Pediatric Heart Network Clinical Research Centers - Boston Children's Hospital

波士顿儿童医院（BCH）的心脏中心（HC）一直是一个热情和富有成效的核心 自2001年成立以来，一直是儿科心脏网络（PHN）的中心。我们在这里展示我们的实力 和能力继续作为PHN核心中心。我们的临床量很大，2015年包括1430例 手术（897例心脏直视手术），1588例导管插入术，23,723例门诊就诊，22,943例超声心动图，以及 > 1，093次心脏MRI。我们的招募在7个PHN中的6个参与中心中处于前四分之一 在本赠款周期内进行的研究，以及在另一个赠款周期内进行的前一半研究。HC参加了83个多中心 该公司负责8个Echo核心实验室，是10项多中心研究的数据协调中心。 在PHN内，自成立以来，我们已经指导了7个成像核心实验室（6个回波，1个MRI）。HC雇用4名 研究护士和24名研究协调员或助理，包括同一名PHN研究护士和PHN 自2005年起担任研究协调员。我们的受试者招募非常出色，在晚上和周末通过 实际上，我们在周六或周日招募了20%的SVR试验受试者。BCH是一个国家 领导集中机构审查委员会的执行工作。我们取消了所有研究成像研究的标识， 开发并提供了新的软件，以去识别从其他中心发送到我们成像的图像 核心实验室。我们在如何利用国家心血管数据库和登记系统方面发挥领导作用， 促进研究，例如，残留病变评分稽查研究确认STS登记数据库的使用 减少协调员的时间。因此，在公共卫生网络地盘评估中，我们获得最高分 PHN研究中心的总体数据质量和及时性（BCH评分为95，中位数为86）。其他体制优势 包括：1）用于将先进生物信息学与临床研究整合的独特资源，例如，使用 采用信息学基础设施（i2 b2/SHRINE），以研究NIH资助的儿科肺 高血压网络（PPHnet）; 2）开发有效的机构审查，研究新模式 管理和研究受试者保护; 3）在成本和价值分析方面的特殊专业知识， 介入和外科CHD手术的性能; 4）开发和应用的创新 诱导多能干细胞（iPSC）用于儿科心脏病; 5）高度发达的安全基础设施 和质量，监测和报告心血管手术特定的质量和安全性的50多个指标， 程序和临床管理。这一基础设施导致了唯一认可的措施（n = 5） 由全国质量论坛制定并由儿科医院提交。在即将到来的赠款期间， 我们将继续致力于PHN，其水平远远超过NIH资金的支持，如前所述 通过我们的PHN“公民评分”，反映PHN在当前资助期内的领导地位（319%）， 是得分第二高的PHN部位（125%）的两倍。总之，BCH具有示例性凭证， 一个PHN核心中心，并坚定不移地致力于PHN正在进行的和未来的研究的成功。

The Heart Center (HC) at Boston Children's Hospital (BCH) has been an enthusiastic and productive Core Center in the Pediatric Heart Network (PHN) since its inception in 2001. We here demonstrate our strengths and capabilities to continue as a PHN Core Center. Our clinical volume is large and in 2015 included 1430 operations (897 open heart), 1588 catheterizations, 23,723 outpatient visits, 22,943 echocardiograms, and >1,093 cardiac MRIs. Our recruitment has been in the top quartile of participating centers for 6 of 7 PHN studies conducted in the current grant cycle, and top half in the other. The HC participates in 83 multicenter trials or registries, directs 8 Echo Core Labs, and is the Data Coordinating Center for 10 multi-center studies. Within the PHN, we have directed 7 imaging Core Labs (6 echo, 1 MRI) since its inception. The HC employs 4 research nurses and 24 research coordinators or assistants, including the same PHN research nurse and PHN study coordinator since 2005. Our subject recruitment is excellent, and available on nights and weekends via a call schedule – in fact, we recruited 20% of SVR trial subjects on Saturdays or Sundays. BCH is a national leader in centralized institutional review board implementation. We de-identify all research imaging studies and developed and made available novel software to de-identify images from other centers sent to our imaging Core Labs. We provide leadership on ways to leverage national cardiovascular databases and registries to facilitate research, e.g., the Residual Lesion Score Audit Study validation of use of the STS registry database to reduce coordinator time. In the PHN Site Assessment, we accordingly received the best score among all PHN sites for overall data quality and timeliness (BCH score 95 vs. median 86). Other institutional strengths include: 1) unique resources for integration of advanced bioinformatics with clinical research, e.g., use of adopted informatics infrastructure (i2b2/SHRINE) to investigators in the NIH-funded Pediatric Pulmonary Hypertension Network (PPHnet); 2) development of efficient new models of institutional review, research administration and study subject protection; 3) special expertise in the analysis of cost and value in the performance of interventional and surgical CHD procedures; 4) innovations in development and application of induced pluripotent stem cells (iPSCs) to pediatric heart disease; 5) highly developed infrastructure in safety and quality that monitors and reports >50 metrics of quality and safety specific to cardiovascular operations, procedures and clinical management. This infrastructure has resulted in the only measures (n = 5) endorsed by the National Quality Forum developed and submitted by a pediatric hospital. In the upcoming grant period, we will continue our commitment to the PHN at a level well beyond that supported by NIH dollars, as indicated by our PHN “Citizenship Score,” reflecting PHN leadership in the current grant period (319%) that is more than twice as high as the next highest scoring PHN site (125%). In summary, BCH has exemplary credentials to be a PHN Core Center and is unwavering in its dedication to the success of the PHN's ongoing and future studies.