Comprehensive landscape analysis for usable real-world wound care data.

Background: The Wound Care Collaborative Community (WCCC) aims to assess current usable real-world data (RWD) sources to determine which real-world databases (DBs) are suitable and usable for studying the natural history of chronic wounds. Randomized controlled trials (RCTs) do not fully reflect the complexity of patients with chronic wounds. Using RWD, establishment of a scientifically grounded "road map" for RCTs is needed to better navigate the real-world complexity of the patients with chronic wounds. The long-term objectives include identifying patients ineligible to receive evidence-based advanced treatment and diagnostic options, reducing patient suffering, and providing decision support for regulatory bodies, payers, and clinicians.

Objective: To identify available and usable RWD on US chronic wound care patients, as an early step toward the WCCC's objectives.

Methods: Using B.R.I.D.G.E. TO DATA® methodology, the WCCC conducted a comprehensive RWD landscape analysis and systematically screened 34 potential sources for chronic wounds. Multiple data elements helped determine suitability and usability.

Results: Four clinical US DBs have "high potential" for elucidating the natural history of chronic wounds; a fifth met the WCCC criteria but has data access restrictions.

Conclusion: Identifying suitable, usable real-world DBs for research is complex. Only 1 DB was found that is fit for purpose and matches the goals to study the natural history of patients with chronic wounds.