International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium.

Autor:	Coens C; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Pe M; European Organisation for Research and Treatment of Cancer, Brussels, Belgium. Electronic address: madeline.pe@eortc.org., Dueck AC; Alliance Statistics and Data Center, Mayo Clinic, Scottsdale, AZ, USA., Sloan J; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA., Basch E; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA., Calvert M; Centre for Patient Reported Outcomes Research, Institute of Applied Health Research and National Institute for Health Research Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK., Campbell A; Patient Relevant Evidence, San Francisco, CA, USA., Cleeland C; Department of Symptom Research, The University of Texas MD Anderson Cancer Center, Houston, TX, USA., Cocks K; Adelphi Values, Bollington, Cheshire, UK., Collette L; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Devlin N; Centre for Health Policy, School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia., Dorme L; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Flechtner HH; Clinic for Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany., Gotay C; School of Population and Public Health, University of British Columbia, Vancouver, BC, Canada., Griebsch I; Boehringer Ingelheim International GmbH, Ingelheim, Germany., Groenvold M; Department of Public Health, Bispebjerg Hospital and University of Copenhagen, Copenhagen, Denmark., King M; School of Psychology, University of Sydney, Sydney, NSW, Australia., Kluetz PG; Office of Hematology and Oncology Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA., Koller M; Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany., Malone DC; College of Pharmacy, University of Arizona, Tucson, AZ, USA., Martinelli F; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Mitchell SA; Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA., Musoro JZ; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., O'Connor D; Medicines and Healthcare products Regulatory Agency, London, UK., Oliver K; International Brain Tumour Alliance, Surrey, UK., Piault-Louis E; Genentech, Roche Group, San Francisco, CA, USA., Piccart M; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium., Quinten C; European Centre for Disease Prevention and Control, Surveillance and Response Support Unit, Epidemiological Methods Section, Stockholm, Sweden., Reijneveld JC; Department of Neurology and Brain Tumor Center, VU University Medical Center, Amsterdam, Netherlands., Schürmann C; Institute for Quality and Efficiency in Health Care, Cologne, Germany., Smith AW; Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA., Soltys KM; Health Canada, Ottawa, ON, Canada., Taphoorn MJB; Department of Neurology, Leiden University Medical Center, Leiden; Department of Neurology, Haaglanden Medical Center, The Hague, Netherlands., Velikova G; Leeds Institute of Cancer and Pathology, University of Leeds, St James's Hospital, Leeds, UK; International Society for Quality of Life Research, Milwaukee, WI, USA., Bottomley A; European Organisation for Research and Treatment of Cancer, Brussels, Belgium.
Jazyk:	angličtina
Zdroj:	The Lancet. Oncology [Lancet Oncol] 2020 Feb; Vol. 21 (2), pp. e83-e96.
DOI:	10.1016/S1470-2045(19)30790-9
Abstrakt:	Patient-reported outcomes (PROs), such as symptoms, function, and other health-related quality-of-life aspects, are increasingly evaluated in cancer randomised controlled trials (RCTs) to provide information about treatment risks, benefits, and tolerability. However, expert opinion and critical review of the literature showed no consensus on optimal methods of PRO analysis in cancer RCTs, hindering interpretation of results. The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data Consortium was formed to establish PRO analysis recommendations. Four issues were prioritised: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardising statistical terminology related to missing data, and determining appropriate ways to manage missing data. This Policy Review presents recommendations for PRO analysis developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, which provides a foundation for endorsement; ongoing developments of these recommendations are also discussed. (Copyright © 2020 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
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