title: Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.
abstract: Measures of health-related quality of life (HRQOL) and other patient-reported outcomes generate important data in cancer randomised trials to assist in assessing the risks and benefits of cancer therapies and fostering patient-centred cancer care. However, the various ways these measures are analysed and interpreted make it difficult to compare results across trials, and hinders the application of research findings to inform publications, product labelling, clinical guidelines, and health policy. To address these problems, the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) initiative has been established. This consortium, directed by the European Organisation for Research and Treatment of Cancer (EORTC), was convened to provide recommendations on how to standardise the analysis of HRQOL and other patient-reported outcomes data in cancer randomised trials. This Personal View discusses the reasons why this project was initiated, the rationale for the planned work, and the expected benefits to cancer research, patient and provider decision making, care delivery, and policy making.
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium. Electronic address: andrew.bottomley@eortc.be.
authors: Andrew
authors: A
authors: Bottomley
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
authors: Madeline
authors: M
authors: Pe
authors: Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
authors: Jeff
authors: J
authors: Sloan
authors: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
authors: Ethan
authors: E
authors: Basch
authors: Methodology and Quality of Life Unit in Cancer, INSERM U1098, Universitary Hospital of Besançon, Besançon, France.
authors: Franck
authors: F
authors: Bonnetain
authors: Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK.
authors: Melanie
authors: M
authors: Calvert
authors: Genentech, a member of the Roche group, San Francisco, CA, USA.
authors: Alicyn
authors: A
authors: Campbell
authors: Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
authors: Charles
authors: C
authors: Cleeland
authors: Adelphi Values, Bollington, Cheshire, UK.
authors: Kim
authors: K
authors: Cocks
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
authors: Laurence
authors: L
authors: Collette
authors: Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.
authors: Amylou C
authors: AC
authors: Dueck
authors: Office of Health Economics, London, UK.
authors: Nancy
authors: N
authors: Devlin
authors: Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.
authors: Hans-Henning
authors: HH
authors: Flechtner
authors: School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
authors: Carolyn
authors: C
authors: Gotay
authors: Obstetrics and Gynecology, Medical University Graz, Graz, Austria.
authors: Eva
authors: E
authors: Greimel
authors: Boehringer-Ingelheim, Frankfurt, Germany.
authors: Ingolf
authors: I
authors: Griebsch
authors: Department of Public Health and Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
authors: Mogens
authors: M
authors: Groenvold
authors: Methodology and Biostatistics department, University Hospital of Angers UNAM, Angers, France.
authors: Jean-Francois
authors: JF
authors: Hamel
authors: School of Psychology and Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
authors: Madeleine
authors: M
authors: King
authors: Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MA, USA.
authors: Paul G
authors: PG
authors: Kluetz
authors: Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
authors: Michael
authors: M
authors: Koller
authors: College of Pharmacy, University of Arizona, Tucson, AZ, USA.
authors: Daniel C
authors: DC
authors: Malone
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
authors: Francesca
authors: F
authors: Martinelli
authors: Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
authors: Sandra A
authors: SA
authors: Mitchell
authors: Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
authors: Carol M
authors: CM
authors: Moinpour
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
authors: Jammbe
authors: J
authors: Musoro
authors: Medicines and Healthcare products Regulatory Agency, London, UK.
authors: Daniel
authors: D
authors: O'Connor
authors: International Brain Tumour Alliance, Surrey, UK.
authors: Kathy
authors: K
authors: Oliver
authors: Genentech, a member of the Roche group, San Francisco, CA, USA.
authors: Elisabeth
authors: E
authors: Piault-Louis
authors: Internal Medicine/Oncology, Institut Jules Bordet, Brussels, Belgium.
authors: Martine
authors: M
authors: Piccart
authors: Health Sciences, University of Aveiro, Aveiro, Portugal; Lenitudes Medical Center & Research, Santa Maria da Feira, Portugal.
authors: Francisco L
authors: FL
authors: Pimentel
authors: European Centre for Disease Prevention and Control, Surveillance and Response Support Unit, Epidemiological Methods Section, Stockholm, Sweden.
authors: Chantal
authors: C
authors: Quinten
authors: VU University Medical Center, Department of Neurology & Brain Tumor Center, Amsterdam, The Netherlands.
authors: Jaap C
authors: JC
authors: Reijneveld
authors: Institute for Quality and Efficiency in Health Care, Cologne, Germany.
authors: Christoph
authors: C
authors: Schürmann
authors: Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
authors: Ashley Wilder
authors: AW
authors: Smith
authors: Health Canada, Ottawa, ON, Canada.
authors: Katherine M
authors: KM
authors: Soltys
authors: Leiden University Medical Center/Medical Center Haaglanden, Leiden/The Hague, Netherlands.
authors: Martin J B
authors: MJB
authors: Taphoorn
authors: Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK.
authors: Galina
authors: G
authors: Velikova
authors: European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
authors: Corneel
authors: C
authors: Coens
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000523:psychology / Q000628:therapy*; D000071066:Patient Reported Outcome Measures; D011788:Quality of Life