Patient characteristics at baseline for T12 model
| Training (n=2548) | Validation (n=1274) | Overall sample (n=3822) | |
| FEV1 | 34.4 (7.3) | 34.3 (7.4) | 34.4 (7.3) |
| Interim change in FEV1 (T12–T0)* | |||
| Greater than >10% (improvement in FEV1) | 782 (31.6%) | 416 (33.8%) | 1198 (32.3%) |
| Between −10% and 10% | 1083 (43.8%) | 514 (41.8%) | 1597 (43.1%) |
| Less than −10% (deterioration in FEV1) | 608 (24.6%) | 300 (24.4%) | 908 (24.5%) |
| Gender (female) | 1209 (47.4%) | 594 (46.6%) | 1803 (47.2%) |
| Age at incident advance CF | 30.8±10.7 (median=28.0) | 30.7±10.9 (median=28.0) | 30.7±10.8 (median=28.0) |
| Race (white) | 2419 (94.9%) | 1213 (95.2%) | 3632 (95.0%) |
| Insurance | |||
| Private insurance only | 1174 (46.1%) | 551 (43.2%) | 1725 (45.1%) |
| Medicare only | 111 (4.4%) | 59 (4.6%) | 170 (4.4%) |
| Combination of any insurance including Medicaid | 1263 (49.6%) | 664 (52.1%) | 1927 (50.4%) |
| BMI | 21.1±3.6 (median=20.4) | 21.0±3.5 (median=20.3) | 21.1±3.6 (median=20.4) |
| Hispanic ethnicity | 114 (4.5%) | 66 (5.2%) | 180 (4.7%) |
| Ventilation machine (non-invasive) | 75 (2.9%) | 42 (3.3%) | 117 (3.1%) |
| Corticosteroids (oral (eg, prednisone)) | 311 (12.2%) | 160 (12.6%) | 471 (12.3%) |
| Patient is on enzymes | 2275 (89.3%) | 1128 (88.5%) | 3403 (89.0%) |
| Oxygen therapy | |||
| No | 1707 (69.0%) | 811 (65.9%) | 2518 (68.0%) |
| Yes, continuously | 90 (3.6%) | 43 (3.5%) | 133 (3.6%) |
| Yes, nocturnal and/or with exertion | 211 (8.5%) | 119 (9.7%) | 330 (8.9%) |
| Yes, during exacerbation | 339 (13.7%) | 204 (16.6%) | 543 (14.7%) |
| Yes, prn | 86 (3.5%) | 37 (3.0%) | 123 (3.3%) |
| Unknown | 40 (1.6%) | 16 (1.3%) | 56 (1.6%) |
| Supplemental feeding | 1306 (51.3%) | 675 (53.0%) | 1981 (51.8%) |
| Haemophilus influenzae (any species) | 174 (6.8%) | 73 (5.7%) | 247 (6.5%) |
| Pseudomonas aeruginosa (found in the culture) | 1930 (75.7%) | 981 (77.0%) | 2911 (76.2%) |
| Burkho complex (Burkholderia species) | 125 (4.9%) | 58 (4.5%) | 183 (4.8%) |
| Other microorganisms | 522 (20.5%) | 289 (22.7%) | 811 (21.2%) |
| Staphylococcus aureus/MRSA† | |||
| +/+ | 697 (27.3%) | 341 (26.7%) | 1038 (27.2%) |
| +/− | 672 (26.4%) | 320 (25.1%) | 992 (25.9%) |
| −/NA | 1108 (43.5%) | 571 (44.8%) | 1679 (43.9%) |
| Pseudomonas aeruginosa/Resistant to aminoglycosides‡ | |||
| +/+ | 690 (27.1%) | 345 (27.1%) | 1035 (27.1%) |
| +/− | 1240 (48.7%) | 636 (49.9%) | 1876 (49.1%) |
| −/NA | 547 (21.5%) | 251 (19.7%) | 798 (20.9%) |
| Pulmonary complications (massive haemoptysis or pneumothorax requiring chest tube) | 115 (4.5%) | 49 (3.8%) | 164 (4.3%) |
| Liver disease, cirrhosis | 85 (3.3%) | 28 (2.2%) | 113 (3.0%) |
| Cancer confirmed by histology | 13 (0.5%) | 4 (0.3%) | 17 (0.4%) |
| Depression | |||
| No | 1843 (74.5%) | 943 (76.7%) | 2786 (75.2%) |
| Yes | 630 (25.5%) | 287 (23.3%) | 917 (24.8%) |
| Renal failure requiring dialysis | 13 (0.5%) | 4 (0.3%) | 17 (0.4%) |
| # of clinic visits in the review year | 4.4±2.9 (median=4.0) | 4.4±2.9 (median=4.0) | 4.4±2.9 (median=4.0) |
| Disabled§ | 571 (22.4%) | 268 (21.0%) | 839 (21.9%) |
| DM or impaired glucose tolerance | 1062 (41.7%) | 579 (45.4%) | 1641 (42.9%) |
| Smoking | 65 (2.5%) | 35 (2.7%) | 100 (2.6%) |
| Mutation class | |||
| 1–3 | 1850 (72.6%) | 921 (72.3%) | 2771 (72.5%) |
| 4–5 | 197 (7.7%) | 89 (7.0%) | 286 (7.5%) |
| Other | 349 (13.7%) | 189 (14.8%) | 538 (14.1%) |
| Unknown missing | 152 (6.0%) | 75 (5.9%) | 277 (5.9%) |
| # of pulmonary exacerbations in the year preceding advanced stage CF diagnosis | 1.8±1.9 (median=1.0) | 2.1±2.1 (median=2.0) | 1.9±1.9 (median=1.0) |
| Interim number of pulmonary exacerbations (T0–T12) | 1.8±1.8 (median=1.0) | 1.9±2.0 (median=1.0) | 1.8±1.9 (median=1.0) |
| Lung transplant in the past 12 months | |||
| No | 2123 (85.8%) | 1037 (84.3%) | 3160 (85.3%) |
| Yes | 350 (14.2%) | 193 (15.7%) | 543 (14.7%) |
*FEV1% change calculated as ([FEV1%T12–FEV1%T0]/[FEV1%T0])×100.
†Refers to presence of MRSA on culture/resistant to vancomycin.
‡Refers to presence of Pseudomonas on culture/resistant to all aminoglycoside.
§Refers to patient unemployed due to a disability.
BMI, body mass index; CF, cystic fibrosis; DM, diabetes mellitus; FEV1, forced expiratory volume in 1 s; MRSA, methicillin-resistant S. aureus; NA, not available.