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      How can malaria rapid diagnostic tests achieve their potential? A qualitative study of a trial at health facilities in Ghana

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      1 , , 1 , 1 , 2
      Malaria Journal
      BioMed Central

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          Abstract

          Background

          Rapid diagnostic tests (RDTs) for malaria are at the early stages of introduction across malaria endemic countries. This is central to efforts to decrease malaria overdiagnosis and the consequent overuse of valuable anti-malarials and underdiagnosis of alternative causes of fever. Evidence of the effect of introducing RDTs on the overprescription of anti-malarials is mixed. A recent trial in rural health facilities in Ghana reduced overprescription of anti-malarials, but found that 45.5% patients who tested negative with RDTs were still prescribed an anti-malarial.

          Methods

          A qualitative study of this trial was conducted, using in-depth interviews with a purposive sample of health workers involved in the trial, ranging from those who continued to prescribe anti-malarials to most patients with negative RDT results to those who largely restricted anti-malarials to patients with positive RDT results. Interviews explored the experiences of using RDTs and their results amongst trial participants.

          Results

          Meanings of RDTs were constructed by health workers through participation with the tests themselves as well as through interactions with colleagues, patients and the research team. These different modes of participation with the tests and their results led to a change in practice for some health workers, and reinforced existing practice for others. Many of the characteristics of RDTs were found to be inherently conducive to change, but the limited support from purveyors, lack of system antecedents for change and limited system readiness for change were apparent in the analysis.

          Conclusions

          When introduced with a limited supporting package, RDTs were variously interpreted and used, reflecting how health workers had learnt how to use RDT results through participation. To build confidence of health workers in the face of negative RDT results, a supporting package should include local preparation for the innovation; unambiguous guidelines; training in alternative causes of disease; regular support for health workers to meet as communities of practice; interventions that address negotiation of health worker-patient relationships and encourage self-reflection of practice; feedback systems for results of quality control of RDTs; feedback systems of the results of their practice with RDTs; and RDT augmentation such as a technical and/or clinical troubleshooting resource.

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          Most cited references35

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          Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

          Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.
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            Overdiagnosis of malaria in patients with severe febrile illness in Tanzania: a prospective study.

            To study the diagnosis and outcomes in people admitted to hospital with a diagnosis of severe malaria in areas with differing intensities of malaria transmission. Prospective observational study of children and adults over the course a year. 10 hospitals in north east Tanzania. 17,313 patients were admitted to hospital; of these 4474 (2851 children aged under 5 years) fulfilled criteria for severe disease. Details of the treatment given and outcome. Altitudes of residence (a proxy for transmission intensity) measured with a global positioning system. Blood film microscopy showed that 2062 (46.1%) of people treated for malaria had Plasmodium falciparum (slide positive). The proportion of slide positive cases fell with increasing age and increasing altitude of residence. Among 1086 patients aged > or = 5 years who lived above 600 metres, only 338 (31.1%) were slide positive, while in children < 5 years living in areas of intense transmission (< 600 metres) most (958/1392, 68.8%) were slide positive. Among 2375 people who were slide negative, 1571 (66.1%) were not treated with antibiotics and of those, 120 (7.6%) died. The case fatality in slide negative patients was higher (292/2412, 12.1%) than for slide positive patients (142/2062, 6.9%) (P < 0.001). Respiratory distress and altered consciousness were the strongest predictors of mortality in slide positive and slide negative patients and in adults as well as children. In Tanzania, malaria is commonly overdiagnosed in people presenting with severe febrile illness, especially in those living in areas with low to moderate transmission and in adults. This is associated with a failure to treat alternative causes of severe infection. Diagnosis needs to be improved and syndromic treatment considered. Routine hospital data may overestimate mortality from malaria by over twofold.
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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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                Author and article information

                Journal
                Malar J
                Malaria Journal
                BioMed Central
                1475-2875
                2010
                14 April 2010
                : 9
                : 95
                Affiliations
                [1 ]Clinical Research Unit, London School of Hygiene & Tropical Medicine Keppel Street, London, WC1E 7HT, UK
                [2 ]Dangme West District Health Directorate, Ghana District Health Service, PO Box DD1, Dodowa, Ghana
                Article
                1475-2875-9-95
                10.1186/1475-2875-9-95
                2859355
                20398262
                eef5ad31-52c4-4c52-a512-aa9166685e6d
                Copyright ©2010 Chandler 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
                : 9 December 2009
                : 14 April 2010
                Categories
                Research

                Infectious disease & Microbiology
                Infectious disease & Microbiology

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