Measuring health-related quality of life in clinical trials in cystic fibrosis

作者：Abbott J^*; Hart A; Havermans T; Matossian A; Goldbeck L; Barreto C; Bergsten Brucefors A; Besier T; Catastini P; Lupi F; Staab D

来源：Journal of Cystic Fibrosis, 2011, 10: S82-S85.

DOI：10.1016/S1569-1993(11)60013-1

• Cystic fibrosis
• Clinical trial
• Quality of life measurement
• Patient-reported outcome

The inclusion of health-related quality of life (HRQoL) as an outcome measure in cystic fibrosis (CF) clinical trials can supply important patient-reported information not captured by other endpoints. Both an appropriate HRQoL measure and sound methodology are required in order to draw valid inferences about treatments and HRQoL. This paper provides the current consensus of the HRQoL Outcomes Group. Particular consideration has been given to the appropriateness of measurement scales, the rationale for including specific domains as endpoints, the importance of considering baseline ceiling effects and the difficulties of data interpretation. Guidance is provided on HRQoL measurement in National and European CF clinical trials.

• 出版日期2011-6