NCHS Questionnaire Design Research Laboratory

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Centers for Disease Control and Prevention

National Center for Health Statistics

3311 Toledo Road

Hyattsville, Maryland 20782

April 26, 2007

Ms. Margo Schwab

Office of Management and Budget

725 17th Street, N.W.

Washington, DC 20503

Dear Ms. Schwab:

The staff of the NCHS Questionnaire Design Research Laboratory (QDRL) plans to conduct research to evaluate a Cancer Screening Supplement (sample adult and sample child) for the National Health Interview Survey (NHIS) under (OMB No. 0920-0222, exp. 02/28/10). We propose to advertise for volunteer participants starting June 4, and to start testing as soon as possible after that.

Background Information about Cognitive Testing of Questionnaires

The methodological design of this proposed study is consistent with the design of typical cognitive testing research. The purpose of cognitive testing is not to obtain survey data, but rather to obtain information about the processes people use to answer survey questions as well as to identify any potential problems in the questions.

Data collection procedures for cognitive interviewing are quite different from survey interviewing. While survey interviewers strictly adhere to scripted questionnaires, cognitive interviewers use survey questions as starting points to begin a more detailed discussion of questions themselves: how participants interpret key concepts, their ability to recall the requested information, and the appropriateness of response categories. Because the interviews generate narrative responses rather than statistics, results are analyzed using qualitative methodologies. This type of in-depth analysis reveals problems in particular survey questions and, as a result, can help to improve the overall quality of surveys.

Proposed project: Testing and evaluation of NHIS Cancer Screening Supplement

This project will conform to the usual QDRL procedures for cognitive testing of a questionnaire module.

The proposed NHIS Cancer Screening will be asked of sample adults (aged 18 and over) and proxy sample children. The questions to be cognitively tested primarily focus on cancer screening exams, medical tests, and health conditions. For respondents with children (8-17 years of age), questions will be asked about the HPV virus.

We propose to recruit 20 adults (aged 18 years and older), and some women in that age range that have daughters 8-17 years of age through a combination of a newspaper advertisement, flyers, and our database of previously interviewed participants. The newspaper advertisement/flyer will be used to recruit participants who have taken cancer screening exams, medical tests, and have various health conditions relevant to the questionnaire. The newspaper advertisement/flyer is shown in Attachment 1. Within these constraints, we hope to recruit participants with some demographic variety (particularly in terms of gender, education, race/ethnicity, and income).

Interviews will be conducted in the QDRL, or in a private room of a community facility.

With the consent of the participants, the interviews will be recorded on videotape. Participants will be informed of taping procedures (including observation if applicable) in the process of reviewing the consent forms, and the equipment will be turned on once it is clear that the procedures are understood and agreed upon. Then the interviewer will conduct individual cognitive interviews with as many as 20 participants for 60 minutes each. The testing instrument is shown in Attachment 2. At the end of the interviews, participants will be paid and provided with copies of all papers they signed.

We propose paying participants $40, which is our standard payment. In total, for this project, the maximum respondent burden will be 20 hours of interviewing in addition to travel time.

Attachments (2)

cc:

M. Moien

M. Daneshvar

S. Perryman

Attachment 1 – Advertisement

Participants Wanted for Research Study

The National Center for Health Statistics

is looking for persons aged 18 and over to test questions that may be used on a national survey. Anyone may participate but we are particularly interested in women who have children 8-17 years of age. We would like to talk to you if you have had an HPV virus vaccine, colonoscopy, pap test, tetanus shot, hepatitis vaccine, or mammogram. The interview will be no longer than 60 minutes and participants will receive $40.

FOR MORE INFORMATION,

Please call Karen at: 301-458-4676

Centers for Disease Control and Prevention

National Center for Health Statistics

Attachment 2 -- Instrument to be cognitively tested

Public reporting burden for this collection of information is estimated to average 60 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 CDC/ATSDR Reports Clearance Officer; 1600 Clifton Road, MS D-24, Atlanta, GA 30333, ATTN: PRA (0920-0222).

OMB #0920-0222; Expiration Date: 02/28/10

2008 NHIS Cancer Screening Instrument

Thank you for agreeing to meet here today. Karen has explained that we will be video taping our interview and you gave permission to do that, correct? (If yes, then proceed)

I have in front of me a questionnaire about different health topics that will be administered to people throughout the United States. However, before interviewers begin to do that, we are testing the questionnaire to see whether the questions are phrased well, whether they are difficult to answer, and whether they make sense to people.

First, I would like to read the questions to you and have you answer them exactly as you would if a survey taker were to ask you this information. Then, once we complete the survey questions I will go back and ask you some follow-up questions about how you came up with your answers, how you interpreted certain terms or phrases, and whether the questions were straightforward.

Do you have any questions before we begin?

Okay, let’s start.

A. First, what is your age? _________ [age in years]

B. Do you have any daughters between the ages of 8 and 17?

_________ yes

_________ no

[If yes:] What are the names and ages of those children?

NAME AGE

1. __________________________________ ___________

2. __________________________________ ___________

3. __________________________________ ___________

Men and Women age 40+

FOBT

QA07_B30 A stool blood test, also known as a Fecal Occult Blood Test, is a test to check for colon cancer. It is done at home using a set of 2 or 3 cards to determine whether the stool contains blood. Have you ever done a stool blood test using a home kit?

AF22

YES 1

NO 2 [GO TO QA07_B33]

REFUSED -7 [GO TO QA07_B33]

DON'T KNOW -8 [GO TO QA07_B33]

QA07_B31 When did you have your most recent stool blood test using a home kit to check for colon cancer?

AF24

A YEAR AGO OR LESS 1

MORE THAN 1 YEAR AGO UP TO

2 YEARS AGO 2

MORE THAN 2 YEARS AGO UP TO

5 YEARS AGO 3

MORE THAN 5 YEARS AGO 4

REFUSED -7

DON'T KNOW -8

QA07_B35 What was the main reason you had your most recent stool blood test using a home kit? Was it…

NEW

PART OF A ROUTINE EXAM 1

BECAUSE OF A PROBLEM, OR 2

SOME OTHER REASON 3

REFUSED -7

DON'T KNOW -8

Colonoscopy

QA07_B33  A sigmoidoscopy and a colonoscopy are both tests that examine the bowel by inserting a tube in the rectum. The difference is that during a sigmoidoscopy, you are awake and can drive yourself home after the test; however, during a colonoscopy, you may feel sleepy and you need someone to drive you home. Have you ever had a colonoscopy?

NEW

YES 1

NO 2 [GO TO PN QA07_B36]

REFUSED -7 [GO TO PN QA07_B36]

DON'T KNOW -8 [GO TO PN QA07_B36]

QA07_B34 When did you have your most recent colonoscopy to check for colon cancer?

NEW

A YEAR AGO OR LESS 1

MORE THAN 1 UP TO 5 YEARS AGO 2

MORE THAN 5 UP TO 10 YEARS AGO 3

MORE THAN 10 YEARS AGO 4

REFUSED -7

DON'T KNOW -8

QA07_B32 What was the main reason you had your most recent colonoscopy? Was it…

NEW

PART OF A ROUTINE EXAM 1

BECAUSE OF A PROBLEM, OR 2

SOME OTHER REASON 3

REFUSED -7

DON'T KNOW -8

Sigmoidoscopy

QA07_B36 Have you ever had a sigmoidoscopy?

NEW

YES 1

NO 2 [GO TO PN QA07_B39]

REFUSED -7 [GO TO PN QA07_B39]

DON'T KNOW -8 [GO TO PN QA07_B39]

QA07_B37 When did you have your most recent sigmoidoscopy to check for colon cancer?

NEW

A YEAR AGO OR LESS 1

MORE THAN 1 UP TO 5 YEARS AGO 2

MORE THAN 5 UP TO 10 YEARS AGO 3

MORE THAN 10 YEARS AGO 4

REFUSED -7

DON'T KNOW -8

QA07_B38 What was the main reason you had your most recent sigmoidoscopy? Was it…

NEW

PART OF A ROUTINE EXAM 1

BECAUSE OF A PROBLEM, OR 2

SOME OTHER REASON 3

REFUSED -7

DON'T KNOW -8

QA07_B39 In the past 5 years, has a doctor recommended that you have a sigmoidoscopy, colonoscopy or stool blood test?

NEW

YES 1

NO 2

DID NOT GO TO DOCTOR IN

PAST 12 MONTHS 92

REFUSED -7

DON'T KNOW -8

Females 18+

Hysterectomy

QA07_E5 Have you had a hysterectomy?

AD12

[IF NEEDED, SAY: "A hysterectomy is when the uterus or womb is removed, not just

having your tubes tied to prevent pregnancy."]

YES 1

NO 2

REFUSED -7

DON'T KNOW -8

Pap smear

QA07_E5 Have you ever had a Pap test to check for cervical cancer?

AD4

[IF NEEDED, SAY: "Sometimes, a woman has a routine pelvic exam, she also has a Pap smear to test for cancer of the cervix. A doctor takes a cell sample from the cervix with a small stick or brush and sends it to the lab."]

YES 1

NO 2 [GO TO PN QA07_E8]

REFUSED -7 [GO TO QA07_E9]

DON'T KNOW -8 [GO TO QA07_E9]

QA07_E6 How many Pap tests have you had in the last 6 years?

AD5

_____ PAP SMEARS

NONE 0 [GO TO PN QA07_E8]

REFUSED -7

DON'T KNOW -8

QA07_E7 How long ago did you have your most recent Pap test?

AD6

A YEAR AGO OR LESS 1 [GO TO QA07_E9

MORE THAN 1 UP TO 2 YEARS AGO 2 [GO TO QA07_E9

MORE THAN 2 UP TO 3 YEARS AGO 3 [GO TO QA07_E9

MORE THAN 3 UP TO 5 YEARS AGO 4 [GOTO QA07_E8]

MORE THAN 5 YEARS AGO 5 [GOTO QA07_E8]

REFUSED -7 [GO TO QA07_E9]

DON'T KNOW -8 [GO TO QA07_E9]

QA07_E8 What is the ONE most important reason why you have {NEVER had a Pap test/NOT had a Pap test in the last 3 years}?

AD10

NO REASON/NEVER THOUGHT ABOUT IT 1

DIDN'T KNOW I NEEDED THIS TYPE OF TEST 2

DOCTOR DIDN'T TELL ME I NEEDED IT 3

HAVEN'T HAD ANY PROBLEMS 4

PUT IT OFF/LAZINESS 5

TOO EXPENSIVE/NO INSURANCE/COST 6

TOO PAINFUL, UNPLEASANT,

OR EMBARRASSING 7

HYSTERECTOMY 8

DON'T HAVE A DOCTOR 9

HAD HPV VACCINE 10

HAD HPV DNA TEST 11

OTHER 91

REFUSED -7

DON'T KNOW -8

QA07_E9 In the past 3 years, has a doctor recommended that you have a Pap test?

AD11

YES 1

NO 2

REFUSED -7

DON'T KNOW -8

QA07_E10 When do you expect to have your next Pap test?

NEW

A YEAR OR LESS FROM NOW 1

1-3 YEARS FROM NOW 2

3-5 YEARS FROM NOW 3

MORE THAN 5 YEARS FROM NOW 4

WHEN DOCTOR RECOMMENDS IT 5

NEVER, HAD HPV DNA TEST 6

NEVER, HAD HPV VACCINE 7

NEVER, OTHER REASON 8

REFUSED -7

DON’T KNOW -8

NOTE QA07_E10;

IF QA07_E5 = 1 (Ever had a Pap test) CONTINUE WITH QA07_E10;

else skip to qa07_e11;

QA07_E10 Have you ever had a Pap test where the results were NOT normal?

AD8

YES 1

NO 2

DON’T KNOW -7

REFUSED -8

Females 65 and Under

HPV Awareness

QA07_E11 Have you ever heard of HPV? HPV stands for Human Papillomavirus.

NEW

YES 1

N O 2

REFUSED -7 [GO TO PN QA07_E16]

DON’T KNOW -8

QA07_E12 Where did you hear about HPV? [CODE ALL THAT APPLY]

NEW

health care provider/clinic 1

Family or friends 2

tV advertisement 3

TV News 4

tv show 5

Newspaper or magazine 6

Internet 7

School 8

Other 9

REFUSED -7

DON’T KNOW -8

QA07_E13 Do you think HPV can cause cervical cancer?

NEW

YES 1

NO 2

DON’T KNOW -7

REFUSED -8

QA07_E14 Do you think you can get HPV through sexual contact?

NEW

YES 1

NO 2

DON’T KNOW -7

REFUSED -8

QA07_E15 Do you think HPV causes AIDS?

NEW

YES 1

NO 2

DON’T KNOW -7

REFUSED -8

QA07_E15A Do you think HPV can go away on its own without treatment?

NEW

YES 1

NO 2

DON’T KNOW -7

REFUSED -8

Females 18-27

HPV Vaccine

QA07_E16 Have you ever heard of a vaccine or shot to prevent cervical cancer?

NEW

YES 1

N O 2

REFUSED -7 [GO TO PN QA07_E18]

DON’T KNOW -8

QA07_E17 Have you ever received the HPV vaccine or HPV shots?

NEW

Y ES 1

NO 2

REFUSED -7 [GO TO PN QA07_E18]

DON’T KNOW -8

Q A07_E17a Did you receive all three doses of the HPV vaccine?

YES 1

NO 2

REFUSED -7 [GO TO QA07_E22]

DON’T KNOW -8

IF QA07_E16= no, refused, or don’t know OR QA07_E17= no, refused or don’t know, THEN READ: “HPV is a virus that can cause cervical cancer. A vaccine that protects against HPV has been approved for females ages 9 to 26”

QA07_E18 {HPV is a virus that can cause cervical cancer. A vaccine that protects against HPV has been approved for females ages 9 to 26.} Would you be interested in getting the vaccine?

NEW

YES 1 [GO TO PN QA07_E20]

NO 2

REFUSED -7

DON’T KNOW -8

QA07_E19 What is the MAIN reason you would NOT want to get the vaccine?

NEW

Does not need vaccine 1 [GO TO PN QA07_E22]

Not sexually active 2 [GO TO PN QA07_E22]

Too expensive 3 [GO TO QA07_E21]

T oo OLD for vaccine 4

Doctor didn’t recommend it 5

Worried about safety of vaccine 6

Don’t know where to get vaccine 7 [GO TO PN QA07_E22]

My spouse/family member is against it 8

Don’t know enough about vaccine 9

Other 10

REFUSED -7

DON’T KNOW -8

QA07_E20. The cost of the vaccine may be about $360-500. Would you get the HPV vaccine if you had to pay this

amount?

NEW

YES 1 [GO TO PN QA07_E22]

NO 2 [GO TO QA07_E21]

REFUSED -7 [GO TO PN QA07_E22]

DON’T KNOW -8 [GO TO PN QA07_E22]

QA07_E21 If you could get the HPV vaccine free or at a much lower cost, would you get it?

NEW

YES 1

NO 2

REFUSED -7

DON’T KNOW -8

FEMALES 30+

Mammography

QA07_E22 Have you ever had a mammogram?

AD14

[IF NEEDED, SAY: "A mammogram is an x-ray taken of each breast separately
by a machine that flattens or squeezes each breast."]

YES 1

NO 2

[READ DEFINITION, IF STILL NO, GO TO PN QA07_E25]

REFUSED -7 [GO TO PN QA07_E26]

DON'T KNOW -8 [GO TO PN QA07_E26]

QA07_E23 How many mammograms have you had in the last 6 years? Your best estimate is fine.

AD16

_____ MAMMOGRAMS [HR: 0-99]

NONE 0 [GO TO QA07_E25]

REFUSED -7

DON'T KNOW -8

QA07_E24 How long ago did you have your most recent mammogram?

AD17

A YEAR AGO OR LESS 1

MORE THAN 1 UP TO 2 YEARS AGO 2

MORE THAN 2 UP TO 3 YEARS AGO 3

MORE THAN 3 UP TO 5 YEARS AGO 4

MORE THAN 5 YEARS AGO 5

REFUSED -7 [GO TO PN QA07_E26]

DON'T KNOW -8 [GO TO PN QA07_E26]

QA07_E25 In the past 2 years, has a doctor recommended that you have a mammogram?

AD26

YES 1

NO 2

REFUSED -7

DON'T KNOW -8

Next two Questions for Women 40+

Hormone Replacement Therapy

QA07_E26 Are you currently taking hormone replacement therapy or HRT for menopause?

AD28

[IF NEEDED, SAY: "This is a pill, patch or treatment that gives women more of the

female hormone, estrogen."]

YES 1

NO 2

REFUSED -7 [GO TO NEXT SECTION]

DON'T KNOW -8

QA07_E27 Some women go on and off hormone replacement therapy.  How long have you taken HRT altogether?

NEW

[IF NEEDED, SAY: "Please total all the time you have taken HRT."]

A YEAR OR LESS 1

MORE THAN 1 UP TO 2 YEARS 2

MORE THAN 2 UP TO 4 YEARS 3

MORE THAN 4 UP TO 8 YEARS 4

MORE THAN 8 YEARS 5

REFUSED -7

DON'T KNOW -8

Parental Consent for HPV (for Sample Child Section of NHIS)

Female Sample Children 8+

Parental Consent for HPV Vaccine

QA07_I65 Have you ever heard of a vaccine or shot to prevent cervical cancer?

NEW

YES 1

N O 2

REFUSED -7 [GO TO QA07_I67]

DON’T KNOW -8

QA07_I66 Did {DAUGHTER} ever receive the HPV vaccine or HPV shots?

NEW

YES 1

N O 2

REFUSED -7 [GO TO PN QA07_I67]

DON’T KNOW -8

Q A07_E66a Did {DAUGHTER} receive all three doses of the HPV vaccine?

YES 1

NO 2

REFUSED -7 [GO TO NEXT SECTION]

DON’T KNOW -8

PROGRAMMING NOTE QA07_I67;

IF QA07_I65= no, refused, or don’t know OR QA07_J66= no, refused, or don’t know, THEN READ: “HPV is a virus that can cause cervical cancer. A vaccine that protects against HPV has been approved for females ages 9 to 26.”

QA07_I67 {HPV is a virus that can cause cervical cancer. A vaccine that protects against HPV has been approved for females ages 9 to 26.} If {DAUGHTER}’s doctor recommended the HPV vaccine, would you have her get it?

NEW

YES 1 [GO TO QA07_I69]

NO 2

DON’T KNOW -7

REFUSED -8

QA07_I68 What is the MAIN reason you would NOT want {DAUGHTER} to get the vaccine?

NEW

Does not need vaccine 1 [GO TO NEXT SECTION]

Not sexually active 2 [GO TO NEXT SECTION]

Too expensive 3 [GO TO QA07_I70]

T oo young 4

Doctor didn’t recommend it 5

Worried about safety of vaccine 6

Don’t know where to get vaccine 7

My spouse/family member is against it 8 [GO TO NEXT SECTION]

Don’t know enough about vaccine 9

Other 10

REFUSED -7

DON’T KNOW -8

QA07_I69 The cost of the vaccine may be about $360-500. Would you have {DAUGHTER} get the vaccine if you had to pay this amount?

NEW

YES 1 [GO TO NEXT SECTION]

NO 2 [GO TO QA07_I70]

REFUSED -7 [GO TO NEXT SECTION]

DON’T KNOW -8 [GO TO NEXT SECTION]

QA07_I70 If {DAUGHTER} could get the vaccine free or at a much lower cost, would you have her get it?

NEW

YES 1

NO 2

REFUSED -7

DON’T KNOW -8

HPV – Males and Females age 18-49

Q01. The human papillomavirus is a common virus known to cause genital warts and some cancers, such as cervical cancer in women. Before today, have you ever heard of the Human Papillomavirus or HPV? This is not HIV.

1 Yes

2 No

7 Refused

9 Don’t know

Q02. A vaccine to prevent HPV infection is available and is called the cervical cancer vaccine, HPV shot, or GARDASIL^®. Before today, have you heard of the cervical cancer vaccine, HPV shot, or Gardasil? The vaccine was licensed and approved in June 2006.

1 Yes

2 No [SKIP BEYOND Q04]

7 Refused [SKIP BEYOND Q04]

9 Don’t know [SKIP BEYOND Q04]

Q03. Have you ever had the HPV vaccination?

1 Yes

2 No [SKIP BEYOND Q04]

3 Doctor refused when asked [SKIP BEYOND Q04]

7 Refused [SKIP BEYOND Q04]

9 Don’t know [SKIP BEYOND Q04]

Q04. How many HPV shots did you receive?

___ Number of shots

3 All shots

7 Refused

9 Don’t know

SHINGLES – Males and Females 50+

Q01. Shingles is an outbreak of a rash or blisters on the skin that may be associated with severe pain. The pain is generally on one side of the body or face. Shingles is caused by the chicken pox virus. A vaccine for shingles has been available since May 2006. Have you ever had the Zoster or Shingles vaccine, also called Zostavax^®?

1 Yes

2 No

7 Refused

9 Don’t know

TD/TDAP – All adults 18+

Q01. Have you received a tetanus shot in the past 10 years?

1 Yes

2 No [SKIP BEYOND Q03]

7 Refused [SKIP BEYOND Q03]

9 Don’t know [SKIP BEYOND Q03]

Q02. Was your most recent tetanus shot given in 2005 or later?

1 Yes [SKIP TO CHECKPOINT]

2 No [SKIP BEYOND Q03]

7 Refused [SKIP TO CHECKPOINT]

9 Don’t know [SKIP BEYOND Q03]

Checkpoint:

If R’s age <65 then Q03

Else skip beyond Q03

Q03. [PRONOUNCE “Td” TEE DEE (RHYMES WITH “SEE”). PRONOUNCE “Tdap” TEE DAP (RHYMES WITH “CAP”).]

There are currently two types of tetanus shots available today. One is the Td or tetanus-diphtheria vaccine and the other is called Tdap or Adacel^™. They are similar except the Tdap shot also includes a pertussis or whooping cough vaccine. Thinking back to your most recent tetanus shot, did the doctor tell you the vaccine included the pertussis or whooping cough vaccine? The shot is often called Tdap or ADACEL^™.

1 Yes – included pertussis

2 No – did not include pertussis

3 Doctor did not say

7 Refused

9 Don’t know

HEPATITIS A – All adults 18+

Questions: <insert Q01 and Q02 after the current hepatitis B questions; other questions inserted with existing similar questions on medical conditions and HIV risk>

Existing Core NHIS next two questions:

>SHTHEPB<

AAU.370 Have you EVER received the hepatitis B vaccine?

FR: READ IF NECESSARY: This is given in three separate doses and has been available since 1991. It is recommended for newborn infants, adolescents, and people such as health care workers, who may be exposed to the hepatitis B virus.

(1) Yes (AAU.380)

(2) No (A_ACUT_END)

(7) Refused (A_ACUT_END)

(9) Don’t know (A_ACUT_END)

>SHEPDOS<

AAU.380 Did {you} receive at least 3 doses of the hepatitis B vaccine, or less than 3 doses?

(1) Received at least 3 doses

(2) Received less than 3 doses

(7) Refused

(9) Don’t know

Q01. The hepatitis A vaccine is given as a two dose series routinely to some children starting at 1 year of age, and to some adults and people who travel outside the United States. Although it can be given as a combination vaccine with hepatitis B, it is different from the hepatitis B shot, and has only been available since 1995. Have you ever received hepatitis A vaccine?

1 Yes

2 No [SKIP TO Q03]

7 Refused [SKIP TO Q03]

9 Don’t know [SKIP TO Q03]

Q02. How many hepatitis A shots did you receive?

___ (# of hepatitis A shots)

3 All shots

7 Refused

9 Don’t know

Note to interviewer: The next questions are from the existing NHIS Core (and will be used for comparison with proposed supplement questions)

Q02a. DURING THE PAST 12 MONTHS, have you been told by a doctor or other health

professional that you had any kind of liver condition?

1 Yes

2 No

7 Refused

9 Don’t know

Q03. Has a doctor or other health professional ever told you that you had any kind of chronic, or long-term liver condition?

1 Yes

2 No

7 Refused

9 Don’t know

Q07. Have you ever traveled outside of the United States to countries other than Europe, Japan, Australia, New Zealand or Canada, since 1995?

1 Yes

2 No

7 Refused

9 Don’t know

18