Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis

Abstract Background The non-invasive Cxbladder urine test system has demonstrated clinical utility in ruling out urothelial carcinoma (UC) in patients with asymptomatic microscopic hematuria (AMH), suggesting that the number of invasive diagnostic tests, including cystoscopy, used in this patient po...

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Main Authors: Tony Lough, Qingyang Luo, Carthika Luxmanan, Alastair Anderson, Jimmy Suttie, Paul O’Sullivan, David Darling
Format: Article
Language:English
Published: BMC 2018-03-01
Series:BMC Urology
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12894-018-0327-6
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author Tony Lough
Qingyang Luo
Carthika Luxmanan
Alastair Anderson
Jimmy Suttie
Paul O’Sullivan
David Darling
author_facet Tony Lough
Qingyang Luo
Carthika Luxmanan
Alastair Anderson
Jimmy Suttie
Paul O’Sullivan
David Darling
author_sort Tony Lough
collection DOAJ
description Abstract Background The non-invasive Cxbladder urine test system has demonstrated clinical utility in ruling out urothelial carcinoma (UC) in patients with asymptomatic microscopic hematuria (AMH), suggesting that the number of invasive diagnostic tests, including cystoscopy, used in this patient population may be reduced by Cxbladder testing prior to conducting a full urological work-up. The aim of this study was to demonstrate the enhanced clinical utility of communicating objective information on diagnostic decisions made by individual physicians on individual patients with AMH. Methods Three hundred ninety-six physician-patient decisions were generated from twelve participant physicians evaluating real world case notes from the same 33 patients presenting with AMH. Each physician reviewed and recommended diagnostic tests and procedures based on each patient’s referral data and then re-evaluated their clinical recommendation following disclosure of the non-invasive Cxbladder urine test result. Changes assessed were the total number of requested diagnostic procedures and the number of invasive procedures, including cystoscopy, following addition of information from Cxbladder in the Triage and Triage and Detect modalities. Results Physicians made significant changes to their diagnostic behavior for patients with AMH when presented with Cxbladder test results, including a reduction in the number of total and invasive procedures including cystoscopy for individuals identified as having a low probability of UC. The intensity of investigation was targeted and increased, including use of total procedures and cystoscopy, for patients identified by Cxbladder tests as having a high probability of UC: urologists increased the level of investigation for both total procedures and invasive procedures. The outcome resulted in patients with a high risk of UC receiving appropriate guideline-recommended invasive diagnostic tests. Patients who tested negative were offered fewer and significantly less invasive procedures. This change in physician behavior results in an increased clinical and patient utility, lower risk of missed UC and invasive test-related harm incidents. Conclusions This study demonstrated the potential for increased clinical resolution and significantly enhanced patient management, when physicians consider Cxbladder test results in their clinical evaluation. The change in physician behavior led to more appropriate diagnostic procedure selection and resource allocation to the benefit of both patients and healthcare systems.
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spelling doaj.art-0a266c881a9b40fdb3175d5eeea6b9892022-12-22T02:22:38ZengBMCBMC Urology1471-24902018-03-011811910.1186/s12894-018-0327-6Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysisTony Lough0Qingyang Luo1Carthika Luxmanan2Alastair Anderson3Jimmy Suttie4Paul O’Sullivan5David Darling6Pacific Edge LimitedPacific Edge LimitedPacific Edge LimitedPacific Edge LimitedPacific Edge LimitedPacific Edge LimitedPacific Edge LimitedAbstract Background The non-invasive Cxbladder urine test system has demonstrated clinical utility in ruling out urothelial carcinoma (UC) in patients with asymptomatic microscopic hematuria (AMH), suggesting that the number of invasive diagnostic tests, including cystoscopy, used in this patient population may be reduced by Cxbladder testing prior to conducting a full urological work-up. The aim of this study was to demonstrate the enhanced clinical utility of communicating objective information on diagnostic decisions made by individual physicians on individual patients with AMH. Methods Three hundred ninety-six physician-patient decisions were generated from twelve participant physicians evaluating real world case notes from the same 33 patients presenting with AMH. Each physician reviewed and recommended diagnostic tests and procedures based on each patient’s referral data and then re-evaluated their clinical recommendation following disclosure of the non-invasive Cxbladder urine test result. Changes assessed were the total number of requested diagnostic procedures and the number of invasive procedures, including cystoscopy, following addition of information from Cxbladder in the Triage and Triage and Detect modalities. Results Physicians made significant changes to their diagnostic behavior for patients with AMH when presented with Cxbladder test results, including a reduction in the number of total and invasive procedures including cystoscopy for individuals identified as having a low probability of UC. The intensity of investigation was targeted and increased, including use of total procedures and cystoscopy, for patients identified by Cxbladder tests as having a high probability of UC: urologists increased the level of investigation for both total procedures and invasive procedures. The outcome resulted in patients with a high risk of UC receiving appropriate guideline-recommended invasive diagnostic tests. Patients who tested negative were offered fewer and significantly less invasive procedures. This change in physician behavior results in an increased clinical and patient utility, lower risk of missed UC and invasive test-related harm incidents. Conclusions This study demonstrated the potential for increased clinical resolution and significantly enhanced patient management, when physicians consider Cxbladder test results in their clinical evaluation. The change in physician behavior led to more appropriate diagnostic procedure selection and resource allocation to the benefit of both patients and healthcare systems.http://link.springer.com/article/10.1186/s12894-018-0327-6Asymptomatic microscopic hematuriaBiomarkerClinical parametersClinical utilityCystoscopyDiagnostic
spellingShingle Tony Lough
Qingyang Luo
Carthika Luxmanan
Alastair Anderson
Jimmy Suttie
Paul O’Sullivan
David Darling
Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
BMC Urology
Asymptomatic microscopic hematuria
Biomarker
Clinical parameters
Clinical utility
Cystoscopy
Diagnostic
title Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
title_full Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
title_fullStr Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
title_full_unstemmed Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
title_short Clinical utility of a non-invasive urine test for risk assessing patients with no obvious benign cause of hematuria: a physician-patient real world data analysis
title_sort clinical utility of a non invasive urine test for risk assessing patients with no obvious benign cause of hematuria a physician patient real world data analysis
topic Asymptomatic microscopic hematuria
Biomarker
Clinical parameters
Clinical utility
Cystoscopy
Diagnostic
url http://link.springer.com/article/10.1186/s12894-018-0327-6
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