A measure of quality of life for clinical trials in chronic lung disease.

TLDR

Pulmonary function and exercise capacity poorly predict quality of life, prompting the development of a self‑report questionnaire to assess treatment effects in clinical trials. The questionnaire was constructed from items most frequently reported by 100 patients with chronic airflow limitation, covering dyspnoea, fatigue, emotional function, and mastery, and its responsiveness was evaluated in 13 patients before and after drug optimisation and 28 patients before and after a respiratory rehabilitation programme. The instrument demonstrated excellent reproducibility (CV < 12 %), significant improvements across all four dimensions following treatment or rehabilitation, and strong correlations with spirometry, exercise capacity, and global ratings, confirming its precision, validity, and responsiveness as a disease‑specific quality‑of‑life measure.

Abstract

Since the relationships between pulmonary function, exercise capacity, and functional state or quality of life are generally weak, a self report questionnaire has been developed to determine the effect of treatment on quality of life in clinical trials. One hundred patients with chronic airflow limitation were asked how their quality of life was affected by their illness, and how important their symptoms and limitations were. The most frequent and important items were used to construct a questionnaire evaluating four dimensions: dyspnoea, fatigue, emotional function, and the patient9s feeling of control over the disease (mastery). Reproducibility, tested by repeated administration to patients in a stable condition, was excellent: the coefficient of variation was less than 12% for all four dimensions. Responsiveness (sensitivity to change) was tested by administering the questionnaire to 13 patients before and after optimisation of their drug treatment and to another 28 before and after participation in a respiratory rehabilitation programme. In both cases large, statistically significant improvements in all four dimensions were noted. Changes in questionnaire score were correlated with changes in spirometric values, exercise capacity, and patients9 and physicians9 global ratings. Thus it has been shown that the questionnaire is precise, valid, and responsive. It can therefore serve as a useful disease specific measure of quality of life for clinical trials.