Bhutta 2011.
| Methods | Parallel‐arm cluster‐RCT conducted at 16 sites in Pakistan (Hala and Matiari sub districts) between Feb 2006 and Mar 2008. | |
| Participants |
Sample size: 16 clusters (51409 individuals). Clusters: catchment areas of primary care facilities with adequate numbers of LHWs. Individuals: not described. Exclusion criteria: areas with low numbers of LHWs and areas with poor access were excluded. |
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| Interventions |
Target: health system (health worker education) and community (IEC intervention). Arm 1: the intervention package was delivered by trained LHWs through group sessions consisted of promotion of ANC and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of care seeking. Arm 2: in the control clusters, the LHW programme continued to function as usual and no additional attempt was made to link LHWs with the Dais or communities. |
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| Outcomes |
Trial primary outcome: perinatal and all‐cause neonatal mortality. Review outcomes reported: Primary: ANC coverage (at least 4 visits). Secondary: ANC coverage (at least 1 visit), professional ANC, health facility deliveries, perinatal mortality, stillbirth, neonatal mortality. Follow‐up: every 3 months for 2 years. |
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| Notes | Funders: grants from the WHO and the Saving Newborn Lives programme funded by the Bill & Melinda Gates Foundation. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "From this list of balanced allocations, we selected one scheme using a computer generated random number." |
| Allocation concealment (selection bias) | Unclear risk | Not reported. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Data collectors and their supervisors were masked to cluster allocation p. 406 Bhutta 2011. |
| Recruitment bias (for cluster RCTs) | Low risk | None noted. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 414 lost to follow‐up (less than 1%). |
| Selective reporting (reporting bias) | Low risk | Most relevant outcomes reported. |
| Analysis bias | Low risk | Analysis appropriate for clusters; ICC reported; ITT analysis performed. |
| Other bias | Low risk | No baseline imbalances. |
| Overall risk assessment | Low risk | No serious risk of bias concerns. |