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

波士顿儿童医院(BCH)的心脏中心(HC)一直是热情和富有成效的核心 自2001年成立以来，该中心一直是儿科心脏网络(PHN)的一员。我们在这里展示我们的优势 以及继续成为PHN核心中心的能力。我们的诊疗量很大，2015年包括1430个 手术(897例心内直视手术)，1588例导尿术，23,723例门诊，22,943例超声心动图，以及 &gt；1,093个心脏核磁共振成像。我们的招募人员在7个PHN中的6个参与中心中排名前四 研究是在当前的赠款周期进行的，而上半部分是在另一个赠款周期进行的。房委会参与了83个多中心 试验或注册，领导8个Echo核心实验室，是10个多中心研究的数据协调中心。 在PHN内部，自成立以来，我们已经指导了7个成像核心实验室(6个ECHO，1个MRI)。内务委员会雇用4名员工。 研究护士和24名研究协调员或助理，包括同一名初级保健护士和初级保健护士 自2005年起担任研究协调员。我们的科目招聘非常出色，晚上和周末都可以通过 拜访时间表-事实上，我们在周六或周日招募了20%的SVR试验受试者。BCH是一家全国性的 领导集中的机构审查委员会的实施。我们去除了所有研究成像研究的身份 开发并提供新的软件，以识别发送到我们成像中心的其他中心的图像 核心实验室。我们在如何利用国家心血管数据库和登记方面发挥领导作用 促进研究，例如，残留病变评分审计研究对STS登记数据库的使用进行验证 以减少协调人的时间。在PHN现场评估中，我们获得了所有项目中最好的分数 PHN网站的总体数据质量和及时性(BCH得分95分，中位数86分)。其他机构优势 包括：1)先进的生物信息学与临床研究相结合的独特资源，例如，使用 对NIH资助的儿科肺部的研究人员采用信息学基础设施(i2b2/shine) 高血压网络(PPHnet)；2)开发有效的机构审查、研究的新模式 管理和研究课题保护；3)在成本和价值分析方面的专门知识 执行介入和外科CHD程序；4)开发和应用的创新 诱导多能干细胞(IPSCs)用于儿童心脏病；5)高度安全的基础设施 以及监控和报告心血管手术特有的50项质量和安全指标的质量， 程序和临床管理。这一基础设施已导致批准的唯一措施(n=5) 由一家儿科医院开发并提交的全国质量论坛。在即将到来的赠款期间， 我们将继续我们对PHN的承诺，远远超过NIH资金支持的水平 根据我们的PHN“公民身份评分”，反映PHN在当前授权期内的领导力(319%)超过 是得分第二高的PHN网站(125%)的两倍。总而言之，BCH拥有值得效仿的证书 该中心是PHN的核心中心，并坚定不移地致力于PHN正在进行和未来的研究取得成功。

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.