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 journalArticle


  • Corneel Coens
  • Madeline Pe
  • Amylou C Dueck
  • J Sloan
  • Ethan Basch
  • A Campbell
  • Charles Cleeland
  • K Cocks
  • L Collette
  • N Devlin
  • Lien Dorme
  • Hans-Henning Flechtner
  • C Gotay
  • I Griebsch
  • M Groenvold
  • M King
  • Paul G Kluetz
  • M Koller
  • Daniel C Malone
  • Francesca Martinelli
  • Sandra A Mitchell
  • Jammbe Musoro
  • D O'Connor
  • K Oliver
  • Elisabeth Piault-Louis
  • Martine Piccart
  • C Quinten
  • Jaap C Reijneveld
  • C Schurmann
  • AW Smith
  • Katherine M Soltys
  • M Taphoorn
  • Galina Velikova
  • A Bottomley

Colleges, School and Institutes

External organisations

  • Leeds Institute of Cancer and Pathology
  • University of Leeds


Patient-reported outcomes (PROs), such as symptoms, function and other health- related quality of life aspects, are increasingly evaluated in cancer randomized controlled trials (RCTs) to provide information on treatment risks, benefits, and tolerability. However, expert opinion and critical literature review demonstrated 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 (SISAQOL) Consortium was formed to establish PRO analysis recommendations. Four issues were prioritized: developing a taxonomy of research objectives that can be matched with appropriate statistical methods, identifying appropriate statistical methods for PRO analysis, standardizing statistical terminology related to missing data, and determining appropriate ways to manage missing data. This paper presents PRO analysis recommendations developed through critical literature reviews and a structured collaborative process with diverse international stakeholders, providing a robust foundation for widespread endorsement. Further developments are also discussed.


Original languageEnglish
Pages (from-to)PE83-E96
JournalThe Lancet Oncology
Issue number2
Publication statusPublished - 1 Feb 2020