Skin Pigmentation Assessment

Uses

How it works

Preparation

Risks & contraindications

Highlighted claims

• Skin pigmentation measured by the Monk Skin Tone Scale (categorized as light, medium, or dark) is a prespecified subgroup for heterogeneity-of-treatment-effect analysis. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol
• Two trained research staff members independently assess skin pigmentation at the bedside with input from the patient. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol
• The standardized skin pigmentation protocol requires natural sunlight, scanning the midpoint of the inner forearm, and a visual quality check with repeat scanning if results appear discrepant. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol
• CIELAB values are used to calculate the Individual Topography Angle (ITA), the FDA-recommended objective skin pigmentation metric as of 2025. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol
• 2024 FDA guidance recommends direct skin pigmentation measurement when evaluating pulse oximeters, whose accuracy may vary by skin tone. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol
• Pulse oximeter accuracy may vary by skin tone, which motivates direct pigmentation measurement in the trial. — Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol