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.” |