Working to Solve the Thyroid Cytopathology Conundrum

To the Editor.—Having followed with great interest Dr Vicki Schnadig's editorial regarding the overdiagnosis of thyroid cancer1 and the resulting Letters to the Editor, I am compelled to offer my perspective because legal issues have a central role in the discussion. Schnadig defines overdiagnosis as “detection of a medical condition that, if left undiagnosed, would cause no harm.”1(p1018),2 Schnadig promotes standardization, notes that molecular testing is not yet fully proven, and suggests that asymptomatic thyroid papillary lesions smaller than 2 cm in greatest dimension might best be termed “indolent lesion of epithelial origin” (IDLE).1(p1019) In response, Warrick and Lengerich,3 in a Letter to the Editor, suggest that defensive medicine may have a key role in overdiagnosis and overtreatment of thyroid papillary lesions; Schnadig in reply acknowledges that possibility and suggests that another possible key factor is a “tyranny of guidelines,”4(p415) to wit, an inappropriate overdependence on, and inappropriate professional self-limitation due to, guidelines.Kakudo et al joins this discussion with a Letter to the Editor,5 suggesting that overdiagnosis of papillary thyroid cancers is a North American problem, not shared by the rest of the world, and that it is due to a “malpractice climate” that promotes a great amount of defensive medicine.5 The authors state that other countries do not practice defensive medicine, or if they do they do so uncommonly and suggest, as a solution to the problem of overdiagnosis of papillary thyroid cancers in North America, that there be strict adherence to guidelines by treating physicians, that standardized criteria be used by pathologists for diagnosis of thyroid cancers, and that physicians strive to establish better patient rapport to better explain difficult diagnoses of thyroid lesions.5 The authors also suggest a 2-tiered diagnostic approach, “…one for practice in countries with a high rate of malpractice claims, and the other based on scientific evidence…”5Shah et al, in a Letter to the Editor,6 note that random sections of thyroid tissue submitted at the time of surgery may identify occult lesions and suggest, as a potential solution to the overdiagnosis problem, that the pathologist limit sampling of grossly normal thyroid tissue by close macroscopic examination of the specimen at the time of grossing. Kakudo and Bychkov, adding to the discussion in a Letter to the Editor,7 reiterate the indolent nature of the cytologically-identified thyroid “incidentalomas” and suggest altering guideline terminology to reduce confusion and uncertainty of the patient and the treating physicians. In reply, Schnadig8 notes the possibility of shared decision making in considering patient therapy in these situations and reinforces the need for excellent communication with patients and treating physicians in these cases.Renshaw and Gould, in a Letter to the Editor,9 emphasize the value of reporting risk as part of the pathologist's report in these cases; however, they note there is confusion between risk of malignancy and risk of clinically significant disease. They believe risk of clinically significant disease “should be defined by clinicians rather than pathologists….”9 Schnadig,10 in reply, underscores the extraordinary degree of fear that the words “cancer” and “malignancy” invoke and stresses the responsibility of both pathologists and treating physicians for clear, accurate communication.Two things must be considered. First, whether there actually exists an overdiagnosis of papillary thyroid cancers, and if so, whether it is essentially limited to North America. Second, if there is an overdiagnosis problem, whether defensive medicine has a significant role, whether North America's “malpractice climate” has resulted in a bifurcated diagnostic and therapeutic regimen for patients with papillary thyroid cancer based on their location within or outside of North America, and, if defensive medicine has a significant role, either limited or not limited to North America, how its reduction or elimination could assist in finding a solution to the problem of overdiagnosis.The authors involved in this discussion all agree that overdiagnosis of papillary thyroid cancer is a real and significant patient care issue. Schnadig1 presents a strong assertion for overdiagnosis, and although there is some controversy in the literature,11 other authors have written in support of that assertion.12,13 These authors also observe that there is a worldwide incidence, not limited to North America, of overdiagnosis of papillary thyroid cancer, stating that “[o]verdiagnosis was thought to be a problem specific to developing nations, but … could occur in developing nations also.”13(p2) It is reasonable then to assume that there is a significant problem with overdiagnosis of papillary thyroid cancers worldwide.Defensive medicine exists worldwide.14–17 Defensive medicine includes not only issues of overtesting and overdiagnosis but also attempts to divert potential liability. The defensive medicine issue extends far beyond overdiagnosis of papillary thyroid cancers. Perhaps the “malpractice climate” in North America differs from the rest of the world, but in fact, the existence of defensive medicine worldwide militates against that. In fact, given that in some countries medical negligence is criminalized, it is reasonable that even more defensive medicine would be practiced in those countries rather than in North America or other countries in which medical negligence falls under civil law.16 Indeed, there is some literature that suggests a North American focus might better be divided into countries because, for example, Canadian neurosurgeon defensive medicine differs from United States neurosurgeon defensive medicine.14 Schnadig and others identify additional potential causes of papillary thyroid cancer overdiagnosis, including ethical and potentially legal issues of self-referral, professional advancement, or other conflicts of interest1,18,19; however, given the evidence from the medical literature, it is reasonable to assume that defensive medicine has some significant role in the overdiagnosis of papillary thyroid cancers.The solution to the problem of papillary thyroid cancer overdiagnosis will require multidisciplinary support; however, pathologists are the cornerstone of it. Pathologists must prepare themselves, be strong, and appropriately accept the medical-legal responsibility for their evidence-based diagnoses of these thyroid lesions. This should not be troublesome; in reality pathologists accept medicolegal risk with each case signed out.20 The situation regarding medical-legal risk in these cytopathology cases of papillary thyroid lesions is no different from any other case except that with it the medical legal risk appears highlighted because it exists in a “perfect storm” of diagnostic difficulty, tempting therapeutic intervention, and a defensive medicine climate.Pathologists are powerful influencers on the global stage of medicine; we must seize the opportunity this situation provides us. If the Bethesda system contributes to overtreatment, lobby to change it or replace it with another evidence-based guideline that considers the issue of overdiagnosis, the risk of inappropriate patient concern, and the issue of therapeutic overreach. Perhaps the Schnadig1 suggestion to standardize the pathology criteria so that asymptomatic papillary thyroid lesions smaller than 2 cm be termed IDLE is a sound one. Perhaps further, in cases of IDLE, pathologists should direct the treating physician, in a clearly worded comment, to release the patient with appropriate follow-up but not surgery. If a name change is required, as Schnadig1 proposes, pathologists should not fret; we are comfortable with changing names of lesions and conditions when the evidence-based literature requires it.21A 2-tiered therapeutic system, as proposed by Kakudo et al5 should not, in my opinion, be adopted; it ignores evidence-based medicine as a tribute to the existence of defensive medicine. Evidence-based medicine must be the standard regardless of litigation climate, and pathologists, as the patient's physician and advocate, have a professional obligation to act in accordance with the current medical evidence.Shah et al6 considers the issue of identifying occult nodules unexpectedly in the surgical specimens. Because the unexpected identification of incidentalomas may occur no matter how limited a surgical specimen may be sampled, it behooves those who develop expert guidelines to take into account that possibility, and a pathologist should in that circumstance accurately document the lesional finding and clearly state its indolence and, if it is the case, state that active surveillance is appropriate rather than wider excision.The Schnadig22 reply to Shah et al6 discusses shared decision making. Shared decision making is laudable and requires accurate pathology reporting, including the pathologist's opinion regarding the risk of the identified incidentaloma. The report should heavily inform, in fact guide, the shared decision. Shared decision making cannot be a substitute for pathology reports that do not accurately and clearly address risk.These discussions all touch on patient risk and its evidence-based measurement. To some extent, the conundrum involves the placement of that patient risk; however, in large part this discussion involves the assignment of medical-legal risk. The pathologists' responsibility in these, and indeed in all cases, is to accurately diagnose. In most cases, the diagnosis itself obviously defines the patient risk. In situations like this, in which patient risk is more difficult to determine with finality, medical-legal risk becomes a considered concern; however, it remains the pathologists' responsibility to assign patient risk, even overtly, and guide patient therapy. It is likely that significant, nondelegable medical-legal risk will remain with the pathologist in these situations.It is absolutely pathologists' responsibility to address ever-present and ongoing litigation concerns at the society level. Pathology societies such as the College of American Pathologists must get more involved with the provision of clear evidence-based guidelines for papillary thyroid cancer diagnosis and other diseases and conditions, so that national, and even international, standardization occurs. The College of American Pathologists can also be valuable in developing stronger relationships with our treating physician colleagues' medical societies to assist in working toward clarity in establishing best practices for treating physicians.Whatever the solution to this conundrum, the pathologist in these cases, as in all other cases, accepts the medical-legal risk as a consulted physician determining the best course of action for the patient. Were litigation to follow a diagnosis, appropriate evidence-based literature must be presented by the defendant pathologist's expert witnesses, defending the pathologist's diagnosis and suggested patient course, including acknowledging transparently the level of uncertainty that exists. Medicine must inform law, not the other way around. We as physicians must continue to strive to not treat patients based on fears of malpractice litigation, despite our history of defensive medicine. The most successful malpractice deterrent is good patient care.20“We are the answer; so it has to be the right answer.”23 Pathologists are the diagnostic physicians who guide, and indeed, dictate, therapy. We have the nondelegable responsibility to diagnose accurately and provide counsel regarding appropriate therapy based on our diagnoses. This is true in all areas of pathology, not just papillary thyroid cancer where a perfect storm of influences have led to a problem of overdiagnosis. This remains true, regardless of ethical issues, financial motives, or fear of litigation.

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