PURPOSE Mammography is not always available or feasible. The purpose of this systematic review and meta-analysis is to assess the diagnostic performance of ultrasound as a primary tool for early detection of breast cancer. MATERIALS AND METHODS For this systematic review and meta-analysis, we comprehensively searched PubMed and SCOPUS to identify articles from January 2000 to December 2018 that included data on the performance of ultrasound for detection of breast cancer. Studies evaluating portable, handheld ultrasound as an independent detection modality for breast cancer were included. Quality assessment and bias analysis were performed with the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Sensitivity analyses and meta-regression were used to explore heterogeneity. The study protocol has been registered with the international prospective register of systematic reviews (PROSPERO identifier: CRD42019127752). RESULTS Of the 526 identified studies, 26 were eligible for inclusion. Ultrasound had an overall pooled sensitivity and specificity of 80.1% (95% CI, 72.2% to 86.3%) and 88.4% (95% CI, 79.8% to 93.6%), respectively. When only low- and middle-income country data were considered, ultrasound maintained a diagnostic sensitivity of 89.2% and specificity of 99.1%. Meta-analysis of the included studies revealed heterogeneity. The high sensitivity of ultrasound for the detection of breast cancer was not statistically significantly different in subgroup analyses on the basis of mean age, risk, symptoms, study design, bias level, and study setting. CONCLUSION Given the increasing burden of breast cancer and infeasibility of mammography in certain settings, we believe these results support the potential use of ultrasound as an effective primary detection tool for breast cancer, which may be beneficial in low-resource settings where mammography is unavailable.
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