Guideline-based surveillance and treatment of hepatocellular carcinoma

基于指南的肝细胞癌监测和治疗

• 批准号: 8324500
• 负责人: Jessica A Davila
• 金额: $ 32.47万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-25 至 2014-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8324500
• 关键词: Abdomen; Ablation; Accounting; Address; Adherence; American; Cancer Etiology; Categories; Cessation of life; Chronic Hepatitis B; Cirrhosis; Clinical Practice Guideline; Cohort Studies; Comorbidity; Computerized Medical Record; Data; Development; Diagnosis; Disease; Early Diagnosis; Early treatment; Effectiveness; Etiology; Excision; Financial compensation; Foundations; Future; Guidelines; Healthcare; Healthcare Systems; Hepatitis B; Hepatitis B Virus; Hepatitis C; Hepatitis C virus; Image; Incidence; Intervention; Liver; Liver diseases; Logistic Regressions; Malignant Neoplasms; Medicare; Outcome; Patients; Pensions; Physicians; Practice Guidelines; Primary carcinoma of the liver cells; Provider; Publishing; Recommendation; Reporting; Resources; Retrospective Studies; Risk Factors; Role; Sampling; Serum; Stage at Diagnosis; Staging; Structural Models; Structure; Survival Rate; Testing; Transplantation; Ultrasonography; United States; Update; Veterans; abstracting; administrative database; advanced disease; alpha-Fetoproteins; base; clinical practice; effective therapy; experience; high risk; improved; interest; medical specialties; mortality; non-alcoholic fatty liver; preference; therapy development; wasting

DESCRIPTION (provided by applicant): Hepatocellular carcinoma (HCC) is the fastest rising cause of cancer-related deaths. Survival following diagnosis with HCC is poor unless it is detected early and stage-appropriate treatment is applied. Clinical practice guidelines outline recommendations for HCC surveillance and treatment of HCC. No study has examined the implementation or outcomes of guideline-based HCC surveillance in high risk patients or stage- appropriate treatment in patients who develop HCC. OBJECTIVES: Using data obtained from VA administrative databases combined with information abstracted from national VA electronic medical records using the VA Compensation and Pension Record Interchange application, we propose to address the following Aims: 1) to examine the implementation of guideline-based HCC surveillance in a national sample of patients with cirrhosis, and to examine patient, physician and facility factors associated with appropriate or inappropriate implementation of surveillance; 2) to evaluate the implementation of guideline-based stage-appropriate treatment among patients with HCC, and to examine patient, physician, and facility factors associated with receipt of stage-appropriate treatment; and 3) to examine the effect of guideline-based HCC surveillance and stage-appropriate treatment on survival. METHODS: We propose a retrospective cohort study using two stratified random samples of approximately 1,500 patients with cirrhosis and 1,500 patients with HCC diagnosed during 2006-2009 in VA facilities nationwide. For Aim 1, the outcome will be appropriate (guideline-based surveillance, receipt of an imaging test unrelated to HCC surveillance, no surveillance) versus inappropriate (non-guideline based surveillance, overutilization of surveillance) implementation of HCC surveillance among patients with one of the four primary etiologies for cirrhosis (hepatitis C, non-alcoholic fatty liver disease, hepatitis B, alcoholic liver disease). Patient, physician, and facility factors associated with appropriate implementation of HCC surveillance will be examined using logistic regression. For Aim 2, the outcome will be receipt of stage-appropriate HCC treatment versus stage-inappropriate treatment or no treatment among patients with HCC. Each patient will be assigned to a stage-appropriate treatment category according to current guidelines, which will be compared against the treatment received. Logistic regression will be used to examine predictors of receiving stage-appropriate treatment. For Aim 3, the outcome will be survival among patients with cirrhosis who developed HCC. Receipt of appropriate HCC surveillance and stage-appropriate treatment will be the primary predictors of interest. Marginal structural modeling will be used to examine these associations. IMPACT: This study will examine an important and timely issue in the management of HCC that has not been examined. Findings from this study will provide a strong foundation for developing and implementing a future intervention to improve the delivery of guideline-based HCC surveillance and treatment.

描述（由申请人提供）：肝细胞癌（HCC）是癌症相关死亡上升最快的原因。除非及早发现并采取适合阶段的治疗，否则诊断出 HCC 后的生存率很差。临床实践指南概述了 HCC 监测和 HCC 治疗的建议。尚无研究检验在高危患者中基于指南的 HCC 监测或在发生 HCC 的患者中进行阶段性适当治疗的实施情况或结果。目标：利用从 VA 管理数据库获得的数据，结合使用 VA 补偿和养老金记录交换应用程序从国家 VA 电子病历中提取的信息，我们建议实现以下目标：1）检查基于指南的 HCC 监测在对全国肝硬化患者进行抽样，并检查与适当或不适当的监测相关的患者、医生和设施因素； 2) 评估 HCC 患者中基于指南的分期治疗的实施情况，并检查与接受分期治疗相关的患者、医生和设施因素； 3) 检查基于指南的 HCC 监测和阶段性治疗对生存的影响。方法：我们提出一项回顾性队列研究，使用两个分层随机样本，纳入 2006 年至 2009 年期间在全国 VA 机构诊断出的约 1,500 名肝硬化患者和 1,500 名 HCC 患者。对于目标 1，在患有以下之一的患者中实施 HCC 监测的结果将是适当的（基于指南的监测、接受与 HCC 监测无关的影像学检查、无监测）与不适当的（非基于指南的监测、过度使用监测）肝硬化的四种主要病因（丙型肝炎、非酒精性脂肪肝、乙型肝炎、酒精性肝病）。将使用逻辑回归检查与适当实施 HCC 监测相关的患者、医生和设施因素。对于目标 2，结果将是 HCC 患者接受阶段适当的 HCC 治疗与阶段不适当的治疗或不接受治疗。根据现行指南，每位患者将被分配到适合阶段的治疗类别，并将其与所接受的治疗进行比较。逻辑回归将用于检查接受阶段适当治疗的预测因素。对于目标 3，结果将是发展为 HCC 的肝硬化患者的生存率。接受适当的 HCC 监测和阶段适当的治疗将是主要的预测因素。边际结构模型将用于检查这些关联。影响：本研究将探讨 HCC 治疗中尚未研究的重要而及时的问题。这项研究的结果将为制定和实施未来干预措施奠定坚实的基础，以改善基于指南的 HCC 监测和治疗的实施。