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An epidemiology-based model as a tool to monitor the outbreak of inappropriateness in tumor marker requests: a national scale study

  • Massimo Gion EMAIL logo , Lucia Peloso , Chiara Trevisiol , Elisa Squarcina , Marco Zappa and Aline S.C. Fabricio
Published/Copyright: August 19, 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 54 Issue 3

Abstract

Background: Evaluation of appropriateness of laboratory tests on the basis of individual requests remains a serious problem as the clinical question is usually not reported with the test order. This study explored the comparison of the rate of tumor marker orders with cancer prevalence as a putative indicator of inappropriateness.

Methods: Tumor marker orders (2011 and 2012) were obtained from the Ministry of Health and cancer prevalence from the Italian Association of Cancer Registries. The rate of tumor marker orders was matched with demographic data and tumor prevalence and examined by using the confidence interval approach. Region-to-region and year-to-year variations were also examined. Focus was placed on CEA, CA125, CA19.9 and CA15.3.

Results:Tumor markers ordered in Italy were 13,207,289 in 2012 (221.3/1000 individuals). Given an estimated prevalence of 2,243,953 cancer cases, 7.04 tumor markers appear to be requested for each prevalent case of epithelial cancer per year. The rate of requests of CEA, CA125, CA19.9 and CA15.3 (in aggregate 5,834,167 requests in 2012, 44.2% of total) from the first and the last ranked region (96 and 244/1000 individuals) are significantly different (p<0.01). Region-to-region differences do not correspond to any known variation of prevalence in the different regions.

Conclusions: The developed approach provides a proxy indicator of inappropriateness showing that tumor markers are overused in Italy and their ordering pattern is not related to tumor prevalence. The model is suitable to be validated in other laboratory tests used in diseases whose prevalence is known.

Keywords: appropriateness; biomarkers; epidemiology; oncology; prevalence
Corresponding author: Dr. Massimo Gion, Regional Center for Biomarkers, Department of Clinical Pathology and Transfusion Medicine, Ospedale Civile – Azienda ULSS 12 Veneziana, Campo SS. Giovanni e Paolo, 6777 – 30122 Venezia, Italy, Phone: +39 041 5294260, Fax: +39 041 5294910, E-mail:

Acknowledgments

We wish to thank the Ministry of Health, New National Health IT System (Direzione generale della digitazione, del sistema informativo sanitario e della statistica – Elaborazione a cura dell’Ufficio III – NSIS, flusso di specialistica ambulatoriale – Art. 50 della legge n.326/2009) for allowing us to use the requested biomarker data. We would like to thank the Interregional Biomarkers Working Group – IBWG instituted by the Health Commission of the Italian Permanent Conference for relations between state, regions and autonomous provinces of Trento and Bolzano (Gruppo Tecnico Interregionale “Miglioramento della Pratica Clinica per l’Utilizzo dei Biomarcatori in Oncologia”, Commissione Salute – Conferenza Permanente per i rapporti tra Stato, Regioni e Province Autonome di Trento e Bolzano). In particular, we would like to thank the IBWG members for their important contributions in discussing rough preliminary data: Antonino Iaria (Regional Representative for Calabria); Vincenzo Montesarchio (Regional Representative for Campania); Tommaso Trenti (Regional Representative for Emilia-Romagna); Laura Conti (Regional Representative for Lazio); Luigina Bonelli, and Gabriella Paoli (Regional Representatives for Liguria); Mario Cassani (Regional Representative for Lombardia); Lucia Di Furia (Regional Representative for Marche); Emiliano Aroasio (Regional Representative for Piemonte); Mario Brandi (Regional Representative for Puglia); Marcello Ciaccio, and Antonio Russo (Regional Representatives for Sicilia); Gianni Amunni (Regional Representative for Toscana); Emanuela Toffalori (Representative for Autonomous Province of Trento); Basilio Ubaldo Passamonti (Regional Representative for Umbria); Claudio Pilerci, and Francesca Russo (Regional Representatives for Veneto); Annarosa Del Mistro (Istituto Oncologico Veneto IOV – IRCCS, Veneto Region); Massimo Gion (Coordinator); Aline S.C. Fabricio, and Chiara Trevisiol (Scientific Secretariat of the Regional Center for Biomarkers); and Ornella Scattolin (Organizing Secretariat of the Regional Center for Biomarkers). We would also like to thank Candice Fulgenzi for editorial assistance in the manuscript preparation.

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

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: None declared.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2015-0329) offers supplementary material, available to authorized users.

Received: 2015-4-8
Accepted: 2015-7-15
Published Online: 2015-8-19
Published in Print: 2016-3-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0329
Keywords for this article
appropriateness; biomarkers; epidemiology; oncology; prevalence

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The way of prostate cancer diagnostics
  4. Review
  5. Statistical methods used in the calculation of geriatric reference intervals: a systematic review
  6. Opinion Paper
  7. The side effects of translational omics: overtesting, overdiagnosis, overtreatment
  8. Genetics and Molecular Diagnostics
  9. Rapid detection of non-deletional mutations causing α-thalassemia by multicolor melting curve analysis
  10. General Clinical Chemistry and Laboratory Medicine
  11. Patient pools and the use of “patient means” are valuable tools in quality control illustrated by a bone-specific alkaline phosphatase assay
  12. Long-term stability of glucose: 96-h study using Terumo Glycaemia tubes
  13. Glucose is stable during prolonged storage in un-centrifuged Greiner tubes with liquid citrate buffer, but not in serum and NaF/KOx tubes
  14. Croatian laboratories have a good knowledge of the proper detection and management of hemolyzed, icteric and lipemic samples
  15. Fetal exposure to ethanol: relationship between ethyl glucuronide in maternal hair during pregnancy and ethyl glucuronide in neonatal meconium
  16. Comparing the effect of isotopically labeled or structural analog internal standards on the performance of a LC-MS/MS method to determine ciclosporin A, everolimus, sirolimus and tacrolimus in whole blood
  17. Relationship between matrix metalloproteinase-9 and oxidative stress in drug-free male schizophrenia: a case control study
  18. Comparison of functional fibrinogen (FF/CFF) and FIBTEM in surgical patients – a retrospective study
  19. Reference Values and Biological Variations
  20. Assessment of serum free light chain levels in healthy adults immediately after marathon running
  21. Pharmacokinetics of a novel dosing regimen of oral melatonin in critically ill patients
  22. Cancer Diagnostics
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  24. Comparative analysis of prostate cancer specific biomarkers PCA3 and ERG in whole urine, urinary sediments and exosomes
  25. Infectious Diseases
  26. Comparative evaluation of the Aptima HIV-1 Quant Dx assay and COBAS TaqMan HIV-1 v2.0 assay using the Roche High Pure System for the quantification of HIV-1 RNA in plasma
  27. Evaluating the use of procalcitonin in an asymptomatic, HIV-infected antiretroviral therapy-naïve, South African cohort
  28. Diabetes
  29. Early prediction of gestational diabetes: a practical model combining clinical and biochemical markers
  30. Letters to the Editors
  31. Highly-trained dogs’ olfactory system for detecting biochemical recurrence following radical prostatectomy
  32. More on the accuracy of the Architect enzymatic assay for hemoglobin A1c and its traceability to the IFCC reference system
  33. Assessing quality from an accuracy-based HbA1c proficiency survey
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  35. Between analyser differences in chloride measurements and thus anion gap cause different interpretations of the acid-base balance
  36. Non-albumininuric proteinuria: a urinary tubular marker in the diagnosis of diabetic kidney disease
  37. International Normalized Ratio (INR) testing: analytical and clinical performance of four point-of-care devices versus central laboratory instrumentation analysis
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