Feasibility of Target Trial Emulation (TTE) Study Design Using the Hospital Episode Statistics (HES) Database in England

OBJECTIVES: Many regulatory authorities including NICE (UK), HAS (France) and the EMA propose Target Trial Emulation (TTE) as an ideal approach for the design of RWE studies. It is likely a requirement for increased acceptance of RWE evidence in the future. In England, the Hospital Episode Statistics (HES) database provides high quality RWD with high population coverage. HES records surgical interventions at procedure level for all operations across hospitals in England.

METHODS: Possible target trials (interventional, phase I-III) of a surgical device or intervention with at least one study site in the UK, starting on or after 1^st January 2014 were identified using the clinicaltrials.gov database. An aligning target trial design was then constructed based on this trial, and a subsequent RWD study design developed around the HES database. The alignment between these designs was described to estimate the feasibility of conducting an accurate, and robust, TTE study using the HES database.

RESULTS: Initial feasibility counts for the intervention and placebo procedures in the VOCALIST trial (NCT02973152) indicated over 200 patients had received the procedures of interest, as indicated in HES by OPCS-4 procedure codes. Additionally, many of the trial inclusion and exclusion criteria could be mapped to variables in HES. Reflecting these key study design elements will enable a robust RWE TTE design to be achieved.

CONCLUSIONS: The use of RWE for generating evidence on surgical interventions and surgically implanted medical devices is less well established than in the generation of evidence on medicines. The results of this study indicate that it is likely that a robust, modern TTE design can be achieved using HES for HTA of surgical interventions and devices.