Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals

Karen Matvienko-Sikar; Kerry Avery; Blazeby Jane; Declan Devan; Susanna Dodd; Aoife Egan; Sarah Gorst; Karen Hughes; Pamela Jacobsen; Jamie Kirkham; Jan Kottner; Katie Mellor; Christopher Millward; Smitaa Patel; Ian Saldanha; Valerie Smith; Caroline Terwee; Fiona Quirke; Paula Williamson

doi:10.1016/j.jclinepi.2021.10.012

Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals

Karen Matvienko-Sikar, Kerry Avery, Blazeby Jane, Declan Devan, Susanna Dodd, Aoife Egan, Sarah Gorst, Karen Hughes, Pamela Jacobsen, Jamie Kirkham, Jan Kottner, Katie Mellor, Christopher Millward, Smitaa Patel, Ian Saldanha, Valerie Smith, Caroline Terwee, Fiona Quirke, Paula Williamson

Research output: Contribution to journal › Article › peer-review

45 Citations (SciVal)

Abstract

Objectives
To examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use.

Study Design and Setting
A sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS.

Results
Ninety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%).

Conclusion
COS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.

Original language	English
Pages (from-to)	19-28
Number of pages	10
Journal	Journal of Clinical Epidemiology
Volume	142
Early online date	20 Nov 2021
DOIs	https://doi.org/10.1016/j.jclinepi.2021.10.012
Publication status	Published - 28 Feb 2022

Bibliographical note

Funding Information:
Karen Matvienko-Sikar is supported by a Health Research Board ARPP Research Fellowship (HRB-ARPP-A- 2018-011). Paula Williamson is supported by a MRC Trials Methodology Research Partnership grant (reference MR/S014357/1). Sarah Gorst is supported by a National Institute for Health Research (NIHR) Senior Investigator Award (NF-SI_0513-10025). Jane Blazeby and Paula Williamson are NIHR Senior Investigators. This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design, conduct or reporting of this study.

Keywords

Core outcome sets
Health outcomes
Medical Journals
Outcome reporting
Trial outcomes
Trials

ASJC Scopus subject areas

Epidemiology

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10.1016/j.jclinepi.2021.10.012Licence: CC BY

Cite this

Matvienko-Sikar, K., Avery, K., Jane, B., Devan, D., Dodd, S., Egan, A., Gorst, S., Hughes, K., Jacobsen, P., Kirkham, J., Kottner, J., Mellor, K., Millward, C., Patel, S., Saldanha, I., Smith, V., Terwee, C., Quirke, F., & Williamson, P. (2022). Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals. Journal of Clinical Epidemiology, 142, 19-28. https://doi.org/10.1016/j.jclinepi.2021.10.012

Matvienko-Sikar, K, Avery, K, Jane, B, Devan, D, Dodd, S, Egan, A, Gorst, S, Hughes, K, Jacobsen, P, Kirkham, J, Kottner, J, Mellor, K, Millward, C, Patel, S, Saldanha, I, Smith, V, Terwee, C, Quirke, F & Williamson, P 2022, 'Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals', Journal of Clinical Epidemiology, vol. 142, pp. 19-28. https://doi.org/10.1016/j.jclinepi.2021.10.012

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abstract = "ObjectivesTo examine current practices in late-phase trials published in major medical journals and examine trialists{\textquoteright} views about core outcome set (COS) use.Study Design and SettingA sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS.ResultsNinety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%).ConclusionCOS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.",

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author = "Karen Matvienko-Sikar and Kerry Avery and Blazeby Jane and Declan Devan and Susanna Dodd and Aoife Egan and Sarah Gorst and Karen Hughes and Pamela Jacobsen and Jamie Kirkham and Jan Kottner and Katie Mellor and Christopher Millward and Smitaa Patel and Ian Saldanha and Valerie Smith and Caroline Terwee and Fiona Quirke and Paula Williamson",

note = "Funding Information: Karen Matvienko-Sikar is supported by a Health Research Board ARPP Research Fellowship (HRB-ARPP-A- 2018-011). Paula Williamson is supported by a MRC Trials Methodology Research Partnership grant (reference MR/S014357/1). Sarah Gorst is supported by a National Institute for Health Research (NIHR) Senior Investigator Award (NF-SI_0513-10025). Jane Blazeby and Paula Williamson are NIHR Senior Investigators. This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design, conduct or reporting of this study. ",

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AU - Matvienko-Sikar, Karen

AU - Avery, Kerry

AU - Jane, Blazeby

AU - Devan, Declan

AU - Dodd, Susanna

AU - Egan, Aoife

AU - Gorst, Sarah

AU - Hughes, Karen

AU - Jacobsen, Pamela

AU - Kirkham, Jamie

AU - Kottner, Jan

AU - Mellor, Katie

AU - Millward, Christopher

AU - Patel, Smitaa

AU - Saldanha, Ian

AU - Smith, Valerie

AU - Terwee, Caroline

AU - Quirke, Fiona

AU - Williamson, Paula

N1 - Funding Information: Karen Matvienko-Sikar is supported by a Health Research Board ARPP Research Fellowship (HRB-ARPP-A- 2018-011). Paula Williamson is supported by a MRC Trials Methodology Research Partnership grant (reference MR/S014357/1). Sarah Gorst is supported by a National Institute for Health Research (NIHR) Senior Investigator Award (NF-SI_0513-10025). Jane Blazeby and Paula Williamson are NIHR Senior Investigators. This study was supported by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health and Social Care. The funders had no role in the design, conduct or reporting of this study.

PY - 2022/2/28

Y1 - 2022/2/28

N2 - ObjectivesTo examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use.Study Design and SettingA sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS.ResultsNinety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%).ConclusionCOS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.

AB - ObjectivesTo examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use.Study Design and SettingA sequential multi-methods study was conducted. We examined late-phase trials published between October 2019 and March 2020 in JAMA, NEJM, The Lancet, BMJ, and Annals of Internal Medicine. The COMET database was searched for COS potentially relevant to trials not reporting using a COS; overlap of trial and COS outcomes was examined. An online survey examined awareness of, and decisions to search for and use a COS.ResultsNinety-five trials were examined; 93 (98%) did not report using a COS. Relevant COS were identified for 31 trials (33%). Core outcomes were measured in 9 (23%) studies; all trials measured at least one core outcome. Thirty-one trialists (33%) completed our survey. The most common barrier to COS use was trialist's own outcome preferences and choice (68%). The most common perceived facilitator was awareness and knowledge about COS (90%).ConclusionCOS use in this cohort of trials was low, even when relevant COS were available. Increased use of COS in clinical trials can improve evaluation of intervention effects and evidence synthesis and reduce research waste.

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Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals

Abstract

Bibliographical note

Keywords

ASJC Scopus subject areas

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