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

Karen Matvienko-Sikar; Kerry Avery; Jane M. 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:https://doi.org/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 M. 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

Epidemiology and Data Science (VUmc)

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

15 Citations (Scopus)

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

Keywords

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

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https://doi.org/10.1016/j.jclinepi.2021.10.012

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Matvienko-Sikar, K., Avery, K., Blazeby, J. M., 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. 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 = "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. 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.",

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

author = "Karen Matvienko-Sikar and Kerry Avery and Blazeby, {Jane M.} 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 = "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. Publisher Copyright: {\textcopyright} 2021",

year = "2022",

month = feb,

doi = "https://doi.org/10.1016/j.jclinepi.2021.10.012",

language = "English",

volume = "142",

pages = "19--28",

journal = "J Clin Epidemiol",

issn = "1878-5921",

publisher = "Elsevier USA",

}

Matvienko-Sikar, K, Avery, K, Blazeby, JM, 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

TY - JOUR

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 M.

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 - 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. Publisher Copyright: © 2021

PY - 2022/2

Y1 - 2022/2

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. 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.

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. 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.

KW - Core outcome sets

KW - Health outcomes

KW - Medical Journals

KW - Outcome reporting

KW - Trial outcomes

KW - Trials

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U2 - https://doi.org/10.1016/j.jclinepi.2021.10.012

DO - https://doi.org/10.1016/j.jclinepi.2021.10.012

M3 - Article

C2 - 34715310

SN - 1878-5921

VL - 142

SP - 19

EP - 28

JO - J Clin Epidemiol

JF - J Clin Epidemiol

ER -

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

Abstract

Keywords

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