Skip to main content
SpringerLink
Log in

Big Data und Real-World-Evidenz in der interdisziplinären PAVK-Behandlung

Eine kritische Bestandsaufnahme

Big data and real-world evidence in interdisciplinary treatment of PAOD

A critical stocktaking

  • Leitthema
  • Published:
Gefässchirurgie Aims and scope Submit manuscript

Zusammenfassung

Der wissenschaftliche Stellenwert von Register- und Routinedaten als sogenannte Real-World-Evidenz nimmt in der vaskulären Qualitätsentwicklung und Versorgungsforschung kontinuierlich zu. Durch schnell wachsende digitale Datenbestände und lernende Algorithmen zu deren Verarbeitung ergeben sich immer neue Möglichkeiten, die heute als Big Data oder Smart Data bezeichnet werden. Der große Bedarf an weiteren hochwertigen Studien zur Verbesserung der Evidenzbasis in der Behandlung der peripheren arteriellen Verschlusskrankheit kann durch randomisierte und kontrollierte Studien nicht vollständig gedeckt werden, weshalb die Einführung interdisziplinärer Register und die Nutzung von Routinedaten sinnvoll erscheint. Hierbei sollten allerdings die Vorteile und Limitationen gewissenhaft berücksichtigt werden. Vor dem Hintergrund einer grenzüberschreitenden internationalen Qualitätsentwicklung sollte zudem eine konsequente Harmonisierung bestehender Projekte mit Real-World-Evidenz erfolgen.

Abstract

The scientific value of so-called real-world evidence using registry and health insurance claims data in the vascular quality improvement and healthcare research is continuously increasing. Rapidly growing digital data volumes and sophisticated learning algorithms open up new possibilities, which are nowadays referred to as big data or smart data. Randomized and controlled trials alone obviously cannot cover the great need for high-value studies to improve the evidential basis in the treatment of peripheral arterial occlusive disease (PAOD). Thus, utilization of registry and health insurance claims data seems reasonable; however, the advantages and limitations of these data sources should be carefully considered. Against the backdrop of cross-border international quality improvement, a consistent harmonization of existing projects with real-world evidence should be pursued.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Literatur

  1. Aboyans V, Ricco JB, Bartelink MEL et al (2018) Editor’s choice—2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European society for vascular surgery (ESVS). Eur J Vasc Endovasc Surg 55:305–368

    Article  Google Scholar 

  2. Anonymous (2012) Outcomes after Elective Repair of Infra-renal Abdominal Aortic Aneurysm; A Report from The Vascular Society; March 2012. In: The Vascular Society of Great Britain and Ireland

  3. Baubeta Fridh E, Andersson M, Thuresson M et al (2017) Amputation rates, mortality, and pre-operative comorbidities in patients Revascularised for intermittent claudication or critical limb Ischaemia: a population based study. Eur J Vasc Endovasc Surg 54:480–486

    Article  CAS  Google Scholar 

  4. Beck AW, Sedrakyan A, Mao J et al (2016) Variations in abdominal aortic aneurysm care: a report from the international consortium of vascular registries. Circulation 134:1948–1958

    Article  Google Scholar 

  5. 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

    Article  Google Scholar 

  6. Behrendt CA, Debus ES, Mani K et al (2018) The strengths and limitations of claims based research in countries with fee for service reimbursement. Eur J Vasc Endovasc Surg. https://doi.org/10.1016/j.ejvs.2018.06.001

    Article  PubMed  Google Scholar 

  7. Behrendt CA, Härter M, Kriston L et al (2017) IDOMENEO – Ist die Versorgungsrealität in der Gefäßmedizin Leitlinien- und Versorgungsgerecht? Gefasschirurgie 22:41–47

    Article  Google Scholar 

  8. 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

    Article  Google Scholar 

  9. 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

    Article  Google Scholar 

  10. 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

    Article  Google Scholar 

  11. 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

    Article  Google Scholar 

  12. Behrendt CA, Riess H, Harter M et al (2018) Guideline recommendations and quality indicators for invasive treatment of peripheral arterial disease in Germany : The IDOMENEO study for quality improvement and research in vascular medicine. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 61:218–223

    Article  Google Scholar 

  13. Behrendt CA, Riess HC, Heidemann F et al (2017) Radiation dosage for Percutaneous PAD treatment is different in cardiovascular disciplines: results from an eleven year population based registry in the metropolitan area of hamburg. Eur J Vasc Endovasc Surg 53:215–222

    Article  Google Scholar 

  14. Behrendt CA, Sigvant B, Szeberin Z et al (2018) International variations in amputation practice: a VASCUNET report. Eur J Vasc Endovasc Surg. https://doi.org/10.1016/j.ejvs.2018.04.017

    Article  PubMed  Google Scholar 

  15. 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

    Article  Google Scholar 

  16. Bjorck M, Mani K (2017) Publication of vascular surgical registry data: strengths and limitations. Eur J Vasc Endovasc Surg 54:788

    Article  Google Scholar 

  17. Conte MS, Pomposelli FB (2015) Society for Vascular Surgery Practice guidelines for atherosclerotic occlusive disease of the lower extremities management of asymptomatic disease and claudication. Introduction. J Vasc Surg 61:1S

    Article  Google Scholar 

  18. De Martino RR, Hoel AW, Beck AW et al (2015) Participation in the Vascular Quality Initiative is associated with improved perioperative medication use, which is associated with longer patient survival. J Vasc Surg 61:1010–1019

    Article  Google Scholar 

  19. Debus ES, Kriston L, Schwaneberg T et al (2018) Rationale and methods of the IDOMENEO health outcomes of the peripheral arterial disease revascularisation study in the GermanVasc registry. Vasa :1–7. https://doi.org/10.1024/0301-1526/a000730

    Article  PubMed  Google Scholar 

  20. Debus SE (2014) Vascunet registry validated. Vasa 43:86–87

    Article  Google Scholar 

  21. Destatis SB (2014) Krankenhausdiagnosestatistik. In:Statistisches Bundesamt DeStatis, URL: https://www.gbe-bund.de/, p Gesundheitsberichterstattung des Bundes

  22. Doctorow C (2008) Big data: Welcome to the petacentre. Nature 455:16–21

    Article  CAS  Google Scholar 

  23. Fowkes FG, Rudan D, Rudan I et al (2013) Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet 382:1329–1340

    Article  Google Scholar 

  24. Gerhard-Herman MD, Gornik HL, Barrett C et al (2017) 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. J Am Coll Cardiol 69:e71–e126

    Article  Google Scholar 

  25. Goodney PP, Nolan BW, Eldrup-Jorgensen J et al (2010) Restenosis after carotid endarterectomy in a multicenter regional registry. J Vasc Surg 52:897–904 (905.e891-892; discussion 904–895)

    Article  Google Scholar 

  26. Heuser L, Arnold CN, Morhard D et al (2012) Quality report 2011 of the Germyn Society of Interventional Radiology (DeGIR)—report about treatment quality of minimal invasive procedures. Rofo 184:570–576

    Article  CAS  Google Scholar 

  27. Hoffmann F, Andersohn F, Giersiepen K et al (2008) Validation of secondary data. Strengths and limitations. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 51:1118–1126

    Article  CAS  Google Scholar 

  28. Jones WS, Krucoff MW, Morales P et al (2018) Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements. J Vasc Surg 67:637–644 (e630)

    Article  Google Scholar 

  29. Kalbaugh CA, Gonzalez NJ, Luckett DJ et al (2018) The impact of current smoking on outcomes after infrainguinal bypass for claudication. J Vasc Surg 68:495–502.e1

    Article  Google Scholar 

  30. Komshian S, Cheng TW, Farber A et al (2018) Retrograde popliteal access to treat femoropopliteal artery occlusive disease. J Vasc Surg 68:161–167

    Article  Google Scholar 

  31. Lawall H, Huppert P, Rümenapf G (2015) S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der peripheren arteriellen Verschlusskrankheit

    Google Scholar 

  32. 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

    Article  CAS  Google Scholar 

  33. Malyar N, Furstenberg T, Wellmann J et al (2013) Recent trends in morbidity and in-hospital outcomes of in-patients with peripheral arterial disease: a nationwide population-based analysis. Eur Heart J 34:2706–2714

    Article  Google Scholar 

  34. Nasser MM, Stausberg J, Ito WD et al (2017) Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa 46:262–267

    Article  Google Scholar 

  35. Nordanstig J, Pettersson M, Morgan M et al (2017) Assessment of Minimum Important Difference and Substantial Clinical Benefit with the Vascular Quality of Life Questionnaire-6 when Evaluating Revascularisation Procedures in Peripheral Arterial Disease. Eur J Vasc Endovasc Surg 54:340–347

    Article  CAS  Google Scholar 

  36. Ramkumar N, Suckow BD, Brown JR et al (2018) Sex-based assessment of patient presentation, lesion characteristics, and treatment modalities in patients undergoing peripheral vascular intervention. Circ Cardiovasc Interv 11:e5749

    Article  Google Scholar 

  37. Riess HC, Debus ES, Schwaneberg T et al (2018) Indicators of outcome quality in peripheral arterial disease revascularisations—a Delphi expert consensus. Vasa :1–7. https://doi.org/10.1024/0301-1526/a000720

    Article  PubMed  Google Scholar 

  38. Schwaneberg T, Debus ES, Behrendt CA (2017) Grundlagen der Statistik und Anwendung in der Gefäßchirurgie. Gefasschirurgie 22:420–427

    Article  Google Scholar 

  39. Soden PA, Zettervall SL, Ultee KH et al (2016) Dual antiplatelet therapy is associated with prolonged survival after lower extremity revascularization. J Vasc Surg 64:1633–1644 (e1631)

    Article  Google Scholar 

  40. Technology UDOC-NIOSA (2015) NIST Big Data Interoperability Framework: Volume 1, Definitions

  41. Venermo M, Lees T (2015) International vascunet validation of the swedvasc registry. Eur J Vasc Endovasc Surg 50:802–808

    Article  CAS  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Arbeitsgruppe GermanVasc, Universitäres Herzzentrum Hamburg, Klinik und Poliklinik für Gefäßmedizin, Universitätsklinikum Hamburg Eppendorf, Hamburg, Deutschland

    C.-A. Behrendt, H. C. Rieß & E. S. Debus

Authors
  1. C.-A. Behrendt
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. H. C. Rieß
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. E. S. Debus
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to C.-A. Behrendt.

Ethics declarations

Interessenkonflikt

C.-A. Behrendt, H. C. Rieß und E. S. Debus geben an, dass kein Interessenkonflikt besteht.

Dieser Beitrag beinhaltet keine von den Autoren durchgeführten Studien an Menschen oder Tieren.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Behrendt, CA., Rieß, H.C. & Debus, E.S. Big Data und Real-World-Evidenz in der interdisziplinären PAVK-Behandlung. Gefässchirurgie 24, 13–20 (2019). https://doi.org/10.1007/s00772-018-0462-0

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00772-018-0462-0

Schlüsselwörter

Keywords

Search

Navigation