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Questionnaire Cognitive Interviewing and Pretesting (NCI)

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OMB: 0925-0589

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ATTACHMENT A-1: HINTS 4 QUESTIONNAIRE CONTENT (FDA CYCLE) – ENGLISH

OMB No. 0952-0589

Exp. 04/30/2014

HINTS 4, FDA CYCLE DRAFT INSTRUMENT FOR TESTING

ALL QUESTIONS HIGHLIGHTED IN YELLOW ARE NEW QUESTIONS FOR HINTS FDA AND WILL BE TESTED. ALL OTHER QUESTIONS ARE INCLUDED FOR CONTEXT ONLY.

STATEMENT OF PRIVACY: Collection of this information is authorized by The Public Health Service Act, Sections 411 (42 USC 285 a) and 412 (42 USC 285a-1.a and 285a1.3). The purpose of this data collection is to evaluate whether the survey questions are easy to understand. The results of the data collection will be used to improve the survey instrument. Rights of study participants are protected by The Privacy Act of 1974. Participation is voluntary, and there are no penalties for not participating or withdrawing from the study at any time. Refusal to participate will not affect your benefits in any way. The information collected in this study will be kept private under the Privacy Act and will only be seen by people authorized to work on this project. The report summarizing the findings will not contain any names or identifying information. Identifying information will be destroyed when the project ends.

NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN: Public reporting burden for this collection of information is estimated to average 90 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0589). Do not return the completed form to this address.

For the next THREE questions look at the two packs of cigarettes below.

Cigarette A

Cigarette B

Group 5

F2. Which cigarette do you think is more harmful to your health?

Cigarette A would be much more harmful to your health

Cigarette A would be slightly more harmful to your health

Both cigarettes would be equally harmful to your health

Cigarette B would be slightly more harmful to your health

Cigarette B would be much more harmful to your health

F3. Which cigarette do you think is more addictive?

Cigarette A would be much more addictive

Cigarette A would be slightly more addictive

Both cigarettes would be equally addictive

Cigarette B would be slightly more addictive

Cigarette B would be much more addictive

F4. How believable is it that Cigarette B shown above on the right could be “Low nicotine”?

Not at all believable

A little believable

Somewhat believable

Very believable

F5. Compared to a typical cigarette, would you think that a cigarette pictured above would be

Much more harmful to your health than a typical cigarette

Slightly more harmful to your health than a typical cigarette

Equally harmful to your health as a typical cigarette

Slightly less harmful to your health as a typical cigarette

Much less harmful to your health than a typical cigarette

For the next THREE questions look at the two packs of cigarettes below.

Cigarette A

Cigarette B

Group 8

F6. Which cigarette do you think is more harmful to your health?

Cigarette A would be much more harmful to your health

Cigarette A would be slightly more harmful to your health

Both cigarettes would be equally harmful to your health

Cigarette B would be slightly more harmful to your health

Cigarette B would be much more harmful to your health

F7. Which cigarette do you think is more addictive?

Cigarette A would be much more addictive

Cigarette A would be slightly more addictive

Both cigarettes would be equally addictive

Cigarette B would be slightly more addictive

Cigarette B would be much more addictive

F8. How believable is it that Cigarette B shown above on the left could be “TSNA Free”?

Not at all believable

A little believable

Somewhat believable

Very believable

F9. Compared to a typical cigarette, would you think that a cigarette advertised as “low nicotine” would be…

Much more harmful to your health than a typical cigarette?

Slightly more harmful to your health than a typical cigarette?

Equally harmful to your health as a typical cigarette?

Slightly less harmful to your health than a typical cigarette?

Much less harmful to your health than a typical cigarette?

F10. Compared to a typical cigarette, would you think that a cigarette advertised as “low nicotine” would be…

Much more addictive than a typical cigarette?

Slightly more addictive than a typical cigarette?

Equally addictive as a typical cigarette?

Slightly less addictive than a typical cigarette?

Much less addictive than a typical cigarette?

F11. How believable is it that a cigarette could be “low nicotine”?

Not at all believable

A little believable

Somewhat believable

Very believable

F12. Compared to a typical cigarette, would you think that a cigarette advertised as “TSNA Free” would be…

Much more harmful to your health than a typical cigarette?

Slightly more harmful to your health than a typical cigarette?

Equally harmful to your health as a typical cigarette?

Slightly less harmful to your health than a typical cigarette?

Much less harmful to your health than a typical cigarette?

F13. Compared to a typical cigarette, would you think that a cigarette advertised as “TSNA Free” would be…

Much more addictive than a typical cigarette?

Slightly more addictive than a typical cigarette?

Equally addictive as a typical cigarette?

Slightly less addictive than a typical cigarette?

Much less addictive than a typical cigarette?

F14. How believable is it that a cigarette could be “TSNA Free”?

Not at all believable

A little believable

Somewhat believable

Very believable

G: Dietary Supplements

These next questions ask about dietary supplements such as vitamins, minerals, herbs, and other supplements that you may take in addition to your regular diet.

G1. If you hear or read that a dietary supplement product "may produce anticarcinogenic effects in the body," does this mean that the product may do any of the following things?

	Yes	No

a. Reduce the risk of cancer(s)
b. Treat cancer(s)
c. Completely prevent cancer(s)
d. Cure cancer(s)

G2. If a dietary supplement product says on its package that it "may produce anticarcinogenic effects in the body," does this mean the product may reduce the risk of:

A single type of cancer?

A few or some types of cancer?

or all cancers?

G3. If a dietary supplement product says on its package that it "may reduce the risk of certain cancers," does this mean the product may reduce the risk of:

A single type of cancer?

A few or some types of cancer?

or all cancers?

G4. How much do you agree or disagree with each of the following statements?


a. Cancer is most often caused by a person's behavior or lifestyle
b. Getting checked regularly for cancer helps find cancer when it's easy to treat
c. Cancer is an illness that when detected early can typically be cured
d. It seems like everything causes cancer
e. There's not much you can do to lower your chances of getting cancer
f. There are so many different recommendations about preventing cancer, it's hard to know which ones to follow
g. All cancers have the same causes
h. All cancers can be prevented in the same ways
i. All cancers can be treated in the same ways
j. All cancers can be cured in the same ways
k. All cancers can be avoided through what one eats and drinks
l. All cancers can be avoided by using dietary supplements
m. All cancers can be treated by using dietary supplements instead of drugs or surgery
n. The information you found was hard to understand

Please think about dietary supplements such as vitamins, minerals, herbs, and other supplements that you may take in addition to your regular diet.

G5. Please indicate whether or not you have taken one or more of the following types of dietary supplement(s) in the past 12 months:

	Yes	No

a. Vitamin or Mineral supplements, such as Vitamin C, Vitamin E, iron, or calcium
b. Supplements for enhancing athletic performance
c. Supplements for inducing weight loss
d. Supplements for enhancing sexual or reproductive function
e. Supplements for improving mood or mental health
f. Supplements for pain relief
g. Other supplements to address a health problem or enhance health,including herbs or botanicals

G6. Have you given any dietary supplements to any infant(s), child(ren), or adolescent(s) in your family?

Yes

7. If yes, what was the reason for using the supplement

8. If yes, please provide the name(s) of the supplement(s):

G9. In the past 12 months, have you experienced any health problem that you thought might be related to any dietary supplements you took?

Yes

G10. The last time you had such a problem, what were the major symptoms of the problem?

Heart problems/chest pain

Abdominal pain

Headache

Rashes

Allergy/reaction

Nausea

Blood pressure problems

Diarrhea

Cramping/muscle aches

Sleep problems

Dizziness/fainting

Itching

Anxiety/nervousness

Drowsiness

Vomiting

Other symptom -Specify

G11. What supplement(s) did you think was(were) related to your problem?

Mark all that apply.

Multi-vitamins

“Xenadrine”

Unspecified vitamins/minerals

Iron

Ginko Biloba

Vitamin C

Calcium

“Metabolife”

Vitamin E

Ginseng

“Phen Phen”

St. John’s wort

Vitamin B

Other supplement(s) -Specify

G12. Did you report your problem to any of the following institutions or professional?

		Yes	No

	a. The Food and Drug Administration
	b. The CDC, Centers for Disease Control and Prevention
	c. A health department or poison control center
	d. The manufacturer of the dietary supplement
	e. Your doctor
H: Food and Drug Administration

Let’s think about news reports you hear on medical-product and food safety, the Food and Drug Administration’s (FDA) activities, and how these affect your choices.

H1. What do you think are FDA’s main purposes for requiring product information on medical products?

Mark all that apply.

Legal requirement

Describing how to use the product safely

Manufacturer advertising

Explaining the potential negative effects of using the product

Explaining the benefits from using the product

H2. If the FDA reports that it is investigating an approved drug, does it mean ...

	Yes	No	Not Sure

a. The drug is not safe to use.
b. It is unclear whether the drug is safe to use.
c. The drug is safe to use as directed.
d. I need to ask my doctor whether it’s safe to use the drug.

H3. If a drug you need to take is recalled, would you...

	Yes	No	Not Sure

a. Examine the lot number on my pill bottle?.
b. Stop taking the drug immediately?.
c. Call my doctor to help me understand what to do?.
d. Be careful taking the drug by paying attention to side-effects?.
e. Continue taking the drug as directed?

H4. Under what conditions would you pay attention to reports of an FDA investigation?

	Yes	No	Not Sure

a. If it’s a product you use.
b. If it’s a product that a loved one or a friend uses.
c. You follow all FDA investigations that you hear about
d. You pay little or no attention to FDA investigations.

H5. The FDA uses many sources to share information from investigations into medical products and food that directly affect you. Where would you prefer that FDA present this information?

Mark all that apply.

E-mail

FDA website (http://www.FDA.gov)

MedWatch (http://www.fda.gov/Safety/MedWatch)

Other health or medical-related websites
(e.g., webMD, healthfinder)

Facebook

Twitter

Televised interview with FDA physician

Printed interview with FDA physician in newspaper

YouTube video

H6. If a food you had bought were recalled, would you…

	Yes	No	Not Sure

a. Throw it out.
b. Call your doctor to help you understand what to do with the food.
c. Be careful using the food washing it well and cooking it thoroughly)
d. Continue to eat the food as usual.

H7. How much do you trust the FDA to keep your medical products and foods safe?

Not at all

Somewhat

A lot

H8. How much do you believe those listed below will give you a clear recommendation about how to manage a problem with medical products?


a. Food and Drug Administration (FDA)
b. The manufacturer
c. My doctor
d. The industry’s professional association

H9. How much do you believe those listed below will give you a clear recommendation about how to manage a food safety problem?


a. Food and Drug Administration (FDA)
b. Centers for Disease Prevention & Control (CDC)
c. My doctor
d. USDA (Department of Agriculture)

H10. Do you AGREE or DISAGREE with each of the following statements?


a. The food I buy is safe to eat.
b. The medications I buy are safe to use.
c. The medications I buy are effective.
b. Vaccines that I get are safe.
c. Vaccines that I get are effective.
b. Cosmetics are tested and proved safe before they are sold.
c. Pet food is safe for animals to consume.
b. My medical equipment is safe to use.
c. My medical equipment works well.

I: You and Your Household

I1. What is your age?

Years old

2. What is your current occupational status?

Mark only one.

Employed

Unemployed

Homemaker

Student

Retired

Disabled

Straight Arrow Connector 30 Other-Specify

I3. Have you ever served on active duty in the U.S. Armed Forces, military Reserves or National Guard? Active duty does not include training in the Reserves or National Guard, but DOES include activation, for example, for the Persian Gulf War.

Yes, now on active duty

Yes, on active duty in the last 12 months but
not now

Yes, on active duty in the past, but not in the
last 12 months

No, training for Reserves or
National Guard only

No, never served in the military

I4. What is your marital status?

Married

Living as married

Divorced

Widowed

Separated

Single, never been married

I5. What is the highest grade or level of schooling you completed?

Less than 8 years

8 through 11 years

12 years or completed high school

Post high school training other than college
(vocational or technical)

Some college

College graduate

Postgraduate

I6. Were you born in the United States?

Straight Arrow Connector 24 Yes GO TO I9 below

Straight Connector 22 Straight Connector 23 No

I7. In what year did you come to live in the United States?

Year

I8. How well do you speak English?

Very well

Well

Not well

Not at all

9. Are you of Hispanic, Latino/a, or Spanish origin? One or more categories may be selected.

Mark one or more.

No, not of Hispanic, Latino/a, or Spanish origin

Yes, Mexican, Mexican American, Chicano/a

Yes, Puerto Rican

Yes, Cuban

Yes, another Hispanic, Latino/a, or Spanish origin

I10. What is your race? One or more categories may be selected.

Mark one or more.

White

Black or African American

American Indian or Alaska Native

Asian Indian

Chinese

Filipino

Japanese

Korean

Vietnamese

Other Asian

Native Hawaiian

Guamanian or Chamorro

Samoan

Other Pacific Islander

I11. Including yourself, how many people live in your household?

Number of people

I12. Starting with yourself, please mark the sex, and write in the age and month of birth for each adult 18 years of age or older living at this address.

Sex

Age

M Flowchart: Merge 19 Flowchart: Merge 18 onth Born
(01-12) Flowchart: Merge 17

SELF

Male

Female

Adult 2

Male

Female

Adult 3

Male

Female

Adult 4

Male

Female

Adult 5

Male

Female

I13. How many children under the age of 18 live in your household?

Number of children under 18

I14. Do you currently rent or own your home?

Own

Rent

Occupied without paying monetary rent

I15. Does anyone in your family have a working cell phone?

Yes

I16. Is there at least one telephone inside your home that is currently working and is not a cell phone?

Yes

I17. Thinking about members of your family living in this household, what is your combined annual income, meaning the total pre-tax income from all sources earned in the past year?

$0 to $9,999

$10,000 to $14,999

$15,000 to $19,999

$20,000 to $34,999

$35,000 to $49,999

$50,000 to $74,999

$75,000 to $99,999

$100,000 to $199,999

$200,000 or more

I18. Do you think of yourself as…

Heterosexual, or straight

Homosexual, or gay or lesbian

Bisexual

Something else -Specify

I19. Do you live in the same household with someone who uses tobacco products?

Yes

I20. How many people in your household use tobacco products?

Number of tobacco users

I21. Are you deaf or do you have serious difficulty hearing?

Yes

I22. Are you blind or do you have serious difficulty seeing, even when wearing glasses?

Yes

I23. Because of a physical, mental, or emotional condition, do you have serious difficulty concentrating, remembering, or making decisions?

Yes

I24. Do you have serious difficulty walking or climbing stairs?

Yes

I25. Do you have difficulty dressing or bathing?

Yes

I26. Because of a physical, mental, or emotional condition, do you have difficulty doing errands alone such as visiting a doctor’s office or shopping?

Yes

I27. About how long did it take you to complete the survey?

Write a number in one box below.

Minutes

Hours

28. At which of the following types of addresses does your household currently receive residential mail?

Mark all that apply.

A street address with a house or building number

An address with a rural route number

A U.S. post office box (P.O. Box)

A commercial mail box establishment (such as Mailboxes R Us, and Mailboxes Etc.)

File Type	application/msword
Author	Lori Houck
Last Modified By	Aaron Maitland
File Modified	2013-09-03
File Created	2013-08-23


a. It took a lot of effort to get the information you needed
b. You felt frustrated during your search for the information
c. You were concerned about the quality of the information
d. The information you found was hard to understand


a. A doctor
b. Family or friends
c. Government health agencies (e.g., the Food and Drug administration (FDA), National Institutes of Health (NIH) or Centers for Disease Control and Prevention (CDC))
d. Health organizations or groups (such as the American Cancer Society, American Lung Association or others)
e. Charitable organizations
f. Religious organizations and leaders


a. Online newspapers
b. Print newspapers
c. Special health or medical magazines or newsletters
d. The Internet
e. The radio
f. Local television news programs
g. National or cable television news programs
h. TV in general
h. Social networking sites such as Facebook or Twitter


a. A doctor / pharmacist / health care provider
b. Family or friends
c. Government health agencies (e.g., the Food and Drug administration (FDA), National Institutes of Health (NIH) or Centers for Disease Control and Prevention (CDC))
d. Health organizations or groups (such as the American Cancer Society, American Lung Association or others)
e. Religious organizations and leaders
f. Tobacco companies

	Yes	No

a. Computer at home
b. Computer at work
c. Computer at school
d. Computer in a public place (library, community center, other)
e. On a mobile device (cell phone/smart phone/tablet)
f. On a gaming device / “Smart TV”
g. Other

	Yes	No

a. Visited a social networking site, such as Facebook or LinkedIn
b. Wrote in an online diary or blog (i.e., Web log)
c. Shared photos, videos, or other multimedia content on sites such as YouTube or Instagram
d. Downloaded to a mobile device, such as an MP3 player, cell phone, tablet computer or electronic book device

	Yes	No

a. Looked for health or medical information for yourself?
b. Looked for health or medical information for someone else
c. Looked for information about quitting smoking
e. Participated in an online forum or support group for people with a similar health or medical issue
f. Used a website to help you with your diet, weight, or physical activity
g. Looked for a health care provider
h. Downloaded health information to a mobile device, such as an MP3 player, cell phone, tablet computer or electronic book device
i. Shared health information on social media sites, such as Facebook or Twitter
j. Exchanged social support about health concerns with family or friends
k. Kept track of personal health information such as care received, test results, or upcoming medical appointments
l. Watched a health-related video on YouTube


a. Nicotine is the main substance in tobacco that makes people want to smoke.
b. The nicotine in cigarettes is the substance that causes most of the cancer caused by smoking
c. Addiction to nicotine is something that I am concerned about


a. Cigarette smoking
b. Cigar smoking
c. Smokeless tobacco use
d. Electronic cigarettes
e. Smoking tobacco in a hookah
f. Smoking “roll your own” cigarettes
g. Pipe filled with tobacco


Newspaper (online format)
Newspaper (print format)
Alternative newspaper (print format)
Television
Magazine
Radio
Internet (social media)
Internet (company/org website)
Internet (health-specific website)
Internet (government website)
Billboard
Public transportation
Coupon/Mailings
Community event
Point of sale (such as at or inside convenience stores, drug stores or supermarkets)

	Yes	No

a. The tobacco leaf
b. Tobacco smoke
c. The cigarette carton
d. Glues, inks, and paper
e. The filter
f. Things added to the cigarettes
g. N/A. There are no chemicals in cigarettes

	True	False

a. All tobacco products contain chemicals that may cause harm
b. Research is ongoing to find out which chemicals cause harm

	Yes	No	Not sure

a. Tobacco farmers
b. Federal government
c. State and local health departments
d. Tobacco companies
e. Independent companies/organizations
f. None of the above
g . Other-Specify


a. Centers for Disease Control and Prevention (CDC)
b. Federal Trade Commission (FTC)
c. Food and Drug Administration (FDA)
d. Independent groups
d. National Institutes of Health (NIH)
d. Surgeon General
d. Tobacco industry/tobacco companies
d. US Board of Cancer Prevention (USBCP)


a. Promoting health education programs
b. Improving people’s knowledge of health
c. Encouraging people to quit smoking through willpower
d. Providing support like nicotine patches to help people quit smoking
e. Protecting children from tobacco companies advertising and marketing
f. Encouraging people to seek counseling to quit smoking

Attach A-1_Instrument-to-be-tested-English