Comparative Effectiveness of Advanced Diagnostic Imaging for Hepatic Fibrosis

先进诊断成像对肝纤维化的比较效果

• 批准号: 7936847
• 负责人: Jayant A Talwalkar
• 金额: $ 44.55万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7936847
• 关键词: Address; Adverse event; Affect; Alcoholic Liver Diseases; Alcohols; Area; Award; Biological Assay; Caring; Cessation of life; Chronic; Chronic Hepatitis C; Chronic viral hepatitis; Cirrhosis; Clinical; Clinical effectiveness; Communities; Country; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Diagnostic tests; Disease; Effectiveness; Elasticity; Employment; Ensure; Etiology; Fibrosis; Funding; Future; Goals; Grant; Health; Health Expenditures; Hour; Human; Human Resources; Image; Imaging Techniques; Individual; Knowledge; Liver Fibrosis; Liver diseases; Measures; Medical; Methodology; Methods; Modality; Modeling; Occupations; Outcome; Outcome Measure; Patient Preferences; Patients; Persons; Population; Population Study; Populations at Risk; Procedures; Process; Public Health; Qualifying; Reference Standards; Reliance; Reproducibility; Research; Research Design; Resources; Sampling Errors; Science; Serum; Serum Markers; Staging; Subgroup; Techniques; Testing; Time; Ultrasonography; United States; Work; base; burden of illness; clinical decision-making; clinically significant; comparative effectiveness; cost; cost shifting; design; diagnostic accuracy; economic impact; effectiveness research; follow-up; human subject; improved; innovation; liver biopsy; non-alcoholic fatty liver; novel; prospective; public health relevance

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic, 05-EB-101* - Comparative Effectiveness of Advanced Imaging Procedures. Advances in cross-sectional imaging have revolutionized the medical care provided to individuals with disabling medical conditions. Chronic liver disease and cirrhosis, however, remains a major public health problem within the U.S. population culminating in over 40,000 deaths and $1 billion in health care expenditures annually. The major process responsible for this burden of disease is progressive hepatic fibrosis, which traditionally has been diagnosed by liver biopsy. However, the strict reliance on liver biopsy for detecting hepatic fibrosis is hampered by inherent problems related to sampling error, increased cost, and reduced patient acceptance. In turn, noninvasive methods for detecting hepatic fibrosis have been developed yet their utility in clinical situations remains inadequately established. In the present application, we propose to examine the comparative effectiveness of novel quantitative elasticity imaging techniques and serum marker fibrosis panels for detecting clinically significant hepatic fibrosis measured by liver biopsy among human subjects with chronic liver disease. Our specific aims are to 1) prospectively identify and compare the diagnostic accuracies of quantitative elasticity imaging techniques (MRE and transient elastography) with direct and indirect serum fibrosis marker panels and 2) to determine the clinical effectiveness of quantitative elasticity imaging techniques, serum marker panels, and liver biopsy among 150 subjects with chronic hepatitis C, nonalcoholic fatty liver disease, and alcoholic liver disease. In this application, we also intend to determine the reproducibility of quantitative elasticity imaging in a subgroup of individual subjects, and to identify the optimal diagnostic threshold values for detecting stages F2-F4 hepatic fibrosis by elasticity imaging. The impact of noninvasive testing methods and liver biopsy on clinical decision making and patient-related outcomes will include assessments of procedure-related adverse events, false-positive and false-negative test rates compared to liver biopsy, the potential number of liver biopsies saved with noninvasive testing, cost shifting based on utilization of diagnostic test modalities, and patient preference for individual diagnostic tests. Furthermore, the current study design will allow us to also directly identify and evaluate health-related outcomes and resource utilization beyond the grant period. The resources generated for this project will also facilitate future, highly cost-efficient analyses as new data emerge to support novel aspects of comparative effectiveness. The proposed work is Innovative because it extends groundbreaking, NIH-funded work that seeks to shift current paradigms in the diagnosis of hepatic fibrosis utilizing novel methodologies. The Significance of the proposed research is that it addresses an important problem in the field, and the scientific knowledge gained from this research should yield novel, informative data on the comparative effectiveness of diagnostic testing methods for hepatic fibrosis. In turn, the Potential Impact on health is considered to be broad, as these approaches could accelerate the development and testing of innovative pharmacologic therapies for hepatic fibrosis which affects a growing number of persons in this country. In addition to completing the proposed research, the Economic Impact from this award will result in the ability to hire and retain qualified study personnel for completing the project within a 2 year time frame. The funding will ensure continued employment for established individuals and provide new job opportunities for talented individuals with an inclination toward science. Finally, the proposed grant is designed specifically to deliver results within a 2 year period. PUBLIC HEALTH RELEVANCE: The proposed studies are of an important and under-investigated topic focusing on the comparative effectiveness of noninvasive diagnostic imaging techniques, serum-based assays, and liver biopsy for the accurate detection of hepatic fibrosis among human subjects affected by the most common liver diseases in the United States. The proposed research has relevance to public health, because the fundamental mechanisms being investigated appear common for maintaining health and creating disease in human beings.

描述（由申请人提供）：此申请解决广泛的挑战领域（05）比较有效性研究和特定挑战主题，05-EB-101* - 高级成像程序的比较有效性。横截面成像的进步彻底改变了为患有医疗状况的人提供的医疗服务。然而，慢性肝病和肝硬化仍然是美国人口中的一个重大公共卫生问题，最终导致40,000多人死亡，每年有10亿美元的医疗保健支出。负责这种疾病负担的主要过程是进行性肝纤维化，传统上是通过肝活检诊断的。但是，严格依赖于检测肝纤维化的肝活检受到与采样误差，成本增加和患者接受程度降低有关的固有问题的阻碍。反过来，已经开发了用于检测肝纤维化的非侵入性方法，但在临床情况下的效用仍然不足。在本应用中，我们建议检查新型定量弹性成像技术和血清标记纤维化板的比较有效性，以检测慢性肝病的人类受试者在肝活检中测量的临床意义肝纤维化。我们的具体目的是1）用直接和间接的血清纤维化标记面板和2）确定定量弹性成像技术（MRE和瞬态弹性图）的前瞻性识别和比较诊断精度，并比较血清纤维化标记和2），以确定定量弹性成像的临床有效性，血清标记板在150年中均具有150次效率。和酒精性肝病。在此应用中，我们还打算确定单个受试者亚组中定量弹性成像的可重复性，并通过通过弹性成像来确定检测F2-F4肝纤维化的最佳诊断阈值。非侵入性测试方法和肝活检对临床决策和与患者相关结果的影响将包括评估与程序相关的不良事件，与肝活检相比，与诊断诊断的诊断和诊断性测试效果相比，与肝活检相比，与肝活检相比，肝脏生物疗法的潜在肝脏生物疗法的潜在肝脏生物疗法的潜在肝脏生物疗法的潜在数量和假阴性测试率。此外，当前的研究设计将使我们还可以直接识别和评估与健康相关的结果和资源利用率之后的拨款期。该项目生成的资源还将促进未来，高度成本效益的分析，因为新数据出现了，以支持比较效率的新方面。拟议的工作具有创新性，因为它扩展了开创性的，NIH资助的工作，试图通过新方法来诊断肝纤维化的当前范例。拟议的研究的重要性是它解决了该领域的一个重要问题，从这项研究中获得的科学知识应产生有关肝纤维化诊断测试方法比较有效性的新颖，信息丰富的数据。反过来，对健康的潜在影响被认为是广泛的，因为这些方法可以加速和测试用于肝纤维化的创新药理学疗法，从而影响该国越来越多的人。除了完成拟议的研究外，该奖项的经济影响还将导致能够在2年的时间内聘用和保留合格的研究人员完成该项目。资金将确保为成熟的个人继续就业，并为有才华的人提供新的工作机会。最后，拟议的赠款专门旨在在2年内提供结果。 公共卫生相关性：拟议的研究是一个重要且不足的主题，重点介绍了非侵入性诊断成像技术，基于血清的测定和肝活检的比较有效性，以准确检测到美国最常见的肝脏疾病受试者中肝纤维化的准确检测。拟议的研究与公共卫生有关，因为所研究的基本机制对于维持健康和在人类中造成疾病的基本机制似乎很常见。