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Lancet Oncol. 2016 Nov;17(11):e510-e514. doi: 10.1016/S1470-2045(16)30510-1. Epub 2016 Oct 18.

Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: a start in setting international standards.

Author information

1
European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium. Electronic address: andrew.bottomley@eortc.be.
2
European Organisation for Research and Treatment of Cancer (EORTC Headquarters), Brussels, Belgium.
3
Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.
4
Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.
5
Methodology and Quality of Life Unit in Cancer, INSERM U1098, Universitary Hospital of Besançon, Besançon, France.
6
Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, UK.
7
Genentech, a member of the Roche group, San Francisco, CA, USA.
8
Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
9
Adelphi Values, Bollington, Cheshire, UK.
10
Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA.
11
Office of Health Economics, London, UK.
12
Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.
13
School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada.
14
Obstetrics and Gynecology, Medical University Graz, Graz, Austria.
15
Boehringer-Ingelheim, Frankfurt, Germany.
16
Department of Public Health and Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
17
Methodology and Biostatistics department, University Hospital of Angers UNAM, Angers, France.
18
School of Psychology and Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
19
Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MA, USA.
20
Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
21
College of Pharmacy, University of Arizona, Tucson, AZ, USA.
22
Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
23
Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
24
Medicines and Healthcare products Regulatory Agency, London, UK.
25
International Brain Tumour Alliance, Surrey, UK.
26
Internal Medicine/Oncology, Institut Jules Bordet, Brussels, Belgium.
27
Health Sciences, University of Aveiro, Aveiro, Portugal; Lenitudes Medical Center & Research, Santa Maria da Feira, Portugal.
28
European Centre for Disease Prevention and Control, Surveillance and Response Support Unit, Epidemiological Methods Section, Stockholm, Sweden.
29
VU University Medical Center, Department of Neurology & Brain Tumor Center, Amsterdam, The Netherlands.
30
Institute for Quality and Efficiency in Health Care, Cologne, Germany.
31
Health Canada, Ottawa, ON, Canada.
32
Leiden University Medical Center/Medical Center Haaglanden, Leiden/The Hague, Netherlands.
33
Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK.

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.

PMID:
27769798
DOI:
10.1016/S1470-2045(16)30510-1
[Indexed for MEDLINE]
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