Department of Integrated Traditional Chinese and Western Medicine, Sichuan University West China Hospital, Chengdu, Sichuan, China.
Department of Integrated Traditional Chinese and Western Medicine, Sichuan University West China Hospital/ West China School of Nursing, Chengdu, Sichuan, China.
BMJ Open. 2022 Aug 29;12(8):e057746. doi: 10.1136/bmjopen-2021-057746.
Increasing numbers of patients with non-haematological diseases are infected with invasive pulmonary aspergillosis (IPA), with a high mortality reported which is mainly due to delayed diagnosis. The diagnostic capability of mycological tests for IPA including galactomannan test, (1,3)-β-D-glucan test, lateral flow assay, lateral flow device and PCR for the non-haematological patients remains unknown. This protocol aims to conduct a systematic review and meta-analysis of the diagnostic performance of mycological tests to facilitate the early diagnosis and treatments of IPA in non-haematological diseases.
Database including PubMed, CENTRAL and EMBASE will be searched from 2002 until the publication of results. Cohort or cross-sectional studies that assessing the diagnostic capability of mycological tests for IPA in patients with non-haematological diseases will be included. The true-positive, false-positive, true-negative and false-negative of each test will be extracted and pooled in bivariate random-effects model, by which the sensitivity and specificity will be calculated with 95% CI. The second outcomes will include positive (negative) likelihood ratio, area under the receiver operating characteristic curve and diagnostic OR will also be computed in the bivariate model. When applicable, subgroup analysis will be performed with several prespecified covariates to explore potential sources of heterogeneity. Factors that may impact the diagnostic effects of mycological tests will be examined by sensitivity analysis. The risk of bias will be appraised by the Quality Assessment tool for Diagnostic Accuracy Studies (QUADAS-2).
This protocol is not involved with ethics approval, and the results will be peer-reviewed and disseminated on a recognised journal.
CRD42021241820.
越来越多患有非血液系统疾病的患者感染侵袭性肺曲霉病(IPA),报道的死亡率很高,主要是由于诊断延误。非血液系统患者 IPA 的真菌学检测(包括半乳甘露聚糖检测、(1,3)-β-D-葡聚糖检测、侧向流检测、侧向流设备和 PCR)的诊断能力尚不清楚。本方案旨在对真菌学检测诊断 IPA 的性能进行系统评价和荟萃分析,以促进非血液系统疾病 IPA 的早期诊断和治疗。
将从 2002 年开始至结果发布时,在 PubMed、CENTRAL 和 EMBASE 数据库中进行检索。将纳入评估非血液系统疾病患者 IPA 的真菌学检测诊断能力的队列或横断面研究。将提取并汇总每个检测的真阳性、假阳性、真阴性和假阴性,通过双变量随机效应模型计算敏感性和特异性,并用 95%CI 计算。第二个结果将包括阳性(阴性)似然比、受试者工作特征曲线下面积和诊断 OR,也将在双变量模型中计算。如果适用,将进行亚组分析,使用几个预设协变量来探索潜在的异质性来源。通过敏感性分析检查可能影响真菌学检测诊断效果的因素。将使用诊断准确性研究的质量评估工具(QUADAS-2)评估偏倚风险。
本方案不涉及伦理批准,结果将经过同行评审并在认可的期刊上发表。
PROSPERO 注册号:CRD42021241820。