APPENDIX 2
Screener and Questionnaires
Screener
Recruiting Goals
Participants must be age 18 and over.
For Study 1, participants must have had been diagnosed with insomnia or have experienced the symptoms of insomnia in the past month.
For Study 2, participants must have been diagnosed with high blood pressure.
Participants must be able to read, understand, and speak English.
Participants must not be healthcare professionals.
Participants must not work for a pharmaceutical company, an advertising agency, or a market research company.
An attempt should be made to have an equal number of males and females.
The sample should have some range of education and race/ethnicity represented.
Each interview will last approximately 20 minutes.
Obtain participant’s consent.
SCREENING QUESTIONS
S1. Are you at least 18 years old?
Yes continue
No eliminate [thank respondent politely]
S2. In what year were you born? ______
If Year is > 1994 eliminate [thank respondent politely]
DO NOT READ Don’t Know 8 eliminate [thank respondent politely]
DO NOT READ Refused 9 eliminate [thank respondent politely]
[INTERVIEWER: Recruit range of ages]
S3. Has a doctor or other healthcare provider ever said you have any of the following health problems?
a. Asthma _____Yes _____No [filler]
b. Diabetes _____Yes _____No [filler]
c. Insomnia _____Yes _____No
d. High blood pressure _____Yes _____No
e. Acid reflux or GERD _____Yes _____No [filler]
[STUDY 1: INTERVIEWER: If “no” to S3c, ask S4]
[STUDY 2: INTERVIEWER: If “no” to S3d, eliminate and thank respondent politely]
S4. Have you had any of the following health symptoms in the past month: [randomize]
a. Trouble falling asleep _____Yes _____No
b. Dizziness _____Yes _____No [filler]
c. Trouble staying asleep _____Yes _____No
d. Not feeling rested when you wake up _____Yes _____No
e. Numbness or tingling in your legs _____Yes _____No [filler]
f. Frequent heartburn _____Yes _____No [filler]
[STUDY 1: INTERVIEWER: If “no” to S4a, S4c or S4d, eliminate and thank respondent politely]
S5. Are you trained or employed as a health care professional?
Yes eliminate [thank respondent politely]
No continue
S6. Do you work for a pharmaceutical company, an advertising agency, or a market research
company?
Yes eliminate [thank respondent politely]
No continue
S7. Can you read, understand, and speak English?
Yes eliminate [thank respondent politely]
No continue
S8a. Do you usually wear glasses or contact lenses for reading or watching television?
Yes ask S9b
No continue
S9b. Do you have your glasses or contact lenses with you today?
Yes eliminate [thank respondent politely]
No continue
DEMOGRAPHICS
S10. Gender
Male
Female
S11. How many years of education have you had? [QUOTA: AT LEAST 20% HIGH SCHOOL OR LESS]
Completed grade school
Completed middle school
Completed high school or GED
Some college
Associate’s degree (2-year)
Bachelor’s degree (4-year)
Some postgraduate work
Postgraduate degree (M.A., Ph.D., M.D., J.D., etc.)
S12. Are you:
Hispanic or Latino
Not Hispanic of Latino
S13. Which of these best represents your ethnic group? You may choose one or more. Would you say that you are:
American Indian or Alaska Native
Asian
Black or African American
Native Hawaiian or other Pacific Islander
White
Other
Prefer not to answer
Thank you. I would like to invite you to participate in this study.
Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
DRAFT Questionnaire: PRETEST 1
Programming instructions are indicated in blue font and should be removed prior to fielding.
[PROGRAMMER:
• The viewing time of each page of the ad must be timed separately in milliseconds.
• Program progresses to the questioning in a “one-way” manner.
• Record time in milliseconds spent on each screen (including questions) throughout protocol. ]
Interview Protocol
(Present Informed Consent Form. Participants will be blind to FDA’s sponsorship.)
[PROGRAMMER: Screen 1. TIME SPENT ON SCREEN IN MILLISECONDS]
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 a new product. We will show you an ad for a new product then ask you some questions about it. Your answers are private and will not be connected with your name. Your input is extremely valuable.
[PROGRAMMER: Screen 2. TIME SPENT ON SCREEN IN MILLISECONDS]
[RANDOMLY ASSIGN TO ONE VERSION OF SCREEN 2]
[VERSION 1: CONTROL]
The ad has two pages. We will ask you some questions about the ad after you have finished reading it.
[VERSION 2: INCREASED ATTENTION]
The ad has two pages. We will ask you some questions about the ad after you have finished reading it. Do your best to remember details about the ad. We will ask you to explain your answers.
[VERSION 3: TIME LIMIT]
The ad has two pages. We will ask you some questions about the ad after you have finished reading it. You will have up to 4 minutes to read the ad. The program will automatically move on to the next part of the study after that time.
[VERSION 4: INCREASED ATTENTION + TIME LIMIT]
The ad has two pages. We will ask you some questions about the ad after you have finished reading it. Do your best to remember details about the ad. We will ask you to explain your answers. You will have up to 4 minutes to read the ad. The program will automatically move on to the next part of the study after that time.
[SCREEN 3]
If you want to see a bigger image of the page, you can enlarge the page by clicking on it, and you can flip between the pages by clicking the ”Next” and “Back” buttons at the bottom of the screen. Once you finish reading the ad, please click “Start Next Part of Study” to move to the next part of the study. You may begin when you are ready.
[PROGRAMMER: Record time in milliseconds spent on each page of the print ad.]
[PROGRAMMER: Show stimuli. TIME SPENT ON EACH PAGE IN MILLISECONDS]
[PROGRAMMER: UNLESS OTHERWISE NOTED, RECORD TIME SPENT ON EACH QUESTION IN MILLISECONDS]
Now please answer the following questions based on the ad you saw.
Q1. Were you able to view the ad for DRUG X?
Yes
No [Terminate]
Not sure [Terminate]
Q1b. Please list the thoughts that were going through your mind as you viewed the ad for DRUG X and list them below. Use one line for each thought.
[PROGRAMMER: Five separate text boxes]
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Q2. What type of product is DRUG X? [PROGRAMMER: randomize responses]
Over the counter drug
Prescription drug
Herbal supplement
Lens cleaner
Don't know or uncertain
Q3. What condition does DRUG X treat? [PROGRAMMER: randomize responses]
High blood pressure
Insomnia
Migraine headaches
Seasonal allergies
Diabetes
Acid Reflux/GERD
Don't know or uncertain
[PROGRAMMER: Benefit question series = Q4 through Q7. Risk question series = Q8 through Q12. Randomize order of benefit question series versus risk question series]
Q4. In your own words, what are the benefits of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q5-Q6]
(Perceived Benefit)
Q5. Based on the information in the ad, how effective would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
Q6. Based on the information in the ad, how well would DRUG X work for you?
1 2 3 4 5 6 7
Not at all Moderately Very
well well well
[PROGRAMMER: randomize order of Q7a-h. Record time spent on series]
(Recall of Benefits)
Q7. Based on the information in the ad, please check which of the following are benefits of taking DRUG X.
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Yes |
No |
Don’t Know |
a. DRUG X is taken twice a day.
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x |
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b. DRUG X can be used for up to 3 months.
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x |
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c. DRUG X can help you stay asleep for up to 8 hours.
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x |
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d. DRUG X is safe for people with kidney problems.
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x |
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e. DRUG X treats insomnia in adults and children ages 10 and up.
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x |
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f. DRUG X is the #1 prescribed medication for insomnia.
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x |
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g. DRUG X combines two ingredients.
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x |
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h. DRUG X can be habit-forming.
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x |
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i. DRUG X leaves your system within 4 hours.
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x |
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Q8. In your own words, what are the risks of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q9-Q10]
(Perceived Risk)
Q9. Based on the information in the ad, how safe would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
Safe safe safe
Q10. Based on the information in the ad, how risky would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
risky risky risky
Q11. Based on the information in this ad, how likely is it that you would have a side effect from DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[PROGRAMMER: Randomize order of Q12a-i. Record time spent on series.]
(Recall of Risks)
Q12. Based on the information in the ad, please check which of the following are risks of taking DRUG X.
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Yes |
No |
Don’t Know |
a. TTP is a risk when you take DRUG X
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x |
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b. You need blood tests when taking DRUG X.
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x |
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c. People with liver problems should not take DRUG X.
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x |
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d. A common side effect of DRUG X is ringing in the ears.
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x |
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e. A common side effect of DRUG X is blurred vision.
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x |
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f. People with a history of migraine headaches should not take DRUG X.
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x |
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g. A common side effect of DRUG X is dizziness.
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x |
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h. People with kidney problems should not take DRUG X.
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x |
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i. A common side effect of DRUG X is joint pain.
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x |
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j. DRUG X may cause hallucinations. |
x
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[PROGRAMMER: Rotate order of Q13-Q14]
(Perceived Comparative Benefit and Risk)
Q13. Compared to other treatments you could take for insomnia, how well do you think DRUG X works?
Much better
Somewhat better
About the same
Somewhat worse
Much worse
Q14. Compared to other treatments you could take for insomnia, how safe or risky do you think DRUG X is?
Much safer
Somewhat safer
About the same
Somewhat riskier
Much riskier
[PROGRAMMER: If Q13 = much better (1) or Q13 = somewhat better (2), ask Q15]
Q15. You said DRUG X works better than other treatments for insomnia. What in the ad made you say DRUG X works better?
[PROGRAMMER: Four separate text boxes]
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Codes to be determined through pretesting
[PROGRAMMER: If Q14 = somewhat riskier (4) or Q14 = much riskier (5), ask Q16]
Q16. You said DRUG X was more risky than other treatments for insomnia. What in the ad made you say DRUG X was more risky?
[PROGRAMMER: Four separate text boxes]
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Codes to be determined through pretesting
Q17. Thinking overall about the risks and benefits of DRUG X, would you say it has:
1 2 3 4 5 6 7
More risks Equal risks More benefits
than benefits and benefits than risks
[PROGRAMMER: Randomize order of Q18a-d. Record time spent on series.]
(Risk/Benefit Tradeoff)
Q18. Please rate your agreement or disagreement with each of the following statements.
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Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Behavioral Intention)
Q19a. How likely or not likely are you to look for more information about DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
Q19b. How likely or not likely are you to switch to DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
(Perceived Quality)
Q20. How would you rate the quality of DRUG X?
1 ------- 2------- 3 ------- 4 ------- 5 -------- 6 -------- 7
Poor quality Good quality
[PROGRAMMER: Randomize order of Q21a-c]
(Attitude toward Ad. From Bhutada et al., 2009, Shen & Chen, 2007, and MacKenzie & Lutz, 1989)
Q21. In your opinion, was the ad for DRUG X:
a. 1 2 3 4 5 6 7
Good Bad
b. 1 2 3 4 5 6 7
Pleasant Unpleasant
c. 1 2 3 4 5 6 7
Favorable Unfavorable
(Manipulation Checks)
QP3. In your opinion, was the amount of time you had to read the ad:
1 2 3 4 5 6 7
Too short About right Too long
QP4. How much attention did you pay to the advertisement when you were reading it?
1 2 3 4 5 6 7
A little A lot
Q22a. Do you remember seeing a coupon or other type of offer in the ad for DRUG X?
Yes
No
Not sure
[If OFFER=NONE, skip to Q25a]
[PROGRAMMER: SHOW AD AGAIN]
This ad had information about a coupon or offer for DRUG X. When answering the next few questions, please think only about the coupon or offer mentioned in the ad.
Q22b. What did the coupon or offer say? Please choose one. [PROGRAMMER: Randomize response choices]
“Money-Back Guarantee”
“Free 7-day Trial”
“Free 30-day Trial”
“$20 off cost of your prescription”
“#1 prescribed”
“Buy one, get one free”
“Buy two, get one free”
“$20 off the cost of your co-pay”
Don't know or uncertain
[Programmer: If OFFER=NONE, skip Q23 and Q24]
[PROGRAMMER: SHOW AD AGAIN]
(Inferences about Offer)
Q23a. In your own words, list all your thoughts, reactions and ideas that went through your mind while you were looking at the coupon or offer in the ad for DRUG X. Please use a separate line for each thought.
[PROGRAMMER: Five separate text boxes]
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Q23b. For each of the thoughts, reactions and ideas you listed, indicate whether the thought was positive, negative or neutral.
[PROGRAMMER: Display responses from Q23a. 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 Q24a above in a separate box] |
POSITIVE NEGATIVE NEUTRAL |
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(Peripheral Cue)
Q24a. To what extent do you agree or disagree that the coupon or offer was:
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Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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Q24b. How likely would you be to use this coupon or offer for DRUG X?
1 2 3 4 5 6 7
Definitely use Definitely not
the offer use the offer
[PROGRAMMER: Randomize order of Q25a-d]
(Skepticism)
Q25a. How likely is it that the benefits of the drug presented in this ad are true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25b. How skeptical are you about the truth of the benefits of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
Q25c. How likely is it that the risks of the drug presented in this ad is true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25d. How skeptical are you about the truth of the risks of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
[Q26 BLANK]
[PROGRAMMER: randomize order of Q27a-i. Record time spent on series.]
(Coupon Proneness and Quality-Price Relationship)
Q27. These next few questions are about coupons.
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Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Subjective Health Literacy)
Q28. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?
Never
Rarely
Sometimes
Often
Always
(Objective numeracy)
Q29. Now here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!
[PROGRAMMER: DO NOT randomize Q29a-e]
What is the correct answer:
17 – 8 + 4 = ?
11
13
21
23
29
Don’t know
What is the correct answer:
100 x 15 x 20 = ?
1,500
15,000
30,000
150,000
300,000
Don’t know
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?
___ times out of 1,000 [PROGRAMMER: set acceptable range from 0 to 1,000]
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 BIG BUCKS LOTTERY?
________ people [PROGRAMMER: set acceptable range from 0 to 1,000]
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?
___ percent [PROGRAMMER: set acceptable range from .001 to 100]
[Q30-Q31 BLANK]
Now a few questions to help us describe our sample of participants.
Q32. Do you have sleep problems, such as trouble falling asleep, staying asleep, or insomnia?
Yes
No
Don’t know or uncertain
Q33. In general, how much do you feel you know about sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q34. In general, how much do you feel you know about treatments for sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q35. What type of product are you using to treat your sleep problems? You may select more than one.
Prescription drug
Over the counter drug
Herbal supplement
Some other product
Behavior changes
Nothing/I am not treating my sleep problems {skip to Q37}
Q36. How satisfied or dissatisfied are you with the treatment for your sleep problems that you are using now?
Very satisfied
Somewhat satisfied
Somewhat dissatisfied
Very dissatisfied
(Likelihood of Switching)
Q37. Based on what you read in the ad for DRUG X, how likely are you to switch from your current treatment to DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[Q38, Q39 BLANK]
Q40. What did you use to complete today’s survey?
Laptop computer / Netbook computer
Desktop computer
Handheld phone (iPhone, Blackberry, Droid)
Handheld device other than a phone (iPod Touch, Palm Pilot, iPad)
Other: ________________
Q41. Did you receive any help on the questions that had numbers in them from anything or anyone (e.g., calculator, other person, website)? It’s okay if you did—we just want an honest answer.
Yes (write source_____________)
No
Q42. 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 Q43)
Don’t Know
Q43. Does your current insurance plan help pay for prescription drugs?
Yes
No
Don’t Know
QP1. Did you read the instructions at the beginning of the study?
Yes
No
[End time: ___________________ ]
You have been very helpful. Thank you very much for your participation!
The purpose of this research is to learn about consumer reactions to medical advertising. In order to get a real-life reaction to this information, we created a brand to use in this study. DRUG X is not a real product and it is not available for sale. Please see your healthcare professional for questions about insomnia.
END
Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
DRAFT Questionnaire: PRETEST 2
Programming instructions are indicated in blue font.
[PROGRAMMER:
• The viewing time of each page of the ad must be timed separately in milliseconds.
• Program progresses to the questioning in a “one-way” manner
• Record time in milliseconds spent on each screen (including questions) throughout protocol. ]
Interview Protocol
(Present Informed Consent Form. Participants will be blind to FDA’s sponsorship.)
[PROGRAMMER: Screen 1. TIME SPENT ON SCREEN IN MILLISECONDS]
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 a new product. We will show you an ad for a new product then ask you some questions about it. Your answers are private and will not be connected with your name. Your input is extremely valuable.
[PROGRAMMER: Screen 2. TIME SPENT ON SCREEN IN MILLISECONDS]
The ad has two pages. We will ask you some questions about the ad after you have finished reading it.
[PROGRAMMER: SCREEN 3]
If you want to see a bigger image of the page, you can enlarge the page by clicking on it, and you can flip between the pages by clicking the ”Next” and “Back” buttons at the bottom of the screen. Once you finish reading the ad, please click “Start Next Part of Study” to move to the next part of the study. You may begin when you are ready.
[PROGRAMMER: Record time in milliseconds spent on each page of the print ad.]
[PROGRAMMER: Show stimuli. TIME SPENT ON EACH PAGE IN MILLISECONDS]
[PROGRAMMER: UNLESS OTHERWISE NOTED, RECORD TIME SPENT ON EACH QUESTION IN MILLISECONDS]
Now please answer the following questions based on the ad you saw.
Q1. Were you able to view the ad for DRUG X?
Yes
No [Terminate]
Not sure [Terminate]
Q2. What type of product is DRUG X? [PROGRAMMER: randomize responses]
Over the counter drug
Prescription drug
Herbal supplement
Lens cleaner
Don’t know or uncertain
Q3. What condition does DRUG X treat? [PROGRAMMER: randomize responses]
High blood pressure
Insomnia
Migraine headaches
Seasonal allergies
Diabetes
Acid Reflux/GERD
Don’t know or uncertain
[PROGRAMMER: Benefit question series = Q4 through Q7. Risk question series = Q8 through Q12. Randomize order of benefit question series versus risk question series]
Q4. In your own words, what are the benefits of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q5-Q6]
(Perceived Benefit)
Q5. Based on the information in the ad, how effective would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
Q6. Based on the information in the ad, how well would DRUG X work for you?
1 2 3 4 5 6 7
Not at all Moderately Very
well well well
[PROGRAMMER: randomize order of Q7a-h. Record time spent on series]
(Recall of Benefits)
Q7. Based on the information in the ad, please check which of the following are benefits of taking DRUG X.
|
Yes |
No |
Don’t Know |
a. DRUG X is taken twice a day.
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x |
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b. DRUG X can be used for up to 3 months.
|
x |
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c. DRUG X can help you stay asleep for up to 8 hours.
|
x |
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d. DRUG X is safe for people with kidney problems.
|
x |
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e. DRUG X treats insomnia in adults and children ages 10 and up.
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x |
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f. DRUG X is the #1 prescribed medication for insomnia.
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x |
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g. DRUG X combines two ingredients.
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x |
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h. DRUG X can be habit-forming.
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x |
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i. DRUG X leaves your system within 4 hours.
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x |
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Q8. In your own words, what are the risks of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q9-Q10]
(Perceived Risk)
Q9. Based on the information in the ad, how safe would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
Safe safe safe
Q10. Based on the information in the ad, how risky would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
risky risky risky
Q11. Based on the information in this ad, how likely is it that you would have a side effect from DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[PROGRAMMER: Randomize order of Q12a-i. Record time spent on series.]
(Recall of Risks)
Q12. Based on the information in the ad, please check which of the following are risks of taking DRUG X.
|
Yes |
No |
Don’t Know |
a. TTP is a risk when you take DRUG X
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x |
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b. You need blood tests when taking DRUG X.
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x |
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c. People with liver problems should not take DRUG X.
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x |
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d. A common side effect of DRUG X is ringing in the ears.
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x |
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e. A common side effect of DRUG X is blurred vision.
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x |
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f. People with a history of depression should not take DRUG X.
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x |
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g. A common side effect of DRUG X is dizziness.
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x |
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h. People with kidney problems should not take DRUG X.
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x |
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i. A common side effect of DRUG X is joint pain.
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x |
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j. DRUG X may cause hallucinations. |
x
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[PROGRAMMER: Rotate order of Q13-Q14]
(Perceived Comparative Benefit and Risk)
Q13. Compared to other treatments you could take for insomnia, how well do you think DRUG X works?
Much better
Somewhat better
About the same
Somewhat worse
Much worse
Q14. Compared to other treatments you could take for insomnia, how safe or risky do you think DRUG X is?
Much safer
Somewhat safer
About the same
Somewhat riskier
Much riskier
Q17. Thinking overall about the risks and benefits of DRUG X, would you say it has:
1 2 3 4 5 6 7
More risks Equal risks More benefits
than benefits and benefits than risks
[PROGRAMMER: Randomize order of Q18a-c. Record time spent on series.]
(Risk/Benefit Tradeoff)
Q18. Please rate your agreement or disagreement with each of the following statements.
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Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Behavioral intention)
Q19a. How likely or not likely are you to look for more information about DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
Q19b. How likely or not likely are you to switch to DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
(Perceived Quality)
Q20. How would you rate the quality of DRUG X?
1 ------- 2------- 3 ------- 4 ------- 5 -------- 6 -------- 7
Poor quality Good quality
[Q21 BLANK]
(Manipulation Checks)
Q22a. Do you remember seeing a coupon or other type of offer in the ad for DRUG X?
Yes
No
Not sure
[If OFFER=NONE, skip to Q25a]
Q22b. What did the coupon or offer say? Please choose one. [PROGRAMMER: Randomize response choices]
“Money-Back Guarantee”
“Free 7-day Trial”
“Free 30-day Trial”
“Free refill”
“$20 off cost of your prescription”
“#1 prescribed”
“Buy one, get the next one free”
“Buy two, get the next one free”
“$20 off the cost of your co-pay”
Don't know or uncertain [always last]
[PROGRAMMER: SHOW AD AGAIN]
(Inferences about Offer)
Q23a. In your own words, list all your thoughts, reactions and ideas that went through your mind while you were looking at the coupon or offer in the ad for DRUG X. Please use a separate line for each thought.
[PROGRAMMER: Five separate text boxes]
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Q23b. For each of the thoughts, reactions and ideas you listed, indicate whether the thought was positive, negative or neutral.
[PROGRAMMER: Display responses from Q23a. 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 Q24a above in a separate box] |
POSITIVE NEGATIVE NEUTRAL |
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Q23c. In your own words, describe what you liked and did not like about the coupon or offer.
[PROGRAMMER: Four separate text boxes]
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Q23d. Was the amount of the coupon or offer:
1 2 3 4 5 6 7
Too low Just right Too high
Q23e. How likely would you be to use this coupon or offer for DRUG X?
1 2 3 4 5 6 7
Definitely use Definitely not
the offer use the offer
(Peripheral Cue)
Q24a. To what extent do you agree or disagree that the coupon or offer was:
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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Q24b. How likely would you be to use this coupon or offer for DRUG X?
1 2 3 4 5 6 7
Definitely use Definitely not
the offer use the offer
[PROGRAMMER: Randomize order of Q25a-d]
(Skepticism)
Q25a. How likely is it that the benefits of the drug presented in this ad are true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25b. How skeptical are you about the truth of the benefits of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
Q25c. How likely is it that the risks of the drug presented in this ad is true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25d. How skeptical are you about the truth of the risks of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
[Q26 BLANK]
[PROGRAMMER: randomize order of Q27a-i. Record time spent on series.]
(Coupon Proneness and Quality-Price Relationship)
Q27. These next few questions are about coupons.
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Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Subjective Health Literacy)
Q28. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?
Never
Rarely
Sometimes
Often
Always
(Objective numeracy)
Q29. Now here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!
[PROGRAMMER: DO NOT randomize Q29a-e]
What is the correct answer:
17 – 8 + 4 = ?
11
13
21
23
29
Don’t know
What is the correct answer:
100 x 15 x 20 = ?
1,500
15,000
30,000
150,000
300,000
Don’t know
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?
___ times out of 1,000 [PROGRAMMER: set acceptable range from 0 to 1,000]
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 BIG BUCKS LOTTERY?
________ people [PROGRAMMER: set acceptable range from 0 to 1,000]
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?
___ percent [PROGRAMMER: set acceptable range from .001 to 100]
[Q30 AND Q31 BLANK]
Now a few questions to help us describe our sample of participants.
Q32. Do you have sleep problems, such as trouble falling asleep, staying asleep, or insomnia?
Yes
No
Don’t know or uncertain
Q33. In general, how much do you feel you know about sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q34. In general, how much do you feel you know about treatments for sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q35. What type of product are you using to treat your sleep problems? You may select more than one.
Prescription drug
Over the counter drug
Herbal supplement
Some other product
Behavior changes
Nothing/I am not treating my sleep problems {skip to Q37}
Q36. How satisfied or dissatisfied are you with the treatment for your sleep problems that you are using now?
Very satisfied
Somewhat satisfied
Somewhat dissatisfied
Very dissatisfied
(Likelihood of Switching)
Q37. Based on what you read in the ad for DRUG X, how likely are you to switch from your current treatment to DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[Q38, Q39 BLANK]
Q40. What did you use to complete today’s survey?
Laptop computer / Netbook computer
Desktop computer
Handheld phone (iPhone, Blackberry, Droid)
Handheld device other than a phone (iPod Touch, Palm Pilot, iPad)
Other: ________________
Q41. Did you receive any help on the questions that had numbers in them from anything or anyone (e.g., calculator, other person, website)? It’s okay if you did—we just want an honest answer.
Yes (write source_____________)
No
Q42. 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 Q43)
Don’t Know
Q43. Does your current insurance plan help pay for prescription drugs?
Yes
No
Don’t Know
QP1. Did you read the instructions at the beginning of the study?
Yes
No
[End time: ___________________ ]
You have been very helpful. Thank you very much for your participation!
The purpose of this research is to learn about consumer reactions to medical advertising. In order to get a real-life reaction to this information, we created a brand to use in this study. DRUG X is not a real product and it is not available for sale. Please see your healthcare professional for questions about insomnia.
END
Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
DRAFT Questionnaire: PRETEST 3 AND MAIN STUDIES
Programming instructions are indicated in blue font.
Questions specific to PRETEST 3 / STUDY 1 are in GREEN.
Questions specific to STUDY 2 are in RED.
[PROGRAMMER:
• The viewing time of each page of the ad must be timed separately in milliseconds.
• Program progresses to the questioning in a “one-way” manner
• Record time in milliseconds spent on each screen (including questions) throughout protocol. ]
Interview Protocol
(Present Informed Consent Form. Participants will be blind to FDA’s sponsorship.)
[PROGRAMMER: Screen 1. TIME SPENT ON SCREEN IN MILLISECONDS]
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 a new product. We will show you an ad for a new product then ask you some questions about it. Your answers are private and will not be connected with your name. Your input is extremely valuable.
[PROGRAMMER: Screen 2. TIME SPENT ON SCREEN IN MILLISECONDS]
Some ads have two pages, others have only one. We will ask you some questions about the ad after you have finished reading it.
[PROGRAMMER: Screen 3. TIME SPENT ON SCREEN IN MILLISECONDS]
If you want to see a bigger image of the page, you can enlarge the page by clicking on it, and for two page ads you can flip between the pages by clicking the ”Next” and “Back” buttons at the bottom of the screen. Once you finish reading the ad, please click “Start Next Part of Study” to move to the next part of the study. You may begin when you are ready.
[PROGRAMMER: Record time in milliseconds spent on each page of each print ad.]
[PROGRAMMER: Show stimuli. TIME SPENT ON EACH PAGE IN MILLISECONDS]
[PROGRAMMER: UNLESS OTHERWISE NOTED, RECORD TIME SPENT ON EACH QUESTION IN MILLISECONDS]
Now please answer the following questions based on the ads you saw.
Q1. Were you able to view the ad for DRUG X?
Yes
No [Terminate]
Not sure [Terminate]
Q1b. Please list the thoughts that were going through your mind as you viewed the ad for DRUG X and list them below. Use one line for each thought.
[PROGRAMMER: Five separate text boxes]
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[PRETEST 3 GROUP 1: Provide link on screen to view ad. PRETEST 3 GROUP 2: Do not show ad.]
Q2. What type of product is DRUG X? [PROGRAMMER: randomize responses]
Over the counter drug
Prescription drug
Herbal supplement
Lens cleaner
Not sure
Q3. What condition does DRUG X treat? [PROGRAMMER: randomize responses]
High blood pressure
Insomnia
Migraine headaches
Seasonal allergies
Diabetes
Acid Reflux/GERD
Not sure/Don’t know
[PROGRAMMER: Benefit question series = Q4 through Q7. Risk question series = Q8 through Q12. Randomize order of benefit question series versus risk question series]
Q4. In your own words, what are the benefits of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q5-Q6]
(Perceived Benefit)
Q5. Based on the information in the ad, how effective would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
effective effective effective
Q6. Based on the information in the ad, how well would DRUG X work for you?
1 2 3 4 5 6 7
Not at all Moderately Very
well well well
[PROGRAMMER: randomize order of Q7a-h. Record time spent on series]
(Recall of Benefits)
[PRETEST 3 AND STUDY 1 ONLY]
Q7. Based on the information in the ad, please check which of the following are benefits of taking DRUG X.
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Yes |
No |
Don’t Know |
a. DRUG X is taken twice a day.
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x |
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b. DRUG X can be used for up to 3 months.
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x |
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c. DRUG X can help you stay asleep for up to 8 hours.
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x |
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d. DRUG X is safe for people with kidney problems.
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x |
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e. DRUG X treats insomnia in adults and children ages 10 and up.
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x |
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f. DRUG X is the #1 prescribed medication for insomnia.
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x |
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g. DRUG X combines two ingredients.
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x |
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h. DRUG X can be habit-forming.
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x |
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i. DRUG X leaves your system within 4 hours.
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x |
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[STUDY 2 ONLY]
Q7. Based on the information in the ad, please check which of the following are benefits of taking DRUG X.
|
Yes |
No |
Don’t Know |
a. You take DRUG X once a day.
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X |
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b. DRUG X helps lower your blood pressure.
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X |
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c. You take DRUG X only once a month.
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X |
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d. DRUG X can reduce your bad cholesterol levels.
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X |
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e. DRUG X can reduce your risk of having a stroke.
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X |
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f. DRUG X is the only high blood pressure medication approved to treat children.
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X |
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g. DRUG X can help prevent heart attacks.
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X |
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Q8. In your own words, what are the risks of DRUG X?
[PROGRAMMER: Four separate text boxes]
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[PROGRAMMER: Randomize order of Q9-Q10]
(Perceived Risk)
Q9. Based on the information in the ad, how safe would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
Safe safe safe
Q10. Based on the information in the ad, how risky would DRUG X be for you?
1 2 3 4 5 6 7
Not at all Moderately Very
risky risky risky
Q11. Based on the information in this ad, how likely is it that you would have a side effect from DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[PROGRAMMER: Randomize order of Q12a-i. Record time spent on series.]
(Recall of Risks)
[PRETEST 3 AND STUDY 1 ONLY]
Q12. Based on the information in the ad, please check which of the following are risks of taking DRUG X.
|
Yes |
No |
Don’t Know |
a. TTP is a risk when you take DRUG X
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x |
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b. You need blood tests when taking DRUG X.
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x |
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c. People with liver problems should not take DRUG X.
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x |
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d. A common side effect of DRUG X is ringing in the ears.
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x |
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e. A common side effect of DRUG X is blurred vision.
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x |
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f. People with a history of depression should not take DRUG X.
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x |
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g. A common side effect of DRUG X is dizziness.
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x |
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h. People with kidney problems should not take DRUG X.
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x |
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i. A common side effect of DRUG X is joint pain.
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x |
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j. DRUG X may cause hallucinations. |
x
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[STUDY 2 ONLY]
Q12. Based on the information in the ad, please check which of the following are risks of taking DRUG X.
|
Yes |
No |
Don’t Know |
a. Taking some kinds of over-the-counter cough medicines at the same time as taking DRUG X increases your risk of having a heart attack.
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X |
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b. DRUG X may cause excitability.
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X |
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c. If you have a very slow heart rate, you should not take DRUG X.
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X |
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d. DRUG X may cause you to have blurry vision.
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X |
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e. One of the most common side effects is tiredness.
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X |
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f. Antibiotics may not work as well if you use DRUG X at the same time.
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X |
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g. You should have regular eye exams when you take DRUG X.
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X |
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h. One of the most common side effects is nausea.
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X |
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[PROGRAMMER: Rotate order of Q13-Q14]
(Perceived Comparative Benefit and Risk)
Q13. Compared to other treatments you could take for insomnia, how well do you think DRUG X works?
Much better
Somewhat better
About the same
Somewhat worse
Much worse
Q14. Compared to other treatments you could take for insomnia, how safe or risky do you think DRUG X is?
Much safer
Somewhat safer
About the same
Somewhat riskier
Much riskier
[PROGRAMMER: If Q13 = much better (1) or Q13 = somewhat better (2), ask Q15]
Q15. You said DRUG X works better than other treatments for insomnia. What in the ad made you say DRUG X works better?
[PROGRAMMER: Four separate text boxes]
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Codes to be determined through pretesting
[PROGRAMMER: If Q14 = somewhat riskier (4) or Q14 = much riskier (5), ask Q16]
Q16. You said DRUG X was more risky than other treatments for insomnia. What in the ad made you say DRUG X was more risky?
[PROGRAMMER: Four separate text boxes]
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Codes to be determined through pretesting
Q17. Thinking overall about the risks and benefits of DRUG X, would you say it has:
1 2 3 4 5 6 7
More risks Equal risks More benefits
than benefits and benefits than risks
[PROGRAMMER: Randomize order of Q18a-d. Record time spent on series.]
(Risk/Benefit Tradeoff)
Q18. Please rate your agreement or disagreement with each of the following statements.
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Behavioral Intention)
Q19a. How likely or not likely are you to look for more information about DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
Q19b. How likely or not likely are you to switch to DRUG X?
Not at all likely
Somewhat likely
Very likely
Extremely likely
(Perceived Quality)
Q20. How would you rate the quality of DRUG X?
1 ------- 2------- 3 ------- 4 ------- 5 -------- 6 -------- 7
Poor quality Good quality
[PROGRAMMER: Randomize order of Q21a-c]
(Attitude toward Ad. From Bhutada et al., 2009, Shen & Chen, 2007, and MacKenzie & Lutz, 1989)
Q21. In your opinion, was the ad for DRUG X:
a. 1 2 3 4 5 6 7
Good Bad
b. 1 2 3 4 5 6 7
Pleasant Unpleasant
c. 1 2 3 4 5 6 7
Favorable Unfavorable
(Manipulation Checks)
Q22a. Do you remember seeing a coupon or other type of offer in the ad for DRUG X?
Yes
No
Not sure
[If OFFER=NONE, skip to Q25a]
[PROGRAMMER: SHOW AD AGAIN]
This ad had information about a coupon or offer for DRUG X. When answering the next few questions, please think only about the coupon or offer mentioned in the ad.
Q22b. What did the coupon or offer say? Please choose one. [PROGRAMMER: Randomize response choices]
“Money-Back Guarantee”
“Free 7-day Trial”
“Free 30-day Trial”
“$20 off cost of your prescription”
“#1 prescribed”
“Buy one, get one free”
“Buy two, get one free”
“$20 off the cost of your co-pay”
Don't know or uncertain
[Programmer: If OFFER=NONE, skip Q23 and Q24]
[PROGRAMMER: SHOW AD AGAIN]
(Inferences about Offer)
Q23a. In your own words, list all your thoughts, reactions and ideas that went through your mind while you were looking at the coupon or offer in the ad for DRUG X. Please use a separate line for each thought.
[PROGRAMMER: Five separate text boxes]
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Q23b. For each of the thoughts, reactions and ideas you listed, indicate whether the thought was positive, negative or neutral.
[PROGRAMMER: Display responses from Q23a. 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 Q24a above in a separate box] |
POSITIVE NEGATIVE NEUTRAL |
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(Peripheral Cue)
Q24a. To what extent do you agree or disagree that the coupon or offer was:
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
|
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Q24b. How likely would you be to use this coupon or offer for DRUG X?
1 2 3 4 5 6 7
Definitely use Definitely not
the offer use the offer
[PROGRAMMER: Randomize order of Q25a-d]
(Skepticism)
Q25a. How likely is it that the benefits of the drug presented in this ad are true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25b. How skeptical are you about the truth of the benefits of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
Q25c. How likely is it that the risks of the drug presented in this ad is true?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Likely Likely
Q25d. How skeptical are you about the truth of the risks of the drug presented in this ad?
1 2 3 4 5 6 7 8 9
Not at all Extremely
Skeptical Skeptical
[Q26 BLANK]
[PROGRAMMER: randomize order of Q27a-i. Record time spent on series.]
(Coupon Proneness and Quality-Price Relationship)
Q27. These next few questions are about coupons.
|
Strongly agree |
Somewhat agree |
Neither agree nor disagree |
Somewhat disagree |
Strongly disagree |
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(Subjective Health Literacy)
Q28. How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?
Never
Rarely
Sometimes
Often
Always
(Objective numeracy)
Q29. Now here are some questions that require you to use numbers to solve the problem. Some are easy, and others are more difficult. Please don’t use a calculator: We’d like you to answer on your own. Remember, almost everyone will have trouble with these questions, so don’t be upset if some are difficult—just do your best!
[PROGRAMMER: DO NOT randomize Q29a-e]
What is the correct answer:
17 – 8 + 4 = ?
11
13
21
23
29
Don’t know
What is the correct answer:
100 x 15 x 20 = ?
1,500
15,000
30,000
150,000
300,000
Don’t know
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?
___ times out of 1,000 [PROGRAMMER: set acceptable range from 0 to 1,000]
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 BIG BUCKS LOTTERY?
________ people [PROGRAMMER: set acceptable range from 0 to 1,000]
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?
___ percent [PROGRAMMER: set acceptable range from .001 to 100]
(Subjective Numeracy 1st part)
Q30. For each of the following questions, please check the box that best reflects how good you are at doing the following things:
How good are you at working with fractions?
How good are you at working with percentages?
How good are you at calculating a 15% tip?
How good are you at figuring out how much a shirt will cost if it is 25% off?
(Subjective Numeracy 2nd part)
Q31. For each of the following questions, please check the box that best reflects your answer:
When reading the newspaper, how helpful do you find tables and graphs that are part of a story?
When people tell you the chance of something happening, do you prefer that they use words (“it rarely happens”) or numbers (“there is a 1% chance)?
When you hear a weather forecast, do you prefer predictions using percentages (“there will be a 20% chance of rain”) or predictions using only words (“there is a small chance of rain today”)?
How often do you find numerical information to be useful?
Now a few questions to help us describe our sample of participants.
[PRETEST 3 AND STUDY 1 ONLY]
Q32. Do you have sleep problems, such as trouble falling asleep, staying asleep, or insomnia?
Yes
No
Don’t know or uncertain
Q33. In general, how much do you feel you know about sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q34. In general, how much do you feel you know about treatments for sleep problems?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q35. What type of product are you using to treat your sleep problems? You may select more than one.
Prescription drug
Over the counter drug
Herbal supplement
Something other product
Behavior changes
Nothing/I am not treating my sleep problems {skip to Q37}
Q36. How satisfied or dissatisfied are you with the treatment for your sleep problems that you are using now?
Very satisfied
Somewhat satisfied
Somewhat dissatisfied
Very dissatisfied
[STUDY 2 ONLY]
Q32. Do you have high blood pressure?
Yes
No
Don’t know or uncertain
Q33. In general, how much do you feel you know about high blood pressure?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q34. In general, how much do you feel you know about treatments for high blood pressure?
A lot
A good bit
Some
Only a slight amount
Nothing at all
Q35. What type of product are you using to treat your high blood pressure? You may select more than one.
Prescription drug
Over the counter drug
Herbal supplement
Something other product
Behavior changes
Nothing/I am not treating my sleep problems {skip to Q37}
Q36. How satisfied or dissatisfied are you with the treatment for your high blood pressure that you are using now?
Very satisfied
Somewhat satisfied
Somewhat dissatisfied
Very dissatisfied
(Likelihood of Switching)
Q37. Based on what you read in the ad for DRUG X, how likely are you to switch from your current treatment to DRUG X?
1 2 3 4 5 6 7
Not at all Moderately Very
likely likely likely
[Q38 BLANK]
Q39a. In your opinion, how risky are prescription drugs compared to over-the-counter drugs?
1 2 3 4 5 6 7
Much less risky About Much more risky
the same
Q39b. In your opinion, how effective are prescription drugs compared to over-the-counter drugs?
1 2 3 4 5 6 7
Much less About Much more
effective the same effective
Q40. What did you use to complete today’s survey?
Laptop computer / Netbook computer
Desktop computer
Handheld phone (iPhone, Blackberry, Droid)
Handheld device other than a phone (iPod Touch, Palm Pilot, iPad)
Other: ________________
Q41. Did you receive any help on the questions that had numbers in them from anything or anyone (e.g., calculator, other person, website)? It’s okay if you did—we just want an honest answer.
Yes (write source_____________)
No
Q42. 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 Q43)
Don’t Know
Q43. Does your current insurance plan help pay for prescription drugs?
Yes
No
Don’t Know
QP1. Did you read the instructions at the beginning of the study?
Yes
No
[End time: ___________________ ]
You have been very helpful. Thank you very much for your participation!
The purpose of this research is to learn about consumer reactions to medical advertising. In order to get a real-life reaction to this information, we created a brand to use in this study. DRUG X is not a real product and it is not available for sale. Please see your healthcare professional for questions about insomnia.
END
File Type | application/msword |
File Title | APPENDIX 2 |
Author | Aikin |
Last Modified By | Aikin |
File Modified | 2011-06-13 |
File Created | 2011-06-02 |