Risk of Cancer with Incidental Findings Identified on Ultrasound Imaging

描述（由申请人提供）：在过去的10年里，诊断成像的使用急剧增加。同时，成像技术的惊人进步使越来越小的解剖病变得以检测。这些变化对更早和更精确地诊断广泛的医学疾病的积极影响怎么强调都不为过。然而，随着影像学的应用和分辨率的提高，一个不可避免的结果是越来越多的偶然发现（意外的、无症状的发现）和不确定的发现（与影像学原因有关，但临床意义未知的发现）的诊断。尽管与这些病变相关的病理风险被认为很低，但其临床意义的不确定性和缺乏治疗指南导致了广泛的进一步检测和监测。虽然对这些偶然/不确定的发现的识别和评估可能导致隐匿恶性肿瘤的早期识别和治疗，但由于额外的医生就诊和随访检查，它们也涉及高费用，以及诸如焦虑、进一步检查并发症和不必要治疗等危害。尽管放射科医生报告说，为进一步评估此类病变而进行影像学检查的频率有所上升，但这些发现的真实频率以及与特定偶然/不确定发现相关的癌症风险尚不清楚。因此，很少有基于证据的数据可用于指导这些发现的管理。本研究的目的是1)确定骨盆超声成像的适应症2)评估这些检查中特定超声形态学发现的普遍性，并确定与一系列超声发现（包括良性偶然发现，众多不确定发现和可疑发现）相关的癌症风险和其他准确性统计数据。与特定超声检查结果相关的癌症风险将在未调整的情况下计算，并根据重要的患者因素(如年龄、癌症风险因素（包括乳腺癌和卵巢癌家族史以及血清CA-125水平）进行分层，然后根据重要的混杂因素进行调整。为了完成这一目标，我们将首先对所有超声检查的结果进行分类，然后根据病变类型计算癌症的风险。最后，对于目标3，我们将在确定具体发现后评估监测模式。这一目标的目的是帮助提供有关监测成本的数据，以平衡识别此类病变的潜在利益。该建议侧重于超声成像，因为在放射照相（x射线）之后，超声在进行的成像检查中所占比例最大，并且在这些检查中经常发现偶然/不确定的发现。这些分析的结果将通过提供识别偶然发现的频率的数据来澄清这个问题的严重性，并进一步提供与特定发现相关的癌症风险的数据。为了完成这些目标，我们将对在Group Health注册的患者进行回顾性队列分析，Group Health是位于华盛顿州西雅图的一个大型非营利医疗保健系统，在研究期间（1997 - 2005年），其26万名女性成员接受了超过11万次超声波检查。小组健康收集和存储诊断测试的自动化和详细的临床记录，这些数据通常与区域SEER肿瘤登记数据相关联。此外，卵巢癌风险因素的详细数据可供所有参与者使用。利用这个庞大的、以人群为基础的数据库，我们将完成目标，这些分析的结果将为骨盆超声成像发现的管理提供循证指南。公共卫生相关性：在过去十年中，医学成像的使用急剧增加。同时，成像技术的惊人进步使越来越小的解剖病变得以检测。这些变化对更早和更精确地诊断广泛的医学疾病的积极影响怎么强调都不为过。然而，随着影像技术的应用和分辨率的提高，一个不可避免的结果是诊断出越来越多的偶然和不确定的发现。尽管与这些病变相关的病理风险被认为非常低，但其临床意义的不确定性和缺乏治疗指南可以启动广泛的进一步检测和监测。本研究的目的是确定与超声成像相关的偶然性/不确定性的患病率，并评估与骨盆中确定的特定超声检查相关的癌症风险。目标是为这些偶然发现制定管理策略，以最大限度地发现隐匿性癌症，同时最大限度地减少不必要的影像学监测。

DESCRIPTION (provided by applicant): The use of diagnostic imaging has increased dramatically over the last 10 years. Concurrently, spectacular advances in imaging technology have allowed the detection of increasingly smaller anatomic lesions. The positive impact of these changes on the earlier and more precise diagnosis of a broad range of medical diseases cannot be overstated. However, one unavoidable consequence of the increased utilization and resolution of imaging is the diagnosis of increasing numbers of incidental findings (unexpected, asymptomatic findings) and indeterminate findings (findings related to the reason for imaging, but of unknown clinical significance). Although the risk of pathology associated with these lesions is considered low, uncertainty regarding their clinical significance and lack of guidelines for their management leads to extensive further testing and surveillance. While the identification and evaluation of these incidental/indeterminate findings may lead to the earlier identification and treatment of an occult malignancy, they also involve high costs due to additional physician visits and follow-up testing, as well as harms, such as anxiety, complications from further testing and unnecessary treatment. Although anecdotally radiologists have reported a rise in the how frequently imaging tests are obtained to further evaluate such lesions, the true frequency of these findings and the risk of cancer associated with specific incidental/indeterminate findings is unknown. Consequently, little evidence-based data are available to guide the management of these findings. The aims of the proposed study are 1) to identify the indications that led to ultrasound imaging of the pelvis 2) to evaluate the prevalence of specific ultrasound morphological findings on these examinations and determine the risk of cancer and other accuracy statistics associated with a range of ultrasound findings (including benign appearing incidental findings, numerous indeterminate finding and suspicious findings). The risk of cancer associated with specific ultrasound findings will be calculated unadjusted and stratified for important patient factors (such as age, cancer risk factors including a family history of breast and ovarian cancer and Serum CA-125 levels) and then adjusted for important confounders. In order to complete this aim, we will first categorize the results of all ultrasound examinations and then calculate the risk of cancer by the type of lesion. Lastly for Aim 3) we will evaluate surveillance patterns following the identification of specific findings. The purpose of this aim is to help provide data on the costs of surveillance to balance the potential benefits of the identification of such lesions. This proposal focuses on ultrasound imaging, as after radiography (x-ray), ultrasound accounts for the largest proportion of imaging tests performed, and incidental/indeterminate findings are frequently identified on these examinations. The results of these analyses will clarify the magnitude of this problem by providing data on how frequently incidental findings are identified and further, will provide data on the risk of cancer associated with specific findings. To complete these aims, we will conduct a retrospective cohort analysis of patients enrolled in Group Health, a large not-for-profit healthcare system in Seattle Washington, whose 260,000 female members underwent over 110,000 ultrasound examinations over the years of the study (1997 - 2005). Group Health collects and stores automated and detailed clinical records of diagnostic testing, and these data are routinely linked with regional SEER tumor registry data. Further, detailed data on ovarian cancer risk factors are available for all enrollees. Using this large, population-based database, we will complete the aims, and the results of these analyses will inform the development of evidence-based guidelines for the management of findings identified on ultrasound imaging of the pelvis. PUBLIC HEALTH RELEVANCE: Over the last decade the utilization of medical imaging has increased dramatically. Concurrently, spectacular advances in imaging technology have allowed the detection of increasingly smaller anatomic lesions. The positive impact of these changes on the earlier and more precise diagnosis of a broad range of medical diseases cannot be overstated. However, one unavoidable consequence of the increased utilization and resolution of imaging is the diagnosis of increasing numbers of incidental and indeterminate findings. Although the risk of pathology associated with these lesions is considered very low, uncertainty regarding their clinical significance and lack of guidelines for their management can initiate extensive further testing and surveillance. The aims of the proposed research are to identify the prevalence of incidental/indeterminate associated with ultrasound imaging, and to evaluate the risk of cancer associated with specific ultrasound finings identified in the pelvis. The goal is to develop management strategies for these incidental findings that will maximize the detection of occult cancer, while minimizing unnecessary imaging surveillance.