Idiopathic pulmonary fibrosis (IPF) is a progressive fibrotic lung disease with marked inter-individual heterogeneity in trajectories and outcomes. Despite antifibrotic therapies, reliable risk stratification in routine practice remains suboptimal. OPEN-IPF is a multicentre retrospective observational cohort study designed to build a harmonised real-world dataset across Italian IPF referral centres to enable the development and external validation of machine-learning (ML) models predicting clinically relevant outcomes.
Age ≥18 years
Diagnosis of idiopathic pulmonary fibrosis established according to international guidelines and local multidisciplinary team (MDT) assessment
Availability of baseline clinical and functional data
Availability of follow-up data for at least 12 months, or until a clinically relevant event (e.g., death, lung transplantation)
Interstitial lung disease other than IPF
Lung transplantation performed before the baseline (index) date
Absence of any follow-up information after baseline
Adults with idiopathic pulmonary fibrosis diagnosed according to international guidelines and local multidisciplinary team assessment, followed in routine care at participating Italian referral centres.
Cohort
Retrospective
Not listed
Disease progression (guideline-based functional/composite criteria)
Disease progression defined using guideline-based criteria derived from routinely collected clinical data (e.g., decline in lung function and/or composite progression definitions as per the shared operational document).
Acute exacerbation of IPF (AE-IPF)
Occurrence of AE-IPF during follow-up, adjudicated from routine clinical documentation using standardised operational definitions shared across centres.
Real-world response to antifibrotic therapy
Treatment response assessed in routine clinical practice using longitudinal clinical/functional data and treatment exposure information (type, start, discontinuation)
Overall survival
Time from baseline to death from any cause.
Transplant-free survival
Time from baseline to lung transplantation or death.
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