Patient-Reported Outcomes Correlate with Clinical Outcomes in Patients with Idiopathic Pulmonary Fibrosis

ABSTRACT

Background Idiopathic pulmonary fibrosis (IPF) is characterized by progressive fibrosis and declining quality of life. Patient-reported outcomes (PROs) provide a more comprehensive understanding of a patient’s experience and health status than clinical measures (COs) alone, capturing how patients feel, function, and experience their health. However, the relationship between PROs and COs remains incompletely understood in this population.

Methods We performed a secondary analysis of data from the YES-IPF trial, examining 60 IPF patients who completed a 12-week modified yoga program or continued usual activities. Pearson correlations between 21 PROs and 6 COs (FVC: absolute and percent-predicted, DLCO: absolute and percent-predicted, 6-minute walk test, and GAP: Gender-Age-Physiology index) were assessed at baseline and week. p- values were adjusted using the Benjamini-Hochberg method across 21 PROs for each CO measured.

Findings Several significant correlations were observed between PROs and COs; key findings include total L-IPF correlating with absolute FVC having baseline r = -0.33 (p = 0.03) and 12-week r = 0.42 (p < 0.01), total L-IPF correlating with 6MWT having baseline r = -0.43 (p < 0.01) and 12-week r = -0.37 (p = 0.02), shortness of breath R-scale-PF correlating with absolute DLCO having baseline r = -0.35 (p = 0.04) and 12-week r = -0.49 (p < 0.01), total KBILD correlating with percent-predicted FVC having baseline r = 0.38 (p = 0.03) and 12-week r = 0.43 (p < 0.01), and K-BILD Breathlessness and Activities score correlating with GAP score having baseline r = -0.42 (p = 0.02) and 12-week r = -0.40 (p = 0.02).

Interpretation In IPF patients, breathlessness-specific PROs report correlation with COs of disease severity, while sleep-related and psychological domains demonstrate weaker or minimal correlations. This highlights that PROs and traditional COs measure related but distinct aspects of IPF, supporting their complementary use in clinical trials and patient care.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT02848625

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

This study was a non-blinded, single center, randomized pilot trial conducted by the Center for Interstitial Lung Diseases at the University of Washington Medical Center. It was approved by the Institutional Review Board at the University of Washington and registered with ClinicalTrials.gov (NCT02848625).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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Footnotes

1. Soumik Purkayastha: Data analyses, interpretation of result, writing first draft, revised versions and collated inputs from all authors of the manuscript.

2. Suha Kadura: Data gathering, interpretation of result, writing first draft, revised versions and collated inputs from all authors of the manuscript.

3. Cathie Spino: Reviewed data analyses and interpretation, reviewed manuscript and provided input.

4. Ganesh Raghu: Designed the trial and study protocol, enrolled consenting participants in the study, interpretation of results, supervised the conduct of trial and execution of the trial; manuscript writing.

Funding No funding support was received for this study.

Trial Registration Registered with ClinicalTrials.gov (NCT0284862)

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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