Leslie 2017.
Study characteristics | ||
Methods | Trial design: cRCT Unit of randomization: clinics (Basic Health Centres or Comprehensive Health Centres) Number of clusters: 22 (11 per arm) Data collection: pretested semi‐pictorial forms for data at participant consultation, blood filter spot for PCR at national laboratory Length of follow‐up: 7 months Adjustment for clustering: yes |
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Participants | Target treatment group: not described; all ages Sample size: 79 villages, 2542 participants Exclusion criteria: sought care for the episode of illness from any other source, or referred directly to clinic for any reason prior to diagnosis |
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Interventions | Staff who received training: CHWs Duration of training: half day over and above standard 1‐day refresher malaria case management training for both groups Content of training: treating people who have a positive Pfalciparum mRDT result with SP/AS, and treating those with a pan‐specific (assumed Pvivax) mRDT result with CQ Supervision: as normally supervised by a manager who supplies basic items including essential medicines Antimalarials free to participants: not reported mRDTs free to participants: not reported Additional details: training by national trainers who were not part of the study team, some sessions observed by study staff to ensure they were done according to curriculum. Cotrimoxazole for treatment of pneumonia in children included in standard package. |
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Outcomes | Use of antimalarial when microscopy‐negative, appropriate treatment (defined as antimalarial provision to PCR‐positive participants and no antimalarial provision to PCR‐negative participants), number receiving an antimalarial | |
Notes | Control: CHWs dispensing medicines without test results (community‐based treatment of suspected malaria by clinical diagnosis) Country: Afghanistan Setting: rural Malaria endemicity: moderate‐ and low‐transmission areas Study dates: October 2011–May 2012 Study sponsor: the ACT Consortium through a grant from the Bill & Melinda Gates Foundation to the London School of Hygiene & Tropical Medicine |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized by trial statistician not otherwise involved, using program in R. |
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 | PCR analysis was blinded to allocation. |
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 | Low risk | 86% CHWs received training, consented and enrolled participants. 10% missing data judged acceptable. |
Incomplete outcome data (attrition bias) Number receiving an antimalarial | Low risk | 86% CHWs received training, consented and enrolled participants. 10% missing data judged acceptable. |
Selective reporting (reporting bias) | Low risk | Primary outcome is per protocol, some additional secondary outcomes and no report on cost‐effectiveness. |
Other bias | Unclear risk | Recruitment after randomization, which may have influenced selection, though little baseline imbalance. Control arm had more CHWs with tertiary education, more missing treatment or diagnosis data, and more participants seen at home, although differences in participants were minimal. Contamination and mRDT uptake not described. |