Background
Methods
Design and population
Site
Procedures
Data collection, sample size and statistical analyses
Ethical considerations
Results
Characteristics of the study population
TB treatment decision
HIV-positive (N = 398) | HIV-negative (N = 196) | |||||
---|---|---|---|---|---|---|
No treatment (n = 157) | Empirical treatment (n = 100) | Treatment based on confirmed TB (n = 141) | No treatment (n = 114) | Empirical TB treatment (n = 31) | Treatment based on confirmed TB (n = 51) | |
Age, median years [IQR] | 36 [30–45] | 34 [27–42] | 32 [26–38] | 45.5 [28–59] | 58 [34–70] | 28 [22–37] |
Women | 71.3 | 51.0 | 48.2 | 64.9 | 38.7 | 43.1 |
History of tuberculosis | 40.1 | 31.0 | 12.8 | 30.7 | 9.7 | 7.8 |
Antibiotic prior consultation | 27.4 | 34.0 | 22.9 | 25.4 | 35.5 | 31.4 |
BMIa, median [IQR] | 19.1 [17.8–21.0] | 18.1 [16.2–19.8] | 17.5 [16.0–19.1] | 20.4 [18.4–23.1] | 19.3 [17.0–20.8] | 18.8 [17.4–19.8] |
Moderate/Severe thinness (BMI < 17 Kg/m2) | 14.0 | 33.0 | 44.0 | 7.0 | 29.0 | 11.8 |
Severely ill | 3.9 | 25.3 | 31.4 | 1.8 | 16.7 | 19.6 |
Chest X-ray suggestive of TBb | 0.0 | 41.1 | 30.8 | 0.0 | 45.2 | 40.0 |
Mortality in the six months after the first consultation, and association with TB treatment
HIV-positive (N = 398) | HIV-negative (N = 196) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Unadjusted | Adjusted | Unadjusted | Adjusted | |||||||||||
Deaths n/N (%) | HR | 95% CI | p | aHR | 95% CI | p | Deaths n/N (%) | HR | 95% CI | p | aHR | 95% CI | p | |
Age (per additional year) | 0.98 | 0.95–1.02 | 0.303 | – | – | – | 1.03 | 0.99–1.07 | 0.142 | – | – | – | ||
Sex | ||||||||||||||
Men | 15/152 (9.0) | Ref | 4/88 (4.5) | Ref | ||||||||||
Women | 17/231 (7.4) | 0.81 | 0.40–1.62 | 0.550 | – | – | – | 4/108 (3.7) | 0.79 | 0.20–3.15 | 0.736 | – | – | – |
BMI (Kg/m2) | ||||||||||||||
> =17 | 11/281 (3.9) | Ref | Ref | 6/173 (3.5) | Ref | |||||||||
< 17 | 21/117 (18.0) | 4.91 | 2.36–10-18 | < 0.001 | 3.55 | 1.51–8.35 | 0.004 | 2/23 (8.7) | 2.41 | 0.49–11.93 | 0.282 | – | – | – |
Severely ill | ||||||||||||||
No | 15/320 (4.7) | Ref | Ref | 7/178 (3.9) | Ref | – | ||||||||
Yes | 17/75 (22.7) | 5.32 | 2.66–10.66 | < 0.001 | 2.67 | 1.17–6.12 | 0.020 | 1/17 (5.9) | 1.49 | 0.18–12.10 | 0.710 | – | – | – |
TB history | ||||||||||||||
No | 19/286 (6.6) | Ref | 7/154 (4.5) | Ref | ||||||||||
Yes | 13/112 (11.6) | 1.86 | 0.92–3.76 | 0.086 | – | – | – | 1/42 (2.4) | 0.51 | 0.06–4.17 | 0.532 | – | – | – |
CD4 count (cells/mL) | ||||||||||||||
> =200 | 9/247 (3.6) | Ref | Ref | – | – | – | – | – | – | |||||
< 200 | 20/129 (15.5) | 4.54 | 2.06–9.97 | < 0.001 | 3.21 | 1.42–7.28 | 0.005 | – | – | – | – | – | – | |
ART | ||||||||||||||
Not initiated | 6/58 (10.3) | Ref | Ref | – | – | – | – | – | – | |||||
Initiated before study | 17/184 (9.2) | 0.82 | 0.32–2.09 | 0.680 | 0.74 | 0.27–2.07 | 0.573 | – | – | – | – | – | – | |
Initiated during study | 6/132 (4.5) | 0.37 | 0.12–1.14 | 0.084 | 0.19 | 0.05–0.65 | 0.008 | – | – | – | – | – | – | |
Chest X-ray | ||||||||||||||
Normal | 3/62 (4.8) | Ref | ||||||||||||
Possible TB | 12/164 (7.3) | 1.55 | 0.43–5.50 | 0.496 | – | – | – | – | – | – | – | – | – | |
Suggestive TB | 3/47 (6.4) | 1.31 | 0.26–6.48 | 0.742 | – | – | – | – | – | – | – | – | – | |
TB treatment | ||||||||||||||
No TB treatmenta | 6/157 (3.8) | Ref | Ref | 3/114 (2.6) | Ref | Ref | ||||||||
Empirical treatment | 11/100 (11.0) | 3.04 | 1.12–8.21 | 0.029 | 2.51 | 0.79–7.90 | 0.115 | 4/31 (12.9) | 4.85 | 1.08–21.67 | 0.039 | 4.85 | 1.08–21.67 | 0.039 |
Treatment based on confirmed TB | 15/141 (10.6) | 2.76 | 1.07–7.12 | 0.036 | 1.25 | 0.37–4.21 | 0.718 | 1/51 (2.0) | 0.77 | 0.08–7.41 | 0.822 | 0.77 | 0.08–7.41 | 0.822 |
Age range (years) | Sex | BMI (Kg/m2) | Temperature (°C) | Respiratory rate (/min) | Pulse (/min) | Blood Pressure (mmHg) | Oedema in lower limbs | Xpert result | TB treatment | Reason to start TB treatment | Chest X-ray interpretation and conclusion by site clinician | Chest X-ray interpretation and conclusion by radiologist (quality control) | Symptoms’ assessment at 2 months | Management at 2 months | Days to death | |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Patient 1 | 31–35 | M | 21.5 | 36.7 | 24 | 81 | 228/149 | Yes | Neg | Treated empirically at first consultation | X-ray | Infiltrates, adenopathies; Possible TB | Cardiomegalia, Empyema, Brochiectasis, Not TB | No resolution | Stop TB treatment | 96 |
Patient 2 | 64–65 | M | 17.4 | 36.2 | 20 | 71 | 130/67 | No | Neg | Treated empirically at first consultation | X-ray | Infiltrates; Possible TB | Infiltrates, Possible TB | No resolution | Continue TB treatment | 100 |
Patient 3 | 71–75 | M | 17.8 | 36.5 | 28 | 100 | 140/70 | No | Neg | Treated empirically at first consultation | X-ray | Infiltrates, adenophathies, consolidation, cavities; Definitively TB | Consolidation, Fibrosis, Not TB | Complete resolution | Continue TB treatment | 170 |
Patient 4 | 71–75 | F | 22.5 | 36.0 | 26 | 76 | 170/90 | No | Neg | Treated empirically at first consultation | X-ray | Infiltrates, adenopathies, consolidation, pleural effusion; Definitively TB | Pleural effusion, Cardiomegalia, Not TB | Partial resolution | Continue TB treatment | 93 |
Patient 5 | 21–25 | F | 17.8 | 36.9 | 29 | 95 | 96/63 | No | Pos | Treated after bacteriological confirmation at first consultation | Xpert | Not done | Not done | Partial resolution | Continue TB treatment | 60 |
Patient 6 | 35–40 | F | 13.8 | 36.7 | 34 | 103 | 81/38 | No | Neg | Not treated | – | Missing data | No abnormal findings; Not TB | Not seen; Hospitalized | – | 69 |
Patient 7 | 41–45 | F | 21.0 | 36.9 | 28 | 107 | 140/88 | No | Neg | Not treated | – | Infiltrates, adenopathies, cardiomegalia; Possible TB | Cardiomegalia; Not TB | Complete resolution | No specific treatment | 182 |
Patient 8 | 75–80 | M | 16.6 | 36.6 | 28 | 90 | 120/68 | Yes | Neg | Not treated | – | Infiltrates, adenopathies, cavities; Possible TB | Granuloma, pleural thickening; Not TB | Not seen; Bed ridden at home | – | 103 |