Trial Outcomes & Findings for Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion (NCT NCT06237036)

Recruitment occurred at the Hospital Universitario de Torrejón's Dermatology Department. Investigators identified eligible participants in a community healthcare setting. The recruitment period spanned 18 months, from April 13, 2022, to October 23, 2023. Researchers used the Patient Information Sheet to explain study details before obtaining informed consent. A total of 160 participants were enrolled.

Following enrollment, a significant screening process was conducted to ensure protocol adherence. Of the 400 potential participants initially considered, 240 individuals were excluded primarily due to low protocol adherence. This meticulous selection process ensured that only the 160 participants meeting all predefined eligibility criteria proceeded to the data collection phase. No additional washout or run-in periods were required.

Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion

The Clinical Utility Questionnaire (CUS) is a 13-item instrument assessing the practical value of the Legit.Health Plus device. Scale Ranges: Items 1-10 use a 0-10 Likert scale (0=lowest utility, 10=highest). Items 11-12 are binary, scored as 0 (No) or 10 (Yes). Item 13 is categorical, scored as 0, 4, 8, or 10 based on the amount of consultation time saved. Calculation Method: The Total Raw Score is the sum of all 13 items (Minimum: 0; Maximum: 130). This raw sum is normalized to a 10-point scale using the formula: (Total Raw Score / 130) × 10. Interpretation: The final result is reported as a score from 0 to 10. Higher scores indicate greater perceived clinical utility. A score of 8.0 or higher was the pre-specified threshold for successful validation of the device's utility.

The System Usability Scale (SUS) is a standardized 10-item survey used to evaluate the usability and learnability of the Legit.Health Plus medical device. Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Calculation Method: To calculate the SUS score, individual item responses are transformed into a 0-4 scale. For odd-numbered items (1, 3, 5, 7, 9), the score is the scale position minus 1. For even-numbered items (2, 4, 6, 8, 10), the score is 5 minus the scale position. The sum of these ten transformed scores is then multiplied by 2.5 to normalize the total result to a 10-point scale. Formula: (Sum of Transformed Item Scores) × 2.5. Interpretation: The final score ranges from 0 to 10. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability.

This 8-item questionnaire assesses user experience and satisfaction with the Legit.Health Plus device for remote monitoring. Scale Ranges: Each of the 8 items (e.g., ease of use, empowerment, and support) is rated on a Likert scale from 0 to 10. For most items, 0 represents the lowest level of satisfaction (e.g., "Very difficult" or "Strongly disagree") and 10 represents the highest (e.g., "Very easy" or "Strongly agree"). Calculation Method: The total score is the arithmetic mean of the responses to the 8 individual items. The sum of all item scores is divided by 8 to produce a single value. Interpretation: The final score ranges from 0 to 10. Higher scores indicate greater patient satisfaction with the remote monitoring system and the care received through the application.

The Data Utility Questionnaire (DUQ) is a standardized 5-item survey used to evaluate the utility of the information provided by the Legit.Health Plus medical device in the clinical consultation. Scale Ranges: Each item is rated on a 5-point Likert scale from 1 (Strongly Disagree) to 5 (Strongly Agree). Calculation Method: To calculate the DUQ score, individual item responses are transformed into a 0-4 scale. The sum of these five scores is then multiplied by 100 and divided by (5\*5) to normalize the total result to a 10-point scale. Formula: (Sum of Transformed Item Scores) × 100/(5\*5). Interpretation: The final score ranges from 0 to 100. Higher scores indicate better usability. A score of 6.8 or higher is generally considered above average clinical usability.