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Table 5 Risk of Bias assessment with ROBINS-I tool for the included non-randomized studies

From: Antileukotrienes for the prevention and treatment of chronic lung disease in very preterm newborns: a systematic review

  Confounding Selection of participants into the study Classification of interventions Deviations from intended interventions Missing data Measurement of outcomes Selection of the reported results Overall risk of bias
Rupprecht 2014 Criticala Low Low Low Low Moderatef Low Critical
Min Kim 2009 Lowb Seriousc Low Moderated Moderatee Moderateg Moderateh Serious
Panjwani 2016 No information Seriousi No information No information No information No information No information j Serious
Cheng 2014 No informationk Critical l Moderatem Low No information Moderaten Moderateo Critical
  1. aThe control group consisted of children whose parents provided informed consent for participation in this study (as a control group patient) but not for administration of the medication montelukast (controls 1–5, 8,and 9; Table 1); and children in whom the planned therapy scheme was not possible due to existing or arising contraindications for the study drug (4 children, phenobarbital therapy in controls 6, 7, 10, and 11)
  2. bNo significant difference between groups regarding patients' characteristics
  3. cThere is no clear definition of inclusion and exclusion criteria
  4. dThe study does not specify the exact time for which montelukast was given and for how long co-interventions of the conservative treatment were given, which may lead to relevant differences in co-interventions
  5. eData appears to be complete, although no protocol was published and the study was not registered as a clinical study
  6. fOutcome "Duration for mechanical ventilation" might be biased by unblinded outcome assessor
  7. gOutcome "Need for mechanical ventilation" might be biased by unblinded outcome assessor
  8. hThere is a discrepancy between text of the results section and table about vomiting or diarrhea as an adverse effect
  9. iThe study uses historical cohort as comparator, there is no clear definition of inclusion criteria, exclusion criteria are not well-specified
  10. jOnly abstract is available
  11. kInformation about possible confounding is insufficient
  12. lHistorical cohort, no clear definition of inclusion and exclusion criteria, no control group
  13. mSubjective inclusion criteria
  14. nOutcomes ‘hospital stay’ and ‘respiratory support (duration, days)’ are subjective
  15. oNo protocol published