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: 8136121
• 负责人: GARTH H RAUSCHER
• 金额: $ 34.26万
• 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/8136121
• 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）：我们建议对筛查和诊断乳腺成像方式以及乳腺活检在准确诊断乳腺癌方面进行比较有效性研究。研究结果将帮助临床医生和政策制定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差距需要进一步研究。具体而言，关于数字乳房X线照相术在筛选某些患者亚组方面是否比传统胶片屏幕乳房X线照相术更准确的证据不足。使用计算机辅助检测来协助解释图像正在获得广泛的应用，但利用该技术提高准确性的证据并不完整。超声诊断和磁共振成像的有效性也存在知识差距。我们提出了一项自然实验来检查不同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，该系统是芝加哥大都市地区最大的综合性非营利医疗保健提供系统，也是全国同类系统中排名前 10 的系统之一。倡导者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，他们反映了普通人群乳腺癌风险的差异。伊利诺伊州癌症登记处 (ISCR) 是全美最受认可的基于人群的癌症登记处之一。将 2001 年至 2011 年 AHC 放射学数据库的数据与 ISCR 至 2012 年发生的乳腺癌病例联系起来后，我们将为按重要临床特征分层的不同成像和活检程序建立准确性测量模型。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以检测组织学方面的准确性。所有模型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精细调整。我们还将研究临床实践随时间的变化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之前有关乳腺癌筛查和诊断成像准确性主题的任何研究。这是一项高度创新的自然实验，旨在研究在现实世界中实践的乳腺癌筛查、诊断成像和乳腺活检的连续体之间的关系。鉴于样本量大以及拟议收集有关潜在混杂因素的详细信息，我们相信我们的研究将对文献以及未来的临床、管理和政策决策做出重大贡献。 公共健康相关性：本研究的目的是检查乳腺成像和活检程序在判定或排除乳腺癌诊断方面的相对有效性。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）能够就针对特定患者亚组使用诊断成像和活检程序做出更明智的决定。