Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Greaves, Ronda / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Payne, Deborah A. / Schlattmann, Peter


IMPACT FACTOR 2018: 3.638

CiteScore 2018: 2.44

SCImago Journal Rank (SJR) 2018: 1.191
Source Normalized Impact per Paper (SNIP) 2018: 1.205

Online
ISSN
1437-4331
See all formats and pricing
More options …
Volume 54, Issue 12

Issues

Identifying risk in the use of tumor markers to improve patient safety

Elvira Eva Moreno-Campoy
  • Corresponding author
  • Pharmacy Unit, Health Management Area Serranía de Málaga, Carretera de El Burgo, km 1 29400 Ronda Málaga, Málaga, Spain
  • University of Málaga, Málaga, Spain
  • Email
  • Other articles by this author:
  • De Gruyter OnlineGoogle Scholar
/ Francisco J. Mérida-De la TorreORCID iD: http://orcid.org/0000-0002-1545-3665 / Francisco Martos-CrespoORCID iD: http://orcid.org/0000-0003-4585-5195 / Mario PlebaniORCID iD: http://orcid.org/0000-0002-0270-1711
Published Online: 2016-03-08 | DOI: https://doi.org/10.1515/cclm-2015-0760

Abstract

Background:

Tumor markers (TM) are a routine test that are not always used well, and can lead to unnecessary additional tests, which are not without risks for the patients. So, to implement appropriate strategies to improve the adequate use of TM and, therefore, improve patient safety, is required to analyze the use of TM, identifying risks and establishing if there are differences in their use as a function of their utility.

Methods:

The study was a descriptive, longitudinal, retrospective and systematic study in the area covered by the University Hospital of Padua. In the follow-up 2-year study, 23,059 analytical requests of TM, corresponding to 14,728 patients, were analyzed. For the level of statistical significance it applies an approximation of the normal law (Z statistic) and χ2-test.

Results:

Only 9196 requests (39.88%) out of a total of 23,059 on 5080 patients with neoplastic diseases have been classified as adecuate according to current guidelines. The number of requests per patient was variable (1.57±1.35). In patients with neoplastic diseases this increased to 1.80±1.68. The mean of number of TM per request was 2.4±1.73. The analysis showed an association between the number of requests and the type of marker used.

Conclusions:

The use of TM is variable, mainly of the follow-up markers, when they are used as screening. This inappropriate use, minimizes their utility favoring erroneous interpretations and increases the risk of damage to the patient. So it is essential to implement safe practices in the use of TM.

Keywords: biomarkers tumor; clinical medicine; effectiveness; patient safety; risk assessment; tumor markers; utility

References

  • 1.

    Nieva VF, Sorra J. Safety culture assessment: a tool for improving patient safety in healthcare organizations. Qual Saf Health Care 2003;12:ii17–23.Google Scholar

  • 2.

    Weaver SJ, Lubomksi LH, Wilson RF, Pfoh ER, Martinez KA, Dy SM. Promoting a culture of safety as a patient safety strategy: a systematic review. Ann Intern Med 2013;158:369–74.Google Scholar

  • 3.

    Terol E, Agra Y. Patient safety strategy of the National Health System (Estrategia en seguridad del paciente del Sistema Nacional de Salud). Med Clin (Barc) 2008;131:1–3.Google Scholar

  • 4.

    World Health Organization WHO Regional Office for Europe. A brief synopsis on patient safety [Internet] 2010; [consulted on 17 June 2015]. Available at http://www.euro.who.int/__data/assets/pdf_file/0015/111507/E93833.pdf.

  • 5.

    European Union Network for Patient Safety and Quality of Care:PaSQ [Internet] c2012; [consulted on 17 June 2015]. Available at: www.pasq.eu.

  • 6.

    The Joint Commission [internet] c2015; [consulted on 17 June 2015]. Available at: http://www.jointcommission.org/topics/patient_safety.aspx.

  • 7.

    European Commission. Report from the Commision to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections, 2012; [consulted on 17 June 2015]. Available at: http://ec.europa.eu/health/patient_safety/docs/council_2009_report_en.pdf.

  • 8.

    Agency for Healthcare Research and Quality. Making health caresafer II: An updated critical analysis of the evidence for patient safety practices. Evidence Report No.211. AHRQ Publication No.13-E001-EF. Rockville, 2013.

  • 9.

    Plebani. M. The CCLM contribution to improvements in quality and patient safety. Clin Chem Lab Med 2013;51:39–46.Google Scholar

  • 10.

    Mérida FJ, Moreno EE. Fundamentals of Patient Safety. Analysis and strategies in the clinical laboratory (Fundamentos de Seguridad del Paciente. Análisis y estrategias en el laboratorio clínico). Madrid: Editorial Panamericana, 2011.Google Scholar

  • 11.

    Wachter RM. Understanding Patient Safety, 2nd ed. New York: McGraw-Hill, 2012.Google Scholar

  • 12.

    Plebani M. The journey toward quality and patient safety in laboratory medicine continues. N Am J Med Sci 2014;6:229–30.Google Scholar

  • 13.

    Agra-Varela Y, Fernández-Maíllo M, Rivera-Ariza S, Sáiz-Martínez-Acitorez I, Casal-Gómez J, Palanca-Sánchez I, et al. European union network for Patient Safety and Quality of Care (PASQ). Development and preliminary results in Europe and in the Spanish National Health System. Rev Calid Asist 2015;30:95–102.Google Scholar

  • 14.

    Sölétormos G, Duffy MJ, Hayes DF, Sturgeon CM, Barak V, Bossuyt PM, et al. Design of tumor biomarker-monitoring trials: a proposal by the European group on tumor markers. Clin Chem 2013;59:52–9.Google Scholar

  • 15.

    Carolyn Vachani RN. Patient Guide to Tumor Markers. [Internet]. 2013. Oncolink c2015; [consulted on 17 june 2015]. Available at: http://www.oncolink.org/treatment/article.cfm?id=296.

  • 16.

    Harris L, Fritsche H, Norton ML, Ravdin P, Taube S, Somerfield MR, et al. American society of clinical oncology 2007 update of recommendations for the use of tumor markers in breast cancer [review]. J Clin Oncol 2007;25:5287–312.Google Scholar

  • 17.

    Sturgeon CM. Tumor markers in the laboratory: closing the guideline-practice gap. Clin Biochem 2001;34:353–9.Google Scholar

  • 18.

    Martín A, Alonso L, Ordiz I, Vázquez J, Vizoso F. Clinical utility of serum tumor markers (Utilidad clínica de los marcdores tumorales séricos). Aten Primaria 2003;32:227–39.Google Scholar

  • 19.

    Sharma S. Tumor markers in clinical practice: general principles and guidelines. Indian J Med Paediatr Oncol 2009;30:1–8.Google Scholar

  • 20.

    Sturgeon CM, Lai LC, Duffy MJ. Serum tumour markers: how to order and interpret them. Clinical review. Br Med J 2009;339:852–58. (b3527) [consulted on 27-04-2015] Available at: http://www.bmj.com/content/339/bmj.b3527.

  • 21.

    Perkins GL, Slater ED, Sanders GK, Prichard JG. Serum tumor markers. Am Fam Physician 2003;68:1075–82.Google Scholar

  • 22.

    Duffy MJ. Tumor markers in clinical practice: a review focusing on common solid cancers. Med Princ Pract 2013;22:4–11.Google Scholar

  • 23.

    Sturgeon C. Practice guidelines for tumor marker use in the clinic. Clin Chem 2002;48:1151–9.Google Scholar

  • 24.

    Henry NL, Hayes DF. Uses and abuses of tumor markers in the diagnosis, monitoring and treatment of primary and metastatic breast cancer. The Oncologist 2006;11:541–52.Google Scholar

  • 25.

    Merida FJ [internet]. Clinical Practice 399/Safe use of tumor markers. PaSQ. European Union Network for Patient Safety and Quality of Care; [consulted on 28-04-2015] Available at: http://www.pasq.eu/Wiki/GPDisplayPracticeDetails.aspx?prid=399.

  • 26.

    Fernández A. Martínez A, Gaspar MJ, Filella X, Molina R, Ballesta AM. Serum tumor markers (Marcadores tumorales serológicos). Química Clínica 2007;26:77–85.Google Scholar

  • 27.

    Han SN, Lotgerink A, Gziri MM, Van Calsteren K, Hanssens M, Amant F. Physiologic variations of serum tumor markers in gynecological malignancies during pregnancy: a systematic review. BMC Med 2012;10:86.Google Scholar

  • 28.

    McShane LM, Hayes DF. Publication of tumor marker research results: the necessity for complete and transparent reporting. J Clin Oncol 2012;30:4223–32.Google Scholar

  • 29.

    NCI [Internet]. Instituto nacional del cáncer de Estados Unidos. Tumor markers (Marcadores tumorales) [updated 7-12-2011; consulted on 28-04-2015]. Available at: http://www.cancer.gov/espanol/recursos/hojas-informativas/deteccion-diagnostico/marcadores-de-tumores.

  • 30.

    Molina R, Filella X, Augé JM, Escudero JM. Clinical utility of tumor markers [Current status and future prospects III] (Utilidad clínica de los marcadores tumorales [Estado actual y perspectivas de futuro III]. Roche Diagnostics, 2011.

  • 31.

    EGTM. General information on tumor marker [Internet]. European Group on Tumor Markers c2014; [consulted on 28-04-2015]. Available at: http://www.egtm.eu/professionals/general_info_tumor_markers/.

  • 32.

    ASCO. Practice Guidelines [Internet]. American Society of Clinical Oncology c2015; [consulted on 28-04-2015]. Available at: http://www.instituteforquality.org/practice-guidelines.

  • 33.

    Fleisher M, Dnistrian AM, Sturgeon CM, Lamerz R, Wittliff JL. Practice guidelines and recommendations for use of tumor markers in the clinic. In: Diamandis EP, editor. Tumor markers: physiology, pathobiology, technology, and clinical applications. Washington, DC: AACC Press, 2003:33–63.Google Scholar

  • 34.

    Sturgeon CM, Hoffman BR, Chan DW, Ch’ng SL, Hammond E, Hayes DF, et al. National academy of clinical biochemistry laboratory medicine practice guidelines for use of tumor markers in clinical practice: quality requirements. Clin Chem 2008;54: e1–10.Google Scholar

  • 35.

    Vaidyanathan K, Vasudevan DM. Organ specific tumor markers: what’s new? Indian J Clin Biochem 2012;27:110–20.Google Scholar

  • 36.

    Kantrowitz M. Cancerpoint.com [Internet]. False Positives and False Negatives in Tumor Marker Blood Tests c2005–2009; [consulted on 28-04-2015]. Available at: http://www.kantrowitz.com/cancerpoints/tumormarkerfalsepositives.html.

  • 37.

    Duffy MJ, McGing P. Guidelines for the use of tumor markers. ACBI Association of Clinical Biochemists in Ireland editor, 4th edition, 2010; [consulted on 28-04-2015]. Available at: http://www.acbi.ie/Article.asp?pID=231.

  • 38.

    Wade J, Rosario DJ, Macefield RC, Avery KN, Salter CE, Goodwin ML, et al. Psychological impact of prostate biopsy: physical symptoms, anxiety, and depression. J Clin Oncol 2013;31:4235–41.Google Scholar

  • 39.

    Fowler FJ, Barry MJ, Walker-Corkery B, Caubet JF, Bates DW, Lee JM, et al. The impact of a suspicious prostate biopsy on patients’ psychological, socio-behavioral, and medical care outcomes. J Gen Intern Med 2006;21:715–21.Google Scholar

  • 40.

    Bast RC Jr, Radvin P, Hayes DF, Bates S, Fritsche H Jr, Jessup JM, et al. 2000 update of recommendations for the use of tumor markers in breast and colorectal cancer: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol 2001;19:1865–78.Google Scholar

  • 41.

    Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): explanation an elaboration. BMC Med 2012;10:51.Google Scholar

  • 42.

    Mérida FJ, Moreno EE, Martos F. Impact of the implementation of a protocol for the adequate and safe use of tumor markers (Impacto de la aplicación de un protocolo para el uso adecuado y seguro de marcadores tumorales). Med Clin (Barc) 2015;145:526–8.Google Scholar

  • 43.

    AACC. Cáncer de prostate. Diagnóstico Precoz [internet]. Asociación Española contra el Cáncer c2015; [consulted on 02-07-2015]. Available at: https://www.aecc.es/sobreelcancer/cancerporlocalizacion/cancerdeprostata/Paginas/diagnosticoprecoz.aspx.

  • 44.

    Thompson IM, Tangen CM. Prostate cancer: uncertainty and a way forward. N Engl J Med 2012;367:270–1.Google Scholar

  • 45.

    Prostate cancer: send away the PSA? Lancet 2012;380:307.Google Scholar

About the article

Corresponding author: Elvira Eva Moreno-Campoy, Pharmacy Unit, Health Management Area Serranía de Málaga, Carretera de El Burgo, km 1 29400 Ronda Málaga, Málaga, Spain, Phone: +34677904018, E-mail: ; and University of Málaga, Málaga, Spain


Received: 2015-08-05

Accepted: 2016-01-26

Published Online: 2016-03-08

Published in Print: 2016-12-01


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: The funding organization(s) 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.


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), Volume 54, Issue 12, Pages 1947–1953, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2015-0760.

Export Citation

©2016 Walter de Gruyter GmbH, Berlin/Boston.Get Permission

Comments (0)

Please log in or register to comment.
Log in