International Consortium of Vascular Registries Consensus Recommendations for Peripheral Revascularization Registry Data Collection.
Objectives: To achieve consensus on the minimal core data set for evaluation of peripheral arterial revascularization 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 analyzed to define a minimal core data set and to develop an optimal data set for registries. Up to three different levels of variable specification were suggested to allow inclusion of registries desiring simpler vs. complex data capture, while still allowing for data aggregation based on harmonized 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 dataset. Ultimately, 79 items were recommended for inclusion in minimal core data sets, including 65 items in the Level 1 dataset, and an additional 14 items in the more specific Level 2 and 3 recommended data sets. Data elements were broadly divided into 1) patient characteristics, 2) co-morbidities, 3) current medications, 4) lesion treated, 5) procedure, 6) bypass, 7) endarterectomy, 8) catheter-based intervention, 9) complications, and 10) follow-up.
Conclusions: A modified Delphi study allowed 25 international vascular registry experts to achieve a consensus recommendation for a minimal core data set and an optimal dataset for peripheral arterial revascularization registries. Continued global harmonization of registry infrastructure and definition of items will overcome limitations related to single-country investigations and enhance the development of real world evidence.