for the main comparison.
Glucocorticosteroids for infants with biliary atresia following Kasai portoenterostomy | ||||||
Patient or population: infants with biliary atresia Settings: hospitals Intervention: glucocorticosteroids Comparison: placebo | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Risk Ratio (95% CI) | Number (no) of infants (no of RCTs) | Certainty of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Placebo | Glucocorticosteroids | |||||
All‐cause mortality six months after Kasai portoenterostomy |
19 per 1000 | 19 per 1000 (3 to 131) |
1.00 (0.14 to 6.90) |
104 placebo 107 treatment (2 RCTs, Bezerra 2014; Davenport 2007) |
⊕⊕⊝⊝ low1 | |
Serious adverse event, two years follow‐up |
800 per 1000 | 814 per 1000 (708 to 977) |
1.02 (0.87 to 1.20) |
70 placebo 70 treatment (1 RCT, Bezerra 2014) |
⊕⊕⊝⊝ low2 | A significantly higher proportion of the treatment group had their first serious adverse event in the first 30 days after their Kasai portoenterostomy. |
Health‐related quality of life | There are no data for this outcome in the included trials. | |||||
Infants who did not clear jaundice at six months | 514 per 1000 | 452 per 1000 (303 to 529) |
0.89 (0.67 to 1.17) |
107 placebo 104 treatment (2 RCTs, Bezerra 2014; Davenport 2007) |
⊕⊕⊝⊝ low1 | The required information size for significance for the Trial Sequential Analysis was 540. The number of infants included in this meta‐analysis was 211, corresponding to 39.1% of the required information size. |
All‐cause mortality or liver transplantation at two years | 402 per 1000 | 404 per 1000 (291 to 562) | 1.00 (0.72 to 1.39) | 107 placebo 104 treatment (2 RCTs, Bezerra 2014; Davenport 2007) |
⊕⊕⊝⊝ low1 | The required information size for significance for the Trial Sequential Analysis was 1774. The number of infants included in this meta‐analysis was 211, corresponding to 11.9% of the required information size. |
Subgroup analysis of infants operated on at less than 70 days of age who did not clear their jaundice by six months after Kasai portoenterostomy | 516 per 1000 | 381 per 1000 (210 to 423) | 0.75 (0.55 to 1.11) | 64 placebo 63 treatment (2 RCTs, Bezerra 2014; Davenport 2007) |
⊕⊕⊝⊝ low1 | The required information size for significance for the Trial Sequential Analysis was 538. The number of infants included in this meta‐analysis was 127, corresponding to 23.6% of the required information size. |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval. RCT: randomised clinical trial. | ||||||
GRADE Working Group grades of evidence
|
1 Downgraded two levels due to imprecision of the evidence: Trial Sequential Analysis determined that the sample size was insufficient to detect a difference between the two groups.
2 Downgraded one level due to imprecision of the evidence and another level due to inconsistency of the evidence: there was heterogeneity between the trials and there were inconsistent assessments of what constituted a significant adverse event. Trial Sequential Analysis determined that the sample size was insufficient to detect a difference between the two groups.