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. 2018 May 14;2018(5):CD008735. doi: 10.1002/14651858.CD008735.pub3

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
  • High certainty: this research provides a very good indication of the likely effect; the likelihood that the effect will be substantially different is low.

  • Moderate certainty: this research provides a good indication of the likely effect; the likelihood that the effect will be substantially different is moderate.

  • Low certainty: this research provides some indication of the likely effect; however, the likelihood that it will be substantially different is high.

  • Very low certainty: this research does not provide a reliable indication of the likely effect; the likelihood that the effect will be substantially different is very high.

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.