PrintDownload PDFGet Adobe ReaderDownload to WordDownload as HTMLDownload as XMLCitation Manager
Save to Favorites
Guideline Summary
Guideline Title
Clinical practice guideline: hoarseness (dysphonia).
Bibliographic Source(s)
Schwartz S, Cohen S, Dailey S, Rosenfeld R, Deutsch E, Gillespie B, Granieri E, Hapner E, Kimball E, Krouse H, McMurray S, Medina S, O'Brien K, Ouellette D, Messinger-Rapport B, Stachler R, Strode S, Thompson D, Stemple J, Willging P, Cowley T, McCoy, Bernad P, Patel M. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009 Sep;141(3S2):S1-S31. [21 references]
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Hoarseness (dysphonia)

Note: Hoarseness (dysphonia) is defined as a disorder characterized by altered vocal quality, pitch, loudness, or vocal effort that impairs communication or reduces voice-related quality of life (QOL).

Guideline Category
Counseling
Diagnosis
Evaluation
Management
Prevention
Risk Assessment
Treatment
Clinical Specialty
Family Practice
Otolaryngology
Pediatrics
Speech-Language Pathology
Surgery
Intended Users
Physician Assistants
Physicians
Respiratory Care Practitioners
Speech-Language Pathologists
Guideline Objective(s)
  • To provide evidence-based recommendations on managing hoarseness (dysphonia)
  • To improve the quality of care for patients with hoarseness based on current best evidence
  • To improve diagnostic accuracy for hoarseness (dysphonia), reduce inappropriate antibiotic use, reduce inappropriate steroid use, reduce inappropriate use of anti-reflux medications, reduce inappropriate use of radiographic imaging, and promote appropriate use of laryngoscopy, voice therapy, and surgery
Target Population

Individuals in all age groups evaluated in a setting where hoarseness would be identified or managed

Note: The guideline does not apply to patients with hoarseness with the following conditions: history of laryngectomy (total or partial), craniofacial anomalies, velopharyngeal insufficiency, and dysarthria (impaired articulation). However, the guideline will discuss the relevance of these conditions in managing patients with hoarseness.

Interventions and Practices Considered

Diagnosis

  1. Targeted history
  2. Physical examination
  3. Laryngoscopy
  4. Stroboscopy
  5. Computed tomography (not recommended)
  6. Magnetic resonance imaging (not recommended)

Treatment

  1. Watchful waiting/observation
  2. Education/information
  3. Voice therapy
  4. Anti-reflux medications (recommended for chronic laryngitis only)
  5. Antibiotics (recommendation against routine prescribing)
  6. Steroids (recommendation against routine prescribing)
  7. Surgery
  8. Botulinum toxin (Botox)

Prevention

  1. Voice training
  2. Vocal hygiene
  3. Education
  4. Environmental measures
Major Outcomes Considered

Primary Outcomes

  • Improvement in vocal function
  • Change in voice-related quality of life (QOL)

Secondary Outcomes

  • Complications and adverse events
  • Economic consequences
  • Adherence to therapy
  • Global QOL
  • Return to work
  • Improved communication function
  • Return health care visits

Methodology

Methods Used to Collect/Select the Evidence
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

Several initial literature searches were performed through November 17, 2008 by American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) staff using MEDLINE, The National Guidelines Clearinghouse (NGC) (www.guideline.gov External Web Site Policy), The Cochrane Library, Guidelines International Network (GIN), The Cumulative Index to Nursing and Allied Health Literature (CINAHL), and EMBASE. The initial broad MEDLINE search using "hoarseness[mh]" or "dysphonia[tw]" or "voice disorders[mh]" in any field showed 6032 potential articles:

  1. Clinical practice guidelines were identified by a GIN, NGC, and MEDLINE search using "guideline" as a publication type or title word. The search identified eight guidelines with a topic of hoarseness or dysphonia. After eliminating articles that did not have hoarseness or dysphonia as the primary focus, no guidelines met quality criteria of being produced under the auspices of a medical association or organization and having an explicit method for ranking evidence and linking evidence to recommendations.
  2. Systematic reviews were identified in MEDLINE using a validated filter strategy. That strategy initially yielded 92 potential articles. The final data set included 14 systematic reviews or meta-analyses (including two Cochrane systematic reviews) on hoarseness or dysphonia that were distributed to the panel members.
  3. Randomized controlled trials were identified through the Cochrane Library (Cochrane Controlled Trials Register) and totaled 256 trials with "hoarseness" or "dysphonia" in any field.
  4. Original research studies were identified by limiting the MEDLINE, CINAHL, and EMBASE search to articles on humans published in English. The resulting data set of 769 articles yielded 262 related to therapy, 256 to diagnosis, 205 to etiology, and 46 to prognosis.

Results of all literature searches were distributed to guideline panel members at the first meeting, including electronic listings with abstracts (if available) of the searches for randomized trials, systematic reviews, and other studies. This material was supplemented, as needed, with targeted searches to address specific needs identified in writing the guideline through February 8, 2009.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence
Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence

Evidence Quality for Grades of Evidence

Grade A: Well-designed randomized controlled trials or diagnostic studies performed on a population similar to the guideline's target population

Grade B: Randomized controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies

Grade C: Observational studies (case-control and cohort design)

Grade D: Expert opinion, case reports, reasoning from first principles (bench research or animal studies)

Grade X: Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit over harm

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review
Description of the Methods Used to Analyze the Evidence

These guidelines are intended to reduce inappropriate variations in clinical care, to produce optimal health outcomes for patients, and to minimize harm. The evidence-based approach to guideline development requires that the evidence supporting a policy be identified, appraised, and summarized and that an explicit link between evidence and statements be defined. Evidence-based statements reflect both the quality of evidence and the balance of benefit and harm. The definitions for evidence-based statements are listed in "Ratings Scheme for the Strength of the Evidence" and "Rating Scheme for the Strength of the Recommendations" fields.

Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations

The guideline was developed using an explicit and transparent a priori protocol for creating actionable statements based on supporting evidence and the associated balance of benefit and harm. The multidisciplinary guideline development panel was chosen to represent the fields of neurology, speech-language pathology, professional voice teaching, family medicine, pulmonology, geriatric medicine, nursing, internal medicine, otolaryngology– head and neck surgery, pediatric medicine, and consumers. Several group members had significant prior experience in developing clinical practice guidelines.

In a series of conference calls, the working group defined the scope and objectives of the proposed guideline. During the nine months devoted to guideline development ending in 2009, the group met twice, with interval electronic review and feedback on each guideline draft to ensure accuracy of content and consistency with standardized criteria for reporting clinical practice guidelines.

American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNSF) staff used GEM-COGS, the Guideline Implementability Appraisal and Extractor, to appraise adherence of the draft guideline to methodological standards, to improve clarity of recommendations, and to predict potential obstacles to implementation. Guideline panel members received summary appraisals in April 2009 and modified an advanced draft of the guideline.

Rating Scheme for the Strength of the Recommendations

Guideline Definitions for Evidence-Based Statements

Strong Recommendation: A strong recommendation means the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits, in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent (Grade A or B)*. In some clearly identified circumstances, strong recommendations may be made on the basis of lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Implication: Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.

Recommendation: A recommendation means the benefits exceed the harms (or that the harms exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (Grade B or C)*. In some clearly identified circumstances, recommendations may be made on the basis of lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Implication: Clinicians should also generally follow a recommendation, but should remain alert to new information and sensitive to patient preferences.

Option: An option means that either the quality of evidence that exists is suspect (Grade D)* or that well-done studies (Grade A, B, or C)* show little clear advantage to one approach versus another. Implication: Clinicians should be flexible in their decision making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.

* Refer to "Rating Scheme for the Strength of the Evidence" field above for the definitions of evidence grades.

Cost Analysis

The guideline developers reviewed published cost analyses:

  • The cost of direct laryngoscopy is substantially greater than that of office-based laryngoscopy due to the additional costs of staff, equipment, and additional care required.
  • The costs of magnetic resonance imaging (MRI), however, are significantly more than computed tomography (CT) scanning. Despite these risks and their considerable cost, cross-sectional imaging studies are being used with increasing frequency.
  • Over-prescribing antibiotics may contribute to bacterial resistance to antibiotics. Compared to the years 2001 to 2003, more methicillin-resistant Staphylococcus aureus has been isolated in acute and chronic maxillary sinusitis in the period 2004 to 2006. Antibiotic treatment costs for infectious diseases, such as community-acquired pneumonia, were 33 percent higher in communities with high antibiotic resistance rates (Cochrane review). Thus, overuse of antibiotics for hoarseness has negative potential results for both the individual and the general population.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

The final draft practice guideline underwent extensive, multidisciplinary, external peer review. Comments were compiled and reviewed by the group chairpersons, and a modified version of the guideline was distributed and approved by the development panel.

Recommendations

Major Recommendations

The evidence grades (A-D, X) and evidence-based statements (Strong Recommendation, Recommendation and Option,) are defined at the end of the "Major Recommendations" field.

Statement 1. Diagnosis

Clinicians should diagnose hoarseness (dysphonia) in a patient with altered voice quality, pitch, loudness, or vocal effort that impairs communication or reduces voice-related quality of life (QOL).

Recommendation based on observational studies with a preponderance of benefit over harm.

Evidence Profile:

  • Aggregate evidence quality: Grade C, observational studies for symptoms with one systematic review of QOL in voice disorders and two systematic reviews on medication side effects
  • Benefit: Identify patients who may benefit from treatment or from further investigation to identify underlying conditions that may be serious, promote prompt recognition and treatment, and discourage the perception of hoarseness as a trivial condition that does not warrant attention
  • Harm: Potential anxiety related to diagnosis
  • Cost: Time expended in diagnosis, documentation, and discussion
  • Benefits-harm assessment: Preponderance of benefits over harm
  • Value judgments: None
  • Role of patient preference: Limited
  • Intentional vagueness: None
  • Exclusions: None
  • Policy Level: Recommendation

Statement 2. Modifying Factors

Clinicians should assess the patient with hoarseness by history and/or physical examination for factors that modify management such as one or more of the following: recent surgical procedures involving the neck or affecting the recurrent laryngeal nerve, recent endotracheal intubation, radiation treatment to the neck, a history of tobacco abuse, and occupation as a singer or vocal performer.

Recommendation based on observational studies with a preponderance of benefit over harm.

Evidence Profile:

  • Aggregate evidence quality: Grade C, observational studies
  • Benefit: To identify factors early in the course of management that could influence the timing of diagnostic procedures, choice of interventions, or provision of follow-up care
  • Harm: None
  • Cost: None
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Importance of history taking and identifying modifying factors as an essential component of providing quality care
  • Role of patient preferences: Limited or none
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Recommendation

Statement 3A. Laryngoscopy and Hoarseness

Clinicians may perform laryngoscopy, or may refer the patient to a clinician who can visualize the larynx, at any time in a patient with hoarseness.

Option based on observational studies, expert opinion, and a balance of benefit and harm.

Statement 3B. Indications for Laryngoscopy

Clinicians should visualize the patient's larynx, or refer the patient to a clinician who can visualize the larynx, when hoarseness fails to resolve by a maximum of three months after onset, or irrespective of duration if a serious underlying cause is suspected.

Recommendation based on observational studies, expert opinion, and a preponderance of benefit over harm.

Evidence Profile for Statement 3A: Laryngoscopy and Hoarseness

  • Aggregate evidence quality: Grade C, based on observational studies
  • Benefit: Visualization of the larynx to improve diagnostic accuracy and allow comprehensive evaluation
  • Harm: Risk of laryngoscopy, patient discomfort
  • Cost: Procedural expense
  • Benefits-harm assessment: Balance of benefit and harm
  • Value judgments: Laryngoscopy is an important tool for evaluating voice complaints and may be performed at any time in the patient with hoarseness
  • Intentional vagueness: None
  • Role of patient preferences: Substantial; the level of patient concern should be considered in deciding when to perform laryngoscopy
  • Exclusions: None
  • Policy level: Option

Evidence Profile for Statement 3B: Indications for Laryngoscopy

  • Aggregate evidence quality: Grade C, observational studies on the natural history of benign laryngeal disorders; grade C for observational studies plus expert opinion on defining what constitutes a serious underlying condition
  • Benefit: Avoid missed or delayed diagnosis of serious conditions in patients without additional signs or symptoms to suggest underlying disease; permit prompt assessment of the larynx when serious concern exists
  • Harm: Potential for up to a three-month delay in diagnosis; procedure-related morbidity
  • Cost: Procedural expense
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: A need to balance timely diagnostic intervention with the potential for over-utilization and excessive cost. The guideline panel debated on the maximum duration of hoarseness prior to mandated evaluation and opted to select a "safety net approach" with a generous time allowance (three months), but options to proceed promptly based on clinical circumstances
  • Intentional vagueness: The term "serious underlying concern" is subject to the discretion of the clinician. Some conditions are clearly serious, but in other patients, the seriousness of the condition is dependent on the patient. Intentional vagueness was incorporated to allow for clinical judgment in the expediency of evaluation
  • Role of patient preferences: Limited
  • Exclusions: None
  • Policy level: Recommendation

Statement 4. Imaging

Clinicians should not obtain computed tomography (CT) or magnetic resonance imaging (MRI) of the patient with a primary complaint of hoarseness prior to visualizing the larynx.

Recommendation against imaging based on observational studies of harm, absence of evidence concerning benefit, and a preponderance of harm over benefit.

Evidence Profile:

  • Aggregate evidence quality: Grade C, observational studies regarding the adverse events of CT and MRI; no evidence identified concerning benefits in patients with hoarseness before laryngoscopy
  • Benefit: Avoid unnecessary testing; minimize cost and adverse events; maximize the diagnostic yield of CT and MRI when indicated
  • Harm: Potential for delayed diagnosis
  • Cost: None
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Avoidance of unnecessary testing
  • Role of patient preferences: Limited
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Recommendation against

Statement 5A. Anti-reflux Medication and Hoarseness

Clinicians should not prescribe anti-reflux medications for patients with hoarseness without signs or symptoms of gastroesophageal reflux disease (GERD).

Recommendation against prescribing based on randomized trials with limitations and observational studies with a preponderance of harm over benefit.

Statement 5B. Anti-Reflux Medication and Chronic Laryngitis

Clinicians may prescribe anti-reflux medication for patients with hoarseness and signs of chronic laryngitis.

Option based on observational studies with limitations and a relative balance of benefit and harm.

Evidence Profile for Statement 5A: Anti-reflux Medications and Hoarseness

  • Aggregate evidence quality: Grade B, randomized trials with limitations showing lack of benefits for anti-reflux therapy in patients with laryngeal symptoms, including hoarseness; observational studies with inconsistent or inconclusive results; inconclusive evidence regarding the prevalence of hoarseness as the only manifestation of reflux disease
  • Benefit: Avoid adverse events from unproven therapy; reduce cost; limit unnecessary treatment
  • Harm: Potential withholding of therapy from patients who may benefit
  • Cost: None
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Acknowledgment by the working group of the controversy surrounding laryngopharyngeal reflux, and the need for further research before definitive conclusions can be drawn; desire to avoid known adverse events from anti-reflux therapy
  • Intentional vagueness: None
  • Patient preference: Limited
  • Exclusions: Patients immediately before or after laryngeal surgery and patients with other diagnosed pathology of the larynx
  • Policy level: Recommendation against

Evidence Profile for Statement 5B: Anti-reflux Medication and Chronic Laryngitis

  • Aggregate evidence quality: Grade C, observational studies with limitations showing benefit with laryngeal symptoms, including hoarseness, and observational studies with limitations showing improvement in signs of laryngeal inflammation
  • Benefit: Improved outcomes, promote resolution of laryngitis
  • Harm: Adverse events related to anti-reflux medications
  • Cost: Direct cost of medications
  • Benefits-harm assessment: Relative balance of benefit and harm
  • Value judgments: Although the topic is controversial, the working group acknowledges the potential role of antireflux therapy in patients with signs of chronic laryngitis and recognizes that these patients may differ from those with an empiric diagnosis of hoarseness (dysphonia) without laryngeal examination
  • Patient preference: Substantial role for shared decision making
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Option

Statement 6. Corticosteroid Therapy

Clinicians should not routinely prescribe oral corticosteroids to treat hoarseness.

Recommendation against prescribing based on randomized trials showing adverse events and absence of clinical trials demonstrating benefits with a preponderance of harm over benefit for steroid use.

Evidence Profile:

  • Aggregate evidence quality: Grade B, randomized trials showing increased incidence of adverse events associated with orally administered steroids; absence of clinical trials demonstrating any benefit of steroid treatment on outcomes
  • Benefit: Avoid potential adverse events associated with unproven therapy
  • Harm: None
  • Cost: None
  • Benefits-harm assessment: Preponderance of harm over benefit for steroid use
  • Value judgments: Avoid adverse events of ineffective or unproven therapy
  • Role of patient preferences: Some; there is a role for shared decision making in weighing the harms of steroids against the potential yet unproven benefit in specific circumstances (i.e., professional or avocation voice use and acute laryngitis)
  • Intentional vagueness: Use of the word “routine” to acknowledge there may be specific situations, based on laryngoscopy results or other associated conditions, that may justify steroid use on an individualized basis
  • Exclusions: None
  • Policy level: Recommendation against

Statement 7. Antimicrobial Therapy

Clinicians should not routinely prescribe antibiotics to treat hoarseness.

Strong recommendation against prescribing based on systematic reviews and randomized trials showing ineffectiveness of antibiotic therapy and a preponderance of harm over benefit.

Evidence Profile:

  • Aggregate evidence quality: Grade A, systematic reviews showing no benefit for antibiotics for acute laryngitis or upper respiratory tract infection; grade A evidence showing potential harms of antibiotic therapy
  • Benefit: Avoidance of ineffective therapy with documented adverse events
  • Harm: Potential for failing to treat bacterial, fungal, or mycobacterial causes of hoarseness
  • Cost: None
  • Benefit-harm assessment: Preponderance of harm over benefit if antibiotics are prescribed
  • Values: Importance of limiting antimicrobial therapy to treating bacterial infections
  • Role of patient preferences: None
  • Intentional vagueness: The word “routine” is used in the boldface statement to discourage empiric therapy yet to acknowledge there are occasional circumstances where antibiotic use may be appropriate
  • Exclusions: Patients with hoarseness caused by bacterial infection
  • Policy level: Strong recommendation against

Statement 8A. Laryngoscopy Prior to Voice Therapy

Clinicians should visualize the larynx before prescribing voice therapy and document/communicate the results to the speech-language pathologist.

Recommendation based on observational studies showing benefit and a preponderance of benefit over harm.

Statement 8B. Advocating for Voice Therapy

Clinicians should advocate voice therapy for patients diagnosed with hoarseness (dysphonia) that reduces voice-related QOL.

Strong recommendation based on systematic reviews and randomized trials with a preponderance of benefit over harm.

Evidence Profile for Statement 8A: Visualizing the Larynx

  • Aggregate evidence quality: Grade C, observational studies of the benefit of laryngoscopy for voice therapy
  • Benefit: Avoid delay in diagnosing laryngeal conditions not treatable with voice therapy, optimize voice therapy by allowing targeted therapy
  • Harm: Delay in initiation of voice therapy
  • Cost: Cost of the laryngoscopy and associated clinician visit
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: To ensure no delay in identifying pathology not treatable with voice therapy. Speech-language pathologists (SLPs) cannot initiate therapy prior to visualization of the larynx by a clinician
  • Intentional vagueness: None
  • Role of patient preferences: Minimal
  • Exclusions: None
  • Policy level: Recommendation

Evidence Profile for Statement 8B: Advocating for Voice Therapy

  • Aggregate evidence quality: Grade A, randomized controlled trials and systematic reviews
  • Benefit: Improve voice-related QOL; prevent relapse; potentially prevent need for more invasive therapy
  • Harm: No harm reported in controlled trials
  • Cost: Direct cost of treatment
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Voice therapy is underutilized in managing hoarseness despite efficacy; advocacy is needed
  • Role of patient preferences: Adherence to therapy is essential to outcomes
  • Intentional vagueness: Deciding which patients will benefit from voice therapy is often determined by the voice therapist. The guideline panel elected to use a symptom based criterion to determine to which patients the treating clinician should advocate voice therapy
  • Exclusions: None
  • Policy level: Strong recommendation

Statement 9. Surgery

Clinicians should advocate for surgery as a therapeutic option in patients with hoarseness with suspected: 1) laryngeal malignancy, 2) benign laryngeal soft tissue lesions, or 3) glottic insufficiency.

Recommendation based on observational studies demonstrating a benefit of surgery in these conditions and a preponderance of benefit over harm.

Evidence Profile:

  • Aggregate evidence quality: Grade B, in support of surgery to reduce hoarseness and improve voice quality in selected patients based on observational studies overwhelmingly demonstrating the benefit of surgery
  • Benefit: Potential for improved voice outcomes in carefully selected patients
  • Harm: None
  • Cost: None
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Surgical options for treating hoarseness are not always recognized; selected patients with hoarseness may benefit from newer, less invasive technologies
  • Role of patient preferences: Limited
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Recommendation

Statement 10. Botulinum Toxin

Clinicians should prescribe, or refer the patient to a clinician who can prescribe, botulinum toxin injections for the treatment of hoarseness caused by spasmodic dysphonia.

Recommendation based on randomized controlled trials with minor limitations and preponderance of benefit over harm.

Evidence Profile:

  • Aggregate evidence quality: Grade B, few controlled trials, diagnostic studies with minor limitations, and overwhelmingly consistent evidence from observational studies
  • Benefit: Improved voice quality and voice-related QOL
  • Harm: Risk of aspiration and airway obstruction
  • Cost: Direct costs of treatment, time off work, and indirect costs of repeated treatments
  • Benefit-harm assessment: Preponderance of benefit over harm
  • Value judgments: Botulinum toxin is beneficial despite the potential need for repeated treatments considering the lack of other effective interventions for spasmodic dysphonia
  • Role of patient preferences: Patient must be comfortable with US Food and Drug Administration (FDA) off-label use of botulinum toxin. While strong evidence supports its use, botulinum toxin injection is an invasive therapy offering only temporarily relief of a non–life-threatening condition. Patients may reasonably elect not to have it performed
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Recommendation

Statement 11. Prevention

Clinicians may educate/counsel patients with hoarseness about control/preventive measures.

Option based on observational studies and small randomized trials of poor quality.

Evidence profile

  • Aggregate evidence quality: Grade C, evidence based on several observational studies and a few small randomized trials of poor quality
  • Benefit: Possible prevention of hoarseness in high-risk persons
  • Harm: None
  • Cost: Cost of vocal training sessions
  • Benefits-harm assessment: Preponderance of benefit over harm
  • Value judgments: Preventive measures may prevent hoarseness
  • Role of patient preferences: Patients without symptoms must weigh the benefit of preventive measures based on their risk of developing hoarseness or voice problems
  • Intentional vagueness: None
  • Exclusions: None
  • Policy level: Option

Definitions:

Guideline Definitions for Evidence-Based Statements

Strong Recommendation: A strong recommendation means the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits, in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent (Grade A or B). In some clearly identified circumstances, strong recommendations may be made on the basis of lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Implication: Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.

Recommendation: A recommendation means the benefits exceed the harms (or that the harms exceed the benefits in the case of a negative recommendation), but the quality of evidence is not as strong (Grade B or C). In some clearly identified circumstances, recommendations may be made on the basis of lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Implication: Clinicians should also generally follow a recommendation, but should remain alert to new information and sensitive to patient preferences.

Option: An option means that either the quality of evidence that exists is suspect (Grade D) or that well-done studies (Grade A, B, or C) show little clear advantage to one approach versus another. Implication: Clinicians should be flexible in their decision making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.

Evidence Quality for Grades of Evidence

Grade A: Well-designed randomized controlled trials or diagnostic studies performed on a population similar to the guideline's target population

Grade B: Randomized controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies

Grade C: Observational studies (case-control and cohort design)

Grade D: Expert opinion, case reports, reasoning from first principles (bench research or animal studies)

Grade X: Exceptional situations for which validating studies cannot be performed and there is a clear preponderance of benefit over harm

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The recommendations contained in the practice guideline are based on the best available published data through February 2009. Where data were lacking, a combination of clinical experience and expert consensus was used. The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits

Appropriate evaluation and management of hoarseness (dysphonia) by improving diagnostic accuracy; reducing inappropriate antibiotic use, steroid use, anti-reflux medications, radiographic imaging; and promoting appropriate use of laryngoscopy, voice therapy, and surgery

For benefits of specific interventions considered in the guideline, see the "Major Recommendations" field.

Potential Harms

For harms associated with specific interventions considered in the guideline, see the "Major Recommendations" field.

Contraindications

Contraindications

For patients who have absolute contraindications to magnetic resonance imaging (MRI) such as pacemaker, cochlear implants, heart valve prosthesis, or aneurysmal clip, computed tomography (CT) is a viable alternative.

Qualifying Statements

Qualifying Statements
  • This clinical practice guideline is not intended as a sole source of guidance in managing hoarseness (dysphonia). Rather, it is designed to assist clinicians by providing an evidence based framework for decision-making strategies. The guideline is not intended to replace clinical judgment or establish a protocol for all individuals with this condition, and may not provide the only appropriate approach to diagnosing and managing this problem.
  • Guidelines are never intended to supersede professional judgment; rather, they may be viewed as a relative constraint on individual clinician discretion in a particular clinical circumstance. Less frequent variation in practice is expected for a "strong recommendation" than might be expected with a "recommendation." "Options" offer the most opportunity for practice variability. Clinicians should always act and decide in a way that they believe will best serve their patients' interests and needs, regardless of guideline recommendations. They must also operate within their scope of practice and according to their training. Guidelines represent the best judgment of a team of experienced clinicians and methodologists addressing the scientific evidence for a particular topic.
  • As medical knowledge expands and technology advances, clinical indicators and guidelines are promoted as conditional and provisional proposals of what is recommended under specific conditions, but they are not absolute. Guidelines are not mandates and do not and should not purport to be a legal standard of care. The responsible physician, in light of all the circumstances presented by the individual patient, must determine the appropriate treatment. Adherence to these guidelines will not ensure successful patient outcomes in every situation. The American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) emphasizes that these clinical guidelines should not be deemed to include all proper treatment decisions or methods of care, or to exclude other treatment decisions or methods of care reasonably directed to obtaining the same results.

Implementation of the Guideline

Description of Implementation Strategy

The complete guideline is published as a supplement to Otolaryngology–Head and Neck Surgery to facilitate reference and distribution. The guideline will be presented to American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) members as a mini-seminar at the AAO-HNS annual meeting following publication. Existing brochures and publications by the AAO-HNS will be updated to reflect the guideline recommendations. A full-text version of the guideline will also be accessible free of charge at www.entnet.org External Web Site Policy.

An anticipated barrier to diagnosis is distinguishing modifying factors for hoarseness in a busy clinical setting. This may be assisted by a laminated teaching card or visual aid summarizing important factors that modify management.

Laryngoscopy is an option at any time for patients with hoarseness, but the guideline also recommends that no patient should be allowed to wait longer than three months prior to having his or her larynx examined. It is also clearly recommended that if there is a concern of an underlying serious condition, then laryngoscopy should be immediate. Tables in this guideline regarding causes for concern should help to guide clinicians regarding when more prompt laryngoscopy is warranted. The cost of the laryngoscopy and possible wait times to see clinicians trained in the technique may hinder access to care.

While the guideline acknowledges that there may be a significant role for anti-reflux therapy to treat laryngeal inflammation, empiric use of anti-reflux medications for hoarseness has minimal support and a growing list of potential risks. Avoidance of empiric use of anti-reflux therapy represents a significant change in practice for some clinicians. Educational pamphlets about the unfavorable risk benefit profile of these medications in the absence of gastroesophageal reflux disease (GERD) symptoms or signs of laryngeal inflammation in the face of newly recognized complications of long-term use of proton pump inhibitors may facilitate acceptance of this shift.

Lack of knowledge about voice therapy by practitioners is a likely barrier to advocacy for its use. This barrier can be overcome by educational materials about voice therapy and its indications.

Implementation Tools
Patient Resources
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness

Identifying Information and Availability

Bibliographic Source(s)
Schwartz S, Cohen S, Dailey S, Rosenfeld R, Deutsch E, Gillespie B, Granieri E, Hapner E, Kimball E, Krouse H, McMurray S, Medina S, O'Brien K, Ouellette D, Messinger-Rapport B, Stachler R, Strode S, Thompson D, Stemple J, Willging P, Cowley T, McCoy, Bernad P, Patel M. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009 Sep;141(3S2):S1-S31. [21 references]
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2009 Sep
Guideline Developer(s)
American Academy of Otolaryngology - Head and Neck Surgery Foundation - Medical Specialty Society
Source(s) of Funding

American Academy of Otolaryngology--Head and Neck Surgery Foundation

Guideline Committee

American Academy of Otolaryngology--Head and Neck Surgery Foundation (AAO-HNS) Guideline Development Panel

Composition of Group That Authored the Guideline

Panel members: Seth R. Schwartz, MD, MPH; Seth M. Cohen, MD, MPH; Seth H. Dailey, MD; Richard M. Rosenfeld, MD, MPH; Ellen S. Deutsch, MD; M. Boyd Gillespie, MD; Evelyn Granieri, MD, MPH, MEd; Edie R. Hapner, PhD; C. Eve Kimball, MD; Helene J. Krouse, PhD, RN, ANP-BC; J. Scott McMurray, MD; Safdar Medina, MD; Karen O'Brien, MD, Daniel R. Ouellette, MD; Barbara J. Messinger-Rapport, MD, PhD; Robert J. Stachler, MD; Steven Strode, MD, MEd, MPH; Dana M. Thompson, MD; Joseph C. Stemple, PhD; J. Paul Willging, MD; Terrie Cowley; Scott McCoy, DMA; Peter G. Bernad, MD, MPH; and Milesh M. Patel, MS

Financial Disclosures/Conflicts of Interest

Financial Disclosure and Conflicts of Interest

The cost of developing this guideline, including travel expenses of all panel members, was covered in full by the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Foundation. Potential conflicts of interest for all panel members in the past five years were compiled and distributed before the first conference call. After review and discussion of these disclosures, the panel concluded that individuals with potential conflicts could remain on the panel if they: 1) reminded the panel of potential conflicts before any related discussion, 2) recused themselves from a related discussion if asked by the panel, and 3) agreed not to discuss any aspect of the guideline with industry before publication. Lastly, panelists were reminded that conflicts of interest extend beyond financial relationships and may include personal experiences, how a participant earns a living, and the participant's previously established "stake" in an issue.

Disclosures

Competing interests: Seth M. Cohen, TAP Pharmaceuticals: patient education grant; Seth H. Dailey, Bioform: one time consultant (2008); Ellen S. Deutsch, Kramer Patient Education: reviewer; M. Boyd Gillespie, Restore Medical (Medtronic): research support; study site for Pillar-CPAP study; Helene J. Krouse, Alcon: Speaker's Bureau; Schering-Plough: grant funding; Daniel R. Ouellette, Pfizer: Speaker' Bureau; Boehringer Ingleheim: Speaker's Bureau; Barbara J. Messinger-Rapport, Forest: speaker; Novartis: speaker; Robert J. Stachler, GlaxoSmithKline: consultant; Steven Strode, Central AR Veterans Healthcare System: employee; American Academy of Family Physicians: delegate; commission member; E.Doc America: for-profit health information service; Joseph C. Stemple, KayPentax: product grant; Plural Publishing: author royalties and Speaker's Bureau; J. Paul Willging, expert witness: hourly fee to review medical records and comment on quality of care–pediatric ENT-related.

Sponsorships: Sponsor and funding source: AAO-HNS. The cost of developing this guideline, including travel expenses of all panel members, was covered in full by the AAO-HNS Foundation. Members of the AAO-HNS and other allied health/physician organizations were involved with the study design and conduct; collection, analysis, and interpretation of the data; and writing or approval of the manuscript.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the Otolaryngology - Head and Neck Surgery Web site External Web Site Policy.

Print copies: Available from Seth R. Schwartz, MD, MPH, Virginia Mason Medical Center, 1100 Ninth Avenue, MS X10-ON, PO Box 900, Seattle, WA 98111. E-mail address: seth.schwartz@vmmc.org.

Availability of Companion Documents

None available

Patient Resources

Patient health information on hoarseness and a fact sheet on voice therapy is available from American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) Foundation Web site External Web Site Policy.

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on April 2, 2010. The information was verified by the guideline developer on April 9, 2010.

Copyright Statement

Permission is granted to reproduce the aforementioned material in print and electronic format at no charge subject to the following conditions:

  1. If any part of the material to be used (for example, figures) has appeared in our publication with credit or acknowledgement to another source, permission must also be sought from that source. If such permission is not obtained then that material may not be included in your publication/copies.
  2. Suitable acknowledgement to the source must be made, either as a footnote or in a reference list at the end of your publication, as follows:

    "Reprinted from Publication title, Vol number, Author(s), Title of article, Pages No., Copyright (Year), with permission from American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc."

  3. Reproduction of this material is confined to the purpose for which permission is hereby given.
  4. This permission is granted for non-exclusive world English rights only. For other languages please reapply separately for each one required.

Disclaimer

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

Read full disclaimer...