A vision to the future: value-based laboratory medicine

Author:

Plebani Mario1,Cadamuro Janne2,Vermeersch Pieter3,Jovičić Snežana4,Ozben Tomris56,Trenti Tommaso7,McMillan Brian8,Lowe Christopher R.9,Lennerz Jochen10,Macintyre Elizabeth11,Gabelli Carlo12,Sandberg Sverre13,Padoan Andrea1415,Wiencek Joesph R.16,Banfi Giuseppe1718,Lubin Ira M.19,Orth Matthias2021,Carobene Anna22,Zima Tomáš23,Cobbaert Christa M.2425,van Schaik Ron H.N.26,Lippi Giuseppe27ORCID

Affiliation:

1. Department of Laboratory Medicine , University of Padova , Padova , Italy

2. Department of Laboratory Medicine , Paracelsus Medical University , Salzburg , Austria

3. Clinical Department of Laboratory Medicine , UZ Leuven , Leuven , Belgium

4. Department of Medical Biochemistry, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia

5. Medical Faculty, Department of Medical Biochemistry , Akdeniz University , Antalya , Türkiye

6. Medical Faculty, Clinical and Experimental Medicine , University of Modena and Reggio Emilia , Modena , Italy

7. Bianalisi Group Monza , Roma, Italy

8. Centre of Primary Care and Health Services Research , University of Manchester , Manchester , UK

9. Trinity College , University of Cambridge , Cambridge , UK

10. BostonGene , Waltham , MA , USA

11. Onco-Hematology Laboratory , Necker Hospital and Université Paris Cité , Paris , France

12. Research Centre for Brain Aging (CRIC) , University Hospital of Padua , Padova , Italy

13. Noklus, Haraldsplass Deaconess Hospital , Bergen , Norway

14. Department of Medicine , University of Padova , Padova , Italy

15. Laboratory Medicine Unit , University-Hospital of Padova , Padova , Italy

16. Department of Pathology, Microbiology, and Immunology , Vanderbilt School of Medicine , Nashville , TN , USA

17. IRCCS Galeazzi Sant’Ambrogio , Milan , Italy

18. University Vita e Salute San Raffaele , Milan , Italy

19. Division of Laboratory Systems , Center for Laboratory Systems and Response, Centers for Disease Control and Prevention , Atlanta , GA , USA

20. Medical Faculty of Mannheim , Vinzenz von Paul Kliniken gGmbH , Stuttgart , Germany

21. Heidelberg University , Heidelberg , Germany

22. Laboratory Medicine , IRCCS San Raffaele Scientific Institute , Milan , Italy

23. Institute of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine , Charles University and General University Hospital , Prague , Czech Republic

24. Department of Clinical Chemistry and Laboratory Medicine , Leiden University Medical Center , Leiden , The Netherlands

25. EFLM Committee on European Regulatory Affairs and EFLM Liaison to BioMed Alliance in Europe , Brussels , Belgium

26. Department of Clinical Chemistry , Erasmus MC University Medical Center , Rotterdam , The Netherlands

27. Section of Clinical Biochemistry , University of Verona , Verona , Italy

Abstract

Abstract The ultimate goal of value-based laboratory medicine is maximizing the effectiveness of laboratory tests in improving patient outcomes, optimizing resources and minimizing unnecessary costs. This approach abandons the oversimplified notion of test volume and cost, in favor of emphasizing the clinical utility and quality of diagnostic tests in the clinical decision-making. Several key elements characterize value-based laboratory medicine, which can be summarized in some basic concepts, such as organization of in vitro diagnostics (including appropriateness, integrated diagnostics, networking, remote patient monitoring, disruptive innovations), translation of laboratory data into clinical information and measurable outcomes, sustainability, reimbursement, ethics (e.g., patient empowerment and safety, data protection, analysis of big data, scientific publishing). Education and training are also crucial, along with considerations for the future of the profession, which will be largely influenced by advances in automation, information technology, artificial intelligence, and regulations concerning in vitro diagnostics. This collective opinion paper, composed of summaries from presentations given at the two-day European Federation of Laboratory Medicine (EFLM) Strategic Conference “A vision to the future: value-based laboratory medicine” (Padova, Italy; September 23–24, 2024), aims to provide a comprehensive overview of value-based laboratory medicine, projecting the profession into a more clinically effective and sustainable future.

Publisher

Walter de Gruyter GmbH

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