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Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

Ahmed, Khaled, Kyte, Derek, Keeley, Thomas, Efficace, Fabio, Armes, Jo, Brown, Julia, Calman, L, Copland, Chris, Gavin, Anna, Glaser, Adam , Greenfield, Diana M, Lanceley, Anne, Taylor, Rachel, Velikova, Galina, Brundage, Michael, Mercieca-Bebber, Rebecca, King, Madeleine T. and Calvert, Melanie (2016) Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol BMJ Open, 6 (9).

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Abstract

Introduction: Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points.

Methods and analysis: Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion.

Ethics and dissemination: The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account and UOB departmental website (http://www.birmingham.ac.uk/cpro0r).

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
NameEmailORCID
Ahmed, KhaledUNSPECIFIEDUNSPECIFIED
Kyte, DerekUNSPECIFIEDUNSPECIFIED
Keeley, ThomasUNSPECIFIEDUNSPECIFIED
Efficace, FabioUNSPECIFIEDUNSPECIFIED
Armes, Jojo.armes@surrey.ac.ukUNSPECIFIED
Brown, JuliaUNSPECIFIEDUNSPECIFIED
Calman, LUNSPECIFIEDUNSPECIFIED
Copland, ChrisUNSPECIFIEDUNSPECIFIED
Gavin, AnnaUNSPECIFIEDUNSPECIFIED
Glaser, AdamUNSPECIFIEDUNSPECIFIED
Greenfield, Diana MUNSPECIFIEDUNSPECIFIED
Lanceley, AnneUNSPECIFIEDUNSPECIFIED
Taylor, RachelUNSPECIFIEDUNSPECIFIED
Velikova, GalinaUNSPECIFIEDUNSPECIFIED
Brundage, MichaelUNSPECIFIEDUNSPECIFIED
Mercieca-Bebber, RebeccaUNSPECIFIEDUNSPECIFIED
King, Madeleine T.UNSPECIFIEDUNSPECIFIED
Calvert, MelanieUNSPECIFIEDUNSPECIFIED
Date : 1 September 2016
Identification Number : 10.1136/bmjopen-2016-012863
Copyright Disclaimer : Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/
Additional Information : Trial registration number: PROSPERO CRD42016036533.
Depositing User : Clive Harris
Date Deposited : 30 Oct 2017 11:09
Last Modified : 30 Oct 2017 11:09
URI: http://epubs.surrey.ac.uk/id/eprint/844678

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