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Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
  1. Ameeta Retzer1,2,
  2. Thomas Keeley3,
  3. Khaled Ahmed1,2,
  4. Jo Armes4,
  5. Julia M Brown5,
  6. Lynn Calman6,
  7. Chris Copland7,
  8. Fabio Efficace8,
  9. Anna Gavin9,
  10. Adam Glaser10,
  11. Diana M Greenfield11,
  12. Anne Lanceley12,
  13. Rachel M Taylor13,
  14. Galina Velikova10,14,
  15. Michael Brundage15,
  16. Rebecca Mercieca-Bebber1,16,17,
  17. Madeleine T King16,17,
  18. Melanie Calvert1,2,
  19. Derek Kyte1,2
  1. 1 Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK
  2. 2 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  3. 3 PAREXEL International, London, UK
  4. 4 School of Health Sciences, University of Surrey, Guildford, UK
  5. 5 UKCRC Registered CTU Network, University of Leeds, Leeds, UK
  6. 6 Faculty of Health Sciences, University of Southampton, Southampton, UK
  7. 7 NCRI Psychosocial Oncology and Survivorship CSG, York, UK
  8. 8 Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy
  9. 9 N. Ireland Cancer Registry, Queen’s University Belfast, Centre for Public Health, Belfast, UK
  10. 10 Leeds Institute of Cancer & Pathology, University of Leeds, Leeds, UK
  11. 11 Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  12. 12 UCL EGA Institute for Women’s Health, University College London, London, UK
  13. 13 Cancer Division, University College Hospitals NHS Foundation Trust, London, UK
  14. 14 Patient Centred Outcomes Group: Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK
  15. 15 Queen’s Department of Oncology School of Medicine, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada
  16. 16 Central Clinical School, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
  17. 17 Psycho-Oncology Cooperative Research Group, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia
  1. Correspondence to Dr Melanie Calvert; m.calvert{at}bham.ac.uk

Abstract

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).

PROSPERO registration number CRD42016036533.

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

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Footnotes

  • Contributors The study concept and design was conceived by DK, TK, FE, JA, JMB, LC, CC, AnG, AdG, DMG, AL, RMT, GV, MB, RM-B, MTK and MC. AR and KA will recruit, screen and consent participants and will undertake the interviews with input and supervision from DK and MC. AR prepared the first draft of the manuscript. DK, TK, FE, JA, JMB, LC, CC, AnG, AdG, DMG, AL, RMT, GV, MB, RM-B, MTK and MC all provided edits and critiqued the manuscript for intellectual content.

  • Funding This study was funded by Macmillan Cancer Support (grant number: 5592105).

  • Competing interests JA, LC, CC, AnG, AdG, DMG, DK and AL are all members of the National Cancer Research Institute Psychosocial Oncology and Survivorship CSG subgroup: ‘Understanding and measuring the consequences of cancer and its treatment’. FE receives consultancy fees from Bristol-Myers Squibb, Seattle Genetics, TEVA and Incyte; and research funding from Lundbeck, TEVA and Amgen. GV receives grants from the National Institute for Health Research and Yorkshire Cancer Research, and personal fees from Roche, Genentech, Eisai and Novartis. MC has received personal fees from Astellas Pharma and Ferring and chairs the ISOQOL Best Practice for PROs in Trials Taskforce. JMB receives grants from the National Institute of Health Research, Yorkshire Cancer Research, Macmillan and Roche. JA is in receipt of grant funding from EU FP7 Framework. AdG is in receipt of grants from Candlelighters, National Institute for Health Research, Macmillan Cancer Support, Prostate Cancer UK and Yorkshire Cancer Research. MTK and RM-B have received project funding from Abbvie and Alcon. MTK cochairs the ISOQOL Best Practice for PROs in Trials Taskforce. DK and RM-B are members of the ISOQOL Best Practice for PROs in Trials Taskforce.

  • Patient consent Not required.

  • Ethics approval The study was approved by the research ethics committee at the University of Birmingham (Ref: ERN_17–0085) on 20 February 2017.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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