Influence of rapid malaria diagnostic tests on treatment and health outcome in fever patients, Zanzibar: a crossover validation study.
BACKGROUND
The use of rapid diagnostic tests (RDTs) for Plasmodium falciparum malaria is being suggested to improve diagnostic efficiency in peripheral health care settings in Africa. Such improved diagnostics are critical to minimize overuse and thereby delay development of resistance to artemisinin-based combination therapies (ACTs). Our objective was to study the influence of RDT-aided malaria diagnosis on drug prescriptions, health outcomes, and costs in primary health care settings.


RESULTS
We conducted a cross-over validation clinical trial in four primary health care units in Zanzibar. Patients of all ages with reported fever in the previous 48 hours were eligible and allocated alternate weeks to RDT-aided malaria diagnosis or symptom-based clinical diagnosis (CD) alone. Follow-up was 14 days. ACT was to be prescribed to patients diagnosed with malaria in both groups. Statistical analyses with multilevel modelling were performed. A total of 1,887 patients were enrolled February through August 2005. RDT was associated with lower prescription rates of antimalarial treatment than CD alone, 361/1005 (36%) compared with 752/882 (85%) (odds ratio [OR] 0.04, 95% confidence interval [CI] 0.03-0.05, p<0.001). Prescriptions of antibiotics were higher after RDT than CD alone, i.e., 372/1005 (37%) and 235/882 (27%) (OR 1.8, 95%CI 1.5-2.2, p<0.001), respectively. Reattendance due to perceived unsuccessful clinical cure was lower after RDT 25/1005 (2.5%), than CD alone 43/882 (4.9%) (OR 0.5, 95% CI 0.3-0.9, p = 0.005). Total average cost per patient was similar: USD 2.47 and 2.37 after RDT and CD alone, respectively.


CONCLUSIONS
RDTs resulted in improved adequate treatment and health outcomes without increased cost per patient. RDTs may represent a tool for improved management of patients with fever in peripheral health care settings.


BACKGROUND
(Clinicaltrials.gov) NCT00549003.
Msellem
Mwinyi I
MI
Malaria Control Programme, Ministry of Health and Social Welfare, Zanzibar, Tanzania.
Mårtensson
Andreas
A
Rotllant
Guida
G
Bhattarai
Achuyt
A
Strömberg
Johan
J
Kahigwa
Elizeus
E
Garcia
Montse
M
Petzold
Max
M
Olumese
Peter
P
Ali
Abdullah
A
Björkman
Anders
A
D000328:Adult; D000962:Antimalarials / Q000627:therapeutic use; D037621:Artemisinins / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D018592:Cross-Over Studies; D003955:Diagnostic Tests, Routine; D004359:Drug Therapy, Combination; D005334:Fever / Q000188:drug therapy / Q000209:etiology*; D006801:Humans; D016778:Malaria, Falciparum / Q000175:diagnosis* / Q000188:drug therapy; D016017:Odds Ratio; D055656:Prescriptions; D013636:Tanzania; D016896:Treatment Outcome
D000962:Antimalarials; D037621:Artemisinins; C031327:artemisinin