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. 2020 Dec 16;2020(12):CD011545. doi: 10.1002/14651858.CD011545.pub2

Walker 2016.

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). Mean participation rate was 20.5%. During follow‐up of 1 year there were 50,589 live births in the 24 hospitals.
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 Primary outcome: hospital‐based neonatal mortality. Secondary outcomes: maternal complications (obstetric haemorrhage, hysterectomy, and eclampsia), and a composite of maternal complications (obstetric hysterectomy, obstetric haemorrhage and maternal death). Additional exploratory outcome (before main data analysis started): mode of delivery.
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 Quote: "..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 probably unaware of allocation. Healthcare providers were not blinded, probably low impact on results.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "There was no blinding in this study ... The data analysts were also not blinded to the study assignments."
Incomplete outcome data (attrition bias)
All outcomes Low risk There seemed to be no withdrawals after the baseline data collection. The authors report on missing data for all clinics in the first, fifth and ninth‐month postintervention. The missing data were equal for each site.
Selective reporting (reporting bias) Low risk Although the intended outcome measures have been adjusted, these adjustment have been described in the manuscript and have been performed before the main data analysis had taken place.
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.

MCQ: multiple choice questionnaire