East Carolina University Bariatric Surgery Clinical Center

东卡罗莱纳大学减肥外科临床中心

• 批准号: 8317685
• 负责人: WALTER Julius PORIES
• 金额: $ 44.97万
• 依托单位: EAST CAROLINA UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2003
• 资助国家: 美国
• 起止时间: 2003-09-30 至 2014-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8317685
• 关键词: Achievement; Address; African American; Age; Characteristics; Clinical; Community Hospitals; Data; Data Collection; Data Element; Databases; Enrollment; Genetic Markers; Hispanics; Individual; Instruction; Link; Metabolism; Metric; Obesity; Operative Surgical Procedures; Outcome; Participant; Patients; Population; Process; Recruitment Activity; Research Infrastructure; Serological; Site; Subgroup; Surgeon; System; Time; Universities; Vital Status; bariatric surgery; care delivery; clinical care; clinical research site; cohort; economic outcome; follow-up; health economics; male; operation; patient population; psychosocial

LABS was conceived to address important issues in bariatric surgery and metabolism in the obese and morbidly obese. LABS aims to explore relationships of patient characteristics, clinical conditions, serologic and genetic markers, process of care, and clinical, psychosocial and health economic outcomes. The primary achievements of LABS in its first 5 years have been to define the domains of exploration, identify appropriate metrics and enroll 5105 participants in LABS land achieve vital status data for 99% due for at 30 days post-surgery. In addition, 1947 participants in LABS 2 have been recruited with data collected for 91% for 6 months follow-up. An extension of LABS would build on the rigorous research infrastructure across 10 clinical sites at the 6 clinical centers representing several care delivery systems and patient populations. LABS enrolls patients from 6 academic and 4 community hospitals undergoing operations by 33 surgeons. These sites have created a cohort with considerable diversity of important patient characteristics. LABS includes 21% males (range across sites 16% to 32%), 9% Black/African-Americans (range 0% to 24%), 7% Hispanics (range 1% to 16%), 10% age 60+ years (range 5%-18%), and 10% BMI 60+ kg/m2 (range 6% to 27%). These features have been linked to short and long-term outcomes and represent critical subgroups that have not been adequately characterized because they appear infrequently in most single-center cohorts. Importantly, the diversity across sites is more likely to represent the bariatric surgery population in the U.S. than would be possible from any individual site. RELEVANCE (See Instructions): Critical scientific advantages of the multi-center LABS consortium compared to single-center studies include: 1) The ability to recruit a larger number of patients, in a comparable, or shorter, period of time and 2) A research infrastructure with rigorous data collection practices, high levels of data accuracy and completeness, rigorous follow-up, and a comprehensive database of clearly defined data elements.

LABS的构想是为了解决肥胖症患者的减肥手术和代谢中的重要问题， 病态的肥胖LABS旨在探索患者特征、临床状况、血清学 和遗传标记，护理过程，以及临床，心理社会和卫生经济结果。的 LABS在其头5年的主要成就是确定了勘探领域，识别了 适当的指标，并在实验室招募5105名参与者，在30岁时达到99%的生命状态数据 手术后几天。此外，LABS 2招募了1947名参与者，收集了91%的数据 随访6个月。 实验室的扩展将建立在6个临床研究中心的严格研究基础设施之上。 代表几个护理提供系统和患者群体的临床中心。实验室招募患者 来自6所学术医院和4所社区医院的33名外科医生正在进行手术。这些网站有 创建了一个具有相当多的重要患者特征的队列。LABS包括21%的男性 （各研究中心的范围为16%至32%）、9%黑人/非洲裔美国人（范围为0%至24%）、7%西班牙裔美国人（范围为1% 10%年龄60+岁（范围5%-18%），10% BMI 60 + kg/m2（范围6%-27%）。这些特征 与短期和长期结果有关，代表了尚未被纳入研究的关键亚组。 充分表征，因为它们在大多数单中心队列中很少出现。重要的是 不同研究中心的差异更可能代表美国的减肥手术人群， 任何一个单独的网站都可以。 相关性（见说明）： 与单中心研究相比，多中心实验室联盟的关键科学优势包括： 1)在相当或更短的时间内招募更多患者的能力，以及2）A 研究基础设施，具有严格的数据收集实践，高水平的数据准确性， 完整性、严格的后续行动以及明确定义的数据元素的综合数据库。