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. Author manuscript; available in PMC: 2014 Jun 16.
Published in final edited form as: Cochrane Database Syst Rev. 2012 Apr 18;4:CD009148. doi: 10.1002/14651858.CD009148.pub2
Methods Randomised.
Participants 735 women with high-risk pregnancies referred for fetal well-being testing
Interventions Fetal biophysical profile versus non-stress test.
Outcomes Apgar score, positive and negative predictive value of the test
Notes
Risk of bias
Bias Authors’ judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly assigned -using flip of a coin.
Allocation concealment (selection bias) Unclear risk Not described.
Blinding of participants and personnel (performance bias)
All outcomes
Low risk “Neither patient nor referring physician was aware of which testing scheme had been assigned.” Study also described as “prospective blind study” - blinding only broken in women in whom a major lethal fetal anomaly was detected
Blinding of outcome assessment (detection bias)
All outcomes
High risk Not blinded.
Incomplete outcome data (attrition bias)
All outcomes
Low risk All patients appear to be accounted for within the results tables: scheme A, N=360 scheme B, N=375, total number patients referred = 735
Selective reporting (reporting bias) Unclear risk Unclear - not clearly documented which outcomes were to be collected as part of the study
Other bias Low risk “Obstetric risk factors at initial referral did not vary significantly between groups.”