Ethical Considerations for Continued Observation of Thyroid Lesions

Commentary and Response to Discussion by
Brendan C. Stack Jr., MD, and Peter Angelos, MD, PhD

Discussion by R. Michael Tuttle, MD

question marks, colorful blocksShared-decision making and use of a surveillance protocol is central to management of patients with differentiated thyroid cancer who prefer ongoing surveillance over biopsy or surgery, noted Brendan C. Stack Jr., MD, and Peter Angelos, MD, PhD, in an opinion piece in JAMA Otolaryngology–Head & Neck Surgery. While differentiated thyroid cancer often is associated with a low risk for progression, patients should be educated that “there are never guarantees in medicine,” the authors noted.

Use of an observation protocol is not appropriate for all patients, and should only be considered for carefully selected patients on institutional review board (IRB)-approved protocols, the authors suggested. The decision to observe rather than biopsy a nodule that has suspicious features on ultrasound should take into account the risk of the thyroid lesion as well as the patient’s temperament.

“The temperament of the patient refers to a complex assessment done by the experienced physician or surgeon in the clinical encounter, and it represents the provider’s gestalt assessment of the patient,” explained Dr. Stack, Professor of Otolaryngology-Head and Neck Surgery, University of Arkansas for Medical Sciences, Little Rock, AR. “The specific temperament we are referring to here is acceptance and/or aversion of risk.  There is risk to observation, including cancer growth and spread. The implications of these risks may be clinically irrelevant (delayed treatment is no worse than the treatment that would have been offered on presentation) or catastrophic (widespread progression of a cancer during a short period of observation).”

“There is also risk to treatment such as complications of surgery, especially complications that result from more extensive surgical resections,” Dr. Stack said. “An example of this would be performing a total thyroidectomy for a small, low-risk thyroid cancer that might otherwise be selected for observation. Many of these tumors can be well managed with hemithyroidectomy. When a total thyroidectomy is offered and executed, risks of hypoparathyroidism and airway obstruction are potential complications that do not exist with hemithyroidectomy,” Dr. Stack noted.

Dr. Stack added that the recently released management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer feature the options of observation and hemithyroidectomy for small low risk thyroid cancers more prominently than the previous version of the guidelines. He added that the guidelines “represent the ongoing evolution of our understanding and approach to patient-centered thyroid cancer care.”

Patient Education is Essential
Patient education is crucial for an observation protocol and should include the following elements, according to the authors:

  • The clinical behavior of thyroid cancer, including the symptoms that may occur with progression (eg, neck mass, dysphagia, hoarseness)
  • The importance of committing to long-term follow-up visits
  • The prognosis of well-differentiated thyroid cancer
  • The ability to opt for surgery in the future

For patients who prefer an observation protocol, the authors recommended developing a written contract delineating clinical changes that would warrant a change from observation to biopsy or surgery. Thresholds that might dictate a change from observation may include “specified increase in the greatest measured diameter from baseline over a defined time interval, evidence of extrathyroidal capsular spread, and/or appearance of a new suspiciously enlarged lymph node,” the authors noted.

Discussion

R. Michael Tuttle, MD
Professor of Medicine and Endocrinologist
Memorial Sloan Kettering Cancer Center
New York, NY

While I certainly agree that patients must be provided with understandable and accurate information regarding the risks, benefits, and alternatives of all treatment options, I strongly disagree with [the authors’] opinion that any management option short of immediate biopsy and surgical resection for even the smallest papillary microcarcinoma must be done within the context of an IRB-approved protocol rather than as part of routine clinical practice. I also disagree with having patients sign a “surveillance contract” in order to avoid immediate FNA and surgery. This approach stigmatizes certain patient choices and places undue pressure on patients to accept a surgical approach, which apparently would be acceptable without signing a contract.

All the major published guidelines have consistently noted that immediate biopsy is not required for thyroid nodules less than 5-10 mm, even if they are highly suspicious by ultrasonography. If immediate surgical resection were of paramount importance and a requirement for all patients outside of a clinical trial, the guidelines would recommend biopsy for all suspicious thyroid nodules regardless of size (followed by urgent surgery), which is clearly not the case.

Furthermore, the 2015 American Thyroid Association clinical practice guidelines present active surveillance as clinically acceptable “alternative to immediate surgery” in patients with very low risk tumors, at high surgical risk, with relatively short expected life spans, or with concurrent medical conditions that require priority treatment.1 Multiple studies have demonstrated that papillary microcarcinomas are highly prevalent in asymptomatic adults (at least 10% of the adults in the U.S. have papillary microcarcinomas) and yet rarely develop into clinically significant disease even when simply followed with observation. Given the very indolent nature of low risk thyroid cancer, the risks associated with thyroid surgery and the imperfect nature of thyroid hormone replacement therapy are likely to outweigh the potential treatment benefit in most patients.

Therefore, I agree with the authors that a shared decision making model requires a presentation of all reasonable treatment options that would include both an immediate surgical approach and a thoughtful observational management approach in properly selected patients. To guide proper patient selection for an observational management approach, we recently published a clinical framework that classifies patients as ideal, appropriate, or inappropriate for active surveillance based on tumor/neck ultrasound findings, patient characteristics, and medical team characteristics.2

But rather than requiring an IRB-approved protocol or a surveillance contract for patients interested in an active surveillance approach in low risk papillary thyroid cancer, we document in the clinical record our discussion of the risks, benefits, and alternatives, just as we would for any of the key decisions that arise as part of routine clinical management in patients with differentiated thyroid cancer (eg, extent of initial surgery, extent of neck dissection, role of RAI ablation/therapy, role of systemic therapies, etc).  This approach provides appropriate documentation that all reasonable options have been presented to the patient without placing undue pressure on them to accept an immediate surgery for a tumor that is very unlikely to cause any clinical harm.

References
1. Haugen BR Md, Alexander EK, Bible KC, et al. 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer. Thyroid. 2015 Oct 14. [Epub ahead of print]

2. Brito JP, Ito Y, Miyauchi A, Tuttle RM, et al. A clinical framework to facilitate risk stratification when considering an active surveillance alternative to immediate biopsy and surgery in papillary microcarcinoma. Thyroid. 2015 Nov 5. [Epub ahead of print]

Response to Discussion

Brendan C. Stack Jr, MD, and Peter Angelos, MD, PhD

It seems to us that the only things that Dr. Tuttle disagrees with regarding our editorial are: 1) that patients on observation protocols should be part of IRB-approved studies and 2) that a written observation contract should be signed. We respectfully disagree with Dr. Tuttle about an approach that we felt would best serve practitioners across all practice settings at the present time with current guidelines. Much of what Dr. Tuttle states about immediate biopsy and treatment is not what we recommended. We subscribe to the latest version of the ATA guidelines. Any inferences of deviation from these guidelines were not intended.

November 30, 2015

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