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

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

Purpose: Evidence 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. Methods: Semi-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. Results: Forty-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. Conclusion: Misconceptions 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.

cancer, patient-reported outcomes, protocol, qualitative, reporting, trials
2045-7634
5475-5487
Retzer, Ameeta
a0f690ea-f899-4d5f-a206-8006ec804544
Calvert, Melanie
36a5cfc0-c2e9-411f-9ec2-4d93841004c4
Ahmed, Khaled
9795ab7b-a9fa-41e9-b46c-7199c6676ffd
Keeley, Thomas
ceb9ee0d-105d-44dd-b3cf-6e69cf41c630
Armes, Jo
d72d1004-457a-4f30-bec7-329e696fe34f
Brown, Julia M.
c3cb7bd2-60f6-46d9-af12-08bf89acccf3
Calman, Lynn
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Gavin, Anna
e887a323-7787-4455-82f7-531198db885d
Glaser, Adam W.
9ce6cbd6-98e5-4dc3-a74c-91a9e45feb1c
Greenfield, Diana M.
a60538ed-7a21-4bd6-b58a-381e1bd159b6
Lanceley, Anne
2b91cde8-7ce3-4f9d-bb6c-166e939ecf77
Taylor, Rachel M.
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Velikova, Galina
60a74ab1-7fba-4d7a-8b40-598ed8398393
Brundage, Michael
e6049d49-386b-4680-8161-90b9abb36a0f
Efficace, Fabio
487f70ae-2ae9-49d9-b86f-672050fa71af
Mercieca-Bebber, Rebecca
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King, Madeleine T.
dec1f735-f6a9-4d0b-80d9-0e94a692b5f6
Kyte, Derek
d694bd71-54c4-46de-a0c5-bd9d91054c64
Retzer, Ameeta
a0f690ea-f899-4d5f-a206-8006ec804544
Calvert, Melanie
36a5cfc0-c2e9-411f-9ec2-4d93841004c4
Ahmed, Khaled
9795ab7b-a9fa-41e9-b46c-7199c6676ffd
Keeley, Thomas
ceb9ee0d-105d-44dd-b3cf-6e69cf41c630
Armes, Jo
d72d1004-457a-4f30-bec7-329e696fe34f
Brown, Julia M.
c3cb7bd2-60f6-46d9-af12-08bf89acccf3
Calman, Lynn
9ae254eb-74a7-4906-9eb4-62ad99f058c1
Gavin, Anna
e887a323-7787-4455-82f7-531198db885d
Glaser, Adam W.
9ce6cbd6-98e5-4dc3-a74c-91a9e45feb1c
Greenfield, Diana M.
a60538ed-7a21-4bd6-b58a-381e1bd159b6
Lanceley, Anne
2b91cde8-7ce3-4f9d-bb6c-166e939ecf77
Taylor, Rachel M.
99abdd17-69fe-4860-bed9-b1073cb489db
Velikova, Galina
60a74ab1-7fba-4d7a-8b40-598ed8398393
Brundage, Michael
e6049d49-386b-4680-8161-90b9abb36a0f
Efficace, Fabio
487f70ae-2ae9-49d9-b86f-672050fa71af
Mercieca-Bebber, Rebecca
3b26632c-6d6d-49f4-b3c7-e507a4b9e0c6
King, Madeleine T.
dec1f735-f6a9-4d0b-80d9-0e94a692b5f6
Kyte, Derek
d694bd71-54c4-46de-a0c5-bd9d91054c64

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. and Kyte, Derek (2021) International perspectives on suboptimal patient-reported outcome trial design and reporting in cancer clinical trials: A qualitative study. Cancer Medicine, 10 (16), 5475-5487. (doi:10.1002/cam4.4111).

Record type: Article

Abstract

Purpose: Evidence 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. Methods: Semi-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. Results: Forty-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. Conclusion: Misconceptions 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.

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More information

Accepted/In Press date: 25 June 2021
Published date: 5 July 2021
Keywords: cancer, patient-reported outcomes, protocol, qualitative, reporting, trials

Identifiers

Local EPrints ID: 451168
URI: http://eprints.soton.ac.uk/id/eprint/451168
ISSN: 2045-7634
PURE UUID: 4bc0c015-1484-4c24-9204-9d13005b4e89
ORCID for Lynn Calman: ORCID iD orcid.org/0000-0002-9964-6017

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Date deposited: 14 Sep 2021 15:31
Last modified: 28 Apr 2022 02:06

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Contributors

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

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