Advertisement

Gefässchirurgie

, Volume 24, Issue 1, pp 13–20 | Cite as

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

Eine kritische Bestandsaufnahme
  • C.-A. BehrendtEmail author
  • H. C. Rieß
  • E. S. Debus
Leitthema
  • 233 Downloads

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.

Schlüsselwörter

Periphere arterielle Verschlusskrankheit Epidemiologie Gesundheitsforschung Register Behandlungsergebnisse 

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

A critical stocktaking

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.

Keywords

Peripheral arterial disease Epidemiology Health services research Registries Patient outcome assessment 

Notes

Einhaltung ethischer Richtlinien

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.

Literatur

  1. 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 55:305–368CrossRefGoogle Scholar
  2. 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 IrelandGoogle Scholar
  3. 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 54:480–486CrossRefGoogle Scholar
  4. 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 134:1948–1958CrossRefGoogle Scholar
  5. 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 56:217–237CrossRefGoogle Scholar
  6. 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 CrossRefPubMedGoogle Scholar
  7. 7.
    Behrendt CA, Härter M, Kriston L et al (2017) IDOMENEO – Ist die Versorgungsrealität in der Gefäßmedizin Leitlinien- und Versorgungsgerecht? Gefasschirurgie 22:41–47CrossRefGoogle Scholar
  8. 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 22:17–27CrossRefGoogle Scholar
  9. 9.
    Behrendt CA, Heidemann F, Riess HC et al (2017) Registry and health insurance claims data in vascular research and quality improvement. Vasa 46:11–15CrossRefGoogle Scholar
  10. 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 55:601–602CrossRefGoogle Scholar
  11. 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 88:944–949CrossRefGoogle Scholar
  12. 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 61:218–223CrossRefGoogle Scholar
  13. 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 53:215–222CrossRefGoogle Scholar
  14. 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 CrossRefPubMedGoogle Scholar
  15. 15.
    Bisdas T, Stachmann A, Weiss K et al (2014) Nationales Register für die Erstlinientherapiestrategien bei Patienten mit kritischer Extremitätenischämie (CRITISCH-Register). Gefasschirurgie 19:135–140CrossRefGoogle Scholar
  16. 16.
    Bjorck M, Mani K (2017) Publication of vascular surgical registry data: strengths and limitations. Eur J Vasc Endovasc Surg 54:788CrossRefGoogle Scholar
  17. 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 61:1SCrossRefGoogle Scholar
  18. 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 61:1010–1019CrossRefGoogle Scholar
  19. 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 CrossRefPubMedGoogle Scholar
  20. 20.
    Debus SE (2014) Vascunet registry validated. Vasa 43:86–87CrossRefGoogle Scholar
  21. 21.
    Destatis SB (2014) Krankenhausdiagnosestatistik. In:Statistisches Bundesamt DeStatis, URL: https://www.gbe-bund.de/, p Gesundheitsberichterstattung des Bundes
  22. 22.
    Doctorow C (2008) Big data: Welcome to the petacentre. Nature 455:16–21CrossRefGoogle Scholar
  23. 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 382:1329–1340CrossRefGoogle Scholar
  24. 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–e126CrossRefGoogle Scholar
  25. 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)CrossRefGoogle Scholar
  26. 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 184:570–576CrossRefGoogle Scholar
  27. 27.
    Hoffmann F, Andersohn F, Giersiepen K et al (2008) Validation of secondary data. Strengths and limitations. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 51:1118–1126CrossRefGoogle Scholar
  28. 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)CrossRefGoogle Scholar
  29. 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.e1CrossRefGoogle Scholar
  30. 30.
    Komshian S, Cheng TW, Farber A et al (2018) Retrograde popliteal access to treat femoropopliteal artery occlusive disease. J Vasc Surg 68:161–167CrossRefGoogle Scholar
  31. 31.
    Lawall H, Huppert P, Rümenapf G (2015) S3-Leitlinie zur Diagnostik, Therapie und Nachsorge der peripheren arteriellen VerschlusskrankheitGoogle Scholar
  32. 32.
    Lees T, Troeng T, Thomson IA et al (2012) International variations in infrainguinal bypass surgery—a VASCUNET report. Eur J Vasc Endovasc Surg 44:185–192CrossRefGoogle Scholar
  33. 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 34:2706–2714CrossRefGoogle Scholar
  34. 34.
    Nasser MM, Stausberg J, Ito WD et al (2017) Rationale and design of the RECording COurses of vasculaR Diseases registry (RECCORD registry). Vasa 46:262–267CrossRefGoogle Scholar
  35. 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 54:340–347CrossRefGoogle Scholar
  36. 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:e5749CrossRefGoogle Scholar
  37. 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 CrossRefPubMedGoogle Scholar
  38. 38.
    Schwaneberg T, Debus ES, Behrendt CA (2017) Grundlagen der Statistik und Anwendung in der Gefäßchirurgie. Gefasschirurgie 22:420–427CrossRefGoogle Scholar
  39. 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)CrossRefGoogle Scholar
  40. 40.
    Technology UDOC-NIOSA (2015) NIST Big Data Interoperability Framework: Volume 1, DefinitionsGoogle Scholar
  41. 41.
    Venermo M, Lees T (2015) International vascunet validation of the swedvasc registry. Eur J Vasc Endovasc Surg 50:802–808CrossRefGoogle Scholar

Copyright information

© Springer Medizin Verlag GmbH, ein Teil von Springer Nature 2018

Authors and Affiliations

  1. 1.Arbeitsgruppe GermanVasc, Universitäres Herzzentrum HamburgKlinik und Poliklinik für Gefäßmedizin, Universitätsklinikum Hamburg EppendorfHamburgDeutschland

Personalised recommendations