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.

项目摘要/摘要老年人（≥65岁）中炎症性肠病（IBD）的患病率正在上升，并且有限基于循证治疗这些老年人的指南。在多发病的老年患者中，治疗决策不仅应考虑疾病并发症的风险，而且还应考虑治疗并发症和非IBD的风险肠外并发症。因此，为了告知最佳治疗方法，对有必要对不同疗法对所有这些结果的比较影响。现有的单中心观察性研究受到样本量较小的限制，由于医疗保健碎片而导致的数据缺失，而基于行政索赔的研究受到缺乏详细临床数据的限制；这些限制可以通过链接两个数据源来克服。在这个以患者为导向的Mendored职业发展奖中提案，Siddharth Singh博士提议：（ AIM＃1.1）表征疾病伯恩和治疗方式，（AIM＃1.2）使用并预测使用使用机器学习算法和（AIM＃2.1）比较总体效率和（AIM＃2.2）不同的安全性 IBD老年患者的治疗策略。这将使用高度创新的信息来研究与IBD老年患者的基于多站点的电子病历（EMR）同类的方法他们相应的Medicare主张。基于EMR的队列将促进表型和疾病的严重程度评估以及与Medicare索赔的联系将增加暴露和结果确定，克服医疗保健分裂和短期随访的挑战。中心假设是，老年人与年轻人有系统的风险特征在系统上不同，并且使用生物学单一疗法更安全，并且与仅使用长期皮质类固醇相比，更有效的治疗IBD的方法，非生物学免疫调节剂单一疗法以及生物制剂和免疫调节剂的联合疗法。访问 PSCANNER的先进基础设施（以患者为中心的可伸缩国家有效性研究），13个PCORI资助的临床数据研究网络之一，以及整个Medicare数据库在UCSD上高度支持和进行环境，并通过协作跨学科的心态以及来自潜水员背景的导师和顾问的经验丰富的团队（临床信息，比较有效性研究，IBD疗法）是该应用的关键优势。除了直接通知临床 IBD老年患者的治疗方法练习，该建议将增强通过在应用临床信息中提供独特的技能，保护隐私的记录联系，候选人技术，预测分析和比较有效性研究，并创建了多个机构的EMR- 基于特征良好的IBD患者的同类，与Medicare主张有关。这最终将有助于候选人的长期目标是建立独立的IBD研究职业，专注于比较有效性研究和人口健康管理采用新颖的基于信息的方法。