Prostate Specific Antigen Assay Standardization Bias Could Affect Clinical Decision Making

Background Prostate-specific antigen is the biochemical gold standard for the (early) detection and monitoring of prostate cancer. Interpretation of prostate-specific antigen is both dependent on the method and cut-off. The aim of this study was to examine the effect of method-specific differences and cut-off values in a national external quality assessment scheme (EQAS). Methods The Dutch EQAS for prostate-specific antigen comprised an annual distribution of 12 control materials. The results of two distributions were combined with the corresponding cut-off value. Differences between methods were quantified by simple linear regression based on the all laboratory trimmed mean. To assess the clinical consequence of method-specific differences and cut-off values, a clinical data-set of 1040 patients with an initial prostate-specific antigen measurement and concomitant conclusive prostate biopsy was retrospectively collected. Sensitivity and specificity for prostate cancer were calculated for all EQAS participants individually. Results In the Netherlands, seven different prostate-specific antigen methods are used. Interestingly, 67% of these laboratories apply age-specific cut-off values. Methods showed a maximal relative difference of 26%, which were not reflected in the cut-off values. The largest differences were caused by the type of cut-off, for example in the Roche group the cut-off value differed maximal 217%. Clinically, a fixed prostate-specific antigen cut-off has a higher sensitivity than an age-specific cut-off (mean 89% range 86–93% versus 79% range 63–95%, respectively). Conclusions This study shows that the differences in cut-off values exceed the method-specific differences. These results emphasize the need for (inter)national harmonization/standardization programmes including cut-off values to allow for laboratory-independent clinical decision-making.

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The Clinical Applications of Serum and Urinary Biomarkers in Prostate Cancer

Société Internationale d’Urologie Journal ◽

10.48083/kdck6642 ◽

2020 ◽

Vol 1 (1) ◽

pp. 30-38

Author(s):

Renu S Eapen ◽

Peter E Lonergan ◽

Dominic Bagguley ◽

Sean Ong ◽

Ben Condon ◽

...

Keyword(s):

Prostate Cancer ◽

Decision Making ◽

Clinical Decision Making ◽

Clinical Care ◽

Clinical Stage ◽

Specific Antigen ◽

Clinical Decision ◽

Urine Biomarkers ◽

Clinical Scenarios ◽

Risk Prognosis

At every stage of the prostate cancer journey from screening and diagnosis to management of advanced disease, patients and clinicians face dilemmas and decisions that can impact long-term outcomes. Although traditional risk stratification in prostate cancer is based on serum prostate specific antigen, clinical stage and Gleason score, in recent years, biomarkers have been developed that may be useful in several clinical scenarios. Biomarkers that can accurately predict an individual patient’s risk, prognosis, and response to specific treatments could lead to improvements in decision-making and clinical care. Although there is evidence to support the use of biomarkers to guide management decisions, the optimal scenario in which to use them, how to interpret the results, and how to incorporate those results into clinical decision-making can be confusing. Nevertheless, in the era of personalized and precision medicine, it is important for clinicians to be aware of what tests are available, what clinical questions they seek to answer, and what limitations they have. This review focuses on the serum and urine biomarkers for the management of prostate cancer that have been under intense investigation in recent years.

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Clinical Decision Making and Oral Motor Treatments

ASHA Leader ◽

10.1044/leader.ftr3.10082005.8 ◽

2005 ◽

Vol 10 (8) ◽

pp. 8-35 ◽

Cited By ~ 9

Author(s):

Heather M. Clark

Keyword(s):

Decision Making ◽

Clinical Decision Making ◽

Clinical Decision ◽

Oral Motor

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Debates in Dysphagia Management: How Do You Use Evidence-Based Practice in Your Dysphagia Patient Care?

Perspectives on Swallowing and Swallowing Disorders (Dysphagia) ◽

10.1044/sasd20.4.121 ◽

2011 ◽

Vol 20 (4) ◽

pp. 121-123

Author(s):

Jeri A. Logemann

Keyword(s):

Decision Making ◽

Patient Care ◽

Clinical Outcomes ◽

Clinical Judgment ◽

Clinical Decision Making ◽

Evidence Based Practice ◽

Clinical Decision ◽

Evidence Based ◽

Clinical Method ◽

Do So

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.

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