(C-052) Using Real-World Data Landscaping to Address Gaps in Patient Insights: A Real-Use Case Study in Chronic Wound Care

Background: Randomized controlled trials (RCTs) are the clinical gold standard for evaluating treatment efficacy but often exclude patients with a complicated clinical profile due to strict eligibility criteria. Therefore, RCTs are not ideal for studying the natural history of a disease. Real-world data (RWD) are useful for more nuanced insight into disease by capturing granular patient, disease, and treatment information across diverse healthcare settings.

Objectives: To test a novel RWD search methodology for identifying available and usable/ suitable databases (DBs) on US chronic wound care patients.

Methods: A targeted methodology was developed to 1) search for RWD sources and 2) evaluate their suitability and usability for studying the natural history of chronic wounds. Searches using keyword synonyms for “real-world data”, “USA”, and “wound” or “ulcer” were conducted in Google, PubMed and B.R.I.D.G.E. TO DATA® (www.bridgetodata.org). Search results were then profiled for chronic wound care using 48 standardized data fields available to the Wound Care Collaborative Community (WCCC). Criteria included the availability of longitudinal, structured data on wound characteristics, treatment, and outcomes across various care settings. DB profiles were systematically assessed for breadth, quality, suitability, and usability with a checklist developed by the authors.

Results: The search yielded 34 potential RWD sources. DB profiling identified 5 high-potential sources for capturing detailed RWD on patients, wound characteristics, and treatment. These databases demonstrated the ability to track longitudinal outcomes, analyze granular clinical details, and support broad geographic and demographic representation. However, high data licensing fees, data access restrictions, and variability in data completeness highlighted challenges in using RWD for research. The U.S. Wound Registry was particularly suited for the WCCC’s natural history of disease study,[6] exemplifying how targeted methodologies can uncover comprehensive, research-ready datasets.

Conclusions: This study underscores the importance of systematic methodologies for identifying and leveraging RWD as a complementary approach to RCTs. Although the findings of this real-use case study are limited to the evaluated databases and may not be generalizable to other data sources or patient populations, this novel targeted RWD methodology can identify DBs with critical insights into complex care scenarios.

[6] Vlad LG et al. Comprehensive landscape analysis for usable real-world wound care data. Wounds. 2024 Nov;36(11):384-391.