Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) renewal

青少年减肥手术纵向评估 (Teen-LABS) 更新

• 批准号: 8927611
• 负责人: THOMAS HARRIS INGE
• 金额: $ 111.83万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-23 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8927611
• 关键词: Achievement; Acute; Address; Adolescence; Adolescent; Adult; Affect; Age; Ancillary Study; Area; Bariatrics; Basic Science; Benefits and Risks; Body Weight decreased; Caregivers; Characteristics; Child; Childhood; Clinical; Collection; Communities; Comorbidity; DNA; Data; Data Collection; Data Coordinating Center; Development; Discipline; Effectiveness; Enrollment; Evaluation; Evolution; Family dynamics; Fostering; Functional disorder; Funding; Future; Goals; Grant; Health; Hybrids; Instruction; Liver; Longitudinal Studies; Medical center; Morbid Obesity; National Institute of Diabetes and Digestive and Kidney Diseases; Nutritional; Obesity; Operative Surgical Procedures; Outcome; Outcome Study; Participant; Patients; Peer Review; Phase; Phenotype; Physical activity; Physiological; Plasma; Procedures; Process; Protocols documentation; Publications; Recruitment Activity; Research; Research Design; Research Infrastructure; Research Personnel; Resolution; Risk; Safety; Sampling; Schedule; Scientist; Self Perception; Severities; Site; Specimen; Staging; Study Subject; Subgroup; System; Teenagers; Time; Tissues; Urine; Youth; age group; bariatric surgery; base; care delivery; clinical decision-making; clinically significant; cohort; cost; dissemination research; early onset; evidence base; falls; follow-up; high risk; obesity in children; patient population; programs; psychosocial; repository; research study; response; treatment effect; working group

2006 as an ancillary study to the Longitudinal Assessment of Bariatric Surgery (LABS) study. Long range goals are to detail the outcomes of bariatric surgery in youth over multiple decades including multigenerational effects of treatment. The immediate goals are to address important gaps in our understanding of the impact of early onset obesity and the efficacy and safety of bariatric surgery in adolescents compared to adults. The primary achievements of Teen-LABS during the first funding cycle include; 1. establishment of a strong collaborative multi-institutional working group of investigators committed to Teen-LABS, 2. defining the principal domains of the study, building on the study design of the LABS consortium, 3. establishing a functional research infrastructure including multiple committees and a data coordinating center, 4. enrollment, as of January 31, 2011, of 83% of the planned 250 adolescent and caregiver participants, 5. initiating a 2 year outcomes study, 6. supporting the needs of 11 Teen-LABS ancillary and 4 substudies. In addition to documenting the immediate trajectories of weight loss, acute changes in comorbidities, and safety of bariatric procedures in adolescents over 2 years, a thorough examination of the durability and consequences of surgery beyond 2 years will address a major gap in our understanding of the long term outcome of bariatric surgery in this high risk group of patients. In the next 5 years, the consortium will concentrate on scientifically critical research questions that cannot be addressed with the limited follow-up that currently exists. In the renewal period, Teen-LABS will examine mid- and longer-term outcomes. An extension will permit Teen-LABS to continue to collect follow-up data in parallel with the LABS consortium, now already in their second funding cycle. Teen-LABS will be expanded and establish new relationships with experts in other disciplines to permit the evaluation of myriad emerging effects of surgery in a vulnerable patient population, as well as effects that change over time, and determine whether the response to surgery in adolescent age groups differs from adults. The research approach in this proposal will focus on 1) retention strategies that will maintain the cohort, insuring availability for longer term study and 2) dissemination of research findings from baseline characterization and early outcomes. An extension of Teen-LABS will build on the already productive five center research network, representing several care delivery systems and patient populations. Teen-LABS enrolls from four academic pediatric medical centers with dedicated adolescent bariatric programs and one adult academic center with a hybrid adult-adolescent bariatric program that jointly serves as a LABS/Teen-LABS site. We have collaboratively assembled a well-phenotyped adolescent cohort with a range of patient characteristics, and undergoing state of-the-art surgical procedures. The critical scientific strengths of the multicenter Teen-LABS consortium include a diverse participant base to insure generalizability of findings, the ability to recruit a large number of subjects including important subgroups, the use of an existing research infrastructure with meticulous and high quality baseline and follow-up data collection practices, and an outstanding group of clinician scientists who continues to contribute greatly to the interpretation of the findings from the studies. The data coordinating center will continue to insure very high levels of data accuracy and completeness so that the investigators will be able to produce a long list of publications addressing important research questions with clinical significance. This proposal describes the process by which the Teen-LABS study was initiated, the consortium's progress to date, and provides our goals for the next five years of study.

2006年作为减肥手术纵向评估（LABS）研究的辅助研究。长期目标是详细说明数十年来青少年减肥手术的结果，包括治疗的多代效应。近期目标是解决我们对早发性肥胖的影响以及与成人相比青少年减肥手术的有效性和安全性的理解方面的重要差距。在第一个供资周期内，Teen-LABS的主要成就包括：1。建立一个强有力的合作多机构工作组的调查人员致力于青少年实验室，2。定义研究的主要领域，建立在LABS联盟的研究设计基础上，3.建立包括多个委员会和数据协调中心的功能性研究基础设施，4.截至2011年1月31日，计划招募250名青少年和护理人员参与者中的83%，5.开始为期2年的结果研究，6.支持11项Teen-LABS辅助研究和4项子研究的需求。除了记录体重减轻的即时轨迹，合并症的急性变化，以及2年以上青少年减肥手术的安全性外，对2年以上手术的持久性和后果的彻底检查将解决我们对这一高风险患者组减肥手术长期结局的理解中的主要差距。在未来5年内，该联盟将专注于目前存在的有限后续行动无法解决的科学关键研究问题。在更新期间，Teen-LABS将检查中期和长期结果。延期将使Teen-LABS能够继续与LABS联盟并行收集后续数据，该联盟现已进入第二个供资周期。Teen-LABS将扩大并与其他学科的专家建立新的关系，以允许评估脆弱患者人群中手术的无数新兴影响，以及随时间变化的影响，并确定青少年年龄组对手术的反应是否与成人不同。本提案中的研究方法将侧重于：1）保持队列的保留策略，确保长期研究的可用性; 2）传播基线表征和早期结局的研究结果。Teen-LABS的扩展将建立在已经富有成效的五个中心研究网络的基础上，代表几个医疗服务系统和患者群体。青少年实验室从四个学术儿科医学中心招收专门的青少年减肥计划和一个成人学术中心与混合成人青少年减肥计划，共同作为一个实验室/青少年实验室网站。我们合作组建了一个具有一系列患者特征的表型良好的青少年队列，并接受了最先进的外科手术。多中心Teen-LABS联盟的关键科学优势包括多样化的参与者基础，以确保研究结果的普遍性，招募大量受试者（包括重要亚组）的能力，使用现有的研究基础设施以及细致和高质量的基线和随访数据收集实践，以及一群杰出的临床科学家，他们继续为解释研究结果做出巨大贡献。数据协调中心将继续确保非常高水平的数据准确性和完整性，以便研究者能够编制一长串解决具有临床意义的重要研究问题的出版物。该提案描述了Teen-LABS研究启动的过程，该联盟迄今为止的进展，并提供了我们未来五年的研究目标。