Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis.
Rapid diagnosis of tuberculosis with the Xpert MTB/RIF assay in high burden countries: a cost-effectiveness analysis.
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DOI：
10.1371/journal.pmed.1001120
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发表时间：
2011-11
期刊：
影响因子：
15.8
通讯作者：
Cobelens F
中科院分区：
文献类型：
--
作者：
Vassall A;van Kampen S;Sohn H;Michael JS;John KR;den Boon S;Davis JL;Whitelaw A;Nicol MP;Gler MT;Khaliqov A;Zamudio C;Perkins MD;Boehme CC;Cobelens F
Frank Cobelens 及其同事进行的一项成本效益研究表明，Xpert MTB/RIF 是一种经济有效的结核病诊断方法，适合在低收入和中等收入环境中使用。 Xpert MTB/RIF (Xpert) 是一种很有前途的新型结核病 (TB) 快速诊断技术，具有适合大规模推广的特点。然而，由于检测费用昂贵，结核病项目管理者和政策制定者对中低收入环境的承受能力表示担忧。我们使用决策分析模型估计引入 Xpert 对结核病护理成本和成本效益的影响，并将 Xpert 的引入与印度、南非和乌干达的涂片显微镜检查和临床诊断的基本案例进行比较。 Xpert 的引入增加了所有三种环境中结核病病例的发现；与基本情况相比，疑似结核病患者群体中的 72%–85% 上升至 95%–99%。诊断费用（包括对所有疑似结核病患者进行检测的费用）也有所增加：当使用 Xpert 涂片显微镜检查“作为补充”和“替代”涂片显微镜检查时，每个结核病病例的诊断费用（包括对所有疑似结核病患者进行检测的费用）分别从 28 美元至 49 美元增加至 133 美元至 146 美元和 137 美元至 151 美元。与基本情况相比，在涂片显微镜检查的基础上使用 Xpert 的增量成本效益比 (ICER) 范围为每避免残疾调整生命年 (DALY) 41 美元至 110 美元。同样，使用 Xpert“替代”涂片显微镜的 ICERS 范围为每个避免的 DALY 52 美元至 138 美元。这些 ICER 低于世界卫生组织 (WHO) 的支付意愿门槛。我们的结果表明，与低收入和中等收入环境中涂片显微镜检查和涂片阴性结核病临床诊断的基本情况相比，Xpert 是一种具有成本效益的结核病诊断方法，在低收入和中等收入环境中，Xpert 能够大幅增加病例发现率，在改善结核病诊断和控制方面具有重要潜力。通过部署 Xpert 为结核病项目带来成本效益的程度主要取决于当前的结核病诊断实践。在扩大规模期间需要进一步的工作来验证这些发现。 请参阅本文后面的编辑摘要 结核病 (TB) 是一种细菌性疾病，感染世界三分之一的人口。这种疾病是由结核分枝杆菌引起的，这种细菌最常感染肺部（称为肺结核），并通过感染者咳嗽、打喷嚏或说话而在人与人之间传播。结核病的症状包括胸痛、体重减轻、发烧和持续咳嗽，有时伴有血。只有 5%–10% 的结核病感染者会生病或具有传染性，但免疫系统较弱的人，例如艾滋病毒呈阳性的人，更有可能患上这种疾病。据估计，2009 年结核病已导致 170 万人死亡，目前是艾滋病毒感染者死亡的主要原因。虽然结核病可以通过六个月的抗生素疗程来治疗，但有效诊断结核病并不总是那么简单，耐药性正成为一个日益严重的问题。诊断结核病最常见和最简单的方法之一是痰涂片显微镜检查技术，该技术包括在显微镜下检查肺部物质是否存在引起结核病的细菌。然而，尽管价格便宜且相对简单，但该检测并不总能检测出活动性结核病（涂片阴性），也无法确定引起结核病的细菌是否对抗生素具有耐药性。世界卫生组织最近认可了一种新的快速检测方法，称为Xpert MTB/RIF（简称Xpert），用于结核病的初步诊断。该测试使用 DNA 扩增方法来可靠、快速地检测结核病以及感染细菌是否对抗生素利福平产生耐药性。新测试价格昂贵，因此有人担心该测试在低收入和中等收入国家可能不具有成本效益。研究人员使用一种称为建模的技术来模拟 10,000 名疑似结核病患者在经历假设的诊断和治疗途径时的结果。该模型将引入 Xpert 的相关成本与两种不同场景的基本案例进行了比较。在基本病例中，所有疑似结核病患者均进行了两次痰涂片镜检，如果涂片阴性则进行临床诊断。对于不同的情况，除了两次痰涂片镜检（如果患者涂片呈阴性）之外还使用 Xpert，或者使用 Xpert 作为所有患者痰涂片镜检的替代品。根据具体国家的估计，应用不同的输入参数，以便模型反映 Xpert 在印度、南非和乌干达的实施情况。在研究人员的模型中，Xpert 的引入增加了在任何环境下被正确诊断为结核病的结核感染患者的比例。然而，在这两种情况下，检测到的每个 TB 病例的成本都增加了约 100 美元。尽管检测成本显着增加，但由于假阳性病例数量减少，治疗成本仅适度增加。例如，当印度使用 Xpert 取代痰涂片显微镜检查时，预计用于假阳性诊断的治疗费用百分比将从 22% 降至 4%。该模型用于计算不同环境中 Xpert 实施的不同场景的增量成本效益比（ICER——避免的每个伤残调整生命年 [DALY] 的额外成本）。与基本情况相比，在痰涂片显微镜检查的基础上引入 Xpert 产生的 ICER 范围为每避免 DALY 41 美元至 110 美元，而引入 Xpert 代替痰涂片显微镜检查产生的 ICER 范围为每避免 DALY 52 美元至 138 美元。研究结果表明，在低收入和中等收入国家，除了痰涂片显微镜检查之外或代替痰涂片显微镜检查，实施 Xpert 将具有成本效益。计算出的 ICER 低于世界卫生组织针对所有环境的“支付意愿门槛”。也就是说，通过引入 Xpert 避免的每个 DALY 的增量成本低于每个国家的人均国内生产总值（2010 年印度为 1,134 美元，南非为 5,786 美元，乌干达为 490 美元）。然而，作者指出，实现 ICER 低于“支付意愿门槛”并不一定意味着各国有资源来实施测试。研究人员还指出，他们的研究存在局限性；与 Xpert 规模扩大相关的额外未知成本和某些参数（例如患者成本）未包含在模型中。尽管该模型强烈表明 Xpert 具有成本效益，但研究人员警告称，在全面扩大规模之前，应仔细监测和评估 Xpert 的首次推出。请通过此摘要的在线版本访问这些网站：http://dx.doi.org/10.1371/journal.pmed.1001120。 世界卫生组织提供有关结核病各个方面的信息，包括结核病诊断和遏制结核病伙伴关系（部分信息有多种语言版本） 美国疾病控制和预防中心提供有关结核病的信息，包括有关结核病诊断的信息 MedlinePlus 提供有关结核病的更多信息的链接（英语和西班牙语）
A cost-effectiveness study by Frank Cobelens and colleagues reveals that Xpert MTB/RIF is a cost-effective method of tuberculosis diagnosis that is suitable for use in low- and middle-income settings. Xpert MTB/RIF (Xpert) is a promising new rapid diagnostic technology for tuberculosis (TB) that has characteristics that suggest large-scale roll-out. However, because the test is expensive, there are concerns among TB program managers and policy makers regarding its affordability for low- and middle-income settings. We estimate the impact of the introduction of Xpert on the costs and cost-effectiveness of TB care using decision analytic modelling, comparing the introduction of Xpert to a base case of smear microscopy and clinical diagnosis in India, South Africa, and Uganda. The introduction of Xpert increases TB case finding in all three settings; from 72%–85% to 95%–99% of the cohort of individuals with suspected TB, compared to the base case. Diagnostic costs (including the costs of testing all individuals with suspected TB) also increase: from US$28–US$49 to US$133–US$146 and US$137–US$151 per TB case detected when Xpert is used “in addition to” and “as a replacement of” smear microscopy, respectively. The incremental cost effectiveness ratios (ICERs) for using Xpert “in addition to” smear microscopy, compared to the base case, range from US$41–$110 per disability adjusted life year (DALY) averted. Likewise the ICERS for using Xpert “as a replacement of” smear microscopy range from US$52–$138 per DALY averted. These ICERs are below the World Health Organization (WHO) willingness to pay threshold. Our results suggest that Xpert is a cost-effective method of TB diagnosis, compared to a base case of smear microscopy and clinical diagnosis of smear-negative TB in low- and middle-income settings where, with its ability to substantially increase case finding, it has important potential for improving TB diagnosis and control. The extent of cost-effectiveness gain to TB programmes from deploying Xpert is primarily dependent on current TB diagnostic practices. Further work is required during scale-up to validate these findings. Please see later in the article for the Editors' Summary Tuberculosis (TB) is a bacterial disease that infects one-third of the world's population. The disease is caused by Mycobacterium tuberculosis, a bacterium that most commonly infects the lungs (known as pulmonary TB) and is transmitted from person to person when an infected individual coughs, sneezes, or talks. The symptoms of TB include chest pain, weight loss, fever, and a persistent cough that sometimes contains blood. Only 5%–10% of people who are infected with TB become sick or infectious, but people with weakened immune systems, such as individuals who are HIV-positive, are more likely to develop the disease. TB is estimated to have killed 1.7 million people in 2009 and is currently the leading cause of death among people infected with HIV. Although TB can be treated with a six-month course of antibiotics, effectively diagnosing TB is not always straightforward and drug resistance is becoming an increasing problem. One of the most common and simple methods to diagnose TB is a technique called sputum smear microscopy, which involves examining matter from the lungs under a microscope for the presence of TB-causing bacteria. However, despite being cheap and relatively simple, the test does not always detect active TB (smear-negative) and cannot determine whether the TB-causing bacteria are resistant to antibiotics. The World Health Organization has recently endorsed a new rapid test, called Xpert MTB/RIF (referred to as Xpert), for the initial diagnosis of TB. The test uses DNA amplification methods to reliably and quickly detect TB and whether infecting bacteria are resistant to the antibiotic rifampicin. The new test is expensive so there are concerns that the test might not be cost-effective in low- and middle-income countries. The researchers used a technique called modeling to simulate the outcome of 10,000 individuals with suspected TB as they went through a hypothetical diagnostic and treatment pathway. The model compared the costs associated with the introduction of Xpert to a base case for two different scenarios. In the base case all individuals with suspected TB had two sputum smear microscopy examinations followed by clinical diagnosis if they were smear-negative. For the different scenarios Xpert was either used in addition to the two sputum smear microscopy examinations (if the patient was smear-negative) or Xpert was used as a replacement for sputum smear microscopy for all patients. Different input parameters, based on country-specific estimates, were applied so that the model reflected the implementation of Xpert in India, South Africa, and Uganda. In the researcher's model the introduction of Xpert increased the proportion of TB-infected patients who were correctly diagnosed with TB in any of the settings. However, the cost per TB case detected increased by approximately US$100 in both scenarios. Although the cost of detection increased significantly, the cost of treatment increased only moderately because the number of false-positive cases was reduced. For example, the percentage of treatment costs spent on false-positive diagnoses in India was predicted to fall from 22% to 4% when Xpert was used to replace sputum smear microscopy. The model was used to calculate incremental cost effectiveness ratios (ICERs—the additional cost of each disability-adjusted life year [DALY] averted) for the different scenarios of Xpert implementation in the different settings. In comparison to the base case, introducing Xpert in addition to sputum smear microscopy produced ICERs ranging from US$41 to US$110 per DALY averted, while introducing Xpert instead of sputum smear microscopy yielded ICERs ranging from US$52 to US$138 per DALY averted. The findings suggest that the implementation of Xpert in addition to, or instead of, sputum smear microscopy will be cost-effective in low- and middle-income countries. The calculated ICERs are below the World Health Organization's “willingness to pay threshold” for all settings. That is the incremental cost of each DALY averted by introduction of Xpert is below the gross domestic product per capita for each country ($1,134 for India, $5,786 South Africa, and $490 for Uganda in 2010). However, the authors note that achieving ICERs below the “willingness to pay threshold” does not necessarily mean that countries have the resources to implement the test. The researchers also note that there are limitations to their study; additional unknown costs associated with the scale-up of Xpert and some parameters, such as patient costs, were not included in the model. Although the model strongly suggests that Xpert will be cost-effective, the researchers caution that initial roll-out of Xpert should be carefully monitored and evaluated before full scale-up. Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001120. The World Health Organization provides information on all aspects of tuberculosis, including tuberculosis diagnostics and the Stop TB Partnership (some information is in several languages) The US Centers for Disease Control and Prevention has information about tuberculosis, including information on the diagnosis of tuberculosis disease MedlinePlus has links to further information about tuberculosis (in English and Spanish)
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影响因子：
3.7
作者：
Lukoye D;Cobelens FG;Ezati N;Kirimunda S;Adatu FE;Lule JK;Nuwaha F;Joloba ML
通讯作者：
Joloba ML
影响因子：
56.3
作者：
Holtz, Timothy H.;Kabera, Gaetan;Rustomjee, Roxana
通讯作者：
Rustomjee, Roxana
DOI：
10.1056/nejmoa0905848
发表时间：
2010-02-25
期刊：
The New England journal of medicine
影响因子：
--
作者：
Abdool Karim SS;Naidoo K;Grobler A;Padayatchi N;Baxter C;Gray A;Gengiah T;Nair G;Bamber S;Singh A;Khan M;Pienaar J;El-Sadr W;Friedland G;Abdool Karim Q
通讯作者：
Abdool Karim Q
DOI：
10.1016/0962-8479(95)90013-6
发表时间：
1995-10-01
期刊：
TUBERCLE AND LUNG DISEASE
影响因子：
--
作者：
RIEDER, HL;ENARSON, DA
通讯作者：
ENARSON, DA
影响因子：
3.7
作者：
Dowdy, David W.;Lourenco, Maria C.;Dorman, Susan E.
通讯作者：
Dorman, Susan E.