Objective: Technology and advances in clinical care have changed the management of abdominal aortic aneurysms (AAAs) but the clinical effectiveness of continuing advances needs to be assessed. To facilitate rapid synthesis of new evidence and improve stakeholder representation, including patients, the concept of core outcome sets has been developed. Core outcome sets, reflecting the needs of all stakeholders, have been established across several surgical specialties. This study aimed to develop an international core outcome set for intact
AAA repair.
Methods: Following COMET methodology, potential outcomes were identified from
a systematic review of published outcomes and focus groups involving patients, carers, and
nurses. A 38 question Delphi consensus survey in lay language was developed (with
translation to local languages); this included 35 themes identified from the findings of the
systematic review and three themes from the focus groups. All three of the themes identified
by the focus groups (cognitive, physical, and social functioning) can be evaluated from
quality of life instruments, with overall quality of life being identified from the systematic
review. The survey was completed by patients, carers or family members, vascular nurses,
vascular surgeons, trainees, interventional radiologists, anaesthetists, and industry partners
from six European countries. After two rounds of the survey, the top outcomes were
discussed at a face to face multistakeholder consensus meeting.
Results: The 38 item questionnaire was amended after piloting among all stakeholder groups. After the first round of the Delphi survey (98 respondents), 15 questions were eliminated and 11 further questions were eliminated after round two (90 respondents). This left two outcome questions for discussion at the consensus meeting, where the top six outcomes were unanimously endorsed: mortality at 30 days (or in hospital if longer), secondary AAA rupture, overall quality of life and retention of cognitive functioning after recovery, 5 year survival, and continued sac growth.
Conclusion: Six core outcomes are recommended for use as a minimum framework in all
future studies and registries of intact open and endovascular AAA repair. Further work to
select instruments for quality of life and define instruments for cognitive functioning is
needed.
This study aimed to develop an international core outcome set for intact
AAA repair.
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
Disease Category: Heart & circulation
Disease Name: Abdominal aortic aneurysm
Age Range: 50 - 120
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Device manufacturers
- Families
- Governmental agencies
- Researchers
- Service providers
- Service users
- 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.