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. 2020 Nov 20;86(3):e71–e79. doi: 10.1097/QAI.0000000000002567

TABLE 2.

Risk, Risk Differences, and Their 97.5% CI of Primary End Points at 12 months

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).