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      A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon: a study protocol for a randomized controlled trial

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          Abstract

          Background

          Governments and donors all over Africa are searching for sustainable, affordable and cost-effective ways to improve the quality of malaria case management. Widespread deficiencies have been reported in the prescribing and counselling practices of health care providers treating febrile patients in both public and private health facilities. Cameroon is no exception with low levels of adherence to national guidelines, the frequent selection of non-recommended antimalarials and the use of incorrect dosages. This study evaluates the effectiveness and cost-effectiveness of introducing two different provider training packages, alongside rapid diagnostic tests (RDTs), designed to equip providers with the knowledge and practical skills needed to effectively diagnose and treat febrile patients. The overall aim is to target antimalarial treatment better and to facilitate optimal use of malaria treatment guidelines.

          Methods/Design

          A 3-arm stratified, cluster randomized trial will be conducted to assess whether introducing RDTs with provider training (basic or enhanced) is more cost-effective than current practice without RDTs, and whether there is a difference in the cost effectiveness of the provider training interventions. The primary outcome is the proportion of patients attending facilities that report a fever or suspected malaria and receive treatment according to malaria guidelines. This will be measured by surveying patients (or caregivers) as they exit public and mission health facilities. Cost-effectiveness will be presented in terms of the primary outcome and a range of secondary outcomes, including changes in provider knowledge. Costs will be estimated from a societal and provider perspective using standard economic evaluation methodologies.

          Trial Registration

          ClinicalTrials.gov: NCT00981877

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          Most cited references20

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          Rapid diagnostic tests compared with malaria microscopy for guiding outpatient treatment of febrile illness in Tanzania: randomised trial.

          To compare rapid diagnostic tests (RDTs) for malaria with routine microscopy in guiding treatment decisions for febrile patients. Randomised trial. Outpatient departments in northeast Tanzania at varying levels of malaria transmission. 2416 patients for whom a malaria test was requested. Staff received training on rapid diagnostic tests; patients sent for malaria tests were randomised to rapid diagnostic test or routine microscopy Proportion of patients with a negative test prescribed an antimalarial drug. 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. 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. Clinical trials NCT00146796 [ClinicalTrials.gov].
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            Malaria misdiagnosis: effects on the poor and vulnerable.

            Effective and affordable treatment is recommended for all cases of malaria within 24 h of the onset of illness. Most cases of "malaria" (ie, fever) are self-diagnosed and most treatments, and deaths, occur at home. The most ethical and cost-effective policy is to ensure that newer drug combinations are only used for true cases of malaria. Although it is cost effective to improve the accuracy of malaria diagnosis, simple, accurate, and inexpensive methods are not widely available, particularly in poor communities where they are most needed. In a recent study in Uganda, Karin Kallander and colleagues emphasise the difficulty in making a presumptive diagnosis of malaria, and highlight the urgent need for improved diagnostic tools that can be used at community and primary-care level, especially in poorer populations (Acta Trop 2004; 90: 211-14). WHERE NEXT? Health systems need strengthening at referral and community level, so that rapid accurate diagnosis and effective treatment is available for those who are least able to withstand the consequences of illness. Indirect evidence strongly suggests that misdiagnosis of malaria contributes to a vicious cycle of increasing ill-health and deepening poverty. Much better direct evidence is needed about why and how misdiagnosis affects the poor and vulnerable.
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              Changes in health workers' malaria diagnosis and treatment practices in Kenya

              Background Change of Kenyan treatment policy for uncomplicated malaria from sulphadoxine-pyrimethamine to artemether-lumefantrine (AL) was accompanied by revised recommendations promoting presumptive malaria diagnosis in young children and, wherever possible, parasitological diagnosis and adherence to test results in older children and adults. Three years after the policy implementation, health workers' adherence to malaria diagnosis and treatment recommendations was evaluated. Methods A national cross-sectional, cluster sample survey was undertaken at public health facilities. Data were collected using quality-of-care assessment methods. Analysis was restricted to facilities with AL in stock. Main outcomes were diagnosis and treatment practices for febrile outpatients stratified by age, availability of diagnostics, use of malaria diagnostic tests, and test result. Results The analysis included 1,096 febrile patients (567 aged <5 years and 529 aged ≥5 years) at 88 facilities with malaria diagnostics, and 880 febrile patients (407 aged <5 years and 473 aged ≥5 years) at 71 facilities without malaria diagnostic capacity. At all facilities, 19.8% of young children and 28.7% of patients aged ≥5 years were tested, while at facilities with diagnostics, 33.5% and 53.7% were respectively tested in each age group. Overall, AL was prescribed for 63.6% of children aged <5 years and for 65.0% of patients aged ≥5 years, while amodiaquine or sulphadoxine-pyrimethamine monotherapies were prescribed for only 2.0% of children and 3.9% of older children and adults. In children aged <5 years, AL was prescribed for 74.7% of test positive, 40.4% of test negative and 60.7% of patients without test performed. In patients aged ≥5 years, AL was prescribed for 86.7% of test positive, 32.8% of test negative and 58.0% of patients without test performed. At least one anti-malarial treatment was prescribed for 56.6% of children and 50.4% of patients aged ≥5 years with a negative test result. Conclusions Overall, malaria testing rates were low and, despite different age-specific recommendations, only moderate differences in testing rates between the two age groups were observed at facilities with available diagnostics. In both age groups, AL use prevailed, and prior ineffective anti-malarial treatments were nearly non-existent. The large majority of test positive patients were treated with recommended AL; however, anti-malarial treatments for test negative patients were widespread, with AL being the dominant choice. Recent change of diagnostic policy to universal testing in Kenya is an opportunity to improve upon the quality of malaria case management. This will be, however, dependent upon the delivery of a comprehensive case management package including large scale deployment of diagnostics, good quality of training, post-training follow-up, structured supervisory visits, and more intense monitoring.
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                Author and article information

                Journal
                Trials
                Trials
                BioMed Central
                1745-6215
                2012
                6 January 2012
                : 13
                : 4
                Affiliations
                [1 ]Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK
                [2 ]Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK
                [3 ]Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK
                [4 ]Laboratory for Public Health Research Biotechnologies. The Biotechnology Center, The University of Yaoundé I, Box 8094 Yaoundé, Cameroon
                [5 ]Laboratory for Public Health Research Biotechnologies. The Biotechnology Center, The University of Yaoundé I, Box 8094 Yaoundé, Cameroon
                [6 ]Laboratory for Public Health Research Biotechnologies. The Biotechnology Centre, the University of Yaoundé I, Box 8094 Yaoundé, Cameroon
                [7 ]Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, UK
                [8 ]Laboratory for Public Health Research Biotechnologies. The Biotechnology Center, The University of Yaounde I, Box 8094 Yaounde, Cameroon
                Article
                1745-6215-13-4
                10.1186/1745-6215-13-4
                3307479
                22225699
                6cfbbc5d-ef78-423e-a811-3d4693d6016e
                Copyright ©2012 Wiseman et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 22 September 2011
                : 6 January 2012
                Categories
                Study Protocol

                Medicine
                cost-effectiveness,rapid diagnostics tests (rdts),malaria
                Medicine
                cost-effectiveness, rapid diagnostics tests (rdts), malaria

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