EVIDENCE-BASED CHILD HEALTH: A COCHRANE REVIEW JOURNAL Evid.

-Based Child Health 2: 160162 (2007) Published online in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/ebch.113

Characteristics and Key Findings Tables Characteristics and key ndings for Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers
Elvira van Dalen* and Leontien Kremer
Department of Paediatric Oncology, Emma Childrens Hospital/Academic Medical Center, University of Amsterdam, The Netherlands

This is a commentary on a Cochrane review, published in this issue of EBCH, published as: Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers. Cochrane Database of Systematic Reviews 2006, Issue 2. Art. No.: CD004790. DOI: 10.1002/14651858.CD004790.pub2; and as a shorterned version as: Lee C, Gong Y, Brok J, Boxall EH, Gluud C. Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis. BMJ. 2006 Feb 11; 332: 32836. DOI: 10.1136/bmj.38719.435833.7C. Further information for this Cochrane review is available in this issue of EBCH in the accompanying EBCH Summary and Commentary articles.

The tables presented here contain the characteristics (Table I) and key ndings (Table II) of the Cochrane review Hepatitis B immunisation for newborn infants of hepatitis B surface antigen-positive mothers.
Table I. Characteristics of the systematic review and included randomized controlled trials
Systematic review Use of intention-to-treat (ITT) analysis described in Concealmethods of ment of review-section allocation No Adequate 6/30 Inadequate 24/30 Quality of included RCTs #

Search strategy Databases/registers Cochrane Neonatal Group Controlled Trials Register; Cochrane Hepato-Biliary Group Controlled Trials Register; CENTRAL; MEDLINE; EMBASE Handsearching/scanning references of relevant articles Contacting experts Yes Language restriction No

Total N of RCTs 30#

N of authors For selection of RCTs 1 author (and validated by 3 other authors)

Blinding of care providers and patients This review dened blinding as: adequate, if the trial was described as double blind and the method of blinding involved identical placebo or active drugs; unclear, if the trial was described as double blind, but the method of blinding was not described;

Blinding of outcome assessors See blinding of care providers and patients.

Completeness of follow-up Adequate (100%) 2/30 Inadequate (<100%) 14/30 Unclear from RCT 11/30 Unclear from review 3/30

N of included participants Not reported For data extraction 3 independent N of authors comparisons 11 For quality assessment 2 independent authors

*Correspondence to: Elvira van Dalen, Department of Paediatric Oncology, Emma Childrens Hospital/Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands. E-mail: ebch@amc.uva.nl. Copyright 2007 John Wiley & Sons, Ltd.

Characteristics and key ndings for Hepatitis B immunisation for newborn infants. . .

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Table I. (Continued)
Systematic review Use of intention-to-treat (ITT) analysis described in Concealmethods of ment of review-section allocation Quality of included RCTs #

Search strategy

Total

N of authors

Blinding of care providers and patients not performed, if the trial was not double blind It was not stated who (care provider, patient, outcome assessor) should be blind in order to be called double blind. Adequate 3/30 Not performed 19/30 Unclear 8/30

Blinding of outcome assessors

Completeness of follow-up

# In the text of the review it is stated that 29 RCTs are included in this review, however in the table of included studies 30 RCTs are described (the study of Ip 1989 is mentioned several times and for comparisons AB, AC and BC it is stated that these are the same trial and for comparisons AD, BD and CD this is also stated, therefore, we counted the study of Ip 89 as 2 RCTs).

Table II. Key ndings based on selection of clinical relevant outcomes

Comparison 01. Vaccine vs placebo or no intervention Outcome Hepatitis B events according to type of vaccine N Studies 5# N Children 403 Method Relative risk (Fixed) 95% CI Result 0.28 [0.20, 0.40] Inference Favours vaccine (but note ) I2 54.2%

Comparison 02. RV vs PDV Outcome Hepatitis B events N Studies 5# N Children 382 Method Relative risk (Fixed) 95% CI Result 1.00 [0.70, 1.42] Inference No evidence of effect I2 29.4%

Comparison 03. High-dose vs low-dose vaccine Outcome Hepatitis B events N Studies 5 N Children 582 Method Relative risk (Fixed) 95% CI Result 0.91 [0.57, 1.46] Inference No evidence of effect I2 1.8%

Comparison 04. Three-dose PDV plus HBIG vs two-dose PDV plus HBIG Outcome Hepatitis B events N Studies 1 N Children 74 Method Relative risk (Fixed) 95% CI Result 0.50 [0.05, 5.28] Inference No evidence of effect I2 NA

(continued overleaf )

Copyright 2007 John Wiley & Sons, Ltd.

Evid.-Based Child Health 2: 160162 (2007) DOI: 10.1002/ebch.113

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E. van Dalen and L. Kremer

Table II. (Continued)

Comparison 05. PDV at birth vs PDV at one month Outcome Hepatitis B events N Studies 1 N Children 108 Method Relative risk (Fixed) 95% CI Result 0.70 [0.18, 2.77] Inference No evidence of effect I2 NA

Comparison 06. One type of PDV vs another type of PDV Outcome Hepatitis B events N Studies 11 N Children 120 Method Relative risk (Fixed) 95% CI Result 0.50 [0.22, 1.15] Inference No evidence of effect I2 NA

Comparison 07. Four RV vaccinations vs three RV vaccinations Outcome Hepatitis B events N Studies 1 N Children 97 Method Relative risk (Fixed) 95% CI Result 1.49 [0.51, 4.37] Inference No evidence of effect I2 NA

Comparison 08. One type of RV vs another type of RV with same vaccination schedule Outcome Hepatitis B events (3 comparisons) N Studies 1-2$ N Children 98-143 Method Relative risk (Fixed) 95% CI Result Subtotals only Inference 3/3 no evidence of effect I2 NA/0%

Comparison 09. HBIG vs placebo or no intervention Outcome Hepatitis B events Adverse effects N Studies 14# 1 N Children 1086 136 Method Relative risk (Fixed) 95% CI Relative risk (Fixed) 95% CI Result 0.52 [0.44, 0.63] 3.47 [0.14, 83.67] Inference Favours HBIG No evidence of effect I2 6.3% NA

Comparison 10. Multiple HBIG plus PDV vs single HBIG plus PDV Outcome Hepatitis B events N Studies 2 N Children 198 Method Relative risk (Fixed) 95% CI Result 0.87 [0.30, 2.47] Inference No evidence of effect I2 0%

Comparison 11. PDV plus HBIG vs placebo or no intervention Outcome Hepatitis B events Adverse events N Studies 4# 2 N Children 246 105 Method Relative risk (Fixed) 95% CI Relative risk (Fixed) 95% CI Result 0.08 [0.03, 0.17] 0.29 [0.07, 1.13] Inference Favours PDV plus HBIG No evidence of effect I2 0% 0%

RV: recombinant vaccine; PDV: plasma derived vaccine; HBIG: hepatitis B immunoglobulin; Substantial heterogeneity (Higgins JPT, Green S, eds. Cochrane Handbook for Systematic Reviews of Interventions 4.2.5 [updated May 2005]. In: The Cochrane Library, Issue 2, 2006. Chichester: John Wiley & Sons, Ltd.); NA not applicable; # Based on analyses table and gures, in text different numbers of trials are reported; $ Comparison 8 does not have an overall estimate, but gives estimates for three subgroups, for each subgroup either one or two studies were available.

Copyright 2007 John Wiley & Sons, Ltd.

Evid.-Based Child Health 2: 160162 (2007) DOI: 10.1002/ebch.113