Rapid diagnostic tests versus clinical diagnosis for managing people with fever in malaria endemic settings.
Rapid diagnostic tests versus clinical diagnosis for managing people with fever in malaria endemic settings.
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DOI：
10.1002/14651858.cd008998.pub2
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发表时间：
2014-04-17
影响因子：
8.4
通讯作者：
Garner, Paul
中科院分区：
文献类型：
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作者：
Odaga, John;Sinclair, David;Lokong, Joseph A.;Donegan, Sarah;Hopkins, Heidi;Garner, Paul
2010年，世界卫生组织建议所有疑似疟疾患者在治疗前接受疟疾检测。在非洲农村地区，通常无法使用光学显微镜。诊断依赖于检测发烧，并且推测大多数人都服用了抗疟药物。快速诊断检测 (RDT) 提供了一种可以改善管理的即时检测，特别是对于 RDT 排除了疟疾诊断的患者。评估与使用临床诊断的算法相比，将 RDT 引入诊断和治疗发烧患者的算法是否可以改善健康结果、减少抗疟药处方且安全。我们检索了 Cochrane 传染病组专业登记册；中央（科克伦图书馆）；医学线；电子数据库；西纳尔；紫丁香；以及截至 2014 年 1 月 10 日符合条件的试验的对照试验元登记册。我们联系了该领域的研究人员并审查了所有纳入试验的参考文献列表，以确定是否有任何其他试验。比较 RDT 支持的算法和仅使用临床诊断的算法来诊断和治疗生活在疟疾流行地区的发热患者的个体或整群随机试验 (RCT)。两位作者独立应用纳入标准并提取数据。我们使用通用逆方差方法结合了单独和集群随机对照试验的数据。我们将所有结果表示为具有 95% 置信区间 (CI) 的风险比 (RR)，并使用 GRADE 方法评估证据质量。我们纳入了 7 项试验，纳入了 17,505 名发烧或报告有发烧史的人。两项单独随机试验和五项整群随机试验。所有试验均在非洲农村地区进行。在大多数试验中，诊断和治疗疟疾的卫生工作者是接受过不到一周 RDT 支持诊断培训的护士或临床官员。卫生工作者规定遵守 RDT 结果的情况差异很大：RDT 结果为阴性但接受抗疟药物治疗的参与者人数从 0% 到 81% 不等。总体而言，RDT 支持的诊断对治疗后 4 至 7 天仍然不适的参与者数量影响很小或没有影响（6990 名参与者，五项试验，低质量证据）；但使用 RDT 可以将抗疟药处方减少多达四分之三（17,287 名受试者，七项试验，中等质量证据）。正如预期的那样，在卫生工作者遵守 RDT 结果较高且疟疾真实患病率较低的地方，抗疟药处方的减少量最高。使用 RDT 来支持诊断并没有对抗生素处方产生一致的影响，一些试验显示 RDT 组抗生素处方较高，而另一些试验显示 RDT 组抗生素处方较低（13,573 名受试者，五项试验，证据质量非常低）。一项试验报告了中度流行地区所有入组患者的疟疾显微镜检查，因此我们可以比较 RDT 和临床诊断组中实际经过显微镜检查证实疟疾感染但未接受抗疟药物的患者人数。两种诊断策略之间没有发现差异（1280 名受试者，一项试验，低质量证据）。如果卫生工作者遵守测试结果，结合 RDT 的算法可以大大减少抗疟疾处方。尚未证明引入 RDT 可以改善患者的健康结果，但坚持测试结果似乎不会导致比推定治疗更糟糕的临床结果。专注于改善 RDT 阴性患者的护理可以改善发热儿童的健康结果。 Cochrane 合作组织的研究人员对在传统上仅根据临床症状进行诊断的地区引入快速诊断测试 (RDT) 来诊断疟疾的效果进行了回顾。在搜索相关试验后，他们纳入了 7 项随机对照试验，纳入了 17,505 名发烧患者。什么是 RDT 以及它们如何改善患者护理 RDT 是一种易于使用的诊断试剂盒，可以从患者的一滴血液中检测出导致疟疾的寄生虫。它们不需要实验室设施或广泛的培训，可以在 20 分钟内提供简单的阳性或阴性结果，使其适合在疟疾病例最多的非洲农村地区使用。通过引入 RDT 来改善疟疾诊断不太可能改善真正的疟疾患者的健康结果，因为即使卫生工作者仅依靠临床症状，他们也可能会接受抗疟药物。然而，对于非疟疾引起的发烧患者，RDT 可以通过促使卫生工作者更早寻找和治疗发烧的真正原因来改善健康结果。研究内容 在这些试验中，使用 RDT 进行诊断对治疗后四到七天仍然不适的人数影响很小或没有影响（低质量证据）。然而，使用 RDT 可以将抗疟药处方减少多达四分之三（中等质量证据），并且在卫生工作者仅在检测呈阳性后才开出抗疟药且疟疾不太常见的地区，这种减少幅度最高。使用 RDT 来支持诊断并没有对抗生素处方产生一致的影响，一些试验显示抗生素处方增加，另一些则显示减少（证据质量非常低）。使用 RDT 并没有导致更多的疟疾患者被错误诊断为没有疟疾并被送回家而不接受治疗（低质量证据）。
In 2010, the World Health Organization recommended that all patients with suspected malaria are tested for malaria before treatment. In rural African settings light microscopy is often unavailable. Diagnosis has relied on detecting fever, and most people were given antimalarial drugs presumptively. Rapid diagnostic tests (RDTs) provide a point‐of‐care test that may improve management, particularly of people for whom the RDT excludes the diagnosis of malaria. To evaluate whether introducing RDTs into algorithms for diagnosing and treating people with fever improves health outcomes, reduces antimalarial prescribing, and is safe, compared to algorithms using clinical diagnosis. We searched the Cochrane Infectious Disease Group Specialized Register; CENTRAL (The Cochrane Library); MEDLINE; EMBASE; CINAHL; LILACS; and the metaRegister of Controlled Trials for eligible trials up to 10 January 2014. We contacted researchers in the field and reviewed the reference lists of all included trials to identify any additional trials. Individual or cluster randomized trials (RCTs) comparing RDT‐supported algorithms and algorithms using clinical diagnosis alone for diagnosing and treating people with fever living in malaria‐endemic settings. Two authors independently applied the inclusion criteria and extracted data. We combined data from individually and cluster RCTs using the generic inverse variance method. We presented all outcomes as risk ratios (RR) with 95% confidence intervals (CIs), and assessed the quality of evidence using the GRADE approach. We included seven trials, enrolling 17,505 people with fever or reported history of fever in this review; two individually randomized trials and five cluster randomized trials. All trials were conducted in rural African settings. In most trials the health workers diagnosing and treating malaria were nurses or clinical officers with less than one week of training in RDT supported diagnosis. Health worker prescribing adherence to RDT results was highly variable: the number of participants with a negative RDT result who received antimalarials ranged from 0% to 81%. Overall, RDT supported diagnosis had little or no effect on the number of participants remaining unwell at four to seven days after treatment (6990 participants, five trials, low quality evidence); but using RDTs reduced prescribing of antimalarials by up to three‐quarters (17,287 participants, seven trials, moderate quality evidence). As would be expected, the reduction in antimalarial prescriptions was highest where health workers adherence to the RDT result was high, and where the true prevalence of malaria was lower. Using RDTs to support diagnosis did not have a consistent effect on the prescription of antibiotics, with some trials showing higher antibiotic prescribing and some showing lower prescribing in the RDT group (13,573 participants, five trials, very low quality evidence). One trial reported malaria microscopy on all enrolled patients in an area of moderate endemicity, so we could compare the number of patients in the RDT and clinical diagnosis groups that actually had microscopy confirmed malaria infection but did not receive antimalarials. No difference was detected between the two diagnostic strategies (1280 participants, one trial, low quality evidence). Algorithms incorporating RDTs can substantially reduce antimalarial prescribing if health workers adhere to the test results. Introducing RDTs has not been shown to improve health outcomes for patients, but adherence to the test result does not seem to result in worse clinical outcomes than presumptive treatment. Concentrating on improving the care of RDT negative patients could improve health outcomes in febrile children. Cochrane Collaboration researchers conducted a review of the effects of introducing rapid diagnostic tests (RDTs) for diagnosing malaria in areas where diagnosis has traditionally been based on clinical symptoms alone. After searching for relevant trials, they included seven randomized controlled trials, which enrolled 17,505 people with fever. What are RDTs and how might they improve patient care RDTs are simple to use diagnostic kits which can detect the parasites that cause malaria from one drop of the patient's blood. They do not require laboratory facilities or extensive training, and can provide a simple positive or negative result within 20 minutes, making them suitable for use in rural areas of Africa where most malaria cases occur. Improving malaria diagnosis by introducing RDTs is unlikely to improve the health outcomes of people with true malaria as they would probably have received antimalarials even if the health worker was relying on clinical symptoms alone. However, for patients with fever not due to malaria, RDTs could improve health outcomes by prompting the health worker to look for and treat the true cause of their fever earlier. What the research says In these trials, diagnosis using RDTs had little or no effect on the number of people remaining unwell four to seven days after treatment (low quality evidence). However, using RDTs reduced the prescription of antimalarials by up to three‐quarters (moderate quality evidence), and this reduction was highest where health workers only prescribed antimalarials following a positive test, and where malaria was less common. Using RDTs to support diagnosis did not have a consistent effect on the prescription of antibiotics, with some trials showing an increase in antibiotic prescription and some showing a decrease (very low quality evidence). Use of RDTs did not result in more patients with malaria being incorrectly diagnosed as not having malaria and being sent home without treatment (low quality evidence).