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Registries, Research, and Quality Improvement

Open ArchivePublished:March 13, 2020DOI:https://doi.org/10.1016/j.ejvs.2020.02.014
      It is a distinct honour to be invited by the European Society for Vascular Surgery (ESVS) to deliver this lecture on Evidence in Vascular Surgery in honour of our esteemed colleague Janet Powell. Professor Powell has spearheaded numerous important randomised controlled trials (RCTs) in vascular surgery, for which she deserves our gratitude. In this regard, there is no debate that RCTs provide Level A evidence, the gold standard for clinical decision making. However RCTs have challenges, including high cost, narrow patient selection and performance by expert surgeons in specialised centres, which may limit broad applicability. By contrast, observational studies involving registries offer only Level B evidence, but with real world data that may be more generalisable than RCTs. Registry based studies have different challenges, including potential confounding based on patient or treatment selection bias. Such studies often require propensity or other matching strategies to compare different groups and cannot always account for confounding if relevant data are not available. However, both RCTs and observational registry studies share the goal of improving healthcare quality. Thus, they are complementary and valuable when properly applied and interpreted. Today, I will focus on how registries, and registry derived research, can be used to improve quality.

      Clinical Registries and Quality Improvement

      In recent years, clinical registries have grown in popularity and have been described in detail in multivolume publications.
      They are defined as an organised system that collects uniform clinical data to evaluate outcomes for patients defined by a disease or treatment, for a predetermined purpose.
      Major uses for clinical registries include data for research, audits for quality assurance or credentialing, and evaluation of device and drug performance. To be used for quality improvement, clinical registries must collect actionable data and provide feedback to providers to promote change. Today I will use examples from the ESVS VASCUNET,,
      • Mitchell D.
      • Venermo M.
      • Mani K.
      • Bjorck M.
      • Troeng T.
      • Debus S.
      • et al.
      Quality improvement in vascular surgery: the role of comparative audit and Vascunet.
      the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI),
      ,
      • Cronenwett J.L.
      • Kraiss L.W.
      • Cambria R.P.
      The society for vascular surgery vascular quality initiative.
      the International Consortium of Vascular Registries (ICVR),
      ,
      • Venermo M.
      • Sedrakyan A.
      • Cronenwett J.
      International Consortium of vascular registries.
      and the Vascular Low Frequency Disease Consortium (VLFDC)
      registries.
      What is the potential role for registries in quality improvement (QI)? Without a registry, surgeons cannot track their outcomes, benchmark their results with others, or be aware of practice differences. Further, it is difficult for individual practitioners to perceive a need for change based on their own practice. The small number of adverse events even in a busy practice prevents recognition of cause and effect patterns, and the insular nature of surgical practice makes it difficult to learn from others. Registries that collect and share comparative data provide the opportunity for learning and QI. When granular information from registries reveals variation in patient or treatment selection or outcome, this variation identifies opportunity for improvement. The foundational principle of registry use for QI is that all surgeons want to do their best, and believe that they are. But if they are provided with trusted, objective data that suggest that they are not doing the best, they will change their practice. Awareness is required to stimulate change, and registries can provide this.

      Registry Induced Practice Change

      In 2004, when the VQI existed only in New England,
      • Cronenwett J.L.
      • Likosky D.S.
      • Russell M.T.
      • Eldrup-Jorgensen J.
      • Stanley A.C.
      • Nolan B.W.
      • et al.
      A regional registry for quality assurance and improvement: the vascular study group of northern new England (VSGNNE).
      pre-operative statin use before arterial surgery was analysed among the initial 25 surgeons participating. While they believed that nearly all their patients were receiving this evidence based treatment, only 50% of patients had been prescribed a statin pre-operatively. By providing this “report card” and subsequent follow up reports to competitive surgeons, pre-operative statin usage increased to 80% within three years, and all surgeons significantly improved their performance. This simple observation provided early evidence that benchmark reports could be a strong motivator for practice change.
      In 2008, the second annual VASCUNET report showed a higher mortality rate after elective open abdominal aortic aneurysm (AAA) repair in the UK when compared with other VASCUNET countries (8% vs. 2–4%).
      • Gibbons C.
      • Björck M.
      • Jensen L.P.
      • Laustsen J.
      • Lees T.
      • Moreno-Carriles R.
      • et al.
      The second vascular surgery database report.
      This awareness led to further analysis by the Vascular Society of Great Britain and Ireland (VSGBI), which suggested that worse results could be attributed to low volume centres.
      • Earnshaw J.J.
      • Mitchell D.C.
      • Wyatt M.G.
      • Lamont P.M.
      • Naylor A.R.
      Remodelling of vascular (surgical) services in the UK.
      This led to quality standards being developed, including recommendations for a multidisciplinary care team, the availability of endovascular aneurysm repair (EVAR) treatment, a dedicated vascular team available 24/7, and a minimum hospital annual volume for performing such treatment. These recommendations led to more centralised AAA repair in fewer UK centres with a substantial reduction in elective open AAA repair mortality to 2.4%.
      • Earnshaw J.J.
      • Mitchell D.C.
      • Wyatt M.G.
      • Lamont P.M.
      • Naylor A.R.
      Remodelling of vascular (surgical) services in the UK.
      Based on this experience, the VSGBI developed a national QI programme for AAA treatment that included improving the patient experience, best practice protocols including pre-operative checklists and care pathways, QI methodology, regional collaboratives, and communication of benchmark outcomes to participants. Their publication is a primer on how to conduct a national QI programme based on awareness through registry data.
      • Potgieter R.
      • Mitchell D.
      • McCleary J.
      Delivering a national quality improvement programme for patients with abdominal aortic aneurysms.
      Registry derived research can also lead to QI. In 2015, a VQI analysis of 50 000 patients undergoing arterial procedures demonstrated a 24% improvement in five year survival if patients were discharged on antiplatelet and statin therapy.
      • De Martino R.R.
      • Hoel A.W.
      • Beck A.W.
      • Eldrup-Jorgensen J.
      • Hallett J.W.
      • Upchurch G.R.
      • et al.
      Participation in the Vascular Quality Initiative is associated with improved perioperative medication use, which is associated with longer patient survival.
      Analysis across 300 VQI participating centres at that time showed that the rate of patients being prescribed these optimal medications ranged from 30% to 100%, with the best results associated with longer centre participation in VQI. Publication of this information and launch of a national QI project resulted in substantial improvement in the use of antiplatelet agents and statins after arterial treatment. Future analysis will hopefully demonstrate improved survival based on this change, but this project already demonstrates the potential for national QI through a registry based initiative.

      Translating Registry Data Into Quality Improvement

      The above projects have demonstrated that benchmark reports showing variation can motivate practice change to improve quality. An additional feature incorporated into the SVS VQI is its organisation into 18 regional quality groups across the USA and Canada, where physicians, nurses, researchers, and data managers and administrators meet semi-annually to discuss regional data reports that often reveal variation in outcomes and processes of care across centres.
      • Woo K.
      • Eldrup-Jorgensen J.
      • Hallett J.W.
      • Davies M.G.
      • Beck A.
      • Upchurch Jr., G.R.
      • et al.
      Regional quality groups in the society for vascular surgery® vascular quality initiative.
      ,
      • Liao E.
      • Eisenberg N.
      • Kaushal A.
      • Montbriand J.
      • Tan K.T.
      • Roche-Nagle G.
      Utility of the Vascular Quality Initiative in improving quality of care in Canadian patients undergoing vascular surgery.
      These smaller group meetings promote ownership, trust, and collaboration and have been an important sustaining feature of VQI. These groups have developed regional QI projects to match their interests, including reduction in rates of myocardial infarction, haematoma after interventional procedures, surgical site infection, contrast nephropathy, and smoking. To stimulate regional and even hospital specific QI projects, the SVS Patient Safety Organisation (PSO) conducts an annual meeting with presentation and awards for QI projects, as well as a robust website with a detailed QI project guide. Further, dedicated PSO staff lead monthly calls of individual hospital QI project leaders to share successes, solve problems, and learn from each other. In 2018, 55 centres participating in VQI conducted local QI projects based on their VQI data. Translating registry data into QI at the local level is an important indicator of clinical registry success.

      Actionable Registry Reports

      Clinical registries must provide actionable feedback to participating centres and physicians to achieve QI. The SVS VQI, through its technology partner M2S, Inc. has created web based, real time reports for its members. One of the most effective has been Centre Opportunity Profile for Improvement (COPI) reports, which identify factors that each centre can change to improve their outcomes. These reports are driven by multivariable models that identify significant factors associated with important outcomes and provide each centre with a report that shows which specific factors, such as certain post-operative complications, could be changed at their centre to improve overall results (Fig. 1).
      Figure 1
      Figure 1Vascular Quality Initiative (VQI) Centre Opportunity Profile for Improvement (COPI) report showing risk factors associated with hospital length of stay (LOS) > 2 days after elective EVAR. This example illustrates the opportunity for this centre to reduce LOS by decreasing specific post-operative complications which were in the highest 75th percentile compared with other VQI centres.
      Reports that show significant variation can also help move outliers toward more standard practice. Rates of more controversial treatments, such as carotid endarterectomy (CEA) or stenting (CAS) for asymptomatic stenosis, show large variation across VQI centres (Fig. 2). Such variation exists not only within VQI, but across the ICVR registries, where the percentage of carotid treatment done for asymptomatic stenosis ranges from 0 to 75% across different countries.
      • Venermo M.
      • Wang G.
      • Sedrakyan A.
      • Mao J.
      • Eldrup N.
      • DeMartino R.
      • et al.
      Editor's choice - carotid stenosis treatment: variation in international practice patterns.
      This demonstrates an important opportunity for international collaboration to harmonise practice recommendations and use registry reports to monitor adherence to practice guidelines, and hopefully to motivate practice change.
      Figure 2
      Figure 2Percentage of carotid treatment done for asymptomatic patients in Vascular Quality Initiative (VQI) 2016–2019. Each dot represents the mean percentage of treated patients who were asymptomatic in each of 201 centres. More asymptomatic patients were treated by carotid endarterectomy (CEA), but variation across centres was high for both CEA and carotid artery stenting (CAS).

      Improving Patient and Treatment Selection

      Accurate identification of high surgical risk can sometimes lead to selection of less invasive interventional or medical management. Accurate prediction of life expectancy can better select patients for prophylactic treatment, such as elective AAA repair. Research from registry data has created multivariable models for such risk prediction, but many of these are complex, and thus difficult to translate into practice. As an interim solution, the SVS VQI has collaborated with QxMD to provide smartphone and web based applications to predict stroke risk after carotid treatment,
      • Goodney P.P.
      • Likosky D.S.
      • Cronenwett J.L.
      Vascular Study Group of Northern New E
      Factors associated with stroke or death after carotid endarterectomy in Northern New England.
      ruptured AAA mortality,
      • Robinson W.P.
      • Schanzer A.
      • Li Y.
      • Goodney P.P.
      • Nolan B.W.
      • Eslami M.H.
      • et al.
      Derivation and validation of a practical risk score for prediction of mortality after open repair of ruptured abdominal aortic aneurysms in a US regional cohort and comparison to existing scoring systems.
      and post-operative cardiac complications
      • Bertges D.J.
      • Neal D.
      • Schanzer A.
      • Scali S.T.
      • Goodney P.P.
      • Eldrup-Jorgensen J.
      • et al.
      The vascular quality initiative cardiac risk index for prediction of myocardial infarction after vascular surgery.
      ,
      • Bertges D.J.
      • Goodney P.P.
      • Zhao Y.
      • Schanzer A.
      • Nolan B.W.
      • Likosky D.S.
      • et al.
      The vascular study group of new England cardiac risk index (VSG-CRI) predicts cardiac complications more accurately than the revised cardiac risk index in vascular surgery patients.
      among others (Fig. 3). The ideal solution would avoid the need for additional data entry into such programmes by automatically uploading structured data from the electronic medical record (EMR) to a registry and then automatically downloading risk calculations and patient specific practice recommendations from the registry (Fig. 4). Such technological innovations are being undertaken and will increase the value of registry data.
      Figure 3
      Figure 3Smartphone calculator using Vascular Quality Initiative (VQI) algorithm allows calculation of myocardial infarction risk after infrainguinal bypass after input of associated risk factor values.
      Figure 4
      Figure 4Advances in registry and electronic medical record (EMR) technology will create the opportunity for relevant structured data to be directly uploaded to registries, and in return, for patient specific care guidelines to be downloaded to the EMR to affect practice at the point of care.

      Registry Research and Quality Improvement

      The major vascular registries (VASCUNET, VQI, ICVR, VLDFC) have generated Big Data for research, with over one million procedures registered and over 300 peer reviewed publications resulting. In some cases, registries represent the only practical means to answer an important clinical question, such as the risk or benefit of using protamine to reverse heparin after CEA. While an RCT would be ideal, a low frequency endpoint such as re-operation for bleeding after CEA would require thousands of randomised patients and is unlikely to be funded or conducted. However, when this question was raised at a VQI regional meeting in 2008, there were over 4000 CEAs registered, in which protamine had been used in 46%. Importantly, protamine use was not biased by patient characteristics, but rather by surgeon preference, which eliminated a source of confounding. Analysis showed that protamine use was associated with a threefold reduction in re-operation for bleeding (1.7% vs. 0.6%) without increased thrombotic complications (stroke or myocardial infarction).
      • Stone D.H.
      • Nolan B.W.
      • Schanzer A.
      • Goodney P.P.
      • Cambria R.A.
      • Likosky D.S.
      • et al.
      Protamine reduces bleeding complications associated with carotid endarterectomy without increasing the risk of stroke.
      These results were presented regionally and led to a rapid, significant increase in the rate of protamine use by VQI surgeons, and a corresponding reduction in serious bleeding complications.
      • Patel R.B.
      • Beaulieu P.
      • Homa K.
      • Goodney P.P.
      • Stanley A.C.
      • Cronenwett J.L.
      • et al.
      Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England.
      This project was one of the first demonstrations that registry based research could develop new knowledge that would rapidly change practice to improve outcomes by surgeons who had an ownership stake in the process.
      The potential to use the efficient infrastructure of existing registries to conduct RCTs has been suggested since 2013
      • Lauer M.S.
      • D'Agostino R.B.
      • Sr
      The randomized registry trial--the next disruptive technology in clinical research?.
      and successfully conducted in cardiology
      • Rao S.V.
      • Hess C.N.
      • Barham B.
      • Aberle L.H.
      • Anstrom K.J.
      • Patel T.B.
      • et al.
      A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.
      and other specialties. Detailed protocols for registry embedded RCTs have been published.
      This represents an important opportunity for vascular surgeons, both within national registries and internationally.

      Device Evaluation in Vascular Registries

      Vascular treatment has evolved to include the use of many implantable devices which can be recorded in registries. Post-market assessment of device safety and performance is critical as such devices are often used in different patients and disease severities than when tested in more focused pre-market trials. Both the European Commission and the US Food and Drug Administration (FDA) have emphasised the importance of total product lifecycle device evaluation using real world evidence from registries.
      ,
      Accordingly, several national registries including VQI have now added specific device identifiers to allow analysis. Registry data from the VQI have been used successfully to meet post-market regulatory requirements
      • Whatley E.
      • Malone M.
      Current considerations on real-world evidence use in FDA regulatory submissions.
      and to develop contemporary objective performance goals for superficial femoral and popliteal artery treatment with balloon angioplasty, stenting, and atherectomy.
      • Malone M.
      SPEED: a new initiative in real-world pad evidence evaluation.
      Most recently, VQI data were used to analyse late mortality after peripheral arterial treatment with paclitaxel coated balloons and stents, to help inform FDA regulatory decisions.
      • Bertges D.
      Real-world data collection regarding paclitaxel treatment: the society for vascular surgery vascular quality initiative.
      The ICVR is now beginning to coordinate specific device evaluations internationally to more rapidly understand device performance and identify safety issues.

      International Consortium of Vascular Registries

      The ICVR is a collaboration of 16 national registries from VASCUNET and VQI that was organised in 2014 to analyse and learn from international variation in patient and treatment selection, medical device usage, and outcomes.
      ,
      • Venermo M.
      • Sedrakyan A.
      • Cronenwett J.
      International Consortium of vascular registries.
      Studies have shown significant variation in the use of EVAR vs. open AAA repair
      • Beck A.W.
      • Sedrakyan A.
      • Mao J.
      • Venermo M.
      • Faizer R.
      • Debus S.
      • et al.
      Variations in abdominal aortic aneurysm care: a report from the international Consortium of vascular registries.
      and CEA vs. CAS
      • Venermo M.
      • Wang G.
      • Sedrakyan A.
      • Mao J.
      • Eldrup N.
      • DeMartino R.
      • et al.
      Editor's choice - carotid stenosis treatment: variation in international practice patterns.
      across participating countries. Further, more aggressive treatment of asymptomatic carotid stenosis and smaller AAAs was more frequent in countries with fee for service rather than population based reimbursement.
      • Venermo M.
      • Wang G.
      • Sedrakyan A.
      • Mao J.
      • Eldrup N.
      • DeMartino R.
      • et al.
      Editor's choice - carotid stenosis treatment: variation in international practice patterns.
      ,
      • Beck A.W.
      • Sedrakyan A.
      • Mao J.
      • Venermo M.
      • Faizer R.
      • Debus S.
      • et al.
      Variations in abdominal aortic aneurysm care: a report from the international Consortium of vascular registries.
      A recent ICVR study found significantly worse mortality in low volume centres for both elective and ruptured AAA repair, but not for EVAR, which has implications for regionalisation of care in different countries.
      • Scali S.T.
      • Beck A.W.
      • Sedrakyan A.
      • Mao J.
      • Venermo M.
      • Faizer R.
      • et al.
      Hospital volume Association with abdominal aortic aneurysm repair mortality: analysis of the international Consortium of vascular registries.
      Current ICVR studies are focused on improving procedural outcome variation and evaluating the performance of EVAR device for treating ruptured AAA. Thus, ICVR provides not only the opportunity for larger research data sets across countries, but the opportunity to develop shared practice guidelines and quality initiatives based on these data. The collaborative approach of ICVR has not been actualised in many specialties and is has been possible because of the historical close relationships that have been promoted by vascular surgery leaders internationally.

      Vascular Low Frequency Disease Consortium

      The clinical registries described above capture frequently performed vascular procedures to allow benchmarking and quality improvement across centres. They are not focused on treatment of rare vascular diseases, which would be difficult to benchmark with any accuracy. However, collaborative collection of data about low frequency diseases presents a significant opportunity that has been organised at UCLA as the VLFDC.
      This voluntary collaborative now involves 232 centres worldwide and uses the Redcap web based platform for entry of de-identified patient data. Each participating centre may choose to contribute data to specific projects of interest. Since 2003, 10 collaborative studies have been completed including femoral
      • Lawrence P.F.
      • Harlander-Locke M.P.
      • Oderich G.S.
      • Humphries M.D.
      • Landry G.J.
      • Ballard J.L.
      • et al.
      The current management of isolated degenerative femoral artery aneurysms is too aggressive for their natural history.
      and renal
      • Klausner J.Q.
      • Lawrence P.F.
      • Harlander-Locke M.P.
      • Coleman D.M.
      • Stanley J.C.
      • Fujimura N.
      • et al.
      The contemporary management of renal artery aneurysms.
      artery aneurysms, carotid body tumors,
      • Kim G.Y.
      • Lawrence P.F.
      • Munoz A.
      • Oderich G.
      • Luna-Ortiz K.
      • Farley S.
      • et al.
      Distance to the base of skull: a new predictor of complications in carotid body tumor resection.
      popliteal adventitial cysts,
      • Motaganahalli R.L.
      • Smeds M.R.
      • Harlander-Locke M.P.
      • Lawrence P.F.
      • Fujimura N.
      • DeMartino R.R.
      • et al.
      A multi-institutional experience in adventitial cystic disease.
      and Ehlers-Danlos syndrome.
      • Shalhub S.
      • Byers P.H.
      • Hicks K.L.
      • Coleman D.M.
      • Davis F.M.
      • De Caridi G.
      • et al.
      A multi-institutional experience in vascular Ehlers-Danlos syndrome diagnosis.
      These studies have been able to rapidly accumulate a large number of patients as a result of this collaboration and have produced significant new knowledge. Many new studies are under way, creating an opportunity for any centre to productively contribute data.

      Challenges and Solutions for Vascular Registries

      The greatest challenge for current clinical registries is the need for duplicate data entry separate from the EMR in most cases. This requires significant effort and often limits the volume of data that can be collected. Ideally, structured data governed by the appropriate medical society would be directly entered into the EMR during the process of care, which would then allow direct data extraction into registries. This solution is being developed by EMR companies and registry technology providers and will probably be available over the next five years (Fig. 4). It is important for vascular surgeons and their registries to be involved in this process. Validating the accuracy of data and the inclusion of consecutive cases is also a challenging requirement for clinical registries. This currently requires expensive, external chart review
      • Bergqvist D.
      • Bjorck M.
      • Lees T.
      • Menyhei G.
      Validation of the VASCUNET registry - pilot study.
      or auditing against other sources, such as claims data.
      • Cronenwett J.L.
      • Likosky D.S.
      • Russell M.T.
      • Eldrup-Jorgensen J.
      • Stanley A.C.
      • Nolan B.W.
      • et al.
      A regional registry for quality assurance and improvement: the vascular study group of northern new England (VSGNNE).
      In the future, direct extraction of structured “source” data from the EMR should also solve this issue.
      Collecting long term follow up data is challenging for registries but is particularly important to evaluate the late performance of medical devices and the benefit of prophylactic procedures designed to reduce future risk, such as elective EVAR. In hospital or even 30 day outcomes are not sufficient to evaluate many vascular treatments, as has recently been emphasised by the ESVS Executive Committee.
      • Sillesen H.
      • Debus S.
      • Dick F.
      • Eiberg J.
      • Halliday A.
      • Haulon S.
      • et al.
      Long Term evaluation should be an integral part of the clinical implementation of new vascular treatments - an ESVS Executive Committee Position Statement.
      With difficulty, VQI has been able to collect one year follow up for 70% of cases based on data entered at the time of office follow up.
      • Cronenwett J.L.
      • Kraiss L.W.
      • Cambria R.P.
      The society for vascular surgery vascular quality initiative.
      However, even longer follow up is ideal and challenged by patients who later receive care from different providers. One solution to this challenge is to derive follow up information from claims data or national health system data that can be linked successfully with the initial registry data. This requires patient identifiers for the most precise linkage, or potentially probabilistic matching, which are not always possible based on specific national regulations. The Vascular Implant Surveillance and Interventional Outcomes Network (VISION) is a coordinated registry network that has successfully linked VQI registry data with subsequent Medicare claims data to create five year outcomes.
      The derived outcomes are limited to events clearly identified in claims data but have been validated for outcomes such as re-intervention after EVAR by chart review.
      • Columbo J.A.
      • Kang R.
      • Hoel A.W.
      • Kang J.
      • Leinweber K.A.
      • Tauber K.S.
      • et al.
      A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.
      This methodology has the potential to add important long term data to registry research and quality improvement projects. In the future, there may also be solutions provided by more global integration of EMR systems that capture longitudinal structured patient information.
      Finally, pooling data across different registries is a challenge that requires harmonisation of variables and definitions. Long existing registries may be reluctant to modify data elements that could limit future use of existing data. Nonetheless, the value of international harmonisation is clear, and efforts to define minimum data elements for vascular registries in the ICVR are under way, with the initial publication focused on peripheral arterial revascularisation.
      • Behrendt C.A.
      • Bertges D.
      • Eldrup N.
      • Beck A.W.
      • Mani K.
      • Venermo M.
      • et al.
      International Consortium of vascular registries consensus recommendations for peripheral revascularisation registry data collection.
      This ICVR methodology proposes different levels of complexity for variable reporting that would allow more advanced registries to record complex data yet allow harmonisation with more simple data based on common core definitions. Registry based research is also now challenged by evolving regulations intended to ensure patient privacy that may limit the opportunity to share data across countries to create the large datasets necessary to evaluate rare diseases or outcomes.
      • Behrendt C.A.
      • Joassart Ir A.
      • Debus E.S.
      • Kolh P.
      The challenge of data privacy compliant registry based research.
      The European Union General Data Protection Regulation (GDPR) is the most recent example, and challenges vascular researchers to develop creative solutions that comply with regulations but allow important international research.

      Conclusions

      Vascular registries provide data for research and benchmarking reports for providers that are being used to improve healthcare quality. Current registry challenges will be met with technological solutions including extraction of structured data from EMR systems and providing practice guidelines at the point of care. It is important for vascular societies to manage this process, including governance, harmonisation of data elements, and definitions of quality measures. The era of big data is upon us. Either we can manage this, or others will manage it for us. Vascular surgeons have taken a leadership role in successfully collecting substantial data in current registries. Our challenge now is to develop processes that translate registry data into QI. Regional QI groups with regular meetings in VQI have fostered more participation, ownership, and practice change, and represent one potential option. Every vascular surgeon interested in quality should participate in a QI registry. We all want to improve and be the best. Thank you.

      References

      1. Registries for Evaluating Patient Outcomes: A User’s Guide. 3rd ed. 2019 (Available at:)
      2. ESVS VASCUNET. 2019 (Available at:)
        • Mitchell D.
        • Venermo M.
        • Mani K.
        • Bjorck M.
        • Troeng T.
        • Debus S.
        • et al.
        Quality improvement in vascular surgery: the role of comparative audit and Vascunet.
        Eur J Vasc Endovasc Surg. 2015; 49: 1-3
      3. Society for vascular surgery vascular quality initiative patient safety organization. 2019 (Available at:)
        • Cronenwett J.L.
        • Kraiss L.W.
        • Cambria R.P.
        The society for vascular surgery vascular quality initiative.
        J Vasc Surg. 2012; 55: 1529-1537
      4. International Consortium of Vascular Registries. 2019 (Available at:)
        • Venermo M.
        • Sedrakyan A.
        • Cronenwett J.
        International Consortium of vascular registries.
        Gefässchirurgie. 2019; 24: 9-12
      5. Vascular low frequency disease Consortium. 2019 (Available at:)
        • Cronenwett J.L.
        • Likosky D.S.
        • Russell M.T.
        • Eldrup-Jorgensen J.
        • Stanley A.C.
        • Nolan B.W.
        • et al.
        A regional registry for quality assurance and improvement: the vascular study group of northern new England (VSGNNE).
        J Vasc Surg. 2007; 46: 1093-1101
        • Gibbons C.
        • Björck M.
        • Jensen L.P.
        • Laustsen J.
        • Lees T.
        • Moreno-Carriles R.
        • et al.
        The second vascular surgery database report.
        European Society for Vascular Surgery, 2008 (Available at:)
        • Earnshaw J.J.
        • Mitchell D.C.
        • Wyatt M.G.
        • Lamont P.M.
        • Naylor A.R.
        Remodelling of vascular (surgical) services in the UK.
        Eur J Vasc Endovasc Surg. 2012; 44: 465-467
        • Potgieter R.
        • Mitchell D.
        • McCleary J.
        Delivering a national quality improvement programme for patients with abdominal aortic aneurysms.
        2012 (Available at:)
        • De Martino R.R.
        • Hoel A.W.
        • Beck A.W.
        • Eldrup-Jorgensen J.
        • Hallett J.W.
        • Upchurch G.R.
        • et al.
        Participation in the Vascular Quality Initiative is associated with improved perioperative medication use, which is associated with longer patient survival.
        J Vasc Surg. 2015; 61: 1010-1019
        • Woo K.
        • Eldrup-Jorgensen J.
        • Hallett J.W.
        • Davies M.G.
        • Beck A.
        • Upchurch Jr., G.R.
        • et al.
        Regional quality groups in the society for vascular surgery® vascular quality initiative.
        J Vasc Surg. 2013; 57: 884-890
        • Liao E.
        • Eisenberg N.
        • Kaushal A.
        • Montbriand J.
        • Tan K.T.
        • Roche-Nagle G.
        Utility of the Vascular Quality Initiative in improving quality of care in Canadian patients undergoing vascular surgery.
        Can J Surg. 2019; 62: 66-69
      6. VQI annual meeting. 2019 (Available from:)
      7. SVS VQI quality improvement projects. 2019 (Available at:)
      8. COPI 2014 – sample EVAR LOS report. 2019 (Available at:)
        • Venermo M.
        • Wang G.
        • Sedrakyan A.
        • Mao J.
        • Eldrup N.
        • DeMartino R.
        • et al.
        Editor's choice - carotid stenosis treatment: variation in international practice patterns.
        Eur J Vasc Endovasc Surg. 2017; 53: 511-519
      9. Calculate by QxMD. 2019 (Available at:)
        • Goodney P.P.
        • Likosky D.S.
        • Cronenwett J.L.
        • Vascular Study Group of Northern New E
        Factors associated with stroke or death after carotid endarterectomy in Northern New England.
        J Vasc Surg. 2008; 48: 1139-1145
        • Robinson W.P.
        • Schanzer A.
        • Li Y.
        • Goodney P.P.
        • Nolan B.W.
        • Eslami M.H.
        • et al.
        Derivation and validation of a practical risk score for prediction of mortality after open repair of ruptured abdominal aortic aneurysms in a US regional cohort and comparison to existing scoring systems.
        J Vasc Surg. 2013; 57: 354-361
        • Bertges D.J.
        • Neal D.
        • Schanzer A.
        • Scali S.T.
        • Goodney P.P.
        • Eldrup-Jorgensen J.
        • et al.
        The vascular quality initiative cardiac risk index for prediction of myocardial infarction after vascular surgery.
        J Vasc Surg. 2016; 64: 1411-1421
        • Bertges D.J.
        • Goodney P.P.
        • Zhao Y.
        • Schanzer A.
        • Nolan B.W.
        • Likosky D.S.
        • et al.
        The vascular study group of new England cardiac risk index (VSG-CRI) predicts cardiac complications more accurately than the revised cardiac risk index in vascular surgery patients.
        J Vasc Surg. 2010; 52: 674-683
        • Stone D.H.
        • Nolan B.W.
        • Schanzer A.
        • Goodney P.P.
        • Cambria R.A.
        • Likosky D.S.
        • et al.
        Protamine reduces bleeding complications associated with carotid endarterectomy without increasing the risk of stroke.
        J Vasc Surg. 2010; 51: 559-564
        • Patel R.B.
        • Beaulieu P.
        • Homa K.
        • Goodney P.P.
        • Stanley A.C.
        • Cronenwett J.L.
        • et al.
        Shared quality data are associated with increased protamine use and reduced bleeding complications after carotid endarterectomy in the Vascular Study Group of New England.
        J Vasc Surg. 2013; 58: 1518-1524
        • Lauer M.S.
        • D'Agostino R.B.
        • Sr
        The randomized registry trial--the next disruptive technology in clinical research?.
        N Engl J Med. 2013; 369: 1579-1581
        • Rao S.V.
        • Hess C.N.
        • Barham B.
        • Aberle L.H.
        • Anstrom K.J.
        • Patel T.B.
        • et al.
        A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial.
        JACC Cardiovasc Interv. 2014; 7: 857-867
      10. Recommendations for a national medical device evaluation system. Medical Device Registry Task Force. 2019 (Available at:)
      11. The European union medical device regulation of 2017. 2017 (Available at:)
        • Whatley E.
        • Malone M.
        Current considerations on real-world evidence use in FDA regulatory submissions.
        Endovasc Today. 2017; 16: 106-108
        • Malone M.
        SPEED: a new initiative in real-world pad evidence evaluation.
        Endovasc Today. 2018; 17: 57-59
        • Bertges D.
        Real-world data collection regarding paclitaxel treatment: the society for vascular surgery vascular quality initiative.
        Endovasc Today. 2019; 18: 74-75
        • Beck A.W.
        • Sedrakyan A.
        • Mao J.
        • Venermo M.
        • Faizer R.
        • Debus S.
        • et al.
        Variations in abdominal aortic aneurysm care: a report from the international Consortium of vascular registries.
        Circulation. 2016; 134: 1948-1958
        • Scali S.T.
        • Beck A.W.
        • Sedrakyan A.
        • Mao J.
        • Venermo M.
        • Faizer R.
        • et al.
        Hospital volume Association with abdominal aortic aneurysm repair mortality: analysis of the international Consortium of vascular registries.
        Circulation. 2019; 140: 1285-1287
        • Lawrence P.F.
        • Harlander-Locke M.P.
        • Oderich G.S.
        • Humphries M.D.
        • Landry G.J.
        • Ballard J.L.
        • et al.
        The current management of isolated degenerative femoral artery aneurysms is too aggressive for their natural history.
        J Vasc Surg. 2014; 59: 343-349
        • Klausner J.Q.
        • Lawrence P.F.
        • Harlander-Locke M.P.
        • Coleman D.M.
        • Stanley J.C.
        • Fujimura N.
        • et al.
        The contemporary management of renal artery aneurysms.
        J Vasc Surg. 2015; 61: 978-984
        • Kim G.Y.
        • Lawrence P.F.
        • Munoz A.
        • Oderich G.
        • Luna-Ortiz K.
        • Farley S.
        • et al.
        Distance to the base of skull: a new predictor of complications in carotid body tumor resection.
        J Vasc Surg. 2015; 62: 534-535
        • Motaganahalli R.L.
        • Smeds M.R.
        • Harlander-Locke M.P.
        • Lawrence P.F.
        • Fujimura N.
        • DeMartino R.R.
        • et al.
        A multi-institutional experience in adventitial cystic disease.
        J Vasc Surg. 2017; 65: 157-161
        • Shalhub S.
        • Byers P.H.
        • Hicks K.L.
        • Coleman D.M.
        • Davis F.M.
        • De Caridi G.
        • et al.
        A multi-institutional experience in vascular Ehlers-Danlos syndrome diagnosis.
        J Vasc Surg. 2020; 71: 149-157
        • Bergqvist D.
        • Bjorck M.
        • Lees T.
        • Menyhei G.
        Validation of the VASCUNET registry - pilot study.
        Vasa. 2014; 43: 141-144
        • Sillesen H.
        • Debus S.
        • Dick F.
        • Eiberg J.
        • Halliday A.
        • Haulon S.
        • et al.
        Long Term evaluation should be an integral part of the clinical implementation of new vascular treatments - an ESVS Executive Committee Position Statement.
        Eur J Vasc Endovasc Surg. 2019; 58: 315-317
      12. Vascular implant surveillance and interventional outcomes network. 2019 (Available at:)
        • Columbo J.A.
        • Kang R.
        • Hoel A.W.
        • Kang J.
        • Leinweber K.A.
        • Tauber K.S.
        • et al.
        A comparison of reintervention rates after endovascular aneurysm repair between the Vascular Quality Initiative registry, Medicare claims, and chart review.
        J Vasc Surg. 2019; 69: 74-79
        • Behrendt C.A.
        • Bertges D.
        • Eldrup N.
        • Beck A.W.
        • Mani K.
        • Venermo M.
        • et al.
        International Consortium of vascular registries consensus recommendations for peripheral revascularisation registry data collection.
        Eur J Vasc Endovasc Surg. 2018; 56: 217-237
        • Behrendt C.A.
        • Joassart Ir A.
        • Debus E.S.
        • Kolh P.
        The challenge of data privacy compliant registry based research.
        Eur J Vasc Endovasc Surg. 2018; 55: 601-602

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