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 无症状的胆石症通常需要手术治疗，在美国， 人群，成为症状;这发生在胆结石阻塞胆囊的消化引流， 胰腺、肝脏或肠。在美国，每年有100万人患上霍乱， 切除胆囊以治疗这种诊断的症状性胆石病（dSGD）。病人是否 一个更病态和昂贵的紧急情况，而不是非紧急胆囊切除术，可能取决于许多 这些因素在很大程度上是未知的。然而，由于紧急胆囊切除术被认为可能 如果胆囊结石疾病可以完全避免， 高质量的预防和非手术治疗，或当手术表明，它可以是选择性的，而不是一个 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。K23的目标是 是开始以人口为基础的研究疾病需要紧急手术，目前代表超过两个- 美国医院医疗服务的三分之一，以及令人震惊的总死亡率和成本的一半以上。这将开始 一项关于急诊胆囊切除术的频率和死亡率的研究， DSGD的人口经验。本研究的主要假设是急诊死亡率高于 非紧急胆囊切除术;如果dSGD的自然史从紧急转为非紧急 胆囊切除术，这导致dSGD的总体死亡率降低。该计划的目标是 研究开始将提供基于人口的数据，以减少不太安全的紧急手术， 更安全的非紧急手术或非手术治疗，降低美国dSGD的总体死亡率， 过程建议的研究与候选人的职业发展目标和4年的培训非常吻合， 指导计划，以发展成为一个独立的临床流行病学家研究消化系统疾病，需要 紧急手术该候选人正在从主要的临床职业转向研究职业。他有很强 在急诊外科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， 声称数据研究，更深层次的生物统计专业知识，新的技能，合作的混合方法，以病人为导向 研究，并指导过渡到设计自己的新病因学研究。导师团队由 在临床流行病学研究和培训，胆结石流行病学，推理， 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。研究和培训将发生在罗格斯大学，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员。在这一结论 项目，候选人将记录自然流行病学和dSGD的总体死亡率， 美国，以及如何这可能会或可能不会改变，以应对增加医疗保险。这将通知 候选人设计未来的病因学（R 01）研究，以了解并最终降低dSGD的死亡率。