Analytical performance goals for measuring prostate-specific antigen

1993 ◽  
Vol 39 (7) ◽  
pp. 1525-1529 ◽  
Author(s):  
H A Fritsche ◽  
R J Babaian
Keyword(s):  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Clinical Decision ◽  
Clinical Applications ◽  
Analytical Performance ◽  
Performance Goals ◽  
Clinical Use ◽  
Psa Test ◽  
Decision Points ◽  
Medical Relevance

Abstract We have assessed the feasibility of using fixed-limit criteria based on medical relevance and biological variation for evaluating the analytical performance of the prostate-specific antigen (PSA) test. The estimated within-subject variation of serum PSA is on the order of 10-20% at clinical decision points. The calculated performance goals of 5-10% CV are attainable with current immunoassay technology and agree with precision goals based on clinical experience and the current clinical use of the test. However, new clinical applications of PSA may require a degree of analytical performance that current methods may not be able to provide. The PSA model demonstrates the need for biologically based fixed-limit criteria for all tumor-marker tests.

scholarly journals The patient perspective on a first raised PSA test

2015 ◽  
Vol 7 (3) ◽  
pp. 213
Author(s):  
Charis Brown ◽  
Fraser Hodgson ◽  
Zuzana Obertova ◽  
Michael Holmes ◽  
Ross Lawrenson
Keyword(s):  
Prostate Specific Antigen ◽  
Patient Perspective ◽  
Care Pathway ◽  
Specific Antigen ◽  
Digital Rectal Examination ◽  
Patient Experiences ◽  
Test Methods ◽  
Psa Test ◽  
Psa Testing ◽  
General Practices

INTRODUCTION: Approximately 350 000 prostate-specific antigen (PSA) tests are undertaken in New Zealand on a quarter of a million men each year. A number of studies have looked at PSA testing done by general practitioners (GPs) and subsequent outcomes. Few have looked at the patient perspective after a raised PSA result. AIM: To explore patient experiences up to and following a raised PSA test. METHODS: Thirty-one general practices within the Midland region were recruited. Community laboratory databases were used to identify all men with a first raised PSA test during 2010. Questionnaires were sent to these men. RESULTS: One hundred and ninety-four (63%) eligible responses were received from 307 eligible men delivered questionnaires. For 54% of men this was their first PSA test. Most men (66%) identified that their PSA test was initiated by their GP. Forty-three percent of men identified having symptoms at the time of their first raised PSA test. A digital rectal examination (DRE) was performed on 73% of men at the time of the test. Fifty-eight percent of men were referred to see a specialist. Maori men were less likely to be referred after a raised PSA. Of all men referred, 61% received a biopsy. DISCUSSION: PSA testing is predominantly initiated by GPs. We found the care pathway is variable for men after an elevated PSA result. Standardisation of the pathway prior to and post diagnosis would assist patients in knowing what to expect and would aid in GP management of men being investigated for prostate cancer. KEYWORDS: Patient care; prostate-specific antigen; screening, opportunistic

scholarly journals Patient Provider Continuity and Prostate Specific Antigen Testing: Impact of Continuity on Receipt of a Non-recommended Test

2021 ◽  
Vol 8 ◽  
Author(s):  
Arch G. Mainous ◽  
Benjamin J. Rooks ◽  
Elvira S. Mercado ◽  
Peter J. Carek
Keyword(s):  
Prostate Specific Antigen ◽  
Continuity Of Care ◽  
Specific Antigen ◽  
Behavioral Risk ◽  
Psa Test ◽  
Advantages And Disadvantages ◽  
Psa Screening ◽  
Personal Doctor ◽  
Nationally Representative ◽  
To Receive

Background: Continuity of care with a regular physician has been associated with treatment adherence but it is unclear if continuity of care may lead to inappropriate treatments. We assessed the relationship between the receipt of prostate-specific antigen (PSA) screening, a non-recommended test, and having continuity with a single personal doctor.Methods: We analyzed the 2016 and 2018 Behavioral Risk Factor Surveillance System (BRFSS). Responses from men aged 40 and older with no symptoms or family history of prostate cancer were analyzed (unweighted n = 232,548, representing 36,919,766 individuals). Continuity with one doctor was analyzed in relation to discussions of advantages and disadvantages of PSA tests, provider recommendation to receive a test and receipt of a PSA test.Results: 39.5% of men received PSA screening during the time that the test was not recommended. Having a single personal doctor was associated with discussion of both advantages (53.3 vs. 29.7%, p < 0.001) and disadvantages (24.2 vs. 13.5%, p < 0.001) of PSA tests but also a recommendation to receive a PSA test (45.3 vs. 29.3%, p < 0.001). The adjusted odds of receiving a PSA test was higher among those with a single personal doctor compared to those without (OR 2.31; 95% CI, 2.17–2.46).Conclusion: In a nationally representative sample during the time when PSA screening was not recommended by the US Preventive Services Taskforce, having a single personal doctor was associated with both recommendations for the test and receipt of the test. These findings emphasize the importance of the patient physician relationship and the need for evidence-based care.

scholarly journals Assessing Preference Shift and Effects on Patient Knowledge and Decisional Conflict: Cross-Sectional Study of an Interactive Prostate-Specific Antigen Test Patient Decision Aid (Preprint)

2018 ◽  
Author(s):  
Peter Scalia ◽  
Glyn Elwyn ◽  
Jan Kremer ◽  
Marjan Faber ◽  
Marie-Anne Durand
Keyword(s):  
Prostate Specific Antigen ◽  
Decision Aid ◽  
Specific Antigen ◽  
Decisional Conflict ◽  
Patient Decision Aid ◽  
Web Based ◽  
Psa Test ◽  
Psa Testing ◽  
Patient Decision ◽  
The Web

BACKGROUND Randomized trials of Web-based decision aids for prostate-specific antigen (PSA) testing indicate that these interventions improve knowledge and reduce decisional conflict. However, we do not know about these tools’ impact on people who spontaneously use a PSA testing patient decision aid on the internet. OBJECTIVE The objectives of this study were to (1) determine the impact of the Web-based PSA Option Grid patient decision aid on preference shift, knowledge, and decisional conflict; (2) identify which frequently asked questions (FAQs) are associated with preference shift; and (3) explore the possible relationships between these outcomes. METHODS Data were collected between January 1, 2016, and December 30, 2017. Users who accessed the Web-based, interactive PSA Option Grid were provided with 3 options: have a PSA test, no PSA test, or unsure. Users first declared their initial preference and then completed 5 knowledge questions and a 4-item (yes or no) validated decisional conflict scale (Sure of myself, Understand information, Risk-benefit ratio, Encouragement; SURE). Next, users were presented with 10 FAQs and asked to identify their preference for each question based on the information provided. At the end, users declared their final preference and completed the same knowledge and decisional conflict questions. Paired sample t tests were employed to compare before and after knowledge and decisional conflict scores. A multinomial regression analysis was performed to determine which FAQs were associated with a shift in screening preference. RESULTS Of all the people who accessed the PSA Option Grid, 39.8% (186/467) completed the interactive journey and associated surveys. After excluding 22 female users, we analyzed 164 responses. At completion, users shifted their preference to “not having the PSA test” (43/164, 26.2%, vs 117/164, 71.3%; P<.001), had higher levels of knowledge (112/164, 68.3%, vs 146/164, 89.0%; P<.001), and lower decisional conflict (94/164, 57.3%, vs 18/164, 11.0%; P<.001). There were 3 FAQs associated with preference shift: “What does the test involve?” “If my PSA level is high, what are the chances that I have prostate cancer?” and “What are the risks?” We did not find any relationship between knowledge, decisional conflict, and preference shift. CONCLUSIONS Unprompted use of the interactive PSA Option Grid leads to preference shift, increased knowledge, and reduced decisional conflict, which confirms the ability of these tools to influence decision making, even when used outside clinical encounters.

Estimate of population coverage with the prostate specific antigen (PSA) test to screen for prostate cancer in a metropolitan area of northern Italy

2002 ◽  
Vol 9 (4) ◽  
pp. 179-180 ◽  
Author(s):  
A. Russo ◽  
M. Autelitano ◽  
A. Bellini ◽  
L. Bisanti
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Health Information System ◽  
Northern Italy ◽  
Local Health ◽  
Male Population ◽  
High Coverage ◽  
Psa Test ◽  
History Of

The use of the prostate specific antigen (PSA) test in the period 1999–2000 in a population of 311 822 men, aged 40 years or more, resident in Milan, Italy, was examined. Data were drawn from the outpatient database of the local health information system. A total of 139 350 PSA tests were used in 83 943 subjects. Overall, 26.9% of the male population aged 40 or older, with no history of prostate cancer, received a PSA test in the 2 year study period. For subjects older than 50 the rate rose to 34%. Results show a high coverage of the male population in northern Italy with screening using the PSA test for prostate cancer.

On the Clinical Usefulness of the Free-to-Total Prostate-Specific Antigen Ratio

2006 ◽  
Vol 21 (1) ◽  
pp. 1-5 ◽  
Author(s):  
S. Ciatto ◽  
T. Rubeca ◽  
R. Franceschini ◽  
C. Trevisiol ◽  
M. Confortini ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Specific Antigen ◽  
Clinical Usefulness ◽  
Clinical Use ◽  
Prostate Biopsies ◽  
Total Prostate Specific Antigen ◽  
Total Psa

The free-to-total prostate-specific antigen ratio (F/T PSA) is associated with the presence of prostate cancer and is thus used as an indicator for suspicion of prostate cancer and as a determinant for biopsy. We reviewed a recent retrospective series of 966 consecutive prostate biopsies where F/T PSA was blindly determined and did not influence biopsy indication. We simulated the association of F/T PSA with biopsy outcome and its impact as a biopsy determinant. When adopting an F/T PSA cutoff of 10%, 13%, 16% or 20% among random sextant biopsies in the 4–10 ng/mL total PSA range, the sensitivity was 15%, 37%, 55% and 72% and the specificity 89%, 80%, 64% and 44%, respectively. Using F/T PSA as a biopsy determinant, from 1.7 to 2.6 cancer biopsies would have been delayed to avoid 10 benign biopsies. As this balance is not acceptable, F/T PSA has no role as a biopsy indicator and its clinical use is questionable.

Clinical interpretation of prostate-specific antigen values: Type of applied cut-off value exceeds methods bias as the major source of variation

2019 ◽  
Vol 56 (2) ◽  
pp. 259-265 ◽  
Author(s):  
Lieke JJ Klinkenberg ◽  
Eef GWM Lentjes ◽  
Arjen-Kars Boer
Keyword(s):  
Prostate Cancer ◽  
Prostate Specific Antigen ◽  
Clinical Decision Making ◽  
Specific Antigen ◽  
Clinical Decision ◽  
Relative Difference ◽  
Clinical Consequence ◽  
External Quality Assessment Scheme ◽  
Data Set ◽  
Annual Distribution

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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