This is a cross-sectional study that will be conducted across Japan using an online patient-reported outcome questionnaire.
This study tries to find out the attitudes toward and experiences of the emotional and/or social impact of side effects associated with antifibrotic (AF) treatment among Japanese patients with Idiopathic Pulmonary Fibrosis (IPF)/Progressive Pulmonary Fibrosis (PPF), and how are these attitudes associated with patients' individual characteristics.
Patients with IPF aged 40 years or older who received nintedanib or pirfenidone within the previous 4 weeks, or patients with PPF aged 18 years or older who received nintedanib within the previous 4 weeks
Patients capable of responding to a self-administered questionnaire
Patients treated with nerandomilast (including clinical trials)
Patients with PPF treated with pirfenidone
Patients currently hospitalized
Patients with malignant tumors
The study population will consist of patients with IPF and PPF who meet the inclusion criteria and do not meet any exclusion criteria (outlined below), and have provided informed consent to participate in the study using an electronic informed consent form (eICF).
Cohort
Cross-sectional
Not listed
Mean (95% CI) scores for the PESaM side effects sub-domain in the overall population
The score of patient experiences and satisfaction with medications (PESaM) side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Mean (95% CI) scores for the PESaM side effects sub-domain by IPF/PPF group, and by AF treatment
The score of of PESaM side effects sub-domain ranges from 0-4, with higher scores indicating a lower burden of side effects and a more positive (favorable) patient experience.
Mean (95% CI) scores for the EQ-5D-5L
The quality of life (Qol) 5 dimensions 5-level (EQ-5D-5L) index score ranges from less than 0 (states valued as worse than death, with a minimum of -0.025 based on the Japanese tariff) to 1 (perfect health). Higher scores indicate a better health-related quality of life.
Mean (95% CI) scores for the SDM-Q-9
The 9-Item Shared Decision-Making Questionnaire (SDM-Q-9) score is derived as a sum of the nine items, each rated on a 6-point Likert scale from 0 (completely disagree) to 5 (completely agree) and it ranges from 0 to 45. A higher score indicates a greater degree of patient involvement in the shared decision-making process (reflecting better shared decision-making).
Reliability (Cronbach's α) of PESaM side effects sub-domain
To evaluate the reliability of the PESaM side effects sub-domain, Cronbach's alpha will be calculated.
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