Testis Ca screening: Why USPSTF ‘D’ grade is misguided

The U.S. Preventive Services Task Force (USPSTF) recommendations are based on a rigorous review of existing peer-reviewed evidence and are intended to help primary care clinicians and patients decide together whether a preventive service is right for a patient’s needs. Each year, the USPSTF makes a report to Congress that identifies critical evidence gaps in research related to clinical preventive services and recommends priority areas that deserve further examination.

Recommendations made by the USPSTF are independent of the U.S. government and should not be construed as an official position of any government body. However, in 2010, the Patient Protection and Affordable Care Act (ACA) created a link between USPSTF recommendations and various coverage requirements. Duly, some advocacy groups and others have frequently misinterpreted the ACA linkage as licensing the Task Force to explicitly recommend for or against coverage. Needless to say, the increasing influence of USPSTF recommendations in our health care system is clear and obvious.

Regarding testicular cancer screening, the USPSTF currently suggests that there is a lack of available evidence demonstrating that routine testicular cancer (TCa) screening (including both testicular self-examination [TSE] and clinician examination) has greater yield and/or accuracy for detecting TCa at more curable stages than chance discovery (Ann Intern Med 2011; 154:483-6). The Task Force also claims that, generally, TCa is >90% curable and that TCa screening is unlikely to offer meaningful health benefits.

One adverse outcome readily offered as evidence that TCa screening should not be recommended is the potential onset of anxiety associated with a false-positive result. Essentially, according to the USPSTF, among others (eg, Lin and Sharangpani, Ann Intern Med 2010; 153:396-9), TSE and clinician examinations have limited value; thus the reason for a “D” recommendation.

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In 1996, the Task Force indicated that it found little evidence to suggest a recommendation for or against routine screening of the testes for cancer as the evidence base was insufficient. TCa screening was granted a “C” recommendation, essentially stating that the Task Force doesn’t know if TCa screening is beneficial or detrimental. Fair enough. Interestingly, the Task Force included some language suggesting that those males deemed “high risk” could possibly be consulted about performing routine screening for the disease to reduce the risk of late-stage discovery.

When it comes to empirical evidence, the Task Force aims to analyze randomized controlled trials (RCTs) for forming the foundation of its recommendations. Pertaining specifically to TCa screening, two glaring issues come about regarding this standard:

First, it’s nearly impossible to conduct a TCa screening RCT that is methodologically rigorous enough to produce the kind of evidence necessary to make a conclusive decision on TCa screening effectiveness. Second, there are no RCTs currently that assess TCa screening, which is mostly due to the previous point as well as a dearth of available funds to conduct such work.

Nevertheless, in 2004, the Task Force reevaluated its “C” recommendation for TCa screening and came to the conclusion that there was “fair” evidence that TCa screening harms outweigh the benefits. One of the main arguments for this change from a “C” to a “D” recommendation (ie, unsupportive of the behavior) was that no studies were produced that demonstrated a reduced mortality of TCa from routine screening. What is also evident is that no evidence emerged demonstrating harms of TCa screening either. It was a wash, just like in 1996.

However, instead of upholding the “C” recommendation, the recommendation was switched to a “D.” Even though the USPSTF changed the rules for what constitutes a “C” recommendation in which it recommends that the select service should be offered to select individuals due to their particular risk of the disease in question, the evidence still doesn’t support the switch from a “C” to a “D.”

Continue to the next page for more.In fact, that new definition further supports the Task Force’s previous stance in which TCa screening should be discussed with high-risk individuals. This position is also currently shared by the AUA, 2014 (“Men’s Health Checklist”); Society for Adolescent Health and Medicine, 2012 (J Adolesc Health 2012; 50:424-5); and American Cancer Society, 2015 (“Signs and Symptoms of Testicular Cancer”) (table). If anything, the recommendation should be an “I,” whereby there is no conclusive evidence demonstrating harm or benefit for an informed decision to be made regarding TCa screening. It certainly should not be a “D” according to the Task Force’s own methodology and operational definitions of the recommendation system.

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In 2008, the Task Force called for a new review of TCa screening. In 2010, Lin and Sharangpani responded to the call and rubber-stamped the Task Force’s “D” recommendation (Ann Intern Med 2010; 153:396-9). However, the authors were hardly unique in their conclusions; that is, there is no new evidence showcasing benefits nor harms from TCa screening.

The problem with Lin and Sharangpani’s piece, and, in fact, the entirety of the Task Force’s “D” recommendation, can be reduced to two primary points:

First, there are no RCTs to assess TCa screening benefits or harms to make a conclusive recommendation. The evidence used in determining such recommendations simply doesn’t exist. However, the Task Force does recognize the difficulty in producing RCTs for most topics and does accept non-RCT designs to inform the recommendation process. Even with this more liberal standard of evidence, in the case of TCa screening, no studies match up to the needed designs testing asymptomatic males. Again, the evidence doesn’t exist.

Second, the Task Force indicates that “fair” evidence exists suggesting the harms of screening outweigh the benefits. Fair evidence is generally defined by the Task Force when existing evidence is sufficient enough to determine the effect upon health outcomes. However, the Task Force fails to define what “sufficient” means. It is left to the discretion of the reviewer, which is probably a primary causal factor to the current issue. What sufficient means for one person may mean something different to another person. But this relates back to the first point, which is that there is no evidence. How can evidence be fair and/or sufficient if it doesn’t exist?

The USPSTF “D” recommendation is not grounded in empirical evidence. Simply, according to the Task Force’s methodology, the evidence does not exist to recommend anything. The recommendation, therefore, should be an “I.” We would advocate for the recommendation to be changed back to a “C,” but to be fair, there is no smoking gun evidence to suggest that TCa screening is beneficial either.

There are studies currently underway that are trying to build a body of evidence demonstrating TCa screening’s benefit. Further, there is an emerging body of evidence suggesting TCa screening is beneficial beyond detecting cancer and may also be helpful in detecting hydroceles, varicoceles, possible hernias, and any type of scrotal skin issue including some sexually transmitted infections, among other concerns (Am J Mens Health 2015; 9:506-18). Not only can males detect these issues, but they can become more familiar with their bodies, which is an all-around positive outcome to achieve.

Conclusion

We suggest the following actions in order to assuage this issue:

• Encourage the Task Force to reopen its review of TCa screening.

• Encourage more funding opportunities to produce the kind of evidence needed to make a recommendation.

• In lieu of a new review, the current “D” recommendation should be changed to an “I” (insufficient evidence) recommendation, as there is no evidence to suggest either way TCa screening is harmful or beneficial.

• The Task Force review board should consist of content-specific experts to inform the decision-making process regarding the recommendation for TCa screening. Is it a truly informed decision if not one content expert is sitting on the review panel?

As a reference, a critique of this entire review process is provided for by Rovito et al (Prev Med Rep 2016; 3:361-6.

Michael J. Rovito PhD, CHES, FMHI

Ajay K. Nangia, MBBS

Dr. Rovito is assistant professor of health sciences at the University of Central Florida and founder/chairman of Men’s Health Initiative, Orlando, and Dr. Nangia is professor and vice-chair of urology at the University of Kansas Medical Center, Kansas City.

Section Editor Christopher M. Gonzalez, MD, MBA, is professor and chair of the department of urology at Loyola University Chicago Stritch School of Medicine, Maywood, IL.