A randomized controlled trial of digital breast tomosynthesis versus digital mammography in population-based screening in Bergen: interim analysis of performance indicators from the To-Be trial
A randomized controlled trial of digital breast tomosynthesis versus digital mammography in population-based screening in Bergen: interim analysis of performance indicators from the To-Be trial
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DOI：
10.1007/s00330-018-5690-x
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发表时间：
2019-03-01
影响因子：
5.9
通讯作者：
Hofvind, Solveig
中科院分区：
文献类型：
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作者：
Aase, Hildegunn S.;Holen, Asne S.;Hofvind, Solveig
ObjectivesTo描述一个随机对照试验（RCT）的数字乳腺断层合成，包括合成二维乳腺X线摄影（DBT）与数字乳腺X线摄影（DM）在以人群为基础的乳腺癌筛查计划，并比较选定的二次筛查结果为两个techniques.MethodsThis RCT，在卑尔根进行的一部分，BreastScreen挪威，是由地区委员会批准的医疗健康研究伦理。邀请所有在卑尔根的筛选参与者参加，其中89%（14，274/15，976）在第一年集中，并随机分配到DBT（n = 7155）或DM（n = 7119）。二次筛查结果分层乳腺摄影密度和比较使用双样本t检验，卡方检验，方差分析，负二项回归和测试的比例（Z测试）。ResultsMean阅读时间为1分11秒DBT和41秒DM（P < 0.01）。DBT达成共识的平均时间为3分12秒，DM为2分12秒（p < 0.01），而DBT和DM达成共识时讨论的病例率分别为6.4%和7.4%（p = 0.03）。DBT的召回率为3.0%，DM为3.6%（p = 0.03）。对于非致密乳房的女性，DBT的回忆率为2.2%，DM为3.4%（p = 0.04）。对于乳房致密的女性来说，这一比例没有差异（两者均为3.6%）。每次检查的平均腺体剂量为2.96毫戈瑞DBT和2.95毫戈瑞DM（p = 0.433）。结论中期分析的筛选RCT显示，DBT需要更长的阅读比DM，但有显着较低的召回率比DM。我们发现两种技术之间的辐射剂量没有差异。关键点中心点在本RCT中，DBT与较长的解释时间相关，DBT的回忆率低于DM中心点，DBT和DM之间的平均腺体辐射剂量没有差异
ObjectivesTo describe a randomized controlled trial (RCT) of digital breast tomosynthesis including synthesized two-dimensional mammograms (DBT) versus digital mammography (DM) in a population-based screening program for breast cancer and to compare selected secondary screening outcomes for the two techniques.MethodsThis RCT, performed in Bergen as part of BreastScreen Norway, was approved by the Regional Committees for Medical Health Research Ethics. All screening attendees in Bergen were invited to participate, of which 89% (14,274/15,976) concented during the first year, and were randomized to DBT (n = 7155) or DM (n = 7119). Secondary screening outcomes were stratified by mammographic density and compared using two-sample t-tests, chi-square tests, ANOVA, negative binomial regression and tests of proportions (z tests).ResultsMean reading time was 1 min 11 s for DBT and 41 s for DM (p < 0.01). Mean time spent at consensus was 3 min 12 s for DBT and 2 min 12 s for DM (p < 0.01), while the rate of cases discussed at consensus was 6.4% and 7.4%, respectively for DBT and DM (p = 0.03). The recall rate was 3.0% for DBT and 3.6% for DM (p = 0.03). For women with non-dense breasts, recall rate was 2.2% for DBT versus 3.4% for DM (p = 0.04). The rate did not differ for women with dense breasts (3.6% for both). Mean glandular dose per examination was 2.96 mGy for DBT and 2.95 mGy for DM (p = 0.433).ConclusionsInterim analysis of a screening RCT showed that DBT took longer to read than DM, but had significantly lower recall rate than DM. We found no differences in radiation dose between the two techniques.Key Points center dot In this RCT, DBT was associated with longer interpretation time than DM center dot Recall rates were lower for DBT than for DM center dot Mean glandular radiation dose did not differ between DBT and DM