William J. Catalona, MD; Anthony V. D'Amico, MD; William F. Fitzgibbons, MD; Omofolasade Kosoko-Lasaki, MD; Stephen W. Leslie, MD; Henry T. Lynch, MD; Judd W. Moul, MD; Marc S. Rendell, MD; Patrick C. Walsh, MD
Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M12-0991.
Requests for Single Reprints: Marc S. Rendell, MD, The Creighton Diabetes Center, 601 North 30th Street, Omaha, NE 68131; e-mail, Rendell@asndi.com.
Current Author Addresses: Dr. Catalona: 675 North St. Clair Street, Suite 20-150, Chicago, IL 60611.
Dr. D'Amico: Brigham and Women's Hospital, 75 Francis Street #Asb1, Boston, MA 02115.
Dr. Fitzgibbons: Skyline Medical Center, 1908 North 203rd Street Suite 2, Elkhorn, NE 68022.
Dr. Kosoko-Lasaki: Health Sciences Office of Multicultural and Community Affairs, Hixson Lied Building, Suite L23, Creighton University, 2500 California Plaza, Omaha, NE 68178.
Dr. Leslie: Department of Surgery, Division of Urology, Suite 3700, 601 North 30th Street, Omaha, NE 68131.
Dr. Lynch: Hereditary Cancer Center and Department of Preventive Medicine, Creighton University, 2500 California Plaza, Omaha, NE 68178.
Dr. Moul: Division of Urologic Surgery, DUMC 3707-Room 1562 Duke South, Duke University Medical Center, Durham, NC 27705.
Dr. Rendell: The Creighton Diabetes Center, 601 North 30th Street, Omaha, NE 68131.
Dr. Walsh: Johns Hopkins Hospital, Park 224, Baltimore, MD 21287.
Author Contributions: Conception and design: W.J. Catalona, W.F. Fitzgibbons, J.W. Moul, M.S. Rendell, P.C. Walsh.
Analysis and interpretation of the data: W.J. Catalona, A.V. D'Amico, S.W. Leslie, H.T. Lynch, M.S. Rendell, P.C. Walsh.
Drafting of the article: W.J. Catalona, A.V. D'Amico, S.W. Leslie, J.W. Moul, M.S. Rendell, P.C. Walsh.
Critical revision of the article for important intellectual content: W.J. Catalona, A.V. D'Amico, W.F. Fitzgibbons, S.W. Leslie, J.W. Moul, M.S. Rendell, P.C. Walsh.
Final approval of the article: W.J. Catalona, A.V. D'Amico, W.F. Fitzgibbons, O. Kosoko-Lasaki, S.W. Leslie, H.T. Lynch, J.W. Moul, M.S. Rendell, P.C. Walsh.
Administrative, technical, or logistic support: S.W. Leslie, M.S. Rendell.
Collection and assembly of data: W.J. Catalona, A.V. D'Amico, S.W. Leslie.
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Tanner J., Caverly, MD, Instructor of Medicine
University of Colorado Denver School of Medicine
May 24, 2012
NUMBERS NEEDED - BUT NOT RELATIVE RISK
Weighing the potential benefits and harms of PSA-screening is difficult. In their response to the updated guidelines, Catalona et al. claim that the USPSTF underestimated the benefits of PSA-screening. This claim would have been more credible had they not presented the benefit data exclusively in terms of relative risk reduction - a format that has long been known to inflate estimations of benefit (1). Catalona and colleagues also claim that the USPSTF overestimated the harms of PSA- screening. Unfortunately, their response did not attempt to quantify the harms of overdiagnosis and overtreatment at all, reinforcing a view that these downsides can simply be ignored. Interpretation of existing evidence and which evidence to highlight continues to differ dramatically in the PSA-screening debate. When attempting to think clearly about this issue, however, there is no substitute for directly comparing quantitative estimates of both benefits and harms in the best format available. In this case, the best format would be numbers needed to screen, numbers needed to treat, and numbers needed to harm - not relative risk.
1. Fahey, T., S. Griffiths, and T. J. Peters. "Evidence Based Purchasing: Understanding Results of Clinical Trials and Systematic Reviews." BMJ?: British Medical Journal 311, no. 7012 (October 21, 1995): 1056-1060.
Brandon P, Combs, Assistant Professor of Medicine
University of Colorado School of Medicine
Resistance to Change Practice
The recent editorial by Catalona, et al in response to updated PSA screening guidelines by the USPSTF is emblematic of the systemic problem of overuse and resistance to incorporate high quality evidence from randomized controlled trials into clinical practice (1). It is impressive that the USPSTF should be criticized for relying on the two largest published randomized controlled trials to date and focusing on the balance between mortality benefit and harms of treatment instead of theoretical downstream harms of undiagnosed malignancy. It is also misleading to suggest that the mortality benefit observed with radical prostatectomy versus watchful waiting in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), where only 5% of prostate tumors were identified by screening and 75% were palpable at presentation, offers evidence in support of screening for cancer by PSA (2). Finally, though use of relative risk reduction as opposed to absolute risk reduction in expressing benefit of a treatment is a persuasive means to sell devices or drugs, it does not contribute meaningfully to clinical discourse between patient and physician when weighing the risks and benefits of screening for cancer.
1. Catalona WJ, D'Amico AV, Fitzgibbons WF, Kosoko-Lasaki O, Leslie SW, Lynch HT, Moul JW, Rendell MS, Walsh PC. "What the U.S. Preventive Services Task Force Missed in Its Prostate Cancer Screening Recommendation." Ann Intern Med. 2012 [Epub ahead of print 22 May 2012].
2. Bill-Axelson A, Holmberg L, Ruutu M, Garmo H, Stark JR, Busch C, et al; SPCG-4 Investigators. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med. 2011;364:1708-17.
Radhakanth K, Shenoy, Radiation Oncologist
Queen Elizabeth Hospital
May 26, 2012
Re:Resistance to Change Practice
1Mary Pat Raimondi, MS, RD, 2Robert Ratner, MD, 3Todd Hobbs, MD, 4Henry Rodriguez, MD
1Vice President of Strategic Policy and Partnerships, Academy of Nutrition and Dietetics, Washington, DC 2Chief Scientific & Medical Officer, American Diabetes Association, Alexandria, VA 3Chief
November 20, 2015
Conflict of Interest:
MPR, RR, and HR have no disclosures; TH is an employee of Novo Nordisk, Inc.
Comment on: Screening for Abnormal Blood Glucose and Type 2 Diabetes Mellitus: U.S. Preventive Services Task Force Recommendation Statement
To the Editor:The final U.S. Preventive Services Task Force (USPSTF) diabetes screening guideline, published on October 26, 2015, (1) improves upon the 2008 guideline it replaces, as more of the 8.1 million Americans living with undiagnosed diabetes and the 86 million with prediabetes (2) are targeted for screening. Also, this “B” level guideline recommends intensive lifestyle change programs for adults identified with abnormal blood glucose, a tremendous step forward in helping people with prediabetes prevent progression to type 2 diabetes and those with diabetes prevent complications. That’s the good news.Unfortunately, the final guideline will fail to identify significant numbers of Americans with undiagnosed diabetes or prediabetes – and denies them important benefits of preventive interventions or early disease detection and treatment. That’s a significant step backwards.Compared with the 2014 draft, the final guideline changed the population targeted for screening from all adults with widely accepted risk factors for diabetes to a narrower population of adults aged 40 to 70 years who are overweight or obese. (1) Absent are several critical factors placing patients at high risk for diabetes. Rates of undiagnosed diabetes are significantly higher in Asian Americans (61%+), Hispanic Americans (50%+), and Black Americans (33%+) compared with non-Hispanic whites. (3) The focus on weight alone is particularly problematic for Asian Americans, who are at risk for diabetes at a lower body mass index than USPSTF identifies for screening. (4)Additionally, women with a history of gestational diabetes are at the highest risk, with 50% developing type 2 diabetes within five years. (5) For many new mothers with GDM, beginning screening at age 40 is too little, too late.Most fundamentally, the final guideline portrays diabetes solely as a risk factor for cardiovascular disease, (1) completely ignoring the importance of screening to detect type 2 diabetes and treat it appropriately in order to reduce retinopathy, nephropathy and neuropathy – the complications most amenable to prevention through glucose control.Despite these shortcomings, the new guideline will encourage screening at no cost for many more at-risk patients, as well as expand access to intensive behavioral counseling for those with abnormal glucose levels. Moving forward, we encourage primary care providers to review all risk factors identified by the American Diabetes Association in considering patients for screening. Our organizations stand ready to support the primary care community in its efforts to tackle the enormous and growing challenges posed by diabetes. Our patients deserve nothing less.1. Siu A, on behalf of the U.S. Preventive Services Task Force. Screening for abnormal blood glucose and type 2 diabetes mellitus: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2015; doi:10.7326/M15-2345.2. Division of Diabetes Translation, National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2014. Atlanta: Centers for Disease Control and Prevention; 2014. Accessed at www.cdc.gov/diabetes/pubs/statsreport14 /national-diabetes-report-web.pdf on 16 November 2015.3. Menke A, Casagrande S, Geiss L, Cowie C. Prevalence of and trends in diabetes among adults in the United States, 1988-2012. JAMA. 2015; 314(10):1021-1029.4. Hsu WC, Araneta MR, Kanaya AM, Chiang JL, Fujimoto W. BMI cut points to identify at-risk Asian Americans for type 2 diabetes screening. Diabetes Care. 2015; 38:150–158. 5. Kim C, Newton K, Knopp R. Gestational diabetes and the incidence of type 2 diabetes. Diabetes Care. 2002; 25(10):1862-1868.
Catalona WJ, D'Amico AV, Fitzgibbons WF, Kosoko-Lasaki O, Leslie SW, Lynch HT, et al. What the U.S. Preventive Services Task Force Missed in Its Prostate Cancer Screening Recommendation. Ann Intern Med. 2012;157:137-138. doi: 10.7326/0003-4819-157-2-201207170-00463
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Published: Ann Intern Med. 2012;157(2):137-138.
Cancer Screening/Prevention, Hematology/Oncology, Prevention/Screening, Prostate Cancer.
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