Pretests

National Consumer Survey: Web Version (As of 5-20-2011)

screener and introduction

The U.S. Food and Drug Administration, also known as the FDA, is conducting an important study on people’s opinions of medical products. Your opinions, and the opinions of people like you, are very important to the FDA.

This study is sponsored by the FDA but is being conducted by RTI, a not-for-profit research organization, and Precision Opinion research. Your participation is voluntary and the survey will only take 15 minutes. If you have questions about the study, you can contact the study supervisor toll-free at 1-XXX-XXX-XXXX. If you have questions about your rights as a study participant, you can call 1-866-214-2043.

All of your answers will be kept private and only the overall study data will be reported. By participating in the survey, you will help the FDA design better programs to improve the Nation’s health.

In this survey, the phrase “medical products” includes many things. It includes:

• Things that might be used at a visit to your doctor or dentist like vaccinations or shots, lasers for eye surgery, or dental fillings;

• Things you might get during a hospital visit like an x-ray, blood transfusion, implant, or pacemaker;

• Things you might buy off the shelf like over-the-counter drugs, vitamins, stop-smoking patches, thermometers, hearing aids, pregnancy tests, and blood sugar testing kits; and

• Things you need a prescription for like contact lenses and prescription drugs.

1. Based on this list of examples, have you (or a family member you make health decisions for) used or received treatment with any medical products in the past 3 months?

3		Yes
2		No
1		Not sure

IF Q1 = "No," “Not sure,” or missing  DISPLAY: Thank you. At this time, we are only surveying adults age 18 or older who have recent experience with a medical product. We appreciate your time. Have a good day. CODE CASE AND TERMINATE

IF Q1 = "Yes" DISPLAY: The phrase “medical products” will be used often in this survey. Click on “medical products” at any time during this survey to see the list of examples repeated.

Attitudes & opinions

2. How much do you agree or disagree that when FDA approves a medical product as being “safe and effective,” it means…? [RANDOMIZE]

98 Don’t know
Strongly disagree
Disagree
Agree
Strongly agree
a. The medical product has no life-threatening risks
b. The medical product can have minor risks, such as slightly irritating side effects
c. The medical product only has risks that are unlikely to happen
d. The medical product offers benefits that are greater than the risks
e. The medical product is safe for anyone to use
f. The medical product will help everyone who uses it
g. The medical product was approved because FDA had enough scientific information about it

3. How much do you agree or disagree with the following statements? [RANDOMIZE]

98 Don’t know
Strongly disagree
Disagree
Agree
Strongly agree
a. All medical products have side effects
b. Some side effects of using medical products are hard to keep from happening
c. Medical products that have been available for 5 years or more are safer than newer medical products
d. Medical products used by a lot of people are safer than medical products used by fewer people
e. Medical products that only need to be used for a few days or weeks are safer than medical products that need to be used for a longer time
f. Over-the-counter medical products are safer than prescription medical products
g. All over-the-counter medical products are approved by FDA
h. FDA can make companies pull unsafe medical products off store shelves

DRUGS

The next questions are about over-the-counter drugs that you can buy off the shelf without a prescription.

4. Have you ever taken more of an over-the-counter drug than the amount the label says you can take during a 24-hour period of time?

3		Yes
2		No
1		Not sure

5. [Ask if Q4 = “Yes”] Why did you take more than the label said you can take?

[CODE ALL RESPONSES]

01 It was an accident

02 Didn’t read the label

03 Thought taking more of the drug would treat my symptoms better

04 Did not think my health would suffer if I took more of the drug

05 Previously had taken the prescription version

06 Over-the-counter drugs are safer than prescription drugs

07 Over-the-counter drugs are weaker than prescription drugs

08 My physician told me to take more

09 Did not get better taking the recommended amount

10 Other (please specify)

11 Not sure

99 Refused

6. Have you ever seen a label on an over-the-counter drug that includes directions and warnings?

3		Yes
2		No
1		Not sure

7. [Ask if Q6 = “Yes”] Before you use an over-the-counter drug for the first time, how often do you read the label?

5		Always
4		Often
3		Sometimes
2		Rarely
1		Never
98		Don’t know

8. [Ask if Q7 = “Always”, “Often”, “Sometimes”, or “Rarely”] Before you use an over-the-counter drug for the first time, how often do you check the ingredients?

5		Always
4		Often
3		Sometimes
2		Rarely
1		Never
98		Don’t know

9. [Ask if Q6 = “Yes”] How easy or difficult is it to understand the label on over-the-counter drugs?

4		Very easy
3		Easy
2		Difficult
1		Very difficult
98		Don’t know

10. In the past 3 months, have you…

1 Not sure
2 No
3 Yes
a. Refilled a prescription for a drug you were already taking?
b. Filled a new prescription for a drug you were not already taking?
c. Taken more than the prescribed daily amount of a drug to make it work better?
d. Taken less than the prescribed daily amount of a drug to make it last longer?
e. Taken less than the prescribed daily amount of a drug to avoid side effects?

11. [Ask if Q10b = “Yes”] Think about the new prescription you filled most recently. Did you read any of the written information you got with it?

3		Yes
2		No
1		Not sure

12. [Ask if any Q11 = “Yes”] How much do you agree or disagree that the written information you got with your prescription…

98 Don’t recall
Strongly disagree
Disagree
Agree
Strongly agree
a. Explained situations in which the drug should not be used?.
b. Was easy to understand?
c. Helped you use the drug correctly?.

13. [RANDOMIZE WITH Q19] How well or poorly would you say a cholesterol-lowering drug works if it helps 75% (or 3 out of every 4) people who use it?

4		Very well
3		Well
2		Poorly
1		Very poorly
98		Don’t know

For the next two questions, imagine you are taking a prescription drug. Initial reports from 10 patients across the country suggest the drug is causing a rare side effect. FDA is going to investigate. [RANDOMIZE Q14 AND Q15]

14. If the drug could cause you to be hospitalized, how soon would you want this information? [RANDOMIZE ORDER OF “BEFORE” AND “AFTER”]

1		Before the investigation even starts
2		During the investigation, as soon as early results are available
3		After the investigation can provide firm advice on what to do
98		Don’t know

15. If the drug could cause a relatively minor problem, such as a slight skin rash, how soon would you want this information? [RANDOMIZE ORDER OF “BEFORE” AND “AFTER”]

1		Before the investigation even starts
2		During the investigation, as soon as early results are available
3		After the investigation can provide firm advice on what to do
98		Don’t know

16. Suppose you are taking a prescription drug for a long-lasting health condition. You think you may need to stop taking the drug because you heard about a new and serious side effect. How much do you agree or disagree that the Internet and media can provide you with enough information to make this decision without checking with your doctor?

4		Strongly agree
3		Agree
2		Disagree
1		Strongly disagree
98		Don’t know

17. Suppose you become really dizzy after taking a prescription drug and the label does not list dizziness as a side effect. How likely or unlikely are you to inform the following authorities of this side effect? [RANDOMIZE]

98 Don’t know
Very unlikely
Unlikely
Likely
Very likely
a. Your doctor
b. Your pharmacist
c. The Food and Drug Administration (or FDA)
d. The Centers for Disease Control and Prevention (or CDC)
e. The company that made the drug

18. Before today, did you know that you can report medical product problems or side effects directly to the FDA by telephone?

3		Yes
2		No
1		Not sure

[Show after responding] For your information, the telephone number to report problems or side effects is 1-800-FDA-1088.

19. [RANDOMIZE WITH Q13] How safe or unsafe would you say a cholesterol-lowering drug is if it causes a minor skin rash in 25% (or 1 out of every 4) people who use it?

4		Very safe
3		Safe
2		Unsafe
1		Very unsafe
98		Don’t know

20. How often do you need to have someone help you understand instructions, pamphlets, or other written material from your doctor or pharmacy?

5		Always
4		Often
3		Sometimes
2		Rarely
1		Never
98		Don’t know

MEDICAL DEVICES

21. Are you the parent or caregiver of a child under 3 years old?

3		Yes
2		No

22. [Ask if Q21 = “Yes”] An infant sleep positioner is a product intended to keep a baby in a desired position (such as on their back, side, or stomach) while sleeping. Thinking of your youngest child, have you used an infant sleep positioner?

3		Yes
2		No
1		Not sure

23. [Ask if Q22 = “Yes”] Did you use the infant sleep positioner for any of the following reasons?

1 Not sure
2 No
3 Yes
a. To prevent the chance of Sudden Infant Death Syndrome (SIDS),
b. To keep your baby from getting a flat head
c. To prevent or treat reflux
d. To follow the advice of your baby’s doctor
e. To follow the advice of your family or friends
f. Some other reason (please specify)

24. [Ask if Q22 = “Yes”] How did you obtain the infant sleep positioner for your youngest child?

1		Bought it new
2		Bought it used
3		Received it as a gift
4		Hand-me-down from an older child in the family
5		Hand-me-down from another family
6		Other (please specify)

25. Do you wear contact lenses?

2		Yes
1		No

26. [Ask if Q25 = “Yes”] Have you ever read the instructions for contact lens solution?

3		Yes
2		No
1		Not sure

27. [Ask if Q26 = “Yes”] How easy or difficult was it to understand those instructions?

4		Very easy
3		Easy
2		Difficult
1		Very difficult
98		Don’t recall

FDA COMMUNICATIONS

28. How much do you agree or disagree with the following statements about how new risks of medical products are communicated to the public?

98 Don’t know
Strongly disagree
Disagree
Agree
Strongly agree
a. Communications about new risks are made available as soon as possible.
b. Communications about new risks are understandable to you.
c. Communications about new risks are useful to you.

29. How much do you agree or disagree that the FDA gives the public enough information about how it makes its decisions?

4		Strongly agree
3		Agree
2		Disagree
1		Strongly disagree
98		Don’t know

30. How much do you agree or disagree that the FDA is a trustworthy source of information about medical products?

4		Strongly agree
3		Agree
2		Disagree
1		Strongly disagree
98		Don’t know

31. How much do you trust each of the following sources to give you correct information about medical products? [RANDOMIZE]

98 Don’t know
1 Not at all
2 A little
3 A lot
a. Your doctor
b. Your pharmacist
c. Information in books, newspapers, or magazines (not including advertisements)
d. TV or radio news
e. The Food and Drug Administration (or FDA)
f. The company that made the medical product
g. Your health insurance company

32. Overall, how satisfied are you with how FDA communicates health-related information to the public?

4		Very satisfied
3		Satisfied
2		Dissatisfied
1		Very dissatisfied
98		Don’t know

FDA WEBSITE

33. In the past 6 months, have you visited the Food and Drug Administration’s website (www.fda.gov)?

3		Yes
2		No
1		Not sure

34. [Ask if Q33 = "Yes"] Thinking of the most recent time you visited FDA’s website, what type of information were you most interested in finding?

1							General information about FDA
2							A product label (which includes reasons to use the product, directions, side effects to know about, and more)
3							Recalls or Public Health Notifications
	4							Information on how to report a problem
5							Some other type of product information (please specify)
			98						Don’t recall

35. [Ask if Q34 = any except “General information about FDA” or “Don’t recall”] What type of product was this information for?

1		Food
2		Drug
3		Medical device
4		Vaccine, blood, or biologic
5		Other (please specify)
98		Don’t recall

36. [Ask if Q33 = Yes] In general, how easy or difficult was it to find the information you were looking for?

4		Very easy
3		Easy
2		Difficult
1		Very difficult
97		I could not find the information
98		Don’t recall

37. [Ask if Q36 = “Very easy”, “Easy”, “Difficult”, or “Very difficult”] In general, how easy or difficult was it to understand the information after you found it?

4		Very easy
3		Easy
2		Difficult
1		Very difficult
98		Don’t recall

Background information

38. In general, would you say your health is…?

5		Excellent
4		Very good
3		Good
2		Fair
1		Poor
98		Don’t know

39. Do you have any kind of health care coverage, including health insurance, prepaid plans such as HMOs, or government plans such as Medicare?

2		Yes
1		No
98		Don’t know

40. [Ask if Q39 = "Yes"] Does your current health coverage help pay for prescription drugs?

2		Yes
1		No
98		Don’t know

41. What is the highest degree or level of school that you have completed?

1		Less than high school
2		High school graduate or GED
3		Technical or vocational school
4		Some college
7		Bachelor's degree
8		Master's, doctoral, or professional school degree

42. Are you of Hispanic, Latino, or Spanish origin?

2		Yes
1		No

43. What is your race? Please select one or more.

		White
		Black or African-American
		American Indian or Alaska Native
		Asian
		Native Hawaiian or other Pacific Islander

44. What year were you born?

Year

45. Are you…?

1		Male
2		Female

46. Do you have any comments or concerns that you were not able to express in answering this survey?

[Show if Q21 = “Yes”] You indicated in the survey that you are a parent or caregiver. Many people are not aware that the Food and Drug Administration and the Consumer Product Safety Commission are currently urging caregivers to stop using infant sleep positioners because information suggests the risk of suffocation associated with their use. To learn more, please visit www.fda.gov or call 1-800-638-2041.

Thank you for taking time to complete and submit this survey.

If you have questions related to your rights as a survey respondent, you may call RTI’s Office of Research Protections toll-free at 1-866-214-2043. If you have further questions about the study, you may contact a study team member toll-free at 1-XXX-XXX-XXXX.

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