Harms of Hepatocellular Carcinoma Screening in Patients with Cirrhosis

肝硬化患者肝细胞癌筛查的危害

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要在美国，肝细胞癌 (HCC) 的发病率正在上升，预计将成为第三大癌症到2030年，癌症死亡原因超过90%的HCC发生在肝硬化，HCC是导致死亡的主要原因对于这些患者。尽管一些专业协会建议使用腹部超声和阿尔法甲胎蛋白 (AFP)，一种血清生物标志物，肝硬化患者每 6 个月检测一次，文献中的局限性排除了共识建议。两项系统评价得出了先前研究的显着结论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) 筛查阳性患者的诊断评估造成的身体和经济伤害（例如造影剂损伤、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。由于 HCC 筛查的生存获益似乎不大，需要进行全面的危害评估，为指导方针提供信息，在初级保健之间建立共识提供者和专家，并指导患者和提供者有关 HCC 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益处（~30% 保险不足）和种族多样化（>50% 黑人或西班牙裔）人群的 3000 名肝硬化患者其次是 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）在四年的时间内，我们建议：目标 1：评估 HCC 筛查对 a) 后续检查造成的身体伤害、b) 经济伤害和 c) 通过电子病历对严重肝功能障碍或合并症患者进行过度诊断数据、手动图表审查和经过验证的调查措施目标 2：评估 HCC 筛查对筛查相关心理社会危害的影响，例如癌症特异性通过纵向验证的措施来消除担忧、情境焦虑、情绪障碍和决策后悔和定性访谈目标 3：创建并传播收益和危害的资产负债表，以告知患者、护士、提供者、医疗机构、付款人和政策制定者了解肝硬化患者 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危害是否因患者、提供者、和医疗保健系统因素。这些数据将补充同时收集的有关筛查的数据受益于随机试验，提供有关利弊的最高质量数据在制定有关 HCC 筛查的政策决策时进行 HCC 筛查。我们将立即翻译我们的研究结果，以促进患者与提供者的讨论，为付款人的决策提供信息报销，并指导肝硬化患者 HCC 筛查的政策决策。