Bernabe-Ortiz Antonio, Ruiz-Alejos Andrea, Miranda J Jaime, Mathur Rohini, Perel Pablo, Smeeth Liam
CRONICAS Center of Excellence in Chronic Diseases, Universidad Peruana Cayetano Heredia, Lima, Peru.
Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, United Kingdom.
PLoS One. 2017 Oct 30;12(10):e0187297. doi: 10.1371/journal.pone.0187297. eCollection 2017.
The EZSCAN is a non-invasive device that, by evaluating sweat gland function, may detect subjects with type 2 diabetes mellitus (T2DM). The aim of the study was to conduct a systematic review and meta-analysis including studies assessing the performance of the EZSCAN for detecting cases of undiagnosed T2DM.
METHODOLOGY/PRINCIPAL FINDINGS: We searched for observational studies including diagnostic accuracy and performance results assessing EZSCAN for detecting cases of undiagnosed T2DM. OVID (Medline, Embase, Global Health), CINAHL and SCOPUS databases, plus secondary resources, were searched until March 29, 2017. The following keywords were utilized for the systematic searching: type 2 diabetes mellitus, hyperglycemia, EZSCAN, SUDOSCAN, and sudomotor function. Two investigators extracted the information for meta-analysis and assessed the quality of the data using the Revised Version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) checklist. Pooled estimates were obtained by fitting the logistic-normal random-effects model without covariates but random intercepts and using the Freeman-Tukey Arcsine Transformation to stabilize variances. Heterogeneity was also assessed using the I2 measure. Four studies (n = 7,720) were included, three of them used oral glucose tolerance test as the gold standard. Using Hierarchical Summary Receiver Operating Characteristic model, summary sensitivity was 72.0% (95%CI: 60.0%- 83.0%), whereas specificity was 56.0% (95%CI: 38.0%- 74.0%). Studies were very heterogeneous (I2 for sensitivity: 79.2% and for specificity: 99.1%) regarding the inclusion criteria and bias was present mainly due to participants selection.
The sensitivity of EZSCAN for detecting cases of undiagnosed T2DM seems to be acceptable, but evidence of high heterogeneity and participant selection bias was detected in most of the studies included. More studies are needed to evaluate the performance of the EZSCAN for undiagnosed T2DM screening, especially at the population level.
EZSCAN是一种非侵入性设备，通过评估汗腺功能，可能检测出2型糖尿病（T2DM）患者。本研究的目的是进行一项系统评价和荟萃分析，纳入评估EZSCAN检测未诊断T2DM病例性能的研究。
方法/主要发现：我们检索了观察性研究，包括评估EZSCAN检测未诊断T2DM病例的诊断准确性和性能结果。检索了OVID（Medline、Embase、全球健康）、CINAHL和SCOPUS数据库以及二级资源，直至2017年3月29日。系统检索使用了以下关键词：2型糖尿病、高血糖、EZSCAN、SUDOSCAN和汗腺运动功能。两名研究人员提取信息进行荟萃分析，并使用诊断准确性研究质量评估修订版（QUADAS-2）清单评估数据质量。通过拟合无协变量但有随机截距的逻辑正态随机效应模型并使用Freeman-Tukey反正弦变换来稳定方差，获得合并估计值。还使用I2指标评估异质性。纳入了四项研究（n = 7720），其中三项使用口服葡萄糖耐量试验作为金标准。使用分层汇总接受者操作特征模型，汇总敏感性为72.0%（95%CI：60.0%-83.0%），而特异性为56.0%（95%CI：38.0%-74.0%）。关于纳入标准，研究存在很大异质性（敏感性的I2为79.2%，特异性的I2为99.1%），且主要由于参与者选择存在偏差。
EZSCAN检测未诊断T2DM病例的敏感性似乎可以接受，但在纳入的大多数研究中发现了高度异质性和参与者选择偏差的证据。需要更多研究来评估EZSCAN在未诊断T2DM筛查中的性能，尤其是在人群层面。
