Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trialBMJ 2007; 334 doi: https://doi.org/10.1136/bmj.39073.496829.AE (Published 22 February 2007) Cite this as: BMJ 2007;334:403
- Hugh Reyburn, clinical senior lecturer and project leader1,
- Hilda Mbakilwa, clinical officer2,
- Rose Mwangi, social scientist3,
- Ombeni Mwerinde, biostatistician and project data manager3,
- Raimos Olomi, professor of paediatrics4,
- Chris Drakeley, senior lecturer and project senior scientist1,
- Christopher J M Whitty, professor of international health and project coordinator1
- 1Department of Infectious and Tropical Disease, London School of Hygiene and Tropical Medicine, London WCIE 7HT, and Joint Malaria Programme, Moshi, Tanzania
- 2Joint Malaria Programme, Moshi, Tanzania
- 3Kilimanjaro Christian Medical Centre and Joint Malaria Programme, Moshi, Tanzania
- 4Kilimanjaro Christian Medical Centre, Moshi, Tanzania
- Correspondence to: H Reyburn, Joint Malaria Programme, PO Box 2228, KCMC, Moshi, Tanzania
- Accepted 13 December 2006
Objective To compare rapid diagnostic tests (RDTs) for malaria with routine microscopy in guiding treatment decisions for febrile patients.
Design Randomised trial.
Setting Outpatient departments in northeast Tanzania at varying levels of malaria transmission.
Participants 2416 patients for whom a malaria test was requested.
Intervention Staff received training on rapid diagnostic tests; patients sent for malaria tests were randomised to rapid diagnostic test or routine microscopy
Main outcome measure Proportion of patients with a negative test prescribed an antimalarial drug.
Results Of 7589 outpatient consultations, 2425 (32%) had a malaria test requested. Of 1204 patients randomised to microscopy, 1030 (86%) tested negative for malaria; 523 (51%) of these were treated with an antimalarial drug. Of 1193 patients randomised to rapid diagnostic test, 1005 (84%) tested negative; 540 (54%) of these were treated for malaria (odds ratio 1.13, 95% confidence interval 0.95 to 1.34; P=0.18). Children aged under 5 with negative rapid diagnostic tests were more likely to be prescribed an antimalarial drug than were those with negative slides (P=0.003). Patients with a negative test by any method were more likely to be prescribed an antibiotic (odds ratio 6.42, 4.72 to 8.75; P<0.001). More than 90% of prescriptions for antimalarial drugs in low-moderate transmission settings were for patients for whom a test requested by a clinician was negative for malaria.
Conclusions Although many cases of malaria are missed outside the formal sector, within it malaria is massively over-diagnosed. This threatens the sustainability of deployment of artemisinin combination treatment, and treatable bacterial diseases are likely to be missed. Use of rapid diagnostic tests, with basic training for clinical staff, did not in itself lead to any reduction in over-treatment for malaria. Interventions to improve clinicians' management of febrile illness are essential but will not be easy.
Trial registration Clinical trials NCT00146796.
We thank all the patients and staff at the study sites for their support and participation. Alan Minja, Kereja Mlay, and Rajabu Malahiyo were key hospital staff. Anna Mtei, Emmanuel Mwakasungula, Lilian Ngowi, Boniface Njau, Yustina Mushi, Happiness Manaso, Mary Urio, and Nico Funga collected outpatient data. Kini Chonya and Jan Ostermann assisted with data analysis. Magdalena Massawe, James Kalabashanga, and Hatibu Athumani read research blood films. This study was done as part of the Joint Malaria Programme in northeast Tanzania.
Contributors: HR, CD, and CJMW designed the trial, with help from RO. HR was the project leader. HM, RM, and OM led the trial team, and CD led the laboratory aspects. HR and CJMW drafted the paper, with input from all authors. HR is the guarantor.
Funding: The study was sponsored by the Gates Malaria Partnership, with funding from the Bill and Melinda Gates Foundation. The sponsors had no part in the design, conduct, or analysis of the study.
Competing interests: None declared.
Ethical approval: Ethics committees of the National Institute for Medical Research, Tanzania, and the London School of Hygiene and Tropical Medicine.
- Accepted 13 December 2006