Quality of life as an outcome measure in clinical trials

The Quality of Life-Bronchiectasis (QOL-B), is a new, self-administered, patient-reported outcome measure assessing symptoms, functioning and health-related quality of life for patients with non-cystic fibrosis (CF) bronchiectasis. It was developed using the FDA Guidance on Patient-Reported Outcomes (FDA, 2009) and with consultations from the FDA. Thus, it can be used as a primary or secondary endpoint in clinical trials of new medications. It contains 37 items on 8 scales (Respiratory Symptoms, Physical, Role, Emotional and Social Functioning, Vitality, Health Perceptions and Treatment Burden). Psychometric ana…