Christian-Alexander Behrendt1, Daniel Bertges2, Nikolaj Eldrup3, Adam W Beck4, Kevin Mani5, Maarit Venermo6, Zoltán Szeberin7, Gabor Menyhei8, Ian Thomson9, Georg Heller10, Pius Wigger11, Gudmundur Danielsson12, Giuseppe Galzerano13, Cristina Lopez14, Martin Altreuther15, Birgitta Sigvant5, Henrik C Rieß16, Art Sedrakyan17, Barry Beiles18, Martin Björck5, Jonathan R Boyle19, E Sebastian Debus16, Jack Cronenwett20. 1. Department of Vascular Medicine, University Heart Centre Hamburg, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. Electronic address: ch.behrendt@uke.de. 2. Division of Vascular Surgery, University of Vermont Medical Center, Burlington, VT, USA. 3. Department of Cardio-Thoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark. 4. Division of Vascular Surgery and Endovascular Therapy, University of Alabama at Birmingham, AL, USA. 5. Department of Surgical Sciences, Uppsala University, Uppsala, Sweden. 6. Department of Vascular Surgery, Helsinki University Hospital and University of Helsinki, Helsinki, Finland. 7. Department of Vascular Surgery, Semmelweis University, Budapest, Hungary. 8. Department of Vascular Surgery, Pecs University Medical Centre, Pecs, Hungary. 9. Department of Vascular Surgery, Dunedin School of Medicine, Dunedin Hospital, Dunedin, New Zealand. 10. Department of Vascular Surgery, Kantonsspital St. Gallen, Switzerland. 11. Department of Surgery, Kantonspital, Winterthur, Switzerland. 12. Reykjavik Venous Centre, Domus Medica, Reykjavík, Iceland. 13. Vascular Surgery, Misericordia Hospital of Grosseto, Usl Toscana Sud-Est, Grosseto, Italy. 14. Department of Vascular Surgery, University Hospital of Granada, Spain. 15. Department of Vascular Surgery, St. Olavs Hospital, Trondheim, Norway. 16. Department of Vascular Medicine, University Heart Centre Hamburg, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany. 17. Healthcare Policy and Research, Weill Cornell Medical College, New York, NY, USA. 18. Australian and New Zealand Society for Vascular Surgery, Melbourne, Australia. 19. Department of Vascular Surgery, Cambridge University Hospitals NHS Trust, Cambridge, UK. 20. Department of Surgery Dartmouth-Hitchcock Medical Centre, Lebanon, NH, USA.
Abstract
OBJECTIVE/ BACKGROUND: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions. RESULTS: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up. CONCLUSION: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.
OBJECTIVE/ BACKGROUND: To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries. METHODS: A modified Delphi approach was used to achieve consensus among international vascular surgeons and registry members of the International Consortium of Vascular Registries (ICVR). Variables, including definitions, from registries covering open and endovascular surgery, representing 14 countries in ICVR, were collected and analysed to define a minimum core data set and to develop an optimum data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries with simpler versus more complex data capture, while still allowing for data aggregation based on harmonised core definitions. RESULTS: Among 31 invited experts, 25 completed five Delphi rounds via internet exchange and face to face discussions. In total, 187 different items from the various registry data forms were identified for potential inclusion in the recommended data set. Ultimately, 79 items were recommended for inclusion in minimum core data sets, including 65 items in the level 1 data set, and an additional 14 items in the more specific level 2 and 3 recommended data sets. Data elements were broadly divided into (i) patient characteristics; (ii) comorbidities; (iii) current medications; (iv) lesion treated; (v) procedure; (vi) bypass; (vii) endarterectomy (viii) catheter based intervention; (ix) complications; and (x) follow up. CONCLUSION: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimum core data set and an optimum data set for peripheral arterial revascularisation registries. Continued global harmonisation of registry infrastructure and definition of items will overcome limitations related to single country investigations and enhance the development of real world evidence.
Authors: Artur Kotov; Deven A Blasche; Frederik Peters; Philip Pospiech; Ulrich Rother; Konstantinos Stavroulakis; Jürgen Remig; Christian Schmidt-Lauber; Thomas Zeller; Hartmut Görtz; Jörg Teßarek; Christian-Alexander Behrendt Journal: J Clin Med Date: 2022-08-14 Impact factor: 4.964
Authors: Christian-Alexander Behrendt; Birgitta Sigvant; Jenny Kuchenbecker; Matthew J Grima; Marc Schermerhorn; Ian A Thomson; Martin Altreuther; Carlo Setacci; Alexei Svetlikov; Elin H Laxdal; Frederico Bastos Goncalves; Eric A Secemsky; E Sebastian Debus; Kevin Cassar; Barry Beiles; Adam W Beck; Kevin Mani; Daniel Bertges Journal: Eur J Vasc Endovasc Surg Date: 2020-09-29 Impact factor: 7.069