title: Methodological and statistical issues of quality of life (QoL) and economic evaluation in cancer clinical trials: report of a workshop.
abstract: In recent years, quality of life (QoL) and economic evaluations have become increasingly important as additional outcome measures in cancer clinical trials. However, both fields of research are relatively new and in need of finding solutions to a substantial number of specific methodological problems. This paper reports on the proceedings of a symposium aimed at summarising and discussing some of the most contentious methodological and statistical issues in QoL and economic evaluations. In addition, possible solutions are indicated and the most pertinent areas of research are identified. Issues specific to QoL evaluations that are addressed include clinically meaningful changes in QoL scores; how to analyse QoL data and to handle missing and censored data and integration of length of life and QoL outcomes. Issues specific to economic evaluations are the advantages and disadvantages of various outcome measures; statistical methods to analyse economic data and choice of decision criteria and analytical perspective. How to perform QoL and economic evaluations in large and simple trials and whether the gap between QoL and utility measures can be bridged are also discussed.
authors.affiliation: EORTC Data Centre, Brussels, Belgium.
authors.forename: N
authors.initials: N
authors.lastname: Neymark
authors.forename: W
authors.initials: W
authors.lastname: Kiebert
authors.forename: K
authors.initials: K
authors.lastname: Torfs
authors.forename: L
authors.initials: L
authors.lastname: Davies
authors.forename: P
authors.initials: P
authors.lastname: Fayers
authors.forename: B
authors.initials: B
authors.lastname: Hillner
authors.forename: R
authors.initials: R
authors.lastname: Gelber
authors.forename: G
authors.initials: G
authors.lastname: Guyatt
authors.forename: P
authors.initials: P
authors.lastname: Kind
authors.forename: D
authors.initials: D
authors.lastname: Machin
authors.forename: E
authors.initials: E
authors.lastname: Nord
authors.forename: D
authors.initials: D
authors.lastname: Osoba
authors.forename: D
authors.initials: D
authors.lastname: Revicki
authors.forename: K
authors.initials: K
authors.lastname: Schulman
authors.forename: K
authors.initials: K
authors.lastname: Simpson
mesh_terms: D002986:Clinical Trials as Topic / Q000191:economics*; D003365:Costs and Cost Analysis; D006801:Humans; D009369:Neoplasms / Q000191:economics* / Q000628:therapy; D011788:Quality of Life