TACTILE : Validation of a Teleconsultation-Based Predictive Score for the Diagnosis of Acute Appendicitis in Children Using Artificial Intelligence Methods

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-16
SponsorUniversity Hospital, Angers

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Score-based appendicitis risk classification in teleconsultation

    Diagnostic test

    Medical 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

1,500 Participants
are divided into 2 treatment groups
Group A: High risk group of children according to diagnostic score of appendicitisOther 1 intervention
Group B: Low risk group of children according to diagnostic score of appendicitisOther 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline and Day 15

Secondary outcomes

1

Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis

AUC non-inferiority margin of 0.1

Time frame
Baseline and Day 15
2

Additional performance metrics of the predictive models

sensitivity, specificity, precision, recall, AUC-precision recall

Time frame
Baseline and Day 15
3

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)

Time frame
Baseline
4

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)

Time frame
Baseline

Other outcomes

Sponsors and contacts

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