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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Appendicitis
• Intervention / Treatment: Diagnostic test: Score-based appendicitis risk classification in teleconsultation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthieu Le Lay; Phone Number: +33 (0)2 41 35 58 91; Email: DRCI-Promotion-Interne@chu-angers.fr
• Study Contact Backup: Name: Lydia FLAUX, Medical Doctor; Phone Number: +33 (0)2.41.35.44.10; Email: Lydia.Flaux@chu-angers.fr

Study Locations

• France
  • Angers, France, 49000
    • Angers, University Hospital
    • Contact: Lydia FLAUX, Medical Doctor; Phone Number: +33 (0)2.41.35.44.10; Email: Lydia.Flaux@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Diagnostic test: Score-based appendicitis risk classification in teleconsultation; 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
Other: 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	Diagnostic test: Score-based appendicitis risk classification in teleconsultation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and Day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis	AUC non-inferiority margin of 0.1	Baseline and Day 15
Additional performance metrics of the predictive models	sensitivity, specificity, precision, recall, AUC-precision recall	Baseline and Day 15
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)	Baseline
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)	Baseline
Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses	median (IQR) scores in the different alternative diagnoses	Baseline and Day 15

Collaborators and Investigators

• Sponsor: University Hospital, Angers
• Investigators: Principal Investigator: Lydia FLAUX, Medical Doctor, University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: validation study; Pediatric medicine; telediagnosis
• Additional Relevant MeSH Terms: Intestinal Diseases; Infections; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Cecal Diseases; Intraabdominal Infections; Appendicitis
• Other Study ID Numbers: 49RC24_0251; 2025-A02854-45 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No