Treatment Approaches and Outcomes in Pouch-related Disorders after Colectomy for Ulcerative Colitis

溃疡性结肠炎结肠切除术后储袋相关疾病的治疗方法和结果

• 批准号: 10530669
• 负责人: Edward Barnes
• 金额: $ 20.01万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-05 至 2025-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10530669
• 关键词: Acute; Address; Affect; Anastomosis - action; Anti-Tumor Necrosis Factor Therapy; Anus; Area; Award; Big Data; Biological Response Modifier Therapy; Chronic; Clinical; Clinical Data; Clinical Investigator; Clinical Research; Clinical Sciences; Clinical Trials; Colectomy; Colitis; Comparative Effectiveness Research; Counseling; Crohn' s disease; Crowding; Curative Surgery; Data; Development; Development Plans; Diagnosis; Disease; Dysplasia; Educational workshop; Ensure; Environment; Epidemiology; Faculty; Foundations; Frequencies; Funding; Future; Goals; Ileal Reservoirs; Inflammatory; Inflammatory Bowel Diseases; Institution; K-Series Research Career Programs; Knowledge; Laboratories; Machine Learning; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Mentorship; Methods; Modeling; Multiomic Data; North Carolina; Operative Surgical Procedures; Outcome; Outcome Assessment; Patient Care; Patient Outcomes Assessments; Patients; Peer Review; Population; Positioning Attribute; Pouchitis; Prediction of Response to Therapy; Prevention strategy; Privatization; Productivity; Prospective cohort; Qualitative Research; Quality of life; Refractory; Registries; Reporting; Research; Research Methodology; Research Personnel; Research Project Grants; Restorative Proctocolectomy; Risk; Risk Factors; Scientist; Structure; Symptoms; TNF gene; Techniques; Time; Training; Translational Research; Treatment Protocols; Ulcerative Colitis; United States National Institutes of Health; Universities; Work; Writing; candidate selection; career; career development; clinical care; cognitive interview; comparative effectiveness; comparative effectiveness study; design; effectiveness research; effectiveness study; experience; fecal microbiome; gastrointestinal; high risk; higher education; improved; indexing; individual patient; instrument; interest; machine learning method; member; microbiota; novel; novel therapeutics; outcome prediction; patient oriented research; precision medicine; predictive signature; prospective; response; skills; tool; treatment strategy

PROJECT SUMMARY This overall goal of this mentored patient-oriented research career development award is to improve our understanding of pouchitis and other inflammatory conditions after restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA). Dr. Barnes is a motivated clinical researcher at the University of North Carolina at Chapel Hill (UNC), with a specific interest in the study of inflammatory bowel diseases. Over the next five years, Dr. Barnes will work with his mentorship committee to continue his progression towards his goal of independence. His mentorship committee includes experts in gastrointestinal epidemiology and comparative effectiveness (Kappelman), patient reported outcomes [(PROs) DeWalt], and precision medicine (Kosorok). Each member has an established track record of mentoring junior faculty, consistent peer-reviewed support, and high research productivity. Dr. Barnes’s career development objectives are as follows: 1) develop a new skillset in comparative effectiveness research using real-world data; 2) obtain knowledge and experience in the development of PRO assessments; 3) acquire new skills in machine learning and precision medicine principles which will allow for the incorporation of clinical and microbiota data into new risk modeling for patients undergoing restorative proctocolectomy with IPAA, and 4) transition to independence. To achieve his career development objectives, Dr. Barnes will participate in structured coursework, conduct mentored research, and will participate in workshops through the North Carolina Translational and Clinical Sciences Institute, including the R-Writing Group. The research and training environment at UNC is well established. For fiscal year 2019, UNC ranked tenth among both private and public universities nationwide for National Institutes of Health (NIH) research funding to domestic institutions of higher education. The specific aims of this research project are 1) to evaluate the comparative effectiveness of specific biologic therapies for the treatment of chronic inflammatory conditions of the pouch after IPAA; 2) to develop PRO items for evaluating quality of life and specific symptom domains among patients after IPAA. Techniques for PRO development will include identifying symptom domains relevant to patients after IPAA using qualitative research methods, selecting candidate items for IPAA-specific PROs using existing PRO instruments where appropriate, and performing cognitive interviews with patients after IPAA to ensure content validity; and 3) to demonstrate novel methods for identifying predictors of chronic pouchitis using a machine learning approach. Expanding an existing prospective cohort, Dr. Barnes will utilize the stool microbiome, laboratory data and clinical variables to create signatures for identifying predictors of chronic pouchitis. The combination of mentorship, didactics, and research experiences offered through this K23 proposal will allow Dr. Barnes to develop a unique skillset that will aid in his ultimate transition to independence as a clinical investigator and research scientist.

项目摘要 这个指导性的以患者为导向的研究职业发展奖的总体目标是提高我们的 了解回肠代直肠结肠切除术后的结肠袋炎和其他炎症状况 贮袋肛管吻合术（IPAA）。巴恩斯博士是一个积极的临床研究人员在北大学 卡罗莱纳在查佩尔山（北卡罗来纳州），在炎症性肠病的研究特别感兴趣。来 在接下来的五年里，巴恩斯博士将与他的导师委员会合作，继续他的进步， 独立的目标。他的导师委员会包括胃肠流行病学专家， 比较有效性（Kappelman）、患者报告结局[（PRO）DeWalt]和精准医疗 （Kosorok）.每个成员都有指导初级教师的既定记录，一致的同行评审 支持和高研究生产力。巴恩斯博士的职业发展目标如下：1）发展 使用真实世界数据进行比较有效性研究的新技能; 2）获得知识， PRO评估开发经验; 3）获得机器学习和精确度方面的新技能 医学原则，允许将临床和微生物群数据纳入新的风险建模 对于接受IPAA修复性直肠结肠切除术的患者，以及4）过渡到独立。实现 他的职业发展目标，巴恩斯博士将参加结构化的课程，进行辅导 研究，并将参加研讨会通过北卡罗来纳州转化和临床科学 研究所，包括R-Writing Group。研究和培训环境在ESTA是完善的。为 2019财政年度，在全国私立和公立大学中排名第十， 卫生研究院（NIH）的研究经费，以国内高等教育机构。具体目标是 研究项目是：1）评估特定生物疗法的比较有效性， 治疗IPAA后的慢性炎症性疾病; 2）开发PRO项目用于评估 IPAA后患者的生活质量和特定症状领域。PRO开发技术将 包括使用定性研究方法确定与IPAA后患者相关的症状域， 在适当情况下，使用现有PRO工具为IPAA特定PRO选择候选项目，以及 在IPAA后对患者进行认知访谈，以确保内容的有效性;以及3）证明新的 使用机器学习方法识别慢性结肠袋炎的预测因子的方法。扩展一个 在现有的前瞻性队列中，巴恩斯博士将利用粪便微生物组、实验室数据和临床变量， 创建识别慢性结肠袋炎预测因子的特征。导师制、教学法和 通过这项K23提案提供的研究经验将使巴恩斯博士能够发展出一套独特的技能， 将有助于他最终过渡到独立作为一个临床调查员和研究科学家。