title: Statistical issues in quality-of-life assessment.
abstract: In recent years, the assessment of drug effects on quality of life (QOL) has become very popular in clinical trials. QOL assessment quantifies the ability of a person to function normally in society. It may be used to distinguish between therapies that appear to be equally efficacious and equally safe. QOL is usually assessed by a QOL instrument, which consists of a number of questions. A QOL instrument is a very subjective tool that usually has a large variation. To ensure the accuracy and reliability of QOL assessment in clinical trials, the adopted QOL instrument should be validated. Some statistical tests are proposed for validation of a QOL instrument in terms of validity, reliability, test-retest reproducibility, responsiveness, and sensitivity. Some statistical issues regarding the validation of utility analysis and calibration for QOL against life events and/or disease status will also be discussed.
authors.affiliation: Biostatistics and Data Management, Bristol-Myers Squibb Company, Plainsboro, New Jersey 08536, USA.
authors.forename: S C
authors.initials: SC
authors.lastname: Chow
authors.forename: F Y
authors.initials: FY
authors.lastname: Ki
mesh_terms: D002138:Calibration; D002986:Clinical Trials as Topic; D006801:Humans; D011788:Quality of Life; D015203:Reproducibility of Results; D012107:Research Design; D013223:Statistics as Topic