CEDRN Pandemic Preparedness Registry

The registry will capture standardized clinical, sociodemographic, treatment, outcome, and linkage-ready identifiers for consecutive patients tested for influenza A/B, SARS-CoV-2, and RSV as the test cohort; the platform is designed to pivot rapidly to any emergent pandemic respiratory pathogen by adding pathogen-specific elements to a modular data dictionary. The registry harmonizes data from pre-hospital, ED, and in-hospital encounters across Canadian sites, and enables linkages to provincial and national administrative, vaccination, dispensing, genomics, and vital statistics datasets.

With this registry, we aim to:

1. Implement a plan to improve research preparedness for pandemics and health emergencies by developing and implementing a pandemic data dictionary to collect data on respiratory pathogens with pandemic potential, and expanding collaborations.
2. Accelerate the creation of a curated, accessible, national dataset that captures the continuum of care delivery from ED arrival to hospital discharge, including from rural sites, that can be linked with administrative health outcome and health services utilization, vaccination, testing and genomic data.
3. Strengthen the capacity to conduct interdisciplinary, equity-focused, multi-jurisdictional, patient-oriented research during pandemics and health emergencies by expanding training, mentorship and collaborations, guided by an open science framework.
4. Expand national and international collaborations to enable research participation by diverse groups, optimize coordination, minimize research duplication and enable rapid external validation of our findings to optimize generalizability, including collaborating with international organizations such as the International Severe Acute Respiratory Emergency Infections Consortium (ISARIC) and the World Health Organization (WHO).

Our research plan is to use these data to:

i) evaluate patient presentations, disease severity, treatments, procedures, health services utilization, and in-hospital mortality by subgroup, over time and by geographic region; ii) derive and validate prediction rules for safe ED discharge and mortality; iii) examine patient-reported outcomes and complications; iv) evaluate the uptake and real-world drug safety and effectiveness of antivirals; v) evaluate vaccine effectiveness in vulnerable subgroups of the population; and vi) investigate the feasibility of real-time data collection across Canada

We hypothesize that there will be variations in the patient presentations, disease severity, treatments provided, procedures, health services utilization, in-hospital mortality, treatment uptake and effectiveness among different subgroups of ED patients experiencing respiratory viral illness and that these characteristics could be used to derive a clinical decision rule to predict safe ED discharge and mortality.

Study Design:

We will develop and implement a pandemic data dictionary and map data elements to clinical information systems. We will pilot data extraction and program automated data extraction/uploads from clinical information systems before launching study protocols in preparation for emerging pandemic pathogens and seasonal influenza outbreaks.

We will create a single nationally-harmonized curated accessible dataset. It will capture the patient journey from ambulance arrival to hospital discharge filling critical gaps in administrative data, including individual-level sociodemographic variables, clinical signs and symptoms, investigations, pre-hospital, ED and hospital medications, interventions and clinical course.

Our research plan will generate data that will guide important patient care and health policy decisions for these respiratory illnesses. Importantly, we will be able to rapidly pivot our work and research infrastructure to any emerging pathogen, if needed, based on the advice of our Scientific \& Public Health and Indigenous Advisories or WHO recommendations.

Study Population:

The registry includes all emergency department patients tested for influenza A/B, SARS-CoV-2, or RSV. In future outbreaks, the registry will expand to include patients tested for the new pandemic pathogen. Those not tested are excluded.

Ethics:

The registry operates under a waiver of consent for retrospective data collection due to minimal risk, infeasibility of obtaining consent for all patients, and the risk of selection bias if vulnerable populations are excluded.

Database creation:

Data fields - we will develop and implement a pandemic data dictionary and map data elements to clinical information systems. We will pilot data extraction and program automated data extraction/uploads from clinical information systems before launching study protocols in preparation for emerging pandemic pathogens and seasonal influenza outbreaks. To refine our pandemic data dictionary, we have reviewed updated ISARIC data collection forms for variables necessary to capture sufficient information about our viral pathogens of interest. We will add genomic data specifications to support linkages with pathogen genomic data in the future. The inclusion of ISARIC variables will produce data that can be meta-analyzed using the same variables and outcomes collected on the same respiratory pathogens worldwide.

We will engage with team members, collaborators, PWLLE, Indigenous and Scientific \& Public Health Advisories, clinicians, and end-users to refine the scope, granularity, priority, and appropriateness of data elements in workshops. We will use an inclusive, open, and equity and diversity lens to reduce the risk of unconscious bias. For pre-existing data elements, we will note the times they were used and any usability issues encountered. We will consider the volume of data and weigh newly proposed/refined data elements against their anticipated use, impact and our ability to automate data extraction from clinical information systems.

Data Source - we will collect information that is normally ascertained by healthcare workers caring for patients with suspected or confirmed respiratory pathogens as part of routine care. This information can be accessed by patient chart review at each hospital site. We will obtain operational approvals for access to medical records (be they physical, electronic, or hybrid) at all participating sites.

Data Collection - we will reach out to each participating site's health authority or data analytics group to extract electronic health records (EHRs). We will extract patient information, demographics, vitals, emergency department treatments (i.e. time stamps, disposition) and medications, laboratory tests (i.e. pathogen testing, and blood work), hospital admission information, and discharge diagnoses. We will use computation and manual assessments to evaluate the conformance, completeness, and accuracy of key variables.