OMB #: 0925-0593
OMB Expiration Date: 8/31/2014
Child Urine Instrument, Phase 2g
OMB Specification
Child Urine Instrument
Event Category: |
Time-Based |
Event: |
6M, 12M, 36M, 60M |
Administration: |
N/A |
Instrument Target: |
Child |
Instrument Respondent: |
Primary Caregiver |
Domain: |
Biospecimen |
Document Category: |
Sample Collection |
Method: |
Data Collector Administered |
Mode (for this instrument*): |
In-Person, CAI |
OMB Approved Modes: |
In-Person, CAI |
Estimated Administration Time: |
14 minutes |
Multiple Child/Sibling Consideration: |
Per Child |
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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Child Urine Instrument
TABLE OF CONTENTS
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Child Urine Instrument
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 |
|
FIRST NAME AND LAST NAME |
30 |
CHARACTER |
|
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
|
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 |
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.
(TIME_STAMP_BUC_ST).
PROGRAMMER INSTRUCTIONS |
|
BUC00100/(URINE_INTRO). I would like to collect a sample of {C_FNAME/the child}’s urine. Before I do so, I will explain this collection and ask you some questions.
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
CONTINUE |
1 |
COLLECTION_METHOD |
REFUSED |
-1 |
|
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
BUC03000/(REFUSE_REASON). I am sorry that you have chosen not to participate in this collection. Can you tell me why?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
CONCERN ABOUT ALLERGIC REACTION/SKIN IRRITATION |
1 |
BUC05000 |
CHILD HAS A DIAPER RASH |
2 |
BUC05000 |
PHYSICAL LIMITATION |
3 |
BUC05000 |
PARTICIPANT ILL/EMERGENCY |
4 |
BUC05000 |
LANGUAGE ISSUE |
5 |
BUC05000 |
NO TIME |
6 |
BUC05000 |
UNABLE TO URINATE |
7 |
BUC05000 |
UNCOMFORTABLE WITH COLLECTION PROCEDURES |
8 |
BUC05000 |
OTHER |
-5 |
|
REFUSED |
-1 |
BUC05000 |
DON'T KNOW |
-2 |
BUC05000 |
SOURCE |
National Children’s Study, Legacy Phase (Modified) (6M Child) |
BUC04000/(REFUSE_REASON_OTH). SPECIFY: ______________________________________
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
SOURCE |
National Children’s Study, Legacy Phase (Modified) (6M Child) |
BUC05000. That’s fine. Thank you for your time.
SOURCE |
National Children’s Study, Vanguard Phase (Adult Blood) |
PROGRAMMER INSTRUCTIONS |
|
BUC06000/(COLLECTION_METHOD). HOW WILL THE URINE BE COLLECTED?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
NCS PROVIDED URINE BAG |
1 |
BUC09000 |
NCS PROVIDED CUP |
2 |
BUC08000 |
OTHER |
-5 |
|
BUC07000/(COLLECTION_METHOD_OTH). SPECIFY: ____________________
BUC08000. When did {C_FNAME/the child} last urinate?
DATA COLLECTOR INSTRUCTIONS |
|
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
(LT_URINE_MM) LAST URINATION – DATE: MONTH
|___|___|
M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_URINE_DD) LAST URINATION – DATE: DAY
|___|___|
D D
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_URINE_YYYY) LAST URINATION – DATE: YEAR
|___|___|___|___|
Y Y Y Y
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_URINE_2) LAST URINATION – TIME
|___|___| : |___|___|
H H M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_URINE_3) LAST URINATION – AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
PROGRAMMER INSTRUCTIONS |
|
BUC09000. When was the last time {C_FNAME/the child}’s diaper was changed?
DATA COLLECTOR INSTRUCTIONS |
|
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
(LAST_CHANGE_MM) LAST DIAPER CHANGE - DATE: MONTH
|___|___|
M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LAST_CHANGE_DD) LAST DIAPER CHANGE – DATE: DAY
|___|___|
D D
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LAST_CHANGE_YYYY) LAST DIAPER CHANGE – DATE: YEAR
|___|___|___|___|
Y Y Y Y
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LAST_CHANGE_TIME) LAST DIAPER CHANGE - TIME
|___|___| : |___|___|
H H M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LAST_CHANGE_TIME _UNIT) LAST DIAPER CHANGE – AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
BUC10000. When was the last time {C_FNAME/the child} had anything to eat or drink?
DATA COLLECTOR INSTRUCTIONS |
|
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
(LT_EAT_DRINK_MM) LAST EAT OR DRINK - DATE: MONTH
|___|___|
M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_EAT_DRINK_DD) LAST EAT OR DRINK - DATE: DAY
|___|___|
D D
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_EAT_DRINK_YYYY) LAST EAT OR DRINK - DATE: YEAR
|___|___|___|___|
Y Y Y Y
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_EAT_DRINK_TIME) LAST EAT OR DRINK - TIME
|___|___| : |___|___|
H H M M
Label |
Code |
Go To |
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
(LT_EAT_DRINK_TIME_UNIT) LAST EAT OR DRINK – AM/PM
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
BUC11000/(ATE_MEAT). How much of what {C_FNAME/the child} ate was beef, pork, tuna, or salmon?
Label |
Code |
Go To |
NONE |
1 |
|
Less than one quarter of the meal |
2 |
|
One quarter to one half of the meal |
3 |
|
More than one half but less than three quarters of the meal |
4 |
|
Three quarters or more, but not all of the meal |
5 |
|
All of the meal |
6 |
|
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
SOURCE |
National Children’s Study, Legacy Phase (Modified) |
PROGRAMMER INSTRUCTIONS |
|
BUC12000/(CARE_PRODUCTS). Have you or anyone else used any of the following products on the child's diaper area in the past 24 hours?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
Child powder/talc/cornstarch |
1 |
|
Diaper cream/ointment |
2 |
|
Vaseline |
3 |
|
Child wipes |
4 |
|
Child shampoo/body wash |
5 |
|
Child lotion |
6 |
|
Baby oil |
7 |
|
NONE |
8 |
|
OTHER |
-5 |
|
REFUSED |
-1 |
|
DON'T KNOW |
-2 |
|
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
PROGRAMMER INSTRUCTIONS |
|
BUC12100/(CARE_PRODUCTS_OTH). SPECIFY: ________________________________________
SOURCE |
National Children’s Study, Legacy Phase (6M Child) |
(TIME_STAMP_BUC_ET).
PROGRAMMER INSTRUCTIONS |
|
(TIME_STAMP_DCC_ST).
PROGRAMMER INSTRUCTIONS |
|
DCC01000/(CLEANSE_METHOD). HOW WAS THE CHILD’S GENITAL AREA CLEANSED?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
SOAP AND WATER |
1 |
|
WATER ONLY |
2 |
|
DID NOT CLEANSE |
3 |
PLACED_BAG_1 |
DCC02000/(CLEANSE_DONE_BY). WHO CLEANSED THE CHILD’S GENITAL AREA?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
DATA COLLECTOR |
1 |
PLACED_BAG_1 |
ADULT CAREGIVER |
2 |
PLACED_BAG_1 |
OTHER |
-5 |
|
DCC03000/(CLEANSE_DONE_BY_OTH). SPECIFY: ________________________________________
DCC04000/(PLACED_BAG_1). WHO PLACED THE URINE BAG ON THE CHILD?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
DATA COLLECTOR |
1 |
BAG_2_USED |
ADULT CAREGIVER |
2 |
BAG_2_USED |
ADULT CAREGIVER REFUSED BAG PLACEMENT |
3 |
COLLECTION_COMMENT |
OTHER |
-5 |
|
DCC05000/(PLACED_BAG_1_OTH). SPECIFY: _________________________________
DCC06000/(BAG_2_USED). WAS A SECOND BAG USED?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
YES |
1 |
|
NO |
2 |
SPECIMEN_STATUS |
ADULT CAREGIVER REFUSED BAG PLACEMENT |
3 |
COLLECTION_COMMENT |
DCC07000/(BAG_2_USED_REASON). REASON FOR USING SECOND BAG.
Label |
Code |
Go To |
FIRST BAG LEAKED |
1 |
PLACED_BAG_2 |
FIRST BAG TORN/PULLED OFF |
2 |
PLACED_BAG_2 |
FIRST BAG SPILLED |
3 |
PLACED_BAG_2 |
BOWEL MOVEMENT |
4 |
PLACED_BAG_2 |
OTHER |
-5 |
|
DCC08000/(BAG_2_USED_REASON_OTH). SPECIFY: _____________________________________
DCC09000/(PLACED_BAG_2). WHO PLACED THE SECOND BAG ON THE CHILD?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
DATA COLLECTOR |
1 |
SPECIMEN_STATUS |
ADULT CAREGIVER |
2 |
SPECIMEN_STATUS |
OTHER |
-5 |
|
DCC10000/(PLACED_BAG_2_OTH). SPECIFY: __________________________
DCC11000/(SPECIMEN_STATUS). STATUS OF THE URINE COLLECTION
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
COLLECTED |
1 |
|
NOT COLLECTED |
2 |
|
PROGRAMMER INSTRUCTIONS |
|
DCC12000/(NO_SPECIMEN_REASON).
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
BAG LEAKED |
1 |
COLLECTION_LOCATION |
BAG TORN/PULLED OFF |
2 |
COLLECTION_LOCATION |
BAG SPILLED |
3 |
COLLECTION_LOCATION |
CONTAINER/CUP SPILLED |
4 |
COLLECTION_LOCATION |
CUP LEAKED |
5 |
COLLECTION_LOCATION |
SPECIMEN CONTAMINATED |
6 |
COLLECTION_LOCATION |
PHYSICAL LIMITATION |
7 |
COLLECTION_LOCATION |
CAREGIVER ILL/EMERGENCY |
8 |
COLLECTION_LOCATION |
COLLECTION SUPPLIES MALFUNCTIONED |
9 |
COLLECTION_LOCATION |
NO URINE TO TRANSFER |
10 |
COLLECTION_LOCATION |
CHILD ILL/EMERGENCY |
11 |
COLLECTION_LOCATION |
NO TIME |
12 |
COLLECTION_LOCATION |
OTHER |
-5 |
|
REFUSED |
-1 |
COLLECTION_LOCATION |
DCC13000/(NO_SPECIMEN_REASON_OTH). SPECIFY: _____________________________________________
PROGRAMMER INSTRUCTIONS |
|
DCC14000/(BAG_REMOVED_BY). WHO REMOVED THE BAG FROM THE CHILD?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
DATA COLLECTOR |
1 |
SPECIMEN_ID |
ADULT CAREGIVER |
2 |
SPECIMEN_ID |
OTHER |
-5 |
|
DCC15000/(BAG_REMOVED_BY_OTH). SPECIFY: __________________________
DCC16000/(SPECIMEN_ID). URINE COLLECTION CUP SPECIMEN ID
|___|___|___|___|___|___|___|___|___|-|___|___|___|___|
DATA COLLECTOR INSTRUCTIONS |
|
PROGRAMMER INSTRUCTIONS |
|
DCC17000.
DATA COLLECTOR INSTRUCTIONS |
|
(URINE_COLLECT_MM) DATE CHILD URINE SPECIMEN WAS COLLECTED - MONTH
|___|___|
M M
(URINE_COLLECT_DD) DATE CHILD URINE SPECIMEN WAS COLLECTED - DAY
|___|___|
D D
(URINE_COLLECT_YYYY) DATE CHILD URINE SPECIMEN WAS COLLECTED - YEAR
|___|___|___|___|
Y Y Y Y
(URINE_COLLECT_TIME) TIME CHILD URINE SPECIMEN WAS COLLECTED
|___|___| : |___|___|
H H M M
(URINE_COLLECT_TIME_UNIT)
Label |
Code |
Go To |
AM |
1 |
|
PM |
2 |
|
DCC18000/(COLLECTION_LOCATION). WHERE DID THE URINE COLLECTION OCCUR?
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
HOME |
1 |
COLLECTION_COMMENT |
CLINIC |
2 |
COLLECTION_COMMENT |
OTHER LOCATION |
-5 |
|
DCC19000/(COLLECTION_LOCATION_OTH). SPECIFY: _________________________________
DCC20000/(COLLECTION_COMMENT). RECORD ANY PROBLEMS OR CONCERNS ABOUT THE COLLECTION.
DATA COLLECTOR INSTRUCTIONS |
|
Label |
Code |
Go To |
NO COMMENTS |
1 |
DCC22000 |
COMMENT |
2 |
|
DCC21000/(COLLECTION_COMMENT_OTH). SPECIFY: _________________________________
DCC22000. {That’s fine. Thank you for your time./Thank you for the child’s participation in this sample collection.}
PROGRAMMER INSTRUCTIONS |
|
(TIME_STAMP_DCC_ET).
PROGRAMMER INSTRUCTIONS |
|
Public reporting burden for this collection of information is estimated to average 14 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.
File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
File Modified | 0000-00-00 |
File Created | 2021-01-28 |