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J Urol ; : The purpose of this guideline is to provide a clinical framework for the diagnosis, evaluation, and follow-up of microhematuria MH. The initial draft evidence report included evidence published from January through February A second search conducted to update the report included studies published up to December Five systematic reviews and 91 primary literature studies met the study selection criteria and were chosen to form the evidence base. These publications were used to create the majority of the clinical framework.
When sufficient evidence existed, the body of evidence for a particular modality was assigned a strength rating of A high , B moderate , or C low ; and evidence-based statements of Strong, Moderate, or Conditional Recommendation were developed.
Additional information is provided as Clinical Principles and Expert Opinions when insufficient evidence existed. See text and algorithm for definitions and detailed diagnostic, evaluation, and follow-up information. Clinicians should not define microhematuria by positive dipstick testing alone. A positive urine dipstick test trace blood or greater should prompt formal microscopic evaluation of the urine.
In patients with microhematuria, clinicians should perform a history and physical examination to assess risk factors for genitourinary malignancy, medical renal disease, gynecologic and non-malignant genitourinary causes of microhematuria. Clinical Principle. Clinicians should perform the same evaluation of patients with microhematuria who are taking antiplatelet agents or anticoagulants regardless of the type or level of therapy as patients not on these agents.
In patients with findings suggestive of a gynecologic or non-malignant urologic etiology, clinicians should evaluate the patients with appropriate physical examination techniques and tests to identify such an etiology. In patients diagnosed with gynecologic or non-malignant genitourinary sources of microhematuria, clinicians should repeat urinalysis following resolution of the gynecologic or non-malignant genitourinary cause.
If microhematuria persists or the etiology cannot be identified, clinicians should perform risk-based urologic evaluation. In patients with hematuria attributed to a urinary tract infection, clinicians should obtain a urinalysis with microscopic evaluation following treatment to ensure resolution of the hematuria. Clinicians should refer patients with microhematuria for nephrologic evaluation if medical renal disease is suspected.
However, risk-based urologic evaluation should still be performed. Following initial evaluation, clinicians should categorize patients presenting with microhematuria as low-, intermediate-, or high-risk for genitourinary malignancy based on the accompanying tables Tables 3 and 4. In low-risk patients with microhematuria, clinicians should engage patients in shared decision-making to decide between repeating urinalysis within six months or proceeding with cystoscopy and renal ultrasound.
Low-risk patients who initially elected not to undergo cystoscopy or upper tract imaging and who are found to have microhematuria on repeat urine testing should be reclassified as intermediate- or high-risk.
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. Clinicians should perform cystoscopy and renal ultrasound in patients with microhematuria categorized as intermediate-risk for malignancy.
Clinicians should perform cystoscopy and axial upper tract imaging in patients with microhematuria categorized as high-risk for malignancy. Clinicians should perform white light cystoscopy in patients undergoing evaluation of the bladder for microhematuria. In patients with persistent or recurrent microhematuria previously evaluated with renal ultrasound, clinicians may perform additional imaging of the urinary tract. In patients with microhematuria who have a family history of renal cell carcinoma or a known genetic renal tumor syndrome, clinicians should perform upper tract imaging regardless of risk category.
Expert Opinion. Clinicians should not use urine cytology or urine-based tumor markers in the initial evaluation of patients with microhematuria.
Clinicians may obtain urine cytology for patients with persistent microhematuria after a negative workup who have irritative voiding symptoms or risk factors for carcinoma in situ. In patients with a negative hematuria evaluation, clinicians may obtain a repeat urinalysis within 12 months. For patients with a prior negative hematuria evaluation and subsequent negative urinalysis, clinicians may discontinue further evaluation for microhematuria.
For patients with a prior negative hematuria evaluation who have persistent or recurrent microhematuria at the time of repeat urinalysis, clinicians should engage in shared decision-making regarding need for additional evaluation. For patients with a prior negative hematuria evaluation who develop gross hematuria, significant increase in degree of microhematuria, or new urologic symptoms, clinicians should initiate further evaluation.
Urologic etiologies for hematuria include malignancy, infection, inflammation, calculus disease, benign prostatic hyperplasia BPH , and congenital or acquired anatomic abnormalities.
When considering the risk of malignancy in patients with hematuria, a recent prospective observational study of over 3, patients referred for evaluation of hematuria noted a While most experts agree that patients with GH should be evaluated with cystoscopy, upper tract imaging and urinary cytology, significant variability exists across current guidelines and consensus statements regarding MH, particularly the definition of MH, criteria for evaluation, as well as the appropriate components of the evaluation, including the optimal imaging modality.
Indeed, the principal goal of the Guideline was to minimize the likelihood of missing a malignancy diagnosis. At the same time, practice-pattern assessments have demonstrated significant inconsistencies in the evaluation of patients presenting with hematuria. Women with hematuria have been especially prone to delays in evaluation, often due to practitioners ascribing hematuria to a urinary tract infection UTI or gynecologic source, resulting in inadequate evaluation and delay in cancer diagnosis.
As such, the need exists to develop and disseminate clear guideline recommendations for evaluation of hematuria that limit the unnecessary risks and costs associated with the over-evaluation of patients who are at low risk for malignancy, while at the same time addressing the delays in diagnosis of important urologic conditions caused by widespread under-evaluation and variations in care.
In the process, it is recognized that tailoring the intensity of evaluation to patient risk, as opposed to recommending intensive evaluation for every patient irrespective of harms and costs, will inevitably introduce the potential for some missed cancers. Nonetheless, the proposed approach seeks to optimize the balance of detection and risk at both the patient and health system level. In addition, the Panel aims to put forth an actionable set of recommendations that will facilitate standardization in order to minimize unnecessary variations and the risk of under-evaluation and delayed diagnosis of important urologic conditions.
The recommendations herein, based on analysis of the best available evidence, represent a patient-centered approach by maximizing the opportunities to diagnose important urologic conditions in a timely fashion, while avoiding unnecessary evaluations in low-risk patients. The systematic review utilized to inform this guideline was conducted by an independent methodological consultant.
Determination of the guideline scope and review of the final systematic review to inform guideline statements was conducted in conjunction with the MH Panel. Funding of the Panel was provided by the AUA; panel members received no remuneration for their work. A systematic review was conducted to inform on appropriate diagnosis, evaluation, and follow-up in patients with suspected and confirmed MH.
The methodologist, in consultation with the expert panel, developed criteria for inclusion and exclusion of studies based on the Key Questions and the populations, interventions, comparators, and outcomes PICO of interest.
Based on a low volume of studies identified enrolling solely MH patients, studies that enrolled a combination MH and GH population were included in the evidence base. Studies enrolling the two populations were described separately in text and tables. Control articles, which were deemed important and relevant by the Panel, were compared with the draft literature search strategy output, and the final strategy was updated as necessary to capture all control articles.
All hits from the OVID literature search were input into reference management software EndNote X7 , where duplicate citations were removed. Abstracts were reviewed by the methodologist to determine if the study addressed the Key Questions and if the study met study design inclusion criteria. For all research questions, randomized controlled trials RCTs , observational studies, and case-control studies were considered for inclusion in the evidence base.
Studies had to enroll at least 30 patients per study arm. Case series, letters, editorials, in vitro studies, studies conducted in animal models, and studies not published in English were excluded from the evidence base. Full-text review was conducted on studies that passed the abstract screening phase. Studies were compared to the predetermined PICO as outlined below. The dual-review trained the methodologist, who then completed full-time review of the remaining studies. A second search was conducted to update the report to include studies published up to December Data were extracted from all studies that passed full-text review by the methodologist.
All extracted data were audited by an independent auditor. Quality assessment for all retained studies was conducted.
Using this method, studies deemed to be of low quality would not be excluded from the systematic review, but would be retained, and their methodological strengths and weaknesses discussed where relevant. To define an overall study quality rating for each included study, risk of bias as determined by validated study-type specific tools, was paired with additional important quality features.
Additional important quality features, such as study design, comparison type, power of statistical analysis, and sources of funding were extracted for each study. GRADE defines a body of evidence in relation to how confident guideline developers can be that the estimate of effects as reported by that body of evidence is correct.
Evidence is categorized as high, moderate, low, and very low; and assessment is based on the aggregate risk of bias for the evidence base plus limitations introduced as a consequence of inconsistency, indirectness, imprecision, and publication bias across the studies. Upgrading of evidence is possible if the body of evidence indicates a large effect or if confounding would suggest either spurious effects or would reduce the demonstrated effect.
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. To this end, pooling of data was conducted in three areas using RevMan.
For studies that reported raw data on patient factors and their association with malignant diagnosis, unadjusted odds ratios were calculated and pooled using a random-effects Mantel-Haenszel method. Finally, prevalence of both malignant and benign diagnoses in relation to the type of hematuria work-up received by patients were calculated and pooled using a random-effects inverse-variance method.
For all other areas, pooling was determined to be inappropriate based on heterogeneity of population, reference standard, or reported outcomes. 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.
By definition, Grade A evidence is evidence about which the Panel has a high level of certainty, Grade B evidence is evidence about which the Panel has a moderate level of certainty, and Grade C evidence is evidence about which the Panel has a low level of certainty. All three statement types may be supported by any body of evidence strength grade. Body of evidence strength Grade A in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances and that future research is unlikely to change confidence.
Body of evidence strength Grade B in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence could change confidence. Body of evidence strength Grade C in support of a Strong or Moderate Recommendation indicates that the statement can be applied to most patients in most circumstances but that better evidence is likely to change confidence.
Conditional Recommendations also can be supported by any evidence strength. Where gaps in the evidence existed, the Panel provides guidance in the form of Clinical Principles or Expert Opinions with consensus achieved using a modified Delphi technique if differences of opinion emerged.
Expert Opinion refers to a statement, achieved by consensus of the Panel, that is based on members’ clinical training, experience, knowledge, and judgment for which there may or may not be evidence. An integral part of the guideline development process at the AUA is external peer review. The AUA conducted a thorough peer review process to ensure that the document was reviewed by experts in the diagnosis, evaluation, and follow-up of MH. Additionally, a call for reviewers was placed on the AUA website from December , to allow any additional interested parties to request a copy of the document for review.
The draft guideline document was distributed to peer reviewers. All peer review comments were blinded and sent to the Panel for review. In total, 66 reviewers provided comments, including 51 external reviewers. At the end of the peer review process, a total of comments were received.
Following comment discussion, the Panel revised the draft as needed. As such, microscopic quantification remains the referent standard for defining hematuria. In a recent study evaluating the correlation between degree of MH and malignancy among a group of over 46, patients, Matulewicz et al.