Kalyango 2012a.
Study characteristics | ||
Methods |
Design: cluster‐randomized controlled trial Unit of randomization: groups of villages (parishes) |
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Participants |
Inclusion criteria: children aged 6–59 months in study villages who received treatment from CHWs for any illness; identified from CHW registers, traced to their homes and enrolled in study. All enrolled children were included in the analysis for treatment outcomes. Only children with pneumonia symptoms were included in the analysis for prompt and appropriate antibiotics for pneumonia symptoms Exclusion criteria: none reported |
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Interventions |
Intervention
Comparison
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Outcomes |
Coverage of appropriate treatment:
Coverage of careseeking to an 'appropriate provider'of treatment services
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Notes |
Objective: to determine the effect of integrated malaria and pneumonia management, compared to malaria only management by CHWs, on receiving prompt and appropriate antibiotics for pneumonia symptoms. Location: Eastern Uganda, Iganga Municipality. Funding source: SIDA and UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was done by a statistician that was independent of the study using stratified block randomization. Iganga‐Mayuge HDSS has 65 villages which make up 26 parishes that were divided into eight urban and 18 rural clusters (parishes). The clusters from the rural area were further grouped into three strata based on the population size of children less than five years: i) 190–320, ii) 321– 390, and iii) 391 and above, resulting in six clusters in each of these strata. The clusters from the urban area were grouped into two strata based on population sizes of iv) 280–430, and v) 431 and above. Random numbers were generated in blocks of six for the rural clusters and in blocks of four for the urban clusters." |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was done by a statistician that was independent of the study using stratified block randomization." |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants and personnel. Lay health workers would have known if they received additional training and this may have biased their performance. Allocation was by village and parents may have known that the health workers at their primary health centre had received additional training and this may have biased their care seeking behaviour or responses to questionnaires, or both. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Data collectors were not blinded; however, they were independent of the intervention. It is not clear whether being independent would have mitigated the risk of detection bias due to not being blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All children enrolled on day 1 were assessed on day 4." |
Selective reporting (reporting bias) | High risk | Mortality was the primary outcome measure of the registered trial (ISRCTN52966230), but this outcome has never been published. |
Baseline outcomes similar | Unclear risk | Baseline outcomes (careseeking and quality of care) were not assessed. The history of children with illness at baseline was similar between arms, with the exception of the % of children with fast breathing per respiration count by field assistants on day 1 – which was higher in the intervention arm compared to the control arm. This may have had an effect on outcomes for careseeking and quality of care. Imbalances in the number of children treated per arm could have resulted in a loss of power, possibly dampening any effect of the intervention. |
Baseline characteristics similar | Low risk | Baseline characteristics were similar except for higher % rural population in control clusters. |
Contamination | Unclear risk | There were no buffer zones between the intervention clusters and control clusters and caregivers from the control clusters may have accessed care in the intervention clusters, possibly dampening any positive effect of the intervention. |
Other bias | Unclear risk | No other apparent source of bias. |