Improving Surgical Risk Prediction and Decision Making among Patients with Cirrhosis

改善肝硬化患者的手术风险预测和决策

基本信息

批准号：
10598551
负责人：
Nadim Mahmud
金额：
$ 16.66万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10598551
关键词：
Acute Cholecystitis Address Age American Award Biometry Calibration Cardiac Child Cirrhosis Clinical Complex Conceptions Counseling Data Data Set Databases Decision Analysis Decision Making Development Discrimination Educational workshop Etiology Feedback Fostering Funding Future General Population Goals Grant Health Policy Health system Hepatitis C Heterogeneity Hospitals Impairment Knowledge Laboratories Literature Liver diseases Medical Mentorship Methods Modeling Modernization Natural History Operative Surgical Procedures Orthopedics Pathway interactions Patient Selection Patients Pennsylvania Perception Policy Research Population Positioning Attribute Postoperative Period Provider Qualitative Methods Qualitative Research Quality of life Relative Risks Research Research Methodology Research Personnel Retrospective Studies Risk Risk Estimate Risk Factors Sample Size Schools Severities Severity of illness Societies Sodium Structure Surgeon System Techniques United States National Institutes of Health Universities Validation Veterans Veterans Health Administration chronic liver disease clinical care clinical center clinical epidemiology clinical implementation clinical practice cohort design disease classification end stage liver disease experience improved innovation markov model meetings minimally invasive mortality mortality risk nonalcoholic steatohepatitis novel operation palliation predictive modeling predictive tools prognostic prognostic tool risk prediction risk prediction model risk stratification statistics surgical risk symposium tool web app

项目摘要

PROJECT SUMMARY Patients with cirrhosis have increased surgical risk relative to the general population Several risk factors have been established to predict cirrhosis surgical risk. These are reflected in the primary clinical tools used for risk prediction—the Model for End-stage Liver Disease-sodium (MELD-Na), Child-Turcotte-Pugh (CTP) score, and the Mayo surgical risk score—which rely on age, cirrhosis severity, ASA physical status score, and etiology of liver disease. However, significant heterogeneity in post-operative mortality by surgery type (e.g., cardiac versus orthopedic) suggests that these tools are inadequate. The literature on cirrhosis surgical risk prediction is further limited by: 1) single-center designs with small sample sizes, 2) lack of granular data for risk prediction, 3) evidence of poor prediction score calibration, 4) lack of key stakeholder involvement to inform real-world implementation of prediction tools, and 5) no incorporation of decision analysis methods to compare surgery to non-operative management. The impact of these shortcomings is that many patients with cirrhosis are denied necessary surgery due to overestimates of risk, and others receive surgery with inaccurate prognostic counseling or inadequate consideration of non-operative options. Granular, population-level data are needed to address the above gaps. By using national Veterans Health Administration (VHA) and University of Pennsylvania Hospital System (UPHS) data, we hypothesize that we will be able to create and implement an accurate, well-calibrated cirrhosis surgical risk calculator with broad clinical utility. The primary aims of this proposal are as follows: Aim 1 – derive, internally validate, and externally validate cirrhosis surgical risk models for short- and intermediate-term post-operative mortality among diverse patients with cirrhosis.; Aim 2 – create a web application for surgical risk prediction informed by key stakeholder input.; Aim 3 – use Markov modeling to compare operative to non-operative management pathways and determine optimal clinical decisions for a common clinical scenario: acute cholecystitis. This proposal will foster Dr. Nadim Mahmud's development as an independent, NIH-funded clinical researcher with a focus on improving risk prediction for patients with chronic liver diseases, as well as specific expertise in advanced prediction modeling, qualitative methods, and decision analysis. This will be facilitated through a comprehensive mentorship plan consisting of: 1) biweekly to monthly meetings with his mentorship team, 2) formal coursework in advanced prediction modeling, qualitative research methods, and decision analysis through the Center for Clinical Epidemiology and Biostatistics (CCEB), Wharton School, Department of Health Policy Research (HPR), Operations, Information, and Decisions Department (OIDD), and Department of Statistics (STAT) at the University of Pennsylvania, 3) structured research workshops and national conferences, and 4) conception, development, and submission of future grants during the latter portion of the award period to further explore issues related to surgical risk prediction among patients with cirrhosis.

项目概要肝硬化患者的手术相对风险相对于一般人群有所增加几个危险因素已建立预测肝硬化手术风险的方法，这些都反映在用于风险的主要临床工具中。预测——终末期肝病钠模型 (MELD-Na)、Child-Turcotte-Pugh (CTP) 评分和梅奥手术风险评分——依赖于年龄、肝硬化严重程度、ASA 身体状况评分和病因然而，不同手术类型（例如心脏手术）的术后死亡率存在显着异质性。与骨科）表明这些工具是不够的。进一步受到以下因素的限制：1）样本量较小的单中心设计，2）缺乏详细的风险数据预测，3) 预测分数校准不佳的证据，4) 缺乏关键利益相关者的参与来提供信息预测工具的实际实施，以及 5) 没有结合决策分析方法进行比较这些缺点是手术转非手术治疗的影响。由于高估风险而被拒绝进行必要的手术，还有一些人接受了不准确的手术预后咨询或对非手术方案考虑不足。需要利用国家退伍军人健康管理局 (VHA) 和大学来解决上述差距。宾夕法尼亚医院系统 (UPHS) 数据，我们勇敢地说我们将能够创建和实施准确、校准良好的肝硬化手术风险计算器，具有广泛的临床实用性。建议如下：目标 1 – 推导、内部验证和外部验证肝硬化手术风险不同肝硬化患者的短期和中期术后死亡率模型。；目标 2 – 根据关键利益相关者的输入创建一个用于手术风险预测的网络应用程序。目标 3 – 使用马尔可夫建模以比较手术与非手术治疗途径并确定最佳临床针对常见临床情况的决策：急性胆囊炎该提案将促进 Nadim Mahmud 博士的决策。作为一名独立的、由 NIH 资助的临床研究人员进行开发，重点是改善以下疾病的风险预测患有慢性肝病的患者，以及高级预测模型、定性这将通过全面的指导计划来促进，其中包括： 1) 每两周到每月与他的导师团队举行一次会议，2) 高级预测的正式课程通过临床流行病学中心进行建模、定性研究方法和决策分析和生物统计学 (CCEB)、沃顿商学院、卫生政策研究系 (HPR)、运营、大学信息与决策系 (OIDD) 和统计系 (STAT) 宾夕法尼亚州，3) 组织研究研讨会和全国会议，以及 4) 构思、开发、并在资助期的后半段提交未来的赠款，以进一步探讨与肝硬化患者的手术风险预测。