International Union against Tuberculosis and Lung Disease, South East Asia Regional office, New Delhi, India.
National Institute for Research in Tuberculosis, ICMR, Chennai, India.
PLoS One. 2018 Oct 29;13(10):e0205233. doi: 10.1371/journal.pone.0205233. eCollection 2018.
Early and accurate diagnosis of tuberculosis is a priority for TB programs globally to initiate treatment early and improve treatment outcomes. Currently, Ziehl-Neelsen (ZN) stain-based microscopy, GeneXpert and Light Emitting Diode-Fluorescence Microscopy (LED-FM) are used for diagnosing pulmonary drug sensitive tuberculosis. Published evidence synthesising the cost-effectiveness of these diagnostic tools is scarce.
PubMed, EMBASE and Cost-effectiveness analysis registry were searched for studies that reported on the cost-effectiveness of GeneXpert and LED-FM, compared to ZN microscopy for diagnosing pulmonary TB. Risk of bias was assessed independently by four authors using the Consensus Health Economic Criteria (CHEC) extended checklist. The data variables included the study settings, population, type of intervention, type of comparator, year of study, duration of study, type of study design, costs for the test and the comparator and effectiveness indicators. Incremental cost-effectiveness ratio (ICER) was used for assessing the relative cost-effectiveness in this review.
Of the 496 studies identified by the search, thirteen studies were included after removing duplicates and studies that did not fulfil inclusion criteria. Four studies compared LED-FM with ZN and nine studies compared GeneXpert with ZN. Three studies used patient cohorts and eight were modelling studies with hypothetical cohorts used to evaluate cost-effectiveness. All these studies were conducted from a health system perspective, with four studies utilising cost utility analysis. There were considerable variations in costing parameters and effectiveness indicators that precluded meta-analysis. The key findings from the included studies suggest that LED-FM and GeneXpert may be cost effective for pulmonary TB diagnosis from a health system perspective.
Our review identifies a consistent trend of the cost effectiveness of LED-FM and GeneXpert for pulmonary TB diagnosis in different countries with diverse context of socio-economic condition, HIV burden and geographical distribution. However, all the studies used different parameters to estimate the impact of these tools and this underscores the need for improving the methodological issues related to the conduct and reporting of cost-effectiveness studies.
早期、准确地诊断结核病是全球结核病规划的首要任务，以便及早开始治疗并改善治疗效果。目前，萋-尼氏抗酸染色显微镜检查、GeneXpert 和发光二极管荧光显微镜检查（LED-FM）被用于诊断肺结核。但缺乏关于这些诊断工具的成本效益的已发表证据综合研究。
我们在 PubMed、EMBASE 和成本效益分析登记处检索了报道 GeneXpert 和 LED-FM 与 ZN 显微镜检查相比，用于诊断肺结核的成本效益的研究。四位作者使用共识健康经济标准（CHEC）扩展清单独立评估偏倚风险。数据变量包括研究地点、人群、干预类型、比较类型、研究年份、研究持续时间、研究设计类型、测试和比较器的成本以及效果指标。在本次综述中，使用增量成本效益比（ICER）来评估相对成本效益。
通过搜索共确定了 496 项研究，在去除重复项和不符合纳入标准的研究后，共纳入了 13 项研究。四项研究将 LED-FM 与 ZN 进行了比较，九项研究将 GeneXpert 与 ZN 进行了比较。三项研究使用了患者队列，八项研究是使用假设队列的模型研究，用于评估成本效益。所有这些研究都是从卫生系统的角度进行的，其中四项研究使用了成本效用分析。成本参数和效果指标存在很大差异，因此无法进行荟萃分析。纳入研究的主要结果表明，从卫生系统的角度来看，LED-FM 和 GeneXpert 可能对肺结核的诊断具有成本效益。
我们的综述发现，在具有不同社会经济条件、HIV 负担和地理分布背景的不同国家，LED-FM 和 GeneXpert 对肺结核诊断的成本效益具有一致的趋势。然而，所有研究都使用了不同的参数来估计这些工具的影响，这凸显了改进与成本效益研究的进行和报告相关的方法问题的必要性。
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