Psychometric Properties of the Living With Pulmonary Fibrosis (L-PF) Questionnaire in Patients With Idiopathic Pulmonary Fibrosis
Speaker(s)
Sjöström-Bujacz A1, Fischer K2, Lauer A2, Pimple P3, Jozsa IG2, Skaltsa K4, Swigris J5
1IQVIA, Solna, AB, Sweden, 2Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany, 3Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA, 4IQVIA, Barcelona, Spain, 5National Jewish Health, Center for Interstitial Lung Disease, Department of Medicine, Denver, CO, USA
Presentation Documents
OBJECTIVES: Idiopathic pulmonary fibrosis (IPF) is characterized by progressive fibrosis, abnormal lung function, and burdensome symptoms that impair patients’ quality of life. Living with Pulmonary Fibrosis (L-PF) is a 44-item patient-reported outcome measure (PROM) assessing symptoms and impacts of pulmonary fibrosis. We evaluated the psychometric properties of L-PF-44 in an IPF clinical trial population (FIBRONEER™-IPF; NCT05321069).
METHODS: Our analyses were based on clinical trial data from FIBRONEER™-IPF (N=1,177). Confirmatory factor analysis (CFA) was performed to verify the pre-specified factor structure of L-PF. Symptoms domain was represented as a second-order factor including cough, dyspnea, and fatigue sub-domains. Impacts domain was represented as a single factor correlated with the symptoms domain. The appropriateness of this factor solution was evaluated with model fit indices (comparative fit index [CFI], root mean square error of approximation [RMSEA], and standardized root mean squared residual [SRMR]). To allow for cross-validation of the model, CFA was performed sequentially: first using the calibration dataset with ∼50% of randomly selected baseline data, second using the validation dataset with the remaining 50% of baseline data, and third using the full available sample at Week 12.
RESULTS:
The factor structure of L-PF showed adequate model fit for baseline calibration, baseline validation, and Week 12 analyses (CFI 0.890, 0.897, 0.905; RMSEA 0.101, 0.102, 0.104; SRMR 0.102, 0.101, 0.101, respectively). Standardized factor loadings were acceptable for all items, ranging from 0.573–0.979 for symptoms and 0.478–0.923 for impacts. High second-order factor loadings (range across analyses for cough: 0.753–0.783; dyspnea: 0.802–0.829; fatigue: 0.897–0.915) confirmed that symptoms sub-domains were consistent with each other.CONCLUSIONS:
This study provided initial evidence for the structural validity of L-PF in an IPF clinical trial population. Further psychometric properties of L-PF domains and sub-domains (construct validity, reliability, responsiveness) are ongoing and will be presented at the conference.Code
PCR196
Topic
Patient-Centered Research
Topic Subcategory
Instrument Development, Validation, & Translation
Disease
Rare & Orphan Diseases, Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)