From a medicolegal perspective, as well as on ethical and moral grounds, obtaining informed consent from patients prior to treatment is critically essential. In fact, in many – if not all – malpractice suits, one of the primary elements of the complaint indicates a lack of informed consent prior to treatment. Basically, plaintiffs claim that they do not fully understand the risks of undergoing a given treatment and alternative options, including the option to do nothing (as well as risks of doing nothing).

While most clinicians would likely argue that their patients are well-educated, a recent study in JADA1 suggests that even with signed written informed consent forms, they may, in fact, not understand what dentists think they do.

The 7 elements of informed consent

Seven elements of informed consent have been identified2, and informed consent is typically not considered to be adequately obtained unless all of these have been met by the patient or their legal guardian/representative:

informed consent Figure 1
  1. The patient must be competent to understand what is presented.
  2. The patient must voluntarily make the decision, not under any kind of coercion.
  3. Material information – that which is essential to making a wise decision – must be fully disclosed.
  4. The plan for treatment must be clear.
  5. The patient must adequately comprehend material information and the plan.
  6. The patient must clearly make a decision to proceed with the plan.
  7. The treatment plan must be authorized by the patient.

Informed refusal occurs only when elements 1-5 have been met, but the patient opts not to accept the plan.

While it is tempting for dentists to assume that they are obtaining informed consent when they have patients read a form and sign it to acknowledge understanding, signed forms only memorialize an attempt to inform the patient. Forms do not replace active discussion. Considering that "...the 'average' American reads at a 7th or 8th grade level,"3 it is doubtful that most patients understand fully the terminology used in informed consent documents like "paresthesia," "loss of function," "discomfort," etc. Therefore, obtaining informed consent – and informed refusal – is a process, not a single event.

The process of informed consent

informed consent Figure 2 and Cover Image

The informed consent process needs to be a cultural norm in the dental practice, using the "Tell, Show, Do" technique as much as possible. For example, in my practice, the process actually begins at the handshake with any new patient. During every conversation regarding the patient's dental health, it is my goal to educate the patient about some aspect of their condition, even if it's just "You're doing great! Your gums aren't bleeding at all, but there are some issues with your teeth that I'd like to explore with you."

While who actually can obtain informed consent depends on the laws of each state, a good rule of thumb is that whoever is actually performing a given procedure should be the person to obtain the informed consent. However, all staff members can and should play a significant role in the process. Assistants, for example, can educate patients, introduce appropriate brochures, show patients videos, review informed consent forms with patients, and serve as a witness to any discussion that doctors have with their patients. Fees can be addressed by any of the staff members who typically handle that responsibility in the practice. The doctor's role in obtaining informed consent can be as simple as making it a point to ask the patient if they have any questions or concerns about the treatment being provided and to verify with the patient what is planned for the appointment prior to initiating any treatment.

In my office, for example, it is routine for me to sit down just before donning my gloves or mask, while my hands are drying from washing or disinfection, and simple say something like, "Good morning, Mrs. Jones. As I understand, we're going to be repairing some of your front teeth today and I know that Ashley has discussed this with you. Is that right? Do you have any questions or concerns before we begin?" By doing so, if all of the other details have been handled by my team members, I am solidifying the informed consent process for that day.

A friend of mine, William Leffler, D.D.S., J.D., simplified the elements in the informed consent process.4 He suggests simply asking yourself before starting any treatment of any kind: "Is (your patient) in the BARN?" The acronym BARN means:

B: Do they understand the BENEFITS of your proposed treatment?

A: Do they know their reasonable ALTERNATIVES to your proposed treatment?

R: Do they understand the reasonably foreseen RISKS of your proposed treatment?

N: Do they know what will happen if they do NOTHING?

Some studies have been done in the medical literature, and some in dental literature, about the effectiveness of the informed consent process.1 Essentially, verbal discussions between a provider and a patient alone tend to be insufficient. Signed forms are problematic without discussion, due to literacy issues and necessary understanding of detail. When a provider has a verbal discussion along with providing informed consent forms, understanding is improved, but still tends to fall short of optimal informed consent/refusal. However, recall by patients and understanding of the risks, benefits and alternatives to treatments rendered significantly improve by adding adjunctive materials like brochures, and especially with animations or videos related to planned procedures. This, by the way, parallels what effective educators understand about the way people learn: Some learn by seeing, some learn by doing and some learn by reading; all learn by engaging.

Ways to engage your dental patients

informed consent Figure 3

Fortunately, dentistry offers many opportunities to engage our patients. Many companies for implants branded crown materials, etc., produce brochures and pamphlets. However, we need to be careful to ensure that, when we use these materials, they objectively discuss other reasonable options. Website use has expounded exponentially over the last decade, mostly for marketing purposes; however, some practices discuss the services they provide on their websites. A word of caution here: Be sure that information is objective and honest if you intend to use it as part of the informed consent process. Videos are also available to show patients about planned procedures.

Please allow me to interject here. I have had the good fortune to use several types of videos for patient education over the years in my practice, and I even served as an author for one particular company. However, in my opinion, the Spear Patient Education videos and materials are by far the best I have seen. They allow the dentist to print out written summaries of the information presented in the well-made narrated animations, and the videos are even available to embed into individual practice websites. For an example of how this can be done, feel free to take a look at my practice website: www.doctorhuff.net.

The importance of keeping a record

informed consent Figure 4

Incidentally, from a risk management perspective, it is extremely wise to keep a hard or scanned copy of any literature (with dates that they came into use and ceased to be in use in your practice) that you have freely available to your patients, even if they are simply available in a conspicuously displayed rack in your private office or reception lounge. For digital media, be sure to record the source (website) of the producing company, or keep saved copies of videos when possible. One company, I know, does not permit copying of their proprietary videos, and they update them yearly; make sure you note this. Even if you have your own website that has been rewritten, or a company is out of business that had digital media that you used, the pages can usually be retrieved through sites like WayBackMachine (http://archive.org/web/).

In the event of a lawsuit or board investigation, it may be extremely helpful to you to be able to prove that you had multiple sources of freely available information to assist in the informed consent process and to establish that patient education is the culture of your practice. By all means, however, be sure to carefully read any brochures or promotional literature that you have in your office before making it available to your patients! Plaintiff attorneys may demand copies of all marketing and educational materials that could have been available to their clients in an effort to prove that you made no attempt to provide alternative sources of information to make procedures more understandable.

The fact of the matter is, our patients likely are not as informed as we think they are. Written informed consent, discussion between the dentist and the patient about treatment at the patient's level of understanding, and the use of appropriate animations and visual aids together provide for effective informed consent. As the authors of the JADA article conclude:

"According to the available literature, adult dental patients do not always show adequate levels of understanding and information recollection from their informed consent processes, although they usually think that they understood the information provided

well. Usually, an immediate improvement of understanding and recall capabilities among adult dental patients was gained when adjunct information methods were used."1

References

1. Narjara Conduru Fernandes Moreira, et al. Informed consent comprehension and recollection in adult dental patients: A systematic review. JADA 2016:147(8):605-619.

2. http://medical-dictionary.thefreedictionary.com/informed+consent

3. https://en.wikipedia.org/wiki/Literacy_in_the_United_States

4. http://www.dentaleconomics.com/articles/print/volume-102/issue-6/feature/are-your-patients-in-the-barn-or-are-you-in-the-doghouse.html