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Breast Cancer ScreeningConflicting Guidelines and Medicolegal Risk FREE ONLINE FIRST
Published online May 30, 2013
There is considerable inconsistency and controversy in today's guidelines regarding breast cancer screening. Although the presence of a wide range of professionally endorsed options arguably gives physicians a broader set of clinically valid choices, these options may paradoxically leave clinicians feeling more exposed to claims of malpractice.
Consider the decision about how to best manage a healthy, 52-year-old woman who has no risk factors for breast cancer and presents for routine screening. Guidelines issued by 4 highly respected organizations provide conflicting recommendations about the appropriate interval for screening mammography of women aged 40 to 74 years at average risk of breast cancer, and whether clinical breast examination (CBE) should be performed.1- 4 The 2008 American College of Radiology and 2003 American Cancer Society guidelines recommend annual screening mammography for asymptomatic, average risk women aged 40 years and older.1,4 The American Cancer Society also recommends periodic CBE, “preferably annually.” In contrast, 2009 US Preventive Services Task Force (USPSTF) guidelines recommend biennial mammography for women aged 50 to 74 years and deem existing evidence insufficient to support a conclusion about the benefit of CBE.2 The 2011 American College of Obstetricians and Gynecologists guidelines state that CBE should be performed annually and that although mammography should be offered annually, biennial mammography may be “more appropriate or acceptable” for some women.3
In this case example, a physician who is inclined to adhere to USPSTF recommendations and advise biennial mammography without CBE may fear that this choice will expose him or her to greater liability risk. The physician may wonder whether the decision would stand up to allegations of malpractice in the event of a delayed diagnosis of cancer because other reputable guidelines recommending more frequent CBE and mammography were not followed. The dilemma is intensified if the radiologist interpreting the patient's last screening mammogram, relying on American College of Radiology guidelines, recommended annual screening to the patient despite no concerning findings.
What role would the practice guidelines likely play in malpractice litigation? Practice guidelines are designed to synthesize evidence and promote adherence to standardized, evidence-based courses of treatment about which expert bodies in the medical community have reached agreement. The legal standard of care in malpractice cases (negligence), on the other hand, is set by how a reasonable practitioner would perform in a similar situation. In determining whether care meets the legal standard, courts seek to make a determination of what is reasonable under the circumstances, and often look at customary practice (either local or national) in the process. Courts have repeatedly held that expert witnesses can use practice guidelines when testifying about the legal standard of care, but guidelines alone do not establish it.5 Nevertheless, deviating from a reputable guideline can give any physician pause; unfortunately, in this breast cancer screening situation, deviation is inescapable.
It may be tempting to reason that more frequent mammography and CBE reduces the risk of being sued by decreasing the likelihood of missing an early diagnosis of breast cancer. However, clinicians must weigh this possible medicolegal benefit against 3 countervailing considerations. First, mammography can involve physical and emotional harm to patients, especially due to false-positive results.2- 3 Second, at a population level, the gain in detection comes at a significant price. Performing CBE costs less, but may lead to additional follow-up imaging costs and undue worry for patients, and it detects relatively few cases of cancer that would be missed with regular mammography. Third, recent evidence suggests that despite its effectiveness in detecting early-stage breast cancer, screening mammography may have only small effects on breast cancer mortality.6
The USPSTF's recommendation was based on the finding that biennial mammography “produced 70% to 99% of the benefit of annual screening, with a significant reduction in the number of mammograms required and therefore a decreased risk for harms.”2 One interpretation of the USPSTF's recommendation is that at both the patient level and the societal level, the marginal benefit from additional screening is outweighed by the harm. But a plaintiff's attorney might still argue that the USPSTF is conceding that biannual screening is less effective than annual screening in detecting cancer. While physicians may be justified in ordering mammograms less frequently, they may be concerned about how well the attorney's argument might play before a jury. What should physicians do in situations like this?
When guidelines offer conflicting recommendations, physicians should strive to secure the patient's understanding that based on the current guidelines, there is more than one “right” answer when it comes to breast cancer screening. Physicians should also clearly document in the medical record the rationale for their recommendation and the final decision after discussion with the patient. Such communication and documentation can help demonstrate the reasonableness of treatment decisions and avoid potential lawsuits. Physicians should also understand that the greatest liability risk for missed diagnosis of breast cancer may not arise from inadequate screening in asymptomatic patients. A study of closed claims found that the majority of claims for missed or delayed diagnosis of breast cancer were due to failure to order proper evaluation of known clinical (eg, palpable lumps) or mammographic abnormalities.7
To help physicians feel safer in exercising discretion about which breast cancer screening guideline to follow, 2 system-level changes could be made. First, physician practices, hospitals, and health systems should ensure that their physicians—whether primary care physicians, obstetrician-gynecologists, radiologists, breast cancer surgeons, oncologists, or others—give patients consistent recommendations. For example, recommendations in a mammography results letter that reflect 1 set of screening guidelines when the ordering physician is following another may create both confusion and legal risk. Similar consequences may ensue when a treating oncologist or surgeon tells a patient with breast cancer properly detected on biennial screening that he or she would have performed screening annually. Creating consistent recommendations will require that institution-wide, multidisciplinary teams come together to generate consensus decisions. As larger integrated health systems or accountable care organizations become more prevalent, the need for consistency will only grow.
Second, state legislatures could pass “safe harbors” laws that afford liability protection to physicians who comply with approved guidelines or protocols.8 Safe harbors would not only clearly signal to physicians what the courts (and society) consider a reasonable course of action, but also would help educate patients about the standard of care and whether their physician departed from it. With greater assurance about what the law permits, physicians could focus clinical conversations on what makes sense for the patient rather than what is needed to protect against liability risk. Ultimately, by offering clinicians a direct incentive for adhering to accepted standards, safe harbors might reduce unnecessary variation, lower costs, and improve the quality and safety of care.
In summary, the presence of conflicting practice guidelines may heighten physicians' sense of vulnerability to allegations of malpractice. Fortunately, these types of overt conflicts among guidelines are rare. Physicians should resist the temptation to reflexively follow the more aggressive guideline simply to avoid liability risk—needless cost and harm can result. Rather, they should clearly communicate and document the rationale for the recommended screening strategy. Such communication may also bring to light patient values and preferences that help the physician choose the best screening strategy for each individual patient.
AUTHOR INFORMATION
Published Online: May 30, 2013. doi:10.1001/jama.2013.7100
Author Contributions: The authors contributed equally to the conception and writing of the manuscript.
Conflict of Interest Disclosures: Both authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Mello reports receiving support from an investigator award in health policy research from the Robert Wood Johnson Foundation and receiving honoraria from various hospitals and professional societies for presentations on the topic of malpractice reform. Dr Kachalia reports receiving honoraria from QuantiaMD, Zurich Insurance Group, and various hospitals and professional societies for presentations on the topics of safety and malpractice reform.
REFERENCES
American College of Radiology. ACR practice guideline for the performance of screening and diagnostic mammography. 2008. http://www.acr.org/~/media/ACR/Documents/PGTS/guidelines/Screening_Mammography.pdf. Accessed August 31, 2012
Screening for breast cancer: US Preventive Services Task Force recommendation statement. Ann Intern Med. 2009;151(10):716-726W-236
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American College of Obstetricians and Gynecologists. Practice bulletin No. 122: breast cancer screening. Obstet Gynecol. 2011;118(2 pt 1):372-382
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Smith RA, Saslow D, Sawyer KA, et al; American Cancer Society High-Risk Work Group; American Cancer Society Screening Older Women Work Group; American Cancer Society Mammography Work Group; American Cancer Society Physical Examination Work Group; American Cancer Society New Technologies Work Group; American Cancer Society Breast Cancer Advisory Group. American Cancer Society guidelines for breast cancer screening: update 2003. CA Cancer J Clin. 2003;53(3):141-169
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Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. Univ PA Law Rev. 2000;149(3):645-710
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Bleyer A, Welch HG. Effect of three decades of screening mammography on breast-cancer incidence. N Engl J Med. 2012;367(21):1998-2005
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Gandhi TK, Kachalia A, Thomas EJ, et al. Missed and delayed diagnoses in the ambulatory setting: a study of closed malpractice claims. Ann Intern Med. 2006;145(7):488-496
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Bovbjerg RR, Berenson RA. The value of clinical practice guidelines as malpractice “safe harbors.” 2012. http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2012/rwjf72667. Published April 2012. Accessed May 22, 2013
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