Understanding diagnostic tests 1: sensitivity, specificity and predictive values

Akobeng, Anthony K

doi:10.1111/j.1651-2227.2006.00180.x

Cited by 585 publications

(490 citation statements)

References 9 publications

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“…The ligand-binding assay results were used as the reference standard for calculating measures of test performance, and additional calculations were performed, comparing the ligand-binding and immunohistochemical assays, with progression on tamoxifen (5-year disease-free survival) as the reference standard. 22 …”

Section: Discussionmentioning

confidence: 99%

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

et al. 2016

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Breast cancers are routinely assessed for estrogen receptor status using immunohistochemical assays to assist in patient prognosis and clinical management. Specific assays vary between laboratories, and several antibodies have been validated and recommended for clinical use. As numerous factors can influence assay performance, many laboratories have opted for ready-to-use assays using automated stainers to improve reproducibility and consistency. Three commonly used autostainer vendors-Dako, Leica, and Ventana-all offer such estrogen receptor assays; however, they have never been directly compared. Here, we present a systematic comparison of three platform-specific estrogen receptor ready-to-use assays using a retrospective, tamoxifen-treated, breast cancer cohort from patients who were treated in Calgary, Alberta, Canada from 1985 to 2000. We found all assays showed good intra-observer agreement. Inter-observer pathological scoring showed some variability: Ventana had the strongest agreement followed closely by Dako, whereas Leica only showed substantial agreement. We also analyzed each estrogen receptor assay with respect to 5-year disease-free survival, and found that all performed similarly in univariate and multivariate models. Determination of measures of test performance found that the Leica assay had a lower negative predictive value than Dako or Ventana, compared with the original ligand-binding assay, while other measures-sensitivity, specificity, positive predictive value, and accuracywere comparable between the three ready-to-use assays. When comparing against disease-free survival, the difference in negative predictive value between the vendor assays were not as extreme, but Dako and Ventana still performed slightly better than Leica. Despite some discordance, we found that all ready-to-use assays were comparable with or superior to the ligand-binding assay, endorsing their continued use. Our analysis also allowed for exploration of estrogen receptor-negative, progesterone receptor-positive cases, and we discovered that this phenotype was not consistent across the assays, suggesting this might be an artifact. Endocrine therapy is standard treatment for hormone receptor-positive breast cancers that can improve patient survival. 1-3 Estrogen receptor and progesterone receptor analysis is routinely performed by immunohistochemical assays on breast cancer specimens to classify hormone receptor status and determine patient prognosis and management. [1][2][3][4] Eventually, immunohistochemical-based testing replaced the ligand-binding assay as the standard method for determining hormone receptor status. 5 The switch from ligand-binding assay to immunohistochemistry did not occur at a specific time point, and varied by location and laboratories between the mid-90s and early 2000s. Although estrogen and progesterone receptor are both routinely evaluated, patient management decisions are typically made on the basis of estrogen receptor results alone as the role of progesterone receptor in breast cancer patie...

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Section: Discussionmentioning

confidence: 99%

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

et al. 2016

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“…However, the reported prevalence of HIT is extremely low, less than 0.2-5% in patients receiving heparin 16,27,28 and less than 0.5% in ICU patients, 4,12,19,29 and it should be noted that the negative predictive value of a diagnostic test is higher when the prevalence of the target disease in the population to be tested is lower. 30 The positive predictive value of the 4Ts score was as low as 15.4%, a value less than the previously reported range from 21.4% to 100%. [8][9][10]15,[22][23][24][25][26] The false-positive rate of the 4Ts score (percentage of "4T high score" patients in the non-HIT patients) was 11.8%, a value comparable to those previously reported (0-15.3%).…”

Section: Discussionmentioning

confidence: 46%

Relationship between the 4Ts scoring system and the antiplatelet factor 4/heparin antibodies test in critically ill patients

Matsumura

Nakada

Oda

2013

Acute Medicine & Surgery

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Aim: Heparin-induced thrombocytopenia (HIT) is an adverse drug reaction and potentially progresses to fatal thrombosis. The 4Ts scoring system has been reported as a clinical pretest for HIT. However, its usefulness in critically ill patients has not yet been thoroughly examined. Thus, we evaluated the clinical usefulness of the 4Ts score in the diagnosis of HIT in critically ill patients. Methods:One hundred and four critically ill patients who were admitted to our intensive care unit and who underwent the antiplatelet factor 4/heparin complex antibodies (PF4/heparin Ab) test with suspected HIT were enrolled in the study. The primary endpoint variable was the 4Ts score. The secondary endpoint variables were laboratory data, length of stay, and mortality, compared between thePF4/ heparin Ab positive and negative groups.Results: There was no significant difference in the 4Ts scores between the PF4/heparin Ab positive and negative groups. The positive predictive value (HIT patients/4T high score patients) was 15.4% (2/13), the negative predictive value (non-HIT patients/4T low score patients) was 87.5% (42/48), and the false-negative rate for the 4Ts score (4T low score patients/HIT patients) was as high as 54.5% (6/11). The PF4/heparin Ab positive patients had longer stay in intensive care compared to the PF4/heparin Ab negative patients (P = 0.035). Conclusions:The present study showed the discrepancy between the 4Ts score and PF4/heparin Ab. When HIT is suspected in critically ill patients, an immediate HIT antibody test and initiation of therapeutic management of HIT are required regardless of the 4Ts score.

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“…Mientras que la sensibilidad y la especifi cidad son medidas importantes de la precisión diagnóstica de una prueba, no son de uso práctico en el ámbito clínico, es decir, no ayuda a los médicos en la estimación de la probabilidad de la enfermedad. Para este propósito, el VPP y el VPN tienen una mayor utilidad y son más apropiados 10 . Los resultados de nuestro estudio demostraron que la sensibilidad promedio para cualquier criterio clínico usado en forma aislada fue baja (34%) y disminuyó aún más cuando 2 ó 3 criterios estaban presentes (11 y 6% respectivamente).…”

Section: Discussionunclassified

Rendimiento de la evaluación clínica en el diagnóstico de fractura de huesos propios nasales

et al. 2012

Rev Chil Cir

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Clinical assessment in the diagnosis of bone fractures in patients with nasal trauma Introduction: The aim of this study was to evaluate the performance of clinical assessment in the diagnosis of bone fractures in patients with nasal trauma. Methods: Retrospective review of medical records of 220 patients with nasal trauma treated at the Maxillofacial Surgery Department of Hospital Workers in Santiago was performed. Eight clinical criteria were evaluated: epistaxis, ecchymosis, swelling, nasal injury, airway obstruction, nasal deviation, irregular nasal dorsum, and acute septal injury. The gold standard for diagnosis of nasal fracture was the radiological evaluation. The sensitivity, specifi city, and positive/negative predictive value (PPV/NPV) were calculated for each separate clinical criteria (8), for all possible combinations of 2 clinical criteria (28) and 3 clinical criteria (56). Results: For any of the 8 criteria, the average sensitivity and negative predictive values for nasal fracture was very low (< 35%). However, the specifi city and positive predictive values were relatively high (> 90%) and increased, respectively, when at least one criterion was present (92% and 94% respectively), when 2 clinical criteria were present (98% and 96%, respectively), and when at least 3 clinical criteria were present (100% for both). Conclusion: The presentation of the clinical criteria can be a valuable method for diagnosis of nasal fracture, however, when these clinical criteria are absent, the possibility of nasal fracture cannot be excluded, although the possibility is remote.

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Understanding diagnostic tests 1: sensitivity, specificity and predictive values

Abstract: The usefulness of diagnostic tests,

Cited by 585 publications

References 9 publications

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

Relationship between the 4Ts scoring system and the antiplatelet factor 4/heparin antibodies test in critically ill patients

Rendimiento de la evaluación clínica en el diagnóstico de fractura de huesos propios nasales

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