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

Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol
Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol
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).
Ahmed, Khaled
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Kyte, Derek
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Keeley, Thomas
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Efficace, Fabio
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Armes, Jo
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Brown, Julia M.
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Calman, Lynn
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Copland, Chris
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Gavin, Anna
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Glaser, Adam
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Greenfield, Diana M.
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Lanceley, Anne
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Taylor, Rachel
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Velikova, Galina
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Brundage, Michael
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Mercieca-Bebber, Rebecca
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King, Madeleine T.
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Calvert, Melanie
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Ahmed, Khaled
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Kyte, Derek
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Keeley, Thomas
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Efficace, Fabio
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Armes, Jo
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Brown, Julia M.
cc31c369-afef-4309-831a-ef4cafb3f365
Calman, Lynn
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Copland, Chris
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Gavin, Anna
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Glaser, Adam
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Greenfield, Diana M.
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Lanceley, Anne
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Taylor, Rachel
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Velikova, Galina
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Brundage, Michael
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Mercieca-Bebber, Rebecca
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King, Madeleine T.
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Calvert, Melanie
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Ahmed, Khaled, Kyte, Derek, Keeley, Thomas, Efficace, Fabio, Armes, Jo, Brown, Julia M., Calman, Lynn, 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 (e012863). (doi:10.1136/bmjopen-2016-012863). (PMID:27655263)

Record type: Article

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).

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More information

Accepted/In Press date: 26 August 2016
e-pub ahead of print date: 21 September 2016
Published date: 21 September 2016
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 402554
URI: https://eprints.soton.ac.uk/id/eprint/402554
PURE UUID: 8ee1476d-3bd8-4ed0-9964-8316f6a2a1e3
ORCID for Lynn Calman: ORCID iD orcid.org/0000-0002-9964-6017

Catalogue record

Date deposited: 11 Nov 2016 14:37
Last modified: 06 Jun 2018 12:29

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Contributors

Author: Khaled Ahmed
Author: Derek Kyte
Author: Thomas Keeley
Author: Fabio Efficace
Author: Jo Armes
Author: Julia M. Brown
Author: Lynn Calman ORCID iD
Author: Chris Copland
Author: Anna Gavin
Author: Adam Glaser
Author: Diana M. Greenfield
Author: Anne Lanceley
Author: Rachel Taylor
Author: Galina Velikova
Author: Michael Brundage
Author: Rebecca Mercieca-Bebber
Author: Madeleine T. King
Author: Melanie Calvert

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