Incidence and Prevalence of Interstitial Lung Disease and their progressive fibrosing phenotypes in 6 European Countries (PERSEIDS)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective epidemiological study

Study drug and medical condition

• Medical condition to be studied:
  Interstitial lung disease

  Idiopathic pulmonary fibrosis

  Hypersensitivity pneumonitis

  Sarcoidosis

  Mixed connective tissue disease
• Additional medical condition(s):
  Idiopathic non-specific interstitial pneumonia, Unclassifiable idiopathic interstitial pneumonia, Exposure-related interstitial lung disease, Other fibrosing interstitial lung disease, Systemic sclerosis-associated interstitial lung disease Rheumatoid arthritis-associated interstitial lung disease and Other diffuse connective tissue disease.

Population studied

• Short description of the study population:
  Phase 1: all adults listed in source databases during 2014-2018.; Phase 2: first 100 patients at each database with a code/keyword for any non-IPF F-ILD from 2016.; Inclusion criteria; - Phase 1: All adult subjects listed in the participating hospital databases aged ≥18 in each calendar year of the index period (i.e. 2014, 2015, 2016, 2017 and 2018) will constitute the source population, which will be used to identify the cases for each studied condition;  Phase 2: First 100 patients23 with a health encounter at sites participating in Phase 2 from 1st January 2016 onwards including an ICD/keyword for any "other (non-IPF) fibrosing ILD" (as defined in Phase 1)
• 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)
• Estimated number of subjects:
  12990656

Study design details

• Main study objective:
  Phase 1: To estimate, in 6 European countries, the incidence rate and prevalence of SSc, ILD, ILD associated to SSc (SSc-ILD), Fibrosing ILD, IPF and other fibrosing ILD. Phase 2: To estimate, in 6 European countries, the percentage of other (non-IPF) fibrosing ILD patients with a progressive phenotype (PF-ILD), UIP pattern and PF-ILD with UIP pattern
• Outcomes:
  Phase 1: Crude prevalence and crude incidence rate of SSc, ILD, SSc-ILD, fibrosing ILD, IPF and other fibrosing ILD per 100 000 persons in each site/country, overall for the study period (2014-2018) and annuallyPhase 2: Percentage of other (non-IPF) fibrosing ILD patients with PF-ILD, UIP pattern and PF-ILD with UIP pattern, Phase 1: Crude prevalence and incidence rate for each clinical ILD and fibrosing ILD diagnosis overall for the study period (2014-2018) and annually. Phase 2: PPV, overall and by country and site, of the algorithm used for identifying fibrosing ILD (non-IPF) cases in Phase 1.
• Data analysis plan:
  Statistical analyses will be of exploratory and descriptive nature. The study is not designed to confirm (or refute) pre-defined hypotheses.Descriptive analyses will be conducted to report the results of this study. Continuous variables will be presented as mean values, medians, ranges, interquartile range (IQR), and standard deviations and categorical variables will be presented as absolute and relative frequencies, together with 95% confidence intervals.

Documents

Study results

PERSEIDS_abstract_09December2020