Oral Health Group
Feature

Informed Consent, Record Keeping and Adverse Outcomes

November 1, 2012
by Bruce Glazer


Record keeping and informed consent are the two courses most frequently imposed on dentists involved in collegial undertakings. An undertaking can be voluntary or it can be imposed, by either the ICR (Inquiries, Complaints and Reports) or the Discipline Committee of the RCDS(O). Record keeping and informed consent appear on the RCDS(O) web site separately, yet they are intimately connected, as they form the bedrock of Risk Management. Informed consent in particular is problematic because many ill-informed dentists still believe that a signature on a consent form is all that is required to avoid liability, either in a civil lawsuit or in a college complaint process. In today’s adverse legal climate, such is not the case. The key to establishing proper informed consent concerns the scope of the discussions surrounding a proposed treatment and the chart entries recording such discussions.1 As mentioned before, a signed consent is not evidence of a discussion. The ultimate test regarding informed consent is the discussion that occurred before treatment commenced and the records that confirm those discussions.

This failure to obtain proper informed consent is a consistent problem and makes defense of a dentist difficult. Without detailed record keeping, informed consent is not possible. There are ten essential requirements in clinical record keeping starting with identification data, medical history, dental history, clinical examination, radiographic examination, diagnosis, treatment plan, reference to consent, progress notes, and ending with exit notes.2 The initial intake forms must contain both a medical and a dental questionnaire. These forms are an essential part of the ten steps of proper record keeping. Once the questionnaire has been thoroughly reviewed by the dentist, dated and signed by both the dentist and the patient, a detailed clinical examination follows. Dentists are referred to Dental Recordkeeping Guidelines RCDS(O) revised 2008 and Medical History Recordkeeping RCDS(O), Second Revision May 2008 to complete their examination intake records. This examination can be either specific (a single area of the mouth) or a complete examination. It is this detailed examination, which leads to an all-important diagnosis (very often not recorded), and a subsequent treatment plan. Proper records, which include charting, radiographs, photographs, and models will ultimately define both the diagnosis and the treatment plan. “Clinical records are a communication tool allowing a patient’s care to be accessed by the treating dentist, the patient themselves and other healthcare workers.”3 It is most frustrating when dental records are poorly completed even when the clinical work is acceptable.

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According to statistics compiled by DPL (UK), prosthodontics is the number one area for complaints in the commonwealth. The Canadian Dental Protective Association (CDPA) has statistically found the same. The question is, why? Along with its high cost is the expectation of perfection. As a multi-step process, all prosthodontic procedures are open to the summation of errors phenomena that can lead to a mediocre result.3 The CDPA confirms the opinions of other indemnifiers that the genesis of most complaints is the confluence of both precipitating (adverse outcome) and predisposing factors (poor communication, rudeness). Managing these risk factors is a productive exercise and will definitely reduce the possibility of a college complaint and/or civil litigation.

Most practitioners consider records as an afterthought and, as such, they are lacking in the detail needed for a rigorous defense. It is not possible to present material risk, an integral part of the consent process, unless all the possible complicating factors are recognized, recorded and included in the development of a treatment plan. These complicating factors will only become apparent through proper diagnostics. Other than a simple exam or non-invasive dentistry, for which implied consent applies, no dentistry should be performed until express consent has been clearly given by the patient.

In the case of elective procedures it is even more important to discuss the risks and benefits. Courts will find the consent process invalid if the patient did not receive enough material information. The best evidence of a full discussion still lies in the practitioner’s own notes. Printed lists are not adequate. Each patient is unique and the consent process must be tailored to the individual and the procedure planned. Depending on the complexity of the operation, the health and anatomical anomalies of the patient coupled with material variations, the risk factors can change. Many times the practitioner must factor in his or her own success record as compared to that of the world literature. If the informed consent process is delegated to someone other than the dentist, this person must be well trained and the dentist must personally end the discussions by directly enquiring from the patient if there are questions. Failure to do so, according to lawyers intimately involved in Health Law, will weaken the informed consent process. This lack of informed consent is a consistent problem and makes defense of a dentist difficult. Without detailed record keeping, informed consent is not possible.

In the case of a smile makeover it is imperative at the onset of treatment to understand the patients’ motivation for seeking an enhancement to their appearance and for selecting you as their clinician. Up to 15 percent of patients seeking cosmetic treatments suffer from body dysmorphic disorder.4 The patient’s expectations must be qualified in order to determine if they can realistically be met, bearing in mind the difference between a patient’s and a dentist’s perception of appearance. What may look natural to a dentist may seem entirely wrong to a patient. Any patient who feels their wishes have not been met will not be persuaded to think otherwise. If the patient does not consider that the clinician has delivered what was promised, they could potentially sue for breach of contract even if there is little or no prospect of the claim succeeding. All complaints, whether civil or collegial, should be taken seriously as either may have consequences on your ability to practice. This caveat is made evident when applying for license renewal in Ontario where a yes or no response is required to the following question: “Has a Superior Court, General Division, made a finding of professional negligence or malpractice against you?”

A distinction has to be made between elective treatment that is reversible and that which is not; obviously the latter carries a much greater risk. The popularity of smile makeovers creates the risk of clinicians selling the benefits of cosmetic enhancement while skating lightly over the risks in order to “close the deal”. When a patient arrives, having already decided what enhancement procedures they are seeking, care must be taken to temper such enthusiasm, so that the patient can fully understand the risks, rather than the clinician allowing themselves to be carried away by the patient’s own plan for the perfect smile. Even though the patient is keen to go ahead, this does not relieve the clinician of the obligation to thoroughly attend to the informed consent process, which lays down both the benefits and the risk of treatment. It is extremely important that the patient understand how committed they will be to the procedure. After preparing the teeth for veneers, patients will frequently allege that they did not realize that the procedure involved cutting sound enamel; instead believing misleading text in the literature that compared veneers to false nails.

ADVERSE OUTCOMES AND COMMON PITFALLS
Adverse outcomes abound and include: the potential for lost pulpal vitality that requires endodontic therapy, fractured or debonded veneers, extended time needed to achieve the desired result due to high patient demands
, and periodontal problems that may be created by the less than ideal margins. Dental Protection (UK), the largest indemnifier of dentists in the commonwealth has reported a 47 per cent increase in the number of complaints regarding dental veneer cases over the last five years.

Images from Figure 1-3 display a combination of veneers and full porcelain restorations where mistakes made at the chair and in the lab necessitated 4 remakes.

Common Pitfalls include wrong diagnosis/poor case selection, not recognizing parafunctional activity at the onset, failure to recognize the complexity of the case and referring to a more qualified practitioner, lack of radiographs, no vitality testing, no periodontal assessment, insufficient tooth structure, debonding, occlusal disharmony, problems with aesthetics – too bulky, wrong color, size, insufficient translucency, poor fit, improper consent, lack of information about the longevity of the restorations and the need for maintenance and possible replacement.

CDPA has documented the following concerns:

• Poor Outcome

• Treating beyond your scope (this is considered a breach of the Dentistry Act and is misconduct)

• Failure to give treatment options

• Failure to provide written treatment plans and cost estimates

• Failure to deal with complaints satisfactorily

• Poor communication

• Poor or altered non-contemporaneous dental records

ADVERSE OUTCOMES
The informed consent process can only take the dentist so far if an adverse outcome occurs during treatment. If possible, adverse outcomes should be discussed and form an integral part of the informed consent process as a material risk of treatment. When it occurs as the result of an inadvertent error, not anticipated either by staff or operator, it becomes a highly charged issue for both the patient and the dentist. Many times, the resultant outcome was discussed as a possibility (material risk), but now that it has occurred, what is the proper course of action? The event must be acknowledged and all efforts must be focused on the patient’s well being. Informed consent again must be addressed, as patients must provide consent in order to treat the adverse event. Disclosure is one of the key ingredients to avoid civil and collegial punishment. Just how much to reveal is not always readily apparent. A description of the events should be given to the patient and it should include the future consequences and the treatment required to resolve the problem. It has been suggested that clinical errors are the result of a cascade of events rather than one isolated incident. When an adverse event occurs it is important, in addition to caring for the patient, to address the reason(s) for the failure by means of a review process. This process should include all causative factors from staff to equipment. It is important not to discuss the reasons for the outcome with anyone until this review process has been completed and all causative factors are known.

Once an adverse outcome has occurred the complexity of the disclosure process depends on the gravity of the potential consequences. It is important to understand the differences between the presentation of informed consent and that of an adverse outcome. In the informed consent process we are advising the possibility of the other as a material risk. An adverse outcome is the result of an incident, which may have been discussed during the consent process, but while the likelihood of its occurrence is relatively small, the impact on the patient can be catastrophic. It is not related to any underlying medical or dental condition, but rather to the care provided to the patient. Some of these incidents are related to clinical errors, others are not.

Adverse outcomes are inevitable, but when they are the result of clinical error or poor treatment planning, they can be particularly worrying. When they occur during treatment, the interpretation of the incident varies between the patient and the clinician. We know that patients need: acknowledgment, an expression of regret, an opportunity to discuss their views, a sincere dialogue aimed at satisfying their needs, and a solution to their problem – possibly by referral. Most of all, they need continuity of care. The time to dismiss a patient is not after an adverse event has occurred.

A well-made crown, which fails due to the fracture of an endodontically-treated tooth, causes a patient to feel that they have nothing at the end of treatment and a clinician to feel that no harm has been done. The patient, however, has no tooth and they are out of pocket the cost. While this example is not related to an error, nonetheless we all make mistakes; it is how we deal with them that count in the end. The patient may suffer many emotions including frustration, anger, and sadness, which may influence their expectations of how they should be managed by the dental team. The dentist is not immune from these emotional responses either. They may also suffer from panic attacks, shame, fear, self-doubt, isolation and sadness.

THE REAL DILEMMA
For the dentist, the problem is how to have an open and honest conversation with the patient after the adverse event has occurred. It is difficult to meet the patient’s needs whilst overcoming the emotional barriers that exist. While specialists do not receive special training in this area, they do encounter more adverse outcomes due to the inherent complexity of the cases referred to them and through time learn to deal with them. There is no doubt that even when things go wrong, a favorable outcome is possible. If the adverse outcome is a result of error, it is important as mentioned previously that a root cause analysis is undertaken and time allocated by the clinician to reflect and learn from this event. When the team is involved, it is even more important to discuss openly what happened and how the team will deal with it in the future to ensure it does not happen again. The conversation that follows needs to be well structured and one that does not acknowledge fault, but rather expresses sympathy for the inconvenience and suffering that the incident may cause. Fee reduction is not necessary, but sometimes will dull the pain and lessen the inconvenience cost. It certainly is inappropriate to charge more fees to cover additional treatment needed to correct the problem. Looking into medical injury in 2002, the National Health Service in the UK found that only 11% of those afflicted wanted financial compensation and even less, 6% wanted disciplinary action, 34% wanted an apology, 23% wanted an inquiry into the causes, and 17% wanted support in dealing with the consequences. These findings are consistent in other parts of the world. Many dentists believe that an apology may pave the way for a college complaint and damage a dentist’s reputation or (his or her) practice. At least that is what is believed even if the statistics tell us otherwise. There is no question that admitting error or discussing an adverse outcome is an emotionally challenging experience. Our natural instinct is to say nothing and hope it will go away. Such is the cause of many prosthodontic complaints that are discovered later on by the patient. It is a known fact that lawsuits and complaints result from a feeling of abandonment and/or cover up by the dentist. As difficult as it may be at the time of the incident, it is important to communicate with the patient that something has gone wrong. One of our greatest fears is that an expression of regret could be seen as an admission of guilt or liability. The most important aspect of the admission is honesty. If you have taken out the wrong tooth, you have taken out the wrong tooth, and the patient needs to be told

Sticking to the basics is the best way of avoiding problems. Spending more time in the diagnostic stage of patient care will translate into better record keeping and the essential informed consent d
ialogue. This approach will not guarantee the elimination of adverse outcomes but will lessen the likelihood of a catastrophic event.OH

Bruce Glazer is the Prosthodontic Consultant to the editorial board of Oral Health. He, as well, serves as the Communication Editor and a Dental Advisor for the Canadian Dental Protective Association (CDPA). Dr. Glazer thanks Dental Protection Limited (UK) for their help in developing this article.

Oral Health welcomes this original article.

REFERENCES

1. Cronk E. Informed Consent in 2001:Don’t Leave the Office Without it. Dispatch RCDSO June 2001.

2. D’Cruz. Risk Management in Clinical Practice. BDJ 209:19-23, 2010

3. Glazer B. When 90% Is Not Good Enough. Oral Health November 2007.

4. Veneers. RiskWise UK Dental Protection June 2011.

5. Disclosure of Unanticipated Outcomes. A Toolkit for Dentists. Canadian Dental Association-Committee on Clinical and Scientific Affairs 2010.


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