CAROS Data Dictionary_ Feb24 {24DS}

CARGOS Data Dictionary_Final 23Feb2024.xlsx

[NCCHSTP] Strengthening US Response to Resistant Gonorrhea (SURRG)

CAROS Data Dictionary_ Feb24 {24DS}

OMB: 0920-1242

Document [xlsx]
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Overview

LAB TABLE
CLINIC TABLE
ALERT REPORT


Sheet 1: LAB TABLE

Variable Name Variable Definition/Description Value Definition Var Type Var Length Null Allowed? Acceptable Null Value
CARGOS_SPEC_ID Unique Specimen ID consisting of sentinel site code + YYYYMM (month isolate collected) + isolate number (001 through 999) generated at the clinic/lab.

If a patient has more than one specimen on the same date, the CARGOS_SPEC_ID will be the unique identifier for each specimen.
Note: This CARGOS_SPEC_ID must be included on the specimen sent to the ARLN and will be used to link laboratory, clinic, and epi investigation data.
Character ID.
Ex: ABC-202301-001
ABC-202301-199
char 14 No
SITE 3 character sentinel site code. DEN=Denver (CO)
char 3 No
PATIENTID Unique patient/person identification number; 18 character limit. ID must be unique per person and cannot include any personally identifiable information (PII). CARGOS grantees may elect to have this ID match the unique patient ID generated from their NEDDS Surveillance system for GC-positive patients or other unique patient ID.

Note: This patient ID must be the same as the patient ID attached to CARGOS isolates sent to the ARLN and will be used to link all laboratory, clinical, and epi investigation data.

char 18 No
EVENTID Case ID/Event ID of case. Event identifier distinguishes each GC diagnosis, or for GC-negative contacts, each clinic testing visit event. This ID stays the same for the entire GC event, which could include testing, treatment, and TOC visits. This ID is up to 18 characters in length.
char 18 No
LAB_GENDER Gender 1=Male
2=Female
3=Female-to-male transgender (FTM)
4=Male-to-female transgender (MTF)
5=Other gender identity (including: non-binary, transgender unspecified, etc.)
8=Refused to Answer
9=Unknown
char 1 No
JURIS_PHL Local public health laboratory where specimen was processed DEL=Denver PHL (CO) char 3 No
FACILITY Submitter facility ID from where specimen was collected. Facility codes (See Appendix for more details) char 6 No
SPEC_COLLECT_DATE Specimen collection date YYYY/MM/DD; YYMMDDs10. date 10 No
SPEC_SOURCE Source of specimen collection B=Blood
C=Conjunctival
E=Endocervical
O=Other
P=Pharyngeal
R=Rectal
U=Urethral
UR=Urine
V=Vaginal
NC=Not captured
char 2 No
TESTTYPE Type of specimen test 1=Culture
2=Nucleic acid amplification test (NAAT)
3=Molecular probe/AMR assay
8=Other
9=Unknown
char 1 No 9=unknown
NMENING Isolate presumed to be N. meningitidis.

Isolates are suggestive of N. meningitidis when they have “discordant results” demonstrated by bacterial growth on culture consistent with N. gonorrhoeae (positive culture) and have a negative gonorrhea NAAT result. In the case of urethral specimens, the isolate should demonstrate Gram-negative intracellular diplococci by microscopy but have a negative gonorrhea NAAT result.

Please note: Variable used to identify isolates presumed to be N. meningitidis. For all isolates presumed to be N. meningitidis, select response option "1" and leave DATESENTARLN blank. For all N. gonorrhoeae isolates, leave null.
1= Presumed N. meningitidis isolate
char 1 Yes null
OTH_TEST Other test
char 50 Yes null
OTH_RESULT Other test result
char 50 Yes null
DATESENTARLN Date isolate sent to ARLN laboratory YYYY/MM/DD; YYMMDDs10. date 10 Yes null
PENA311 Molecular testing result for penA 311 genetic marker.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
PENA311_DATE Date of molecular test for penA 311 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
PENA515 Molecular testing result for penA 515 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
PENA515_DATE Date of molecular test for penA 515 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
PENA545 Molecular testing result for penA 545 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
PENA545_DATE Date of molecular test for penA 545 genetic mutation YYYY/MM/DD; YYMMDDs10. date 10 Yes null
GYRA91 Molecular testing result for gyrA 91 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
GYRA91_DATE Date of molecular test for gyrA 91 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
_23S2611 Molecular testing result for 23S 2611 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
_23S2611_DATE Date of molecular test for 23S 2611 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
_23S2059 Molecular testing result for 23S 2059 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
_23S2059_DATE Date of molecular test for 23S 2059 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
PORA Molecular testing result for por A genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
PORA_DATE Date of molecular test for por A genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null
PENA501 Molecular testing result for penA 501 genetic mutation.

Note: For N. gonorrhoeae isolates only
0=Mutation absent
1=Mutation present
2=Test failed
3=Indeterminate
9=Test not performed
char 1 Yes null
PENA501_DATE Date of molecular test for penA 501 genetic mutation. YYYY/MM/DD; YYMMDDs10. date 10 Yes null

Sheet 2: CLINIC TABLE

Variable Name Variable Definition/Description Value Definition Var Type Var Length Null Allowed? Acceptable Null Value
PATIENTID Unique patient/person identification number; 18 character limit. ID must be unique per person and cannot include any personally identifiable information (PII). CARGOS grantees may elect to have this ID match the unique patient ID generated from their NNDSS Surveillance system for GC-positive patients or other unique patient ID.

Note: This patient ID must be the same as the patient ID attached to CARGOS isolates sent to the ARLN and will be used to link all laboratory, clinical, and investigation data.

char 18 No
EVENTID Case ID/Event ID of case. Event identifier distinguishes each GC diagnosis, or for GC-negative contacts, each clinic testing visit event. This ID stays the same for the entire GC event, which could include testing, treatment, and TOC visits. This ID is up to 18 characters in length.
char 18 No
STATE Patient's state of residence 2-digit FIPS STATE code char 2 No
VISDATE Date of clinic visit YYYY/MM/DD; YYMMDDs10. date 10 No
CL_FACILITY Submitter clinic ID where specimen was collected Facility codes assigned by CDC char 6 No
GENDER Patient’s gender. How do you describe your gender identity? 1=Male
2=Female
3=Female-to-male transgender (FTM)
4=Male-to-female transgender (MTF)
5=Other gender identity (including: non-binary, transgender unspecified, etc.)
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
SEXBIRTH Sex assigned at birth. What sex were you assigned at birth? 1=Male
2=Female
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
AGE Patient age 999=Unknown num 3 No 12<PT_AGE<=99 or PT_AGE=999
HISP_ETH Ethnicity: Hispanic or Latino

Is the patient of Hispanic ethnicity?
0=No, not Hispanic/Latino
1=Yes, Hispanic/Latino
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
AIAN Race: AI/AN-American Indian or Alaskan Native

Does the patient identify as American Indian or Alaska Native?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
ASIAN Race: Asian

Does the patient identify as Asian?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
NHOPI Race: NH/PI-Native Hawaiian or Other Pacific Islander

Does the patient identify as Native Hawaiian or Pacific Islander?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
BLACK Race: Black or African American

Does the patient identify as black or African-American?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
WHITE Race: White

Does the patient identify as White?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
MULTIRACE Race: Multirace

Does the patient identify as Multirace?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
OTHRACE Race: Other

Does the patient identify as Other race?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
GENDER_SP Gender of sex partners

Provider documented gender of patient’s sex partners. For example, sex with partners who are males and/or F-to-M transgender only should be recorded as 1 (Males only). Sex with a questioning/nonbinary/intersex partner should be recorded as 9 (Unknown/Gender not listed). Sex partners who include male and female partners or questioning/intersex partner(s) AND male and/or female partners should be recorded as 3 (more than 1 gender).
1=Males only (includes F-to-M transgender)
2=Females only (includes M-to-F transgender)
3=More than 1 gender
8=Refused to answer
9=Unknown/Gender not listed
char 1 No 9=unknown/gender not listed
HIV_STATUS Patient- or provider-reported current HIV status 0=HIV-negative
1=HIV-positive
8=Refused to answer
9=Unknown
char 1 No 9=unknown
TRMT1 What is the patient's treatment for gonorrhea? 00=none
03=spectinomycin (Trobicin) 2 gm
04=ceftriaxone (Rocephin) 250 mg
05=ceftriaxone (Rocephin) 125 mg
06=ciprofloxacin (Cipro) 500 mg
07=cefoxitin (Mefoxin) 2 gm
12=cefixime (Suprax) 400 mg
14=cefpodoxime proxetil (Vantin) 200 mg
15=ofloxacin (Floxin) 400 mg
17=ceftizoxime (Cefizox) 500 mg
18=cefotaxime (Claforan) 500 mg
21=azithromycin (Zithromax) 2 gm
22=levofloxacin (Levaquin) 250 mg
23=cefpodoxime proxetil (Vantin) 400 mg
24=ceftibuten (Cedax) 400 mg
25=cefdinir (Omnicef ) 300 mg
26=cefdinir (Omnicef ) 600 mg
27= gemifloxacin 320 mg
28= gentamicin 240 mg (or weight-based dosage)
29=ceftriaxone (Rocephin) 500 mg
30=ceftriaxone (Rocephin) 1g
31=cefixime (Suprax) 800 mg
77=other (please indicate in Other medication prescribed)
99=unknown
char 2 No
MEDICATION1_OTH If TRMT1 was coded as 77 for ‘other’, please provide the name of the other medication. Free text field char 50 Yes Null
TRMT2 If a second antimicrobial was given specifically for the patient’s gonorrhea treatment, what was it?

Note: Please only complete TRMT2 for patients who received two antimicrobials for gonorrhea treatment.
11=azithromycin (Zithromax) 1 gm
21=azithromycin (Zithromax) 2 gm
28= gentamicin 240 mg (or weight-based dosage)
31=cefixime (Suprax) 800 mg
77=other (please indicate in Other medication prescribed)
char 2 Yes Null
MEDICATION2_OTH If TRMT2 was coded as 77 for ‘other’, please provide the name of the other medication. Free text field char 50 Yes Null
DATETX Date patient received treatment for gonococcal infection YYYY/MM/DD; YYMMDDs10. date 10 No Null
HIV_PREP Current patient HIV PrEP use 0=No
1=Yes
7=Not applicable
8=Refused to Answer
9=Unknown
char 1 No 7=not applicable if patient self-reports being HIV-positive
DOXY_PEP Has patient taken doxycycline for STI post-exposure prophylaxis within 60 days of clinic visit? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 Yes Null
MENING_VAX Prior history of meningococcal vaccination 1= MenACWY vaccine only
2= MenB vaccine only
3= Men ACWY + MenB vaccine
4= Meningococcal/meningitis vaccine,
but unknown
5= No meningitis vaccine
9= Unknown
char 1 Yes null

Sheet 3: ALERT REPORT

Variable Name Variable Definition/Description Value Definition Var Type Var Length Null Allowed? Acceptable Null Value
PATIENTID Unique patient/person identification number; 18 character limit. ID must be unique per person and cannot include any personally identifiable information (PII). CARGOS grantees may elect to have this ID match the unique patient ID generated from their NNDSS Surveillance system for GC-positive patients or other unique patient ID.

Note: This patient ID must be the same as the patient ID attached to CARGOS isolates sent to the ARLN and will be used to link all laboratory, clinical, and investigation data.

char 18 No
EVENTID Case ID/Event ID of case. Event identifier distinguishes each GC diagnosis, or for GC-negative contacts, each clinic testing visit event. This ID stays the same for the entire GC event, which could include testing, treatment, and TOC visits. This ID up to 18 characters in length.
char 18

CARGOS_SPEC_ID Unique Specimen ID consisting of sentinel site code + YYYYMM (month isolate collected) + isolate number (001 through 999) generated at the clinic/lab.

If a patient has more than one specimen on the same date, the CARGOS_SPEC_ID will be the unique identifier for each specimen.
Note: This CARGOS_SPEC_ID must be included on the specimen sent to the ARLN and will be used to link laboratory, clinic, and epi investigation data.
Character ID.
Ex: ABC-202301-001
ABC-202301-199
char 14 No
FACILITY Submitter facility ID from where specimen was collected. Facility codes (See Appendix for more details) char 6 No
STATE Patient's state of residence State FIPS char 2 No
SPEC_COLLECT_DATE Specimen collection date YYYY/MM/DD; YYMMDDs10. date 8 No
SPEC_SOURCE Source of specimen collection

**To be reported for each isolate collected at initial evaluation
B=Blood
C=Conjunctival
E=Endocervical
O=Other
P=Pharyngeal
R=Rectal
U=Urethral
UR=Urine
V=Vaginal
NC=Not captured
char 2 No
GENDER Patient’s gender. How does the patient describe their current gender identity? 1=Male
2=Female
3=Female-to-male transgender (FTM)
4=Male-to-female transgender (MTF)
5=Other gender identity
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
SEXBIRTH Sex assigned at birth. What sex was the patient assigned at birth? 1=Male
2=Female
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
AGE Patient age 999=Unknown num 3 No 999=unknown
HISP_ETH Ethnicity: Hispanic or Latino

Is the patient of Hispanic ethnicity?
0=No, not Hispanic/Latino
1=Yes, Hispanic/Latino
8=Refused to Answer
9=Unknown
char 1 No 9=unknown
AIAN Race: AI/AN-American Indian or Alaskan Native

Does the patient identify as American Indian or Alaska Native?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
ASIAN Race: Asian

Does the patient identify as Asian?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
NHOPI Race: NH/PI-Native Hawaiian or Other Pacific Islander

Does the patient identify as Native Hawaiian or Pacific Islander?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
BLACK Race: Black or African American

Does the patient identify as black or African-American?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
WHITE Race: White

Does the patient identify as White?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
MULTIRACE Race: Multirace

Does the patient identify as Multirace?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
OTHRACE Race: Other

Does the patient identify as Other race?
0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No 9=unknown
GENDER_SP Gender of sex partners

Provider documented gender of patient’s sex partners. For example, sex with partners who are males and/or F-to-M transgender only should be recorded as 1 (Males only). Sex with a questioning/nonbinary/intersex partner should be recorded as 9 (Unknown/Gender not listed). Sex partners who include male and female partners or questioning/intersex partner(s) AND male and/or female partners should be recorded as 3 (more than 1 gender).
1=Males only (includes F-to-M transgender)
2=Females only (includes M-to-F transgender)
3=More than 1 gender
8=Refused to answer
9=Unknown/Gender not listed
char 1 No 9=unknown/gender not listed
ETEST_DATE Date of completion of Etest (final result) YYYY/MM/DD; YYMMDDs10. date 10 No
CFX_MIC_DD Etest Cefixime MIC reported in doubling dilutions
Record the MIC number only (ignore greater than (>) or less than (<) symbols), >256 recorded as 256
999=insufficient growth
Blank if Etest not performed

**To be reported for each isolate collected at initial evaluation with Etest performed
0.016, 0.032, 0.064, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16, 32, 64, 128, 256, 999 num 8 No
CRO_MIC_DD Etest Ceftriaxone MIC reported in doubling dilutions
Record the MIC number only (ignore greater than (>) or less than (<) symbols), >256 recorded as 256
999=insufficient growth
Blank if Etest not performed

**To be reported for each isolate collected at initial evaluation with Etest performed
0.002, 0.004, 0.008, 0.016, 0.032, 0.064, 0.125, 0.25, 0.50, 1, 2, 4, 8, 16, 32, 999 num 8 No
TRMT1 What is the patient's treatment for gonorrhea? 00=none
03=spectinomycin (Trobicin) 2 gm
04=ceftriaxone (Rocephin) 250 mg
05=ceftriaxone (Rocephin) 125 mg
06=ciprofloxacin (Cipro) 500 mg
07=cefoxitin (Mefoxin) 2 gm
12=cefixime (Suprax) 400 mg
14=cefpodoxime proxetil (Vantin) 200 mg
15=ofloxacin (Floxin) 400 mg
17=ceftizoxime (Cefizox) 500 mg
18=cefotaxime (Claforan) 500 mg
21=azithromycin (Zithromax) 2 gm
22=levofloxacin (Levaquin) 250 mg
23=cefpodoxime proxetil (Vantin) 400 mg
24=ceftibuten (Cedax) 400 mg
25=cefdinir (Omnicef ) 300 mg
26=cefdinir (Omnicef ) 600 mg
27= gemifloxacin 320 mg
28= gentamicin 240 mg (or weight-based dosage)
29=ceftriaxone (Rocephin) 500 mg
30=ceftriaxone (Rocephin) 1g
31=cefixime (Suprax) 800 mg
77=other (please indicate in Other medication prescribed)
99=unknown
char 2 No
MEDICATION1_OTH If TRMT1 was coded as 77 for ‘other’, please provide the name of the other medication. Free text field char 50 Yes Null
TRMT2 If a second antimicrobial was given specifically for the patient’s gonorrhea treatment, what was it?

Note: Please only complete TRMT2 for patients who received two antimicrobials for gonorrhea treatment.
11=azithromycin (Zithromax) 1 gm
21=azithromycin (Zithromax) 2 gm
28= gentamicin 240 mg (or weight-based dosage)
31=cefixime (Suprax) 800 mg
77=other (please indicate in Other medication prescribed)
char 2 Yes Null
MEDICATION2_OTH If TRMT2 was coded as 77 for ‘other’, please provide the name of the other medication. Free text field char 50 Yes Null
DATETX Date patient received gonorrhea treatment YYYY/MM/DD; YYMMDDs10. date 10 No
TRAVEL Has the patient traveled outside of US in the past 3 months? 0=No
1=Yes
9=Unknown
char 1 No
TRAVEL_FOLLOW1 If TRAVEL="Yes", please specify location(s) (if known). Free text field char 50

TRAVEL_FOLLOW2 If TRAVEL="Yes", did the patient report having sex while outside of the US? 0=No
1=Yes
9=Unknown
char 1

CONTACT_TRAVEL In the past 3 months, did the patient have sex with someone who traveled from outside the US within the 6 months prior to sexual encounter? 0=No
1=Yes
9=Unknown
char 1

SEXWORK Does patient have a history of giving or receiving drugs/money/food/lodging for sex in the previous 12 months (prior to the initial evaluation)? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
SXPHARYNGEAL At initial evaluation: Does the patient report any pharyngeal/throat symptoms (e.g., pain, discomfort)? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
SXDYSURIA At initial evaluation: Does the patient report dysuria? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
SXDISCHARGE At initial evaluation: Does the patient report genital discharge? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
SXRECTAL At initial evaluation: Does the patient report rectal symptoms (e.g. pain or tenesmus)? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
SXABDOMEN At initial evaluation: Does the patient report abdominal pain? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
DOXY_PEP At initial evaluation: Has patient taken doxycycline for STI post-exposure prophylaxis within 60 days of clinic visit? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 Yes 9=unknown or null
TOC Did the patient return for a test-of-cure visit? 0=No
1=Yes
9=Unknown
char 1 No
TOC_DATE Date of patient's test-of-cure visit YYYY/MM/DD; YYMMDDs10. date 10 No
TOC_SEXACT Has the patient been sexually active between treatment and test-of-cure visit? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
TOC_SXSTATUS Did the patient present with new, persistent, or worsening symptoms at the test-of-cure visit? If yes, please specify symptom(s) using variables TOC_SXPHARYNGEAL, TOC_SXDYSURIA, TOC_SXDISCHARGE, TOC_SXRECTAL, TOC_SXABDOMEN 0=No
1=Yes
8=Refused to answer
9=Unknown




TOC_SXPHARYNGEAL At test-of-cure evaluation: Does the patient report any pharyngeal/throat symptoms (e.g., pain, discomfort)? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
TOC_SXDYSURIA At test-of-cure evaluation: Does the patient report dysuria? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
TOC_SXDISCHARGE At test-of-cure evaluation: Does the patient report genital discharge? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
TOC_SXRECTAL At test-of-cure evaluation: Does the patient report rectal symptoms (e.g. pain or tenesmus)? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
TOC_SXABDOMEN At test-of-cure evaluation: Does the patient report abdominal pain? 0=No
1=Yes
8=Refused to answer
9=Unknown
char 1 No
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