A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair

Matthew Machin; Anders Wanhainen; Mario D'Oria; Mark Koelemaij; Stavros Kakkos; Matthew Joe Grima; Janet T Powell; collaborators

doi:10.1016/j.ejvs.2024.04.029

A Core Outcome Set for Intact Abdominal Aortic Aneurysm Repair

Eur J Vasc Endovasc Surg. 2024 Apr 25:S1078-5884(24)00365-4. doi: 10.1016/j.ejvs.2024.04.029. Online ahead of print.

Authors

Matthew Machin¹, Anders Wanhainen², Mario D'Oria³, Mark Koelemaij⁴, Stavros Kakkos⁵, Matthew Joe Grima⁶, Janet T Powell⁷; collaborators

Collaborators

collaborators:
Ian Loftus⁸, Bilal Azhar⁸, Matthew Bown⁹, Pinar Ulug⁷, Colin Bicknell⁷, Sadie Syed¹⁰, Louise Allen¹¹, Anna Pouncey⁷, Adam Haque¹², Robert Hinchliffe¹³, Aleksandra Staniszewska¹³, Andrew Tambyraja¹⁴, Daniel Carradice¹⁵, Rachel Bell¹⁶, Bijan Modarai¹⁷, Nadeem Shaida¹⁸, Santi Trimarchi¹⁹, Wolf Hans Eilenberg²⁰, Regula von Allmen²¹, Sandro Lepidi²², Nicola Troisi²³, Gioele Simonte²⁴, Enrico Gallitto²⁵, Germano Melissano²⁶, Luca Mezzetto²⁷, Giovanni Tinelli²⁸, Stefano Fazzini²⁹, Ciro Ferrer³⁰, Marco Franchin³¹, Luca Bertoglio³², Daniele Bissacco³³, Eva Jangland³⁴, Jean-Baptiste Ricco³⁵

Affiliations

¹ Department of Surgery and Cancer, Imperial College London, London, UK. Electronic address: matthew.machin12@imperial.ac.uk.
² Department of Surgical Sciences, Vascular Surgery, Uppsala University, Uppsala, Sweden; Department of Surgical and Perioperative Sciences, Surgery, Umeå University, Umeå, Sweden.
³ Division of Vascular and Endovascular Surgery, Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy.
⁴ Department of Vascular Surgery, Amsterdam University Medical Centre, Amsterdam, the Netherlands.
⁵ Department of Vascular Surgery, Division of Surgery, University of Patras, Patras, Greece.
⁶ Faculty of Medicine and Surgery, University of Malta, Malta.
⁷ Department of Surgery and Cancer, Imperial College London, London, UK.
⁸ St George's Vascular Institute, St George's NHS Trust, London, UK.
⁹ Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.
¹⁰ Department of Anaesthetics, Imperial College NHS Healthcare Trust, St Mary's Hospital, London, UK.
¹¹ Department of Vascular Surgery, Imperial College NHS Healthcare Trust, St Mary's Hospital, London, UK.
¹² Academic Unit of Surgery, University of Manchester, Manchester, UK.
¹³ Bristol Centre for Surgical Research, University of Bristol, Bristol, UK.
¹⁴ Department of Clinical Surgery, The University of Edinburgh, Edinburgh, UK.
¹⁵ Academic Vascular Surgical Unit, Hull York Medical School, Hull, UK.
¹⁶ Northern Vascular Centre, Freeman Hospital, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
¹⁷ Academic Department of Vascular Surgery, School of Cardiovascular Medicine and Sciences, King's College London, Guy's and St Thomas' Hospital, London, UK.
¹⁸ Department of Radiology, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
¹⁹ Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy.
²⁰ Department of Vascular Surgery, Medical University of Vienna, Vienna, Austria.
²¹ Swiss Cardiovascular Centre, Department of Cardiovascular Surgery, University Hospital Bern and University of Bern, Bern, Switzerland.
²² Division of Vascular and Endovascular Surgery, Department of Medical Surgical and Health Sciences, University of Trieste, ASUGI, Trieste, Italy.
²³ Vascular Surgery Unit, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
²⁴ Unit of Vascular and Endovascular Surgery, Santa Maria della Misericordia Hospital, Perugia, Italy.
²⁵ Vascular Surgery, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, IRCCS Sant'Orsola-Malpighi Hospital, Bologna, Italy.
²⁶ Department of Vascular Surgery, Vita-Salute San Raffaele University School of Medicine, IRCCS San Raffaele Hospital, Milan, Italy.
²⁷ Unit of Vascular Surgery, Integrated University Hospital and Trust of Verona, Verona, Italy.
²⁸ Unit of Vascular Surgery, Fondazione Policlinico Universitario Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy.
²⁹ Vascular Surgery Unit, Biomedicine and Prevention Department, Tor Vergata University, Rome, Italy.
³⁰ Unit of Vascular Surgery, Department of Surgery, Sapienza University of Rome, Rome, Italy.
³¹ Department of Cardio-Thoracic and Vascular Surgery of the ASST Settelaghi University Teaching Hospital, Varese, Italy.
³² Division of Vascular Surgery, Department of Clinical and Experimental Sciences (DSCS), University and ASST Spedali Civili Hospital of Brescia, Brescia, Italy.
³³ Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
³⁴ Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
³⁵ Department of Clinical Research, University of Poitiers, Poitiers, France.

PMID: 38677466
DOI: 10.1016/j.ejvs.2024.04.029

Abstract

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.

Keywords: Abdominal aortic aneurysm; Core outcome set; Evidence based medicine; Patient and public involvement.