Table 1

Criteria used for assessing the risk of bias in included studies

CriterionNone/minimalModerateHigh
Eligibility criteriaConsecutive unselected population
Selected from a general population
Eligibility criteria explained
Selected from general population but criteria not clearly defined
Eligibility criteria not clearly explained
Sample selection ambiguous
Sample likely not representative
Highly selected population
Methods for determining HSV-2 statusMethodology clearly defined and replicable
Laboratory details including cut-off values reported
HSV-2 seroconverters were properly accounted for
Methodology stated but details unclearMethodology poorly defined or implemented and not replicable
Methods for ascertaining infant HIV statusMethodology clearly defined and replicable
Laboratory details including cut-off values reported
PCR-based testing or Ab-based testing at appropriate timepoints
Methodology stated but details unclearMethodology poorly defined or implemented and not replicable
Methods to account for confoundingControlled for, or excluded, patients with key confounders (eg, ARV, anti-HSV therapy, mode of delivery, feeding strategy)Controlled for, or excluded, only certain confounders (eg, ARV, anti-HSV therapy, mode of delivery, feeding strategy)Did not control for, or exclude, patients with key confounders (eg, ARV, anti-HSV therapy, mode of delivery, feeding strategy)
AnalysisSample size calculation performed and achieved
Analysis appropriate, no concerns
Sample size calculation unclear, but all available patients studied
Sample size not achieved but explanation given
Analysis appropriate by minor concerns
Sample size calculation unclear or not performed, or sample size not achieved
Analysis has major concerns
AttritionNo/minimal attrition (<10%)
Reasons for losses to follow-up explained
Moderate attrition (10%–20%)
Reasons for LTFU incompletely explained
High attrition (>20%)
Reasons for LTFU not explained
OverallAt least three items at low risk of bias
No more than two items at moderate risk
At least three items at low to moderate risk of bias
No more than item at high risk of bias
Not meeting criteria for low or moderate risk of bias
  • HSV, herpes simplex virus.