Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis

项目总结/摘要 肝细胞癌（HCC）的发病率在美国正在上升，预计将成为美国第三大肝细胞癌。 到2030年，癌症死亡率。超过90%的肝癌发生在肝硬化，肝癌是导致死亡的主要原因 对于这些患者。虽然一些专业协会建议使用腹部超声和阿尔法 肝硬化患者每6个月一次的血清生物标志物甲胎蛋白（AFP），文献局限性 排除了协商一致的建议。两项系统性综述得出结论，先前的研究具有显著的 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） 来自筛查阳性患者的诊断评估的身体和经济损害（例如，对比损伤， 辐射暴露，活检并发症）; 2）过度诊断;和3）由于阳性或 不确定的筛选结果。因为HCC筛查的生存益处似乎不大， 需要进行全面的危害评估，以便为指导方针提供信息，在初级保健中建立共识 提供者和专家，并指导患者和提供者关于HCC筛查的决策。 利用一项多中心随机试验评估筛查在社会经济学方面的益处（约30%）， 保险不足）和种族多样性（>50%的黑人或西班牙裔）人群的3000例肝硬化患者 随后在3个医疗保健机构（学术三级保健中心，安全网卫生系统，退伍军人 事务系统），我们建议： 目的1：评估HCC筛查对以下方面的影响：a）随访检查造成的身体损害，B）经济损害，以及 c）通过电子病历对严重肝功能障碍或共病患者进行过度诊断 数据、手动图表审查和经验证的调查措施 目的2：评估HCC筛查对筛查相关心理社会危害的影响，例如癌症特异性 焦虑，情境焦虑，情绪障碍和决策后悔，通过纵向验证措施， 定性访谈 目标3：创建和传播利益和危害的资产负债表，以告知患者，护士，提供者， 医疗保健组织、支付者和政策制定者对肝硬化患者进行HCC筛查的价值 我们将使用混合效应回归分析来确定筛查相关伤害是否因患者、提供者 医疗保健系统因素。这些数据将补充同时收集的有关筛选的数据 从随机试验中获益，以提供关于 在制定HCC筛查政策时进行HCC筛查。我们会立即 翻译我们的研究结果，以促进患者-提供者讨论，告知付款人决定， 报销，并指导肝硬化患者HCC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.