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From volume to value: a watershed moment for the clinical laboratory

  • Rossella Tomaiuolo ORCID logo EMAIL logo and Giuseppe Banfi
Published/Copyright: October 2, 2023
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 62 Issue 4

Abstract

The clinical laboratory is often evaluated for the volume of testing. However, it is undeniable that laboratory tests affect clinical decision-making and are included in many clinical guidelines, meaning their contribution to determining clinical outcomes. Therefore, the clinical laboratory professional has the task of enhancing laboratory tests by optimizing the request and reporting phase and addressing patient outcomes. This opinion paper, presenting practical examples of managing value-based health care in the clinical laboratory context, underlines the need to shift towards value-based management to optimize outcome-based health care.

Keywords: clinical outcomes; outcome-based health care; effectiveness
Corresponding author: Rossella Tomaiuolo, Vita-Salute San Raffaele University, 20132 Milan, Italy; and IRCCS Istituto Ortopedico Galeazzi, Milan, Italy, E-mail:

  1. Research ethics: Not applicable.

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Competing interests: The authors state no conflict of interest.

  5. Research funding: None declared.

  6. Data availability: Not applicable.

References

1. Website of the European association of value-based health care. http://www.eavbhc.org [Accessed 7 July 2023].Search in Google Scholar

2. Pennestrì, F, Lega, F, Banfi, G. From volume to value: improving peri-operative elective pathways through a road map from fast-track orthopedic surgery. Health Serv Manag Res 2022 Sep 13. https://doi.org/10.1177/09514848221127623 [Epub ahead of print].Search in Google Scholar PubMed PubMed Central

3. Porter, ME. A strategy for health care reform—toward a value-based system. N Engl J Med 2009;361:109–12. https://doi.org/10.1056/nejmp0904131.Search in Google Scholar PubMed

4. Porter, ME. What is value in health care? N Engl J Med 2010;363:2477–81. https://doi.org/10.1056/nejmp1011024.Search in Google Scholar

5. Pennestrì, F, Banfi, G. Value based healthcare: the role of laboratory medicine. Clin Chem Lab Med 2019;57:798–801. https://doi.org/10.1515/cclm-2018-1245.Search in Google Scholar PubMed

6. Hallworth, MJ. The 70 % claim: what is the evidence base? Ann Clin Biochem 2011;48:487–8. https://doi.org/10.1258/acb.2011.011177.Search in Google Scholar PubMed

7. Plebani, M. Quality and future of clinical laboratories: the Vico’s whole cyclical theory of the recurring cycles. Clin Chem Lab Med 2018;56:901–8. https://doi.org/10.1515/cclm-2018-0009.Search in Google Scholar PubMed

8. Malmivaara, A. Real-Effectiveness Medicine – pursuing the best effectiveness in the ordinary care of patients. Ann Med 2013;45:103–6. https://doi.org/10.3109/07853890.2011.653394.Search in Google Scholar PubMed

9. Lindblad, S, Ernestam, S, Van Citters, AD, Lind, C, Morgan, TS, Nelson, EC. Creating a culture of health: evolving healthcare systems and patient engagement. QJM 2017;110:125–9. https://doi.org/10.1093/qjmed/hcw188.Search in Google Scholar PubMed

10. https://www.choosingwisely.org [Accessed 7 July 2023].Search in Google Scholar

11. Spoyalo, K, Lalande, A, Rizan, C, Park, S, Simons, J, Dawe, P, et al.. Patient, hospital and environmental costs of unnecessary bloodwork: capturing the triple bottom line of inappropriate care in general surgery patients. BMJ Open Qual 2023;12:e002316. https://doi.org/10.1136/bmjoq-2023-002316.Search in Google Scholar PubMed PubMed Central

12. Currie, GR, Gerber, B, Lorenzetti, D, MacDonald, K, Benzeler, SM, Bernier, FP, et al.. Developing a framework of costs elements of socioeconomic burden of rare disease: a scoping review. Pharmacoeconomics 2023;41:803–18. https://doi.org/10.1007/s40273-023-01262-x.Search in Google Scholar PubMed

13. Sempios, CT, Heijboer, AC, Bikle, DD, Bollerslev, J, Bouillon, R, Brannon, PM, et al.. Vitamin D assays and the definition of hypovitaminosis D: results from the first international conference on controversies in vitamin D. Br J Clin Pharmacol 2018;84:2194–207. https://doi.org/10.1111/bcp.13652.Search in Google Scholar PubMed PubMed Central

14. Ferrari, D, Lombardi, G, Banfi, G. Concerning the vitamin D reference range: pre-analytical and analytical variability of vitamin D measurement. Biochem Med 2017;27:030501. https://doi.org/10.11613/bm.2017.030501.Search in Google Scholar

15. McDonagh, TA, Merta, M, Adamo, M, Gadrner, RS, Baumbach, A, Bohm, M, et al.. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J 2021;42:3599–726. https://doi.org/10.1093/eurheartj/ehab368.Search in Google Scholar PubMed

16. Writing Committee Members, ACC/AHA Joint Committee Members. AHA/ACC/HFSA guidelines for the management of heart failure. J Card Fail 2022;28:e1–167. https://doi.org/10.1016/j.cardfail.2022.02.010.Search in Google Scholar PubMed

17. Braisch, U, Koenig, W, Rothenbacher, D, Denkinger, M, Friedrich, N, Felix, SB, et al.. N-terminal pro brain natriuretic peptide reference values in community-dwelling older adults. ESC Heart Failure 2022;9:703–1712. https://doi.org/10.1002/ehf2.13834.Search in Google Scholar PubMed PubMed Central

18. Lundgren, M, Ridefelt, P, Karlsson, M, Norling, A, larsson, A. Interlaboratory variation for NTproBNP among Swedish laboratories in an external quality program 2011–21. Clin Chem Lab Med 2023;61:1643–51. https://doi.org/10.1515/cclm-2023-0051.Search in Google Scholar PubMed

19. Wu, AHB, Christenson, RH, Greene, DN, Jaffe, AS, Kavsak, PA, Ordonez-Lianos, J, et al.. Clinical laboratory practice recommendations for the use of cardiac troponin in acute coronary syndrome: expert opinion from the academy of the American association for clinical chemistry and the task force on clinical applications of cardiac bio-markers of the international federation of clinical chemistry and laboratory medicine. Clin Chem 2018;64:645–55. https://doi.org/10.1373/clinchem.2017.277186.Search in Google Scholar PubMed

20. Collinson, P, Aakre, KM, Saenger, A, Body, R, Hammarsten, O, Jaffe, AS, et al.. Cardiac troponin measurement at the point of care: educational recommendations on analytical and clinical aspects by the IFCC Committee on Clinical Applications of Cardiac Bio-Markers (IFCC C-CB). Clin Chem Lab Med 2023;61:989–98. https://doi.org/10.1515/cclm-2022-1270.Search in Google Scholar PubMed

21. Plebani, M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741–51.10.1515/cclm-2013-0075Search in Google Scholar PubMed

22. Greenberg, N. Update on current concepts and meanings in laboratory medicine — standardization, traceability and harmonization. Clin Chim Acta 2014;432:49–54. https://doi.org/10.1016/j.cca.2013.12.045.Search in Google Scholar PubMed

23. Colombini, A, Divieto, C, Tomaiuolo, R, Mortati, L, Petiti, J, Di Resta, C, et al.. The total testing process harmonization: the case study of SARS-CoV-2 serological tests. Clin Chem Lab Med 2023;61:2084–93. https://doi.org/10.1515/cclm-2023-0353.Search in Google Scholar PubMed

24. Davidson, J. Harmonisation of GH assays in Australasia. Clin Biochem Rev 2012;33:101–2.Search in Google Scholar

25. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: the diagnosis and management of patients with primary biliary cholangitis. J Hepatol 2017;67:145–67. https://doi.org/10.1016/j.jhep.2017.03.022.Search in Google Scholar PubMed

26. Tietz, NW, Rodgerson, DO. Clinical chemistry – quo vadis? Clin Chem 1988;34:190–1. https://doi.org/10.1093/clinchem/34.1.190.Search in Google Scholar

27. Pisapia, A, Banfi, G, Tomaioulo, R. The novelties of the regulation of health technology assessment, a key achievement for European Union health policies. Clin Chem Lab Med 2022;60:1160–3. https://doi.org/10.1515/cclm-2022-0228.Search in Google Scholar PubMed

28. Expert Panel on effective ways of investing in Health (EXPH) Defining value in “value-based healthcare”; 2019. https://ec.europa.eu/health/sites/health/files/expert_panel/docs/024_defining-value-vbhc_en.pdf [Accessed 21 Sept 2023].Search in Google Scholar
Received: 2023-08-08
Accepted: 2023-09-25
Published Online: 2023-10-02
Published in Print: 2024-03-25

© 2023 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
  38. Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
  39. Re.: Louise Guillaume et al. Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers. Clin Chem Lab Med 2023;61(7):1319–1326; https://doi.org/10.1515/cclm-2022-0966
  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
https://doi.org/10.1515/cclm-2023-0870
Keywords for this article
clinical outcomes; outcome-based health care; effectiveness

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Value-based laboratory medicine: the time is now
  4. Review
  5. Cardiovascular risk evaluation in pregnancy: focus on cardiac specific biomarkers
  6. Opinion Papers
  7. From volume to value: a watershed moment for the clinical laboratory
  8. APS calculator: a data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
  9. Guidelines and Recommendations
  10. Analytical interference of intravascular contrast agents with clinical laboratory tests: a joint guideline by the ESUR Contrast Media Safety Committee and the Preanalytical Phase Working Group of the EFLM Science Committee
  11. Genetics and Molecular Diagnostics
  12. Specifications of qPCR based epigenetic immune cell quantification
  13. General Clinical Chemistry and Laboratory Medicine
  14. An appraisal of the practice of duplicate testing for the detection of irregular analytical errors
  15. Machine learning-based nonlinear regression-adjusted real-time quality control modeling: a multi-center study
  16. The effect of ratios upon improving patient-based real-time quality control (PBRTQC) performance
  17. Diagnostic sample transport via pneumatic tube systems: data logger and their algorithms are sensitive to transport effects
  18. Ambulatory human chorionic gonadotrophin (hCG) testing: a verification of two hCG point of care devices
  19. Monitoring patients with celiac disease on gluten free diet: different outcomes comparing three tissue transglutaminase IgA assays
  20. Verification, implementation and harmonization of automated chemiluminescent immunoassays for MPO- and PR3-ANCA detection
  21. Performance evaluation of a novel platelet count parameter, hybrid platelet count, on the BC-780 automated hematology analyzer
  22. Reference Values and Biological Variations
  23. Pediatric reference intervals for serum neurofilament light and glial fibrillary acidic protein using the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) cohort
  24. Biological variation of serum neopterin concentrations in apparently healthy individuals
  25. Short-term biological variation of serum tryptase
  26. Cancer Diagnostics
  27. Quantification of the lung cancer tumor marker CYFRA 21-1 using protein precipitation, immunoaffinity bottom-up LC-MS/MS
  28. Cardiovascular Diseases
  29. Prognostic significance of chronic myocardial injury diagnosed by three different cardiac troponin assays in patients admitted with suspected acute coronary syndrome
  30. Deep learning-based NT-proBNP prediction from the ECG for risk assessment in the community
  31. Diabetes
  32. Innovations in HbA1c analysis: finding the balance between speed and accuracy. An investigation of a potential new Secondary Reference Measurement Procedure for the IFCC
  33. Precise glucose measurement in sodium fluoride-citrate plasma affects estimates of prevalence in diabetes and prediabetes
  34. Infectious Diseases
  35. Urinary phenotyping of SARS-CoV-2 infection connects clinical diagnostics with metabolomics and uncovers impaired NAD+ pathway and SIRT1 activation
  36. Letters to the Editor
  37. Analytical performance specifications for measurement uncertainty in therapeutic monitoring of immunosuppressive drugs
  38. Capillary blood collection tubes containing serum separator gel result in lower measurements of oestradiol and total testosterone
  39. Re.: Louise Guillaume et al. Biological variation of CA 15-3, CA 125 and HE 4 on lithium heparinate plasma in apparently healthy Caucasian volunteers. Clin Chem Lab Med 2023;61(7):1319–1326; https://doi.org/10.1515/cclm-2022-0966
  40. A comparison of cannabidiol (CBD) concentrations in venous vs. fingertip-capillary blood
  41. Identification of sulfamethoxazole’s residues in sulfamethoxazole induced kidney stones by mass spectrometry
  42. Impact of different preservation methods on urinary red blood cell counts
  43. Diagnosis of IRAK-4-deficiency by flow cytometric measurement of IκB-α degradation
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