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| ID | Type | Description | Link |
|---|---|---|---|
| C2M25045 | Other Grant/Funding Number | Internal funding KULeuven |
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| Name | Class |
|---|---|
| AZ Delta | OTHER |
| University Hospital, Antwerp | OTHER |
| Ziekenhuis Oost-Limburg | OTHER |
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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.
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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of lung function predictions (FEV1) | Proportion of correct and incorrect FEV1 predictions compared to the observed measure | at 1 and 2-year follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in clinical outcomes between correct and incorrect lung function predictions (FEV1) | Differences between patients with correct and incorrect individual lung function predictions for FEV1 on clinical endpoints (such as mortality, hospitalisations, frailty, health status and step-up in care | at 1 and 2-year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic respiratory diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marieke Wuyts | Contact | 016 34 31 59 | marieke.wuyts@kuleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Wim Janssens | UZ/KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Antwerpen | Not yet recruiting | Edegem | 2650 | Belgium |
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| Accuracy of lung function predictions |
Proportion of correct and incorrect lung function predictions (FVC, TLC, RV/TLC, DLCO) compared to the observed measure |
| at 1 and 2-year follow-up |
| Differences in clinical outcomes between correct and incorrect lung function predictions | Differences between patients with correct and incorrect individual lung function predictions for FVC, TLC, RV/TLC, DLCO on clinical endpoints (such as mortality, hospitalisations, frailty, health status and step-up in care) | at 1 and 2-year follow-up |
| Identifying the minimal needed to make predictions | Minimal number of tests/length of follow-up required for optimal predictions | after 2 years |
| Performance of ML-based predictions compared to linear regression analysis | Comparison of the ML-based predictions for individual and population lung function changes with predictions based on linear regression on individual historical data | at 1 and 2-year follow-up |
| Overall description of population | Sociodemographic information, health status, comorbidities, frailty, disease labels, interventions and prognosis of individuals with a chronic respiratory disease | baseline, 1 and 2-year follow-up |
| Ziekenhuis Oost-Limburg | Not yet recruiting | Genk | 3600 | Belgium |
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| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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| AZ Delta | Not yet recruiting | Roeselare | 8800 | Belgium |
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