key: cord-0994779-k0vgjifb authors: Rao, Suchitra; Kwan, Bethany M.; Curtis, Donna; Swanson, Angela; Bakel, Leigh Anne; Bajaj, Lalit; Boguniewicz, Juri; Lockwood, Justin; Ogawa, Kaleigh; Katherine, Pemberton; Fuhlbrigge, Robert C.; Brumbaugh, David; Givens, Patricia; Grayck, Eva Nozik; Sills, Marion R. title: Implementation of a Rapid Evidence Assessment Infrastructure during the COVID-19 Pandemic to Develop Policies, Clinical Pathways, Stimulate Academic Research, and Create Educational Opportunities date: 2020-10-20 journal: J Pediatr DOI: 10.1016/j.jpeds.2020.10.029 sha: a4829cba007c94238315d23bd7a5d446cc3cb4e0 doc_id: 994779 cord_uid: k0vgjifb nan Rapid evidence assessment, disaster preparedness, incident command, clinical effectiveness. Children We used the Replicating Effective Programs (REP) framework to organize this report. The REP framework is an implementation science framework commonly used in quality improvement and health services research to guide selection, adaptation, and implementation of evidence-based interventions in real-world care settings (5) (6) (7) . The REP has four phases: the pre-conditions phase involves identification of the need, and determining most effective strategies; pre-implementation incorporates the development, orientation and logistics of the program; the implementation phase encompasses the roll out and dissemination of the various components, and the maintenance and evolution phase involves organizational steps to sustain the intervention in the short and long term. Figure 1 (available at www.jpeds.com) summarizes application of each phase for development and implementation of CCREADS. In March 2020, the ICT called for rapid review of the emerging literature for high priority questions, including screening and treatment of children with suspected or confirmed SARS-CoV-2 infection, and protection of healthcare workers. To achieve this goal, J o u r n a l P r e -p r o o f CHCO assembled a team of clinician-scientists by issuing a hospital-wide request for volunteers representing all CHCO clinical and scientific sections. Soon after SAC co-leaders were selected, they met with ICT to establish a mission statement: The mission of the SAC is to advise CHCO incident command, faculty providers, and referring provider community on clinical aspects of the COVID-19 epidemic. The SAC will review existing literature and provide timely feedback on high priority questions to incident command. Based on input from its members, the SAC mission evolved from purely addressing the needs of the ICT to developing and updating clinical guidance for COVID-19 evaluation, management and healthcare worker protection that were not already being addressed by other hospital teams. We considered potential barriers to implementation of SAC and CCREADS, including the rapid growth of the literature, including accelerated peer-reviewed publications from diverse international settings and preprints not yet peer-reviewed, required a rapid evidence assessment approach. Such an approach needed to evolve from traditional literature review standards, be nimble and efficient, and consider varied levels of evidence, settings, and study populations. Although rapidly evolving, the literature featured minimal evidence specific to pediatric populations, requiring the SAC to make recommendations at times in the absence of robust data, with the need to re-evaluate recommendations as new scientific literature emerged. In a novel pandemic context, the J o u r n a l P r e -p r o o f hospital's existing clinical pathways planning and development processes needed to be significantly accelerated to respond to demand from clinicians given limited local experience, the challenges associated with a rapidly-evolving body of literature, and the absence of published guidelines. The SAC aligned with the ICT goals of team member safety and an evidence-based approach to patient care. In addition, the SAC aligned with the CHCO mission to encompass research and education as well as clinical and operational needs; and with the academic mission of the University of Colorado Anschutz Medical Campus. The SAC leveraged Campus scientific resources including health sciences librarians, ethicists, and dissemination and implementation scientists. The SAC team initially assembled by the ICT was a multidisciplinary translational team, After the ICT presented the first set of urgent questions to the SAC, SAC leadership developed a process for clarifying the scientific issues, priority-setting, rapid evidence assessment, and reporting findings to the ICT. (Figure 2 ) The SAC and ICT leadership recognized the need for an organized set of tools for the organization and dissemination of the work products, which overlapped with existing functions of the hospital's CE program. The CE team includes clinical and operational leaders, process improvement professionals and data analysts working collaboratively with front-line caregivers to develop and oversee the Clinical Pathways program, lead large-scale quality improvement initiatives, and align clinical outcomes with emerging J o u r n a l P r e -p r o o f payment models. CE identified and assigned key team members to facilitate SAC efforts, including adaptation of existing templates and web-based development tools to improve effectiveness and efficiency overall. The CE and SAC teams developed an internal guidance to this set of processes and templates-the CCREADS-on a team web-based collaborative platform site. The SAC assessed existing resources available for addressing hospital needs and overcoming barriers. We then identified the most effective approach to rapid assessment of the literature and for adapting CE workflows to meet SAC goals. A process for rapid review relevant to COVID-19 was established (Table I; The entire SAC met between twice weekly to once monthly depending on the level of ICT response activation to review the status of guidance documents being developed, updates by the working groups, and incoming questions; to set team priorities; and to address working group needs for support from SAC leadership or the CE team. All SAC members reviewed each document, and feedback was used to improve the scientific rigor of each guidance document as well as the templates and processes used in their preparation. The SAC leadership met with the CE team after each meeting to further discuss implementation of the action items from each meeting and to prepare for the next ICT report-out. Report-out meetings with ICT were initially twice weekly and included a report-out template. By leveraging the collective expertise of a diverse group of experts, the SAC iteratively developed 19 clinical guidance resources to guide local care teams on screening, monitoring, treatment and escalation of patients with suspected or confirmed SARS-CoV-2 or MIS-C, including 3 institutional clinical pathways (Table II; available at www.jpeds.com). Clinical pathways translate best available evidence into an actionable J o u r n a l P r e -p r o o f format to help physicians make decisions in specific clinical circumstances (9) . These pathways include dynamic algorithms integrated in the Electronic Health Record (EHR) and available at the point-of care, as well as externally available to peer organizations via the hospital's website. They required weekly reassessment and amendment incorporating emerging scientific literature, guidelines, and local institutional data. Updates to guidance documents were logged in a SAC tracking document. This document provided the input for each SAC team meeting agenda, and action items from each meeting were added to the tracking document. New incoming questions were adapted based on a template. As a result, a rapid-cycle improvement framework was applied utilizing CE and research community expertise to identify, critically appraise and apply findings from key studies to the local context. The SAC infrastructure afforded opportunities to conduct expedited research and quality improvement to answer questions related to COVID-19 in pediatric populations. For example, despite an extensive rapid evidence assessment, there remained uncertainty regarding the reliability of pre-operative SARS CoV-2 testing in the pediatric setting, which was affecting hospital policies regarding PPE, clearance wait times and testing protocols. We formed a peri-operative taskforce comprising members of the SAC and conducted a quality assurance initiative by comparing pre-operative upper respiratory samples with intraoperative upper and lower respiratory tract samples. After obtaining necessary approvals, we were able to rapidly design a protocol, implement the collection of samples and analyze data over a two-month period (publication under review). The SAC's multi-disciplinary team meetings enable a cross-pollination of ideas J o u r n a l P r e -p r o o f and research questions, with opportunities for ongoing future collaborations. To date, SAC members have published 4 peer-reviewed manuscripts related to SAC work, as well as 2 non peer-reviewed articles, and 2 non-peer-reviewed meeting abstracts (10) (11) (12) (13) (14) . Because of the benefit of the SAC to hospital operations, the SAC's structure and processes have been written into the institution's "Pandemic Playbook". In the case of another novel threat, the SAC can then be stood up in a shorter amount of time. Given the rapidly changing evidence related to COVID, the SAC continues to update its guidance statements quarterly or as new key evidence is released. Content experts continue to monitor evolving evidence and update guidance and pathways monthly or more often as applicable. The SAC is also using process and outcome metrics to further adapt the COVID-19 and MIS-C clinical pathways. Based on epidemiologic projections and the clinical research pipeline-including over 2,900 COVID-related studies in ClinicalTrials.gov, the SAC projects that the COVID-19 pandemic curve and ongoing COVID-related scientific discovery will extend into 2022. Anticipating the potential need to scale up efforts in response to pandemic surges, the SAC will operate with flexibility depending on institutional needs as well as the pace of scientific discovery to meet future needs. The SAC was developed in response to our health-system driven demand for evidence. We engaged a diverse team of scientific experts and hospital leaders in a wellcoordinated and timely pandemic response that met operational and academic goals with an infrastructure that is customizable. We have developed a process for prioritizing J o u r n a l P r e -p r o o f CE processes for rapid implementation and dissemination. Our iterative experience can inform not only our institution's CE processes to match future evidence delivery needs, but in addition, through sharing our processes and templates on public websites, we plan to disseminate our learned experience with other healthcare systems interested in replicating the SAC's framework in their specific settings. Complete Title: Use of Incident Command System for Disaster Preparedness: A Model for an Emergency Department COVID-19 Response The Role of Hospital Medicine in Emergency Preparedness: A Framework for Hospitalist Leadership in Disaster Preparedness, Response, and Recovery Literature review on medical incident command The CTSA as an exemplar framework for developing multidisciplinary translational teams The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments Using Implementation Science to Adapt a Training Program to Assist Surgeons with High-Stakes Communication Early Mobility in the Hospital: Lessons Learned from the STRIDE Program AgileMD Integrated Clinical Pathways Clinical pathways: effects on professional practice, patient outcomes, length of stay and hospital costs Pediatric laryngoscopy and bronchoscopy during the COVID-19 pandemic: A four-center collaborative protocol to improve safety with perioperative management strategies and creation of a surgical tent with disposable drapes COVID-19 anticoagulation recommendations in children Neonates Hospitalized with Community-Acquired SARS-CoV-2 in a Colorado Neonatal Intensive Care Unit International PICU COVID-19 Collaborative 2020 [Available from: PRE-CONDITIONS • Identifying the need: • No existing COVID clinical pathways • Need for rapid process to review and synthesize the quickly accruing and mixed-quality evidence • Need for rapid process to develop incident-related guidance for COVID patients in diverse settings • Defining the SAC Mission • Creation of charter statement • Identifying potential barriers • Rapid growth of literature • Lack of evidence in pediatrics • Delay in implementation of evidence in clinical practice • Ensuring fit of SAC processes and outputs to the organizational context • In alignment with Incident Command, hospital and academic mission PRE-IMPLEMENTATION • Formation of the team • Identification of members diverse in clinical specialty, training, translational research phase, career stage • Development of goal-directed organizational structure and processes • Rapid evidence assessment • Implementation processes dissemination • Intranet guidance website • External guidance website • Presenting posters and lectures at meetings • Collaborating on national organizations' guidelines MAINTENANCE & EVOLUTION • Update • Disseminate methods for developing a Scientific Advisory Council for other healthcare systems to use (website)