Informed Consent: Does it Begin With Public Awareness?

By Linda G. Levin posted 02-19-2017 04:33 PM

  

Every health care provider is familiar with the term "informed consent." It is an integral part of the provision of any medical or dental procedure. During the process of informed consent, the health care provider discloses the relevant information to a competent patient so the patient can make the voluntary decision to accept or refuse treatment. The elements of informed consent include a description of the procedure to be performed, any risks, benefits and uncertainties related to the procedure as well as alternative procedures, confirmation that the patient understands the presented information and finally, documentation of the acceptance or declination of the intervention by the patient. In a review of the literature it seems that these are the consistent components of the informed consent process, however the emerging model of the patient as a consumer of health care services is leading to a re-examination of what needs to be disclosed during the informed consent process.

While we tend to focus on the particulars of treatment, does the patient also need to be informed of physician/dentist-specific variables such as professional experience, training, potential economic and research conflicts, provider illness or disability, or operative logistics and devices (1)? 

If we extrapolate from the experience of our medical colleagues, the courts have said yes in certain instances. In the court case of Johnson v. Kokemoor, the court held that a health care provider may have a legal responsibility to disclose their level of experience with a given technique (2). This case resulted when a patient suffered complications from an aneurism clip procedure performed by an inexperienced physician. In Barriocanal v. Gibbs, a medical negligence/wrongful death case held that the neurosurgeon failed to inform the patient that he had not performed that type of surgery recently and that other nearby hospitals had more expertise in that type of surgery. The court held that this failure to disclose violated the standard of care.

In Goldberg v. Boone, a surgeon performed a procedure that led to brain injury but he failed to disclose that he had only performed one similar operation in the last three years prior and that more experienced surgeons were nearby. The court examined whether this information was material to a reasonable person's decision to consent to surgery by a relatively inexperienced surgeon (3). All in all, case law has maintained the qualifications and experience of the provider are not relevant to informed consent except where such information is material and relevant to the decision making process (4). Therein lie the problem and the source of vagary in the definition of informed consent. When would the competency and training of your neurosurgeon not be material to your brain surgery?

Confounding the issue is that informed consent is determined by state case law, so the requirements vary and are not set in stone. The ADA's approach to this issue reflects this. The ADA Code of Ethics  and Professional Conduct addresses informed consent in a very general manner, as follows (5):

Principle 1: The dentist has a duty to respect the patient's rights to self-determination and confidentiality.

This principle expresses the concept that professionals have a duty to treat the patient according to the patient's desires, within the bounds of accepted treatment, and to protect the patient's confidentiality. Under this principle, the dentist's primary obligations include involving patients in treatment decisions in a meaningful way, with due consideration being given to the patient's needs, desires and abilities, and safeguarding the patient's privacy.

The ADA's Statement on Patient Rights and Responsibilities includes guidelines that patients have a right to choose their dentist and schedule an appointment in a timely manner and that they have a right to know the education and training of their dentist and the dental care team. The American Medical Association's code of ethics is similarly general and does not require physicians to disclose personal risk, training or performance measures to help their patients make an informed choice. By contrast, the American College of Surgeons does address the need to acknowledge physician-specific variables should the patient inquire but stops short of mandating full disclosure by the physician (6). The ACS' "Qualifications of the Responsible Surgeon," also states, "Surgeons are expected to study and evaluate new procedures and to become knowledgeable of and proficient with advances that are appropriate. Technical skill alone is insufficient to qualify a surgeon to perform new procedures. Procedural skills should be acquired within the context of in-depth knowledge about the disease to be treated."

So how is this relevant to us? When a patient is presented informed consent for root canal treatment by a general dentist what obligation does the dentist have to describe their training and clinical experience in performing the procedure? Asked another way, is it reasonable to request the credentials of the provider? Would it necessarily change the patient's decision to have root canal treatment performed by that particular health care provider? Should the general dentist also tell the patient that there is a specialist who has more experience and training in the recommended procedure? Is this information relevant and material to consenting to root canal treatment with a dentist? Bal writes that the health care provider must ask the question, "If one of my family members were having this procedure what information would be deemed relevant and important to making a decision to have the procedure by this particular practitioner."(1)

We have all used this analogy: "If it were your child or mother, who would you choose to perform your root canal?" Any rational person would choose the best-trained and experienced person to render care.

In most states, disclosure of the competency of the operator is not mandatory to fulfill the requirements of informed consent. With this in mind, the concept of a focused and accurate public awareness campaign that highlights the skills and experience of the endodontist becomes an important service to our patients as well as an important component of the informed consent process. In revising and prioritizing our strategic plan for the AAE, your Board of Directors and officers recognized the need to inform our patients and referring doctors about the unique qualifications of an endodontic specialist. If our patients understand that all endodontists are general dentists but not all general dentists are endodontists, the relevance of specialty care comes into sharper focus for them. Then and only then are they fully informed to make the decision of who will provide their endodontic care. Then and only then can they truly give informed consent.

(1) B.Sonny Bal and TJ Choma. "What to Disclose? Revisiting Informed Consent. Clin Orthop Relat Res. 2012 May; 470(5): 1346-1356. 

(2) Johnson v Kokemoor, 545 NW2d 495 (Wis 1996).

(3) Brigham J. Lundberg. Goldberg v Boone: Getting Away With 'Murder'-An Attempt to Exploit the Arbitrary Limits on Cross-examination Questioning, 67 MD. L REV 780 (2008).

(4) Degennaro v Tandom, 873 A2d 191, 191 (Conn App Ct 2005).

(5) ADA Code of Ethics. Chicago, Ill, USA: American Dental Association Council on Ethics, Bylaws and Judicial Affairs, 2016.

(6) Russell TR. I Need an Operation…Now What? A Patient's Guide to a Safe and Successful Outcome. Chicago, Ill, USA: American College of Surgeons; 2008.

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03-17-2017 12:38 AM

Thank you Dr. Levin for your very articulate presentation of this dilemma. Informed consent has it's origins from Common Law(1) and is required from all of us prior to initiation of any procedure that involves the potential of injury..i.e. all procedures. Considering the physical and mental injury that results from a "bad root canal" and the subsequent damage to the endodontic profession it is worth addressing this as a standard of care issue. For this to be effective though, it would have to be presented at state and local levels.
If endodontists can demonstrate that this information would more frequently than not lead to the patient changing their mind as well as lead to fewer non-healing root canal treated teeth then the boards would consider this relevant to their mission of protecting the public. Every health board finds ways to be more relevant and I have good reason to believe that this is a fair enough issue that would be heard if it has not been heard already.
In my few months of private practice as an endodontist I have found that this is a very significant differentiating factor in influencing patients' provider selection.

Reference
1. Becher, Virgil, Jr.,: The Informed Consent for the Surgical Procedure: An Introduction. Contemporary Orthopaedics 17:1, pp. 15, 1988.

02-20-2017 12:55 PM

The through and interesting 'blog" by Dr Levin and the thoughtful comment by 
Dr. Schiffman , illustrate the great potential for the AAE "Connection".
Dr. Schiffman concludes his remarks saying 'The patient respects their Generalist;
"We as Specialists hope their Generalist respects us."
It seems to me that as an association we must and should do more than hope.
Respect most often increases with -AWARENESS- which leads us back to the 
answer to Dr. Levin's question asked in her "blog and her answer that our AAE Board will direct the focus of our next public awareness campaign where it will do the most good. Congratulations and good luck !

02-20-2017 08:54 AM

Writing from the point of view as an Endodontist, while the knowledge base and procedural skills are open to all dentists, logic would dictate that the specialist should be able to see deeper into the waters than the Generalist. 

Yes, Plato did not have university training and Mozart did not graduate a school of fine arts. Although I’m confident should technology eventually come up with a real time, zero radiation guided device controlled by the likes of an iPhone 7 (its technical virtues might reduce the need for our services), currently the Endodontist is the queen of the dental chess board when it comes to diagnosing and treating pulpal disease. 

If the realm of Endodontics was reduced to white lines on final radiographs, the point would still be missed. All Endodontists are humbled by images of the arcane anatomy of cleared teeth. A carpenter will tell you that the critical element is where the new work integrates with the existing structure. All dentists manage the apical seal like blind men. These are some of the burdens of the practitioners of our craft. Yet it does not make us all equal in execution. Knowledge implies power. There is a quality known as nuance; in what we do nuance is power. Consider whether the concept of weak vs wide even enters the mind of the non-specialist? 

The number of variables in each Endodontic case, from diagnosis to final seal, is as unique as a snowflake. Technology attempts to make the process closer to knocking out hamburgers at McDonalds; we know better. Like a better ski, emerging technology makes the process better for all practitioners. But like a better ski, the better technology does not make the intermediate into a seasoned skier.

Surely the thought has occurred to each of us upon re-treating a failed case that the level of treatment that we are undoing begs the question of competence in the original diagnosis. Taken one further step, did that practitioner arrive at the primary etiology and either address it or consider whether doing the procedure was appropriate? 

In an ideal world patients would ask the right questions and insurance carriers would value the work of the specialist above that of the Generalist. As an Endodontist, I might not know some things other Endodontists know, but I do know about a lot of things  that the Generalist has never considered. 

Which brings me back to the sledgehammer of the law known as informed consent. Fine tuned words on paper reflecting the very harsh realities of legal actions are one thing. The dental community is at its best when all parties are respected for what they bring to the table. Gentleman’s agreements work well among gentlemen. In the final analysis, the patient respects their Generalist; we as specialists hope their Generalist respects us.