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

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  • 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
  • Francesca Martinelli
  • Sandra A Mitchell
  • Jammbe Z Musoro
  • Daniel O'Connor
  • Kathy Oliver
  • Elisabeth Piault-Louis
  • Martine Piccart
  • Chantal Quinten
  • Jaap C Reijneveld
  • Christoph Schürmann
  • Ashley Wilder Smith
  • Katherine M Soltys
  • Martin J B Taphoorn
  • Galina Velikova
  • Andrew Bottomley
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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.

Original languageEnglish
JournalThe Lancet Oncology
Volume21
Issue number2
Pages (from-to)e83-e96
Number of pages14
ISSN1470-2045
DOIs
Publication statusPublished - Feb 2020

Bibliographical note

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© 2020 Elsevier Ltd

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Copyright 2020 Elsevier B.V., All rights reserved.

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