Endorsement II Appx A Questionnaire

Appendix A

Endorser Status and Actual Use in Direct-to-Consumer Television Ads

Questionnaire

OMB Control No. 0910-xxxx

Expiration date: xx/xx/xxxx

According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910- xxxx and the expiration date is xx/xx/xxxx. The time required to complete this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden to PRAStaff@fda.hhs.gov.

Congratulations, you qualify for the study! We appreciate your willingness to participate.

Now we will show you a television ad for a new prescription drug. After you have viewed the ad, we will ask you some questions about it.

Please make sure your speakers are on and your volume is turned up.

[PANEL PROVIDER: INSERT VIDEO CHECK]

[Programmer: Display video stimulus, and program it so participants have to watch the video twice before moving on to the survey.]

[Programmer: Add page break]

1. How much attention did you pay to the ad? [ATTENDB]

1 Very little	2	3	4	5 Very much
○	○	○	○	○

2. Please write any thoughts and feelings you had after seeing the ad. [ELAB]

2. [STUDY 1] Drug Y is for adults with…

• Lupus

• High blood pressure

• Rheumatoid arthritis

• Chronic obstructive pulmonary disease (COPD)

• Osteoporosis

• Hepatitis B or C

[Programmer: Add page break]

2. . [STUDY 2] Drug X is for adults with…

• High cholesterol

• Obesity

• Type 2 diabetes

• High blood pressure

• Pancreatitis

• Type 1 diabetes

[Programmer: Add page break]

2. I think the ad was… [Programmer: Randomize]

	Strongly Disagree	Somewhat Disagree	Neither Disagree nor Agree	Somewhat Agree	Strongly Agree
a. Honest [ATT_AD_1A]	○	○	○	○	○
b. Trustworthy [ATT_AD_1B]	○	○	○	○	○
c. Convincing [ATT_AD_1C]	○	○	○	○	○
d. Biased [ATT_AD_1D]	○	○	○	○	○
e. Credible [ATT_AD_1E]	○	○	○	○	○

[Programmer: Add page break]

Now we are going to ask you some questions about your attitudes and opinions regarding the drug product.

2. How well would [STUDY 1: Drug Y/STUDY 2: Drug X] manage [STUDY 1: rheumatoid arthritis/STUDY 2: type 2 diabetes] [WELLRED1]

Not at all well 1	2	3	4	5	Extremely well 6
○	○	○	○	○	○

2. How likely is it that you would experience at least one side effect if you took [STUDY 1: Drug Y/STUDY 2: Drug X]? [EXP_SE1]

Not at all likely 1	2	3	4	5	Extremely likely 6
○	○	○	○	○	○

2. To what extent do you think [STUDY 1: Drug Y/STUDY 2: Drug X]’s side effects would affect your physical health? [SE_HLTH1]

Not at all likely 1	2	3	4	5	Extremely likely 6
○	○	○	○	○	○

[Programmer: Add page break]

2. [ASK IN PRETEST, THEN DETERMINE IF IT SHOULD BE RETAINED OR CUT FOR MAIN STUDY] In addition to treating [STUDY 1: rheumatoid arthritis/STUDY 2: type 2 diabetes], there are other advantages to taking [STUDY 1: Drug Y/STUDY 2: Drug X]. [OTH_ADV1]

Strongly disagree 1	2	3	4	5	Strongly agree 6
○	○	○	○	○	○

[Programmer: Add page break]

2. How likely is it that taking [STUDY 1: Drug Y/STUDY 2: Drug X] would improve your quality of life? [IMP_QOL1]

Not at all likely 1	2	3	4	5	Extremely likely 6
○	○	○	○	○	○

2. The benefits of [STUDY 1: Drug Y/STUDY 2: Drug X] outweigh any side effects it may have. [BENES1]

Strongly disagree 1	2	3	4	5	Strongly agree 6
○	○	○	○	○	○

[Programmer: Add page break]

2. Based on this ad, would you do any of the following:

[Programmer: Add soft prompts to this question that alert participants if they forgot to answer one or more items.]

	Yes	No
a. Talk with friends and relatives about [STUDY 1: Drug Y/STUDY 2: Drug X]. [DTC_BI_1A]	○	○
b. Learn about the risks and benefits of [STUDY 1: Drug Y/STUDY 2: Drug X]. [DTC_BI_1B]	○	○
c. Talk with my doctor about [STUDY 1: Drug Y/STUDY 2: Drug X]. [DTC_BI_1C]	○	○
d. Talk with my pharmacist about [STUDY 1: Drug Y/STUDY 2: Drug X]. [DTC_BI_1D]	○	○
e. Ask my doctor to prescribe [STUDY 1: Drug Y/STUDY 2: Drug X]. [DTC_BI_1E]	○	○

[Programmer: Add page break]

Now we would like to ask you some questions related to your attitudes towards and perceptions of the [PHYSICIAN/PATIENT] in the ad.

2. Please rate your attitude towards the [PHYSICIAN/PATIENT] featured in the ad, using the following scales below: [Attitudes toward endorser] [Programmer: Randomize]

a. [ATT_END_1A]

1	2	3	4	5
Bad				Good
○	○	○	○	○

b. [ATT_END_1B]

1	2	3	4	5
Unpleasant				Pleasant
○	○	○	○	○

c. [ATT_END_1C]

1	2	3	4	5
Unfavorable				Favorable
○	○	○	○	○

d. [ATT_END_1C]

1	2	3	4	5
Like				Dislike
○	○	○	○	○

[Programmer: Add page break]

[Review CRED_END_1A, CRED_END_1B, CRED_END_1C after pretesting]

2. To me, the [PHYSICIAN/PATIENT] featured in the ad is… [Programmer: Randomize].

a. [CRED_END_1D] [Analyze item alone and as part of composite]

1	2	3	4	5
Not an expert				Expert
○	○	○	○	○

b. [CRED_END_1E]

1	2	3	4	5
Inexperienced				Experienced
○	○	○	○	○

c. [CRED_END_1F]

1	2	3	4	5
Unknowledgeable				Knowledgeable
○	○	○	○	○

d. [CRED_END_1G]

1	2	3	4	5
Unqualified				Qualified
○	○	○	○	○

e. [CRED_END_1H]

1	2	3	4	5
Undependable				Dependable
○	○	○	○	○

f. [CRED_END_1I]

1	2	3	4	5
Dishonest				Honest
○	○	○	○	○

g. [CRED_END_1J]

1	2	3	4	5
Unreliable				Reliable
○	○	○	○	○

h. [CRED_END_1K]

1	2	3	4	5
Insincere				Sincere
○	○	○	○	○

i. [CRED_END_1L]

1	2	3	4	5
Untrustworthy				Trustworthy
○	○	○	○	○

j. [ATT_END_1D]

1	2	3	4	5
Unconvincing				Convincing
○	○	○	○	○

k. [ATT_END_1E]

1	2	3	4	5
Unbelievable				Believable
○	○	○	○	○

l. [ATT_END_1F]

1	2	3	4	5
Biased				Unbiased
○	○	○	○	○

m. [ATT_END_1F]

1	2	3	4	5
Not Genuine				Genuine
○	○	○	○	○

[Programmer: Add page break]

2. Did the ad include any of the following information…

[Programmer: Randomize]

	Yes	No
1. Description of the product’s risks [INFO_AD_1]	○	○
2. Description of the product’s benefits [INFO_AD_2]	○	○
3. A statement that the [PHYSICIAN/PATIENT] in the ad actually [PRESCRIBES/USES] [STUDY 1: Drug Y/STUDY 2: Drug X] [INFO_AD_3]	○	○
4. A statement that the [PHYSICIAN/PATIENT] in the ad is an actor [INFO_AD_3]	○	○
5. How much the drug costs [INFO_AD_4]	○	○

[Programmer: Add page break]

Next, a question about the [PHYSICIAN/PATIENT] featured in the ad.

2. [ASK IN PRETEST, THEN DETERMINE IF SHOULD BE RETAINED OR CUT FOR MAIN STUDY] Do you remember seeing any text stating that the [PHYSICIAN/PATIENT] [PRESCRIBES/USES] [STUDY 1: Drug Y/STUDY 2: Drug X]? [REC_AD_1]

• Yes

• No

• Don’t know

2. [ASK IN PRETEST, THEN DETERMINE IF IT SHOULD BE RETAINED OR CUT FOR MAIN STUDY] Do you remember seeing any text stating that the [PHYSICIAN/PATIENT] in the ad was an actor? [REC_AD_2]

• Yes

• No

• Don’t know

[Programmer: Add page break]

Finally, a few questions about you.

2. On a typical day, approximately how many hours do you spend watching television? [TV]

• Less than 1 hour

• 1 to 2 hours

• 3 to 4 hours

• 5 hours or more

• Don't know/refused

2. What is the highest level of school you have completed or the highest degree you have received? (Select one.) [EDUC]

• Less than high school

• High school graduate – high school diploma or equivalent (for example: GED)

• Some college, but no degree

• Associate or two-year college degree

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

• Advanced or post-graduate degree (for example: Master’s degree, MD, DDS, JD, PhD, EdD)

[Programmer: Add page break]

2. Are you now covered by any form of health insurance or health plan? This would include any private insurance plan through your employer or a plan that you purchased yourself, as well as a government program like Medicare or Medicaid. [INSURE]

• Yes  Continue

• No  Skip to Q21

[Programmer: Add page break]

2. Does your current health insurance plan help pay for prescription medicines, or not? [INSURE_RX_COV]

• Yes

• No

2. In general, would you say your health these days is… [HEALTH]

• Excellent

• Very good

• Good

• Fair

• Poor

[Programmer: Add page break]

[DEBRIEFING] [STUDY 1: Drug Y/STUDY 2: Drug X] is not a real product and it is not available for sale. The [PHYSICIAN/PATIENT] depicted in this ad did not endorse this fictitious product and was not paid for this advertisement. The purpose of this research is to understand how people think about information in prescription drug advertisements. In order to get an unbiased reaction to this information, we created a brand for this study. Please see your healthcare professional for questions about [STUDY 1: rheumatoid arthritis/STUDY 2: type 2 diabetes].

[Programmer: Add page break]

2. On a scale of 1-5, where 1 is completely negative and 5 is completely positive, how would you rate your experience of taking part in this survey? [DEBRIEF_1A]

• 1 - Completely negative

• 2 - Somewhat negative

• 3 - Neither negative nor positive

• 4 - Somewhat positive

• 5 - Completely positive

2. Please tell us the main reasons for your rating score. [DEBRIEF_1B]

[Programmer: Add page break]

Please click the submit button to complete the survey.

[Programmer: Add page break]

Thank you for completing the survey!

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