TABLE 2.
Endpoints | Clinician (MD) (N = 845), Number (%) | Nurse (NS) (N = 841), Number (%) | Risk Difference (NS-MD), (Point Estimate, 97.5% CI) |
Individual Outcomes | |||
Died | 8/845 (0.9) | 11/841 (1.3) | 0.4 (−1.1 to 0.9) |
LTFU | 213/845 (25.2) | 191/841 (22.7) | 1.7 (−1.9 to 4.9) |
Toxicity | 8/845 (0.9) | 8/841 (0.9) | −0.1 (−1.1 to 0.9) |
VF* | 46/548 (8.4) | 48/570 (8.4) | 0.4 (−3.3 to 4.0) |
Composite outcome | |||
Intention-to-treat analysis (complete cases analysis) | 259/692 (37.4) | 233/699 (33.3) | −4.1 (−9.8 to 0.2) |
Intention-to-treat analysis (MI) | 314/845 (37.2) | 284/841 (33.8) | −3.4 (−9.1 to 2.5) |
Per-protocol analysis | 257/685 (37.5) | 232/685 (33.9) | −3.6 (−10.5 to 0.6) |
Per-protocol analysis (MI) | 303/815 (37.2) | 274/803 (34.1) | −3.1 (−8.8 to 2.8) |
Risk difference = Risk in nurse arm − Risk among clinician arm.
Total individual events may not add up to total composite events because a patient could have multiple events, thus were counted once. Seventy-four participants in WHO stage 3/4 enrolled in error, thus excluded from both intention-to-treat and per-protocol analyses.
VF = virological failure.
Missing data; VF: (clinician = 297/845, nurse = 271/841), composite (clinician = 153/845, nurse = 142/841).