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An epidemiology-based model to estimate the rate of inappropriateness of tumor marker requests

  • Massimo Gion EMAIL logo , Roberta Franceschini , Claudia Rosin , Chiara Trevisiol , Lucia Peloso , Marco Zappa and Aline S.C. Fabricio
Published/Copyright: February 6, 2014
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 52 Issue 6

Abstract

Background: Appropriateness of tumor markers (TMs) has been retrospectively studied in limited patients’ series, matching the requests to clinical records. Methods to monitor appropriateness suitable for use on a large scale are required. This study aims to establish and validate an innovative model to estimate appropriateness based on the comparison between the number of TMs requested and the expected requests inferred from epidemiological data.

Methods: The number of CA15.3, CA19.9 and CA125 requests theoretically expected according to the epidemiology of malignancies in a known geographic area (2 Italian regions) was compared with the number of TMs actually requested – the surveyed requests projected on a regional scale – during a given time span (1 year). The expected number of requests was calculated comparing TMs recommended by guidelines in different clinical scenarios with the prevalence or incidence figures of the examined diseases (carcinomas of breast, pancreas and biliary tract, ovary and endometrium).

Results: Suitability of the model was demonstrated with the analysis of 1,891,070 TM requests surveyed in 66 laboratories from Veneto and Tuscany regions. The percentage difference over the total of expected TMs (delta%) ranged from −6.9% for CA15.3 to +1022.6% for CA19.9 in Veneto and from +35.7% for CA15.3 to +1842.6% for CA19.9 in Tuscany.

Conclusions: The presented model was effective in demonstrating higher than expected TM request rates, possibly associated with inappropriate use. Moreover, it can be applied on a large scale survey setting since it circumvents the unavailability of clinical information on test orders.

Keywords: appropriateness; epidemiology; inappropriate tumor marker requesting; tumor markers
Corresponding author: Massimo Gion, Regional Center for Biomarkers, Department of Clinical Pathology, Ospedale Civile, Azienda ULSS 12 Veneziana, Campo SS. Giovanni e Paolo, 6777–30122 Venice, Italy, Phone: +39 041 5294260, Fax: +39 041 5294910, E-mail:

Acknowledgments

We thank members of the Working Group on Tumour Markers of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC): Dr E. Aroasio, Dr M. Correale, Dr M. Cristoferi, Dr R. Dittadi, Dr A. Dolci, Dr A. Fortunato, Dr M. Paganuzzi, Dr T. Rubeca, Dr G. Ruggeri and Dr M.T. Sandri for advising the authors on the study design. We are grateful to Mrs O. Scattolin and Mrs S. Vescovo for administrative assistance. We would also like to thank C. Fulgenzi for editorial assistance in manuscript preparation. This work was partially supported by Italian Association for Research on Cancer (AIRC) (grant n°12214); Istituto Oncologico Veneto IOV – IRCCS, Padova, Italy; AVAPO Venezia Onlus Ricerca Oncologica “Biomarcatori”, Venezia, Italy.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.

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Received: 2013-8-29
Accepted: 2013-12-22
Published Online: 2014-2-6
Published in Print: 2014-6-1

©2014 by Walter de Gruyter Berlin/Boston

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https://doi.org/10.1515/cclm-2013-0708
Keywords for this article
appropriateness; epidemiology; inappropriate tumor marker requesting; tumor markers

Articles in the same Issue

  1. Frontmatter
  2. Editorials
  3. Quo vadis, biomarkers?
  4. Translational researchers beware! Unreliable commercial immunoassays (ELISAs) can jeopardize your research
  5. Reviews
  6. Tracing a roadmap for vitamin B12 testing using the health technology assessment approach
  7. Meta-analysis: diagnostic accuracy of anti-cyclic citrullinated peptide 2 antibody and anti-cyclic citrullinated peptide 3 antibody in rheumatoid arthritis
  8. Perspectives
  9. Present and future of cancer biomarkers
  10. Opinion Paper
  11. A repository for “rare” tumor markers?
  12. Genetics and Molecular Diagnostics
  13. Characterization of a complex CYP2D6 genotype that caused an AmpliChip CYP450 Test® no-call in the clinical setting
  14. General Clinical Chemistry and Laboratory Medicine
  15. Tighter precision target required for lactate testing in patients with lactic acidosis
  16. The revised Lund-Malmö GFR estimating equation outperforms MDRD and CKD-EPI across GFR, age and BMI intervals in a large Swedish population
  17. Validation of a point-of-care (POC) lactate testing device for fetal scalp blood sampling during labor: clinical considerations, practicalities and realities
  18. Dabigatran, rivaroxaban, apixaban, argatroban and fondaparinux and their effects on coagulation POC and platelet function tests
  19. Evaluation of clinical cases in External Quality Assessment Scheme (EQAS) for the urinary sediment
  20. N Latex FLC serum free light-chain assays in patients with renal impairment
  21. A new high-sensitive nephelometric method for assaying serum C-reactive protein based on phosphocholine interaction
  22. A sensitive chemiluminescence imaging immunoassay for simultaneous detection of serum oxidized lipoprotein(a) and low density lipoprotein
  23. Quantification of teicoplanin in plasma by LC-MS with online sample clean-up and comparison with QMS® assay
  24. Cancer Diagnostics
  25. An epidemiology-based model to estimate the rate of inappropriateness of tumor marker requests
  26. Evaluation of INK4A promoter methylation using pyrosequencing and circulating cell-free DNA from patients with hepatocellular carcinoma
  27. Cardiovascular Diseases
  28. The in vitro stability of novel cardiovascular and sepsis biomarkers at ambient temperature
  29. Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments
  30. Infectious Diseases
  31. Serum miR-122 levels are related to coagulation disorders in sepsis patients
  32. Letter to the Editors
  33. Effect of storage conditions and freeze/thaw cycles on serum and plasma levels of anti-acetylcholine receptor (AChR) antibody
  34. Enzymatic isotope dilution mass spectrometry (IDMS) traceable serum creatinine is preferable over Jaffe in neonates and young infants
  35. Vitamin D, atopy, immunity
  36. 25-Hydroxy vitamin D levels in chronic urticaria and its correlation with disease severity from a tertiary care centre in South India
  37. High prevalence of anti-thyroid antibodies associated with a low vitamin D status in a pediatric cohort
  38. Serum melatonin levels in psoriasis and associated depressive symptoms
  39. Congress Abstracts
  40. ISMD2014 Tenth International Symposium on Molecular Diagnostics
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