Pilot Study for the Clinical Validation of an Artificial Intelligence Algorithm to Optimize the Appropriateness of Dermatology Referrals.
Trial ID: NCT06228014
Status: COMPLETED
Study type: OBSERVATIONAL
Start date: 2022-11-23
Completion date: 2025-05-06
Sponsor: AI Labs Group S.L
Collaborators: Osakidetza; Servicio Vasco de Salud Osakidetza, Spain; Hospital de Cruces
Conditions: Skin Diseases; Skin Condition
Locations: University Hospital of Cruces
Countries: Spain
Enrollment: 200
Age range: 18 Years - None
Sex: ALL

Summary:
The goal of this observational prospective and analytical study is to validate that the device is a valid tool for improving the adequacy of referrals to dermatology. As a secondary objectives the investigators set out to validate that the device reduces costs in secondary care; to validate that the device reduces dermatology waiting lists and to validate that the device optimizes clinical flow in Osakidetza.

The primary care physician will explain to the patient what his/her participation in the study will consist of by means of the Patient Information Sheet. The patient, in turn, will be able to ask all the questions he/she considers appropriate in order to clarify all his/her doubts regarding the study. If the patient wishes to participate in the study, he/she will sign the Informed Consent Form and will be assigned a study code. After signing the informed consent, the data collection process begins. The Principal Investigator and/or collaborating investigators assigned to this task will collect demographic data (age, sex) and data related to the diagnosis, characteristics and treatment of the pathology.

Primary care physicians should take photographs showing the areas affected by the pathology. These photographs will be taken with their own smartphone or using a mobile dermatoscope if the use of a mobile dermatoscope is clinically relevant. The primary care physician, will record the photographs periodically, uploading the images to a Google Drive folder that the study sponsor will enable at the beginning of the study. The photographs are named using a code that includes the patient ID (NNN) and photograph number (nn).

Primary care physicians will assess the patient\&#39;s pathology as they would in a routine consultation and record their diagnosis and referral criteria, and associate them with the patient\&#39;s photographs and demographic data to be collected by the research team telematically at the end of the study duration.

These information transfers and the storage of the photographs will be in line with the European Regulation 2016/679 of 27 April on the protection of natural persons with regard to the processing of personal data and the free movement of such data and the Organic Law 3/2018 of 5 December on the Protection of Personal Data and guarantee of digital rights.

The specialist physicians will have a period of one month after the end of the recruitment period to evaluate and label the photographs taken. In this labeling process they will record their diagnosis, and whether they consider that the referral has been appropriate or not. This information will be collected by the research team telematically at the end of the study duration.

This transfer of information and storage of the photographs will comply with European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and with Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights.

Eligibility criteria:
Inclusion Criteria:

* Patients with skin pathologies.
* Patients aged 18 years or older.
* Patients who have signed the informed consent for the study.

Exclusion Criteria:

* Patient who at the investigator\&#39;s discretion will not comply with the study procedures.

Outcomes:
Number of patients with inappropriate referrals