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Reconciling the Clinical Practice Guidelines on Bell's Palsy from the AAO-HNSF and the AAN Seth R. Schwartz, Stephanie L. Jones, Thomas S. D. Getchius and Gary S. Gronseth Otolaryngology -- Head and Neck Surgery 2014 150: 709 DOI: 10.1177/0194599814529079 The online version of this article can be found at: http://oto.sagepub.com/content/150/5/709

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Commentary

Reconciling the Clinical Practice Guidelines on Bell’s Palsy from the AAO-HNSF and the AAN

Otolaryngology– Head and Neck Surgery 2014, Vol. 150(5) 709–711 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814529079 http://otojournal.org

Seth R. Schwartz, MD, MPH1, Stephanie L. Jones2, Thomas S. D. Getchius3, and Gary S. Gronseth, MD4

Sponsorships or competing interests that may be relevant to content are disclosed at the end of this article.

Abstract Bell’s palsy, named after the Scottish anatomist, Sir Charles Bell, is the most common acute mononeuropathy, or disorder affecting a single nerve, and is the most common diagnosis associated with facial nerve weakness/paralysis. In the past 2 years, both the American Academy of Neurology (AAN) and the American Academy of Otolaryngology—Head and Neck Surgery Foundation (AAO-HNSF) have published clinical practice guidelines aimed to improve the quality of care and outcomes for patients diagnosed with Bell’s palsy. This commentary aims to address the similarities and differences in the scope and final recommendations made by each guideline development group. Keywords Bell’s palsy, guidelines, methodology, facial nerve

Guideline Development Group Composition

Received November 13, 2013; revised February 18, 2014; accepted March 4, 2014.

This commentary is published simultaneously Otolaryngology–Head and Neck Surgery and Neurology.

evidence-based recommendations regarding the use of steroids and antiviral medications for newly diagnosed patients with Bell’s palsy. In fact, the AAN effort was undertaken as an update to a ‘‘Practice Parameter: Steroids, Acyclovir, and Surgery for Bell’s Palsy’’ published in 2001.3 The AAO-HNSF scope is much broader. It was conceived as an opportunity to improve the quality of care for patients with Bell’s palsy by identifying quality improvement opportunities in the diagnosis and management of the condition. Accordingly, the AAO-HNSF guideline makes several recommendations regarding the clinical diagnosis of the condition, the use of testing in the evaluation of these patients (or, more specifically, recommendations against the use of routine laboratory testing and imaging), recognition of the importance of eye care, and finally recommendations for follow-up of these patients if total return to normal function does not occur.

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he clinical practice guideline on Bell’s palsy, recently produced by the American Academy of Otolaryngology— Head and Neck Surgery Foundation (AAO-HNSF),1 follows closely on the heels of the guideline on Bell’s palsy published by the American Academy of Neurology (AAN).2 In an effort to provide harmonization between these 2 guidelines for the end users, authors and staff from both clinical practice guidelines (CPGs) have worked together to develop this commentary and are submitting for publication to both Neurology and Otolaryngology– Head and Neck Surgery. Both CPGs were developed to improve patient care and reduce variations in practice. With this spirit in mind, this commentary will compare and contrast the 2 clinical practice guidelines.

Scope The most notable difference between the guidelines is their scope. The AAN guideline scope is limited to making

The guideline produced by the AAO-HNSF was a full multidisciplinary panel including 17 members from diverse clinician groups that manage Bell’s palsy (otolaryngology–head and neck surgery, neurotology, neurology, facial plastic and reconstructive surgery, emergency medicine, primary care, otology, nursing, physician assistants, and consumers). Fewer than half of the group members were otolaryngologists. In contrast, the AAN guideline was written by 2 authors with oversight and support from the 20-plus members of the AAN guideline development subcommittee (GDS)—all of whom are neurologists. Therefore, the AAN CPG is not multidisciplinary.

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Virginia Mason Medical Center, Seattle, Washington, USA American Academy of Otolaryngology—Head and Neck Surgery Foundation, Alexandria, Virginia, USA 3 American Academy of Neurology, Minneapolis, Minnesota, USA 4 University of Kansas Medical Center, Kansas City, Kansas, USA 2

Corresponding Author: Seth R. Schwartz, MD, MPH, Virginia Mason Medical Center, Seattle, 1100 35 Ninth Ave, MS X10-ON, PO Box 900, Seattle, WA 98111, USA. Email: [email protected]

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Otolaryngology–Head and Neck Surgery 150(5)

Table 1. Oral Steroid and Antiviral Therapy Recommendations. Topic Oral steroids

Antiviral therapy

AAN Recommendation

AAO-HNSF Recommendation

For patients with new-onset Bell’s palsy, oral steroids should be offered to increase the probability of recovery of facial nerve function. For patients with new-onset Bell’s palsy, antivirals (in addition to steroids) might be offered to increase the probability of recovery of facial function.

Clinicians should prescribe oral steroids within 72 hours of symptom onset for patients with Bell’s palsy who are 16 years and older. Clinicians may offer oral antiviral therapy in addition to oral steroids within 72 hours of symptom onset for patients with Bell’s palsy.

Abbreviations: AAN, American Academy of Neurology; AAO-HNSF, American Academy of Otolaryngology—Head and Neck Surgery Foundation.

Clinical Practice Guideline–Systematic Review Intersection

outweigh the benefits is discussed. However, the AAOHNSF discussion of harms and benefits is more explicit.

The development of both guidelines involved a systematic review of the literature and made recommendations based on the results of these reviews. The AAN performed its own systematic review of the literature, which included duplicate and independent study selection and data abstraction, constructed relevant evidence tables, and was explicit in assessing the risk of bias and explaining the evidence synthesis methods used. The AAO-HNSF, however, developed its CPG using the existing 30 systematic reviews/meta-analyses that were already published.

Assessment of the Evidence

Format of Recommendations The composition of the recommendations or key action statements for both CPGs attempts to spell out exactly what action is to be taken, by whom, and under what circumstance. Table 1 compares the oral steroid and antiviral therapy recommendations more closely. In the oral steroids recommendations, the AAO-HNSF was more specific, stating ‘‘within 72 hours,’’ while AAN choose to be vague, stating ‘‘with new onset.’’ The AAN used a passive voice, while the AAO-HNSF used the active voice. The rationale for why the clinician should take action is included in the AAN statement, while the AAO-HNSF includes this information in the evidence profile and supporting text.

Benefits vs Harms The key action statements (KAS) in the AAO-HNSF guideline and the recommendations in the AAN guideline are arrived at through review and weighing of the evidence and an assessment of the harms and benefits of carrying out the recommended action. A harm/benefit assessment is an important component of guidelines. The strength of a given recommendation is arrived at through a combination of both of these elements. In the AAO-HNSF guideline, the benefit/ harm assessment is stated in the evidence profile for each KAS. The AAN discussed the potential harms of the therapies, along with the benefits throughout the supporting text. In addition, in the ‘‘Clinical Context Situation’’ of the AAN guideline, an example of a situation where the harms might

A few recent high-quality randomized controlled trials (RCTs) have assessed the impact of steroids and antiviral therapy in patients newly diagnosed with Bell’s palsy. Both guidelines recognized the quality of these studies and accordingly recommended for the use of steroids in newly diagnosed patients. Both also recognized the clear lack of efficacy for oral antiviral therapy without steroids and recommended against independent use of this class of drugs. Both guidelines also acknowledged a lack of strong evidence for the efficacy of combined steroid and antiviral therapy (both class 1 RCTs found no benefit of combined therapy). Despite this lack of strong evidence, both concluded that existing studies did not rule out the possibility of some small benefit of combined therapy. The AAN observed that several RCTs of antivirals and steroids vs steroids alone suggested a benefit of the combination. In the AAN guideline, these ‘‘positive’’ studies were determined to have a high risk of bias (class IV)4 because of the absence of blinded, independent outcomes assessment. Thus, in the AAN guideline, the reason for discounting these ‘‘positive’’ studies was transparently stated. By contrast, the flaws of the ‘‘positive’’ antivirals studies were not discussed in detail in the AAO-HNSF guideline. Thus, the reasons the AAO-HNSF guideline discounted these studies was not clearly stated.

Conclusion The fact that both groups arrived at the same recommendations regarding the use of steroids and antiviral medications using different processes demonstrates the robustness of these recommendations. Table 2 provides a quick comparison of the 2 guidelines. Ultimately, these 2 documents are complementary. The methods for CPG development and interpretation of the evidence are evolving. A best method has not been identified. Both the AAO-HNS/F and AAN recognize the need to improve their guideline development processes for additional clarity and transparency.

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Table 2. Comparison of AAO-HNSF and AAN Bell’s Palsy Guidelines. AAO-HNSF Content Recommend steroids Recommend against antivirals alone Option for combined therapy Recommend history and physical examination to rule out other causes Recommends against routine laboratory testing and routine imaging Recommend eye care if impaired eye closure Recommend follow-up if incomplete resolution Methods Group composition Systematic review Harm/benefit assessment

AAN

Yes Yes Yes Yes Yes Yes Yes

Yes Yes Yes NR NR NR NR

Multidisciplinary Yes Yes

Single specialty Yes Yes

Abbreviations: AAN, American Academy of Neurology; AAO-HNSF, American Academy of Otolaryngology—Head and Neck Surgery Foundation; NR, no recommendation for or against (beyond the scope of the clinical practice guideline); Yes, addressed in the clinical practice guideline.

For future guidelines, the AAN has adopted a structured format of recommendation wording similar to the AAOHNSF.5 In addition, the AAN now uses a modified Delphi process for transparently considering factors other than the quality of the evidence for formulating recommendations. This new process was used in the recently published sports concussion6 and atrial fibrillation AAN guidelines.7 The AAO-HNSF recognizes that to continue developing high-quality guidelines, it will need to be more transparent in the description of its methods for synthesizing the evidence from existing systematic reviews. The AAO-HNSF does not have the resources to develop its own systematic reviews and will continue to use high-quality reviews performed by other organizations to inform its guidelines. These organizations include other specialty societies, such as the AAN, the Agency for Healthcare Research and Quality Evidence-based Practice Centers, and the Cochrane Collaboration. As guideline developers, we must work together to create the best CPGs for our respective constituents and those allied health professionals who treat the patients we serve. We must also teach each other. There is much to learn. Author Contributions Seth R. Schwartz, wrote and edited the article; Stephanie L. Jones, editorial contribution; Thomas S. D. Getchius, editorial contribution; Gary S. Gronseth, writing and editorial contribution.

Disclosures Competing interests: Seth R. Schwartz had paid travel to one meeting from the Cochlear Corp, Oticon Medical and is the author of the AAO-HNSF ‘‘Clinical Practice Guideline: Bell’s Palsy.’’ Stephanie L. Jones is an employee of the AAO-HNSF. Thomas S. D. Getchius is an employee of American Academy of Neurology and has a spouse employed by Cigna Health. Gary S. Gronseth is the

Associate Editor of Neurology (a compensated position), a member of the Editorial Advisory Board of Neurology Now (noncompensated), and a Senior Evidence-Based Medicine Methodologist for the American Academy of Neurology (a compensated position). Sponsorships: None. Funding source: None.

References 1. Baugh R, Basura G, Ishii L, et al. Clinical practice guideline: Bell’s palsy. Otolaryngol Head Neck Surg. 2013;149(3)(suppl): S1-S27. 2. Gronseth GS, Paduga R. Evidence-based guideline update: steroids and antivirals for Bell palsy: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2012;79:2209-2213. 3. Grogan PM, Gronseth GS. Practice parameter: steroids, acyclovir, and surgery for Bell’s palsy. Neurology. 2001;56:830-836. 4. American Academy of Neurology (ANN). Clinical Practice Guideline Process Manual. St Paul, MN: ANN; 2011. 5. Rosenfeld RM, Shiffman RN, Robertson P. Clinical Practice Guideline Development Manual, Third Edition: a quality-driven approach for translating evidence into action. Otolaryngol Head Neck Surg. 2013;148(1)(suppl):S1-S55. 6. Giza CC, Kutcher JS, Ashwal S, et al. Summary of evidencebased guideline update: evaluation and management of concussion in sports. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2013;80:22502257. 7. Culebras A, Messe SR, Chaturvedi S, Kase CS, Gronseth G. Summary of evidence-based guideline update: prevention of stroke in nonvalvular atrial fibrillation. Report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014;82:1-9.

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Reconciling the clinical practice guidelines on Bell's palsy from the AAO-HNSF and the AAN.

Bell's palsy, named after the Scottish anatomist, Sir Charles Bell, is the most common acute mononeuropathy, or disorder affecting a single nerve, and...
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