Comparative effectiveness of breast imaging modalities: a natural experiment

乳腺成像方式的有效性比较：自然实验

• 批准号: 8326993
• 负责人: GARTH H RAUSCHER
• 金额: $ 37.24万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8326993
• 关键词: Comparative; effectiveness; breast; imaging; modalities

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.

描述(由申请人提供)：我们建议进行一项筛查和诊断性乳房成像模式与乳房活检在准确诊断乳腺癌方面的比较有效性研究。结果将帮助临床医生和政策制定者在乳腺癌检测方法中进行选择，同时将过度诊断和不必要的活检降至最低。乳腺癌诊断领域的几个知识空白需要进一步研究。具体地说，关于数字乳房X光检查是否比传统的胶片屏幕乳房X光检查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，但利用这项技术提高准确性的证据并不完整。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来检验不同的成像方式和乳腺活检程序在诊断乳腺癌方面的比较有效性。我们正在与Advocate Health Care(AHC)合作，AHC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，也是全国同类系统中排名前十的机构之一。倡导患者是城市和郊区的，具有不同的种族/民族和社会经济背景，他们反映了普通人群中乳腺癌风险的差异。伊利诺伊州癌症登记处(ISCR)是美国最受认可的以人群为基础的癌症登记处之一。在将2001年至2011年AHC放射学数据库的数据与ISCR至2012年的乳腺癌发病病例联系起来后，我们将根据重要的临床特征为不同的成像和活检程序建立精确度测量模型。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到的组织学方面的准确性。所有型号都将根据测量的设施、放射科医生和患者的特征以及日历时间进行精细调整。我们还将研究随着时间的推移，临床实践的变化和新技术的引入可能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。这是一项极具创新性的自然实验，旨在研究乳腺癌筛查、诊断成像和乳腺活检这一连续过程中的关系，这是在现实世界中实践的。考虑到大的样本量和关于潜在混杂因素的详细信息的拟议收集，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：这项研究的目标是检查乳房成像和活检程序在排除或排除乳腺癌诊断方面的比较有效性。这项研究将创建可推广的知识，临床医生和政策制定者可以使用这些知识来最大限度地检测乳腺癌，同时将过度诊断和不必要的活检降至最低。这项研究的结果将允许临床医生(包括初级保健医生、放射科医生和乳房健康专家)、管理保健组织、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。