Introduction

In previous chapters of this book, we provided an overview of evidence-based clinical practice,¹ explained how to search for² and critically appraise articles about therapy,³ harm,⁴ and diagnosis,⁵ and described how to use systematic reviews.⁶ In this chapter, we define clinical practice guidelines, describe the process of developing guidelines and the basic components of a recommendation, and provide a structure for determining the trustworthiness of recommendations about patient management included in clinical practice guidelines.

Evidence-Based Clinical Practice Guidelines

According to the Institute of Medicine⁷ of the National Academies, clinical practice guidelines are “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.” Although the authors of evidence-based guidelines follow a systematic process to identify, select, assess, and summarize evidence, they rely on the consensus of a group of decision makers, also known as a guideline panel. After reviewing the evidence, the panel typically recommends a specific course of action on the basis of the implications for those who may be affected by the recommendation. The panel’s mission is to interpret the available evidence and to consider the clinical context in which the recommendations will be applied.

Because of differences in clinical contexts and in clinicians’ attitudes toward benefits and harms, members of various guideline panels might evaluate the same body of evidence but not necessarily make the same recommendations. For example, there are major discrepancies between the recommendations formulated by guideline panels from the American Heart Association (AHA)⁸ and the National Institute for Health and Care Excellence (NICE)⁹ regarding the use of antibiotic prophylaxis for preventing infective endocarditis in patients who are at risk for developing this condition and who are undergoing invasive dental procedures. In 2008, both of these guideline panels^8,9 conducted rigorous systematic reviews that showed similar results. Although the AHA recommended the use of prophylaxis for patients with particular cardiac conditions, NICE recommended against its use in all patients, regardless of the perceived susceptibility of the patient to develop infective endocarditis. In this case, AHA guideline panelists placed a higher value on the potential benefit of the intervention than the adverse events and cost, whereas NICE panelists considered that the risk and cost of antibiotic prophylaxis outweighed the minimal benefits of administering the intervention.

Structured Process of Developing Management Recommendations

Decision-making is ubiquitous in clinical practice. Consciously or unconsciously, clinicians weigh the potential short- and long-term benefits and harms, burden of the treatment, and costs associated with alternative courses of action to arrive at a decision consistent with the patient’s best interest.¹⁰ By consulting guidelines whose authors have documented in a systematic manner both the evidence and the rationale for specific recommendations, clinicians can make sound decisions about clinical options for typical patients.

The process of developing recommendations begins when an institution or an organization defines a health care problem as a priority and initiates a call to develop guidelines to address the health care problem. After defining the scope of the guideline (for example, focusing on primary, secondary, or tertiary care) and the target audience (for example, dentists or other health care professionals who contribute to the management of oral conditions), the institution or organization selects a panel of experts and charges the panel with the task of defining the questions the guideline will answer. These questions include details about patients, clinical options (that is, one or more courses of action), and target outcomes. Using the questions, the panel (which may be expanded to include other collaborators such as information specialists and clinical epidemiologists) undertakes systematic searches of the literature to identify the highest quality available evidence, arrive at the best estimates of benefits and harms, and assess their certainty or confidence in those estimates. On the basis of evidence summaries generated from this process, the panel formulates and grades the strength of the recommendations. After producing and publishing the guideline, the panel can monitor its implementation and update the guideline when new evidence emerges (Figure 1).10,11

Figure 7.1. The Process of Developing and Updating Clinical Guidelines

Where to Find Clinical Practice Guidelines

Specific databases presenting full versions or brief summaries of evidence-based clinical practice guidelines are available (see Chapter 2). For example, by using the Trip database (www.tripdatabase.com), clinicians can find references to guidelines, which are organized according to the region in which they were developed, and links to full texts of guidelines. Databases that provide summaries of guidelines relevant to dentistry include the National Guideline Clearinghouse (www.guideline.gov) and the American Dental Association (ADA) Center for Evidence-Based Dentistry (http://ebd.ADA.org/en/evidence).

Critically Appraising Patient Management Recommendations

Regardless of whether the recommendations address preventive, diagnostic, or therapeutic interventions, clinicians need to determine the extent to which a clinical practice guideline provides trustworthy recommendations.

Are the Recommendations Clear and Comprehensive?

Optimal recommendations use a standardized format that clearly describes the suggested course of action, which alternatives were considered, and to which group of patients and under what specific clinical circumstances the recommendations apply.¹⁴

Clinicians should only follow guidelines when dealing with “typical” patients because exceptions can arise. For example, a clinician should amend all recommendations regarding antibiotics or anesthetics if a patient is allergic to a particular drug. Also, if a clinician is determining the course of action in the case of a patient who might need antibiotic prophylaxis before undergoing dental procedures, for example, the clinician should consider whether the patient has had a prior joint infection or an immune deficiency.

The extent to which guidelines should address the more common of the atypical or unusual clinical situations is a matter for the guideline panel to consider. For example, the authors of clinical guidelines may face criticism for failing to address the likelihood of multimorbidity, which commonly occurs in patients in a clinical practice.

In whatever way a panel decides to address atypical or unusual clinical situations, it is likely that they will find it impossible to foresee all the idiosyncratic situations that could arise in patient care. This is one reason that following clinical guidelines should not supersede following a clinician’s judgment; instead, clinical guidelines should provide the sort of guidance that, it is hoped, will apply to most or even nearly all of the situations that typically confront clinicians. Therefore, clinicians should anticipate that guidelines will address a broad range of patients, including most of the kinds of patients that a clinician is likely to see. Guidelines that do not do this provide only limited assistance for clinical care.

Is the recommended intervention clear and actionable?

Sometimes recommendations are too vague to provide a clear course of action to clinicians. For example, consider the following recommendation: In children, teenagers, or young adults undergoing cancer treatment—“if any invasive dental procedure is required, this should be undertaken by either a consultant or specialist pediatric dentist as appropriate.”¹⁵ Although this recommendation attempts to inform clinicians about the type of dental professional to whom they should refer a cancer patient who requires an invasive dental procedure, it fails to be specific, referring to this professional as a “consultant” (any dental professional in any specialty can be classified as a consultant). In addition, the recommendation provides two options (consultant or specialist pediatric dentist) without offering clear guidance about when or how to choose either option. An additional limitation is the use of the expression “as appropriate,” without providing additional information about how clinicians should determine what is and what is not appropriate. Another issue that may influence clinicians’ ability to act on a recommendation is a potential discrepancy between the intended population or type of patients that the panel members defined and the type of patient a clinician has in the dental chair. The credibility of recommendations is lower when the guideline panel’s definition of the patients is vague or when the patients are different from the ones the clinician wants to apply the recommendations to.

Another example is provided in the guideline addressing the prevention of orthopedic implant infection in patients undergoing dental procedures, which was developed by the American Academy of Orthopedic Surgeons (AAOS) and the ADA in 2012.¹² The authors declared, “We are unable to recommend for or against the use of topical oral antimicrobials in patients with prosthetic joint implants or other orthopedic implants undergoing dental procedures,” and graded the recommendation as “inconclusive.”^12,16 Clinicians interested in using topical oral antimicrobials in this type of patient would find no guidance from the AAOS and ADA guideline¹² and, forced to rely on their own resources (in situations in which they perhaps cannot spend the time nor have the skills to make their own assessment of the relevant evidence), could become understandably frustrated. In contrast, a guideline by the ADA Council on Scientific Affairs¹³ states the following: “In general, for patients with prosthetic joint implants, prophylactic antibiotics are not recommended prior to dental procedures to prevent prosthetic joint infection.”¹³ In this case, a clear course of action is defined (although it would be optimal if the recommendation were worded so that it is clearly a recommendation against prophylaxis, such as, “We recommend against the use of prophylaxis,” omitting the potentially frustrating qualification “In general” that suggests that there are exceptions that the recommendation has not specified).

Is the alternative clear?

Many times, for a particular clinical problem, clinicians may use a range of potentially effective treatments. When formulating recommendations, the guideline panel should state explicitly what options they considered. If the alternative course of action is not stated clearly, the recommendation remains ambiguous. For example, consider the following recommendation: “Advise adults that use of sucrose-free polyol (xylitol only or polyol combinations) chewing gum for 10 to 20 minutes after meals may reduce incidence of coronal caries.”¹⁷ Should clinicians advise patients to use chewing gum for 10 to 20 minutes after meals as opposed to not chewing gum at all, or when toothbrushing is not possible, or in addition to toothbrushing? This recommendation is unclear about whether chewing gum can replace toothbrushing or whether it should be considered an adjuvant measure to reduce the risk of coronal caries. Moreover, it is unclear whether clinicians simply should provide patients with information or encourage use of the gum. Recommendation statements should be clear and complete enough to be used and interpreted without the need to read the full text of the guideline.

Were all the relevant outcomes important to patients explicitly considered?

For any recommendation, the guideline panel should determine the balance between the benefits and the harms. This balance depends on the outcomes that were identified as being relevant for decision-making. Clinicians assessing the trustworthiness of recommendations should judge whether the panel considered all patient-important outcomes. A patient-important outcome is an outcome for which—even if it were the only outcome improved by treatment—the patient still would consider receiving the intervention, in the face of some adverse effects, costs, and burden.^18,19

Examples of patient-important outcomes in dentistry include having a prosthetic joint infection after undergoing an invasive dental procedure, oral health-related quality of life, tooth loss, pain, trismus, aesthetic issues, or dental implant failure. Surrogate outcomes may not be considered to be important individual outcomes, but they are associated with patient-important outcomes. Unfortunately, the effects of interventions on surrogates do not guarantee beneficial effects on the associated patient-important outcomes.²⁰ Surrogate outcomes in dentistry include bacteremia after an invasive dental procedure, levels of pocket probing depth, clinical attachment level, and bleeding on probing.²¹ When guideline panels use surrogate outcomes to determine the balance between benefits and harms, the resulting recommendations are less credible than when the guideline panel bases recommendations on patient-important outcomes.

Was the Recommendation Made on the Basis of the Best Current Evidence?

Guideline panelists formulating recommendations should use the best available current evidence. Clinicians using recommendations should focus on the methodology of the systematic review(s) conducted to identify, select, assess, and summarize the relevant evidence. To determine the credibility of this process, users of clinical guidelines should determine whether the literature search was comprehensive, reproducible, and current.⁶

Recommendations made on the basis of the results of systematic reviews whose authors used suboptimal or unclear methods are less credible.¹⁴ For example, the longstanding practice of prescribing antibiotic prophylaxis for all patients with prosthetic joints who need invasive dental procedures,²² probably “just to be on the safe side,” was common before 1997, when no guidelines using a systematic approach to review and summarize the literature on the topic were available. In 1997, the ADA and AAOS conducted an exhaustive review of the literature to determine whether antibiotic prophylaxis was effective in these patients.²³ On the basis of all the evidence, the 1997 guideline panel recommended (for the first time in history) against the use of antibiotic prophylaxis in patients with prosthetic joints who were undergoing invasive dental procedures, a situation that determined a dramatic change in clinical practice.²³ The contrast in clinical practice before and after the 1997 recommendation²³ highlights the value of conducting comprehensive systematic reviews of the literature to inform decision-making.

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