23.7 Survey

OMB #: 0925-0593

OMB Expiration Date: 8/31/2014

Child Microbiome Stool SAQ, Phase 2g

OMB Specification

Child Microbiome Stool SAQ

Event Category:	Time-Based
Event:	24M
Administration:	N/A
Instrument Target:	Child
Instrument Respondent:	Primary Caregiver
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, CAI
Estimated Administration Time:	13 minutes
Multiple Child/Sibling Consideration:	Per Child
Special Considerations:	N/A
Version:	1.0
MDES Release:	4.0

*This instrument is a self-administered questionnaire (SAQ) that should be mailed to the participant prior to the visit/call. The participant should be asked to complete the SAQ prior to the scheduled visit/call and either mail it back to the ROC (in the case of the phone visit) or keep it and give it to the interviewer at the time of the in-person visit. *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 Microbiome Stool SAQ

TABLE OF CONTENTS

GENERAL PROGRAMMER INSTRUCTIONS: 1

CHILD MICROBIOME STOOL SAQ 3

FOR OFFICE USE ONLY 6

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Child Microbiome Stool 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.

CHILD MICROBIOME STOOL SAQ

CMS01000. As part of the National Children’s Study, we are asking you to provide a sample of the child’s stool. Please follow the instructions provided in the child stool collection kit to collect the sample.

 

After you have collected the stool sample, please complete the information on this form.

CMS02000/(COLLECT_STOOL). Were you able to collect the child’s stool sample? Check one.

Label	Code	Go To
Yes	1	CMS03000
No	2	STOOL_COLLECTION_COMMENTS

SOURCE

National Children's Study, Vanguard Phase (Modified) (12M)

CMS03000. On what date did you collect the sample? 

SOURCE

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

(COLLECT_STOOL_MM) |___|___|

   M    M

(COLLECT_STOOL_DD) |___|___|

   D    D

(COLLECT_STOOL_YYYY) |___|___|___|___|

   Y     Y    Y     Y

CMS04000. At what time did you collect the sample?

SOURCE

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

(COLLECT_STOOL_TIME) |___|___|:|___|___|

   H    H       M     M

(COLLECT_STOOL_TIME_UNIT) (circle one)  AM/PM

Label	Code	Go To
AM	1
PM	2

CMS05000/(TAKEN_MED_CHILD). In the past month, has the child taken, used or received any of the following?

(Select all that apply)

Label	Code	Go To
Antibiotics (such as penicillin, Amoxil, Z-pak or other similar medicines)	1
Antifungals (such as Lotrimin, Micatin, or similar medicated creams or capsules)	2
Nasally-delivered live, attenuated influenza vaccine (flu shot given as a nose spray, such as Flu Mist)	3
None	4
Don't know	-2

SOURCE

New

CMS06000/(TAKEN_PROBIOTIC_CHILD). In the past month, has the child taken any probiotic supplements (such as Culturelle) or had yogurt (such as Activia) in their diet at least once a week?

Label	Code	Go To
Yes	1
No	2
Don't know	-2

SOURCE

New

CMS07000/(COLD_PACKS_FROZEN). Before placing the stool sample in the shipper, had the cold packs been frozen for 12 hours or more?

Label	Code	Go To
Yes	1
No	2
Don't know	-2

SOURCE

New

CMS07100/(STOOL_COLLECTION_COMMENTS). Is there anything you want to tell us about collecting the child's stool sample?  If you could not collect the stool sample, please tell us why:

 

______________________________________________________________________________________________________________

______________________________________________________________________________________________________________

______________________________________________________________________________________________________________

SOURCE

National Children's Study, Vanguard Phase (Modified) (12M)

CMS08000. 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

 

|__|__|__|__|__|__|__|__|__| - |__|__|__|__|

FOU02000/(P_ID). Child 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 13 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.