International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study

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International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study. / Retzer, Ameeta; Calvert, Melanie; Ahmed, Khaled; Keeley, Thomas; Armes, Jo; Brown, Julia M; Calman, Lynn; Gavin, Anna; Glaser, Adam W; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel M; Velikova, Galina; Brundage, Michael; Efficace, Fabio; Mercieca-bebber, Rebecca; King, Madeleine T.; Kyte, Derek.

In: Cancer Medicine, 05.07.2021.

Research output: Contribution to journalArticlepeer-review

Harvard

Retzer, A, Calvert, M, Ahmed, K, Keeley, T, Armes, J, Brown, JM, Calman, L, Gavin, A, Glaser, AW, Greenfield, DM, Lanceley, A, Taylor, RM, Velikova, G, Brundage, M, Efficace, F, Mercieca-bebber, R, King, MT & Kyte, D 2021, 'International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study', Cancer Medicine. https://doi.org/10.1002/cam4.4111

APA

Retzer, A., Calvert, M., Ahmed, K., Keeley, T., Armes, J., Brown, J. M., Calman, L., Gavin, A., Glaser, A. W., Greenfield, D. M., Lanceley, A., Taylor, R. M., Velikova, G., Brundage, M., Efficace, F., Mercieca-bebber, R., King, M. T., & Kyte, D. (2021). International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study. Cancer Medicine. https://doi.org/10.1002/cam4.4111

Vancouver

Author

Retzer, Ameeta ; Calvert, Melanie ; Ahmed, Khaled ; Keeley, Thomas ; Armes, Jo ; Brown, Julia M ; Calman, Lynn ; Gavin, Anna ; Glaser, Adam W ; Greenfield, Diana M ; Lanceley, Anne ; Taylor, Rachel M ; Velikova, Galina ; Brundage, Michael ; Efficace, Fabio ; Mercieca-bebber, Rebecca ; King, Madeleine T. ; Kyte, Derek. / International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study. In: Cancer Medicine. 2021.

Bibtex

@article{57682a684ab4428faa0a7d3a64d9fc13,
title = "International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study",
abstract = "PurposeEvidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.MethodsSemi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame.ResultsForty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists{\textquoteright} reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified.ConclusionMisconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.",
keywords = "Patient-reported outcomes, protocol, reporting, qualitative, cancer, trials",
author = "Ameeta Retzer and Melanie Calvert and Khaled Ahmed and Thomas Keeley and Jo Armes and Brown, {Julia M} and Lynn Calman and Anna Gavin and Glaser, {Adam W} and Greenfield, {Diana M} and Anne Lanceley and Taylor, {Rachel M} and Galina Velikova and Michael Brundage and Fabio Efficace and Rebecca Mercieca-bebber and King, {Madeleine T.} and Derek Kyte",
year = "2021",
month = jul,
day = "5",
doi = "10.1002/cam4.4111",
language = "English",
journal = "Cancer Medicine",
issn = "20457634",
publisher = "John Wiley & Sons",

}

RIS

TY - JOUR

T1 - International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: a qualitative study

AU - Retzer, Ameeta

AU - Calvert, Melanie

AU - Ahmed, Khaled

AU - Keeley, Thomas

AU - Armes, Jo

AU - Brown, Julia M

AU - Calman, Lynn

AU - Gavin, Anna

AU - Glaser, Adam W

AU - Greenfield, Diana M

AU - Lanceley, Anne

AU - Taylor, Rachel M

AU - Velikova, Galina

AU - Brundage, Michael

AU - Efficace, Fabio

AU - Mercieca-bebber, Rebecca

AU - King, Madeleine T.

AU - Kyte, Derek

PY - 2021/7/5

Y1 - 2021/7/5

N2 - PurposeEvidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.MethodsSemi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame.ResultsForty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists’ reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified.ConclusionMisconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.

AB - PurposeEvidence suggests that the patient-reported outcome (PRO) content of cancer trial protocols is frequently inadequate and non-reporting of PRO findings is widespread. This qualitative study examined the factors influencing suboptimal PRO protocol content, implementation, and reporting, and use of PRO data during clinical interactions.MethodsSemi-structured interviews were conducted with four stakeholder groups: (1) trialists and chief investigators; (2) people with lived experience of cancer; (3) international experts in PRO cancer trial design; (4) journal editors, funding panelists, and regulatory agencies. Data were analyzed using directed thematic analysis with an iterative coding frame.ResultsForty-four interviews were undertaken. Several factors were identified that could influenced effective integration of PROs into trials and subsequent findings. Participants described (1) late inclusion of PROs in trial design; (2) PROs being considered a lower priority outcome compared to survival; (3) trialists’ reluctance to collect or report PROs due to participant burden, missing data, and perceived reticence of journals to publish; (4) lack of staff training. Strategies to address these included training research personnel and improved communication with site staff and patients regarding the value of PROs. Examples of good practice were identified.ConclusionMisconceptions relating to PRO methodology and its use may undermine their planning, collection, and reporting. There is a role for funding, regulatory, methodological, and journalistic institutions to address perceptions around the value of PROs, their position within the trial outcomes hierarchy, that PRO training and guidance is available, signposted, and readily accessible, with accompanying measures to ensure compliance with international best practice guidelines.

KW - Patient-reported outcomes

KW - protocol

KW - reporting

KW - qualitative

KW - cancer

KW - trials

U2 - 10.1002/cam4.4111

DO - 10.1002/cam4.4111

M3 - Article

C2 - 34219395

JO - Cancer Medicine

JF - Cancer Medicine

SN - 20457634

ER -