Table 1.
Summary of results of TSA
| Effect size | Incidence, or variance | I2 (%) | D2 (%) | RIS | % of RIS attained | Pooled effect (TSA adjusted 95% CI) | Z-curve passed the conventional boundaries? | Z-curve passed the TSA boundaries? | Z-curve passed the futility boundaries? |
|---|---|---|---|---|---|---|---|---|---|
| Overall mortality (12 studies, n = 802) | |||||||||
| RRR: 10.0% | 17.4% | 0 | 0 | 19,155 | 4.19 | NA | Yes | No | No |
| RRR: 20.0%* | 17.4% | 0 | 0 | 4584 | 17.5 | 0.66 (0.17, 2.55) | Yes | No | No |
| RRR: 30.0%* | 17.4% | 0 | 0 | 1944 | 41.3 | 0.66 (0.38, 1.14) | Yes | No | No |
| Intensive care unit length of stay (6 studies, n = 380) | |||||||||
| MIREDIF 1 day | 51.1 | 39 | 69.9 | 7119 | 18.7 | − 3.62 (− 14.30, 7.06) | Yes | No | No |
| MIREDIF 2 days* | 51.1 | 39 | 69.9 | 1781 | 21.3 | − 3.62 (− 9.80, 2.56) | Yes | No | No |
| MIREDIF 3 days* | 51.1 | 39 | 69.9 | 792 | 48.0 | − 3.62 (− 7.73, 0.49) | Yes | No | No |
| Hospital length of stay (3 studies, n = 200) | |||||||||
| MIREDIF 1 day | 312.2 | 0 | 0 | 13,122 | 1.5 | NA | Yes | No | No |
| MIREDIF 2 days* | 312.2 | 0 | 0 | 3281 | 3.1 | − 7.51 (− 27.50, 12.48) | Yes | No | No |
| MIREDIF 3 days* | 312.2 | 0 | 0 | 1459 | 13.7 | − 7.51 (− 27.50, 12.48) | Yes | No | No |
| Diarrhea incidence (11 studies, n = 765) | |||||||||
|
RRR: 15.0%* |
37.4 | 51 | 60.5 | 7644 | 10.0 | 0.70 (0.20, 2.49) | Yes | No | No |
| RRR: 25.0% | 37.4 | 51 | 60.5 | 2678 | 28.6 | 0.70 (0.38, 1.29) | Yes | No | No |
|
RRR: 35.0%* |
37.4 | 51 | 60.5 | 1325 | 57.7 | 0.70 (0.45, 1.09) | Yes | No | No |
TSA trial sequential analysis, I2 Between-trial heterogeneity, D2 diversity-estimate, RRR relative risk reduction, MIREDIF minimally relevant difference, RIS required information size, NA not applicable, CI confidence interval
*Post-hoc sensitivity analyses