Clinical validation of a mHealth App for wound assessment: correlation and reliability study (Preprint)

Background: Clinical evaluation of a pressure ulcer is based on quantitative and qualitative evaluation. In clinical practice, acetate tracing is the standard technique used to measure wound surface area; however, it is difficult to use in daily practice (because of material availability, data storage issues, and time needed to calculate the surface area). Planimetry techniques developed with mobile health (mHealth) apps can be used to overcome these difficulties. Objective: The goal of this study was to evaluate the metrological properties of a free-access mHealth app, called imitoMeasure, to assess pressure ulcers. Methods: This was a noninterventional, validation study. We included patients with spinal cord injury presenting with a pressure ulcer, regardless of its stage or location. We performed wound measurements with a ruler, and we performed acetate tracing using a transparent dressing with a wound measurement grid. Wound evaluation via the mHealth app was conducted twice by the main investigator and also by a coinvestigator to determine validity, intrarater reproducibility, and interrater reproducibility. Bland-Altman plots and intraclass correlation coefficients were used to compute the minimal detectable change percentage. Results: Overall, 61 different pressure ulcers were included. The validity, intrarater reproducibility, and interrater reproducibility of the mHealth app vs acetate tracing (considered the method of reference) were good, with intraclass correlation coefficients of 0.97 (95% CI 0.93-0.99), 0.99 (95% CI 0.98-0.99), and 0.98 (95% CI 0.96-0.99), respectively, and minimal detectable change percentages between 17% and 35%. Conclusions: The imitoMeasure app had good validity and reproducibility. It could be an alternative to standard wound assessment methods. Further studies on larger and more diverse wounds are needed. Trial Registration: ClinicalTrials.gov NCT04402398; http://clinicaltrials.gov/ct2/show/NCT04402398