CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain.
Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain.
Cancer Med. 2021 Apr;10(7):2191-2204. doi: 10.1002/cam4.3803. Epub 2021 Mar 5.
Diagnostic mammography projections (DxMM) have been traditionally used in the assessment of women recalled after a suspicious screening mammogram. Digital breast tomosynthesis (DBT) reduces the tissue overlap effect, thus improving image assessment. Some studies have suggested DBT might replace DxMM with at least equivalent performance.
To evaluate the replacement of DxMM with DBT in women recalled at screening.
We searched PubMed, EMBASE, and the Cochrane Library databases to identify diagnostic paired cohort studies or RCTs comparing DBT vs DxMM, published in English that: reported accuracy outcomes, recruited women recalled for assessment at mammography screening, and included a reference standard. Subgroup analysis was performed over lesion characteristics. We provided pooled accuracy estimates and differences between tests using a quadrivariate model. We assessed the certainty of the evidence using the GRADE approach.
We included ten studies that reported specificity and sensitivity. One study included 7060 women while the remaining included between 52 and 738 women. DBT compared with DxMM showed a pooled difference for the sensitivity of 2% (95% CI 1%-3%) and a pooled difference for the specificity of 6% (95%CI 2%-11%). Restricting the analysis to the six studies that included women with microcalcification lesions gave similar results. In the context of a prevalence of 21% of breast cancer (BC) in recalled women, DBT probably detects 4 (95% CI 2-6) more BC cases and has 47 (95%CI 16-87) fewer false-positive results per 1000 assessments. The certainty of the evidence was moderate due to risk of bias.
The evidence in the assessment of screen-recalled findings with DBT is sparse and of moderate certainty. DBT probably has higher sensitivity and specificity than DxMM. Women, health care providers and policymakers might value as relevant the reduction of false-positive results and related fewer invasive diagnostic procedures with DBT, without missing BC cases.
诊断性乳房 X 线摄影投影（DxMM）传统上用于评估因可疑筛查性乳房 X 线摄影而召回的女性。数字乳腺断层合成术（DBT）减少了组织重叠效应，从而改善了图像评估。一些研究表明，DBT 可能具有与 DxMM 至少等效的性能，可以替代 DxMM。
评估 DBT 在筛查召回女性中的替代作用。
我们检索了 PubMed、EMBASE 和 Cochrane 图书馆数据库，以确定比较 DBT 与 DxMM 的诊断性配对队列研究或 RCT，这些研究发表于英文期刊，报告了准确性结果，招募了在乳房 X 线摄影筛查中因评估而被召回的女性，并纳入了参考标准。对病变特征进行了亚组分析。我们使用四变量模型提供了汇总准确性估计值和测试之间的差异。我们使用 GRADE 方法评估证据的确定性。
我们纳入了十项研究，这些研究报告了特异性和敏感性。一项研究纳入了 7060 名女性，其余研究纳入了 52 至 738 名女性。与 DxMM 相比，DBT 的敏感性汇总差异为 2%（95%CI 1%-3%），特异性汇总差异为 6%（95%CI 2%-11%）。将分析仅限于纳入微钙化病变女性的六项研究，结果相似。在召回女性乳腺癌（BC）患病率为 21%的情况下，DBT 可能会检测到 4 例（95%CI 2-6 例）更多的 BC 病例，每 1000 例评估减少 47 例（95%CI 16-87 例）的假阳性结果。由于存在偏倚风险，证据的确定性为中度。
DBT 评估筛查召回结果的证据很少，且确定性为中度。DBT 的敏感性和特异性可能高于 DxMM。女性、医疗保健提供者和决策者可能会重视 DBT 带来的假阳性结果减少以及相关的侵入性诊断程序减少，而不会漏诊 BC 病例。
