The practice of evidence-based medicine combines physician experience, knowledge of current literature, and patient preferences. Different grading systems are used to evaluate current levels of evidence and recommendations. A variety of common instruments are used to measure outcomes in facial plastic surgery. These instruments are used for expert data collection, including assessment of pathology and response to treatment, or for patient-reported outcome measures, including quality of life, disability, and daily function. Integration of data collection requires storage and protection of health information. We provide an outline to what is involved in understanding evidence-based medicine and incorporating it into daily practice.
Key points
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Evidence-based medicine combines physician experience, knowledge of current literature, and patient preferences.
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Levels of evidence (LOE), determined by the design of the study, are applied to studies pertaining to clinical treatments and outcomes.
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The LOE should not imply a sense of quality, as there are studies with low LOE that provide strong recommendations, and likewise there are studies with high LOE that are flawed or fail to provide strong recommendations.
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Patient-reported outcome measures in facial plastic surgery evaluate quality of life, functional impact, disability, and body image.
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Expert data collection can be applied to facial nerve function, scar assessment, and facial rejuvenation.
Introduction/Overview of evidence-based medicine
The introduction of evidence-based medicine (EBM), defined by Sackett and colleagues as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients,” caused a paradigm shift in how medicine is practiced. Medical schools and graduate medical education now incorporate EBM into training of medical students and residents. EBM, however, is a lifelong practice, and is thus important to continue even after graduation from residency. At its core, EBM incorporates 3 basic concepts: using the best research evidence available, applying the clinical expertise of the clinician, and understanding patient values. It is important for the practicing facial plastic surgeon to understand these concepts inherent in EBM so as to improve the health outcomes of patients and improve the quality of research in the field.
Incorporation of EBM into practice, more specifically, involves formulating clinically relevant questions, collecting the appropriate information, evaluating results, and applying the information to patient care. In this article, we aim to provide the building blocks to understanding and practicing EBM:
- 1.
Understanding level of evidence and strength of recommendations in clinically relevant literature
- 2.
Keeping updated with current literature and recommendations, and knowing where to search for pertinent information regarding specific clinical questions
- 3.
Collection of data (patient-reported, observer-reported, and objective photodocumentation)
- 4.
Evaluation of results and application to patient care as well as personal development
Introduction/Overview of evidence-based medicine
The introduction of evidence-based medicine (EBM), defined by Sackett and colleagues as “the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients,” caused a paradigm shift in how medicine is practiced. Medical schools and graduate medical education now incorporate EBM into training of medical students and residents. EBM, however, is a lifelong practice, and is thus important to continue even after graduation from residency. At its core, EBM incorporates 3 basic concepts: using the best research evidence available, applying the clinical expertise of the clinician, and understanding patient values. It is important for the practicing facial plastic surgeon to understand these concepts inherent in EBM so as to improve the health outcomes of patients and improve the quality of research in the field.
Incorporation of EBM into practice, more specifically, involves formulating clinically relevant questions, collecting the appropriate information, evaluating results, and applying the information to patient care. In this article, we aim to provide the building blocks to understanding and practicing EBM:
- 1.
Understanding level of evidence and strength of recommendations in clinically relevant literature
- 2.
Keeping updated with current literature and recommendations, and knowing where to search for pertinent information regarding specific clinical questions
- 3.
Collection of data (patient-reported, observer-reported, and objective photodocumentation)
- 4.
Evaluation of results and application to patient care as well as personal development
Levels of evidence
Levels of evidence (LOE) are designations from the Oxford Centre for Evidence-Based Medicine (OCEBM) scale that stratify “likely best evidence” based on rigor of study design and susceptibility to bias. It was designed to act as a shortcut to assist clinicians in rapid appraisal of the available evidence; searching for studies based on LOE allows clinicians to efficiently narrow down searches to manageable quantities. LOE is assigned only to clinical and therapeutic studies. Studies that are basic science, non–human-based, diagnostic, and cadaver-based are not assigned LOE. The hierarchy of evidence ( Table 1 ) assigns LOE in ascending order starting with the expert opinion, assigned the lowest LOE score of 5, and ending with randomized controlled trials (RCTs) and meta-analyses, assigned the highest LOE score of 1. However, a higher LOE does not necessarily indicate more useful evidence, as studies with higher LOEs are typically associated with common diseases and more uncommon and rarer diseases are associated with lower LOEs. Similarly, the surgical literature has been shown to have more studies associated with lower LOE, whereas studies dealing with nonsurgical treatment modalities tend to have higher LOE.
| Level of Study | Types of Studies |
|---|---|
| Level 1 | Randomized controlled trial (RCT) or meta-analysis of RCTs |
| Level 2 | Prospective (cohort or outcomes) study with an internal control group or meta-analysis or prospective, controlled studies |
| Level 3 | Retrospective (case-control) study with an internal control group or a meta-analysis of retrospective, controlled studies |
| Level 4 | Case series without an internal control group, retrospective reviews, uncontrolled cohort studies |
| Level 5 | Expert opinion without explicit critical appraisal, or on the basis of physiology/bench research |
Although LOE can provide insight into the quality of study design, it is important to understand that LOE does not evaluate the quality of evidence within a particular study. Similarly, LOE designation does not provide recommendations with any degree of certainty, as that decision must be made based on several factors: the clinician’s background knowledge of the disease process and available treatment options, the similarities of study population characteristics to the patient, and the compatibility of patient values and circumstances with the treatment option.
Strength of recommendations
The strength of a clinical recommendation is equally important and complementary to knowledge of the LOE. It is important to understand the distinction between quality of evidence and strength of recommendation, as failure to distinguish the 2 may lead to confusion. A weak recommendation may be provided despite high quality of evidence; likewise, low quality of evidence can result in strong recommendations. Of the classification systems available, the GRADE (Grades of Recommendation, Assessment, Development, and Evaluation) approach assesses the quality of evidence and strength of recommendations in health care, and has been widely adopted by organizations including the World Health Organization, the American College of Physicians, and the Cochrane Collaboration. This system is distinct from the LOE assigned by the OCEBM, and uses its own criteria to assess both quality of evidence and subsequent strength of recommendations ( Table 2 ). Quality of evidence is graded high, moderate, low, or very low. Strength of recommendations are strong or weak, and for or against using an intervention. Factors that affect the strength of recommendation include quality of evidence, uncertainty about the balance between desirable and undesirable effects, patient values and preferences, and whether the intervention represents a wise use of resources.
| Recommendation | Strength of Recommendation |
|---|---|
| 1 | Strong recommendation for using an intervention |
| 2 | Weak recommendation for using an intervention |
| 3 | Weak recommendation against using an intervention |
| 4 | Strong recommendation against using an intervention |
The American Academy of Pediatrics uses another classification scheme that has been adopted by several other resources. This system evaluates both quality of evidence and strength of recommendations. Grades of evidence are similar to other classification schemes, with RCTs receiving the highest grades and observational studies receiving the lowest grades. Statements based on evidence are given strong recommendations, recommendations, option, or no recommendation.
Resources for evidence-based medicine
Staying updated on current evidence can be challenging during practice. Fortunately, there are many resources for current evidence available in different forms of media. Major journal publications now assign LOE to articles regarding therapeutic and clinical topics. Committees and expert panels frequently publish guidelines that incorporate the most updated EBM, and provide recommendations with corresponding strengths of recommendations. Online reviews and databases, such as the Cochrane Review, are repositories of EBM. Online journal Web sites provide options for e-mail alerts to notify subscribers of new EBM articles. Additionally, subscribers can sign up for daily or weekly e-mails from these Web sites that highlight new and upcoming articles and provide synopses. A summary of various resources for EBM are compiled in Table 3 .
| Type of Resource | Examples |
|---|---|
| Academic journals | The Laryngoscope , Otolaryngology—Head and Neck Surgery , JAMA Facial Plastic Surgery |
| Online databases | UpToDate, Cochrane Reviews, National Guidelines Clearinghouse, Essential Evidence Plus |
| E-mail updates | Daily POEMs (“Patient-Oriented Evidence that Matters”) from Essential Evidence Plus |
Incorporating evidence-based medicine into practice
Practicing EBM is more than just staying current on the best clinical evidence; it involves incorporating the guidelines in clinical decision-making and collecting outcome measure data on patients. Incorporating guidelines in clinical decision-making often requires an algorithmic approach, and can be implemented with the help of the electronic medical record. Collecting outcome data allows for more precise, reliable data points with which to make the clinical decisions, as well as give the surgeon feedback about how he or she is performing.
Outcome measures
Outcome measures are becoming increasingly prevalent in EBM. They can be classified as patient-reported outcomes measures (PROMs) or clinical or efficacy outcomes (expert data collection). Patient-reported outcomes primarily involve questionnaires assessing quality of life (QOL) or patient satisfaction regarding a health-related condition. Clinical outcomes, on the other hand, involve objective and observational assessments, and are used in case-control studies, cohort studies, and RCTs.
On a larger scale, outcome measures are driving health care funding and reimbursement at the governmental level. The Agency for Health Care Research and Quality uses outcome measures to make recommendations to other Department of Health and Human Services agencies like the Centers for Medicare and Medicaid Services. Two of the most common outcome measures used to assess global individual function are the Short Form-36 and activities of daily living. When creating other outcome measures (such as those specific to facial plastic surgery), these often serve as the referent standard with which to compare reliability and consistency. Surgeries performed by facial plastic and reconstructive surgeons (FPRSs) will eventually come under more rigorous outcome measure scrutiny and will have to prove effective. Although few FPRS-specific patient-reported and clinical outcome measures existed decades ago, more outcome measures have been created over the past few decades and have been validated in multiple studies.
Most FPRS outcome measures have focused on clinical outcomes, but patient QOL and functional outcomes are trending and are being incorporated into outcome measures. The scope of outcome measures in facial plastic surgery encompasses a multitude of patient-reported scales and observer-reported scales, including facial nerve grading systems, scar-assessment scales, and facial wrinkle scales. Here we review several of the more commonly used outcome measures used in facial plastic surgery.
Expert data collection
Facial Nerve Grading Systems
Facial nerve assessment is one of the most commonly studied outcome measures in both facial plastic surgery and otolaryngology. Grading facial nerve injury is necessary to communicate and document severity of injury and improvement of function with treatment. Several objective grading scales of facial nerve injury have been created and are regularly used. These scales focus on the appearance of resting symmetry and symmetry during voluntary motion. Synkinesis, abnormal involuntary facial movement that occurs with voluntary movement of different facial muscle groups due to abnormal regeneration of facial nerve fibers, has been incorporated into more recently created facial nerve grading scales.
The House-Brackmann Facial Nerve Grading System (HBFNGS), first introduced in 1983 and then adopted by the Facial Nerve Disorders Committee of the American Academy of Otolaryngology—Head and Neck Surgery in 1984, has been validated in numerous studies and has been widely used in multiple clinical applications. This system evaluates facial asymmetry at rest and in motion. Gross observations are made in comparison with the normal side. Facial motion is evaluated based on facial thirds (upper third: forehead, middle third: eye, lower third: mouth). The grading system determines severity of injury, from normal (House-Brackmann Grade I) to total paralysis (House-Brackmann Grade VI), based on degree of movement and gross asymmetry as determined by the observer ( Table 4 ). Despite its widespread use and applicability, there are limitations to the grading system. The application of a single grade represents the global function of the facial nerve, but there actually may be varying levels of functional impairment to different facial muscle groups. Although typically the grade reflects the poorest functioning muscle group, other more functional muscle groups may not be adequately characterized with a single grade. A study by Reitzen and colleagues in 2009 showed that a single grade did not fully communicate facial function, but that regional assessment of different facial muscle groups more accurately communicated facial function.
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