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

被引：26

作者：

Abbott, J. ^{[1
]}

Hart, A.

Havermans, T. ^{[2
]}

Matossian, A. ^{[3
]}

Goldbeck, L. ^{[4
]}

Barreto, C. ^{[5
]}

Bergsten-Brucefors, A. ^{[6
]}

Besier, T. ^{[4
]}

Catastini, P. ^{[7
]}

Lupi, F. ^{[8
]}

Staab, D. ^{[9
]}

机构：

[1] Univ Cent Lancashire, Sch Psychol, Preston PR1 2HE, Lancs, England

[2] Univ Hosp Leuven, B-3000 Louvain, Belgium

[3] Erasme Univ Hosp, B-1070 Brussels, Belgium

[4] Univ Clin Ulm, D-89075 Ulm, Germany

[5] Univ Hosp Santa Maria, P-1649035 Lisbon, Portugal

[6] Huddinge Univ Hosp, SE-14186 Stockholm, Sweden

[7] Univ Florence, Meyer Hosp, I-50132 Florence, Italy

[8] Univ Bologna, I-40127 Bologna, Italy

[9] Charite Humboldt Univ, D-10117 Berlin, Germany

来源：

JOURNAL OF CYSTIC FIBROSIS | 2011年 / 10卷

关键词：

Cystic fibrosis; Clinical trial; Quality of life measurement; Patient-reported outcome; QUESTIONNAIRE; ADOLESCENTS; VALIDATION; ADULTS; SATISFACTION;

D O I：

10.1016/S1569-1993(11)60013-1

中图分类号：

R56 [呼吸系及胸部疾病];

学科分类号：

摘要：

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. (C) 2011 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

引用

页码：S82 / S85

页数：4

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