Ohnmar 2012.
Study characteristics | ||
Methods | Trial design: cRCT Unit of randomization: village Number of clusters: 59 Data collection: pre‐ and postintervention surveys (either self‐completed or interviews) of participants reporting fever when screened at household and individual level, death registers and verbal autopsy surveys (at endline assessment), volunteer and midwives' logbooks (at endline) Length of follow‐up: 11 months Adjustment for clustering: yes |
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Participants | Target treatment group: adults and children Sample size: 59 villages (21 intervention, 17 comparison 1, 21 comparison 2) Exclusion criteria: infants (no age given), pregnancy, symptoms such as sore throat, difficult urination, ear discharge, cough, loose stools, skin ulcers |
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Interventions | Staff who received training: unpaid volunteers Duration of training: 2 days Content of training: treating P falciparum malaria after positive mRDT with AL, and treating presumptive P Vivax with CQ Supervision: midwives in nearest health facility routinely monitored/supervised volunteers during their monthly immunization visits. Malaria supervisors also occasionally visited volunteers. Antimalarials free to participants: unclear mRDTs free to participants: yes Additional details: volunteers displayed posters announcing availability of free mRDTs; there were educational flip charts in local languages for volunteers to educate participants; supervisors demonstrated impregnation of nets, though not as part of training; 1 co‐intervention village with paid mRDT services |
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Outcomes | All‐cause and malaria mortality, hospitalization | |
Notes | Control: unpaid volunteers dispensing medicines without test results (community‐based treatment of suspected malaria by clinical diagnosis) Country: Myanmar Setting: rural Malaria endemicity: moderate endemicity all year round, transmission peak June/July Study dates: March 2009–February 2010 Study sponsor: WHO/SEARO‐TDR Small Grants Scheme, New Delhi, India |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | High risk | No allocation concealment. |
Blinding of participants and personnel (performance bias) Mortality | Low risk | Not blinded, but mortality unlikely to be affected by knowledge of intervention. |
Blinding of participants and personnel (performance bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Low risk | Not blinded, hospitalizations unlikely to be affected by knowledge of intervention. |
Blinding of outcome assessment (detection bias) Mortality | Low risk | Not blinded, unlikely to be affected by knowledge of intervention. |
Blinding of outcome assessment (detection bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Low risk | Not blinded, unlikely to be affected by knowledge of intervention. |
Incomplete outcome data (attrition bias) Mortality | High risk | 4/21 intervention villages dropped out (2 before, 2 after training). Problems capturing mortality data as planned. |
Incomplete outcome data (attrition bias) Antimalarial prescribing to microscopy‐ or PCR‐negative people, appropriate treatment | Unclear risk | 4/21 intervention villages dropped out (2 before, 2 after training), unclear how this would affect outcome. |
Other bias | Unclear risk | Recruitment after randomization, which could have influenced selection, though little baseline imbalance. Intervention villages smaller, closer to health facility than controls, otherwise similar. Participants similar except intervention group less likely to be Bamar/Buddhist. Villages had to be ≥ 2 hours away from nearest selected villages, however there was evidence of contamination. 9 volunteers had ≥ 1‐month period without any mRDT activity. It is not known whether this inactive period was due to his/her absence, mRDT shortage, or no cases of fever. |