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

Research output: Contribution to journalArticlepeer-review

4 Citations (Scopus)
168 Downloads (Pure)

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.

Original languageEnglish
Article numbere017282
JournalBMJ open
Volume8
Issue number2
DOIs
Publication statusPublished - 3 Feb 2018

Keywords

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

Fingerprint

Dive into the research topics of 'Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol'. Together they form a unique fingerprint.

Cite this