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      Comparison of the Harms, Advantages, and Costs Associated With Alternative Guidelines for the Evaluation of Hematuria

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          Key Points

          Question

          What are the harms, advantages, and costs associated with alternative guidelines for examining patients with hematuria?

          Findings

          In a microsimulation modeling study of a hypothetical cohort of 100 000 adults with hematuria, uniform computed tomography scanning appeared to be associated with more than 500 secondary cancers from imaging-associated radiation exposure and was approximately twice the cost of alternative approaches.

          Meaning

          The balance of harms, advantages, and costs of hematuria evaluation may be optimized with risk stratification and more selective application of diagnostic testing in general and computed tomography imaging in particular.

          Abstract

          This microsimulation modeling study evaluates the current guidelines for testing hematuria in adults, comparing the recommended procedures, outcomes, cancer detection rates, costs, advantages, and risks associated with each.

          Abstract

          Importance

          Existing recommendations for the diagnostic testing of hematuria range from uniform evaluation of varying intensity to patient-level risk stratification. Concerns have been raised about not only the costs and advantages of computed tomography (CT) scans but also the potential harms of CT radiation exposure.

          Objective

          To compare the advantages, harms, and costs associated with 5 guidelines for hematuria evaluation.

          Design, Setting, and Participants

          A microsimulation model was developed to assess each of the following guidelines (listed in order of increasing intensity) for initial evaluation of hematuria: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA). Participants comprised a hypothetical cohort of patients (n = 100 000) with hematuria aged 35 years or older. This study was conducted from August 2017 through November 2018.

          Exposures

          Under the Dutch and CUA guidelines, patients received cystoscopy and ultrasonography if they were 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients received different combinations of cystoscopy, ultrasonography, and CT urography or no evaluation on the basis of risk factors. Under the AUA guidelines, all patients 35 years or older received cystoscopy and CT urography.

          Main Outcomes and Measures

          Urinary tract cancer detection rates, radiation-induced secondary cancers (from CT radiation exposure), procedural complications, false-positive rates per 100 000 patients, and incremental cost per additional urinary tract cancer detected.

          Results

          The simulated cohort included 100 000 patients with hematuria, aged 35 years or older. A total of 3514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%-4.0%). The AUA guidelines missed detection for the fewest number of cancers (82 [2.3%]) compared with the detection rate of the HRI (116 [3.3%]) and KP (130 [3.7%]) guidelines. However, the simulation model projected 108 (95% CI, 34-201) radiation-induced cancers under the KP guidelines, 136 (95% CI, 62-229) under the HRI guidelines, and 575 (95% CI, 184-1069) under the AUA guidelines per 100 000 patients. The CUA and Dutch guidelines missed detection for a larger number of cancers (172 [4.9%] and 251 [7.1%]) but had 0 radiation-induced secondary cancers. The AUA guidelines cost approximately double the other 4 guidelines ($939/person vs $443/person for Dutch guidelines), with an incremental cost of $1 034 374 per urinary tract cancer detected compared with that of the HRI guidelines.

          Conclusions and Relevance

          In this simulation study, uniform CT imaging for patients with hematuria was associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. Risk stratification may optimize the balance of advantages, harms, and costs of CT.

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          Most cited references38

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          Overdiagnosis in cancer.

          This article summarizes the phenomenon of cancer overdiagnosis-the diagnosis of a "cancer" that would otherwise not go on to cause symptoms or death. We describe the two prerequisites for cancer overdiagnosis to occur: the existence of a silent disease reservoir and activities leading to its detection (particularly cancer screening). We estimated the magnitude of overdiagnosis from randomized trials: about 25% of mammographically detected breast cancers, 50% of chest x-ray and/or sputum-detected lung cancers, and 60% of prostate-specific antigen-detected prostate cancers. We also review data from observational studies and population-based cancer statistics suggesting overdiagnosis in computed tomography-detected lung cancer, neuroblastoma, thyroid cancer, melanoma, and kidney cancer. To address the problem, patients must be adequately informed of the nature and the magnitude of the trade-off involved with early cancer detection. Equally important, researchers need to work to develop better estimates of the magnitude of overdiagnosis and develop clinical strategies to help minimize it.
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            Radiologic and nuclear medicine studies in the United States and worldwide: frequency, radiation dose, and comparison with other radiation sources--1950-2007.

            The U.S. National Council on Radiation Protection and Measurements and United Nations Scientific Committee on Effects of Atomic Radiation each conducted respective assessments of all radiation sources in the United States and worldwide. The goal of this article is to summarize and combine the results of these two publicly available surveys and to compare the results with historical information. In the United States in 2006, about 377 million diagnostic and interventional radiologic examinations and 18 million nuclear medicine examinations were performed. The United States accounts for about 12% of radiologic procedures and about one-half of nuclear medicine procedures performed worldwide. In the United States, the frequency of diagnostic radiologic examinations has increased almost 10-fold (1950-2006). The U.S. per-capita annual effective dose from medical procedures has increased about sixfold (0.5 mSv [1980] to 3.0 mSv [2006]). Worldwide estimates for 2000-2007 indicate that 3.6 billion medical procedures with ionizing radiation (3.1 billion diagnostic radiologic, 0.5 billion dental, and 37 million nuclear medicine examinations) are performed annually. Worldwide, the average annual per-capita effective dose from medicine (about 0.6 mSv of the total 3.0 mSv received from all sources) has approximately doubled in the past 10-15 years. (c) RSNA, 2009.
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              Contrast-induced nephropathy in patients undergoing primary angioplasty for acute myocardial infarction.

              The aim of this research was to assess the incidence, clinical predictors, and outcome of contrast-induced nephropathy (CIN) after primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Contrast-induced nephropathy is associated with significant morbidity and mortality after PCI. Patients undergoing primary PCI may be at higher risk of CIN because of hemodynamic instability and unfeasibility of adequate prophylaxis. In 208 consecutive AMI patients undergoing primary PCI, we measured serum creatinine concentration (Cr) at baseline and each day for the following three days. Contrast-induced nephropathy was defined as a rise in Cr >0.5 mg/dl. Overall, CIN occurred in 40 (19%) patients. Of the 160 patients with baseline Cr clearance >/=60 ml/min, only 21 (13%) developed CIN, whereas it occurred in 19 (40%) of those with Cr clearance 75 years (odds ratio [OR] 5.28, 95% confidence interval [CI] 1.98 to 14.05; p = 0.0009), anterior infarction (OR 2.17, 95% CI 0.88 to 5.34; p = 0.09), time-to-reperfusion >6 h (OR 2.51, 95% CI 1.01 to 6.16; p = 0.04), contrast agent volume >300 ml (OR 2.80, 95% CI 1.17 to 6.68; p = 0.02) and use of intraaortic balloon (OR 15.51, 95% CI 4.65 to 51.64; p < 0.0001) were independent correlates of CIN. Patients developing CIN had longer hospital stay (13 +/- 7 days vs. 8 +/- 3 days; p < 0.001), more complicated clinical course, and significantly higher mortality rate (31% vs. 0.6%; p < 0.001). Contrast-induced nephropathy frequently complicates primary PCI, even in patients with normal renal function. It is associated with higher in-hospital complication rate and mortality. Thus, preventive strategies are needed, particularly in high-risk patients.
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                Author and article information

                Journal
                JAMA Intern Med
                JAMA Intern Med
                JAMA Intern Med
                JAMA Internal Medicine
                American Medical Association
                2168-6106
                2168-6114
                29 July 2019
                October 2019
                29 July 2020
                : 179
                : 10
                : 1352-1362
                Affiliations
                [1 ]Department of Health Policy and Management, University of North Carolina Gillings School of Global Public Health, Chapel Hill
                [2 ]University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill
                [3 ]Division of eHealth, Quality and Analytics, Social Policy, Health and Economics Research Unit, RTI International, Research Triangle Park, North Carolina
                [4 ]Departments of Radiology, Epidemiology and Biostatistics, University of California at San Francisco, San, Francisco
                [5 ]Department of Urology, Kaiser Permanente Southern California, Los Angeles, California
                [6 ]Department of Urology, Geisinger Health, Danville, Pennsylvania
                [7 ]Department of Urology, University of North Carolina School of Medicine, Chapel Hill
                [8 ]Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, Chapel Hill
                [9 ]Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon
                Author notes
                Article Information
                Accepted for Publication: May 7, 2019.
                Corresponding Author: Matthew E. Nielsen, MD, MS, Department of Urology, University of North Carolina School of Medicine, 2107 Physicians Office Building, Campus Box 7235, Chapel Hill, NC 27599 ( mnielsen@ 123456med.unc.edu ).
                Published Online: July 29, 2019. doi:10.1001/jamainternmed.2019.2280
                Author Contributions: Drs Georgieva and Nielsen had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: Georgieva, Wheeler, Erim, Smith-Bindman, Loo, Ng, Raynor, Nielsen.
                Acquisition, analysis, or interpretation of data: Georgieva, Wheeler, Erim, Smith-Bindman, Garg, Raynor, Nielsen.
                Drafting of the manuscript: Georgieva, Erim, Smith-Bindman, Nielsen.
                Critical revision of the manuscript for important intellectual content: Wheeler, Erim, Smith-Bindman, Loo, Ng, Garg, Raynor, Nielsen.
                Statistical analysis: Georgieva, Erim, Smith-Bindman, Nielsen.
                Administrative, technical, or material support: Wheeler, Erim, Smith-Bindman, Loo, Ng, Raynor.
                Supervision: Wheeler, Erim, Smith-Bindman, Nielsen.
                Conflict of Interest Disclosures: Dr Wheeler reported receiving grants from Pfizer outside of the submitted work. Dr Raynor reported being a paid consultant for Intuitive Surgical and Terumo Medical outside of the submitted work. Dr Nielsen reported receiving grants from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Agency for Healthcare Research and Quality, and American Cancer Society; being a paid consultant for the American College of Physicians High Value Care Task Force; and serving on the medical advisory board of Grand Rounds, all outside of the submitted work. No other disclosures were reported.
                Funding/Support: Drs Georgieva and Nielsen were supported in part by the University Cancer Research Fund, a resource provided by the State of North Carolina via the University of North Carolina Lineberger Comprehensive Cancer Center.
                Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
                Article
                PMC6664383 PMC6664383 6664383 ioi190048
                10.1001/jamainternmed.2019.2280
                6664383
                31355874
                1ef7d197-6ecb-461b-a0bd-1805178af964
                Copyright 2019 American Medical Association. All Rights Reserved.
                History
                : 21 November 2018
                : 7 May 2019
                Categories
                Research
                Research
                Original Investigation
                Less Is More
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