Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Dec 11, 2020
Date Accepted: Jan 20, 2021
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Clinical validation of a mHealth App for wound assessment: correlation and reliability study
ABSTRACT
Background:
The clinical evaluation of a pressure ulcer is based on a quantitative and qualitative evaluation. In clinical practice, the technique of reference to measure wound surface is the use of acetate tracing, however it is difficult to use in daily practice (availability of the material, data storage issues, time needed to calculate the surface are). Planimetry techniques developed with mobile health (mHealth) apps can overcome these difficulties.
Objective:
To evaluate the metrological properties of a free access mHealth app to assess pressure ulcers.
Methods:
This was a non-interventional validation study (2019_IRB-MTP_06-02). 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 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 with a co-investigator (validity study, intra and inter-rater reproducibility). The Bland-Altman plot and intraclass correlation coefficient (ICC) were used to compute the minimal detectable change expressed as percentage (MDC%).
Results:
Overall, 61 different pressure ulcers were included. Analyses showed that the validity and intra- and inter-rater reliability of the mHealth app vs. acetate tracing (considered the method of reference) were good, with ICC respectively at 0.97 (0.93-0.99), 0.99 (0.98-0.99) and 0.98 (0.96-0.99), and a MDC% between 17 and 35%.
Conclusions:
This study unveils the good validity and reproducibility of the imitoMeasure app. It could be a proper alternative to standard wound assessment methods. Further studies are needed, especially on larger and more diverse wounds. Clinical Trial: ClinicalTrials.gov NCT04402398
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