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Prostate Cancer Early Detection 2021

Peter R. Carroll, MD, MPH, Professor of Prostate Cancer and Urology at the University of California, San Francisco, examines data from randomized controlled trials that studied prostate-specific antigen (PSA) testing and mortality. He emphasizes that data show that the number of patients screened and diagnosed to avoid one death improves significantly over time and thus it is important to recognize the long-term impact of screening. Dr. Carroll briefly discusses American Urological Association (AUA), U.S. Preventive Services Task Force (USPSTF), American Cancer Society (ACS), and National Comprehensive Cancer Network (NCCN) recommendations, noting that some recommendations are vague with regard to biopsy. Dr. Carroll then displays a pictogram of what he calls “the Achilles heel of PSA screening.” It shows that among 1,000 men in the US, about 250 have an elevated PSA. If all patients with elevated PSA are biopsied, the results show that half have no disease and, of the remaining men, about 30-40 percent have low-risk disease. He cites harmful effects of overtreatment, mentioning sepsis as an example, but concludes that the harms outweigh the benefits in this screening paradigm. Dr. Carroll then explains that detection paradigms have changed from a “detect all, treat all” approach to a “detect some, treat some” approach, utilizing surveillance for patients with lower-risk disease. Dr. Carroll outlines NCCN Guidelines for 2021, which include a continuation of support for early detection efforts; baseline testing at age 45; germline testing; an acknowledgment that optimal screening of high-risk patients (e.g., African-American men) is not completely known; provisions for alternatives to routine biopsy; and a recognition of the value of active surveillance for low-risk cancers. He highlights the recommendation that digital rectal examination (DRE) should be used as a complement to PSA testing, not as a standalone screening test. Dr. Carroll concludes that DRE could not be implemented effectively in a nationwide screening program. Dr. Carroll explains that, increasingly, doctors are opting for tests of specificity (biomarker or MRI) before opting for biopsies. He asserts the value of using MRI before biopsy, since MRI targeting increases the detection of high-grade cancers while limiting the detection of low-grade cancers. However, he explains that a decision not to biopsy requires use of a biomarker test along with MRI, since the negative predictive value (NPV) of MRI is 85 percent. He cites the PROMIS trial and asserts that a negative MRI alone is insufficient. Dr. Carroll then cites data from a recent trial in the NEJM showing that MRI-targeted biopsy decreases the likelihood of negative or benign biopsy and testing with biomarkers can reduce biopsies by 20-65 percent while missing few (2.5-8 percent) high-grade cancers. He asserts that recent studies suggest that upfront biomarker testing with conditional MRI may be the most efficient strategy for early detection, with cost and availability being strong considerations. He supports this assertion with data on various biomarker tests as well as early detection algorithms. Dr. Carroll returns to the NCCN recommendations on management of biopsy results before concluding his discussion, reemphasizing that prostate cancer early detection in well-informed, healthy men saves lives.

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Wellness: The Other Side of the Burnout Coin

Grand Rounds in Urology Contributing Editor Neil H. Baum, MD, Professor of Urology at Tulane Medical School, considers the causes and consequences of burnout in urologists and makes suggestions for developing a urologist wellness program. He explains that urologists are unwell because they work an average of 50 to 60 hours per week, tend to be type-A perfectionists, have to deal with increased paperwork, have lost autonomy, and are forced to focus on cost rather than on patients. Dr. Baum notes that the COVID-19 pandemic has exacerbated the problems doctors face, and anxiety and depression among doctors has increased from 10% before the pandemic to 40% now. He also explains that, unlike in some other professions, there are few resources available to physicians to aid them in wellness, although there is now a physician support line. Dr. Baum then lists the consequences of physicians being unwell, most notably job dissatisfaction leading to a failure to discuss treatment options and answer patients’ questions, which in turn leads to poor patient compliance, unfavorable outcomes, more malpractice suits, and more negative online reviews. Conversely, physician wellness improves quality of care for patients, enhances patient satisfaction and online reviews, and leads to increased personal and professional success for the physicians. Dr. Baum concludes with some suggestions for starting a wellness program for urologists, highlighting the success of a counseling program at a hospital which saw a significant decrease in exhaustion, burnout, and sick leave among physicians in the program.

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GUIDE – A New Initiative For a National Bio Repository

E. David Crawford, MD, Editor-in-Chief of Grand Rounds in Urology and Professor of Urology at the University of California, San Diego, and Matthew O. Leavitt, MD, Chief Executive Officer at PathNet, Inc., present the GUIDE initiative to disrupt current data and bio-specimen collection and streamline the exchange of clinical data. Dr. Crawford offers a vision for integrated data-sharing and then introduces Dr. Leavitt, who describes the process. In order to create personalized treatment plans, Dr. Leavitt reasons that individual patients’ data must be shared between institutions and contends that our current disconnected health systems present a variety of institutional, economic, and data-based barriers to this goal. He then discusses the DDx Foundation, a public non-profit which builds and supports clinical data exchanges that is governed by physicians and supported by allied industry partners. Their aim is to create a network of clinic and hospital bio-repositories that will lead to standardization of patient-informed consent, specimen handling, and data curation. Instead of owning data or specimens, DDx Foundation contractually handles the specimen-data transactions with third parties, and the value of this data is then passed back to the clinical contributors. Dr. Leavitt then walks through the process from consent to data exchange. He describes how utilizing edge computing to capture and analyze patient data at the clinical site instead of in a centralized cloud server creates a more cost-effective method of testing. Once data is collected, it is distributed to a regional tissue data hub automatically and the information is anonymized for data and specimen marketplace and de-identified for future care of the patient. Finally, through regional bio-repositories, data is then shared in a central trust where it can be accessed by researchers across the country for retrospective analysis or clinical trials. Dr. Leavitt concludes by describing the benefits for researchers, clinics, data contributors, and patients.

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