Cancer Control - Letter to Dr. Schwab

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

March 3, 2014

Margo Schwab, Ph.D.

Office of Management and Budget

725 17th Street, N.W.

Washington, DC 20503

Dear Dr. Schwab:

The staff of the NCHS Questionnaire Design Research Laboratory (QDRL) (OMB No. 0920-0222, exp. 06/30/2015) plans to evaluate the 2015 NHIS Cancer Control Supplement.

We propose to start recruiting for volunteer participants as soon as we receive clearance 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. As you know, the purpose of cognitive testing is to obtain information about the processes people use to answer survey questions as well as to identify any potential problems in the questions. The analysis will be qualitative.

Proposed project: 2015 NHIS Cancer Control Supplement

We propose to recruit 40 respondents (18 years of age and older) in order to iteratively evaluate the 2015 NHIS Cancer Control Supplement. The testing procedure conforms to the cognitive interviewing techniques that have been described in QDRL’s generic OMB clearance package (No. 0920-0222, exp. 06/30/2015).

The questions to be cognitively tested primarily focus on general health, risk behaviors, cancer screening exams, and medical tests. Topics include physical activity, sun protection/indoor tanning, breast cancer, cervical cancer, lung cancer, prostate cancer, colorectal cancer, genetic testing for cancer risk, family history of breast cancer/ovarian cancer, and non-cigarette tobacco use.

Recruitment will include women who have had mammograms and follow-up procedures, men who have had a PSA test, individuals who have had genetic counseling for cancer risk, individuals who use tanning devices, and individuals who use non-cigarette tobacco including cigars, pipes, hookahs, cigarillos, bidis, chewing tobacco, snuff, dip, snus or dissolvable tobacco.

The newspaper advertisements/flyers used to recruit respondents are shown in Attachment 2. The screener used to determine eligibility of individuals responding to the newspaper advertisements/flyers is shown in Attachment 3 (the 5-minute burden for the screener is included in the 1-hour burden). Note that wording of the document has been approved and is contained within our umbrella package. Only project specific information has been added to the document. 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 by QDRL staff members with English speaking respondents. All interviews conducted in the Questionnaire Design Research Laboratory will be video and audio recorded to allow researchers to review the behaviors and body language of the respondents. Interviews conducted offsite will only be audio recorded. These recordings will allow researchers to insure the quality of their interview notes.

After respondents have been briefed on the purpose of the study and the procedures that QDRL routinely takes to protect human subjects, respondents will be asked to read and sign an Informed Consent document. Respondents will also be asked to fill in their demographic characteristics on the Respondent Data Collection Sheet. Note that these documents are contained in our umbrella package.

The interviewer will then ask the respondent to confirm that he/she understands the information in the Informed Consent, and then state that we would like to record the interview. The recorder will be turned on once it is clear that the procedures are understood and agreed upon. The interviewer will then orient the respondent to the cognitive interview with the following introduction:

Lauren may have told you that we will be working on some questions that will eventually be added to national surveys. Before that happens, we like to test them out on people like yourself. The questions we are testing today focus on general health, cancer risk behaviors, cancer screening exams, medical tests, and non-cigarette tobacco use. We are interested in your answers, but also in how you go about making them. I may also ask you questions about the questions—whether they make sense, what you think about when you hear certain words, and so on.

I will read each question to you, and I’d like you to answer as best you can. Please try to tell me what you are thinking as you figure out how to answer. Also, please tell me if:

there are words you don’t understand,

the question doesn’t make sense to you,

you could interpret it more than one way,

it seems out of order,

or if the answer you are looking for is not provided.

The more you can tell us, the more useful it will be to us as we try to develop better questions. Okay? Do you have any questions before we start? If yes, answer questions. If not, let’s get started.

After the interview, respondents will be given the thank-you letter (document contained in umbrella package) signed by Charles J. Rothwell, Director of NCHS, a copy of the informed consent document, and $40.

After the interview, respondents will also be asked to read the Special Consent for Expanded Use of Video and Audio Recordings. Note that this document is contained in our umbrella package. There will be no coercion and the respondents will be told that they can call and reverse the decision at any time if they change their minds. If respondents do sign the special consent form they will be given a copy of that as well.

Extreme care will be taken with all recordings and paperwork from the interviews conducted off-site. Recordings and identifying paperwork will be stored in a secured travel case until returned to NCHS, at which point they will be transferred to the usual secured locked storage cabinets.

We propose paying participants $40, which is our standard payment. In total, for this project, the maximum respondent burden will be 40 hours of interviewing. A burden table for this project is shown below:

Projects	Number of Participants	Number of Responses/ Participant	Average hours per response	Response burden
QDRL Interviews
2) Other Questionnaire Testing	40	1	1	40

Attachments (3)

cc:

V. Buie

T. Richardson

DHHS RCO

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