Carlos Canelo-Aybar1,2, Lourdes Carrera3, Jessica Beltrán2, Margarita Posso2,4, David Rigau2, Annette Lebeau5, Axel Gräwingholt6, Xavier Castells4, Miranda Langendam7, Elsa Pérez8, Paolo Giorgi Rossi9, Ruben Van Engen10, Elena Parmelli11, Zuleika Saz-Parkinson11, Pablo Alonso-Coello1,2. 1. CIBER de Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. 2. Department of Clinical Epidemiology and Public Health, Biomedical Research Institute Sant Pau (IIB Sant Pau), Barcelona, Spain. 3. Universidad Nacional Mayor de San Marcos, Lima, Perú. 4. Department of Epidemiology and Evaluation, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Spain. 5. Institute of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. 6. Radiologie am Theater, Paderborn, Germany. 7. Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam Public Health Institute, Amsterdam, The Netherlands. 8. University Hospital Dr. Josep Trueta, Girona, Spain. 9. Epidemiology Unit, Azienda USL - IRCCS di Reggio Emilia, Reggio Emilia, Italy. 10. LRCB, Dutch Expert Centre for Screening, Nijmegen, The Netherlands. 11. European Commission, Joint Research Centre (JRC), Ispra, Italy.
Abstract
BACKGROUND: 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. OBJECTIVE: To evaluate the replacement of DxMM with DBT in women recalled at screening. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
BACKGROUND: 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. OBJECTIVE: To evaluate the replacement of DxMM with DBT in women recalled at screening. METHODS: 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. RESULTS: 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. CONCLUSION: 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.
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