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Screening Tests Spark Controversy Screening Tests, continued from page 1 The Choosing Wisely Campaign dilemma we face,” he said. “But I think people trained in clinical lab science have a lot to offer here, and I hope they can help us educate clinicians.” Harris was a member of the United States Preventive Services Task Force (USPSTF) from 2003–2008. Overuse Looms, But Evades Easy Measurement Whether they be regulators, lawmakers, or pundits on the evening news, all seem to agree that the cost of healthcare is becoming unsustainable. Most recently, Medicare has projected that by 2020, national health spending could reach $4.6 trillion and comprise nearly 20% of gross domestic product. Making matters worse, it appears that the nation is addicted to profligate testing and treatments that by some estimates consume up to 30% of healthcare spending. Despite this highly charged atmosphere, professional and consumer groups have chosen to team up and weigh in on how the nation should grapple with its healthcare spending problem. In a first-of-itskind response to overuse, a new campaign called Choosing Wisely from the <strong>American</strong> Board of Internal Medicine Foundation has brought together nine top medical societies as well as Consumer Reports to educate both physicians and patients about common unnecessary tests and treatments. Each physician specialty society published a list of “Five Things Physicians and Patients Should Question.” Many of the 45 items implicate unnecessary imaging or laboratory screening tests (See Box, right). Two separate but related initiatives from the <strong>American</strong> College of Physicians (ACP) parallel Choosing Wisely. ACP, a Choosing Wisely participant, has announced its own partnership with Consumer Reports. The two organizations are developing patientoriented brochures and other resources to help patients understand the benefits, harms, and costs of tests and treatments <strong>for</strong> common clinical issues. The resources will be derived from ACP’s evidence-based clinical practice recommendations published in Annals of Internal Medicine and on the Consumer Reports website. This patient-centered initiative comes 2 years after ACP’s other project, the High Value, Cost-Conscious Care Initiative, which was aimed at physicians. The most recent product from the High Value, Cost-Conscious care series, published in January <strong>2012</strong>, focused on screening and diagnostic tests. ACP convened a workgroup of physicians under a consensus-based process to identify tests that did not reflect high-value care (Ann Intern Med <strong>2012</strong>;156:147–149). Similar to Choosing Wisely, ACP’s list of 37 clinical scenarios includes many imaging tests, but about half encompass clinical lab tests (See Online Extra). Despite testing being a target, many of the group’s recommendations may not provoke much controversy in the lab community. But if laboratorians do disagree with such recommendations, new research reveals that the medical literature on overuse of lab tests is extremely limited. A study published as part of the Archives of Internal Medicine’s Less Is More series re- viewed 114,831 publications over 21 years and found only 172 articles that addressed overuse of healthcare (Arch Intern Med <strong>2012</strong>;172:171–178). The majority of the studies focused on four interventions: antibiotics <strong>for</strong> upper respiratory tract infections, and three cardiovascular procedures. Just a handful addressed lab tests, notably PSA and fecal occult blood testing (FOBT). According to study coauthor Salomeh Keyhani, MD, MPH, the reason <strong>for</strong> the paucity of studies on overuse of lab tests is clear: too few definitive guidelines. “If you want to eliminate inappropriate care, you have to designate what exactly is inappropriate, which is not an easy thing,” she said. “Diagnostic tests are a particular challenge in terms of establishing when it’s appropriate to order them. The indications <strong>for</strong> diagnostic testing are not routinely evaluated in the same way as indications <strong>for</strong> therapeutic procedures.” Keyhani is an assistant professor of medicine and of health evidence and policy at the Mount Sinai School of Medicine in New York. Moreover, where guidelines do exist, whether <strong>for</strong> tests or treatments, they often conflict, Keyhani noted. “In the U.S., we have a free market <strong>for</strong> guidance,” she said. “We have every single medical specialty society with its own emphasis and own focus putting out guidelines, and to some extent, they disagree.” Data and Decision-Making With screening tests showing up on lists of questionable practices and under the spotlight <strong>for</strong> research on overuse, there should be no surprise that screening tests also stimulate the most public controversy. To be sure, the public has strong opinions. A seminal study in 2004 found that 74% of <strong>American</strong> adults believed that finding cancer early via screening saved lives most or all of the time, and many said that an 80-year-old who chose not to be screened was irresponsible (JAMA 2004;291:71–78). In addition, two-thirds of respondents indicated they would want to be screened <strong>for</strong> a cancer even if no treatment was available. More recently, in 2011 a draft “D” recommendation—the strongest negative statement—from USPSTF against PSA screening at any age led to public outcry and widespread media coverage (CLN 2011;37:11). USPSTF also took a more cautious view of Pap testing in March of this year, recommending women ages 21 to 65 be screened only every 3 years. Then in April, USPSTF published draft recommendations on screening <strong>for</strong> chronic kidney disease that contains an “I” statement <strong>for</strong> insufficient evidence. In recent years, USPSTF advisories have taken on more weight as most payers, including Medicare, rely heavily on their recommendations to make decisions about coverage and reimbursement. Evidence suggests that cancer screening tests in particular have unusual patterns of utilization: potentially significant overuse in some cases, and underuse in others. A Government Accountability Office (GAO) report released in January found that use of some screenings—<strong>for</strong> cardiovascular disease and cervical cancer—by Medicare beneficiaries generally aligned with clini- Group Urges Patients, Physicians to Question Tests Nine leading physician specialty societies have identified specific tests or procedures that they say are commonly used but not always necessary in their respective fields and put <strong>for</strong>ward “Five Things Physicians and Patients Should Question.” Created by the <strong>American</strong> Board of Internal Medicine (ABIM), the ABIM Foundation spearheaded the campaign. Consumer Reports—the world’s largest independent product testing organization—is working with the ABIM Foundation and the specialty societies to lead the ef<strong>for</strong>t. Consumer Reports will also work with other consumer-oriented organizations such as AARP. The nine participating specialty societies include the <strong>American</strong> Academy of Allergy, Asthma and Immunology, <strong>American</strong> Academy of Family Physicians, <strong>American</strong> College of Cardiology, <strong>American</strong> College of Physicians, <strong>American</strong> College of Radiology, <strong>American</strong> Gastroenterological <strong>Association</strong>, <strong>American</strong> Society of <strong>Clinical</strong> Oncology, <strong>American</strong> Society of Nephrology, and <strong>American</strong> Society of Nuclear Cardiology. “By identifying tests and procedures that might warrant additional conversations between doctors and patients, we are able to help patients receive better care through easy-to-use and accessible in<strong>for</strong>mation,” said James A. Guest, JD, president and CEO of Consumer Reports. “We’re looking <strong>for</strong>ward to being a part of this innovative ef<strong>for</strong>t working with the ABIM Foundation, the specialty societies, and our eleven consumer communications collaborators to get this important message out to diverse populations of patients.” In addition, the campaign announced eight new participating specialty societies that will release lists in fall <strong>2012</strong>: <strong>American</strong> Academy of Hospice and Palliative Medicine, <strong>American</strong> Academy of Otolaryngology–Head and Neck Surgery, <strong>American</strong> College of Rheumatology, <strong>American</strong> Geriatrics Society, <strong>American</strong> Society <strong>for</strong> <strong>Clinical</strong> Pathology, <strong>American</strong> Society of Echocardiography, Society of Hospital Medicine, and Society of Nuclear Medicine. Examples from “Things Physicians and Patients Should Question”: ® Don’t per<strong>for</strong>m unproven diagnostic tests, such as immunoglobulin G (IgG) testing or an indiscriminate battery of immunoglobulin E (IgE) tests, in the evaluation of allergy. ® Don’t routinely do diagnostic testing in patients with chronic urticaria. ® Don’t per<strong>for</strong>m Pap smears on women younger than age 21 or who have had a hysterectomy <strong>for</strong> non-cancer disease. ® In patients with low pretest probability of venous thromboembolism (VTE), obtain a high-sensitivity D-dimer measurement as the initial diagnostic test; don’t obtain imaging studies as the initial diagnostic test. ® Do not repeat colorectal cancer screening by any method <strong>for</strong> 10 years after a high-quality colonoscopy is negative in average-risk individuals. ® Don’t per<strong>for</strong>m surveillance testing (biomarkers) or imaging (PET, CT, and radionuclide bone scans) <strong>for</strong> asymptomatic individuals who have been treated <strong>for</strong> breast cancer with curative intent. ® Don’t per<strong>for</strong>m routine cancer screening (mammography, colonoscopy, PSA, Pap smears) <strong>for</strong> dialysis patients with limited life expectancies and without signs or symptoms of conditions detected by these tests. cal recommendations, but other cancer screening tests did not. For example, even though USPSTF recommends biannual breast cancer screening in women ages 65 to 74, only two out of three beneficiaries in this age group received a mammogram in 2008 or 2009. In the case of colorectal cancer screening, only one in four beneficiaries ages 65 to 75 received any of the recommended regimens. With PSA testing <strong>for</strong> prostate cancer, overuse was the problem: almost half of men age 75 or older were tested, contrary to USPSTF recommendations. In a more striking example, researchers at the University of Chicago Medical Center evaluated changes in national screening rates be<strong>for</strong>e and after the USPSTF 2008 recommendation against PSA screening in men older than 75. They found that PSA screening rates were unchanged from 2005 to 2010 in all age groups (JAMA <strong>2012</strong>; 307:1692–1694). Apparently, physicians See Screening Tests, continued on page 4 CliniCal laboratory news <strong>June</strong> <strong>2012</strong> 3
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