Journal article

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

Corneel Coens, Madeline Pe, Amylou C Dueck, Jeff Sloan, Ethan Basch, Melanie Calvert, Alicyn Campbell, Charles Cleeland, Kim Cocks, Laurence Collette, Nancy Devlin, Lien Dorme, Hans-Henning Flechtner, Carolyn Gotay, Ingolf Griebsch, Mogens Groenvold, Madeleine King, Paul G Kluetz, Michael Koller, Daniel C Malone Show all

The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2020


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 w..

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Funding Acknowledgements

The European Organisation for Research and Treatment of Cancer received an unrestricted education grant from Boehringer Ingelheim to initiate this work and from Genentech, a member of the Roche Group, for continuity funding. We thank the International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research for their support and review of the final manuscript and we thank Gina Mazza for the help with the survey research in the missing data part. This publication reflects the views of the individual authors and should not be construed to represent official views or policies of the US Food and Drug Administration, US National Cancer Institute, Medicines and Healthcare products Regulatory Agency, Institute for Quality and Efficiency in Health Care, Health Canada, the UK National Health Service, the National Institute for Health Research, or the UK Department of Health. This study received no funding from the US National Institutes of Health (NIH). AWS and SAM are employed by NIH. No other authors were fully or partly NIH funded, employed by NIH, or are in receipt of an NIH grant.