The Natural History of Overall Mortality with Diagnosed Symptomatic Gallstone Disease in the United States: A Sequential Mixed-methods Study Evaluating Emergency, Non-emergency, and No Cholecystectomy

美国诊断有症状胆结石病的总体死亡率的自然史：一项评估紧急、非紧急和不进行胆囊切除术的序贯混合方法研究

• 批准号: 10664339
• 负责人: Gregory Lance Peck
• 金额: $ 23.02万
• 依托单位: RUTGERS BIOMEDICAL AND HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10664339
• 关键词: Abdomen; Address; Behavioral; Biological; Biometry; Caring; Case Fatality Rates; Cessation of life; Cholecystectomy; Cholelithiasis; Clinical; Clinical Investigator; Cognitive; Collaborations; Data; Data Set; Data Sources; Decision Making; Development Plans; Diagnosis; Digestive System Disorders; Disease; Drainage procedure; Emergency Situation; Ensure; Environment; Epidemiologic Methods; Epidemiologist; Epidemiology; Etiology; Excision; Fostering; Foundations; Frequencies; Funding; Future; Gallbladder; Goals; Health Insurance; Healthcare; Hospitalization; Hospitals; Inpatients; Insurance; Intervention; Intestines; Investigation; Liver; Medicaid; Medical; Mentors; Mentorship; Methods; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Natural History; Natural experiment; Operative Surgical Procedures; Outpatients; Pancreas; Patients; Persons; Policies; Population; Population Research; Population Study; Postoperative Complications; Prevalence; Prevention; Primary Prevention; Procedures; Process; Public Health; Publishing; Qualitative Methods; Research; Research Personnel; Research Support; Risk; Risk Factors; Secondary Prevention; Selection Bias; Series; Suggestion; Symptoms; Techniques; Testing; Training; United States; Unnecessary Surgery; career; career development; clinical epidemiology; cost; design; disadvantaged background; epidemiology study; experience; gallstone disease; health care delivery; high risk; human old age (65+); insight; mortality; mortality risk; novel; operation; patient oriented research; population based; prevent; programs; response; skills; social; tertiary prevention; trend

Project Abstract Surgery is often indicated when asymptomatic gallstone disease, with a prevalence as high as 20% in the US population, becomes symptomatic; this occurs when gallstones block the digestive drainage of the gallbladder, pancreas, liver, or intestine. Cholecystectomy, occurring in a million people in the US annually, is the surgical removal of the gallbladder to treat this diagnosed symptomatic gallstone disease (dSGD). Whether patients have a more morbid and costly emergency rather than a non-emergency cholecystectomy, may depend on many factors which are largely unknown. However, since emergency cholecystectomy has been suggested to possibly have 5 to 10x the mortality elective cholecystectomy has, if gallstone disease could be avoided completely via high-quality prevention and non-surgical therapy, or when surgery is indicated it could be elective rather than an emergency, overall mortality from this extremely common condition might be reduced. The objective of this K23 is to start population-based research on disease requiring emergency surgery, currently representing over two- thirds of healthcare delivery in US hospitals and alarmingly over half of total mortality and cost. This will begin with a study of the frequency of, and mortality from, emergency cholecystectomy, informed by the overall population experience with dSGD. The main hypothesis of this study is emergency has higher mortality than non-emergency cholecystectomy; if the natural history of dSGD were shifted from emergency to non-emergency cholecystectomy this leads to a decrease in the overall mortality rate with dSGD. The goal this program of research begins will be to provide population-based data to decrease less safe emergency surgery, moving toward safer non-emergency surgery or non-surgical care, decreasing the overall US mortality of dSGD in the process. The proposed study fits well with the candidate’s career development goals and 4-year training and mentoring program to evolve into an independent clinical epidemiologist studying digestive diseases requiring emergency surgery. The candidate is pivoting from a primarily clinical career to a research career. He has strong experience in emergency surgery and public health, and seeks training in rigorous clinical epidemiology methods, claims data research, deeper biostatistical expertise, new skills to collaborate on mixed-methods patient-oriented research, and a mentored transition to designing new etiologic studies of his own. The mentorship team consists of recognized experts in clinical epidemiology research and training, gallstone epidemiology, inferential biostatistics, prevention and qualitative methods, and emergency surgery, who will oversee the execution of the training and career development plan. Research and training will occur at Rutgers, which is a ripe environment for fostering this junior investigator through a transition to research independence. At the conclusion of this project, the candidate will have documented the natural epidemiology and the overall mortality of dSGD in the US, and how this may or may not have changed in response to increasing health insurance. This will inform the candidate’s design of future etiologic (R01) studies to understand and eventually to reduce mortality from dSGD.

项目摘要 当无症状的胆结石疾病时，通常需要进行手术，在美国，胆结石的患病率高达 20% 当胆结石阻塞胆囊的消化引流时，就会出现症状， 在美国，每年有一百万人接受胰腺、肝脏或肠道切除术。 切除胆囊来治疗这种诊断出的症状性胆石病 (dSGD)。 与非紧急胆囊切除术相比，更严重、更昂贵的紧急情况可能取决于许多因素 然而，由于有人建议紧急胆囊切除术，这些因素在很大程度上是未知的。 如果可以通过以下方式完全避免胆结石疾病，则选择性胆囊切除术的死亡率是选择性胆囊切除术的 5 至 10 倍 高质量的预防和非手术治疗，或者当需要手术时，它可以是选择性的而不是一次性的 紧急情况下，这种极其常见的疾病的总体死亡率可能会降低。 将开始针对需要紧急手术的疾病进行基于人群的研究，目前代表超过两个 美国医院三分之一的医疗服务以及令人震惊的总死亡率和费用的一半以上将开始。 一项关于紧急胆囊切除术的频率和死亡率的研究，根据总体情况进行了解 dSGD 的人群经验 本研究的主要假设是紧急情况的死亡率高于紧急情况。 非紧急胆囊切除术；如果 dSGD 的自然病程从紧急转为非紧急 胆囊切除术可降低 dSGD 的总体死亡率，这是该计划的目标。 研究开始将提供基于人群的数据，以减少不安全的紧急手术，移动 转向更安全的非紧急手术或非手术护理，降低美国 dSGD 的总体死亡率 拟议的研究与候选人的职业发展目标和 4 年培训非常吻合。 发展成为一名独立的临床流行病学家，研究消化系统疾病，需要导师 该候选人正在从主要的临床职业转向研究职业。 具有急诊手术和公共卫生方面的经验，并寻求严格的临床流行病学方法的培训， 索赔数据研究、更深入的生物统计专业知识、以患者为导向的混合方法合作的新技能 研究，以及指导他自己设计新的病因学研究的过渡。指导团队由以下人员组成。 临床流行病学研究和培训、胆结石流行病学、推断方面的公认专家 生物统计学、预防和定性方法以及紧急手术，谁将监督执行 培训和职业发展计划将在罗格斯大学进行，这是一个成熟的环境。 通过向研究独立性的过渡来培养这位初级研究者。 项目中，候选人将记录 dSGD 的自然流行病学和总体死亡率 美国，以及随着健康保险的增加，这种情况可能会或可能不会发生变化，这将告知人们。 候选人设计未来的病因学 (R01) 研究，以了解并最终降低 dSGD 的死亡率。