Facilitating clinical trials in hip fracture in the UK : the role and potential of the National Hip Fracture Database and routinely collected data.

AIMS: The aim of this study was to evaluate the suitability, against an accepted international standard, of a linked hip fracture registry and routinely collected administrative dataset in England to embed and deliver randomized controlled trials (RCTs). METHODS: First, a bespoke cohort of individuals sustaining hip fractures between 2011 and 2016 was generated from the National Hip Fracture Database (NHFD) and linked to individual Hospital Episode Statistics (HES) records and mortality data. Second, in order to explore the availability and distribution of outcomes available in linked HES-Office of National Statistics (ONS) data, a more contemporary cohort with incident hip fracture was identified within HES between January 2014 and December 2018. Distributions of the outcomes within the HES-ONS dataset were reported using standard statistical summaries; descriptive characteristics of the NHFD and linked HES-ONS dataset were reported in line with the Clinical Trials Transformation Initiative recommendations for registry-enabled trials. RESULTS: Case ascertainment of the NHFD likely exceeds 94%. The assessment of the robustness, relevance, and reliability of the datasets was favourable. Outcomes from the HES-ONS dataset were concordant with other contemporaneous prospective cohort studies with bespoke data collection frameworks. CONCLUSION: Our findings support the feasibility of the NHFD and HES-ONS to support a registry-embedded, data-enabled RCT.