Zusammenfassung
Das Feld der vaskulären Registerforschung hat sich in den letzten Jahrzehnten deutlich verändert. Immer weitere und stetig wachsende Datenquellen stehen heute für vielfältige Projekte der Qualitätsentwicklung und Versorgungsforschung zur Verfügung. Innovative Methoden der Datenanalysen aus den Bereichen Big Data und maschinelles Lernen eröffnen dabei neue Möglichkeiten für die Vorhersage von Gesundheitsereignissen und die Generierung von Hypothesen. Dabei versteht sich die moderne Registerforschung vor allem als komplementäres Forschungsgebiet, um die Ergebnisse randomisierter kontrollierter Studien zu ergänzen. Neben den offensichtlichen Vorteilen ergeben sich allerdings auch Herausforderungen aus den Bereichen Haftung, Methodik und Datenschutz.
Abstract
The field of vascular registry-based research has rapidly developed during the last few decades. Increasingly more and continuously growing data sources are becoming available for heterogeneous projects of quality improvement and health services research. Innovative methods of data analysis in the field of big data and machine learning open up new possibilities for the prediction of health events and for generating hypotheses. Thereby, modern registry-based research is understood in particular as a complementary field of research in order to supplement the results of randomized controlled studies; however, in addition to the obvious advantages of registries, there are also new challenges from the fields of liability, methods, and data protection.
Literatur
Arndt H, Nordanstig J, Bertges DJ et al (2022) A Delphi consensus on patient reported outcomes for registries and trials including patients with intermittent claudication: recommendations and reporting standard. Eur J Vasc Endovasc Surg 64:526–533
Behrendt C‑A, Adili F, Böckler D et al (2022) Das Qualitätssicherungs- und Deviceregister des Deutschen Instituts für Gefäßmedizinische Gesundheitsforschung der DGG im Zeitalter von COVID-19, Big Data und künstlicher Intelligenz. Gefässchirurgie 27:317–320
Behrendt C‑A, Kreutzburg T, Nordanstig J et al (2022) The OAC3-PAD risk score predicts major bleeding events on year after hospitalisation for peripheral artery disease. Eur J Vasc Endovasc Surg 63:503–510
Behrendt C‑A, Peters F, Mani K (2020) The swinging pendulum of evidence – Is there a reality behind results from randomized trials and real-world data? Lessons learned from the paclitaxel debate. Eur J Vasc Endovasc Surg 59(4):510–511. https://doi.org/10.1016/j.ejvs.2020.01.029
Behrendt C‑A, Schwaneberg T, Hischke S et al (2020) Data privacy compliant validation of health insurance claims data – the IDOMENEO approach. Gesundheitswesen 82(S 02):S94–S100. https://doi.org/10.1055/a-0883-5098
Behrendt CA, Bertges D, Eldrup N et al (2018) International consortium of vascular registries consensus recommendations for peripheral revascularisation registry data collection. Eur J Vasc Endovasc Surg 56:217–237
Behrendt CA, Bischoff MS, Schwaneberg T et al (2019) Population based analysis of gender disparities in 23,715 percutaneous endovascular revascularisations in the metropolitan area of Hamburg. Eur J Vasc Endovasc Surg 57:658–665
Behrendt CA, Bjorck M, Schwaneberg T et al (2019) Editor’s choice - recommendations for registry data collection for revascularisations of acute limb ischaemia: a Delphi consensus from the international consortium of vascular registries. Eur J Vasc Endovasc Surg 57:816–821
Behrendt CA, Heidemann F, Haustein K et al (2017) Percutaneous endovascular treatment of infrainguinal PAOD: results of the PSI register study in 74 German vascular centers. Gefasschirurgie 22:17–27
Behrendt CA, Heidemann F, Riess HC et al (2017) Registry and health insurance claims data in vascular research and quality improvement. Vasa 46:11–15
Behrendt CA, Joassart Ir A, Debus ES et al (2018) The challenge of data privacy compliant registry based research. Eur J Vasc Endovasc Surg 55:601–602
Behrendt CA, Pridohl H, Schaar K et al (2017) Clinical registers in the twenty-first century: balancing act between data protection and feasibility? Chirurg 88:944–949
Behrendt CA, Rieß HC, Debus ES (2018) Big Data und Real-World-Evidenz in der interdisziplinären PAVK-Behandlung. Gefässchirurgie 24:13–20
Behrendt CA, Rother U, Rümenapf G et al (2020) Geschlechterspezifische Unterschiede bei der endovaskulären Behandlung der peripheren arteriellen Verschlusskrankheit – Eine systematische Literaturübersicht. Gefässchirurgie 25:587–602
Behrendt CA, Schwaneberg T, Hischke S et al (2020) Data privacy compliant validation of health insurance claims data: the IDOMENEO approach. Gesundheitswesen 82:S94–S100
Behrendt CA, Sigvant B, Kuchenbecker J et al (2020) Editor’s choice—international variations and sex disparities in the treatment of peripheral arterial occlusive disease: a report from VASCUNET and the international consortium of vascular registries. Eur J Vasc Endovasc Surg 60:873–880
Behrendt CA, Sigvant B, Szeberin Z et al (2018) International variations in amputation practice: a VASCUNET report. Eur J Vasc Endovasc Surg 56:391–399
Behrendt CA, Venermo M, Cronenwett JL et al (2019) VASCUNET, VQI, and the international consortium of vascular registries—unique collaborations for quality improvement in vascular surgery. Eur J Vasc Endovasc Surg 58:792–793
Bisdas T, Stachmann A, Weiss K et al (2014) Nationales Register für die Erstlinientherapiestrategien bei Patienten mit kritischer Extremitätenischämie (CRITISCH-Register). Gefasschirurgie 19:135–140
Bjorck M, Beiles B, Menyhei G et al (2014) Editor’s choice: contemporary treatment of popliteal artery aneurysm in eight countries: a report from the vascunet collaboration of registries. Eur J Vasc Endovasc Surg 47:164–171
Davenport TH, Patil DJ (2012) Data scientist: the sexiest job of the 21st century. Harv Bus Rev 90:70–76
Doctorow C (2008) Big data: welcome to the petacentre. Nature 455:16–21
Elixhauser A, Steiner C, Harris DR et al (1998) Comorbidity measures for use with administrative data. Med Care 36:8–27
Hatzl J, Behrendt CA, Schmitz-Rixen T et al (2023) Outcomes of endovascular repair of infrarenal penetrating aortic ulcers. Vasa 52(3):169–174. https://doi.org/10.1024/0301-1526/a001060
Hilbert M, Lopez P (2011) The world’s technological capacity to store, communicate, and compute information. Science 332:60–65
Jelani QU, Petrov M, Martinez SC et al (2018) Peripheral arterial disease in women: an overview of risk factor profile, clinical features, and outcomes. Curr Atheroscler Rep 20:40
Jung G, Leinweber ME, Karl T et al (2022) Real-world data of popliteal artery aneurysm treatment: analysis of the POPART registry. J Vasc Surg 75:1707–1717.e2
Kotov A, Peters F, Debus ES et al (2021) The prospective GermanVasc cohort study. Vasa 50(6):446–452. https://doi.org/10.1024/0301-1526/a000966
Kreutzburg T, Peters F, Kuchenbecker J et al (2021) Editor’s choice—the GermanVasc score: a pragmatic risk score predicts five year amputation free survival in patients with peripheral arterial occlusive disease. Eur J Vasc Endovasc Surg 61:248–256
Kuehnl A, Salvermoser M, Erk A et al (2018) Spatial analysis of hospital incidence and in hospital mortality of abdominal aortic aneurysms in Germany: secondary data analysis of nationwide hospital episode (DRG) data. Eur J Vasc Endovasc Surg 55:852–859
Lapébie FX, Aboyans V, Lacroix P et al (2021) Editor’s choice—external applicability of the COMPASS and VOYAGER-PAD trials on patients with symptomatic lower extremity artery disease in France: the COPART registry. Eur J Vasc Endovasc Surg 62:439–449
Lareyre F, Behrendt C‑A, Chaudhuri A et al (2023) Applications of artificial intelligence for patients with peripheral artery disease. J Vasc Surg 77(2):650–658.e1. https://doi.org/10.1016/j.jvs.2022.07.160
Lareyre F, Chaptoukaev H, Kiang SC et al (2022) Telemedicine and digital health applications in vascular surgery. J Clin Med 11:6047
Lees T, Troeng T, Thomson IA et al (2012) International variations in infrainguinal bypass surgery—a VASCUNET report. Eur J Vasc Endovasc Surg 44:185–192
Malyar N, Stausberg J, Langhoff R et al (2020) Demographic and procedural characteristics in the RECording COurses of vasculaR Diseases (RECCORD) registry—the first 1000 patients. Vasa 49:382–388
Mani K, Lees T, Beiles B et al (2011) Treatment of abdominal aortic aneurysm in nine countries 2005–2009: a vascunet report. Eur J Vasc Endovasc Surg 42:598–607
Mani K, Venermo M, Beiles B et al (2015) Regional differences in case mix and peri-operative outcome after elective abdominal aortic aneurysm repair in the vascunet database. Eur J Vasc Endovasc Surg 49:646–652
Mathes T, Buehn S, Prengel P et al (2018) Registry-based randomized controlled trials merged the strength of randomized controlled trails and observational studies and give rise to more pragmatic trials. J Clin Epidemiol 93:120–127
Mayor J, Preventza O, Mills JL Sr. et al (2021) Persistent underrepresentation of female patients in US trials of common vascular diseases since 2008. J Vasc Surg 73:e23
Menyhei G, Bjorck M, Beiles B et al (2011) Outcome following carotid endarterectomy: lessons learned from a large international vascular registry. Eur J Vasc Endovasc Surg 41:735–740
Peters F, Behrendt CA (2022) External validation of the OAC3-PAD risk score to predict major bleeding events using the prospective GermanVasc cohort study. Eur J Vasc Endovasc Surg 64(4):429–430. https://doi.org/10.1016/j.ejvs.2022.07.055
Peters F, Kreutzburg T, Kuchenbecker J et al (2020) Behandlungsqualität in der operativ-interventionellen Gefäßmedizin – was können Routinedaten der Krankenkassen leisten? Gefässchirurgie. https://doi.org/10.1007/s00772-020-00664-x
Peters F, Kreutzburg T, Riess HC et al (2020) Editor’s choice—optimal pharmacological treatment of symptomatic peripheral arterial occlusive disease and evidence of female patient disadvantage: an analysis of health insurance claims data. Eur J Vasc Endovasc Surg 60:421–429
Peters F, Kuchenbecker J, Kreutzburg T et al (2020) Long-term effectiveness and safety of initiating statin therapy after index revascularization in patients with peripheral arterial occlusive disease. J Am Heart Assoc 9:e18338
Petersen T, Blochberger M, Mueller T et al (2019) Sichere und datenschutzgerechte Umsetzung medizinischer Register. Datenschutz Datensich 43:507–512
Quan H, Sundararajan V, Halfon P et al (2005) Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care 43:1130–1139
Rao SV, Hess CN, Barham B et al (2014) 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 7:857–867
Reinecke H, Unrath M, Freisinger E et al (2015) Peripheral arterial disease and critical limb ischaemia: still poor outcomes and lack of guideline adherence. Eur Heart J 36:932–938
Schmitz-Rixen T, Löffler A‑K, Steinbauer M et al (2023) Versorgung des intakten abdominellen Aortenaneurysmas (AAA) 2020/2021. Gefässchirurgie. https://doi.org/10.1007/s00772-022-00967-1
Søgaard M, Nielsen PB, Skjøth F et al (2022) Revascularisation for symptomatic peripheral artery disease: external applicability of the VOYAGER PAD trial. Eur J Vasc Endovasc Surg 63:285–294
Steffen M, Schmitz-Rixen T, Jung G et al (2019) The DIGG risk score : a risk predictive model of perioperative mortality after elective treatment of intact abdominal aortic aneurysms in the DIGG register. Chirurg 90:913–920
Stock J, Petersen T, Behrendt C‑A et al (2022) Privatsphärefreundliches maschinelles Lernen. Informatik Spektrum 45:70–79
Stock J, Petersen T, Behrendt C‑A et al (2022) Privatsphärefreundliches maschinelles Lernen. Informatik Spektrum 45:137–145
Sutzko DC, Mani K, Behrendt CA et al (2020) Big data in vascular surgery: registries, international collaboration and future directions. J Intern Med 288:51–61
Tsantilas P, Kuehnl A, Kallmayer M et al (2018) Risk of stroke or death is associated with the timing of carotid artery stenting for symptomatic carotid stenosis: a secondary data analysis of the German statutory quality assurance database. JAHA 7(7):e7983
van Walraven C, Austin PC, Jennings A et al (2009) A modification of the Elixhauser comorbidity measures into a point system for hospital death using administrative data. Med Care 47:626–633
Venermo M, Wang G, Sedrakyan A et al (2017) Editor’s choice—carotid stenosis treatment: variation in international practice patterns. Eur J Vasc Endovasc Surg 53:511–519
Vikatmaa P, Mitchell D, Jensen LP et al (2012) Variation in clinical practice in carotid surgery in nine countries 2005–2010. Lessons from VASCUNET and recommendations for the future of national clinical audit. Eur J Vasc Endovasc Surg 44:11–17
Wieseler B, Neyt M, Kaiser T et al (2023) Replacing RCTs with real world data for regulatory decision making: a self-fulfilling prophecy? BMJ 380:e73100
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Interessenkonflikt
C.-A. Behrendt, M. Steinbauer, I. Hinterseher, L. Cotta, F. Adili und J. Heckenkamp geben an, dass kein Interessenkonflikt besteht.
Für diesen Beitrag wurden von den Autor/-innen keine Studien an Menschen oder Tieren durchgeführt. Für die aufgeführten Studien gelten die jeweils dort angegebenen ethischen Richtlinien.
Additional information
QR-Code scannen & Beitrag online lesen
Rights and permissions
About this article
Cite this article
Behrendt, CA., Steinbauer, M., Hinterseher, I. et al. Moderne gefäßchirurgische Registerforschung. Gefässchirurgie 28, 355–363 (2023). https://doi.org/10.1007/s00772-023-01015-2
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00772-023-01015-2