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Pathologists and Lab Professionals: Choosing Tests Wisely for Clinicians and Patients

BY LEE HILBORNE, MD, MPH, FASCP, DLM(ASCP)CM

LEE-Hilborne

Lee Hillborne, MD, MPH, FASCP, DLM(ASCP)CM, served as the 2011 to 2012 chair of the ASCP Institute Advisory Committee and spearheaded the process of determining and then defining these five tests physicians and patients should question. He is professor of pathology and laboratory medicine at the David Geffen School of Medicine, University of California at Los Angeles; global health researcher, RAND Corp, Santa Monica, Calif; and medical director of Quest Diagnostics, Southern California.

 

“The Top Five list would be a prescription for how, within that specialty, the most money could be saved most quickly without depriving any patient of meaningful medical benefit.”1
Howard Brody, MD, PhD

       When Howard Brody, MD, PhD, urged physicians within each medical specialty society to identify the top five tests that physicians and patients should question in 2010, he sparked the goal underlying the Choosing Wisely campaign. Choosing Wisely aims to promote conversations between physicians and patients about utilizing the most appropriate tests and treatments, and avoiding care whose harm may outweigh the benefits. A multiyear effort from the American Board of Internal Medicine (ABIM) Foundation, Choosing Wisely supports and engages physicians to become better stewards of finite health care resources.
       Currently, health care delivery in the United States contains practices that may provide little, if any, benefit to patients. According to a recent report from the Institutes of Medicine, as much as 30% of US health care is duplicative or unnecessary.2 When health care resources are wasted, it threatens the nation’s ability to deliver the highest quality of care possible to all patients.
       Pathologists need to play a leadership role in addressing these challenges. Like all physicians, pathologists have the ethical responsibility to place the interests of their patients above anything else when providing care. That’s why the American Society for Clinical Pathology (ASCP), Chicago, which represents more than 100,000 pathologists and laboratory professionals, joined the Choosing Wisely campaign in 2012 and announced its five initial tests on February 21, 2013.

Room for Improvement
       It is critical that pathologists and laboratory professionals contribute to improving patient care and reducing the high cost of health care in the United States. Unnecessary testing may lead to inappropriate treatment decisions and consume unnecessary resources. The primary goal of the initiative is to avoid negative consequences associated with the overuse of medical services.
       More money is spent per capita on health care in the United States than in any other country worldwide, and health care expenditures will account for 19.8% of the nation’s gross domestic product by 2020 if current spending trends remain unchanged.3 Worst of all, patients in the United States may have the most expensive care, but despite this investment, health outcomes are not the best in the world.
osherov       According to a 2010 report from the Commonwealth Fund, the United States health system ranked last overall compared to these six other industrialized countries—Australia, Canada, Germany, the Netherlands, New Zealand, and the United Kingdom. The Commonwealth Fund report measured the nations’ health system performance in five areas: quality, efficiency, access to care, equity, and the ability to lead long, healthy, productive lives.
       The United States spent $7,290 per capita compared to $3,737 spent per capita in the Netherlands, which ranked first among the seven in the Commonwealth Fund report. The level of spending in the United States threatens the sustainability of public health programs, such as Medicare and Medicaid, strains the budgets of families and businesses that struggle to cover the costs of health care, and undermines the nation’s ability to solve ongoing economic challenges. While Choosing Wisely is aimed at reducing care that provides no benefit by encouraging physician and patient conversations, making these wise choices now may help mitigate more difficult decisions about how care is delivered in the future.
       One of the five tests ASCP reviewers selected concerns avoiding preoperative testing for low-risk patients. For example, if a healthy patient with no indication of problems is having a bunion removed, the physician does not need to check the patient’s coagulation, cholesterol, and blood counts in the absence of a history that would make this important. Not everybody needs to have their vitamin D levels tested (see first test listed below). But as discussed below, there are many situations where vitamin D testing is helpful. The patient and physician together must evaluate the patient’s clinical situation, accounting for other factors that influence risk for vitamin D deficiency, such as the patient’s complexion and degree of sun exposure.
       As these laboratory test recommendations are unveiled, the next step is for pathologists and laboratory professionals to educate clinicians and patients about when patients need these five medical laboratory tests and when they do not. Most are needed in select situations; others on the list are never needed. Additionally, laboratory tests are usually so reliable that physicians and patients do not realize they have limitations. By becoming consultants to clinicians and patients, pathologists and laboratory professionals can improve the diagnostic value of laboratory tests while preventing the misuse of resources.

The Process for Determining the Five Tests
       The ASCP list of five initial tests that physicians and patients should question was spearheaded by the Society’s Institute Advisory Committee. The review panel examined hundreds of options based on both the practice of pathology and evidence available through an extensive review of the literature. Cost was not the primary concern in selecting these five tests. However, these initial five recommendations, if instituted, would result in higher-quality care, lower costs, and more effective use of our laboratory resources and personnel. Given the breadth of our practice, this is just an initial list. There are many other services that could be more appropriately used with the input of pathologists and laboratory professionals.

                                                              ASCP Initial Five Tests

|1| Do not perform population-based screening for 25-OH-Vitamin D deficiency.
Vitamin D deficiency is common in many populations, particularly in patients at higher latitudes, during winter months, and in those with limited sun exposure. Over-the-counter Vitamin D supplements and increased summer sun exposure are sufficient for most otherwise healthy patients. Laboratory testing is appropriate in higher risk patients (eg, osteoporosis, chronic kidney disease, malabsorption, some infections, obese individuals) when results will be used to institute more aggressive therapy.4,5,6,7

|2| Do not perform low-risk HPV testing.
National guidelines provide for high-risk HPV testing in patients with certain abnormal Pap smears and in other select clinical indications. The presence of high-risk HPV leads to more frequent examination or more aggressive investigation (eg, colposcopy and biopsy). There is no medical indication for low-risk HPV testing because the infection is not associated with disease progression and there is no treatment or therapy change indicated when low-risk HPV is identified.8,9,10

|3| Avoid routine preoperative testing for low-risk surgeries without a clinical indication.
Most preoperative tests performed on elective surgical patients are normal. Findings influence management in under 3% of patients tested. In almost all cases, no adverse outcomes are observed when clinically stable patients undergo elective surgery, irrespective of whether an abnormal test is identified. Preoperative testing is appropriate in symptomatic patients and those with risk factors for which diagnostic testing can provide clarification of patient surgical risk.11,12,13,14,15

|4| Only order Methylated Septin 9 (SEPT9) on patients for whom conventional diagnostics are not possible.
Methylated Septin 9 (SEPT9) is a plasma test to screen patients for colorectal cancer. Its sensitivity and specificity are similar to commonly ordered stool guaiac or fecal immune tests. It offers an advantage over no testing in patients who refuse these tests or who, despite aggressive counseling, decline to have recommended colonoscopy. The test should not be considered as an alternative to standard diagnostic procedures when those procedures are possible.16,17

|5| Do not use the bleeding time test to guide patient care.
The bleeding time test is an older assay that has been replaced by alternative coagulation tests. The relationship between the bleeding time test and the risk of a patient’s actually bleeding has not been established. Further, the test leaves a scar on the forearm. There are other reliable tests of coagulation available to evaluate the risks of bleeding in appropriate patient populations.18,19,20


Conclusion

       Participation in the Choosing Wisely campaign is critical for physicians and their medical specialty societies to help facilitate use of the most appropriate tests and treatments for individual patients. Up to 30% of medical care in the United States is duplicative or not appropriate. These services add no value, and in some cases result in harm. That is why the ASCP decided to participate in Choosing Wisely and add the voice of pathologists and laboratory professionals to the conversations to improve patient care while reducing costs.
       Now that pathologists and laboratory professionals have unveiled the first five tests, they need to educate clinicians and patients about when patients need these medical laboratory tests and when they do not. But it does not end with these five tests. There are so many medical laboratory tests that can be re-evaluated.
       At the end of this process of selecting five tests to launch ASCP’s participation in the Choosing Wisely campaign, the participating pathologists and laboratory professionals from ASCP realized that these announced five tests are just the beginning. Pathologists and laboratory professionals need to continually reflect on appropriate test utilization and educate clinicians and patients about which tests are the most appropriate for individual patients.

Lee Hilborne, MD, MPH, FASCP, DLM(ASCP)CM, is a contributing writer for CLP. For more information, contact Editor Judy O’Rourke, jorourke@nullallied360.com

References
1. Brody H. Medicine’s ethical responsibility for health care reform—The top five list. N Engl J Med. 2010;362:283-285. January 28, 2010. DOI: 10.1056/NEJMp0911423.

2. Smith M, Saunders R, Stuckhardt L, et al. Best care at lower cost: The path to continuously learning health care in America. Institute of Medicine. 2012. Accessed January 16, 2013, at http://www.nap.edu/catalog.php?record_id=13444. 

3. National Health Expenditure Projections 2010–2020. Centers for Medicare and Medicaid Services. Available at: https//www.cms.gov/NationalHealthExpendData/downloads/proj2010.pdf. Accessed January 16, 2013.

4. Sattar N, Welsh P, Panarelli M, Forouchi NG. Increasing requests for vitamin D measurement: costly, confusing, and without credibility. Lancet. 2012;379:95-96.

5. Bilinski K, Boyages S. The rising cost of vitamin D testing in Australia: time to establish guidelines for testing. Med J Aust. 2012;197(2):90.

6. Lu C. Pathology consultation on vitamin D testing: clinical indications for 25(OH) vitamin D measurement [Letter to the editor]. Am J Clin Pathol. 2012;137:831.

7. Holick M, Binkely N, Bischoll-Ferrari H, et al. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011;96(7):1911-1930.

8. Lee JW, Berkowitz Z, Saraiya M. Low-risk human papillomavirus testing and other non recommended human papillomavirus testing practices among U.S. health care providers. Obstet Gynecol. 2011 Jul;118(1):4-13.

9. Saslow D, Solomon D, Lawson H, et al. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. Am J Clin Pathol. 2012;137:516-542.

10. Zhao C, Chen X, Onisko A, Kanbour A, Austin RM. Follow-up outcomes for a large cohort of U.S. women with negative imaged liquid-based cytology finding sand positive high risk human papillomavirus test results. Gynecol Oncol. 2011; 122:291-296.

11. Keay L, Lindsley K, Tielsch J, Katz J, Schein O. Routine preoperative medical testing for cataract surgery (Review). In: The Cochrane Collaboration. John Wiley & Jones Ltd; 2012.

12. Katz R, Dexter F, Rosenfeld K, et al. Survey study of anesthesiologists’ and surgeons’ ordering of unnecessary preoperative laboratory tests. Anesth & Analg. 2011;112(1):207-212.

13. Munro J, Booth A, Nicholl J. Routine preoperative testing: a systematic review of the evidence. Health Technol Assess. 1997;1(12):1-62.

14. Reynolds TM. National Institute for Health and Clinical Excellence guidelines on preoperative tests: the use of routine preoperative tests for elective surgery. Ann Clin Biochem. 2006;43:13-16.

15. Capdenat Saint-Martin E, Michel P, Raymond JM, et al. Description of local adaptation of national guidelines and of active feedback for rationalizing preoperative screening in patients at low risk from anaesthetics in a French university hospital. Qual Health Care. 1998;7:5-11.

16. Rösch T, Church T, Osborn N, et al. Prospective clinical validation of an assay for methylated SEPT9 DNA for colorectal cancer screening in plasma of average risk men and women over the age of 50 [abstract]. Gut. 2010;59(suppl III):A307.

17. Ahlquist DA, Taylor WR, Mahoney DW, et al. The stool DNA test is more accurate than the plasma septin 9 test in detecting colorectal neoplasia. Clin Gastroenterol Hepatol. 2012 Mar; 10(3):272-7.e1.

18. Lehman C, Blaylock R, Alexander D, Rodges G. Discontinuation of the bleeding time test without detectable adverse clinical impact. Clin Chem. 2001;47(7):1204-1211.

19. Peterson P, Hayes T, Arkin C, et al. The preoperative bleeding time test lacks clinical benefit. Arch Surg. 1998;133(2):134-139.

20. Lind SE. The bleeding time does not predict surgical bleeding. Blood. 1991;77(12):2547-2552.