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

Publication Date:
2018-02-09
Publisher:
BMJ Publishing
Electronic ISSN:
2044-6055
Topics:
Medicine
Keywords:
Open access, Oncology
Published by:
http://group.bmj.com/
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autor Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
beschreibung 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.
citation_standardnr 6159516
datenlieferant ipn_articles
feed_id 151627
feed_publisher BMJ Publishing
feed_publisher_url http://group.bmj.com/
insertion_date 2018-02-09
journaleissn 2044-6055
publikationsjahr_anzeige 2018
publikationsjahr_facette 2018
publikationsjahr_intervall 7984:2015-2019
publikationsjahr_sort 2018
publisher BMJ Publishing
quelle BMJ Open
relation http://bmjopen.bmj.com/cgi/content/short/8/2/e017282?rss=1
schlagwort Open access, Oncology
search_space articles
shingle_author_1 Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
shingle_author_2 Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
shingle_author_3 Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
shingle_author_4 Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
shingle_catch_all_1 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
Open access, Oncology
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.
Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_2 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
Open access, Oncology
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.
Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_3 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
Open access, Oncology
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.
Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
BMJ Publishing
2044-6055
20446055
shingle_catch_all_4 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
Open access, Oncology
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.
Retzer, A., Keeley, T., Ahmed, K., Armes, J., Brown, J. M., Calman, L., Copland, C., Efficace, F., Gavin, A., Glaser, A., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Mercieca-Bebber, R., King, M. T., Calvert, M., Kyte, D.
BMJ Publishing
2044-6055
20446055
shingle_title_1 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
shingle_title_2 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
shingle_title_3 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
shingle_title_4 Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
timestamp 2025-06-30T23:32:35.934Z
titel Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
titel_suche Evaluation of patient-reported outcome protocol content and reporting in UK cancer clinical trials: the EPiC study qualitative protocol
topic WW-YZ
uid ipn_articles_6159516