Skarbinski 2009 KEN.
Methods | Cluster RCT; randomized by health facilities Stratified random selection of facilities, by transmission settings (high/low) and facility type (hospitals, health centres and dispensaries) Took into account a design effect of two in sampling Reference slide taken. Results not reported Trial lasted four months |
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Participants | Inclusion: age ≥ 5 years, irrespective of condition Number of participants randomized: Intervention arm: 799 Number analysed for primary outcome (prescribing of antimalarials): 669 (16.3% loss) |
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Interventions | Intervention: RDTs for fever patients ≥ 5 years Control: Presumptive treatment of fever Boh groups received training and held guidelines RDT performed by health workers Health workers complied with guidelines partially: 41% of participants with negative RDT results received antimalarials |
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Outcomes | Primary outcomes:
Secondary outcomes:
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Notes | Country: Kenya RDT: paracheck Setting: all referral levels of facilities, 60 in total, 30 in each arm Transmission: Hyperendemic or holoendemic at some sites and low and seasonal at others. Dates: June to September 2006 Funding: USAID |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Systematic allocation. |
Allocation concealment (selection bias) | Unclear risk | Although probabilistic sampling was used in selecting the participating health facilities, the participants had foreknowledge of intervention assignments. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Both the trial participants and personnel were aware of intervention allocation. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Both the trial participants and personnel were aware of the diagnoses and prescriptions. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Per protocol analysis; loss to follow‐up was high, more at the intervention facilities (20.2%) than at the control facilities (11.2%). |
Selective reporting (reporting bias) | Low risk | Reported on all pre‐specified outcomes (prescribing of ACT); did not explicitly report on overall antimalarial prescribing, but the summary data were available for inclusion in the review. |
Other bias | Low risk | Baseline imbalance minimised by stratifying facilities by level and randomly selecting within each level. Summary data were adjusted for baseline imbalance. Results could be biased towards the null, because some facilities in the comparison arms had RDT. Loss of complete clusters: not reported. |