Screening for Severe Illness at Diagnosis Has the Potential to Prevent Early TB Deaths: Programmatic Experience From Karnataka, India

Hemant Deepak Shewade; Sharath Burugina Nagaraja; Basavarajachar Vanitha; Hosadurga Jagadish Deepak Murthy; Madhavi Bhargava; Anil Singarajipura; Suresh G. Shastri; Bharatkumar Hargovandas Patel; Kajal Davara; Ramesh Chandra Reddy; Ajay M.V. Kumar; Anurag Bhargava

doi:10.9745/GHSP-D-21-00736

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FIGURE 1
Kaplan-Meier Failure Curve Depicting the Cumulative Proportion of Early Deaths (Within 2 Months) Over Time Among People With TB^a Notified by Public Health Facilities in 16 Districts in Karnataka, India From October 15 to November 30, 2020, N=3,010
^a Age ≥15 years, all forms, without known drug-resistant disease at diagnosis.
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FIGURE 2
Kaplan-Meier Failure Curves Depicting the Cumulative Proportion of Early Deaths (Within 2 Months) Over Time, Stratified by High Risk of Severe Illness Among People With TB^a Notified by Public Health Facilities in 16 Districts in Karnataka, India From October 15 to November 30, 2020, N=3,010
Abbreviation: RR, respiratory rate.
Note: Very severe undernutrition is body mass index <14 kg/m² or 14–15.9 with bilateral leg swelling. Log rank P value <0.05 for all.
^a Age ≥15 years, all forms, without known drug-resistant disease at diagnosis.

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TABLE 1.

Characteristics of People With TB Notified by Public Health Facilities of 16 Districts in Karnataka, India, October 15 to November 30, 2020, Stratified by High Risk of Severe Illness Status^a

Baseline Characteristics^b		High Risk of Severe Illness at Baseline(Exposure)			Unadjusted P Value for Association With^c
Baseline Characteristics^b	Total, No. (%) (N=3,010)^b	Exposure, No. (%) (n=537)	No Exposure, No. (%) (n=992)	Unknown, No. (%) (n=1,481)	Exposure	Outcome^d
Demographic
Age, years
15–24	475 (15.8)	79 (14.7)	155 (15.6)	241(16.3)	.88	<.01
25–34	609 (20.2)	112 (20.9)	192 (19.4)	305 (20.6)
35–44	617 (20.5)	112 (20.9)	209 (21.1)	296 (20.0)
45–54	573 (19.0)	93 (17.3)	197 (19.9)	283 (19.1)
55–64	413 (13.7)	74 (13.8)	132 (13.3)	207 (14.0)
≥65	323 (10.7)	67 (12.5)	107 (10.8)	149 (10.1)
Means (SD)	41.8 (15.8)	42.3 (16.6)	42.0 (15.4)	41.6 (15.8)	.17	<.01
Gender
Men	2,033 (67.5)	364 (67.8)	679 (68.4)	990 (66.8)	.70	<.01
Women	977 (32.5)	173 (32.2)	313 (31.6)	491 (33.2)
District					<.01	.33
Clinical
Test used for diagnosis
Rapid molecular	1,623 (53.9)	291 (54.2)	496 (50.0)	836 (56.4)	<.01	.49
Microscopy/culture	564 (18.7)	99 (18.4)	195 (19.7)	270 (18.2)
Chest radiograph	272 (9.0)	65 (12.1)	103 (10.4)	104 (7.0)
Others^e	551 (18.3)	82 (15.3)	198 (20.0)	271 (18.3)
Bacteriological confirmation (yes)	2,275 (75.6)	418 (77.8)	715 (72.1)	1,142 (77.1)	.01	.92
Site
Pulmonary	2,185 (72.6)	446 (83.1)	763 (76.9)	976 (65.9)	<.01	<.01
Extra-pulmonary	667 (22.2)	90 (16.8)	228 (23.0)	349 (23.6)
Missing	158 (5.2)	1 (0.2)	1 (0.1)	156 (10.5)
Previous treatment (yes)	473 (15.7)	111 (20.7)	137 (13.8)	225 (15.2)	<.01	.38
HIV
Positive	225 (7.5)	37 (6.9)	72 (7.3)	116 (7.8)	<.01	<.01
Negative	2,526 (83.9)	483 (89.9)	874 (88.1)	1,169 (78.9)
Unknown	259 (8.6)	17 (3.2)	46 (4.6)	196 (13.2)
DM
Yes	505 (16.8)	83 (15.5)	191 (19.3)	231 (15.6)	<.01	<.01
No	2,084 (69.2)	413 (76.9)	724 (73.0)	947 (63.9)
Unknown	421 (14.0)	41 (7.6)	77 (7.8)	303 (20.5)
Health system related
Bank details available (yes)	2,352 (78.1)	443 (82.5)	837 (84.4)	1,072 (72.4)	<.01	<.01
Peripheral health institute–notification facility
District/teaching	1,937 (66.6)	274 (54.9)	572 (59.3)	1,091 (75.4)	<.01	.46
Subdistrict level	767 (26.4)	192 (38.5)	325 (33.7)	250 (17.3)
Primary level	206 (7.1)	33 (6.6)	67 (7.0)	106 (7.3)
Time interval between diagnosis and starting treatment
Within 1 day	1,758 (58.4)	313 (58.3)	582 (58.7)	863 (58.3)	.02	<.01
2–6 days	997 (33.1)	191 (35.6)	337 (34.0)	469 (31.7)
7 days and longer	255 (8.5)	33 (6.1)	73 (7.3)	149 (10.1)
Median (IQR)	1 (0.3)	1 (0.3)	1 (0.3)	1 (0.3)	.67	<.01

Abbreviations: DM, diabetes mellitus; IQR, interquartile range; SD, standard deviation.
↵a Age ≥15 years, all forms, without known drug-resistant disease at diagnosis.
↵b Source is the routinely collected baseline data in NIKSHAY updated as on December 15, 2020.
↵c Chi square test for categorical variable, ANOVA for age (continuous data), Krushkal Wallis for time interval (continuous data).
↵d Early death (within 2 months).
↵e Includes instances where test of diagnosis was missing.

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TABLE 2.
Distribution of Early Deaths (Within 2 Months) Among People With TB^a Notified by Public Health Facilities of 16 Districts in Karnataka, India, October 15 to November 30, 2020
Time Period No. (%) (N=195) Cumulative %
Within 1 day 25 (12.8) 12.8
2–6 days 34 (17.4) 30.3
7–13 days 41 (21.0) 51.3
14–27 days 40 (20.5) 71.8
28 days and longer 55 (28.2) 100
↵a Age ≥15 years, all forms, without known drug-resistant disease at diagnosis.

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TABLE 3.

Association (Unadjusted) Between Death and High Risk of Severe Illness and Its Individual Components Among People With TB^a Notified by Public Health Facilities of 16 Districts in Karnataka, India, October 15 to November 30, 2020

		Incidence
	Total, N=3,010	Deaths, No. (%)	Rate per 100 pm^b	RR^c	95%CI
		195 (6.5)	3.5	-
High risk of severe illness
Yes	537	48 (8.9)	4.8	2.33	1.54, 3.52
Unknown	1481	109 (7.4)	4.2	1.92	1.34, 2.75
No	992	38 (3.8)	2.0	Ref
BMI <14kg/m² or 14–15.9 with leg swelling
Yes	184	26 (14.1)	7.9	3.15	2.04, 4.86
Unknown	1488	109 (7.3)	4.2	1.63	1.20, 2.22
No	1338	60 (4.5)	2.4	Ref
Unable to stand without support
Yes	148	26 (17.6)	10.3	4.04	2.64, 6.20
Unknown	1481	109 (7.4)	4.2	1.69	1.25, 2.30
No	1381	60 (4.3)	2.3	Ref
Respiratory rate >24/min and/or oxygen saturation <94%
Yes	345	31 (9.0)	4.9	1.95	1.27, 2.98
Unknown	1494	110 (7.4)	4.2	1.60	1.16, 2.19
No	1171	54 (4.6)	2.4	Ref
Respiratory rate >24/min
Yes	232	23 (9.9)	5.5	1.92	1.21, 3.03
Unknown	1580	110 (7.0)	3.9	1.35	0.99, 1.82
No	1198	62 (5.2)	2.7	Ref
Oxygen saturation <94%
Yes	155	15 (9.7)	5.4	1.86	1.09, 3.17
Unknown	1569	113 (7.2)	4.1	1.38	1.03, 1.85
No	1286	67 (5.2)	2.7	Ref

Abbreviations: BMI, body mass index; CI, confidence interval; PM, person-months; RR, relative risk.
↵a Age ≥15 years, all forms, without known drug-resistant disease at diagnosis.
↵b Incidence of deaths per 100 person-months of follow up.
↵c RR calculated as a ratio of incidence proportions.