Development of a core outcome set for clinical studies reporting the outcomes of patients undergoing repair of degenerative infrarenal abdominal aortic aneurysms

From a randomised trial of the management of ruptured abdominal aortic aneurysm (AAA) it became evident that the outcomes most important to patients are seldom documented and reported. Therefore the aim of this project is to produce a core outcome set for AAA repair outcomes, applicable across Europe.

We have conducted separate systematic reviews for the outcomes reported for repair of ruptured and intact AAA, presenting separate data for open surgical repair and endovascular repair within each review. The systematic reviews are registered in PROSPERO CRD42019130119

The Swedish collaborators are doing the first round of patient focus groups, Their findings will be validated by questionnaires to patients in the UK and at least one other European country. Vascular nurses, service budget holders and industry also will be consulted prior to a Delphi consensus process, The Delphi consensus will be conducted principally through the auspices of the European Society of Vascular Surgery and their affiliated groups of vascular nurses and patients.

The expected outcomes are 2 separate sets of core outcomes, each of 8=12 items, one for ruptured AAA (mortality >30%) and one for intact AAA (mortality <3%).


Janet Powell Imperial College London
Matthew Bown Univeristy of Leicester
Anders Wanhainen University of Uppsala
Eva Jagland University of Uppsala
Matthew Machin, Imperial College London
Pinar Ulug Imperial College London
Kamashi Pandirajan, University of Leicester

Further Study Information

Current Stage: Ongoing
Date: September 2019 - December 2021
Funding source(s): To be confirmed

Health Area

Disease Category: Heart & circulation

Disease Name: Abdominal aortic aneurysm

Target Population

Age Range: 50 - 120

Sex: Either

Nature of Intervention: Surgery

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Families
- Governmental agencies
- Researchers
- Service providers
- Service users

Study Type

- COS for clinical trials or clinical research
- COS for practice


- Consensus meeting
- Delphi process
- Focus group(s)
- Survey
- Systematic review

Systematic review, followed by focus groups to tease out key issues/outcomes, especially those rarely reported by surgeons. Validation of focus group findings in at least 3 European countries. Finally European-wide Delphi consensus group and, if COVID-19 allows, a consensus conference meeting.

Systematic review details on PROSPERO CRD42019130119.