Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis

肝硬化患者肝细胞癌筛查的危害

• 批准号: 10018464
• 负责人: Amit Singal
• 金额: $ 60.99万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10018464
• 关键词: Abdomen; Anxiety; Biological Markers; Biopsy; Cancer Etiology; Caring; Cause of Death; Cessation of life; Cirrhosis; Colorectal Cancer; Complement; Computerized Medical Record; Consensus; Data; Decision Making; Detection; Diagnostic; Eligibility Determination; Equilibrium; Evaluation; Future; Gastroenterology; Goals; Guidelines; Health system; Healthcare Systems; Hispanics; Incidence; Indolent; Injury; Intervention; Interview; Light; Literature; Liver Dysfunction; Malignant Neoplasms; Manuals; Measurement; Measures; Nurses; Parents; Patients; Policies; Population Heterogeneity; Primary carcinoma of the liver cells; Professional Organizations; Protocols documentation; Provider; Public Health; Radiation exposure; Randomized Controlled Trials; Recommendation; Regression Analysis; Regrets; Role; Schedule; Screening Result; Screening for Prostate Cancer; Screening procedure; Serum; Specialist; Surveys; System; Testing; Time; Training; Translating; Ultrasonography; Underinsured; Veterans; affective disturbance; alpha-Fetoproteins; care providers; clinical practice; comorbidity; experience; follow-up; health care service organization; health care settings; high risk; liver transplantation; malignant breast neoplasm; mortality risk; psychosocial; racial diversity; randomized trial; safety net; screening; screening guidelines; socioeconomics; systematic review; tertiary care; tumor

PROJECT SUMMARY / ABSTRACT The incidence of hepatocellular carcinoma (HCC) is rising in the U.S and is projected to become the 3rd leading cause of cancer death by 2030. Over 90% of HCC occur in cirrhosis, and HCC is the leading cause of death for these patients. Although several professional societies recommend use of abdominal ultrasound and alpha fetoprotein (AFP), a serum biomarker, every 6 months in patients with cirrhosis, limitations in the literature have precluded consensus recommendations. Two systematic reviews concluded prior studies have notable limitations including a lack of data regarding screening harms. Potential harms of HCC screening include: 1) physical and financial harms from diagnostic evaluation in screen-positive patients (e.g., contrast injury, radiation exposure, biopsy complications); 2) overdiagnosis; and 3) psychosocial harms due to positive or indeterminate screen results. Because the survival benefit of HCC screening appears modest, a comprehensive harms assessment is needed to inform guidelines, build consensus among primary care providers and specialists, and guide patient and provider decision-making about HCC screening. Leveraging a multi-center randomized trial assessing screening benefits in a socioeconomically (~30% underinsured) and racially diverse (>50% Black or Hispanic) population of 3000 patients with cirrhosis followed in 3 healthcare settings (academic tertiary care center, safety-net health system, and Veterans Affairs system) over a 4-year period, we propose to: Aim 1: Assess the effect of HCC screening on a) physical harms due to follow-up tests, b) financial harms, and c) overdiagnosis in patients with severe liver dysfunction or comorbid illness, through electronic medical record data, manual chart review, and validated survey measures Aim 2: Assess the effect of HCC screening on screening-related psychosocial harms, e.g. cancer-specific worry, situational anxiety, mood disturbances, and decisional regret, through longitudinal validated measures and qualitative interviews Aim 3: Create and disseminate a balance sheet of benefits and harms to inform patients, nurses, providers, healthcare organizations, payers, and policymakers about the value of HCC screening in patients with cirrhosis We will use mixed-effect regression analysis to identify if screening-related harms differ by patient, provider, and healthcare system factors. These data will complement concurrently collected data about screening benefits from the randomized trial to provide the highest quality data available about benefits and harms of HCC screening at a time when policy decisions about HCC screening are being made. We will immediately translate our study findings to facilitate patient-provider discussions, inform payer decisions about reimbursement, and guide policy decisions on HCC screening in patients with cirrhosis.

项目摘要 /摘要 肝细胞癌（HCC）的发生率在美国正在上升，预计将成为第三名 到2030年，癌症死亡的原因。超过90％的HCC发生在肝硬化中，HCC是死亡的主要原因 对于这些患者。尽管几个专业社会建议使用腹部超声和α 胎儿蛋白（AFP），一种血清生物标志物，每6个月患有肝硬化患者，文献局限性 排除了共识建议。两项系统的评论得出的结论是先前的研究很明显 局限性，包括缺乏有关筛查危害的数据。 HCC筛查的潜在危害包括：1） 筛查阳性患者诊断评估受到的身体和财务危害（例如，对比损伤， 辐射暴露，活检并发症）； 2）过度诊断； 3）由于积极或 不确定的屏幕结果。因为HCC筛查的生存优势似乎适中 需要进行全面的危害评估，以告知准则，在初级保健之间建立共识 提供者和专家，并指导有关HCC筛查的患者和提供者的决策。 利用多中心随机试验评估社会经济中的筛查益处（〜30％） 投资不足）和3000例肝硬化患者的种族多样性（> 50％黑人或西班牙裔）人群 紧随其后的3个医疗机构（学术三级护理中心，安全网卫生系统和退伍军人 事务系统）在4年内，我们建议： 目标1：评估HCC筛查对a）随访测试引起的身体危害的影响，b）财务危害和 c）通过电子病历严重肝功能障碍或合并症患者过度诊断 数据，手动图表审查和经过验证的调查措施 AIM 2：评估HCC筛查对筛查相关的社会心理伤害的影响，例如癌症特异性 通过纵向验证的措施，担心，情境焦虑，情绪障碍和决策的遗憾 和定性访谈 目标3：创建并传播福利和损害的资产负债表，以告知患者，护士，提供者， 医疗保健组织，付款人和决策者关于肝硬化患者的HCC筛查价值 我们将使用混合效应回归分析来确定患者，提供者，与筛查相关的危害是否有所不同 和医疗保健系统因素。这些数据将同时收集有关筛查的数据 随机试验中的好处是提供有关福利和危害的最高质量数据 HCC筛查在进行有关HCC筛查的政策决策时。我们将立即 翻译我们的研究结果以促进患者提供讨论，告知付款人的决定 报销肝硬化患者HCC筛查的政策决策。