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

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Diagnostic performance of the teleconsultation-based appendicitis score [Time frame: Baseline and Day 15]

Secondary outcome measures (5)

• Non-inferiority of the teleconsultation-based score compared with standard pediatric emergency consultation diagnosis [Time frame: Baseline and Day 15]
• Additional performance metrics of the predictive models [Time frame: Baseline and Day 15]
• Feasibility and acceptability of parent-assisted clinical examination [Time frame: Baseline]
• Association between teleconsultation-based scores and clinical diagnosis probability assessed by the investigator [Time frame: Baseline]
• Distribution of teleconsultation-based scores across alternative (non-appendicitis) diagnoses [Time frame: Baseline and Day 15]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 1 center

• Angers, University Hospital — Angers

Identifiers

NCT: NCT07479849 · 49RC24_0251 · 2025-A02854-45

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗