ARDA Validation

• Research type

  Research Study

• Full title

  Investigation of Aneurysm Repair Decision Aid (ARDA) for Management of Abdominal Aortic Aneurysms: Safety Validation and Impact Assessment.

• IRAS ID

  213647

• Contact name

  S.R. Vallabhaneni

• Contact email

  fempop@liv.ac.uk

• Sponsor organisation

  Royal Liverpool and Broadgreen University Hospitals NHS trust

• Duration of Study in the UK

  0 years, 11 months, 31 days

• Research summary

  Title:
  Investigation of ‘Aneurysm Repair Decision Aid (ARDA)’ for Management of Abdominal Aortic Aneurysms: Safety Validation and Impact Assessment.

  Background:
  Abdominal aortic aneurysm (AAA) is a ballooning of the main artery supplying the body; large AAAs may grow until they burst (rupture), at which point 80% of patients die. Currently, surgery is considered if the AAA causes pain or reaches 55 mm in diameter. As with all surgery, there are risks associated with repair. The Aneurysm Repair Decision Aid (ARDA) is a custom-designed computer program aims to provide information to help patients and surgeons decide on the best treatment strategy for the AAA. The main information ARDA provides is the expected AAA growth rate and risk of rupture, the chance a patient will need AAA repair, the chance a patient will survive AAA repair and the chance a patient will survive for 5 and 10 years following AAA repair.

  Aim:
  The aims of this study are 1) to develop a clinical decision tool based on ARDA and 2)
  to validate ARDA utilising data from the National Vascular Registry (NVR)

  Method:
  This study will be a retrospective cohort study using existing data retrieved from the NVR.

  Impact assessment:
  The impact on NHS resource utilisation will be estimated from treatment and follow-up costs.

  Setting/Participants
  This study will be conducted by researchers in Royal Liverpool and Broadgreen University Hospitals NHS Trust. All patients who underwent elective AAA repair in the Uk recorded on the National Vascular Registry between Jan 2012 and Dec 2015 will be included in the analyses.

  Study Interventions and Measures
  • Review of electronic records from the NVR.
  • Primary endpoints are aneurysm-related mortality and all-cause mortality.
  • Secondary endpoints are cost effectiveness of utilisation of the ARDA tool.

  Broad Timetable:
  The study will run provisionally from August 2017 till end of July 2018.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  17/EE/0313

• Date of REC Opinion

  26 Jul 2017

• REC opinion

  Favourable Opinion