Use of core outcome sets was low in clinical trials published in major medical journals

Karen Matvienko-sikar; Kerry Avery; Jane Blazeby; Declan Devane; Susanna Dodd; Aoife M Egan; Sarah L Gorst; Karen Hughes; Pamela Jacobsen; Jamie J Kirkham; Jan Kottner; Katie Mellor; Christopher P Millward; Smitaa Patel; Fiona Quirke; Ian J Saldanha; Valerie Smith; Caroline B Terwee; Amber E Young; Paula R 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, Jane Blazeby, Declan Devane, Susanna Dodd, Aoife M Egan, Sarah L Gorst, Karen Hughes, Pamela Jacobsen, Jamie J Kirkham, Jan Kottner, Katie Mellor, Christopher P Millward, Smitaa Patel, Fiona Quirke, Ian J Saldanha, Valerie Smith, Caroline B Terwee, Amber E Young, Paula R Williamson

Birmingham Clinical Trials Unit

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

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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.

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	29 Oct 2021
DOIs	https://doi.org/10.1016/j.jclinepi.2021.10.012
Publication status	Published - Feb 2022

Bibliographical note

Journal Pre-proof available online 29/10/2021. Final version not yet published as of 15/11/2021.

Keywords

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

ASJC Scopus subject areas

Epidemiology

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https://linkinghub.elsevier.com/retrieve/pii/S0895435621003413

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Matvienko-sikar, K., Avery, K., Blazeby, J., Devane, D., Dodd, S., Egan, A. M., Gorst, S. L., Hughes, K., Jacobsen, P., Kirkham, J. J., Kottner, J., Mellor, K., Millward, C. P., Patel, S., Quirke, F., Saldanha, I. J., Smith, V., Terwee, C. B., Young, A. E., & Williamson, P. R. (2022). Use of core outcome sets was low in clinical trials published in major medical journals. Journal of Clinical Epidemiology, 142, 19-28. Advance online publication. https://doi.org/10.1016/j.jclinepi.2021.10.012

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title = "Use of core outcome sets was low in clinical trials published in major medical journals",

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.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.",

keywords = "Core outcome sets, trials, trial outcomes, Health outcomes, Outcome reporting, Trials, Trial outcomes, Medical Journals",

author = "Karen Matvienko-sikar and Kerry Avery and Jane Blazeby and Declan Devane and Susanna Dodd and Egan, {Aoife M} and Gorst, {Sarah L} and Karen Hughes and Pamela Jacobsen and Kirkham, {Jamie J} and Jan Kottner and Katie Mellor and Millward, {Christopher P} and Smitaa Patel and Fiona Quirke and Saldanha, {Ian J} and Valerie Smith and Terwee, {Caroline B} and Young, {Amber E} and Williamson, {Paula R}",

note = "Journal Pre-proof available online 29/10/2021. Final version not yet published as of 15/11/2021. ",

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doi = "10.1016/j.jclinepi.2021.10.012",

language = "English",

volume = "142",

pages = "19--28",

journal = "Journal of Clinical Epidemiology",

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Matvienko-sikar, K, Avery, K, Blazeby, J, Devane, D, Dodd, S, Egan, AM, Gorst, SL, Hughes, K, Jacobsen, P, Kirkham, JJ, Kottner, J, Mellor, K, Millward, CP, Patel, S, Quirke, F, Saldanha, IJ, Smith, V, Terwee, CB, Young, AE & Williamson, PR 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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T1 - Use of core outcome sets was low in clinical trials published in major medical journals

AU - Matvienko-sikar, Karen

AU - Avery, Kerry

AU - Blazeby, Jane

AU - Devane, Declan

AU - Dodd, Susanna

AU - Egan, Aoife M

AU - Gorst, Sarah L

AU - Hughes, Karen

AU - Jacobsen, Pamela

AU - Kirkham, Jamie J

AU - Kottner, Jan

AU - Mellor, Katie

AU - Millward, Christopher P

AU - Patel, Smitaa

AU - Quirke, Fiona

AU - Saldanha, Ian J

AU - Smith, Valerie

AU - Terwee, Caroline B

AU - Young, Amber E

AU - Williamson, Paula R

N1 - Journal Pre-proof available online 29/10/2021. Final version not yet published as of 15/11/2021.

PY - 2022/2

Y1 - 2022/2

N2 - ObjectivesTo examine current practices in late-phase trials published in major medical journals and examine trialists’ views about core outcome set (COS) use.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.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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KW - trial outcomes

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KW - Trial outcomes

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DO - 10.1016/j.jclinepi.2021.10.012

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JO - Journal of Clinical Epidemiology

JF - Journal of Clinical Epidemiology

ER -

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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