Karen Matvienko-Sikar1, Kerry Avery2, Jane M Blazeby2, Declan Devane3, Susanna Dodd4, Aoife M Egan5, Sarah L Gorst4, Karen Hughes4, Pamela Jacobsen6, Jamie J Kirkham7, Jan Kottner8, Katie Mellor9, Christopher P Millward10, Smitaa Patel11, Fiona Quirke12, Ian J Saldanha13, Valerie Smith14, Caroline B Terwee15, Amber E Young16, Paula R Williamson4. 1. School of Public Health, University College Cork, Ireland. Electronic address: Karen.msikar@ucc.ie. 2. 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. 3. 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. 4. Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), MRC/NIHR Trials Methodology Research Partnership, Liverpool, UK. 5. Division of Endocrinology, Diabetes and Metabolism, Mayo Clinic School of Medicine, Rochester, MN, USA. 6. Department of Psychology, University of Bath, Bath, UK. 7. Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, UK. 8. Charité-Universitätsmedizin Berlin, Institute of Clinical Nursing Science, Berlin, Germany. 9. Centre for Statistics in Medicine, Nuffield Department of Orthopedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 10. Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK; Institute of Systems, Molecular & Integrative Biology, University of Liverpool, Liverpool, UK. 11. Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK. 12. 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. 13. 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. 14. School of Nursing and Midwifery, University of Dublin Trinity College, Ireland. 15. Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands. 16. Centre for Surgical Research, Population Health Sciences Bristol Medical School, Bristol, UK.
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.
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.
Authors: Christoffer Bruun Korfitsen; Marie-Louise Kirkegaard Mikkelsen; Anja Ussing; Karen Christina Walker; Jeanett Friis Rohde; Henning Keinke Andersen; Simon Tarp; Mina Nicole Händel Journal: Int J Environ Res Public Health Date: 2022-01-07 Impact factor: 3.390