Introduction In patients with Chronic Obstructive Pulmonary Disease (COPD), symptoms in the early morning have been reported as being the most troublesome and can negatively impact quality of life. This abstract summarises the development and psychometric testing of the Early Morning Symptoms of COPD Instrument (EMSCI) designed to collect data to evaluate COPD patients’ experiences early in the morning.
Methods Following a literature review and clinical expert interviews, four focus groups were conducted to identify initial concepts and develop draft items for the EMSCI. One-on-one cognitive debriefing interviews were conducted with 10 COPD patients to confirm item readability, and comprehensiveness. Data from a clinical trial [AUGMENT] in COPD patients (N = 1663) was used for item analyses to inform item-reduction and scoring; and to evaluate psychometric properties. Test-retest reliability was assessed using intra-class coefficient (ICC). Correlations with baseline assessments including the SGRQ, E-RS, and FEV1 were used to evaluate concurrent validity.
Results Focus group participants (n = 27, mean age = 68.1 y) reported mucus/phlegm (80%), shortness of breath (52%), coughing (48%), tightness in chest (24%), wheezing (8%) and chest congestion (8%) as the most common early morning symptoms. Limitations to activities and rescue medication use in the early morning were reported by 56% and 24% respectively. Cognitive interviews of early versions of the EMSCI suggested the items were comprehensive, relevant and interpreted as intended. Analyses of EMSCI data collected in the Phase 3 trial confirmed a one-factor structure for the symptom severity items. Reliability was confirmed for the 6-item symptom severity (ICC = 0.84), overall symptom severity (ICC = 0.84), activity limitation (ICC = 0.85), and rescue medication (ICC = 0.62) scores. Concurrent validity (Table 1) was supported by positive correlations with both the SGRQ and the E-RS scores.
Conclusions The EMSCI is a reliable and valid instrument that was developed based on patients’ experiences to evaluate early morning symptoms and impacts of COPD. It is available to be used for clinical decision making and as a clinical study endpoint for the evaluation of new treatments.