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

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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; Kyte, Derek.

In: BMJ open, Vol. 8, No. 2, e017282, 03.02.2018.

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Retzer, A, Keeley, T, Ahmed, K, Armes, J, Brown, JM, Calman, L, Copland, C, Efficace, F, Gavin, A, Glaser, A, Greenfield, DM, Lanceley, A, Taylor, RM, Velikova, G, Brundage, M, Mercieca-Bebber, R, King, MT, Calvert, M & Kyte, D 2018, 'Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol', BMJ open, vol. 8, no. 2, e017282. https://doi.org/10.1136/bmjopen-2017-017282

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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 ; Kyte, Derek. / Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol. In: BMJ open. 2018 ; Vol. 8, No. 2.

Bibtex

@article{713f7d229a724d35ad7caac12205bb7a,
title = "Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials:: the EPiC study qualitative protocol",
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 that 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: Semistructured 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 members, statisticians and research nurses 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 Network; (2) NCRI Consumer Liaison Group 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-reviewed journals, patient groups and social media (@CPROR_UoB; http://www.birmingham.ac.uk/cpror).PROSPERO REGISTRATION NUMBER: CRD42016036533.",
keywords = "cancer clinical trials, mixed methods, patient reported outcomes, quality of life",
author = "Ameeta Retzer and Thomas Keeley and Khaled Ahmed and Jo Armes and Brown, {Julia M} and Lynn Calman and Chris Copland and Fabio Efficace and Anna Gavin and Adam Glaser and Greenfield, {Diana M} and Anne Lanceley and Taylor, {Rachel M} and Galina Velikova and Michael Brundage and Rebecca Mercieca-Bebber and King, {Madeleine T} and Melanie Calvert and Derek Kyte",
note = "{\circledC} 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.",
year = "2018",
month = "2",
day = "3",
doi = "10.1136/bmjopen-2017-017282",
language = "English",
volume = "8",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "2",

}

RIS

TY - JOUR

T1 - Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials:

T2 - the EPiC study qualitative protocol

AU - Retzer, Ameeta

AU - Keeley, Thomas

AU - Ahmed, Khaled

AU - Armes, Jo

AU - Brown, Julia M

AU - Calman, Lynn

AU - Copland, Chris

AU - Efficace, Fabio

AU - Gavin, Anna

AU - Glaser, Adam

AU - Greenfield, Diana M

AU - Lanceley, Anne

AU - Taylor, Rachel M

AU - Velikova, Galina

AU - Brundage, Michael

AU - Mercieca-Bebber, Rebecca

AU - King, Madeleine T

AU - Calvert, Melanie

AU - Kyte, Derek

N1 - © 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.

PY - 2018/2/3

Y1 - 2018/2/3

N2 - 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 that 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: Semistructured 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 members, statisticians and research nurses 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 Network; (2) NCRI Consumer Liaison Group 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-reviewed journals, patient groups and social media (@CPROR_UoB; http://www.birmingham.ac.uk/cpror).PROSPERO REGISTRATION NUMBER: CRD42016036533.

AB - 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 that 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: Semistructured 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 members, statisticians and research nurses 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 Network; (2) NCRI Consumer Liaison Group 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-reviewed journals, patient groups and social media (@CPROR_UoB; http://www.birmingham.ac.uk/cpror).PROSPERO REGISTRATION NUMBER: CRD42016036533.

KW - cancer clinical trials

KW - mixed methods

KW - patient reported outcomes

KW - quality of life

U2 - 10.1136/bmjopen-2017-017282

DO - 10.1136/bmjopen-2017-017282

M3 - Article

VL - 8

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 2

M1 - e017282

ER -