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.
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 |
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Pages (from-to) | 19-28 |
Number of pages | 10 |
Journal | Journal of Clinical Epidemiology |
Volume | 142 |
Early online date | 20 Nov 2021 |
DOIs | |
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