2 artigos com a tag "Clinical trials"

Conclusions​

In the prospective arm of IDEI_2023, Legit.Health’s malignancy score achieved an AUC of 96.69% (89.00%-100.00%) for distinguishing malignant from benign pigmented lesions, using histopathology as the reference. The interval shown is the 95% confidence interval. This result comes from a small prospective sample; confirmation in an independent population is planned.

The device algorithms demonstrate moderate accuracy in predicting the Ludwig score for FAA. The overall accuracy was 47% in the prospective analysis, improving to 53% in the latest model. There is a low incidence of predicted grades differing by two grades from the investigator's score and a 50% correlation between the alopecia percentage and the investigator's score. These results indicate the potential of the device solution as a tool for estimating the Ludwig score for the FAA. Besides that, expanding the dataset and incorporating more diverse image samples could enhance the model's robustness and generalizability.

Summary​

• Code: LEGIT.HEALTH_IDEI_2023
• Status: Finished
• Start date: January 25th, 2024
• Finish date: August 23rd, 2024
• Acceptance criteria:
  • An improvement of diagnostic accuracy of 10% (Ferri et al. 2020)
  • Scores equal to or greater than 70 on the System Usability Scale (SUS)
  • An AUC equal to or greater than 80.00% detecting malignancy
  • A sensitivity equal to or greater than 80.00% detecting malignancy
  • A specificity equal to or greater than 84.00% detecting malignancy

The Dermatology Image Quality Assessment (DIQA) technology, which ensures the clinical utility of images for remote consultations and clinical trials. This was published in the Journal of the American Academy of Dermatology.