“The variability in recommendations [for hematuria evaluation] and our study’s findings highlight implicit value judgments and a potentially high burden of harms not historically considered in many guidelines’ development process," says Matthew E. Nielsen, MD, MS.
A simulation study analyzing the harms, advantages, and costs associated with different guideline recommendations for initial evaluation of hematuria found that no approach diagnoses every cancer and suggest that the incremental costs and radiation-associated harms occurring with the most intensive recommendation, which advocates a one-size-fits-all approach with computed tomography scanning, may outweigh marginal benefits in terms of diagnostic yield, said Matthew E. Nielsen, MD, MS.
“The rationale for aggressively testing a larger fraction of the population that presents with hematuria is to minimize the risk of missing any cancer, and that is a reasonable and well-intentioned rationale. However, the fact that current guidelines for hematuria evaluation provide differing recommendations reflects that there is some uncertainty about the best strategy in this space,” said Dr. Nielsen, of the University of North Carolina School of Medicine, Chapel Hill.
He continued, “The variability in recommendations and our study’s findings highlight implicit value judgments and a potentially high burden of harms not historically considered in many guidelines’ development process. Urologists may want to consider discussing with patients the relative benefits and harms associated with different approaches and potentially consider applying risk-stratified approaches that focus the most intensive testing on the highest risk patients as a way to improve the value of care for this patient population.”
For the analysis, which was published online ahead of print in JAMA Internal Medicine (July 29, 2019), a microsimulation model was developed to assess 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 for a hypothetical 100,000-patient cohort evaluated according to the recommendations from five different guidelines.
The guidelines evaluated were (listed in order of increasing intensity) the Dutch, Canadian Urological Association, Kaiser Permanente, Hematuria Risk Index, and the AUA. The characteristics of the patient cohort were derived using data from the two largest published series of patients undergoing evaluation for hematuria and included subsets with gross hematuria as well as microscopic hematuria. All patients were assumed to be 35 years of age and older.
Diagnostic yields for bladder cancer, renal cell carcinoma (RCC), and upper-tract urothelial cancer (UTUC) were considered separately and as a function of which patients would undergo cystoscopy and imaging and with which modality. Real-world data on CT radiation doses were used to account for variations that exist in clinical practice.
Next:Fewest number of cancers was missed by following AUA guidelinesThe results showed that the number of cancers missed with each guideline varied inversely with the intensity of their recommended evaluation. The fewest number of cancers was missed by following the AUA guidelines, which was the most intense, recommending cystoscopy and CT urography for all patients aged 35 years and older.
Considering the three guidelines that make recommendations on using CT urography, the projected number of radiation-induced cancers was highest for the AUA guidelines, and its cost was approximately twofold greater than that of any of the other guidelines. Compared to the Hematuria Risk Index, which lies immediately below the AUA guideline in the intensity of its recommended evaluation, the AUA guideline was associated with an incremental cost of more than $1 million per urinary tract cancer detected.
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Dr. Nielsen noted there has been limited evidence about the relative harms, advantages, and costs of different diagnostic approaches for evaluating patients with hematuria. Although cost-effectiveness analyses have been undertaken previously, their methods had several limitations. Specifically, the previous studies focused on patients with asymptomatic microscopic hematuria, one study’s model did not separate diagnostic yields of the different imaging modalities for RCC and UTUC, and the previous research did not account for real-world variation in CT doses.
“Studies of this nature reflect simplified representations of reality with limitations noted in the paper. However ,we believe our approach provides a lens through which clinicians may consider more explicitly the tradeoffs of different approaches with the ultimate goal of optimizing these tradeoffs for the benefit of our patients.”