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Biomarkers in the ED - useful or useless

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All biomarkers are awesome predictors of badness. Elevated hS-troponins after non-cardiac surgery or an acute exacerbation of COPD are associated with increased mortality. In seemingly healthy people elevated D-dimer levels are associated with increased mortality, just like NT-proBNP levels predict mortality in patients with end-stage renal disease.

A biomarker, in its broadest sense, is defined as ” a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” (NIH Biomarkers Definitions Working group, 2001). This definition includes everything from laboratory tests to blood pressure measurements or an ultrasound scan. The clinical assessment in the emergency department is based on the subjective history of the patient in combination with all available biomarkers and their change over time. Yet the notion that biomarkers are ”objectively measured” can lead to an overestimation of their individual importance in the bigger clinical picture.

Overtesting and overdiagnosis have serious consequences not only for patients, but also for the health care system. In a clinical context the ease of getting a laboratory test leads to a lower threshold for testing, which has been shown to increase testing without affecting relevant clinical endpoints. Also, when a biomarker becomes part of the standardized workup for a certain symptom, primary care centers and emergency telephone services will refer patients to the emergency department for testing, even when the pretest probability is low.

This bias is not an inherent problem of biomarkers themselves, but of the decision making process of clinicians. The human brain fears uncertainty, and anything that adds to the feeling of knowing is rewarding, which is the most probable explanation of overtesting in settings where medico-legal risks for the clinicians are low. The ever increasing numbers of patients seeking emergency care to rule out serious conditions is a development driven by medical professionals and is fueled by the perceived increased certainty provided by biomarker testing.

Veröffentlicht in: Gesundheit & Medizin
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Biomarkers in the ED - useful or useless

  1. 1. Bringing sexy back? biomarkers - useful or useless? Katrin Hruska
  2. 2. No disclosures
  3. 3. N Engl J Med 2015; 373:1916-1925November 12,
  4. 4. ”in the near future, high suPAR levels probably will inform physician-patient conversations about preventing kidney disease"
  5. 5. ”rigorous NEJM study is a significant breakthrough in preventive medicine"
  6. 6. Groundbreaking blood test predicts kidney disease FIVE YEARS BEFORE symptoms appear
  7. 7. ”Trisaq's product strategy has been designed to yield early proof-of- concept as well as commercialization opportunities” ”Conservatively estimated, Trisaq's current pipeline of products can benefit about 15-25% of all CKD patients and their combined sales potential well exceeds $1 billion.
  8. 8. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
  9. 9. Novel Blood Biomarker May Predict CKD Risk Outcomes studies necessary to prove clinical efficacy
  10. 10. suPAR: Strong and independent predictor of survival
  11. 11. Rather young and healthy than old and sick
  12. 12. The primary endpoint was to create an accurate prognostication score of death by combining APACHE II score and serum suPAR.
  13. 13. 💀 14 ng/mL 3-70 ng/mL 1-65 ng/mL 😀 9 ng/mL suPAR levels and survival in sepsis range:
  14. 14. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  15. 15. suPAR Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  16. 16. APACHE II
  17. 17. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  18. 18. Copyright ©2012 Giamarellos-Bourboulis et al.; licensee BioMed Central Ltd. Crit Care. 2012; 16(4): R149.
  19. 19. Mortality% 0 10 20 30 40 i ii iii iv Apache II<17 Apache II≥17 suPAR ≥12 suPAR ≥12 ”validated” in a Swedish cohort
  20. 20. Mortality% 0 10 20 30 40 i ii iii iv suPAR ≥12 suPAR ≥12 the high mortality in stratum (ii) may be due to small number of patients in this group (n = 21) and chance variations in mortality. Apart from that aberration, the findings validate those from the larger Greek study ”validated” in a Swedish cohort
  21. 21. ”this strong discriminative prognostic score developed in Greek patients was validated in a cohort of Swedish patients” ”There is no doubt that suPAR has strong prognostic value in ICU patients. However, in many cases this knowledge may not lead to lifesaving interventions, as limited treatment options are efficient in severely ill sepsis patients”
  22. 22. Prediction of 30 day mortality compared to Danish Emergency Process Triage
  23. 23. Agreement in 55% of cases ”additional biomarkers other than CT are needed" ”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”
  24. 24. ”we acknowledge the editorial and statistical contribution of Leslie S. Prichep, PhD”
  25. 25. A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a therapeutic intervention
  26. 26. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives A surrogate endpoint is a biomarker that is intended to substitute for a clinical endpoint
  27. 27. A clinical endpoint is a characteristic or variable that reflects how a patient feels, functions or survives A surrogate endpoint is a biomarker that is intended to substitute for a critical endpoint
  28. 28. Image: Bengt Nyman SNTF
  29. 29. photo: Michele di Trani So you think you’re in pain?

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