Development and Evaluation of an Artificial Intelligence Model for the Diagnosis of Aeroallergies

Study Overview
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Brief Summary
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To improve accuracy and take out human error, Hippo Dx previously developed S.P.A.T., an automated skin prick test. Now, Hippo Dx will develop and evaluate a S.P.A.T. artificial intelligence (AI) medical software to support physicians in the read out of the test results from an automated skin prick test. In this study 700 images will be collected to develop the AI model, an additional 200 images will be collected to evaluate performance of the AI model. In a last independent cohort of 100 patients, performance of read-out by the physician will be compared with read out by the physician supported by the S.P.A.T. AI medical software. The primary endpoint is the accuracy of the maximal wheal size measurement by S.P.A.T. AI versus the maximal wheal size measurement by the physician. It is a prospective multicentric study that will include 1000 study participants from different countries.

Official Title
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Development and Evaluation of an Artificial Intelligence Model to Support Read Out of Skin Prick Automated Test Results for the Diagnosis of Aeroallergies

Conditions
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Allergy

Intervention / Treatment
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* Device: Skin Prick Automated Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens will be included. Exclusion Criteria: Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment Use of antihistaminic medication < 7 days before the start of the study Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study Use of topical corticoids on the forearm < 7 days before the start of the study Use of Omalizumab < 6 months before the start of the study Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery) Incapacitated individuals Individuals who do not speak the local language (Dutch - French) Individuals who cannot read or write

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Allergy<br>Adults aged 18 years or above, consulting the outpatient clinic for an allergy diagnosis to aeroallergens with skin prick automated test device. | Device: Skin Prick Automated Test<br>* Detection of sensitisation to specific allergens via the skin prick automated test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Equivalency of S.P.A.T. artificial intelligence versus physician | The equivalency of the maximal wheal diameter as measured by S.P.A.T. AI versus the maximal wheal diameter as assessed by the physician. | 15 minutes after the diagnostic test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision of S.P.A.T. artificial intelligence versus physician | Likelihood that the S.P.A.T. AI maximal wheal diameter measurement lays within the range of the maximal wheal size measurement of 3 independent physicians. | 15 minutes after the diagnostic test | 
| Intra-reader variability of S.P.A.T. read out by physicians | Variation in maximal wheal size diameter of the same image by 3 independent physicians. | 15 minutes after the diagnostic test | 
| Comparison of different methods (maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician | Accuracy of the maximal wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician. | 15 minutes after the diagnostic test | 
| Comparison of S.P.A.T. artificial intelligence supporting the physician versus physician | Inter-reader variability of read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone. | 15 minutes after the diagnostic test | 
| Time impact of S.P.A.T. artificial intelligence supporting the physician versus physician | Total time required to perform read out of S.P.A.T. results by the physician supported by the S.P.A.T. AI software versus the physician alone. | 15 minutes after the diagnostic test | 
| Comparison of different methods (mean - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician | Accuracy of mean wheal diameter by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician. | 15 minutes after the diagnostic test | 
| Comparison of different methods (wheal area - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician | Accuracy of wheal area by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician. | 15 minutes after the diagnostic test | 
| Comparison of different methods (HEP index - maximal wheal diameter) of read out by S.P.A.T. artificial intelligence versus physician | Accuracy of HEP-index measurement by S.P.A.T. AI versus the maximal wheal diameter measurement by the physician. | 15 minutes after the diagnostic test |