University of Surrey

Test tubes in the lab Research in the ATI Dance Research

Evaluation of Patient-Reported Outcome Protocol Content and Reporting in UK Cancer Clinical Trials: The EPiC study qualitative protocol

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).

Evaluation of patient-reported outcome protocol content and reporting.pdf - Version of Record
Available under License Creative Commons Attribution Non-commercial.

Download (239kB) | Preview


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;

Strengths and limitations • This novel study will capture perspectives on the barriers and enablers of optimal PRO practice from a comprehensive range of stakeholders with experience of PRO data collection and reporting. • The semi-structured interview format ensures a replicable process while allowing sufficient freedom to explore new and emerging concepts. • The recruitment strategy involves seeking participants through networks occupied by EPiC Senior Management Group members. However, any limitation to sample representativeness and diversity will be mediated through the use of other recruitment avenues including the authorship lists of the protocols/publications included in Phase I. • Study is at risk of self-selection and social-desirability bias. Participants are likely to take part if they have a pre-existing interest in PROs specifically and when recounting their experiences and insights are likely to wish to portray themselves in a positive manner due to the nature of this study.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
Retzer, Ameeta
Keeley, Thomas
Ahmed, Khaled
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
Kyte, Derek
Date : 3 February 2018
Copyright Disclaimer : © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Depositing User : Clive Harris
Date Deposited : 30 Nov 2017 14:19
Last Modified : 16 Jan 2019 19:05

Actions (login required)

View Item View Item


Downloads per month over past year

Information about this web site

© The University of Surrey, Guildford, Surrey, GU2 7XH, United Kingdom.
+44 (0)1483 300800