Evaluation of a Training Course for General Practitioners Within the Melanoma Multimedia Education Programme of the Italian Melanoma Intergroup: A Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,531
- 试验地点
- 10
- 主要终点
- Change in Melanoma Knowledge After MelaMEd Training
研究概览
简要总结
The goal of this trial was to learn whether the MelaMEd online training program could improve doctors' skills in the early detection and management of melanoma, the most aggressive type of skin cancer. The participants were primary care physicians, including general practitioners, general practice trainees, and pediatricians.
The main questions were:
Did the training improve doctors' ability to identify skin lesions that might be melanoma? Did the training improve their knowledge of melanoma prevention, diagnosis, and management? Did the training help doctors make better decisions about referring patients to a dermatologist?
Participants first completed an online questionnaire. It included questions about melanoma and images of skin lesions. Participants then completed the MelaMEd online training course.
After the training, participants completed a second questionnaire with the same main questions. They also answered questions about their confidence in managing melanoma and their experience with the course.
Researchers compared each participant's answers before and after the training. There was no separate comparison group.
详细描述
MelaMEd, which stands for Melanoma Multimedia Education, is an online educational program developed by the Italian Melanoma Intergroup. The program was designed mainly for general practitioners and other primary care physicians involved in melanoma prevention, early detection, and referral.
The educational intervention consisted of a free asynchronous e-learning course titled "Early Diagnosis and Management of the Therapeutic Diagnostic Pathway of Melanoma." The course included video lessons, clinical images, interactive cases, and switches between video lectures and the IMI MelaMEd multimedia atlas on the MelaMEd Platform.
The educational content covered melanoma risk factors, sun exposure and sun protection, skin examination, clinical recognition rules, differential diagnosis, referral decisions, histopathology, staging, and treatment. Clinical recognition rules included the ABCDE rule, the EFG rule, and the "Ugly Duckling" sign.
The study used a prospective, single-group, before-and-after design. Eligible participants were general practitioners, general practitioners in training, and pediatricians working in the healthcare areas of participating Italian Melanoma Intergroup centers. Participation was voluntary.
Before the training, participants completed an online questionnaire. The questionnaire included seven multiple-choice questions about melanoma knowledge and 10 images of skin lesions. For each image, participants were asked to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Licensed general practitioners, general practitioners in training, or pediatricians working in the healthcare system areas served by participating Italian Melanoma Intergroup centers.
- •Voluntary agreement to participate in the study evaluation.
- •Confirmation that the participant had read and understood the information on personal data processing.
- •Authorization for the processing of personal data in accordance with European Union Regulation 2016/679.
排除标准
- •No formal exclusion criteria were specified.
- •Individuals who did not authorize the processing of their personal data could access the MelaMEd educational course and platform but were not included in the evaluation of the training program.
研究组 & 干预措施
MelaMEd Online Training
Participants received the MelaMEd asynchronous online educational program, including video lessons, interactive clinical cases, and access to the MelaMEd multimedia platform. Knowledge of melanoma, diagnostic performance, referral decisions, and self-reported confidence were assessed before and after the training. No control or comparison arm was included.
干预措施: MelaMEd Online Training Program (Behavioral)
结局指标
主要结局
Change in Melanoma Knowledge After MelaMEd Training
时间窗: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Melanoma knowledge was assessed using seven multiple-choice questions covering ultraviolet radiation, complete skin examination, the ABCDE rule, the EFG rule, the Ugly Duckling sign, dermoscopy, and Breslow thickness. For each question, the percentage of participants selecting the correct answer was calculated before and after training using matched responses. Higher percentages indicate better melanoma knowledge.
Change in Diagnostic Performance Across 10 Skin Lesion Cases
时间窗: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Diagnostic performance was assessed using 10 clinical images of melanocytic and non-melanocytic skin lesions. For each case, participants classified the lesion as benign or malignant and selected the most likely diagnosis from four options. The percentages of correct benign or malignant classifications and correct diagnoses were calculated before and after training using matched responses. Pooled sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy were also calculated. Higher values indicate better diagnostic performance.
Change in Dermatology Referral Decisions for Skin Lesions
时间窗: Pre-training baseline and post-training assessment within 10 days of completion of the online course
Using the same 10 clinical cases, participants indicated whether the person should be referred to a dermatologist for specialist assessment and possible excision. For each case, the percentage of participants selecting referral was calculated before and after training using matched responses. Changes were interpreted according to the reference diagnosis, with the aim of increasing referral of malignant lesions and reducing unnecessary referral of benign lesions.
次要结局
- Change in Self-Reported Confidence in Melanoma Prevention and Detection(Pre-training baseline and post-training assessment within 10 days of completion of the online course)
- Participant Satisfaction and Perceived Usefulness of the MelaMEd Training(Post-training assessment within 10 days of completion of the online course)
研究者
Federica Zamagni
Biostatistician
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS