Набор скоро начнётся NCT07479849

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

Без фазы С лечением Acute Appendicitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Score-based appendicitis risk classification in teleconsultation.
Кому может быть актуально: Состояния в реестре: Acute Appendicitis. Базовые параметры: 3 лет — 16 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Диагностический тест 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

Первичные конечные точки

Diagnostic performance of the teleconsultation-based appendicitis score [Срок оценки: Baseline and Day 15]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

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