Evaluation of a reception and thawing assistance tool for securing the Car-t Cells circuit

Objective
Car-t cells require a specific and complex circuit. In this context, the implementation of a technological tool, augmented reality glasses to digitize and facilitate the traceability of the circuit of these therapies, has been initiated.
The objective is to evaluate the tool during 2 risky stages of the circuit: reception and thawing.

Methods
A 3-axis evaluation grid has been developed:
* Organizational axis: 7 items including process duration outside the tank, reduction of paper traceability;
* Tehnical/IT axis: 7 items including consistency of process steps, IT problems, tool misuse;
* Ergonomic axis: 12 items including compatibility with personal protective equipment (PPE), usable photos, use of voice control, perceived visual fatigue,
4 trained operators participated in the evaluation. The Likert scale was used as a scoring system and a usability questionnaire (F-SUS, F-system Usability Scale) was completed. The tests were carried out under conditions similar to real ones. For the descriptive analysis of the results, Excel^® (2019 version, Microsoft, Redmond, Washington, USA) was used.

Results
In total, 32 reception tests (R) and 32 thawing tests (T) were performed (8 per operator). The F-SUS questionnaire obtained an average score of 83/100±7, judging the usability of the tool very acceptable.
Regarding the organizational axis, the duration of the process does not alter the quality of the product (2min 48s±41s outside the tank against 3min 0s without glasses). The number of information to be written has been reduced from 14 to 0 (R) and 10 to 1 (T). Backup accessibility and data readability on the software are rated 5/5±0 and 4.5/5±0.5 respectively.
Regarding the technical axis, random computer problems were observed: 39.1% of the tests presented a repeat of label scan (max 5/test), 25.0% short latencies (maximum 4/test), 10.9% a procedure stop (max 1/test). 4 misunderstandings of the glasses have been listed.
For the ergonomic axis, regarding PPE, only the visor rated 1.8/5±1.3 presents a constraint. The manipulation is rated 4.7/5±0.5, the use of voice commands 3.9/5±0.7. 97.9% (n=427) of the photos taken are exploitable. The perception of visual fatigue is evaluated at 4.3/5 0.8.

Discussion-conclusion
In view of these results, the glasses allow a notable decrease in written traceability. It issues did not occur during critical process steps. Nevertheless, degraded procedures must be implemented. The tool was deemed easy to use. Finally, the glasses make it possible to simplify and secure the organization of the circuit.
In the future, changes to the software as well as adaptations of the tool may allow its use in practice.

References
 Lecoutre A., Vasseur M., Courtin J., Hammadi S., Decaudin B., Odou P. A prospective, single-centre study of the feasibility of the use of augmented reality for improving the safety and traceability of injectable investigational cancer drug compounding. Helyon. 2024.

Keywords: Smart glasses, digital technology, targeted molecular therapy

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