Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017

Study Overview
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Brief Summary
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Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD. The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD. This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.

Official Title
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Non-interventional Study Describing Epidemiology, Clinical Characteristics, Prognosis and Healthcare Costs of PF-ILD and SSc-ILD Patients in France, 2010-2017

Conditions
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Lung Diseases, Interstitial, Lung Disease With Systemic Sclerosis

Intervention / Treatment
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* Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalized for PF-ILD and SSc-ILD in France between 01/01/2010 and 31/12/2017 Men or women aged ≥ 18 years old at diagnosis Exclusion Criteria: Patients treated by anti-fibrotic Patients diagnosed with IPF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PF-ILD and SSc-ILD patients<br>PF-ILD and SSc-ILD patients | Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD<br>* epidemiology, characteristics, healthcare resources and associated costs of patients diagnosed with non-IPF PF-ILD and SSc-ILD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PF-ILD and SSc-ILD patients | The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: the epidemiology (incidence and prevalence), the characteristics of patients, the healthcare resource use and associated costs | Between 2010 and 2017 | 
| Prevalence of PF-ILD and SSc-ILD patients | The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: the epidemiology (incidence and prevalence), the characteristics of patients, the healthcare resource use and associated costs | Between 2010 and 2017 | 
| characteristics of PF-ILD and SSc-ILD patients | The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: the epidemiology (incidence and prevalence), the characteristics of patients, the healthcare resource use and associated costs | Between 2010 and 2017 | 
| healthcare resource use of PF-ILD and SSc-ILD patients | The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: the epidemiology (incidence and prevalence), the characteristics of patients, the healthcare resource use and associated costs | Between 2010 and 2017 | 
| associated costs of PF-ILD and SSc-ILD patients | The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: the epidemiology (incidence and prevalence), the characteristics of patients, the healthcare resource use and associated costs | Between 2010 and 2017 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France. | correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France. | Between 2010 and 2017 | 
| Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France. | correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France. | Between 2010 and 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive fibrosing interstitial lung disease, Systemic Sclerosis-Associated Interstitial Lung Disease