title: Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana.
abstract: OBJECTIVE
  To test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis.
  
  
  METHODS
  Randomised, controlled, open label clinical trial.
  
  
  METHODS
  Four clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria ("microscopy setting") and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms ("clinical setting").
  
  
  METHODS
  Patients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients.
  
  
  METHODS
  The primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years.
  
  
  RESULTS
  Of the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm.
  
  
  CONCLUSIONS
  Where microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.
authors.affiliation: Dangme West District Health Directorate, Dodowa, Ghana. ansahekdr@yahoo.co.uk
authors.forename: Evelyn K
authors.initials: EK
authors.lastname: Ansah
authors.forename: Solomon
authors.initials: S
authors.lastname: Narh-Bana
authors.forename: Michael
authors.initials: M
authors.lastname: Epokor
authors.forename: Samson
authors.initials: S
authors.lastname: Akanpigbiam
authors.forename: Alberta Amu
authors.initials: AA
authors.lastname: Quartey
authors.forename: John
authors.initials: J
authors.lastname: Gyapong
authors.forename: Christopher J M
authors.initials: CJ
authors.lastname: Whitty
mesh_terms: D000293:Adolescent; D000328:Adult; D000553:Ambulatory Care; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000962:Antimalarials / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D003951:Diagnostic Errors / Q000706:statistics & numerical data*; D005260:Female; D005869:Ghana; D006801:Humans; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000188:drug therapy; D008297:Male; D008853:Microscopy / Q000706:statistics & numerical data*; D011933:Reagent Kits, Diagnostic; D014504:Urban Health; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000962:Antimalarials; D011933:Reagent Kits, Diagnostic