US Clinical Review Reinforces Need for Cxbladder in Hematuria Guidelines
24th September 2019
The Journal of the American Medical Association (JAMA) has published a clinical review paper highlighting the need for safer, non-invasive and accurate diagnostic tests and procedures for the detection and management of bladder cancer that can help lower the need for, and impact on patients, from radiation based imaging.
This study, co-authored by Kaiser Permanente, Geisinger Health and other leading healthcare institutions in the USA, compared the harms, advantages and costs associated with five different sets of national or local guidelines for the evaluation of patients presenting to the clinic with hematuria for evaluation for bladder cancer: Dutch, Canadian Urological Association (CUA), Kaiser Permanente (KP), Hematuria Risk Index (HRI), and American Urological Association (AUA).
The review clearly shows that a need exists for safer, non-invasive and accurate diagnostic tests and procedures for the detection and management of bladder cancer that can help lower the need for CT imaging, says Pacific Edge CEO Dave Darling. "The Cxbladder suite of non-invasive diagnostic tests, with their accurate rule-out of patients, who do not have bladder cancer, provides urologists with an opportunity to address the significant shortcomings, highlighted in this study, of the current AUA guidelines for the evaluation of patients with hematuria."
The authors of the review simulated the effect of using each set of guidelines on 100,000 patients to determine detection rates and cost effectiveness, along with the potential to produce co-morbidities including new cancers. The guidelines vary considerably in the intensity and number of options used in the clinical evaluation of hematuria, particularly with regard to the use of computed tomography (CT) scans, which are expensive and carry potential harms associated with radiation exposure. Under the Dutch and CUA guidelines, patients undergo cystoscopy and ultrasonography if they are 50 years or older (Dutch) or 40 years or older (CUA). Under the KP and HRI guidelines, patients receive different combinations of cystoscopy, ultrasonography, CT urography, or no evaluation, with the choice based on risk factors. Under the AUA guidelines, all patients 35 years or older receive cystoscopy and CT urography.
Of the 100,000 patient simulations, a total of 3,514 patients had urinary tract cancers (estimated prevalence, 3.5%; 95% CI, 3.0%–4.0%). The AUA guidelines missed the fewest number of cancers (82 [2.3%]) compared with the other guidelines: the missed detection rate was 116 [3.3%] with the HRI, 130 [3.7%] with KP, 172 [4.9%] with CUA and 251 [7.1%] with Dutch guidelines. However, the simulation model estimated that radiation-induced cancers would develop in 108 (95% CI, 34–201) per 100,000 patients under the KP guidelines, 136 (95% CI, 62–229) under the HRI guidelines, and 575 (95% CI, 184–1,069) under the AUA guidelines. Although the CUA and Dutch guidelines missed detection of a larger number of cancers, there were no radiation-induced secondary cancers with these protocols. The cost of hematuria evaluation using the AUA guidelines ($939/person) was approximately double the cost of using any of the other 4 guidelines (e.g. $443/person for Dutch guidelines), and the incremental cost was $1,034,374 per urinary tract cancer detected compared with that of the HRI guidelines.
For patients with hematuria requiring evaluation for bladder cancer, the more rigorous guidelines cost significantly more, with marginal gains in the number of tumors identified. Guidelines with extensive use of CT imaging were associated with increased costs and harms of secondary cancers, procedural complications, and false positives, with only a marginal increase in cancer detection. The authors state; “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 CT imaging in particular.” The most extensive/aggressive clinical guidelines (AUA) when compared with the most conservative identify the highest number of cancer cases but at a cost of incurring the highest number of new radiation-induced cancer cases. The AUA guidelines generated 5.3-times more radiation induced cancers than the KP guidelines. (575 vs 108).