BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is a rare disease with a median survival of 3-5 years after diagnosis with limited treatment options. The aim of this study is to assess the psychometric characteristics of the Short Form 36 Health Status Questionnaire (SF-36) in IPF and to provide disease specific minimally important differences (MID). METHODS: Data source was the European IPF Registry (eurIPFreg). The psychometric properties of the SF-36 version 2 were evaluated based on objective clinical measures as well as subjective perception. We analysed acceptance, feasibility, discrimination ability, construct and criterion validity, responsiveness and test-retest-reliability. MIDs were estimated via distribution and anchor-based approaches. RESULTS: The study population included 258 individuals (73.3% male; mean age 67.3 years, SD 10.7). Of them 75.2% (194 individuals) had no missing item. The distribution of several items was skewed, although floor effect was acceptable. Physical component score (PCS) correlated significantly and moderately with several anchors, whereas the correlations of mental component score (MCS) and anchors were only small. The tests showed mainly significant lower HRQL in individuals with long-term oxygen therapy. Analyses in stable individuals did not show significant changes of HRQL except for one dimension and anchor. Individuals with relevant changes of the health status based on the anchors had significant changes in all SF-36 dimensions and summary scales except for the dimension PAIN. PCS and MCS had mean MIDs of five and six, respectively. Mean MIDs of the dimensions ranged from seven to 21. CONCLUSION: It seems that the SF-36 is a valid instrument to measure HRQL in IPF and so can be used in RCTs or individual monitoring of disease. Nevertheless, the additional evaluation of longitudinal aspects and MIDs can be recommended to further analyse these factors. Our findings have a great potential impact on the evaluation of IPF patients. TRIAL REGISTRATION: The eurIPFreg and eurIPFbank are listed in https://clinicaltrials.gov ( NCT02951416 ).

1st Faculty of Medicine Thomayer University Hospital Prague Prague Czech Republic

AGAPLESION Lung Clinic Waldhof Elgershausen Greifenstein Germany

Cardio Pulmonary Institute EXC 2026 Project ID 390649896 Justus Liebig University Giessen Giessen Germany

Department of Clinical and Molecular Biomedicine Università degli Studi di Catania Catania Italy

Department of Pulmonology Semmelweis University Budapest Hungary

Department of Thoracic Surgery Vienna University Hospital Vienna Austria

European IPF Registry and Biobank Giessen Germany

Helmholtz Zentrum München German Research Center for Environmental Health Neuherberg Germany

Hospital Clinico San Carlos Madrid Spain

Institut National de la Santé et de la Recherche Médicale Hôpital Bichat Service de Pneumologie Paris France

Interstitial Lung Disease Unit Royal Brompton Hospital London UK

Ludwig Maximilians University Munich Center of Health Sciences Munich Germany

Ospedale San Gerardo Monza Italy

Reference Center for Rare Pulmonary Diseases Centre Hospitalier Universitaire Dijon Bourgogne INSERMU1231 Université Bourgogne Franche Comté Dijon France

Universities of Giessen and Marburg Lung Center Giessen Marburg Germany

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NCT02951416