Abstract
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. 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. 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. (Clinicaltrials.gov) NCT00549003.
Highlights
Morbidity and mortality due to Plasmodium falciparum malaria have been increasing in sub-Saharan Africa since the early 1990s, concomitantly with spread of resistance to commonly used monotherapies, i.e., chloroquine and sulfadoxine-pyrimethamine [1,2]
rapid diagnostic tests (RDTs) may represent a tool for improved management of patients with fever in peripheral health care settings
The development of rapid diagnostic tests (RDTs) for P. falciparum malaria offers a potential alternative in remote and poorly resourced health facilities that are beyond the reach of high-quality microscopy services [10,11,12,13,14]
Summary
Morbidity and mortality due to Plasmodium falciparum malaria have been increasing in sub-Saharan Africa since the early 1990s, concomitantly with spread of resistance to commonly used monotherapies, i.e., chloroquine and sulfadoxine-pyrimethamine [1,2]. In two recently published studies on the implication of RDT use at the health facility level on drug prescription, both describe major problems with test efficiency when used in clinical practice [15,20] This may be attributed to different messages regarding the risk of withholding malaria treatment to patients with negative test results [21]. 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). In ACT, artemisinin derivatives (new, fast-acting antimalarial drugs) are used in combination with another antimalarial to reduce the chances of P. falciparum becoming resistant to either drug
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