Belgian Lung Function Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Chronic Respiratory Diseases. Базовые параметры: от 18 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
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Belgian Lung Function Study: Personalised Longitudinal Lung Function Analysis as a Marker of Disease Progression
Обзор
Currently, it remains unclear how to manage serial lung function measurements in a clinical setting. The investigators aimed to tackle this problem by developing a machine learning (ML) model that can accurately predict population and individual lung function trajectories. These predictions would enable the investigators to identify positive or negative deviations, thereby revealing unexpected disease patterns. A prospective validation is needed that includes data on mortality, hospitalisations, emergency-room visits and patient-reported outcomes. Within this study, the goal is to validate the ML model with the data collected from this observational study.
Подробное описание
The objective of this study is to explore the clinical value of models predicting longitudinal lung function patterns in individuals with chronic respiratory diseases across Belgium.
1. The investigators will assess the accuracy of individualised lung function prediction models in a multicentre lung function dataset with prospective clinical and lung function follow-up. 2. The investigators will evaluate important health outcomes, step-up in care, patient-reported outcomes in individuals identified with an expected and unexpected observed trajectory as compared to the predicted population and individualised trajectory.
The hypothesis is that patients with an unexpected decline in lung function will have worse health outcomes, such as a higher mortality rate and more hospitalisations, compared to patients with an expected lung function pattern. The investigators hypothesise to observe better health outcomes and lower mortality rates in patients with an unexpectedly positive lung function evolution compared to patients with an expected negative lung function pattern.
Individuals will be recruited from 4 Belgian Hospitals (UZ Leuven, UZ Antwerpen, AZ Delta, ZOL Genk). Based on the annual rate of pulmonary function testing in these hospitals, a sample size of 1.000 participants per centre is anticipated within one year of inclusions, resulting in a total sample size of 4.000 patients.
All available historical lung function data of included individuals will be retrieved from the individuals medical file. Additionally, the individual will be prospectively followed for 2 years where all lung function data will be collected.
Первичные конечные точки
- Accuracy of lung function predictions (FEV1) [Срок оценки: at 1 and 2-year follow-up]
Вторичные конечные точки (6)
- Differences in clinical outcomes between correct and incorrect lung function predictions (FEV1) [Срок оценки: at 1 and 2-year follow-up]
- Accuracy of lung function predictions [Срок оценки: at 1 and 2-year follow-up]
- Differences in clinical outcomes between correct and incorrect lung function predictions [Срок оценки: at 1 and 2-year follow-up]
- Identifying the minimal needed to make predictions [Срок оценки: after 2 years]
- Performance of ML-based predictions compared to linear regression analysis [Срок оценки: at 1 and 2-year follow-up]
- Overall description of population [Срок оценки: baseline, 1 and 2-year follow-up]
Критерии участия
Критерии включения
- Above 18 years old
- Diagnosed with a chronic respiratory disease and followed up in one of the participating Belgian hospitals
- Performed a complete lung function test (spirometry, body plethysmography and diffusion capacity) at baseline
- Have at least 3 historical spirometry measurements over a minimal time window of 2 years prior to inclusion
- Planned routine follow-up within standard clinical care in one of the participating hospitals
Критерии исключения
- Patients who have had a lung transplantation
- Patients not being able to give consent to participate
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 4 центра
- UZ Antwerpen — Edegem
- Ziekenhuis Oost-Limburg — Genk
- UZ Leuven — Leuven
- AZ Delta — Roeselare
Идентификаторы
NCT: NCT07419555 · S70923 · C2M25045