Comparative Risks and Benefits of Pharmacological Therapies for Older Patients with Inflammatory Bowel Diseases

老年炎症性肠病患者药物治疗的风险和益处比较

基本信息

批准号：
10395453
负责人：
Siddharth Singh
金额：
$ 16.92万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-01 至 2023-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10395453
关键词：
Adrenal Cortex Hormones Adult Affect Algorithms Benefits and Risks Biological Biological Products Cardiovascular system Cessation of life Clinical Data Clinical Informatics Combined Modality Therapy Comparative Effectiveness Research Computerized Medical Record Data Data Sources Databases Disease Effectiveness Elderly Environment Fracture Funding Future Goals Healthcare Hospitalization Hospitals Immunomodulators Incidence Infection Inflammatory Bowel Diseases Informatics Infrastructure Intestines K-Series Research Career Programs Link Malignant Neoplasms Medicare Medicare claim Mentors Mentorship Methods Modeling Observational Study Operative Surgical Procedures Outcome Patient risk Patients Pattern Pharmacology Phenotype Predictive Analytics Prevalence Reporting Research Research Methodology Risk Risk Estimate Safety Sample Size Severity of illness Site Steroids Techniques Testing Therapeutic Therapeutic immunosuppression Thromboembolism Treatment Effectiveness base burden of illness career clinical practice cohort comorbidity comparative comparative effectiveness comparative safety compare effectiveness cost disorder risk effectiveness research evidence base experience follow-up health management high risk individualized medicine innovation machine learning algorithm mortality mortality risk multiple chronic conditions novel older patient optimal treatments patient oriented personalized medicine population health privacy preservation risk minimization risk prediction skills treatment risk treatment strategy young adult

项目摘要

PROJECT SUMMARY/ABSTRACT The prevalence of inflammatory bowel diseases (IBD) in older adults (≥65y) is rising, and there is limited evidence-based guidance on treating these older adults. In older patients with multi-morbidity, treatment decisions should factor in not only risk of disease complications, but also treatment complications and non-IBD, extra-intestinal complications. Hence, to inform optimal treatment approach, a comprehensive assessment of comparative effects of different therapies on all of these outcomes is warranted. Existing single-center observational studies are limited by small sample size, and missing data due to fragmented health care, whereas administrative claims-based studies are limited by lack of detailed clinical data; these limitations can be overcome by linking the two data sources. In this patient-oriented mentored career development award proposal, Dr. Siddharth Singh proposes to: (Aim #1.1) characterize disease burden and treatment patterns, (Aim #1.2) assess and predict risks of death, disease, treatment and extra-intestinal complications using machine-learning algorithms and (Aim #2.1) compare overall effectiveness and (Aim #2.2) safety of different treatment strategies in older patients with IBD. This will be studied using a highly innovative informatics-based approach in a multi-site, electronic medical record (EMR)-based cohort of older patients with IBD, linked to their corresponding Medicare claims. The EMR-based cohort will facilitate phenotyping and disease severity assessment, and linkage to Medicare claims will augment exposure and outcome ascertainment, overcoming challenges of fragmentation of healthcare and short follow-up. The central hypothesis is that, that older adults have systematically different risk profiles than younger adults, and using biologic monotherapy is a safer and more effective approach to treating IBD, as compared to using long-term corticosteroids alone, non-biologic immunomodulator monotherapy, and combination therapy of biologics and immunomodulators. The access to the advanced infrastructure of pSCANNER (Patient-centered Scalable National Network for Effectiveness Research), one of 13 PCORI-funded Clinical Data Research Networks, and entire Medicare database, in a highly supportive and conducive environment at UCSD, with cross-disciplinary mentorship by a collaborative and experienced team of mentors and advisors from diverse backgrounds (clinical informatics, comparative effectiveness research, IBD therapeutics) is a key strength of this application. Besides directly informing clinical practice on treatment approaches in older patients with IBD, this proposal will enhance the career of the candidate by providing unique skills in applied clinical informatics, privacy-preserving record linkage techniques, predictive analytics, and comparative effectiveness research, and create a multi-institutional, EMR- based cohort of well-characterized IBD patients, linked with Medicare claims. This will ultimately contribute to the candidate's long-term goal of establishing an independent IBD research career focusing on comparative effectiveness research and population health management using novel informatics-based approaches.

项目概要/摘要老年人（≥65 岁）炎症性肠病（IBD）的患病率正在上升，但目前的情况有限治疗这些老年人的循证指导对于患有多种疾病的老年患者，治疗。决策不仅应考虑疾病并发症的风险，还应考虑治疗并发症和非IBD，因此，需要对肠外并发症进行全面评估，以告知治疗方法。现有的单中心研究有必要比较不同疗法对所有这些结果的影响。观察性研究受到样本量小以及医疗保健分散导致数据缺失的限制，而基于行政主张的研究因缺乏详细的临床数据而受到限制；在这个以患者为导向的职业发展奖中，可以通过链接两个数据源来克服这一问题。提案中，Siddharth Singh 博士建议：（目标#1.1）描述疾病负担和治疗模式，（目标#1.2）使用以下方法评估和预测死亡、疾病、治疗和肠外并发症的风险机器学习算法和（目标#2.1）比较不同算法的整体有效性和（目标#2.2）安全性老年 IBD 患者的治疗策略将使用高度创新的基于信息学的方法进行研究。该方法针对老年 IBD 患者进行多地点、基于电子病历 (EMR) 的队列研究，与他们相应的医疗保险索赔基于 EMR 的队列将有助于表型和疾病严重程度。评估以及与医疗保险索赔的联系将增加暴露和结果确定，克服医疗保健分散和随访时间短的挑战中心假设是，老年人。与年轻人相比，其风险状况存在系统性不同，使用生物单一疗法是一种更安全、更安全的方法。与长期单独使用皮质类固醇、非生物制剂相比，这是治疗 IBD 更有效的方法免疫调节剂单一疗法以及生物制剂和免疫调节剂的联合治疗。 pSCANNER 的先进基础设施（以患者为中心的可扩展国家有效性网络）研究），13 个 PCORI 资助的临床数据研究网络之一，以及整个医疗保险数据库，加州大学圣地亚哥分校 (UCSD) 提供高度支持和有利的环境，并由协作者进行跨学科指导以及来自不同背景（临床信息学、比较学）的经验丰富的导师和顾问团队除了直接为临床提供信息外，有效性研究（IBD 治疗）也是该应用的关键优势。老年 IBD 患者治疗方法的实践，该提案将提高 IBD 患者的职业生涯候选人通过提供应用临床信息学、隐私保护记录链接方面的独特技能技术、预测分析和比较有效性研究，并创建一个多机构、EMR- 基于特征明确的 IBD 患者队列，与医疗保险索赔相关联，这最终将有助于候选人的长期目标是建立独立的 IBD 研究生涯，重点关注比较使用基于信息学的新颖方法进行有效性研究和人口健康管理。