Extending the Hughes Abdominal Repair Trial: Long-term Follow-Ups by Routine Data (exHART-FURD)
End of project summary:
Background: The Hughes Abdominal Repair Trial, known as the HART trial (ISRCTN 25616490) took place between 2013 and 2017, recruiting over 800 participants across England and Wales. HART aimed to evaluate the clinical and cost effectiveness of the ‘Hughes’ surgical closure in reducing incisional hernia rates following surgery for bowel cancer. The primary outcome was clinically detected incisional hernia rates at 12-months post-surgery. The trial did not detect a statistically significant difference between the technique under investigation and the surgeon’s choice closure method. HART was not funded to assess medium- or long-term outcomes.
In this project, we proposed to use routinely collected medical data to assess whether any long-term benefit exists for patients within HART. Using national health data repositories (SAIL, NHS Digital) we sought to link participants’ Electronic Heath Records (HER), including GP and Hospital records, to ascertain evidence of hernia and other health impacts.
Main Messages:
- An agreed legal basis is required to request access to data held by SAIL and NHS Digital; this can be difficult to establish post hoc, with potential for delays.
- Careful advance planning, gaining the necessary GDPR-compliant permissions on initial recruitment, can mitigate such delays.
- Wales-based HART participant research records were successfully linked to routinely medical data via SAIL.
- Logistical delays related in part to governance processes existing in silos and also to the COVID-19 pandemic meant that it was not possible to link England-based HART participants’ data.
- HART study records matched well with EHR data.
- Over 2000 dates related to further operations were identified within the 5-year follow-up period.
- Approximately 1% of further surgeries appeared to be linked to HART study participation.
- 55 participant deaths were confirmed; 19 further deaths were identified.