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participate in quarterly collaborative learning meetings noted for unblinding hospital performance data [ 5 ].
In 2014, with no current congenital cardiopulmonary bypass( CPB) registries, various experts within the congenital perfusion community and leaders from the PERForm registry began working to develop a pediatric perfusion registry. From this work, the PediPERForm Learning Network( PLN) and its associated congenital perfusion registry became active. They began collecting data in October 2021 where real time data and clinical questions can be addressed immediately. PLN became the American Society of Extracorporeal Technology’ s official societal partner in 2021 which facilitates cooperation and professional development between the two organizations.
Description
A workgroup of 10 – 20 congenital perfusionists across the US, Europe, and Australia began regularly set conference calls to develop the congenital registry and decided on six areas of focus: Anticoagulation, equipment usage and circuit selection, fluid balance, prime constituents, laboratory values( e. g., hematocrit, lactates, and creatinine), and blood product usage( Table 1). Field definitions and data specifications were defined and agreed upon by the workgroup. Furthermore, when applicable, the definitions were harmonized with the STS-CHSD and Adult PERForm registries. Over 130 data definitions were documented. Subsequently, the data collection instrument was tested at four pediatric centers within the workgroup, iteratively enhancing the rigor of our approach through feedback from our contributing members.
To support the interdisciplinary nature of the intended work, facilitate ease of implementation, reduce start-up costs, and take advantage of a great deal of experience and expertise [ 6 ], the decision was made to partner with the Pediatric Cardiac Critical Care Consortium( PC 4) under the collaboration umbrella of Cardiac Networks United( CNU). PC 4 was instrumental to the development of PLN by providing expert opinions on PLN’ s framework, sharing Institutional Review Boards( IRBs), and sharing of data managers and data management. This strategic partnership also allows for sharing of longitudinal data across registries through established regulatory pathways at participating institutions.
PLN governance consists of three organizational committees. The Executive Committee comprises at least seven members, including the PLN Co-Directors, the Scientific Review( SRC) and Quality Improvement( QIC) committee chairs, and three at-large members. Duties of the Executive Committee include general oversight and strategic direction of the network, the development, maintenance, and optimization of organizational partnerships, minimization of redundancy and data integration across CNU registries, periodic evaluation, and modification of data fields and definitions, providing the SRC and QIC committees with guidance and direction, and assist the SRC and QIC decision making when necessary and appropriate.
PLN’ s SRC consists of the SRC Chair, one representative from AmSECT’ s Quality Improvement Committee, one representative from AmSECT’ s Pediatric and Congenital Perfusion
Committee, and two to four at large members from PLN participating centers. Duties of the SRC include review, acceptance, or feedback to data and research requests utilizing PLN data.
The QIC consists of standing members, including the QIC Chair, representation from AmSECT’ s Quality Improvement Committee, representation from AmSECT’ s Pediatric and Congenital Perfusion Committee, and one ad hoc representative from each member institution. Duties of the QIC include identifying variations in practice, development, and dissemination of quality improvement projects aimed to improve care during pediatric and congenital CPB.
Data may be entered into the PLN registry using three software solutions. CardioAccess( Fort Lauderdale, Florida) and Lumedx( Interlad Medical Systems, Montreal, Quebec) are two software programs designed for data collection for the STS and other cardiac-related registries. CardioAccess and Lumedx have PLN modules and extract data fields from other modules in the STS software. Alternatively, a hospital may develop its data entry software. All three options require software validation by PLN leadership. PLN records are then submitted to Arbormetrix’ s( Ann Arbor, Michigan) live reporting dashboard within one month of the date of surgery. The reporting platform is separated into eight categories: Equipment, Blood Products, Prime, Fluid Management, Lab Parameters, Case Mix, Cardiopulmonary Bypass, and Data Quality. These categories are further broken down into Blinded Site Comparison, Perfusionist Comparison, and Institutional reports within the Arbormetrix live dashboard( Table 2).
To maintain data privacy, the Blinded Site Comparison report enables authorized users to identify their centers, with the identification of other centers masked through a centrally maintained and secured blinded identifier. The Institutional reports allow participating centers to evaluate trends in their data and in the Perfusionist Comparison reports, centers may view their institutions’ perfusionist data too. Reports and fields may be filtered by the surgeon, perfusionist, anesthesiologist, date range, six age categories, eight weight groups, five STAT rankings, primary benchmark procedures, deep hypothermic circulatory arrest use, and five lengths of bypass time periods( Table 3). The data is harvested monthly from Arbormetrix to the PC 4 Data Coordinating Center at the University of Michigan. Requests for data interpretation and statistical analysis for research and quality projects are performed by PLN’ s data coordinators.
By design, each participating institution designates a clinical champion tasked with managing their center’ s data entry and accuracy, facilitating all regulatory and contractual matters, and coordinating mandatory audit procedures at their institution. This clinical champion also provides their center with informative data such as benchmarking information comparing their site to the rest of PLN and internal performance data. It handles personnel changes in the registry fields. Institutional members must also be active members in PC 4( contracting with the University of Michigan, PLN is considered a module of PC 4) and obtain IRB approval or exemption prior to data submission. Adherence to these participation requirements allows the institution access to benchmarking data, structured reports,