Study identification

EU PAS number

EUPAS1000000644

Study ID

1000000644

Official title and acronym

Non-Invasive Prospective Pilot in a Live Environment for the improvement of the diagnosis of skin pathologies in primary care

DARWIN EU® study

No

Study countries

Spain

Study description

Dermatological conditions represent a significant portion of primary care consultations, constituting approximately 5% of all visits. However, discrepancies between diagnoses made by general practitioners and dermatologists remain substantial, with concordance rates between 57% and 65.52%.
This gap in expertise often leads to misdiagnoses, incorrect referrals, and delays in appropriate treatment, particularly in rare and severe conditions.
The limited availability of dermatologists, especially in rural areas, further complicates patient care, underscoring the need for innovative solutions to optimize resource allocation and improve diagnostic accuracy.
Teledermatology has shown promise in reducing the pressure on in-person consultations by enabling remote assessments.
However, the adoption of artificial intelligence (AI) presents a transformative opportunity to enhance the diagnostic capabilities of general practitioners. The device has already been validated in the diagnosis of skin conditions and offers advanced tools, such as the automatic scoring of diverse pathologies. This pilot study aims to evaluate whether the use of the device can increase the true accuracy of healthcare professionals (HCPs) in the diagnosis of multiple dermatological conditions.
The main aim of this study is to validate that the information provided by the device increases the true accuracy of general practitioners in the diagnosis of multiple dermatological conditions.
This is a prospective observational analytical and cross-sectional study. It is designed to assess if the use of the medical device by dermatologists and general practitioners can increase the accuracy in the diagnosis of multiple dermatological conditions, who will be presented with 30 images of patients with different skin conditions.
In this case, the data collection will include the diagnosis accuracy for different dermatological pathologies.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Gaston Roustan 0000-0003-3632-9636

Primary lead investigator
ORCID number:
0000-0003-3632-9636

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
No external funding
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable