Observational Analysis on the Socio-economic Impact of Idiopathic Pulmonary Fibrosis (IPF) in Spain (OASIS-IPF)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Healthcare resource utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Pharmacoeconomic study

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

Population studied

• Short description of the study population:
  Patients with Idiopathic Pulmonary Fibrosis (IPF).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Idiopathic Pulmonary Fibrosis (IPF) patients
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  - To compare the economic impact of Idiopathic Pulmonary Fibrosis (IPF) according to FVC % predicted level (FVC<50%, FVC 50-80%, FVC>80%), in adult patients through estimation of annual direct and indirect costs associated with the disease at in one year.
• Outcomes:
  Main sociodemographic and clinical variables will be collected in order to describe population included in the study. In order to compare the economic impact of Idiopathic Pulmonary Fibrosis (IPF) according to FVC % predicted level (FVC<50%, FVC 50-80%, FVC>80%) in adult patients through estimation of annual direct and indirect costs associated with the disease. Estimate the QoL:- SGRQ - EQ-5D-5L questionnaires - Barthel index.Explore the determinants of costs and to estimate the direct and indirect costs.The number of exacerbation events observed during the study period Explore the impact of the disease on the patient’s caregiver:- Zarit Burden Interview
• Data analysis plan:
  - A descriptive analysis of all variables collected will be performed.- For each patient, the annual direct costs, and indirect costs will be quantified. - Mean, standard deviation, % confidence interval of the mean, median and interquartile range will be calculated for the scores obtained with the SGRQ questionnaire collected and absolute and relative frequencies will be calculated for the scores obtained with the EQ-5D-5L questionnaire collected.- If sample size allows for it, bivariate and multivariate analysis will be performed in order to explore the variables impacting costs and QoL for each study subpopulation. - Descriptive analyses will be carried out of the total number of acute IPF-related exacerbations as well as the use of resources and costs associated with the events according to the predicted FVC at the time of inclusion- Descriptive analyses will be carried out of direct and indirect costs and patient QoL according to the change in FVC over one year.