Patient-Reported Outcome Scale for Idiopathic Pulmonary Fibrosis: Development and Validation in China

Area of Science:

• Pulmonary Medicine
• Clinical Trial Methodology
• Patient-Reported Outcomes

Background:

• Idiopathic pulmonary fibrosis (IPF) requires reliable outcome measures for clinical trials.
• Existing measures may not fully capture the patient experience in IPF.

Purpose of the Study:

• To develop and validate the Idiopathic Pulmonary Fibrosis Patient-Reported Outcome (IPF-PRO) scale.
• To establish a scientifically sound measure for IPF clinical trials.

Main Methods:

• Literature review, expert/patient interviews, and panel discussions informed scale development.
• Classical test theory and item response theory (IRT) guided item selection through field surveys.
• A formal survey assessed the final 18-item IPF-PRO's measurement properties.

Main Results:

• The IPF-PRO comprises 18 items across four domains: physiology, psychology, environment, and satisfaction.
• Excellent reliability (Cronbach's α = 0.917, generalized coefficient = 0.931) and validity (content, structural, criterion, discriminant) were confirmed.
• The scale demonstrated high response (100%) and completion rates (100%) with a median completion time of 7 minutes.

Conclusions:

• The 18-item IPF-PRO is a reliable and valid patient-reported outcome measure.
• The IPF-PRO is suitable for use in clinical trials investigating idiopathic pulmonary fibrosis.