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

• 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
• 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

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.

项目摘要 肝硬化患者相对于一般人群手术风险增加。 用于预测肝硬化手术风险。这些反映在用于风险的主要临床工具中 预测-终末期肝病模型-钠（MELD-Na）、Child-Turcotte-Pugh（CTP）评分，以及 马约手术风险评分--依赖于年龄、肝硬化严重程度、阿萨身体状况评分和 肝脏疾病然而，不同手术类型的术后死亡率存在显著异质性（例如，心脏 与矫形外科相比）表明这些工具是不够的。肝硬化手术风险预测的文献 进一步受限于：1）单中心设计，样本量小，2）缺乏风险的粒度数据 预测，3）预测评分校准不佳的证据，4）缺乏关键利益相关者的参与，以告知 预测工具的实际实施，以及5）没有纳入决策分析方法进行比较 手术到非手术治疗。这些缺点的影响是，许多肝硬化患者 由于高估了风险而被拒绝进行必要的手术，其他人则接受了不准确的手术。 预后咨询或对非手术选择考虑不足。人口级别的细粒度数据 需要解决上述差距。通过使用国家退伍军人健康管理局（VHA）和大学 宾夕法尼亚州医院系统（UPHS）的数据，我们假设，我们将能够创建和实施 一个准确的，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。其主要目的是 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 各种肝硬化患者中短期和中期手术后死亡率的模型。目的2 - 创建一个网络应用程序，用于根据关键利益相关者的输入进行手术风险预测。目标3 -使用马尔可夫 建模以比较手术与非手术管理途径，并确定最佳临床 常见临床情况的决定：急性胆囊炎。这项提案将促进纳迪姆·马哈茂德博士的 作为一个独立的，NIH资助的临床研究人员，重点是改善风险预测， 慢性肝病患者，以及高级预测建模，定性分析， 方法和决策分析。这将通过一个全面的指导计划来促进，该计划包括： 1)与他的导师团队每两周或每月举行一次会议，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，卫生政策研究部（HPR），业务， 信息和决策系（OIDD）和统计系（STAT）， 宾夕法尼亚州，3）结构化的研究讲习班和全国会议，和4）概念，发展， 并在授标期后期提交今后的赠款，以进一步探讨与以下方面有关的问题： 肝硬化患者手术风险预测