The Development and Initial Psychometric Testing of a Patient-Reported Outcome Measure to Assess COPD-Related...

Area of Science:

• Pulmonary Medicine
• Psychology
• Health Sciences

Background:

• Emotional distress is common in COPD patients and impacts self-management.
• Existing tools primarily measure general anxiety and depression, not COPD-specific distress.
• A validated instrument for COPD-Related Emotional Distress (CRED) is needed.

Purpose of the Study:

• To develop and validate a preliminary item list for measuring CRED in COPD patients.
• To create a tool that captures distress specific to the COPD experience.
• To improve understanding of the relationship between CRED and self-management behaviors.

Main Methods:

• A mixed-methods study followed FDA guidelines, including qualitative research and literature review.
• Content validity was assessed through patient interviews and a clinician survey.
• Psychometric properties were evaluated in a cross-sectional study of 264 COPD patients, comparing with established scales (CAT, HADS, mMRC).

Main Results:

• The German COPD-Related Emotional Distress questionnaire-version 1 (CRED-V1) has 36 items and confirmed content validity.
• Psychometric testing identified six subcategories (two formative, four reflective) with high reliability (Cronbach's alpha >0.8).
• A total CRED score (CRED-TS) was calculable (R²=0.656), with CAT and HADS depression scores being significant predictors.

Conclusions:

• This study reports the initial development of an innovative tool for assessing CRED in COPD patients.
• The CRED-V1 demonstrates potential as a reliable and valid measure of COPD-specific emotional distress.
• This new instrument can enhance the assessment and management of emotional well-being in COPD care.