Print page Print page
Switch language
The Capital Region of Denmark - a part of Copenhagen University Hospital

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

Research output: Contribution to journalReviewResearchpeer-review

  1. Trastuzumab for early-stage, HER2-positive breast cancer: a meta-analysis of 13 864 women in seven randomised trials

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Variation in the risk of colorectal cancer in families with Lynch syndrome: a retrospective cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Twice-daily chemoradiotherapy in limited-stage small-cell lung cancer - Authors' reply

    Research output: Contribution to journalLetterResearchpeer-review

  1. Regional and age differences in specialised palliative care for patients with pancreatic cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Bereavement among adult siblings: An examination of health service utilization and mental health outcomes

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Early specialised palliative care: interventions, symptoms, problems

    Research output: Contribution to journalJournal articleResearchpeer-review

  • 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
View graph of relations

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
Issue number2
Pages (from-to)e83-e96
Number of pages14
Publication statusPublished - Feb 2020

Bibliographical note

Publisher Copyright:
© 2020 Elsevier Ltd

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

ID: 59912774