Computer Aided Screening for Tuberculosis in Low Resource Environments (CASTLE) trial data – Data Codebook

Persistent identifier

10.17037/DATA.00003552

Description

CASTLE is a cluster randomised trial comparing enhanced TB diagnostics (urine SILVAMP-LAM plus urine LF-LAM plus digital chest Xray with computer aided diagnosis plus usual care) to usual care alone, among adults living with HIV admitted to hospital. Clusters are day of admission to hospital. Primary outcome is TB treatment started prior to hospital discharge. Secondary outcomes are all-cause mortality at 56 days from enrolment, undiagnosed TB at time of discharge from hospital, and TB treatment initiation within 24 hours of enrolment. Data collected using a combination of face-to-face questionnaire, laboratory test results, and information gathered from written medical records by trained research assistants.

Data codebook

Castle cohort sharing codebook

The following variables are contained in the Castle_cohort_sharing dataset.

Variable name	Variable label	Answer label	Answer code	Variable type
id	Participant ID number			Numeric
cluster_n	Cluster number			Numeric
b004_arm	Trial arm			Numeric
a101_sex	Sex			String
		female	female
		male	male
a999_ageg	Age group			String
		Age 18 - 29 years	[18,30]
		Age 30 - 39 years	(30,40]
		Age 40 - 49 years	(40,50]
		Age 50 - 59 years	(50,60]
		Age 60 years and older	(60,Inf]
a999_artstatus	ART status			String
		a) Never taken ART	a) Never taken ART
		b) Previously on ART	b) Previously on ART
		c) On ART, less than 6 months	c) On ART, less than 6 months
		d) On ART, more than 6 months	d) On ART, more than 6 months
a306_ns	Night sweats			String
		No	No
		Yes	Yes
a307_wl	Weight loss			String
		No	No
		Yes	Yes
a308_fev	Fever			String
		No	No
		Yes	Yes
a303_cough	Current cough (any duration)			String
		No	No
		Yes	Yes
a999_tbsx	Any one of more TB symptoms (fever, cough, night sweats, weight loss)			String
		No	no_tb_sx
		Yes	tb_sx
a309_walk	Able to walk unaided			String
		No	No
		Yes	Yes
a310_tbsus	Was TB in the differential diagnosis according to medical admission notes? (Did the clinician "suspect" TB?)			String
		No	No
		Yes	Yes
z999_cd4under100	CD4 count			String
		a) Under 100 cells/mm3	a) Under 100
		b) 100+ cells/mm3	b) 100+
		c) No CD4 measured	c) No CD4 measured
z999_cd4low	CD4 count			String
		a) Under 100 cells/mm3	a) Under 100
		b) 100 to 200 cells/mm3	b) 100 to 200
		c) 200 or more cells/mm3	c) 200 or more
		d) No CD4 measured	d) No CD4 measured
z999_vlcat	HIV viral load			String
		a) Undetectable	a) Undetectable
		b) 40 to 400 copies/mL	b) 40 to 400
		c) 400 to 1000 copies/mL	c) 400 to 1000
		d) Over 1000 copies/mL	d) high
		e) Not done	e) Not done
b999_cad	CAD4TB score			String
		Not applicable	NA
		0 - 9	(0,10]
		10 -19	(10,20]
		20 - 29	(20,30]
		30 - 39	(30,40]
		40 - 49	(40,50]
		50 - 59	(50,60]
		60 - 69	(60,70]
		70 - 79	(70,80]
		80 - 89	(80,90]
		90 - 100	(90,100]
		Not applicable	NA
b304_alere	Alere LF-LAM results (done by trial team)			String
		Not applicable	NA
		Negative	Alere_neg
		Positive (Grade 1)	Grade_1_pos
		Positive (Grade 2)	Grade_2_pos
b302_fuji	Fuji SILVAMP-LAM result			String
		Not applicable	NA
		Negative	Fuji_neg
		Positive	Fuji_pos
z999_xpert	Sputum Xpert NAAT result			String
		Not performed	not done
		Negative	neg
		Positive	pos
z999_sputum_cult	Sputum culture result			String
		Negative	a) Negative
		M. tb	b) M. tb
		Mycobacterium other than TB (MOTT)	c) MOTT
		Contaminated	d) Contaminated
		No sputum produced	e) No sputum produced
z999_lighthouselam	Alere LF-LAM result done by routine care			String
		Positive	Positive
		Negative	Negative
		Not done	Not done
z999_tbdx	TB diagnostic results			String
		TB tested positive. Treatment provided	a) TB treatment
		TB tested positive. No treatment	b) TB test pos, no treatment
		No TB detected	c) No TB
z999_los	Length of stay in hospital			String
		Less than 1 day	[0,1]
		1 to 3 days	(1,4]
		4 to 6 days	(4,7]
		7 to 13 days	(7,14]
		14 to 20 days	(14,21]
		21 days or longer	(21,Inf]
e999_treatment	Started on TB treatment			String
		No	0
		Yes	1
z999_outcome	Outcome at 56 days			String
		a) Died in hospital	a) Died in hospital
		b) Died at home	b) Died at home
		c) Alive at 56 days	c) Alive at 56 days
		d) LTFU	loss to follow-up
z999_undiag	Undiagnosed TB at 56 days			Numeric
		No	0
		Yes	1
z999_tbrx24h	TB treatment starteed within 24 hours enrollment			String
		Not applicable	NA
		Within 24 hours	within_24h
		After 24 hours	after 24h
z999_tbrx24h_num	TB treatment starteed within 24 hours enrollment			Numeric
		No	0
		Yes	1
z999_failure	Death occurred			Numeric
		No	0
		Yes	1
z999_time2out	Time to outcome (death or end of follow up)	Number of days from enrollment to outcome		Numeric
z999_time2out_num	Time to outcome (death or end of follow up)	Number of days from enrollment to outcome		Numeric
b999_fujidone	Was urine Fuji SILVAMP-LAM test done?			String
		Not done	a) Fuji_not_done
		Done	b) Fuji_done
		Not applicable	NA
z999_alerelamdone	Was urine Alere LF-LAM test done?			String
		Not done	a) aLAM_not_done
		Done	b) aLAM_done
		Not applicable	NA
b999_dcxrcaddone	Was a Xray done and CAD4TB score obtained?			String
		Not done	a) CAD_not_done
		Done	b) CAD_done
		Not applicable	NA
z999_xpertdone	Was a sputum Xpert done?			String
		Not done	a) Xpert_not_done
		Done	b) Xpert_done
		Not applicable	NA
z999_cultdone	Was a sputum culture for TB done?			String
		Not done	a) Cult_not_done
		Done	b) Cult_done
		Not applicable	NA
e019_reasonall	What were the reasons for starting TB treatment? (List all that apply)			String
		Xpert positive sputum	1
		FujiLAM positive	2
		AlereLAM positive	3
		Digital Chest X-ray with high CAD score	4
		Clinical interpretation of digital Chest X-ray appearance (regardless of CAD score)	5
		Appearance of a conventional (non-digital chest Xray)	6
		CSF results	7
		Xpert on a non-sputum sample	8
		FASH scan (ultrasound)	9	String
		Not applicable	NA
e020_mainreason	What was the one main reason for starting TB treatment? (Choose one)			String
		Xpert positive sputum	1
		FujiLAM positive	2
		AlereLAM positive	3
		Digital Chest X-ray with high CAD score	4
		Clincial interpretation of igital Chest X-ray appearance (regardless of CAD score)	5
		Apperance of a conventional (non-digital chest Xray)	6
		CSF results	7
		Xpert on a non-sputum sample	8
		FASH scan (ultrasound)	9
		Not applicable	NA

Castle_trial_sharing_codebook

The following variables are contained with the Castle_trial_sharing dataset.

Variable name	Variable label	Answer label	Answer code	Variable type
id	Participant ID			String
cluster_n	Cluster number			Numeric
b004_arm	Trial arm			Numeric
		Usual care arm	1
		Intervention arm	2
a101_sex	Sex			String
		female	female
		male	male
a999_ageg	Age group			String
		Age 18 - 29 years	[18,30]
		Age 30 - 39 years	(30,40]
		Age 40 - 49 years	(40,50]
		Age 50 - 59 years	(50,60]
		Age 60 years and older	(60,Inf]
a999_artstatus	ART Status			String
		a) Never taken ART	a) Never taken ART
		b) Previously on ART	b) Previously on ART
		c) On ART, less than 6 months	c) On ART, less than 6 months
		d) On ART, more than 6 months	d) On ART, more than 6 months
a306_ns	Night sweats			String
		No	No
		Yes	Yes
a307_wl	Weight loss			String
		No	No
		Yes	Yes
a308_fev	Fever			String
		No	No
		Yes	Yes
a303_cough	Current cough (any duration)			String
		No	No
		Yes	Yes
a999_tbsx	Any one of more TB symptoms (fever, cough, night sweats, weight loss) present			String
		Yes	tb_sx
		No	no_tb_sx
a309_walk	Able to walk unaided			String
		No	No
		Yes	Yes
a310_tbsus	Was TB in the differential diagnosis according to medical admission notes? (Did the clinician "suspect" TB?)			String
		No	No
		Yes	Yes
z999_cd4under100	CD4 count			String
		a) Under 100	a) Under 100
		b) 100+	b) 100+
		c) No CD4 measured	c) No CD4 measured
z999_cd4low	CD4 count			String
		a) Under 100	a) Under 100
		b) 100 to 200	b) 100 to 200
		c) 200 or more	c) 200 or more
		d) No CD4 measured	d) No CD4 measured
z999_vlcat	HIV viral laod			String
		a) Undetectable	a) Undetectable
		b) 40 to 400	b) 40 to 400
		c) 400 to 1000	c) 400 to 1000
		d) high	d) high
		e) Not done	e) Not done
b999_cad	CAD4TB score			String
		0 - 9	(0,10]
		10 -19	(10,20]
		20 - 29	(20,30]
		30 - 39	(30,40]
		40 - 49	(40,50]
		50 - 59	(50,60]
		60 - 69	(60,70]
		70 - 79	(70,80]
		80 - 89	(80,90]
		90 - 100	(90,100]
		Not applicable	NA
b304_alere	Alere LF-LAM results (done by trial team)			String
		Negative	Alere_neg
		Positive (Grade 1)	Grade_1_pos
		Positive (Grade 2)	Grade_2_pos
		Positive (Grade 3)	Grade_3_pos
		Positive (Grade 4)	Grade_4_pos
		Not applicable	NA
b302_fuji	Fuji SILVAMP-LAM result			String
		Positive	Fuji_pos
		Negative	Fuji_neg
		Invalid / indeterminate	Fuji_ind
		Not applicable	NA
z999_xpert	Sputum Xpert NAAT result			String
		Positive	pos
		Negative	neg
		Not done	not done
z999_sputum_cult	Sputum culture result			String
		a) Negative	a) Negative
		b) M. tb	b) M. tb
		c) MOTT	c) MOTT
		d) Contaminated	d) Contaminated
		e) No sputum produced	e) No sputum produced
z999_lighthouselam	Alere LF-LAM result done by routine care			String
		Positive	Positive
		Negative	Negative
		Not done	Not done
z999_tbdx	TB diagnostic results			String
		a) TB treatment	a) TB treatment
		b) TB test pos, no treatment	b) TB test pos, no treatment
		c) No TB	c) No TB
z999_los	Length of stay in hospital			String
		Less than 1 day	[0,1]
		1 to 3 days	(1,4]
		4 to 6 days	(4,7]
		7 to 13 days	(7,14]
		14 to 20 days	(14,21]
		21 days or longer	(21,Inf]
e999_treatment	Started on TB treatment			String
		No	0
		Yes	1
z999_outcome	Outcome at 56 days
		a) Died in hospital	a) Died in hospital
		b) Died at home	b) Died at home
		c) Alive at 56 days	c) Alive at 56 days
		d) Loss to Follow-up	d) LTFU
z999_undiag	Undiagnosed TB at 56 days			String
		No	0
		Yes	1
z999_tbrx24h	TB treatment starteed within 24 hours enrollment			String
		Within 24 hours	within_24h
		After 24 hours	after 24h
		Not applicable	NA
z999_tbrx24h_num	TB treatment starteed within 24 hours enrollment			Numeric
		No	0
		Yes	1
z999_failure	Death occurred			Numeric
		No	0
		Yes	1
z999_time2out	Time to outcome (death or end of follow up)	Number of days from enrollment to outcome		Numeric
z999_time2out_num	Time to outcome (death or end of follow up)	Number of days from enrolment to outcome		Numeric
b999_fujidone	Was urine Fuji SILVAMP-LAM test done?			String
		Not done	a) Fuji_not_done
		Done	b) Fuji_done
z999_alerelamdone	Was urine Alere LF-LAM test done?			String
		Not done	a) aLAM_not_done
		Done	b) aLAM_done
b999_dcxrcaddone	Was a Xray done and CAD4TB score obtained?			String
		Not done	a) CAD_not_done
		Done	b) CAD_done
z999_xpertdone	Was a sputum Xpert done?			String
		Not done	a) Xpert_not_done
		Done	b) Xpert_done
z999_cultdone	Was a sputum culture for TB done?			String
		Not done	a) Cult_not_done
		Done	b) Cult_done
e019_reasonall	What were the reasons for starting TB treatment? (List all that apply)			String
		Xpert positive sputum	1
		FujiLAM positive	2
		AlereLAM positive	3
		Digital Chest X-ray with high CAD score	4
		Clincial interpretation of igital Chest X-ray appearance (regardless of CAD score)	5
		Apperance of a conventional (non-digital chest Xray)	6
		CSF results	7
		Xpert on a non-sputum sample	8
		FASH scan (ultrasound)	9
		Not applicable	NA
e020_mainreason	What was the one main reason for starting TB treatment? (Choose one)			String
		Xpert positive sputum	1
		FujiLAM positive	2
		AlereLAM positive	3
		Digital Chest X-ray with high CAD score	4
		Clinical interpretation of digital Chest X-ray appearance (regardless of CAD score)	5
		Appearance of a conventional (non-digital chest Xray)	6
		CSF results	7
		Xpert on a non-sputum sample	8
		FASH scan (ultrasound)	9
		Not applicable	NA