OBJECTIVES: To develop a self-administered patient reported outcome (PRO) instrument to evaluate patients’ experience of early morning symptoms of Chronic Obstructive Pulmonary Disease (COPD).
METHODS: A literature review and interviews with six clinical experts were performed to identify concepts for the evaluation of early morning symptoms of COPD and to develop a focus group discussion guide. Four focus groups were conducted with a total of 27 COPD patients who experienced COPD symptoms at night or in the early morning. Qualitative data was analyzed using ATLAS.ti to identify key concepts and patient terminology which were then used to create a conceptual framework and to generate items and response options for the new PRO instrument. One-on-one cognitive debriefing interviews were conducted with 10 COPD patients to assess item readability, comprehensiveness, and content validity.
RESULTS: Focus group participants had a mean age of 68.1 years, were 51.9% female, and had a range of COPD severity levels: 7.4% GOLD I (mild), 55.6% GOLD II (moderate), 14.8% GOLD III (severe), 22.2% GOLD IV (very severe). Most of the participants experienced COPD symptoms in the early morning (n25, 92.6%). Patients noted symptoms such as cough and impacts such as restricted morning activities. Cognitive debriefing interviews demonstrated that the items were comprehensive, relevant and interpreted as intended. A few items were edited to improve clarity based on feedback from the patients.
CONCLUSIONS: The Early Morning Symptoms of COPD Instrument (EMSCI) is a PRO instrument developed to evaluate the full range of early morning symptoms of COPD. The instrument was developed based on patients’ experiences to support content validity. The EMSCI can be used to characterize COPD patients’ experience of early morning symptoms for clinical decision making and for the evaluation of new treatments.
