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Development and Initial Validation Analyses of the Living with Idiopathic Pulmonary Fibrosis Questionnaire
- Source :
- American Journal of Respiratory and Critical Care Medicine
- Publication Year :
- 2020
- Publisher :
- American Thoracic Society, 2020.
-
Abstract
- Rationale: Several new drugs for idiopathic pulmonary fibrosis (IPF) are in development. Tools are needed to assess whether these drugs benefit patients on outcomes that matter most to them. Health-related quality of life (HRQL) is one such outcome. It is influenced by many factors, but symptoms and their impacts are two strong drivers. Objectives: To develop a questionnaire to assess symptoms, disease impacts, and HRQL specifically for patients with IPF. Methods: Working with the U.S. Food and Drug Administration through the Drug Development Tool Qualification process, focus groups, concept elicitation, and cognitive debriefing interviews were conducted to inform the development of a 44-item pilot questionnaire. The pilot paper-and-pen questionnaire was migrated to an equivalent electronic version and field-tested in a 14-day study. Response data were subjected to psychometric testing, including exploratory factor analysis, item calibration using item response theory models, test-retest reliability, and validity testing. Measurements and Main Results: A total of 125 patients with IPF (62.4% men) completed the longitudinal study. The mean ± SD age of the cohort was 69 ± 7.60 years, and the mean FVC% predicted was 71 ± 20.0. After factor and item analyses, 35 items were retained, and these comprise the two modules (symptoms and impacts) of the Living with IPF (L-IPF) questionnaire. The L-IPF yields five scales demonstrating good psychometric properties, including correlation with concurrently collected FVC% predicted and the ability to discriminate between patients with differing levels of IPF severity. Conclusions: The L-IPF is a new questionnaire that assesses symptoms, disease impacts, and HRQL in patients with IPF.
- Subjects :
- Pulmonary and Respiratory Medicine
validity
medicine.medical_specialty
Critical Care and Intensive Care Medicine
Interstitial Lung Disease
03 medical and health sciences
Idiopathic pulmonary fibrosis
0302 clinical medicine
Surveys and Questionnaires
medicine
Humans
Patient Reported Outcome Measures
030212 general & internal medicine
Intensive care medicine
Health related quality of life
business.industry
questionnaire
Original Articles
respiratory system
idiopathic pulmonary fibrosis
medicine.disease
humanities
respiratory tract diseases
health-related quality of life
030228 respiratory system
patient-reported outcomes
business
Subjects
Details
- ISSN :
- 15354970 and 1073449X
- Volume :
- 202
- Database :
- OpenAIRE
- Journal :
- American Journal of Respiratory and Critical Care Medicine
- Accession number :
- edsair.doi.dedup.....009a5e5e9a55547f47dd27600082454d