CQDER CMS 10-day Letter 042016

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 19. 2016

Margo Schwab, Ph.D.

Office of Management and Budget

725 17th Street, N.W.

Washington, DC 20503

Dear Dr. Schwab:

The NCHS Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) (OMB No. 0920-0222, exp. 06/30/2015) in collaboration with the Centers for Medicare and Medicaid Services (CMS) and NORC at the University of Chicago plans to conduct a cognitive interviewing study to evaluate two alternative versions of the NHIS Spanish-language sexual identity question. The study will also include a two-part gender identity question—one of the two gender identity questions suggested by the HHS data council sexual orientation/gender identity work group. Findings will be used to inform NCHS surveys, the Medicare Current Beneficiary Survey (MCBS, OMB #0938-1275, exp. 05/31/2018) as well as other Federal surveys collecting sexual orientation and gender identity data. In July 2015, CMS conducted a cognitive interviewing study, and those findings, consistent with earlier CCQDER studies, indicated comprehension difficulty in the Spanish language version. This study will explore a potential solution to this particular question-response problem.

We propose to start recruiting for participants as soon as OMB approval is received.

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 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: NCHS & CMS Spanish Cognitive Interviewing Health Study

For ease of review, attachments have been submitted in both English and Spanish. The Spanish questions proposed for evaluation are included as Attachment 1b, while Attachment 1a captures the questions in English. The questionnaire consists of the sexual orientation and gender identity questions as well as other health care and demographic questions to provide context. The testing procedure conforms to the cognitive interviewing techniques that have been described in CQDER’s generic OMB clearance package (No. 0920-0222, exp. 07/31/2018).

We propose to recruit up to 40 respondents aged 18 and over. Sample selection will ensure demographic variety, particularly in terms of gender, age, and education.

NORC researchers will carry out recruitment through senior centers, health clinics, community centers, organizations with LGBT focus/members, Craigslist, and through community networks. The Recruitment Message is contained in Attachment 2a&b. The ten minute Eligibility Screening Script used to determine eligibility of individuals responding to the Recruitment Message is shown in Attachment 3a&b. Note that wording of the template has been approved and is contained within our umbrella package. Only project specific information has been added to the document. It is anticipated that as many as 60 individuals may need to be screened in order to recruit 40 respondents.

The cognitive interviews will be conducted in-person with the individual Spanish-speaking respondent and an NORC interviewer for no more than 60 minutes. Interviews may be conducted at NORC’s various Chicago and Bethesda office locations or at a mutually agreed upon location. After respondents have been briefed on the purpose of the study and the procedures that CCQDER routinely takes to protect human subjects, participants will be asked to read (or have read to them) and sign an Informed Consent (Attachment 4a&b). Only project specific information has been added to the document. Respondents will also be asked to fill in their demographic characteristics on the Respondent Data Collection Sheet (Attachment 5a&b). This document is contained in our umbrella package. The burden for completion of this form is captured in the interview. The interviews will be audio recorded to allow researchers to ensure the quality of their interview notes. Two CCQDER Contractors (Swan Solutions, CDC Contract #200-2015-62383, CCQDER Mission Support Services) will travel to Chicago and Bethesda to work alongside NORC interviewers. The two Swan Solutions contractors will be responsible for audio recording the interviews, as well as safeguarding and securing all materials with Personal Identifiable Information (PII) including the telephone screener, informed consent, respondent data collection sheet, and audio recordings in a secured travel case until returned to NCHS, at which point they will be transferred to the usual secured locked storage cabinets.

NORC staff conducting the Spanish cognitive interviews will complete NCHS Confidentiality training at http://www.cdc.gov/nchs/about/policy/confidentiality_training/index.html and sign a Nondisclosure Affidavit (provided by NCHS). The contractor will send hardcopies of the NCHS Confidentiality Training certificates and original signed hardcopies of the Nondisclosure Affidavits to Karen Whitaker, Program Specialist, CQDER.

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:

[fill staff name] 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 a variety of people. The question topics range from healthcare to basic demographic questions such as race, and education. I will ask you to fill out a questionnaire. After you complete the questionnaire, I will ask you questions about the questions—whether they make sense, what you think about when you hear certain words, and so on.

I may ask you 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.

We propose giving participants $40 incentives, which is our standard incentive. After the interview, respondents will be given the thank-you letter (Attachment 6a&b/document contained in umbrella package) signed by Charles J. Rothwell, Director of NCHS, a copy of the informed consent, and $40.

In total, for this project, the maximum respondent burden will be 50 hours. A burden table for this project is shown below:

Form Name	Number of Participants	Number of Responses/ Participant	Average hours per response	Response Burden (in hours)
Screener	60	1	10/60	10
Questionnaire	40	1	60/60	40

Attachments (6)

cc:

V. Buie

T. Richardson

DHHS RCO

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