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

Ameeta Retzer; Thomas Keeley; Khaled Ahmed; 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; Derek Kyte

doi:10.1136/bmjopen-2017-017282

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

BMJ Open. 2018 Feb 3;8(2):e017282. doi: 10.1136/bmjopen-2017-017282.

Authors

Ameeta Retzer^{1

2}, Thomas Keeley³, Khaled Ahmed^{1

2}, Jo Armes⁴, Julia M Brown⁵, Lynn Calman⁶, Chris Copland⁷, Fabio Efficace⁸, Anna Gavin⁹, Adam Glaser¹⁰, Diana M Greenfield¹¹, Anne Lanceley¹², Rachel M Taylor¹³, Galina Velikova^{10

14}, Michael Brundage¹⁵, Rebecca Mercieca-Bebber^{1

16

17}, Madeleine T King^{16

17}, Melanie Calvert^{1

2}, Derek Kyte^{1

2}

Affiliations

¹ Centre for Patient Reported Outcomes Research (CPROR), University of Birmingham, Birmingham, UK.
² Institute of Applied Health Research, University of Birmingham, Birmingham, UK.
³ PAREXEL International, London, UK.
⁴ School of Health Sciences, University of Surrey, Guildford, UK.
⁵ UKCRC Registered CTU Network, University of Leeds, Leeds, UK.
⁶ Faculty of Health Sciences, University of Southampton, Southampton, UK.
⁷ NCRI Psychosocial Oncology and Survivorship CSG, York, UK.
⁸ Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
⁹ N. Ireland Cancer Registry, Queen's University Belfast, Centre for Public Health, Belfast, UK.
¹⁰ Leeds Institute of Cancer & Pathology, University of Leeds, Leeds, UK.
¹¹ Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
¹² UCL EGA Institute for Women's Health, University College London, London, UK.
¹³ Cancer Division, University College Hospitals NHS Foundation Trust, London, UK.
¹⁴ Patient Centred Outcomes Group: Leeds Institute of Cancer and Pathology, University of Leeds, Leeds, UK.
¹⁵ Queen's Department of Oncology School of Medicine, Queen's University Cancer Research Institute, Kingston, Ontario, Canada.
¹⁶ Central Clinical School, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
¹⁷ Psycho-Oncology Cooperative Research Group, Faculty of Science, University of Sydney, Sydney, New South Wales, Australia.

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.

Keywords: cancer clinical trials; mixed methods; patient reported outcomes; quality of life.

Publication types

Evaluation Study
Research Support, Non-U.S. Gov't

MeSH terms

Clinical Trials as Topic
Health Personnel*
Humans
Neoplasms / therapy*
Patient Reported Outcome Measures*
Qualitative Research
Research Design*

Grants and funding

PDF-2016-09-009/DH_/Department of Health/United Kingdom