Меню
Набор скоро начнётся NCT06988358

Early Identification of Children With Asthma

Наблюдательное Asthma in Children

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: Group of children identified by the algorithm as having asthma, Group of children not identified by the algorithm as having asthma.
Кому может быть актуально
Состояния в реестре: Asthma in Children. Базовые параметры: 24 мес. — 71 мес. · 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 →
Официальное название

Early Identification of Children With Asthma in Electronic Medical Records in Primary Care

Обзор

GPs are one of the key players in the early diagnosis of chronic diseases, such as asthma in pre-school children, by detecting symptoms of illness as early as possible. Patient health data is collected on an ongoing basis in GPs' electronic medical records, but remains little exploited despite its potential. Helping GPs to identify asthma in pre-school children, based on the information in their electronic medical records, could help them to diagnose the condition early and thereby reduce the morbidity and mortality associated with it. An algorithm developed and evaluated in a primary care data warehouse should help GPs to identify children with a diagnosis of asthma at an early stage.

Подробное описание

Asthma is the most common chronic disease affecting children. It is defined by repeated episodes of heterogeneous respiratory symptoms, such as wheezing, breathlessness, chest tightness and cough, which vary in time and intensity, as well as variable expiratory flow limitation. Asthma in pre-school children corresponds to asthma in children under the age of 6.

Diagnosis in children is particularly complex, due to the difficulty of performing respiratory tests such as spirometry, and the fact that symptoms often diminish with age. Diagnosis is based on a number of factors, including response to treatment and the absence of a differential diagnosis. Although asthma in pre-school children is frequent and sometimes serious, it is under-diagnosed and not optimally treated. GPs are among the key players in the early diagnosis of chronic diseases, by detecting symptoms of illness as early as possible. Patient health data is collected on an ongoing basis in GPs' electronic medical records, but remains little exploited despite its potential.

Helping GPs to identify asthma in pre-school children, based on the information in their electronic medical records, could help them to diagnose the condition at an early stage, thereby reducing the morbidity and mortality associated with it.

An algorithm, developed and evaluated in a primary care data warehouse, should help GPs to identify children with a diagnosis of asthma at an early stage.

Вмешательства

  • Диагностический тест Group of children identified by the algorithm as having asthma
    150 medical files of children identified by the algorithm as having asthma will be randomly selected for expert appraisal.
  • Диагностический тест Group of children not identified by the algorithm as having asthma
    150 medical files of children not identified by the algorithm as having asthma will be randomly selected for expert appraisal.

Первичные конечные точки

  • Evaluating the sensitivity of an algorithm for the early identification of extracurricular children with asthma [Срок оценки: At enrollment visit]
  • Assessing the specificity of an algorithm for the early identification of pre-school children with asthma [Срок оценки: At enrollment visit]
  • Assessing the positive predictive value of an algorithm for the early identification of pre-school children with asthma [Срок оценки: At enrollment visit]
  • Assessing the negative predictive value of an algorithm for the early identification of pre-school children with asthma [Срок оценки: At enrollment visit]
Вторичные конечные точки (7)
  • Reliability of an algorithm for the early identification of children of pre-school age (2 years) [Срок оценки: At enrollment visit]
  • Reliability of an algorithm for the early identification of children of pre-school age (4 years) [Срок оценки: At enrollment visit]
  • Reliability of an algorithm for the early identification of children of pre-school age (5 years and 11 months) [Срок оценки: At enrollment visit]
  • Population with asthma identified by the algorithm [Срок оценки: At enrollment visit]
  • Number of asthma patients newly detected thanks to the algorithm [Срок оценки: At enrollment visit]
  • Estimate of the percentage of asthma patients identified using this algorithm who were not initially identified by their GPs [Срок оценки: At enrollment visit]
  • Estimate of the percentage of asthma patients identified using this algorithm who were not initially identified by their GPs [Срок оценки: At enrollment visit]

Критерии участия

Критерии включения

  • Children aged 2 years 0 days to 5 years 11 months and 30 days inclusive
  • Consultation in one of the 4 Maisons de Santé Pluriprofessionnelle connected to the PRIMEGE Normandie primary care data warehouse: Neufchâtel-en-Bray, Val-de-Reuil, Le Grand-Quevilly and Rouen Carmes.
  • At least two consultations between the ages of 2 and 5, with a general practitioner in the same care setting
  • Parents having been informed of the use of data from electronic medical records and having expressed no objection to the use of this data

Критерии исключения

  • Children under 2 years of age
  • Children aged 6 years 0 days and over
  • Recourse by a patient's legal representative to one of the RGPD rights restricting the use of their data in the context of research

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Франция · 3 центра
  • Maison de Santé Amstrong — Le Grand-Quevilly
  • Maison de Santé des Carmes — Rouen
  • Maison de Santé de la Plaine — Val-de-Reuil

Идентификаторы

NCT: NCT06988358 · 2022/0349/HP

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗