Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana.
Rapid testing for malaria in settings where microscopy is available and peripheral clinics where only presumptive treatment is available: a randomised controlled trial in Ghana.
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DOI：
10.1136/bmj.c930
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发表时间：
2010-03-05
期刊：
影响因子：
--
通讯作者：
Whitty CJ
中科院分区：
文献类型：
--
作者：
Ansah EK;Narh-Bana S;Epokor M;Akanpigbiam S;Quartey AA;Gyapong J;Whitty CJ
目的：在西非检验快速诊断检测对抗疟药和抗生素处方的影响，无论是在显微镜用于诊断疟疾的地方，还是在依赖临床诊断的临床（外围）环境中。设计随机、对照、开放标签临床试验。 加纳南部农村Dangme West区的四个诊所，其中一个使用显微镜诊断疟疾（“显微镜设置”），三个没有显微镜，根据临床症状诊断疟疾（“临床设置”）。 参与者疑似疟疾患者。干预患者被随机分配到快速诊断测试或当前的诊断方法在诊所（显微镜或临床诊断）。采集所有患者的血液样本，用于研究显微镜载玻片。主要结果测量主要结果是对任何年龄的患者的抗疟药处方，其双读研究幻灯片为疟疾阴性。主要的次要结果是抗疟药的正确处方，测试结果对抗生素处方的影响，以及5岁以下儿童抗疟药的正确处方。结果筛选的9236例患者中，3452例在临床环境中随机分配，3811例在显微镜环境中随机分配。随访至28天为97.6%（7088/7263）。在显微镜检查中，快速诊断检测组1400例研究载玻片阴性患者中有722例（51.6%）接受了疟疾治疗，而显微镜检查组1389例患者中有764例（55.0%）接受了疟疾治疗（校正比值比0.87，95%CI 0.71 - 1.1; P=0.16）。在临床环境中，1072例研究载玻片阴性的快速诊断检测组患者中有578例（53.9%）接受了疟疾治疗，而临床诊断组1090例载玻片阴性的患者中有982例（90.1%）接受了疟疾治疗（比值比0.12，95%CI 0.04 - 0.38; P=0.001）。快速诊断测试的使用导致抗疟药和抗生素在临床上更好的靶向，但不是在儿童和成人的显微镜设置。有5岁以下的儿童在28天的后续行动中，任何arm. Conclusion显微镜已经存在，引入快速诊断检测处方行为的影响有限。然而，在无法使用显微镜的情况下，使用快速诊断测试大大减少了抗疟药物的过度处方，没有任何临床危害的证据，并更好地靶向抗生素。 试用注册ClinicalTrials.gov NCT 00493922。
Objective To test in West Africa the impact of rapid diagnostic tests on the prescription of antimalarials and antibiotics both where microscopy is used for the diagnosis of malaria and in clinical (peripheral) settings that rely on clinical diagnosis. Design Randomised, controlled, open label clinical trial. Setting Four clinics in the rural Dangme West district of southern Ghana, one in which microscopy is used for diagnosis of malaria (“microscopy setting”) and three where microscopy is not available and diagnosis of malaria is made on the basis of clinical symptoms (“clinical setting”). Participants Patients with suspected malaria. Interventions Patients were randomly assigned to either a rapid diagnostic test or the current diagnostic method at the clinic (microscopy or clinical diagnosis). A blood sample for a research microscopy slide was taken for all patients. Main outcome measures The primary outcome was the prescription of antimalarials to patients of any age whose double read research slide was negative for malaria. The major secondary outcomes were the correct prescription of antimalarials, the impact of test results on antibiotic prescription, and the correct prescription of antimalarials in children under 5 years. Results Of the 9236 patients screened, 3452 were randomised in the clinical setting and 3811 in the microscopy setting. Follow-up to 28 days was 97.6% (7088/7263). In the microscopy setting, 722 (51.6%) of the 1400 patients with negative research slides in the rapid diagnostic test arm were treated for malaria compared with 764 (55.0%) of the 1389 patients in the microscopy arm (adjusted odds ratio 0.87, 95% CI 0.71 to 1.1; P=0.16). In the clinical setting, 578 (53.9%) of the 1072 patients in the rapid diagnostic test arm with negative research slides were treated for malaria compared with 982 (90.1%) of the 1090 patients with negative slides in the clinical diagnosis arm (odds ratio 0.12, 95% CI 0.04 to 0.38; P=0.001). The use of rapid diagnostic tests led to better targeting of antimalarials and antibiotics in the clinical but not the microscopy setting, in both children and adults. There were no deaths in children under 5 years at 28 days follow-up in either arm. Conclusion Where microscopy already exists, introducing rapid diagnostic tests had limited impact on prescriber behaviour. In settings where microscopy was not available, however, using rapid diagnostic tests led to a significant reduction in the overprescription of antimalarials, without any evidence of clinical harm, and to better targeting of antibiotics. Trial registration ClinicalTrials.gov NCT00493922.
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DOI：
10.4269/ajtmh.2008.79.826
发表时间：
2008-12-01
影响因子：
3.3
作者：
Ssekabira, Umaru;Bukirwa, Hasifa;Dorsey, Grant
通讯作者：
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影响因子：
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作者：
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影响因子：
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作者：
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影响因子：
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作者：
Zurovac, D;Ndhlovu, M;Snow, RW
通讯作者：
Snow, RW
DOI：
10.2471/blt.07.042259
发表时间：
2008-02-01
期刊：
Bulletin of the World Health Organization: International Journal of Public Health
影响因子：
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作者：
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通讯作者：
Mills, A