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

Cohort Studies Delphi Technique Humans Outcome Assessment, Health Care Periodicals as Topic Publications Research Design Research Report Treatment Outcome
Core outcome sets Health outcomes Medical Journals Outcome reporting Trial outcomes Trials

Journal

Journal of clinical epidemiology
ISSN: 1878-5921
Titre abrégé: J Clin Epidemiol
Pays: United States
ID NLM: 8801383

Informations de publication

Date de publication:
02 2022
Historique:
received: 14 08 2021
revised: 08 10 2021
accepted: 20 10 2021
pubmed: 30 10 2021
medline: 12 4 2022
entrez: 29 10 2021
Statut: ppublish

Résumé

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

Identifiants

DOI: 10.1016/j.jclinepi.2021.10.012 PMID: 34715310
pubmed: 34715310
pii: S0895-4356(21)00341-3
doi: 10.1016/j.jclinepi.2021.10.012
pii:
doi:

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

19-28

Subventions

Organisme : Medical Research Council
ID : MR/K025643/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/S014357/1
Pays : United Kingdom
Organisme : Department of Health
ID : NF-SI_0513-10025
Pays : United Kingdom

Informations de copyright

Copyright © 2021. Published by Elsevier Inc.

Auteurs

Karen Matvienko-Sikar (K)

School of Public Health, University College Cork, Ireland. Electronic address: Karen.msikar@ucc.ie.

Kerry Avery (K)

NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.

Jane M Blazeby (JM)

NIHR Bristol Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Bristol Medical School, Population Health Sciences, University of Bristol, Bristol, UK.

Declan Devane (D)

Aras Moyola, School of Nursing and Midwifery, National University of Ireland, Galway, 26 Upper Newcastle, Galway, H91 E3YV, Ireland; Health Research Board Trials Methodology Research Network, National University of Ireland, Galway, Ireland.

Susanna Dodd (S)

Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.

Aoife M Egan (AM)

Division of Endocrinology, Diabetes and Metabolism, Mayo Clinic School of Medicine, Rochester, MN, USA.

Sarah L Gorst (SL)

Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.

Karen Hughes (K)

Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.

Pamela Jacobsen (P)

Department of Psychology, University of Bath, Bath, UK.

Jamie J Kirkham (JJ)

Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK.

Jan Kottner (J)

Charité-Universitätsmedizin Berlin, Institute of Clinical Nursing Science, Berlin, Germany.

Katie Mellor (K)

Centre for Statistics in Medicine, Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.

Christopher P Millward (CP)

Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK; Institute of Systems, Molecular & Integrative Biology, University of Liverpool, Liverpool, UK.

Smitaa Patel (S)

Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.

Fiona Quirke (F)

Health Research Board Trials Methodology Research Network, National University of Ireland, Galway, Ireland; College of Medicine, Nursing and Health Sciences, National University of Ireland Galway, Galway, Ireland.

Ian J Saldanha (IJ)

Department of Health Services, Center for Evidence Synthesis in Health, Policy and Practice, and Department of Epidemiology, Brown University School of Public Health, Providence, RI, USA.

Valerie Smith (V)

School of Nursing and Midwifery, University of Dublin Trinity College, Ireland.

Caroline B Terwee (CB)

Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Amber E Young (AE)

Centre for Surgical Research, Population Health Sciences Bristol Medical School, Bristol, UK.

Paula R Williamson (PR)

Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK.

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