Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD).

BACKGROUND: The morning tends to be the most difficult time of day for many patients with chronic obstructive pulmonary disease (COPD) when symptoms can limit one's ability to perform even simple activities. Morning symptoms have been linked to higher levels of work absenteeism, thereby increasing the already substantial economic burden associated with COPD. A validated patient-reported outcome (PRO) instrument designed to capture morning symptoms will allow for a more comprehensive approach to the evaluation of treatment benefit in COPD clinical trials. METHODS: A qualitative interview study was conducted among a sample of symptomatic adults with COPD. Concept elicitation interviews (n = 35) were conducted to identify COPD morning symptoms, followed by cognitive interviews (n = 21) to ensure patient comprehension of the items, instructions and response options of the draft COPD Morning Symptom Diary (COPD-MSD). All interview transcript data were coded using ATLAS.ti software for content analysis. RESULTS: Mean age of the concept elicitation and cognitive interview sample was 65.0 years (±7.5) and 62.3 years (±8.3), respectively. The study sample represented the full range of COPD severity (Global Initiative for Chronic Lung Disease [GOLD] classifications I-IV) and included a mix of racial backgrounds, employment status and educational achievement. During the concept elicitation interviews, the three most frequently reported morning symptoms were shortness of breath (n = 35/35; 100 %), phlegm/mucus (n = 31/35; 88.6 %), and cough (n = 30/35; 85.7 %). A group of clinical and instrument development experts convened to review the concept elicitation data and develop the initial 32-item draft COPD-MSD. Cognitive interviews indicated subjects found the draft COPD-MSD to be comprehensive, clear, and easy to understand. The COPD-MSD underwent minor editorial revisions and streamlining based on cognitive interviews and input from the experts to yield the final 19-item daily diary. CONCLUSIONS: This study supports the content validity of the new COPD-MSD and positions the diary for quantitative psychometric testing

Psychophysiological processes of stress in chronic physical illness: a theoretical perspective

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/75576/1/j.1365-2648.1990.tb01843.x.pd

Reliability and Validity of the Modified Erikson Psychosocial Stage Inventory in Diverse Samples

The Modified Erikson Psychosocial Stage Inventory (MEPSI) is a relatively simple survey measure designed to assess the strength of psychosocial attributes that arise from progression through Erikson's eight stages of development. The purpose of this study was to employ secondary analysis to evaluate the internal-consistency reliability and construct validity of the MEPSl acrossfour diverse samples: healthy young adults, hemophilic men, healthy older adults, and older adults with chronic obstructive pulmonary disease. Special attention was given to the performance of the measure across gender, with exploratory analyses examining possible age cohort and health status effects. Internal-consistency estimates for the aggregate measure were high, whereas subscale reliability levels varied across age groups. Construct validity was supported across samples. Gender, cohort, and health effects offered interesting psychometric and theoretical insights and direction for further research. Findings indicated that the MEPSI might be a useful instrumentfor operationalizing and testing Eriksonian developmental theory in adults.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/68351/2/10.1177_019394599501700205.pd