ORLANDO, FL USA (UroToday.com) - Dr. David Penson presented a state-of-the-art lecture on evidence-based versus consensus-based guidelines on PSA testing. Consensus based guidelines are developed by experts who informally evaluate and establish recommendations. Evidence-based guidelines use an unbiased and transparent process determined a priori. To give a historical context, prior to 2009 there were no high-quality completed randomised control trials RCTs directly randomizing men to screening vs. non-screening. All guidelines prior to 2009 that made definitive recommendations were based on expert consensus/opinion.
Then, in 2009, results from the ERSPC and PLCO trials were released. The PLCO trial was a negative but flawed study, finding no significant difference in PC death between screening and usual care. The ERSPC trial was positive, but not positive enough. At 11 years of follow-up, there was a significant difference in the cumulative hazard of death from PC. There have been 5 guidelines released on PC screening. The 3 consensus-based guidelines are ACP, NCCN, and ACS, while the two evidence-based guidelines are the AUA and USPSTF guidelines.
Among all 5 guidelines, there is one key point of agreement: population-wide routine screening without informed consent (i.e., mass PSA testing at health fairs) is not recommended. Those who feel screening should be considered propose shared decision-making in which the patient is informed. The American College of Physicians suggests men aged 50-69 years should be informed about the limited potential benefits and substantial harms of PC screening. These guidelines, however, are not evidence or consensus based, leading Dr. Penson to “dismiss these guidelines.” The NCCN guidelines represent a statement of the evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. The strength of PSA testing recommendations varies with age 45-49 years (category 2b); 50-70 years (category 2a); age ≥ 70 years (2B).
The ACS guidelines state that for normal risk men, informed decision making should start at the age of 50, and not be offered for patients with a < 10-year life expectancy. The problem with consensus-based guidelines is the introduction of bias based on the constitution of the expert panel. Panel experts have preconceived notions, and uniform consensus cannot always be achieved. So what makes a trustworthy evidence-based guideline? They should be based on a systematic review of the evidence, be developed by a multidisciplinary panel, and be based on explicit and transparent processes. So why are the USPSTF PC screening guidelines so discordant with other guidelines? There were no cancer specialists or survivors on the USPSTF panel, and bias was introduced in the a priori inclusion criteria used for systematic review. USPSTF elected not to use simulation models that show a benefit for PC screening, but used such models in the breast cancer screening guidelines. Dr. Penson said, “the 2012 USPSTF recommendation was a foregone conclusion.”
So what lessons can be learned? Evidence-based guidelines are preferred but far from perfect. Bias can be introduced into even the most transparent processes. What should urologists do? “No one is suggesting population wide screening, but rather, shared decision making. Urologists should reconsider the entire discussion with an open mind, and emotional and anecdotal arguments have no role.” We must be honest with our patients and ourselves; if not, there will be widespread ramifications.
Presented by David F. Penson, MD, MPH at the American Urological Association (AUA) Annual Meeting - May 16 - 21, 2014 - Orlando, Florida USA
Vanderbilt University Medical Center, Nashville, TN USA
Written by Jeffrey J. Tomaszewski, MD, medical writer for UroToday.com