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

2006年作为减肥手术纵向评估（实验室）研究的辅助研究。长期目标是详细描述几十年来青少年减肥手术的结果，包括治疗的多代效应。当前的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上的重要差距。青少年实验室在第一个资助周期的主要成就包括：1. 2.建立一个强大的多机构合作研究小组，致力于青少年实验室；2 .定义研究的主要领域，以实验室联盟的研究设计为基础；3 .建立包括多个委员会和数据协调中心在内的功能性研究基础设施；截至2011年1月31日，计划的250名青少年和照顾者参与者中有83%的人报名参加。启动一项为期2年的结果研究；支持11个青少年实验室辅助研究和4个子研究的需求。除了记录2年以上青少年体重减轻的直接轨迹、合共病的急性变化和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群体减肥手术长期结果的理解中的一个主要差距。在未来5年，该联盟将专注于目前有限的随访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。延期将允许Teen-LABS继续收集后续数据，与实验室联盟并行，现在已经进入第二个资助周期。青少年实验室将扩大规模，并与其他学科的专家建立新的关系，以便对易受伤害的患者群体中出现的无数手术效果以及随时间变化的效果进行评估，并确定青少年群体对手术的反应是否与成年人不同。本提案中的研究方法将侧重于：1)保留策略，以维持队列，确保长期研究的可用性；2)传播基线特征和早期结果的研究成果。Teen-LABS的扩展将建立在已经富有成效的五个中心研究网络上，代表几个护理提供系统和患者群体。青少年实验室招收了来自四个学术儿科医学中心的青少年减肥项目和一个成人学术中心的成人-青少年混合减肥项目，该中心共同作为实验室/青少年实验室网站。我们合作组装了一个具有一系列患者特征的表型良好的青少年队列，并进行了最先进的外科手术。多中心青少年实验室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；招募包括重要亚组在内的大量受试者的能力；利用现有的研究基础设施，以细致和高质量的基线和后续数据收集实践，还有一群杰出的临床科学家，他们继续为研究结果的解释做出巨大贡献。数据协调中心将继续确保高水平的数据准确性和完整性，以便研究人员能够产生一长串的出版物，解决具有临床意义的重要研究问题。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。

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.