Treatment Decision: 20 Decision-Making in Managing the Caries Process
To arrive at an appropriate, efficient, minimally interventional approach for treating caries, the fundamentals of the pathogenesis and diagnosis of caries described in the preceding chapters need to be duly considered (Chapters 1–8). The synthesis of these elements was delineated in Chapter 9, and basic noninvasive measures which should be complemented by risk-related noninvasive measures were described (Chapters 10–13). The fundamentals of microinvasive and minimally invasive techniques were also discussed (Chapters 14–19) and will be further explained with reference to patient cases in the practical (second) part of this book (Chapters 24–26).
In addition to the biological limits and the addressed problems of patient compliance with noninvasive measures (Chapter 13), the patient′s expectations are also relevant for an adequate caries management. Frequently, invasive procedures are viewed by many of those involved in the health care system, and patients as well, as the appropriate way to manage the caries process. These procedures are consequently honored, be it psychologically (the dentist who drills is a good one, because it is an active response), and/or financially. The “wait and watch” approach of noninvasive therapy, largely based on self-management, is viewed with a certain amount of skepticism, as are microinvasive procedures. Frequently, the patient and even the dentist are afraid of the uncontrollable, rapid progression of caries lesions in the early stages of the process. In addition, dentists fear leaving microorganisms within the tooth after sealing, caries infiltration, or restoration. These considerations often lead the dentist to intervene prematurely with invasive treatment, and extensively excavate the dentin when preparing the cavity (Chapter 18). It is possible, however, to modify the existing treatment philosophy of frequent premature invasive treatment toward a less invasive approach when presented with a thorough diagnosis that reveals the possibilities and limits of the three basic treatment options: noninvasive, microinvasive, and (minimally) invasive therapy for the various sites of caries.
This chapter addresses the following topics:
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Fundamentals of evidence-based dentistry
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Fundamentals of shared decision-making
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Changing the treatment philosophy from “drill and fill” to “heal and seal”
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Limits of noninvasive therapeutic options
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Limits of microinvasive therapeutic options
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Limits of invasive therapeutic options
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Use of decision trees in choosing therapies
Fundamentals of Evidence-Based Dentistry
Therapeutic efficiency was generally evaluated unsystematically well into the 20th century. Valid and reliable assessment criteria for clinical studies based on good scientific practice and evidence-based dentistry took a long time to become established. In systematic reviews, the available literature was often filtered with a personal bias, and treatment recommendations were based on consensus or the individual opinion of (hopefully) well recognized professionals in their respective fields; initially, medicine and dentistry were more or less “eminence-based.”
BACKGROUND
The idea of evidence-based medicine dates back to the concept of “medical arithmetic” developed by British physicians. The expression is found for the first time in an article by the Scottish physician, George Fordyce, published in 1793. One of the first controlled clinical studies was also performed in Great Britain. In 1753, James Lind published the results of his experiment performed on a ship of the British fleet. He investigated how best to treat scurvy, a frequent affliction of seafarers at the time. Today, we know that this disease is caused by a vitamin C deficiency and can be easily avoided and treated. At the time, however, scurvy cost a countless number of seamen their life. James Lind prescribed six different treatment methods to 12 patients. He used the standard therapy of the time (administration of a medication for disinfection) and what can be described as a negative control (one glass of seawater daily). However, the consumption of two oranges and one lemon a day was the most successful since this was the only therapy that contained vitamin C.
In the German-speaking region, the Hungarian physician Ignaz Semmelweis (1818–1865) who worked in Vienna was the first author to recommend the introduction of “systematic clinical observation” in medical research (1848).
The book published in 1972, Effectiveness and Efficiency: Random Reflections on Health Services by Archie Cochrane, a British epidemiologist, marks the beginning of current international efforts to pursue evidence-based medicine. His observations during his wartime imprisonment in a German prisoner-of-war camp in Greece contributed to his demand for evidence-based medicine.1 Many of his fellow prisoners suffered from leg edema, and Cochrane was unaware of how best to treat it. He considered two potential therapies: 2 tablespoons of yeast extract, or 1 vitamin C tablet daily. For the study, 20 volunteers were randomized (according to prisoner number) into two groups. Although the mechanism remained unclear, the edema of the prisoners in the yeast extract group decreased significantly. Later, he described this initial clinical study as the worst yet most successful of his career. His subsequent works led to the increasing acceptance of clinical epidemiology and controlled studies. Today, Cochrane is chiefly known for the international network named after him for the evaluation of efficacy in medicine—the Cochrane Collaboration. 2
NOTE
Evidence-based medicine or evidence-based practice is understood as a systematic medical approach that is based on the best available data to provide the best possible care for patients.
Evidence-based medicine is a standardized, transparent procedure for evaluating data from studies. After collecting the relevant evidence in the medical literature relating to a specific clinical problem, the quality or validity of the evidence is assessed using clinical epidemiological tools, and the magnitude of the effect is evaluated. However, this evidence is only applied to specific patients filtered through the clinical experience of the care provider, who takes into consideration the patient′s wishes.3
NOTE
“Evidence-based medicine: what it is and what it isn′t.—It′s about integrating individual clinical expertise and the best external evidence.”4
The process involves several steps:
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Identify a relevant issue from a clinical case that can be answered.
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Plan and perform a search of the clinical literature.
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Critically evaluate the searched literature (evidence) in regard to validity and usefulness.
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Apply the selected and evaluated evidence to the individual case.
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Evaluate your own efforts.
Source: www.ebm-netzwerk.de (accessed April 19, 2011)
Patients are not treated according to a manual; this would make medicine and dentistry highly impersonal. Rather, the conclusions of the international dental and medical literature that were reached using the aforementioned principles are referenced to choose the best possible therapy (i.e., the therapy with the greatest prospect of healing or stabilizing the disease). The dentist or physician arrives at a therapy together with the patient in a participatory atmosphere.
The relevant literature on a clinical issue is evaluated using classes of evidence (Agency for Healthcare Research and Quality). Class Ia studies have the highest class of evidence, and class IV studies have the lowest class of evidence. The higher the evidence class of the recommended therapy, the better the scientific validation ( Table 20.1 ).
Treatment Recommendations
Treatments are recommended based on their classes of evidence (source: www.ebm-netzwerk.de). These are categorized as follows:
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Grade A: at least one randomized controlled study of generally high quality and consistency that directly relates to the recommendation and was not extrapolated (evidence classes Ia and Ib).
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Grade B: well-run clinical trials (excluding randomized clinical trials) that directly relate to the recommendation (evidence classes II or III), or an extrapolation from evidence level I if there is no reference to the specific issue.
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Grade C: reports from circles of experts or an expert opinion and/or clinical experience from recognized authorities (evidence category IV), or extrapolations from evidence classes IIa, IIb, or III; this level indicates that high-quality, directly applicable clinical trials were or are not available.
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Good clinical practice: when there are no experimental, scientific studies for a specific treatment method, or studies are impossible or are not being pursued yet, the treatment method remains conventional and agreement exists within a consensus group, this method is recommended as good clinical practice.
Study Types
Evidence-based dentistry and evidence-based medicine are concerned with the evaluation and assessment of clinical trials and cohort and case-control studies. In dentistry and medicine, numerous other types of studies are used. These also need to be rated to help practicing dentists evaluate therapies and diagnostic methods. In this context, it should be noted that some terms are used synonymously by the industry when marketing medical products and which can give a wrong impression about the level of evidence. This occurs sometimes when data from laboratory studies are used that purportedly demonstrate the effectiveness of a therapy or material. Laboratory studies may actually only indicate the effect of a material, for example, using so-called surrogates. A “surrogate” is a parameter that is associated with a clinical result. When interpreting such studies, care should be taken to determine whether the measured effect is also clinically significant and not just statistically significant.
Example. In a laboratory experiment with 20 samples per group, the bond strength to the enamel of a new adhesive system is greater by 5 MPa than the bond strength of an earlier system. For example, the bond strength of the older material is 40 MPa, and the bond strength of the new material is 45 MPa. Assuming a standard deviation of 5 MPa, a statistically significant difference between these values exists, given a significance level of p <0.05 and a power of 0.8). Stated more simply, the new system adheres to the enamel significantly better than the older material under laboratory conditions. The question then arises as to whether this statistically-significant higher value of a surrogate parameter is also clinically relevant: does the higher bond strength of the new material result in a longer lasting restoration? This cannot be determined from the above laboratory investigation. Frequently, there is insufficient proof of the surrogate′s relevance to the clinical result. This principle also applies to other areas of dentistry, which is why the request for (more) clinical trials is generally justified. Given these facts, laboratory results purportedly demonstrating the superiority of a new product or therapeutic approach need to be considered with a healthy degree of skepticism.
So-called in-situ studies provide an initial impression of therapeutic efficacy, or they can be used as more economical substitute methods to obtain clinical surrogate parameters. They cannot, however, replace clinical trials. The same applies to animal studies.
Another type of study, the health economic evaluation, assesses cost as a function of the efficacy and effectiveness of medical treatment or prevention options, that is, the cost-effectiveness or efficiency ( Table 20.2 ).
Complex studies are performed that usually consider numerous factors. One problem with these studies is that the data are generally based on the assumptions or results of other studies, which must have a sufficient level of evidence. Only a few areas of dentistry possess enough data for them to be used in health economic evaluations.5,6
Shared Decision-Making
The communication between the patient and physician and importance of models of interaction between professionals and clients are becoming increasingly important around the world. In many European and North American countries as well as Australia, an effort is under way to reinforce patient rights and actively include patients in the medical decision-making process.7 The health care goal is to provide relevant information to enable independent patient decisions that are considered appropriate by both the physician and patient and that are jointly implemented in a spirit of mutual responsibility.
NOTE
In many countries, attempts are under way to influence health care policy to enhance patients’ rights and include patients in the medical decision-making process.
In addition to giving greater credence to the patient′s perspective and giving greater respect to the patient′s desires, patient compliance and greater satisfaction of everyone involved in the decision-making process are considered the key advantages of the “responsible patient.” In the following, various doctor/patient interaction models will be presented, their advantages and disadvantages will be compared, and the shared decision-making process will be described in detail.
NOTE
In the shared decision-making process, a joint therapeutic decision is reached by the physician and patient.
The Doctor–Patient Relationship
For a majority of doctors and many patients as well, especially of the older generation, including a lay person in a frequently complex decision-making process requires a change in attitude regarding the doctor–patient interaction. Historically, this behavior has been paternalistic,8 that is, the physician has access to the relevant (evidence-based) information and makes decisions for the naïve patient. If the patient is well-informed about his or her illness and potential forms of therapy, and the doctor still makes decisions without involving the patient, the interaction model is one characterized by dominance.9
NOTE
Historically, the doctor–patient relationship has been paternalistic. The “doctor knows best” principle frequently ignores the patient′s perspective and is therefore crisis-prone.
It is a matter of professional responsibility to always consider the patient′s well-being and offer the best possible evidence-based therapy. However, the patient′s perspective is frequently forgotten, especially when it is believed that we are particularly good practitioners and only seek the best for our patients. For patients, an interaction model characterized by paternalism can be rather pleasant, since they enjoy a passive role and only have to follow explanations and instructions.8 Paternalistic professionals are frequently felt to be competent, especially when their decision is formulated in a friendly matter and appears plausible to the patient. If the physician is unable to satisfy the patient′s expectations or, for example, disregards social or economic factors that can have unforeseeable consequences for the patient′s life, the patient will have problems with acceptance. The asymmetrical doctor–patient relationship generated by an unequal level of professional knowledge frequently causes communication problems and crises.10 The asymmetry can cause general dissatisfaction in both doctor and patient, damage trust, lead to a lack of compliance, or cause the patient to switch to a different physician.8
Beyond dominance, classic sociology describes interactive models of informed choice and a consumer attitude. The models are distinguished according to the location of the decision, whether the person is a physician or patient, and access to and use of relevant information. Informed choice or a consumer attitude is the opposite of the dominant or paternalistic doctor–patient relationship, respectively. In both cases, the patient makes the decision independently. In the first model, the patient collects information beforehand, whereas a consumer more or less uses the doctor as a source of information and makes his or her decision autonomously based on that information.9
Including the Patient in the Decision-Making Process
Now that the Internet is available and there is free access to medical knowledge, we are increasingly encountering very well-informed patients who do not want to be considered passive “consumers” of therapies but rather want to be seen as equal partners involved in health care issues. Neither pure patient autonomy nor physician paternalism allows decision-making on an equal footing. The increased use of dialogue is reflected in shared decision-making. The goal of shared decision-making is to include the patient and perhaps his or her relatives in the medical decision-making process so that the patient′s individual needs and values are taken into account.11 By establishing a level of common knowledge, the asymmetry between the doctor–patient relationship is counteracted, the patient is able to understand diagnoses and therapies and simultaneously assumes responsibility for all the decisions.
NOTE
Shared decision-making describes an interactive model in which the doctor and patient choose a therapy as partners based on the individual patient′s needs.
This interactive model has been well received by both doctors and patients.12 More than 80% of all adult patients strongly endorse a model of shared decision-making, yet only 45% follow through.13 Nearly the same percentages are reflected for doctors; frequently a lack of time, missing, or incorrect information, patient fears or poor payment are cited as barriers to implementing shared decision-making in medical and dental offices.14 Older patients and patients lower on the socioeconomic scale tend to favor physician-based decision-making. There are also cultural and national differences. For example, only 43% of Spaniards want to actively participate in the decision-making process, whereas this is desired by 93% of the Swiss. Originally, shared decision-making was felt to be particularly appropriate in the treatment of chronic diseases or when alternative therapeutic options existed. Contrastingly, shared decision-making was not felt to be necessary when clear diagnoses existed and there were no alternative therapies. This may be essentially true; however, shared decision-making represents a style of physician communication as well as an attitude toward the patient and should not degenerate into a dominant or paternalistic form of interaction. Decision-making is of course faster when there are no alternative therapies; however, waiting and observing and refraining from immediate therapy is always an option that should be considered. In emergencies and situations in which patients feel overwhelmed, shared decision-making may be inappropriate.
NOTE
Shared decision-making is particularly useful when several therapeutic options can be discussed.
The advantages of shared decision-making include15:
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Greater patient satisfaction
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Enhanced quality of life
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Improved understanding of the disease
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Control of the situation
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Enhanced patient compliance
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Reduction of fear
Implementing Shared Decision-Making in Practice
There are a few requirements to successfully implement shared decision-making.16 Since shared decision-making is a professional–client interaction model, at least two parties are needed to participate in the process. It can be very useful to include others in the decision-making process, in addition to the doctor and patient, such as parents, family members, or non-physician medical personnel. It is important to actively include all participating patients and share all relevant information. Once a consensus has been reached, the parties commit to implement the decision and to jointly bear responsibility. To employ joint decision-making in a medical practice, the medical provider must possess basic communication skills and be able to carry out a structured medical discussion according to the Calgary–Cambridge Observation Guide (CCOG).17 Many universities have reacted to the demand to provide social and communication skills, and related content has been incorporated in medical and dental coursework.
The Nine Steps of Shared Decision-Making
Table 20.3 shows the individual steps involved in shared decision-making.18
The process starts when the doctor and patient agree that a decision needs to be made (first step). In the second step, the doctor offers his or her patient the option of shared decision-making on an equal footing. It should be emphasized that the treatment option represents a consensus that is reached between doctor and patient, but the patient has the final word. Assuming that the patient accepts the offer of shared decision-making, the information exchange phase begins with a discussion (third step). The physician informs the patient of existing therapeutic options and their benefits, side-effects, cost, etc. The presentation of the different modes of treatment should be as free of judgment as possible and based on the available evidence. The patient informs the doctor of his or her preferences as well as any reservations, worries, and fears. The advantages and disadvantages of all potential options are discussed, and the physician assumes the role of the expert who offers information. The patient interprets this information based on his or her own values and chooses a therapy. In describing the individual options, the doctor should make sure in the response phase (fifth step) that the patient has understood all the information before asking for the preferred alternative in the decision-making phase (sixth step). After this phase, both parties can provide the reasons for their perspective; the physician will provide a medical perspective and the patient will probably provide a personal perspective (seventh step). Once all information has been exchanged, the doctor and patient should jointly arrive at a decision (eighth step). It is important for both parties to justify this decision on a medical basis and taking into account all personal considerations. Then the parties commit to implement the plan of therapy (ninth step).
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Steps in shared decision-making |
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1. Agreement that a decision needs to be made |
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2. Offer of shared decision-making |
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3. Presentation of treatment options |
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4. Risk/benefit analysis of the individual options |
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5. Patient response, expectations |
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6. Which options are preferred? |
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7. Reasoning and decision-making phase |
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8. A joint decision is reached |
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9. Individual commitment to implement the decision |
Shared decision-making does not mean that the doctor offers potential treatment alternatives to the patient and directly or indirectly influences the patient′s choice through the presentation. The frequently asked question of the best therapy cannot be answered without an awareness of the patient′s needs. The patient′s question “what would you do in my situation?” may indicate a desire for paternalism, but it can also mean that the patient has not been given enough information, or is overwhelmed by the situation, or does not want to deal with it. To help inform the patient, decision trees (below) are used that depict all relevant information about a therapy in a patient-appropriate manner, that is, primarily visual information. Some health insurance companies provide their patients with decision trees relating to important issues. In dentistry, decision trees are not very widely used; however, there are some indications that their use makes shared decision-making and evidenced-based dentistry easier.
Decisions, Decisions: Noninvasive, Microinvasive, or (Minimally) Invasive?
When in Rome, Do as the Romans Do
As described in the preceding chapters, noninvasive and microinvasive therapies exist for the treatment of early lesions. These generally do not work for advanced stages of caries, and minimally invasive forms of therapy should be employed. It is difficult to identify the correct point in time for invasive therapy. This is illustrated by studies in which dentists were asked at which stage of approximal caries, as assessed on bitewing radiographs, they felt that a restoration was appropriate ( Table 20.4 ).
The information provided by the dentists differs from country to country and within a country. In France, a filling is frequently inserted when the radiograph reveals that the caries extends up to the enamel–dentin junction,19 whereas dentists in Norway tend to be more cautious.20–22 The approach of Brazilian dentists is similar to that of Scandinavian dentists,23 whereas dentists sometimes prepare a cavity much earlier in Scotland (older data) and in the United States.24,25
NOTE
The choice of invasive therapy for approximal caries differs widely in different parts of the world.
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