TACTILE : Validation of a Teleconsultation-Based Predictive Score for the Diagnosis of Acute Appendicitis in Children Using Artificial Intelligence Methods
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Diagnostic performance of the teleconsultation-based appendicitis score
研究概览
简要总结
Acute appendicitis is the most common abdominal surgical emergency in children and a frequent cause of pediatric emergency department visits. Diagnosis may be challenging due to variable clinical presentations and overlapping symptoms with other causes of abdominal pain. The increasing use of telemedicine further limits access to direct physical examination.
This study aims to evaluate and validate a predictive clinical score designed for teleconsultation to estimate the probability of acute appendicitis in children. The score is based on symptom history and simple clinical signs assessed remotely with the assistance of a parenton a 10 item checklist. During an emergency visit for acute abdominal pain, voluntary children aged 3 to 16 years and their parents will be guided by a medical student through the checklist in conditions simulating a teleconsultation. The score will be recorded for research purposes only and will not influence clinical management. All participants will subsequently undergo standard medical evaluation and management by an emergency physician, who will independently assess the probability of acute appendicitis based on routine clinical practice. The diagnostic performance of the simulated teleconsultation will then be evaluated using advanced statistical and artificial intelligence-based methods and compared with standard in-person pediatric emergency consultation.
详细描述
Several clinical prediction models exist for pediatric appendicitis; however, most require laboratory or imaging data and are not suitable for telemedicine settings. To address this limitation, a teleconsultation-oriented diagnostic checklist was developed using a Delphi consensus methodology. The checklist includes 10 items: three symptom-related questions (pain location, fever, upper digestive symptoms) and seven simple clinical examination items, yielding a total score ranging from 0 to 16.
This prospective, single-center study will be conducted in the pediatric emergency department of Angers University Hospital, France. Children aged 3 to 16 years presenting with non-specific abdominal pain will be eligible. During the emergency visit, a medical student will guide the child and parent through the checklist in conditions simulating a teleconsultation. The score will be recorded for research purposes only and will not influence clinical management.
All participants will subsequently undergo standard medical evaluation and management by an emergency physician, who will independently assess the probability of acute appendicitis based on routine clinical practice. Parents and clinicians will complete questionnaires evaluating feasibility, acceptability, and perceived usefulness of the teleconsultation-based assessment.
Participants will be followed for 15 days to establish the final diagnosis of appendicitis or alternative conditions, using hospital medical records or structured follow-up questionnaires for patients discharged home.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 16 years
- •Presentation to the pediatric emergency department with unexplained abdominal pain
- •Affiliation with a social security or health insurance system
- •Written informed consent from a legal guardian and assent from the child, when applicable
排除标准
- •Previous appendectomy
- •Hemodynamic instability
- •Known medical condition likely to cause chronic or recurrent abdominal pain
- •Inability of the child or parents to understand French
- •Referral with prior laboratory or imaging investigations
- •Participation in the study within the previous 48 hours
研究组 & 干预措施
High risk group of children according to diagnostic score of appendicitis
After diagnostic score assessment, children are assigned to the High risk group using computational technique from artificial intelligence then followed-up for 15 days
干预措施: Score-based appendicitis risk classification in teleconsultation (Diagnostic Test)
Low risk group of children according to diagnostic score of appendicitis
After diagnostic score assessment, children are assigned to the Low risk group using computational technique from artificial intelligence then followed-up for 15 days
干预措施: Score-based appendicitis risk classification in teleconsultation (Diagnostic Test)
结局指标
主要结局
Diagnostic performance of the teleconsultation-based appendicitis score
时间窗: Baseline and Day 15
Area Under the Receiver Operating Characteristic Curve (AUC ≥ 0.75), with an overall diagnostic accuracy (accuracy ≥ 0.80)
次要结局
- Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis(Baseline and Day 15)
- Additional performance metrics of the predictive models(Baseline and Day 15)
- Feasibility and acceptability of parent-assisted clinical examination(Baseline)
- Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator(Baseline)
- Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses(Baseline and Day 15)