Table 2.
Clinical and respiratory parameters measured at TB treatment completion, 6-month and 12-month study visits
| Parameter | TB treatment completion | 6-month visit | 12-month visit | P value: |
| (n=405) | (n=376) | (n=368) | Baseline vs 12 months* | |
| Self-reported symptom prevalence (%, 95% CI ) † | ||||
| Breathlessness | ||||
| Never/only with chest infections | 227 (56.0%, 51.1% to 60.9%) | 283 (75.3%, 70.6% to 79.5%) | 282 (76.6%, 72.0% to 80.9%) | <0.001 |
| Few days per month | 161 (39.8%, 35.0% to 44.7%) | 79 (21.0%, 17.0% to 25.5%) | 76 (20.7%, 16.6% to 25.2%) | |
| ≥Several days per week | 17 (4.2%, 2.5% to 6.6%) | 14 (3.7%, 2.1% to 6.2%) | 10 (2.7%, 1.3% to 4.9%) | |
| Cough | ||||
| Never/only with chest infections | 259 (64.0%, 59.1% to 68.6%) | 284 (75.5%, 70.9% to 79.8%) | 307 (83.4%, 79.2% to 87.1%) | <0.001 |
| Few days per month | 135 (33.3%, 28.8% to 38.2%) | 76 (20.2%, 16.3% to 24.6%) | 54 (14.7%, 11.2% to 18.7%) | |
| ≥Several days per week | 11 (2.7%, 1.4% to 4.8%) | 16 (4.3%, 2.5% to 6.8%) | 7 (1.9%, 0.8% to 3.9%) | |
| Sputum production | ||||
| Never/only with chest infections | 300 (74.1%, 69.5% to 78.3%) | 300 (79.8%, 75.4% to 83.7%) | 318 (86.4%, 82.5% to 89.7%) | <0.001 |
| Few days per month | 97 (23.9%, 19.9% to 28.4%) | 70 (18.6%, 14.8% to 22.9%) | 47 (12.8%, 9.5% to 16.6%) | |
| ≥Several days per week | 8 (2.0%, 0.9% to 3.9%) | 6 (1.6%, 0.6% to 3.4%) | 3 (0.8%, 0.2% to 2.4%) | |
| Wheeze | ||||
| Never/only with chest infections | 372 (91.8%, 88.7% to 94.3%) | 346 (92.0%, 88.8% to 94.6%) | 352 (95.7%, 93.0% to 97.5%) | 0.091 |
| Few days per month | 29 (7.2%, 4.8% to 10.1%) | 28 (7.5%, 5.0% to 10.6%) | 16 (4.3%, 2.5% to 7.0%) | |
| ≥Several days per week | 4 (1.0%, 0.3% to 2.5%) | 2 (0.5%, 0.1% to 1.9%) | 0 | |
| Any respiratory symptom, ≥monthly | 246 (60.7%, 55.8% to 65.5%) | 138 (36.7%, 31.8% to 41.8%) | 113 (30.7%, 26.0% to 35.7%) | <0.001 |
| Self-reported symptom impact (%, 95% CI ) | ||||
| Impact of chest on activities | ||||
| Does not stop any activities | 200 (49.4%, 44.4% to 54.4%) | 290 (77.1%, 72.5% to 81.3%) | 295 (80.2%, 75.7% to 84.1%) | <0.001 |
| Prevents one to two activities | 165 (40.7%, 35.9% to 45.7%) | 69 (18.4%, 14.6% to 22.6%) | 57 (15.5%, 11.9% to 19.6%) | |
| Prevents most/all activities | 40 (9.9%, 7.2% to 13.2%) | 17 (4.5%, 2.7% to 7.1%) | 16 (4.3%, 2.5% to 7.0%) | |
| Impact of chest on work | ||||
| Does not affect work | 243 (60.0%, 55.0% to 64.8%) | 309 (82.2%, 77.9% to 85.9%) | 323 (87.8%, 84.0% to 90.9%) | <0.001 |
| Interferes with/made me change work | 148 (36.5%, 31.8% to 41.4%) | 57 (15.2%, 11.7% to 19.2%) | 38 (10.3%, 7.4% to 13.9%) | |
| Made me stop work | 14 (3.5%, 1.9% to 5.7%) | 10 (2.7%, 1.3% to 4.8%) | 7 (1.9%, 0.8% to 3.9%) | |
| Breathless at rest/during personal care | 2 (0.5%, 0.1% to 1.8%) | 2 (0.5%, 0.1% to 1.9%) | 2 (0.5%, 0.1% to 1.9%) | 1.000 |
| Walks slower than peers/stops for rest at own pace | 108 (26.8%, 22.5% to 31.4%) | 57 (15.2%, 11.7% to 19.2%) | 64 (17.4%, 13.7% to 21.7%) | 0.002 |
| Breathless on hills | 176 (43.7%, 38.8% to 48.7%) | 82 (21.8%, 17.7% to 26.3%) | 83 (22.6%, 18.4% to 27.2%) | <0.001 |
| Quality of life | ||||
| Self-reported general health (%, 95% CI) | ||||
| Poor/fair | 115 (28.4%, 24.1% to 33.1%) | 54 (14.4%, 11.0% to 18.3%) | 22 (6.0%, 3.8% to 8.9%) | <0.001 |
| Good/excellent | 290 (71.6%, 66.9% to 75.9%) | 322 (85.6%, 81.7% to 89.0%) | 346 (94.0%, 91.1% to 96.2%) | |
| SGRQ total score (median, IQR) | 8.8 (1.3–23.4) | 0.4 (0–10.6) | 0.4 (0–6.9) | <0.001 |
| SGRQ symptom score (median, IQR) | 10.3 (2.7–23.1) | 2.7 (0–13.7) | 2.7 (0–13.7) | <0.001 |
| SGRQ activity score (median, IQR) | 11.2 (0–35.5) | 0 (0–11.9) | 0 (0–6.2) | <0.001 |
| SGRQ impact score (median, IQR) | 5.6 (0–15.5) | 0 (0–5.7) | 0 (0–3.7) | <0.001 |
| Clinical observations | ||||
| BMI (kg/m2) (median, IQR) | 20.5 (19.0–22.3) | 21.0 (19.4–22.7) | 21.1 (19.5–23.2) | <0.001 |
| Oxygen saturations (%) (median, IQR) | 98 (97–99) | 98 (97–99) | 98 (97–98) | <0.001 |
| Hypoxaemia (sats<92%) (%, 95% CI) | 6 (1.5%, 0.5% to 3.2%) | 6 (1.6%, 0.6% to 3.4%) | 4 (1.1%, 0.3% to 2.8%) | 0.706 |
| Respiratory rate (breaths/minute) (median, IQR) | 18 (17–20) | 19 (18–21) | 20 (19–22) | <0.001 |
| Heart rate (beats/minute) (median, IQR) | 78 (68–89) | 77 (68–86) | 77 (67–86) | 0.019 |
| Pedal oedema (%, 95% CI) | 7 (1.7%, 0.7% to 3.5%) | 3 (0.8%, 0.2% to 2.3%) | 3 (0.8%, 0.2% to 2.4%) | 0.317 |
| Palatal Kaposi sarcoma (n=368) (%, 95% CI) | 8 (2.2%, 0.9% to 4.2%) | 10 (2.7%, 1.3% to 4.8%) | 1 (0.3%, 0.0% to 1.5%) | 0.008 |
| Blood tests | ||||
| Haemoglobin (g/dL) (median, IQR) | 13.7 (12.3–15.1) | |||
| Positive aspergillus IgG ELISA (%, 95% CI) | 3 (0.7%, 0.2% to 2.1%) | 2 (0.5%, 0.1% to 1.9%) | 0.564 | |
| 6 min ute walk test ( n = 395 / 355 ) | ||||
| Distance (m) (mean, SD) | 568 m (79.7 m) | 611.2 m (71.0 m) | <0.001 | |
| Spirometry ( n = 365 / 341 / 336 ) ‡ | ||||
| FEV1 z-score (mean, SD) | −1.06 (1.26) | −0.90 (1.25) | −0.88 (1.19) | <0.001 |
| FVC z-score (mean, SD) | −0.91 (1.23) | −0.66 (1.19) | −0.61 (1.09) | <0.001 |
| FEV1/FVC ratio z-score (mean, SD) | −0.38 (1.26) | −0.51 (1.28) | −0.54 (1.29) | <0.001 |
| Pattern of spirometry (%, 95% CI) | ||||
| Obstruction (FEV1/FVC ratio <LLN) | 52 (14.2%, 10.8% to 18.3%) | 61 (17.9%, 14.0% to 22.4%) | 60 (17.9%, 13.9% to 22.4%) | <0.001 |
| Low FVC (FEV1/FVC ratio ≥LLN and FVC <LLN) | 73 (20.0%, 16.0% to 24.5%) | 45 (13.2%, 9.8% to 17.3%) | 43 (12.8%, 9.4% to 16.8%) | |
| Normal (FEV1/FVC ratio ≥LLN and FVC ≥LLN) | 240 (65.8%, 60.6% to 70.6%) | 235 (68.9%, 63.7% to 73.8%) | 233 (69.4%, 73.5% to 82.6%) | |
| CXR findings ( n = 403 / 361 ) | ||||
| % abnormal parenchyma (median (IQR), (range)) | 2.9 (0.4–9.2) (0–51.7) | 2.1 (0–7.1) (0–70.8) | <0.001 | |
| Ring and tramline severity score (0–18) (median (IQR), (range)) | 1 (0–3) (0–13.5) | 1 (0–2.5) (0–14.5) | 0.1 | |
*Pairwise comparisons between baseline and 12-month data using McNemar’s test for categorical variables, and Student’s t-test/Wilcoxon rank-sum for continuous variables.
†Symptom questions derived from SGRQ: Over the past 3 months I have (had shortness of breath / coughed / brought up sputum / had attacks of wheezing): not at all/only with chest infections / a few days a month / several days a week / most days a week; If you have tried to work in the past 3 months: my chest trouble does not affect my work / my chest trouble interferes with my work or made me change my work / my chest trouble made me stop work; Which of these statements best describes how your chest affects you: It does not stop me doing anything I would like to do / it stops me doing one to two things I would like to do / it stops me doing most of the things I would like to do / it stops me doing everything I would like to do.
‡BOLD standard data available for n=365/405 at baseline, n=341/376 at 6 months, and n=336/368 at 12 month study visits. Data age / sex / height standardised using GLI 2012 African-American reference ranges to generate z-scores.
BMI, body mass index; CXR, chest radiography; GLI-2012, Global Lung Initiative 2012; LLN, lower limit of normal; SGRQ, St George’s Respiratory Questionnaire.