While interest in learning system development permeates many academic institutions, actualizing these systems oftentimes requires the cultivation of professional relationships and extensive networks over long timeframes.8 Driven by national urgency from the COVID-19 pandemic, the evolution of the UAB COVID-19 CORE progressed rapidly, spanning approximately 6 weeks from initial development until the number of network contributors doubled (Figure 2). This growth was driven by targeted recruitment of key stakeholders as well as an open invitation for anyone interested to join this initiative. Contributors to the UAB COVID-19 CORE are organized and recruited according to the engines and components of the LHS framework, ensuring that each component is well represented and providing diverse perspectives for larger contributions within the system.

3.1 The learning engine: UAB Medicine

As the cornerstone of the UAB Health System, UAB Medicine provides comprehensive primary and subspecialty care services with over 90 000 hospital discharges and 1.6 million outpatient visits annually.15 Established in 1945, UAB Hospital is a level 1 trauma center with over 1100 beds located in Birmingham, Alabama. From the outset of the pandemic, COVID-19 CORE participation included front-line providers and clinical leaders representing contributors within the learning engine. Thus, providers directly engaged in the provision of COVID-19 testing and treatment serve as drivers of the UAB Medicine Learning Engine by contributing essential insights into variations of clinical practice associated with COVID-19, highlighting high-priority research questions, and suggesting options of data collection from within the clinical environment.16

3.2 The research engine: Center for Outcomes and Effectiveness Research and Education and Center for Clinical and Translational Sciences

The UAB Center for Outcomes and Effectiveness Research and Education (COERE) and Center for Clinical and Translational Sciences (CCTS) afforded extant infrastructure and interdisciplinary expertise to support the UAB Research Engine. These research centers developed collaborative relationships between investigators within the university and health system representing medical informatics, regulation and compliance, biostatistics, epidemiology, and research design resources. The research engine allowed for dissemination and widespread communication of emerging evidence throughout the university.

3.3 Seven organizational components 3.3.1 Organization and collaborations component: Executive leadership committee

The COVID-19 CORE Executive Leadership Committee is responsible for governance, management, and strategic decision-making within the collaborative. Deputy directors from UAB Medicine, COERE, and CCTS comprise the executive committee and are responsible for day-to-day operations in steering the evolving enterprise, identifying budgetary needs, and communicating with an institutional but independent advisory committee. The advisory committee includes senior leadership from the UAB Health System, UAB President's office, centers, institutes, and academic schools providing critical feedback. The Executive Leadership Committee functions autonomously but with open lines of bidirectional communication with the advisory committee. While the reporting structures for COVID-19 CORE to the advisory committee did not immediately provide scientific guidance on health system policies during the pandemic, planning and reorganization continues to better align the advisory committee capacities to inform health system policies from knowledge generated within the LHS.

The Executive Leadership Committee determines the primary functions of the COVID-19 CORE initiative: (a) conducting secondary analyses of existing data related to testing, treatment, community, and population health outcomes and (b) developing a longitudinal, observational COVID-19 cohort study to evaluate the long-term sequelae and outcomes of COVID-19 infections. The committee is also charged with identifying and securing intramural and extramural sources of funding; such that, the Executive Leadership Committee develops and maintains the LHS plan to leverage existing human and technological resources within the institution, increases institutional capacity for dedicated LHS human resources, and identifies areas of critical need for additional human or technological resources. While the initial LHS was largely volunteer-driven, this committee also leveraged in kind support from the CCTS, COERE, and Informatics Institute to maximize efficiency with existing institutional resources.

A distributed leadership model was established with the Executive Leadership Committee providing overarching strategic vision, and empowering the Research Coordinating Committee, Scientific and Programmatic Working Groups, and other domains to make tactical decisions within their component's role as situated in the larger framework. For example, each Scientific Working Group leadership team was asked to identify two priority projects for their group, but given the flexibility to work with their membership to decide on these projects.

3.3.2 Performance component: Research coordinating committee

A Research Coordinating Committee was established to set short-term objectives, define success, and establish processes to guide the activities of the Scientific and Data Components within the COVID-19 CORE LHS framework. The committee defined three critical phases of activity: (a) foundational phase, (b) implementation phase, and (c) scientific phase. The foundational phase, focused upon building the team and COVID-19 database, led to the formation of three programmatic working groups (PWG) charged with determining data elements for inclusion in a comprehensive, mutually shared COVID-19 database. Initially incorporating UAB electronic health records and health system data, the implementation phase represents an ongoing process of building the shared database, with efforts to incorporate public health, community, novel patient-level questionnaires, and patient-reported outcome (PRO) data over time. Scientific working groups (SWG) emerged within the scientific phase to complement and support the PWG, driven by internal conflicts emanating from efforts to build a foundational database and platform but absent critical guidance from scientific and research questions. Thus, the SWG are designed to support topical interest areas of the network contributors and align study concepts with data collection and analysis.

3.3.3 Ethics and security component: Oversight and ethics committee

Engagement with leadership from the UAB Institutional Review Board served as a precursor to the establishment of a COVID-19 CORE Oversight and Ethics Committee. The LHS framework describes an inherent tension between the Performance Component and the Ethics and Security Component8; this tension is essential to safeguard human subjects and the UAB Medicine enterprise, ensuring COVID-19 CORE research and clinical activities are conducted in alignment with ethical principles. The COVID-19 pandemic highlighted the inherent pressures in academia to be first; with “under review” manuscripts regularly reported in the mainstream media as preprints prior to rigorous peer review and publication.17 By emphasizing clinical and scientific rigor, ethics, reproducibility, and transparency the Oversight and Ethics Committee balanced the time pressure and aspirations within the Research Coordinating Committee. In addition, the Oversight and Ethics Committee also served to ensure diversified engagement of research participants, ethical research methods, and a variety of new studies to reduce health disparities based on prior research.18-20 The ethics committee monitored participation of participants and clinical stakeholders to ensure inclusivity and representation relative to the large population of patients admitted with COVID-19.

3.3.4 Scientific component: Scientific working groups

According to our LHS framework, the Scientific Component was charged with identifying relevant and priority research questions derived from the learning engine that were both context reflective and content specific. Thematic SWG, co-led by two to three individuals, were established to serve this function and were open to participation from any interested student, faculty, or staff from the health system or academic schools of UAB. Initially, three working groups were formed, including health disparities, neurocognition, and critical care.

As other thematic areas of interest emerge, new working groups can be recommended via the COVID-19 CORE website. The Executive Leadership Committee established approval guidelines for new SWG based upon alignment with the principal goals of the COVID-19 CORE, overlap with existing working groups, and feasibility of accessing requisite data to meet their objectives. For example, based upon these principles, a proposal to establish a financial and operational implications SWG was approved, whereas the behavioral medicine interventions working group was not approved because prospectively enrolling participants for interventions was beyond the stated scope of the COVID-19 CORE. Subsequent to the initial SWG, working groups focusing on chronic comorbidities, patient safety and quality, and healthcare worker wellness and satisfaction have been approved (Figure 2).

3.3.5 Data component: Programmatic working groups

Identifying available data elements, desired data elements, and sources of data access pertaining to COVID-19 testing and treatment was a recognized challenge early in the LHS development. At the local level, these challenges included varying data structures from different sources, reporting lags, staffing, and resource constraints to address gaps in technical infrastructure and collection of new data elements. Within the public health level, inconsistent archiving procedures limited the potential sources of data. A key learning within this component was the need for focused attention and resources for data transformation and access.

Three unique areas were selected, with the formation of PWG, to identify data elements including: health system data, public health and community data, questionnaire and PRO data. The health system data group compiled currently available data, classified as discrete elements in the electronic health record (EHR), amenable to data query vs unstructured elements requiring manual abstraction; the latter of which were abstracted following a coordinated gateway process (Figure 3). Data derived from this process were used in local level decision-making, informing the implementation of inpatient telehealth approaches to facilitate remote clinician rounds within the UAB hospital system and support conservation efforts for personal protective equipment during national shortages throughout the pandemic.21

UAB COVID-19 Collaborative Outcomes Research Enterprise (CORE): Gateway process. The workflow to generate data sets providing transformed study specific data sets from extracted health system data. Beginning with submissions of study concept proposals, this process is followed by a scientific gateway meeting with lead study investigators including representatives from the EDW of the Informatics Institute, along with clinical informatics, biostatistics, epidemiology, and research design (BERD), and outcomes research experts from the Research Coordinating Committee (RCC) of COVID-19 CORE. CCTS BERD, Center for Clinical and Translational Science Biostatistics, Epidemiology, and Research Design; COERE, Center for Outcomes and Effectiveness Research and Education; EDW, Enterprise Data Warehouse; HSP, human subjects protocol; IRB, institutional review board; NHS, not human subjects; RISC IT, Research and Informatics Service Center—Information Technology

The public health and community group determined local and state health department individual-level surveillance data related to COVID-19. These data were not immediately available for research purposes and were identified through community testing venues that might augment data captured via UAB Medicine. The questionnaire and selected PRO, informed by National Institutes of Health (NIH) guidance, represented validated instruments for data capture and synthesis during index encounters for COVID-19 related medical services and/or via longitudinal follow-up in a convalescent phase.22

3.3.6 Information technology component: UAB Informatics Institute

The UAB Informatics Institute's Enterprise Data Warehouse (EDW), i2B2 framework, and data query tool contributed an existing infrastructure for the extraction and management of UAB Medicine health system data within the LHS framework.23 The need emerged for qualified personnel to group raw diagnostic, procedural, and other codes housed in i2B2 into composite clinical variables needed for statistical analysis. A team within the Research and Informatics Service Center—Information Technology (RISC), with substantial data transformation experience for HIV health system research, filled this role for the COVID-19 CORE, establishing a novel process to engage investigators interested in conducting secondary analyses utilizing health system data (Figure 3).

By reorganizing the use of existing institutional resources into new scientific and data gateway processes, the information technology component provided a refined platform for investigators to access and evaluate health system data. For example, these data were used by UAB researchers within the Quality and Safety SWG to quickly produce a retrospective analysis of hospital-acquired pressure injuries during the early stages of the pandemic, determining if the newly adopted inpatient telehealth approaches were able to simultaneously minimize the onset of pressure injuries and reduce the risk of COVID-19 exposure among nursing staff.24 Results from this analysis were used to inform and alter the operations of UAB Wound, Ostomy, and Continence (WOC) nursing staff and direct resources within the UAB nursing administration to produce a hospital-acquired pressure injury root cause analysis.24

3.3.7 Patient outcomes component: Patient and stakeholder advisory group

The Patient Outcomes Component is a mechanism for stakeholder perspectives and experiences to be captured while informing operations within the Organization and Collaborations, Performance, and Ethics and Security Components. The importance of this component is exemplified both in the prominence of stakeholder partnerships in patient-centered outcomes research and increased focus on patient experience by health systems (Figure 1). Social distancing restrictions and the speed at which research and patient care pathways developed in response to COVID-19 represented a challenge to traditional stakeholder engagement processes.16 Thus, the patient and stakeholder engagement committee included five members selected for inclusivity and diversity relative to the larger population of patients and caregivers in the health system.25 Because of the prioritization of patient care and strain on the healthcare system, this committee largely represented a convenience sample of patients and stakeholders connected to the hospital and institution. Strategic planning for a larger UAB LHS initiative, catalyzed by COVID-19 CORE, includes prioritization of recruitment of a broader swath of patients and stakeholders to maximize inclusivity and representation.

The stakeholder network of the UAB COVID-19 CORE was further developed with active participation, defined as participation within biweekly or monthly meetings, of frontline healthcare providers. Ongoing outreach to Birmingham city and Alabama state communities, through social media and weekly online events related to COVID-19, and established relationships with community partners predating the COVID-19 pandemic are supporting further developments of the network.26