Projahnmo Research Foundation, Dhaka, Bangladesh
School of Nursing and Midwifery, College of Science, Health and Engineering, La Trobe University, Melbourne, Victoria, Australia.
BMJ Open. 2021 Aug 18;11(8):e052212. doi: 10.1136/bmjopen-2021-052212.
Tuberculosis (TB) continues to be a significant health burden, most commonly affecting the lungs and referred to as pulmonary TB (PTB). Diagnostic techniques of PTB primarily rely on expectorated sputum samples. However, the diagnostic yields are often hindered due to insufficient volume and quality of the sputum specimens. Moreover, some individuals are unable to provide sputum samples due to scanty sputum production or difficulty in coughing up and require an invasive procedure to obtain a respiratory sample, such as bronchoscopic or gastric aspiration. Thus, challenges in the acquisition of respiratory specimens warrant an alternate specimen. Therefore, this systematic review aims to evaluate the diagnostic accuracy of a stool specimen for the diagnosis of PTB in adults.
We will search MEDLINE (Ovid), Embase (Ovid), Web of Science and Cochrane database from inception to April 2021 using a comprehensive search strategy. Two reviewers will independently perform screening, data extraction and quality assessment. The risk of bias assessment and applicability of results of eligible studies will be performed using the Quality of Diagnostic Accuracy Studies-2 tool. Bivariate random-effects models will be performed to calculate pooled sensitivity, specificity, positive likelihood ratio and negative likelihood ratio and diagnostic odds ratio along with 95% CI of stool specimen for each reported diagnostic method against any of the reference standard test (ie, mycobacterial culture or smear microscopy or Xpert assay using respiratory specimens). Heterogeneity between studies will be assessed by I statistics and Q statistic of the χ test.
The results will be disseminated through publishing in a peer-reviewed medical journal and public presentations in relevant national and international conferences. As this is a systematic review of publicly available data, ethics approval is not required.
CRD42021245203.
结核病（TB）仍然是一个重大的健康负担，最常影响肺部，称为肺结核（PTB）。PTB 的诊断技术主要依赖于咳出的痰液样本。然而，由于痰液标本的体积和质量不足，诊断效果往往受到阻碍。此外，由于痰液生成量少或难以咳出，一些人无法提供痰液样本，需要进行有创性程序以获取呼吸道样本，如支气管镜或胃抽吸。因此，获取呼吸道标本的挑战需要替代标本。因此，本系统评价旨在评估粪便标本在诊断成人肺结核中的诊断准确性。
我们将从建库至 2021 年 4 月使用全面的搜索策略在 MEDLINE（Ovid）、Embase（Ovid）、Web of Science 和 Cochrane 数据库中进行搜索。两名评审员将独立进行筛选、数据提取和质量评估。将使用诊断准确性研究质量工具（Quality of Diagnostic Accuracy Studies-2）评估合格研究的偏倚风险评估和结果适用性。将使用双变量随机效应模型计算每种报告的诊断方法的粪便标本的汇总敏感性、特异性、阳性似然比、阴性似然比和诊断比值比以及与任何参考标准测试（即使用呼吸道标本的分枝杆菌培养或涂片显微镜检查或 Xpert 检测）的 95%CI。通过 χ 检验的 I 统计量和 Q 统计量评估研究之间的异质性。
结果将通过在同行评议的医学期刊上发表和在相关的国家和国际会议上进行公开演讲来传播。由于这是对公开可用数据的系统评价，因此不需要伦理批准。
PROSPERO 注册号：CRD42021245203。
