Comparative effectiveness of breast imaging modalities: a natural experiment

描述（由申请人提供）：我们建议进行一项筛查和诊断性乳腺成像模式与乳腺活检在准确诊断乳腺癌方面的有效性比较研究。研究结果将帮助临床医生和决策者选择乳腺癌检测方法，同时最大限度地减少过度诊断和不必要的活检。乳腺癌诊断领域的若干知识差距需要进一步研究。具体而言，关于数字乳腺X射线摄影是否比传统的胶片屏幕乳腺X射线摄影更准确地筛查某些患者亚组的证据不足。使用计算机辅助检测来帮助解释图像正在得到广泛的使用，但是使用这种技术来提高准确性的证据是不完整的。在诊断超声和磁共振成像的有效性方面也存在知识差距。我们提出了一个自然的实验，以检查不同的成像方式和乳腺活检程序在诊断乳腺癌的比较有效性。我们与Advocate Health Care（AHC）合作，AHC是大都会芝加哥地区最大的综合非营利医疗保健提供系统，也是全国同类系统中的前十名。倡导患者是城市和郊区，具有不同的种族/民族和社会经济背景，他们反映了一般人群中乳腺癌风险的变化。伊利诺伊州癌症登记处（ISCR）是美国最受认可的基于人群的癌症登记处之一。在将2001年至2011年AHC放射学数据库的数据与ISCR至2012年的乳腺癌病例联系起来后，我们将根据重要的临床特征对不同成像和活检程序的准确性进行建模。我们还将评估成像和活检程序在检测更具侵袭性的乳腺癌亚型和更难检测的组织学类型方面的准确性。所有型号都将根据测量的设施、放射科医生和患者特征以及日历时间进行微调。我们还将研究随着时间的推移，临床实践和新技术的引入如何影响成像和活检的准确性。这项拟议研究的样本量将远远超过任何先前关于乳腺癌筛查和诊断成像准确性的研究。这是一个高度创新的自然实验，旨在研究乳腺癌筛查，诊断成像和乳腺活检在现实世界中实践的连续体之间的关系。考虑到大样本量和潜在混杂因素的详细信息收集，我们相信我们的研究将对文献和未来的临床，管理和政策决策做出重大贡献。 公共卫生相关性：本研究的目的是检查乳腺成像和活检程序在裁定或排除乳腺癌诊断的比较有效性。这项研究将创造可供临床医生和政策制定者使用的通用知识，以最大限度地提高乳腺癌检测率，同时最大限度地减少过度诊断和不必要的活检。这项研究的结果将使临床医生（包括初级保健医生，放射科医生和乳腺健康专家），管理式医疗机构，健康保险公司和政府付款人（包括CMS和州医疗补助机构）就特定患者亚组的诊断成像和活检程序的使用做出更明智的决定。

DESCRIPTION (provided by applicant): We propose to conduct a comparative effectiveness study of screening and diagnostic breast imaging modalities and breast biopsies in accurately diagnosing breast cancer. Results will aid clinicians and policymakers in selecting among breast cancer detection methods while minimizing over-diagnoses and unnecessary biopsies. Several knowledge gaps in the area of breast cancer diagnosis require further study. Specifically, the evidence regarding whether digital mammography is more accurate than conventional film- screen mammography for screening certain patient subgroups is insufficient. Use of computer-aided detection to assist in interpreting images is gaining widespread use, but the evidence for improved accuracy with this technology is incomplete. There are also knowledge gaps in effectiveness for diagnostic ultrasound and magnetic resonance imaging. We propose a natural experiment to examine the comparative effectiveness of different imaging modalities and breast biopsy procedures in diagnosing breast cancer. We are partnering with Advocate Health Care (AHC), the largest integrated not-for-profit health care delivery system in the metropolitan Chicago region and one of the top 10 of its kind in the nation. Advocate patients are urban and suburban and have diverse racial/ethnic and socioeconomic backgrounds, and they reflect variation in breast cancer risk in the general population. The Illinois State Cancer Registry (ISCR) is one of the most highly recognized population-based cancer registries in the nation. After linking data from the AHC radiology database for years 2001 through 2011 with incident breast cancer cases from ISCR through 2012, we will model accuracy measures for different imaging and biopsy procedures stratified by important clinical characteristics. We will also evaluate the accuracy of imaging and biopsy procedures in detecting more aggressive breast cancer subtypes and more difficult to detect histologies. All models will adjust finely for measured facility, radiologist and patient characteristics, and calendar time. We will also examine how changes over time in clinical practices and introduction of new technologies may have affected imaging and biopsy accuracy. The sample size for this proposed study would far exceed any prior study on the topic of screening and diagnostic imaging accuracy in breast cancer. This is a highly innovative natural experiment that proposes to examine relations across the continuum of breast cancer screening, diagnostic imaging, and breast biopsy as practiced in a real-world setting. Given the large sample size and the proposed collection of detailed information on potential confounders, we believe that our study will make a substantial contribution to the literature and to future clinical, administrative, and policy decision-making. PUBLIC HEALTH RELEVANCE: The goal of this study is to examine the comparative effectiveness of breast imaging and biopsy procedures in ruling in or ruling out a breast cancer diagnosis. This study will create generalizeable knowledge that can be used by clinicians and policymakers to maximize breast cancer detection while minimizing over-diagnoses and unnecessary biopsies. Results of this study will allow clinicians (including primary care physicians, radiologists, and breast health specialists), managed care organizations, health insurance companies, and government payers (including CMS and state Medicaid agencies) to make more informed decisions regarding the use of diagnostic imaging and biopsy procedures for specific patient subgroups.