Title: Changing the paradigm of pressure injury (PI) prevention: Translating sub epidermal moisture (SEM) assessment technology from bench to bedside

Abstract

Background: The current standard of pressure injury (PI) care does not provide anatomically specific prevention to at-risk patients. SEM assessment technology uses clinically proven algorithms to identify increased risk of PIs. Anatomy-specific SEM assessments enable clinicians to provide early and precise interventions that are significantly effective in PI prevention. Purpose: Formal, controlled clinical studies were conducted to demonstrate the value of SEM assessment technology in identifying increased risk of PIs. Subsequently the technology was implemented as an adjunct to routine clinical assessments in everyday PI care practice in multiple care settings. Methodology: Two foundational observational studies enrolled 125 participants with confirmed PIs or suspected deep tissue injury and 50 healthy study participants. A third blinded, longitudinal, prospective clinical study enrolled 189 participants. A formal, pragmatic, real-world pressure ulcer reduction program (PURP) evaluated 2,439 patients across 34 care facilities by incorporating SEM technology as the only change to existing daily PI prevention workflows. Results: Observational studies resulted in: • Two spatial algorithms indicating sensitivity of 87-82% and specificity of 88-51% at the conservative cutoff of SEM Δ ≥ 0.6. • Receiver operating characteristic (ROC) curves computed areas-under-the-curve (AUC) of 0.7809-0.9181 (95% CI, p<0.0001). The third blinded study resulted in: • Sensitivity of 87.5% (95% CI) and specificity 32.9% (95% CI). • AUC was 0.6713 (95% CI, p <0.001). Real-world data analysis showed: • 90.5% PI incidence reduction in acute care settings. • 3-fold reduction in incidence risk with SEM assessment technology as a dominant quality strategy over other care pathways. • Sensitivity of 62.3-75.0% and a specificity of 45.2-61.7% with AUC’s ranging from 62.5-66.0% (95% CI, p<0.001). Conclusion: The diagnostic accuracy of SEM assessment technology exceeded that of clinical judgment alone in both controlled clinical study settings and in a variety of care settings with diverse real-world population. SEM assessment technology has advanced from bench to bedside in the real world.