Abstract
An important outcome of any clinical intervention is the change in the subject's own perceived state of health. This can be categorized as health-related quality of life (HRQL), utility (preference-based health state), and daily life performance. 174 Swedish subjects with chronic obstructive pulmonary disease (COPD) (mean age 64.3 ± 12 years) completed five self-administered questionnaires: Short Form 36 (SF-36), St George's Respiratory Questionnaire (SGRQ), EuroQol-5D (EQ-5D), Health States-COPD (HS-COPD), and Work Productivity and Activity Impairment Questionnaire for COPD (WPAI-COPD). The subjects scored these outcomes instruments for ease of completion using a 5-point scale. The time taken to complete them was noted and the administrators' opinion of the subjects' comprehension of the questionnaires recorded using a 4-point scale.A score of 1–3 ("very easy" to "acceptable") was recorded by 92% of subjects for the SF-36, 90% for SGRQ, 80% for EQ-5D, 83% for WPAI-COPD, and 53% for HS-COPD. The HS-COPD was graded "very difficult" to complete by 21% of subjects compared with 3–5% of subjects for the other questionnaires. The mean time taken to complete all questionnaires was 39 minutes, and the large majority of subjects scored "good" for understanding by the administrator. Age correlated significantly with the degree of the subject's opinion of the ease of completion of five outcomes instruments, while the influence of gender, socio-economic status and disease severity was not statistically significant.
Highlights
Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible airways disease characterized by emphysema and chronic bronchitis, resulting in breathlessness, cough and sputum
Respiratory diseases are among the three principal causes of lost working days worldwide and COPD is responsible for the majority of the loss [3]
Their use is established in many fields, such as the gastrointestinal and oncology fields, questionnaires are rarely used as primary endpoints in clinical studies of respiratory disease
Summary
Chronic obstructive pulmonary disease (COPD) is a progressive and largely irreversible airways disease characterized by emphysema and chronic bronchitis, resulting in breathlessness, cough and sputum. Subjects with COPD experience increasing deterioration of their health-related quality of life (HRQL), with greater impairment in their ability to work and declining participation in social and physical activities. HRQL, utility, and productivity impairment outcomes instruments are increasingly used in clinical studies. Their use is established in many fields, such as the gastrointestinal and oncology fields, questionnaires are rarely used as primary endpoints in clinical studies of respiratory disease. The European Agency for the Evaluation of Medicinal Products (EMEA) states that, in clinical studies of COPD, symptomatology should be a primary endpoint, and the use of a disease-specific HRQL questionnaire is recommended [4]. Several disease-specific and generic questionnaires suited to the respiratory field have been developed in recent years
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