Asymptomatic Microscopic Hematuria—Rethinking the Diagnostic Algorithm

Subak, Leslee L.; Grady, Deborah

doi:10.1001/jamainternmed.2017.0758

Cited by 14 publications

(9 citation statements)

References 11 publications

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“…Accordingly, routine use of Cxbladder would likely reduce the burden of care for both patients and healthcare systems through the more selective use of invasive procedures, particularly CT scans, without compromising the desire of patients and physicians to achieve direct visualization and identification of any tumor as part of the diagnostic process [ 29 ]. This is consistent with suggestions made by Halpern and colleagues (2017) [ 2 ] regarding the cost-effective use of diagnostic procedures in patients with AMH, while also addressing criticism of the clinical implications of advocating for a blanket replacement of CT scans with ultrasound [ 30 ]. Furthermore, the utility of Cxbladder as a risk assessment tool is likely to be further enhanced by introduction of the Cxbladder Resolve test as a third step for patients with physician-directed protocol result that identifies patients with a high probability of high-grade UC [ 31 ].…”

Section: Discussionsupporting

confidence: 87%

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

Lough¹,

Luo²,

Luxmanan

et al. 2018

BMC Urol

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BackgroundThe 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.MethodsThree 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.ResultsPhysicians 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.ConclusionsThis 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.Electronic supplementary materialThe online version of this article (10.1186/s12894-018-0327-6) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 87%

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

Lough¹,

Luo²,

Luxmanan

et al. 2018

BMC Urol

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“…These aforementioned concerns call for rethinking the diagnostic strategy and to base the evaluation of patients based on risk factors such as age, gender, smoking history or carcinogen exposure [8,9]. Therefore, recent research has focused on biomarkers that can reliably predict which patients with hematuria are at high risk for BC [10].…”

Section: Introductionmentioning

confidence: 99%

Diagnostic Performance of Novel Urine-Based mRNA Tests (Xpert and Urinary Metabolomics Markers Assay) for Bladder Cancer Detection in Patients with Hematuria

Elsawy

Awadalla

Maher

et al. 2020

BLC

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BACKGROUND: Hematuria is the most frequent presenting symptom in the vast majority of bladder cancer (BC) patients. The current recommended evaluation of hematuria includes cross sectional imaging and cystoscopy with possible high negative results, expensive costs and substantial patient burden. OBJECTIVES: To validate novel urine-based mRNA-dependant tests; Xpert test and urinary metabolomics assay (CRAT and SLC 25A20genes expression) for BC detection in patients with hematuria. METHODS: Patients presented with hematuria to our tertiary care hospital were evaluated by CT urogram and office white light cystoscopy with subsequent inpatient biopsy for positive findings. Voided precystoscopy urine samples were prospectively collected. Xpert test, assay of targeted urinary metabolomics and cytology, were performed. The tests characteristics presumably were calculated based on the ability to identify BC noninvasively. RESULTS: Between March 2018 and June 2019, 181 patients were included in the final analysis with mean (±SD) age 62 (±10) years with 168 (92.8%) males. Macroscopic hematuria was encountered in 153 (84.5%) patients with irritative bladder symptoms in 48 (26.5%) patients. BC was confirmed by cystoscopy/biopsy in 36 (19.9%) patients. The performance characteristics of Xpert alone (SN: 73%, SP: 83%, NPV: 92%, PPV: 52%) (AUC 0.84, 95% CI 0.75–0.93, p = 0.001), metabolomics assay alone (SN: 89%, SP: 93%, NPV: 97%, PPV: 78%) (AUC 0.91, 95% CI 0.85–0.98, p < 0.001) and combination of both test results (SN: 66%, SP: 98%, NPV: 92%, PPV: 97%) (AUC 0.83, 95% CI 0.74–0.93, p = 0.001) were notably superior to urine cytology (SN: 30%, SP: 84%, NPV: 83%, PPV: 33%) (AUC 0.58, 95% CI 0.47–0.69, p = 0.154) for BC prediction. Cystoscopy-negative patients (CNP) were followed-up for a median (range) 12 (2–19) months. Re-cystoscopy was done for 35 patients with persistent symptoms. BC was diagnosed in 6 patients. Xpert and urinary metabolomics results were observably positive in those 6 patients. CONCLUSION: Xpert test and assay of urinary metabolomics (CRAT and SLC 25A20 genes expression) have the potential for BC detection in hematuria patients. These non invasive urine based tests can help prioritization of the use of invasive diagnostic tests in systems with long waiting times.

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“…And a number of large studies have found, even with thorough and long-term follow-up, a large proportion of microhematuria cases result in no diagnosis ever being made. 7,8 Lastly, what is the role of routine screening in asymptomatic individuals? The one-time obligatory urinalysis as part of every "yearly checkup"?…”

Section: What 'S the Take Home ?mentioning

confidence: 99%

A 39-Year-Old Man With Microscopic Hematuria

Rubin¹

2022

Consultant

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A 39-year-old man attended a "screening day" sponsored by his workplace. At the event, a nurse practitioner took his medical history; performed a physical examination; drew blood for lipid studies, a complete blood cell panel, and metabolic panel; collected a stool sample for occult blood screening; collected a urine sample for a urinalysis; and conducted an electrocardiography scan.The man's history was wonderfully negative for serious illness. He had no major medical diagnoses or surgical history. He had an administrative white-collar job, regularly went to the gym, and was in good physical shape. His examination findings were entirely within normal limits, including blood pressure (110/70 mmHg) and BMI (22 kg/m 2 ).However, the next day he was given a report and summary of his findings that demonstrated the urinalysis dipstick stained faintly positive for blood. A microscopic urine examination revealed 3 to 5 red blood cells per high power field (RBC/ HPF). Everything else was nonremarkable and within normal limits. The summary prompted him to see a physician for further evaluation of the urine abnormality.

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Asymptomatic Microscopic Hematuria—Rethinking the Diagnostic Algorithm

Cited by 14 publications

References 11 publications

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

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

Diagnostic Performance of Novel Urine-Based mRNA Tests (Xpert and Urinary Metabolomics Markers Assay) for Bladder Cancer Detection in Patients with Hematuria

A 39-Year-Old Man With Microscopic Hematuria

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