Journal of Cystic Fibrosis
Volume 10, Supplement 2 , Pages S82-S85, June 2011

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

  • J. Abbott

      Affiliations

    • University of Central Lancashire, Preston, PR1 2HE, UK
    • Corresponding Author InformationCorresponding author: Professor Janice Abbott, School of Psychology, University of Central Lancashire, Preston, PR1 2HE, UK. Tel.: +44 (0)1772 893790
    • ,
  • A. Hart

      Affiliations

    • University of Central Lancashire, Preston, PR1 2HE, UK
    • ,
  • T. Havermans

      Affiliations

    • University Hospital Leuven, 3000 Leuven, Belgium
    • ,
  • A. Matossian

      Affiliations

    • University Hospital Erasme, 1070 Brussels, Belgium
    • ,
  • L. Goldbeck

      Affiliations

    • University Clinic Ulm, D-89075 Ulm, Germany
    • ,
  • C. Barreto

      Affiliations

    • University Hospital Santa Maria, 1649-035 Lisbon, Portugal
    • ,
  • A. Bergsten-Brucefors

      Affiliations

    • University Hospital Huddinge, SE-141 86 Stockholm, Sweden
    • ,
  • T. Besier

      Affiliations

    • University Clinic Ulm, D-89075 Ulm, Germany
    • ,
  • P. Catastini

      Affiliations

    • Meyer Hospital Florence University, 50132 Florence, Italy
    • ,
  • F. Lupi

      Affiliations

    • University of Bologna, 40127 Bologna, Italy
    • ,
  • D. Staab

      Affiliations

    • Charité Humboldt University, 10117 Berlin, Germany

Abstract 

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.

Keywords:  Cystic fibrosis , Clinical trial , Quality of life measurement , Patient-reported outcome

No full text is available. To read the body of this article, please view the PDF online.

To access this article, please choose from the options below

Login to an existing account or Register a new account.

  • Purchase this article for 31.50 USD (You must login/register to purchase this article)

    Online access for 24 hours. The PDF version can be downloaded as your permanent record.

  • Subscribe to this title

    Get unlimited online access to this article and all other articles in this title 24/7 for one year.

  • Claim access now

    For current subscribers with Society Membership or Account Number.

  • Visit SciVerse ScienceDirect to see if you have access via your institution.
 

PII: S1569-1993(11)60013-1

doi:10.1016/S1569-1993(11)60013-1

Journal of Cystic Fibrosis
Volume 10, Supplement 2 , Pages S82-S85, June 2011

Article Tools