BACKGROUND

clinical trials test the effectiveness or efficacy of treatments. It is important that researchers evaluate interventions with the most meaningful outcome measures. The 2014 hip fracture core outcome set recommended that mortality, mobility, pain, activities of daily living and health-related quality of life (HRQOL) should be assessed in all trials of patient with hip fracture. The purpose of this analysis was to determine the uptake of these recommendation.

METHODS

all trials registered from 1997 to 2018 recruiting participants following hip fracture were identified from the ClinicalTrials.gov trials registry. The frequency of each core domain adopted annually were assessed.

RESULTS

311 trials were identified and analysed. On analysing trial registries for years which presented a minimum of 10 registrations, full core outcome set adoption ranged from 0% (2017; 2018) to 24% (2009). Mortality and mobility were the most consistently reported domains (mortality: 27% (2017) to 56% (2011); mobility: 36% (2015) to 60% (2004)). In contrast, pain and HRQOL were least reported (pain: 14% (2017) to 61% (2015); HRQOL: 10% (2010) to 11% (2008)). There was no clear change in core outcome domain set adoption following the publication of Hayward et al.'s (2014) core outcome set.

CONCLUSIONS

there has been limited adoption of the hip fracture core outcome set from its publication in 2014. Further consideration to improve implementation is required to improved uptake.