OBJECTIVES: With the substantial burden of severe viral lower respiratory tract disease (LRTD) on healthcare systems and patients, we aimed to evaluate the current global Real-World Data (RWD) landscape for LRTD research.

METHODS: RWD sources for severe viral LRTD diagnosed within inpatient settings were identified using targeted literature search terms based on iterative combinations of countries, data types, disease-specific terms, study design/analysis, and outcomes. The project involved 18 core countries i.e., the United States (US), Europe (United Kingdom, France, Germany, Italy, Spain, Netherlands), Nordics (Finland, Sweden, Norway, Denmark) Israel, China, South Korea, Japan, Australia, Brazil, Canada, and multinational sources. Sources identified outside of core countries of scope were also evaluated to address a larger global LRTD data landscape. Sources up to 2024 (including those in development) were triaged and ranked based on pre-defined quality, access, and value parameters for in-depth analysis, followed by interviews with selected data custodians.

RESULTS: Overall, 448 data sources and 16 data types were assessed. Among these, 75 sources met the criteria for in-depth analysis, of which 21 (28.0%) were electronic health records as the most common data type, 66 (88.0%) sources were disease agnostic and 7 (10.7%) had unclear or restricted access. The most represented regions/countries were Europe (n=18; 24.0%), US (n=16; 21.3%) and Nordic countries (n=7; 9.3%). Data on clinical outcomes (n=69; 92.0%) and mortality (n=61; 81.3%) were well captured, while information on patient-reported outcomes (PROs) (n=13; 17.3%) and non-clinical specialist care (n=29; 38.6%) were limited. Legal and patient privacy regulations, review board approvals, and governmental permissions were common barriers to data access.

CONCLUSIONS: Despite identifying numerous sources globally, access barriers and specialised datasets limit wider research opportunities which are crucial for surveillance and pandemic preparedness. Newer initiatives encourage open access via national electronic health systems, common data models, and increased inclusion of PROs to elicit patient outcomes.