About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Previous appendectomy
Hemodynamic instability
Known medical condition likely to cause chronic or recurrent abdominal pain
Inability of the child or parents to understand French
Trial design
Parallel
Treatments tested in this trial
Score-based appendicitis risk classification in teleconsultation
Diagnostic testMedical students will use a diagnostic grid of 10 items (3 medical interview items and 7 clinical examination items) rated each from 0 to 2 when receiving children with abdominal pain in emergency room. As in teleconsultation, parents will be asked to follow and execute instructions (delivered by medical students). A diagnostic score will be established for each patient. After these procedures, children will receive standard care provided by emergency physicians
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic performance of the teleconsultation-based appendicitis score
Area Under the Receiver Operating Characteristic Curve (AUC ≥ 0.75), with an overall diagnostic accuracy (accuracy ≥ 0.80)
Secondary outcomes
Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis
AUC non-inferiority margin of 0.1
Additional performance metrics of the predictive models
sensitivity, specificity, precision, recall, AUC-precision recall
Feasibility and acceptability of parent-assisted clinical examination
assessment using Likert-scale satisfaction questionnaires (scale in 5 point scale) minimum : 1 Strongly disagree (worse outcome) maximum : 5 Strongly agree (better outcome)
Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator
correlation scores with a significant level of the correlation coefficient (r \> 0.7)
Sponsors and contacts
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