Elizabeth Glaser Pediatric AIDS Foundation, Dar es Salaam, Tanzania.
Ifakara Health Institute, Bagamoyo, Tanzania.
Cochrane Database Syst Rev. 2021 May 6;5(5):CD012972. doi: 10.1002/14651858.CD012972.pub2.
The World Health Organization (WHO) recommends Xpert MTB/RIF in place of smear microscopy to diagnose tuberculosis (TB), and many countries have adopted it into their diagnostic algorithms. However, it is not clear whether the greater accuracy of the test translates into improved health outcomes.
To assess the impact of Xpert MTB/RIF on patient outcomes in people being investigated for tuberculosis.
We searched the following databases, without language restriction, from 2007 to 24 July 2020: Cochrane Infectious Disease Group (CIDG) Specialized Register; CENTRAL; MEDLINE OVID; Embase OVID; CINAHL EBSCO; LILACS BIREME; Science Citation Index Expanded (Web of Science), Social Sciences citation index (Web of Science), and Conference Proceedings Citation Index - Social Science & Humanities (Web of Science). We also searched the WHO International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Pan African Clinical Trials Registry for ongoing trials.
We included individual- and cluster-randomized trials, and before-after studies, in participants being investigated for tuberculosis. We analysed the randomized and non-randomized studies separately. DATA COLLECTION AND ANALYSIS: For each study, two review authors independently extracted data, using a piloted data extraction tool. We assessed the risk of bias using Cochrane and Effective Practice and Organisation of Care (EPOC) tools. We used random effects meta-analysis to allow for heterogeneity between studies in setting and design. The certainty of the evidence in the randomized trials was assessed by GRADE.
We included 12 studies: eight were randomized controlled trials (RCTs), and four were before-and-after studies. Most included RCTs had a low risk of bias in most domains of the Cochrane 'Risk of bias' tool. There was inconclusive evidence of an effect of Xpert MTB/RIF on all-cause mortality, both overall (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.75 to 1.05; 5 RCTs, 9932 participants, moderate-certainty evidence), and restricted to studies with six-month follow-up (RR 0.98, 95% CI 0.78 to 1.22; 3 RCTs, 8143 participants; moderate-certainty evidence). There was probably a reduction in mortality in participants known to be infected with HIV (odds ratio (OR) 0.80, 95% CI 0.67 to 0.96; 5 RCTs, 5855 participants; moderate-certainty evidence). It is uncertain whether Xpert MTB/RIF has no or a modest effect on the proportion of participants starting tuberculosis treatment who had a successful treatment outcome (OR) 1.10, 95% CI 0.96 to 1.26; 3RCTs, 4802 participants; moderate-certainty evidence). There was also inconclusive evidence of an effect on the proportion of participants who were treated for tuberculosis (RR 1.10, 95% CI 0.98 to 1.23; 5 RCTs, 8793 participants; moderate-certainty evidence). The proportion of participants treated for tuberculosis who had bacteriological confirmation was probably higher in the Xpert MTB/RIF group (RR 1.44, 95% CI 1.29 to 1.61; 6 RCTs, 2068 participants; moderate-certainty evidence). The proportion of participants with bacteriological confirmation who were lost to follow-up pre-treatment was probably reduced (RR 0.59, 95% CI 0.41 to 0.85; 3 RCTs, 1217 participants; moderate-certainty evidence).
AUTHORS' CONCLUSIONS: We were unable to confidently rule in or rule out the effect on all-cause mortality of using Xpert MTB/RIF rather than smear microscopy. Xpert MTB/RIF probably reduces mortality among participants known to be infected with HIV. We are uncertain whether Xpert MTB/RIF has a modest effect or not on the proportion treated or, among those treated, on the proportion with a successful outcome. It probably does not have a substantial effect on these outcomes. Xpert MTB/RIF probably increases both the proportion of treated participants who had bacteriological confirmation, and the proportion with a laboratory-confirmed diagnosis who were treated. These findings may inform decisions about uptake alongside evidence on cost-effectiveness and implementation.
世界卫生组织（WHO）建议用 Xpert MTB/RIF 取代痰涂片显微镜检查来诊断结核病（TB），许多国家已将其纳入诊断算法。然而，目前尚不清楚该检测方法的更高准确性是否能转化为改善的健康结果。
评估 Xpert MTB/RIF 对疑似结核病患者的临床结局的影响。
我们检索了以下数据库，无语言限制，从 2007 年至 2020 年 7 月 24 日：Cochrane 传染病组（CIDG）专业注册库；CENTRAL；MEDLINE OVID；Embase OVID；CINAHL EBSCO；LILACS BIREME；科学引文索引扩展版（Web of Science）、社会科学引文索引（Web of Science）和会议论文引文索引-社会科学与人文（Web of Science）。我们还检索了世界卫生组织国际临床试验注册平台、ClinicalTrials.gov 和泛非临床试验注册中心正在进行的试验。
我们纳入了疑似结核病患者的个体和群组随机试验以及前后对照研究。我们分别分析了随机和非随机研究。对于每一项研究，两位综述作者独立地使用预试验的数据提取工具提取数据。我们使用 Cochrane 工具和有效实践和组织保健（EPOC）工具评估了偏倚风险。我们使用随机效应荟萃分析来允许研究在设置和设计上存在异质性。在随机试验中，证据的确定性通过 GRADE 进行评估。
我们纳入了 12 项研究：8 项为随机对照试验（RCT），4 项为前后对照研究。大多数纳入的 RCT 在 Cochrane“风险偏倚”工具的大多数领域中具有低偏倚风险。目前尚不能确定 Xpert MTB/RIF 是否会对全因死亡率产生影响，总体而言（风险比（RR）0.89，95%置信区间（CI）0.75 至 1.05；5 项 RCT，9932 名参与者，中质量证据），且仅限于有 6 个月随访的研究（RR 0.98，95%CI 0.78 至 1.22；3 项 RCT，8143 名参与者；中质量证据）。在已知感染 HIV 的参与者中，死亡率可能降低（比值比（OR）0.80，95%置信区间（CI）0.67 至 0.96；5 项 RCT，5855 名参与者；中质量证据）。目前尚不确定 Xpert MTB/RIF 是否会对开始结核病治疗的参与者的治疗成功率产生影响（OR 1.10，95%置信区间（CI）0.96 至 1.26；3 项 RCT，4802 名参与者；中质量证据）。对于治疗结核病的参与者比例，Xpert MTB/RIF 可能没有或仅有适度的影响（RR 1.10，95%CI 0.98 至 1.23；5 项 RCT，8793 名参与者；中质量证据）。Xpert MTB/RIF 对接受治疗的结核病患者比例的影响也不确定（RR 1.10，95%CI 0.98 至 1.23；5 项 RCT，8793 名参与者；中质量证据）。在 Xpert MTB/RIF 组中，接受治疗的结核病患者中有细菌学证实的比例可能更高（RR 1.44，95%置信区间（CI）1.29 至 1.61；6 项 RCT，2068 名参与者；中质量证据）。治疗前有细菌学证实的失访比例可能降低（RR 0.59，95%置信区间（CI）0.41 至 0.85；3 项 RCT，1217 名参与者；中质量证据）。
我们无法确定使用 Xpert MTB/RIF 而非痰涂片显微镜检查是否会对全因死亡率产生影响。Xpert MTB/RIF 可能会降低已知感染 HIV 的参与者的死亡率。我们不确定 Xpert MTB/RIF 是否会对治疗或治疗成功的比例产生适度影响。它可能不会对这些结果产生实质性影响。Xpert MTB/RIF 可能会增加接受治疗的参与者中有细菌学证实的比例，以及接受治疗的具有实验室确诊诊断的参与者的比例。这些发现可能会影响与成本效益和实施相关的证据一起对采用的决策。
