Belgian Lung Function Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Respiratory Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Belgian Lung Function Study: Personalised Longitudinal Lung Function Analysis as a Marker of Disease Progression
Overview
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.
Detailed description
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.
Primary outcome measures
- Accuracy of lung function predictions (FEV1) [Time frame: at 1 and 2-year follow-up]
Secondary outcome measures (6)
- Differences in clinical outcomes between correct and incorrect lung function predictions (FEV1) [Time frame: at 1 and 2-year follow-up]
- Accuracy of lung function predictions [Time frame: at 1 and 2-year follow-up]
- Differences in clinical outcomes between correct and incorrect lung function predictions [Time frame: at 1 and 2-year follow-up]
- Identifying the minimal needed to make predictions [Time frame: after 2 years]
- Performance of ML-based predictions compared to linear regression analysis [Time frame: at 1 and 2-year follow-up]
- Overall description of population [Time frame: baseline, 1 and 2-year follow-up]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients who have had a lung transplantation
- Patients not being able to give consent to participate
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 4 centers
- UZ Antwerpen — Edegem
- Ziekenhuis Oost-Limburg — Genk
- UZ Leuven — Leuven
- AZ Delta — Roeselare
Identifiers
NCT: NCT07419555 · S70923 · C2M25045