Comparative effectiveness of breast imaging modalities: a natural experiment

描述（由申请人提供）：我们建议进行乳腺成像筛查和诊断方式与乳腺活检在准确诊断乳腺癌方面的比较有效性研究。结果将有助于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。乳腺癌诊断领域的一些知识空白需要进一步研究。具体来说，关于数字乳房x线照相术是否比传统胶片筛查乳房x线照相术更准确地筛查某些患者亚群的证据还不充分。使用计算机辅助检测来协助解释图像正得到广泛的应用，但这种技术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空白。我们提出一个自然实验来检验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。我们正在与倡导医疗保健（AHC）合作，这是芝加哥大都会地区最大的综合非营利性医疗保健提供系统，也是全国十大医疗保健系统之一。倡导患者来自城市和郊区，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差异。伊利诺伊州癌症登记处（ISCR）是全国最受认可的以人群为基础的癌症登记处之一。在将AHC放射学数据库2001年至2011年的数据与ISCR至2012年的乳腺癌病例联系起来之后，我们将根据重要的临床特征对不同的成像和活检程序进行分层，建立准确性测量模型。我们还将评估成像和活检方法在检测更具侵袭性的乳腺癌亚型和更难以检测的组织学方面的准确性。所有模型将微调测量设备，放射科医生和病人的特点，和日历时间。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。这项研究的样本量将远远超过以往任何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，旨在检验在现实世界中实践的乳腺癌筛查、诊断成像和乳腺活检连续体之间的关系。鉴于样本量大，并建议收集潜在混杂因素的详细信息，我们相信我们的研究将对文献和未来的临床、行政和政策决策做出重大贡献。

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.