<strong>Clinical</strong> Laboratory News eDiTorial sTaff editor—Nancy Sasavage, PhD senior editor—Genna Rollins senior editor—Bill Malone editorial assistant—Laura Kachin contributors—Hubert W. Vesper, PhD, and Julianne Cook Botelho, PhD boarD of eDiTors chair—Amy Saenger, PhD Mayo Clinic, Rochester, Minn. members—Lorin M. Bachmann, PhD, DABCC VCU Health System, Richmond, Va. Andrew Don-Wauchope, MD Juravinski Hospital and Cancer Center, Hamilton, Ontario Jacqueline Fisher Children’s Hospital Boston, Boston, Mass. Steven Goss, PhD Siemens Healthcare Diagnostics, Newark, Del. Pamela Steele, PhD Covance, Inc., Indianapolis, Ind. aacc officers President— W. Greg Miller, PhD, DABCC, FACB President-elect—Robert H. Christenson, PhD, DABCC, FACB Treasurer—D. Robert Dufour, MD secretary—Elizabeth L. Frank, PhD, DABCC, FACB Past-President—Ann Gronowski, PhD aDverTising sales Scherago International, Inc. 525 Washington Blvd, Ste. 3310 Jersey City, NJ 07310 Phone: (201) 653-4777, Fax: (201) 653-5705 E-mail: aacc@scherago.com President—H.L. Burklund v.P. of sales—Mike Minakowski sr. Director of sales & marketing —Steven A. Hamburger Traffic manager—Qien Porter subscriPTions <strong>American</strong> <strong>Association</strong> <strong>for</strong> <strong>Clinical</strong> <strong>Chemistry</strong>, Inc. 1850 K Street, NW, Suite 625 Washington, DC 20006 Phone: (202) 857-0717 or (800) 892-1400 Fax: (202) 887-5093 E-mail: custserv@aacc.org Subscriptions to <strong>Clinical</strong> Laboratory News are free to qualified laboratory professionals in the United States. AACC members outside the U.S. pay $87 <strong>for</strong> postage. The subscription price <strong>for</strong> those who do not qualify <strong>for</strong> a free subscription is $87/year in the U.S. and $130/ year outside the U.S. For more in<strong>for</strong>mation, contact the AACC Customer Service Department at (800) 892-1400 or (202) 857-0717 or custserv@aacc.org. eDiTorial corresPonDence Nancy Sasavage, PhD, Editor <strong>Clinical</strong> Laboratory News 1850 K Street, NW, Suite 625 Washington, DC 20006 Phone: (202) 835-8725 or (800) 892-1400 Fax: (202) 835-8725 E-mail: nsasavage@aacc.org Contents copyright © <strong>2012</strong> by the <strong>American</strong> <strong>Association</strong> <strong>for</strong> <strong>Clinical</strong> <strong>Chemistry</strong>, Inc., except as noted. Printed in the U.S.A. <strong>Clinical</strong> laboratory news (issn 0161-9640) is the authoritative source <strong>for</strong> timely analysis of issues and trends affecting clinical laboratories, clinical laboratorians, and the practice of clinical laboratory science. @cln_aacc 4 CliniCal laboratory news <strong>June</strong> <strong>2012</strong> Few Understand the Evidence screening Tests, continued from page 3 and patients had completely ignored the USPSTF recommendation. Patients’ enthusiasm alone may not be to blame <strong>for</strong> such a discrepancy between recommendations and practice. There also is reason to doubt that physicians themselves can comprehend or communicate even the basic facts about evidence when it comes to screening tests. A nationally representative survey of internal medicine physicians found that a majority were easily stumped by questions about basic statistics and would recommend a screening test to save lives based on irrelevant evidence (Ann Intern Med <strong>2012</strong>;156:340–349). The researchers expected that physicians would understand that in screening tests, survival statistics are susceptible to lead-time and overdiagnosis biases. In fact, more than 20 years ago the National Cancer Institute concluded that reduced mortality in a randomized trial could be the only reliable evidence that a screening test saved lives. However, when presented with evidence about two hypothetical screening tests, physicians in the study overwhelmingly favored a test backed by evidence of improved 5-year survival over one with an improved mortality rate. The inability of some physicians to interpret data about screening tests appears even more dire considering how USPSTF and other groups have leaned toward optional shared decision-making in their recommendations. This concept emphasizes the importance of doctor-patient collaboration to arrive at healthcare decisions and puts greater emphasis on patient autonomy and choice. The concept gained momentum especially with PSA testing after USPSTF’s 2008 “I” recommendation <strong>for</strong> prostate cancer screening in men younger than 75, which suggested that these men “should be assisted in considering their personal preferences be<strong>for</strong>e deciding whether to be tested.” Many opinion leaders in healthcare expressed deep frustration with this strategy, questioning shared decision-making <strong>for</strong> controversial screening tests <strong>for</strong> which the evidence perplexes both doctors and patients. For example, Allan Brett, MD, is among those who welcomed USPSTF’s more conservative 2011 draft recommendations against using PSA tests to screen <strong>for</strong> prostate cancer. After those draft recommendations were published, Brett, a professor of medicine at the University of South Carolina School of Medicine and member of the university’s Center <strong>for</strong> Bioethics and Medical Humanities, wrote an editorial praising USPSTF <strong>for</strong> giving physicians clearer guidance (N Engl J Med 2011; 365:1949–1951). “For two decades, primary care physicians have been expected to present a flawed online extra low-value scenarios <strong>for</strong> lab Tests go to the <strong>June</strong> issue of CLN at www.aacc.org screening test to patients, cloaking the flaws in an elaborate ritual of in<strong>for</strong>med decision making. In turn, men have been expected to make sense of a confusing mix of hypothetical outcomes,” he wrote. Due to the difficulty of digesting the data on screening, these patient-physician discussions about PSA testing were “essentially a charade,” and their decisions “reflected their general concerns about cancer or their general inclination to accept or resist medical interventions.” Brett is also the editor-in-chief of Journal Watch General Medicine. Brett also recently wrote about coping with patient pressure <strong>for</strong> unnecessary tests and procedures more generally (JAMA <strong>2012</strong>;307:149–150). Physicians have been overcorrecting <strong>for</strong> their traditionally paternalistic tendencies since the 1980s, he argued. Now the pendulum has swung too far, with physicians’ intellectual authority routinely questioned. “Yes, there should be a partnership between doctors and patients in decision-making, but when it crosses the boundary into things that don’t plausibly confer medical benefit, physicians should be able to say no,” he told CLN. These pressures on physicians are one reason that Harris advocates the use of outcomes tables that do a better job of capturing all of the potential benefits and harms of a particular screening test. “If you don’t lay it out <strong>for</strong> people, it’s hard <strong>for</strong> them to see what is meant by harms,” he said. “We need to help people see that the benign blood test that you agree to when you have a doctor visit can end up being the first step in a cascade of events that, after a while, you won’t be able to control. And that cascade can end up with your being helped, but it might also result in your being hurt.” But is it possible that giving patients more choices can boost screening where underutilization is a problem? New evidence suggests that in the case of colon cancer screening, offering patients choices about the type of test boosted compliance (Arch Intern Med <strong>2012</strong>;172:575–582). The researchers viewed these results as particularly significant because patients frequently avoid recommended colon cancer screening. They found that patients <strong>for</strong> whom colonoscopy was recommended were less likely to complete colorectal cancer screening than either those <strong>for</strong> whom FOBT was recommended or those who were given a choice between FOBT or colonoscopy. Only 38.2% of the participants in the colonoscopy group completed that procedure, compared with 67.2% in the FOBT group and 68.8% of those allowed to choose their own screening method. In an invited commentary on the study, Theodore Levin, MD, urged physicians to See screening Tests, continued on page 6 Immunoassay Reagents <strong>for</strong> <strong>Chemistry</strong> Analyzers K-ASSAY The Assay You Can Trust... ® Suitable <strong>for</strong> most chemistry analyzers such as Cobas ® , Roche/Hitachi, Beckman Synchron ® , Olympus, etc. Lipid Assessment Apolipoprotein AI Apolipoprotein AII ** Apolipoprotein B Apolipoprotein CII ** Apolipoprotein CIII ** Apolipoprotein E ** Lipoprotein(a) Coagulation Anti-Thrombin III D-Dimer Factor XIII ** FDP ** FDP-E ** Fibrinogen Plasminogen Nutritional Status Ferritin Prealbumin Transferrin Anemia Ferritin Allergy Total IgE Inflammation / Cardiac Anti-Streptolysin O Complement C3 & C4 C-Reactive Protein High-Sensitive CRP Wide-Range CRP Ferritin Fibrinogen Microalbumin Rheumatoid Factor Diabetes / Stroke Alpha-1 Microglobulin Fructosamine Hemoglobin A1c Insulin Microalbumin Serum Proteins Alpha-1 Acid Glycoprotein Alpha-1 Anti-Trypsin Alpha-1 Microglobulin Haptoglobin IgA, IgG, IgM Transferrin Kidney Function Cystatin C ** For Research Use Only. 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