title: Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials.
abstract: Breast cancer is the leading cause of cancer death among women worldwide, and increasingly, randomised controlled trials of this disease are measuring the health-related quality of life of these patients. In this systematic Review, we assess the adequacy of methods used to report health-related quality of life (HRQOL) from 49 eligible randomised controlled trials of advanced breast cancer. We compare our findings with those from the literature to investigate whether the standard of HRQOL reporting in this field has changed. We conclude that the overall reporting of HRQOL has improved, but some crucial aspects remain problematic, such as the absence of HRQOL research hypotheses and the overemphasis on statistical rather than clinical significance. Additionally, new challenges are arising with the emergence of novel treatments and the advent of personalised medicine, and improved HRQOL tools are required to cover the range of side-effects of newer therapies.
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium. Electronic address: irina.ghislain@eortc.be.
authors.forename: Irina
authors.initials: I
authors.lastname: Ghislain
authors.affiliation: European Centre for Disease Prevention and Control, Stockholm, Sweden.
authors.forename: Efstathios
authors.initials: E
authors.lastname: Zikos
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
authors.forename: Corneel
authors.initials: C
authors.lastname: Coens
authors.affiliation: European Centre for Disease Prevention and Control, Stockholm, Sweden.
authors.forename: Chantal
authors.initials: C
authors.lastname: Quinten
authors.affiliation: Breast Reconstruction Quality of Life Group, University of Bristol, Bristol, UK.
authors.forename: Vasiliki
authors.initials: V
authors.lastname: Balta
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Tryfonidis
authors.affiliation: Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
authors.affiliation: Breast International Group, Brussels, Belgium.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Zardavas
authors.affiliation: Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria.
authors.forename: Eva
authors.initials: E
authors.lastname: Nagele
authors.affiliation: Department of Obstetrics and Gynecology, Medical University of Graz, Graz, Austria.
authors.forename: Vesna
authors.initials: V
authors.lastname: Bjelic-Radisic
authors.affiliation: Breast Unit, Champalimaud Clinical Center, Lisbon, Portugal.
authors.forename: Fatima
authors.initials: F
authors.lastname: Cardoso
authors.affiliation: Academic Medical Center, Amsterdam, Netherlands.
authors.forename: Mirjam A G
authors.initials: MAG
authors.lastname: Sprangers
authors.affiliation: Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.affiliation: European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
mesh_terms: D001943:Breast Neoplasms / Q000556:secondary* / Q000628:therapy*; D005260:Female; D006801:Humans; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires