December, 2000

Informed Consent in Orthodontics

En Español

John R. Vaselaney, DDS, ARM

Many allegations of professional negligence are accompanied by an allegation of a lack of informed consent. In today’s consumerist environment, the informed consent process assumes greater importance as a vehicle for patient education, doctor-patient communication, and sound risk management.

Although some dentists may consider the informed consent process burdensome and time consuming, it does have a number of positive risk management effects. The informed consent discussion is the first step in managing the patient’s – and parents’ – expectations for treatment outcomes and reducing the chance of a misunderstanding. Patients who have an understanding of the risks of treatment will be less likely to institute a malpractice claim if one of the described risks actually occurs. Chart documentation of the informed consent process provides the best defense against patient allegations that they were inadequately informed about the proposed treatment and the potential for injury. Moreover, a patient alleging a claim based upon “lack of informed consent” must prove that informed consent was not given. Good communication and documentation by the dentist will increase that burden.

What is informed consent?

Informed consent is the process by which a patient is provided sufficient information to make an informed, reasoned decision regarding the proposed treatment. It is consent given by a patient, without coercion or fraud, based upon the patient’s reasonable understanding of what will take place, including the need for treatment, the benefits of treatment, any alternative treatments available, and the risks of treatment or of refusing treatment for the diagnosed condition.

Informed consent is not simply a piece of paper, although proper documentation of the informed consent process is an important aspect of patient management and risk management. The informed consent process consists of two major components:

• Discussion, including disclosure and patient education
• Documentation in the patient record, which often includes the use of written informed consent forms.

Most patients have a reasonable idea of the basic dental procedures that occur during routine examinations and treatment in a general dentistry office. Thus, patients often imply permission to have work done when they visit a general dentist’s office for routine care. Typically, orthodontic treatment would not fall within the realm of what a reasonable person would commonly know. This lack of knowledge about the benefits, alternatives, and risks of orthodontic treatment necessitates that the orthodontist inform the patient about these matters before the patient can provide an informed consent.

Informed consent represents the exclusive right for patients to determine what is done to their bodies. All states require that a patient provide a dentist with informed consent before each evaluation or treatment is started. Consider the informed consent process an educational experience for the patient with you as the teacher. The patient must receive information about the proposed treatment designed to enable him to reach an informed decision concerning its risks and benefits.

What am I required to tell the patient?

The doctrine of informed consent requires that the patient be given sufficient information about, and consider, the following:

• the nature of the proposed treatment, which includes the:
• necessity for treatment – your diagnosis
• benefits of treatment
• prognosis of treatment
• time involved
• cost involved (this isn’t part of the informed consent doctrine, per se, but more patients will make treatment decisions based on finances than on any other single factor, so I believe it should be included in the discussion)
• reasonable alternatives to the proposed treatment, including the alternative of not having the proposed treatment
• the foreseeable, material risks and potential complications of the proposed treatment

The information requiring disclosure as a basis for informed consent may differ according to the complexity of treatment and the degree of risk presented by the proposed treatment. The information for a surgical case should, therefore, be significantly more detailed than for a simple midline diastema closure.

Information pertinent to the nature of the proposed treatment should explain why your diagnosis justifies the need for treatment, as well as an explanation of the anticipated benefits.

An approximation of the prognosis of the treatment is required. No dental provider can, or should, promise a specific prognosis to a patient. Indicate the prognosis in general terms such as excellent, good, fair, or poor. More extensive discussions with the patient about any treatment recommendation with only a fair prognosis would help the patient make a more informed decision. Treating patients with a poor prognosis is a risky proposition and should be avoided. Keep in mind that predictive analysis such as model surgery and computer-altered photos may create patient expectations that exceed the final case result.

Advise the patient of an approximate cost of the treatment, including retention, and an estimate of the time involved. Be certain to update the patient whenever there is a change in cost, time or prognosis.

A patient also must understand the alternatives to the recommended treatment. You are not ordinarily required to list every available alternative orthodontic approach to treat the case. However, the alternatives presented are usually those which have a better prognosis, are less costly, involve less time, or are less risky. Some examples are surgical versus non-surgical, extraction versus non-extraction, and removable versus fixed appliances. Patients should be told why the recommended treatments are preferred over the alternatives. Patients should understand at what point in the treatment certain alternatives will no longer be available, such as in extraction cases. Additionally, general dentists performing orthodontics should inform patients that an orthodontist can also perform the procedure, if the patient prefers to see a specialist.

The patient’s treatment decision should consider the risks of the recommended treatment. You are required to inform the patient of the foreseeable, material risks of treatment. A foreseeable, material risk is one which has a reasonable likelihood of occurring and about which a reasonable person would be assumed to take an interest. As with the discussion of alternative treatments, the list of potential risks need not be all-inclusive, but should be pertinent to the patient’s condition and needs. Concentrate on risks that most commonly occur, such as periodontal inflammation, enamel decalcification, root resorption, and relapse. You should also disclose the risks, if any, of not having the recommended orthodontic treatment.

Throughout the informed consent discussion, the patient should be given every opportunity to ask questions. Your duty is to answer the questions as clearly and completely as possible and to confirm that the patient understands your replies.

That sounds like a lot of information. Can I use aids such as videotapes and CD-ROM presentations to make the process less time consuming?

Absolutely. There are many ways to inform and educate patients, including the use of CD-ROMs, pamphlets, professional or self-made videos, placards, and discussions with staff members. Regardless of what methods are used, it remains the ultimate responsibility of the dentist to be certain the patient understands what has been presented and to answer any remaining questions. Always ask both the patient and the parent, “Do you have any questions about the information you have been given or about the proposed treatment?”

Whenever adjunct aids are used, their use should be documented in the patient’s record. This can easily be done with abbreviations or short notations, such as “Pt. and mother viewed ortho tape #3″ or “Pt’s father given AAO pamphlet #12-B.” In this way, you can refer back to the tape or pamphlet if questions arise in the future. It also serves to document your education of the party granting consent.

Keep in mind that an informed consent form is also an excellent tool for educating patients.

Any other suggestions regarding the discussion?

Although you may have presented informed consent information thousands of times, it is most likely the first time the patient or parent is hearing it. “Dentalese” is often confusing, so use uncomplicated language the patient and parents will understand. If you use technical terms, provide explanations. Approach the discussion with empathy and reason, and give all participating parties every opportunity to ask questions. Present your need to obtain informed consent as a benefit to the patient. When patients are made aware that the discussion is for their own best interests, they will be more receptive and cooperative with the process.

It is desirable for you to have a staff member present during the informed consent discussion to witness the conversation and make the patient and parent(s) feel more at ease. In certain instances, it may be prudent to encourage an adult patient to have a family member present in the room as well, both for emotional support and to assist in achieving an understanding of the information.

Am I legally required to use a written informed consent form?

No. Being a process, and not a specific document, a patient can give an exclusively oral informed consent that would generally be valid in most jurisdictions. Additionally, I am not aware of any jurisdiction that legally mandates the use of a written form. However, the lack of a statute does not minimize the importance of documenting the informed consent process should a future claim arise.

What documentation of the informed consent process should be in the patient’s chart?

The ideal record entry documents what was discussed, what questions were asked, what answers were given, who was present, what handouts or aids were used, and that informed consent was given by the patient. While it is often impractical to document the entire discussion, the prudent dentist will always make some type of acceptable entry in the treatment record documenting the receipt of informed consent. An abbreviation such as “RPIC” (“received patient’s informed consent”) supplemented by additional important information regarding alternatives and risks (“patient understands possibility of relapse…”) and specific questions answered (“patient asked about possible speech changes; I advised her that some changes may occur …”) might be sufficient documentation to protect the dentist if a disagreement arises.

Such an entry should be made regardless of whether a written informed consent form is used or if the consent is entirely verbal.

If a written form is not required and I can simply make a chart entry, why would I use a written form?

There are a number of significant advantages to the written informed consent form. The first is that a written informed consent form provides more complete documentation of the information you disclosed to the patient or guardian. It more fully documents the nature, benefits, alternatives, and risks of treatment in a concise manner and doesn’t rely on the memory of you or the patient. In the event of a malpractice claim, your written consent form will be a vital element of your defense.

The second advantage is that the copy given to the patient can be reviewed at the patient’s leisure, permitting the reinforcement of the information given about benefits, alternatives, and risks.

The last advantage is that a written informed consent form serves as an excellent framework for your discussion with the patient, making the dialogue more concise, orderly, and easier to understand.

What do I need to know about written informed consent forms?

Written informed consent forms are used to supplement, but not replace, informed consent discussions. As in your discussion, your written informed consent form should use uncomplicated language that the patient will understand.

Written informed consent forms should include the following minimum information: the name of the dentist who will be providing care, the name of the treatment(s), procedure(s), or appliance(s), the nature of the proposed treatment (necessity and benefits), the general risks of the procedure and any specific risks for this patient, and the available alternatives to the recommended treatment. Additionally, the form should be able to be tailored to a particular patient’s needs using checklists and/or fill-in blanks.

Some dentists also include blank areas for patients to describe, in their own words, their understanding of the discussion. Written patient comments serve to verify that the patient has understood the information presented. Keep the original form in the patient’s chart to document the specific information given to the patient, then document the use of the form in the progress notes. Always give the patient a copy of the form to keep. It is advisable that you have the patient sign and date the form, although this is not necessary to prove that an informed consent discussion took place.

Can I simply hand the patient the form and ask them to sign it after reading it?

Although written forms, brochures, videotapes, and discussions with your staff may be used to supply the patient with information about the proposed treatment, an oral discussion must always occur between you and the patient. The discussion should be tailored to the needs of each individual case, even if only for an exchange of questions and answers after the patient has already been provided with pertinent information.

Hand the patient the form, discuss it, ask for questions, answer them, and then have the patient sign the form.

What if something truly unusual occurs that is not listed as a risk on the form?

That is why you have malpractice insurance – because not every risk can be identified, considered, or avoided. The doctrine of informed consent requires you to disclose those risks that have a reasonable likelihood of occurring, not every conceivable risk. Remote risks are a part of dentistry. If something untoward occurs, manage the events as best you can keeping the best interests of the patient at the heart of your decisions.

At what age is an individual “legal” to sign his or her own consent form?

This is a state-regulated issue. In most states, the “age of majority” – the age of adulthood at which time a person is legally responsible for their own actions – is 18 years. It would be advisable to know the appropriate age for your state before an issue arises.

Most states have provisions that permit the courts to grant “emancipated minor” status to persons under the age of majority in circumstances that meet specific legal criteria. Keep in mind that events such as childbirth and marriage under the age of 18 may not necessarily emancipate the individual.

When treating a minor, obtain the informed consent of the parent or guardian prior to beginning treatment. A minor cannot consent to his or her own treatment unless legally declared emancipated by the court.

In divorced families, do both parents need to sign the consent form?

No. It is only necessary for one parent (or guardian) to sign the form or provide verbal consent. However, it is essential that the parent granting consent be legally entitled to do so. We have all heard how contentious divorces can be, to the point where some divorce decrees have stipulated that a non-custodial parent be stripped of parental rights. If a natural parent has no parental rights, that individual is precluded from granting consent on behalf of his or her child.

Is consent dependent in any way on who is paying the bill?

No. Consent can be granted only by an adult patient for his or her own treatment, by a parent or guardian on behalf of a minor child, or by a guardian legally approved by the court for an adult incapable of granting his or her own consent (e.g., Alzheimer’s, mental illness, retardation). The person paying the bill might or might not be the person legally authorized to grant consent.

For example, the bill-paying parents of a 21 year-old college student – though they may have accepted legal responsibility for the financial aspects of treatment – are not permitted to grant consent. Consent can only be given by the child – an adult in his or her own right in the eyes of the law.

Divorces can present the most trying situations for the orthodontist. The following scenario may even be familiar to you. A divorced mother with custody of 10 year-old Tommy agrees to orthodontic treatment and grants her consent. However, she refuses to sign any documents assuming financial responsibility because her divorce agreement stipulates that her ex-husband is 100% responsible for health care expenses. Tommy’s father, who has parental rights but no custodial rights, thinks Tommy looks and functions fine and refuses to grant consent or pay for treatment. Meanwhile, the mother becomes increasingly insistent that you begin treatment.

This presents quite a dilemma: you want to help the child but have no desire to become embroiled in the battle between Tommy’s parents. Legally, the mother’s consent is all you need to begin treatment. But from a practical perspective, it would be inadvisable to proceed until someone – a parent, grandparent, aunt, whomever – first assumes financial responsibility for the case. Keep in mind that one of the most effective risk management techniques is to simply say “no” to unreasonable requests from patients and parents.

What should an orthodontist do if a minor child comes to the appointment alone or is brought by a minor sibling?

It depends on what you had planned for that appointment and how comfortable you are treating the patient without a parent present. If the appointment is for something simple that has already been discussed and consented to by the parent or guardian, go ahead with treatment. Be certain you do not perform any treatment transcending the limitations of the prior consent.

If the appointment includes making a treatment decision that will require consent, you can either phone the parent and obtain consent verbally (be sure to document your conversation in the chart) or reappoint the patient at a time when the parent will be present.

Even if consent has already been given, there may be certain appointments when the planned treatment is rather involved (such as when banding and bracketing a case), and you wish to have a parent accompany the child. You may institute an office policy that requires a parent to be present for treatment to proceed. If you have such a policy, be certain to clearly inform parents about it beforehand.

If an orthodontist refers a patient to another provider, what responsibility does the orthodontist have for informing the patient regarding the risks of the referred procedures?

In general, the referring orthodontist does not have a duty to disclose the risks of the referred procedure. Those risks would be addressed by the provider of that specific treatment. For instance, an orthodontist who refers a patient to an oral surgeon for the extraction of all four third molars generally does not have a duty to disclose the risks specific to the extraction surgery.

Although a general duty does not exist, your jurisdiction may have more stringent requirements of which you should be aware. For example, the Hawaii Supreme Court found an orthodontist liable for failing to disclose the surgical risks associated with orthognathic surgery. As a result of this decision, every health care provider in Hawaii must disclose all risks of treatment, even those risks associated with treatment to be performed by another practitioner. The potential ramifications of the Hawaii Supreme Court decision have increased the burdens imposed on all health care providers in the state.

Does having obtained informed consent provide any protection for a true instance of malpractice?

The patient’s granting of his or her informed consent acknowledges and accepts that there are risks associated with the proposed treatment when performed within or above the standard of care by the dentist. Naturally, every patient assumes that his or her dentist will provide treatment that meets or exceeds the standard of care, that is, what a reasonable and prudent dentist would do in the same or similar circumstances.

Untoward events can and do occur, even when the dentist performs treatment properly. It is in these cases that the patient’s informed consent is most helpful to the dentist’s defense, as these are the risks the patient assumed when granting informed consent.

The risks associated with a dentist’s breach of the standard of care are not contemplated in the informed consent process. Therefore, the patient’s granting of informed consent will not prohibit the patient from alleging malpractice. For example, eighteen months into a three year case you note on a periapical film that the roots of the mandibular anteriors have severely resorbed. You say nothing to the patient and continue orthodontic treatment without addressing the resorption. The fact that you listed root resorption on the consent form will not absolve you of malpractice allegations.

Keep in mind that a patient cannot consent to a negligent act and thereby waive the dentist’s professional duty to practice within or above the standard of care. If a patient asks you to perform treatment that raises professional concerns as well as your potential liability exposure, do not agree to perform the treatment.

How do the courts determine whether or not a dentist’s informed consent discussion is adequate?

It depends on the applicable standard of care used by the court for making such a judgment, which can differ from one jurisdiction to the next.

One of two standards will generally apply. The reasonable physician standard asks, “What would a reasonable and prudent physician [dentist], under similar circumstances, disclose?” The reasonable patient standard holds that the physician [dentist] must disclose all information about the treatment which a reasonable patient would deem material to his or her decision.

Whatever the standard, securing informed consent is far less expensive than failing to do so.

What should I do if my patient does not speak or understand English?

Patients who cannot understand the information you present would likely be considered unable to provide informed consent in the eyes of the court. It doesn’t matter whether the patient speaks French, Korean, Spanish, Russian, or even English — you still have the same duty to discuss the treatment with the patient, acknowledge patient understanding, and obtain informed consent. If this process cannot be implemented, it would be most prudent to NOT treat the patient.

Some patients will come to your office with a family member or advocate who is able to translate for them. In these instances, have the advocate sign the informed consent form as well, to acknowledge the presence and services of the translator. Also have the translator record his or her name, address, and phone number in case questions arise later, and place this information in the record.

If you routinely treat patients who speak the same foreign language, have your consent forms translated into that language to facilitate the informed consent process. Ensure that the form is completed in the language that the patient can comprehend.

While the information and suggestions contained in this published material have been developed from sources believed to be reliable, Continental Casualty Company (CNA) and its affiliates accept no legal responsibility for the correctness and completeness of this material and its applicability to specific factual situations. This material is not legal advice and is not intended to substitute for a doctor’s professional judgment. If counsel is required, a professional should be retained. CNA is a registered service mark of CNA Financial Corporation. © CNA Financial Corporation 2000.

Contributed by:

John R. Vaselaney, DDS, ARM
Assistant Vice President, Risk Management; CNA HealthPro