Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials

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Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials. / Kyte, Derek; Retzer, Ameeta; Ahmed, Khaled; Keeley, Thomas; Armes, Jo; Brown, Julia M; Calman, Lynn; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel M; Velikova, Galina; Brundage, Michael; Efficace, Fabio; Mercieca-bebber, Rebecca; King, Madeleine T.; Turner, Grace; Calvert, Melanie.

In: Journal of the National Cancer Institute, Vol. 111, No. 11, djz038, 11.04.2019.

Research output: Contribution to journalArticle

Harvard

Kyte, D, Retzer, A, Ahmed, K, Keeley, T, Armes, J, Brown, JM, Calman, L, Gavin, A, Glaser, A, Greenfield, DM, Lanceley, A, Taylor, RM, Velikova, G, Brundage, M, Efficace, F, Mercieca-bebber, R, King, MT, Turner, G & Calvert, M 2019, 'Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials', Journal of the National Cancer Institute, vol. 111, no. 11, djz038. https://doi.org/10.1093/jnci/djz038

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Author

Kyte, Derek ; Retzer, Ameeta ; Ahmed, Khaled ; Keeley, Thomas ; Armes, Jo ; Brown, Julia M ; Calman, Lynn ; Gavin, Anna ; Glaser, Adam ; Greenfield, Diana M ; Lanceley, Anne ; Taylor, Rachel M ; Velikova, Galina ; Brundage, Michael ; Efficace, Fabio ; Mercieca-bebber, Rebecca ; King, Madeleine T. ; Turner, Grace ; Calvert, Melanie. / Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials. In: Journal of the National Cancer Institute. 2019 ; Vol. 111, No. 11.

Bibtex

@article{ac5bf074051d4b888ad27cf7c0973eb7,
title = "Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials",
abstract = "Background: Patient-Reported Outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods: We systematically investigated a cohort of randomized controlled cancer trials which included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results: Protocols (101 sourced, 44.3{\%}) included a mean of 10/33 (range = 2–19, SD = 4) PRO protocol checklist items. Recommended items frequently omitted included: the rationale and objectives underpinning PRO collection and approaches to minimise/address missing PRO data. Of 160 trials with published results, 61 (38.1{\%}, 95{\%} CI = 30.6{\%} to 45.7{\%}) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49,568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean inclusion of 3/14 (range = 0–11, SD = 3) CONSORT PRO Extension checklist items). Over half of trials publishing PRO results in a secondary publication (12/22, 54.5{\%}) took 4 or more years to do so following trial closure, with 8 (36.4{\%}) taking 5-8 years and one trial publishing after 14 years. Conclusions: PRO protocol content is frequently inadequate, and non-reporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.",
keywords = "cancer, follow-up, guidelines, surrogate endpoints, patient self-report, reporting standards, performance reporting",
author = "Derek Kyte and Ameeta Retzer and Khaled Ahmed and Thomas Keeley and Jo Armes and Brown, {Julia M} and Lynn Calman and Anna Gavin and Adam Glaser 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 Grace Turner and Melanie Calvert",
year = "2019",
month = "4",
day = "11",
doi = "10.1093/jnci/djz038",
language = "English",
volume = "111",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "11",

}

RIS

TY - JOUR

T1 - Systematic evaluation of Patient-Reported Outcome protocol content and reporting in cancer trials

AU - Kyte, Derek

AU - Retzer, Ameeta

AU - Ahmed, Khaled

AU - Keeley, Thomas

AU - Armes, Jo

AU - Brown, Julia M

AU - Calman, Lynn

AU - Gavin, Anna

AU - Glaser, Adam

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 - Turner, Grace

AU - Calvert, Melanie

PY - 2019/4/11

Y1 - 2019/4/11

N2 - Background: Patient-Reported Outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods: We systematically investigated a cohort of randomized controlled cancer trials which included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results: Protocols (101 sourced, 44.3%) included a mean of 10/33 (range = 2–19, SD = 4) PRO protocol checklist items. Recommended items frequently omitted included: the rationale and objectives underpinning PRO collection and approaches to minimise/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% CI = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49,568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean inclusion of 3/14 (range = 0–11, SD = 3) CONSORT PRO Extension checklist items). Over half of trials publishing PRO results in a secondary publication (12/22, 54.5%) took 4 or more years to do so following trial closure, with 8 (36.4%) taking 5-8 years and one trial publishing after 14 years. Conclusions: PRO protocol content is frequently inadequate, and non-reporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

AB - Background: Patient-Reported Outcomes (PROs) are captured within cancer trials to help future patients and their clinicians make more informed treatment decisions. However, variability in standards of PRO trial design and reporting threaten the validity of these endpoints for application in clinical practice. Methods: We systematically investigated a cohort of randomized controlled cancer trials which included a primary or secondary PRO. For each trial, an evaluation of protocol and reporting quality was undertaken using standard checklists. General patterns of reporting where also explored. Results: Protocols (101 sourced, 44.3%) included a mean of 10/33 (range = 2–19, SD = 4) PRO protocol checklist items. Recommended items frequently omitted included: the rationale and objectives underpinning PRO collection and approaches to minimise/address missing PRO data. Of 160 trials with published results, 61 (38.1%, 95% CI = 30.6% to 45.7%) failed to include their PRO findings in any publication (mean 6.43-year follow-up); these trials included 49,568 participants. Although two-thirds of included trials published PRO findings, reporting standards were often inadequate according to international guidelines (mean inclusion of 3/14 (range = 0–11, SD = 3) CONSORT PRO Extension checklist items). Over half of trials publishing PRO results in a secondary publication (12/22, 54.5%) took 4 or more years to do so following trial closure, with 8 (36.4%) taking 5-8 years and one trial publishing after 14 years. Conclusions: PRO protocol content is frequently inadequate, and non-reporting of PRO findings is widespread, meaning patient-important information may not be available to benefit patients, clinicians and regulators. Even where PRO data are published, there is often considerable delay and reporting quality is suboptimal. This study presents key recommendations to enhance the likelihood of successful delivery of PROs in the future.

KW - cancer

KW - follow-up

KW - guidelines

KW - surrogate endpoints

KW - patient self-report

KW - reporting standards

KW - performance reporting

U2 - 10.1093/jnci/djz038

DO - 10.1093/jnci/djz038

M3 - Article

VL - 111

JO - Journal of the National Cancer Institute

JF - Journal of the National Cancer Institute

SN - 0027-8874

IS - 11

M1 - djz038

ER -