Pilot Study for the Clinical Validation of an Artificial Intelligence Algorithm to Optimize the Appropriateness of Dermatology Referrals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of patients with inappropriate referrals
研究概览
简要总结
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's pathology as they would in a routine consultation and record their diagnosis and referral criteria, and associate them with the patient'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.
详细描述
Skin-related diseases are a frequent reason for consultation in primary care; some studies quantify it at approximately 5% of all consultations made, mainly by the working population. This represents a considerable consumption of resources and makes an efficient approach to these conditions a key step in optimizing the performance of primary care.
Many studies show discrepancies in opinion between the opinions of primary care physicians and dermatologists, with percentages of agreement in their diagnoses ranging from 57% to 65.52% depending on the study. In general, primary care physicians do not demonstrate adequate knowledge of skin diseases, their diagnosis and treatments.
This human limitation when evaluating skin diseases is also reflected in the effort and time required to estimate the degree of involvement of a patient or the stage of the pathology. So much so, that it ends up being a very unrewarding task and can lead to poor adherence to the protocol and inadequate referrals.
Time consumption is of particular concern given that the number of medical professionals, especially in dermatology, is not sufficient in relation to the demand that exists. Access of the general population to a dermatology specialist is complicated, due to the low number (3 dermatologists per 100,000 inhabitants), making it even more difficult in small population centers. Because of this, screening for dermatologic lesions should be performed by the primary care physician, whose diagnostic capacity is even lower and can increase the risk of misdiagnosis.
In this regard, the literature shows a discordance of 55% to 65% between the primary care physician and the specialist6 and studies confirm a number of expected features: common dermatological diseases are often unrecognized or misdiagnosed by non-dermatologists, due to the particular profiles of common diagnoses in this activity (drug-induced rash, fungal infections).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with skin pathologies.
- •Patients aged 18 years or older.
- •Patients who have signed the informed consent for the study.
排除标准
- •Patient who at the investigator's discretion will not comply with the study procedures.
研究组 & 干预措施
Patients with any kind of skin pathologies
Adult patients (≥ 18 years) with skin pathologies seen in the primary care service of health centers referring to Cruces and Basurto University Hospitals. Patients participating in this study did not receive any specific treatment as part of the research protocol. Patients continued their regular prescribed medications and treatments as directed by their primary healthcare providers. No additional medications or treatments were administered as part of this study.
结局指标
主要结局
Number of patients with inappropriate referrals
时间窗: The moment of enrollment
We define an inappropriate referral as one that, according to the criteria of the specialists consulted in the study, does not require the attention of a dermatologist in order to be treated, as may be the case of seborrheic keratosis. For this purpose, a photograph will be taken and the date of the patient's visit to the clinic and the criteria for moving to the next stage of the care process will be recorded
次要结局
- Cost reduction(The moment of enrollment)
- Demographical Data(The moment of enrollment)
- Waiting list reduction(The moment of enrollment)
- Clinical data(The moment of enrollment)
- Data on the primary care physician(The moment of enrollment)