| Title: |
Endovascular treatment of peripheral arterial disease : Endo-STAR framework for the design, conduct, and reporting of trials |
| Authors: |
Zywicka, Ewa M.; Moore, Andrew J.; Twine, Christopher; Behrendt, Christian-Alexander; Bosiers, Michel; Brodmann, Marianne; Choke, Edward; DeBorst, Gert J.; Diamantopoulos, Athanasios; Enzmann, Florian; Farber, Alik; Ansel, Gary; Gattuso, Dario; Goh, Gerard S.; Yann, Goueffic; Jansen, Shirley; Landini, Mario; Lejay, Anne; Lichtenberg, Michael; Menard, Matthew; Mezes, Peter; Mills, Joseph; Nixon, Jane; Nordanstig, Joakim; O'Connell, Kelly; Ozdemir, Baris; Patrone, Lorenzo; Puppala, Sapna; Saratzis, Athanasios; Secemsky, Eric A.; Sigrid, Nikol; Stavroulakis, Konstantinos; Steiner, Sabine; Teraa, Martin; Van Herzeele, Isabelle; Venermo, Maarit; Zeller, Thomas; Mouton, Ronelle; Hinchliffe, Robert J. |
| Contributors: |
Verisuonikirurgian yksikkö; HUS Abdominal Center; Clinicum; University of Helsinki |
| Publisher Information: |
Oxford University Press |
| Publication Year: |
2025 |
| Collection: |
Helsingfors Universitet: HELDA – Helsingin yliopiston digitaalinen arkisto |
| Subject Terms: |
Inter-society consensus; Qualitative research; Management; Interventions; Guidelines; Surgery; anesthesiology; intensive care; radiology |
| Description: |
Background Endovascular technologies continue to evolve to meet the large and growing burden of peripheral arterial disease. The overall quality of published RCTs in endovascular treatments for peripheral arterial disease is low, resulting in uncertainty over treatment effectiveness. The aim of this study was to develop a framework to improve the design, conduct, and reporting of future clinical trials for infrainguinal endovascular treatments of peripheral arterial disease.Methods The authors undertook the design, development, and pilot testing of a novel framework. The study comprised four distinct phases. Phase 1 represented the development of a preliminary framework using content analysis of endovascular interventions described in previously published RCTs. Phase 2 consisted of focus groups with key stakeholders to further develop, revise, and achieve initial consensus on the framework. Phase 3 corresponded to the creation of a modified Delphi questionnaire to achieve final consensus on the framework. Phase 4 included cognitive interviews with professionals designing or undertaking endovascular lower limb trials to pilot test the framework.Results Content analysis of 228 endovascular interventions from 112 RCTs identified six key themes, relevant to endovascular peripheral arterial disease interventions, for the framework: expertise; setting; anaesthesia; imaging; intervention components (access; crossing lesion; treating lesion (lesion preparation; intervention; intervention optimization; bailout intervention; and treatment of non-target lesions); and closure of artery); and pharmacological interventions. Further refinements were made to the framework as a result of feedback from three focus groups and a Delphi questionnaire. The framework deconstructs an endovascular intervention into its component parts. The final framework can be accessed at www.endo-star.com. Pilot testing evaluated comprehension, clarity, and completeness of interpretation.Conclusion The Endo-STAR framework deconstructs endovascular ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
English |
| Relation: |
This work was undertaken with the support of the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, the Linder Foundation, and the Department of Research & Innovation at North Bristol NHS Trust.; https://hdl.handle.net/10138/595809; 105003029795; 001468441000001 |
| Availability: |
https://hdl.handle.net/10138/595809 |
| Rights: |
cc_by ; info:eu-repo/semantics/openAccess ; openAccess |
| Accession Number: |
edsbas.77244741 |
| Database: |
BASE |