Retzer, Ameeta, Keeley, Thomas, Ahmed, Khaled, Armes, Jo, Brown, Julia M., Calman, Lynn, Copland, Chris, Efficace, Fabio, Gavin, Anna, Glaser, Adam, Greenfield, Diana M., Lanceley, Anne, Taylor, Rachel M., Velikova, Galina, Brundage, Michael, Mercieca-Bebber, Rebecca, King, Madeleine T., Calvert, Melanie and Kyte, Derek (2018) Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol. BMJ Open, 8 (2), 1-5. (doi:10.1136/bmjopen-2017-017282).
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 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: Semi-structured 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 (TMG) members, statisticians and research nurses (RNs) 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 (UKCRC-UKCTU) Network; (2) NCRI CLG 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-review journals, patient groups and social media (@CPROR_UoB; http://www.birmingham.ac.uk/cpror).
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