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Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol

Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
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).
2044-6055
1-5
Retzer, Ameeta
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Keeley, Thomas
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Ahmed, Khaled
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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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Efficace, Fabio
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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 M.
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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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Kyte, Derek
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Retzer, Ameeta
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Keeley, Thomas
ceb9ee0d-105d-44dd-b3cf-6e69cf41c630
Ahmed, Khaled
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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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Efficace, Fabio
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Gavin, Anna
e887a323-7787-4455-82f7-531198db885d
Glaser, Adam
47f40b4c-2ff7-4c0e-a137-67564d0c29bc
Greenfield, Diana M.
a60538ed-7a21-4bd6-b58a-381e1bd159b6
Lanceley, Anne
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Taylor, Rachel M.
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Velikova, Galina
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Brundage, Michael
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Mercieca-Bebber, Rebecca
3b26632c-6d6d-49f4-b3c7-e507a4b9e0c6
King, Madeleine T.
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Calvert, Melanie
36a5cfc0-c2e9-411f-9ec2-4d93841004c4
Kyte, Derek
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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).

Record type: Article

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

Accepted/In Press date: 24 November 2017
e-pub ahead of print date: 3 February 2018
Published date: February 2018

Identifiers

Local EPrints ID: 416126
URI: http://eprints.soton.ac.uk/id/eprint/416126
ISSN: 2044-6055
PURE UUID: 6a417825-7224-41a2-9284-809c53adc433
ORCID for Lynn Calman: ORCID iD orcid.org/0000-0002-9964-6017

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Date deposited: 05 Dec 2017 17:30
Last modified: 16 Mar 2024 05:59

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Contributors

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

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