Skip to main content

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