Clinical study
Inter-operator and inter-device agreement and reliability of the SEM Scanner

https://doi.org/10.1016/j.jtv.2015.01.003Get rights and content
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Highlights

  • SEM Scanner will provide reproducible results regardless of the device or user.

  • Agreement and reliability meet or exceed values for current PU assessment tools.

  • SEM Scanner is a promising, objective, reliable tool for assessing pressure ulcers.

Abstract

Objective

The SEM Scanner is a medical device designed for use by healthcare providers as part of pressure ulcer prevention programs. The objective of this study was to evaluate the inter-rater and inter-device agreement and reliability of the SEM Scanner.

Methods

Thirty-one (31) volunteers free of pressure ulcers or broken skin at the sternum, sacrum, and heels were assessed with the SEM Scanner. Each of three operators utilized each of three devices to collect readings from four anatomical sites (sternum, sacrum, left and right heels) on each subject for a total of 108 readings per subject collected over approximately 30 min. For each combination of operator-device-anatomical site, three SEM readings were collected. Inter-operator and inter-device agreement and reliability were estimated.

Results

Over the course of this study, more than 3000 SEM Scanner readings were collected. Agreement between operators was good with mean differences ranging from −0.01 to 0.11. Inter-operator and inter-device reliability exceeded 0.80 at all anatomical sites assessed.

Conclusion

The results of this study demonstrate the high reliability and good agreement of the SEM Scanner across different operators and different devices. Given the limitations of current methods to prevent and detect pressure ulcers, the SEM Scanner shows promise as an objective, reliable tool for assessing the presence or absence of pressure-induced tissue damage such as pressure ulcers.

Keywords

Pressure ulcer
Reproducibility
Medical device

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