Study characteristics |
Methods |
Pair‐matched, cluster‐randomised controlled trial comparing simulation‐based team training with no intervention. |
Participants |
A total of 450 healthcare providers in the intervention group participated in the training course (305 completed all 3 training days). In total, 641 births were observed (318 births in intervention group, and 323 births in control group). |
Interventions |
The intervention comprised the PRONTO training sessions, a simulation‐based team training, using in situ simulations. There were 3 training days: 2 starting days followed by 1 training day after 2‐3 months. Training content: humanised birth, patient communication, evidence‐based practices, teamwork and communication, obstetric haemorrhage, neonatal resuscitation, shoulder dystocia, pre‐eclampsia/eclampsia. |
Outcomes |
Performance of routine practices: 1) Active management of third stage of labour; 2) Delayed cord clamping; 3) Skin‐to‐skin contact; 4) Episiotomy; 5) Fundal uterine pressure; 6) Uterine sweeping |
Notes |
Multicentre trial including 24 hospitals, Mexico. Study period: 2010‐2013. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
High risk |
Randomly (computerised) generated. Comment: in the main publication of this study (Walker 2016), there is the following described: "except for 2 pairs of hospitals in Mexico State, in which the member of the pair that was to receive the intervention was discretionally chosen by the local MOH". Probably high risk on selection bias. |
Allocation concealment (selection bias) |
High risk |
11/24 included hospitals dropped out prior to the start of baseline data collection. These hospitals were replaced and the new hospitals were allocated to the opposite study arm of the remaining hospital from the matched pair. |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Labouring women were blinded to allocation. Healthcare providers were not blinded, probably low impact on results. |
Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Quote: "The observers … and were not blinded to treatment allocation". However, the authors state that the observers were unable to assess which of the providers had participated in the training. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Probably no missing data. |
Selective reporting (reporting bias) |
High risk |
No missing data concerning the reported outcome measures in the article. |
Other bias |
High risk |
High risk on recruitment bias as participants were recruited after the clusters had been randomised. Clustering effect has been taken into account. |