Vinnicombe Sarah, Pinto Pereira Snehal M, McCormack Valerie A, Shiel Susan, Perry Nick, Dos Santos Silva Isabel M
Breast Unit, St Bartholomew's Hospital, Barts and The London NHS Trust, West Smithfield, London EC1A7BE, England.
Radiology. 2009 May;251(2):347-58. doi: 10.1148/radiol.2512081235.
To (a) compare the performance of full-field digital mammography (FFDM), using hard-copy image reading, with that of screen-film mammography (SFM) within a UK screening program (screening once every 3 years) for women aged 50 years or older and (b) conduct a meta-analysis of published findings along with the UK data.
The study complied with the UK National Health Service Central Office for Research Ethics Committee guidelines; informed patient consent was not required, since analysis was carried out retrospectively after data anonymization. Between January 2006 and June 2007, a London population-based screening center performed 8478 FFDM and 31 720 SFM screening examinations, with modality determined by the type of machine available at the screening site. Logistic regression was used to assess whether breast cancer detection rates and recall rates differed between screening modalities. For the meta-analysis, random-effects models were used to combine study-specific estimates, if appropriate.
A total of 263 breast cancers were detected. After adjustment for age, ethnicity, area of residence, and type of referral, there was no evidence of differences between FFDM and SFM in terms of detection rates (0.68 [95% confidence interval {CI}: 0.47, 0.89] vs 0.72 [95% CI: 0.58, 0.85], respectively, per 100 screening mammograms; P = .74), recall rates (3.2% [95% CI: 2.8, 3.6] vs 3.4% [95% CI: 3.1, 3.6]; P = .44), positive predictive value (PPV) of an abnormal mammogram, or characteristics of detected tumors. Meta-analysis of data from eight studies showed a slightly higher detection rate for FFDM, particularly at 60 years of age or younger (pooled FFDM-SFM difference: 0.11 [95% CI: 0.04, 0.18] per 100 screening mammograms), but no clear modality differences in recall rates or PPVs.
Within a routine screening program, FFDM with hard-copy image reading performed as well as SFM in terms of process indicators; the meta-analysis was consistent with FFDM yielding detection rates at least as high as those for SFM.
(a) 在英国一项针对50岁及以上女性的筛查项目（每3年筛查一次）中，比较使用硬拷贝图像阅片的全数字化乳腺钼靶摄影（FFDM）与屏-片乳腺钼靶摄影（SFM）的性能；(b) 对已发表的研究结果以及英国的数据进行荟萃分析。
本研究遵循英国国家医疗服务体系中央研究伦理委员会的指导原则；由于分析是在数据匿名化后进行的回顾性分析，因此无需患者知情同意。2006年1月至2007年6月期间，伦敦一个基于人群的筛查中心进行了8478例FFDM和31720例SFM筛查检查，检查方式由筛查地点可用的机器类型决定。采用逻辑回归评估筛查方式之间乳腺癌检出率和召回率是否存在差异。对于荟萃分析，适当情况下使用随机效应模型合并特定研究的估计值。
共检测出263例乳腺癌。在对年龄、种族、居住地区和转诊类型进行调整后，没有证据表明FFDM和SFM在检出率（每100例筛查乳腺钼靶摄影分别为0.68 [95%置信区间{CI}：0.47, 0.89] 与0.72 [95% CI：0.58, 0.85]；P = 0.74）、召回率（3.2% [95% CI：2.8, 3.6] 与3.4% [95% CI：3.1, 3.6]；P = 0.44）、异常乳腺钼靶摄影的阳性预测值（PPV）或所检测肿瘤的特征方面存在差异。对八项研究的数据进行荟萃分析显示，FFDM的检出率略高，尤其是在60岁及以下人群中（每100例筛查乳腺钼靶摄影的FFDM - SFM合并差异：0.11 [95% CI：0.04, 0.18]）但在召回率或PPV方面没有明显的检查方式差异。
在常规筛查项目中，使用硬拷贝图像阅片的FFDM在过程指标方面与SFM表现相当；荟萃分析结果与FFDM的检出率至少与SFM一样高的结论一致。
