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
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
收藏
页码:S82 / S85
页数:4
相关论文
共 14 条
  • [1] Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: A critical review
    Abbott J.
    Hart A.
    [J]. Health and Quality of Life Outcomes, 3 (1)
  • [2] The European DISABKIDS project: Development of seven condition-specific modules to measure health related quality of life in children and adolescents
    Baars R.M.
    Atherton C.I.
    Koopman H.M.
    Bullinger M.
    Power M.
    Bullinger M.
    Schmidt S.
    Petersen C.
    Koopman H.
    Baars R.
    Hoare P.
    Power M.
    Atherton C.
    Simeoni M.C.
    Tsanakas J.
    Karagianni P.
    Hatziagorou E.
    Vidalis A.
    Chaplin J.E.
    Quittan M.
    Schuhfried O.
    Hachemian N.
    Thyen U.
    Müller-Godeffroy E.
    [J]. Health and Quality of Life Outcomes, 3 (1)
  • [3] The adaptations of a quality of life questionnaire for routine use in clinical practice: the Chronic Respiratory Disease Questionnaire in cystic fibrosis
    Bradley, J
    Dempster, M
    Wallace, E
    Elborn, S
    [J]. QUALITY OF LIFE RESEARCH, 1999, 8 (1-2) : 65 - 71
  • [4] Donadio F, 2009, J ENDOCRINOL INVEST, V32, P576, DOI [10.1007/BF03346511, 10.3275/6360]
  • [5] Development of a disease specific health related quality of life measure for adults and adolescents with cystic fibrosis
    Gee, L
    Abbott, J
    Conway, SP
    Etherington, C
    Webb, AK
    [J]. THORAX, 2000, 55 (11) : 946 - 954
  • [6] Gee L, 2002, J Cyst Fibros, V1, P137, DOI 10.1016/S1569-1993(02)00079-6
  • [7] Questions on life satisfaction for adolescents and adults with cystic fibrosis - Development of a disease-specific questionnaire
    Goldbeck, L
    Schmitz, TG
    Heinrich, G
    Herschbach, P
    [J]. CHEST, 2003, 123 (01) : 42 - 48
  • [8] Comparison of three generic questionnaires measuring quality of life in adolescents and adults with cystic fibrosis: The 36-item short form health survey, the quality of life profile for chronic diseases, and the questions on life satisfaction
    Goldbeck, L
    Schmitz, TG
    [J]. QUALITY OF LIFE RESEARCH, 2001, 10 (01) : 23 - 36
  • [9] Development of the Cystic Fibrosis Questionnaire (CFQ) for assessing quality of life in pediatric and adult patients
    Henry, B
    Aussage, P
    Grosskopf, C
    Goehrs, JM
    [J]. QUALITY OF LIFE RESEARCH, 2003, 12 (01) : 63 - 76
  • [10] Klijn Peter H, 2004, J Cyst Fibros, V3, P29