Riley 2011.
Study characteristics | ||
Methods | Cluster‐randomised trial comparing a combination of simulation and didactics, didactics only, and no intervention. | |
Participants | All employed multi‐professional labour and delivery staff members: 36 (simulation) versus 60 (didactics only) versus 38 participants (control) | |
Interventions | 2‐3 hours didactics versus didactics combined with simulation‐based team training (in situ) versus no intervention. Training content: condensed TeamSTEPPS curriculum (used simulated scenarios: uterine rupture, placental abruption, postpartum haemorrhage) |
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Outcomes | Patient outcome: perinatal morbidity and mortality (weighted adverse outcomes scores). Culture of safety. Follow‐up: approximately 12 months. | |
Notes | Multicentre study including 3 hospitals, USA. Study period: 2005‐2008. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation type not described in manuscript/reported in correspondence. |
Allocation concealment (selection bias) | High risk | Randomisation type not described in manuscript/reported in correspondence. Besides, as there were only 3 study groups and 3 clusters, allocation might have been foreseen. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Patients (outcome measure) were probably unaware of study allocation. Blinding of participants was not possible, however probably unlikely to affect outcome measures. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Data‐collectors were local personnel of participating hospitals. Data‐analyst might have been blinded (from correspondence). |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No clusters lost to follow‐up. From correspondence quote: "We had no missing data. All data were downloaded from the medical record." Although not mentioned in the manuscript, probably low risk of attrition bias. |
Selective reporting (reporting bias) | Low risk | No not reported outcomes. No published study protocol available. |
Other bias | High risk | High risk on performance bias as the simulation group received the TeamSTEPPS curriculum within the context of a clinical scenario, while the didactic group received no information about these scenarios. Clustering has not been taken into account. |