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

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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.