Jessica Fletcher1,2, Katie Jane Sheehan3, Toby O Smith1,4. 1. Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. 2. Physiotherapy Department, Connect Health, Milton Keynes, UK. 3. Department of Population Health Sciences, School of Population Health and Environmental Sciences, Kings College London, London, UK. 4. Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.
Abstract
BACKGROUND: Core outcome sets are an agreed recommendation to inform the selection of outcome measures in clinical trials. There has been low uptake of the 2014 hip fracture core outcome set. The reasons for this remain unclear. The aim of this study was to understand the reasons for the non-adoption and approaches to increase adoption of the hip fracture core outcome set. METHODS: Randomised controlled trials from PubMed (2017-2019) and ClinicalTrials.gov (2015-2019) were identified. Corresponding authors for each identified trial (n = 302) were surveyed using five questions on awareness of the hip fracture core outcome set, reasons for non-adoption and approaches to increase adoption. Data were analysed descriptively using frequencies, mean values and standard deviations. RESULTS: Fifty-four percent of the respondents (n = 43) were aware of the concept of core outcome set. Only 15% (n = 12) based the outcome measure selection on the 2014 hip fracture core outcome set. Key reasons for non-adoption included the following: authors being unaware and perceived inappropriateness to their trial design. Eighty-six percent (n = 69) of respondents agreed to the need for increased awareness of core outcome sets through research training, academic and clinical journal requirements, and funding or publication stipulations. Eighty-eight percent (n = 70) of respondents indicated the current core outcome set required revision to focus on trials investigating people with cognitive impairment, caregivers, rehabilitation, surgical interventions and anaesthetic trial designs. CONCLUSION: Barriers to the adoption of the hip fracture core outcome set centre on education, awareness of the core outcome sets and applicability to the breath of hip fracture trial designs. Further consideration should be made to address these, to improve the harmonisation of outcome measures across hip fracture trials.
BACKGROUND: Core outcome sets are an agreed recommendation to inform the selection of outcome measures in clinical trials. There has been low uptake of the 2014 hip fracture core outcome set. The reasons for this remain unclear. The aim of this study was to understand the reasons for the non-adoption and approaches to increase adoption of the hip fracture core outcome set. METHODS: Randomised controlled trials from PubMed (2017-2019) and ClinicalTrials.gov (2015-2019) were identified. Corresponding authors for each identified trial (n = 302) were surveyed using five questions on awareness of the hip fracture core outcome set, reasons for non-adoption and approaches to increase adoption. Data were analysed descriptively using frequencies, mean values and standard deviations. RESULTS: Fifty-four percent of the respondents (n = 43) were aware of the concept of core outcome set. Only 15% (n = 12) based the outcome measure selection on the 2014 hip fracture core outcome set. Key reasons for non-adoption included the following: authors being unaware and perceived inappropriateness to their trial design. Eighty-six percent (n = 69) of respondents agreed to the need for increased awareness of core outcome sets through research training, academic and clinical journal requirements, and funding or publication stipulations. Eighty-eight percent (n = 70) of respondents indicated the current core outcome set required revision to focus on trials investigating people with cognitive impairment, caregivers, rehabilitation, surgical interventions and anaesthetic trial designs. CONCLUSION: Barriers to the adoption of the hip fracture core outcome set centre on education, awareness of the core outcome sets and applicability to the breath of hip fracture trial designs. Further consideration should be made to address these, to improve the harmonisation of outcome measures across hip fracture trials.
Authors: Alexandra M B Korall; Dawn Steliga; Sarah E Lamb; Stephen R Lord; Rasheda Rabbani; Kathryn M Sibley Journal: Trials Date: 2022-08-26 Impact factor: 2.728