AUA lobbies USPSTF on draft research plan

January 1, 2016

Article

The U.S. Preventive Services Task Force, which in 2012 recommended against PSA-based screening for prostate cancer, is developing a new research plan for updating recommendations that urology practices will be expected to follow once it is finalized.

Bob GattyWashington-The U.S. Preventive Services Task Force (USPSTF), which in 2012 recommended against PSA-based screening for prostate cancer, is developing a new research plan for updating recommendations that urology practices will be expected to follow once it is finalized.

The USPSTF posted information about the project in late October 2015 and invited public comments through Nov. 25, a time frame that coincided with the publication of data in the Journal of Urology (2015; 194:1587-93) and JAMA (2015; 314:2054-61; and 2015; 314:2077-9) pointing to the recommendation’s detrimental effects on diagnosis and treatment. PSA screening has also been in the headlines recently due to a controversial quality measure proposed by the Centers for Medicare & Medicaid Services that would potentially penalize providers for ordering PSA tests. (For more on this measure, see urologytimes.com/PSA-measure.)

AUA, others submit comments

Among comments submitted to USPSTF regarding its new research plan were those from the AUA, which urged close consultation with urology and offered numerous specific recommendations and alterations, and the nonprofit Prostate Cancer International (PCI), which cited “major omissions” in the proposed plan.

“While the USPSTF panel is composed of independent national experts in prevention and evidence-based medicine, urology representation is noticeably absent,” wrote J. Stuart Wolf, Jr., MD, chair of the AUA’s Science & Quality Council, in the AUA’s comments.

Dr. Wolf said the AUA and its members “strongly believe that blanket statements regarding PSA testing directed at the entire male population disregard the published benefits associated with such testing in men who may be at higher risk than the average male; as such, we applaud USPSTF in its efforts to incorporate risk stratification into its recommendations regarding PSA testing.”

Next: Key points offered by the AUA for development of the new policy

Some key points offered by the AUA for development of the new policy:

The AUA supports investigation of using a baseline PSA prior to the potential onset of other conditions that may affect PSA, such as BPH, as a strategy for risk stratification. “Modeling data has shown that such a baseline can be used to guide alternative screening strategies for prostate cancer and lead to reductions in false positive tests and overdiagnosis,” Dr. Wolf wrote.

The definition of morbidity should be expanded to include the side effects from the use of androgen deprivation therapy.

Both the positive and negative values of PSA need to be considered in reference to the screening test itself and not just the potential biopsy. “The screening process can be viewed as more than just a PSA,” said Dr. Wolf, “and might be viewed instead as an algorithm that may include PSA testing, biopsy and appropriate imaging to improve diagnostic accuracy.”

In his comments, Dr. Wolf pointed out that the treating physician’s duty is “to present the best available data on the benefits/harms associated with PSA testing, and this can only be presented through appropriate risk stratification. Ultimately, the final decision to undergo PSA testing is left to the patient and his own interpretation of the balance between risks and benefits.”

As such, he encouraged the USPSTF “to pursue additional research into how a patient assesses that risk/benefit trade-off and, ultimately, makes a decision as to whether or not he should be tested.”

Next - PCI: Plan fails to discriminate benefits, harms

PCI: Plan fails to discriminate benefits, harms

Some of the omissions identified by PCI included the following:

The plan and related research questions fail to discriminate between the benefits and harms associated with drawing blood for PSA testing and the process of making decisions based on PSA test results.

A “major omission” is the failure to mention the value of digital rectal examinations in association with PSA testing.

The plan and related research questions fail to address the key issue of the harms and benefits of having a prostate biopsy and “the many things that can be done” to determine whether a biopsy is necessary and ensure that the biopsy’s quality is optimized by the use of MRI scans prior to biopsy.

PCI said it believes USPSTF “is seeking to conduct a serious re-evaluation of the value of screening for prostate cancer based on PSA testing of men who fall into certain appropriate categories.”

Meanwhile, efforts continued on Capitol Hill to enact legislation aimed at reforming the process by which the USPSTF reviews and develops recommendations for clinical preventive services.

The AUA, American Association of Clinical Urologists, and LUGPA are pushing a bill sponsored by Reps. Marsha Blackburn (R-TN) and Bobby Rush (D-IL) that would require that a “balanced representation of primary and specialty care providers” and other key stakeholders in the health care community are involved in the development and review of USPSTF recommendations.

Other changes mandated by the bill would be publishing a draft research plan to guide the systematic evidence review process, considering findings and research by federal agencies and departments, and making the evidence review available for public comment.