Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Measuring health-related quality of life in clinical trials in cystic fibrosis
AU - Abbott, Janice
AU - Hart, Anna
AU - Havermans, T
AU - Matossian, A
AU - Goldbeck, L
AU - Barreto, C
AU - Bergsten-Brucefors, A
AU - Besier, T
AU - Catastini, P
AU - Lupi, F
AU - Staab, D
PY - 2011/6
Y1 - 2011/6
N2 - 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.
AB - 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.
KW - Cystic fibrosis
KW - Clinical trial
KW - Quality of life measurement
KW - Patient-reported outcome
U2 - 10.1016/S1569-1993(11)60013-1
DO - 10.1016/S1569-1993(11)60013-1
M3 - Journal article
VL - 10
SP - S82-S85
JO - Journal of Cystic Fibrosis
JF - Journal of Cystic Fibrosis
IS - Supplement 2
ER -