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Save my name, email, and website in this browser for the next time I comment. Table of Contents. Create a list of references, citations and a bibliography. Insert citations anytime during your writing process. Open the application in Word via the control panel and select the content for importing. Enable the creation of a common space and upload content. The HRI was subsequently validated in a cohort of 3, women undergoing evaluation of hematuria, with urologic cancer identified in 0.
Meanwhile, a separate model, the Haematuria Cancer Risk Score HCRS was developed based on a multivariable analysis of 3, patients evaluated in UK hospitals and externally validated in a cohort of Swiss patients. The Panel acknowledges that Grade A evidence does not support stratification as affecting clinical outcomes or survival. Nevertheless, the Panel believes that there is value to creating categories to broadly estimate the likelihood of an underlying malignant diagnosis in order to facilitate patient-centered testing strategies across the heterogeneous population with hematuria.
This risk grouping system is intended as a simple tool for application in clinical practice as a general framework to support patient counseling and diagnostic testing decisions. To develop the risk groupings, the Panel first defined characteristics associated with the lowest and highest risk for urinary tract malignancy.
Numerous clinical and demographic factors were incorporated as well into the grouping system, with each placed into a category based on unanimous expert consensus and available published data. For example, the substantially increased risk of malignant diagnosis in patients with a history of GH, compared to MH, has been described in numerous reports. Other forms of tobacco exposure, such as cigars, chewing tobacco and vaporized tobacco products, may also pose a risk for bladder cancer, although the data to date are less robust.
Unique to the AUA Guideline Risk Stratification System is the incorporation of age-specific thresholds for men and women, drawing on observations across the literature of relatively greater risks for male patients at younger ages than their female counterparts.
With respect to tobacco exposure, this system incorporates considerations of duration and intensity of tobacco exposure, in accord with standards from the cancer screening literature. Finally, the AUA Guideline Risk Stratification System explicitly incorporates recognized risk factors for urothelial cancer Table 3 into the considerations for recommending diagnostic evaluation. The Panel also appreciates that the intermediate-risk group is somewhat heterogeneous, and the outcomes of patients within this group may still exhibit some variation along the spectrum of risk of urinary tract malignancy.
Ultimately, the Panel recognizes the need for prospective validation of these risk groups in large, contemporary patient cohorts in order to further refine performance for identifying underlying urinary tract malignancy. The Panel acknowledges that the overall rate of urologic malignancy among patients with MH is low, 14 and that the likelihood of diagnosing malignancy in a patient with MH is related to the presence or absence of established cancer risk factors.
Limited evidence exists regarding the benefits and risks of evaluating patients at low risk for urologic malignancy with imaging and cystoscopy. The literature review highlighted the low rate of urologic malignancy in patients presenting with MH, with a reported incidence of 0 to 6.
Meanwhile, a Samson et al. For low-risk patients in particular, the likelihood of upper tract malignancy is exceedingly low. This low risk of diagnosing a malignancy must be balanced against the potential harms of obtaining imaging, including the implications of false positive detection. Nevertheless, it should be recognized that some extra-urinary findings may be clinically relevant. Nonetheless, these conditions usually present with associated symptoms or signs to prompt a symptom-directed evaluation.
Therefore, cystoscopy may not be mandated to identify benign conditions in otherwise asymptomatic patients at low risk for malignancy. Therefore, the Panel believes that for low-risk MH patients, clinicians should discuss cystoscopy and imaging with renal ultrasound as options for evaluation, but should also review the option to repeat UA, with a plan to escalate to cystoscopy and imaging if the MH is found to persist.
The Panel recognizes that many factors will be a part of this shared decision-making process, including patient preferences and risk tolerance.
At the same time, the Panel advises that if an initial evaluation is not undertaken, recheck of the UA for persistence of MH should take place. While the Panel recognizes the absence of robust data to prescribe a specific timing of the repeat UA in this setting and acknowledges that patient preferences and risk factors will be incorporated with clinical discretion to guide the process, the Panel would recommend that repeat UA be performed within six months in order to limit the delay in diagnosis of curable malignancy should an underlying cancer be present.
In such patients, clinicians should perform cystoscopy and upper tract imaging in accordance with recommendations for these risk strata. In low-risk patients who do not undergo initial evaluation, the Panel does recommend repeat UA to evaluate for the resolution versus persistence of MH.
In one large study, patients who had persistent MH on repeat urine testing had a higher rate of malignancy on subsequent evaluation as compared with those who had negative repeat urine testing. According to the risk stratification schema previously presented, patients with persistent MH are classified as either intermediate or high risk for malignancy, in part dependent upon the degree of MH at the repeat UA Table 4. The goal of upper tract imaging in MH patients is to identify malignancies of the renal parenchyma and upper tract urothelium, as well as to identify actionable non-malignant diagnoses of the kidney, collecting system, and ureters.
The choice of imaging modality involves tradeoffs between diagnostic accuracy versus risk. The Panel believes that the role of cystoscopy and upper tract imaging in the evaluation of the MH patient may be refined by using the proposed risk stratification structure. Studies of MH patients have consistently demonstrated that when a urologic malignancy is detected during evaluation, the most frequent cancer found is bladder cancer. Regarding the choice of upper tract imaging, CT urography provides excellent delineation of the excretory urinary tract, is very sensitive for urinary stones, readily identifies renal cortical lesions, and provides extra-urinary information as well.
Renal ultrasound is relatively less expensive, does not involve ionizing radiation, and has reasonable discrimination for cortical lesions. At the same time, cystoscopy represents a critical component of the MH evaluation given the limited sensitivity of CT and ultrasound for identifying bladder cancer.
Notably, given the overall population-level prevalence of MH, healthcare resource allocation is impacted by the choice of imaging to evaluate these patients.
Indeed, Halpern et al. Meanwhile, a recent modeling study determined that for a cohort of , patients with hematuria, 17 there would be a total of 93 patients with UTUC 0. This study concluded that while the less intense evaluation e.
As previously stated, cystoscopy represents a critical component of the MH evaluation because imaging with CT urogram or ultrasound has limited sensitivity for identifying bladder cancer. The Panel concluded that patients who meet the high-risk criteria are at a sufficient risk for harboring a diagnosis of urothelial cancer to also warrant multiphasic cross-sectional imaging to evaluate both the renal parenchyma and the urothelium, using CT urography if there are no contraindications to its use.
Of note, while multiple protocols fall under the moniker of CT urography, the overall intent of these studies is to provide unenhanced and enhanced views of the kidneys to identify renal cortical tumors and determine whether they enhance; and to provide delayed views of the renal collecting systems and ureters in order to identify upper tract urothelial tumors.
A host of additional urinary tract and extra-urinary findings may also be identified, including urinary lithiasis and anatomic abnormalities.
Given the range of options available for evaluation of the renal parenchyma and upper tract urothelium with CT and the absence of strong evidence to support one technique over another, the Panel recommends using a protocol that optimizes imaging performance characteristics while minimizing radiation exposure. While there is not to date a single practiced standardized dose reduction strategy, options include split bolus protocols and radiation dosage adjustment for body mass index BMI.
Contraindications to contrast-enhanced CT include chronic kidney disease and allergy to iodine-based contrast. In such patients, the Panel recommends magnetic resonance MR urography as an alternative imaging modality. Pregnant patients constitute a unique population for which there are little data for guidance. Since few pregnant patients will fall into the high risk group, the Panel recommends initially obtaining renal ultrasonography for MH during pregnancy, with consideration of multiphasic CT or MR urography after delivery.
MR urography has adequate sensitivity for renal cortical tumors and upper tract urothelial tumors, but lower sensitivity for nephrolithiasis. In addition, contraindications to MR urography include metal implants and claustrophobia. Of note, NSF was initially described in patients with poor renal function receiving gadolinium for MRI studies; however, contemporary rates of NSF have decreased, likely due to awareness of the risk and the development of newer gadolinium-based contrast agents.
Moreover, it should be acknowledged that MRI has a lower detection rate than CT for the detection of stone disease. For patients with contraindications to CT and MR urography, imaging of the renal cortex may be achieved with either non-contrast CT or renal ultrasound to assess the renal cortex and retrograde pyelography RPG to assess the urothelium. Nevertheless, BLC studies to date have been reported among patients with bladder cancer rather than MH cohorts being screened for bladder cancer.
As such, the generalizability of this approach to MH patients remains uncertain. In addition, the available studies have noted a somewhat reduced specificity for BLC compared with WLC, which in turn could lead to an increased rate of unnecessary biopsy. Moreover, BLC involves additional cost and time expenditure, and has not been widely validated for flexible cystoscopy. Thus, given the lack of evidence supporting a role for enhanced cystoscopy to evaluate MH patients in the absence of an established bladder cancer diagnosis, the Panel concludes that WLC should be utilized in the evaluation of MH.
While renal ultrasound provides an evaluation of the renal cortex, the sensitivity of this modality for detecting ureteral pathology, in particular UTUC, is diminished. Nevertheless, in these cases, clinicians may choose to obtain further imaging to include delineation of the urothelium such as CT urography, MR urography, or RPG. As insufficient evidence exists regarding the preferred modality in this scenario, the choice of imaging remains at provider discretion.
The Panel does not recommend using urine cytology or urine-based tumor markers in the initial evaluation of MH since insufficient evidence exists that routine use would improve detection of bladder cancer. Indeed, to demonstrate that a marker would provide incrementally additive information to cystoscopy, future studies will need to show that a meaningful number of cancers would be found in patients where cystoscopy was normal and a biomarker was positive.
Currently, such data do not exist, and, in fact, limited data exist to support an additive clinical benefit of cytology or urine markers in patients undergoing cystoscopy to detect bladder cancer. For example, a prospective study of 2, patients evaluated the added benefit of obtaining cytology during the initial evaluation of MH. In addition, there are costs associated with the Likewise, a study of urine cytology obtained from patients noted that a positive cytology detected urothelial carcinoma in only 4 patients with normal cystoscopy, of whom 2 had CIS and 2 had upper tract disease.
Moreover, no bladder cancer or UTUC was diagnosed based on a suspicious urinary cytology test alone. Twenty-two patients had a positive urinary cytology result despite a normal cystoscopy and upper tract imaging. Twelve patients Five patients Collectively, therefore, data to date indicate that cytology rarely identifies cancer in the setting of normal cystoscopy and imaging. One area for which cytology may have a role is in improving detection of CIS.
Similarly, while urine markers have been evaluated in conjunction with cystoscopy in the hematuria setting, studies have not evaluated the likelihood of cancer in the setting of a normal cystoscopy.
A systematic review with meta-analysis assessed the diagnostic test characteristics of FDA-approved urinary biomarker assays for detection of bladder cancer.
A concern regarding these studies is the lack of a true comparative analysis of markers, as in several cases the series represent case-control studies. The strength of the body of evidence underpinning the use of urine-based tumor markers was graded Level C.
The aggregate risk of bias across all included studies was critical, and in addition the evidence was downgraded for inconsistency of results. A further limitation of the studies is a lack of evaluation concerning whether these markers add information independent of the cystoscopy itself. An important component of the current guideline is to offer a risk-stratified approach to the type and intensity of evaluation for patients with MH.
To date, few studies have evaluated the role of markers to improve risk stratification, and the strength of evidence of these few studies remains insufficient to recommend them currently. The potential future role for markers in risk stratification is addressed in Future Directions. The decision to follow patients after completion of a negative hematuria evaluation represents a balance of various considerations.
Relevant factors include the potential to subsequently detect a previously undiagnosed urologic malignancy or clinically significant urologic condition, as well as the potential to detect a malignancy or clinically significant urologic condition that the patient develops following initial hematuria evaluation.
In addition, clinicians may be concerned about dismissing a patient from care, including worries over medicolegal implications. These putative benefits must be contextualized, however, with the repeated anxiety and inconvenience to the patient of continued monitoring, as well as the increased costs to the healthcare system of additional investigation.
Importantly, moreover, the very limited diagnostic yield of repeated evaluations noted to date from studies of patients followed after a negative hematuria evaluation must also be recognized.
Indeed, among patients who underwent repeat CT urogram within three years after prior CT urogram, none of the patients whose initial scan was without suspicious findings demonstrated malignancy on the second imaging study, while among the 45 patients with suspicious initial CT urogram findings, 4 malignancies were diagnosed, 3 of which were in fact incidental to the initial suspicious finding.
A repeat UA represents an initial, non-invasive modality for continued monitoring. To avoid prolonged delays if an undiagnosed malignancy were present, the Panel offers that this subsequent UA be performed within 12 months of the initial evaluation. Patients with a negative follow-up UA may be discharged from further hematuria evaluation given the very low risk of malignancy, while patients with persistent MH merit shared decision-making regarding next steps in care.
Specifically, given the associations noted between the presence of GH, 4,22,23,,66,, higher degrees of MH, 13,76,78 and urologic symptoms 22,69 with the diagnosis of malignancy or clinically significant benign conditions, presentation with any of these should merit further evaluation. Nevertheless, the low overall risk of malignancy in this population must again be acknowledged; therefore, a uniform approach to investigation in this setting cannot be mandated.
The goal of this guideline is to improve the evaluation and management of patients with hematuria. Due to the combination of a relatively high prevalence of MH in the adult population with a low likelihood of identifying clinically-significant disease, this guideline aims to provide a risk-based framework for testing.
Moreover, it is recognized that many patients with hematuria are not currently undergoing evaluation, and thus another goal of risk-based recommendations is to improve utilization of the guideline by patients and clinicians.
Nevertheless, the Panel recognizes the paucity of high-level supporting evidence for the guideline statements, and acknowledges several notable areas where gaps in knowledge exist, which represent opportunities for future investigation to meaningfully enhance care.
For example, new automated instruments, based either on flow cytometry or digitized microscopy, are increasingly utilized to perform UA. One area of particular importance for additional study will be to validate the risk groups that have been outlined herein. Specifically, it remains to be determined whether these current divisions between risk groups accurately reflect differences in cancer risk.
Ideally, large prospective cohort studies will form the basis for such validation. Moreover, the current risk stratification focuses primarily on risk factors for urothelial cancer. That is, smoking, obesity, hypertension, and chronic kidney disease represent established risk factors for RCC, of which only smoking is represented in current risk stratification.
The potential benefits of reducing exposure to radiation and contrast agents with attendant risk of renal issues and allergies and decreasing healthcare cost are substantial; 17,18,94 however, there exists the risk with this approach of missing small renal masses, upper tract urothelial cancers, and small stones. Another topic that merits continued investigation is the potential role of urinary biomarkers in the evaluation of patients with MH. Urothelial cancers are in contact with the urine, and this fact has been utilized to evaluate the differential expression of proteins, RNA, DNA, and changes in methylation and cells among patients with malignant and benign conditions.
There are multiple markers currently available and in development to help with detection of bladder cancer in hematuria patients. While there is insufficient evidence to recommend use of these markers routinely in the evaluation of patients with MH, the potential exists for these markers to improve risk stratification over the clinical variables put forth herein, and thereby improve an individualized approach to MH evaluation.
For example, biomarkers may in the future be used to calculate a pre-test probability of finding urothelial carcinoma, which may in turn guide the intensity of subsequent evaluation. In order to adopt a risk-stratified approach incorporating markers, future studies will be necessary to determine if urine markers improve risk stratification.
A prospective randomized trial is currently open that randomizes patients based on clinical risk and marker status NCT Patients in the marker arm will have a clinical risk stratification, such that patients with low clinical risk and a negative marker will not have cystoscopy but follow-up only, while those with a positive marker or higher risk based on clinical factors will undergo a standard evaluation with cystoscopy.
This marker-based approach will be compared to a standard evaluation in the control arm. Such randomized trials will provide the strength of evidence needed to establish a role for markers in patients with hematuria. Another area worthy of further evaluation is whether enhanced cystoscopy has a role in the detection of bladder cancer among patients with hematuria. However, there is insufficient evidence with regard to the role of enhanced cystoscopy in hematuria patients without an established bladder cancer diagnosis.
Opportunities to reduce radiation exposure with imaging represents another ongoing focus of investigation. The natural history — and, as an extension, the recommended follow-up — of patients with hematuria following a completed, negative evaluation also represents a relevant topic for future study. Many patients with MH will have persistent findings of microscopic blood — likely due to benign causes that may or may not be recognized — and the optimal approach to these patients has not been established.
Continued evaluations risk patient anxiety as well as potentially unnecessary resource allocation. These concerns are likewise relevant for low-risk patients who initially choose surveillance rather than evaluation. Hematuria is a highly prevalent condition, impacting a large population whose evaluation is managed by a wide variety of practitioners.
The impact of this guideline on intensity and frequency of evaluation will need to be studied to determine if the utilization of recommendations has improved. While viewing Guideline Statements on a desktop computer, use the left navigation to jump to different parts of the page.
Standard Operating Procedures Overview. COI Disclosure. Purpose The purpose of this guideline is to provide a clinical framework for the diagnosis, evaluation, and follow-up of microhematuria MH.
Guideline Statements Diagnosis and Definition of Microhematuria 1. Clinical Principle 4. Clinical Principle 6.
Clinical Principle 7. Clinical Principle Risk Stratification 9. In such patients, clinicians should perform cystoscopy and upper tract imaging in accordance with recommendations for these risk strata Strong Recommendation; Evidence Level: Grade C Intermediate-Risk Moderate Recommendation; Evidence Level: Grade C If there are contraindications to multiphasic CT urography and MR urography, clinicians may utilize retrograde pyelography in conjunction with non-contrast axial imaging or renal ultrasound.
Expert Opinion Expert Opinion Urinary Markers Expert Opinion Follow-Up Methodolgy The systematic review utilized to inform this guideline was conducted by an independent methodological consultant. Searches and Article Selection A systematic review was conducted to inform on appropriate diagnosis, evaluation, and follow-up in patients with suspected and confirmed MH.
Data Abstraction Data were extracted from all studies that passed full-text review by the methodologist. Risk of Bias Assessment Quality assessment for all retained studies was conducted. Data Synthesis One of the main objectives for the guideline is to establish a risk model to stratify patients based on their risk for underlying urologic malignancy. Determination of Evidence Strength The AUA employs a three-tiered strength of evidence system to underpin evidence-based guideline statements.
Table 1 The AUA categorizes body of evidence strength as Grade A well-conducted and highly-generalizable RCTs or exceptionally strong observational studies with consistent findings , Grade B RCTs with some weaknesses of procedure or generalizability or moderately strong observational studies with consistent findings , or Grade C RCTs with serious deficiencies of procedure or generalizability or extremely small sample sizes or observational studies that are inconsistent, have small sample sizes, or have other problems that potentially confound interpretation of data.
Proper Sample Collection For most initial evaluations, a random midstream clean-catch collection is sufficient. Analytic Technique Analytic techniques vary, with some now using flow cytometry rather than microscopy. Guideline Statement 3 3. Patient-centered approach to diagnostic evaluation The Panel recognizes that patients presenting with hematuria represent a heterogeneous population with a broad spectrum of risk for underlying malignant causes based on clinical and demographic features. Risk Stratification Several risk stratification models have been described from cohorts of patients undergoing evaluation of hematuria.
Guideline Statement 10 Guideline Statement 11 Guideline Statement 12 Guideline Statement 13 Mariani AJ, Mariani MC, Macchioni C et al: The significance of adult hematuria: 1, hematuria evaluations including a risk-benefit and cost-effectiveness analysis.
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Urology ; 55 JAMA ; Henning A, Wehrberger M, Madersbacker S et al: Do differences in clinical symptoms and referral patterns contribute to the gender gap in bladder cancer? BJU Int ; Am J Med ; J Am Soc Nephrol ; 25 : Paper 5: a qualitative study with experts suggests that test accuracy data alone is rarely sufficient for decision making.
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