RESUMEN
Since March 2022, the centralized cytotoxic preparation unit at the Lille University Hospital (Lille, France) is equipped with augmented reality eyewear for preparation and quality control. The technology enables a user-friendly guided step by step preparation process. It also assists the user by identifying vials through data matrix scan and recording photos at different stages of preparation in order to replace the in-process double visual inspection which will now be carried out a posteriori during the release control. In this paper, we evaluate user feedback and model the learning curve for this new tool. The team's feedback was evaluated using the System Usability Scale (SUS) and Short User Experience Questionnaire (S-UEQ). Both questionnaires showed very good acceptance of the tool by our teams, with scores of 79.7 for the SUS and 2.014 for the UEQ. Finally, a learning curve was drawn up according to Wright, showing a learning curve of 91%. This study shows that the tool has been very well integrated into our preparation unit.
Asunto(s)
Realidad Aumentada , Curva de Aprendizaje , Humanos , Neoplasias , Interfaz Usuario-Computador , Francia , Control de Calidad , Antineoplásicos/uso terapéuticoRESUMEN
The compounding of injectable cancer drugs for clinical trials often requires specific procedures, with limited access to the starting materials and especially the active compound. These characteristics prevent the application of qualitative or quantitative analyses and quality control techniques. Hence, for some very complex compounding operations, double visual inspection is considered to be less reliable, more time-consuming and more human-resource-intensive than other methods. The compounding team at Lille University Hospital (Lille, France) has equipped one of its preparation areas with a new device: augmented reality (AR) eyewear connected to an oncology drug management system, as a support tool for compounding and quality control. The tool has been tested, adapted and improved within the unit and is now used for investigational drug compounding on a routine basis. In a prospective, single-centre study, we evaluated the feasibility of the implementation of this novel AR approach for the compounding of injectable investigational cancer drugs. During the 6-month study period, 564 clinical trial compounding operations were performed with the AR eyewear. The proportion of poor-quality photos taken with the AR eyewear fell over time, as users became more familiar with the tool. A user satisfaction survey highlighted a very high level of uptake and a wish to broaden the scope of the compounding performed with AR support. The AR eyewear constitutes an innovative, cost-effective tool that increased the level of safety without disrupting the unit's operating procedures. The tool's flexibility enabled its integration into a variety of working environments. The various improvements now being developed should help to further boost the added value of this novel device.
RESUMEN
Nivolumab was first authorized at a weight-based dose (WBD) of 3â mg/kg every two weeks (Q2W). Since 2017, a fixed dose (FD) regimen [first 240 mg Q2W and then 480 mg per month (Q4W)] was allowed. The objective of the study was to compare a WBD regimen and an FD regimen with regard to effectiveness and safety. We conducted a single-center, retrospective, real-life study of consecutive adult patients who had received a WBD of nivolumab or an FD of 480â mg Q4W. The primary endpoint was the occurrence of grade ≥3 immune-related adverse events (irAEs). The secondary endpoints were overall survival and cost of the treatment. In all, 342 patients were included: 71 in the WBD cohort and 271 in the FD cohort. Of these patients, 201 patients (59.6%) experienced an irAE, and 24 of these events were graded as ≥3. At 12 months, there was no significant difference in irAE occurrence between the two cohorts [hazard ratio (95% confidence interval): 0.54 (0.21-1.36), P â =â 0.19]. The 12-month overall survival rate was significantly lower in the WBD cohort ( P â <â 0.001). Switching from a fortnightly weight dose to a fixed monthly dose halves the cost of hospitalization. Our results did not show a significant difference between WBD and FD cohort in the occurrence of severe irAEs. However overall survival appeared to be significantly higher in FD group. Some clinical trials are investigating a hybrid dosing regimen in which a WBD is capped by an FD. The present results need to be confirmed in prospective studies.