Case Abstraction Form

Form Approved

OMB No. 0920-1011

Exp. Date 03/31/2017

Case Abstraction Form

Demographics

Question	Code	Variable
RVCT number		RVCT
Last Name		Lname
First Name		Fname
Alternate Names/Nicknames/Aliases:		Alias
Date of Birth (MM/DD/YY)		DOB
Age (years)		Age
Gender (1=Male, 2=Female, 3=Other, 99=missing)		Sex
Race/Ethnicity (1=Black, 2=White, 3=Hispanic/Latino, 4= American Indian/Alaskan Native, 5=Native Hawaiian/Pacific Islander, 6=Asian, 7=Other, 99=Missing) [Mark all that apply]		Race
Tribe If American Indian, then specify tribe:		Tribe
Tribe A residence If lives on Tribe A reservation, specify which area: 1=northwest of Yuma, 2=southwest of Yuma, 3=south of Yuma		Residence
If lives elsewhere, specify		Other
Locating Information, if available: Addresses: Phones: How long at this address? Be sure to list any other known addresses during last 3 years.
Country of Birth (1=United States, 2=Other [foreign-born], 99=missing) If foreign-born, then specify country:		Birth Country

Date of arrival (MM/DD/YY) For patients born outside the United States, enter the date of arrival in the United States.

Arrival

TB Risk Factors

Question	Code	Variable
HIV infection (0=No, 1=Yes, 99=Unknown)		HIV
Diabetes (0=No, 1=Yes, 99=Unknown)		DM
If diabetic, most recent HbA1C		A1C
Chronic Renal Failure (0=No, 1=Yes, 99=Unknown)		ESRD
Immunosuppression other than HIV (e.g. organ transplant, chemotherapy, medications such as steroids, TNF blockers. 0=No, 1=Yes, 99=Unknown)		Immune
Mental illness (0=No, 1=Yes, 99=Unknown) (Axis I diagnosis not related to substance abuse, e.g. mood disorders, schizophrenia, anxiety disorders)		Mental
Injection drug use-recent (Within 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		IDU_rvct
Injection drug use-ever (Prior to 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		IDU_ever
Injection drug names (open ended) list all drugs injected ever		IDU_list
Non-injection drug use-recent (Within 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		NIDU_rvct
Non-injection drug use-ever (Prior to 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		NIDU_ever
Non-Injection drug names (open ended) list all non-injection drugs used ever		NIDU_list
Excess alcohol use-recent (Within 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		EtOH_rvct
Excess alcohol use-ever (Prior to 1 year of TB diagnosis. 0=No, 1=Yes, 99=Unknown)		EtOH_ever
Smoking commercial tobacco regularly (i.e., most days) for at least 1 year at time of diagnosis (0=No, 1=Yes, 99=Unknown)		Tobacco
Homeless/unstable housing within 1 year of diagnosis? (0=No, 1=Yes 99=Unknown)		Home1
Homeless/unstable housing >1 year before diagnosis? (0=No, 1=Yes 99=Unknown)		Home2
Use of homeless shelter within 1 year of diagnosis? 0=No, 1=Yes 99=Unknown		Shelter1
Use of homeless shelter >1 year before diagnosis? 0=No, 1=Yes 99=Unknown		Shelter2
Shelter names (open ended) list all homeless shelters used		Shelter_list
At least 1 night in correctional/detention facility within 1 year of diagnosis? (0=No, 1=Yes 99=Unknown)		Incarc1
At least 1 night in correctional/detention facility >1 year before diagnosis? (0=No, 1=Yes 99=Unknown)		Incarc2
Incarceration facility names (open ended) list all correctional/detention facilities where stayed at least 1 night		Incarc_list
Residence in long term care facility within 1 year of diagnosis? (0=No, 1=Yes 99=Unknown)		LTCF1
Residence in long term care facility>1 year before diagnosis? (0=No, 1=Yes 99=Unknown)		LTCF2
If known exposure to TB case, exposure type: (1=own household, 2=homeless shelter, 3=jail, 4=other household, 5=bar, 6= hotel, 7=Other: ______________) List name of site if known:________________________		TBexp ExpOth ExpSite

TB Case Characteristics

Question	Code	Variable
How was case recognized or detected? (1=symptoms, 2=contact investigation, 3=routine TB screening by healthcare provider, 4=incidental finding by healthcare provider, 5=other, 99=unknown)		Caserec
Cough (0=not present 1= present, 99=unknown)		Cough
Fever (0=not present 1= present, 99=unknown)		Fever
Night Sweats (0=not present 1= present, 99=unknown)		Sweats
Weight Loss (0=not present 1= present, 99=unknown)		Weight
Other TB Symptoms (list)		OthSx
Date of first symptom onset (Enter the first date the patient began experiencing symptoms in the format MM/DD/YY)		DateSx
Site of disease (1=pulmonary, 2=extrapulmonary, 3=both pulmonary and extrapulmonary)		TBSite
Diagnostic CXR result (1=Negative, 2=Abnormal, possibly TB, 3=Abnormal, not consistent with TB, 4=Unknown [not completed or not available])		CXRrslt
Diagnostic chest radiograph (CXR) result date (Enter the date of the patient’s most recent CXR completed as part of current diagnostic workup leading to patient’s current diagnosis of TB. MM/DD/YY)		CXRdate
Cavitary disease on CXR? (0=No, 1=Yes, 99=Unknown)		CavCXR
Cavitary disease on CT? (0=No, 1=Yes, 99=Unknown)		CavCT
Sputum AFB smear positive disease? (0=No, 1=Yes, 2=Sputum never submitted)		Sputum
Sputum smear converted to negative (0=No, 1=Yes <2 months of treatment, 2=Yes >2 months of treatment, 3=Unknown/NA)		Smearconv
Other site AFB smear positive? (0=No, 1=Yes, 99=Unknown) Specify Site:__________________		OthSmear OthSite
Culture-confirmed disease? (0=No, 1=sputum only, 2=non-sputum specimen, 3=both sputum and non-sputum specimens, 4=specimens never submitted, 99=Unknown)		Culture
If culture confirmed, list GENType		GENType
Culture converted to negative (0=No, 1=Yes <2 months of treatment, 2=Yes >2 months of treatment, 3=Unknown/NA)		Cxconv
Diagnosis date (MM/DD/YY) (the earliest date of the following: positive smear, positive culture, positive PCR test, or abnormal chest x-ray/CT scan)		Dxdate
Drug susceptibility based on molecular testing (1=Pan-susceptible, 2=INH resistance, 3=rifampin resistance, 4=multiple resistance, including MDR TB, 88=pending, 99=unknown)		Suscept_Mol
Drug susceptibility based on culture (1=Pan-susceptible, 2=INH resistance, 3=rifampin resistance, 4=multiple resistance, including MDR TB, 88=pending, 99=unknown)		Suscept_DST
INH resistance level (highest concentration at which isolate is resistant)		INHR
RIF resistance level (highest concentration at which isolate is resistant)		RIFR
Specify any other detected resistance		Oth_R
Diagnostic TST result (Enter the patient’s TST result, if completed as part of the diagnostic workup leading to the patient’s current diagnosis of TB. 1=negative, 2=positive, 3=positive with conversion [>10mm increase in last 2 years], 4=not done due to prior positive TST, 5=not done for other reason, 99=result unknown)		TST
Diagnostic TST reading (mm reading)		TSTmm
Diagnostic TST date (MM/DD/YY)		TSTdate
Diagnostic QFT result (Enter the patient’s qualitative QFT result, if completed as part of the diagnostic workup leading to the patient’s current diagnosis of TB. 1=negative, 2=positive, 3=indeterminate, 4=not done, 99=unknown)		QFT
Diagnostic QFT value (result-nil). (Enter the quantitative result of the patient’s current QFT result, 99=Unknown. Leave blank if not performed.)		QFTvalue
Diagnostic QFT date (MM/DD/YY)		QFTdate
Diagnostic T.Spot result (Enter the patient’s qualitative result, if completed as part of the diagnostic workup leading to the patient’s current diagnosis of TB. 1=negative, 2=positive, 3=indeterminate, 4=borderline, 5=not done, 99=unknown)		TSpot
Diagnostic T.Spot value (Enter the quantitative result of the patient’s current result, 99=Unknown. Leave blank if not performed.)		TSpotvalue
Diagnostic T.Spot date (MM/DD/YY)		TSpotdate
Treatment (1=On treatment, 2=Completed full treatment, 3=Completed partial treatment, 4=Died during treatment, 5= Died before treatment, 6=died after treatment, 7=awaiting treatment initiation, 8=refused treatment, 99=Unknown)		TBrx
Start date of initial TB treatment (Enter the date of antituberculosis medication in the format MM/DD/YY.)		TBRxdate
If applicable, date of change to MDR TB regimen (Enter the date of antituberculosis medication in the format MM/DD/YY.)		MDRRxdate
List MDR TB regimen		MDRregimen
Date of treatment completion if done (Enter the date of antituberculosis medication in the format MM/DD/YY.)		Rxcomp
History of loss to follow-up or non-compliance during this TB treatment course (0= No, 1= Yes, 99=Unknown)		TBfu
If died, then enter date of death (MM/DD/YY)		Deathdate
If died, then enter cause of death		Deathcause

Previous TB episodes and LTBI history

Question	Code	Variable
Prior TB disease? (0=No, 1=Yes, 99=Unknown)		PrevTB
Year of previous diagnosis (YYYY)		Prevyr
If prior TB, exposure type (1=own household, 2=homeless shelter, 3=jail, 4=other household, 5=bar, 6= hotel, 7=Other: ______________)		PrevTBexp PrevTBexpoth
If prior TB, drug susceptibility (1=Pan-susceptible, 2=INH resistance, 3=rifampin resistance, 4=multiple resistance, incl. MDR TB, 88=pending, 99=unknown)		Prevresist
If prior TB, Genotype (GENType)		PrevGENtype
TB treatment completed (0= No, 1= Yes, 2=In progress, 99=Unknown)		PrevTBRx
History of loss to follow-up or non-compliance during TB treatment (0= No, 1= Yes, 99=Unknown)		PrevTBfu
Previous positive test for LTBI 0= No, 1= Pos TST, 2=Pos IGRA, 99=Unknown)		HxLTBI
Previous TST result date (Enter the date of the patient’s most recent TST before any test conducted as part of current diagnostic workup leading to patient’s current diagnosis of TB. MM/DD/YY)		PrevTSTdate
Previous TST result (MM) (Enter the mm reading of the patient’s previous TST result. 99=Unknown)		PrevTSTmm
Previous TST interpretation (1=Negative, 2=Positive, 3=Unknown)		PrevTSTrslt
Previous QFT result date (Enter the date of the patient’s most recent QFT before any a test conducted as part of current diagnostic workup leading to patient’s current diagnosis of TB. MM/DD/YY)		PrevQFTdate
Previous QFT result (Enter value [result-nil]. 99= unknown)		PrevQFTnum
Previous QFT interpretation (1=Negative, 2=Convertor, 3=Unknown)		PrevQFTrslt
Diagnostic T.Spot result (Enter the patient’s qualitative result, if completed as part of the diagnostic workup leading to the patient’s current diagnosis of TB. 1=negative, 2=positive, 3=indeterminate, 4=not done, 99=unknown)		PrevTSpot
Diagnostic T.Spot value (Enter the quantitative result of the patient’s current result, 99=Unknown. Leave blank if not performed.)		PrevTSpotvalue
Diagnostic T.Spot date (MM/DD/YY)		PrevTSpotdate
Previous chest radiograph (CXR) result date (Enter the date of the patient’s most recent CXR before any CXR conducted as part of current diagnostic workup leading to patient’s current diagnosis of TB. MM/DD/YY)		DateprevCXR
Previous CXR result (1=Negative, 2=Abnormal, possibly TB, 3=Abnormal, not consistent with TB, 99=Unknown [not completed or not available])		PrevCXRrslt
Initiated treatment for LTBI? 0=offered but refused, 1=never offered by provider, 2=yes, initiated, 99=unknown		LTBIRxStart
Prior LTBI treatment completed 0= No, 1= Yes, 99=Unknown		HxLTBIRx

Infectious Period Determination

Question	Code	Variable
Date of infectious period beginning (format MM/DD/YY) -For symptomatic patients, start the infectious period 3 months before “Date of symptom onset” recorded on page 2. -For asymptomatic patients who have sputum smear-positive or cavitary disease, start the infectious period 3 months before the “Diagnosis date” recorded on page 2. -For asymptomatic patients without sputum smear-positive or cavitary disease, start the infectious period 1 month before the “Diagnosis date” recorded on page 2		IPopen
Date of infectious period end (format MM/DD/YY) For patients who are not isolated, the infectious period can be closed when the following three conditions are met: Treatment with an adequate regimen (based on drug susceptibility results) for ≥2 weeks, AND The patient shows clinical improvement, AND Three consecutive sputum smears are negative (which have been obtained at least 8 hours apart) For patients who are isolated (e.g. in a hospital) until these three conditions are met, then use date of isolation as the end of the infectious period.		IPend

Public reporting burden of this collection of information is estimated to average 4 hours 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 Reports Clearance Officer; 1600 Clifton Road NE, MS D-74 Atlanta, Georgia 30333; ATTN: PRA (0920-1011)