Enrollment

Evaluating the Quality of Interview Data Collected by Teratology Information

Services About Pregnancy Outcomes, Maternal and Infant Health,

Following Medication Use During Pregnancy and Lactation

09/03/2009

ATTACHMENT D1: Enrollment Interview

APPROVED

OMb# __0920 -XXXX__________

omb exp. date____/____/_____

Before conducting this interview, complete the Subject Identification form to assign a subject ID for this participant, then enter that number and the date of the interview below.

SUBJECT ID# ________________

Date of Interview _____/_____/_______

Ask these questions only after informed consent for participation has been obtained and before conducting any other interview.

Note: Read only the wording that appears in regular font when conducting the interview. Wording in italics contains instructions to the interviewer and should not be read.

If conducting this interview during the same call when verbal informed consent was obtained, skip the following paragraph and begin with the interview below.

If conducting this interview at a time different from when verbal informed consent was obtained, begin with the following paragraph.

Hello. May I speak with <Name of the woman>? This is <Project coordinator’s name> from the <Name of teratology information service>. I am calling about the project to learn about the safety of medicines during pregnancy and breastfeeding that we are conducting with the Centers for Disease Control and Prevention. It is time for your first interview. This could take up to 30 minutes. Is now a convenient time for me to conduct that interview? (Circle one)

Yes

No

If no, go to tracking form.

I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer. I also want to remind you that whether or not you complete the entire study will not affect the medical care you receive or your use of the <Name of teratology information service>. You can call the service at any time to obtain information and counseling about medicines or other exposures while you are pregnant or breastfeeding regardless of whether you participate in the study.

Before we begin, do you have any questions for me about the study?

Public reporting burden of this collection of information is estimated to average 10 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 Information Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXXX).

Interview

I’d like to start off by asking some questions about you. I want to remind you that all of your answers will be kept private and that you can choose not to answer any question you do not want to answer.

1. How old are you? ___________ years _____Don’t know or refused

2. How tall are you? ___________ feet __________inches _____Don’t know or refused

3. What was your weight just before you became pregnant? (Ask her for an approximate weight if she doesn’t know) ___________ pounds __________Don’t know or refused

4. Is your ethnic group Hispanic or Latino?

   1. Yes

   2. No

   3. Don’t know or refused

5. Now I’m going to read a list of racial groups. Please tell me which ones apply to you. You can select more than one. (Read all choices except Don’t know or refused; Circle all that apply)

   1. American Indian or Alaska Native

   2. Asian

   3. Black or African American

   4. Native Hawaiian or Other Pacific Islander

   5. White

   6. Don’t know or refused

6. Which of the following best describes your education? (Read all choices except Don’t know or refused; Circle only one)

   1. Attended high school

   2. Attended college

   3. Attended graduate school after college

   4. Don’t know or refused

7. Which of the following best describes your household income? (Read all choices except Don’t know or refused; Circle only one)

   1. Less than $10,000

   2. Between $10,000‍ and $25,000

   3. Between $25,000 and $50,000

   4. $50,000 or more

   5. Don’t know or refused

Go to Initial Pregnancy Interview or Initial Breastfeeding Interview.

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