Table 4.
Proposed Alternative Reporting of Trial Data in Which Primary Outcome of Interest Is Ventilator Duration
| ARMA | ALVEOLI | FACTT | ALTA | OMEGA | |
|---|---|---|---|---|---|
| Intervention | Low VT | Higher PEEP | Conservative | Albuterol | Supplements |
| Control | High VT | Lower PEEP | Liberal | Placebo | Formula |
| Extubated alive (composite) | |||||
| SHR | 1.30 | 0.91 | 1.30 | 0.79 | 0.73 |
| 95% CI | 1.09 to 1.54 | 0.75 to 1.11 | 1.12 to 1.51 | 0.60 to 1.02 | 0.56 to 0.97 |
| P value | 0.003 | 0.356 | <0.001 | 0.072 | 0.027 |
| 28-d mortality | |||||
| Intervention | 24% | 22% | 26% | 20% | 22% |
| Control | 34% | 22% | 29% | 14% | 13% |
| RR 28-d mortality | 0.70 | 1.04 | 0.86 | 1.47 | 1.70 |
| 95% CI | 0.57 to 0.87 | 0.76 to 1.42 | 0.69 to 1.08 | 0.87 to 2.51 | 0.99 to 2.91 |
| P value | 0.001 | 0.810 | 0.186 | 0.159 | 0.049 |
| Mean ± SD ventilator days in 28-d survivors | |||||
| Intervention | 8.9 ± 7.1 | 8.3 ± 6.0 | 8.2 ± 5.8 | 6.8 ± 6.0 | 7.3 ± 5.2 |
| Control | 8.6 ± 7.8 | 8.7 ± 6.2 | 10.3 ± 6.4 | 7.1 ± 5.9 | 6.9 ± 5.1 |
| Δ Mean ventilator days in survivors | 0.26 | −0.32 | −2.02 | −0.24 | 0.46 |
| 95% CI | −0.96 to 1.47 | −1.57 to 0.93 | −2.95 to −1.10 | −1.88 to 1.39 | −1.01 to 1.93 |
| Student’s t test P value | 0.680 | 0.619 | <0.001 | 0.770 | 0.539 |
Definition of abbreviations: ALTA = Albuterol for the Treatment of Acute Lung Injury; ALVEOLI = Assessment of Low Tidal Volume and Elevated End-expiratory Volume to Obviate Lung Injury; ARMA = Respiratory Management in ARDS; CI = confidence interval; FACTT = Fluid and Catheter Treatment Trial; OMEGA = Omega Nutritional Supplement Trial; PEEP = positive end-expiratory pressure; RR = risk ratio; SHR = subdistribution hazard ratio.