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: 8332935
• 负责人: THOMAS HARRIS INGE
• 金额: $ 112.82万
• 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/8332935
• 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; Commit; 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; 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几十年来青少年减肥手术的结果，包括治疗的多代影响。眼前的目标是解决我们对早发性肥胖的影响以及青少年减肥手术与成人相比的有效性和安全性的理解方面的重要差距。青少年实验室在第一个资助周期中的主要成就包括：1.建立一个致力于青少年实验室的强大的协作多机构调查工作组，2.确定研究的主要领域，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的功能性研究基础设施，4.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%的人登记，5.启动一项为期2年的结果研究，6.支持11个青少年实验室附属研究和4个子研究的需求。除了记录超过两年的青少年减肥手术的即时减肥轨迹、合并症的急性变化和安全性外，对超过两年的手术的持久性和后果的彻底检查将解决我们对减肥手术在这一高危患者群体中的长期结果的理解中的一个主要差距。在接下来的5年里，该联盟将专注于科学上的关键研究问题，这些问题不是目前存在的有限后续行动所能解决的。在续展期间，青少年实验室将检查中期和长期结果。延期将允许Teen-Labs继续与实验室联盟并行收集后续数据，目前已处于第二个资助周期。青少年实验室将扩大，并与其他学科的专家建立新的关系，以评估手术对脆弱患者群体的无数新影响，以及随时间变化的影响，并确定青少年年龄段对手术的反应是否与成年人不同。这项建议中的研究方法将侧重于1)保持队列的保留战略，确保长期研究的可用性，以及2)从基线特征和早期结果传播研究结果。青少年实验室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，代表几个护理提供系统和患者群体。青少年实验室来自四个学术儿科医疗中心和一个成人学术中心，前者拥有专门的青少年减肥计划，后者拥有成人和青少年混合减肥计划，共同充当实验室/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。多中心青少年实验室联盟的关键科学优势包括确保研究结果的普适性的多样化参与者基础，招募包括重要亚组在内的大量受试者的能力，使用具有细致和高质量的基线和后续数据收集实践的现有研究基础设施，以及继续为解释研究结果做出巨大贡献的杰出临床科学家团队。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，以便研究人员能够制作一份长长的出版物清单，解决具有临床意义的重要研究问题。这份提案描述了青少年实验室研究的启动过程，联盟到目前为止的进展，并提供了我们未来五年研究的目标。