Authors' results and conclusions: Six original papers were obtained from the systematic review found in the preliminary search. In the definite search (period 2005-2007), 271 additional references were retrieved. After duplicates had been discarded and inclusion criteria were applied to all papers by means of reading the titles and abstracts, 24 documents remained. Once they were fully read, 13 were discarded as they did not meet the inclusion criteria, remaining 11 original papers. These 11 papers reported results from 6 studies. All the studies found were focused on assessing the diagnostic performance of the mammographies and intermediate outcomes of screening. The studies were clasified according to the design’s validity (comparabilityof the groups and existence of follow-up after screening), since QUADAS tool did not discriminate much in this case (all the studies were in a range between 7 and 9 positive answers of the 14 questions of QUADAS). Results are reported separately for each group of studies. Comparison of DM and TM in terms of diagnostic performance, based on the most valid studies (with comparable cohorts and follow-up after screening):In this group, there were included results from 3 studies: a randomised clinical trial (Oslo II, with 23.929 women) and two single-cohort studies (each woman received a TM and a DM: Oslo I – 3.683 women- and DMIST -49.258 women). The sensitivity of DM was higher to that of TM in the randomised clinical trial, but no statistically significant differences were found in the two single-cohort studies with follow-up. Likewise no differences between DM and TM were found in terms of interval cancer detection rate, false-negative rate or negative predictive value. In two of the studies the specificity of DM was lower than that of TM and the false-positive rate was higher with DM. However, no differences between both types of mammographies were found in the third study (despite it was the one with the highest sample size). These differences between the studies in terms of the results on specificity could be related to different forms of interpreting the mammographies and to the studies’ context (population programmes in the two studies which showed lower specificity of DM and opportunistic screening in the study that did not find any difference between mammographies).Only one of the studies with follow-up data (DMIST, based on opportunistic screening of breast cancer) reported results segmented by age and other variables. In women aged less than 50, who were perimenopausal or had dense breasts, DM showed a bigger area under the ROC curve and a higher sensitivity than TM; and there were no differences in specificity and positive predictive value. Comparison of DM and TM in terms of diagnostic performance, based on the papers that do not include follow-up data after screening:The two Oslo studies (I and II) also provided results from the screening without taking into account the follow-up. Moreover there were a single cohort study (with 4.489 women) and two double-cohort studies – cohorts selected separately: one of them was screened with DM and the other with TM - (with 343.002 and 28.770 women) that provided data on diagnostic performance without follow-up after screening. All these studies show that the rate of breast cancer in a screening round is not significantly different when either DM or TM is used.Only two of the studies provided data on the percentage of carcinomas in situ, but results were different between them: one did not find differences between DM and TM, and the other one reported higher percentage with DM.Of the five studies that provided data on positive predictive value, the three considered to have high validity (with comparable groups) and another one (with two separate cohorts) concluded that there were no differences between DM and TM. Just one study with separate cohorts reported higher positive predictive value with DM. Comparison between DM and TM in terms of other outcomes:No studies were found that provided comparison data between DM and TM in terms of either mortality or any other health outcomes. The results on the comparison of DM and TM in terms of recall rate after a screening mammography were divergent among the studies. The strictest studies in the reading of the mammographies did not find differences between DM and TM, except for the subgroup of women aged 50-69 in the only one clinical trial (higher recall rate after DM). In the rest of studies, the results were different: the highest recall rate was after DM in one study and after TM in another one.The percentage of biopsies was reported in two single-cohort studies. The results were different among them: the study that obtained a higher score in the validity scale (QUADAS) did not find differences between DM and TM while the one with lower validity found a higher biopsy rate after TM.

Authors' recommendations: No important differences were found between DM and TM in terms of sensitivity, cancer detection rate and positive predictive value, regardless of the design’s validity. The results on specificity, percentage of carcinomas in situ, recall rate and percentage of biopsies showed greater discrepancies among the studies. Therefore, it cannot be concluded that there is a clear advantage of a type of mammography over the other one. Finally, there was not found data about the comparison of screening with DM and TM in terms of mortality and other health outcomes.

Project Status: Completed

URL for project: https://www.aetsa.org/publicacion/rendimiento-diagnostico-de-la-mamografia-digital-en-el-cribado-del-cancer-de-mama/

Year Published: 2009

URL for published report: https://www.aetsa.org/download/publicaciones/antiguas/AETSA_2007-09_MamografiaDigital.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Andalusian Health Technology Assessment Area

Contact Address: Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309

Contact Name: aetsa.csalud@juntadeandalucia.es

Contact Email: aetsa.csalud@juntadeandalucia.es

Copyright: Andalusian Agency for Health Technology Assessment (AETSA)