Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals: Core outcome set use in clinical trials

Karen Matvienko-Sikar; Kerry Avery; Jane Blazeby; Declan Devane; Susanna Dodd; Aoife Egan; Sarah Gorst; Karen Hughes; Pamela Jacobsen; Jamie Kirkham; Jan Kottner; Katie Mellor; Christopher Millward; Smitaa Patel; Fiona Quirke; Ian Saldanha; Valerie Smith; Caroline Terwee; Amber Young; 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: Core outcome set use in clinical trials

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

Division of Population Health, Health Services Research & Primary Care (L5)

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

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
Journal	Journal of Clinical Epidemiology
Volume	142
Early online date	26 Oct 2021
DOIs	https://doi.org/10.1016/j.jclinepi.2021.10.012
Publication status	Published - 1 Feb 2022

Keywords

Core Outcome Sets
Trials
Trial Outcomes

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10.1016/j.jclinepi.2021.10.012

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Matvienko-Sikar, K., Avery, K., Blazeby, J., Devane, D., Dodd, S., Egan, A., Gorst, S., Hughes, K., Jacobsen, P., Kirkham, J., Kottner, J., Mellor, K., Millward, C., Patel, S., Quirke, F., Saldanha, I., Smith, V., Terwee, C., Young, A., & Williamson, P. (2022). Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals: Core outcome set use in clinical trials. Journal of Clinical Epidemiology, 142, 19-28. 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: Core outcome set use in clinical trials",

abstract = "Objectives. To 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 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{\textquoteright}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. ",

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author = "Karen Matvienko-Sikar and Kerry Avery and Jane Blazeby and Declan Devane 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 Fiona Quirke and Ian Saldanha and Valerie Smith and Caroline Terwee and Amber Young and Paula Williamson",

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

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

TY - JOUR

T1 - Use of Core Outcome Sets was Low in Clinical Trials Published in Major Medical Journals

T2 - Core outcome set use in clinical trials

AU - Matvienko-Sikar, Karen

AU - Avery, Kerry

AU - Blazeby, Jane

AU - Devane, 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 - Quirke, Fiona

AU - Saldanha, Ian

AU - Smith, Valerie

AU - Terwee, Caroline

AU - Young, Amber

AU - Williamson, Paula

PY - 2022/2/1

Y1 - 2022/2/1

N2 - 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.

AB - 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.

KW - Core Outcome Sets

KW - Trials

KW - Trial Outcomes

U2 - 10.1016/j.jclinepi.2021.10.012

DO - 10.1016/j.jclinepi.2021.10.012

M3 - Article

SN - 0895-4356

VL - 142

SP - 19

EP - 28

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: Core outcome set use in clinical trials

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Keywords

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