Stratification of Non-alcoholic Fatty Liver Disease using the SAFE Score

使用 SAFE 评分对非酒精性脂肪肝进行分层

基本信息

批准号：
10264889
负责人：
W. Ray KIM
金额：
$ 48.17万
依托单位：
STANFORD UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-16 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10264889
关键词：
Adult Affect American Area Caring Cartoons Characteristics Cirrhosis Clinic Clinical Clinical Research Communities Consultations Custom Data Data Pooling Diabetes Mellitus Diagnosis Diagnostic Diagnostic tests Disease Enrollment Fatty acid glycerol esters Fibrosis Future Goals Health Policy Healthcare Hepatology High Prevalence Individual Intervention Liver Liver Cirrhosis Liver Fibrosis Magnetic Resonance Malignant neoplasm of liver Measurement Measures Methods Modeling Monitor Morbidity - disease rate Non-Insulin-Dependent Diabetes Mellitus Outcome Patients Performance Personal Satisfaction Policy Maker Population Predictive Value Prevalence Primary Health Care Probability Process Public Health Research Resource Allocation Risk Risk Assessment Role Screening procedure Sensitivity and Specificity Stratification Testing Therapeutic Agents Time base chronic liver disease cohort combat design disorder risk elastography evidence base experience follow-up high risk improved innovation mathematical model medical specialties mortality non-alcoholic fatty liver disease nonalcoholic steatohepatitis novel patient population patient stratification prospective prospective test risk stratification therapeutically effective tool vibration

项目摘要

Non-alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease with a rapidly increasing public health burden, affecting a third of American adults. NAFLD represents a spectrum of disorders ranging from simple steatosis to non-alcoholic steatohepatitis (NASH) which may result in progressive hepatic fibrosis and cirrhosis. While the majority of NAFLD patients do not develop or succumb to severe liver problems, liver fibrosis, particularly that of stage 2 or higher is a well-established marker of liver-related morbidity as well as overall mortality. Currently, no dedicated clinical tool exists to assess future risks and guide management in NAFLD patients in the community. In this application, we propose a precision tool with which to risk stratify community NAFLD patients so that patients at risk of developing future complications are directed to specialty care, while others may be monitored without unnecessary diagnostic testing or interventions. We have recently developed the Steatosis-Associated Fibrosis Estimator (SAFE) score designed to rule out stage 2 fibrosis in NAFLD patients. In our preliminary assessment of the model, it had a high negative predictive value – a score of <0 accurately predicted lack of significant fibrosis. The studies proposed in this application will prospectively test the score in 3 different patient populations (1) NAFLD patients referred to specialty Hepatology Clinics, (2) NAFLD patients diagnosed in Primary Care Clinics, and (3) type 2 diabetes patients attending Diabetes Clinics. By comparing the SAFE score and non-invasive indicators of liver fibrosis (i.e., liver stiffness measurement), we will validate the score’s diagnostic characteristics in these patients when used for one time risk assessment and for longitudinal follow-up and, if necessary, make further refinements to the score. With the proposed studies, we will have a well-validated clinical tool with which we will confidently risk-stratify patients with NAFLD in the community and screen for high risk NAFLD in patient populations at high risk, such as patients with type 2 diabetes. An effective means to correctly stratify NAFLD patients will improve efficiency of care, optimize healthcare resource allocation and facilitate clinical research, ultimately benefiting the well-being of patients with the common condition.

非酒精性脂肪肝病（NAFLD）是慢性肝病的常见原因，公众迅速增加健康伯恩（Health Burnen）影响了三分之一的美国成年人。 NAFLD代表一系列疾病，从简单脂肪变性到非酒精性脂肪性肝炎（NASH），这可能导致进行性肝纤维化和肝硬化。尽管大多数NAFLD患者不会出现或屈服于严重的肝脏问题，肝纤维化，特别是第2阶段或更高是与实时发病率和整体死亡率的完善的标志。目前，没有存在专门的临床工具，以评估社区NAFLD患者的未来风险和指导管理。在此应用中，我们提出了一种精确的工具，以使社区NAFLD患者的风险分层，以使患者处于发展未来并发症的风险是针对专业护理的，而其他人可能会受到监控不必要的诊断测试或干预措施。我们最近开发了与脂肪变性相关的纤维化估计量（安全）分数旨在排除NAFLD患者的2阶段纤维化。在我们对模型，它具有较高的负预测值 - 得分<0 <0准确地预测缺乏明显的纤维化。研究在此应用中提出的可能会测试3个不同患者人群的分数（1）NAFLD患者转介到特种肝病学诊所，（2）在初级保健诊所诊断出的NAFLD患者和（3）2型糖尿病参加糖尿病诊所的患者。通过比较肝纤维化的安全评分和非侵入性指标（即肝脏刚度测量），我们将在这些患者中验证分数的诊断特征风险评估和纵向随访，并在必要时对分数进行进一步的改进。通过拟议的研究，我们将拥有一个验证良好的临床工具，我们将确信将患者风险分解。 NAFLD在社区中，并在高风险的患者人群中进行高风险NAFLD，例如患者 2型糖尿病。正确分层NAFLD患者的有效手段将提高护理效率，优化医疗保健资源分配并促进临床研究，最终使患者的福祉受益常见条件。