Follow-up Breastfeeding Interview

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

09/03/09

ATTACHMENT D7: FOLLOW-UP BREASTFEEDING Interview

APPROVED

OMb# __0920 -XXXX__________

omb exp. date____/____/_____

SUBJECT ID# ________________

Date of Interview _____/_____/_______

Ask these questions only if the enrollment and initial breastfeeding interviews were completed on a previous date.

Before beginning the interview, obtain the following information from the last breastfeeding interview:

Date of the last interview _____________________________________________________

Section A:

Sex of the baby _____________________________________________________________

Baby’s age at the last interview (calculated from the birth date) ______________________

Section B:

List of all medications she reported having taken while breastfeeding __________________

__________________________________________________________________________

Section C:

List of all medical conditions she reported having while breastfeeding _________________

__________________________________________________________________________

Section D:

List of all other exposures she reported having while breastfeeding ____________________

__________________________________________________________________________

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.

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. You completed the most recent interview for this study on <Date of last interview>. It is now time for the next interview. This takes about 15 minutes on average. Is now a convenient time for me to conduct that interview? (Circle one)

Yes

No

If no, go to tracking form.

Public reporting burden of this collection of information is estimated to average 15 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).

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?

Section A

First, I’d like to ask some questions to update our information about your baby and breastfeeding since your last interview. This includes both nursing your baby at the breast, and pumping your breast and feeding the baby breast milk through a bottle or tube. As a reminder, your last interview was on <date of last interview> and at that time your baby was approximately <infant’s age at last interview> weeks/months old.

1. Is your baby alive now?

1. Yes

2. No

3. Don’t know or refused

If yes, go to Question 3 in this section.

2. When did your baby die?

1. Date _____/_____/_______

2. Baby’s age at death ______________________________________________________

3. Other response __________________________________________________________

4. Don’t know or refused

Go to Question 10 in this section.

3. How much did your baby weigh the last time he/she was weighed?

__________ pounds __________ ounces _____Don’t know or refused

3. When was that? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Number of days ago__________________________________________________________

3. Number of weeks ago ________________________________________________________

4. Number of months ago _______________________________________________________

5. Baby’s age ________________________________________________________________

6. Other response _____________________________________________________________

7. Don’t know or refused

3. Are you currently breastfeeding?

1. Yes

2. No.

3. Don’t know or refused

If no or don’t know/refused, go to Question 10 in this section.

3. On average, how often does your baby breastfeed?

1. Every ________ hours.

2. Number of times in 24 hours __________________________________________________

3. Other response _____________________________________________________________

4. Don’t know or refused

3. Do you also give your baby formula?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Section B.

3. How old was your baby the first time he/she received formula?

1. Days of age ________________________________________________________________

2. Weeks of age _______________________________________________________________

3. Months of age ______________________________________________________________

4. Other response _____________________________________________________________

5. Don’t know or refused

9. On average, how often does he/she receive formula?

1. Every ________ hours.

2. Number of times in 24 hours __________________________________________________

3. Other response _____________________________________________________________

4. Don’t know or refused

Go to Section B.

9. Have/Did you breastfed/breastfeed at some time since our last interview?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to End of Interview.

9. How old was your baby when he/she last received breast milk?

1. Days of age ________________________________________________________________

2. Weeks of age _______________________________________________________________

3. Months of age ______________________________________________________________

4. Other response _____________________________________________________________

5. Don’t know or refused

Section B

Next, I’d like to update our information about medicines you took while breastfeeding at any time since your last interview. This includes prescription medicines that you got from a doctor or pharmacy; over-the-counter medicines such as Tums or Tylenol; vitamins; herbals; and other dietary supplements. I’ll be asking about how much medicine you took and how often you took it (them).

Sometimes it is helpful to have the medicine bottles, or a calendar or other reminder, in front of you when answering these questions. Do you want to take a minute to collect these items?

(If yes, wait for her to collect the items, then continue)

Again, 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. During your last interview, you said you had taken the medicine(s) (read list of medications from last breastfeeding interview). Have you taken this/any of these medicine(s) while you were breastfeeding since your last interview?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 17 in this section.

If yes but only one medicine is listed from the last pregnancy interview, go to Question 3 in this

section.

2. Which of these medicines have you taken? __________________________________________

_________________________________________________ _____Don’t know or refused

3. First/Next, let’s talk about (name of the first/next medicine). When since your last interview did you first/next take (name of the first/next medicine) while you were breastfeeding? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Baby’s age ________________________________________________________________

3. Taking it continuously since the last interview ____________________________________

4. Other response _____________________________________________________________

5. Don’t know or refused

4. How many (name of the medicine) pills/teaspoons did you take at a time the first/next/that time you took it? ____________________________________ _____Don’t know or refused

4. How many milligrams were in each pill/teaspoon?

______________________________________________ _____Don’t know or refused

4. How often did you take that dose? For example, how many times per day, per week, or per month? (Complete the one that best reflects the answer given)

1. Number of times per day ___________________________________________________

2. Number of times per week __________________________________________________

3. Number of times per month _________________________________________________

4. Other response ___________________________________________________________

5. Don’t know or refused

4. Did the dose of <name of the medicine> or how often you took it change (again) while you were taking it that time?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Question 9 in this section.

4. When did the dose of (name of medicine) change? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

   1. Date _____/_____/_______

   2. Number of days or weeks after starting the medicine _______________________________

   3. Baby’s age ________________________________________________________________

   4. Other response _____________________________________________________________

   5. Don’t know or refused

Go to Question 4 in this section.

4. Are you still taking <name of the medicine>?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Question 11 in this section.

4. And are you still taking (read the dose and frequency from the last response to Questions 4 and 5)?

   1. Yes

   2. No

   3. Don’t know or refused

If yes, go to Question 13 in this section.

If no, ask her to clarify when she started taking her current dose. Then, go to Question 13 in this section.

4. When did you stop taking <name of medicine> that time? For example, how many days or weeks did you take it, or how old was your baby when you stopped?

   1. Number of days ____________________________________________________________

   2. Number of weeks ___________________________________________________________

   3. Number of months __________________________________________________________

   4. Baby’s age ________________________________________________________________

   5. Other response _____________________________________________________________

   6. Don’t know or refused

4. Have you taken <name of the medicine> again since then while you were breastfeeding?

   1. Yes

   2. No

   3. Don’t know or refused

If yes, go to Question 3 in this section.

4. Did/Have you notice(d) any change in your milk supply at any time while you were taking (name of the medicine) or right after you stopped taking it?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 15 in this section.

4. What changes did you notice? List all you can think of. _____________________________________________________________________________

_________________________________________________ _____Don’t know or refused

4. Did you notice any physical or behavioral changes in your baby while you were taking <name of the medicine>? Examples might include a change in appetite, more sleepiness, irritability, or change in the frequency or consistency of bowel movements?

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused and there are more medicines on the list, go to Question 3 in this section for the next medicine. If there are no more medicines on the list, go to Question 17 in this section.

4. What changes did you notice? List all you can think of. ______________________________________________________________________________________________________________________________ _____Don’t know or refused

If there are more medicines on the list, go to Question 3 in this section for the next medicine. If there are no more medicines on the list, proceed with Question 17 in this section.

4. Have you taken any other medicines while you were breastfeeding at any time since your last interview? This includes prescription medicines that you got from a doctor or pharmacy; over-the-counter medicines such as Tums or Tylenol; vitamins; herbals; and other dietary supplements.

   1. Yes

   2. No

   3. Don’t know or refused

If no or don’t know/refused, go to Section C.

4. What other medicines did you take while you were breastfeeding? List all the medicines you can think of even if you took them for a short time or only occasionally when needed.

(Ask for both trade and generic names of each medicine; If the medicine has a name that is common to multiple preparations, such as Tylenol, ask her for the exact name of the preparation, e.g., Tylenol PM, Tylenol Sinus, Tylenol Arthritis, etc.)

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

4. First/Next, let’s talk about (name of the first/next medicine). What condition did you take it for? _____________________________________________________________________________

_________________________________________________ _____Don’t know or refused

4. When did you first have <the condition>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days, weeks, months, or years before ___________________________

3. If during pregnancy, weeks or months of gestation _________________________________

4. Mother’s age at onset ________________________________________________________

5. Baby’s age at onset __________________________________________________________

6. Other response _____________________________________________________________

7. Don’t know or refused

Go to Question 3 in this section.

Section C

Next, I’d like to update our information about any other medical conditions you’ve had while you were breastfeeding since your last interview. Again, 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.

If she reported having no other medical conditions at the last interview, go to Question 7 in this section.

1. During your last interview, you said you had had (read list of medical conditions from last breastfeeding interview). Have you had this (any of these) condition(s) at any time while you were breastfeeding since your last interview?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 6 in this section.

If yes but only one condition is listed from the last pregnancy interview, go to Question 3 in this

section.

2. Which conditions have you had while breastfeeding? List all you can think of. _____________________________________________________________________________ _________________________________________________ _____Don’t know or refused

2. First/Next, let’s talk about (name of the first/next condition). When while you were breastfeeding since your last interview did you first have <name of the first/next condition> again? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Baby’s age ________________________________________________________________

3. Had it continuously since the last interview ______________________________________

4. Other response _____________________________________________________________

5. Don’t know or refused

2. Did you take any medicine for <name of the condition> while you were breastfeeding since your last interview that we haven’t already talked about?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused and there are more conditions on the list, go to Question 3 in this section. If there are no more conditions on the list, go to Question 6 in this section.

5. What medicine did you take for <name of the condition>?

(Ask for both trade and generic names of each medicine; If the medicine has a name that is common to multiple preparations, such as Tylenol, ask her for the exact name of the preparation, e.g., Tylenol PM, Tylenol Sinus, Tylenol Arthritis, etc.)

___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

Go to Section B, Question 3.

6. Have you had any (other) medical conditions while you were breastfeeding since your last interview that we haven’t already talked about, even if you did not take medicine for them? Examples might be a sore throat or sinus infection, asthma, depression, blood pressure, or diabetes.

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Section D.

6. What did you have? List all you can think of. _____________________________________________________________________________

_________________________________________________ _____Don’t know or refused

(If she doesn’t know the name of the condition, ask her to describe it and its symptoms)

6. First/Next, let’s talk about (name of the first/next condition). When while you were breastfeeding since your last interview did you first have <name of the condition>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. If before conception, days, weeks, months, or years before ___________________________

3. If onset during pregnancy, weeks or months of gestation ____________________________

4. Baby’s age at onset __________________________________________________________

5. Mother’s age at onset ________________________________________________________

6. Other response _____________________________________________________________

7. Don’t know or refused

Go to Question 4 in this section.

Section D

Finally, I’d like to update our information about some other exposures that you might have had while you were breastfeeding since your last interview. 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. Have you smoked a cigarette at any time while you were breastfeeding since your last interview?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 4 in this section.

2. On average, how many cigarettes did you smoke per day? (1 pack = 20 cigarettes, half a pack = 10)

   1. Number of cigarettes_________________________________________________________

   2. Number of packs____________________________________________________________

   3. Other response _____________________________________________________________

   4. Don’t know or refused

3. When was the last time you smoked a cigarette? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

   1. Date _____/_____/_______

   2. Baby’s age ________________________________________________________________

   3. Other response _____________________________________________________________

   4. Don’t know or refused

4. Have others in your home or workplace smoked while you were breastfeeding since your last interview?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to Question 6 in this section.

4. How many people in your home or workplace smoked while you were breastfeeding? (Do not include the woman herself)

_____________________________________________ ______Don’t know or refused

4. Since your last interview while you were breastfeeding, on average how often have you had a drink of alcohol? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day ____________________________________________________

2. Number of times per week ___________________________________________________

3. Number of times per month __________________________________________________

4. Didn’t drink

5. Other response _____________________________________________________________

6. Don’t know or refused

If she didn’t drink or doesn’t know/refused, go to Question 10 in this section.

7. On average, how many drinks did you have at one time while you were breastfeeding? One drink is equal to one glass of wine like you would have at a restaurant, one bottle or can of beer, or 1 ounce of hard liquor either in a mixed drink or straight up. When was the last time you had a drink? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

   1. Number of drinks per day __________________________________________________

   2. Number of drinks per week _________________________________________________

   3. Number of drinks per month ________________________________________________

   4. Other response ___________________________________________________________

   5. Don’t know or refused

8. What was the most number of drinks you had on any one occasion while you were breastfeeding since your last interview?

_____________________________________________ ______Don’t know or refused

9. When was the last time you had a drink? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date _____/_____/_______

2. Baby’s age ________________________________________________________________

3. Other response _____________________________________________________________

4. Don’t know or refused

9. Since your last interview while you were breastfeeding, have you used any (other) recreational drugs?

1. Yes

2. No

3. Don’t know or refused

If no or don’t know/refused, go to End of Interview.

9. What (other) recreational drugs did you use? List all you can think of. ­____________________

_____________________________________________ ______Don’t know or refused

9. While you were breastfeeding, on average, how often did you use <name of the first/next drug>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Number of times per day _____________________________________________________

2. Number of times per week ____________________________________________________

3. Number of times per month ___________________________________________________

4. Other response _____________________________________________________________

5. Don’t know or refused

9. When was the last time you used <name of the drug>? (Complete the one that best reflects the answer given; probe for specifics if she is unsure)

1. Date ______________________________________________________________________

2. Baby’s age ________________________________________________________________

3. Other response _____________________________________________________________

4. Don’t know or refused

If there are more drugs on the list, go to Question 12 in this section for the next drug. If there are no more drugs on the list, proceed with Question 14 in this section.

9. Did you use any (other) recreational drugs while you were breastfeeding?

1. Yes

2. No

3. Don’t know or refused

If yes, go to Question 11 in this section.

If no or don’t know/refused, go to End of Interview.

End of Interview

That is the end of this interview. I truly want to thank you for taking the time to complete it.

If woman is taking a chronic medication or frequently takes a periodic medication, proceed with the following:

Your contribution to this study is very important. Before we hang up, do you have any questions for me?_______________________________________________________________________

_____________________________________________________________________________

Your next interview is scheduled for about 2 months from now. That will be approximately <Calculated date based on date of this interview>.

Go to tracking form.

If woman is not taking a chronic medication and does not frequently take a periodic medication, proceed with the following:

This is also the end of the study for you. Your contribution has been very important. Before we hang up, do you have any questions for me or any feedback about the study?________________

_____________________________________________________________________________

_____________________________________________________________________________

Did you find it difficult or burdensome to participate in this study?

Yes

No

Not sure

If yes or not sure, ask

How was it difficult or burdensome? _____________________________________________

___________________________________________________________________________