Urologists Debunk Misleading, Grossly Inaccurate Prostate Cancer Biopsy Study
TALLAHASSEE, Fla., April 13, 2012 /PRNewswire/ -- The Large Urology Group Practice Association (LUGPA), representing more than 1,800 urologists, today disputed a study published this week in the journal Health Affairs. LUGPA leaders stressed that the study grossly misrepresents the prevailing urological standard of care and scurrilously criticizes physicians for adopting evidence based clinical protocols. They pointed out that the study is methodologically flawed, misleading and factually inaccurate.
Jean Mitchell, the author of the study "Self-Referral for Pathology of Biopsy Specimens Linked to Increased Use and Lower Prostate Cancer Detection," states urology groups with integrated pathology services inappropriately perform prostate biopsies. This study, which reviewed data for only 2005‐07, was funded by the College of American Pathology (CAP) and the American Clinical Laboratory Association (ACLA) – organizations with vested interests in preserving historical monopolies in pathology services.
"This study simply furthers the political agenda of its sponsors to recapture lost market share and does not deserve credible recognition," states Dr. Deepak A. Kapoor, President of LUGPA and Chairman and CEO of Integrated Medical Professionals, PLLC. "To suggest that certain practices are performing extra and unnecessary pathology work for their own remuneration when they are working within rational clinical guidelines is offensive. It shows a total lack of understanding of proper prostate cancer diagnosis."
According to Kapoor, this study utilized suspect methodology in small numbers of hand selected groups, producing results inconsistent with both the scientific literature and direct clinical observations.
Mitchell asserts that common practice is to collect samples from six areas of the prostate for a total of six cores (known as sextant biopsies), but all of the standard criteria for grouping cancers into risk are based on biopsies of 12 parts of the prostate gland.
Numerous international organizations including the National Comprehensive Cancer Network, the American Urological Association and the Canadian Urologic Association have issued practice guidelines recommending the use of extended (10-12 core) biopsy protocols to improve cancer detection rates. Of note is that these guidelines were based on literature that was published before the study period, all facts that Mitchell completely ignores in her work.
For more than a decade, the peer review literature has been clear:
- The detection of clinically significant prostate cancer is improved with increased number of cores.
- Staging and grading of cancer is substantially improved with increased number of cores.
- The need for repeat prostate biopsy is reduced when more cores are initially taken.
- Complication rates are not increased with increased number of cores.
The data on this is so overwhelming, even the pathology organization that funded the study was forced to acknowledge the recommendation of the National Comprehensive Cancer Network's guidelines on Prostate Cancer Early Detection, and commercial labs routinely provide 12 or more vials for specimen collection in their prostate biopsy kits.
Mitchell further states, "There is no clinical rationale for placing each core in a separate jar." This again ignores prevailing standards of care; to map the location of prostate cancer requires separating the cores into individual containers. This provides information about laterality of disease, volume of cancer in each location, along with Gleason scoring of each core – all of which are of profound importance to planning both surgical and radiation therapy treatments.
Mitchell hand selected 11 counties out of more than 3,100 in the United States, reviewing only 9,976 biopsies in urology groups with in‐house urology pathology labs. Mitchell claims that positive biopsy rates fell from 27.4 percent to around 21 percent, as much as 14 percent lower than her control group – a claim that is hardly credible given that extended biopsies are reported to increase the detection rate of clinically significant cancer by more than 30 percent. To verify this, eight of the largest urology groups from across the United States reviewed their actual positive biopsy rates from their in-house pathology labs. The results were staggering: with between two and seven years of follow-up, an aggregate 42,474 prostate biopsies were performed with 16,990 positives, or 40 percent. This difference between Mitchell's work, calculated by mathematical manipulation of carefully selected claims data, and actual data derived from real-time tracking of results from a broad cross section of groups can only be explained by a serious flaw in the algorithm Mitchell used to derive her data.
True academic research, as well as clinical experience, confirms that 12 core prostate biopsies are the gold standard for the most accurate diagnosis for prostate cancer. Mitchell's own data shows that urology groups with in-house pathology labs routinely performed 12 cores, when practices in her control group only did six. Honest interpretation of Mitchell's data suggests that patients treated by integrated urology groups received more appropriate, evidence-based treatment than those treated elsewhere.
Please visit http://lugpa.org/about/press.aspx to read LUGPA's complete response to Mitchell's faulty and misleading analysis.
LUGPA represents 95 large urology group practices in the United States, with more than 1,800 physicians who make up more than 20 percent of the nation's practicing urologists. LUGPA and its member practices are committed to best practices, research, data collection, and benchmarking to promote quality clinical outcomes. Visit http://lugpa.org/default.aspx for more information.
SOURCE Large Urology Group Practice Association
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