Continuation of the Longitudinal Assessment of Bariatric Surgery (LABS) - DCC

描述(由申请人提供)： 实验室旨在解决成人减肥手术和新陈代谢方面的重要问题，探索患者特征、临床条件、血清和遗传标记以及临床、心理社会和健康经济结果之间的关系。实验室的主要成就是建立了一个研究联盟及其基础设施；确定了探索领域、具体的研究问题和有效的研究设计，以有效地解决这些问题；确定了适当的衡量标准；设计和实施了一个基于网络的数据收集系统和一个广泛的数据库；完成了5000多名参与者的队列，以研究减肥手术的短期安全性；招募了大约2000名参与者参加旨在解决长期安全性和有效性的2400人队列；并实施了2项子研究。数据协调中心(DCC)提供后勤和行政支持以及数据库管理、网站建设和维护、计算机系统、流行病学、生物统计学和方法学方面的专业知识。在这次拟议的实验室续建期间，DCC将继续在研究设计、实施、分析、后勤和管理的各个方面为该联盟提供支持。这包括维护分布式数据录入和数据库管理系统；与NIDDK支持的生物显微镜和数据储存库保持联系；必要时与中心实验室签订分包合同；在活组织标本跟踪和数据收集方面协助研究病理学家；维护和改进具有公共、私人、参与者和系统区域的研究网站；向临床中心、NIDDK项目科学家、委员会和小组委员会、中央设施和数据与安全监测委员会(DSMB)提供后勤支持；分析和报告研究结果，以更好地向研究人员和公众通报减肥手术后的长期结果。 肥胖是一个主要的公共健康问题，预计未来还会增加。减肥手术是目前最有效的长期治疗方法。这个多中心联盟的创建是为了“促进……减肥外科的临床、流行病学和行为研究的协调”。数据协调中心提供后勤和科学支持，并开发核心数据库。

DESCRIPTION (provided by applicant): LABS was conceived to address important issues in bariatric surgery and metabolism in adults, exploring relationships of patient characteristics, clinical conditions, serologic and genetic markers, and clinical, psychosocial and health economic outcomes. The primary achievements of LABS have been establishing a research consortium and its infrastructure; defining domains of exploration, specific research questions and an effective study design to efficiently address those questions; identifying appropriate metrics; designing and implementing a web-based data collection system and an extensive database; completing a cohort of over 5000 participants to study the short-term safety of bariatric surgery; enrolling approximately 2000 participants into a 2400 person cohort intended to address longer term safety and efficacy; and implementing 2 substudies. The Data Coordinating Center (DCC) provides logistical and administrative support and expertise in database management, website construction and maintenance, computer systems, epidemiology, biostatistics, and methodology. During this proposed continuation of LABS, the DCC will continue to support the consortium in all aspects of study design, conduct, analysis, logistics, and administration. This includes maintaining the distributed data entry and database management systems; maintaining contact with the NIDDK-supported biospecimen and data repositories; administering a subcontract with a Central Laboratory if necessary; assisting the study pathologist with respect to biopsy specimen tracking and data collection; maintaining and improving the study website that has public, private, participant and systems areas; providing logistical support to the Clinical Centers, NIDDK Project Scientist, committees and subcommittees, central facilities, and Data and Safety Monitoring Board (DSMB); and analyzing and reporting study results to better inform the research and public communities regarding long-term outcomes following bariatric surgery. Obesity is a major public health problem expected to increase in the future. Bariatric surgery is currently the most effective long term therapy. This multi-center consortium was created to "facilitate coordinated clinical, epidemiological, and behavioral research in...bariatric surgery". The data coordinating center provides logistical and scientific support, and developed the core database.