Attachment A

Toll-Free Statement Internet Research - Participant Screener and Questionnaire


Toll-Free Statement Internet Research

Participant Screener

Draft



Recruitment Criteria


N = 1600


Sixteen hundred people will be recruited over the Internet to participate in a survey lasting no more than 15 minutes.


Participants will be randomly assigned to 10 conditions.

• Gender:

• Roughly equal distribution of men and women:

• At least 40%-60% men in each condition


• Age:

• Must be 21 years or older

• Spectrum of ages from 20s to 80s

• No more than 15% under age 25 in each condition

• At least 40% over age 55 in each condition


• Spectrum from high school grad to post grad

• No more than 30% with advanced degrees

• At least 15% with high school education or less


Screener for Toll-Free participants (Please place in appropriate Internet format)

  1. What is your date of birth?



  1. Can you read English?



  1. Gender:



  1. What level of education have you reached?



  1. Are you:



  1. Which of these best represents your ethnic group? You may choose one or more. Would you say that you are:




Toll-Free Statement Internet Research

Participant Questionnaire

Draft




We will obtain gender, age, ethnicity, and education from the Synovate screener.

Statements will be shown in context (i.e., with other label info).




Thank you for agreeing to participate today. This study looks at information that comes with prescription drugs or on over-the-counter drug labels. We are interested in what your reactions are to the different types of information you might see there. Your participation will help provide the best information for people all over the country. All of your answers are anonymous and confidential. Please answer the questions honestly. The study should take approximately 15 minutes….{standard instructions for participating in studies from vendor}


[Ensure a progression bar that allows participants to determine how far through the study they are. Also ensure that they have an option to continue the study at a later time if necessary]




First, we would like you to look at a [prescription bottle][drug label], one similar to those you may have received or bought at a pharmacy. After you have spent as much time as you like looking at the [bottle][label], please click the “Next” button to answer some questions about it.


[PROGRAMMER: Show [prescription drug container] or [OTC drug label] –randomly assigned]

[PROGRAMMER—within Rx or OTC condition, randomly assign statements]


Imagine you have taken a drug with this information on the label. Please think about each of the following situations and answer each question as best you can.


1. a. How likely would you be to do the following things if you had a mild side effect of this drug? [RANDOMIZE response options]

Not at all

likely

Somewhat

likely

Moderately

likely

Very likely

Extremely likely

Call your doctor right away






Call FDA right away






Treat with another OTC drug






Go to the emergency room right away






Call the poison control center right away






Call your doctor next day or later






Call FDA next day or later






Do nothing






Do something else







1. b. Please select the action above that you would do first if you had a mild side effect of this drug.


2. a. How likely would you be to do the following things if you had a severe side effect of this drug? [RANDOMIZE response options]

Not at all

likely

Somewhat

likely

Moderately likely

Very likely

Extremely likely

Call your doctor right away






Call FDA right away






Treat with another OTC drug






Go to the emergency room right away






Call the poison control center right away






Call your doctor next day or later






Call FDA next day or later






Do nothing






Do something else







2. b. Please select the action above that you would do first if you had a severe side effect of this drug.


3. a. How likely would you be to do the following things if you took an accidental overdose of this drug? [RANDOMIZE response options]

Not at all

likely

Somewhat

likely

Moderately likely

Very likely

Extremely likely

Call your doctor right away






Call FDA right away






Treat with another OTC drug






Go to the emergency room right away






Call the poison control center right away






Call your doctor next day or later






Call FDA next day or later






Do nothing






Do something else







3. b. Please select the action above that you would do first if you took an accidental overdose of this drug.




The following questions are about the following statement:


[Insert statement]

[Statement should be visible at top of screen for remainder of study]


Think just about this statement when answering the next few questions.



4. Thinking about the drug information you saw, why would you call your doctor after experiencing a side effect? (please check all that apply) [RANDOMIZE response options]



5. Thinking about the bottle you saw, why would you call FDA after experiencing a side effect? (please check all that apply) [RANDOMIZE response options]




6. How likely are you to call FDA if you have a side effect?


- Very likely


7. When you call this number, who do you think you will talk to? (please select one) [RANDOMIZE response options]






8.

How likely would you be to report the following types of side effects to the FDA?

Not at all

likely

Somewhat

likely

Moderately likely

Very likely

Extremely likely

Side effects that bothered me for a few days






Side effects that did not go away






Side effects that made me miserable






Side effects that sent me to my doctor






Side effects that sent me to the emergency room






Side effects that killed someone I know






Side effects not listed on the label






All side effects I had









9. Which of the following side effects would you report? (please check all that apply)




10. Which of the following best describes what “serious side effect” means to you? (please select one)



11. When you contact the FDA about side effects, what do you think will happen to the information you give? (please check all that apply) [RANDOMIZE response options]



12. Why wouldn’t you call the FDA? (please check all that apply) [RANDOMIZE response options]



13. How understandable or confusing is the statement at the top of your screen? (please select one)



14. How clear is this statement? (please select one)



15. If you were given a website, how likely would you be to use it? (please select one) [ASK ONLY of those who do not have website in their statement]



16. Out of the following choices, which would you be most likely to do if you wanted to report a side effect? (please select one) [ASK ONLY of those who do have website in their statement]



17. How important do you think reporting side effects to the FDA is? (please select one)



18. a. Have you ever experienced a reaction or side effect from a prescription drug?


- Yes

- No (skip to 19)


18. b. What did you do after you had that side effect? (please select one)



19. a. Have you ever experienced a reaction or side effect from an over-the-counter drug?



19. b. What did you do after you had that side effect? (please select one)


20. a. Are you currently taking any prescription drugs?



20. b. How many? (type in number)


21. a. Are you currently taking any over-the-counter drugs?



21. b. How many? (type in number).

____




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