Plint 2009 (G+P vs P+P).
| Methods | See Plint 2009 | |
| Participants | See Plint 2009 | |
| Interventions | See Plint 2009 This glucocorticoid versus placebo comparison includes data from Group 3 (dexamethasone + placebo) versus Group 4 (placebo and placebo) |
|
| Outcomes | See Plint 2009 | |
| Funding | See Plint 2009 | |
| Notes | See Plint 2009 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer‐generated randomization sequence, stratified by center, used randomised permuted blocks of 8 and 12." |
| Allocation concealment (selection bias) | Low risk | "Codes were secured at each center’s pharmacy until enrolment and data entry were complete. In order to conceal the allocation sequence, the pharmacy at each site prepared the study drugs in sequentially numbered, visually identical packets." |
| Blinding (performance bias and detection bias) Health care use ((re)admissions, LOS, return visits) | Low risk | Double‐blind; "The active drugs and placebo were identical in appearance, volume, weight, odor, and taste." |
| Blinding (performance bias and detection bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | Double‐blind; "The active drugs and placebo were identical in appearance, volume, weight, odor, and taste." |
| Blinding (performance bias and detection bias) Patient/parent‐reported outcomes (symptoms, QoL) | Low risk | Double‐blind; "The active drugs and placebo were identical in appearance, volume, weight, odor, and taste." |
| Blinding (performance bias and detection bias) Other outcomes (adverse events, others) | Low risk | Double‐blind; "The active drugs and placebo were identical in appearance, volume, weight, odor, and taste." |
| Incomplete outcome data (attrition bias) Health care use ((re)admissions, LOS, return visits) | Low risk | 3 patients with missing outcome data |
| Incomplete outcome data (attrition bias) Clinical parameters (severity scales, SpO2, respiratory and heart rate) | Low risk | 3 patients with missing outcome data |
| Incomplete outcome data (attrition bias) Patient/parent‐reported outcomes (symptoms, QoL) | Low risk | 3 patients with missing outcome data |
| Incomplete outcome data (attrition bias) Other outcomes (adverse events, others) | Low risk | 3 patients with missing outcome data |
| Selective reporting (reporting bias) | Low risk | Published report includes all pre‐specified and expected outcomes; study protocol was available |
| Other bias | Low risk | No significant baseline imbalances; no other sources of bias |
| Overall risk of bias | Low risk | All applicable domains low risk of bias |