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Auris Nasus Larynx

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A summary of the Clinical Practice Guideline for the Diagnosis

and Management of Voice Disorders, 2018 in Japan
Hirohito Umeno a,*, Masamitsu Hyodo b, Tomoyuki Haji c, Hirotaka Hara d,
Mitsuyoshi Imaizumi e, Miyoko Ishige f, Masanobu Kumada g, Kiyoshi Makiyama h,
Noriko Nishizawa i, Koichiro Saito j, Osamu Shiromoto k, Atsushi Suehiro l,
Goro Takahashi m, Ichiro Tateya l, Koichi Tsunoda n, Koichi Omori l
a
Department of Otolaryngology-Head and Neck Surgery, Kurume University School of Medicine, Japan
b
Department Otolaryngology, Kochi University School of Medicine, Japan
c
Kurashiki Central Hospital, Japan
d
Department of Otolaryngology, Kawasaki Medical School, Japan
e
Department of Otolaryngology, School of Medicine, Fukushima Medical University, Japan
f
Speech Pathology and Hearing Course, Department of Rehabilitation, Faculty of Medical Science and Welfare, Tohoku Bunka Gakuen
University, Japan
g
Kumada Clinic, Japan
h
Department of Otorhinolaryngology-Head and Neck Surgery, Nihon University School of Medicine, Japan
i
School of Rehabilitation Sciences, Health Sciences University of Hokkaido, Japan
j
Kyorin University School of Medicine, Department of Otolaryngology-Head and Neck Surgery, Japan
k
Department of Communication Sciences and Disorders, Faculty of Health and Welfare, Prefectural University of Hiroshima, Japan
l
Department of Otolaryngology-Head and Neck Surgery, Graduate School of Medicine, Kyoto University, Japan
m
Yamahoshi Ear, Nose, and Throat Clinic, Japan
n
Department of Artificial Organs and Medical Creation, National Institute of Sensory Organs, National Hospital Organization Tokyo Medical
Center, Japan

A R T I C L E I N F O A B S T R A C T

Article history: Objective: To develop a summary of the first version of the Clinical Practice Guideline of Voice Disorders
Received 19 June 2019 for Diagnosis, Management, and Treatment in Japan by the Clinical Practice Guideline Committee of the
Accepted 6 September 2019 Japan Society of Logopedics and Phoniatrics and The Japan Laryngological Association. The
Available online xxx
2018 recommendations, based on a review of the scientific literature, are intended to serve as clinical
practice guidelines for the diagnosis, management, and treatment of voice disorders in Japan.
Keywords:
Methods: A summary of the original version of the Clinical Practice Guideline of Voice Disorders
Clinical practice guidelines
Voice disorders
for Diagnosis, Management, and Treatment in Japan was described. Recommendations for the
Japanese version diagnosis, management, and treatment of voice disorders were prepared. Twelve clinical questions
Clinical questions (CQs) regarding the diagnosis, management, treatment, and effectiveness of therapy for voice
disorders were also prepared.
Results: A summary of the first version of the clinical practice guidelines for the diagnosis,
management, and therapy of voice disorders was prepared and is presented. Additionally, answers to
the 12 CQs on the diagnosis, management, treatment, and effectiveness of voice disorder therapy
were prepared, and include evidence-based recommendations.

* Corresponding author.
E-mail address: umeno2@med.kurume-u.ac.jp (H. Umeno).

https://doi.org/10.1016/j.anl.2019.09.004
0385-8146/© 2019 Published by Elsevier B.V.

Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
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Conclusion: These guidelines present a summary of the standard approaches for the diagnosis and
treatment of voice disorders and relevant CQs that consider the medical environments in Japan. We
hope that the guidelines will assist physicians in clinical settings for patients with voice disorders.
1. Introduction
Voice disorders have adverse effects on the physical, mental,
and functional quality of life of affected patients and have a
variety of causes. The diagnosis and management of voice
disorders have shown significant developments over time.
However, the therapies used to treat voice disorders vary
according to the intentions of each doctor, speech pathologist,
or institution. Consequently, clinical practice guidelines for
diagnosis and management would be useful. As part of the
development of these guidelines, we considered clinical
questions (CQs) concerning the evaluation, examination, and
therapy of voice disorders that we answer in this paper.
However, the text structure does not follow that of original
version. We omit some description that are present in the
original.As a rule, we reviewed the papers up to 2014 and
published the Japanese version of the Clinical Practice
Guideline for the Diagnosis and Management of Voice
Disorders, 2018. This paper is generally a summary, but minor
corrections were necessary for subsequent papers regarding
5.4. and CQ3.
2. Criteria for determining recommendation grades
A summary of the CQs relevant to the evaluation,
examination, and therapy of voice disorders were prepared to
help develop guidelines. A comprehensive literature search of
studies published through the end of 2014 was performed. Other
useful literature was added as needed. The databases used were
PubMed and the Japan Medical Abstract Society Web.
Subsequently, three members were assigned the task of
collecting scientific evidence concerning each CQ from the
selected papers. After a consensus was reached by the
preparation committee, the results were evaluated, consolidat-
ed, and codified. Levels of evidence I–IV were determined as
follows according to Minds 2007: I, systematic review/
metanalysis of randomized controlled trials; II, at least one
well-designed comparative study with randomization; III,
comparative studies without randomization; IVa, analytic
epidemiological study (cohort study); IVb, analytic epidemio-
logical study (case-control study, cross-sectional study ); V,
description research (case studies, case series); VI, expert
committee reports, opinions, and/or the opinions of respected
authorities except for patients’ data. The recommendation
levels adopted were Strong Recommendation and Recommen-
dation. When a recommendation was difficult to support with
two types of evidence, we decided not to present it or termed it a
Conditional Recommendation. These recommendation levels
are not absolute; diagnostic or therapeutic decisions should be
made according to the patient’s condition and wishes, and the
Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
© 2019 Published by Elsevier B.V.
available resources of each medical facility. However, the
guiding principles presented here can be applied tentatively in
clinical settings. After evaluation of the results of this process
and reviews by external experts, the principles will be further
developed into more formal guidelines for diagnosis and
treatment. The principles and handling of conflicts of interest
will be reevaluated after considering the feedback from this first
version of the guidelines.
3. Pre-release review
Before the publication of the Guideline, public comments
were solicited from the Japan Society of Logopedics and
Phoniatrics, the Japan Laryngological Society, and the Oto-
Rhino-Laryngological Society of Japan. Corrections were then
made where necessary.
4. Definition and classification of voice disorders
Voice disorders are diseases that cause dysphonia, which is
defined as an altered vocal quality, pitch, loudness, or vocal
effort that impairs communication and affects the quality of life
as assessed by a clinician [1].
In this Guideline, voice disorders were classified based on
the Classification Manual for Voice Disorders-1 [2]
published by the American Speech–Language–Hearing
Association with modification so as to fit the general clinical
practice in Japan. The classifications of voice disorders are
presented in Table 1.
5. Examinations and diagnosis
5.1. Interview
To evaluate a patient with hoarseness, the following
information should be obtained: type of onset (e.g., sudden,
gradual), duration of dysphonia, potential inciting events,
how the condition affects the patient, associated symptoms
(e.g., swallowing, breathing difficulties), modifying factors,
current medications, habits (e.g., smoking, alcohol use), a
detailed medical history, current medical condition, and
history of prior surgery. Care must be taken when
interviewing children or patients with cognitive impairment
or severe emotional burdens because they may be unaware of
their own hoarseness [1,3].
5.2. Perceptual voice evaluation
The voice is both a physiological phenomenon and a
psychological one. Therefore, the voice cannot be sufficiently
described and thoroughly evaluated without psychological
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Table 1 6000 Sychiaric and psychological disorders affecting voice

Classification of voice disorders. 6100 Somatic symptom and related disorders
6110 Psychogenic voice disorder
1000 Structural pathologies of the larynx 6120 Other somatic symptom and related disorders
1100 Laryngeal neoplasm, dysplasia 6200 Depressive disorders
1110 Low grade dysplasia, leukoplakia 6210 Major depressive disorder
1120 Laryngeal malignancy, carcinoma in-situ 6220 Other depressive disorders
1130 Laryngeal papilloma 6300 Gender identity disorder
1140 Other neoplasm 6400 Other sychiaric and psychological disorders
1200 Mucosal abnormalities of the vocal fold 7000 Neurologic disorders affecting voice
1210 Vocal fold nodules 7100 Peripheral nervous system/neuromascular junction pathology
1220 Vocal fold polyp 7110 Superior laryngeal nerve paralysis
1230 Vocal fold cyst 7120 Unilateral recurrent laryngeal nerve paralysis
1240 Reinke’s edema 7130 Bilateral recurrent laryngeal nerve paralysis
1250 Vocal fold scar 7140 Myasthenia gravis
1260 Vocal fold sulcus 7150 Other peripheral nervous system/neuromascular
1270 Laryngeal granuloma junction pathology
1280 Other mucosal abnormalities of the vocal fold 7200 Central nervous system disturbance
1300 Vascular abnormalities of the vocal fold 7210 Adductor spasmodic dysphonia
1310 Vocal fold hemorrhage 7220 Abductor dpasmodic dysphonia
1320 Varix and ectasia of the vocal fold 7230 Mixed abductor/adductor spasmodic dysphonia
1400 Congenital and maturational laryngeal abnormalities 7240 Tremor affecting voice
1410 Congenital webs (synechia) 7250 Parkinson disease
1420 Laryngomalacia 7260 Other central nervous system disturbance
1430 Presbyphonia 8000 Other disorders affecting voice
1440 Other congenital and maturational laryngeal abnormalities 8100 Muscle tension dysphonia
1500 Laryngeal scar/stenosis 8110 Hyperfunction
1510 Subglottic stenosis 8120 Hypofunction
1520 Glottic/laryngeal stenosis 8200 Puberphonia
2000 Inflammatory conditions of the larynx 8300 Ventricular dysphonia
2100 Cricoarytenoid and cricothyroid arthritis 8400 Paradoxical vocal fold movement disorder (vocal cord
2200 Acute inflammation of the laryngeal mucosa dysfunction)
2210 Acute laryngitis 8500 Other disorders affecting voice, including functional voice
2220 Acute subglottic laryngitis disorders
2230 Acute epiglottitis 9000 Voice disorders: undiagnosed or not otherwise specified (NOS)
2300 Laryngopharyngeal reflux
2400 Chemical sensitivity/irritable larynx syndrome
2500 Other inflammatory conditions of the larynx
3000 Trauma or injury of the larynx
3100 Internal laryngeal trauma
3110 Laryngeal mucosa trauma
examinations. The GRBAS Scales (defined below) are
3120 Arytenoid dislocation representative of psychological examinations that have been
3200 External laryngeal trauma developed in Japan and internationally established. These scales
4000 Systemic conditions affecting voice consist of a scale of general aspect represented by G (Grade)
4100 Endocrine and metabolic diseases and four scales of specific aspects represented by R (Rough), B
4110 Hypothyroidism
4120 Hyperthyroidism
(Breathy), A (Asthenic), and S (Strained). Each item is scored
4130 Sexual hormone imbalances as 0 for normal, 1 for slight deviance, 2 for moderate deviance,
4140 Growth hormone abnormalities or 3 for severe deviance. The GRBAS Scales are effective and
4150 Other endocrine and metabolic diseases useful; however, it should be noted that the scales reproduction
4200 Immunologic rate and reliability vary according to the proficiency of the
4210 Allergic diseases of the upper respiratory tract
4220 Acquired immunodeficiency syndrome
examiner [4].
4230 Collagen diseases
4240 Othr immunologic diseases 5.3. Patient-reported outcome measures
4300 Musculo skeletal conditions
4310 Fibromyalgia Voice disorders have been mainly evaluated by objective
4320 Other musculo skeletal conditions methods, such as laryngoscopy, acoustic analysis, and
4400 Dehydration
aerodynamic assessment. Recently, as a subjective evaluation
5000 Aerodigestive disorders affecting voice
5100 Respiratory Diseases by patients with voice disorders, the Voice Handicap Index
5110 Asthma (VHI) and Voice-Related Quality of Life (V-RQOL) were
5120 Chronic obstructive pulmonary disease developed in the United States from the viewpoint of the
5200 Digastric diseases disorders’ effects on patient quality of life. The revised
5210 Gastroesophageal reflux disease
translated versions of the Japanese VHI, VHI-10, and V-RQOL
5300 Infectious diseases of the aerodigestive tract
5310 Pneumonia were examined for their reliability and validity through
5320 Tuberculosis domestic multi-facility cooperation. These versions have been
5330 Fungal infections recognized as highly reliable and validated as patient-reported
5340 Other infectious diseases of the aerodigestive tract outcome measures [5,6].

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5.4. Laryngoscopy (See CQ3)
Laryngoscopy is an essential tool for visualizing the larynx
when diagnosing the cause of a voice disorder. The laryngeal
mirror, rigid rod-lens telescope, and flexible fiberoptic/distal
chip endoscope are used for laryngoscopy. Of these, the flexible
endoscope provides relatively lower invasiveness and better
visualization of the larynx than those of other methods.
Laryngostroboscopy is particularly useful for the detailed
evaluation of voice disorders because it enables examiners to
observe the mucosal wave.
5.5. Aerodynamic assessment
The aerodynamic assessment method is defined as “individual
or combined measurements of voice strength, pitch, expiratory
flow in phonation and maximum phonation time (MPT)” [7]. This
method enables examiners to understand the pathological
conditions related to vocal-fold vibration, and it is useful to
compare the patient’s voice before and after treatment [8].
However, it should be noted that sex, age, and measurement
conditions affect the results of the aerodynamic assessment.
5.6. Voice profile
Vocal intensity varies according to pitch and vice-versa. A
voice profile measures pitch, intensity, and the mean flow rate
simultaneously. Changes in each of the three parameters can be
evaluated as well as the relationships between two parameters.
A voice profile can be used both in assessment and in treatment.
Because the results obtained from this examination can differ
depending on the patient, it is better to compare a patient’s voice
before and after treatment and examine chronological changes.
5.7. Acoustic analysis (See CQ5)
Acoustic analysis is an objective evaluation of voice
disorders that analyzes speech signals and provides quantitative
evaluations. Representative measures of acoustic analysis are
the pitch period perturbation quotient (PPQ), amplitude
perturbation quotient (APQ), and harmonic-to-noise ratio
(HNR). Compared with perceptual voice evaluation methods,
such as the GRBAS Scales, it has been considered more useful
as an objective evaluation, especially for evaluating treatment
effectiveness [9,10]. However, microphone quality, analog-to-
digital (A/D) conversion sampling rates, and environmental
noise may affect acoustic analysis to a considerable extent. It is,
therefore, important to understand the limitations of acoustic
analysis before clinical use.
5.8. Laryngeal electromyography
Laryngeal electromyography (LEMG) evaluates the activity
of the laryngeal muscles or the dominant nerve qualitatively and
quantitatively by inserting electrodes into the intralaryngeal
muscles for recording action potentials generated in the
muscles. LEMG is useful to differentiate between paralysis
of the vagus nerve and that of the recurrent nerve. However, it
should be noted that the sensitivity and specificity of LEMG in
Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
the diagnosis and prognosis of vocal-fold paralysis are variable;
therefore, the results of LEMG should always be evaluated with
care.
6. Treatments
6.1. Pharmacotherapy
6.1.1. Antibiotics
Administration of antibiotic drugs is recommended for
laryngitis associated with microbial infection. The dosage or
period of the administration should be carefully considered to
prevent the development of drug resistance or side effects [11].
6.1.2. Non-steroidal anti-inflammatory drugs and other
anti-inflammatory drugs
Various kinds of anti-inflammatory drugs are available. For
example, tranexamic acid is often administered for vocal cord
hemorrhage and redness. Carbocysteine is used for the purpose
of repair of airway mucous membrane and viscosity reduction
of sputum. Nonsteroidal anti-inflammatory drugs may be
effective in cases in which sore throat causes inappropriate
vocalization.
6.1.3. Corticosteroids
Corticosteroids have various routes of administration: oral,
inhalation, nebulizer, and intravenous and local injections. In all
routes, the dosage or period of the administration should be
carefully considered to prevent side effects.
6.1.4. Botulinum toxin (BT)
Local injection of BT into intralaryngeal muscles is an
established treatment for spasmodic dysphonia (SD) [12–15].
SD is a focal dystonia limited to the inner laryngeal muscles
[13] and reported as 3–4 times more common in females than
males in Japan [14,15]. Ninety-five percent of SD is the
adductor type, which is caused by hyperadduction of the
thyroarytenoid muscle. Five percent is the abductor type, which
is caused by hyperactivity of the posterior cricoarytenoid or
failure of the lateral cricoarytenoid or thyroarytenoid muscle
[14]. Mixed types in which both types coexist are rarely found.
BT is effective for the adduction type, but the effect of BT
usually only lasts 2 or 3 months [15]. Side effects, such as
breathy hoarseness or mild aspiration, appear on average for
about 2 weeks after injection. BT treatment is also performed
for the abduction type, but the effective rate is lower than that of
the adductor type because of the difficulty of approaching the
objective muscle anatomically. BT treatment is regarded as the
first-choice treatment method for SD in the guideline of the
American Otolaryngology and Head and Neck Surgery Society.
In Japan, BT was also approved as a treatment by the national
health insurance in 2018.
6.1.5. Proton pump inhibitors (PPIs) (See CQ8)
The use of a PPI is recommended for speech disorders in
which gastroesophageal reflux disease is considered to be the
cause or exacerbation factor and also as a diagnostic treatment
for suspected cases. For example, PPI is useful in cases of
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muscle tension dysphonia, which is caused by reflux of gastric
acid.
6.1.6. Antianxiety agents
Anxiolytic may be effective for dysphonia based on
psychological factors or mental disease. Collaboration between
psychotherapists and voice therapists is recommended.
6.2. Voice therapy
6.2.1. Application and evidence
Voice therapy is provided for dysphonia with no morpho-
logical abnormality. Voice therapy is also applicable to motor
diseases, such as vocal-fold paralysis, Parkinson’s disease, or
psychogenic vocal disorders. Voice therapy has a long history
both in direct and indirect therapy, and methodologies of the
therapies based on various theoretical systems have been
developed, but its classification or application has not been
established adequately. The number of clinical reports
discussing the target diseases or methodology has been
increasing, but the evidence of therapeutic effects has been
insufficient [16,17].
To achieve excellent results, laryngologists and speech–
language therapists should understand the pathophysiology
correctly, choose the appropriate method according to the
condition of a patient, and clarify the goal of treatment.
Discussions about the therapeutic effects and treatment plan
should be held as often as necessary.
6.2.2. Direct voice therapy
Symptomatic voice therapy
Symptomatic voice therapy is an approach that directly
corrects abnormal speech behavior by focusing on individual
speech states, such as pitch, strength, and quality. For example,
Yawn-sigh, chewing, or Straw phonation are performed for
vocal hyperfunction, and the pushing method is performed for
glottic insufficiency.
Physiologic voice therapy
In recent years, a series of therapeutic programs have been
developed. Vocal Function Exercises comprise a method that
improves vocal function by strengthening the internal
laryngeal muscles and modifying the abnormal balance of
the muscles [18]. Resonant Voice Therapy aims to normalize
the vocal-fold vibration by balancing the three essentials of
voice production: respiration, phonation, and resonance [19].
The accent method is used to learn rhythmic breathing and
phonation by speaking to a rhythm with an accent [20]. Lee
Silverman Voice Treatment was developed originally for
patients with Parkinson syndrome. This method requires
patients to produce a loud voice with maximum effort to
acquire distinct pronunciation [21].
6.2.3. Indirect voice therapy
There is no doubt that most of the functional voice disorders
result from inappropriate speaking behaviors or lifestyles, and
vocal hygiene is the most important treatment to improve
pathological vocal function. The term “vocal hygiene”
previously simply meant patient education but recently includes
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Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
5
also stress management, avoidance of stimulus, consideration
of environmental factors, and systematic voice hygiene
program.
6.3. Surgical treatment
6.3.1. Objects
(1) Benign lesions of the vocal fold
Benign lesions such as nodules, polyps, cysts, polypoid
vocal folds, and sulcus vocalis show abnormal mucosal
vibrations and result in hoarseness. In cases in which
conservative treatment cannot improve the lesions, phonomi-
crosurgery should be considered.
(2) Glottic incompetence
Glottic incompetence caused by vocal-fold unilateral
paralysis, atrophy, or defects show up as breathy hoarseness.
Injection laryngoplasty or type I thyroplasty [22] are applicable
to small glottic gaps, and arytenoid adduction (AA) [23] or a
combination of AA and type I thyroplasty is applicable to large
glottic gaps.
(3) Spasmodic dysphonia and functional dysphonia
For adductive type SD, BT injection into the thyroarytenoid
muscle, type II thyroplasty [24], or myotomy of the
thyroarytenoid muscle are available. Type III thyroplasty is
applicable to adolescent transitional dysphonia.
(4) Lesions suspicious for malignancy
Hoarseness may show up as a symptom of malignant disease
of vocal fold and may require biopsy or lesion resection for
definitive diagnosis. Surgery should be considered when
symptoms, such as abnormal blood vessels, ulceration, and
irregular lesions, are found.
6.3.2. Phonomicrosurgery under general anesthesia
Phonomicrosurgery is performed for the following purposes:
removal of benign lesions of vocal folds, such as polyps,
polypoid vocal folds, cysts, nodules, sulcus, and injection/
lipoinjection thyroplasty for glottic insufficiency [25], and
biopsy or observation of the lesion suspected as malignancy.
6.3.3. Fiberoptic laryngeal surgery under local anesthesia
Fiberoptic laryngeal surgery involves the removal of vocal
cord lesions, injection, and biopsy by insertion of forceps
through oral or endoscopic channels while inserting an
endoscope through the nasal cavity to monitor the larynx
[26]. Since this procedure is performed under local anesthesia,
the voice of the patient and the mucosal wave of the vocal fold
can be monitored during the surgery. In addition, cases in which
general anesthesia is difficult or laryngeal exposure is difficult
can be indicated for this operation.
6.3.4. Framework surgery
Laryngeal framework surgery is a procedure in which the
length, position, or tension of the vocal folds are indirectly
regulated not by surgically invading the vocal fold but rather the
cartilages of the larynx. For glottic incompetence due to
unilateral vocal-fold paralysis, type I thyroplasty or AA is
performed. Type I thyroplasty is a method in which the
paralyzed vocal fold is medialized by biomaterials or autografts
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via a small window created on the thyroid cartilage. AA is a
technique in which the vocal fold is adducted by rotating the
arytenoid cartilage. Large posterior glottic gaps or level
differences are good indications of this procedure, and both
may be used in combination. Type II thyroplasty is applicable to
adductive type SD, and type III thyroplasty is applicable to
adolescent transitional dysphonia. Type IV thyroplasty is
performed to raise the pitch by expanding the vocal folds [27].
7. Clinical questions
CQ-1
Are GRBAS Scales effective and useful for voice quality
evaluation? (Strong Recommendation)
Vocal sounds are not only a physiological phenomenon but
also a psychological one because they should be recognized by
the human brain. Therefore, physical and psychological aspects
of voice quality should be evaluated.
Evaluation of physical aspects includes many parameters
that are useful as well as highly objective and reproductive.
Even with a combination of these parameters, the voice cannot
be described and evaluated sufficiently without evaluation of
the psychological aspects. GRBAS Scales are effective and
useful for the latter aspects [4,28,29].
GRBAS Scales have been produced in Japan and are
internationally established. GRBAS Scales consist of a scale for
the general aspect of G (Grade) and four scales of specific
aspects of R (rough), B (breathy), A (asthenic), and S (strained).
These aspects have been extracted by performing multiplex
analysis using many adjectives by which voice can be
described. Again, the scales were produced in Japan, and these
analyzed adjectives were also Japanese. Therefore, language
differences should be discussed. Several studies have been
conducted in terms of language differences [4] (Level III).
Official voice samples published by the Japan Society of
Logopedics and Phoniatrics are available to show the nature of
these aspects of G, R, B, A, and S. These samples are necessary
to be heard by evaluators to make reproduction rates higher
between both inner and inter-evaluators [28] (Level III).
Sustained vowels are the best tasks for GRBAS Scales
because sustained vowels are easy for evaluators to focus on the
sustained voice characteristics without articular or prosodic
characters [29] (Level III).
In the GRBAS Scales, four grades of scale are recommended
because of their high reproduction rate and sufficient resolution
[30] (Level III).
CQ2
Are the Japanese versions of the VHI and V-RQOL useful as
patient-reported outcome measures? (Strong Recommendation)
The revised translated versions of the VHI and V-RQOL are
highly reliable and validated. They are, therefore, strongly
recommended as subjective evaluation tools for voice disorders.
In the United States, Jacobson et al. developed VHI in
1997 as a subjective evaluation tool for patients with voice
disorders, and Hogikyan et al. developed the V-RQOL measure
in 1999 [31,32] (Level IV). Furthermore, VHI and V-RQOL
have been translated into many foreign languages and have high
reliability and validity [33] (Level I). The Voice Committee of
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Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
the Japan Society of Logopedics and Phoniatrics revised a
recommended version for VHI and V-RQOL in Japanese.
The revised translated versions of the Japanese VHI and
V-RQOL were examined for their reliability and validity
through domestic multi-facility cooperation. The participants
were 173 adults with voice disorders, who consulted eight ear,
nose, and throat clinics, and 105 healthy volunteers [5,6] (Level
IV). As a result, the Cronbach a coefficient, which indicates
internal consistency, has shown high reliability with VHI
(a = 0.98) and V-RQOL score (a = 0.94). Additionally,
significant differences in the total scores were observed
between the groups with and without voice disorders [5,6]
(Level IV). That is, a correspondence with the external criteria
based on objective evaluation (presence/absence of voice
disorders) was also recognized and validated.
CQ3 Is laryngoscopy useful to assess dysphonia? (Strong
Recommendation)
Laryngoscopy is an essential tool for visualization of the
larynx to diagnose the cause of dysphonia [3] (Level VI) [34],
(Level V). A laryngeal mirror, rigid rod-lens telescope, and
flexible fiberoptic/distal chip endoscope are used for laryngos-
copy. Of these, flexible endoscopy provides relatively less
invasiveness and better visualization of the larynx than those of
other options. Thus, flexible endoscopy is considered to be the
most cost-effective option for visualizing the larynx [34].
Laryngoscopy should be performed when dysphonia fails to
resolve or improve within 4 weeks, beyond the time period
required for the recovery of viral laryngitis, which is the most
common cause of dysphonia. However, laryngeal visualization
should be performed irrespective of duration in patients with
dysphonia who require escalation of care. The history and
physical examination results that suggest escalation of care
include (1) recent surgical procedures involving the head, neck,
or chest, (2) recent endotracheal intubation, (3) presence of a
concomitant neck mass, (4) respiratory distress or stridor, (5)
history of tobacco abuse, (6) symptoms concerning rapidly
progressive neurological disorders, and (7) whether the patient
uses their voice professionally [3]. Early laryngoscopy in these
patients could minimize morbidity and mortality as well as
reduce the negative quality of life consequences in patients with
dysphonia.
Neonates with dysphonia should undergo laryngoscopy to
identify congenital anomalies that could affect their abilities to
breathe or swallow. However, dysphonia in children is less
frequently a sign of a serious underlying condition than are
benign laryngeal diseases [3]. Furthermore, it has been reported
that a history of hoarseness had been observed only in 55.6% of
pediatric patients with vocal-fold diseases, which suggests the
importance of findings other than hoarseness to identify patients
who should undergo laryngoscopy [35] (Level IVb).
CQ4
When is laryngostroboscopy useful? (Recommendation)
Laryngostroboscopy is useful for diagnosis of voice
disorders. It is also useful for the diagnosis and monitoring
of malignant tumors. Its use in the medical care of vocal
impairment is recommended.
Laryngostroboscopy was useful for the diagnosis of patients
with voice disorders in 27.2% of cases [36] (Level IVb) and was
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effective for evaluation during follow-up in 122/352 cases [37]
(Level IVb). A study of its diagnostic performance for lesion
invasion depth found that the mucosal wave was lost in 70% of
patients with lesions that had invaded the vocal ligament or
vocal cord muscles. In the other 30%, the mucosal wave was
present, which suggests that laryngostroboscopy may have only
limited usefulness in cancer diagnosis [38] (Level IVb). An
investigation of its association with the histopathological
diagnosis of leukoplakia of the vocal cords found that the
mucosal wave was diminished or absent in 95% of patients with
severe dysplasia or invasive carcinoma [39] (Level IVb). A
systematic review of its usefulness during post-treatment
follow-up of patients with laryngeal cancer found that
laryngostroboscopy was useful in monitoring before and after
laryngeal cancer treatment and for diagnosis of recurrence [40]
(Level I).
CQ5
Is acoustic analysis of voice clinically useful? (Recommen-
dation)
Acoustic analysis is useful in objective evaluation of voice
disorders, especially for evaluating effectiveness of treatment
[9,10] (Level III, V). However, it is still insufficiently
satisfactory to separate voice disorders from normal voices
or differentiate each vocal pathology only by acoustic analysis.
Though many measures of acoustic analysis such as pitch
period perturbation quotient (PPQ), amplitude perturbation
quotient (APQ) and harmonic to noise ratio (HNR) have been
widely used, it is still uncertain which of them could most
correlate to auditory perceptual evaluation of the voice. It is
important to understand the meaning and limitations of these
measures before using them clinically. In addition, most of
them need to measure cycle to cycle pitch periods precisely.
There are quite a few computer programs for acoustic analysis
with their own algorithms in extracting cycle to cycle pitch
periods, which may cause more or less different results of
computation in the same parameters. In addition, quality of
microphones, sampling rates of A/D conversion, environmental
noise may affect acoustic analysis to a considerable extent.
Therefore, attention should be paid to compare the results of
acoustic analysis obtained from different computed systems or
recording environment [41] (Level III).
On the other hand, cepstral analysis does not require cycle to
cycle analysis and can be applied to analyze continuous speech
as well as sustained vowels. And a meta-analytic study showed
that cepstral analysis could be the most promising acoustic
measure of dysphonia severity [42] (Level I). Therefore, it has
been popularly used recently in the United States and European
countries.
The multiparameter acoustic indices which were designed to
objectively estimate dysphonia severity and track treatment
outcomes were reported to be promising [43] (Level III), which
may indicate the future trends of acoustic analysis of dysphonia.
Again, acoustic analysis is useful in objective evaluation of
voice disorders, especially for evaluating effectiveness of
treatment. However, some more evidence is still needed in
using acoustic analysis properly to separate voice disorders
from normal voices or differentiate each vocal pathology.
CQ6
Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
7
Is aerodynamic assessment useful? (Recommendation)
The Japan Society of Logopedics and Phoniatrics Phonatory
Function Examination Methods Review Committee have
described items for examination and their associated procedures
in a guideline. Among these, the aerodynamic assessment
method is defined as “measurement of voice strength,
measurement of pitch, measurement of expiratory flow in
phonation, measurement of MPT, measured individually or
combined” [7] (Level 6).
Differences in phonatory function analyzer results according
to sex and age have been reported. In studies of healthy
volunteers that used the air-flow interruption method,
expiratory pressure and airway resistance decreased signifi-
cantly in the elderly group [44] (Level 4b), and the parameters
and differences associated with sex were also clarified [45]
(Level 4b).
Research on voice disorders by comprehensively evaluating
a plurality of parameters has made it possible to understand the
pathological conditions related to vocal-fold vibration, and a
comparison between pathological cases pre- and post-treatment
showed that the research was useful for evaluating treatment
effects [8] (Level 4b). A study of changes in expiratory pressure
and airway resistance during sound pressure loading for groups
with or without voice disorders found that exhalation
adjustment corresponded to the presence or absence of
laryngeal adjustment ability and high/low glottic resistance
[46] (Level 4b).
CQ7
What is the value of medications for Muscle Tension
Disorder (MTD)? (Conditional Recommendation)
Voice therapy is mainly used as a treatment for MTD. On the
other hand, medication for MTD is an additional option. For
example, a PPI can be prescribed when discomfort caused by
acid reflux is thought to be one cause of voice problems in MTD
patients.
MTD is an entity in which hyperactivity of the laryngeal
muscle makes it difficult to phonate and was presented
originally by Morrison et al. [47]. Koufman et al. [48] classified
MTD into four types:
Type 1 posterior glottic chink
Type 2 supraglottic lateral proximity
Type 3 supraglottic antero-posterior proximity
Type 4 supraglottic antero-posterior closure
MTD is also classified in terms of causes as primary MTD
and secondary MTD.
In primary MTD, no organic disease as a cause has been
found. Primary MTD includes functional or psychological
causes. In secondary MTD, primary organic symptoms, such as
laryngeal palsy and protrusions of vocal folds, are secondary
causes of MTD.
Again, voice therapy is the main treatment either for primary
or secondary MTD. It is easily understood that medication can
be optional for secondary MTD to treat the primary organic
symptom. Furthermore, it is noteworthy that even for primary
MTD, medication can be optional when symptoms, such as
reflux of acid and post-nasal drip, are an additional cause of
worsening symptoms in primary MTD. Especially, the efficacy
of PPIs was reported by several papers in primary cases in
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which acid reflux were found [49,50] (Level V). Diagnostic
treatment by PPI can be recommended for MTD cases in which
acid reflux are suspected.
CQ8
How should psychological dysphonia be treated? (Condi-
tional recommendation)
Psychological dysphonia is classified into psychiatric
diseases according to the Diagnostic and Statistical Manual
(DSM)-5 and psychiatric treatment alone or combined with
voice therapy is the main treatment [51,52] (Levels IVa, V).
Medication can be optional to treat background psychiatric
disease or as diagnostic treatment [53,54] (Levels V, IVb).
Psychological dysphonia is classified into psychiatric
diseases according to the DSM-5 and is thought of as a
somatophysical symptom caused by background psychiatric
disease. Therefore, it should be diagnosed by psychiatrists. For
otolaryngologists, it is important to suspect this disease when
the symptom is difficult to treat by medication or voice therapy
[53,54]. Psychiatric treatment alone or combined with voice
therapy is the main treatment [51,52]. Voice therapy also is an
important diagnostic treatment, and in some cases, psychologi-
cal dysphonia has been diagnosed as a result of voice therapy
for other suspected diseases. Voice therapy is also important
when psychological dysphonia is accompanied by other
diseases, such as SD.
Medication is an optional treatment for background
psychiatric disease or as diagnostic treatment [53,54].
CQ9
Is corticosteroid therapy recommended to treat dysphonia?
Because of the significant risk profile of systemic or inhaled
steroids and the limited evidence of benefit, corticosteroids
should not be used empirically. Furthermore, side effects from
corticosteroids can occur with short- or long-term use, and
clinicians should not routinely prescribe corticosteroids for
patients with dysphonia prior to visualization of the larynx [3]
(Level VI).
However, low-quality evidence supports the effectiveness of
steroid application for hoarse patients with croup, allergies,
lichen planus, and autoimmune disorders [34] (Level V).
Additionally, steroid administration should be considered for
hoarse patients with compromised airways to decrease edema
and inflammation after appropriate evaluation of the cause of
the compromise [3].
Regarding direct injection of corticosteroids into the vocal
fold (vocal-fold steroid injection, VFSI), a systemic review and
meta-analysis of six articles involving 321 patients concluded
that VFSI was well-tolerated under local anesthesia in an office
setting [55] (Level I). Furthermore, this article proved the
significant improvement due to both objective (MPT) and
subjective (VHI) measurements after VFSI in patients with
dysphonia induced by benign vocal-fold disorders. Future
studies with large sample sizes and long follow-up periods
would show more accurate effects of VFSI.
CQ10
What are appropriate indications for voice therapy?
(Recommendation)
A combination of direct and indirect voice therapy is
effective for dysphonia of functional origin or resulting from
Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004
voice misuse. No preventive effect in high-risk voice users has
yet been confirmed.
A meta-analysis of six randomized controlled trials (RCTs)
on interventions to prevent voice disorders in adults who were
at risk of developing a voice disorder but had not yet been
identified as having one concluded that the evidence for direct,
indirect, and combined voice training was low [56] (Level I).
However, in patients with hoarseness of functional origin or
resulting from voice misuse, the effectiveness of a combination
of direct and indirect voice therapy has been reported in several
RCTs [57,58] (Level II). The combination was shown to be
effective for improving voice quality, as assessed by self-rated
and observer-rated methods, for outpatients aged >16 years
with a primary symptom of persistent hoarseness for 2 months
and without any relevant organic pathology (for example,
polyp, papilloma, tumor, or vocal cord palsy) or need for
surgery. There was also evidence that the remedial effect of
voice therapy remained significant at medium- and long-term
follow-up [58] (Level II). Although two RCTs reported
therapeutic effects for indirect voice training given indepen-
dently of direct training [57,59] (Level II), the evidence was not
confirmed by a meta-analysis [56] (Level I).
CQ11
Is surgical treatment effective in patients with unilateral
vocal fold paralysis? (Recommendation)
Injection laryngoplasty using collagen, hyaluronic acid, and
autologous fat is effective for improving vocal function in
patients with unilateral vocal fold paralysis. However, volume
loss is a disadvantage, and injection laryngoplasty is thought to
be a good indication for patients with a relatively small glottal
gap [60] (Level V). Calcium hydroxyapatite paste has been
reported to improve voice function to prevent this disadvantage
[61] (Level III). Framework surgery (type I thyroplasty and AA
surgery) are also effective for vocal functional improvement in
patients with unilateral vocal-fold paralysis [62] (Level III). AA
has been combined with TP I because AA is not able to correct
vocal fold bowing alone [63] (Level III). Long-term voice
functional efficacy of refined nerve-muscle pedicle flap
implantation combined with AA for treatment of severe
breathy dysphonia caused by unilateral vocal fold paralysis has
been reported [64] (Level V). In cases in which nerve
reconstruction surgery was simultaneously able to be performed
in patients whose recurrent laryngeal nerve had been cut or
resected during the operation, vocal function improved or was
prevented from deteriorating [65] (Level III).
CQ12
Is voice therapy after phonomicrosurgery effective?
(Recommendation)
Voice therapy after laryngeal microsurgery for vocal nodules
has a significant decrease in recurrence rate [66] (Level IVb).
Following surgery for vocal polyps, postoperative voice therapy
can improve patients’ vocal discomfort, emotional responses,
and everyday self-perception [67] (Level IVb). Voice therapy
may significantly improve the postoperative voice quality of
patients with vocal cord polyps [68] (Level III). Three days of
voice rest followed by the appropriate therapeutic vocal
stimulation may be recommended for patients after phonomi-
crosurgery [69] (Level II).
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8. Conclusions
We described the standard approaches for diagnosis and
treatment of voice disorders and presented relevant CQs that
consider the medical environments in Japan. The intention of
this guideline is not to require the therapeutic managements
described here but rather to provide useful information to
physicians in clinical settings. We hope that this guideline will
contribute to appropriate diagnosis and treatment for patients
with voice disorders.
Disclosure statement
Production of this guideline was funded by the Japan Society
of Logopedics and Phoniatrics and the Japan Laryngological
Association. None of the members of the guideline committee
has received any personal financial support from related
companies or organizations.
Ethical statement
1) This material is the authors’ own original work, which has
not been previously published elsewhere.
2) The paper is not currently being considered for publication
elsewhere.
3) The paper reflects the authors’ own research and analysis in a
truthful and complete manner.
4) The paper properly credits the meaningful contributions of
co-authors and co-researchers.
5) The results are appropriately placed in the context of prior
and existing research.
6) All sources used are properly disclosed (correct citation).
Literally copying of text must be indicated as such by using
quotation marks and giving proper reference.
7) All authors have been personally and actively involved in
substantial work leading to the paper, and will take public
responsibility for its content.
Acknowledgements
A summary of the Clinical Practice Guideline for the
Diagnosis and Management of Voice Disorders, 2018 in Japan
was revised by the members of the Subcommittee of Clinical
Practice Guidelines for diagnosis and management of voice
disorder 2018 composed by the Japan Society of Logopedics
and Phoniatrics, the Japan Laryngological Society and
evaluated by the Oto-Rhino-Laryngological Society of Japan.
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Please cite this article in press as: Umeno H, et al. A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice
Disorders, 2018 in Japan. Auris Nasus Larynx (2019), https://doi.org/10.1016/j.anl.2019.09.004