Cardiac Neurodevelopmental Outcome Collaborative: founding period, vision, and mission

A confluence of two events resulted in the development of the Cardiac Neurodevelopmental Outcome Collaborative. In 2012, a multi-disciplinary group from the paediatric cardiovascular and developmental scientific and clinical communities published the American Heart Association and American Academy of Pediatrics Scientific Statement entitled, “Neurodevelopmental Outcomes in Children with Congenital Heart Disease: Evaluation and Management,”^{Reference Marino, Lipkin and Newburger5} and the first Cardiac Neurodevelopmental Symposium was held at Boston Children’s Hospital. Leaders of these two novel accomplishments determined there remained a gap in understanding the best practices in neurodevelopmental and psychosocial services for individuals and their families with paediatric and congenital heart disease. Furthermore, innovative clinical, quality improvement, and research opportunities with collaboration across multiple disciplines and institutions were needed to address these gaps.

Out of the first Cardiac Neurodevelopmental Symposium a founding steering committee was formed, composed of multi-disciplinary leaders from paediatric cardiology, cardiothoracic surgery, anaesthesia, cardiac nursing, psychology, neuropsychology, developmental pediatrics, neurology, critical care pediatrics, epidemiology and biostatistics, and cardiovascular research. This leadership group created three focussed multi-disciplinary working groups tasked with Cross-site Collaboration, Infant/Toddler Assessment and Management, and School-age Assessment and Management. Over the next few years, the Infant/Toddler and School-age working groups worked to define recommended neurodevelopmental test batteries for each age group to facilitate cross-site collaboration (see Ware et al and Ilardi and colleagues., this issue).

The Cardiac Neurodevelopmental Outcome Collaborative was incorporated in the state of Michigan in October, 2015. The founding Steering Committee approved the Bylaws in April, 2016, and the Cardiac Neurodevelopmental Outcome Collaborative received IRS 501c3 status designation in October, 2016. The first multi-disciplinary Elected Officials and Steering Committee assumed office in the summer 2016. At its inception, 28 institutional partners from North America and Europe joined the Collaborative to work together to prevent neurologic injury and improve the neurodevelopmental and psychosocial outcomes and health-related quality of life of our high-risk paediatric cardiac population.

Vision, mission, structure, function, and partnerships

The “Vision” and “Mission” of the Cardiac Neurodevelopmental Outcome Collaborative are detailed in Figure 1. The Executive Committee of the inaugural Steering Committee initially designed and populated a slate of Standing Committees (Fig 1). Each Standing Committee’s responsibilities and goals are outlined in the bylaws and are summarised in Table 1. The Steering Committee presides over and ensures that the activities of the standing committees and cores are in alignment with the Collaborative’s vision, mission, and goals. Standing Committees were populated through a competitive application process and each include patients and/or caregivers to promote their perspectives in all of the Collaborative’s endeavours. The Community Outreach Standing Committee is chaired by two patients and/or caregivers, who also serve as voting Patient/Caregiver Representatives on the Steering Committee.

Figure 1.

Vision and Mission of the Cardiac Neurodevelopmental Outcome Collaborative.

Table 1.

Standing committees responsibilities, goals, and close collaborators

Once formed, each Standing Committee focussed on their role in forwarding the mission and vision (Fig 1) of the Cardiac Neurodevelopmental Outcome Collaborative. The Research and the Database Committees were tasked with identifying the data collection for the clinical registry while balancing the breadth of data that would be of interest with the logistics of effort required by sites. Similarly, representatives from the Research, Quality Improvement, and Database Committees met frequently with members of the Executive Committee to clarify the role and content of the database, how data entry would occur, how data quality would be optimised, how data would be analysed, and how pertinent data would be made available to the member centres. The discussion ultimately led to prioritising funding and releasing requests for applications for three cores: a Neurodevelopmental Core Lab to support the testing approach of member centres and ensure the quality and fidelity of neurodevelopmental data collection; a Data Coordinating Centre to manage and ensure the quality of the clinical data registry; and, a Data Analysis Core to conduct data and statistical analyses. With the establishment of these cores, a representative from each was asked to join the Steering Committee.

Once the Steering Committee was established with representatives from the Executive Committee, Standing Committees, and Core labs (Fig 2), committee members drafted a Manual of Operations including information related to neurodevelopmental testing, steps to contribute to the registry, and outlining how individual members can initiate research and quality improvement projects in concert with the registry. To optimise efficiency and accuracy of data collection, the Collaborative partnered with Cardiac Networks United, a collaboration of quality improvement registries that currently includes the Pediatric Cardiac Critical Care Consortium, Pediatric Acute Care Cardiology Collaborative, National Pediatric Cardiology Quality Improvement Collaborative, and Advanced Cardiac Therapies Improving Outcomes Network, and also with ArborMetrix, a healthcare technology company. Enhancing efficiency, the Cardiac Neurodevelopmental Outcome Collaborative data registry launched as a module of the Pediatric Cardiac Critical Care Consortium registry in May 2019. Each site has real time access to their own data and quality improvement metrics in a dashboard provided by ArborMetrix. The Data Coordinating Centre and Neurodevelopmental Core lab work collaboratively to ensure the accuracy and fidelity of the data (Fig 3). The Data Coordinating Centre will also be developing a separate data entry portal for sites that are not members of Pediatric Cardiac Critical Care Consortium.

Figure 2.

Current Cardiac Neurodevelopmental Outcome Collaborative Steering Committee organisational structure.

Figure 3.

Data management and analysis flow chart.

Collaborative approach to defining the agenda for research and quality improvement

The Cardiac Neurodevelopmental Outcome Collaborative endeavoured in 2018 to summarise the state of the field and define the cardiac neurodevelopmental research and quality improvement agenda for the next decade by bringing together a multi-disciplinary, multi-national group of experts and patient/caregiver stakeholders for a two-day pre-meeting in advance of its annual scientific sessions. The effort was supported by an R13 grant from the National Heart, Lung, and Blood Institute in collaboration with the Ann & Robert H. Lurie Children’s Hospital of Chicago, and harnessed the knowledge and expertise of over 60 cardiac neurodevelopmental research and clinical leaders from more than 10 disciplines, experts in quality improvement science and health disparities, patients and parents to identify significant gaps in knowledge and critical questions that must be answered to advance neurodevelopmental care and outcomes.

Six multi-disciplinary working groups (each 10–12 members including patient, parents, and experts in health disparities) were formed corresponding with key domains of neurodevelopmental care and outcomes: Foetal Brain Development and Neuroprotection; Surgical/Perioperative Neuroprotection and Neurodevelopment; Characterisation of Neurodevelopmental and Psychological Outcomes; Neurodevelopmental and Psychosocial Intervention; Parent Mental Health and Family Functioning; and Neurodevelopmental Outreach, Education, and Advocacy. Results and recommendations based on this work will be disseminated through a series of manuscripts in an upcoming issue of Cardiology in the Young, and will guide the Collaborative’s investigational aims for years to come. In fact, Cardiology in the Young and the Cardiac Neurodevelopmental Outcome Collaborative are also pleased to announce that Cardiology in the Young will serve as the official journal of the Cardiac Neurodevelopmental Outcome Collaborative.

Current state and future goals

The Cardiac Neurodevelopmental Outcome Collaborative is currently in an exciting growth phase. Institutional membership has increased each year, and in 2020, there were 41 institutional members, primarily from North America (www.cardiacneuro.org). The 8th Annual Scientific Sessions of the Cardiac Neurodevelopmental Outcome Collaborative, held in 2019 in Toronto, Canada, was the largest meeting to date, with over 300 multi-disciplinary attendees. Since the registry platform launched in May, 2019, sites have entered data from neurodevelopmental evaluations for infants, toddlers, and preschool-age children, and a module for capturing data from school-age children is scheduled to launch in 2020. Through collaborations within Cardiac Networks United, investigators will be able to answer important questions efficiently from a broad multicentre perspective and with decreased reliance on costly and perhaps less representative single-centre clinical trials. With the growth of quality improvement registries, transparent collaboration alone can lead to improved outcomes and the ability to conduct trials within a registry may also be feasible. ^{Reference Clauss, Anderson and Lannon41–Reference Gaies, Pasquali and Banerjee47}

We anticipate that the Cardiac Neurodevelopmental Outcome Collaborative will benefit its member institutions by improving neurodevelopmental and psychosocial outcomes at the lowest cost, maximising patient and family experience, and facilitating a fully integrated service network of allied professionals including medical, mental health, education, and habilitative service providers. The Neurodevelopmental Core Lab, in collaboration with the Education and Training Committee, will continue to develop the initial work of the School Age and Infant/Toddler Working groups with the goal of developing and refining approaches to evaluation and management within member institutions. Through the network of leaders within the Collaborative, mentorship to developing programs related to navigating administrative and funding barriers is available. The scientific, clinical, and quality improvement information generated by the Collaborative will be critical for demonstrating value-added to payers (governmental and private). The Collaborative also will generate critical data that may be linked to other paediatric cardiovascular databases to create next generation critical predictor and longitudinal outcomes data across childhood and adolescence, and ultimately into adulthood. The information generated by the Collaborative will be critical to patients, parents, medical caregivers, medical institutions and health systems, and state and national health policy leaders.