To achieve consensus on the minimum core data set for evaluation of peripheral arterial revascularisation outcomes and enable collaboration among international registries.
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.
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.
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.
The International Consortium of Vascular Registries (ICVR) has rapidly developed into a global collaborative. Given the importance of vascular devices for public health, this is a priority direction for regulators, manufacturers, payers and patients advocacy groups. It is an innovative effort building on successes achieved in orthopedics and promotes cohesion among international registries. The ICVR will enable a collaboration of stakeholders to create a sustainable global system to evaluate the safety and efficacy of new and existing vascular devices and procedures, while promoting innovation and quality improvement.
Large scale use of real world data in vascular research projects has become a central point for discussion among scientific collaborations worldwide. As there is a distinct diversity of patients with various vascular diseases undergoing a broad range of diagnostic and treatment approaches, it remains unclear whether results from randomised controlled trials (RCTs) can always reflect the non-homogeneous treatment reality. In addition, the design of a RCT is not suited for quality improvement. To improve the paucity of evidence and to implement quality improvement in vascular maintenance, several national registries and international collaborations such as VASCUNET (including 12 registries in Europe, Australia, and New Zealand) or the International Consortium of Vascular Registries (ICVR) are collecting an increasing amount of data.
Recently, data privacy compliance, as well as the strengths and limitations of registry based research in vascular medicine have been scrutinised,1–3 and health insurance claims, as a source of real world evidence, regain the attention of the scientific community. In several European countries health insurance claims and statutory hospital episode statistics are becoming accessible for secondary research.4