Ndyomugyenyi 2016.
Study characteristics | ||
Methods | Trial design: cRCT Unit of randomization: village Number of clusters: 127 Data collection: registers kept by CHWs prospectively on all children seeking treatment for fever and blood slide results Length of follow‐up: 12 months Adjustment for clustering: yes |
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Participants | Target treatment group: children < 5 years old Sample size: 127 (63 Bwambara, 64 Nyakishenyi) Exclusion criteria: referral of children with danger signs or other signs for referral |
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Interventions | Staff who received training: CHWs Duration of training: 4 days Content of training: treating Pfalciparum malaria after positive mRDT with AL or rectal AS, and referring if negative mRDT as appropriate Supervision: close supervision by project staff for 6 months through meetings (promoting accurate and complete records, how to handle difficult situations), scaled back thereafter to when CHWs collected supplies Antimalarials free to participants: not reported mRDTs free to participants: not reported Additional details: community sensitization on diagnostic testing for malaria |
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Outcomes | Use of antimalarial when microscopy‐negative, appropriate treatment (defined as microscopy‐positive, received antimalarial and microscopy‐negative did not receive an antimalarial), number receiving an antimalarial | |
Notes | Control: CHWs dispensing medicines without test results (community‐based treatment of suspected malaria by clinical diagnosis) Country: Uganda Setting: rural Malaria endemicity: in Bwambara, lower altitudinal area meso‐endemic with moderate‐to‐high transmission; in Nyakishenyi, epidemic‐prone highland with low transmission, hypo‐endemic Study dates: July 2011–December 2011 Study sponsor: the ACT Consortium, through a grant from the Bill and Melinda Gates Foundation to the London School of Hygiene and Tropical Medicine. Sian Clarke supported by the Wellcome Trust through a Research Career Development Fellowship (084933) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Within each transmission area, villages (clusters) were randomly allocated using a random number table in Epi Info to intervention or control (though no mention of independent statistician). |
Allocation concealment (selection bias) | Unclear risk | Not described. |
Blinding of participants and personnel (performance bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Unclear risk | No mention of blinding, unclear how this could affect outcome. |
Blinding of participants and personnel (performance bias) Number receiving an antimalarial | Unclear risk | No mention of blinding, unclear how this could affect outcome. |
Blinding of outcome assessment (detection bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Low risk | Reference microscopy blinded to results. |
Blinding of outcome assessment (detection bias) Number receiving an antimalarial | Unclear risk | No mention of blinding, unclear how this could affect outcome. |
Incomplete outcome data (attrition bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Unclear risk | After training, CHWs in villages located close to the border of the study area started to receive febrile children from outside the study district; these villages were subsequently withdrawn from the trial: 1/31 clusters in the intervention arm, 2/32 in control for moderate/high transmission – modified ITT analysis. |
Incomplete outcome data (attrition bias) Number receiving an antimalarial | Unclear risk | After training, CHWs in villages located close to the border of the study area started to receive febrile children from outside the study district; these villages were subsequently withdrawn from the trial: 1/31 clusters in the intervention arm, 2/32 in the control for moderate/high transmission – modified ITT analysis. |
Selective reporting (reporting bias) | Low risk | Appears to correlate with NCT01048801, however that record refers to a different paper which could be incorrect. |
Other bias | Unclear risk | Recruitment after randomization, which could have influenced selection, though little baseline imbalance. Possible differences in low transmission, unclear how this would affect outcome (e.g. sex, CHW previous experience). Contamination and mRDT uptake were not described (no explanation of why the number of consultations in the control arm usually exceeded those in the mRDT arm). |