Adelaide Health Technology Assessment (AHTA), Discipline of Public Health, The University of Adelaide, Adelaide, SA 5005, Australia.
Breast Cancer Res Treat. 2013 Feb;137(3):665-76. doi: 10.1007/s10549-012-2393-x. Epub 2013 Jan 4.
The objective of this study aimed to systematically identify and evaluate all the available evidence of safety, effectiveness and diagnostic accuracy for three emerging classes of technology promoted for breast cancer screening and diagnosis: Digital infrared thermal imaging (DITI), electrical impedance scanning (EIS) and elastography. A systematic search of seven biomedical databases (EMBASE, PubMed, Web of Science, CRD, CINAHL, Cochrane Library, Current Contents Connect) was conducted through March 2011, along with a manual search of reference lists from relevant studies. The principal outcome measures were safety, effectiveness, and diagnostic accuracy. Data were extracted using a standardised form, and validated for accuracy by the secondary authors. Study quality was appraised using the quality assessment of diagnostic accuracy studies tool, while heterogeneity was assessed using forest plots, Cooks' distance and standardised residual scatter plots, and I (2) statistics. From 6,808 search results, 267 full-text articles were assessed, of which 60 satisfied the inclusion criteria. No effectiveness studies were identified. Only one EIS screening accuracy study was identified, while all other studies involved symptomatic populations. Significant heterogeneity was present among all device classes, limiting the potential for meta-analyses. Sensitivity and specificity varied greatly for DITI (Sens 0.25-0.97, Spec 0.12-0.85), EIS (Sens 0.26-0.98, Spec 0.08-0.81) and ultrasound elastography (Sens 0.35-1.00, Spec 0.21-0.99). It is concluded that there is currently insufficient evidence to recommend the use of these technologies for breast cancer screening. Moreover, the high level of heterogeneity among studies of symptomatic women limits inferences that may be drawn regarding their use as diagnostic tools. Future research employing standardised imaging, research and reporting methods is required.
本研究旨在系统地识别和评估所有现有的关于三种新兴技术在乳腺癌筛查和诊断中的安全性、有效性和诊断准确性的证据：数字红外热成像（DITI）、电阻抗扫描（EIS）和弹性成像。通过 2011 年 3 月，对 7 个生物医学数据库（EMBASE、PubMed、Web of Science、CRD、CINAHL、Cochrane 图书馆、Current Contents Connect）进行了系统搜索，并对相关研究的参考文献进行了手动搜索。主要结果测量指标为安全性、有效性和诊断准确性。使用标准化表格提取数据，并由次要作者验证准确性。使用诊断准确性研究质量评估工具评估研究质量，同时使用森林图、Cooks 距离和标准化残差散点图以及 I（2）统计量评估异质性。从 6808 个搜索结果中，评估了 267 篇全文文章，其中 60 篇符合纳入标准。没有发现有效性研究。只确定了一项 EIS 筛查准确性研究，而其他所有研究都涉及有症状的人群。所有设备类别均存在显著异质性，限制了荟萃分析的可能性。DITI 的敏感性和特异性差异很大（Sens 0.25-0.97，Spec 0.12-0.85），EIS（Sens 0.26-0.98，Spec 0.08-0.81）和超声弹性成像（Sens 0.35-1.00，Spec 0.21-0.99）。结论是，目前没有足够的证据推荐使用这些技术进行乳腺癌筛查。此外，对有症状女性的研究存在很高的异质性，限制了对其作为诊断工具的使用的推断。需要进行未来的研究，采用标准化的成像、研究和报告方法。
