Global Evaluation of the Interstitial Lung Disease Diagnostic Pathway (Global ILD-MDT study)

Study type

• Study topic:
  Disease /health condition

  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Diagnostic practice/accuracy
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Interstitial lung disease

Population studied

• Short description of the study population:
  Interstitial lung disease patients.
• Age groups:
  • Paediatric Population (< 18 years)

    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  Interstitial Lung Disease (ILD) patients
• Estimated number of subjects:
  60

Study design details

• Main study objective:
  To identify features of ILD MDTs associated with more accurate diagnosis of IPF with a view to improving diagnostic accuracy and patient stratification to optimise treatment outcomes worldwide.
• Data analysis plan:
  Phase I analysis will be descriptive, comparing reported diagnostic practices by region, country economic status, and participant expertise. Phase II analysis will also be descriptive, with the use of agreement measures such as Cohen's Kappa statistic to explore diagnostic agreement. Diagnostic accuracy compared to the several different reference groups: the diagnosis of the clinican providing the case details, the diagnosis of an expert MDT with global representation, the diagnosis as indicated by available follow-up data.