Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis

项目摘要/摘要 在美国，肝细胞癌的发病率正在上升，预计将成为全球第三大癌症 2030年前导致癌症死亡的原因。超过90%的肝细胞癌发生在肝硬变，而肝细胞癌是主要的死亡原因。 对这些病人来说。尽管有几个专业协会建议使用腹部超声波和阿尔法 血清生物标记物甲胎蛋白(AFP)在肝硬变患者中每6个月检测一次，文献中的局限性 排除了协商一致的建议。先前研究得出的两个系统回顾值得注意 局限性，包括缺乏关于筛查危害的数据。肝癌筛查的潜在危害包括：1) 筛查阳性患者的诊断评估造成的身体和经济损害(例如，对比损伤， 辐射暴露、活检并发症)；2)过度诊断；以及3)阳性或 不确定的筛选结果。由于肝细胞癌筛查的生存益处似乎不大， 需要全面的危害评估来为指导方针提供信息，在初级保健中建立共识 并指导患者和提供者关于肝细胞癌筛查的决策。 利用多中心随机试验评估筛查在社会经济方面的好处(约30% 保险不足)和种族多样性(&gt；50%黑人或西班牙裔)人口中的3000名肝硬化患者 紧随其后的是3个医疗保健环境(学术三级护理中心、安全网医疗系统和退伍军人 )，我们建议在四年内： 目的1：评估肝细胞癌筛查对a)因随访检查造成的身体损害，b)财务损害，以及 C)通过电子病历对严重肝功能障碍或合并疾病的患者过度诊断 数据、手动图表审查和经过验证的调查措施 目的2：评估肝细胞癌筛查对筛查相关心理社会伤害的影响，例如癌症特异性 焦虑、情境性焦虑、情绪紊乱和决策后悔，通过纵向验证的测量 和定性访谈 目标3：创建并分发一份利害表，以告知患者、护士、提供者、 医疗机构、付款人和政策制定者对肝硬变患者肝细胞癌筛查价值的看法 我们将使用混合效应回归分析来确定筛查相关损害是否因患者、提供者、 以及医疗保健系统因素。这些数据将补充同时收集的有关筛查的数据 从随机试验中获益，以提供有关以下物质的益处和危害的最高质量数据 在做出关于肝癌筛查的政策决定的时候进行肝癌筛查。我们会立即 翻译我们的研究结果以促进患者与提供者的讨论，向支付者提供关于 报销，并指导对肝硬化患者进行肝细胞癌筛查的政策决策。

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.