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. 2022 Sep 8;2022(9):CD009527. doi: 10.1002/14651858.CD009527.pub3

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
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
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
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
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.