http://oto.sagepub.com/Otolaryngology -- Head and Neck Surgery

http://oto.sagepub.com/content/141/3_suppl/S1The online version of this article can be found at:

DOI: 10.1016/j.otohns.2009.06.744 2009 141: S1Otolaryngology -- Head and Neck Surgery

Stemple, J. Paul Willging, Terrie Cowley, Scott McCoy, Peter G. Bernad and Milesh M. PatelR. Ouellette, Barbara J. Messinger-Rapport, Robert J. Stachler, Steven Strode, Dana M. Thompson, Joseph C.

Granieri, Edie R. Hapner, C. Eve Kimball, Helene J. Krouse, J. Scott McMurray, Safdar Medina, Karen O'Brien, Daniel Seth R. Schwartz, Seth M. Cohen, Seth H. Dailey, Richard M. Rosenfeld, Ellen S. Deutsch, M. Boyd Gillespie, Evelyn

Clinical Practice Guideline : Hoarseness (Dysphonia)

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GUIDELINE

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OBmendations on managing hoarseness (dysphonia), defined as adisorder characterized by altered vocal quality, pitch, loudness, orvo

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OtolaryngologyHead and Neck Surgery (2009) 141, S1-S31

019doical effort that impairs communication or reduces voice-relatedality of life (QOL). Hoarseness affects nearly one-third of thepulation at some point in their lives. This guideline applies to all

groups evaluated in a setting where hoarseness would bentified or managed. It is intended for all clinicians who areely to diagnose and manage patients with hoarseness.RPOSE: The primary purpose of this guideline is to improvegnostic accuracy for hoarseness (dysphonia), reduce inappropriateibiotic use, reduce inappropriate steroid use, reduce inappropriate

of anti-reflux medications, reduce inappropriate use of radio-phic imaging, and promote appropriate use of laryngoscopy, voicerapy, and surgery. In creating this guideline the American Acad-y of OtolaryngologyHead and Neck Surgery Foundation se-ted a panel representing the fields of neurology, speech-languagehology, professional voice teaching, family medicine, pulmonol-, geriatric medicine, nursing, internal medicine, otolaryngologyd and neck surgery, pediatrics, and consumers.SULTS: The panel made strong recommendations that 1) the

nician should not routinely prescribe antibiotics to treat hoarse-s and 2) the clinician should advocate voice therapy for patientsgnosed with hoarseness that reduces voice-related QOL. The

ing the recurrent laryngeal nerve, recent endotracheal intubation,radiation treatment to the neck, a history of tobacco abuse, andoccupation as a singer or vocal performer; 3) the clinician shouldvisualize the patients larynx, or refer the patient to a clinician whocan visualize the larynx, when hoarseness fails to resolve by amaximum of three months after onset, or irrespective of durationif a serious underlying cause is suspected; 4) the clinician shouldnot obtain computed tomography or magnetic resonance imagingof the patient with a primary complaint of hoarseness prior tovisualizing the larynx; 5) the clinician should not prescribe anti-reflux medications for patients with hoarseness without signs orsymptoms of gastroesophageal reflux disease; 6) the clinicianshould not routinely prescribe oral corticosteroids to treat hoarse-ness; 7) the clinician should visualize the larynx before prescribingvoice therapy and document/communicate the results to thespeech-language pathologist; and 8) the clinician should prescribe,or refer the patient to a clinician who can prescribe, botulinumtoxin injections for the treatment of hoarseness caused by adductorspasmodic dysphonia. The panel offered as options that 1) theclinician may perform laryngoscopy at any time in a patient withhoarseness, or may refer the patient to a clinician who can visu-alize the larynx; 2) the clinician may prescribe anti-reflux medi-

Received June 26, 2009; accepted June 26, 2009.

4-5998/$36.00 2009 American Academy of OtolaryngologyHead and Neck Surgery Foundation. All rights reserved.linical practice guideline:

eth R. Schwartz, MD, MPH, Seth M.eth H. Dailey, MD, Richard M. Rosenlen S. Deutsch, MD, M. Boyd Gillespelyn Granieri, MD, MPH, MEd, Edie

elene J. Krouse, PhD, RN, ANP-BC, Jafdar Medina, MD, Karen OBrien, Marbara J. Messinger-Rapport, MD, Pteven Strode, MD, MEd, MPH, Danaseph C. Stemple, PhD, J. Paul Willg

cott McCoy, DMA, Peter G. Bernad,attle, WA; Durham, NC; Madison, WI; B; New York, NY; Atlanta, GA; Reading,rt Monroe, VA; Cleveland, OH; Little Ro

incinnati, OH; Milwaukee, WI; Princeton,onsorships or competing interests that may be relevant to con-t are disclosed at the end of this article.STRACT

JECTIVE: This guideline provides evidence-based recom-:10.1016/j.otohns.2009.06.744 by goto.sagepub.comDownloaded from arseness (Dysphonia)

hen, MD, MPH,, MD, MPH,MD,Hapner, PhD, C. Eve Kimball, MD,cott McMurray, MD,

aniel R. Ouellette, MD,Robert J. Stachler, MD,Thompson, MD,, MD, Terrie Cowley,, MPH, and Milesh M. Patel, MS,lyn, NY; Wilmington, DE; Charleston,

; Detroit, MI; Uxbridge, MA;AR; Rochester, MN; Lexington, KY;Washington, DC; and Alexandria, VAel made recommendations that 1) the clinician should diagnose

arseness (dysphonia) in a patient with altered voice quality,ch, loudness, or vocal effort that impairs communication oruces voice-related QOL; 2) the clinician should assess theient with hoarseness by history and/or physical examination fortors that modify management, such as one or more of theuest on May 5, 2013

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S2 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009ion for patients with hoarseness and signs of chronic laryngitis;3) the clinician may educate/counsel patients with hoarseness

ut control/preventive measures.SCLAIMER: This clinical practice guideline is not intendeda sole source of guidance in managing hoarseness (dysphonia).ther, it is designed to assist clinicians by providing an evidence-ed framework for decision-making strategies. The guideline is

t intended to replace clinical judgment or establish a protocol forindividuals with this condition, and may not provide the onlyropriate approach to diagnosing and managing this problem.

2009 American Academy of OtolaryngologyHead and Neckrgery Foundation. All rights reserved.

early one-third of the population has impaired voiceproduction at some point in their lives.1,2 Hoarse-

ss is more prevalent in certain groups, such as teachersd older adults, but all age groups and both genders can beected.1-6 In addition to the impact on health and quality ofe (QOL),7,8 hoarseness leads to frequent health care visitsd several billion dollars in lost productivity annually fromrk absenteeism.9 Hoarseness is often caused by benign orf-limited conditions, but may also be the presentingmptom of a more serious or progressive condition requir-

prompt diagnosis and management.The terms hoarseness and dysphonia are often used in-changeably, although hoarseness is a symptom of alteredice quality and dysphonia is a diagnosis. Dysphonia maybroadly defined as an alteration in the production of

ice that impairs social and professional communication.contrast, hoarseness is a coarse or rough quality to theice. Although the two terms are not synonymous, theideline working group decided to use the term hoarsenessthis guideline because it is more recognized and under-

od by patients, most clinicians, and the lay press.The target patient for this guideline is anyone presentingth hoarseness (dysphonia).Hoarseness (dysphonia) is defined as a disorder charac-terized by altered vocal quality, pitch, loudness, or vocaleffort that impairs communication or reduces voice-re-lated QOL.Impaired communication is defined as a decreased orlimited ability to interact vocally with others.Reduced voice-related QOL is defined as a self-perceiveddecrement in physical, emotional, social, or economicstatus as a result of voice-related dysfunction.

This working definition, developed by the guidelinenel, assumes that hoarseness affects people differently.me individuals may have altered voice quality, vocalort, pitch, or loudness; others may experience problemsth communication and diminished voice-related QOL.The guideline is intended for all clinicians who are likelydiagnose and manage patients with hoarseness and ap-es to any setting in which hoarseness would be identified,nitored, treated, or managed. The guideline does notply to patients with hoarseness with the following condi-ns: history of laryngectomy (total or partial), craniofacial me

by goto.sagepub.comDownloaded from omalies, velopharyngeal insufficiency, and dysarthriapaired articulation). However, the guideline will discussrelevance of these conditions in managing patients with

arseness.There are a number of patients with modifying factorswhom many of the recommendations of the guideline

y not apply. There is some discussion of these factors andw they might modify management. A partial list includesor laryngeal surgery, recent surgical procedures involv-

the neck or affecting the recurrent laryngeal nerve,ent endotracheal intubation, radiation treatment to the

ck, and patients who are singers or performers.

UIDELINE PURPOSE

e primary purpose of this guideline is to improve theality of care for patients with hoarseness based on currentst evidence. Expert consensus to fill evidence gaps, whened, is explicitly stated, and is supported with a detailedidence profile for transparency. Specific objectives of theideline are to reduce inappropriate variations in care,duce optimal health outcomes, and minimize harm.The guideline is intended to focus on a limited number ofality improvement opportunities, deemed most importantthe working group, and is not intended to be a compre-

nsive, general guide for managing patients with hoarse-ss. In this context, the purpose is to define actions thatuld be taken by clinicians, regardless of discipline, toliver quality care. Conversely, the statements in thisideline are not intended to limit or restrict care providedclinicians based on assessment of individual patients.While there is evidence to guide management of certain

uses of hoarseness, there are currently no evidence-basednical practice guidelines. There are variations in the usethe laser, voice therapy, steroids, and postoperative voicet and in the treatment of reflux-related laryngitis.10-13fferences in training, preference, and resource availabilityuence management decisions. A guideline is necessaryen this practice variation and the significant public health

rden of hoarseness.This guideline addresses the identification, diagnosis,atment, and prevention of hoarseness (dysphonia) (TableIn addition, it highlights needs and management optionsspecial populations or in patients who have modifyingtors. Furthermore, this guideline is intended to enhanceaccurate diagnosis of hoarseness (dysphonia), promote

propriate intervention in patients with hoarseness, high-ht the need for evaluation and intervention in specialpulations, promote appropriate therapeutic options withtcomes assessment, and improve counseling and educa-n for prevention and management of hoarseness. Thisideline may also be suitable for deriving a performance

asure on hoarseness.

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S3Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)RDEN OF HOARSENESS

arseness has a lifetime prevalence of 29.9 percent (per-ntage of people affected at some point in their life) and aint prevalence of 6.6 percent (percent of people affecteda given point in time) in adults aged 65 years or under.1her cross-sectional studies have found a similar highetime prevalence of voice complaints of 28.8 percent in

general population.2 Higher prevalence rates of hoarse-ss have been shown in telemarketers (31%),4 aerobicstructors (44%),5 and teachers (58%).2,6 Women are morequently affected than men, with a 60:40 F:M ratio.1,3,14Hoarseness may affect all age groups. Among children,valence rates vary from 3.9 percent to 23.4 percent,15-17

th the most affected age range of 8 to 14 years.18 Voiceblems persist four years or longer after identification inpercent of children with a voice disorder, suggesting an

portunity for early intervention.19 In addition, olderults are also at particular risk,3 with a point prevalence ofpercent20 and a lifetime incidence up to 47 percent.20,21Hoarseness has significant public health implications.tients suffer social isolation, depression, and reduced dis-se-specific and general QOL.1,8,22,23 For example, pa-nts with hoarseness caused by neurologic disorders (Par-son disease, spasmodic dysphonia, vocal tremor, or

cal fold paralysis) reported severe levels of voice handi-p and reduced general health-related QOL, comparable topairments observed in patients with congestive heart fail-, angina, and chronic obstructive pulmonary disease.7,8Hoarseness may also impair work-related function.proximately 28 million US workers have occupationst require use of voice.9 In the general population, 7.2

rcent of individuals surveyed missed work for one orre days within the preceding year because of a problem

able 1terventions considered in hoarseness guidelineevelopment

iagnosis Targeted historyPhysical examinationLaryngoscopyStroboscopyComputed tomography (CT)Magnetic resonance imaging (MRI)

reatment Watchful waiting/observationEducation/informationVoice therapyAnti-reflux medicationsAntibioticsSteroidsSurgeryBotulinum toxin (BOTOX)

revention Voice trainingVocal hygieneEducationEnvironmental measuresth their voice.1 Among teachers this rate increases to 20IntNu by goto.sagepub.comDownloaded from rcent,6,14 resulting in a $2.5 billion loss among US adultscause of missed work annually.9Medical, surgical, and behavioral treatment options existmanaging hoarseness. Among the general population,

wever, only 5.9 percent of those with hoarseness soughtatment.1 Similarly, only 14.3 percent of teachers hadnsulted a physician or speech-language pathologist forarseness, even though voice function is essential to theirfession.2 In some circumstances, complete resolution of

arseness may not be achieved and the clinicians respon-ilities will include minimizing hoarseness and optimizingtient function as well as assisting the patient in develop-

understanding and realistic expectations.Lack of awareness about hoarseness and its causes aretential barriers to appropriate care. Among older adults,ividuals commonly attribute their hoarseness to advanc-age. Such assumptions may prevent or delay those with

arseness from obtaining treatment. Improved educationong all health professionals24 and efficient medical careessential for reducing the health burden of hoarseness.25dequate insurance coverage has been cited as a cause oflure to seek treatment for both functional voice problems,seen in singers,25 and life-threatening ones, as seen in

ncer patients.26The primary outcomes considered in this guideline areprovement in vocal function and change in voice-relatedL. Secondary outcomes include complications and ad-

rse events. Economic consequences, adherence to ther-y, global QOL, return to work, improved communicationction, and return health care visits were also considered.e high prevalence, significant individual and societal im-cations, diversity of interventions, and lack of consensuske this an important condition for an up-to-date, evi-

nce-based practice guideline.

ENERAL METHODS AND LITERATUREARCH

e guideline was developed using an explicit and trans-rent a priori protocol for creating actionable statementssed on supporting evidence and the associated balancebenefit and harm.27,28 The multidisciplinary guidelinevelopment panel was chosen to represent the fields ofurology, speech-language pathology, professional voiceching, family medicine, pulmonology, geriatric medi-e, nursing, internal medicine, otolaryngologyhead and

ck surgery, pediatric medicine, and consumers. Severalup members had significant prior experience in develop-clinical practice guidelines.

Several initial literature searches were performedough November 17, 2008 by AAO-HNSF staff usingEDLINE, The National Guidelines Clearinghouse (NGC)ww.guideline.gov), The Cochrane Library, Guidelines

ernational Network (GIN), The Cumulative Index torsing and Allied Health Literature (CINAHL), and

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S4 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009BASE. The initial broad MEDLINE search using hoarse-ss[mh] or dysphonia[tw] or voice disorders[mh] iny field showed 6032 potential articles:

Clinical practice guidelines were identified by a GIN,NGC, and MEDLINE search using guideline as apublication type or title word. The search identified eightguidelines with a topic of hoarseness or dysphonia. Aftereliminating articles that did not have hoarseness or dys-phonia as the primary focus, no guidelines met qualitycriteria of being produced under the auspices of a med-ical association or organization and having an explicitmethod for ranking evidence and linking evidence torecommendations.Systematic reviews were identified in MEDLINE using avalidated filter strategy.29 That strategy initially yielded92 potential articles. The final data set included 14 sys-tematic reviews or meta-analyses (including two Co-chrane systematic reviews) on hoarseness or dysphoniathat were distributed to the panel members.Randomized controlled trials were identified through theCochrane Library (Cochrane Controlled Trials Register)and totaled 256 trials with hoarseness or dysphoniain any field.Original research studies were identified by limiting theMEDLINE, CINAHL, and EMBASE search to articleson humans published in English. The resulting data setof 769 articles yielded 262 related to therapy, 256 todiagnosis, 205 to etiology, and 46 to prognosis.

Results of all literature searches were distributed toideline panel members at the first meeting, includingctronic listings with abstracts (if available) of therches for randomized trials, systematic reviews, ander studies. This material was supplemented, as needed,

th targeted searches to address specific needs identified initing the guideline through February 8, 2009.In a series of conference calls, the working group definedscope and objectives of the proposed guideline. Duringnine months devoted to guideline development ending in

09, the group met twice, with interval electronic reviewd feedback on each guideline draft to ensure accuracy ofntent and consistency with standardized criteria for re-rting clinical practice guidelines.30AAO-HNSF staff used GEM-COGS,31 the Guidelineplementability Appraisal and Extractor, to appraise ad-rence of the draft guideline to methodological standards,improve clarity of recommendations, and to predict po-tial obstacles to implementation. Guideline panel mem-

rs received summary appraisals in April 2009 and mod-d an advanced draft of the guideline.The final draft practice guideline underwent extensive,ltidisciplinary, external peer review. Comments were

mpiled and reviewed by the group chairpersons, and adified version of the guideline was distributed and ap-ved by the development panel. The recommendationsntained in the practice guideline are based on the bestan

iss by goto.sagepub.comDownloaded from ailable published data through February 2009. Whereta were lacking, a combination of clinical experience andpert consensus was used. A scheduled review process willcur at five years from publication, or sooner if new com-lling evidence warrants earlier consideration.

assification of Evidence-Based Statementsidelines are intended to reduce inappropriate variationsclinical care, to produce optimal health outcomes for

tients, and to minimize harm. The evidence-based ap-ach to guideline development requires that the evidence

pporting a policy be identified, appraised, and summa-ed and that an explicit link between evidence and state-nts be defined. Evidence-based statements reflect bothquality of evidence and the balance of benefit and harm

t is anticipated when the statement is followed. Thefinitions for evidence-based statements32 are listed inbles 2 and 3.Guidelines are never intended to supersede professionalgment; rather, they may be viewed as a relative con-

aint on individual clinician discretion in a particular clin-l circumstance. Less frequent variation in practice ispected for a strong recommendation than might bepected with a recommendation. Options offer thest opportunity for practice variability.33 Clinicians

ould always act and decide in a way that they believe willst serve their patients interests and needs, regardless ofideline recommendations. They must also operate withinir scope of practice and according to their training.idelines represent the best judgment of a team of expe-nced clinicians and methodologists addressing the scien-c evidence for a particular topic.32Making recommendations about health practices in-lves value judgments on the desirability of various out-mes associated with management options. Values appliedthe guideline panel sought to minimize harm and dimin-unnecessary and inappropriate therapy. A major goal ofcommittee was to be transparent and explicit about how

lues were applied and to document the process.

nancial Disclosure and Conflicts of Intereste cost of developing this guideline, including travel ex-nses of all panel members, was covered in full by theO-HNS Foundation. Potential conflicts of interest for all

nel members in the past five years were compiled andtributed before the first conference call. After review andcussion of these disclosures,34 the panel concluded thatividuals with potential conflicts could remain on the

nel if they: 1) reminded the panel of potential conflictsfore any related discussion, 2) recused themselves from aated discussion if asked by the panel, and 3) agreed not tocuss any aspect of the guideline with industry beforeblication. Lastly, panelists were reminded that conflicts oferest extend beyond financial relationships and may in-de personal experiences, how a participant earns a living,d the participants previously established stake in anue.35

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S5Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)ARSENESS (DYSPHONIA) GUIDELINETION STATEMENTS

ch action statement is organized in a similar fashion:tement in boldface type, followed by an italicized state-nt on the strength of the recommendation. Several para-phs then discuss the evidence base supporting the state-nt, concluding with an evidence profile of aggregate

idence quality, benefit-harm assessment, and statement ofsts. Lastly, there is an explicit statement of the valuegments, the role of patient preferences, and a repeattement of the strength of the recommendation. An over-w of evidence-based statements in the guideline and theirerrelationship is shown in Table 4.The role of patient preference in making decisions de-ves further clarification. For some statements the evi-nce base demonstrates clear benefit, which would mini-ze the role of patient preference. If the evidence is weakbenefits are unclear, however, not all informed patientsght opt to follow the suggestion. In these cases, thectice of shared decision making, where the management

able 2uideline definitions for evidence-based statements

Statement Definition

trong recommendation A strong recommendation meof the recommended approaexceed the harms (or that thexceed the benefits, in the cnegative recommendation) aquality of the supporting evexcellent (Grade A or B*). Inidentified circumstances, strrecommendations may be mlesser evidence when high-qis impossible to obtain andbenefits strongly outweigh t

ecommendation A recommendation means theexceed the harms (or that ththe benefits, in the case of arecommendation), but the qevidence is not as strong (GIn some clearly identified cirrecommendations may be mlesser evidence when high-qis impossible to obtain andbenefits outweigh the harm

ption An option means either that tevidence that exists is suspeor that well-done studies (GC*) show little clear advantaapproach vs another.

See Table 3 for definition of evidence grades.cision is made by a collaborative effort between thenician and the informed patient, becomes more useful.

gapro by goto.sagepub.comDownloaded from ctors related to patient preference include (but are notited to) absolute benefits (number needed to treat), ad-

rse effects (number needed to harm), cost of drugs orts, frequency and duration of treatment, and desire to takeavoid antibiotics. Comorbidity can also impact patientferences by several mechanisms, including the potentialdrug-drug interactions when planning therapy.

ATEMENT 1. DIAGNOSIS: Clinicians should diag-se hoarseness (dysphonia) in a patient with alteredice quality, pitch, loudness, or vocal effort that im-irs communication or reduces voice-related QOL.commendation based on observational studies with aeponderance of benefit over harm.

pporting Texte purpose of this statement is to promote awareness ofarseness (dysphonia) by all clinicians as a condition thaty require intervention or additional investigation. Theposed diagnosis (dysphonia) is based on strictly clinical

teria, and does not require testing or additional investi-

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Clinicians should also generally followa recommendation, but shouldremain alert to new information andsensitive to patient preferences.

ality ofrade D*), B, orone

Clinicians should be flexible in theirdecision making regardingappropriate practice, although theymay set bounds on alternatives;patient preference should have asubstantial influencing role.Falimve

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S6 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009Some patients with objectively minor changes may beable to work and have a significant decrement in QOL.hers with significant disease such as malignancy mayve minimal functional impairment of their voice. Of pa-nts with laryngeal cancer, 52 percent thought theirarseness was harmless and delayed seeing a physician.36cordingly, patients with minimal objective voice changed significant complaints as well as patients with limited

able 3vidence quality for grades of evidence

rade Evidence quality

A Well-designed randomized controlled trialsor diagnostic studies performed on apopulation similar to the guidelinestarget population

B Randomized controlled trials or diagnosticstudies with minor limitations;overwhelmingly consistent evidencefrom observational studies

C Observational studies (case-control andcohort design)

D Expert opinion, case reports, reasoningfrom first principles (bench research oranimal studies)

X Exceptional situations where validatingstudies cannot be performed and thereis a clear preponderance of benefit overharm

able 4utline of guideline action statements

Hoarseness (dysphonia) (statement number)

I. Diagnosisa. Diagnosis (Statement 1)b. Modifying factors (Statement 2)c. Laryngoscopy and hoarseness (Statement 3A)d. Indications for laryngoscopy

(Statement 3B)e. Imaging prior to laryngoscopy (Statement 4)

II. Medical therapya. Anti-reflux therapy for hoarseness in the absence of

or chronic laryngitis (Statement 5A)b. Anti-reflux therapy with chronic laryngitis (Statemenc. Corticosteroid therapy (Statement 6)d. Antimicrobial therapy (Statement 7)

II. Voice therapya. Laryngoscopy prior to beginning (Statement 8A)b. Advocating for

(Statement 8B). Invasive therapiesa. Advocating surgery in selected patients (Statement 9b. Botulinum toxin for adductor spasmodic dysphonia

(Statement 10)

. Prevention (Statement 11)

by goto.sagepub.comDownloaded from mplaints but with objective alterations of voice qualityrrant evaluation.Patients with hoarseness may experience discomfort with

eaking, increased phonatory effort, and weak voice, asll as altered quality such as wobbly or shaky voice,athiness, and raspiness.20,37,38 While a breathy voicey signify vocal fold paralysis or another cause of incom-te vocal fold closure, a strained voice with altered pitchpitch breaks is common in spasmodic dysphonia.39

anges in voice quality may be limited to the singing voiced not affect the speaking voice. Among infants and youngildren, an abnormal cry may signify underlying pathologyluding vocal fold paralysis, laryngeal papilloma, or other

stemic conditions.Listening to the voice (perceptual evaluation) in a critical

d objective manner may provide important diagnosticormation. Characterizing the patients complaint andice quality is important for assessing hoarseness severityd for differentiating among specific causes of hoarseness,ch as muscle tension dysphonia and spasmodic dyspho-.40,41Hoarseness may impair communication. Difficulty being

ard and understood while using the telephone has beenorted in the geriatric population.20,38 Trouble being

ard in groups and problems being understood are alsommon complaints among hoarse patients.37 Conse-ently, patients describe less confidence, decreased social-tion, and impaired work-related function.1,37Hoarseness may lead to decreased voice-related QOL

d a decrement in physical, social, and emotional aspects

Statement strength

RecommendationRecommendationOptionRecommendation

Recommendation against

Recommendation against

OptionRecommendation againstStrong recommendation against

RecommendationStrong recommendation

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by goto.sagepub.comDownloaded from global QOL similar to those associated with other chroniceases, such as congestive heart failure and chronic ob-uctive pulmonary disease.7,8Clinicians should consider input from proxies when di-

nosing hoarseness (dysphonia). Of patients with vocald cancer, 40 percent waited three months before seekingdical attention for their hoarseness. Furthermore, 16.7

rcent only sought treatment after encouragement fromer people.36 These data highlight the fact that hoarsenessy not be recognized by the patient.Children and patients with cognitive impairment or se-

re emotional burden may be unaware or unable to recog-e and report on their own hoarseness.42 QOL studies iner adults have required proxy input in approximately 25

rcent of the geriatric population.43 While self-report mea-res for hoarseness are available, patients may be unable tomplete them.44-46 In these cases, proxy judgments bynificant others about QOL are a good alternative.42 Mod-te agreement has been shown between adult patients andir communication partners on the Voice Handicap Index.rent proxy self-report measures have also been validateduse in the pediatric population.38,47

When evaluating a patient with hoarseness, the clini-n should obtain a detailed medical history (Table 5)d review current medications (Table 6) as this infor-tion may identify the cause of the hoarseness (dyspho-) or an alternative underlying condition that may war-t attention.

Evidence profile for Statement 1: Diagnosis

Aggregate evidence quality: Grade C, observational stud-

able 5ontinued

Allergic rhinitisChronic rhinitisHypertension (because of certain medications used

for this condition)Schizophrenia (because of anti-psychotics used for

mental health problems)Osteoporosis (because of certain medications used

for this condition)Asthma, chronic obstructive pulmonary disease

(because of use of inhaled steroids)Aneurysm of thoracic aorta (rare cause)Laryngeal cancerLung cancer (or metastasis to the lung)Thyroid cancerHypothyroidism and other endocrinopathiesVocal fold nodulesVocal fold paralysisVocal abuseChemical laryngitisChronic tobacco useSjgren syndromeAlcohol (moderate to heavy use or abuse)able 5ertinent medical history for assessing a patientith hoarseness48-50

oice-specific questionsDid your problem start suddenly or gradually?Is your voice ever normal?Do you have pain when talking?Does your voice deteriorate or fatigue with use?Does it take more effort to use your voice?What is different about the sound of your voice?Do you have a difficult time getting loud or

projecting?Have you noticed changes in your pitch or range?Do you run out of air when talking?Does your voice crack or break?

ymptomsGlobus pharyngeus (persisting sensation of lump

in throat)DysphagiaSore throatChronic throat clearingCoughOdynophagia (pain with swallowing)Nasal drainagePost-nasal drainageNon-anginal chest painAcid refluxRegurgitationHeartburnWaterbrash (sudden appearance of salty liquid in

the mouth)Halitosis (bad breath)FeverHemoptysisWeight lossNight sweatsOtalgia (ear pain)Difficulty breathingedical history relevant to hoarsenessOccupation and/or avocation requiring extensive

voice use (ie, teacher, singer)Absenteeism from occupation due to hoarsenessPrior episode(s) of hoarsenessRelationship of instrumentation (intubation, etc) to

onset of hoarsenessRelationship of prior surgery to neck or chest to

onset of hoarsenessCognitive impairment (requirement for proxy

historian)Anxietycute conditionsInfection of the throat and/or larynx: viral,

bacterial, fungalForeign body in larynx, trachea, or esophagusNeck or laryngeal trauma

hronic conditionsStrokeDiabetesParkinsons diseaseDiseases from the Parkinsons Plus family

(progressive supranuclear palsy, etc)Myasthenia gravisMultiple sclerosisAmyotrophic lateral sclerosis (ALS)ies for symptoms with one systematic review of QOL inuest on May 5, 2013

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S8 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009voice disorders and two systematic reviews on medica-tion side effectsBenefit: Identify patients who may benefit from treatmentor from further investigation to identify underlying con-ditions that may be serious, promote prompt recognitionand treatment, and discourage the perception of hoarse-ness as a trivial condition that does not warrant attentionHarm: Potential anxiety related to diagnosisCost: Time expended in diagnosis, documentation, anddiscussionBenefits-harm assessment: Preponderance of benefitsover harmValue judgments: NoneRole of patient preference: LimitedIntentional vagueness: NoneExclusions: NonePolicy Level: Recommendation

ATEMENT 2. MODIFYING FACTORS: Cliniciansould assess the patient with hoarseness by historyd/or physical examination for factors that modifynagement such as one or more of the following: re-

nt surgical procedures involving the neck or affectinge recurrent laryngeal nerve, recent endotracheal intu-tion, radiation treatment to the neck, a history ofacco abuse, and occupation as a singer or vocal per-mer. Recommendation based on observational studies

th a preponderance of benefit over harm.

pporting Texte term modifying factors as used in this recommenda-n refers to details elicited by history taking or physical

able 6edications that may cause hoarseness

MedicationMechanism of impact

on voice

oumadin, thrombolytics,phosphodiesterase-5inhibitors

Vocal fold hematoma51-53

iphosphonates Chemical laryngitis54

ngiotensin-convertingenzyme inhibitors

Cough55

ntihistamines, diuretics,anticholinergics

Drying effect onmucosa56,57

anocrine, testosterone Sex hormone production/utilization alteration58,59

ntipsychotics, atypicalantipsychotics

Laryngeal dystonia60,61

haled steroids Dose-dependent mucosalirritation,62 fungallaryngitisamination that provide a clue to the presence of an im-rtant underlying etiology of hoarseness (dysphonia) that wi

by goto.sagepub.comDownloaded from y lead to a change in management. The history andysical examination of the patient with hoarseness mayvide insight into the nature of the patients conditionor to the initiation of a more in-depth evaluation.Surgery on the cervical spine via an anterior approach

s been associated with a high incidence of voice prob-s. Recurrent laryngeal nerve paralysis has been reported

range from 1.27 percent to 2.7 percent.63-65 Assessmentth laryngoscopy suggests an even higher incidence.66 Theidence of hoarseness immediately following anterior cer-al spine surgery may be as high as 50 percent.67 Hoarse-

ss resulting from anterior cervical spine surgery may ory not resolve over time.68,69Thyroid surgery has been associated with voice disor-

rs. Patients with thyroid disease requiring surgery mayve hoarseness and identifiable abnormalities on indirectyngoscopy prior to surgery.70 Thyroidectomy may causearseness as a result of recurrent laryngeal nerve paralysisup to 2.1 percent of patients.71 Surgery in the anteriorck can also lead to injury to the superior laryngeal nerveth resulting voice alteration, although this is uncom-n.72

Carotid endarterectomy is frequently associated withstoperative voice problems73 and may result in recurrentyngeal nerve damage in up to 6 percent of patients.74,75rgery to achieve an urgent airway or on the larynx directlyy alter its structure, resulting in abnormal voice.76,77Surgical procedures not involving the neck may alsoult in hoarseness (dysphonia). Hoarseness following car-c surgery is a common problem, occurring in 17 percent31 percent of patients.78,79 Hoarseness may result fromanges in position or manipulation of the endotracheal tubefrom lengthy procedures.78 Recurrent laryngeal nerve

ury occurs in about 1.4 percent of patients during cardiacrgery.78 The left recurrent laryngeal nerve is damagedre commonly than the right as it extends into the chest

d loops under the arch of the aorta. Damage may resultm direct physical injury to the nerve or hypothermicury due to cold cardioplegia.80Surgery for esophageal cancer frequently results in dam-

e to the recurrent laryngeal nerve with subsequent hoarse-ss. In one study, 51 of 141 patients undergoing esopha-ctomy for cancer had laryngeal nerve paralysis, with 30 ofse patients having persistent paralysis one year following

rgery.81 The implantation of vagal nerve stimulators forractable seizures has been associated with hoarseness inmany as 28 percent of patients.82Prolonged endotracheal intubation has been associatedth hoarseness. Direct laryngoscopy of patients intubatedmore than four days (mean nine days) demonstrates thatpercent of patients have laryngeal injury.83 The injury

tterns seen in the patients with prolonged intubation in-de laryngeal edema and posterior and medial vocal folderation. As many as 44 percent of patients with pro-ged intubation may develop vocal fold granulomasthin four weeks of being extubated. In this study, 18uest on May 5, 2013

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S9Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)rcent of patients had prolonged true vocal fold immobilityat least four weeks after extubation.84 Another study

lowing a large group of patients for several years foundronic phonatory dysfunction in many patients after long-m intubation.85Short-term intubation for general anesthesia may resulthoarseness and vocal fold pathology in over 50 percent ofses.86 While most symptoms resolved after five days,longed symptoms may result from vocal fold granuloma.hoarseness persists, the remoteness of the index eventy confound the evaluating clinician. Use of a laryngealsk airway may reduce postsurgical complaints of dis-

mfort, but does not objectively reduce hoarseness.87Long-term intubation of neonates may result in voiceblems related to arytenoid and posterior commissureeration and cartilage erosion.88 Children with a history oflonged intubation may have long-term complications of

arseness and arytenoid dysfunction.Voice disorders are common in older adults and signif-ntly affect the QOL in these patients.21 Vocal fold atro-y with resulting hoarseness (dysphonia) is a commonorder of older adults and is frequently undiagnosed bymary care providers.89,90 Hoarseness resulting from neu-ogic disorders such as cerebral vascular accident andrkinson disease is also more common in elderly pa-nts.91-94 Multiple sclerosis can lead to hoarseness in pa-nts of any age.95Chronic hoarseness (dysphonia) is quite common inung children and has an adverse impact on QOL.96 Prev-nce ranges from 15 percent to 24 percent of the popula-n.17,97 In one study, 77 percent of hoarse children hadcal fold nodules.17 These may persist into adolescence ift properly treated.98 Craniofacial anomalies such as oro-ial clefts are associated with abnormal voice,99 but thesefrequently resonance disorders requiring very different

rapies than for hoarse children with normal anatomicalvelopment.Hoarseness or dysphonia in infants may be recognizedly by an abnormal cry, and suspicion of such symptomsould prompt consultation with an otolaryngologist.100hen infants do present with hoarseness, underlying etiol-ies such as birth trauma, an intracranial process such asnold-Chiari malformation or posterior fossa mass, or me-stinal pathology should be considered.101Hoarseness in tobacco smokers is associated with anreased frequency of polypoid vocal fold lesions and head

d neck cancer.102 Accordingly, this requires an expedientessment for malignancy as the potential cause of hoarse-

ss. In addition, in patients treated with external beamiation for glottic cancer, radiation treatment is associated

th hoarseness in about 8 percent of cases.103,104Patients who use inhaled corticosteroids for the treatmentasthma or chronic obstructive pulmonary disease maysent to a clinician with hoarseness that is a side effect ofrapy either from direct irritation or from a fungal infec-

n of the larynx.105 po

by goto.sagepub.comDownloaded from Singers or vocal performers should be identified by thenician when eliciting a history from the hoarse patient.ese patients have significant impairment with symptomst may be subclinical in other patients. They may be more

bject to voice over-use or have a different etiology forir symptoms, and hoarseness may have a more significantpact on their QOL or ability to earn income. For example,ile hoarseness is relatively rare following thyroid sur-

ry, there are objective, measurable changes in the voice ofst patients that could affect pitch and the ability tog.106 Singers are also prone to develop microvascular

tasias that affect voice and require specific therapy.107To a slightly lesser degree, individuals in a number ofer occupations or avocations, such as teachers andrgy, depend on voice use. As an example, over 50 percentteachers have hoarseness, and vocal overuse is a com-n, but not exclusive, etiologic factor.108 Clinicians

ould inquire about an individuals voice use in order totermine the degree to which altered voice quality maypact the individual professionally.

Evidence profile for Statement 2: Modifying Factors

Aggregate evidence quality: Grade C, observationalstudiesBenefit: To identify factors early in the course of man-agement that could influence the timing of diagnosticprocedures, choice of interventions, or provision of fol-low-up careHarm: NoneCost: NoneBenefits-harm assessment: Preponderance of benefit overharmValue judgments: Importance of history taking and iden-tifying modifying factors as an essential component ofproviding quality careRole of patient preferences: Limited or noneIntentional vagueness: NoneExclusions: NonePolicy level: Recommendation

ATEMENT 3A. LARYNGOSCOPY AND HOARSE-SS: Clinicians may perform laryngoscopy, or may

fer the patient to a clinician who can visualize theynx, at any time in a patient with hoarseness. Optionsed on observational studies, expert opinion, and a bal-ce of benefit and harm.

ATEMENT 3B. INDICATIONS FOR LARYNGOS-PY: Clinicians should visualize the patients larynx,refer the patient to a clinician who can visualize theynx, when hoarseness fails to resolve by a maximumthree months after onset, or irrespective of duration iferious underlying cause is suspected. Recommendationsed on observational studies, expert opinion, and a pre-

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S10 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009pporting Texte purpose of these statements is to highlight the importante of visualizing the larynx and vocal folds in managing atient with hoarseness, especially if the hoarseness fails toprove within three months of onset (Statement 3B). Pa-nts with persistent hoarseness may have a serious under-ng disorder (Table 7) that would not be diagnosed unless

larynx was visualized. This does not, however, implyt all patients must wait three months before laryngoscopyperformed, because, as outlined below, early assessmentsome patients with hoarseness may improve manage-nt. Therefore, clinicians may perform laryngoscopy, orer to a clinician for laryngoscopy, at any time (Statement) if deemed appropriate based on the patients specificnical presentation and modifying factors.

ryngoscopy and Hoarsenesssualization of the larynx is part of a comprehensive eval-tion for voice disorders. While not all clinicians have theining and equipment necessary to visualize the larynx,se who do may examine the larynx of a patient present-with hoarseness at any time if considered appropriate.

though most hoarseness is caused by benign or self-ited conditions, early identification of some disordersy increase the likelihood of optimal outcomes.There are a number of conditions where laryngoscopy attime of initial assessment allows for timely diagnosis

d management. Laryngoscopy can be used at the bedsidepatients with hoarseness after surgery or intubation to

ntify vocal fold immobility, intubation trauma, or otherurces of postsurgical hoarseness. Laryngoscopy plays atical role in evaluating laryngeal patency after laryngealuma where visualization of the airway allows for assess-nt of the need for surgical intervention and for following

tients in whom immediate surgery is not required.109,110

able 7onditions leading to suspicion of a seriousnderlying cause

oarseness with a history of tobacco or alcohol useoarseness with concomitant discovery of a neckmassoarseness after traumaoarseness associated with hemoptysis, dysphagia,odynophagia, otalgia, or airway compromiseoarseness with accompanying neurologicsymptomsoarseness with unexplained weight lossoarseness that is worseningoarseness in an immunocompromised hostoarseness and possible aspiration of a foreign bodyoarseness in a neonatenresolving hoarseness after surgery (intubation orneck surgery)Laryngoscopy is used routinely for diagnosing laryngealncer. The usefulness of laryngoscopy for establishing the un

by goto.sagepub.comDownloaded from gnosis and the benefit of early detection have led theitish medical system to employ fast-track screening clin-for laryngeal cancer that mandate laryngoscopy withindays of suspicion of laryngeal cancer.111,112 Fungal lar-

gitis from inhalers and other causes is best diagnosedth laryngoscopy and must be distinguished from malig-ncy.113Unilateral vocal fold paralysis causes breathy hoarseness

d is often caused by thoracic, cervical, or brain tumorst either compress or invade the vagus nerve or itsnches that innervate the larynx. Stroke may also present

th hoarseness due to vocal fold paralysis. Vocal foldralysis is routinely identified, characterized, and followedlaryngoscopy.79,114In patients with cranial nerve deficits or neuromuscular

anges, laryngoscopy is useful to identify neurologicuses of vocal dysfunction.115 Benign vocal fold lesionsch as vocal fold cysts, nodules, and polyps are readilytected on laryngoscopy. Visualization of the larynx mayo provide supporting evidence in the diagnosis of laryn-pharyngeal reflux.116Hoarseness caused by neurologic or motor neuron dis-

se such as Parkinson disease, amyotrophic lateral sclero-, and spasmodic dysphonia may have laryngoscopic find-s that the clinician can identify to initiate management ofunderlying disease.117 Office laryngoscopy is also a

tical tool in the evaluation of the aging voice.Neonates with hoarseness should undergo laryngoscopyidentify vocal fold paralysis,118 laryngeal webs,119 orer congenital anomalies that might affect their ability toallow or breathe.120Hoarseness in children is rarely a sign of a serious un-

rlying condition and is more likely the result of a benignion of the larynx such as a vocal fold polyp, nodules, orst.121 However, determining if laryngeal papilloma is theology of hoarseness in a child is particularly importanten the high potential for life-threatening airway obstruc-n and the potential for malignant transformation.122 Aarse child with other symptoms such as stridor, airwaystruction, or dysphagia may have a serious underlyingblem such as a Chiari malformation,123 hydrocephalus,

ull base tumors, or a compressing neck or mediastinalss. Persistent hoarseness in children may be a symptomvocal fold paralysis with underlying etiologies that in-de neck masses, congenital heart disease, or previous

rdiothoracic, esophageal, or neck surgery.124

dications for Laryngoscopyryngoscopy is indicated for the assessment of hoarsenessymptoms fail to improve or resolve within three months,at any time the clinician suspects a serious underlyingorder. In this context serious describes an etiology thatuld shorten the lifespan of the patient or otherwise reducefessional viability or voice-related QOL. If the clinician

concerned that hoarseness may be caused by a serious

derlying condition, the optimal way to address this con-uest on May 5, 2013

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S11Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)rn is by visualization of the vocal folds with laryngos-py.The major cause of community-acquired hoarseness isal. Symptoms from viral laryngitis typically last 1 to 3eks.125,126 Symptoms of hoarseness persisting beyonds time warrant further evaluation to insure that no malig-ncy or morbid conditions are missed and to allow furtheratment to be initiated based on specific benign patholo-s if indicated. One population-based cohort study127 ande large case-control study128 have shown that delays ingnosis of laryngeal cancer lead to higher stages of dis-

se at diagnosis and worse prognosis. In the cohort study,lay longer than three months led to poorer survival.The expediency of laryngoscopy also depends on patient

nsiderations. Singers, performers, and patients whoseelihood depends upon their voice will not be able to waiteral weeks for their hoarseness to resolve as they may be

able to work in the interim. In fact, a number of profes-nals with high vocal demands may benefit from imme-te evaluation.Even in the absence of serious concern or patient con-erations indicating immediate laryngoscopy, persistentarseness should be evaluated to rule out significant pa-logy such as cancer or vocal fold paralysis. In the ab-ce of immediate concern, there is little guidance from therature on the proper length of time a hoarse patient canshould be observed before visualization of the larynx isndated. The working group weighed the risk of delayedgnosis against the potential over-utilization of resources

d selected a fairly long window of three months prior tondating laryngoscopy. This safety net approach, based on

pert opinion, was designed to address the main concern ofworking group that many patients with persistent

arseness are currently experiencing delayed diagnosis ornot undergoing laryngoscopy at all.

chniques for Visualizing the Larynxfferent techniques are available for laryngoscopy andnfer varying levels of risk. The working group does notve recommendations as to the preferred method. Choicemethod is at the discretion of the evaluating clinician.Office laryngoscopy can be performed transorally with arror or rigid endoscope, transnasally with a flexible fi-roptic or distal-chip laryngoscope, and with either halo-n light or stroboscopic light application.129 The surfaced mobility of the vocal folds are well assessed with thesels.Stroboscopy is used to visualize the vocal folds as theyrate, allowing for an assessment of both anatomy andction during the act of phonation.130 When hoarseness

mptoms are out of proportion to the laryngoscopic exam-tion, stroboscopy should be considered. The addition ofoboscopic light allows for an assessment of the pliabilitythe vocal folds, making additional pathologies such ascal fold scar easy to identify. Stroboscopy has resulted in

131ered diagnosis in 47 percent of cases, and stroboscopicrameters aid in the differentiation of specific vocal fold

by goto.sagepub.comDownloaded from thology, such as polyps and cysts.132 Surgical endoscopyth magnification (microlaryngoscopy) is utilized moreen when more detailed examination, manipulation, orpsy of the structures is required.133In the adult, visualization by indirect mirror examinationy be limited by patient tolerance and photo documenta-n is not possible. Discomfort in transnasal laryngoscopyusually mitigated by the application of topical deconges-t and/or anesthetic such as lidocaine. A study of 1208

tients evaluated by fiberoptic laryngoscopy for assess-nt of vocal fold paralysis after thyroidectomy showed nonificant adverse events.134 No other reports of significantks of fiberoptic laryngoscopy were found in a detailedEDLINE search using key words: laryngoscopy, compli-tions, risk, and adverse events. Transoral examinations of

larynx may be preceded by topical lidocaine to the throatd carries similarly minimal risk.Operative laryngoscopy carries more substantial risk but

nerally allows for ease of tissue manipulation and biopsy.sks associated with direct laryngoscopy with general an-hesia, include airway distress; dental trauma; oral cavity,pharyngeal, and hypopharyngeal trauma; tongue dyses-sia; taste changes; and cardiovascular risk.135-137 The

st of direct laryngoscopy is substantially greater than thatoffice-based laryngoscopy due to the additional costs offf, equipment, and additional care required.138-140Special consideration is given to children for whomyngoscopy requires either advanced skill or a specializedting. With the advent of small-diameter flexible laryngo-pes, awake, flexible laryngoscopy can be employed inclinic in children as young as newborns but is subject toskill of the clinician and comfort with children. The

vantage is that this examination allows for evaluation ofth anatomy and function of the larynx in the hoarse child.rect laryngoscopy under anesthesia with or without acroscope may be used to verify flexible fiberoptic find-s, manage laryngeal papillomas or other vocal fold le-ns, and further define laryngeal pathology such as con-nital anomalies of the larynx. Intraoperative palpation of

cricoarytenoid joint may also help differentiate betweencal fold paralysis and fixation.

Evidence profile for Statement 3A: Laryngoscopy andarseness

Aggregate evidence quality: Grade C, based on observa-tional studiesBenefit: Visualization of the larynx to improve diagnosticaccuracy and allow comprehensive evaluationHarm: Risk of laryngoscopy, patient discomfortCost: Procedural expenseBenefits-harm assessment: Balance of benefit and harmValue judgments: Laryngoscopy is an important tool forevaluating voice complaints and may be performed at anytime in the patient with hoarseness

Intentional vagueness: Noneuest on May 5, 2013

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S12 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009Role of patient preferences: Substantial; the level of pa-tient concern should be considered in deciding when toperform laryngoscopyExclusions: NonePolicy level: Option

Evidence profile for Statement 3B: Indications for La-goscopy

Aggregate evidence quality: Grade C, observational stud-ies on the natural history of benign laryngeal disorders;grade C for observational studies plus expert opinion ondefining what constitutes a serious underlying conditionBenefit: Avoid missed or delayed diagnosis of seriousconditions in patients without additional signs or symp-toms to suggest underlying disease; permit prompt assess-ment of the larynx when serious concern existsHarm: Potential for up to a three-month delay in diagno-sis; procedure-related morbidityCost: Procedural expenseBenefits-harm assessment: Preponderance of benefit overharmValue judgments: A need to balance timely diagnosticintervention with the potential for over-utilization andexcessive cost. The guideline panel debated on the max-imum duration of hoarseness prior to mandated evalua-tion and opted to select a safety net approach with agenerous time allowance (three months), but options toproceed promptly based on clinical circumstancesIntentional vagueness: The term serious underlying con-cern is subject to the discretion of the clinician. Someconditions are clearly serious, but in other patients, theseriousness of the condition is dependent on the patient.Intentional vagueness was incorporated to allow for clin-ical judgment in the expediency of evaluationRole of patient preferences: LimitedExclusions: NonePolicy level: Recommendation

ATEMENT 4. IMAGING: Clinicians should not ob-n computed tomography (CT) or magnetic resonanceaging (MRI) of the patient with a primary complainthoarseness prior to visualizing the larynx. Recommen-tion against imaging based on observational studies ofrm, absence of evidence concerning benefit, and a pre-nderance of harm over benefit.

pporting Texte purpose of this statement is not to discourage the use ofaging in the comprehensive work-up of hoarseness, buther to emphasize that it should be used to assess forecific pathology after the larynx has been visualized.Laryngoscopy is the primary diagnostic modality for

aluating patients with hoarseness. Imaging studies, in-ding CT and MRI, have also been used, but are unnec-

ary in most patients because most hoarseness is self-ited or caused by pathology that can be identified by im

by goto.sagepub.comDownloaded from yngoscopy. The value of imaging procedures before la-goscopy is undocumented; no articles were found in the

stematic literature review for this guideline regarding thegnostic yield of imaging studies prior to laryngeal exam-tion. Conversely, the risk of imaging studies is wellcumented.The risk of radiation-induced malignancy from CT scans

small but real. More than 62 million CT scans per year aretained in the United States for all indications, including 4llion performed on children (nationwide evaluation ofay trends). In a study of 400,000 radiation workers in theclear industry who were exposed to an average dose of 20Vs (a typical organ dose from a single CT scan for an

ult), a significant association was reported between theiation dose and mortality from cancer in this cohort.ese risks were quantitatively similar to those reported formic bomb survivors.141 Children have higher rates oflignancy and a longer lifespan in which radiation-in-ced malignancies can develop.142,143 It is estimated thatout 0.4 percent of all cancers in the United States may beributable to the radiation from CT studies.144,145 The risky be higher (1.5% to 2%) if we adjust this estimate basedour current use of CT scans.There are also risks associated with IV contrast dye usedincrease diagnostic yield of CT scans.146 Allergies to

ntrast dye are common (5% to 8% of the population).vere, life-threatening reactions, including anaphylaxis,cur in 0.1 percent of people receiving iodinated contrastterial, with a death rate of up to one in 29,500 peo-.147,148While MRI has no radiation effects, it is not without risk.review of the safety risks of MRI149 details five mainsses of injury: 1) projectile effects (anything metal thatts attracted by the magnetic field); 2) twisting of indwell-

metallic objects (cerebral artery clips, cochlear implants,shrapnel); 3) burning (electrical conductive material in

ntact with the skin with an applied magnetic field, ie,G electrodes or medication patches); 4) artifacts (radio-quency effects from the device itself simulating pathol-y); and 5) device malfunction (pacemakers will fire in-propriately or work at an elevated frequency, thustorting cardiac conduction).150The small confines of the MRI scanner may lead toustrophobia and anxiety.151 Some patients, children inrticular, require sedation (with its associated risks). Thedolinium contrast used for MRI rarely induces anaphy-tic reactions,152,153 but there is recent evidence of renalicity with gadolinium in patients with pre-existing renalease.154 Transient hearing loss has been reported, but thisusually avoided with hearing protection.155 The costs ofRI, however, are significantly more than CT scanning.spite these risks and their considerable cost, cross-sec-nal imaging studies are being used with increasing fre-ency.156-158After laryngoscopy, evidence does support the use of

aging to further evaluate 1) vocal fold paralysis or 2) auest on May 5, 2013

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S13Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)ss or lesion of the vocal fold or larynx that suggestslignancy or airway obstruction.159 If vocal fold palsy isted and recent surgery can explain the cause of the pa-ysis, imaging studies are generally not useful. If thealth care provider suspects a lesion along the recurrentyngeal nerve, imaging studies are indicated.Unexplained vocal fold paralysis found on laryngoscopyrrants imaging the skull base to the thoracic inlet/arch ofaorta. Including these anatomic areas allows for evalu-

on of the entire path of the recurrent laryngeal nerve as itps around the arch of the aorta on the left side. On theht, it will show any lesions in the lung apex along theurse of the right recurrent laryngeal nerve as it loopsund the subclavian artery. One study showed that a

mplete radiographic work-up improved rates of diagno-,160 but there is no consensus on whether CT or MRI istter for evaluating the recurrent laryngeal nerve.161,162sions at the skull base and brain are best evaluated usingMRI of the brain and brain stem with gadolinium en-

ncement. If a patient presents with additional lower cra-l nerve palsy, the skull base, particularly the jugularamen (CN IX, X, XI), should be evaluated.159Primary lesions of the larynx, pharynx, subglottis, thy-d, and any pertinent lymph node groups can also bealuated by imaging the entire area. Intravenous contrasty help to distinguish vascular lesions from normal pa-logy on CT. Due to the substantial dose of ionizingiation delivered to the radiosensitive thyroid gland,163examination in children is cautioned when MRI is avail-

le.There is still significant controversy whether MRI or CTthe preferred study to evaluate invasion of laryngeal

rtilage. Before the advent of the helical CT, MRI was theferred method.164 The extent of bone marrow infiltrationmalignant tumors (ie, nasopharyngeal carcinoma) can beessed with MRI of the skull base.165 MRI is preferred in

ildren and can easily be extended to include the medias-um to help evaluate congenital and neoplastic lesions.r those patients who have absolute contraindications toRI such as pacemaker, cochlear implants, heart valvesthesis, or aneurysmal clip, CT is a viable alternative.Imaging studies are valuable tools in diagnosing certain

uses of hoarseness in children. A plain chest radiographll aid in the diagnosis of a mediastinal mass or foreigndy. A CT scan can elucidate more detail if the initialiography fails to show a lesion. A soft tissue radiographthe neck can aid in the diagnosis of an infectious or

ergic process.166 CT imaging has been the test of choicecongenital cysts, laryngeal webs, solid neoplasms, and

ternal trauma, as it provides adequate resolution withoutving to sedate the patient as may be necessary for MRI.e risk of radiation must be weighed against these benefits.RI is the better option for imaging the brain stem.166FDG-PET imaging is used increasingly to assess patientsth head and neck cancer. PET scans may help identify

diastinal or pulmonary neoplasms that cause vocal fold in

by goto.sagepub.comDownloaded from ralysis.167 PET scanning is very costly, however, and maye false-positive results in patients with vocal fold paral-

is. FDG activity in the normal vocal fold can be misin-preted as a tumor.168

Evidence profile for Statement 4: Imaging

Aggregate evidence quality: Grade C, observational stud-ies regarding the adverse events of CT and MRI; noevidence identified concerning benefits in patients withhoarseness before laryngoscopyBenefit: Avoid unnecessary testing; minimize cost andadverse events; maximize the diagnostic yield of CT andMRI when indicatedHarm: Potential for delayed diagnosisCost: NoneBenefits-harm assessment: Preponderance of benefit overharmValue judgments: Avoidance of unnecessary testingRole of patient preferences: LimitedIntentional vagueness: NoneExclusions: NonePolicy level: Recommendation against

ATEMENT 5A. ANTI-REFLUX MEDICATIOND HOARSENESS. Clinicians should not prescribe

ti-reflux medications for patients with hoarsenessthout signs or symptoms of gastroesophageal refluxease (GERD). Recommendation against prescribingsed on randomized trials with limitations and observa-nal studies with a preponderance of harm over benefit.

ATEMENT 5B. ANTI-REFLUX MEDICATIOND CHRONIC LARYNGITIS. Clinicians may pre-ibe anti-reflux medication for patients with hoarse-

ss and signs of chronic laryngitis. Option based onservational studies with limitations and a relative bal-ce of benefit and harm.

pporting Texte primary intent of this statement is to limit widespreade of anti-reflux medications as empiric therapy for hoarse-ss without symptoms of GERD or laryngeal findingsnsistent with laryngitis, given the known adverse effectsthe drugs and limited evidence of benefit. The purpose ist to limit use of anti-reflux medications in managingyngeal inflammation, when inflammation is seen on la-goscopy (eg, laryngitis denoted by erythema, edema,undant tissue, and/or surface irregularities of the inter-tenoid mucosa, arytenoid mucosa, posterior laryngealcosa, and/or vocal folds). To emphasize these dual con-erations, the working group has split the statement intort A, a recommendation against empiric therapy forarseness, and part B, an option to use anti-reflux therapy

managing properly diagnosed laryngitis.

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S14 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009ti-Reflux Medications and the Empiriceatment of Hoarsenesse benefit of anti-reflux treatment for hoarseness in pa-nts without symptoms of esophageal reflux (heartburnd regurgitation) or evidence for esophagitis is unclear. Achrane systematic review of 302 eligible studies thatess the effectiveness of anti-reflux therapy for patientsth hoarseness did not identify any high-quality trialseting the inclusion criteria.169 For example, a nonran-mized study on treating patients with documented refluxstomach contents into the throat (laryngopharyngeal re-x) with twice-daily proton pump inhibitors (PPIs) couldt be included in the review because hoarseness was onlye component of the reflux symptom index and not antcome separate from heartburn.170 One randomized, pla-bo-controlled trial was also not included because it didt separate hoarseness as an outcome from other laryngealmptoms.171 However, the response rate for the laryngealmptoms was 50 percent in the PPI group compared to 10rcent in the placebo group.A randomized trial published after the Cochrane reviewanti-reflux treatment for hoarseness included 145 subjectsth chronic laryngeal symptoms (throat clearing, cough,bus, sore throat, or hoarseness and no cardinal GERD

mptoms) and laryngoscopic evidence for laryngitisythema, edema, and/or surface irregularities of the inter-tenoid mucosa, arytenoid mucosa, posterior laryngealcosa, and/or vocal folds).172 Subjects received eithermeprazole 40 mg twice daily or placebo for 16 weeks.ere was no evidence for benefit in symptom score oryngopharyngeal reflux health-related QOL score between

groups at the end of the study. However, this studyluded patients with one of many possible laryngeal

mptoms and excluded patients with heartburn three orre days per week.172The benefits of anti-reflux medication for control ofRD symptoms are well documented. High-quality con-lled studies demonstrate that PPIs and H2RA (hista-ne-2 receptor antagonist) improve important clinical out-mes in esophageal GERD over placebo, with PPIsmonstrating superior response.173,174 Response rates forphageal symptoms and esophagitis healing are high (ap-ximately 80% for PPIs).173,174In patients with hoarseness and a diagnosis of GERD,

ti-reflux treatment is more likely to reduce hoarseness.ti-reflux treatment given to patients with GERD (basedpositive pH probe, esophagitis on endoscopy, or pres-

ce of heartburn or regurgitation) showed improvedronic laryngitis symptoms, including hoarseness, overse without GERD.175There is some evidence supporting the pharmacologicalatment of GERD without documented esophagitis, but

number needed to treat tends to be higher.173 Thesedies have esophageal symptoms and/or mucosal healing

outcomes, not hoarseness. lar

by goto.sagepub.comDownloaded from While generally safe for therapy shorter than two months,longed therapy with PPIs and H2RAs for greater thanee months has been associated with significant risk.RAs are associated with impaired cognition in older

ults.176,177 PPI use may increase the risk of bacterial gastro-teritis, specifically campylobacter and salmonella178 andssibly clostridium difficile.179 Epidemiological studieso associate PPIs with community-acquired pneumo-.180,181 Although patients with primary voice disordersy differ from those in the above mentioned studies, theating clinician needs to consider these adverse events.rthermore, PPIs may impair the ability of clopidogrel toibit platelet aggregation activity,182 to varying degrees

pending upon the particular PPI.Higher doses such as the twice-daily PPI therapy may

rry a higher risk than once-daily therapy, and older adultsy be more likely than younger adults to be harmed.183though pneumonia is more common in young childrening PPIs, the prevalence of profound regurgitation andallowing disorders is high in that population, so it isficult to draw conclusions about the effect of the drugelf.184Use of PPI may interfere with calcium absorption andne homeostasis. PPI use is associated with an increasedk for hip fractures in older adults.185 PPIs decrease vita-n B12 (cobalamin) absorption in a dose-dependent man-r,186 and serum vitamin B12 levels may underestimate theulting serum cobalamin deficiency.187 PPI use also de-ases iron absorption and may cause iron deficiency ane-a.188 Additionally, acid-suppressing drugs (both H2RAsd PPIs) were associated with an increased risk of pancre-tis in a case-controlled study, not explained by theghtly higher risk of pancreatitis seen in patients withRD symptoms alone.189For patients with hoarseness and GERD, a trial ofti-reflux therapy may be prescribed. If hoarseness doest respond or if symptoms worsen, then pharmacologi-l therapy should be discontinued and a search forernative causes of hoarseness should be initiated withyngoscopy.

ti-Reflux Medications and Treatment ofronic Laryngitis

ryngoscopy is helpful in determining whether anti-refluxatment should be considered in managing a patient witharseness. Increased pharyngeal acid reflux events arere common in patients with vocal process granulomas

mpared to controls.190 Also, erythema in the vocal folds,tenoid mucosa, and posterior commissure has improved

th omeprazole treatment in patients with sore throat,oat clearing, hoarseness, and/or cough.191 While no dif-ences in hoarseness improvement was seen between threenths of esomeprazole vs placebo, one small randomized

ntrolled trial found that findings of erythema, diffuse

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S15Schwartz et al Clinical practice guideline: Hoarseness (Dysphonia)owed greater improvement in the treatment arm comparedplacebo.192More improvement in signs of laryngitis of the true vocalds (such as erythema, edema, redundant tissue, and/orrface irregularities), posterior cricoid mucosa, and aryte-id complex were noted in patients whose laryngeal symp-

s, including hoarseness, responded to four months ofI treatment compared to nonresponders.193 Additionally,

above abnormalities of the interarytenoid mucosa ande vocal folds were predictive of improvement in laryn-al symptoms, including hoarseness.193Reflux of stomach contents into the laryngopharynx is anportant consideration in the management of patients withyngeal disorders. Reflux of gastric contents into the hy-pharynx has been linked with subglottic stenosis.194se-control studies have shown that GERD may be a risktor for laryngeal cancer,195 and that anti-reflux therapyy reduce the risk of laryngeal cancer recurrence.196 Bet-healing and reduced polyp recurrence after vocal fold

rgery in patients taking PPIs compared to no PPIs haveo been described.197PPI treatment may improve laryngeal lesions and ob-tive measures of voice quality. Observational studiesve demonstrated that vocal process granulomas, whichy cause hoarseness, have resolved or regressed afteratment with anti-reflux medication with or withoutice therapy.198 Case series also have shown improvedoustic voice measures of voice quality after one to twonths of PPI therapy compared to baseline.199Nonetheless, there are limitations of the endoscopic la-geal examination in diagnosing patients who may re-

ond to PPIs. The presence of abnormal findings, such asinterarytenoid bar, has been noted in normal individu-

.177 In addition, in a study of healthy volunteers nottinely using anti-reflux medication and with GERD

mptoms no more than three times per month, erythema ofmedial arytenoid, posterior commissure hypertrophy,

d pseudosulcus were noted.200 Furthermore, the presencespecific findings depended upon the method of laryngos-py (rigid vs flexible) and the inter-rater reliability rangedm moderate to poor depending on the specific finding.200a study of patients with hoarseness from a variety ofgnoses, problems with intra- and inter-rater reliability fordings of edema and erythema of the vocal folds andtenoids have also been noted.201Further research exploring the sensitivity, specificity,

d reliability of laryngoscopic examination findings is nec-ary to determine which signs are associated with treat-nt response with respect to hoarseness and which tech-ues are best to identify them.

Evidence profile for Statement 5A: Anti-reflux Medica-ns and Hoarseness

Aggregate evidence quality: Grade B, randomized trials withlimitations showing lack of benefits for anti-reflux therapy in

patients with laryngeal symptoms, including hoarseness; ob- ro

by goto.sagepub.comDownloaded from servational studies with inconsistent or inconclusive results;inconclusive evidence regarding the prevalence of hoarse-ness as the only manifestation of reflux diseaseBenefit: Avoid adverse events from unproven therapy;reduce cost; limit unnecessary treatmentHarm: Potential withholding of therapy from patientswho may benefitCost: NoneBenefits-harm assessment: Preponderance of benefit overharmValue judgments: Acknowledgment by the workinggroup of the controversy surrounding laryngopharyngealreflux, and the need for further research before definitiveconclusions can be drawn; desire to avoid known adverseevents from anti-reflux therapyIntentional vagueness: NonePatient preference: LimitedExclusions: Patients immediately before or after laryn-geal surgery and patients with other diagnosed pathologyof the larynxPolicy level: Recommendation against

Evidence profile for Statement 5B: Anti-reflux Medica-n and Chronic Laryngitis

Aggregate evidence quality: Grade C, observationalstudies with limitations showing benefit with laryngealsymptoms, including hoarseness, and observationalstudies with limitations showing improvement in signsof laryngeal inflammationBenefit: Improved outcomes, promote resolution of lar-yngitisHarm: Adverse events related to anti-reflux medicationsCost: Direct cost of medicationsBenefits-harm assessment: Relative balance of benefitand harmValue judgments: Although the topic is controversial, theworking group acknowledges the potential role of anti-reflux therapy in patients with signs of chronic laryngitisand recognizes that these patients may differ from thosewith an empiric diagnosis of hoarseness (dysphonia)without laryngeal examinationPatient preference: Substantial role for shared decisionmakingIntentional vagueness: NoneExclusions: NonePolicy level: Option

ATEMENT 6. CORTICOSTEROID THERAPY:inicians should not routinely prescribe oral cortico-roids to treat hoarseness. Recommendation against

escribing based on randomized trials showing adverseents and absence of clinical trials demonstrating ben-ts with a preponderance of harm over benefit for ste-

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S16 OtolaryngologyHead and Neck Surgery, Vol 141, No 3S2, September 2009pporting Textal steroids are commonly prescribed for hoarseness andute laryngitis, despite an overwhelming lack of support-

data of efficacy. A systematic search of MEDLINE,NAHL, EMBASE, and the Cochrane Library revealed nodies supporting the use of corticosteroids as empiricrapy for hoarseness except in special circumstances ascussed below.Although hoarseness is often attributed to acute inflam-tion of the larynx, the temptation to prescribe systemic oraled steroids for acute or chronic hoarseness or laryngitis

ould be avoided because of the potential for significantd serious side effects. Side effects from corticosteroids cancur with short- or long-term use, although the frequencyreases with longer durations of therapy (Table 8).202 Addi-nally, there are many reports implicating long-term inhaledroid use as a cause of hoarseness.208-219Despite these side effects, there are some indications forroid use in specific disease entities and patients. A spe-c and accurate diagnosis should be achieved, however,

fore beginning this therapy. The literature does supportroid use for recurrent croup with associated laryngitis indiatric patients220 and allergic laryngitis.212,221 Patientsth chronic laryngitis and dysphonia may have environ-ntal allergy.221 In limited cases, systemic steroids have

en reported to provide quick relief from allergic laryngitisperformers.212,221 While these are not high-quality trials,y suggest a possible role for steroids in these selected

tient populations. Additionally, in patients acutely depen-nt on their voice, the balance of benefit and harm may beifted. The length of treatment for allergy-associated dys-onia with steroids has not been well defined in the liter-re.Pediatric patients with croup and other associated symp-

able 8ocumented side effects of short- and long-termteroid therapy202-207

ipodystrophyypertensionardiovascular diseaseerebrovascular diseasesteoporosispaired wound healingyopathyataractseptic ulcersfectionood disorderphthalmologic disorderskin disordersenstrual disordersvascular necrosisancreatitisiabetogenesiss such as hoarseness had better outcomes when treatedth systemic steroids.220 Steroids should also be consid- vie

by goto.sagepub.comDownloaded from d in patients with airway compromise to decrease edemad inflammation. An appropriate evaluation and determi-tion of the cause of the airway compromise is requiredor to starting the steroid therapy. Steroids are also helpfulsome autoimmune disorders involving the larynx such asstemic lupus erythematosus, sarcoidosis, and Wegenernulomatosis.222,223

Evidence profile for Statement 6: Corticosteroid Therapy

Aggregate evidence quality: Grade B, randomized trialsshowing increased incidence of adverse events associatedwith orally administered steroids; absence of clinical tri-als demonstrating any benefit of steroid treatment onoutcomesBenefit: Avoid potential adverse events associated withunproven therapyHarm: NoneCost: NoneBenefits-harm assessment: Preponderance of harm overbenefit for steroid useValue judgments: Avoid adverse events of ineffective orunproven therapyRole of patient preferences: Some; there is a role forshared decision making in weighing the harms of steroidsagainst the potential yet unproven benefit in specific cir-cumstances (ie, professional or avocation voice use andacute laryngitis)Intentional vagueness: Use of the word routine to ac-knowledge there may be specific situations, based onlaryngoscopy results or other associated conditions, thatmay justify steroid use on an individualized basisExclusions: NonePolicy level: Recommendation against

ATEMENT 7. ANTIMICROBIAL THERAPY: Cli-ians should not routinely prescribe antibiotics to treatarseness. Strong recommendation against prescribingsed on systematic reviews and randomized trials showingffectiveness of antibiotic therapy and a preponderance ofrm over benefit.

pporting Textarseness in most patients is caused by acute laryngitis or

viral upper respiratory infection, neither of which arecterial infections. Since antimicrobials are only effectivebacterial infections, their routine, empiric use in treating

tients with hoarseness is unwarranted.Upper respiratory infections often produce symptoms of

re throat and hoarseness, which may alter voice qualityd function. Acute upper respiratory infections caused byrainfluenza, rhinovirus, influenza, and adenovirus haveen linked to laryngitis.224,225 Furthermore, acute laryngi-is self-limited, with patients having improvement in 7 todays undergoing pl