EXPOSURE TO LYRICA Ad]

Q51. Have you ever seen any advertising for Lyrica before today?

• Yes

• No

• Unsure

Q52. Have you ever prescribed 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 provider-targeted prescription drug ads and to learn how they use this information to understand how well prescription drugs work. Veridan is not a product currently for sale. 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.

23