Morris 2004b.
| Methods | This trial is the same as that described in Morris 2004a above. Due to RevMan requirements, we have replicated the 'Risk of bias' assessments below. However, Morris 2004b describes a specific 'both packages' arm of Morris 2004a and not a different study. | |
| Participants | For our review's Comparison 2, Morris 2004b is the 'both packages' trial arm compared with the control group. | |
| Interventions | See Morris 2004a. | |
| Outcomes | See Morris 2004a. | |
| Notes | See Morris 2004a. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Within each stratum, random allocation was achieved by a child drawing coloured balls from a box, without replacement. Thus, the randomisation was both stratified and blocked." |
| Allocation concealment (selection bias) | Low risk | "The aperture of the box was sufficiently small that once the child had inserted his or her arm, it was impossible for him or her to see the coloured balls. From the day of the randomisation onwards, there was no attempt to conceal the allocation." |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Surveys were conducted by an independent data collection company. Not clear if individual interviewers would have been aware of cluster assignment. |
| Recruitment bias (for cluster RCTs) | Low risk | None noted. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Study flow chart included. Loss to follow‐up less than 5% in all arms. |
| Selective reporting (reporting bias) | Low risk | Relevant outcomes reported. |
| Analysis bias | Low risk | Analysis appropriate for clusters (no ICC reported); ITT analysis performed. |
| Other bias | High risk | The intervention involving direct transfer of resources to health teams and part of the service‐level package was not successfully implemented in the relevant clusters. Non baseline imbalances noted. |
| Overall risk assessment | Unclear risk | We were uncertain whether the risk of bias concerns relating to poor implementation impacted the results. |