Pretest consumers

Study of Clinical Efficacy Information in Professional Labeling and Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs

Consumer Pretest Questionnaire_051311

Pretest consumers

OMB: 0910-0692

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Last updated 5/13/11

Consumer Pretest Questionnaire


N = 100


*Administer informed consent*


Pretest Questionnaire


Quilarix (lexitacisprin) is a new prescription drug that helps reduce symptoms of chronic pain. It comes in tablet form and is generally taken two times a day. Possible side effects include stomach upset, dizziness, and dry mouth.


Q1. Please read the following statements (each participant sees one version and answers corresponding questions):


Version A


• 30 out of 100 people on the drug Quilarix reduced their pain symptoms.

• 20 out of 100 people on placebo reduced their pain symptoms.


a. What do these statements mean to you?


Possible codes (to be applied for all versions):

• Quilarix works/more people who took Quilarix had effect

• Quilarix does not work

• Clinical trial/a test was used

• Don’t know


b. What does “placebo” mean here?


Possible codes (to be applied for all versions):

• Full understanding

• Reference to clinical trial/test/experiment/research

• People did not take a drug

• People did not do anything to fix symptoms

• It’s another drug

• Don’t know

• Blood sugar/diabetes reference

• Incorrect other than “it’s another drug?”


Version B


• 30 out of 100 people on the drug Quilarix reduced their pain symptoms.

• 20 out of 100 people on sugar pill reduced their pain symptoms.


a. What do these statements mean to you?

b. What does “sugar pill” mean here?


Version C


• 30 out of 100 people on the drug Quilarix reduced their pain symptoms.

• 20 out of 100 people without Quilarix reduced their pain symptoms.


a. What do these statements mean to you?

b. What does “without Quilarix” mean here?


Version D


• 30 out of 100 people on the drug Quilarix reduced their pain symptoms.

• 20 out of 100 people with no treatment reduced their pain symptoms.


a. What do these statements mean to you?

b. What does “with no treatment” mean here?



2. Please provide a guess as to how many people in the US have a heart attack in a given year.


_____ out of 100.



3. Cobyrel (cobyrexen) is a prescription drug that has been shown to reduce the risk of having a heart attack in people who are at risk for heart problems. It is available in three different dosage forms: as a pill, a shot, or a patch applied to the skin. Possible side effects of Cobyrel include nightsweats, headache, and muscle weakness.


Please read the following statements (each participant sees all three versions on the screen at once and they can access the versions as they answer the questions below):


Version A


Cobyrel (cobyrexen) reduced the risk of heart attack.

• 96/100 people avoided a heart attack while on Cobyrel.

• 95/100 people avoided a heart attack without Cobyrel.


Version B


Cobyrel (cobyrexen) reduced the risk of heart attack.

• 96/100 people did not have a heart attack while on Cobyrel.

• 95/100 people did not have a heart attack without Cobyrel.


Version C


Cobyrel (cobyrexen) reduced the risk of heart attack.

• 4/100 people had a heart attack while on Cobyrel.

• 5/100 people had a heart attack without Cobyrel.



  1. What do these statements mean to you?

Possible codes:

• All same

• Different versions mean different things


• Drug is effective

• Drug is not effective

• Don’t know


  1. Do the statements say the same thing? Why or why not?


Possible codes:

• Yes

• No

-difference in effectiveness

-difference in riskiness

• Don’t know


  1. Please rank the statements from most to least on the following attributes:


-Understandable

-Believable

-Clear

-Easy to read

-Persuasive



When researchers want to know if a drug works, they conduct a clinical trial. In clinical trials, some people are given the real drug and others are given a fake drug (a placebo). No one knows who got what. The researchers then look to see if people who got the real drug do better than people who did not get the real drug. Sometimes there is a big difference and people who got the real drug do much better than people who got the fake drug, meaning that the real drug works very well. Sometimes there is a small difference and people who got the real drug only do a little better than people who got the fake drug, meaning that the real drug works a little bit, but does not do much more than not taking any drug at all would.


4. Please read the following sentences and fill in the blanks based on what you think a BIG difference would be between the drug Quilarix and a fake drug.

a.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __5__ out of 100 people without Quilarix reduced their pain symptoms.


b.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __25_ out of 100 people without Quilarix reduced their pain symptoms.


c.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __50_ out of 100 people without Quilarix reduced their pain symptoms.


5. Please read the following sentences and fill in the blanks based on what you think a SMALL difference would be between the drug Quilarix and a fake drug.

a.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __5__ out of 100 people without Quilarix reduced their pain symptoms.


b.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __25_ out of 100 people without Quilarix reduced their pain symptoms.


c.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __50_ out of 100 people without Quilarix reduced their pain symptoms.



6. Please read the following sentences and fill in the blanks based on what you think NO DIFFERENCE would be between the drug Quilarix and a fake drug.

a.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __5__ out of 100 people without Quilarix reduced their pain symptoms.


b.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __25_ out of 100 people without Quilarix reduced their pain symptoms.


c.

• _____ out of 100 people on the drug Quilarix reduced their pain symptoms.

• __50_ out of 100 people without Quilarix reduced their pain symptoms.



7. What does “fake drug” mean to you? (open-ended)


Possible codes to be determined.


8. How likely do you think it would be that 5 out of 100 people would experience less pain if they did not take any drug at all?


1

2

3

4

5

Not at all likely


Somewhat likely


Very likely


9. How likely do you think it would be that 25 out of 100 people would experience less pain if they did nothing to treat it at all?


1

2

3

4

5

Not at all likely


Somewhat likely


Very likely


10. How likely do you think it would be that 50 out of 100 people would experience less pain if they did nothing to treat it at all?


1

2

3

4

5

Not at all likely


Somewhat likely


Very likely




The purpose of this research is to develop materials to learn about how people feel about and understand how well prescription drugs work from information provided in ads. In order to get a real-life reaction to this information, we created brands to use in this study. QUILARIX and COBYREL are not real products and are not available for sale. Please see your healthcare professional for questions about your health and your medical conditions.


This concludes the project today. Thank you for your time.





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File Typeapplication/msword
File TitleConsumer Pretest Questionnaire
AuthorBRAMANA
Last Modified ByBRAMANA
File Modified2011-05-13
File Created2011-05-13

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