Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol

Research output: Contribution to journalArticle


  • Thomas Keeley
  • Jo Armes
  • Julia M Brown
  • Lynn Calman
  • Chris Copland
  • Fabio Efficace
  • Anna Gavin
  • Adam Glaser
  • Diana M Greenfield
  • Anne Lanceley
  • Rachel M Taylor
  • Galina Velikova
  • Michael Brundage
  • Rebecca Mercieca-Bebber
  • Madeleine T King
  • Melanie Calvert

Colleges, School and Institutes

External organisations

  • Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK.
  • PAREXEL International, London, United Kingdom.
  • School of Veterinary Medicine, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.
  • University of Leeds
  • Department of Child Health, Clinical and Experimental Sciences, Faculty of Medicine, Southampton General Hospital, University of Southampton, Southampton
  • NCRI Psychosocial Oncology and Survivorship CSG, York, UK.
  • Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
  • N. Ireland Cancer Registry, Queen's University Belfast, Centre for Public Health, Belfast, UK.
  • UCL EGA Institute for Women's Health, University College London, London, UK.
  • Cancer Division, University College Hospitals NHS Foundation Trust, London, UK.
  • Queen's Department of Oncology School of Medicine, Queen's University Cancer Research Institute, Kingston, Ontario, Canada.
  • Psycho-Oncology Cooperative Research Group, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia.
  • Institute of Applied Health Research, University of Birmingham, Birmingham, Uk.


INTRODUCTION: Patient-reported outcomes (PROs) are increasingly included within cancer clinical trials. If appropriately collected, analysed and transparently reported, these data might provide invaluable evidence to inform patient care. However, there is mounting indication that the design and reporting of PRO data in cancer trials may be suboptimal. This programme of research will establish via three interlinked studies whether these findings are applicable to UK cancer trials, and if so, how to best enhance the way PROs are assessed, managed and reported in clinical trials. This study will explore with key stakeholders factors that influence optimal PRO protocol content, implementation and reporting and make recommendations for training and guidance.

METHODS AND ANALYSIS: Semistructured interviews will be conducted with members of key stakeholder groups. The purposive sample of up to 48 participants will include: (1) trial chief investigators, trial management group members, statisticians and research nurses of cancer trials including primary or secondary PRO recruited via the National Cancer Research Institute (NCRI) Clinical Studies Group and Consumer Liaison Group and the UK Clinical Research Collaboration Registered UK Clinical Trial Unit Network; (2) NCRI Consumer Liaison Group members; (3) international experts in PRO oncology trial design; and (4) journal editors and funding bodies. Data will be analysed using directed thematic analysis employing a coding frame and modified as analysis progresses. Formal triangulation of coding and member checking will be employed to enhance credibility.

ETHICS AND DISSEMINATION: This study was approved by the University of Birmingham Ethics Committee (Ref: ERN_17-0085). Findings will be disseminated via conference presentations, peer-reviewed journals, patient groups and social media (@CPROR_UoB; http://www.birmingham.ac.uk/cpror).



Original languageEnglish
Article numbere017282
JournalBMJ open
Issue number2
Publication statusPublished - 3 Feb 2018


  • cancer clinical trials, mixed methods, patient reported outcomes, quality of life