Colbourn 2013.
| Methods | Two‐by‐two factorial cluster‐randomised controlled trial evaluating community‐ and facility‐based interventions to reduce deaths in 3 districts of Malawi | |
| Participants | Randomly sampled approximately 4000 people per cluster and set up community surveillance to track pregnancies, births, and deaths of consenting women Baseline (n = 14,576 births) Intervention (n = 20,576 births) |
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| Interventions | Community mobilisation: 81 volunteer facilitators each formed 9 women's groups, which followed an "action cycle" to identify and prioritise maternal and neonatal health problems. Fifty per cent of groups had maternal and neonatal task forces added to them to enhance antenatal coverage, maternal/neonatal health knowledge, and facility delivery Quality improvement: facility level Control: 17 clusters (out of 62) were assigned to control, where these clusters underwent no interventions |
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| Outcomes | Primary outcomes: maternal, neonatal and perinatal mortality Secondary outcomes: % of deliveries at a health facility, % of maternal deaths subjected to maternal death audit, case‐fatality rates, practice of signal obstetrical care at community level, number of women's groups mobilised annually, % of pregnant women attending women's groups |
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| Notes | Funding: project was funded by The Health Foundation, London, UK. Project funders commissioned the randomised controlled trial to evaluate the 2 interventions but had no direct input into the design of the study, data collection, nor data analysis | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "clusters were health centre catchment areas assigned using stratified computer generated randomisation" (random number sequence generated in Strata 7) Comment: probably done |
| Allocation concealment (selection bias) | Low risk | Quote: "to ensure concealment of intervention allocation, identification numbers were assigned for each cluster and a random number generated for each" Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "neither participants nor those administering the interventions were blinded to group assignment" Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: insufficient information to permit judgement |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "during the baseline period, the recorded loss to follow‐up to birth outcomes was 19% and during the intervention it was 29%, with higher rates in later months. Given that observed birth rates in the study matched those expected from the crude birth rate 1.27 to within 3%, and that in‐migration probably broadly matched out‐migration, many of the pregnancies recorded by KIs as ‘lost to follow‐up’ may have been recorded as pregnancies by mistake and true loss‐to‐follow‐up was probably much lower; there was little difference in loss‐to‐follow‐up between arms" Comment: probably not |
| Selective reporting (reporting bias) | Low risk | Comment: this is a registered trial, and this study has reported all outcomes mentioned in the protocol |
| Other bias | Low risk | Study seems to be free from other biases |