Optimizing the role of ERCP in evaluating indeterminate bile duct strictures

应聘者描述(由申请人提供)：应聘者(Gregory Cote博士)是印第安纳大学医学院胃肠病和肝病学部的临床医学助理教授。他是一名临床研究人员和先进的胰胆内窥镜医生，他立志成为一名独立的临床调查员，在胰胆内窥镜检查中以患者为导向的结果研究中拥有持续的外部资金，特别强调成本效益/卫生经济学。国际和平研究所正在申请K23学位，以获得受保护的学术时间，以便获得高级流行病学、卫生经济学和大型电子数据库研究方面的技能。除了一个多样化的专家导师团队以及完成结构化的课程工作外，K23提供的受保护时间将使他能够获得使用大型电子数据库完成指导临床研究和完成试点随机临床试验的经验。在拟议的职业发展期间，他的研究重点是研究各种基于ERCP的胆管狭窄诊断策略的流行病学、疗效和成本。在一个 2002年，美国国立卫生研究院发表了一份关于ERCP的最新科学声明，指出ERCP的一个主要局限性是，在胆道梗阻/狭窄的情况下，ERCP对发现恶性肿瘤的敏感性较差。因此，对胆道梗阻患者最具成本效益的诊断方法尚不清楚。这项拟议的研究将评估多种基于ERCP的方法诊断不确定胆管狭窄的增量收益，并确定当前临床实践中胆管狭窄诊断测试的流行病学。众所周知，不明原因胆管狭窄的恶性和良性病因很难区分，但量化这一问题的严重程度并确定与更高强度的诊断测试(即更昂贵的诊断评估)相关的患者和提供者特征的数据有限。由于美国每年有50,000人死于胰腺癌和胆道癌，因此迫切需要改进我们对这些患者的术前评估和管理。PI组建了一支由胰胆管研究(Sherman)和流行病学/健康经济学(Ackermann)专家组成的初级导师团队。他们得到了流行病学和数据库研究(Rosenman)、生物统计学(Hui)和细胞遗传学(Vance)的科学顾问的支持，以及在职业发展和胃肠道流行病学(Imperiale)和胰胆管内窥镜研究(Lehman)方面拥有专业知识的二级导师的支持。PI已经制定了强大的职业规划，并在提供受保护的时间、基础设施和资源方面对候选人有强有力的机构承诺。印第安纳大学医学院初级研究员的培训和进行临床研究的环境非常好。导师团队、职业发展战略、拟议的研究和环境制定了将申请者发展为独立临床研究员的蓝图。

DESCRIPTION (provided by applicant): The candidate (Dr. Gregory Cote) is an Assistant Professor of Clinical Medicine in the Division of Gastroenterology and Hepatology at Indiana University School of Medicine. He is a clinical researcher and advanced pancreatobiliary endoscopist who aspires to become an independent clinical investigator with sustained extramural funding in patient-oriented outcomes research in pancreatobiliary endoscopy, with a particular emphasis on cost effectiveness/health economics. The PI is applying for a K23 to obtain protected academic time for the acquisition of skills in advanced epidemiology, health economics and studies of large electronic databases. In addition to a diverse and expert team of mentors along with completing structured coursework, the protected time offered by a K23 will allow him to gain experience in completing mentoring clinical investigations using large electronic databases and completing a pilot, randomized clinical trial. The focus of his research during the proposed career development period is in studying the epidemiology, efficacy and costs of various ERCP-based diagnostic strategies for the evaluation of bile duct strictures. In a 2002 State-of-the-Science statement on ERCP, the NIH identified a principal limitation of ERCP being its poor sensitivity for detecting malignancy in the setting of a biliary obstruction/strictue. As a result, the most cost effective diagnostic approach to patients with biliary obstruction is unknown. The proposed studies will evaluate the incremental yield of multiple ERCP-based modalities for characterizing indeterminate bile duct strictures and define the epidemiology of diagnostic testing for bile duct strictures in current clinical practice. While it is notoriously dfficult to differentiate malignant and benign etiologies for indeterminate bile duct strictures, there are limited data quantifying the magnitude of this problem and identifying patient and provider characteristics that are associated with more intense diagnostic testing (i.e., a more costly diagnostic evaluation). Since pancreatic and bile duct cancer account for > 50,000 deaths in the United States each year, there is a critical need to improve our preoperative evaluation and management of these patients. The PI has compiled a team of primary mentors from experts in pancreatobiliary research (Sherman) and epidemiology/health economics (Ackermann). These are supported by scientific advisors in epidemiology and database research (Rosenman), biostatistics (Hui) and cytogenetics (Vance), as well as secondary mentors with expertise in career development and GI epidemiology (Imperiale) and pancreatobiliary endoscopy research (Lehman). The PI has assembled a strong career plan and there is a robust institutional commitment to the candidate in terms of offering protected time, infrastructure, and resources. The environment for training and conducting clinical research by junior investigators at Indiana University School of Medicine is outstanding. The mentorship team, career development strategy, proposed research and environment formulate the blueprint for developing the applicant into an independent clinical investigator.