32.5 Survey

Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months and Sibling Birth Enrollment

BreastMilkSAQ

Adult-Focused Biospecimen Collection (Birth)

OMB: 0925-0593

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OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Breast Milk SAQ, Phase 2g

OMB Specification


Breast Milk SAQ


Event Category:

Time-Based

Event:

Birth, 3M

Administration:

N/A

Instrument Target:

Biological Mother

Instrument Respondent:

Biological Mother

Domain:

Biospecimen

Document Category:

Sample Collection

Method:

Self-Administered

Mode (for this instrument*):

In-Person, PAPI

OMB Approved Modes:

In-Person, PAPI;
Phone PAPI;
Web-Based, CAI

Estimated Administration Time:

40 minutes

Multiple Child/Sibling Consideration:

Per Event

Special Considerations:

N/A

Version:

2.0

MDES Release:

4.0


*This instrument is OMB-approved for multi-mode administration but this version of the instrument is designed for administration in this/these mode(s) only.


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Breast Milk SAQ



TABLE OF CONTENTS





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Breast Milk SAQ



GENERAL PROGRAMMER INSTRUCTIONS:

WHEN PROGRAMMING INSTRUMENTS, VALIDATE FIELD LENGTHS AND TYPES AGAINST THE MDES TO ENSURE DATA COLLECTION RESPONSES DO NOT EXCEED THOSE OF THE MDES. SOME GENERAL ITEM LIMITS USED ARE AS FOLLOWS:


DATA ELEMENT FIELDS

MAXIMUM CHARACTERS PERMITTED

DATA TYPE

PROGRAMMER INSTRUCTIONS

ADDRESS AND EMAIL FIELDS

100

CHARACTER


UNIT AND PHONE FIELDS

10

CHARACTER


_OTH AND COMMENT FIELDS

255

CHARACTER

  • Limit text to 255 characters

FIRST NAME AND LAST NAME

30

CHARACTER

  • Limit text to 30 characters

ALL ID FIELDS

36

CHARACTER


ZIP CODE

5

NUMERIC


ZIP CODE LAST FOUR

4

NUMERIC


CITY

50

CHARACTER


DOB AND ALL OTHER DATE FIELDS (E.G., DT, DATE, ETC.)

10

NUMERIC


CHARACTER



  • DISPLAY AS MM/DD/YYYY

  • STORE AS YYYY-MM-DD

  • HARD EDITS:

MM MUST EQUAL 01 TO 12

DD MUST EQUAL 01 TO 31

YYYY MUST BE BETWEEN 1900 AND CURRENT YEAR.

TIME VARIABLES

TWO-DIGIT HOUR AND TWO-DIGIT MINUTE, AM/PM DESIGNATION

NUMERIC

  • HARD EDITS:

HOURS MUST BE BETWEEN 00 AND 12;

MINUTES MUST BE BETWEEN 00 AND 59


Instrument Guidelines for Participant and Respondent IDs:

PRENATALLY, THE P_ID IN THE MDES HEADER IS THAT OF THE PARTICIPANT (E.G. THE NON-PREGNANT WOMAN, PREGNANT WOMAN, OR THE FATHER).


POSTNATALLY, A RESPONDENT ID WILL BE USED IN ADDITION TO THE PARTICIPANT ID BECAUSE SOMEBODY OTHER THAN THE PARTICIPANT MAY BE COMPLETING THE INTERVIEW. FOR EXAMPLE, THE PARTICIPANT MAY BE THE CHILD AND THE RESPONDENT MAY BE THE MOTHER, FATHER, OR ANOTHER CAREGIVER. THEREFORE, MDES VERSION 2.2 AND ALL FUTURE VERSIONS CONTAIN A R_P_ID (RESPONDENT PARTICIPANT ID) HEADER FIELD FOR EACH POST-BIRTH INSTRUMENT. THIS WILL ALLOW ROCs TO INDICATE WHETHER THE RESPONDENT IS SOMEBODY OTHER THAN THE PARTICIPANT ABOUT WHOM THE QUESTIONS ARE BEING ASKED.



A REMINDER:

ALL RESPONDENTS MUST BE CONSENTED AND HAVE RECORDS IN THE PERSON, PARTICIPANT, PARTICIPANT_CONSENT AND LINK_PERSON_PARTICIPANT TABLES, WHICH CAN BE PRELOADED INTO EACH INSTRUMENT. ADDITIONALLY, IN POST-BIRTH QUESTIONNAIRES WHERE THERE IS THE ABILITY TO LOOP THROUGH A SET OF QUESTIONS FOR MULTIPLE CHILDREN, IT IS IMPORTANT TO CAPTURE AND STORE THE CORRECT CHILD P_ID ALONG WITH THE LOOP INFORMATION. IN THE MDES VARIABLE LABEL/DEFINITION COLUMN, THIS IS INDICATED AS FOLLOWS: EXTERNAL IDENTIFIER: PARTICIPANT ID FOR CHILD DETAIL.





BREAST MILK DATA COLLECTION SAQ


BMD01000. As part of the National Children’s Study, we are asking you to provide a breast milk sample from one breast. Please follow the instructions provided in the breast milk collection kit to collect the sample.

 

After you have collected the breast milk sample, please complete the information on both sides of this form.


BMD02000. On what date did you collect the sample?


SOURCE

National Children’s Study, Legacy Phase (Modified) (1M & 6M)


(P_BMQ_MM) |___|___|

   M    M


(P_BMQ_DD) |___|___|

   D    D


(P_BMQ_YYYY) |___|___|___|___|

   Y     Y     Y    Y


BMD03000. At what time did you collect the sample?


SOURCE

National Children’s Study, Legacy Phase (Modified) (1M & 6M)


(P_BMQ_TIME) l___l___l : l___l___l

  H    H        M    M


(P_BMQ_TIME_UNIT)


Label

Code

Go To

AM

1


PM

2



BMD04000/(P_BMQ_HOW_LONG). How long did it take you to collect this sample?


Label

Code

Go To

0 - 10 minutes

1


11 - 20 minutes

2


Over 20 minutes

3



SOURCE

National Children’s Study, Vanguard Phase


BMD05000/(P_BMQ_LAST_FEED). How long before collecting the breast milk sample did you last breast-feed your baby or pump milk from this breast?


Label

Code

Go To

Less than 2 hours

1


2-4 hours

2


Over 4 hours

3



SOURCE

National Children’s Study, Legacy Phase (Modified) (1M & 6M)


BMD06000/(P_BMQ_PUMP). Did you use a pump to collect the sample?


Label

Code

Go To

Yes

1


No

2

P_BMQ_EMPTY


SOURCE

National Children’s Study, Vanguard Phase


BMD07000/(P_BMQ_TYPE_PUMP). What type of pump did you use to collect the sample?


Label

Code

Go To

Electric pump

1


Hand pump

2



SOURCE

National Children’s Study, Vanguard Phase


BMD08000/(P_BMQ_BRAND_PUMP). What is the brand of the pump you used to collect the sample? (Mark one)


Label

Code

Go To

Medela®

1

P_BMQ_EMPTY

AVENT®

2

P_BMQ_EMPTY

Playtex®

3

P_BMQ_EMPTY

Ameda®

4

P_BMQ_EMPTY

Evenflo®

5

P_BMQ_EMPTY

Lansinoh®

6

P_BMQ_EMPTY

Other

-5


Don't Know

-2

P_BMQ_EMPTY


SOURCE

National Children’s Study, Vanguard Phase


BMD09000/(P_BMQ_BRAND_PUMP_OTH). SPECIFY: _________________________________________


SOURCE

National Children’s Study, Vanguard Phase


BMD10000/(P_BMQ_EMPTY). Did you completely empty the breast when collecting the sample?


Label

Code

Go To

Yes

1


No

2


Don't Know

-2



SOURCE

National Children’s Study, Vanguard Phase


BMD11000/(P_BMQ_CAFFEINE). During the 2 hours prior to collecting the breast milk sample, did you eat or drink any food or beverage containing caffeine (for example, coffee, tea, soda, chocolate)?


Label

Code

Go To

Yes

1


No

2



SOURCE

National Children’s Study, Vanguard Phase


BMD12000/(P_BMQ_ALCOHOL). During the 2 hours prior to collecting the breast milk sample, did you drink any alcohol?


Label

Code

Go To

Yes

1


No

2



SOURCE

National Children’s Study, Vanguard Phase


BMD13000. Please write down the name of any prescription, over-the-counter, homeopathic, or non-traditional medicines you have taken in the last 24 hours (including prenatal vitamins). Please be specific. For example, if you took Robitussin DM®, write Robitussin DM®, not Robitussin®. If you did not take any prescription or over-the-counter medications in the last 24 hours, please mark None.


SOURCE

National Children’s Study, Vanguard Phase


(P_BMQ_PRSC_OTC_1) _________________________________________________________


Label

Code

Go To

None

1

P_BMQ_FREEZER


(P_BMQ_PRSC_OTC_2) ______________________________________________________


(P_BMQ_PRSC_OTC_3) ____________________________________________________________


(P_BMQ_PRSC_OTC_4) _________________________________________________


(P_BMQ_PRSC_OTC_5) _________________________________________________


(P_BMQ_PRSC_OTC_6) _____________________________________________________


(P_BMQ_PRSC_OTC_7) _______________________________________________


(P_BMQ_PRSC_OTC_8) _______________________________________________


(P_BMQ_PRSC_OTC_9) ___________________________________________


(P_BMQ_PRSC_OTC_10) __________________________________________


BMD14000/(P_BMQ_FREEZER). How long after collecting your sample did you place it in the freezer?


Label

Code

Go To

0-10 minutes

1


11-20 minutes

2


Over 20 minutes

3


Not Applicable (did not place in freezer)

-7



SOURCE

National Children’s Study, Legacy Phase (Modified) (1M & 6M)


BMD15000. Thank you for participating in the National Children’s Study and for taking the time to complete this information.

 

Please call the Regional Operations Center number located on the last page, if you have any questions.



FOR OFFICE USE ONLY:


FOU01000/(SPECIMEN_ID). Specimen ID:

l__l__l__l__l__l__l__l__l__l - l__l__l__l__l


FOU02000/(P_ID). Participant ID:_________________________________


FOU03000/(R_P_ID). Respondent ID:______________________________________


FOU04000/(EVENT_ID). Visit Type/Event ID:_________________________________________


Public reporting burden for this collection of information is estimated to average 40 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: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0593*). Do not return the completed form to this address.

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