Informed Consent in Spine Surgery

The doctrine of informed consent refers to the requirement that a patient have sufficient information and understanding prior to making decisions about their medical care. The process of obtaining a patient’s informed consent plays a critical role in ensuring ethical and legal standards are met prior to the decision to undergo spine surgery. In general, important components of informed consent include the following: (1) information about the patient’s diagnosis, (2) the treatment recommendation, (3) alternative treatment options, (4) the risks and benefits of the recommended treatment, and (5) the expected result of the treatment options being considered.[1]

The precise legal definition of what constitutes adequate informed consent has evolved over time and varies between jurisdictions. In fact, the seminal case credited with shaping the current legal standard in the United States relates to spine surgery. Canterbury v Spence, which was decided on appeal in 1972, redefined the legal concepts of the doctor-patient relationship and informed consent.[2] The case involved George Canterbury, a 19-yearold man who underwent a thoracic laminectomy in Washington, DC, in 1959 by Dr. William Spence. After a postoperative fall from his hospital bed, Canterbury developed paraparesis and incontinence. He underwent emergent revision surgery after which he did not completely recover. Canterbury filed a lawsuit, claiming that he had not been adequately informed about the risks associated with the procedure.

Although incomprehensible to physicians today, conventional medical doctrine at the time held that physicians not disclose upsetting or negative information to patients in order to prevent emotional harm. This meant that during the pre-Canterbury era, patients were often not told about terminal diagnoses or serious risks associated with treatment. Consistent with this practice, Dr. Spence admitted he did not discuss paralysis as a risk of thoracic laminectomy because he was concerned this would deter the patient from proceeding with surgery. The jury eventually ruled that Dr. Spence did not meet his duty to disclose the risks of surgery. The ruling transformed the standard for disclosure of risk from what another surgeon would deem appropriate to share with a patient to that which a patient would expect to know before electing to proceed with surgery. Today, failure to obtain adequate informed consent is a frequent complaint in malpractice litigation involving spine surgeons. A 2017 review of the Westlaw Next database found that among 233 cases of spine surgery litigation, 153 cases (66%) cited an allegation of inadequate informed consent.[3] A 2011 study of litigation related to cervical spine surgery found that lack of informed consent was involved in 44 (56%) of the 78 cases studied.[4]

Despite its importance, the process of obtaining adequate informed consent from patients prior to spine surgery faces many challenges. Spine conditions and their associated surgical treatments are complex and involve significant detail. Expected outcomes after surgery can be uncertain and the reported risks of many types of spine surgery vary greatly within the literature. Patients undergoing spine surgery may also be of advanced age or may have limited health literacy making it difficult for them to comprehend and retain the information they are given.[5] Chronic pain and the use of psychoactive medications are common in patients undergoing spine surgery and affect patients’ ability to understand complex information. The current structure of the healthcare system places significant time constraints on office visits, further limiting opportunities for discussion. Despite these challenges, surgeons remain obligated to ensure a patient’s informed consent.

It is important to understand that a signed consent form does not mean that the requirements for informed consent have been met. Rather than thinking of consent as a signed document or a single event, surgeons should consider informed consent as a process involving discussion and assessment of patient understanding. There are several steps that spine surgeons can take to improve the process:

• Emphasize the importance of informed consent. Ensure that the patient understands that they play an important role in the decision-making process. Reinforce their autonomy and the fact that the decision to proceed with surgery is theirs.

• Use clear and understandable language. Avoid using complex medical terminology when discussing the procedure with patients. Instead, use plain and simple language to ensure that patients can comprehend the information being provided.

• Provide written materials. Along with the verbal discussion, provide written materials that outline the procedure, potential risks, expected outcomes, and alternative treatment options. These materials can serve as references for patients to review at their own pace and reinforce their understanding.

• Use visual aids. Visual aids such as diagrams, models, or even computer simulations can be utilized to help patients visualize the spine, the surgical procedure, and the potential impact of the surgery. These aids can make complex concepts more accessible and improve patient comprehension.

• Encourage involvement of family members or support persons. Patients may find it helpful to have a family member or a trusted support person present during the informed consent process. This person can provide emotional support and help the patient process the information more effectively.

• Assess understanding. Ask patients to recall the risks and alternatives to surgery that were discussed. Ask them if they fully understand the information they were given and encourage them to ask questions to fill in any gaps in knowledge.

• Document the consent process. Record the details of the discussion, any questions asked, the information provided, and the patient’s agreement to proceed with the surgery. Documentation serves as evidence that the process was conducted appropriately and that the patient was well informed.

Informed consent remains a critical part of patient care in spine surgery. While many obstacles to providing adequate informed consent exist, a variety of strategies are available to help surgeons ensure that a patient has an adequate understanding of their treatment options. Providing effective informed consent strengthens the doctor-patient relationship and enhances patient’s trust. In doing so, spine surgeons can reduce the likelihood of adverse outcomes in malpractice litigation and improve the overall quality of care they provide.

References

1. Walston-Dunham B. Medical Malpractice: Law and Litigation. Thomson/Delmar Learning; 2006.

2. Murphy WJ. Canterbury v. Spence —the case and a few comments. Forum. 1976;11:716-726.

3. Grauberger J, Kerezoudis P, Choudhry AJ, et al. Allegations of failure to obtain informed consent in spinal surgery medical malpractice claims. JAMA Surg. 2017;152:e170544.

4. Epstein NE. A review of medicolegal malpractice suits involving cervical spine. J Spinal Disord Tech. 2011;24:15-19.

5. Lo WB, McAuley CP, Gillies MJ, et al. Consent: an event or a memory in lumbar spinal surgery? A multi-centre, multi-specialty prospective study of documentation and patient recall of consent content. Eur Spine J. 2017;26:2789-2796.

AUTHOR

Brandon P. Hirsch MD

From The CORE Institute in Phoenix, Arizona.