Clinical practice guidelines for aspiration andpharyngeal residue assessment during eating
and swallowing for nursing care: Japan edition

Supervised by
The Japan Academy of Nursing Science (Public Interest Incorporated Association)
Edited by
The Nursing Care Development/Standardization Committee

2021 Edition

Preface
Japan Academy of Nursing Science (JANS) (Public Interest Incorporated Association) was established in1981 to contribute to society both domestically and internationally for establishing and developing "Nursing
Science." In 2017, Prof. Yayoi Kamakura, the former president of JANS, established the "Nursing Care
Development/ Standardization Committee." This committee aims to reinforce the foundations of nursing science and create a system that benefits people requiring nursing care in hospitals or communities, through thedevelopment and standardization of nursing techniques based on evidence from research results. Prof. Hiromi
Sanada was appointed as the first chair of the committee and Prof. Junko Sugama took over as the chair in
2019. The main activity of the committee was the development of a clinical practice guideline for aspirationand pharyngeal residue assessment during eating and swallowing in nursing care. In our guidelines, we decided to focus on the support for basic medical care. In other words, we decided to standardize nursing care techniques for basic human activities, such as sleeping, eating, and excretion, and started with aspiration and pharyngeal residue assessment during eating and swallowing, which are urgent issues that need attention in theolder adults.
This clinical practice guideline for aspiration and pharyngeal residue assessment during eating and swallowing for nursing care adopted achievements from one arm of the research project, on the creation of medicalarts, of the Japan Agency for Medical Research and Development (AMED) (development of new medical
technologies and software, such as surgical, cancer, nursing, and rehabilitation). The AMED research project
conducted in 2016–2018 was on the "Establishment of a multi-healthcare professionals’ collaboration system
to support eating, swallowing, and defecation care in long-term care facilities or home care settings with theintroduction of advanced nursing technologies." The chief project leader was Prof. Hiromi Sanada, the chairperson of JANS’ board of directors. The former JANS Board of Directors approved this adoption. AMED
introduced nursing assessment technologies using ultrasound diagnostic devices or endoscopes and constructed a multi-healthcare professionals’ collaboration system with home/long-term care facilities/hospitals using
information and communication technologies, with the goal to support the older adults to eat independently
until the end of life in their habitual living settings.
This clinical practice guideline on aspiration and pharyngeal residue assessment consists of two parts: Part 1(Basic characteristics of aspiration and pharyngeal residue during eating and swallowing) and Part 2 (Recommendations for clinical questions and systematic review), in accordance with the "Minds Manual for Guidelines Development 2017" published by the Medical Information Network Distribution Service. The clinicalquestions and recommendations in Part 2 consist of the technologies developed in AMED and usual physiological assessments and screening tests, focusing on aspiration and pharyngeal residue assessment.
In addition, the development of this clinical practice guideline is also responsible for building a network of
researchers and training young researchers. Moreover, young members of JANS have been actively involved in
the systematic review process, which is important for the development of clinical practice guidelines, and haveprovided support for the writing and submission of review articles. Using this guideline development process― ii ―

as a model, we have already started to develop the next clinical practice guidelines for incontinence and constipation.
We hope that the development of clinical practice guidelines will standardize nursing care and that the evidence will not only promote scientific nursing care but also aid the development of new technologies and further promotion of nursing research.
Finally, we would like to express our gratitude to the contributions of the Supervisory Committee, theClinical Practice Guideline Development Group, and the Systematic Review Team for their guidance andsupport to JANS at our first attempt in the development of this clinical practice guideline. We would also liketo express our deepest gratitude to the former president of JANS, Prof. Yayoi Kamakura, the Board Members,
the supervisors, the related academic societies that reviewed and provided advice at the pre-publication stage,
and the members of JANS who contributed their opinions through the public comments feature.
Above all, we hope that this clinical practice guideline will contribute to the management of oropharyngeal dysphagia in the future.
2021 March
President, Japan Academy of Nursing Science
Former Chairperson of the Nursing Care Development and Standardization Committee

Hiromi Sanada
Chairperson of the Nursing Care Development and Standardization Committee

Junko Sugama― iii ―

ChapterPreface ……………………………………………………………………………………………………………………ⅱ

Clinical practice guideline overview ……………………………………………………………………1
1．Title ……………………………………………………………………………………………………………………2
2．Purpose ………………………………………………………………………………………………………………2
3．Topic …………………………………………………………………………………………………………………2
4．Expected users and facilities …………………………………………………………………………………2
5．Organization ………………………………………………………………………………………………………2
6．Members and their roles in the organization………………………………………………………………4
1）Supervisory Committee members of Nursing Care Development/Standardization Committee ……42）Clinical Practice Guideline Development Group members ………………………………………5
3）Systematic Review Team members ……………………………………………………………………54）Panel members ………………………………………………………………………………………………6
5）Cooperative members ………………………………………………………………………………………66）Secretariat ……………………………………………………………………………………………………6
7）External Evaluation Committee members ……………………………………………………………7
7．Conflict of Interest (COI) ………………………………………………………………………………………7
8．Clinical practice guideline development method …………………………………………………………81）Development policy …………………………………………………………………………………………82）Development process ………………………………………………………………………………………9（1）Structure of the guideline development organization ………………………………………9（2）Development of scope ………………………………………………………………………………9（3）Systematic review ……………………………………………………………………………………9（4）Development of recommendations ……………………………………………………………11（5）Finalization ……………………………………………………………………………………………12
9．Clinical questions and summary of recommendations ………………………………………………13
1）Focused assessment ……………………………………………………………………………………13
2）List of important clinical topics, clinical questions, and recommendations ………………13
10．Glossary of technical terms ………………………………………………………………………………18
1）Important words ……………………………………………………………………………………………18
2）List of abbreviations ………………………………………………………………………………………18
11．Scope covered by the clinical practice guideline and precautions for use …………………19
12．Relationships between existing clinical practice guidelines ……………………………………19
13．Results of external evaluation and their reflection in the clinical practice guideline ……20

― iv ―

Chapter

14．Public comments and their reflection in the clinical practice guideline ………………………21
15．Sources of funds………………………………………………………………………………………………22
16．Audit criteria ……………………………………………………………………………………………………22
17．Dissemination/implementation of the clinical practice guidelines ……………………………23
18．Post-publication efforts ……………………………………………………………………………………23
1）Organizational structure after release ………………………………………………………………23
2）Effectiveness assessment and monitoring…………………………………………………………23
3）Revisions ……………………………………………………………………………………………………24

Part 1．Basic characteristics of aspiration and pharyngeal residue during eating and swallowing ……25
1．Clinical characteristics ………………………………………………………………………………………26
1）What is dysphagia? ………………………………………………………………………………………26
2）Organs, structures, and functions involved in eating and swallowing………………………26
3）Disorders at each stage of eating and swallowing ………………………………………………29
4）The main causes of dysphagia…………………………………………………………………………30
2．Epidemiological characteristics ……………………………………………………………………………31
3．International trends in the management of oropharyngeal dysphagia …………………………32
1）Roles of professionals ……………………………………………………………………………………32
2）Medical and nursing care fees related to the content of guideline …………………………33
4．Assessment of aspiration and pharyngeal residue during eating and swallowing and nursing care ……34
1）Aim and methods of assessment and nursing care ……………………………………………34
2）Algorithm for nursing care choices based on the assessment ………………………………34
3）Assessment methods ……………………………………………………………………………………36（1）Physical assessment ………………………………………………………………………………36（2）Screening test ………………………………………………………………………………………37（3）Scrutiny and comprehensive evaluation ………………………………………………………40
5．Nursing care selection based on the assessment of aspiration and pharyngeal residue during eating and swallowing ……421）Prevention of aspiration pneumonia …………………………………………………………………42
2）Eating and swallowing rehabilitation (swallowing training) ……………………………………42

Part 2．Recommendation statements and systematic reviews for each CQ 45
1．CQ 1…………………………………………………………………………………………………………………46
1）Recommendations …………………………………………………………………………………………46
2）Background and purpose…………………………………………………………………………………46
3）Explanation …………………………………………………………………………………………………47―v―

4）Database search results…………………………………………………………………………………49
5）Literature search flowchart ……………………………………………………………………………49
6）List after secondary screening…………………………………………………………………………50
7）List of included papers……………………………………………………………………………………51
8）Qualitative systematic review …………………………………………………………………………52
9）Meta-analysis ………………………………………………………………………………………………52
2．CQ 2…………………………………………………………………………………………………………………56
1）Recommendations …………………………………………………………………………………………56
2）Background and purpose…………………………………………………………………………………56
3）Explanation …………………………………………………………………………………………………57
4）Database search results…………………………………………………………………………………57
5）Literature search flowchart ……………………………………………………………………………58
6）List after secondary screening…………………………………………………………………………58
7）List of included papers……………………………………………………………………………………59
8）Qualitative systematic review …………………………………………………………………………59
3．CQ 3, CQ 4, CQ 5 ………………………………………………………………………………………………60
1）Recommendations text for each CQ …………………………………………………………………60
2）Background and purpose…………………………………………………………………………………61
3）Explanation …………………………………………………………………………………………………61
4）Database search results…………………………………………………………………………………64
5）Literature search flowchart ……………………………………………………………………………64
6）List after secondary screening…………………………………………………………………………65
7）List of included papers……………………………………………………………………………………65
8）Qualitative systematic review …………………………………………………………………………65
4．CQ 6…………………………………………………………………………………………………………………68
1）Recommendations …………………………………………………………………………………………68
2）Background and purpose…………………………………………………………………………………68
3）Explanation …………………………………………………………………………………………………69
4）Database search results…………………………………………………………………………………71
5）Literature search flowchart ……………………………………………………………………………72
6）List after secondary screening…………………………………………………………………………73
7）List of included papers……………………………………………………………………………………74
8）Qualitative systematic review …………………………………………………………………………75
9）Meta-analysis ………………………………………………………………………………………………75
5．CQ 7…………………………………………………………………………………………………………………78
1）Recommendations …………………………………………………………………………………………78
2）Background and purpose…………………………………………………………………………………78
3）Explanation …………………………………………………………………………………………………79
4）Database search results…………………………………………………………………………………80
5）Literature search flowchart ……………………………………………………………………………81
6）List after secondary screening…………………………………………………………………………81― vi ―

Chapter7）List of included papers……………………………………………………………………………………82
8）Qualitative systematic review …………………………………………………………………………82
9）Meta-analysis ………………………………………………………………………………………………82
6．CQ 8…………………………………………………………………………………………………………………84
1）Recommendations …………………………………………………………………………………………84
2）Background and purpose…………………………………………………………………………………84
3）Explanation …………………………………………………………………………………………………85
4）Database search results…………………………………………………………………………………86
5）Literature search flowchart ……………………………………………………………………………86
6）List after secondary screening…………………………………………………………………………87
7）List of included papers……………………………………………………………………………………87
8）Qualitative systematic review …………………………………………………………………………87
7．CQ 9…………………………………………………………………………………………………………………89
1）Recommendations …………………………………………………………………………………………89
2）Background and purpose…………………………………………………………………………………89
3）Explanation …………………………………………………………………………………………………89
4）Database search results…………………………………………………………………………………90
5）Literature search flowchart ……………………………………………………………………………91
8．CQ 10 ………………………………………………………………………………………………………………92
1）Recommendations …………………………………………………………………………………………92
2）Background and purpose…………………………………………………………………………………92
3）Explanation …………………………………………………………………………………………………92
4）Database search results…………………………………………………………………………………93
5）Literature search flowchart ……………………………………………………………………………94
9．Summary for the public ………………………………………………………………………………………95

Appendix ……………………………………………………………………………………………………………105
1．Setting table of clinical questions ………………………………………………………………………106
2．Database search formula, evidence evaluation sheet, evidence synthesis sheet…………109
3．The Conflict of Interest Statuses of the Clinical Guideline Formulators………………………132― vii ―

Clinical practice guideline overview

1．Title
Clinical practice guidelines for aspiration and pharyngeal residue assessment during eating and swallowing fornursing care: Japan edition

2．Purpose
The purpose of this clinical practice guideline is to provide and recommend methods of assessing aspirationand pharyngeal residue during eating and swallowing and to select and implement nursing care for adults to prevent the development of aspiration pneumonia through early and appropriate management of oropharyngeal
dysphagia.

3．Topic
Assessment of aspiration and pharyngeal residue during eating and swallowing in adults.

4．Expected users and facilities
The users of this clinical practice guideline are assumed to be nurses who manage oropharyngeal dysphagia incooperation with a wide range of professionals, including physicians, dentists, and speech-language-hearing therapists, in hospitals, nursing homes, and homes.

5．Organization（Figure 1）"Clinical practice guidelines for aspiration and pharyngeal residue assessment during eating and swallowing
for nursing care: Japan edition" development organization was formed by JANS as the main academic society,with three main divisions.
The three main divisions are the Supervisory Committee in the Nursing Care Development/Standardization
Committee, Clinical Practice Guideline Development Group, and Clinical Practice Guideline Development
Systematic Review Team. The Supervisory Committee was formed in April 2018 to develop this clinical practiceguideline and consisted of experts in nursing technology development, gerontological nursing, home care nursing, dysphagia nursing, rehabilitation medicine, medical education, and clinical practice guidelines development―2―

Core: Japan Academy of Nursing Science (Public Interest Incorporated Association)
Supervisory Committee of
Nursing Care Development/
Standardization Committee

Clariﬁcation of the
purpose of creation
Organization

Clinical Practice Guideline
Development Group

Systematic Review Team

Scope development
スコープ
Scope
Determination of clinicalquestions based on key
clinical issues
Development ofrecommendations

Systematic review

Summary report

Cooperative
members

Panel members
Final decision of theguideline

Drafting guideline

Finalization
External Evaluation
Committee members
Publication

Post-publication eﬀorts

Revision
Secretariat

Figure 1: Organizational structure for developing the clinical practice guideline

methodology. The Clinical Practice Guideline Development Group was then formed with experts in nursing
technology development, gerontological nursing, home care nursing, dysphagia nursing, rehabilitation medicine,
dentistry with expertise in dysphagia care, and systematic reviews with the necessary expertise to develop thisguideline. The Systematic Review Team was independent of the Clinical Practice Guideline Development
Group, and its members were recommended and appointed by the Supervisory Committee in Nursing Care
Development/Standardization Committee in May 2018. The selection criteria for Systematic Review Team
members were doctoral degrees, and at least one published original paper for the first author.
In addition to the three divisions, panel members, cooperating members, and a secretariat were also appointed. The panel members were six members from the Clinical Practice Guideline Development Group, including
one rehabilitation physician, one dentist, four nurses, and two certified nurses in dysphagia nursing, and one
speech-language-hearing therapist from the external cooperating members. Panel members convened in October―3―

2019 and April 2020 to determine the recommendations for the clinical practice guideline development process.
A cooperating member was a senior health science information specialist with expertise in the extraction of theliterature for the systematic review. A secretariat served as the management organization for all aspects of theclinical practice guideline development.
These organizations included those who were not members of the JANS and were referred to as external
cooperating members. After the completion of the draft, external evaluation committee members were selectedfrom external evaluation organizations; they were experts and not a part of the above constituent organizations.
The external evaluation committee members were selected from academic organizations in the specialized fields
of geriatrics, rehabilitation, home healthcare, and clinical practice guideline development.

6．Members and their roles in the organization
The names, affiliations, locations of affiliations, and roles of each member of the guideline development
organization are shown in Figure 1, and their roles are listed in the table below.

1）Supervisory Committee members of Nursing Care Development/Standardization
Committee（in alphabetical order, except the Chair）
Name
Junko Sugama(Chair)Affiliation

Location

Role

Research Center for Implementation Nursing Science Toyoake, Aichi
Initiative, School of Health Sciences, Fujita Health
University

Expert in nursing technology
development

Eiichi Saitoh*

Fujita Health University

Toyoake, Aichi

Expert in rehabilitation medicine

Erika Ota

Global Health Nursing, Graduate School of Nursing
Science, St. Luke’s International University

Chuo-ku, Tokyo Expert in clinical practice guideline
development

Hiromi Sanada Department of Gerontological Nursing/Wound CareManagement, Graduate School of Medicine, The
University of Tokyo

Bunkyo-ku,
Tokyo

MasakoYamadaHome Care Nursing, Graduate School of Nursing
Science, St. Luke’s International University

Chuo-ku, Tokyo Expert in home care nursing

MiyukiIshibashi

Department of Frontier Practice Nursing, Graduate
School of Nursing, Chiba University

Chiba, Chiba

Expert in gerontological nursing

Takeo
Nakayama*

Department of Health Informatics, Graduate Schoolof Medicine, Kyoto University

Kyoto, Kyoto

Expert in clinical practice guideline
development

Takeshi
Nomura*Department of Intensive Care Medicine, Tokyo
Women’s Medical University

Shinjuku-ku,
Tokyo

Expert in medical education

Yayoi
Kamakura

Japanese Red Cross Toyota College of Nursing

Toyota, Aichi

Expert in dysphagia nursing* External cooperative members―4―

Expert in gerontological nursing2）Clinical Practice Guideline Development Group members（in alphabetical order, except
the leader and sub-leader）
Name

Affiliation

LocationRole

Junko Sugama(Leader)

Research Center for Implementation Nursing Science Toyoake, Aichi
Initiative, School of Health Sciences, Fujita Health
University

Expert in nursing technology
development

GojiroNakagami(Sub-leader)Department of Gerontological Nursing/Wound CareManagement, Graduate School of Medicine, The
University of Tokyo

Bunkyo-ku,
Tokyo

Expert in gerontological nursing

Erika Ota

Global Health Nursing, Graduate School of Nursing
Science, St. Luke’s International University

Chuo-ku, Tokyo Expert in clinical practice guideline
development

Naoko Sato

Chuo Partners Corporation Tokyo Hikari Nurse
StationChuo-ku, Tokyo Expert in home care nursing

Junko Fukada

Department of Nursing & Health, School of Nursing& Health, Aichi Prefectural University

Nagoya, Aichi

Expert in dysphagia nursing

Seiko Shibata* Department of Rehabilitation Medicine I, School of
Medicine, Fujita Health University

Toyoake Aichi

Expert in rehabilitation medicine

Takashi Hase* Department of Oral and Maxillofacial Surgery, Noto
General Hospital

Nanao, Ishikawa

Expert in Gerodontology

Tatsuto Miki

Toyoake, Aichi

Certified nurse in dysphagia nursing

Department of Nursing, Fujita Health University
Hospital* External cooperative members

3）Systematic Review Team members（in alphabetical order）
Name

Affiliation

Location

Responsible clinicalquestions (CQs)

Aya
Kitamura

Department of Gerontological Nursing/Wound Care Management,
Graduate School of Medicine, The University of Tokyo

Bunkyo-ku,
Tokyo

CQs 3,4,5,9Hiroshi
Noguchi

Department of Physical Electronics and Informatics, Graduate School ofEngineering, Osaka City University

Osaka, OsakaCQs 1,7

Itoko Tobita Graduate School of Medical Safety Management, Jikei University of
Health Care Sciences

Osaka, OsakaCQs 3,4,5,9

Kanae Mukai Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa
University

Kanazawa,
Ishikawa

CQs 1,6

MasaruMatsumotoDepartment of Imaging Nursing Science, Graduate School of Medicine,
The University of Tokyo

Bunkyo-ku,
Tokyo

CQs 1,7

MikakoYoshidaTohoku University Graduate School of Medicine

Sendai, Miyagi

CQs 2,8,10

Mikiko Arita Department of Nursing, Osaka Shin-ai College

Osaka, OsakaCQs 3,4,5,9

Misako Dai

Research Center for Implementation Nursing Science Initiative, School of Toyoake, Aichi
Health Sciences, Fujita Health University

CQs 1,6

Nao Tamai

Department of Imaging Nursing Science, Graduate School of Medicine,
The University of Tokyo

Bunkyo-ku,
Tokyo

CQs 2,8,10Tamae Urai

Faculty of Nursing, Toyama Prefectural University

Toyama, Toyama CQs 3,4,5,9

ToshiakiTakahashi

Global Nursing Research Center, Graduate School of Medicine, The
University of Tokyo

Bunkyo-ku,
Tokyo

CQs 2,8,10

Yohei Okawa Tohoku University School of Medicine

Sendai, Miyagi

CQs 8

Yuka Miura

Bunkyo-ku,
Tokyo

CQs 1,6

Bunkyo-ku,
Tokyo

CQs 2,8,10

Department of Imaging Nursing Science, Graduate School of Medicine,
The University of Tokyo

Yuko Mugita Department of Gerontological Nursing/Wound Care Management,
Graduate School of Medicine, The University of Tokyo―5―4）Panel members（in alphabetical order）
Name

Affiliation

Location

Role

Erika Ota

Global Health Nursing, Graduate School of Nursing
Science, St. Luke’s International University

Chuo-ku, Tokyo Expert in clinical practice guideline
development

GojiroNakagami

Department of Gerontological Nursing/Wound CareManagement, Graduate School of Medicine, The
University of Tokyo

Bunkyo-ku,
Tokyo

Expert in gerontological nursing

Junko Fukada

Department of Nursing & Health, School of Nursing& Health, Aichi Prefectural University

Nagoya, Aichi

Expert in dysphagia nursing

Junko Sugama

Research Center for Implementation Nursing Science Toyoake, Aichi
Initiative, School of Health Sciences, Fujita Health
University

Expert in nursing technology
development

MasakoKurachi*

Department of Speech, Language and Hearing
Sciences, Graduate School of Health and Welfare
Sciences, International University of Health andWelfareNarita, Chiba

Speech-language-hearing therapist

Naoko Sato

Chuo Partners Corporation Tokyo Hikari Nurse
StationChuo-ku, Tokyo Expert in home care nursing

Seiko Shibata* Department of Rehabilitation Medicine I, School of
Medicine, Fujita Health University

Toyoake Aichi

Expert in rehabilitation medicine

TakakoShirasaka

Sakura, Chiba

Certified nurse in dysphagia nursing

Takashi Hase* Department of Oral and Maxillofacial Surgery, Noto
General Hospital

Nanao, Ishikawa

Expert in gerodontology

Tasuto Miki

Department of Nursing, Fujita Health University
Hospital

Toyoake, Aichi

Certified nurse in dysphagia nursing

YukikoYamane*Graduate School of Nursing Science, Asahikawa
Medical University

Asahikawa,
Hokkaido

Certified Nurse in dysphagia nursing

Day Service Try Asu*External cooperative members5）Cooperative members
Name
TakaakiSuzuki*Affiliation
Nara Medical University Library

LocationRole

Kashihara, Nara

Japan Medical Library Association
Health Sciences Information
Professional, distinguished*External cooperative member6）Secretariat
Name
Misako Dai

Affiliation

Location

Research Center for Implementation Nursing Science
Initiative, School of Health Sciences, Fujita Health University

Toyoake, Aichi―6―7）External Evaluation Committee members（alphabetical order）
Name
Eishu Nango

Affiliation

Location

Seibo International Catholic Hospital/ Cochrane Shinjuku-ku,
Japan
Tokyo

Specialty

Academic organization
which recommended
the member

Clinical practiceguideline
development

Cochrane Japan

Itaru Takehara Tokyo Metropolitan Rehabilitation Hospital

Sumida-ku,
Tokyo

Dysphagia
rehabilitation

The JapaneseSociety of Dysphagia
Rehabilitation

Norio
Watanabe

Soseikai General Hospital / Cochrane Japan

Kyoto, Kyoto

Clinical practiceguideline
development

Cochrane Japan

Ritsuko
YamadaSchool of Nursing and Social Services, Health
Sciences University of Hokkaido

Ishikari,
Hokkaido

Geriatric nursing Japan Academy ofGerontological Nursing

Satoru Ebihara Department of Rehabilitation Medicine,
Graduate School of Medicine, Toho University

Ota-ku, Tokyo

Geriatric
medicine

The Japan Geriatrics
Society

Shingo Okada

Hakodate,
Hokkaido

Home healthcare

Japanese Associationfor Home Care
Medicine

Takumi Itagaki Center for Nursing Practice and Education,
Gunma Paz University

Takasaki,
Gunma

Rehabilitation
nursing

Japan Rehabilitation
Nursing Academy

Yasuyo Tanaka Nursing Home Kino Sato

Toyohashi, Aichi Home carenursing

Kitamihara Clinic

Japan Academy of
Nursing for Home
Care

7．Conﬂict of Interest (COI)
Types of COIs considered: Economic and academic COIs were declared.
Method of investigation of potential COIs: COI declarations were made in accordance with the clinical practice guidelines of the Japan Academy of Nursing Science.
The status of COIs for each participant in the development of the clinical practice guideline for the past three
years, dating back to the time of publication of the clinical practice guidelines, is shown in the appendix at theend of this clinical practice guideline.
Description of economic COIs: directorships and advisory positions (1 million JPY or more), stock ownership(profits of 1 million JPY or more, 5% or more of all shares), royalties from patent rights (1 million JPY or
more), lecture fees (500,000 JPY or more), manuscript fees (1 million JPY or more), research expenses fromcompanies and organizations (2 million JPY or more), scholarship donations (incentive donations), endowed
chairs (affiliations), and other remuneration (100,000 JPY or more) related to this clinical practice guideline
were requested to be declared.
Description of academic COI: We asked experts from multiple fields and professions to participate as members of the Clinical Practice Guideline Development Group or Systematic Review Team, and proceeded withthe development of this clinical practice guideline while striving to eliminate the influence of specialization,
intention, academic development, and inter-organizational competition of individuals or professional societies.
We asked the members to declare the following condition: being involved as a member in the development ofother clinical practice guidelines or their equivalents related to this clinical practice guideline.

―7―

When starting the preparation of this clinical practice guideline, all committee members were asked to submit
a COI declaration form, and all committee members confirmed that they had no conflicts of interest that would
affect the preparation of this clinical practice guideline. The authors of the literature covered by the systematic
review (including both first and co-authors) were excluded from the panel meetings when determining the Systematic Reviesresponsibilities and recommendations for the corresponding clinical questions (CQs). In addition,
we requested the submission of COI declarations in different fiscal years and looked for any changes.

8．Clinical practice guideline development method
1）Development policy
Individuals with dysphagia are widely distributed in hospitals, nursing homes, and homes. Common problematic disorders in people with dysphagia are aspiration, in which food enters the trachea, and pharyngeal
residue, in which food is stored in the pharynx. These can lead to choking and aspiration pneumonia, which
threaten the lives of the people. In contrast, emphasizing heavily on safety and restricting oral intake leads to aloss of enjoyment of eating and a decrease in the quality of life of the people. In Japan, multidisciplinary cooperation among physicians, dentists, nurses, speech-language-hearing therapists, physical therapists, occupational
therapists, and care workers has led to the implementation of dysphagia rehabilitation to help people with aspiration and pharyngeal residue during eating and swallowing to eat safely by mouth. Nurses are expected to help
people with aspiration and pharyngeal residue while eating and swallowing to maintain or restore their eating
function in their daily lives. To support the maintenance and restoration of eating and swallowing functions,clinical practice guidelines that can be used in any setting, whether in hospitals, at facilities, or at home, and thatguide the selection of management of oropharyngeal dysphagia provided in collaboration with physicians andother multidisciplinary professionals are needed. In particular, patients receiving care at home and in institutions
have limited opportunities to undergo swallowing videofluoroscopy (VF) and videoendoscopy (VE) by physicians, and nurses are required to collaborate with their physicians, rehabilitation physicians, and other multidisciplinary professionals to conduct assessments. In addition, in recent years, research and educational programson the use of ultrasound diagnostic devices and endoscopes for nurses to observe aspiration and pharyngeal
residues have become more widespread. Hence, there is a need for standardized guidelines on how to use thesedevices for dysphagia care.
Correspondingly, we have developed this clinical practice guideline in accordance with the Minds Manual for
Guideline Development 2017, to provide a specific pathway for making decisions on care selection policies
based on research evidence and multifaceted factors, such as the balance between benefits and harms andpatients' values. The CQs were framed for actual situations encountered while choosing dysphagia care, especially in cases that are difficult to judge and where improvement of clinical outcomes are sought. Recommendations
were determined by panel members from various positions involved in the decision-making process. These
guidelines have been developed to ensure neutrality and transparency.
Since this clinical practice guideline is based on the flow of medical treatment for people with aspiration andpharyngeal residue during eating and swallowing in Japan, and the main users of VFs and VEs overseas may differ from those in Japan, we hereby explain the implementation of VF and VE in the United States (U.S.) and―8―

Europe as examples. In the U.S., speech-language pathologists (SLPs) perform screening tests and detailed examination and evaluation of aspiration and pharyngeal residue during eating and swallowing at the request ofphysicians. Although laws vary by state, SLPs are often in charge of performing VFs and VEs for diagnosis in the
U.S. In Europe, educational programs have been developed in recent years, and SLPs are now in charge of VEs,
but until now, physicians were often in charge of VEs, as is the case in Japan. Systematic reviews of CQs werebased on the literature search for both English and Japanese articles, and the recommendations were based on awide range of evidence from overseas. However, it is necessary to keep in mind the differences in medical systems between Japan and overseas when using the clinical practice guidelines.

2）Development process（Figure 2）
This clinical practice guideline was developed in accordance with the Minds Manual for Guideline Development 2017, which adopts the strength of evidence classification proposed by the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system, which is widely used internationally.
（1）Structure of the guideline development organization
After JANS clarified the purpose of creating this clinical practice guideline, a Supervisory Committee wasformed, and the drafting of the clinical practice guidelines was initiated. In April 2018, in accordance with theMinds Manual for Guideline Development 2017, a Clinical Practice Guideline Development Group wasformed, a secretariat was established, a Systematic Review Team was formed, and cooperating members were
determined.
（2）Development of scope
After the overall scope development policy was decided by the Supervisory Committee, the Guideline Development Group organized the basic characteristics of the disease (aspiration and pharyngeal residue during eating
and swallowing) and selected candidates for CQs. The selected CQ candidates were further narrowed down to
ten CQs in October 2018 under the supervision of the Supervisory Committee, and for each of the shortlisted
CQs, rules related to systematic reviews were determined. The rules include the method of search of evidence(type of evidence, database, search method, period of search), criteria for selection and exclusion of literature,and the method of integration of the results of evidence evaluation. After these steps, the scope was determined.
Following the basic characteristics of aspiration and pharyngeal residue during eating and swallowing and thealgorithm for selecting the management options for oropharyngeal dysphagia, three main items were determinedas the specific content of the scope (items related to the content covered by the clinical practice guideline, items
related to the SR, and items related to the process of making recommendations for finalization and publication).
The first item included the title, purpose, topic, expected users, relationship to existing clinical practice guidelines, key clinical issues, scope of the clinical practice guidelines, and CQ list. The second item, systematic
reviews, included the review schedule, evidence search, literature selection criteria, inclusion and exclusion criteria, and methods of evidence evaluation and synthesis. The third item, from recommendation development to
finalization and publication, included the basic policy of recommendation development, finalization, specificmethods of external evaluation, and the publication schedule.
（3）Systematic review
Systematic Review Team members were appointed and requested to conduct a systematic review of each CQ
from May 2018. While collecting evidence, a search was conducted based on the scope with the help of a Health
Sciences Information Professional, distinguished, for determining search formulas and performing literature―9―Clariﬁcation of the purpose of creation

Structure of the development organization
・Formation of Supervisory Committee
・Formation of Clinical Practice Guideline Development Group・Establishment of secretariat
・Formation of Clinical Practice Guideline Development Systematic Review Team・Determination of cooperating members
Creation of scope・Determination of the overall scope creation policy
・Organize the basic characteristics of disease topics
・Determination of clinical questions
・Determination of systematic review-related matters
・Determination of scope
Systematic review
・Collection of evidence (determination of search formula, literature search)・Screening (primary screening, secondary screening)・Individual evaluation of evidence・Overall evaluation of the evidence
・Meta-analysis by Review Manager
・Creation of report of systematic review
Development of recommendation
・Determination of speciﬁc methods for making recommendations
・Drafting of recommendation text
・Determination of strength of recommendations, creation of recommendations
・Writing of commentary
・Writing of summaries for the general public
Finalization
・Discussion and decision of what to do after the release of the guidelines
・Preparation of a report on the preparation process・Determination of the draft guidelines
・Conduction of external evaluation
・Solicitation of public comments
・Determination of the ﬁnal draft of the guidelines
Publication

Post-release eﬀorts
・Inplementation
・Eﬃcacy evaluation
・Revisions

Figure 2: Guideline development processsearch. After the primary and secondary screening, the pieces of evidence were individually assessed qualitatively
by systematic review and were collectively used as evidence. These pieces of evidence were summarized for theoverall assessment of the body of evidence. Based on the results, systematic review reports were prepared; qualitative synthesis was used as the basis in accordance with the Minds Manual for Guideline Development 2017.

― 10 ―

However, a quantitative synthesis (meta-analysis) was performed for some CQs because they had multiple studies with similar evaluation methods. The systematic reviews were completed in September 2019.
A. Evidence searches
ⅰ．Type of evidence
Individual articles: randomized controlled trials, non-randomized controlled trials, and observational studies
Review articles: systematic reviews
Existing guidelines: In scoping and setting CQs, the Guidelines for the Treatment of Dysphagia (September2018) and Guidelines for the Treatment of Adult Pneumonia (April 2017) were used as references. In the systematic review, we did not use the results of these existing clinical practice guidelines but conducted a new systematic review of all of them.
ⅱ．Database
PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web (Japanese)ⅲ．Searching method
The patient, intervention, control, and outcome (PICO) format was used to search for interventions based on
a combination of P, I, and study design, sometimes specifying C. O was not specified.
ⅳ．Searching period
All articles included in the databases before the end of August 2019.
B. Inclusion and exclusion criteria of articles
Of the existing clinical practice guidelines or systematic review articles addressing the same clinical questions
as this guideline, none were developed in accordance with the Minds Manual for Guideline Development 2017;
therefore, all of them were subjected to a new systematic review. In the case of CQs on care choice interventions,priority was given to systematic reviews which included randomized controlled trials that met the recruitment
criteria; however, observational studies were included even if there were no randomized controlled trials that met
the inclusion criteria. In the case of the CQs on the sensitivity and specificity of assessment for care selection,
cross-sectional observational studies that met the inclusion criteria were included.
C. Evidence evaluation and synthesis of the results
The evaluation method and method of expressing the strength of the body of evidence conformed to the
Minds Manual for Guideline Development 2017. Although a qualitative synthesis was the basic method, quantitative synthesis (meta-analysis) was conducted for CQ1, CQ6, and CQ7 because they included several studies
with similar evaluation methods.
（4）Development of recommendations
The basic policy for the development of the recommendations was based on the Minds Manual for Guideline
Development 2017, with particular attention given to incorporating the perspectives of non-nurses by adding
physicians, dentists, and speech-language-hearing therapists as members of the recommendation panel. The recommendation panel consisted of four nurses, one rehabilitation physician, and one dentist from the Clinical
Practice Guideline Development Group, and one nurse and one speech pathologist as cooperating committee
members. Panel meetings were held in October 2019 and April 2020 to decide the recommendations. The recommendations were decided by a two-thirds majority vote of the panel members on the draft recommendations
prepared by the Guideline Development Group in accordance with the modified Delphi method. If a decision
could not be achieved through voting, the status was set to "no recommendation." Health care costs andresource use were not included in the outcomes but were assessed at the stage of the recommendation decision.

― 11 ―

Table 1: Certainty (strength) of evidence on the overall outcome for making
recommendations/ decisions
A (Strong)

Strong confidence in the appropriateness of the effect estimate to support
recommendations.

B (Moderate)

Moderate confidence in the appropriateness of the effect estimate to support
recommendations.

C (Weak)

Limited confidence in the appropriateness of effect estimate to support
recommendations.

D (Very weak)

Little confidence in the appropriateness of the effect estimate to support
recommendations.

(According to Minds Manual for Guideline Development 2017, p.101)

Table 2: Strength of recommendations and how recommendations are stated.
(1) How to describe the strength of the recommendation?
Strength of recommendation "1": Strongly recommended
Strength of recommendation "2": Weakly recommended (suggested)(Strength of recommendation "None": No clear recommendation can be made)(2) How to write a recommendation statement?
The recommendation statement should be written as follows, with the strength of evidence (A, B, C,or D) added to the strength of recommendation (1), as mentioned above.
1) It is recommended to perform care selection "I" for patient P (1A)
＝ (Strong recommendation, strong certainty of evidence)2) It is recommended to conditionally perform care selection "I" for patient P (2C)
＝ (Weak recommendation, weak certainty of evidence)3) It is suggested not to perform care selection "I" for patient P (2D)
＝ (Weak recommendation, very weak certainty of evidence)4) It is strongly recommended not to perform care selection "I" for patient P (1B)
＝ (Strong recommendation, moderate certainty of evidence)(According to Minds Manual for Guideline Development 2017, p.173)

The meeting members decided on the recommendations based on the strength of evidence for all outcomesfor CQ (Table 1); the balance of benefits and harms; other factors, such as patient values and preferences; burden; and medical costs and resources, which were taken into account in a comprehensive manner. The strengthof the recommendation was classified as 1: strongly recommended or 2: weakly recommended (suggested), andthe certainty of the evidence (strength) was listed together (Table 2). In cases where no clear recommendation
could be made, "None" was selected.
（5）Finalization
The first draft was peer-reviewed by the Clinical Practice Guideline Development Group members inNovember 2020. After the completion of the draft in December 2020, it was validated by the Supervisory Committee in January 2021, and external evaluations were conducted and public comments were collected in February 2021. The Clinical Practice Guideline Development Group examined the results of the external evaluationand public comments, revised the content based on the results, and reached a consensus in an online meeting inMarch 2021. After considering the external evaluations and public comments, the Supervisory Committee of the
Nursing Care Development/Standardization Committee finalized the guidelines in March 2021, and the guidelines were published in June.

― 12 ―

9．Clinical questions and summary of recommendations
1）Focused assessment
The assessments covered in this clinical practice guideline include physical assessment, Repetitive Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test (FT), cervical auscultation, andobservations using an ultrasound diagnostic device and an endoscope.

2）List of important clinical topics, clinical questions, and recommendations
Important clinical topics 1
For adults with dysphagia, is it useful to conduct a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) to assess
aspiration and pharyngeal residues during eating and swallowing?

CQ 1
It is advisable to perform a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia? To avoid duplication with
CQs 3, 4, 5, and 6, assessments using only the Repetitive Saliva Swallowing Test(RSST), Modified Water Swallowing Test (MWST), Food Test (FT), or cervical auscultation were not included here.
Recommendations
We propose to conduct an assessment of aspiration through a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for individuals aged 18 years and older, who
are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］When including observation items that require an understanding of instructional
actions, such as command swallowing of water, care should be taken while applying theprocess to persons with impaired consciousness or severe cognitive impairment.

CQ 2
Is it advisable to manage oropharyngeal dysphagia based on a systematic assessment
using physical assessment techniques (interview, visual inspection, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia. To avoid duplication with CQs 3, 4, 5, and 6, assessments using only Repetitive
Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test
(FT), or cervical auscultation were not included here.

― 13 ―

Recommendations
We propose to manage oropharyngeal dysphagia based on a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspectedof having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］Subsequent screening and diagnostic tests based on a systematic assessment
using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) are necessary for the implementation of appropriate care.

Important clinical topics 2
What aspiration and pharyngeal residue screening tests are useful for adults with dysphagia
to perform aspiration and pharyngeal residue assessments during eating and swallowing?

CQ 3
Is it advisable to screen for aspiration by Repetitive Saliva Swallowing Test (RSST) in
persons over 18 years of age suspected of having dysphagia?
Recommendations
We suggest that individuals aged 18 years and older, who are suspected of having dysphagia, should be screened for aspiration using Repetitive Saliva Swallowing Test (RSST).
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Repetitive Saliva Swallowing Test (RSST) requires movement with an understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment. Caution should be exercised when applying Repetitive Saliva Swallowing Test (RSST) to patients with xerostomia.
Patients with Parkinson's syndrome, who have strong immobility and inactive, are often
judged to be abnormal, regardless of their swallowing function.

CQ 4
Is it advisable to screen for aspiration using the Modified Water Swallowing Test
(MWST) in persons over 18 years of age, who are suspected of having dysphagia?
Recommendations
We suggest screening for aspiration with the MWST in individuals aged 18 years
and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before per-― 14 ―

forming the procedure; Modified Water Swallowing Test (MWST) requires movement withan understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment.

CQ 5
Is it advisable to screen for aspiration by FT (Food Test) for persons over 18 years ofage, who are suspected of having dysphagia?
Recommendations
It is suggested to screen individuals aged 18 years or older suspected of having
dysphagia for aspiration using FT (Food Test).
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before performing the procedure; FT (Food Test) requires movement with an understanding of
instructions, and care should be taken regarding its application to persons with impaired
consciousness or severe cognitive impairment.

CQ 6
Is it advisable to screen for aspiration and pharyngeal residues by cervical auscultationin persons aged 18 years or older, who are suspected of having dysphagia?
Recommendations
Screening for aspiration and pharyngeal residues swallowing by cervical auscultation should be performed in individuals aged 18 years and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Education on screening for aspiration and pharyngeal residues is needed fornurses who perform cervical auscultation.

CQ 7
For persons over 18 years of age suspected of having dysphagia, is it advisable for anurse who has undergone an educational program to screen for aspiration and pharyngeal residues by observation with an ultrasound diagnostic device?
Recommendations
We propose that persons aged 18 years or older, who are suspected of having
dysphagia, receive training in aspiration and pharyngeal residue observation using
an ultrasound diagnostic device, and that persons who have been certified by― 15 ―

their instructors as being at a level where they can practice aspiration and pharyngeal residue observation techniques using ultrasound diagnostic devices arescreened for aspiration using ultrasound diagnostic devices in facilities and homevisit nursing agencies equipped with ultrasound diagnostic devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.

CQ 8
For individuals over 18 years of age, who are suspected of having dysphagia, is it
acceptable for nurses, who have undergone an educational program, to manage oropharyngeal dysphagia based on observations with an ultrasound diagnostic device and conventional methods?
Recommendations
We propose that persons over 18 years of age, who are suspected of having dysphagia, receive training in aspiration and pharyngeal residue observation using
ultrasound diagnostic devices, and that persons, who have been certified by theirinstructors as being at a level where they can practice aspiration and pharyngeal
residue observation using ultrasound diagnostic devices, provide management oforopharyngeal dysphagia based on observations using ultrasound diagnostic
devices in facilities and offices equipped with these devices. In facilities andoffices equipped with ultrasound diagnostic devices, we propose to manage
oropharyngeal dysphagia based on observations using these devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.

― 16 ―

Important clinical topics 3
Is it useful for nurses to observe aspiration and pharyngeal residue using an endoscope toperform aspiration and pharyngeal residue assessment during eating and swallowing in
adults with dysphagia?

CQ 9
For persons over 18 years of age, who are suspected of having dysphagia, should anurse who has undergone an educational program observe aspiration and pharyngeal
residue using an endoscope?
Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in eating and swallowing, who have received training
in the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a medical advisor as being able to practice the observation
technique, can perform endoscopic observation of aspiration and pharyngeal
residue in clinical settings.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）

CQ 10
Should the management of oropharyngeal dysphagia for persons aged 18 years or older
and suspected of having dysphagia be based on endoscopic observation of aspirationand pharyngeal residue by nurses (who have undergone an educational program) in
addition to conventional management?
Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in the field of dysphagia, who have received training in
the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a supervising physician as being able to practice observation
techniques, can manage oropharyngeal dysphagia.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）― 17 ―

10．Glossary of technical terms
1）Important words
Physical assessment
In this clinical practice guideline, physical assessment is defined as a method of assessing the eating and swallowing function from daily observations and is based on the integration of subjective and objective information.
Subjective information was obtained from interviewing the patient and his/her family regarding medical history,eating and swallowing functions from preceding to esophageal phases, and the patient's general condition,
including breathing and nutritional status. Objective information was obtained from physical assessments,
including interviews, visual, palpatory, auscultation, and percussion examinations of the cerebral nervous system(mainly olfactory, optic, trigeminal, facial, glossopharyngeal, vagus, accessory, and hypoglossal nerves), respiratory system, nutritional status related to eating and swallowing, facial appearance, speech, lips, temporomandibular
joint and oral cavity, tongue, soft palate, anterior palatal arch, oral sensation, larynx, trachea, lungs, and generalcondition.
Pyriform fossa (pyriform sinus)
The pyriform fossa (pyriform sinus) is a groove located between the laryngeal folds and the thyroid cartilage
plate. This is where food boluses and fluids pass as they move from the oral cavity to the esophagus; however, if
there is a swallowing dysfunction, food boluses and fluids may accumulate in the pyriform fossa (pyriform
sinus). In this clinical practice guideline, the term "pyriform fossa," which is the name used in the certified nursein dysphagia nursing educational program, will be used.

2）List of abbreviations（Table 3）
The abbreviations used in this clinical practice guideline are listed below.
Table 3: List of abbreviations
Abbreviation
Terms
AMED
Japan Agency for Medical Research and Development
CI
Confidence interval
CQ
Clinical questionCT
Computed tomography
DSS
Dysphagia Severity Scale
EAT-10Eating Assessment Tool-10
ESS
Eating Status Scale
FILS
Food Intake Level Scale
FOIS
Functional Oral Intake Scale
FT
Food Test
ICC
Intraclass correlation coefficient
MASA
The Mann Assessment of Swallowing Ability
MWST
Modified Water Swallowing Test
PAS
Penetration-Aspiration Scale
RSST
Repetitive Saliva Swallowing Test
TOR-BSST The Toronto Bedside Swallowing Screening Test
USUltrasonography
VE
Videoendoscopic examination of swallowing
VF
Videofluoroscopic examination of swallowing(abbreviations listed in alphabetical order).

― 18 ―

11．Scope covered by the clinical practice guideline and precautions for use
This clinical practice guideline covers aspiration and pharyngeal residue assessment during eating and swallowing performed as a nursing task. Aspiration and pharyngeal residue assessment during eating and swallowing
by non-nursing professionals and aspiration assessment that occurs in situations other than eating and swallowing (e.g., during sleep) are outside the scope of this document.
This clinical practice guideline was intended for adults (18 years of age and older) suspected of having dysphagia in hospitals, nursing homes, and homes. It should be noted that the goal of eating and swallowing rehabilitation for adults who have experienced oral intake is to restore function, whereas the goal for pediatric patientswith eating and swallowing disorders is to acquire eating and swallowing functions. In addition, pediatricpatients differ from adults in that they require rehabilitation tailored to their level of development, taking into
account their growth and development. Therefore, the scope of this clinical practice guideline is limited toadults. Gender was not a limitation. Although the severity of dysphagia, causative diseases, and comorbidities are
not limited, some assessment methods need to be carefully applied. Specifically, when using a physical assessment, if it includes observations that require an understanding of the indicated actions, such as fluid swallowing,care should be taken when applying it to patients with impaired consciousness or severe cognitive impairment.
RSST, MWST, and FT should also be used with caution in persons with impaired consciousness or severe cognitive impairment. In addition, when using RSST, care must be taken when applying it to patients with xerostomia. In the case of swallowing observation using an ultrasound diagnostic device and/or an endoscope, the facility or office must have a device capable of making swallowing observations and someone who is adept at using
the observation technique and can conduct an appropriate assessment.

12．Relationships between existing clinical practice guidelines
There are no national or international clinical practice guidelines for the assessment of aspiration and pharyngeal residue during eating and swallowing in adults that have been developed for use by nurses for care selection.
In Japan, the Japanese Respiratory Society published "The Japanese Respiratory Society guidelines for the management of pneumonia in adults 2017" 1) and the Oto-Rhino-Laryngological Society of Japan published the"Clinical practice guidelines for the diagnosis and management of dysphagia 2018 editions" 2) as medical treatment guidelines for physicians. In addition, the Medical Review Committee of the Japanese Society of Dysphagia Rehabilitation published a manual titled "evaluation of eating and swallowing disorders 2019"3) for physicians, dentists, nurses, speech-language-hearing therapists, and professionals from other disciplines. The clinicalpractice guidelines primarily address screening tests and diagnostic evaluation tests such as VF and VE, and themanual covers physical assessment, screening tests, cervical auscultation, and tests for diagnostic evaluation.
However, they include no description of the observation of aspiration and pharyngeal residues by ultrasounddiagnostic devices or endoscopes performed by nurses. "The guidelines for tongue function testing methods as adiagnostic aid in dysphagia rehabilitation" published by the Japanese Society of Gerodontology4) discusses ultrasonography, but focuses on the evaluation of tongue movement during mastication and swallowing. In countries― 19 ―

other than Japan, best practices for the assessment of dysphagia and swallowing by nurses have been published;however, they do not describe the observation of aspiration and pharyngeal residue by ultrasound diagnostic
devices or endoscopes performed by nurses.
Some of the existing clinical practice guidelines, manuals, and best practices describe physical assessment,
screening tests, cervical auscultation, and VE. This clinical practice guideline was developed with these existing
publications as references and provides decision support for nurses regarding aspiration and pharyngeal residue
assessment during the management of oropharyngeal dysphagia.
References
1.
2.
3.
4.

The Japanese Respiratory Society. The Japanese Respiratory Society guidelines for the management of pneumonia in
adults 2017. The Japanese Respiratory Society, Tokyo, 2017.
The Oto-Rhino-Laryngological Society of Japan. Clinical Practice Guidelines for the Diagnosis and Management of Dysphagia 2018. Kanehara Shuppan, Tokyo, 2018.
The Japanese Society of Dysphagia Rehabilitation, Medical Review Committee. Evaluation of Feeding and Swallowing
Disorders 2019.
The Japanese Society of Gerodontology. Guidelines for tongue function testing methods as a diagnostic aid in dysphagia
rehabilitation. 2013.

13．Results of external evaluation and their reﬂection in the clinical practice guideline
This clinical practice guideline underwent external evaluation by representative academic professionals specializing in geriatric medicine, geriatric nursing, dysphagia rehabilitation, rehabilitation nursing, home health care,and home nursing, as well as by experts on how to develop clinical practice guidelines, during the drafting stage,prior to its publication.
Academic societies of representatives specializing in geriatric medicine, gerontological nursing, dysphagia
rehabilitation, rehabilitation nursing, home health care, and home nursing were invited to evaluate and comment freely on the entire draft from the perspective of including the clinical significance and practice. The international standard tool AGREEII1) was used by two experts in the development of the clinical practice guideline.
AGREEII consists of 23 individual items in six domains and an overall assessment. Each item was scored from 1
to 7, and the average of the values scored by the two experts for each domain was calculated.
The results of the external evaluation have been reflected in this guideline as much as possible. The parts that
could not be reflected have been considered in the next revision.
The comments and average scores attached to the AGREE II evaluation are listed below (Table 4).
References
1.

EBM Medical Information Department, Japan Health Care Organization: Agreement II Japanese translation enforcement
version https://minds4.jcqhc.or.jp/minds/guideline/pdf/AGREE2jpn.pdf (Accessed December 2020) (in Japanese)― 20 ―

Table 4: Summary of the results of AGREEII's external evaluation of the pre-publication draft
Domain

Domain 1. Scopeand Purpose

Item

Comments

1. The overall objective(s) of the guideline is (are)specifically described.

The purpose described in the outline states "to prevent ... by assessment", but "by showing andrecommending how to select and implement assessment and nursing care" is more accurate in terms of therole of the guideline.

2. The health question(s) covered by the guideline is (are)specifically described.
3. The population (patients, public, etc.) to whom the guideline ismeant to apply is specifically described

5. The views and preferences of the target population (patients,
public, etc.) have been sought.

6. The target users of the guideline are clearly defined.

7. Systematic methods were used to search for evidence

8. The criteria for selecting the evidence are clearly
described.
9. The strengths and limitations of the body ofevidence are clearly described.
10. The methods for formulating the recommendations are
Domain 3. Rigour of clearly described.
Development
11. The health benefits, side effects, and risks have been
considered in formulating the recommendations.
12. There is an explicit link between the recommendations
and the supporting evidence.
13.The guideline has been externally reviewed by experts
prior to its publication.
14. A procedure for updating the guideline is provided.

The criteria seem to vary among the CQs in some extent, however there are no descriptions for each CQ.

6

6

3.5

7

7
6
5
5.5
6.5
7
7

There is no description regarding the update of the guidline except for update period.

15. The recommendations are specific and unambiguous.

Domain 4. Clarity ofPresentation
16. The different options for management of the condition or healthissue are clearly presented.

There is a difference in the length of the recommendations depending on the CQ, and the long one also
explains the background of the CQ. I think it would be good if you could simplify the recommendations.
Although the target of this clinical practice guideline is nurses, it seems strange to add "Nurses who havereceived an educational program" only for the recommendations of CQ9 and CQ10. Shouldn't CQ7 and
CQ8 be done by "educated nurses" as well?
It was unclear.

17. Key recommendations are easily identifiable.

6

5.5

6
7

18. The guideline describes facilitators and barriers to its
application.
19. The guideline provides advice and/or tools on how therecommendations can be put into practice.
Domain 5.
Applicablity

20. The potential resource implications of applying therecommendations have been considered.
21. The guideline presents monitoring and/ or auditing criteria.

The factors seem to be different for each CQ, but only a brief description of each method as a whole.

6

The "algorithm for selecting swallowing care" inclues "RSST, MWST, FT, cervical auscultation, swallowing
observation with an ultrasonic diagnostic device, swallowing observation with an endoscope". , however thisalgorithm did not state which evaluation method other than endoscopy should be selected, or the order inwhich those evaluations be performed. This will confuse clinicians when implementing the guideline in theclinical setting.

5

Although it describes the organizational structure after publication, it does not show specific methods for
effectiveness evaluation and monitoring.

6.5

7

22. The views of the funding body have not influenced the content
of the guideline.
12. Competing interests of guideline development group members
Domain 6. Etitoarial
have been recorded and addressed.
Independence

6.5
I think that they follow the COI guidelines of the academic society, but it is unnatural that there is no COI at
all, and it may be necessary to review it of the academic society, or to consider the academic COI as well.
At the time of the external evaluation, no information was disclosed regarding the state of conflicts ofinterest among the members. The disclosed conflicts of interest should include not only economic conflictsof interest but also academic conflicts of interest.

Overall
Others5.5
6.5

The target population is considered to be adult patients with dysphagia and adult patients who may havedysphagia, but it is unclear whether the recommendations differ depending on the causative disease orwhether a specific causative disease is assumed.
It is good that the panelists include not only nurses but also physicians, dentists, and speech-languagehearing therapists, but the proportion of nurses is large and it is expected that patients and their families arealso included.
The recommendation panel focuses on the strength of all outcome evidence for CQ (Table 1), the balance
between benefits and harms, and comprehensively considers the values, preferences, burdens, medical costs
and resources of the caregiver. However, there is a CQ for which there is no description that examines thevalues of the recuperator in each CQ.
Although it is generally described, among the five factors of downgrade, inaccuracies and publication bias
are summarized in others, thus it is unclear whether all CQs have been assessed for those points (Stated in
the evaluation sheet of evidence but not in the body text). In CQ7 and 8, the supporting evidence seems to
be an evaluation using an ultrasound diagnostic device by a physician, whereas the recommendation is for its
use by a nurse, so it should be considered whether the evidence will be downgraded in terms of indirectness.
In the "developement process", it is stated that the modified Delphi method was used in making therecommendation decision, but what kind of discussion was made at the panel meeting at each CQ and theresult of the vote are not shown.

4. The guideline development group includes individuals
from all the relevant professional groups.

Domain 2.
Stakeholder
Involvmenet

Average

4.5

6Since the term "guideline" is often treated as always being observed in non-medical contexts, it isrecommended to use the term "clinical practice guideline" to prevent misunderstandings.
Comments regarding the description for Japanese writing were deleted from the comment list.

14．Public comments and their reﬂection in the clinical practice guideline
Public comments were collected for this clinical practice guideline, during the drafting stage, prior to its publication. The invitation for public comments was disseminated to the members of JANS via e-mails and posts on
the website. The draft was posted on the webpage for the members of JANS from February 4 to February 15,
2021, to obtain comments in the form of free responses.
As a result, we received public comments from four JANS members. Of these, the excluding impressions arelisted below: the comments are listed not in the order of submission, but in the order of the contents of this clin-― 21 ―

ical practice guideline. The results of the public comments have been reflected in this clinical practice guideline
as much as possible. The revised content of each comment was subsequently posted on the JANS website.
About the title
I believe that the title "Guideline for Nursing Care" may be misleading, since I believe that you have createdguidelines for assessment and not for specific care content. For example, I think a more appropriate title wouldbe "Guideline for assessment of aspiration and pharyngeal residues during eating and swallowing for nursing
care."[Response] Thank you for this suggestion. You are correct, and we believe that including the term "assessment" would be an appropriate name for the clinical practice guidelines. We have corrected the title as you suggested.
About Part 1
We would like you to consider adding information about teeth and dentures to the physical assessment of theoral cavity. Also, in the clinical setting, physical assessment may be conducted specifically based on the results ofitems in the questionnaire, so we hope that you will consider this as well. The word "refusal" is used in the literature at the end of p. 42, so it would be appreciated if you would consider adding something like "unable toobtain consent."[Response] Thank you for your suggestion. We have added some important information, regarding teeth anddentures, that were not previously included in the content of the physical assessment, as you suggested. In addition, as you pointed out, there are actual clinical situations where physical assessment is conducted based on the
results of the items in the questionnaire. We have added an explanation in the main body of text for clarification.
We have revised the information about the subjects who should be considered for various tests, as you suggested.

15．Sources of funds
Funding for the development of this clinical practice guideline was provided by JANS. No funding wasreceived from any other private company or organization. COIs were collected from the self-reports of the committee members in accordance with the regulations of JANS, and it was confirmed that there were no problems
with the COIs. COIs to be disclosed are described in the Clinical Practice Guideline Overview 7. Conflict ofinterest (COI).

16．Audit criteria
Monitoring will be done by measuring the relationship between the assessments conducted and care choices
made and the onset of aspiration pneumonia and the intake of food in the form desired by the recuperator, once
every year.

― 22 ―

17．Dissemination/implementation of the clinical practice guidelines
There are 10 CQs in this clinical practice guideline, and recommendations for each of them are summarized
in a straightforward manner, clearly indicating what is important. Physical assessment, RSST, MWST or FT,
and neck auscultation, which are useful in treating patients suspected of having eating and swallowing disorders,
do not require special devices and help in the application of these clinical practice guidelines. On the other hand,observation using an ultrasound diagnostic device by a person who has received training in aspiration and pharyngeal residue observation using an ultrasound diagnostic device and who has been certified by the instructor as
having a practicable level of skill in aspiration and pharyngeal residue observation using an ultrasound diagnostic
device is not widely used. This is because only a limited number of facilities and home-visit nursing agencies
have the necessary device and only a limited number of people have mastered the observation technique. Certified nurses, in the field of nursing care for dysphagia, who have received training in the endoscopic observationof aspiration and pharyngeal residue during eating and swallowing and who have been certified by a medical
advisor as being able to perform such observations, or nurses with specialized knowledge and experience in eating and swallowing, can perform endoscopic observations of aspiration and pharyngeal residue. Endoscopy also
has similar disadvantages; the number of facilities and offices that have the applicable device and the number ofpeople who have mastered the observation techniques is limited. The training of people who can acquire observation techniques is an important issue to be considered for the future.
This clinical practice guideline will be published in Japanese and English, and the full text will be available on
the websites of the JANS and Minds. The Japanese version will also be published as a book. This clinical practice guideline includes a summary for the general public. In addition, a digest version and a systematic review
will be published in the Japan Journal of Nursing Science, the official English-language journal of the JANS.
Furthermore, we aim to promote the use of this clinical practice guideline by holding lectures at academic meetings.

18．Post-publication eﬀorts
1）Organizational structure after release
After the release of the clinical practice guidelines, the Supervisory Committee and Clinical Practice Guideline
Development Group will continue their activities to promote the adoption of these clinical practice guidelines,
evaluate their effectiveness, and check for the emergence of new studies that may affect the recommendations of
the guidelines.

2）Effectiveness assessment and monitoring
To evaluate the effectiveness of this clinical practice guideline, we plan to assess whether patient outcomes,
related to aspiration and pharyngeal residue during eating and swallowing, such as the incidence of aspiration
pneumonia, improve with the implementation of this guideline. These will be measured once every year fromthe time of introduction of the clinical practice guidelines.

― 23 ―

3）Revisions
This clinical practice guideline will need to be revised periodically to reflect new evidence and changes in thesituation regarding medical services. The guideline will approximately be revised every three to four years. We
will consider making revisions as needed if new physical assessment techniques, screening tests, or definitive
diagnostic methods are proposed, and if assessment criteria change before that.

― 24 ―

Part 1.

Basic characteristics of aspiration andpharyngeal residue during
eating and swallowing

1．Clinical characteristics

Aspiration during eating and swallowing refers to the flow of food or liquid below the vocal folds into the trachea. Pharyngeal residue during eating and swallowing refers to food or liquid remaining in the pharynx. Since
aspiration and pharyngeal residue are part of dysphagia, a basic understanding of dysphagia is essential. The following will provide an overview of the basic features of aspiration and pharyngeal residue during eating andswallowing.

1）What is dysphagia?
Eating and swallowing refer to the recognition of food, taking it into the oral cavity (catching), forming afood bolus by chewing, sending the food bolus from the oral cavity to the pharynx, sending it from the pharynx
to the esophagus by swallowing reflex, and sending it from the esophagus to the stomach by peristalsis. The term
"dysphagia" refers to a condition in which one of the processes of eating and swallowing is impaired. In dysphagia, examination findings, as well as problems in daily life, such as pneumonia, choking, dehydration, low nutrition, and loss of enjoyment of eating are considered important. Aspiration and pharyngeal residue during eating
and swallowing are part of dysphagia.
The assessment of aspiration and pharyngeal residue during eating and swallowing is very important to prevent aspiration pneumonia. Pneumonia occurring in patients with proven (or strongly suspected) dysphagia andaspiration is called aspiration pneumonia.1) Aspiration pneumonia (Table 1) is caused by aspiration of the fooditself or bacteria attached to food, as well as aspiration of bacteria from the oropharynx, in combination withpoor nutritional status and immunity. The aspiration of bacteria attached to food or oropharyngeal secretions is
the main mechanism by which bacteria enter the lungs.2) Furthermore, the entry of protein-containing food into
the lungs causes lung inflammation.

Table 1: Overview of aspiration pneumonia
Main mechanism

Aspiration of the food itself or bacteria attached to food

Pathophysiological process

Acute inflammatory response of the lung to bacteria or bacterial products

Bacteriological findings

Gram-positive cocci, Gram-negative rods, and anaerobes

Major risk factor

Dysphagia

Susceptible age groups

Usually, older adults

Typical patient clinical features Clinical features of pneumonia in a person with dysphagia and cellular
infiltration of the lung inferred from localized, ill-defined shadows on chest
x-ray in the bronchopulmonary area
Characteristics of the clinicalcondition

Tachycardia, cough, signs of pneumonia

2）Organs, structures, and functions involved in eating and swallowing
Organs associated with eating and swallowing include the lips, tongue, cheeks, teeth, mandible, salivary
glands, hard palate, soft palate, uvula, epiglottis valley, epiglottis, laryngeal vestibule, pyriform fossa, larynx,― 26 ―

Soft palate
Uvula

Hard palate

Epiglottic valley
TongueEpiglottis

Oral vestibule
Pyriform fossa
Laryngeal vestibule

Suprahyoid muscles
Thyroid cartridge

Figure 1: Organs and structures involved in eating and swallowing
Kamakura, Y. (ed.) Dysphagia Nursing: From Physical Assessment to Swallowing Training Igaku Shoin (2000).3) Revised.

hyoid bone, and esophagus (Figure 1).
The sequence of eating and swallowing movements is as follows: after catching food, the food is carried by the
tongue to the molars, then the food is chewed, mixed with saliva, and the chewed food is sequentially sent fromthe oral cavity to the pharynx and esophagus. The process of transporting food to the oral cavity, pharynx, andesophagus is described in more detail. First, when the food approaches the mouth and the mouth voluntarily
opens, the tongue protrudes to the interincisal space. Next, when the food touches the tongue apex, the tongue
retracts back into the mouth with the food. Then, as soon as the food is taken into the mouth, the mouth closes,
and the entire tongue moves backward to move the food on the tongue to the molars (Stage I transport). Whenthe food reaches the molars, the tongue, cheeks, and back teeth are used to crush the food and mix it with saliva
to form a food bolus. During the process of chewing, the gullet is closed by the back of the tongue and soft
palate to prevent the food bolus from moving into the pharynx. As the food is chewed and begins to form small
soft fragments suitable for swallowing, the food bolus is squeezed by the tongue and palate through the narrow
part of the mouth into the pharynx (Stage II transport). Mastication and delivery occur parallelly, and during
mastication, the food bolus is sequentially delivered to the mesopharynx by stage II transport. This stays in thepharynx for 5 to 10 seconds. Next, the soft palate is elevated, and pharyngeal contraction is initiated by the pharyngeal contractor muscles, resulting in the closure of the space between the nasopharynx and the middle pharynx (nasopharyngeal cavity closure*). At about the same time, with the backward movement of the root of the
tongue, the suprahyoid muscle group contracts, and the hyoid bone and larynx are pulled upward and forward,
causing the epiglottis to invert and close the laryngeal opening (laryngeal closure). In this way, the pharyngeal
cavity becomes a closed space in which the swallowing pressure is created by the backward movement of the
tongue and peristaltic-like contractions (pharyngeal contractions), from the top to the bottom, by the upper,
middle, and lower pharyngeal contractor muscles. In addition, the larynx is pulled upward in the anterior direction, which facilitates the widening of the esophageal entrance and pushes the food bolus downward. At thesame time, the upper esophageal sphincter relaxes, the esophageal entrance opens, and the food bolus moves into
the esophagus.

― 27 ―

Esophagus
Trachea

Pyriform fossa

Epiglottic valley
Epiglottis
TongueFood bolus

Figure 2: Movement of the food bolus
Baba, M. and Kamakura, Y. Eating and swallowing disorders from the brain to the body. Gakken Medical Shujunsha. Tokyo, 2013.4) Revised.

*Nasopharyngeal cavity closure: The nasopharyngeal cavity refers to the veropharynx. Although there isno anatomical luminal structure called the "nasopharynx," the term nasopharyngeal cavity, which is
widely used in general, has been used here.

The oral cavity and pharynx, which control swallowing, are also organs that control breathing and speech. In
particular, the pharynx is the site where the food, respiratory, and vocalization pathways intersect. Therefore,
when swallowing, the laryngeal opening is closed by the epiglottis. At the same time, the pseudopharyngeal andvocal cords are closed (vocal cord closure), blocking the passage of the food bolus and the airway to prevent aspiration (airway protection). In addition, breathing stops at this time (swallowing apnea).
The food bolus is pushed in the direction of the pharynx by voluntary movement of the tongue, which thensplits left and right near the epiglottic trough, and flows through the left and right pyriform fossa into the esophagus (Figure 2).
Pharyngeal swallowing is an involuntary movement in which complex movements happen in a short periodwith high reproducibility, and is controlled by the central pattern generator (CPG) in the brainstem. The swallowing CPG consists of a solitary bundle nucleus in the medulla oblongata surrounding the reticular formationand swallowing-related neurons in each motor nucleus. When a food bolus passes through the anterior palatine
arch, which forms the glottis—the entrance to the pharynx, sensory input is provided via afferent nerves, such as
the trigeminal, glossopharyngeal, and superior laryngeal nerves. Stimuli that reach the fox bundle nucleus in the
medulla oblongata reflexively trigger the swallowing CPGs in the reticular formation of the medulla oblongata.
This, in turn, triggers the movement of swallowing-related muscle groups in the pharynx, larynx, and tongue
through centrifugal nerves, such as the trigeminal nerve, vagus nerve, and hypoglossal nerve via the pseudonucleus and surrounding motor nuclei. From the onset of the swallowing CPG to the contraction of the swallowingrelated muscles, the output is always in the same order and same pattern. In addition, the cerebral cortex andlimbic system control the activity of the swallowing reflex center. The cerebral cortex involved in swallowing
includes the primary motor cortex and sensory areas from the mouth to the pharynx and larynx.
The process by which food and drinks are delivered to the pharynx, while chewing food and drinking liquids,― 28 ―

Table 2: Models of eating and swallowing
Four-phase model:
Physiological model(swallowing of liquid oncommand)Process model: Physiologicalmodel (chewing andswallowing of foods)

Five-phase model: Clinicalmodel
Antecedent phase: Food isrecognized by sight, smell, andtouch, and then brought to themouth using eating utensils.
Preparation phase: Food istaken into the mouth andchewed to form a food bolus.

Oral preparation phase: Foodis taken into the mouth andprepared for swallowing.

Stage I transport: Predigested
food is carried by the tongue
to the molars.
Processing: Chewed food ismixed with saliva to form afood bolus.

Oral feeding phase: Foodboluses are pushed into thepharynx with the tongue.

Stage II transport: Chewed
Oral phase: Food boluses arefood is sequentially sent to the delivered to the pharynx bymesopharynx and laryngeal
the tongue.
valley for accumulation.
During this time, theprocessing is still taking place.

Pharyngeal phase: Food boluses that reach the pharynx are transferred into the esophagus byreflex.
Esophageal phase: Food bolus is transferred to the stomach by peristalsis.

respectively, before swallowing is different. Command swallowing of liquids is a process in which water is directed to the pharynx by tongue movement and into the esophagus by the swallowing reflex; this is called the fourphase model. In the four-phase model, oral preparation, oral feeding, the pharyngeal phase, and esophageal
phase proceeded without overlap. On the other hand, chewing and swallowing of food involves chewing to forma food bolus before the pharyngeal phase begins (processing); this is called the process model. Besides, the fivephase model includes a preceding period where people recognize food and take it into the oral cavity. Table 2
summarizes these models.

3）Disorders at each stage of eating and swallowing
Clinically, dysphagia is classified based on the five-phase model into the preceding, preparation, oral, pharyngeal, and esophageal phases. Disorders of the preceding period include food recognition-related disorders, suchas consciousness, dementia, emotional disturbance, intellectual disability, and higher brain dysfunction (e.g.,hemispheric and ideational apraxia). Disorders in the preparation phase include inadequate food bolus formation due to opening and closing disorders, lip closure disorders, masticatory disorders, and oral sensory disorders.
Oral phase disorders include impaired feeding into the pharynx due to impaired tongue movement. Pharyngeal
phase disorders include delayed elicitation of the swallowing reflex, nasopharyngeal insufficiency, glossopharyngeal insufficiency, laryngeal insufficiency, laryngeal elevation insufficiency, esophageal inlet opening insufficiency, and decreased pharyngeal clearance (e.g., residual food bolus in the epiglottic valley, laryngeal vestibule, andpyriform fossa). Disorders of the esophageal phase include decreased esophageal peristalsis and gastroesophageal
reflux due to inadequate esophageal sphincter closure.
The most problematic disorder of the pharyngeal phase is aspiration, in which the food bolus passes beyond
the glottis and enters the trachea. Aspiration is a consequence of oral and pharyngeal disorders and can be classified into ascending, descending, mixed, and dysphagia aspirations based on the relationship between laryngeal
elevation and aspiration. Logemann (1998) classified aspiration into pre-swallowing, mid-swallowing, and post-― 29 ―

Corticobulbar tract

B

A

A or B

Idiopathic supranuclear disorder

A and B

Bilateral supranuclear disorder(Pseudobulbar palsy)

Primary neuron

Cerebral ganglia

CInternuclear disorder (globe palsy)

C
Secondary neuron

DE

D or E

Infranuclear disorderFigure 3: Motorneurons involved in eating and swallowing
Baba, M. and Kamakura, Y. Eating and swallowing disorders from the brain to the body. Gakken Medical Shujunsha. Tokyo,
2013.4) Revised.

swallowing aspiration.5) Pre-swallowing aspiration is aspiration that occurs before the swallowing reflex is triggered, and is due to inadequate closure of the tongue and palate, impaired tongue movement, etc. Aspiration
during swallowing is aspiration that occurs during swallowing and is caused by delayed elicitation of the swallowing reflex, insufficient laryngeal elevation, and inadequate laryngeal closure during the pharyngeal phase.
Post-swallowing aspiration occurs after the completion of the swallowing motion and is due to decreased pharyngeal clearance and post-swallowing breathing pattern starting with inhalation after the swallowing motion.

4）The main causes of dysphagia
The main causes include aging, diseases, and oral medications. Of these, aging and stroke have the greatest
impact; therefore, we have discussed these two in this section. Aging causes a decrease in the number of tastebuds, and the threshold for tastes, such as saltiness and bitterness, increases, making the swallowing reflex lesslikely to be elicited. An increase in olfactory thresholds and a decrease in the ability to discriminate between
odors above the threshold also make elicitation of the swallowing reflex less likely. The decrease in the numberof remaining teeth and bite force results in a decrease in masticatory function and difficulty in forming foodboluses. In addition, with aging, the strength of swallowing-related muscles decreases, fatigue increases, andswallowing pressure decreases. This would result in repetitive swallowing because the food bolus would remainin the epiglottic valley or pyriform fossa after swallowing. When the position of the larynx descends due toaging, laryngeal insufficiency occurs, making aspiration more likely. Decreased swallowing and coughing reflexes
can also lead to aspiration without swallowing or subclinical aspiration. Due to these physiological and age-related physical changes, the older adults are at an increased risk of aspiration and pharyngeal residue.
To understand the pathogenesis of stroke-induced dysphagia, it is necessary to understand the relationshipbetween the nerves associated with eating and swallowing (Figure 3).
Disability due to stroke is divided into three categories (Figure 3). The first is supranuclear disorder, where
the primary neurons (A) or (B) are damaged. This disorder occurs above the nerve nuclei of the brain. Besides, it
is referred to as unilateral supranuclear disorder with the term "unilateral" added to it, when the contralateral― 30 ―

lower motor neurons in the nuclei of the brain involved in swallowing are damaged. However, since the nucleus
accumbens (glossopharyngeal and vagus nerves) are innervated by both sides of the cerebral cortex (bilateral
innervation), the swallowing reflex itself is not impaired by either (A) or (B). In addition, the upper facial nerve
nucleus and part of the hypoglossal nerve nucleus are bilaterally innervated.4)
The second is bilateral supranuclear disorder, where both (A) and (B) are impaired. The glossopharyngeal andvagus nerves of the inferior motor neurons are bilaterally affected, resulting in pseudobulbar palsy and severe
dysphagia, although the swallowing reflex remains.
The third is Case (C), in which the cranial nerve nucleus is damaged. When cerebral nerve nuclei are damaged unilaterally, subnuclear lower motor neurons are damaged, resulting in ball palsy. In this case, the swallowing reflex is diminished or absent, resulting in severe dysphagia.
The recovery phase of stroke and dysphagia depends on the type of disability. In bilateral supranuclear andnuclear disorders, dysphagia that appears in the acute phase often continues to the recovery phase due to
pseudoparalysis or ball palsy. In contrast, in the case of unilateral supranuclear disorder, the swallowing function
improves during the recovery period. In addition, because it is unilateral, the non-paralyzed side compensates forthe impaired side, and the dysphagia resolves. However, as swallowing function declines with age, dysphagia islikely to reappear; therefore, careful monitoring of the patient's progress is important. In addition, if the patient
has recurrent strokes and unilateral supranuclear damage on the non-paralyzed side, the damage becomes bilateral, and even during recovery, the pseudobulbar palsy remains dysphagic.

2．Epidemiological characteristics
The prevalence of dysphagia increases with age. The prevalence of dysphagia in community-dwelling older
adults has been reported to range from 27 to 34%.6, 7) The prevalence of dysphagia varies among settings. The
prevalence of dysphagia in acute geriatric units has been reported to be around 45%.8, 9) In nursing homes, theprevalence has been reported to be 53–70%.10, 11)
In Japan, pneumonia replaced unintentional accidents as the fourth leading cause of death in 1975, and has
been on an upward trend, rising and falling, and replaced cerebrovascular disease as the third leading cause ofdeath in 2011; it accounts for 9.4% of the total deaths in 2015. The all-cause mortality rate for pneumonia is
96.4 (per 100,000 population), but the rate is higher for those aged 80 years or older (972.7).12) Of the estimated1,880,000 cases of pneumonia that occur in Japan, 69.4% cases are among people aged 65 years and older, andanother 630,000 are cases of aspiration pneumonia.13) Since 2017, aspiration pneumonia has been recorded separately from pneumonia, and pneumonia has become the fifth leading cause of death, and aspiration pneumonia
the seventh.12)
Dysphagia is a risk factor for pneumonia among the older adults. Low rates of swallowing function testing are
one of the problems preventing pneumonia among these populations. Twenty-two hospitals in Japan allowed
the survey of patients admitted for the treatment of pneumonia. The findings showed that 75% of the 589
patients admitted to the hospital with pneumonia were aged 70 years or older, and 80.1% of those aged 70 years
or older were diagnosed with aspiration pneumonia. WST was performed in 58.4% of patients admitted to thehospital with pneumonia, and RSST and simple swallowing provocation tests were performed in approximately― 31 ―

20% of the patients. Swallowing angiography was performed in only 6.2% of patients.14)
Cerebrovascular disease is a risk factor for dysphagia. In addition to cerebrovascular disease, traumatic brain
injury, neurological disease, myositis, muscle disease, dementia, and tumors of the oral and pharyngeal regions
are among the causes of dysphagia that contribute to aspiration pneumonia. In the 2012 survey (N = 27,659),
cerebral infarction and cerebral hemorrhage accounted for more than half of all cases.15) Other cases had subarachnoid hemorrhage (5.1%), Parkinson's disease (4.9%), Alzheimer's disease (2.6%), head injury and cerebral
palsy (2.5% each), spinocerebellar degeneration (2.0%), amyotrophic lateral sclerosis (1.1%), and chronic subdural hematoma and disuse syndrome (1.0% each). Some diseases, such as neurological disorders, myositis, andoral and pharyngeal tumors, occur majorly in middle-aged patients; therefore, preventive measures against aspiration pneumonia are necessary not only for the older adults but also for all age groups with dysphagia. The aimof dysphagia rehabilitation for patients with intermediate disabilities who have experienced oral intake and theolder adults is to restore function, whereas that for pediatric patients is to acquire eating and swallowing functions. In addition, pediatric patients differ from adults in that they require rehabilitation tailored to their level ofdevelopment, taking into account their growth and development. In this guideline, we will focus on swallowing
rehabilitation in adults. For this guideline, adults are defined as those aged 18 years or older.

3．International trends in the management of oropharyngeal dysphagia
1）Roles of professionals
In the U.S., SLPs play an important role in the management of oropharyngeal dysphagia. They often conduct
instrumental assessments, using videoendoscopy (VE) and videofluoroscopy (VF). The American Speech-Language-Hearing Association, which is a national professional, scientific, and credentialing association with
211,000 members, officially stated that fiberoptic endoscopy is an imaging procedure that may be utilized by
SLPs to evaluate the swallowing function. SLPs with expertise in dysphagia and specialized training in fiberoptic
endoscopy are professionals qualified to use this procedure independently to assess the swallowing function andrelated functions of other structures. Although SLPs play an important role in the management of oropharyngeal
dysphagia, multidisciplinary teams are involved in its complementary management. Nurses provide physicalassessments or bedside screening tests. Occupational therapists improve feeding behavior and eating during daily
life activities. Dieticians or nutritionists provide recommendations to maintain appropriate caloric and nutritional intake when dietary texture modifications or non-oral feeding are necessary.
In Europe, multidisciplinary teams are involved in the management of oropharyngeal dysphagia, including
physicians, nurses, speech-language therapists, physical therapists, and dieticians. However, instrumental assessments, using VE and VF, are provided by limited physicians. Recently, the demand for the instrumental assessment of dysphagia has increased due to the increase in the number of patients with eating and swallowing disorders in the aging society. The European Society for Swallowing Disorders has started to offer and organize aninterdisciplinary pan-European training curriculum for fiberoptic endoscopic swallowing of swallowing (FEES)
for neurogenic and geriatric dysphagia since 2017. This program is based on the German FEES curriculum,
which has been in use since 2014. This training curriculum is open to all clinicians with an interest in this topic.
It also offers health care professionals the opportunity to acquire qualifications in the area of instrumental dys-

― 32 ―

Table 3: Medical fees for dysphagia rehabilitation
Item

PointsReimbursements related to the field of dysphagia rehabilitation
Functional eating therapy (per day)

1. For more than 30 minutes: 185 points (Calculated per day for patients
within 3 months from the start of treatment, and 4 times per month
thereafter)
2. For less than 30 minutes: 130 points (Calculated per day for stroke patientswith dysphagia, when performed for 15 minutes or more, within 14 days of
onset.)

Swallowing Support fee

200 points (Additional support fee for eating and swallowing is calculated
when necessary guidance and management is provided jointly by multiple
professionals to patients whose eating and swallowing functions are expected
to recover through the actions of a team consisting of multiple professionals
with expertise in supporting the recovery of eating and swallowing functions.)

Nutrition Support Team fee (Once a week)

200 points

Fee for the evaluation of swallowing function
during gastrostomy

2500 points

Endoscopic swallowing function examination

720 points

Fluoroscopic diagnosis

110 points

Contrast injection technique: Swallowing contrast

240 points

Ultrasonography: A mode

150 points

Ultrasonography, tomography, others (head andneck, etc.)

350 points

Fee for oral health and nutrition in facility-based services
Fee for maintenance of oral ingestion (I)28 units/day

Fee for maintenance of oral ingestion (II)

5 units/day

Fee for transition from tube feeding to oral
ingestion

28 units/day

1 point equals 10 Japanese yen.

phagia assessment and expand their range of activities.
In Japan, multidisciplinary teams are involved in the management of oropharyngeal dysphagia, including
physicians, dentists, nurses, speech-language-hearing therapists, physical therapists, occupational therapists, dieticians, and dental hygienists. Instrumental assessments, using VE and VF, are usually provided by physicians inotolaryngology, rehabilitation medicine, or dentists. Nurses and speech-language-hearing therapists often provide physical assessments or screening tests to plan the management of oropharyngeal dysphagia. The JapaneseNursing Association has managed the Training School for Dysphagia Nursing since 2007. They offer paid educational lectures and clinical training for one year and a certification program as a certified dysphagia nurse
through evaluation tests. The educational program included training on VE-based assessment.

2）Medical and nursing care fees related to the content of the guideline
The U.S. has a private insurance system in which each citizen is responsible for purchasing and maintaining
their healthcare insurance coverage. Most people in the U.S. secure insurance through their employers. The costsof traditional diagnostic and therapeutic interventions for dysphagia are covered by payers. The duration oftreatment differs between payers. Premier private insurance covers all treatment sessions needed as long as they
are deemed medically necessary.
In Japan, universal coverage started in 1961, and virtually all Japanese people are covered by social healthinsurance. Patients usually pay 30% of medical costs, but older adults aged 75 or older pay only 10%. Olderadults aged between 70 and 74 pay 20%. In addition, medical subsidies are provided for people with financial
hardships, people with disabilities, infants, and children. Table 3 summarizes the reimbursements related to the― 33 ―

field of dysphagia rehabilitation. One point is equal to ten Japanese yen.

4． Assessment of aspiration and pharyngeal residue during eating andswallowing and nursing care1）Aim and methods of assessment and nursing care
The goal of assessing aspiration and pharyngeal residue during eating and swallowing, and nursing care is toregain the activity and joy of eating. Therefore, we aim to help those who cannot eat at all to eat at least a little,
those who can only eat a little to eat more, and those who have trouble with choking or repeated aspiration
pneumonia to eat safely. The first step in dysphagia rehabilitation is collecting information, and then, the second
step is planning and implementing a training program. Information collection includes understanding thepathogenesis of the primary disease, observation of actual meals, screening tests to identify people who are at riskfor dysphagia disorders, and dynamic observation of relevant organs using images from endoscopy and contrast
studies. Assessment of aspiration and pharyngeal residue and planning of a training program are based on thisinformation. Training is then conducted while ensuring a safe training environment and observing the generalcondition of the patient. Varied knowledge and skills are required to implement these processes. In addition,
dysphagia rehabilitation is performed by a team of physicians, dentists, nurses, speech-language-hearing therapists, physical therapists, occupational therapists, dental hygienists, pharmacists, radiologists, dietitians, cooks,
care staff, medical social workers, and family members.

2）Algorithm for nursing care choices based on the assessment
The algorithm in Figure 4 shows the flow of different steps, including physical assessment, screening, scrutiny
and comprehensive evaluation, goal setting, and care-type selection for implementation, to achieve safe foodintake. Figure 4 was developed by an AMED (Japan Agency for Medical Research Development) study "Construction of a Multi-Professional Collaboration System to Support Eating, Swallowing, and Defecation ofPatients Receiving Care at Home or in Nursing Homes by Introducing Advanced Nursing Techniques." In thisstudy, we attempted to standardize care for "care selection based on observation using an ultrasound diagnostic
device" and "care selection based on observation using a swallowing endoscope," as shown in Figure 4. The
algorithm used to standardize care is as follows:
The algorithm targets individuals suspected of having dysphagia. The CQs in this guideline follow this algorithm. Nurses should perform a systematic assessment using physical assessment techniques (interview, visual
examination, auscultation, palpation, and percussion) to determine symptoms and screen patients for aspiration
and residual pharyngeal swallowing. In the SR of this guideline, physical assessment includes obtaining information from interviewing the patient and family and physically examining the brain and nervous system parts
involved in eating and swallowing (mainly, the olfactory, optic, trigeminal, facial, glossopharyngeal, vagus, accessory, and hypoglossal nerves), the respiratory system, nutritional status, facial appearance, speech, lips, temporomandibular joint, oral cavity, tongue, soft palate, anterior palatal arch, oral sensation, larynx, trachea, lungs, andgeneral condition based on interviews, visual examination, palpation, auscultation, and percussion. In addition,
the Toronto Bedside Swallowing Screening Test (TOR-BSST)16, 17) and the Mann Assessment of Swallowing― 34 ―

Individuals with possible dysphagia
Physical assessment techniques 1)
RSST, MWST, FT, cervical auscultation, ultrasonographic observation2)
No possible
Choices 5)
aspiration
・Swallowing
Aspiration 3)
exercises
・Head elevation
training etc.

Possible silent
aspiration

Residue 4)

Choices 5)・Swallowing exercises
No residue ・Head elevation
training etc.

Possible pharyngeal residue
in the epiglottic valley
Oral residue
and pyriform fossa
Overt aspiration（No wet voice）
Possible pharyngeal residue in theepiglottic valley and pyriform fossa（Wet voice）
・Modiﬁcation of viscosity

Choices 5)・Swallowing
exercises
・Head elevation
No overt ・Modiﬁcation of posturetraining
aspiration
・Modiﬁcation ofviscosity andposture etc.

Choices 5)・Swallowing exercises,
・Guidance on residual
head elevation training
removal methods
No・Multiple swallowing,・Conventional
pharyngeal
Alternating swallowing
suctioning
residue ・Adjusting volume etc.

Overt aspiration

Pharyngeal residue（Wet voice）

Ask a physician in charge todetermine the need for endoscopy

Ask a physician in charge todetermine the need for endoscopy

Not necessary

Choices 5)・Tongue training etc.

Not necessary

Determination ofneed for endoscopy
Necessary

Follow-up

No aspiration

Residue

Aspiration
Aspiration

5)

Choices・Indirect training
etc.

・Modiﬁcation of
No aspiration
viscosity
・Modiﬁcation of
posture・Introduction to
swallowing techniques

Aspiration

No residue at rest andpositive residue after swallowing

Residue afterswallowing
・Determining the needfor Pyriform fossa /epiglottic valley
suctioning

Consult a specialist

・Modiﬁcation of viscosity
・Guidance on residual
removal methods
・Determining the needfor Pyriform fossa /epiglottic valley suctioning
No residue

Pharyngeal residue

Choices 5)・Swallowing exercises
・Head elevation training
・Modiﬁcation of viscosityand posture etc.

Figure 4: The algorithm for making nursing care choices for the management of oropharyngeal dysphagia1）：It refers to a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion).The
Toronto Bedside Swallowing Screening Test (TOR-BSST) and The Mann Assessment of Swallowing Ability (MASA) are generally regarded as screening tests,
but in this guideline, they are regarded as physical assessments.
2）：RSST (Repeated Saliva Swallowing Test), MWST (Modified Water Swallowing Test), FT (Food Test), cervical auscultation, and observation with ultrasound device are positioned as screening tests in this guideline.
3）：Assess by RSST, MWST, FT, cervical auscultation, or ultrasonographic observation.
4）：Assess by MWST, FT, cervical auscultation, or ultrasonographic observation. Ft only assess oral residue
5）：Oral care and nutrition management are commonly included in all care choices.

Ability (MASA)18) are generally regarded as screening tests, but were included for physical assessment in the systematic reviews used for the development of this clinical practice guideline. On the other hand, the screening
tests included RSST, MWST, FT, cervical auscultation, and observation with an ultrasound diagnostic device.

― 35 ―

Table 4: Objective information
Observation point
Face appearance

Observation item
Left-right difference in forehead wrinkles, nasolabial folds, and mouth corners, andeyelid closure

Conversation

Voice volume, voice quality, abnormality of articulation (pa, ta, ka, ga)

Lips

Insufficiency of closure, lateral pull (E), and protrusion (U)Temporomandibular joint Mouth-opening status
Oral cavity

Contamination status, halitosis, number of remaining teeth, and condition and use ofdenturesTongueUnevenness, lichen on tongue, dryness, the difference between the right and left sides atrest, deterioration of movement

Soft palate

Curtain symptoms, deterioration of sensation

Anterior palatine arch

Deterioration of swallowing reflex

Intra-oral sensation

Decreased sensation of the tongue, lips, buccal mucosa, hard palate, and floor of themouthLarynxInsufficient laryngeal movements (saliva swallow commands or swallow commands using
less than 5 ml of water)

Neck

Abnormal cervical breath sounds during swallowing

General condition

Abnormal blood pressure, pulse, respiratory rate, body temperature, weight, chest breathsounds

The screening tests selected differed between those used for the observation of aspiration and those for the observation of pharyngeal residues. Aspiration is assessed by RSST, MWST, FT, cervical auscultation, or an ultrasound diagnostic device. The pharyngeal residue is assessed by MWST, cervical auscultation, or an ultrasounddiagnostic device, and oral residues are assessed by FT. The recommended order of selection of the screening
tests is RSST first, MWST and FT second, and cervical auscultation or observation with an ultrasound diagnostic device third; however, these should be selected according to the subject's intentions and environmental conditions in which these tests are performed. If an abnormality is suspected, appropriate care is selected, but if the
problem persists, it is necessary to ask the attending physician to determine the need for endoscopy. Observation
by an ultrasound diagnostic device should be performed by nurses who have been recognized by their instructors
as being at a level where they can practice aspiration and pharyngeal residue observation techniques using an
ultrasound diagnostic device. If physicians determine that endoscopy is necessary, certified nurses in dysphagia
nursing or nurses and others, who have specialized knowledge and experience in eating and swallowing, whohave received education in endoscopic aspiration and pharyngeal residue observation, and have been recognizedby their supervising physicians as being at a level where they can practice endoscopic aspiration and pharyngeal
residue observation, can observe aspiration using an endoscope. The nurses insert the endoscope through thenasal cavity into the soft palate and observe the pharyngeal cavity. If aspiration or pharyngeal residue is observed,
the patient should be managed, but if the problem persists, the patient should be referred to a specialist, such asa rehabilitation physician, for further examination.

3）Assessment methods（1）Physical assessment
The assessment is based on subjective information obtained from interviews with patients, families, and caregivers, and objective information obtained from visual examination, palpation, auscultation, and percussion.
Objective information includes observations of facial appearance, speech, the lips, temporomandibular joint, oralcavity, tongue, soft palate, anterior palatal arch, oral sensation, larynx, and the general condition (Table 4).3)― 36 ―

Table 5: Duration, limitations, the burden on caregivers, and reliability of screening tests
Time (including
preparation,
implementation,
evaluation, andcleanup)

Limitations on theimplementation for
those with cognitive
declineBurden on
Intra-rater
the caregivers reliability

Inter-rater reliability

RSST (Fukada, 2006) 19)

30 seconds–1 minute

Existence (at thepresent moment)

Elementary
And Middle

r = 0.68

r = 0.95

MWST (Fukada, 2006) 19)

About 2 to 3 minutes

Not much - Yes

Elementary
And Middle

Kappa
coefficient:
0.88

Kappa coefficient:
0.82

FT (Fukada, 2006) 19)

About 2 to 3 minutes

Not much - Yes

Elementary
And Middle

Kappa
coefficient:
0.87

Kappa coefficient:
0.84

TOR-BSST (Martino, 2006;2009) 16, 17)Less than 10 minutes

Not much - Yes

Elementary
And Middle

Kappa: 0.90

ICC = 0.92 (95% CI:
0.85–0.96)

Cervical auscultation*. (Lagarde,2016) 20)

2–3 minutes on each
side

None

Small

Kappa
coefficient:0.35-0.55

AC1: 0.46
ICC: 0.68–0.74
Kappa coefficient:0.17–0.28

Ultrasound diagnostic equipment About 10 minutes

None - not really

Small

Endoscope** (Pisegna, 2018)21)

Not much, but it can Smallbe difficult to get
consent.

About 5 minutes

No data

No dataKappa
coefficient:
0.78

ICC: 0.86

AC1: agreement coefficient 1
ICC: intraclass correlation coefficients
CI: confidence interval*The results obtained by the speech-language pathologist are listed for reference. There are no reports on the results of tests conducted by nurses.
**The results of tests performed by the doctor are listed for reference. There are no reports on the results of tests conducted by nurses.

When conducting physical assessments, especially when observing the respiratory status, it is advisable to properly clean and moisturize the oral cavity, perform positional drainage, and promote pharyngeal clearance before
conducting the assessment.
（2）Screening test
Screening tests include the RSST, MWST, FT, cervical auscultation, and cough test, all of which are appropriate for the patient's condition. Table 5 shows the time required, limitations, and patient burden for the major
screening tests. In clinical practice, screening tests are combined to comprehensively determine the swallowing
function.
Repetitive Saliva Swallowing Test (RSST): This test is performed in a sitting position with the neck slightly
bent forward. Place the second finger on the hyoid bone and the third finger on the laryngeal ridge (thyroid cartilage) and instruct the patient to swallow saliva continuously. Count the number of times the laryngeal ridge
overcomes the third finger and moves upward and forward with the swallowing motion for 30 s. If the numberof swallows is less than three, the patient is considered to be at risk for dysphagia.
Modified Water Swallowing Test (MWST): The evaluation method is shown in Table 6. Pour 3 ml of cold
water into the floor of the mouth with a disposable syringe and instruct the patient to swallow. If the patient isunable to swallow or if subclinical aspiration is suspected, the procedure is terminated immediately. If thepatient swallows and breathes properly, check if there is wet hoarseness in "a-." If there is choking or wet hoarseness, terminate the test immediately and rate the patient’s condition at 3 points. If there is no choking or wet
hoarseness, signal "swallow" and instruct the patient to swallow twice; if the patient can swallow twice within 30
seconds, rate the patient at 5 points; if not, rate the patient at 4 points. To ascertain the voice quality before― 37 ―

Table 6: Evaluation method of MWST
Procedure
1

Pour 3 mL of cold water into the bottom of the mouth andinstruct swallowing.

2

Swallowing error, have the patient do two repetitive swallows.

3

If the evaluation criterion is 4 points or more, repeat up to two
trials.

4

The lowest score is used as the grade.

Evaluation
1 point

No swallowing, choking, and/or respiratory distress2 points

Swallowing present, respiratory urgency (suspicion of subclinicalaspiration)

3 points

Swallowing and good breathing, and swallowing and/or
hoarseness4 points

Swallowing present, breathing good, no swallowing

5 points

In addition to 4, repetitive swallowing can be done twice within
30 seconds

Table 7: Evaluation method of FT
Procedure
1

Place approximately 4 g of swallowing jelly on the anterior dorsal surface ofthe tongue and instruct the patient to swallow.

2

Swallowing error, have the patient do two repetitive swallows.

3

If the evaluation criterion is 4 points or more, repeat up to two trials.

4

The lowest score is used as the grade.

Evaluation
1 point

No swallowing, choking, and/or respiratory distress2 points

Swallowing present, respiratory urgency (suspicion of subclinical aspiration)

3 points

Swallowing present and good respiration, swallowing and/or wet hoarseness,
moderate oral residue

4 points

Swallowing and good breathing, no swallowing, almost no oral residue

5 points

In addition to 4, repetitive swallowing can be done twice within 30 seconds

swallowing the cold water, the patient vocalized before the procedure. If the evaluation score was 4 or more, twotrials were conducted; the worst of the two values was considered the grade. It is important to maintain the oral
environment, especially in areas under the control of the glossopharyngeal and vagus nerves before conducting
the test. In addition to MWST, there are various other methods that vary the amount of water to be consumed.
In general, the water water swallowing test increases the amount of water in stages and assesses whether thepatient can swallow without aspiration. In addition, tongue movement is also observed to assess the tongue
movement leading to chewing, for example, whether the tongue comes out when water is placed on the upperlip.
The Toronto Bedside Swallowing Screening Test (TOR-BSST): The test was developed in 2009 by Martino
et al. in Canada. This is a dysphagia screening test for patients with stroke. A physical assessment (vocalization,
tongue movement, and pharyngeal sensation) was performed first, followed by drinking 10 sips of 5 ml of water,a sip from a glass, and observing the voice changes and swallowing. The examiner needs to undergo the prescribed training.
Food Test (FT): The evaluation method is shown in Table 7. Using a teaspoon, place approximately 4 g of

― 38 ―

jelly on the anterior dorsal surface of the tongue and instruct the patient to swallow. The method of conducting
and judging the test is the same as the MWST, but the difference is that the oral residue after swallowing is the
subject of evaluation. A score of 3 is assigned if there is a moderate amount of oral residue after swallowing, anda score of 4 or higher is assigned if the patient swallows without swallowing and there was no oral residue. If theevaluation score was 4 or more, two trials were conducted, and the worst of the two values was recorded. It is
important to maintain the oral environment, especially in areas innervated by the glossopharyngeal and vagus
nerves before conducting the FT.
Cervical auscultation: The swallowing sound produced in the pharynx when swallowing food boluses and therespiratory sound before and after swallowing are auscultated from the neck, and the nature and length of theswallowing sound and the nature and timing of the respiratory sounds were listened to in order to determine if
the patient had dysphagia in the pharyngeal phase. If there were sounds of food being poured into the pharynx,
wheezing, coughing, or wet hoarseness before the swallowing reflex, an abnormality was suspected.
Cough Test: This test evaluates the presence and frequency of the cough reflex by inhalation of an atomized
cough-inducing substance (1% citric acid saline solution). The cough test screens for responsiveness of the larynx and trachea to stimulation, that is, the risk of silent aspiration. It is not used for the evaluation of aspirationand pharyngeal residue during eating and swallowing, which is the subject of the current guidelines.
In addition to these screening tests, questionnaires may be used to screen and check for symptoms of dysphagia efficiently. Screening questionnaires included the Seirei questionnaire of swallowing, the modified dysphagia
risk assessment scale, and the eating assessment tool-10 (EAT-10). Questionnaires are often administered after
reviewing the chief complaints and medical history. A more detailed physical assessment may also be conductedbased on the information obtained from responses to the questionnaires.
Seirei questionnaire of swallowing: This is a 15-item self-administered questionnaire that assesses the patient's
swallowing status over the last couple of years. If the patient has difficulty completing the questionnaire, it canbe completed by a family member. The 15 items include one item on the history of pneumonia, one item on the
nutritional status, five items on the pharyngeal function, four items on the oral function, three items on theesophageal function, and one item on the glottic defense mechanism. The grading is as follows: A: severe andfrequent symptoms; B: mild and infrequent symptoms; C: no symptoms. If there is at least one A in the patient’s
responses, the patient is considered to have dysphagia. If the patient has at least one B but no A, dysphagia issuspected; if the patient has only one C, dysphagia is considered unlikely.
Modified dysphagia risk assessment scale: This is a 23-item questionnaire that was developed to screen community-dwelling older adults for the risk of dysphagia based on subjective symptoms. The answers provide information on subjective symptoms while eating for the last three months or so. The 23 items consist of seven dysphagia items in the pharyngeal phase, five aspiration items and eight dysphagia items in the preparation and oral
phases, and three dysphagia oral functions in the esophageal stage. Responses are scored as follows: 3 points:
always; 2 points: sometimes; 1 point: rarely; and 0 points: almost never. A patient with a total score of 6 or moreis considered to be at risk of dysphagia.
Eating assessment tool-10 (EAT-10): The questionnaire consists of 10 questions about subjective symptoms
related to dysphagia. Each item is answered on a 5-point scale from 0 (no problem) to 4 (very problematic).
Dysphagia is suspected in a patient with a total score of 3 or more.
The Mann assessment of swallowing ability (MASA): This assessment of swallowing function in acute stroke
patients was developed in the U.S. in 2002. This screening test is used to determine aspiration and dysphagia.

― 39 ―

Table 8: MASA
Score

Dysphagia

178–200

NormalNo abnormalities in swallowing.

168–177

Mild dysphagia

Abnormality in at least one of the elements of swallowing that is delayed, impaired, orinadequate, which adversely affects bolus formation or transport and mildly increases
the risk of dysphagia and aspiration.

139–167

Moderate dysphagia Abnormalities in some of the elements of swallowing, such as delayed, impaired, orinadequate, leading to a moderate increase in the risk of dysphagia and aspiration.

Less than 138

Severe dysphagia

Five or more abnormalities (delayed, impaired, or inadequate) in the clinicalassessment of swallowing that significantly increase the risk of dysphagia andaspiration. This includes direct observation of the respiratory impairment, choking,coughing, skin color changes, wet hoarseness, and delayed oral/pharyngeal transit
time.

170–200

No aspiration risk
score

Swallowing abnormalities not identified.

149–169

Mild aspiration risk
score

Abnormality in at least one of the elements of swallowing that is delayed, impaired, orinadequate, which adversely affects bolus formation or transport and mildly increases
the risk of airway inflow of boluses.

141–148

Moderate aspiration Abnormalities in some of the elements of swallowing, such as delayed, impaired,risk scoreor inadequate swallowing, with a moderately increased risk of airway inflow of foodboluses.

140 or less

Severe aspiration
risk score

Score

Pulmonary aspiration

Several (usually five or more) abnormalities (delayed, impaired, or inadequate) in theclinical assessment of swallowing significantly increase the risk of airway inflow of foodboluses. Direct observation of respiratory impairment, including direct observation of
choking, cyanosis, rattling sounds, or inadequate sputum.

The Japanese version of the MASA was developed in 2014 18) and consists of 24 items. The items included are
the swallowing organ function, awareness, cooperative behavior, auditory comprehension, aphasia, dysarthria,
and respiratory function. The criteria for dysphagia and aspiration are presented in Table 8.
Furthermore, in recent years, screening for aspiration and pharyngeal residue during eating and swallowing
has also been performed using ultrasound diagnostic devices and endoscopes.
With ultrasound diagnostic devices, it is possible to observe swallowing with echo images while food is being
normally consumed and observe aspiration and pharyngeal residue by processing the images. In the case of aspiration and pharyngeal residue, the main areas to be imaged are the airway, pyriform fossa, and epiglottic valley.
An ultrasound diagnostic device is a minimally invasive observation method that can be used to confirm thepresence or absence of aspiration or pharyngeal residue. It is advisable to make observations with ultrasounddiagnostic devices first and then proceed to endoscopic observations if more detailed observations are necessary.
If aspiration, penetration, or pharyngeal residue is observed using ultrasound or endoscopy, care should be taken
to prevent or alleviate aspiration, by adjusting the viscosity of food and liquids and the posture of eating anddrinking and by suctioning the pyriform fossa.
During endoscopic observation, a nasopharyngeal fiberscope (electronic scope) is inserted transnasally to
directly observe the pharyngeal cavity. This makes it possible to observe organic lesions, aspiration, penetration,and pharyngeal residues. In particular, when observing pharyngeal residues, it has the advantage that pharyngeal
residues can be aspirated while directly observing the residue site. However, due to the endoscope's field of viewand blind spots caused by the structure of the pharynx and larynx, it may not be possible to confirm aspirationin the airway.
（3）Scrutiny and comprehensive evaluation
Videoendoscopic examination of swallowing, VE:
A nasopharyngeal fiberscope (electronic scope) is inserted intranasally to observe morphological abnormalities,― 40 ―

swallowing dynamics, and the presence of aspiration or pharyngeal residue. In contrast to screening applications,the purpose of this examination is to diagnose and comprehensively evaluate dysphagia in general and determine
the possibility of oral intake and compensatory methods for dysphagia in particular.
Videofluoroscopic examination of swallowing, VF:
Adjusted food mixed with a contrast agent was used, and its swallowing was observed using an X-ray fluoroscopy system. Similar to VE, morphological abnormalities, functional abnormalities, and pharyngeal residues
can be observed, and aspiration can also be observed. VF can also be used to determine the eating conditions
within which oral intake is possible and safe and compensatory methods for dysphagia. Compared to VE, it aids
the observation of the entire space from the oral cavity to the esophagus; however, because of radiation exposure,the fluoroscopy time and frequency are limited, making it unsuitable for frequent observations.
Computed tomography, CT:
This is a method for observing the swallowing process with contrast-enhanced food using a continuous scanning method called the dynamic volume scan. By creating volume-rendered images of soft tissues, bones, airway
surfaces, and contrast media, it is possible to make three-dimensional depictions and dynamic analysis of swallowing and observe morphological abnormalities, functional abnormalities, residues, and aspiration. The threedimensional view allows the evaluation of laryngeal closure during swallowing, as well as the movement and timing of organs related to laryngeal closure. However, because of radiation exposure, the fluoroscopy time and frequency are limited, making it unsuitable for frequent observations.
Ultrasonography, US:
In contrast to screening applications, ultrasonography is used to assess muscle morphology and swallowing
motion. Muscle morphology is evaluated in the tongue and suprahyoid muscle groups. For swallowing motion,
the tongue movement, hyoid-laryngeal movement, and contraction of the perihyoid muscles during swallowing
are evaluated.
Swallowing pressure test (Manometry):
This method captures the relaxation state of the esophageal inlet and pharyngeal contractility as changes inpressure. A catheter with a pressure transducer is inserted nasally through the pharynx and into the esophagus tomeasure the intra-pharyngeal and intra-esophageal pressures.
Electromyogram test:
This test evaluates the contractile state and activity patterns of the muscles involved in swallowing. Surface
electromyography is commonly used in the fields of eating and swallowing. Surface electrodes are placed on thesurface of the body where the muscles are to be checked for contraction, and the examinee is instructed to movethe muscles voluntarily. The waveforms obtained are analyzed to evaluate the coordinated movements of themuscles.
Based on the above findings, it is possible to classify the severity of dysphagia and aspiration.
There are various severity classifications, but the most frequently used classifications in Japan include Dysphagia Severity Scale, Eating Status Scale, ability to swallow grade, and Food Intake Level Scale. The Functional
Oral Intake Scale (FOIS) was developed in the U.S.
Dysphagia Severity Scale (DSS): A seven-level classification that assesses the oral and pharyngeal function. If
there was no aspiration, the severity was categorized from 7 (normal range) to 5 (oral problems); if there wasaspiration, the severity was categorized from 4 (opportunity aspiration) to 1 (salivary aspiration).
Eating status scale (ESS): This scale was developed to assess the oral and pharyngeal function with DSS and― 41 ―

evaluate the actual eating status. Medical stability was defined as the absence of problems related to aspiration
pneumonia, choking, dehydration, or low nutrition in the past 1–2 months.
Ability to swallow grade: A 10-point scale that assesses the ability to swallow. Ten (normal ability to eat and swallow) is normal; 9 (able to take regular food orally, requires clinical observation and guidance) to 7 (swallows food,takes all three meals orally) is classified as mild (oral only); 6 (takes three meals orally plus supplemental nutrition) to
4 (able to three meals orally plus supplemental feeding; taken for pleasure) is classified as moderate (oral plus supplemental feeding), and 3 (aspiration can be reduced under the right conditions and intake training is possible) to 1 (hasdifficulty or inability to swallow, no indication for swallowing training) is classified as severe (non-oral).
Food Intake Level Scale (FILS): Developed by the same researchers who created the ability to swallow grade.
The FILS is a 10-point scale based on observations of eating situations and daily intake. If a person is eating only
orally and has no problems with swallowing, he or she is rated at level 10; at level 9 (no food restrictions, eating
three meals orally) to level 7 (swallowing diet, eating all three meals orally) with mild problems. In the case oforal intake and alternative feeding, the patient is rated at level 6 (mainly taking three meals of swallowed foodorally with alternative feeding for shortages) to level 4 (taking less than one meal of (fun level) swallowed foodorally but mainly considers alternative feeding). If there is no oral intake, the patient is rated at level 3 (swallowing training with very small amounts of food) to level 1 (no swallowing training).
Functional Oral Intake Scale (FOIS): Assesses actual eating status. There are seven levels, ranging from level 7(all oral intake without restriction) to level 1 (no oral intake).
Penetration-aspiration scale (PAS): There are eight levels; based on VF results, the depth of penetration andthe presence or absence of expulsion of food are evaluated. If the food enters the airway but remains above thevocal cords, it is called penetration; if it crosses the vocal cords and enters the trachea, it is called aspiration. One
indicates that food does not enter the airway; 2 (enters the airway above the vocal cords but is expelled from the
airway) to 5 (enters the airway and touches the vocal cords but is not expelled from the airway) indicate penetration; 6 (enters the airway below the vocal cords but is expelled above the vocal cords) to 8 (enters the airway
above the vocal cords but is expelled from the airway) indicate laryngeal penetration. Six (enters the airway
below the vocal cords but exits above the vocal cords) to 8 (enters the airway below the vocal cords but does notcause swelling) are classified as aspiration, and 8 is subclinical aspiration.

5．Nursing care selection based on the assessment of aspiration and pharyngeal residue during eating and swallowing
Nursing care based on the assessment of aspiration and pharyngeal residue during eating and swallowing
includes the prevention of aspiration pneumonia and eating and swallowing rehabilitation (swallowing training).

1）Prevention of aspiration pneumonia
Preventing aspiration associated with eating requires the adjustment of eating patterns, use of compensatory
methods, such as posture, and appropriate assistance. Preventing aspiration due to saliva requires oral care andpyriform fossa aspiration to suction out the pharyngeal residue. It is also necessary to improve the ability to
expectorate secretions, such as coughing, which is necessary in the event of aspiration.

― 42 ―

2）Eating and swallowing rehabilitation (swallowing training)
Eating and swallowing rehabilitation is divided into indirect training without food and direct training withfood, which is selected according to the type and severity of dysphagia.
Indirect training includes exercises for swallowing-related muscle groups and is essentially safe because it does
not involve food. These include oral care, neck, mandibular, lip, tongue, and cheek exercises, cold pressure stimulation of the anterior palatal arch, head elevation exercises (Shaker exercises), blowing, and pushing and pulling
exercises. Swallowing techniques are voluntary adjustments of some swallowing movements to promote safer
swallowing, such as the Mendelsohn maneuver, supraglottic swallow, and effortful swallowing. Repeatedly performing these techniques can also increase muscle strength. Therefore, they should be repeated as indirect training until their effectiveness in preventing aspiration and pharyngeal retention is confirmed, after which they canbe performed as part of direct training.
Direct training is conducted by ingesting food, with measures taken to prevent aspiration and residue to the
maximum extent possible by adjusting the eating posture, food form, bite size, and swallowing method. The
adjustment of eating patterns is determined based on assessment using screening tests and imaging studies, but
the goal is to achieve chewing and swallowing as much as possible while paying attention to safety. This isbecause chewing produces saliva, which aids in food bolus formation and enhances taste sensation. In addition,
it provides activity to the swallowing muscle groups.
To prevent aspiration, swallowing methods, such as awareness of swallowing; postures, such as head flexion
and neck flexion; and breath-holding swallowing should be used. If there is pharyngeal residue, swallowing techniques such as turning the neck to the affected side (residue side) and guiding the food bolus to the healthy side
(non-residue side) before swallowing, alternating liquid and solid swallowing, and multiple swallows are used. In
addition, to remove pharyngeal residue after swallowing, the neck is rotated to the non-residue side, and empty
swallowing is performed.
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21.

Teramoto S, Fukuchi Y, Sasaki K, et al. High incidence of aspiration pneumonia in community-and hospital-acquired
pneumonia in hospitalized patients: A multicenter, prospective study in Japan. J Am Geriatric Soc 2008; 56(3): 577-579.
Yamawaki M. Evidence-based dysphagia and risk factors for pneumonia. J Swallow Med 2017;6(1):6-12. (in Japanese)
Martino R, Nicholson G, Teasell R, et al. Silver F, Diamant N. Interrater reliability of the toronto bedside swallowing
screening test (TOR-BSST (c)). Dysphagia 2006; 21(4): 330-330.
Martino R, Silver F, Teasell R, et al. The Toronto Bedside Swallowing Screening Test (TOR-BSST): development andvalidation of a dysphagia screening tool for patients with stroke. Stroke 2008; 40(2): 555-561.
By Giselle Mann, Translated and edited by Ichiro Fujishima. MASA Japanese Edition Dysphagia Assessment, Medical
and Dental Publishers, Tokyo, 2014.
Fukada Y, Kamakura Y, Banzai T, et al. A study on a screening system for risk of dysphagia in the elderly. Journal of theJapanese Society of Feeding and Swallowing Rehabilitation 2006;10(1):31-42. (in Japanese)
Lagarde ML, Kamalski DM, van den Engel-Hoek L. The reliability and validity of cervical auscultation in the diagnosis ofdysphagia: a systematic review. Clin Rehabil 2016; 30(2): 199-207.
Pisegna JM, Borders JC, Kaneoka A, et al. Reliability of untrained and experienced raters on FEES: rating overall residue
is a simple task. Dysphagia 2018; 33(5): 645-654.

― 44 ―

Part 2.
Recommendation statements andsystematic reviews for each CQ

1．CQ 1

CQ 1
It is advisable to perform a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia? To avoid duplication with
CQs 3, 4, 5, and 6, assessments using only the Repetitive Saliva Swallowing Test(RSST), Modified Water Swallowing Test (MWST), Food Test (FT), or cervical auscultation were not included here.
1）Recommendations
We propose to conduct an assessment of aspiration through a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for individuals aged 18 years and older, who
are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］When including observation items that require an understanding of instructional
actions, such as command swallowing of water, care should be taken while applying theprocess to persons with impaired consciousness or severe cognitive impairment.

2）Background and purpose
In the field of swallowing rehabilitation, systematic assessment using physical assessment techniques (interview, visual examination, ausucultation, palpation, and percussion), which do not require special devices, can beeasily performed at home and in treatment facilities and is widely used.
Physical assessment techniques are based on the integration of subjective and objective information. The subjective information was obtained from interviews with the patient and family members on topics related to thepreceding, preparation, oral, pharyngeal, and esophageal phases, and on the general condition, including respiration and nutritional status. Based on the results of the interview, objective information is obtained from thephysical assessment of the brain and nervous system (mainly olfactory, optic, trigeminal, facial, glossopharyngeal,
vagus, accessory, and hypoglossal nerves), respiratory system, and nutritional status related to eating and swallowing, facial appearance, speech, lips, temporomandibular joint, oral cavity, tongue, soft palate, anterior palatine arch, oral sensation, larynx, trachea, lungs, and general condition. Physical assessment includes visual, palpatory, auscultatory, and percussion examinations1).
Physical assessment techniques are often performed before screening tests, such as RSST, MWST, FT, andcough test. Physical assessment of the cerebral nervous system, respiratory system, etc. can assess the eating andswallowing function of the recuperators with impaired consciousness or cognitive impairment who have difficulty understanding instructional actions. However, physical assessment techniques used in actual clinical practicevary in terms of the person performing the examination and the content, and the sensitivity and specificity of theassessment are not clear. In this guideline, we examined the sensitivity and specificity of the assessment of dys-

― 46 ―

phagia using physical assessment techniques from domestic and international literature. The reference standard
for confirming sensitivity and specificity was VF or VE.

3）Explanation
This systematic review searched for the sensitivity and specificity of the assessment of dysphagia using physicalassessment techniques. Cross-sectional observational studies or cohort studies were selected. Twenty-three articles
were included in this systematic review. Of these, 22 articles used sensitivity and specificity as outcomes in thedetection of aspiration,2)-23) and one study used sensitivity and specificity as outcomes in the prediction of pneumonia.24) There were no relevant articles that used the sensitivity and specificity of pharyngeal residue detection as
an outcome. Of the 22 articles that used sensitivity and specificity as outcomes for aspiration detection, three used the
MASA,7), 11), 21) and two used TOR_BSST, 17), 22) and oxygen saturation was used as a criterion in two studies3), 17).
With regard to objective information, lip closure, tongue movement, voice quality, laryngeal elevation, cough,consciousness level, cognitive function, history of pneumonia, food intake, voluntary swallowing, dysarthria, pharyngeal reflexes, nasopharyngeal closure, occlusion, facial expression, tongue muscle strength, oral residue, liveliness, choking when swallowing water or food, and changes in voice quality were used as indicators. In the literature, the outcomes were the sensitivity and specificity of detection of the onset of pneumonia, and the indicators
were the palatal reflex* (stimulation of the anterior palatal arch and observation of the elevation of the soft palate),laryngeal movement, pharyngeal residue, lip closure, and tongue movement.
＊

In addition to the swallowing reflex, other reflexes triggered by the stimulation of the oral cavity and pharynx
are the palatoglossal and pharyngeal strangulation reflexes. Pharyngeal strangulation reflex: Pressing theroot of the tongue or the pharyngeal mucosa with a tongue depressor causes the pharynx to close due tocontraction of the pharyngeal contractile muscles, elevation of the soft palate, and retraction of the tongue.

We conducted a meta-analysis of 22 studies using sensitivity and specificity as outcomes in the detection of aspiration. The integrated sensitivity was 0.82 (95% confidence interval [CI]: 0.72–0.89) and specificity was 0.76
(95% CI: 0.69–0.83). Here, we conducted a meta-analysis by dividing the literature into 2)-6), 8), 9), 12)-15), 17)-23), which
included observations that required understanding of instructions, such as swallowing water orders, food swallowing, and medical interviews, and 7), 10), 11), 16), which did not include observations that required understanding of
instructions. We calculated the integrated sensitivity and specificity of aspiration detection. The physical examination techniques used in each study are summarized in Table 1. As a result, there were 18 references that included
observation items requiring instructional understanding, with an integrated sensitivity of 0.84 (95% CI: 0.74–0.91)
and specificity of 0.71 (95% CI: 0.64–0.77). There were four references that did not include observations requiring
instructional comprehension, with an integrated sensitivity of 0.64 (95% CI: 0.32–0.88) and specificity of 0.91
(95% CI: 0.82–0.97). For intra-rater reliability, TOR_BSST had an intraclass correlation coefficient of 0.92. Forinter-rater reliability, the kappa coefficient for MASA was 0.75. No other physical assessment techniques for intraor inter-rater reliability have been described in the literature.
In one study with pneumonia as the outcome, the sensitivity and specificity on the second day of hospitalization were 0.86 and 0.71, respectively, and those on the fourth day of hospitalization were 0.75 and 0.67, respectively24). The inter-rater agreement for each measure ranged from 82.0 to 95.3%.
In the assessment of aspiration using physical assessment techniques, when observation items that require anunderstanding of instructions, such as water swallowing tests, are included, the sensitivity is higher but the specificity is lower than when they are not included. In predicting the onset of pneumonia, both sensitivity and speci-― 47 ―

Table 1: List of physical assessment techniques used in the paper
Paper

Physical assessment techniqueMann, 2000 21）

MASA

González, 2011 7）

MASA

Ohira, 2017 11）

MASA

Toscano, 2019 17）

Water swallowing test (TOR_BSST), laryngeal elevation, SpO2Martino, 2009 22）

Water swallowing test (TOR_BSST)

Ramsey, 2006 3）

Lip closure, tongue movement, voice quality, water swallowing test, SpO2

Yousovich, 2018 4）

Cough, voice quality, choking (water swallowing test)

Newton, 1994 19）

Subjective symptoms, level of consciousness, water swallowing test

Baylow, 2009 2）

Observation of 28 items, including history of pneumonia, oral and pharyngeal stages, and water swallowing
test

Baumann, 2017 13）

Oral function, voice quality, water swallowing test

Smith, 2009 15）

Cognitive function, cough, water swallowing test

Vogel, 2017 5）Interview, medical history, intake status, water swallowing test

Zhou, 2011 8）

Neurological findings, voluntary swallowing, dysarthria, pharyngeal reflexes, palatal closure, water
swallowing test

Mandysova, 2011 9）

Occlusion, tongue, facial muscles, shoulders, water swallowing test

Edmiaston, 2014 18）

Level of consciousness, facial muscles, tongue, palate, water swallowing test

Branco, 2019 20）

Lip closure, leakage from lips, prolonged oral phase, oral retention, multiple swallows, laryngeal elevation,
cervical auscultation, water swallowing test

Daniels, 1997 6）

Facial appearance, lips, temporomandibular joint, tongue, curtain signs, voice, articulation, gag reflex,
coughing, cough after swallowing, water swallowing test

Nishiwaki, 2005 12）

Lip closure, tongue movement, palate, pharyngeal reflexes, voice quality (water swallowing test), speech
function Figures represent the results of the water swallowing test only.

Daniels, 2016 16）

Vitality, dysarthria, voice quality, cough, water swallowing test

Hey, 2013 14）

Three of the following: organic dysarthria, wet hoarseness, tongue movement, and tongue muscle strength.

Keage, 2017 10）

Pharyngeal reflexes, respiration, lip, palate, laryngeal function, tongue, cognition

Mortensen, 2016 23）

Facial observation, saliva swallowing

Yamane, 2015 24）

Palatal reflex, laryngeal movement, pharyngeal residue, lip closure, tongue movement

ficity are high on the second day of hospitalization but not that high on the fourth day of hospitalization. The
different studies have different evaluation indices, and there is a large variation in sensitivity and specificity
depending on the evaluation index and evaluator. The studies also included cases in which the evaluator of thephysical examination technique performed the reference standard, VF or VE, and cases in which the VF or VE
evaluator knew the results of the physical examination technique; this incorporated a risk of bias. When the outcome was sensitivity and specificity of aspiration, both imprecision and publication bias were judged to be"none." When the outcome was the sensitivity and specificity of predicting the development of aspiration pneumonia, both imprecision and publication bias were judged to be "unlikely." Based on the above, the certainty ofthe evidence was judged to be "weak."In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine therecommendation were cost, the willingness of the target population, burden on the target population, reliability
and feasibility of the assessment methods, and non-directiveness of the studies included in the systematic review.
Physical assessment techniques cost little when performed without test foods and are less painful for patients.
The risk of aspiration is also very low when observations are made without the use of fluids or food. In addition,
unless the food used is not to the patient's preference, it is unlikely that the use of physical assessment techniques
will deviate significantly from the patient's wishes. However, the reliability and feasibility of the results should beconsidered with caution because the physical examination technique requires experience and education, and in astudy that was the subject of the systematic review, the person who conducted the assessment was a speech-lan-― 48 ―

guage-hearing therapist, and the study was mainly conducted on acute stroke patients. Results of the voting indicated that five of the seven members voted for a "weak recommendation for implementation" and two voted fora "strong recommendation for implementation," with 71% in favor of a "weak recommendation for implementation." The wording of the recommendation was: "We propose to conduct an assessment of aspiration througha systematic assessment using physical assessment techniques."
The facilitating factor in the application of this clinical practice guideline is that physical assessment techniques can be performed without the use of special devices. The disincentive is that it requires experience andeducation to conduct the assessment.

4）Database search results
Aspiration pneumonia, aspiration, bedside assessment, bedside evaluation, bedside screen, clinical assessment,
deglutition disorder, dysphagia, physical assessment, physical examination, pneumonia, predictive value, (dysphagia, swallowing pneumonia, aspiration pneumonia, attracted pneumonia, physical examination, physicalexamination, screening, pneumonia-swallowing, assessment, physical assessment, bedside assessment, physicalexamination [in Japanese]) were used as keywords. The databases included PubMed (until August 31, 2019),
Embase (until August 31, 2019), CINAHL (until August 31, 2019), Cochrane Library (until August 31, 2019),
and Ichushi-Web (until August 31, 2019). As a result, 1090 studies were identified, and 23 observational studies
were recruited after screening. The database search formulas are included in the appendix.

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 1,090)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 1,090)

Records excluded(n = 971)

Full-text articles assessed for eligibility(2nd Screening) (n = 119)

Full-text articles
excluded withreasons (n = 96)

Studies included in qualitative synthesis(n = 23)

Studies included in quantitativesynthesis (meta-analysis) (n = 22)

Figure 1: Literature search flowchart― 49 ―

6）List after secondary screening
Table 2: List after secondary screening
Literature

DesignP

Index test

Referencestandard

O

Ramsey, 2006 Cross-sectional
study

Patients in the acute Lip closure, tongue movement,
stage of stroke
voice quality, water swallowing test,
SPO2

VF

Sensitivity and specificity of
aspiration detection

Toscano,2019

Cross-sectional
study

Patients within 72
hours after stroke
onset

TOR_BSST, laryngeal elevation,
SPO2

VE

Sensitivity and specificity of
aspiration detection

Martino,2009

Cross-sectional
study

Stroke patients

TOR_BSST

VF

Sensitivity and specificity of
aspiration detection

Mann, 2000

Cohort study

Patients with firstever and acutestrokeMASA

VF

Sensitivity and specificity of
aspiration detection

González,
2011

Cross-sectional
study

Patients withdysphagia

MASA

VF

Sensitivity and specificity of
aspiration detection

Ohira, 2017

Cross-sectional
study

Patients who havesuffered a brain
injury (includingtrauma and stroke)

MASA

VF

Sensitivity and specificity of
aspiration detection

Yousovich,
2018

Cross-sectional
study

Patients withdysphagia

Cough, voice quality, choking (water VE
swallowing test)

Sensitivity and specificity of
aspiration detection

Newton,1994

Cross-sectional
study

Brain tumor patients Subjective symptoms, level ofVFwith dysphagia
consciousness, water swallowing test

Sensitivity and specificity of
aspiration detection

Baylow, 2009 Cross-sectional
study

Patients in the acute Observation of 28 items, including
stage of stroke
the history of pneumonia, oral
and pharyngeal stages, and water
swallowing test

VF

Sensitivity and specificity of
aspiration detection

Baumann,2017

Cross-sectional
study

Patients after lungtransplantation

Oral function, voice quality, water
swallowing test

VE/VF

Sensitivity and specificity of
aspiration detection

Smith, 2009

Cross-sectional
study

Ischemic stroke
patients

Cognitive function, cough, water
swallowing test

VE/VF

Sensitivity and specificity of
aspiration detection

Vogel, 2017

Cross-sectional
study

Neurodegenerative
disease patientsInterview, medical history, intake
status, water swallowing test

VF

Sensitivity and specificity of
aspiration detection

Zhou, 2011

Cross-sectional
study

Stroke patients

Neurological findings, voluntaryswallowing, dysarthria, pharyngeal
reflex, palatal closure, water
swallowing test

VF

Sensitivity and specificity of
aspiration detection

Mandysova,
2011

Cross-sectional
study

Patients withdysphagia

Occlusion, tongue, facial muscles,
shoulders, water swallowing test

VE

Sensitivity and specificity of
aspiration detection

Hey, 2013

Cross-sectional
study

Postoperative
patients with headand neck cancer

Three of the following: organic
dysarthria, wet hoarseness, tongue
movement, and tongue muscle
strength

VE

Sensitivity and specificity of
aspiration detection

Edmiaston,
2014

Cross-sectional
study

Acute stroke patients Level of consciousness, facialmuscles, tongue, palate, water
swallowing test

VF

Sensitivity and specificity of
aspiration detection

Lip closure, leakage from lips,
VF
prolonged oral phase, oral retention,
multiple swallows, laryngeal
elevation, cervical auscultation, water
swallowing test

Sensitivity and specificity of
aspiration detection

VF

Sensitivity and specificity of
aspiration detection

Branco, 2019 Cross-sectional
study

Patients with
Parkinson's disease

Daniels, 1997 Cross-sectional
study

Patients in the acute Facial appearance, lips, TMJ,
stage of stroke
tongue, curtain signs, voice,articulation, gag reflex, coughing,cough after swallowing, water
swallowing test

Nishiwaki,
2005

Cross-sectional
study

Stroke patients

Lip closure, tongue movement,
VFpalate, pharyngeal reflex, voice
quality (water swallowing test),
speech function.
Aspiration detection sensitivity andspecificity are based on the results of
the water swallowing test only.

Sensitivity and specificity of
aspiration detection

Kaege, 2017

Cross-sectional
study

Patients withFriedreich's ataxia

Pharyngeal reflex, respiration, lip,
palate, laryngeal function, tongue,
cognition

VF

Sensitivity and specificity of
aspiration detection

Daniels, 2016 Cross-sectional
study

Patients suspected of Vitality, dysarthria, voice quality,
having stroke
cough, water swallowing test

VF

Sensitivity and specificity of
aspiration detection

Mortensen,
2016

Cross-sectional
study

Patients with headtraumaFacial observation, saliva swallowing VE

Sensitivity and specificity of
aspiration detection

Yamane,2015

Cohort study

Patients in the acute Palatal reflex, laryngeal movement,
stage of strokepharyngeal residue, lip closure,
tongue movement― 50 ―

Blood test, Sensitivity and specificity
radiograph, of risk determination for
and CT
aspiration pneumonia

Exclusion

Comment7）List of included papers
Table 3: List of included papers
Included
papersRamsey DJC, Smithard DG,
Kalra L.

Can pulse oximetry or a bedside swallowing assessment be used to detect aspiration after stroke? Stroke
2006; 37(12): 2984-2988.

Included
papers

Baylow HE, Goldfarb R, TaveiraCH, et al.

Accuracy of clinical judgment of the chin-down posture for dysphagia during the clinical/bedsideassessment as corroborated by videofluoroscopy in adults with acute stroke. Dysphagia 2009; 24(4): 423433.

Included
papersYousovich R, Levi A, Kaplan D,
et al.

The clinical "bedside" assessement of the dysphagia patient differences with food and fluids intake.
Dysphagia 2018; 33(4): 533. Abstract

Included
papersVogel AP, Rommel N, Sauer C,
et al.

Clinical assessment of dysphagia in neurodegeneration (CADN): development, validity and reliability of a
bedside tool for dysphagia assessment. J Neurol 2017; 264(6): 1107-1117.

Included
papersDaniels SK, McAdam CP, Briley
K, et al.

Clinical assessment of swallowing and prediction of dysphagia severity. Am J Speech-Language Pathol
1997; 6(4): https://doi.org/10.1044/1058-0360.0604.17

Included
papersGonzalez-Fernandez M, Sein MT, Clinical experience using the Mann assessment of swallowing ability for identification of patients at risk
Palmer JB.
for aspiration in a mixed-disease population. Am J Speech-Language Pathol 2011; 20(4): 331-336.

Included
papersZhou Z, Salle J, Daviet J, et al.

Included
papersMandysova P, Skvrnakova J, Ehler Development of the Brief Bedside Dysphagia Screening Test in the Czech Republic. Nurs Health Sci
E, et al.
2011; 13(4): 388-395.

Included
papersKeage MJ, Delatycki MB, Gupta I, Dysphagia in Friedreich Ataxia. Dysphagia 2017; 32(5): 626-635.
et al.

Included
papersOhira M, Ishida R, Maki Y, et al.

Evaluation of a dysphagia screening system based on the Mann assessment of swallowing ability for use independent older adults. Geriatr Gerontol Int 2017; 17(4): 561-657.

Included
papersNishiwaki K, Tsuji T, Liu M, etal.

Identification of a simple screening tool for dysphagia in patients with stroke using factor analysis ofmultiple dysphagia variables. J Rehabil Med 2005; 37(4): 247-251.

Included
papersBaumann B, Byers S,
Wasserman-Wincko T, et al.

Postoperative swallowing assessment after lung transplantation. Annal Thoracic Surg 2017; 104(1): 308312.

Included
papersHey C, Lange BP, Aere C, et al.

Predictability of oral and laryngopharyngeal function for aspiration and limitation of oral intake in patients
after surgery for head and neck cancer. Anticancer Res 2013; 33(8): 3347-3353.

Included
papersSmith Hammond CA, Goldstein
LB, Horner RD, et al.

Predicting aspiration in patients with ischemic stroke: comparison of clinical signs and aerodynamic
measures of voluntary cough. Chest 2009; 135(3): 769-777.

Included
papersDaniels SK, Pathak S, Rosenbek
JC, et al.

Rapid aspiration screening for suspected stroke: Part 1: development and validation. Arch Phys Med
Rehabil 2016; 97(9): 1440-1448.

Included
papersToscano M, Vigano A, Rea A, etal.

Sapienza global bedside evaluation of swallowing after stroke: the GLOBE-3S study. Eur J Neurol 2019;26(4): 596-602.

Included
papers

Edmiaston J, Connor LT, StegerMay K, et al.

A simple bedside stroke dysphagia screen, validated against videofluoroscopy, detects dysphagia andaspiration with high sensitivity. J Stroke Cerebrovasc Dis 2014; 23(4): 712-716.

Included
papersNewton HB, Newton C, Pearl D,
et al.

Swallowing assessment in primary brain tumor patients with dysphagia. Neurology 1994; 44(10): 19271932.

Included
papersBranco LL, Trentin S, Augustin
Schwanke CH, et al.

The swallowing clinical assessment score in parkinson's disease (SCAS-PD) is a valid and low-cost tool forevaluation of dysphagia: A gold-standard comparisons study. J Aging Res 2019; 7984635.

Included
papersMann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis 2000;
10(5): 380-386.

Included
papersMartino R, Silver F, Teasell R, etal.

The toronto bedside swallowing screening test (TOR-BSST) development and validation of a dysphagia
screening tool for patients with stroke. Stroke 2009; 40(2): 555-561.

Included
papersMortensen J, Jensen D,
Kjaersgaard A.

A validation study of the facial-oral tract therapy swallowing assessment of saliva. Clin Rehabil 2016;
30(4): 410-415．

Included
papersDaniels SK, Pathak S, Rosenbek
JC, et al.

Rapid Aspiration Screening for Suspected Stroke: Part 1: Development and Validation. Arch Phys Med
Rehabil 2016; 97(9): 1440-1448.

Included
papersYamane Y, Kamakura Y, Fukada
J, et al.

Development of a Risk Assessment Algorithm for Aspiration Pneumonia in Acute Stroke. J Jpn Soc Feed
Swallow Rehabil 2015; 19(3):201-213.

Combined approach in bedside assessment of aspiration risk post stroke: PASS. Eur J Phys Rehabil Med
2011; 47(3): 441-446.

― 51 ―

8）Qualitative systematic review
Table 4: Qualitative systematic review
CQ

1

P

It is advisable to perform a systematic assessment using physical assessment techniques (interview, visual
examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspected ofhaving dysphagia? To avoid duplication with CQs 3, 4, 5, and 6, assessments using only the Repetitive
Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test (FT), or cervicalauscultation were not included here.
Persons aged 18 years and older suspected of having dysphagia

I

Physical assessment techniquesC

VF or VE

Clinical context

Physical assessment techniques are based on the integration of subjective and objective information. The
subjective information is obtained from the medical history of the patient and family members, the medical
history of the preceding, preparation, oral, pharyngeal, and esophageal phases, and the medical history of
the general condition, including respiration and nutritional status. Based on the results of these interviews,
objective information is obtained from physical examinations of the brain and nervous system (mainly
olfactory, optic, trigeminal, facial, glossopharyngeal, vagus, accessory, and hypoglossal nerves), respiratory
system, nutritional status related to eating and swallowing, facial appearance, speech, lips, temporomandibular
joint, oral cavity, tongue, soft palate, anterior palatal arch, oral sensation, larynx, trachea, lungs, and thegeneral condition. Physical assessment techniques are often performed prior to screening tests, such as RSST
(Repetitive Saliva Swallowing Test), MWST (Modified Water Swallowing Test), FT (Food Test), and coughtest. They can also be used to assess the swallowing function in patients with impaired consciousness or
cognitive impairment.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Decided "none."The risk of bias summary

The risk of bias was "unlikely" because the examiners may have not been blinded or it is not clear if they wereblinded from the index test or reference standard results.

Inconsistency and other Sensitivity and specificity varied, and inconsistency was "unlikely."summary
Comment

Of the 22 references that used sensitivity and specificity as outcomes for aspiration detection, three used
MASA (The Mann Assessment of Swallowing Ability),7), 11), 21) and two used TOR_BSST (Toronto Bedside
Swallowing Screening Test) 17), 22), and oxygen saturation was used as a criterion in two studies3), 17). As
for objective information, the following indicators were recorded: lip closure, tongue movement, voice
quality, laryngeal elevation, cough, the level of consciousness, cognitive function, the history of pneumonia,
food intake, voluntary swallowing, dysarthria, pharyngeal reflex, nasopharyngeal closure, occlusion, facial
expression, tongue muscle strength, oral residue, coughing, liveliness, swallowing function when swallowing
water or food, and changes in voice quality.

O2

True positives, true negatives, false positives, and false negatives in determining risk for aspiration pneumonia

Summary of indirectness

Decided "none."The risk of bias summary

Bias risk was judged to be "unlikely."

Inconsistency and other It was determined to be "unlikely" because there was only one target paper.
summary
Comment

In one study reporting pneumonia as the outcome, the sensitivity and specificity for the outcome on thesecond day of hospitalization were 0.86 and 0.71, respectively, and on the fourth day of hospitalization, thesensitivity and specificity were 0.75 and 0.67, respectively24). The inter-rater agreement for each measure
ranged from 82.0–95.3%.

9）Meta-analysis
We conducted a meta-analysis of 22 studies using the sensitivity and specificity of aspiration detection as outcomes. The integrated sensitivity was 0.82 (95% CI: 0.72–0.89) and specificity was 0.76 (95% CI: 0.69–0.83)(Figure 2). Here, we conducted a meta-analysis of the literature that included observations that required understanding of instructions, such as command water swallowing, food swallowing, and interview 2)-6), 8), 9), 12)-15), 17)-23),,and those that did not include observations that required understanding of instructions. 7), 10), 11), 16) We calculated
the integrated sensitivity and specificity of the aspiration detection. The physical assessment items in each study
are summarized in a table. As a result, there were 18 references that included observation items that required anunderstanding of instructions, with an integrated sensitivity of 0.84 (95% CI: 0.74–0.91) and specificity of 0.71

― 52 ―

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Baumann 2017

59

101

40

97

0.60 [0.49, 0.69]

0.49 [0.42, 0.56]

Baylow 2009

2

5

3

20

0.40 [0.05, 0.85]

0.80 [0.59, 0.93]

Branco 2019

7

3

0

18

1.00 [0.59, 1.00]

0.86 [0.64, 0.97]

Daniels 1997

24

11

2

22

0.92 [0.75, 0.99]

0.67 [0.48, 0.82]

Edmiaston 2014

57

81

3

82

0.95 [0.86, 0.99]

0.50 [0.42, 0.58]

González 2011

36

12

5

73

0.88 [0.74, 0.96]

0.86 [0.77, 0.92]

Hey 2013̲2

28

13

16

23

0.64 [0.48, 0.78]

0.64 [0.46, 0.79]

Mandysova 2011

27

33

4

23

0.87 [0.70, 0.96]

0.41 [0.28, 0.55]

Mann 2000

26

37

2

63

0.93 [0.76, 0.99]

0.63 [0.53, 0.72]

Martino 2009

22

14

4

28

0.85 [0.65, 0.96]

0.67 [0.50, 0.80]

Keage 2017

8

5

4

21

0.67 [0.35, 0.90]

0.81 [0.61, 0.93]
0.88 [0.71, 0.96]

Mortensen 2016

10

4

1

28

0.91 [0.59, 1.00]

Newton 1994

8

1

0

3

1.00 [0.63, 1.00]

0.75 [0.19, 0.99]

Nishiwaki 2005

13

5

14

29

0.48 [0.29, 0.68]

0.85 [0.69, 0.95]

Ohira 2017

15

3

5

27

0.75 [0.51, 0.91]

0.90 [0.73, 0.98]

Ramsey 2006

6

12

1

35

0.86 [0.42, 1.00]

0.74 [0.60, 0.86]

Smith 2009

19

11

14

52

0.58 [0.39, 0.75]

0.83 [0.71, 0.91]

Daniels 2016

27

2

126

95

0.18 [0.12, 0.25]

0.98 [0.93, 1.00]

Toscano 2019

28

5

0

17

1.00 [0.88, 1.00]

0.77 [0.55, 0.92]

Vogel 2017

16

19

3

42

0.84 [0.60, 0.97]

0.69 [0.56, 0.80]

Yousovich 2018 pure 31

11

6

58

0.84 [0.68, 0.94]

0.84 [0.73, 0.92]

Zhou 2011

48

10

6

43

0.89 [0.77, 0.96]

0.81 [0.68, 0.91]

Total

518

398

259

899

0.82 [0.72, 0.89]

0.76 [0.69, 0.83]

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

Speciﬁcity (95% CI)

1

0

0.2

0.4

0.6

0.8

1

Figure 2: Comparison of the sensitivity and specificity of screening for aspiration using physical assessment techniques
Note: TP, true positive; FP, false positive; FN, false negative; TN, true negative.
In cases where two or more results from physical assessment techniques were presented, the value with the best sensitivity and specificity wasincorporated into the analysis.

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Baumann 2017

59

101

40

97

0.60 [0.49, 0.69]

0.49 [0.42, 0.56]

Baylow 2009

2

5

3

20

0.40 [0.05, 0.85]

0.80 [0.59, 0.93]

Branco 2019

7

3

0

18

1.00 [0.59, 1.00]

0.86 [0.64, 0.97]

Daniels 1997

0.67 [0.48, 0.82]

24

11

2

22

0.92 [0.75, 0.99]

Edmiaston 2014 57

81

3

82

0.95 [0.86, 0.99]

0.50 [0.42, 0.58]

Hey 2013̲2

13

16

23

0.64 [0.48, 0.78]

0.64 [0.46, 0.79]

Mandysova 2011 27

33

4

23

0.87 [0.70, 0.96]

0.41 [0.28, 0.55]

Mann 2000

26

37

2

63

0.93 [0.76, 0.99]

0.63 [0.53, 0.72]

Martino 2009

22

14

4

28

0.85 [0.65, 0.96]

0.67 [0.50, 0.80]

Mortensen 2016 10

4

1

28

0.91 [0.59, 1.00]

0.88 [0.71, 0.96]

Newton 1994

8

1

0

3

1.00 [0.63, 1.00]

0.75 [0.19, 0.99]

Nishiwaki 2005

13

5

14

29

0.48 [0.29, 0.68]

0.85 [0.69, 0.95]

Ramsey 2006

6

12

1

35

0.86 [0.42, 1.00]

0.74 [0.60, 0.86]

Smith 2009

19

11

14

52

0.58 [0.39, 0.75]

0.83 [0.71, 0.91]

Toscano 2019

28

5

0

17

1.00 [0.88, 1.00]

0.77 [0.55, 0.92]

Vogel 2017

16

19

3

42

0.84 [0.60, 0.97]

0.69 [0.56, 0.80]

Yousovich 2018 water 24

14

13

55

0.65 [0.47, 0.80]

0.80 [0.68, 0.88]

28

Zhou 2011

48

10

6

43

0.89 [0.77, 0.96]

0.81 [0.68, 0.91]

Total

424

379

126

680

0.84 [0.74, 0.91]

0.71 [0.64, 0.77]

Speciﬁcity (95% CI)

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

1

0

0.2

0.4

0.6

0.8

1

Figure 3: Comparison of sensitivity and specificity of screening for aspiration using physical assessment
techniques. (In cases that include indicators that require the understanding of instructions, such as
water swallowing tests)
Note: TP, true positive; FP, false positive; FN, false negative; TN, true negative.

(95% CI: 0.64–0.77) (Figure 3). There were four references that did not include observations requiring understanding of instructions, with an integrated sensitivity of 0.64 (95% CI: 0.32–0.88) and specificity of 0.91 (95%
CI: 0.82–0.97) (Figure 4).

― 53 ―

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

González 2011

36

12

5

73

0.88 [0.74, 0.96]

0.86 [0.77, 0.92]

Keage 2017

8

5

4

21

0.67 [0.35, 0.90]

0.81 [0.61, 0.93]

Ohira 2017

15

3

5

27

0.75 [0.51, 0.91]

0.90 [0.73, 0.98]

Daniels 2016

27

2

126

95

0.18 [0.12, 0.25]

0.98 [0.93, 1.00]

Total

86

22

140

216

0.64 [0.32, 0.88]

0.91 [0.82, 0.97]

Speciﬁcity (95% CI)

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

1

0

0.2

0.4

0.6

0.8

1

Figure 4: Comparison of the sensitivity and specificity of screening for aspiration using physical assessment techniques. (In cases that do not include indicators that require the understanding of instructions, such as water swallowing tests)
Note: TP, true positive; FP, false positive; FN, false negative; TN, true negative.

References
1.
2.

3.
4.
5.
6.
7.

8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.

Kamakura, Y., ed. Dysphagia Nursing: From Physical Assessment to Swallowing Training Igakushoin, Tokyo 2000. (inJapanese)
Baylow HE, Goldfarb R, Taveira CH, et al. Accuracy of clinical judgment of the chin-down posture for dysphagia during
the clinical/bedside assessment as corroborated by videofluoroscopy in adults with acute stroke. Dysphagia 2009; 24(4):423-433.
Ramsey DJC, Smithard DG, Kalra L. Can pulse oximetry or a bedside swallowing assessment be used to detect aspiration
after stroke? Stroke 2006; 37(12): 2984-2988.
Yousovich R, Levi A, Kaplan D, et al. The clinical "bedside" assessment of the dysphagia patient differences with food andfluids intake. Dysphagia 2018; 33(4): 533. Abstract
Vogel AP, Rommel N, Sauer C, et al. Clinical assessment of dysphagia in neurodegeneration (CADN): development,
validity and reliability of a bedside tool for dysphagia assessment. J Neurol 2017; 264(6): 1107-1117.
Daniels SK, McAdam CP, Briley K, et al. Clinical assessment of swallowing and prediction of dysphagia severity. Am J
Speech-Language Pathol 1997; 6(4): 17-24.
González-Fernandez M, Sein MT, Palmer JB. Clinical experience using the Mann assessment of swallowing ability for
identification of patients at risk for aspiration in a mixed-disease population. Am J Speech-Language Pathol 2011; 20(4):331-336.
Zhou Z, Salle J, Daviet J, Stuit A, et al. Combined approach in bedside assessment of aspiration risk post stroke: PASS.
Eur J Phys Rehabil Med 2011; 47(3): 441-446.
Mandysova P, Skvrnakova J, Ehler E, et al. Development of the Brief Bedside Dysphagia Screening Test in the Czech
Republic. Nurs Health Sci 2011; 13(4): 388-395.
Keage MJ, Delatycki MB, Gupta I, et al. Dysphagia in Friedreich Ataxia. Dysphagia 2017; 32(5): 626-635.
Ohira M, Ishida R, Maki Y, et al. Evaluation of a dysphagia screening system based on the Mann Assessment of Swallowing Ability for use in dependent older adults. Geriatr Gerontol Int 2017; 17(4): 561-657.
Nishiwaki K, Tsuji T, Liu M, et al. Identification of a simple screening tool for dysphagia in patients with stroke using
factor analysis of multiple dysphagia variables. J Rehabil Med 2005; 37(4): 247-251.
Baumann B, Byers S, Wasserman-Wincko T, et al. Postoperative swallowing assessment after lung transplantation. Annal
Thoracic Surg 2017; 104(1): 308-312.
Hey C, Lange BP, Aere C, et al. Predictability of oral and laryngopharyngeal function for aspiration and limitation of oral
intake in patients after surgery for head and neck cancer. Anticancer Res 2013; 33(8): 3347-3353.
Smith Hammond CA, Goldstein LB, Horner RD, et al. Predicting aspiration in patients with ischemic stroke: comparison of clinical signs and aerodynamic measures of voluntary cough. Chest 2009; 135(3): 769-777.
Daniels SK, Pathak S, Rosenbek JC, et al. Rapid Aspiration Screening for Suspected Stroke: Part 1: Development andValidation. Arch Phys Med Rehabil 2016; 97(9): 1440-1448.
Toscano M, Vigano A, Rea A, et al. Sapienza global bedside evaluation of swallowing after stroke: the GLOBE-3S study.
Eur J Neurol 2019; 26(4): 596-602.
Edmiaston J, Connor LT, Steger-May K, et al. A simple bedside stroke dysphagia screen, validated against videofluoroscopy, detects dysphagia and aspiration with high sensitivity. J Stroke Cerebrovasc Dis 2014; 23(4): 712-716.
Newton HB, Newton C, Pearl D, et al. Swallowing assessment in primary brain tumor patients with dysphagia. Neurology 1994; 44(10): 1927-1932.
Branco LL, Trentin S, Augustin Schwanke CH, et al. The swallowing clinical assessment score in parkinson's disease― 54 ―

21.
22.
23.
24.

(SCAS-PD) is a valid and low-cost tool for evaluation of dysphagia: A gold-standard comparison study. J Aging Res 2019;7984635.
Mann G, Hankey GJ, Cameron D. Swallowing disorders following acute stroke: prevalence and diagnostic accuracy.
Cerebrovasc Dis 2000; 10(5): 380-386.
Martino R, Silver F, Teasell R, et al. The toronto bedside swallowing screening test (TOR-BSST) development and validation of a dysphagia screening tool for patients with stroke. Stroke 2009; 40(2): 555-561.
Mortensen J, Jensen D, Kjaersgaard A. A validation study of the facial-oral tract therapy swallowing assessment of saliva.
Clin Rehabil 2016; 30(4): 410-415.
Yamane Y, Kamakura Y, Fukada J, et al. Development of a risk assessment algorithm for aspiration pneumonia in acutestroke patients. Japanese Journal of Feeding and Swallowing Rehabilitation 2015; 19(3):201-213. (in Japanese)― 55 ―

2．CQ 2

CQ 2
Is it advisable to manage oropharyngeal dysphagia based on a systematic assessment
using physical assessment techniques (interview, visual inspection, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia. To avoid duplication with CQs 3, 4, 5, and 6, assessments using only Repetitive
Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test
(FT), or cervical auscultation were not included here.
1）Recommendations
We propose to manage oropharyngeal dysphagia based on a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspectedof having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］Subsequent screening and diagnostic tests based on a systematic assessment
using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) are necessary for the implementation of appropriate care.

2）Background and purpose
Physical assessment techniques, which do not require special devices for swallowing rehabilitation, can be easily performed at home and in treatment facilities, and are widely used.
Physical assessment techniques are methods used for assessing the eating and swallowing function based ondaily observations and are performed by integrating subjective and objective information. Subjective information
is obtained by interviewing patients and their family members about the medical history, preceding, preparation,oral, pharyngeal, and esophageal phases, and general conditions, such as breathing and nutritional status. Basedon the results of these interviews, objective information is obtained from physical examinations of the brain andnervous system (mainly olfactory, optic, trigeminal, facial, glossopharyngeal, vagus, hypoglossal, and accessory
nerves), respiratory system, nutritional status related to eating and swallowing, facial appearance, speech, lips,
temporomandibular joint, oral cavity, tongue, soft palate, anterior palatal arch, and oral sensation. Informationon the larynx, trachea, and lungs, and the general condition is obtained from visual, palpatory, and auscultatory
examinations.1)
Physical assessment techniques are often performed prior to screening tests, such as RSST, MWST, FT, andcough test. Physical examinations of the cerebral nervous and respiratory systems can evaluate the eating andswallowing functions of recuperators with impaired consciousness or cognitive impairment who have difficultyin performing directed movements.
However, the physical assessment techniques used in clinical practice vary in terms of who performs them andwhat they include, and it is not clear whether they contribute to patient outcomes. We investigated the effective-― 56 ―

ness of these techniques.

3）Explanation
The main selection criterion for the evidence was the type of study; randomized controlled trials were included. Observational studies were also included if there were no studies that met the recruitment criteria. The article used for this systematic review was one randomized controlled trial.2) Physical examination techniques were
established as the standard of care for the control group rather than the intervention group. Physical assessment
techniques used in the control group included a history and oral motor assessment by SLPs, followed by bedsideoral and pharyngeal swallowing assessments. Oral intake trials based on the physical examination results and VF
referrals were then conducted as needed. The incidence of pneumonia within 3 months was 1.0% in the intervention group and 3.2% in the control group, with a relative risk of 0.32 (95% CI: 0.06–1.62). In the randomized controlled trial, there was no difference in the incidence of pneumonia between the intervention and control groups.
Although no standardized physical examination technique was provided, it was noted that a detailed neurological and oral motor assessment, including recording the history, voluntary coughing, and palpation of thehyoid bone and laryngeal elevation, was performed by clinically experienced SLPs. These findings suggested thatappropriate care interventions based on information obtained from physical assessment could reduce the incidence of pneumonia. Because there was only one relevant study, the imprecision was judged to be"medium/doubtful (-1)" and the publication bias was judged to be "low (0)."
MASA3) has been widely used in the U.S. and Australia for a long time as a physical assessment technique, andhence, can be used as a reference.
In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine recommendations were cost, subject intent, the burden on the subject, reliability and feasibility of the assessment
methods, and indirectness of the studies included in the systematic review. In a previous study, SLPs were
included as assessors, and the study was conducted on acute stroke patients; therefore, the results need to be generalized for other subjects. Besides, it is necessary to consider that physical assessment techniques require experience and education. Except in a case where the food provided does not suit the preferences of the patient, it isunlikely that the implementation of the physical examination technique will deviate greatly from the intentionsof the patient. As a result, five out of eight participants voted for "weak recommendation to implement," twovoted for "strong recommendation to implement," and one voted for "no recommendation." The recommendation "weak recommendation for implementation" was worded as "we suggest that assessment-based managementfor oropharyngeal dysphagia be provided."
The facilitating factor in the application of this guideline is that physical assessment techniques can be performed without the use of special devices. The disadvantage, however, is that conducting the assessment requires
experience and education.
Based on the above, the recommendation and certainty of evidence for this CQ were assigned GRADE 2C(strength of recommendation: weak, certainty of evidence (strength): weak).

4）Database search results
Aspiration pneumonia, aspiration, bedside assessment, bedside screen, deglutition disorder, deglutition disorder, deglutition, swallow, dysphagia, physical assessment, physical examination, pneumonia, (swallowing, swal-― 57 ―

lowing function assessment, dysphagia, swallowing pneumonia, aspiration in the airway, aspiration pneumonia,
care, aspiration, aspiration pneumonia, residual, physical examination, screening, pneumonia-aspiration, physical assessment, bedside assessment, physical examination, screening [in Japanese]) were used as keywords.
PubMed (until August 31, 2019), Embase (until August 31, 2019), CINAHL (until August 31, 2019),
Cochrane Library (until August 31, 2019), and Ichushi-Web (until August 31, 2019), were used. As a result,
996 studies were identified, and one randomized controlled trial was conducted after screening. The databasesearch formulae are included in the appendix.

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching(n = 996)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 996)

Records excluded(n = 981)

Full-text articles assessed for eligibility(2nd Screening) (n = 15)

Full-text articles
excluded withreasons (n = 14)

Studies included in qualitative synthesis(n = 1)

Studies included in quantitativesynthesis (meta-analysis) (n = 0)

Figure 1: Literature search flowchart6）List after secondary screening
Table 1: List after secondary screening
Literature
Field, 2018

DesignRandomized
controlled trial

P
Acute stroke
patients

I
Addition of reflex coughassessment by inhalation citricacid induction test

― 58 ―

C
Conduct
physicalassessment

O
Aspiration
pneumonia
outbreakExclusion

Comment7）List of included papers
Table 2: List of included papers
Included
papersField M, Wenke R, Sabet A, et al.

Implementing cough reflex testing in a clinical pathway for acute stroke. a pragmatic randomised controlled
trial. Dysphagia 2018; 33(6): 827-839.

8）Qualitative systematic review
Table 3: Qualitative systematic review
CQ

2

P

Is it advisable to manage oropharyngeal dysphagia based on a systematic assessment using physical assessment
techniques (interview, visual inspection, auscultation, palpation, and percussion) for persons aged 18 years
and older suspected of having dysphagia? To avoid duplication with CQs 3, 4, 5, and 6, assessments using
only Repetitive Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test (FT),or cervical auscultation were not included here.
Persons aged 18 years and older with suspected dysphagia

I

Management of oropharyngeal dysphagia based on physical assessment techniques

C

Management of oropharyngeal dysphagia through observation of conventional methods

Clinical context

Physical assessment techniques are based on the integration of subjective and objective information. The
subjective information is obtained from the medical history of the patient and family members, the medical
history of the preceding, preparation, oral, pharyngeal, and esophageal phases, and the medical history of thegeneral condition, including respiration and nutritional status. Based on the results of the interview, objective
information is obtained from the physical examination of the brain and nervous system (mainly olfactory,
optic, trigeminal, facial, glossopharyngeal, vagus, accessory, and hypoglossal nerves), respiratory system,
nutritional status related to eating and swallowing, facial appearance, speech, lips, temporomandibular joint,
oral cavity, tongue, soft palate, anterior palatine arch, and oral sensation. Physical examination of the larynx,
trachea, lungs, and general condition should be performed by visual, palpation, auscultation, and percussion
techniques. Physical assessment techniques are often performed prior to screening tests, such as RSST,
MWST, FT, cough test, etc. Physical examinations of the cerebral nervous system, respiratory system,
etc. can be used to assess the eating and swallowing function of convalescents with impaired consciousness
and cognitive impairment. The results of physical assessment techniques can be used to assess the eating
and swallowing functions of patients with impaired consciousness and cognitive impairment. The resultsof physical assessment techniques are then used to select an appropriate management technique fororopharyngeal dysphagia.

O1

Occurrence of aspiration pneumonia

Summary of indirectness

It was judged to be "low (0)."The risk of bias summary

The intervention was not blinded to patients or medical personnel, and the risk of bias was set at "moderate/suspected (-1)."

Inconsistency and other The risk of imprecision was judged to be "moderate/suspected (-1)" due to the small sample size and number
summaryof events.
Comment

The physical examination technique was not an intervention, but rather a standard of care for the control
group. The physical assessment techniques used in the control group consisted of a history and oral
motor assessment by a speech-language pathologist, followed by a bedside oral and pharyngeal swallowing
assessment. This was followed by an oral intake trial based on physical assessment techniques, and, if
necessary, a referral for swallowing angiography. The incidence of pneumonia within 3 months was 1% in theintervention group and 3.2% in the control group, with a relative risk of 0.32 (95% CI: 0.06–1.62). There wasno significant difference in the incidence of pneumonia between the intervention and control groups.

References
1.
2.
3.

Kamakura, Y., ed. Dysphagia Nursing from Physical Assessment to Swallowing Training. Igakushoin, Tokyo 2000. (inJapanese)
Field M, Wenke R, Sabet A, et al. Implementing cough reflex testing in a clinical pathway for acute stroke. a pragmatic
randomised controlled trial. Dysphagia 2018; 33(6): 827-839.
Mann G. MASA: The Mann assessment of swallowing ability, Thomson Learning, NY, 2002.

― 59 ―

3．CQ 3，CQ 4，CQ 51）Recommendations for each CQ

CQ 3
Is it advisable to screen for aspiration by Repetitive Saliva Swallowing Test (RSST) in
persons over 18 years of age suspected of having dysphagia?
Recommendations
We suggest that individuals aged 18 years and older, who are suspected of having dysphagia, should be screened for aspiration using Repetitive Saliva Swallowing Test (RSST).
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Repetitive Saliva Swallowing Test (RSST) requires movement with an understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment. Caution should be exercised when applying Repetitive Saliva Swallowing Test (RSST) to patients with xerostomia.
Patients with Parkinson's syndrome, who have strong immobility and inactive, are often
judged to be abnormal, regardless of their swallowing function.

CQ 4
Is it advisable to screen for aspiration using the Modified Water Swallowing Test
(MWST) in persons over 18 years of age, who are suspected of having dysphagia?
Recommendations
We suggest screening for aspiration with the MWST in individuals aged 18 years
and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before performing the procedure; Modified Water Swallowing Test (MWST) requires movement withan understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment.

CQ 5
Is it advisable to screen for aspiration by FT (Food Test) for persons over 18 years ofage, who are suspected of having dysphagia?

― 60 ―

Recommendations
It is suggested to screen individuals aged 18 years or older suspected of having
dysphagia for aspiration using FT (Food Test).
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before performing the procedure; FT (Food Test) requires movement with an understanding of
instructions, and care should be taken regarding its application to persons with impaired
consciousness or severe cognitive impairment.

2）Background and purpose
RSST, MWST, and FT are widely used in hospitals, institutions, and homes in Japan to screen for aspirationand pharyngeal residues. These screening tests do not require any special devices and can be easily performed bynurses. In this CQ, we searched for the sensitivity and specificity of these screening tests in adults aged 18 years
and older, as well as their effectiveness for those suspected of having dysphagia.

3）Explanation
Cross-sectional observational studies or cohort studies were selected as evidence. In this systematic review, we
searched for the screening sensitivity and specificity of the RSST, MWST, and FT for dysphagia. As a result, no
articles were extracted that showed the sensitivity and specificity of the combination of RSST, MWST, and FT.
Therefore, this CQ will describe the results of a systematic review showing the screening sensitivity and specificity for each test.
Of the three papers used in the systematic review, one was a cross-sectional observational study on the sensitivity and specificity of RSST for detecting aspiration1), one was a cross-sectional observational study on the sensitivity and specificity of RSST and MWST for detecting aspiration2), and one was a cross-sectional observational
study on the sensitivity and specificity of MWST for detecting aspiration and pharyngeal residue, and those of
the FT for detecting aspiration3). One was a cross-sectional observational study on the sensitivity and specificityof MWST for detecting aspiration and pharyngeal residue, and one was a cross-sectional observational study on
the sensitivity and specificity of the FT for detecting aspiration3).
RSST
The sensitivity and specificity for detecting aspiration by RSST were 0.98 and 0.66, respectively, in a study of
131 patients aged 17 years and older1) and 0.69 and 0.40, respectively, in a study of 82 patients aged 58 years
and older.2) A meta-analysis was difficult to conduct because there were only two references. Sensitivity andspecificity varied among the articles, and the confidence interval was wide owing to the small number of subjects. We judged that there was no imprecision, and publication bias was unlikely. Overall, the certainty of theevidence was judged to be C (weak).
In addition to the certainty of the evidence, cost, subject intent, the burden on the subject, and feasibility of
the assessment method were the main topics of discussion at the panel meeting to determine the recommendation. RSST has the advantages of being painless, costly, and time-saving. Since it does not use food, it is unlikelythat the implementation of the test will be significantly different from the intentions of the patient. On theother hand, there are some points that require attention, for example, it may be difficult to implement the― 61 ―

method in patients with strong xerostomia and in post-stroke patients who are unable to perform the indicatedmovements, and training is necessary when applying the method to elderly patients because errors may occur
while judging the swallowing function. In addition, patients with Parkinson's syndrome who have strong immobility and allodynia are often judged as abnormal, regardless of their swallowing function. Although intra-rater
reliability was not reported in the literature, Fukada et al. reported r = 0.68, and inter-rater reliability r = 0.95. 4)
In addition, caution should be exercised when applying the method to subjects who have difficulty understanding instructions because of cognitive decline, or who have undergone structural changes due to surgery, including changes in the pharynx and larynx. However, it is the safest test method because it does not use drinks or
food. Results of the voting indicated that five out of seven members voted for "weak recommendation for implementation" and two members voted for "strong recommendation for implementation," with 71% in favor of"weak recommendation for implementation."
Based on the above, the strength of the recommendation and evidence for this CQ is GRADE 2C (strengthof recommendation: weak, certainty of evidence (strength): weak).
MWST
The sensitivity and specificity of MWST for detecting aspiration were 0.71 and 0.43, respectively, in a studyof 84 post-stroke patients aged 58 years or older2), and 0.58 and 0.72, respectively, in a study of 155 stroke
patients.3) The sensitivity and specificity for the detection of pharyngeal residues were 0.43 and 0.64, respectively, in a study of 155 stroke patients.3) Meta-analysis was difficult to perform because there were only two articles
and one article on aspiration and pharyngeal residue, respectively. Sensitivity and specificity varied among thearticles, and confidence intervals were wide owing to the small number of subjects. When the outcome was thesensitivity and specificity of aspiration detection, we judged that there was no imprecision, and publication bias
was unlikely. When the outcome was the sensitivity and specificity of pharyngeal residue detection, the imprecision was judged to be "severe" and the publication bias was judged to be "none."
Overall, the strength of evidence was judged to be C (weak).
In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine therecommendation were cost, willingness of the target population, burden on the target population, reliability andfeasibility of the assessment methods, and non-directiveness of the studies included in the systematic review. As areminder, the literature on both aspiration and pharyngeal residue is limited to patients with stroke, except for
those with impaired consciousness or severe cognitive impairment, or those with mildly impaired consciousness;
MWST requires directed movements and should be applied with caution to recuperate patients with impaired
consciousness or severe cognitive impairment. The advantage of MWST is that it can be performed anywherewith water (thickened food) and a syringe at no cost. In hospitals, syringes are not used, to prevent accidents,
and catheter tips are sometimes used. Although intra-rater reliability was not reported in the literature, Fukada et
al. reported k = 0.88 and inter-rater reliability k = 0.82.4) Although it is necessary to educate medical personnel
in conducting screening tests, the benefits of screening are considered to outweigh the burdens, even considering
the costs. In addition, MWST is sometimes used in the calculation of additional oral maintenance (I) (II) in
nursing care fees. The default volume of water for MWST is 3 mL, which is safe, but too small, and the patient
may have difficulty swallowing. In addition, patients with silent aspiration may be less likely to show symptoms,
such as swallowing difficulties.
Water itself is rarely not to the liking of the convalescent, but if a liquid with a thick consistency is used for― 62 ―

safety reasons, it may not be to the liking of the convalescent and may be unacceptable. If the patient can accept
the test meal, the burden on the caregiver should be minimal. There are few disadvantages of using the MWST
screening test for patients suspected of having dysphagia who can understand the instructions; however, it isconsidered to be useful.
This CQ reviews MWST, which assesses the swallowing function with small amounts of water. There are various water swallowing tests with different volumes of water, and systematic reviews on their sensitivities andspecificities5) have been reported. There is also an assessment method that combines WST with oxygen saturation6) and one that controls the amount and viscosity of water.7)
Results of the voting indicated that five out of seven members voted for "weak recommendation to implement" and 2 members voted for "strong recommendation to implement," with 71% in favor of "weak recommendation to implement."
Based on the above, the strength of the recommendation and evidence for this CQ is GRADE 2C (strengthof recommendation: weak; certainty of evidence (strength): weak).
A facilitating factor in the application of the guidelines is that MWST can be performed without the use of
special devices. The inhibiting factor is that it requires experience and education to conduct the assessment.
FT
A study of 155 patients with stroke showed a sensitivity of 0.80 and specificity of 0.39 for aspiration detection
by FT. 3) A meta-analysis was difficult to conduct because there was only one relevant study; the study included asmall number of acute stroke patients from a single institution, and the precision of the results was low. We
judged the imprecision to be "serious" and the publication bias to be "none." Based on the above, the overall
strength of the evidence was judged to be C (weak).
In addition to the certainty of the evidence, the main issues discussed at the panel meeting for the determination of the recommendation were cost, subject intention, the burden on the subject, reliability and feasibility of
the assessment methods, and non-directiveness of the studies included in the systematic review. It should be
noted that the literature is based on stroke patients, excluding those with impaired consciousness or severe cognitive impairment, and the use of jelly. FT requires directed movements and should be applied with caution toconvalescents with impaired consciousness or severe cognitive impairment. FT screens for function during theoral and pharyngeal phases. It has a high sensitivity for aspiration but low specificity. However, it differs from
MWST in that it can determine oral stage impairment (impaired feeding by the tongue) based on oral residues
and can predict post-swallowing aspiration due to oral residues. The cost of the test meal (jelly and pudding)should be considered. The test food used may not be to the liking of the patient, but if the patient can accept thetest food, the burden on the patient should be minimal. It should be noted that there is a high risk of aspirationand choking because the test is performed using food. Intra-rater reliability was not reported in the literature,
but Fukada et al. reported k = 0.87 and inter-rater reliability k = 0.84. 4) Although it can be performed anywherewith a test meal and a spoon, and education of medical personnel is necessary, the benefits of screening outweighthe costs. In summary, there are few disadvantages to using FT to screen for people having dysphagia; however,
it is considered to be useful.
Results of the voting indicated that five of seven members voted for "weak recommendation to implement"
and two members voted for "strong recommendation to implement," with 71% in favor of "weak recommendation to implement."― 63 ―

Based on the above, the strength of the recommendation and evidence for this CQ is GRADE 2C (strengthof recommendation: weak; certainty of evidence (strength): weak).

4）Database search results
Modified Water Swallow Test, Modified Water Swallowing Test, MWST, Repetitive Saliva Swallow Test,
Repetitive Saliva Swallowing Test, RSST, screening. aspiration pneumonia, cough-test, deglutition disorder,
deglutition disorders, dysphagia, pharynx, food-test, function-test, modified water swallow test, modified water
swallowing test, MWST, oropharynx, aspirate, pneumonia, aspiration, repetitive saliva swallow test, residue,
repetitive saliva swallowing test, RSST, screening-test, (swallowing function, dysphagia, dysphagia, swallowing
pneumonia, revised water swallow, revised water swallow, intra-airway aspiration, aspirate pneumonia, aspiration, aspiration pneumonia, residue, cough test, screening Pneumonia-Swallowing, Repeated Saliva, Food Test
[in Japanese]), were used as keywords. The databases included PubMed (until August 31, 2019), Embase (until
August 31, 2019), CINAHL (until August 31, 2019), Cochrane Library (until August 31, 2019), and IchushiWeb (until August 31, 2019). As a result, 362 studies were identified and three observational studies wereadopted after screening. The database search formulae are included in the Appendix.

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching(n = 355)

Additional records identiﬁed
through other sources (n = 7)

Records screened (1st Screening)(n = 362)

Records excluded(n = 271)

Full-text articles assessed for eligibility(2nd Screening) (n = 91)

Full-text articles
excluded withreasons (n = 88)

Studies included in qualitative synthesis(n = 3)

Studies included in quantitativesynthesis (meta-analysis) (n = 0)

Figure 1: Literature search flowchart― 64 ―

6）List after secondary screening
Table 1: List after secondary screening
Literature

DesignP

Index test

Referencestandard

O

Oguchi, 2000

Cross-sectional
study

Patients withfunctional
dysphagia

RSST

VF

Sensitivity andspecificity of aspirationand subclinicalaspiration detection

Watanabe, 2007

Cross-sectional
study

Stroke patients

RSST, MWSTVF

Sensitivity andspecificity of aspiration
detection

Osawa, 2012

Cross-sectional
study

Stroke patients

MWST, FTVF

Sensitivity andspecificity of aspiration
detection

Exclusion

Comment7）List of included papers
Table 2: List of included papers
Included
papersOguchi K, Saitoh E, Baba M, etal.

A review of the Repetitive Saliva Swallowing Test (RSST), a screening test for functional dysphagia (2) A
review of validity. Rehab Med 2000; 37(6):383-388.

Included
papersWatanabe S.

Factors associated with aspiration after stroke. Journal of Aichi Gakuin University Dental Society 2007;
45(4):579-590.

Included
papersOsawa A, Maejima S, Tanahashi
N.

Food Swallowing and Liquid Swallowing in Stroke Patients: Clinical Findings Using the Food Test andthe Modified Water Swallowing Test and a Study of Swallowing Contrastography. Jpn J Rehab Med
2012;49(11):838-845.

8）Qualitative systematic review
Table 3: CQ3 qualitative systematic review
CQ

3

Is it advisable to screen for aspiration by Repetitive Saliva Swallowing Test (RSST) in persons over 18 yearsof age suspected of having dysphagia?

P

Persons over 18 years of age with suspected dysphagia

Index test

RSST

Reference standard

VE or VF

Clinical context

A screening test for aspiration and pharyngeal residue that is widely used in hospitals, institutions, and homes
in Japan is the RSST. This test is performed in a sitting position with the neck slightly bent forward. During a
30-s period, the number of times the laryngeal ridge moves upward and forward over the third finger during
the swallowing motion is counted. If the number of swallows is less than 3, the patient is at risk for dysphagia.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Decided "none."The risk of bias summary

It was judged as "unlikely" because there are reports on whether the examiners were blinded or did not state
if they were blinded to the index tests and reference standards.

Inconsistency and other Inconsistency was judged to be "unlikely" because sensitivity and specificity varied among the papers, andsummary
imprecision was judged to be "unlikely" because the confidence interval was wide due to the small number ofsubjects.
Comment

The sensitivity and specificity of RSST (Repetitive Saliva Swallowing Test) for aspiration detection was 0.98
and 0.66, respectively, in a study of 131 patients aged 17 years and older1) and 0.69 and 0.40, respectively, ina study of 82 patients aged 58 years and older.2)― 65 ―

Table 4: CQ4 qualitative systematic review
CQ

4

Is it advisable to screen for aspiration using the Modified Water Swallowing Test (MWST) in persons over
18 years of age, who are suspected of having dysphagia?

P

Persons aged 18 years and older with suspected dysphagia

Index test

MWST

Reference standard

VE or VF

Clinical context

A screening test for aspiration and pharyngeal residue that is widely used in hospitals, institutions, and homes
in Japan is the MWST. The evaluation method is as follows. Pour 3 ml of cold water into the floor of themouth with a disposable syringe and instruct the patient to swallow. If the patient is unable to swallow or
if subclinical aspiration is suspected, the procedure is terminated immediately. If the patient swallows andbreathes properly, check if there is wet hoarseness in "a-." If there is choking or wet hoarseness, terminate
the test immediately and rate the patient’s condition at 3 points. If there is no choking or wet hoarseness,signal "swallow" and instruct the patient to swallow twice; if the patient can swallow twice within 30 seconds,
rate the patient at 5 points; if not, rate the patient at 4 points. To ascertain the voice quality before swallowing
the cold water, the patient vocalized before the procedure. If the evaluation score was 4 or more, twotrials were conducted; the worst of the two values was considered the grade. It is important to maintain theoral environment, especially in areas under the control of the glossopharyngeal and vagus nerves before
conducting the test. In addition to MWST, there are various other methods that vary the amount of water
to be consumed. In general, the WST increases the amount of water in stages and assesses whether thepatient can swallow without aspiration. In addition, tongue movement is also observed to assess the tongue
movement leading to chewing, for example, whether the tongue comes out when water is placed on the upper
lip.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Decided "none."The risk of bias summary

The risk of bias was judged to be "unlikely" because there were reports that did not describe the index tests
and reference standards.

Inconsistency and other We judged inconsistency to be "unlikely" because there were variations in sensitivity and specificity values
summaryreported in the papers.
Comment

The sensitivity and specificity of the MWST for aspiration detection were 0.71 and 0.43, respectively, in astudy of 84 post-stroke patients aged 58 years and older, and 0.58 and 0.72, respectively, in a study of 155
stroke patients.

Table 5: CQ5 qualitative systematic review
CQ

5

P

Is it advisable to screen for aspiration by FT (Food Test) for persons over 18 years of age, who are suspectedof having dysphagia?
Persons aged 18 years and older with suspected dysphagia

Index test

FT

Reference standard

VE or VF

Clinical context

One screening test for aspiration and pharyngeal residue that is widely used in hospitals, institutions, andhomes in Japan is the FT. The evaluation method is as follows. Using a teaspoon, place approximately 4
g of swallowing jelly on the dorsal anterior surface of the tongue and instruct the patient to swallow. The
method of conducting and judging the test is similar to that of MWST, with the difference that oral residues
after swallowing are the subject of evaluation. A score of 3 is given if there is moderate oral residue afterswallowing, and a score of 4 or higher is given if the patient can swallow without swallowing and there are no
oral residues. If the score is 4 or higher, two trials are conducted and the worst of the two values is used as
the grade. For FT, it is also important to keep the oral environment clean, especially the areas controlled by
the glossopharyngeal and vagus nerves, before conducting the test.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Decided "none."The risk of bias summary

Decided "none."

Inconsistency and other Since there was only one paper, it was judged to be "serious" in terms of imprecision.
summary
Comment

A study of 155 stroke patients showed a sensitivity of 0.80 and specificity of 0.39. The relevant literature is a
study of a small number of acute stroke patients at a single institution, and the precision of the results is low.

― 66 ―

References
1.
2.
3.

4.
5.
6.
7.

Oguchi K, Saitoh E, Baba M, et al. The Repetitive Saliva Swallowing Test (RSST) as a screening test of functional dysphagia (2) validity of RSST. Jpn J Rehabil Med 2000;37(6):383-388. (in Japanese)
Watanabe S. Factors associated with aspiration after stroke. The Aichi-Gakuin journal of dental science 2007;45(4):579590. (in Japanese)
Osawa A, Maeshima S, Tanahashi N. Food and liquid swallowing difficulty in stroke patients: a study based on the findings of food tests, a modified water swallowing test and videofluoroscopic examination of swallowing. Jpn J Rehabil Med
2012;49(11):838-845. (in Japanese)
Fukada J. Research on screening system for risk of dysphagia in the elderly. Jpn J Dysphagia Rehabil 2006;10:31-1042.
(in Japanese)
Brodsky MB, Suiter DM, Gonzalez-Fernandez M, et al. Screening accuracy for aspiration using bedside water swallow
tests: A systematic review and meta-analysis. Chest 2016; 150(1): 148-163.
Lim SH, Lieu PK, Phua SY, et al. Accuracy of bedside clinical methods compared with fiberoptic endoscopic examinationof swallowing (FEES) in determining the risk of aspiration in acute stroke patients. Dysphagia 2001; 16(1): 1-6.
Clave P, Arreola V, Romea M, et al. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal
dysphagia and aspiration. Clin Nutr 2008; 27(6): 806-815.

― 67 ―

4．CQ 6CQ 6
Is it advisable to screen for aspiration and pharyngeal residues by cervical auscultationin persons aged 18 years or older, who are suspected of having dysphagia?
1）Recommendations
Screening for aspiration and pharyngeal residues swallowing by cervical auscultation should be performed in individuals aged 18 years and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Education on screening for aspiration and pharyngeal residues is needed fornurses who perform cervical auscultation.

2）Background and purpose
RSST, MWST, FT, and cervical auscultation are used in hospitals and homes as screening tests for aspirationand pharyngeal residues swallowing in individuals aged 18 years or older who are suspected of having dysphagia.
Cervical auscultation is a physical assessment method in which a stethoscope is used to listen to breathing (tracheal sounds) before and after swallowing on the right and left sides of the neck (the skin just below the cricoid
cartilage on the outer side of the trachea) to determine whether there is aspiration or residual pharyngeal sounds.
This method is less burdensome for the patient and can be performed on patients with cognitive decline who areunable to follow instructions.
The sounds that can be auscultated at the neck are swallowing sounds produced in the pharynx during swallowing of food boluses and breath sounds produced before and after swallowing. The nature and length of theswallowing sounds and the nature and timing of breath sounds are used to determine dysphagia, primarily in thepharyngeal region of the patient. It is very important to ensure that the patient has a clear breath sound before
swallowing and to compare this sound with the breath sounds after swallowing. In a normal patient, a clear
breath sound can be heard before swallowing, followed by a respiratory pause with swallowing, a swallowing
sound, and a clear breath sound after swallowing. On the other hand, aspiration should be suspected if swallowing sounds, such as sputum with swallowing, or bubbling sounds are heard during swallowing, or if wet sounds,
sputum with swallowing, or wheezing-like breath sounds are heard immediately after swallowing. If respiratory
sounds, such as rinsing or vibrating liquids, are heard immediately after swallowing, pharyngeal retention should
be suspected.
A systematic review of the sensitivity and specificity of cervical auscultation was conducted by Lagarde et al.1),
which is also presented in "Assessment of Dysphagia 2019" by the Medical Review Committee of the JapaneseSociety of Dysphagia Rehabilitation. Six references were extracted, but they included articles on sensitivity andspecificity evaluated using questionnaires and oral function tests that evaluate cervical auscultation, sensitivity
and specificity determined using the presence or absence of dysphagia as the reference standard for cervical auscultation, and articles that were not limited to sensitivity and specificity for detecting aspiration and pharyngeal― 68 ―

residues.
We examined whether performing cervical auscultation in individuals aged 18 years or older suspected of having dysphagia contributes to improved outcomes for caregivers and the sensitivity and specificity of detecting
aspiration and pharyngeal residues from domestic and international literature. The reference standard for checking sensitivity and specificity was VF or VE.

3）Explanation
Cross-sectional observational studies or cohort studies were selected. Thirteen articles were used for the systematic review.2)-14)
Sensitivity and specificity were determined from 10 articles describing screening for aspiration based on the
results of respiratory and swallowing sounds obtained by cervical auscultation; for studies showing more than
one result, the best value was used for meta-analysis. The sensitivity was 0.83 (95% CI: 0.72–0.91), which indicates the proportion of those suspected of aspiration by cervical auscultation to those diagnosed with aspirationby VF/VE (the reference standard). Conversely, the combined specificity, which indicates the proportion of
those diagnosed as not having aspiration by cervical auscultation against those diagnosed as not having aspirationby VF/VE, was 0.79 (95% CI: 0.67–0.88). Both sensitivity and specificity are approximately 0.8; therefore, thesensitivity and specificity of screening were high.
The results of a meta-analysis of the sensitivity and specificity of screening for aspiration based on observations of respiratory and swallowing sounds by cervical auscultation showed that the sensitivity was 0.78 (95%
CI: 0.56–0.91) and 0.70 (95% CI: 0.53–0.83), respectively, and the specificity was 0.65 (95% CI: 0.67–0.88)
and 0.85 (95% CI: 0.54–0.97), respectively. A meta-analysis of the sensitivity and specificity of screening for
aspiration was not possible using cervical auscultation observations of both breath and swallow sounds because
the number of publications was small. Although the sensitivity of both breath and swallow sounds was greaterthan 0.70, the specificity of breath sounds was less than 0.70, and the sensitivity and specificity were not highbased on the 95% CIs for both.
We will take a closer look at the sensitivity and specificity of screening for aspiration by cervical auscultationfor (1) breath sounds, (2) swallow sounds, and (3) breath and swallowing sounds. Shaw et al.2) performed cervical auscultation during the swallowing of water, yogurt, etc., and VF within 1 h of swallowing in 105 patients
aged 17–96 years and found that the prevalence of aspiration was 38%, and the sensitivity of cervical auscultation in detecting aspiration was low, at 0.45 (95% CI: 0.29–0.62) and the specificity was high, at 0.88 (95% CI:
0.77–0.95). The sensitivities and specificities for detecting aspiration by food type were 0.38 (95% CI: 0.24–
0.54) and 0.90 (95% CI: 0.80–0.95) for water, respectively, and 0.33 (95% CI: 0.14–0.61), 0.93 (95% CI:
0.85–0.97) for yogurt. The sensitivity was low but the specificity was high. Similarly, Nozue et al.3) performed
cervical auscultation during VF with yogurt-containing barium in 46 patients aged 39-89 years. The prevalenceof aspiration was 35%, and the sensitivity and specificity of cervical auscultation in detecting aspiration were low,
at 0.58 (95% CI: 0.50–0.65) and 0.54 (95% CI: 0.49–0.59), respectively. On the other hand, Inoue et al.4), 5)
examined sensitivity and specificity in 105 patients, mainly in their 70s and 80s, who aspirated after VF withjelly, a yogurt-alike, or liquid barium, using cervical auscultation as a positive test if there were changes in breathsounds before and after swallowing. The risk of selection bias was high, with a sensitivity of 0.93 (95% CI:
0.83–0.98) and specificity of 0.79 (95% CI: 0.63–0.90). Watanabe et al.6), 7) performed cervical auscultation
while swallowing 3 mL of water on the same day as VF in 90 postoperative patients with oral cancer aged 64.5 ±― 69 ―

12.8 years, and found that the prevalence of aspiration was 37% and the sensitivity of detection was 0.91%(95% CI: 0.76–0.98) and specificity was 0.86 (95% CI: 0.74–0.94). In a study by Sugimoto et al.8) with a small
sample size, cervical auscultation was performed on 16 patients aged 13–91 years during VF using barium injelly and liquid form. The results showed that both sensitivity and specificity were high, at 0.80 (95% CI: 0.44–0.97) and 1.00 (95% CI:0.54–1.00), respectively.
Next, five articles determined aspiration by observing swallowing sounds using cervical auscultation. In the
aforementioned study by Watanabe et al.6), 7) the sensitivity was low, at 0.55 (95% CI: 0.36–0.72), and the specificity was high, at 0.96 (95% CI: 0.88–1.00). Conversely, in the study by Nozue et al.3), the sensitivity was high,
at 0.72 (95% CI: 0.65–0.79) and specificity was low, at 0.50 (95% CI: 0.44–0.55). Similarly, in a study by
Stroud et al.9), 16 patients aged 29–65 years underwent cervical auscultation during VF. The prevalence of aspiration was 19%, with a high sensitivity of detection of 0.93 (95% CI: 0.78–0.99) and low specificity of 0.56
(95% CI: 0.47–0.65). In one of the two studies with a high risk of selection bias and small sample size, Leslie etal.10) performed VF and cervical auscultation using a yogurt-alike and liquid barium in 10 healthy subjects aged
24–78 years and 10 stroke patients aged 65–90 years. The sensitivity was 0.80 (95% CI: 0.44–0.97) and specificity was 0.90 (95% CI: 0.55–1.00). On the other hand, Santamato et al.11) performed VE with 10 mL of waterand cervical auscultation on 15 patients with dysphagia in the age group of 56–80 years, and found that theprevalence of aspiration and penetration was 53%, but the sensitivity of detection was low, at 0.50 (95% CI:
0.16–0.84) and specificity was high, at 1.00 (95% CI: 0.59–1.00). In studies that determined aspiration byobserving swallowing sounds, there was a trade-off between sensitivity and specificity.
Three studies determined aspiration by both swallow and breath sounds using cervical auscultation. In the
aforementioned study by Nozue et al.3), the sensitivity was high 0.82 (95% CI: 0.76–0.87) and the specificity
was low 0.47 (95% CI: 0.42–0.52). Caviedes et al.12) performed cervical auscultation with VE while swallowing
jelly in 63 patients aged 70 ± 17 years with cerebrovascular disease admitted to the ICU, and found that theprevalence of aspiration was 27%, with the sensitivity of detection of 0.82 (95% CI: 0.57–0.96) and specificity
of 0.80 (95% CI: 0.66–0.91); both values were high. In a study by Borr et al.13) with a high risk of selection bias,
14 dysphagic patients with aspiration and penetration aged 44–89 years, 25 young and 25 elderly patients were
subjected to neck auscultation during VF while swallowing 10 mL water. The sensitivity was 0.94 (95% CI:
0.88–0.98) and specificity was 0.70 (95% CI: 0.63–0.77); both values were high.
The sensitivity and specificity of screening for aspiration using cervical auscultation tended to be higher whenusing results from both swallowing and breath sounds, and the sensitivity and specificity of detecting aspiration
using only breath or swallow sounds were not high. Inaccuracy was judged as "none" and publication bias as"unlikely" The overall strength of evidence, including intra-rater and inter-rater reliability, was judged to be C
(weak).
One study determined pharyngeal residue after swallowing by breath sounds using neck auscultation. In the
study by Tamura et al.14), the sample size was small, and they performed cervical auscultation during VF andwhile swallowing barium jelly in 8 patients aged 78.4 ± 12.8 years requiring nursing care with dysphagia due tosequelae of cerebrovascular disease. The prevalence of residual pharyngeal sounds was 63%, with a sensitivity of
0.60 (95% CI: 0.15–0.95) and specificity of 0.67 (95% CI: 0.09–0.99); both the values were low. Imprecision
was judged as "serious" and publication bias as "none" Therefore, we judged the strength of the evidence to be
D (very weak).
During the panel meeting to determine the recommendation, in addition to the certainty of the evidence, the― 70 ―

main issues discussed were cost, subject intention, the burden on the subject, reliability and feasibility of theassessment method, and indirectness of the studies included in the systematic review. We would like to recommend cervical auscultation as a screening method because it can be performed as a part of the physical assessment with little time and cost, and if the risk of aspiration and pharyngeal residue is detected at an early stage,
the benefit to the caregiver is great. However, education is necessary to accurately determine the respiratory andswallowing sounds that indicate aspiration. In the study by Nozue3), the Kappa coefficients for intra-rater reliability of respiratory sounds, swallowing sounds, and both were 0.47 (moderate), 0.64 (good), and 0.60 (good),
respectively. In the study by Leslie et al.10), the Kappa coefficient for intra-rater reliability of swallowing sounds
was 0.35 (fair, on average), while the kappa coefficient for inter-rater reliability was much lower at 0.17 (poor).
Similarly, in the study by Stroud et al.9), the Kappa coefficient for intra-rater reliability of cervical auscultation
was 0.55 (moderate), while the kappa coefficient for inter-rater reliability was low, at 0.28 (fair). These suggest
the need for education on cervical auscultation assessment. Because the cervical auscultation method is not limited by the type of liquid or food, it is unlikely that its implementation would be significantly different from theintentions of the caregivers. Results of the voting indicated that 8 out of 9 participants voted for "weak recommendation to perform" and 1 voted for "strong recommendation to perform," with 89% in favor of "weak recommendation to perform."
Based on the above, the strength of the recommendation and evidence for this CQ is GRADE 2C (strengthof recommendation: weak, certainty of evidence (strength): weak).
The facilitating factor in the application of this medical guideline is that the cervical auscultation method canbe performed with a stethoscope and by nurses. The inhibiting factor is that it requires experience and education
to conduct the assessment.

4）Database search results
Aspiration pneumonia, aspiration, auscultation, cervical, deglutition disorder, dysphagia pharynx, oropharynx, pneumonia, residue, stethoscopes, swallowing sound, (swallowing, dysphagia, dysphagia, aspiration, aspiration pneumonia, intraglottic aspiration, aspiration pneumonia, residual, screening, auscultation, pneumonia,
evaluation [in Japanese]) were used as keywords. The databases included PubMed (until August 31, 2019),
Embase (until August 31, 2019), CINAHL (until August 31, 2019), Cochrane Library (until August 31, 2019),
and Ichushi-Web (until August 31, 2019). A total of 336 studies were identified, and 13 observational studies
were recruited after screening. The database search formulae are included in the appendix.

― 71 ―

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 330)

Additional records identiﬁed
through other sources (n = 6)

Records screened (1st Screening)(n = 336)

Records excluded(n = 289)

Full-text articles assessed for eligibility(2nd Screening) (n = 47)

Full-text articles
excluded withreasons (n = 34)

Studies included in qualitative synthesis(n = 13)

Studies included in quantitativesynthesis (meta-analysis) (n = 10)

Figure 1: Literature search flowchart― 72 ―

6）List after secondary screening
Table 1: List after secondary screening
Literature

ReferencestandardO

DesignP

Index test

Shaw, 2004

Cross-sectional
study

Adults who underwent
VF testing

Bronchial auscultation
by PT and observationof clinical signs ofaspiration by SLPs

VF

Sensitivity andspecificity of aspiration
and aspiration risk
detection

Inoue, 2007

Cross-sectional
study

Adults who underwent
VF testing

Cervical auscultation

VF

Sensitivity andspecificity of aspiration
detection

Inoue, 2005

Cross-sectional
study

The average age ofpatients who underwent
VF examination was
72.2 years

Confirmation ofchanges in breathsounds by cervicalauscultation

VF

Sensitivity andspecificity of aspiration
detection

Sugimoto, 2010

Cross-sectional
study

Patients (13–91 years)
who underwent VF
examination

Cervical auscultation

VF

Sensitivity andspecificity of aspiration
detection

Caviedes, 2010

Prospective
observational
study

ICU patients (averageage: 70 years)

Cervical auscultation(and other methods)

V-E

Sensitivity andspecificity of aspiration
detection

Watanabe, 2006

Cross-sectional
study

Postoperative patientswith oral cancer
who underwent VF
examination andscreening tests

Cervical auscultation,
RSST, MWSTVF

Sensitivity andspecificity of aspiration
detection

Ohshige, 2012

Cross-sectional
study

Postoperative oral
cancer patients

Cervical auscultation

VF

Sensitivity andspecificity of aspiration
detection

Borr, 2007

Cross-sectional
study

Patients with dysphagia(mean age: 71 years)
and healthy subjects(25–44 years, 60–97
years)

Analysis of soundwaveforms obtained
from cervicalauscultation

VF

Sensitivity andspecificity of aspirationand penetration
detection

Leslie, 2004

Cross-sectional
study

Healthy volunteers(24–78 years) andstroke patients (65–90
years)

Cervical auscultation

VF

Agreement of aspirationand penetration
detection results amongratersSantamato, 2009 Cross-sectional
study

Patients with dysphagia(mean age: 73.1 years)

Analysis of soundobtained frommicrophones

VE

Sensitivity andspecificity of detectionof aspiration andpenetration

Stroud, 2002

Cross-sectional
study

Patients with dysphagia(29–65 years)

Cervical auscultation

VF

Agreement in aspiration
detection results
between raters

Nozue, 2017

Cross-sectional
study

Dysphagic patients aged Cervical auscultation
39–89 years

VF

Sensitivity andspecificity of detectionof aspiration andpenetration

Tamura, 2008

Cross-sectional
study

Dysphagia due
Food observation andto sequelae of
cervical auscultation
cerebrovascular disease

VF

Residual laryngeal
trough and pyriform
fossa after swallowing― 73 ―

Exclusion

Comment7）List of included papers
Table 2: List of included papers
Included
papersShaw JL, Sharpe S, Dyson SE, etal.

Bronchial auscultation: an effective adjunct to speech and language therapy bedside assessment when
detecting dysphagia and aspiration? Dysphagia 2004; 19(4):211-218.

Included
papersInoue T, Suzuki N.

Physical evaluation during aspiration: Correlation between the results of swallowing angiography, neckauscultation, and breath sound auscultation. J Jpn Soc Res Care Rehab 2007; 17(1):50-56.

Included
papersInoue T, Suzuki N, Deguchi H, et Efficacy of respiratory and cervical auscultation sound assessment during small volume aspiration. J Jpnal.
Soc Food Swallow Rehab 2005; 9: 413-414.

Included
papersSugimoto M, Hara Y, Inaba M, et Determination of aspiration with cervical auscultation and swallowing angiography. Intravenous enteralal.
nutrition 2010; 25(1):1269.

Included
papersCaviedes IR, Lavados PM, Hoppe Nasolaryngoscopic validation of a set of clinical predictors of aspiration in a critical care setting. J
AJ, et al.
Bronchology Interv Pulmonol 2010;17(1):33-38.

Included
papersWatanabe S, Ohshige H, Miyachi Screening tests for dysphagia in postoperative oral cancer patients. Tokeibu Gan 2006; 32(1):34-39.
H, et al.

Included
papersBorr C, Hielscher-Fastabend M,
Lücking A.

Reliability and validity of cervical auscultation. Dysphagia 2007; 22(3):225-234.

Included
papersLeslie P, Drinnan MJ, Finn P, etal.

Reliability and validity of cervical auscultation: A controlled comparison using videofluoroscopy.
Dysphagia 2004; 9(4):231-240.

Included
papersSantamato A , Panza F, Solfrizzi V, Acoustic analysis of swallowing sounds: A new technique for assessing dysphagia. J Rehabil Med 2009;
et al.
41(8):639-645.

Included
papersStroud AE, Lawrie BW, Wiles
CM.

Inter-and intra-rater reliability of cervical auscultation to detect aspiration in patients with dysphagia. Clin
Rehabil 2002; 16(6):640-645.

Included
papersNozue S, Ihara Y, Takahashi K,
Harada Y, Takei Y, Yuasa K,
Yokoyama K.

Accuracy of cervical auscultation in detecting the presence of material in the airway. Clin Exp Dent Res
2017; 3(6):209-214.

Included
papers

Tamura F, Kikutani T, Suda M,
et al.

Relationship between dietary observation evaluation and VF test evaluation of eating and swallowing
function in persons requiring nursing care. Geriatric Denti 2008; 23(1):50-55.

― 74 ―

8）Qualitative systematic review
Table 3: Qualitative systematic review
CQ

6

P

Is it advisable to screen for aspiration and pharyngeal residues by cervical auscultation in persons aged 18
years or older, who are suspected of having dysphagia?
Persons over 18 years of age with a suspected dysphagia

I

Cervical auscultationC

VF or VE

Clinical context

In Japan, RSST (Repetitive Saliva Swallowing Test), MWST (Modified Water Swallowing Test), FT (FoodTest), and cervical auscultation are used as screening tests for aspiration and pharyngeal residues in hospitals
and homes. Among these, cervical auscultation is a physical assessment method in which a stethoscope isused to listen to the breathing (tracheal sounds) before and after swallowing on the right and left sides of
the neck (the skin just below the cricoid cartilage on the outer side of the trachea) to determine if thereis aspiration or residual pharyngeal sounds. This method is less burdensome for the patient and can be
performed on patients with cognitive decline who are unable to follow instructions. The sounds that can be
auscultated at the neck are the swallowing sounds produced in the pharynx during the swallowing of foodand the breathing sounds before and after swallowing. The nature and length of the swallow sounds and thenature and timing of the breath sounds are used to determine dysphagia, primarily in the pharyngeal regionof the patient. It is very important to make sure that the patient has a clear breath sound before swallowing
and compare this sound with the breath sound after swallowing. In a normal patient, a clear breath sound canbe heard before swallowing, followed by a respiratory pause with swallowing, a swallowing sound, and a clear
breath sound after swallowing. On the other hand, aspiration should be suspected if swallowing sounds, suchas sputum with swallowing, and bubbling sounds are heard during swallowing, or if wet sounds, sputum withswallowing, and wheezing-like breath sounds are heard immediately after swallowing. If respiratory sounds,
such as rinsing or vibrating liquid, are heard immediately after swallowing, pharyngeal retention should besuspected.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Studies that included healthy subjects were also included, and indirectness was "unlikely."

The risk of bias summary

The risk of bias was "unlikely" because the examiners may not have been blinded or we were unsure if they
were blinded from the index test or reference standard results.

Inconsistency and othersummary

Sensitivity and specificity varied, and inconsistency was "unlikely."

Comment

The sensitivity and specificity of screening for aspiration using cervical auscultation tend to be higher when
the results of both swallowing and breath sounds are used, but the sensitivity and specificity are not as highwhen aspiration is detected using only breath sounds or only swallowing sounds.

O2

Sensitivity and specificity of detection of the pharyngeal residues (true positive, true negative, false positive,
false negative)

Summary of indirectness

Decided "none."The risk of bias summary

Based on the results of the reference standard test for the index examiners, it was not stated whether they
were blinded or not, and "unlikely" was selected.

Inconsistency and othersummary

The imprecision was judged to be "serious" because there was only one paper.

9）Meta-analysis
We performed a meta-analysis of 10 articles describing screening for aspiration based on the results of breathsounds, swallow sounds, and breath and swallow sounds by cervical auscultation. For studies showing more than
one result, the best value was used for the meta-analysis. The sensitivity of those suspected of having aspiration
by cervical auscultation against the proportion of those diagnosed with aspiration by VF/VE as the reference
standard was 0.83 (95% CI: 0.72–0.91). Conversely, the combined specificity, which indicates the proportionof those diagnosed as not having aspiration by cervical auscultation to those diagnosed as having aspiration by
VF/VE, was 0.79 (95% CI: 0.67–0.88) (Figure 2).
A meta-analysis of the sensitivity and specificity of screening for aspiration based on the results of respiratory
and swallowing sounds using cervical auscultation showed that the sensitivity was 0.78 (95% CI: 0.56–0.91) and
0.70 (95% CI: 0.53–0.83), respectively, and the specificity was 0.65 (95% CI: 0.67–0.88) and 0.85 (95% CI:
0.54–0.97), respectively (Figures 3 and 4).

― 75 ―

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Borr 2007

110

54

7

126

0.94 [0.88, 0.98]

0.70 [0.63, 0.77]

Caviedes 2010

14

9

3

37

0.82 [0.57, 0.96]

0.80 [0.66, 0.91]

Inoue 2005, 2007

62

8

5

30

0.93 [0.83, 0.98]

0.79 [0.63, 0.90]

Leslie 2004

8

1

2

9

0.80 [0.44, 0.97]

0.90 [0.55, 1.00]

Nozue ES+SS 2017 157

191

35

169

0.82 [0.76, 0.87]

0.47 [0.42, 0.52]
1.00 [0.59, 1.00]

Santamato 2009

4

0

4

7

0.50 [0.16, 0.84]

Shaw 2004

18

8

22

57

0.45 [0.29, 0.62]

0.88 [0.77, 0.95]

Stroud 2002

28

57

2

73

0.93 [0.78, 0.99]

0.56 [0.47, 0.65]

Sugimoto 2010

8

0

2

6

0.80 [0.44, 0.97]

1.00 [0.54, 1.00]

Watanabe ES 2006, Ohshige ES 2012 30

8

3

49

0.91 [0.76, 0.98]

0.86 [0.74, 0.94]

336

85

563

0.83 [0.72, 0.91]

0.79 [0.67, 0.88]

Total

439

Speciﬁcity (95% CI)

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

1

0

0.2

0.4

0.6

0.8

1

Figure 2: Comparison of the sensitivity and specificity of screening for aspiration using cervical auscultation.
Note: ES, expiratory sound; SS, swallowing sound; TP, true positive; FP, false positive; FN, false negative; TN, true negative.

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Inoue 2005, 2007

62

8

5

30

0.93 [0.83, 0.98]

0.79 [0.63, 0.90]

Nozue ES 2017 111

0.54 [0.49, 0.59]

165

81

195

0.58 [0.50, 0.65]

Shaw 2004

18

8

22

57

0.45 [0.29, 0.62]

0.88 [0.77, 0.95]

Sugimoto 2010

8

0

2

6

0.80 [0.44, 0.97]

1.00 [0.54, 1.00]

Watanabe ES 2006, Ohshige ES 2012 30
Total

229

8

3

49

0.91 [0.76, 0.98]

0.86 [0.74, 0.94]

189

113

337

0.78 [0.56, 0.91]

0.65 [0.67, 0.88]

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

Speciﬁcity (95% CI)

1

0

0.2

0.4

0.6

0.8

1

Figure 3: Comparison of sensitivity and specificity of screening for aspiration using cervical auscultation(breath sounds)
Note: ES, expiratory sound; TP: true-positive; FP: false-positive; FN: false-negative; TN: true-negative.

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Leslie 2004

8

1

2

9

0.80 [0.44, 0.97]

0.90 [0.55, 1.00]

Nozue ES 2017 139

0.50 [0.44, 0.55]

181

53

179

0.72 [0.65, 0.79]

Santamato 2009

4

0

4

7

0.50 [0.16, 0.84]

1.00 [0.59, 1.00]

Stroud 2002

28

57

2

73

0.93 [0.78, 0.99]

0.56 [0.47, 0.65]

2

15

55

0.55 [0.36, 0.72]

0.96 [0.88, 1.00]

241

76

323

0.70 [0.53, 0.83]

0.85 [0.54, 0.97]

Watanabe SS 2006, Ohshige SS 2012 18
Total

197

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

Speciﬁcity (95% CI)

1

0

0.2

0.4

0.6

0.8

1

Figure 4: Comparison of the sensitivity and specificity of screening for aspiration using cervical auscultation (swallowing sounds)
Note: ES, expiratory sound; SS, swallowing sound; TP: true-positive; FP: false-positive; FN: false-negative; TN: true-negative.

― 76 ―

References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.

Lagarde ML, Kamalski DM, van den Engel-Hoek L. The reliability and validity of cervical auscultation in the diagnosis ofdysphagia: A systematic review. Clin Rehabil 2016; 30(2): 199-207.
Shaw JL, Sharpe S, Dyson SE, et al. Bronchial auscultation: an effective adjunct to speech and language therapy bedsideassessment when detecting dysphagia and aspiration? Dysphagia 2004; 19(4): 211-218.
Nozue S, Ihara Y, Takahashi K, et al. Accuracy of cervical auscultation in detecting the presence of material in the airway.
Clin Exp Dent Res 2017; 3(6): 209-214.
Inoue T, Suzuki N. Physical assessment during aspiration correlation of videofluoroscopy results with cervical auscultation
and breath sound auscultation judgment. J Jpn Soc Respir Care Rehabil. 2007;17:50-56. (in Japanese)
Inoue T, Suzuki N, Deguchi H, et al. Efficacy of respiratory and cervical auscultation sound evaluation during small dose
aspiration. Jpn J Dysphagia Rehabil 2005;9:413-414. (in Japanse)
Watanabe S, Ohshige H, Miyachi H, et al. A screening method for dysphagia after oral cancer surgery. Head Neck Canc
2006;32:34-39. (in Japanese)
Ohshige H, Miyachi H, Watanabe S, et al. Screening tests for dysphagia in postoperative oral cancer patients. Hosp Dent
(Tokyo) 2012; 24(2): 149-155.
Sugimoto M, Hara Y, Inaba M, et al. Determining aspiration with cervical auscultation and videofluoroscopy. J Jpn Soc
Parent Ent Nutrition. 2010;25:1269. (in Japanse)
Stroud AE, Lawrie BW, Wiles CM. Inter-and intra-rater reliability of cervical auscultation to detect aspiration in patientswith dysphagia. Clin Rehabil 2002; 16(6): 640-645.
Leslie P, Drinnan MJ, Finn P, et al. Reliability and validity of cervical auscultation: A controlled comparison using videofluoroscopy. Dysphagia 2004; 19(4): 231-240.
Santamato A, Panza F, Solfrizzi V, et al. Acoustic analysis of swallowing sounds: A new technique for assessing dysphagia.
J Rehabil Med 2009; 41(8): 639-645.
Caviedes IR, Lavados PM, Hoppe AJ, et al. Nasolaryngoscopic validation of a set of clinical predictors of aspiration in a
critical care setting. J Bronchology Interv Pulmonol 2010; 17(1): 33-38.
Borr C, Hielscher-Fastabend M, Lücking A. Reliability and validity of cervical auscultation. Dysphagia 2007; 22(3): 225234.
Tamura F, Kikutani T, Suda M, et al. Relationship between dietary observation evaluation and eating and swallowing
function evaluation by VF test in individuals certified for long-term care. Jpn J Gerodont 2008;23:50-55. (in Japanese)― 77 ―

5．CQ 7CQ 7
For persons over 18 years of age suspected of having dysphagia, is it advisable for anurse who has undergone an educational program to screen for aspiration and pharyngeal residues by observation with an ultrasound diagnostic device?
1）Recommendations
We propose that persons aged 18 years or older, who are suspected of having
dysphagia, receive training in aspiration and pharyngeal residue observation using
an ultrasound diagnostic device, and that persons who have been certified bytheir instructors as being at a level where they can practice aspiration and pharyngeal residue observation techniques using ultrasound diagnostic devices arescreened for aspiration using ultrasound diagnostic devices in facilities and homevisit nursing agencies equipped with ultrasound diagnostic devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.

2）Background and purpose
A definitive diagnosis of dysphagia is made at medical institutions using VF and VE. At home, endoscopic
swallowing observation is used because VF is not available. The endoscope allows the observation of the swallowing function, organic lesions, aspiration, penetration, and residues. However, aspiration cannot be directly
observed because of whiteout. In contrast, observation with an ultrasound device can confirm the presence orabsence of aspiration and residual aspiration with a minimally invasive observation method. Therefore, it isadvisable to first screen for aspiration and pharyngeal residue using minimally invasive ultrasound and then proceed to endoscopic observation if a more detailed observation is considered necessary.
For the screening of patients with dysphagia based on the swallowing function, the The Oto-Rhino-Laryngological Society of Japan has published the "Guidelines for the Treatment of Dysphagia, 2018 Edition."1) This
guideline does not mention observation with an ultrasound diagnostic device. The Japanese Society of Dysphagia Rehabilitation and Medical Review Committee published "Evaluation of Dysphagia 2019" 2) This manual
mainly describes various evaluation methods for dysphagia used in Japan, but does not mention observation
using an ultrasound device. Outside Japan, the National Clinical Guideline for Oropharyngeal Dysphagia
screening and assessment and selected initiatives, such as SST (DK) - Danish Health Authority3) does not mention screening with ultrasound devices.
Therefore, in this CQ, we examined evidence from the domestic and international literature on the sensitivity
and specificity of screening for dysphagia (aspiration, pharyngeal residues) by observation with an ultrasound― 78 ―

device, mainly in patients aged 18 years or older suspected of having dysphagia. The reference standard forchecking sensitivity and specificity was VF or VE.

3）Explanation
Cross-sectional observational studies or cohort studies were selected. The articles used in this systematic
review were four cross-sectional studies on screening with ultrasound devices for the detection of aspiration and
one cross-sectional study for the detection of pharyngeal residue.
One study observed movement of the hyoid bone, one study observed movement of the tongue, and threestudies observed aspiration or residual food bolus or liquid in the trachea, all of which were observed with anultrasound device.
A study4) in which the movement of the hyoid bone during swallowing was observed using an ultrasounddevice was conducted on 52 patients with dysphagia (86.5% of them were stroke patients) aged 61.2 ± 16.4
years in the rehabilitation department of a general hospital in Korea. The prevalence of aspiration and penetration was 60%. The distance traveled by the hyoid bone was observed using an ultrasound system in B-mode
during swallowing of 5 mL of liquid with contrast medium in an upright, neck-straight position. The results
showed that the sensitivity and specificity of detection of aspiration were 0.84 (95% CI: 0.66–0.95) and 0.81
(95% CI: 0.58–0.95), respectively, with the reference standard being VF performed on the same day, with thecutoff point being 13.5 mm. The sensitivity and specificity values were high.
In another study, the vertical movement of the tongue associated with swallowing saliva or liquid was measured in 100 acute stroke patients aged 72.2 ± 10.7 years in a 30-degree head-up position using an ultrasoundmachine in M-mode5). The prevalence of dysphagia was found to be 24%. When the reference standard was VF
and the cutoff point was the velocity of the upward movement of the tongue during swallowing (63.55 Âmm/s), the sensitivity for detecting aspiration was 0.83 (95% CI: 0.63–0.95) and the specificity was 0.88 (95%
CI: 0.79–0.94). Both were high.
A study of aspiration mass detection was conducted in the outpatient dysphagia clinic of a general hospital in
Japan.6) Seventeen dysphagic patients aged 70 ± 7.6 years were asked to swallow thickened liquids and solids,
and an ultrasound device was used to detect aspirated boluses in the trachea using B-mode. Using VF/VE as thereference standard, the sensitivity of aspiration was low, at 0.64 (95% CI: 0.31–0.89), and the specificity was
high, at 0.84 (95% CI: 0.66–0.95).
In addition, a study7) attempted to increase the sensitivity of aspiration by adding image processing to theseimages. Seventeen patients in an outpatient eating and swallowing clinic were asked to swallow thickened liquids
and solids, and when they underwent VE or VF, B-mode video was simultaneously captured with an ultrasoundmachine. The images were processed to sharpen the images and colorize the aspiration findings for observation.
The sensitivity for aspiration detection was 0.91 (95% CI: 0.59–1.00) and the specificity was 0.94 (95% CI:
0.79–0.99). The researchers noted that aspiration of low-viscosity liquids was particularly difficult to detect by
naked eye observation alone because of the short detection time.
A meta-analysis of four studies on aspiration detection by ultrasound showed a high sensitivity of 0.82 (95%
CI: 0.72–0.89) and specificity of 0.87 (95% CI: 0.81–0.92). All studies showed no or low-risk factors thatmight reduce the quality of evidence. Of the studies included in the systematic review, two of four studies were
performed by physicians and two were performed by nurses. We did not downgrade the evidence due to indirectness because the quality of the assessments was considered to be assured if the nurses had received an educa-― 79 ―

tional program on how to perform and observe ultrasound examinations and had been certified by their supervisors as being able to perform them. Uncertainty was judged as "none" and publication bias as "unlikely." As aresult, the certainty (strength) of the evidence was judged to be C (weak).
Regarding pharyngeal residue, there is a study8) in which the nurses attempted to detect pharyngeal residue
with an ultrasound diagnostic device in nine patients, over the age of 60, who swallowed thickened liquids andsolids in an outpatient swallowing clinic at a general hospital in Japan. 8) In the case of pharyngeal residues, theultrasound system showed a high echo area on the vocal cords. Using VE as the reference standard, the prevalence of pharyngeal residue was 68%, and the sensitivity and specificity of the ultrasound system for detecting
pharyngeal residue were both low, at 0.62 (95% CI: 0.32–0.86) and 0.67 (95% CI: 0.22–0.96), respectively.
For residues in the pharynx, only one study was included in the systematic review, and the number of subjects
was small. Therefore, we judged the factors that might reduce the quality of evidence to be "serious" for imprecision and "none" for publication bias. The final strength of the evidence was judged to be D (very weak).
The overall strength of evidence for the sensitivity and specificity of screening for dysphagia using ultrasounddevices was C (weak) because there are only a few studies available for systematic review9) and the number ofsubjects for both aspiration and residues in the pharynx is small.
In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine therecommendation were the potential for disadvantages to the subject, cost, subject intentions, reliability and feasibility of the assessment methods, and non-directiveness of the studies included in the systematic review. Regarding the strength of the recommendation, patients with false-positive results as a result of observations on ultrasound devices may be subjected to unnecessary VE or VF testing or dietary restrictions. Patients with false-negative results are at risk of being offered diets that are not appropriate for their swallowing function, which may be
detrimental. Therefore, efforts should be made to reduce the number of false positives and false negatives basedon dietary observations and other screening results, even if this increases the time and effort spent on testing.
Although it is costly to install an ultrasound system, it is relatively easy to implement screening in facilities
where ultrasound systems are used for other purposes. However, it is essential to educate the implementers totake images and make decisions that will enable screening. Results of the voting indicated that 5 of the 8 members voted for "weak recommendation,"2 for "strong recommendation," and 1 for "no recommendation." Of all
the members, 63% voted in favor of the proposal, which was not enough to reach the standard of 2/3 approval.
However, since it is a less-invasive test and the benefits are expected to outweigh the disadvantages, and since thecost of the test may demotivate with the use of the test, it was decided to provide a "weak recommendation for
implementation" to promote the use of the test in clinical practice in the future.
Based on the above, the strength of the recommendation and evidence for this CQ is GRADE 2C (strengthof recommendation: weak, certainty of evidence (strength): weak).

4）Database search results
Aspiration pneumonia, aspiration, assess, evaluate, deglutition disorders, deglutition, swallow, dysphagia, echo
tomograph, echography, sonography, echotomography, esophagus, pharynx, oropharynx, pneumonia, screening,
predict, test, tests, detect, ultrasonography, ultrasound, (swallowing disorders, swallowing pneumonia, intra-airway aspiration, aspiration pneumonia, test, detect, aspiration, aspiration pneumonia, screening, residual, ultrasound, pneumonia-swallowing, evaluation (in Japanese), were used as keywords. The databases used were
PubMed (until August 31, 2019), Embase (until August 31, 2019), CINAHL (until August 31, 2019),― 80 ―

Cochrane Library (until August 31, 2019), and Ichushi-Web (until August 31, 2019). As a result, 770 studies
were identified, and five observational studies were recruited after screening. The database search formulas areincluded in the appendix.

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 770)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 770)

Records excluded(n = 707)

Full-text articles assessed for eligibility(2nd Screening) (n = 63)

Full-text articles
excluded withreasons (n = 58)

Studies included in qualitative synthesis(n = 5)

Studies included in quantitativesynthesis (meta-analysis) (n = 4)

Figure 1: Literature search flowchart6）List after secondary screening
Table 1: List after secondary screening
Literature

DesignP

Index test

ReferencestandardO

Miura, 2014 Cross-sectional
study

Persons 60 years ofage or older who haveundergone VE or VF
testing

Assessing the presenceof aspiration by looking
at processed ultrasoundimages

VE/VF

Sensitivity andspecificity of aspiration
detection

Miura, 2014 Cross-sectional
study

Patients with dysphagia

Determining aspiration
with ultrasound device

VE/VF

Sensitivity andspecificity of aspiration
detection

Lee, 201652 patients withdysphagia

VF
Using an ultrasoundmachine, calculating the
distance of hyoid bone
movement and comparing
it with healthy subjects, anddetecting penetration andaspiration.

Sensitivity andspecificity of predicting
penetration andaspiration

Tomii, 2011 Cross-sectional
study

Stroke patients withdysphagia

Speed of tongue movement VF
measured in M-mode.

Sensitivity andspecificity of aspiration
detection

Miura, 2016 Cross-sectional
study

Those who have beentested by VE

Ultrasound system detects
the presence of residue inthe epiglottic valley

Sensitivity andspecificity of pharyngeal
residue detection

Cross-sectionalstudy― 81 ―

VE

Exclusion

Comment7）List of included papers
Table 2: List of included papers
Included
papersLee YS, Lee KE, Kang Y, et al.

Usefulness of submental ultrasonographic evaluation for dysphagia. Ann Rehabil Med 2016; 40(2):197205.

Included
papersTomii Y, Matsuoka H, Torii T, et A new ultrasound method for evaluating dysphagia in acute stroke patients. Int J Stroke 2011; 6(3):279al.
280.

Included
papersMiura Y, Nakagami G, Yabunaka Method for detection of aspiration based on B-mode video ultrasonography. Radiol Phys Technol 2014;
K, et al.
7(2):290-295

Included
papersMiura Y, Nakagami G, Yabunaka Method for detecting aspiration based on image processing-assisted B-mode video ultrasonography. J
K, et al.
Nurs Sci Engineer 2014; 1(1):12-20

Included
papersMiura Y, Nakagami G, Yabunaka Detecting pharyngeal post-swallow residue by ultrasound examination: a series. Med Ultrason 2016;
K, et al.
18(3):288-293

8）Qualitative systematic review
Table 3: Qualitative systematic review
CQ

7

P

For persons over 18 years of age suspected of having dysphagia, is it advisable for a nurse who has undergone
an educational program to screen for aspiration and pharyngeal residues by observation with an ultrasounddiagnostic device?
Persons over 18 years of age with suspected dysphagia

I

Observation with an ultrasound diagnostic deviceC

VF or VE

Clinical context

Observation with an ultrasound diagnostic device is a minimally invasive method to check for aspirationand pharyngeal residue. Therefore, it is advisable to first screen for aspiration and pharyngeal residue by
minimally invasive ultrasound observation and then proceed to endoscopic observation if a more detailed
observation is necessary.

O1

True positives, true negatives, false positives, and false negatives in aspiration detection

Summary of indirectness

Decided "none."The risk of bias summary

In some cases, the examiners were not blinded to the results of the index test or reference standard, or it was
unclear whether they were blinded; hence, the risk of bias was judged to be "unlikely."

Inconsistency and other Sensitivity and specificity varied, and inconsistency was judged to be "unlikely."summary
Comment

All studies had no or low risk of factors that might reduce the quality of evidence but had small sample sizes
and low precision.

O2

True positives, true negatives, false positives, and false negatives in the detection of pharyngeal residue

Summary of indirectness

Decided "none."The risk of bias summary

It was unclear whether the examiners were blinded to the results of the reference standard, and the risk ofbias was determined to be "unlikely."

Inconsistency and other The inaccuracy was judged to be "serious" because only one paper was included in the study.
summary
Comment

Only one paper was included in the study and the sample size was small.

9）Meta-analysis
A meta-analysis of four studies that focused on the detection of aspiration by an ultrasound device showed asensitivity of 0.82 (95% CI: 0.72–0.89) and a specificity of 0.87 (95% CI: 0.81–0.92) (Figure 2).

― 82 ―

Study

TP

FP

FN

TN

Sensitivity (95% CI)

Speciﬁcity (95% CI)

Lee 2016

26

4

5

17

0.84 [0.66, 0.95]

0.81 [0.58, 0.95]

Miura 2014a

7

5

4

26

0.64 [0.31, 0.89]

0.84 [0.66, 0.95]

Miura 2014b

10

2

1

29

0.91 [0.59, 1.00]

0.94 [0.79, 0.99]

Tomii 2011

20

9

4

67

0.83 [0.63, 0.95]

0.88 [0.79, 0.94]

Total

63

20

14

139

0.82 [0.72, 0.89]

0.87 [0.81, 0.92]

Speciﬁcity (95% CI)

Sensitivity (95% CI)

0

0.2

0.4

0.6

0.8

1

0

0.2

0.4

0.6

0.8

1

Figure 2: Comparison of sensitivity and specificity of screening for aspiration using an ultrasound diagnostic device.
Note: TP: true positive; FP: false positive; FN: false negative; TN: true negative.

References
1.
2.
3.
4.
5.
6.
7.
8.
9.

The Oto-Rhino-Laryngological Society of Japan. Clinical practice guidelines for the diagnosis and management of dysphagia, 2018. Kanehara Publishing, Tokyo, 2018.
The Japanese Society of Dysphagia Rehabilitation. Medical Review Committee. Evaluation of Dysphagia. 2019.
https://www.jsdr.or.jp/wp-content/uploads/file/doc/assessment2019-announce.pdf
National clinical guideline for oropharyngeal dysphagia – screening, assessment and selected initiatives. Danish Health
Authority, Copenhagen, 2016.
Lee YS, Lee KE, Kang Y, et al. Usefulness of submental ultrasonographic evaluation for dysphagia. Ann Rehabil Med
2016; 40(2): 197-205.
Tomii Y, Matsuoka H, Torii T, et al. A new ultrasound method for evaluating dysphagia in acute stroke patients. Int J
Stroke 2011; 6(3): 279-280.
Miura Y, Nakagami G, Yabunaka K, et al. Method for detection of aspiration based on B-mode video ultrasonography.
Radiol Phys Technol 2014; 7(2): 290-295.
Miura Y, Yabunaka K, Nakagami G, et al. Method for detecting aspiration based on image processing-assisted B-mode
video ultrasonography. J Nurs Sci Engineer 2014; 1(1): 12-20.
Miura Y, Nakagami G, Yabunaka K, et al. Detecting pharyngeal post-swallow residue by ultrasound examination: a caseseries. Med Ultrason 2016; 18(3): 288-293.
Miura Y, Tamai N, Kitamura A, et al. Diagnostic accuracy of ultrasound examination in detecting aspiration and pharyngeal residue in patients with dysphagia: A systematic review and meta-analysis. Jpn J Nurs Sci 2021; 18(2): e12396― 83 ―

6．CQ 8CQ 8For individuals over 18 years of age, who are suspected of having dysphagia, is it
acceptable for nurses, who have undergone an educational program, to manage oropharyngeal dysphagia based on observations with an ultrasound diagnostic device and conventional methods?
1）Recommendations
We propose that persons over 18 years of age, who are suspected of having dysphagia, receive training in aspiration and pharyngeal residue observation using
ultrasound diagnostic devices, and that persons, who have been certified by theirinstructors as being at a level where they can practice aspiration and pharyngeal
residue observation using ultrasound diagnostic devices, provide management oforopharyngeal dysphagia based on observations using ultrasound diagnostic
devices in facilities and offices equipped with these devices. In facilities andoffices equipped with ultrasound diagnostic devices, we propose to manage
oropharyngeal dysphagia based on observations using these devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.

2）Background and purpose
To prevent aspiration pneumonia, it is necessary to evaluate eating and swallowing functions and provide
appropriate management of oropharyngeal dysphagia. Although VF and VE are the gold standard evaluation
methods, ultrasound is a non-invasive evaluation method that does not require the insertion of fibers, X-rays, orcontrast media compared to VF and VE. This is a non-invasive evaluation method. In addition, it is highly
portable and can be used to evaluate residues in the pyriform fossa and epiglottic valley (pharyngeal residues)
and aspiration in the patient during daily eating. This makes it useful as a routine evaluation tool. Besides, if
subclinical aspiration can be detected, which is difficult in conventional observation scenarios, its usefulness forthe management of oropharyngeal dysphagia will be extremely high. However, it is unclear whether managing
oropharyngeal dysphagia using conventional observation methods without medical devices or with ultrasounddiagnostic devices contributes to improved patient outcomes. In this study, we examined the usefulness of ultrasound-based management of oropharyngeal dysphagia in patients aged 18 years or older suspected of having dysphagia based on domestic and international literature.

― 84 ―

3）Explanation
Randomized controlled trials were majorly included; however, observational studies were also included if
there were no studies that met the criteria. In the study by Miura et al.1), residents of a special nursing home who
gave consent were divided into an intervention and a control group. The two groups were divided using a stratified randomization method to avoid bias in the prevalence of dysphagia. The intervention group consisted of 23
patients (mean age, 87 years; 6 with dysphagia [prevalence 26.1%]), and the control group consisted of 23
patients (mean age, 85 years; 5 with dysphagia, 21.7%). The intervention included observations for aspirationand pharyngeal residue four times using an ultrasound diagnostic device during meals for eight weeks (onceevery two weeks), and making recommendations for the management of oropharyngeal dysphagia based on theobservations. Management of oropharyngeal dysphagia was presented in an algorithm, where alternating swallowing was taught if pharyngeal residue was observed by the ultrasound diagnostic equipment. Changes in thefood form and evaluation by VE were recommended if aspiration was observed. The frequency of aspiration andpharyngeal residue in both groups before the commencement of the study and 8 weeks after initiating the intervention was assessed using ultrasound. The percentage of patients with decreased aspiration frequency was 4.3%
in the intervention group and 13.0% in the control group. The median percentage of patients with reduced
aspiration and residue frequency was 31% in the intervention group and 11% in the control group. The odds
ratio (OR) for the incidence of aspiration was 0.30 (95% CI: 0.03–3.15) and that for pharyngeal residue was
0.63 (95% CI: 0.10–4.21). Aspiration pneumonia occurred in two patients (8.7%) in the intervention groupand one patient (4.3%) in the control group, and the OR for aspiration pneumonia was 2.09 (95% CI: 0.18–
24.87). There was no significant reduction in any of the outcomes in the intervention group. The sensitivity andspecificity of detection of aspiration by the ultrasound system in B-mode were 91% and 94%, respectively2), andthe sensitivity and specificity of residue in the pharynx after swallowing were 62% and 67%, respectively3).
Imprecision was judged to be "high (-2)" when the occurrence of aspiration pneumonia was chosen as the outcome, and "medium/doubtful (-1)" when the incidence of aspiration and pharyngeal residue were chosen as theoutcomes. Publication bias was judged to be "low (0)" for both groups. Based on the above, the strength of evidence was determined to be "weak."In addition to the certainty of the evidence, the main issues discussed at the panel meeting to determine therecommendation were the non-directiveness of the studies included in the systematic review, reliability and feasibility of the assessment methods, differences in results depending on the device used, costs, subject intentions,and burden on the subject. The study by Miura et al. was limited to patients aged 65 years and older and did notinclude middle-aged adult subjects; therefore, caution should be exercised in its application to adult patients
aged 18 to 64 years. In addition, with regard to observations on ultrasound devices, it is important to train nurses who understand the anatomy, mechanisms, handling, and characteristics of ultrasound devices related to swallowing. Therefore, although it is a useful examination, it needs to be performed by those who have acquired acertain level of skill and knowledge. The assessment results were also affected by the performance of the ultrasound device used. In addition to training on ultrasound diagnostic devices, education on eating and swallowing
rehabilitation is necessary. Besides, evaluation methods using ultrasound devices are not covered by insurance,
which may increase the burden in terms of cost. As there are no restrictions on the food to be tested, the food to
be used will not deviate greatly from the wishes of the patient. However, as the device will be in contact with theneck, this may not be in accordance with the wishes of the patient. Results of the voting indicated that six out ofeight participants voted for a "weak recommendation to perform the intervention," one voted for a "strong rec-― 85 ―

ommendation to perform the intervention," and one voted for "no recommendation," with 75% in favor of a
weak recommendation to perform the intervention. Therefore, the strength of the recommendation was set to C
(weak).

4）Database search results
Aspiration pneumonia, acoustic, aspiration, dysphagia, care, nursing, deglutition disorder, echography,
echotomography, exercise, training, rehabilitation, residue, swallow, sonography, swallowing care, ultrasound,(swallowing care, swallowing support, swallowing rehab, swallowing training, swallowing support, dysphagia,
swallowing pneumonia, aspiration in the airway, aspiration pneumonia, aspiration, aspiration pneumonia, residual ultrasound, and pneumonia-swallowing [in Japanese]) were used as keywords. The databases used were
PubMed (until August 31, 2019), Embase (until August 31, 2019), CINAHL (until August 31, 2019),
Cochrane Library (until August 31, 2019), and Ichushi-Web (until August 31, 2019). As a result, 139 studies
were identified, and one randomized controlled trial was conducted after screening. The database search formulae are included in the appendix.

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 139)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 139)

Records excluded(n = 124)

Full-text articles assessed for eligibility(2nd Screening) (n = 15)

Full-text articles
excluded withreasons (n = 14)

Studies included in qualitative synthesis(n = 1)

Studies included in quantitativesynthesis (meta-analysis) (n = 0)

Figure 1: Literature search flowchart― 86 ―

6）List after secondary screening
Table 1: List after secondary screening
Literature

DesignP

ICO

Miura, 2018

Randomized
controlled trial

Institutionalized patients
65 years and older
suspected of having
dysphagia

Recommendations
for care throughobservation using
ultrasound diagnostic
devicesCare basedon theobservationof meals

Incidence of aspiration
pneumonia, frequencyof aspiration andpharyngeal residue

Exclusion

Comment7）List of included papers
Table 2: List of included papers
Included
papersMiura Y, Nakagami G, Yabunaka A randomized controlled trial to investigate the effectiveness of the prevention of aspiration pneumonia
K, et al.
using recommendations for swallowing care guided by ultrasound examination. Healthcare 2018; 6(1):15.

8）Qualitative systematic review
Table 3: Qualitative systematic review
CQ

8

For individuals over 18 years of age, who are suspected of having dysphagia, is it acceptable for nurses, whohave undergone an educational program, to manage oropharyngeal dysphagia based on observations with anultrasound diagnostic device and conventional methods?

P

Persons over 18 years of age suspected of having dysphagia

I

Recommendations for the management of oropharyngeal dysphagia based on observations with anultrasound device

C

Management of oropharyngeal dysphagia through observation by conventional methods

Clinical context

Observation with an ultrasound diagnostic device is a minimally invasive method to check for aspirationand pharyngeal residue. Therefore, it is advisable to first screen for aspiration and pharyngeal residue by
minimally invasive ultrasound and then proceed to endoscopic observation if a more detailed observationis necessary. Observation with an ultrasound diagnostic device is used as a screening test for selecting anappropriate management strategy for oropharyngeal dysphagia.

O1

Occurrence of aspiration pneumonia

Summary of indirectness

The study was limited to subjects aged 65 years and older and did not include middle-aged adults (aged 18 to
65 years). Considering the possibility that the outcome may be affected by age, we downgraded the grade andjudged the study as "medium/suspicious (-1)."

The risk of bias summary

It was judged to be "low (0)."Inconsistency and othersummary

For imprecision, the sample size was too small to produce an effect estimate and it was judged to be "high (-2)."

Comment.

Two patients (8.7%) in the intervention group and one patient (4.3%) in the control group had aspiration
pneumonia, and the OR for aspiration pneumonia was 2.09 (95% CI: 0.18–24.87). However, there was no
significant difference between the different interventions.

O2

Incidence of aspiration

Summary of indirectness

The study was limited to subjects aged 65 years and older and did not include middle-aged subjects.
Considering the possibility that the outcome may be affected by age, we downgraded the grade and judged
the study as "medium/suspicious (-1)."

The risk of bias summary

It was judged to be "low (0)."Inconsistency and othersummary

For imprecision, the sample size was too small to produce an effect estimate and it was judged to be"medium/doubtful (-1)."

Comment

The OR for the incidence of aspiration was 0.30 (95% CI: 0.03–3.15), and there was no significant difference
between the different interventions.

O3

Residue rate of pyriform fossa

Summary of indirectness

The study was limited to subjects aged 65 years and older and did not include middle-aged subjects.
Considering the possibility that the outcome may be affected by age, we downgraded the grade and judged
the study as "medium/suspicious (-1)."

The risk of bias summary

It was judged to be "low (0)."Inconsistency and othersummary

For imprecision, the sample size was too small to produce an effect estimate and it was judged to be"medium/doubtful (-1)."

Comment

The OR for pharyngeal residue rate was 0.63 (95% CI: 0.10–4.21), and there was no significant difference
between the different interventions.

― 87 ―

References
1.

2.
3.

Miura Y, Nakagami G, Yabunaka K, et al. A randomized controlled trial to investigate the effectiveness of the preventionof aspiration pneumonia using recommendations for swallowing care guided by ultrasound examination. Healthcare
2018; 6(1): 15.
Miura Y, Nakagami G, Yabunaka K, et al. Method for detecting aspiration based on image processing-assisted B-mode
video ultrasonography. J Nur Sci Eng 2014; 1(1): 12-20.
Miura Y, Nakagami G, Yabunaka K, et al. Detecting pharyngeal post-swallow residue by ultrasound examination: a caseseries. Med Ultrason 2016; 18(3): 288-293.

― 88 ―

7．CQ 9CQ 9For persons over 18 years of age, who are suspected of having dysphagia, should anurse who has undergone an educational program observe aspiration and pharyngeal
residue using an endoscope?
1）Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in eating and swallowing, who have received training
in the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a medical advisor as being able to practice the observation
technique, can perform endoscopic observation of aspiration and pharyngeal
residue in clinical settings.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）

2）Background and purpose
Swallowing endoscopy is an act that falls under the category of medical assistance that can be performed bynurses. Although the percentage is low, at 0.2–0.6%1),2), there are records of nurses performing swallowing observations using endoscopes. Here, swallowing observation by nurses using an endoscope falls under the category of
medical practice. In this guideline, endoscopic swallowing observation by nurses is defined as the observation of
the pharyngeal cavity with an endoscope inserted through the nasal cavity into the soft palate. Certified nurses in
the field of dysphagia nursing who have been trained in endoscopic aspiration and residual pharyngeal observation have the knowledge and skills necessary to perform endoscopic swallowing observations.
However, the sensitivity and specificity of endoscopic observations of aspiration and pharyngeal residue by
educated nurses are unknown. In this study, we have investigated for the degree of agreement between nurses'
and physicians' assessments.

3）Explanation
Cross-sectional observational or cohort studies were included. No articles that presented evidence for this CQ
and met the criteria were extracted. However, certified nurses with dysphagia have the knowledge and skills necessary to perform eating and swallowing function assessments. They attend endoscopic examinations performedby physicians or dentists who specialize in eating and swallowing rehabilitation in clinical practice and evaluatepatients' eating and swallowing functions as team members, from the images obtained.
In the panel meeting to determine the recommendation, the main issues discussed were the intention of thesubject, burden on the subject, reliability and feasibility of the evaluation method, and possibility of future
research and practice. The observation method involves inserting an endoscope from the nasal cavity to the soft

― 89 ―

palate, and since there is almost no pain and it is possible to use foods that match the subject's preferences, invery few cases, this method deviates greatly from the patient’s preferences. With regard to the reliability and feasibility of the evaluation method, an educational program for certified nurses in the field of dysphagia nursing toperform endoscopy and observe aspiration and pharyngeal residue has recently been developed, and the safety
and accuracy of the evaluation have been reported.3) Three certified nurses in dysphagia nursing attended theeducational program and practiced endoscopic swallowing observation on patients. No adverse events occurred
during the practice. The concordance of the evaluation between the three certified nurses and a physician specialized in swallowing rehabilitation was 92.8–94.8% in 10 cases, and 100% in 11 cases. The usefulness of a systematic educational program for swallowing endoscopy has been suggested overseas.4) Results of voting indicatedthat 1 out of 8 participants voted for "weak recommendation for not performing," 1 voted for "strong recommendation for performing," 1 for "weak recommendation for performing," and 5 for "no decision on the recommendation." Therefore, the strength of the recommendation was set to "none." There is a strong need tocontinue discussing this CQ in the future.

4）Database search results
Agreement, concordance, aspiration, deglutition disorder, endoscope, endoscopic assessment, endoscopic evaluation, endoscopy, fiberendoscopic evaluation, interrater, inter-rater, intra-rater, intrarater, pneumonia, swallowing, observer variation, (agreement, disagreement, agreement rate, swallowing, dysphagia, swallowing pneumonia, inter-observer agreement, interobserver variation, intraobserver, interobserver, intraobserver, aspiration
pneumonia, aspiration, aspiration pneumonia, endoscopy, pneumonia-aspiration, interrater, intra-rater, interrater, intra-rater, discrepancy [in Japanese]) were used as keywords. The databases included PubMed (until
August 31, 2019), Embase (until August 31, 2019), CINAHL (until August 31, 2019), Cochrane Library (until
August 31, 2019), and Ichushi-web (until August 31, 2019). As a result, 212 studies were identified, and no
articles were adopted as a result of screening. The database search formulae are included in the appendix.

― 90 ―

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 212)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 212)

Records excluded(n = 197)

Full-text articles assessed for eligibility(2nd Screening) (n = 15)

Full-text articles
excluded withreasons (n = 15)

Studies included in qualitative synthesis(n = 0)Studies included in quantitativesynthesis (meta-analysis) (n = 0)

Figure 1: Literature search flowchart

References
1.

2.
3.
4.

2010 Ministry of Health, Labour and Welfare. Special Scientific Research Project, Survey of Nursing Practice, Researchon Scope of Medical Practice Performed by Nurses. https://www.mhlw.go.jp/stf2/shingi2/2r9852000000sk2ratt/2r9852000000sk5k.pdf (in Japanese)
Japan Medical Association. Japan Medical Association Survey. Survey on the scope of medical practice performed by nursing staff. http://dl.med.or.jp/dl-med/teireikaiken/20101111_3.pdf (in Japanese)
Yoshida M, Kagaya H, Kamakura Y, et al. Safety and the effectiveness of a new education program for nurses to assess
swallowing function using fiberoptic endoscopic evaluation of swallowing. Jpn J Nurs Sci 2020; 17(2): e12313.
Dziewas R, Glahn J, Helfer C, et al. Flexible endoscopic evaluation of swallowing (FEES) for neurogenic dysphagia: training curriculum of the German Society of Neurology and the German stroke society. BMC Med Educ 2016; 16: 70.

― 91 ―

8．CQ 10

CQ 10
Should the management of oropharyngeal dysphagia for persons aged 18 years or older
and suspected of having dysphagia be based on endoscopic observation of aspirationand pharyngeal residue by nurses (who have undergone an educational program) in
addition to conventional management?
1）Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in the field of dysphagia, who have received training in
the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a supervising physician as being able to practice observation
techniques, can manage oropharyngeal dysphagia.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）

2）Background and purpose
VE is a swallowing function assessment that can be performed repeatedly at the bedside or at home if theswallowing function is visualized and the necessary device is used. In the 2018 edition of the Guidelines for theTreatment of Dysphagia1) prepared by the The Oto-Rhino-Laryngological Society of Japan, an endoscopic evaluation of the swallowing function should be performed by a physician familiar with the anatomy and physiologyof the pharynx and larynx to ascertain the state of swallowing and select appropriate treatment options.
In contrast, VE is an act that falls under the category of medical assistance that can be performed by nurses.
Although the percentage is low, at 0.2–0.6%2),3), there is a track record of nurses performing swallowing observations using endoscopes. Certified nurses in dysphagia nursing acquire the necessary knowledge and skills (15hours) to assess the function of eating and swallowing during the nurse education/certification program, andhave the ability to perform physical assessment techniques and screening tests and assess the severity and level ofthe eating status.
However, it is unclear whether conventional management of oropharyngeal dysphagia or endoscopic observation by trained nurses contributes to better outcomes. In the present study, we have investigated the effects ofboth.

3）Explanation
Randomized controlled trials were included as evidence. Observational studies were also included if none of
the studies met the criteria. No articles that provided evidence for this CQ and met the criteria were extracted.
In contrast, the 2018 edition of the The Oto-Rhino-Laryngological Society of Japan guidelines1) states, "Endoscopic swallowing evaluation is recommended as an examination to assess swallowing status and select treatment― 92 ―

options." However, we were not able to extract any article that provided evidence for this CQ, including the references cited in the guidelines.
In the panel meeting to determine the recommendation, the main issues discussed were the intention of thesubject, burden on the subject, reliability and feasibility of the evaluation method, and possibility of future
research and practice. The observation method involves inserting an endoscope from the nasal cavity to the soft
palate, and since there is almost no pain and it is possible to use foods that match the subject's preferences, themethod may deviate greatly from patients’ preferences only in few cases. With regard to the reliability and feasibility of the evaluation method, certified nurses in the field of dysphagia nursing have the knowledge and skills
necessary to conduct a functional evaluation of eating and swallowing, attend a VE conducted by a physician or
dentist specializing in eating and swallowing rehabilitation in a clinical setting, and use the images to evaluate
the patient's eating and swallowing function. They evaluated the patient's eating and swallowing functions asteam members. They also exchanged opinions as team members on the content of management of oropharyngeal dysphagia based on the results, implemented the management of oropharyngeal dysphagia, and educatedother nurses to help them implement it as well.
Recently, an educational program was developed for certified nurses in the field of dysphagia nursing toobserve aspiration and pharyngeal residue using an endoscope and to evaluate eating and swallowing functions.
Although the study was conducted on a small number of patients at a single institution, the safety of the program and accuracy of the evaluation have been reported4). Furthermore, the usefulness of a systematic VE education program has been suggested overseas. Results of the voting indicated that 1 out of 8 people voted for "weakrecommendation for not implementing," 1 voted for "strong recommendation for implementing," 1 for "weakrecommendation for implementing," and 5 for "no judgment on the recommendation." Therefore, the strengthof recommendation was set to "none." There is a strong need to continue discussing this CQ in the future.

4）Database search results
Aspiration pneumonia, aspiration, deglutition disorder, dysphagia, aspirate, endoscopy nurse endoscopy,
nurse endoscopist, non-physician endoscope, nurse specialist, education, nurse's role, nurse practitioners, nurseperformed endoscope, nursing, trained nurse, pneumonia, practice nursing, residue, deglutition, speech-language, endoscope, swallow, advanced,(swallow, dysphagia, swallowing pneumonia, nursing education, nurse'srole, aspiration pneumonia, aspiration, aspiration pneumonia, articulatory language, advanced professional nursing practice, professional nurse, endoscope, endoscopic nursing, nurse practitioner, pneumonia-swallowable [inJapanese]) were used as keywords. The databases included PubMed (until August 31, 2019), Embase (until
August 31, 2019), CINAHL (until August 31, 2019), Cochrane Library (until August 31, 2019), and IchushiWeb (until August 31, 2019). As a result, 419 studies were identified, and no articles were adopted as a result of
screening. The database search formulae are included in the appendix.

― 93 ―

5）Literature search flowchart

PubMed, Embase, CINAHL, Cochrane Library, Ichushi-Web

Total records identiﬁed throughdatabase searching (n = 419)

Additional records identiﬁed
through other sources (n = 0)

Records screened (1st Screening)(n = 419)

Records excluded(n = 417)

Full-text articles assessed for eligibility(2nd Screening) (n = 2)

Full-text articles
excluded withreasons (n = 2)

Studies included in qualitative synthesis(n = 0)Studies included in quantitativesynthesis (meta-analysis) (n = 0)

Figure 1: Literature search flowchart

References
1.
2.

3.
4.
5.

The Oto-Rhino-Laryngological Society of Japan. Clinical Practice Guidelines for the Diagnosis and Management of Dysphagia 2018. Kanehara Publishing Co. 2018. (in Japanese)
2010 Ministry of Health, Labour and Welfare. Special Scientific Research Project, Survey of Nursing Practice, Researchon Scope of Medical Practice Performed by Nurses. https://www.mhlw.go.jp/stf2/shingi2/2r9852000000sk2ratt/2r9852000000sk5k.pdf (in Japanese)
Japan Medical Association. Japan Medical Association Survey. Survey on the scope of medical practice performed by nursing staff. http://dl.med.or.jp/dl-med/teireikaiken/20101111_3.pdf (in Japanese)
Yoshida M, Kagaya H, Kamakura Y, et al. Safety and the effectiveness of a new education program for nurses to assess
swallowing function using fiberoptic endoscopic evaluation of swallowing. Jpn J Nurs Sci 2020; 17(2): e12313.
Dziewas R, Glahn J, Helfer C, et al. Flexible endoscopic evaluation of swallowing (FEES) for neurogenic dysphagia: training curriculum of the German Society of Neurology and the German stroke society. BMC Med Educ 2016; 16: 70.

― 94 ―

9．Summary for the public
The purpose of this guideline is to provide a protocol for nurses to make decisions on how to support people
with impaired eating and swallowing functions, based on findings in the literature, the balance of advantages
and disadvantages, the values of the patient, and other multifaceted factors. In this section, we discuss how nurses can make decisions. In this section, we explain the 10 clinical questions (CQs) that were formulated based on
the assumption that nurses would be asked to make decisions and describe what kind of decisions are recommended.

CQ 1
It is advisable to perform a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia? To avoid duplication with
CQs 3, 4, 5, and 6, assessments using only the Repetitive Saliva Swallowing Test(RSST), Modified Water Swallowing Test (MWST), Food Test (FT), or cervical auscultation were not included here.
Recommendations
We propose to conduct an assessment of aspiration through a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for individuals aged 18 years and older, who
are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］When including observation items that require an understanding of instructional
actions, such as command swallowing of water, care should be taken while applying theprocess to persons with impaired consciousness or severe cognitive impairment.
Physical assessment techniques are methods of assessing impairment in eating and swallowing functions basedon daily observations of the patient's condition and are widely used in hospitals, convalescent homes, and at
home.
The evaluation will be based on information obtained from a person suspected of having eating or swallowing
dysfunction and that obtained from their family members, and observations made by the medical staff. For
example, we will ask about the history of illnesses, whether the patient had problems eating or swallowing,whether the patient had difficulty breathing, and whether the patient was receiving sufficient nutrition. The
medical staff will also visually observe the patient's face and around and inside the mouth, tactilely check the
movement of the throat and chest with their hands, and listen to chest sounds using a stethoscope. In addition,
an evaluation will be made based on the loudness of the voice and smoothness of the speech during a conversation. These physical assessment techniques are often performed first or on a regular basis for people who are suspected of having eating or swallowing dysfunction before screening tests such as RWST, MWST, and FT. Since
it does not require any device, it can be performed in a nursing home or at home.

― 95 ―

Commonly used screening methods to evaluate impairment in eating and swallowing functions include the
RWST, MWST, and FT. RWST is a method of assessing whether a person is at high risk of food or saliva entering the trachea by determining how many times they can repeatedly swallow saliva in 30 seconds. MWST evaluates the ability to successfully swallow 3 mL of cold water. FT asks the patient to eat a mouthful (about 4 g) of
jelly or pudding and assesses whether the patient can swallow it successfully.
In this study, we examined whether the use of physical assessment techniques can be recommended as amethod of assessing eating and swallowing dysfunction in adults who are suspected of having eating and swallowing dysfunction.
As a result, it was determined that the use of physical assessment techniques for the evaluation of impaired
eating and swallowing functions is "weakly recommended (suggested)," based on a review. The review emphasizes the ability to correctly determine whether food is entering the trachea and whether food remains in theback of the throat based on multiple reports that mention that physical assessment techniques can correctly
determine, to some extent, the above parameters. Besides, there is no burden, such as pain. On the other hand,
physical examination techniques require a medical professional with some training.

CQ 2
Is it advisable to manage oropharyngeal dysphagia based on a systematic assessment
using physical assessment techniques (interview, visual inspection, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia. To avoid duplication with CQs 3, 4, 5, and 6, assessments using only Repetitive
Saliva Swallowing Test (RSST), Modified Water Swallowing Test (MWST), Food Test
(FT), or cervical auscultation were not included here.
Recommendations
We propose to manage oropharyngeal dysphagia based on a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) for persons aged 18 years and older suspectedof having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］Subsequent screening and diagnostic tests based on a systematic assessment
using physical assessment techniques (interview, visual examination, auscultation, palpation, and percussion) are necessary for the implementation of appropriate care.
We explored the question of whether the use of physical assessment techniques is advisable to manage eating
and swallowing dysfunction in persons (adults) suspected of having them.
As a result, after considering the importance of reducing pneumonia, the use of physical assessment techniques in the care of patients with eating and swallowing dysfunction was judged to be a "weak recommendation(suggestion)." This was based on the following factors: (1) it has been reported that the care of patients with eating and swallowing dysfunction based on information from physical assessment techniques may reduce pneumonia; (2) there is no burden, such as pain; and (3) on the other hand, sufficient training is required to correctly― 96 ―

assess eating and swallowing dysfunction.

CQ 3
Is it advisable to screen for aspiration by Repetitive Saliva Swallowing Test (RSST) in
persons over 18 years of age suspected of having dysphagia?
Recommendations
We suggest that individuals aged 18 years and older, who are suspected of having dysphagia, should be screened for aspiration using Repetitive Saliva Swallowing Test (RSST).
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Repetitive Saliva Swallowing Test (RSST) requires movement with an understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment. Caution should be exercised when applying Repetitive Saliva Swallowing Test (RSST) to patients with xerostomia.
Patients with Parkinson's syndrome, who have strong immobility and inactive, are often
judged to be abnormal, regardless of their swallowing function.

CQ 4
Is it advisable to screen for aspiration using the Modified Water Swallowing Test
(MWST) in persons over 18 years of age, who are suspected of having dysphagia?
Recommendations
We suggest screening for aspiration with the MWST in individuals aged 18 years
and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before performing the procedure; Modified Water Swallowing Test (MWST) requires movement withan understanding of instructions, and caution should be exercised regarding its application to persons with impaired consciousness or severe cognitive impairment.

CQ 5
Is it advisable to screen for aspiration by FT (Food Test) for persons over 18 years ofage, who are suspected of having dysphagia?
Recommendations
It is suggested to screen individuals aged 18 years or older suspected of having
dysphagia for aspiration using FT (Food Test).

― 97 ―

GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［Caution］To prevent aspiration of oral bacteria, the mouth should be cleaned before performing the procedure; FT (Food Test) requires movement with an understanding of
instructions, and care should be taken regarding its application to persons with impaired
consciousness or severe cognitive impairment.
The term "screening" usually means "sifting"; however, in this context, it refers to using simple tests to quickly assess whether a person has impaired eating and swallowing functions. Screening can identify eating and swallowing difficulties at an early stage; therefore, the problems can be addressed immediately and further testing canbe performed soon. In this way, aspiration, in which food enters the trachea, and pharyngeal residue, in whichfood remains in the back of the throat, can be prevented at an early stage, and the development of pneumonia
can be prevented. Aspiration and pharyngeal residue can be a daily life problem for people with impaired eating
and swallowing functions. This is because food that goes into the trachea or remains in the back of the throat
may contain bacteria from the mouth. This bacteria-laden food may eventually travel from the trachea to thebronchi and lungs, causing inflammation in the lungs. This is called "aspiration pneumonia." To prevent pneumonia, it is necessary to properly assess eating and swallowing functions and provide meals that match thesefunctions. In addition, if a patient is unable to expel food residue in the back of the throat using his/her own
coughing ability, it is necessary to remove it by inserting a catheter through the mouth into the back of thethroat and sucking it out or by swallowing some jelly or other food that passes easily down the throat.
To determine what kind of food to serve and whether food in the back of the throat needs to be removed, it isnecessary to ensure that there is food present in the trachea and back of the throat. When food enters the trachea
and coughing is weak, the cough may not be able to remove it. Therefore, food may repeatedly flow into thelungs through the trachea, eventually leading to pneumonia.
The commonly used methods of screening for aspiration and pharyngeal residue include the RSST, MWST,
and FT. These tests can be performed anywhere, including nursing homes and at home, without the use of special testing instruments.
CQs 3, 4, and 5 examined whether the use of RSST, MWST, and FT is recommended for adults suspected ofhaving impairments in eating and swallowing functions.
The recommendation was based on correctly determining whether food enters the trachea and remains in theback of the throat. From the results, we determined that utilizing RSST, MWST, and FT is weakly recommended (suggested). This was based on the following factors: the report that these tests can correctly determine, tosome extent, whether food enters the trachea and remains in the back of the throat; the fact that there is no burden of pain or distress; and the low cost or short time involved. On the other hand, the accuracy of determination has not yet been confirmed in a sufficient number of subjects. Besides, RSST is difficult to evaluate in people with severely dry mouths or those with difficulty understanding the test procedure. MWST is a safe test
because it uses a small amount of water but some people may have difficulty swallowing too little. You can startwith a small amount of water and see how well it is swallowed, then increase the amount of water, and see how
well it is swallowed. In FT, since the test is performed with a small amount of food, there is a risk that foodenters or gets stuck in the trachea (choking). These screening methods are already widely used in clinical practiceand in the calculation of nursing care fees.

― 98 ―

CQ 6
Is it advisable to screen for aspiration and pharyngeal residues by cervical auscultationin persons aged 18 years or older, who are suspected of having dysphagia?
Recommendations
Screening for aspiration and pharyngeal residues swallowing by cervical auscultation should be performed in individuals aged 18 years and older, who are suspected of having dysphagia.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ Education on screening for aspiration and pharyngeal residues is needed fornurses who perform cervical auscultation.
Cervical auscultation is a method of determining whether food or water has entered the trachea or remains in
the back of the throat by listening to the sounds heard from the trachea before and after swallowing and fromthe throat while swallowing, using a stethoscope. The stethoscope is placed outside the trachea or neck to listen
to the sounds. Since the stethoscope is only placed on the skin, it is easy to use and can be performed on people
who have difficulty in understanding and following instructions of the medical personnel.
Cervical auscultation is a screening method that can be used to easily identify problems with eating and swallowing functions.
This CQ examines whether the use of cervical auscultation is recommended as a screening method for adults
suspected of having impaired eating and swallowing functions.
The use of cervical auscultation was judged to be "weakly recommended (suggested)" after considering
whether the use of screening tests is recommended and whether cervical auscultation can correctly determine
whether food enters the trachea and remains in the back of the throat. This was based on multiple reports that
confirmed that cervical auscultation can correctly determine the above. Moreover, sounds heard with a stethoscope can be judged correctly by a medical professional with a certain amount of training; therefore, we made acomprehensive judgment.

CQ 7
For persons over 18 years of age suspected of having dysphagia, is it advisable for anurse who has undergone an educational program to screen for aspiration and pharyngeal residues by observation with an ultrasound diagnostic device?
Recommendations
We propose that persons aged 18 years or older, who are suspected of having
dysphagia, receive training in aspiration and pharyngeal residue observation using
an ultrasound diagnostic device, and that persons who have been certified bytheir instructors as being at a level where they can practice aspiration and pharyngeal residue observation techniques using ultrasound diagnostic devices are― 99 ―

screened for aspiration using ultrasound diagnostic devices in facilities and homevisit nursing agencies equipped with ultrasound diagnostic devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.
To check for the presence of food in the trachea and throat, the following methods have been used: swallowing food containing barium and confirming its position by X-ray examination or inserting a very thin camera
through the nose and observing the back of the throat. Recently, ultrasound diagnostic devices have been used toconfirm the presence of food in the trachea and throat. An ultrasound diagnostic device emits sound inaudible
to the human ear and uses differences in intensities between sounds sent and received to examine body functions. It is possible to see the inside of the body simply by applying the instrument on the bosy surface; therefore, there is almost no pain during the examination. It is also possible to see food in the trachea and back of thethroat without using special chemicals, such as barium. Recently, these devices have become increasingly small,and it is now possible to take the device home for examination. We examined whether the use of ultrasound isrecommended as a screening method for people suspected of having eating or swallowing dysfunction.
Using a diagnostic ultrasound diagnostic device was weakly recommended (suggested) after considering
whether it can correctly determine if food flows into the trachea and remains in the back of the throat. The recommendation is based on a report that states that an ultrasound device can correctly determine the above, tosome extent. However, observation and image interpretation must be performed and judged by medical professionals with some training. Observation using ultrasound devices is less painful and can be done without using
special chemicals, and we can expect more reports on the accuracy of this method in the future.

CQ 8
For individuals over 18 years of age, who are suspected of having dysphagia, is it
acceptable for nurses, who have undergone an educational program, to manage oropharyngeal dysphagia based on observations with an ultrasound diagnostic device and conventional methods?
Recommendations
We propose that persons over 18 years of age, who are suspected of having dysphagia, receive training in aspiration and pharyngeal residue observation using
ultrasound diagnostic devices, and that persons, who have been certified by theirinstructors as being at a level where they can practice aspiration and pharyngeal
residue observation using ultrasound diagnostic devices, provide management oforopharyngeal dysphagia based on observations using ultrasound diagnostic
devices in facilities and offices equipped with these devices. In facilities andoffices equipped with ultrasound diagnostic devices, we propose to manage― 100 ―

oropharyngeal dysphagia based on observations using these devices.
GRADE 2C（strength of recommendation：weak，certainty of evidence (strength)：weak）［ Caution］ A device connected to a linear probe should be provided. The probe shouldhave a bandwidth in the frequency range of 5‒15 MHz. The resolution of the instrument
should be at a level that can clearly delineate the contours of the thyroid cartilage andepiglottis.
We examined whether using an ultrasound diagnostic device is recommended for selecting care for people(adults) suspected of having eating and swallowing dysfunction.
After focusing on reducing pneumonia and reducing the food flowing into the trachea and that remaining in
the back of the throat, it was determined that using an ultrasound diagnostic device for selecting care for people
with eating and swallowing dysfunction was weakly recommended (suggested). Previous studies have shown thatusing an ultrasound diagnostic device to observe food in the trachea and back of the throat to select care for people with eating and swallowing dysfunction tends to reduce the amount of food that enters the trachea andremain in the back of the throat. Ultrasonography is less painful, but there is a lack of clear data showing thatusing the results of ultrasound for care selection can help prevent pneumonia. Therefore, recommendations weremade based on these reports and their merits. Observation using an ultrasound diagnostic device should be performed by a person with sufficient knowledge and skills. In addition, there are no reports on whether observation using an ultrasound diagnostic device leads to an improvement in quality of life or whether it is cost effective; therefore, further studies are needed. Since observation using ultrasound is less painful and can be performed without using special chemicals, it is expected that there will be more reports on the effects of using thismethod in the future.

CQ 9
For persons over 18 years of age, who are suspected of having dysphagia, should anurse who has undergone an educational program observe aspiration and pharyngeal
residue using an endoscope?
Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in eating and swallowing, who have received training
in the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a medical advisor as being able to practice the observation
technique, can perform endoscopic observation of aspiration and pharyngeal
residue in clinical settings.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）
Endoscopic swallowing is a procedure in which a thin camera is inserted through the nose to the front of the― 101 ―

throat to evaluate the impairment of eating and swallowing functions. The camera allows us to observe how foodand water flow into the back of the throat and stay there. The thin camera can be carried to a medical facility oreven to your home, allowing medical staff to perform the examination anywhere. This method of using an endoscope to evaluate impairment in eating and swallowing functions has been recommended in previous guidelines
as a test for doctors to diagnose impairment and select treatment options.
Endoscopic swallowing observation is legally recognized as a procedure performed by nurses, which is performed in clinical settings. Certified nurses in dysphagia nursing have sufficient knowledge of the eating andswallowing functions to perform physical assessment techniques, screening tests, and assessments of severity ofthe disorder and degree to which the patient can eat. Nurses are trained and certified to evaluate the severity ofdisability and how well the patient is eating. This training includes training in endoscopic swallowing.
We examined whether endoscopic observation by nurses is recommended as a method of assessing eating andswallowing dysfunction in adults suspected of having them.
We focused on whether nurses’ assessments of whether food entered the trachea and remained in the back of
the throat were consistent with physicians' assessments. However, there are no reports that answer this question
yet. Therefore, we are currently not at a point where we can make specific recommendations at this time. In a
recent report, certified nurses were trained to perform endoscopic observations of eating and swallowing functions, and it was possible to perform the observations safely without food getting stuck in the back of thepatient's throat during the observation or the patient getting pneumonia after the examination. It was also
reported that as the experience with making observations increased, doctors’ evaluations and nurses’ evaluations
were in perfect agreement. A training method has been developed to enable nurses to evaluate endoscopic observations as precisely as physicians, and we can expect to see more reports on evaluations by trained nurses in the
future.

CQ 10
Should the management of oropharyngeal dysphagia for persons aged 18 years or older
and suspected of having dysphagia be based on endoscopic observation of aspirationand pharyngeal residue by nurses (who have undergone an educational program) in
addition to conventional management?
Recommendations
This is an area where evidence is expected to accumulate with the developmentof future research, and research should be planned in a well-considered clinicalenvironment. Certified nurses in dysphagia nursing and nurses with specialized
knowledge and experience in the field of dysphagia, who have received training in
the endoscopic observation of aspiration and pharyngeal residue and who havebeen certified by a supervising physician as being able to practice observation
techniques, can manage oropharyngeal dysphagia.
GRADE None（strength of recommendation： None, quality of evidence (strength)：weak）
We examined whether endoscopic observation by nurses is recommended as a method of assessing eating and― 102 ―

swallowing dysfunction in adults suspected of having these.
This study focused on whether endoscopic observation by nurses, in addition to the usual treatment of eating
and swallowing problems, could reduce pneumonia. However, there is no report yet on whether it can reduce
pneumonia. Therefore, we are currently not at a point where we can make specific recommendations for thisquestion. Training nurses in endoscopic observation is already being conducted for nurses who have specialized
knowledge and skills and are certified. We can expect to see more reports on the effectiveness of this method in
the future.

― 103 ―

Appendix

1．Setting table of clinical questions
Key clinical issue 1
Key clinical issue(s) addressed in the scope.
Is it useful to conduct a systematic assessment using physical assessment techniques (interview, visual examination, auscultation, palpation,and percussion) to assess aspiration and pharyngeal residue during eating and swallowing in adults with dysphagia?
Components of CQ
P（Patients, Problem, Population）
GenderNo designation

Age

Over 18 years old

Diseases andconditions

Persons suspected of having dysphagia

Geographic
requirements

None in particular

Other

None in particular

List of I’s (Interventions)/C’s (Comparisons, Controls)
I: Assessment by physical assessment
C: Conventional observation of dysphagia only.
Outcome is adopted when the score is 5 or more.
O (Outcomes) list
Content of outcome

Benefit or harm

Priority

Included or
excludedO1

Occurrence of aspiration pneumonia

Benefit9

pointsIncluded

O2

Incidence of aspiration

Benefit8

pointsIncluded

O3

Residue rate in pyriform fossa

Benefit7

pointsIncluded

O4

Residue rate in the epiglottic valley

Benefit7

pointsIncluded

O5

Sensitivity and specificity of aspiration detection(ref: detection by VE/VF)

Benefit

6.3

pointsIncluded

O6

Sensitivity and specificity of residue detection in
the laryngeal trough (ref: detection by VE/VF)

Benefit

6.3

pointsIncluded

O7

Sensitivity and specificity of residue detection in
the pyriform fossa (ref: detection by VE/VF)

Benefit

5.5

pointsIncluded

O8

Sensitivity and specificity of penetration detection

Benefit

5.5

pointsIncluded

O9

Sensitivity and specificity of determination of theseverity of dysphagia (ref: detection by VE/VF)

Benefit

7.5

pointsIncluded

O10

Sensitivity and specificity of risk determination
for aspiration pneumonia

Benefit

6.3

pointsIncluded

Created CQ
CQ1．It is advisable to perform a systematic assessment using physical assessment techniques (interview, visual examination, auscultation,
palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia?
CQ2．Is it advisable to manage oropharyngeal dysphagia based on a systematic assessment using physical assessment techniques (interview,
visual inspection, auscultation, palpation, and percussion) for persons aged 18 years and older suspected of having dysphagia?

― 106 ―

Key clinical issue 2
Key clinical issue(s) addressed in the scope.
What aspiration and oropharyngeal residue screening tests are useful for adults with dysphagia to assess aspiration and oropharyngeal
residue during eating and swallowing?
Components of CQ
P（Patients, Problem, Population）
GenderNo designation

Age

Over 18 years old

Diseases andconditions

Persons suspected of having dysphagia

Geographic
requirements

Places where an ultrasound system with a linear probe is available.

Other

Exclusion; patients with cancers of the tongue, pharynx and larynx and patients with tracheostomy

List of I’s (Interventions)/C’s (Comparisons, Controls)
I: RSST
I: MWST
I: FT
I: Cervical auscultation
I: Observation using an ultrasound diagnostic device
C: Conventional observation of dysphagia only. An outcome is adopted when the score is 5 or more.
O (Outcomes) list
Content of outcome

Benefit or harm

Priority

Included or
excludedO1

Occurrence of aspiration pneumonia

Benefit9

pointsIncluded

O2

Incidence of aspiration

Benefit8

pointsIncluded

O3

Residue rate in the pyriform fossa

Benefit7

pointsIncluded

O4

Residue rate in the epiglottic valley

Benefit7

pointsIncluded

O5

Sensitivity and specificity of aspiration detection(ref: detection by VE/VF)

Benefit

6.3

pointsIncluded

O6

Sensitivity and specificity of residue detection in
the laryngeal trough (ref: detection by VE/VF)

Benefit

6.3

pointsIncluded

O7

Sensitivity and specificity of residue detection in
the pyriform fossa (ref: detection by VE/VF)

Benefit

7.6

pointsIncluded

O8

Sensitivity and specificity of penetration detection

Benefit

6.5

pointsIncluded

O9

Sensitivity and specificity for determining theseverity of dysphagia (ref: detection by VE/VF)

Benefit7

pointsIncluded

O10

Sensitivity and specificity of risk determination
for aspiration pneumonia

Benefit

7.5

pointsIncluded

Created CQ
CQ3．Is it advisable to screen for aspiration by RSST (repetitive saliva swallowing test) in persons over 18 years of age who are suspectedof having dysphagia?
CQ4．Is it advisable to screen for aspiration using MWST (modified water swallowing test) in persons over 18 years of age who aresuspected of having dysphagia?
CQ5．Is it advisable to screen for aspiration by FT (food test) in persons over 18 years of age who are suspected of having dysphagia?
CQ6．Is it advisable to screen for aspiration and pharyngeal residue using cervical auscultation in persons over 18 years of age who aresuspected of having dysphagia?
CQ7．Is it advisable for a nurse with an educational program to screen for aspiration and pharyngeal residue by observation with anultrasound diagnostic device for persons aged 18 years and older who are suspected of having dysphagia?
CQ8．For those aged 18 years or older and suspected of having dysphagia, should nurses who have undergone an educational program
manage oropharyngeal dysphagia based on the results of observation with an ultrasound device and using conventional methods?

― 107 ―

Key clinical issue 3
Key clinical issue(s) addressed in the scope
For adults with dysphagia, is it useful for nurses to use an endoscope to assess for aspiration and pharyngeal residue during eating andswallowing?
Components of CQ
P（Patients, Problem, Population）
GenderNo designation

Age

Over 18 years old

Diseases andconditions

Persons suspected of having dysphagia

Geographic
requirements

Places where an endoscopy device is available.

Other

None in particular

List of I’s (Interventions)/C’s (Comparisons, Controls)
I: Endoscopic observation by a trained nurse
C: Endoscopic examination by a doctor.
Outcome is adopted when the score is 5 points or more.
O (Outcomes) list
Content of outcome

Benefit or harm

Priority

Included or
exclededO1

Occurrence of aspiration pneumonia

Benefit9

pointsIncluded

O2

Incidence of aspiration

Benefit8

pointsIncluded

O3

Residue rate in the pyriform fossa

Benefit7

pointsIncluded

O4

Residue rate in the epiglottic valley

Benefit7

pointsIncluded

O5

Sensitivity and specificity of aspiration detection(ref: detection by physician)Benefit

6.3

pointsIncluded

O6

Sensitivity and specificity of residue detection in
the laryngeal trough (ref: detection by Dr. V)

Benefit

6.3

pointsIncluded

O7

Sensitivity and specificity of residue detection in
the pyriform fossa (ref: detection by physicians)

Benefit8

pointsIncluded

O8

Sensitivity and specificity of detection ofpenetration (ref: detection by physicians)

Benefit

7.6

pointsIncluded

O9

Sensitivity and specificity of severity classificationof dysphagia (ref: detection by physicians)

Benefit

7.3

pointsIncluded

O10

Sensitivity and specificity of risk determination
for aspiration pneumonia

Benefit

7.6

pointsIncluded

Created CQ
CQ9．For persons over 18 years of age, who are suspected of having dysphagia, should a nurse who has undergone an educational
program observe aspiration and pharyngeal residue using an endoscope?
CQ10．Should the management of oropharyngeal dysphagia for persons aged 18 years or older and suspected of having dysphagia
be based on endoscopic observation of aspiration and pharyngeal residue by nurses (who have undergone an educational program) in
addition to conventional management?

― 108 ―

2．Database search formula, evidence evaluation sheet, evidence synthesis sheet（1）CQ 1
①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search #1 or #2#4

Search bedside assessment*[tiab] OR bedside screen*[tiab] OR bedside evaluation*[tiab] OR physical examination*[tiab] OR physicalassessment*[tiab] OR clinical assessment*[tiab]#5

Search screen*[tiab] OR detect*[tiab]#6

Search "Sensitivity and Specificity"[mh]#7Search "sensitivity and specificity"[tiab] OR predictive value*[tiab]#8

Search #5 or #6 or #7#9

Search #3 and #4 and #8#10

Search "Deglutition Disorders/diagnosis"[majr]#11

Search #4 and #10#12

Search #9 or #11

EmbaseS1((EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia")))S2((TI,AB((aspiration N/2 pneumonia*) OR (deglutition N/2 disorder*) OR (swallowing N/2 disorder*) OR dysphagia*)))S3((S1 or S2))

S4

(TI,AB((bedside N/2 (assessment* OR screen* OR evaluation*)) OR (physical N/2 (examination* OR assessment*)) OR (clinical N/2
assessment*)))S5(TI,AB(screen* OR detect*))

S6(EMB.EXACT.EXPLODE("sensitivity and specificity"))

S7(TI,AB("sensitivity and specificity" OR (predictive P/2 value*)))S8(S5 or S6 or S7)

S9(S3 and S4 and S8)

S10(MJEMB.EXACT("dysphagia -- diagnosis"))S11(S4 and S10)S12

(S9 or S11)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2(aspiration N2 pneumonia*) OR (deglutition N2 disorder*) OR dysphagia*

S3

S1 OR S2

S4

(bedside N2 (assessment* OR screen* OR evaluation*)) OR (physical N2 (examination* OR assessment*)) OR (clinical N2 assessment*)

S5

screen* OR detect*

S6

MH "Sensitivity and Specificity"

S7"sensitivity and specificity" OR (predictive W2 value*)

S8

S5 or S6 or S7

S9

S3 and S4 and S8

S10(MM "Deglutition Disorders/DI")

S11

S4 and S10S12

S9 or S11

― 109 ―

Cochrane Library#1[mh "Pneumonia, Aspiration"] OR [mh "Deglutition Disorders"]#2((aspiration NEAR/2 pneumonia*) OR (deglutition NEAR/2 disorder*) OR dysphagia*):ti,ab,kw#3#1 or #2

#4((bedside NEAR/2 (assessment* OR screen* OR evaluation*)) OR (physical NEAR/2 (examination* OR assessment*)) OR (clinical NEAR/2
assessment*)):ti,ab,kw#5(screen* OR detect*):ti,ab,kw#6[mh "Sensitivity and Specificity"]#7("sensitivity and specificity" OR (predictive NEXT value*)):ti,ab,kw#8#5 or #6 or #7#9#3 and #4 and #8#10[mh "Deglutition Disorders"[mj]/DI]#11#4 and #10#12#9 or #11

#13

#9 or #11 in Cochrane Reviews, Cochrane Protocols#14#9 or #11 in Trials

Ichushi-Web#1

Pneumonia-aspirated/TH or aspiration pneumonia/AL or swallowed pneumonia/AL or attracted pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3#1 or #2

#4(@Dysphagia/MTH) and (SH=Diagnosis) (in Japanese)#5

Screening (in Japanese)/AL or screening/AL or evaluation/AL (in Japanese)#6

Physical Assessment/AL or Bedside Assessment/AL or Physical Assessment/AL or Bedside Assessment/AL or (@Physical Examination/TH
or Physical Examination/AL or Physical Examination/AL) (in Japanese)#7#3 and #5 and #6#8#4 and #6#9#7 or #8

付録_hyo2-1.indd 1― 110 ―

②CQ1 Evidence evaluation sheet (outcomes: sensitivity and specificity of aspiration detection)

Control

Index test

Patients

CQ

VE or VF

N.A.

Pysical assessment techniques

18 years old age and older with suspected dysphagia

CQ1

Index test Reference*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and"none".
Summarize each outcome on a separate sheet.

Patients
Index test

Reference Summary
test
TP

5

12

FP

17

35

TN

0

1

FN

0.56

AUC"

Prevalence

0.41,
0.70

95%
CI

95%
CI

1.00

P-value

Sensitivity

0.88,
1.00

0.42,
1.00

95%
CI

0.77

0.74

Specificity

0.55,
0.92

0.60,
0.86

95%
CI

0.90

0.76

Accuracy

0.78,
0.97

0.62,
0.87

95%
CI

NA

NA

ROC
AUC

NA

NA

95%
CI

NA

NA

P-value

NumberSummary
6

Indirectness*
Flow andtimimg

28

NA

NA

None

NA

NA

None

NA

Low risk

NA

NA

NA

NA

Low riskNA

NA

Low risk

0.61,
0.83

NA

NA

Low risk

0.74

0.61,
0.77

NA

NA

Low risk

0.50,
0.80

0.79,
0.92

NA

Low risk

0.67

0.70

0.71,
0.93

NA

None

Sensitivity and specificity in detecting aspiration

Selection
bias

Low risk

Low risk

0.65,
0.96

0.87

0.76,
0.90

None

Outcome

Referencetest

Low risk

Low risk

0.85

0.53,
0.72

0.84

0.62,
1.00

0.80

0.42,
0.56

0.59,
0.93

0.74

0.53

0.74

0.47,
0.58

0.55,
0.88

NA

NA

NA

NA

NA

NA

NA

NA

NA

0.27,
0.51

0.63

0.77,
0.92

0.84

0.05,
0.85

0.83

0.49

0.38

0.86

0.73,
0.98

0.92
0.40

0.49,
0.69

4

0.76,
0.99

0.73,
0.92

0.07,
0.37

0.58

0.60

28

0.74,
0.96

0.90

0.19，
0.99

0.19

0.28,
0.39

14

0.93

0.51,
0.91

0.75

0.84

0.33

22

0.88

0.68,
0.94

3

0.34

None

0.24,
0.41

0.75

0.63,
1.00

40

Low risk

0.26,
0.55

1.00

0.84

20

14

Low risk

0.33

0.26,
0.45

97

Low risk

5

0.40

0.35,
0.90

5

52

Unlikely

73

5

0.67

0.35

2

11

101

High risk

12

27

0

6

test

VF

Low risk

36

3

3

58

None

19

59

0.22
None

15

1

11

Low risk

None

None

2

None

8

31

Low risk63
Low risk

Unlikely

Low risk

Low risk37

Low risk

Low riskNone

Low risk26

Low risk

Low risk

Low risk

Low risk

Low risk

Low risk

None

None
Low risk

Low risk

Low risk

Low risk

Low risk

Low risk
Unlikely

Low risk

Low riskNone

Low risk

Low risk

Low risk

UnlikelyHigh risk

Low
risk

None

Unlikely

Low risk

Low risk

Low
risk
Low
risk
Low
risk
Low
risk
Low
risk
High
risk
Unknown

Low risk

Low riskUnknown Low risk

0.64,
0.82

Unlikely

Low riskUnknown

Unknown Low risk

Unknown

Low risk

Low riskUnknown

0.71,
0.91

UnknownVF
Low risk

Low riskUnknown

Low risk

Risk of bias*

DesignVE
Low riskUnknownVF

Low risk

Low riskVF

Low risk

Low risk

0.39,
0.75

Low risk

43

4

6

0.27

0.55

0.36

0.50

0.24

0.43,
0.66

0.26,
0.47

0.41,
0.60

0.15,
0.35

0.95

0.64

0.87

0.89

0.84

0.48,
0.78

0.70,
0.96

0.77,
0.96

0.60,
0.97

0.50

0.64

0.41

0.81

0.69

0.46,
0.79

0.28,
0.55

0.68,
0.91

0.56,
0.80

0.62

0.64

0.57

0.85

0.73

0.52,
0.74

0.46,
0.68

0.77,
0.91

0.61,
0.82

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

3

22

18

14

2

0

0.44

0.44

0.25

0.32,
0.58

0.31,
0.58

0.11,
0.45

0.48

0.92

1.00

0.29,
0.68

0.75,
0.99

0.59,
1.00

0.85

0.67

0.86

0.69,
0.95

0.48,
0.82

0.64,
0.97

0.69

0.78

0.89

0.56,
0.56

0.65,
0.88

0.72,
0.98

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

3
10

23

3

16

7

11

29

0.60,
0.89

42
48

33

82

23

None

24

5

0.49

0.76

19
None

27

81

13

Low risk

None

13

0.61,
0.93

16
Low risk

None

57

28

Low risk

Low risk

None

0.98

0.81

None
Low risk

Low risk

None

None

Low risk

Low risk

Low risk

0.35,
0.90

Low risk
Low risk

Low risk

Low risk

Low risk

Unlikely

Low risk

Low risk

0.18

0.67

Low riskNone

Low risk

Low risk

Low risk

0.56,
0.69

Low risk

Unlikely

Low risk

0.18,
0.49

Low risk
Low riskNone

Low risk

Low risk

0.42,
0.58

Low risk

Unlikely

0.61

0.32

None

Low risk

None

None

0.86,
0.99

Low risk

4

NA

126

NA
95

21

NA

2

5

NA

8

NA

27

NA
None

0.75,
0.96

None

0.88

Low risk

0.71,
0.96

Low risk

0.88

Low risk

0.59,
1.00

NA

0.91

NA

0.14,
0.41

NA

0.26

Low risk1

Low risk28

Low risk

4

None

10

Unlikely

None

Low risk

Low risk

Low risk

Low risk

0.43,
0.55

Low risk

0.93,
1.00

None

0.12,
0.25

Low risk

0.55,
0.67

Low risk

Low risk

Low risk

0.21,
0.33

Low risk

VE or VFVE or VF

0.25,
0.45

Low risk

Low risk

Low riskVF
Low risk

Low risk

VE

Low risk
Low risk

Low risk

Low riskUnknown

Low riskVF

Low risk

Low risk

Low riskVF

Low risk

Low risk

Low riskVF

VF

Low risk

Low risk

Low risk

Low risk

VF
VE

VF

VE

VF

Low
risk
Low
risk
Low
risk
Low
risk
Low
risk
Low
risk
High
risk
High
risk
High
risk
High
risk
Low
risk
Low
risk

0.15,
0.30

VF

VE

Low risk

Studies

Reference testID

VF
Low riskRamsey 2006*

Crosssectional
Crosssectional
Crosssectional
VF

Toscano 2019*
Martino 2009*
CohortCrosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional
Crosssectional

Mann 2000*
González 2011
Ohira 2017

Newton 1994*

Yousovich 2018*

Baylow 2009*

Smith 2009*

Baumann 2017*

Vogel 2017*
Zhou 2011*
Mandysova
2011*
Hey 2013*
Edmiaston 2014*
Branco 2019*
Daniels 1997*
Nishiwaki 2005*
Kaege 2017
Daniels 2016
Mortensen 2016*

Comments*Includes water swallowing test or food test

― 111 ―

③CQ1 Evidence synthesis sheet (outcomes: sensitivity and specificity of aspiration detection)
OutcomeN (n)Factors that may reduce the quality of evidence
Publication
Indirectness
Inconsistency Imprecision
bias

DesignLimitation

Final
quality

Effectivenessper 1000
patients

Importance
6.3

True positive

22（518）Cross-sectional

Unlikely

None

Unlikely

None

None

Low

250

True negative

22（899）Cross-sectional

Unlikely

None

Unlikely

None

None

Low

433

6.3

False positive

22（398）Cross-sectional

Unlikely

None

Unlikely

None

None

Low

192

6.3

False negative

22（259）Cross-sectional

Unlikely

None

Unlikely

None

None

Low

125

6.3

Uncertain
results

No reports

—

—

—

—

—

—

—

—

—

④CQ1 Evidence evaluation sheet (outcomes: sensitivity and specificity of risk determination
for aspiration pneumonia)
CQ

CQ1

Patients

18 years old age and older with suspected dysphagia

Index test

Pysical assessment techniques

Control

N.A.

Reference test

X-ray, blood test

Studies

Yamane 2015
(Day 2)
Yamane 2015
(Day 4)

Summarize each outcome on a separate sheet.

Sensitivity and specificity of risk determination for aspiration pneumonia

OutcomeID*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".

Risk of bias*

DesignReference
test

CohortX-ray,
blood test,CT

CohortX-ray,
blood test,
CT

Selection
bias
Low risk

Low risk

Index test

Low risk

Low risk

Indirectness*

Reference
test

Flow andtimimgLow risk

Low risk

Low risk

Low risk

Summary

None

Patients

Index test

Low riskNone

Low risk

Low risk

Low risk

Number
Reference
Summary TP FP TN FN Prevalence
test

95%
CI

Low risk

0.14

0.09,
0.20

0.13

0.08,
0.19

Low risk

None

None

18

15

39

45

94

91

3

5

Sensitivity

95%
CI

0.86

0.64,
0.97

0.75

0.51,
0.91

Specificity

95%
CI

0.71

0.62,
0.78

0.67

0.58,
0.75

Accuracy

95%
CI

ROC
AUC

95%
CI

P-value

0.73

0.65,
0.80

NA

NA

NA

0.68

0.60,
0.75

NA

NA

NA

⑤CQ1 Evidence synthesis sheet (outcomes: sensitivity and specificity of risk determination
for aspiration pneumonia)
Factors that may reduce the quality of evidence
OutcomeTrue
positive
True
negative
False
positive
False
negative
Uncertain
results

N (n)Design1 (18)

Final
quality

Effectivenessper 1000
Importancepatients

Limitation

Indirectness Inconsistency Imprecision

Publication
bias

CohortUnlikely

None

Unlikely

Unlikely

Unlikely

Very low117

6.3

1 (94)

CohortUnlikely

None

Unlikely

Unlikely

Unlikely

Very low610

6.3

1 (39)

CohortUnlikely

None

Unlikely

Unlikely

Unlikely

Very low

253

6.3

1 (3)

CohortUnlikely

None

Unlikely

Unlikely

Unlikely

Very low

19

6.3

No reports

­

­

­

­

­

­

­

­

­

uroku4.indd 1― 112 ―

（2）CQ 2①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search #1 or #2#4

Search bedside assessment*[tiab] OR bedside screen*[tiab] OR physical examination*[tiab] OR physical assessment*[tiab]#5

Search deglutit*[tiab] OR swallow*[tiab]#6

Search #3 and #4 and #5

EmbaseS1(EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia"))

S2(TI,AB((aspiration N/2 pneumonia*) OR (deglutition N/2 disorder*) OR (swallowing N/2 disorder*) OR dysphagia*))

S3(S1 or S2)

S4(TI,AB((bedside N/2 (assessment* OR screen*)) OR (physical N/2 (examination* OR assessment*))))S5(TI,AB(deglutit* OR swallow*))

S6(S3 and S4 and S5)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2(aspiration N2 pneumonia*) OR (deglutition N2 disorder*) OR dysphagia*

S3

S1 OR S2

S4

(bedside N2 (assessment* OR screen*)) OR (physical N2 (examination* OR assessment*))

S5

deglutit* OR swallow*

S6

S3 AND S4 AND S5Cochrane Library#1[mh "Pneumonia, Aspiration"] OR [mh "Deglutition Disorders"]#2((aspiration NEAR/2 pneumonia*) OR (deglutition NEAR/2 disorder*) OR dysphagia*):ti,ab,kw#3#1 or #2

#4((bedside NEAR/2 (assessment* OR screen*)) OR (physical NEAR/2 (examination* OR assessment*))):ti,ab,kw#5(deglutit* OR swallow*):ti,ab,kw#6#3 and #4 and #5#7#3 and #4 and #5 in Cochrane Reviews, Cochrane Protocols#8#3 and #4 and #5 in Trials

Ichushi-Web#1

Pneumonia-aspirated/TH or aspiration pneumonia/AL or swallowed pneumonia/AL or attracted pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3#1 or #2

#4

Bedside Assessment/AL or (Physical Exam/TH or Physical Exam/AL) (in Japanese)#5

Physical Assessment/AL (in Japanese)#6

Swallowing function assessment/AL (in Japanese)#7(Aspiration/TH or Aspiration/AL in the airway) or Residual/AL (in Japanese)#8

Screening (in Japanese)/AL or screening/AL#9#7 and #8#10#4 or #5 or #6 or #9#11

Swallowing/TA and Care/TA (in Japanese)#12#3 and #10 and #11― 113 ―

②CQ2 Evidence evaluation sheet
CQ

CQ2

Patients
Intervention
Control

18 years old age and older with suspected dysphagia* Each item is rated on a scale of "high (-2)", "moderate/doubt (-1)", and "low (0)".
The summary should be reflected in the total evidence on three levels: "high (-2)," "moderate (-1)," and "low (0).

Management of oropharyngeal dysphagia based on pyhsical assessment techniques
Conventional management of oropharyngeal dysphagia based on conventional observation

Summarize on a separate sheet for each outcome

Incidence of aspiration pneumonia
Risk of bias*

OutcomeStudiesID
Field 2017

Selection bias

Exection Detection
Case reduction bias
bias
bias

OthersSelective outcome Early study
reportingdiscontinuation

Design Randomization Concealment

Blind

Blind

ITT

Incomplete
outcomereporting

RCT

­2

­2

0

0

0

0

0

Indirectness*

Number at risk (outcome rate)

Other bias

Sumarry

Patients

Intervention

Control

OutcomeSumarry

0

­1

0

0

0

0

0

0

Control group Control group
denominator numerator
190

6

(％ )

Intervention
group
denominatorIntervention
group
numerator(％ )Effectivenessindex (type)

Effectivenessindex (value)

95% CI

3.2

192

2

1.0

RR

0.32

0.06,1.62③CQ2 Evidence synthesis sheet
CQ
Patients
Intervention

CQ2
18 years old age and older with suspected dysphagia
Management of oropharyngeal dysphagia based on physical asssessment techniques

Control

Conventional management of oropharyngeal dysphagia based on conventional observation

The strength of evidence starts from "strong (A)" for RCTs and from "weak (C)" for observational studies.
* Each domain has three levels: "high (-2)," "moderate/doubtful (-1)," and "low (0).
** Four levels of evidence strength: "strong (A)," "moderate (B)," "weak (C)," and "very weak (D)."*** Importance is the importance of the outcome (1-9)

Body of evidence

Number at risk (outcome rate)
Factors of upgrade Control
Control(％ )(Observational
group
group
bias, etc.)*
study)*
denominator numerator
OthersOutcome
Incidence of aspiration
pneumonia

Design/ N

RCT/1

Risk of bias*­1

Inconsistency*

0

Imprecision*­1

Indirectness* (publication

0

0

0

190

6

3.2

Intervention Intervention
(％ )
group
group
denominator numerator
192

2

1.0

Effectivenessindex (type)
RR

Effectivenessindex (value)

95% CI

Strength ofevidence**

Importance***

0.32

0.06,
1.62

Weak (C)9uroku2.indd 1

202

uroku3.indd 1

202― 114 ―

（3）CQ 3, 4, 5
①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search (pharyn*[tiab] OR oropharyn*[tiab]) AND (aspirat*[tiab] OR residue*[tiab])#4

Search #1 or #2 or #3#5

Search repetitive saliva swallowing test*[tiab] OR repetitive saliva swallow test*[tiab] OR RSST[tiab]#6

Search modified water swallowing test*[tiab] OR modified water swallow test*[tiab] OR MWST[tiab]#7

Search food-test*[tiab] OR cough-test*[tiab]#8

Search swallow*[tiab] AND (function-test*[tiab] OR screening-test*[tiab])#9

Search #5 or #6 or #7 or #8#10

Search #4 and #9

EmbaseS1(EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia"))

S2(TI,AB((aspiration NEAR pneumonia*) OR (deglutition NEAR disorder*) OR (swallowing NEAR disorder*) OR dysphagia*))

S3(TI,AB((pharyn* OR oropharyn*) AND (aspirat* OR residue*)))S4(S1 OR S2 OR S3)

S5(TI,AB("repetitive saliva" P/3 swallow* P/3 test* OR RSST))S6(TI,AB(modified P/3 water P/3 swallow* P/3 test* OR MWST))

S7(TI,AB(food P/3 test* OR cough P/3 test*))S8(TI,AB(swallow* N/3 (function P/3 test* OR screening P/3 test*)))S9(S5 OR S6 OR S7 OR S8)S10(S4 AND S9)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2aspiration pneumonia OR deglutition disorder* OR dysphagia

S3(pharyn* OR oropharyn*) AND (aspirat* OR residue*)

S4

S1 OR S2 OR S3

S5

repetitive saliva swallow* test* OR RSST

S6

modified water swallow* test* OR MWST

S7

food W3 test* OR cough W3 test*

S8

swallow* N3 ((function W3 test*) OR (screening W3 test*))S9

S5 OR S6 OR S7 OR S8S10

S4 AND S9

Cochrane Library#1

MeSH descriptor: ["Pneumonia, Aspiration"] explode all trees#2

aspiration pneumonia or deglutition disorder* or dysphagia:ti,ab,kw#3(pharyn* OR oropharyn*) and (aspiration* or residue*):ti,ab,kw#4#1 or #2 or #3#5((repetitive NEXT saliva NEXT swallow* NEXT test*) OR RSST):ti,ab,kw#6((modified NEXT water NEXT swallow* NEXT test*) OR MWST):ti,ab,kw#7((food NEXT test*) OR (cough NEXT test*)):ti,ab,kw#8(swallow* NEAR/3 ((function NEXT test*) OR (screening NEXT test*))):ti,ab,kw#9{OR #5-#8}#10#4 and #9― 115 ―

Ichushi-Web#1

Pneumonia-Swallowing/TH or Miswelling Pneumonia/AL or Swallowing Pneumonia/AL or Suction Pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3(Swallowing/TH or Swallowing/AL) (in Japanese)#4(Aspiration/TH or Aspiration/AL in the airway) or Residual/AL (in Japanese)#5#3 and #4#6#1 or #2 or #5#7

RSST/AL or "Repetitive Saliva Swallowing Test"/AL or "Repetitive Saliva Swallow Test"/AL or repetitive saliva swallowing (in Japanese)/AL#8

MWST/AL or "Modified Water Swallowing Test"/AL or "Modified Water Swallow Test"/AL or modified water swallowing (in Japanese)/AL#9

Food test/AL or Cough test/AL (in Japanese)#10#7 or #8 or #9#11

Screening/AL or screening/AL or swallowing function/AL (in Japanese)#12#6 and #10 and #11②CQ3 Evidence evaluation sheet (Index test: RSST; outcomes: sensitivity and specificity of
aspiration detection)
CQ
Patients
Index test
Control
Reference test

CQ3
18 years old age and older
RSST（Repetitive Saliva Swallowing Test）
N.A.
VE or VF

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".
Summarize each outcome on a separate sheet.

OutcomeSensitivity and specificity in detecting aspiration

Studies

Risk of bias*

ID

DesignReference
test

Selection
bias

Index test

Indirectness*

Reference test

Flow andtimimgSummary

Patients

Index
test

Number
Reference
test

Summary

TP

FP

TN

CrossOguchi 2000
sectionalVF

Low risk

Low riskUnknown

Low risk

Unlikely

Low risk

Low risk

Low risk

None

51

27

52

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

None

43

12

8

Watanabe
2007

ROC

Prevalence

95% CI

Sensitivity

95% CI

Specificity

95% CI

Accuracy

95% CI

95% CI

P-value

1

0.40

0.31,
0.49

0.98

0.90,
1.00

0.66

0.54,
0.76

0.79

0.71,
0.85

NA

NA

NA

19

0.76

0.65,
0.84

0.69

0.56,
0.80

0.40

0.19,
0.64

0.62

0.51,
0.73

NA

NA

NA

FN

AUC

③CQ3 Evidence synthesis sheet (index test: RSST; outcomes: sensitivity and specificity of
aspiration detection)
付録_hyo2-3.indd 1
OutcomeN (n)DesignTrue positive
True negative

2（94）
2（60）

Cross-sectional
Cross-sectional

Factors that may reduce the quality of evidence
Publication
Indirectness Inconsistency Imprecision
bias
Unlikely
None
Unlikely
None
Unlikely
Unlikely
None
Unlikely
None
Unlikely

False positive
False negative

2（39）
2（20）

Cross-sectional
Cross-sectional

Unlikely
Unlikely

None
None

Unlikely
Unlikely

None
None

Uncertain results

No reports

―

―

―

―

―

Limitation

furoku2.indd 1

Finalquality

Effectivenessper 1000 Importancepatients

Low
Low

441
282

6.3
6.3

Unlikely
Unlikely

Low
Low

183
94

6.3
6.3

―

―

―

―

202

― 116 ―

Q4_furoku4.indd 1④CQ4 Evidence evaluation sheet (index test: MWST; outcomes: sensitivity and specificity of
aspiration detection)
CQ
Patients

CQ4
18 years old age and older

Index test
Control

MWST（Modified Water Swallowing Test）
N.A.

Reference test

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".

VE or VF

Summarize each outcome on a separate sheet.

Sensitivity and specificity in detecting aspiration

OutcomeStudies

Risk of bias*
Reference
test

Selection
bias

Indirectness*
Flow andtimimgIndex
test

Number
Reference
test

ID

DesignWatanabe
2007

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

None

45

12

9

Osawa 2012

CrosssectionalVF

Low risk

Low riskUnknown

Low risk

Unlikely

Low risk

Low risk

Low risk

None

29

29

76

Index test

Reference test

Summary

Patients

Summary

TP

FP

TN

ROC

Prevalence

95%
CI

Sensitivity

95%
CI

Specificity

95% CI

Accuracy

95%
CI

AUC

95%
CI

P-value

18

0.75

0.64,
0.84

0.71

0.59,
0.82

0.43

0.22,
0.66

0.64

0.53,
0.74

NA

NA

NA

21

0.32

0.25,
0.40

0.58

0.43,
0.72

0.72

0.63,
0.81

0.68

0.60,
0.75

NA

NA

NA

FN

⑤CQ4 Evidence synthesis sheet (index test: MWST; outcomes: sensitivity and specificity of
aspiration detection)
Factors that may reduce the quality of evidence
OutcomeTrue
positive
True
negative
False
positive
False
negative
Uncertain
results

Effectivenessper 1000 Importancepatients

Limitation

Final
Indirectness Inconsistency Imprecision Publication bias quality

2（74） Cross-sectional

Unlikely

None

Unlikely

None

Unlikely

Low

310

6.3

2（85） Cross-sectional

Unlikely

None

Unlikely

None

Unlikely

Low

356

6.3

2（41） Cross-sectional

Unlikely

None

Unlikely

None

Unlikely

Low

172

6.3

2（39） Cross-sectional

Unlikely

None

Unlikely

None

Unlikely

Low

163

6.3

—

—

—

—

—

—

—

—

N (n)

DesignNoreports—⑥CQ4 Evidence evaluation sheet (index test: MWST; outcomes: sensitivity and specificity ofpharyngeal residue detection)
CQ
Patients

CQ4
18 years old age and older

Index test
Control
Reference test

MWST（Modified Water Swallowing Test）
N.A.
VE or VF

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".
Summarize each outcome on a separate sheet.

Sensitivity and specificity in detecting pharyngeal residue

OutcomeStudies

Risk of bias*

Indirectness*

NumberID

DesignReference
test

Selection
bias

Index test

Reference test

Flow andtimimgSummary

Patients

Index
test

Reference
test

Summary

TP

FP

TN

FN

Prevalence

95%
CI

Sensitivity

95%
CI

Specificity

95% CI

Accuracy95%
CI

Osawa 2012

CrosssectionalVF

Low risk

Low risk

Low risk

Low riskNone

Low risk

Low risk

Low risk

None

17

41

74

23

0.26

0.19，
0.43
0.33

0.27,
0.59

0.64

0.55,
0.73

0.59

0.51,
0.67

ROC

AUC

95%
CI

P-value

NA

NA

NA

⑦CQ4 Evidence synthesis sheet (index test: MWST; outcomes: sensitivity and specificity ofpharyngeal residue detection)
Factors that may reduce the quality of evidence
OutcomeN (n)DesignTrue
1（17） Cross-sectional
positive
True
1（74） Cross-sectional
negative
False
1（41） Cross-sectional
positive
False
1（23） Cross-sectional
negative
No
Uncertain―
reports
results

Finalquality

Effectivenessper 1000 Importancepatients

Indirectness Inconsistency Imprecision

Publication
bias

None

None

None Serious

None

Low

110

6.3

None

None

None Serious

None

Low

477

6.3

None

None

None Serious

None

Low

265

6.3

None

None

None Serious

None

Low

148

6.3

―

―

―

―

―

―

―

Limitation―

4_furoku6.indd 1

2― 117 ―

⑧CQ5 Evidence evaluation sheet (index test: FT; outcomes: sensitivity and specificity of
aspiration detection)
CQ
Patients

CQ5
18 years old age and older

Index test
Control

FT (Food Test)
N.A.

Reference test

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".

VE or VF

Summarize each outcome on a separate sheet.

Sensitivity and specificity in detecting aspiration

OutcomeStudies

Risk of bias*

Indirectness*

NumberID

DesignReference
test

Selection
bias

Index test

Reference test

Flow andtimimgSummary

Patients

Index
test

Reference
test

Summary

TP

FP

TN

FN

Prevalence

95%
CI

Sensitivity

95%
CI

Specificity

95% CI

Accuracy95%
CI

Osawa 2012

CrosssectionalVF

Low risk

Low risk

Low risk

Low riskNone

Low risk

Low risk

Low risk

None

8

89

56

2

0.06

0.31,
0.12

0.80

0.44,
0.97

0.39

0.31,
0.47

0.41

0.33,
0.49

ROC

AUC

95%
CI

P-value

NA

NA

NA

⑨CQ5 Evidence synthesis sheet (index test: FT; outcomes: sensitivity and specificity of
aspiration detection)
Factors that may reduce the quality of evidence
Publication
Indirectness Inconsistency Imprecision
bias

Final
quality1（8） Cross-sectional

None

None

None Serious

None

Low

52

6.3

1（56） Cross-sectional

None

None

None Serious

None

Low

361

6.3

1（89） Cross-sectional

None

None

None Serious

None

Low

574

6.3

1（2） Cross-sectional

None

None

None Serious

None

Low

13

6.3

―

―

―

―

―

―

―

Outcome

N (n)

True
positive
True
negative
False
positive
False
negative

Uncertain
No reports
results

Design―Limitation―_furoku8.indd 1

Effectivenessper 1000 Importancepatients

202― 118 ―

（4）CQ 6①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search (pharyn*[tiab] OR oropharyn*[tiab]) AND (aspirat*[tiab] OR residue*[tiab])#4

Search #1 or #2 or #3#5

Search "Auscultation"[mh] OR "Stethoscopes"[mh] OR auscultation[tiab] OR stethoscope*[tiab]#6

Search cervical[tiab] OR swallowing sound*[tiab]#7

Search #4 and #5 and #6

EmbaseS1(EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia"))

S2(TI,AB((aspiration NEAR pneumonia*) OR (deglutition NEAR disorder*) OR (swallowing NEAR disorder*) OR dysphagia*))

S3(TI,AB((pharyn* OR oropharyn*) AND (aspirat* OR residue*)))S4(S1 OR S2 OR S3)

S5(EMB.EXACT("auscultation") OR EMB.EXACT.EXPLODE("stethoscope"))S6(TI,AB(auscultation OR stethoscope*))

S7(S5 or S6)

S8(TI,AB(cervical OR swallowing P/2 sound*))S9(S4 and S7 and S8)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2aspiration pneumonia OR deglutition disorder* OR dysphagia

S3(pharyn* OR oropharyn*) AND (aspirat* OR residue*)

S4

S1 OR S2 OR S3

S5(MH "Auscultation") OR (MH "Stethoscopes")

S6

auscultation OR stethoscope*

S7

S5 OR S6S8

S4 AND S7

Cochrane Library#1

MeSH descriptor: ["Pneumonia, Aspiration"] explode all trees#2

aspiration pneumonia or deglutition disorder* or dysphagia:ti,ab,kw#3(pharyn* OR oropharyn*) and (aspiration* or residue*):ti,ab,kw#4#1 or #2 or #3#5

MeSH descriptor: ["Auscultation"] explode all trees#6(auscultation OR stethoscope*):ti,ab,kw#7#5 or #6

#8

(cervical OR swallowing sound*):ti,ab,kw#9#4 and #7 and #8

Ichushi-Web#1

Pneumonia-Swallowing/TH or Aspiration Pneumonia/AL or Swallowing Pneumonia/AL or Suction Pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3(Swallowing/TH or Swallowing/AL) (in Japanese)#4(Aspiration/TH or Aspiration/AL in the airway) or Residual/AL (in Japanese)#5#3 and #4#6#1 or #2 or #5#7

Auscultation/TH or Auscultation/AL (in Japanese)#8

Screening/AL or Detection/AL or Inspection/AL or Evaluation/AL (in Japanese)#9#6 and #7 and #8― 119 ―

6_furoku2.indd 1②CQ6 Evidence evaluation sheet (outcomes: sensitivity and specificity of aspiration detection)
CQ

CQ6

Patients*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".

18 years old age and older

Index test

Cervical auscultation

Control

N.A.

Reference test

VE or VF

Summarize each outcome on a separate sheet.

OutcomeSensitivity and specificity in detecting aspiration

Studies

Risk of bias*
Reference
Selection bias
test

Indirectness*

NumberID

DesignIndex test

Reference
test

Flow andtimimgSummary

Patients

Index test

Reference Summary
test

TP

FP

TN

FN

ROC
AUC

95% CI

P-value

Shaw 2004（Respiratory sound）

CrosssectionalVF

Low risk

Low risk

Low risk

Low riskNone

Low risk

Low risk

Low risk

なし

18

8

57

22

0.38

0.29,
0.48

0.45

0.29,
0.62

0.88

0.77,
0.95

0.71

0.57,
0.76

NA

NA

NA

Inoue 2005,
2007（Respiratory sound）

Crosssectional

VF

High risk

Unknown

Low risk

Low risk

UnlikelyHigh risk

Low risk

Low risk

Unlikely

62

8

30

5

0.64

0.54,
0.73

0.93

0.83,
0.98

0.79

0.63,
0.90

0.88

0.80,
0.93

NA

NA

NA

Sugimoto 2010
（Respiratory sound）

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

8

0

6

2

0.63

0.35,
0.85

0.80

0.44,
0.97

1.00

0.54,
1.00

0.88

0.62,
0.98

NA

NA

NA

Nozue 2017
（Respiratory sound）

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

111

165

195

81

0.35

0.31,
0.39

0.58

0.50,
0.64

0.54

0.49,
0.59

0.55

0.51,
0.60

NA

NA

NA

Caviedes 2010
（Respiratory and swallowing sound）

Crosssectional

VE

Low risk

Low riskUnknown

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

14

9

37

3

0.27

0.17,
0.40

0.82

0.57,
0.96

0.80

0.66,
0.91

0.81

0.69,
0.90

NA

NA

NA

Borr 2007（Respiratory and swallowing sound）

Crosssectional

VF

High risk

Unknown

Low risk

Low risk

UnlikelyHigh risk

Low risk

Low risk

Unlikely

110

54

126

7

0.39

0.34,
0.45

0.94

0.88,
0.98

0.70

0.63,
0.77

0.79

0.74,
0.84

NA

NA

NA

Nozue 2017
（Respiratory and swallowing sound）

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

157

191

169

35

0.35

0.31,
0.39

0.82

0.76,
0.87

0.47

0.42,
0.52

0.59

0.55,
0.63

NA

NA

NA

Watanabe, 2006, Ohshige 2012
（Swallowing sound）

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

18

2

55

15

0.37

0.27,
0.47

0.55

0.36,
0.72

0.96

0.88,
1.00

0.81

0.71,
0.89

NA

NA

NA

Watanabe, 2006, Ohshige 2012
（Respiratory sound）

CrosssectionalVF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

30

8

49

3

0.37

0.27,
0.47

0.91

0.76，
0.98

0.86

0.74,
0.94

0.88

0.79,
0.94

NA

NA

NA

Santamato2009（Swallowing sound）

Crosssectional

VE

High risk

Low riskUnknown

Low risk

UnlikelyHigh risk

Low risk

Low risk

Unlikely

4

0

7

4

0.53

0.27,
0.79

0.50

0.16,
0.84

1.00

0.59,
1.00

0.73

0.45,
0.92

NA

NA

NA

Stroud 2002
（Swallowing sound）

CrosssectionalVF

Low risk

Low riskUnknown

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

28

57

73

2

0.19

0.13,
0.26

0.93

0.78,
0.99

0.56

0.47,
0.65

0.63

0.55,
0.71

NA

NA

NA

Leslie 2004
（Swallowing sound）

Crosssectional

VF

High risk

Low riskUnknown

Low risk

UnlikelyHigh risk

Low risk

Low risk

Unlikely

8

1

9

2

0.50

0.27,
0.73

0.80

0.44,
0.97

0.90

0.55,
1.00

0.85

0.62,
0.97

NA

NA

NA

Nozue 2017
（Swallowing sound）

Crosssectional

0.35

0.31,
0.39

0.72

0.65,
0.79

0.50

0.44,
0.55

0.58

0.53,
0.62

NA

NA

NA

VF

Low riskUnknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

なし

139

181

179

53

Prevalence 95% CI Sensitivity 95% CI Specificity 95% CI Accuracy 95% CI*Shaded cells were excluded from the meta-analysis due to duplication*1 If healthy subjects were included in the study, they were evaluated high risk for selection bias and high risk for indirectnessty*2 Blinding unknown, but if the order is stated, the first test is low risk and the later tests cannot be said to be unaffected, so it is assumed to be unknown.
*3 Boor 2007, Leslie 2004, Nozue 2017 detect penetration and aspiration together as "abnormal".
*4 Nozue 2017 had another cervical auscultation 3 weeks later to measure the accuracy of both. There was no significant difference between the first and second time, and only the results of the first time are shown in the table.
*5Boor 2007 tested the same subject 9 times, Stroud 2002 tested the same subject 10 times, and Nozue 2017 tested the same subject 12 times. TP and other values are listed as sums.
*6. In Boor 2007, the evaluation by STs, students, and the general public were described, but there was no significant difference and only the evaluation by STs is described in the table.

③CQ6 Evidence synthesis sheet (outcomes: sensitivity and specificity of aspiration detection)
Factors that may reduce the quality of evidence

Final
Publication quality
bias

Crosssectional

Unlikely Unlikely Unlikely

None

Unlikely

Low

309

6.3

10 (563)

Crosssectional

Unlikely Unlikely Unlikely

None

Unlikely

Low

396

6.3

10 (336）

Crosssectional

Unlikely Unlikely Unlikely

None

Unlikely

Low

236

6.3

Crosssectional

Unlikely Unlikely Unlikely

None

Unlikely

Low

60

6.3

—

—

—

—

—

N (n)

DesignTrue
positive

10 (439)

True
negative
False
positive

Effectivenessper 1000 Importancepatients

Limitation Indirectness Inconsistency Imprecision

OutcomeFalse
10 (85）
negative
Uncertain
No reports
results

―

—

—

—

20

④CQ6 Evidence evaluation sheet (outcomes: sensitivity and specificity of pharyngeal
residue detection)
CQ

CQ6

Patients

18 years old age and older

Index test
Control
Reference test

Cervical auscutlation
N.A.
VE or VF

Summarize each outcome on a separate sheet.

Accuracy in detecting pharyngeal residue inthe pyriform fossa and epiglottic valley

OutcomeStudiesID*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".

Risk of bias*
DesignTamura 2008
Cross（Respiratory sound） sectional

Reference
test

VF

Selection
bias

Low risk

Index test

Unknown

Reference
test

Unknown

Indirectness*
Flow andSummary
timimgLow risk

Unlikely

Patients

Low risk

Index
test

Low risk

Number
Reference
Summary
test

Low riskTP

None― 120 ―

3

FP

1

TN

2

FN

2

Prevalence

95%
CI

0.63

0.24,
0.91

Sensitivity

95%
CI

Specificity 95% CI Accuracy

95%
CI

ROC
AUC

95%
CI

P-value

0.60

0.15,
0.95

0.09,
0.99

0.24,
0.91

NA

NA

NA

0.67

0.63

⑤CQ6 Evidence synthesis sheet (outcomes: sensitivity and specificity of pharyngeal residue
detection)
OutcomeTrue
positive
True
negative
False
positive

CQ6_furoku5.indd 1

False
negative
Uncertain
results

N (n)

1 (3)
1 (2)
1 (1)

DesignCrosssectional
Crosssectional
Crosssectional

Factors that may reduce the quality of evidence
EffectivenessFinal
per 1000 Importance
Publication
quality
Limitation Indirectness Inconsistency Imprecisionpatients
bias
Unlikely

None

None

Serious

None

Unlikely

None

None

Serious

None

Unlikely

None

None

Serious

Very
low
Very
low

375

6.3

250

6.3

None

Very
low

125

6.3

250

6.3

―

―

1 (2)

Crosssectional

Unlikely

None

None

Serious

None

Very
low

No reports

―

―

―

―

―

―

―

― 121 ―

（5）CQ 7①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search #1 or #2#4

Search "Ultrasonography"[mh]#5Search ultrason*[tiab] OR ultrasound*[tiab] OR echotomograph*[tiab] OR echo tomograph*[tiab] OR echograph*[tiab] OR sonograph*[tiab]
OR ultra sound*[tiab]#6

Search #4 or #5#7

Search screening[tiab] OR predict*[tiab] OR test[tiab] OR tests[tiab] OR detect*[tiab] OR assess*[tiab] OR evaluat*[tiab]#8

Search deglutit*[tiab] OR swallow*[tiab] OR esophag*[tiab] OR pharyn*[tiab] OR oropharyn*[tiab]#9

Search #3 and #6 and #7 and #8

EmbaseS1((EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia")))S2((TI,AB((aspiration NEAR pneumonia*) OR (deglutition NEAR disorder*) OR (swallowing NEAR disorder*) OR dysphagia*)))S3(S1 OR S2)

S4

EMB.EXACT.EXPLODE("echography")

S5(TI,AB(ultrason* OR ultrasound* OR echotomograph* OR (echo PRE/2 tomograph*) OR echograph* OR sonograph* OR (ultra PRE/2
sound)))S6(S4 OR S5)

S7(TI,AB(deglutit* OR swallow* OR dysphagia* OR esophag* OR pharyn* OR oropharyn*))

S8(TI,AB(screening OR predict* OR test OR tests OR detect* OR assess* OR evaluat*))

S9((S3 AND S6 AND (S7 NEAR S8)))

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2aspiration pneumonia OR deglutition disorder* OR dysphagia

S3

S1 OR S2

S4

(MH "Ultrasonography+")S5

ultrason* OR ultrasound* OR echotomograph* OR echo tomograph* OR echograph* OR sonograph* OR ultra sound*

S6

S4 OR S5

S7

screening OR predict* OR test OR tests OR detect* OR assess* OR evaluat*

S8deglutit* OR swallow* OR esophag* OR pharyn* OR oropharyn*

S9

S3 AND S6 AND S7 AND S8Cochrane Library#1

MeSH descriptor: ["Pneumonia, Aspiration"] explode all trees#2(aspiration pneumonia or deglutition disorder* or dysphagia):ti,ab,kw#3#1 or #2

#4

MeSH descriptor: [Ultrasonography] explode all trees#5(ultrason* or ultrasound* or echotomograph* or echo tomograph* or echograph* or sonograph* or ultra sound*):ti,ab,kw#6#4 or #5

#7((deglutit* OR swallow* OR dysphagia* OR esophag* OR pharyn* OR oropharyn*) near/5 (screening OR predict* OR test OR tests OR
detect* OR assess* OR evaluat*)):ti,ab,kw#8#3 and #6 and #7― 122 ―

Ichushi-Web#1

Pneumonia-Swallowing/TH or Aspiration Pneumonia/AL or Swallowing Pneumonia/AL or Suction Pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3(Swallowing/TH or Swallowing/AL) (in Japanese)#4(Aspiration/TH or Aspiration/AL in the airway) or Residual/AL (in Japanese)#5#3 and #4#6#1 or #2 or #5#7

Screening/AL or screening/AL or detection/AL or testing/AL or evaluation/AL (in Japanese)#8(Ultrasound/TH or Ultrasound/AL) (in Japanese)#9#6 and #7 and #8②CQ7 Evidence evaluation sheet (outcomes: sensitivity and specificity of aspiration detection)
CQ

CQ7

Patients

18 years old age and older

Index test

Screening for eating and swallowing disorders byobservation with ultrasound diagnostic device

Control
Reference test

N.A.
VE or VF

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".
Summarize each outcome on a separate sheet.

Sensitivity and specificity in detecting aspiration

OutcomeStudies

Risk of bias*
Reference test

Selection bias

Index test

Indirectness*

Reference
test

Flow andtimimgSummary

Patients

Index test

Number
Reference
Summary
test

Prevalence

95%
CI

Sensitivity

95%
CI

Specificity 95% CI Accuracy

95%
CI

ROC
AUC

95%
CI

P-value

1

0.26

0.14,
0.42

0.91

0.59,
1.00

0.94

0.79,
0.99

0.93

0.81,
0.99

NA

NA

NA

26

4

0.26

0.14,
0.42

0.64

0.31,
0.89

0.84

0.66,
0.95

0.79

0.63,
0.90

NA

NA

NA

9

67

4

0.24

0.20,
0.39

0.83

0.63,
0.95

0.88

0.79,
0.94

0.87

0.79,
0.93

NA

NA

NA

26

4

17

5

0.60

0.45,
0.73

0.84

0.66,
0.95

0.81

0.58,
0.95

0.83

0.70,
0.92

NA

NA

NA

20

1

20

11

0.60

0.45,
0.73

0.65

0.45,
0.81

0.95

0.76,
1.00

0.77

0.63,
0.87

NA

NA

NA

TP

FP

TN

ID

DesignMiura 2014b

Crosssectional

VE/ VF

Unknown

Unknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

None

10

2

29

Miura 2014a

Crosssectional

VE/ VF

Unknown

Unknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

None

7

5

Tomii 2011

Crosssectional

VF

Unknown

Unknown

Unknown

Unknown

Unlikely

Low risk

Low risk

Low riskNone

20

Lee 2016_hbd

Crosssectional

VF

Unknown

Unknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low riskNone

Lee 2016_delta

Crosssectional

VF

Unknown

Unknown

Low risk

Low risk

Unlikely

Low risk

Low risk

Low risk

None

FN*1. Lee 2016 included laryngeal invasion. Accuracy is described both using hyoid bone displacement and delta value. The meta-analysis uses the evaluation using hyoid bone displacement.

③CQ7 Evidence synthesis sheet (outcomes: sensitivity and specificity of aspiration detection)
Outcome

付録_hyo2-7.indd 1

True
positive
True
negative
False
positive
False
negative
Uncertain
results

N (n)

4 (63)
4 (139)4 (20）
4 (14）
No reports

DesignCrosssectional
Crosssectional
Crosssectional
Crosssectional―

Factors that may reduce the quality of evidence
Effectiveness
Final
Publication quality per 1000 Importancepatients
bias

Limitation Indirectness Inconsistency Imprecision
Unlikely

None

Unlikely

None

Unlikely

Low

267

6.3

Unlikely

None

Unlikely

None

Unlikely

Low

589

6.3

Unlikely

None

Unlikely

None

Unlikely

Low

85

6.3

Unlikely

None

Unlikely

None

Unlikely

Low

59

6.3

―

―

―

―

―

―

―

―

7_furoku2.indd 1

2― 123 ―

④CQ7 Evidence evaluation sheet (outcomes: sensitivity and specificity of pharyngeal
residue detection)
CQ
Patients

CQ7
18 years old age and older

Index test

Screening for eating and swallowing disorders by observation
with ultrasound diagnostic device

Control
Reference test

N.A.
VE or VF

*Risk of bias, indirectness
Each domain will be rated on three levels: "high risk," "low risk," and "unknown.
The summary should be reflected in the body of evidence in three levels: "serious", "unlikely", and "none".
Summarize each outcome on a separate sheet.

Sensitivity and specificity in detecting pharyngeal residue

OutcomeStudies

Risk of bias*

Indirectness*

NumberID

DesignReference test

Selection bias

Index test

Reference
Flow and timimg Summary
test

Patients

Index test

Reference
Summary
test

TP

FP

TN

FN

Prevalence

95%
CI

Sensitivity

95%
CI

Specificity 95% CI Accuracy

95%
CI

ROC
AUC

95%
CI

P-value

Miura 2016

Crosssectional

VE

Unknown

Unknown

Low risk

Low risk

Low risk

Low risk

8

2

4

5

0.68

0.43,
0.87

0.62

0.32,
0.86

0.67

0.22,
0.96

0.38,
0.84

NA

NA

NA

Low risk

Unlikely

None

0.63

⑤CQ7 Evidence synthesis sheet (outcomes: sensitivity and specificity of pharyngeal residue
detection)
OutcomeN (n)DesignTrue
positive

1 (8）Crosssectional

Truenegative
False
positive
False
negative

1 (4）
1 (2）
1 (5）

Uncertain
No reports
results

Crosssectional
Crosssectional

Factors that may reduce the quality of evidence
EffectivenessFinal
per 1000 Importance
Publication
qualitypatients
bias

Limitation Indirectness Inconsistency Imprecision
Unlikely

None

None

Serious

None

Very low

421

6.3

Unlikely

None

None

Serious

None

Very low

211

6.3

Unlikely

None

None

Serious

None

Very low

105

6.3

Crosssectional

Unlikely

None

None

Serious

None

Very low

263

6.3

­

­

­

­

­

­

­

­

­

furoku4.indd 1

202― 124 ―

（6）CQ 8①Database search formula
PubMed#1"Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

aspiration*[tiab] OR residue*[tiab]#4#1 or #2 or #3#5

deglutit*[tiab] OR swallow*[tiab]#6care[tiab] OR ("nursing"[sh] OR "nursing"[mh]) OR ("rehabilitation"[sh] OR "rehabilitation"[tiab] OR "rehabilitation"[mh]) OR exercise*[tiab]
OR training[tiab]#7"Ultrasonography"[mh]#8ultrason*[tiab] OR ultrasound*[tiab] OR echotomograph*[tiab] OR echo tomograph*[tiab] OR echograph*[tiab] OR sonograph*[tiab] ORultra sound[tiab] OR acoustic[tiab]#9#7 or #8

#10

#4 and #5 and #6 and #9

EmbaseS1(EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia"))

S2(TI,AB((aspiration NEAR pneumonia*) OR (deglutition NEAR disorder*) OR (swallowing NEAR disorder*) OR dysphagia*))

S3(TI,AB(aspiration* OR residue*))

S4(S1 or S2 or S3)

S5(TI,AB(deglutit* OR swallow*) AND QU(RH))

S6(TI,AB((deglutit* OR swallow*) NEAR (care OR management OR rehabilitation OR exercise* OR training)))

S7(S5 or S6)

S8

EMB.EXACT.EXPLODE("echography")

S9(TI,AB(ultrason* OR ultrasound* OR echotomograph* OR (echo PRE/2 tomograph*) OR echograph* OR sonograph* OR (ultra PRE/2
sound) OR acoustic))

S10(S8 or S9)

S11(S4 and S7 and S10)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2aspiration pneumonia OR deglutition disorder* OR dysphagia

S3

aspiration* OR residue*

S4

S1 OR S2 OR S3

S5(deglutit* OR swallow*) AND (MW "NU" OR MW "RH")

S6(deglutit* OR swallow*) N5 (care OR management OR rehabilitation OR exercise* OR training)

S7

S5 OR S6

S8

MH Ultrasonography+

S9

ultrason* OR ultrasound* OR echotomograph* OR echo tomograph* OR echograph* OR sonograph* OR ultra sound* OR acoustic

S10

S8 OR S9S11

S4 AND S7 AND S10

Cochrane Library#1[mh "Pneumonia, Aspiration"] or [mh "Deglutition Disorders"]#2

aspiration pneumonia or deglutition disorder* or dysphagia:ti,ab,kw#3

aspiration* or residue*:ti,ab,kw#4#1 or #2 or #3#5((deglutit* or swallow*) near/5 (care or management or rehabilitation or exercise* or training)):ti,ab,kw#6[mh Ultrasonography]#7(ultrason* or ultrasound* or echotomograph* or echo tomograph* or echograph* or sonograph* or ultra sound* or acoustic):ti,ab,kw#8#6 or #7

#9

#4 and #5 and #8― 125 ―

Ichushi-Web#1

Pneumonia-Swallowing/TH or Aspiration Pneumonia/AL or Swallowing Pneumonia/AL or Suction Pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3(Swallowing/TH or Swallowing/AL) (in Japanese)#4(Aspiration/TH or Aspiration/AL in the airway) or Residual/AL (in Japanese)#5#3 and #4#6#1 or #2 or #5#7

Swallowing Care/AL or Swallowing Training/TH or Swallowing Training/AL or Swallowing Rehab/AL or Swallowing Support/AL or
Swallowing Assistance/AL (in Japanese)#8(Ultrasound/TH or Ultrasound/AL) (in Japanese)#9#6 and #7 and #8②CQ8 Evidence appraisal sheet (outcome: incidence of aspiration pneumonia)
CQ

CQ8

Patients
Intervention

18 years old age and older
Management of oropharyngeal dysphagia based on ultrasound observations* Each item is rated on a scale of "high (-2)", "moderate/doubt (-1)", and "low (0)".
The summary should be reflected in the total evidence on three levels: "high (-2)," "moderate (-1)," and "low (0).

Control

Conventional management of oropharyngeal dysphagia based onconventional observation

Summarize on a separate sheet for each outcome

Incidence of aspiration pneumonia

OutcomeRisk of bias*
StudiesID

Design

Miura
2018

RCT

Selection bias

Exection bias

Detection
bias

Randomization Concealment

Blind

Blind

ITT

Incomplete
outcomereportingSelective
outcomereporting

Early study
discontinuation

Other bias

­2

­2

­2

0

0

0

0

0

0

Case reduction bias

OthersNumber at risk (outcome rate)

Indirectness*

Sumarry Patients Intervention Control Outcome
­1

0

0

0

0

Sumarry

Control
Controlgroup
group
denominator numerator(％ )Intervention Intervention
group
group
denominator numerator

(％ )

­1

23

4.3

23

8.7

1

2

Effectiveness Effectivenessindex (type) index (value)
OR

2.09

95% CI
0.18,
24.87③CQ8 Evidence evaluation sheet (outcome: incidence of aspiration)
CQ

CQ8

Patients
Intervention* Each item is rated on a scale of "high (-2)", "moderate/doubt (-1)", and "low (0)".
The summary should be reflected in the total evidence on three levels: "high (-2)," "moderate (-1)," and "low (0).

18 years old age and older with suspected dysphagia
Management of oropharyngeal dysphagia based on pyhsical assessment techniques

付録_hyo2-8.indd 1

Summarize on a separate sheet for each outcome

Conventional management of oropharyngeal dysphagia based onconventional observation

Control

Incidence of aspiration

OutcomeRisk of bias*
StudiesID

Design

Miura
2018

RCT

Selection bias

Exection bias

Randomization Concealment

00Detection
bias

Case reduction bias

Others

Blind

Blind

ITT

Incomplete
outcomereporting

­2

­2

­2

0

Number at risk (outcome rate)

Indirectness*

Selective
outcomereporting

Early study
discontinuation

Other bias

0

0

0

Sumarry Patients Intervention Control Outcome
­1

0

0

0

Sumarry

Control
Controlgroup
group
denominator numerator(％ )Intervention Intervention
group
group
denominator numerator

(％ )

­1

23

13.0

23

4.3

0

3

1

Effectiveness Effectivenessindex (type) index (value)
OR

0.30

95% CI

0.03, 3.15

④CQ8 Evidence evaluation sheet (outcome: incidence of pharyngeal residue in the pyriform
fossa)CQ

CQ8

Patients
Intervention* Each item is rated on a scale of "high (-2)", "moderate/doubt (-1)", and "low (0)".
The summary should be reflected in the total evidence on three levels: "high (-2)," "moderate (-1)," and "low (0).

18 years old age and older
Management of oropharyngeal dysphagia based on ultrasound observations

Summarize on a separate sheet for each outcome

Conventional management of oropharyngeal dysphagia based on conventional
observation

Controluroku2.indd 1

202
Incidence of pharyngeal residue in the pyriform fossa

OutcomeRisk of bias*
StudiesID

Design

Miura
2018

RCT

Selection bias

Exection bias

Detection bias

Randomization Concealment

Blind

Blind

ITT

Incomplete
outcomereportingSelective
outcomereporting

Early study
discontinuation

Other bias

­2

­2

­2

0

0

0

0

0

0

Case reduction bias

OthersNumber at risk (outcome rate)

Indirectness*

Sumarry Patients Intervention Control Outcome

0

uroku3.indd 1

­1

0

0

0

Sumarry

Control Control
group
group
denominator numerator(％ )Intervention Intervention
group
group
denominator numerator

(％ )

­1

23

13.0

23

8.7

3

2

Effectiveness Effectivenessindex (type) index (value)
OR

0.63

95% CI
0.10,
4.2

2021

― 126 ―

⑤CQ8 Evidence synthesis sheet
CQ

CQ8

Patients

18 years old age and older

Intervention

Management of oropharyngeal dysphagia based on ultrasound observations

Control

Conventional management of oropharyngeal dysphagia based on conventional observation

The strength of evidence starts from "strong (A)" for RCTs and from "weak (C)" for observational studies.
* Each domain has three levels: "high (-2)," "moderate/doubtful (-1)," and "low (0).
** Four levels of evidence strength: "strong (A)," "moderate (B)," "weak (C)," and "very weak (D)."*** Importance is the importance of the outcome (1-9)

Body of evidence

Number at risk (outcome rate)

Outcome

Design/ N

Risk ofbias*

Incidenceof aspiration
pneumonia

RCT/1

0

Incidence of
aspiration

Incidence of
pyaryngeal residue
in the pyriform
fossa

RCT/1

RCT/1

0

0

Inconsistency* Imprecision*

0

0

0

­2

­1

­1

Indirectness*

­1

­1

­1

Others
Factors of upgrade Control
Control(publication (Observational
group
group
bias, etc.)*
study)*
denominator numerator

0

0

0

23

23

23

1

3

3

(％ )

4.3

13.0

13.0

Intervention Intervention
group
group
denominator numerator

23

23

23

8_furoku5.indd 1

2

1

2

(％ )

8.7

4.3

8.7

Effectiveness EffectivenessStrength of
95% CI
Importance***index (type) index (value)evidence**

OR

OR

OR

2.09

0.18,
24.8

0.30

0.03,
3.15

0.63

0.10,
4.21

弱 (C)

弱 (C)

弱 (C)

Comments

98Miura's study assessed the increase or
decrease in incidence after 8 weeks
compared to baseline. In the present
study, we evaluated the actual numberof cases after 8 weeks. In other words, if
there was even one aspiration or residual
after 8 weeks, it was included in thenumber of patients.

7

Miura's study assessed the increase or
decrease in incidence after 8 weeks
compared to baseline. In the present
study, we evaluated the actual numberof cases after 8 weeks. In other words, if
there was even one aspiration or residual
after 8 weeks, it was included in thenumber of patients.

2― 127 ―

（7）CQ 9①Database search formula
PubMed#1

Search "Pneumonia, Aspiration/diagnosis"[mh] OR "Deglutition Disorders/diagnosis"[mh]#2Search "Endoscopy"[mh]#3Search endoscop*[tiab]#4

Search #2 or #3#5

Search #1 and #4#6

Search (endoscopic evaluation[tiab] OR endoscopic assessment[tiab] OR fiberendoscopic evaluation[tiab]) AND swallowing[tiab]#7

Search #5 or #6#8

Search "Observer Variation"[mh]#9Search agreement*[tiab] OR concordance[tiab]#10

Search intra-rater[tiab] OR intrarater[tiab] OR inter-rater[tiab] OR interrater[tiab]#11

Search #8 or #9 or #10#12

Search #7 and #11

EmbaseS1(EMB.EXACT.EXPLODE("aspiration pneumonia -- diagnosis")) OR (EMB.EXACT.EXPLODE("dysphagia -- diagnosis"))S2

EMB.EXACT.EXPLODE("endoscopy")

S3

TI,AB(endoscop*)

S4(S2 or S3)

S5(S1 and S4)

S6(TI,AB(((endoscopic OR fiberendoscopic) N/2 (evaluation OR assessment)) N/2 swallowing))

S7(S5 or S6)

S8(EMB.EXACT.EXPLODE("observer variation"))S9(TI,AB(agreement* OR concordance))

S10(TI,AB("intra-rater" OR intrarater OR "inter-rater" OR interrater))

S11(S8 or S9 or S10)

S12

(S7 and S11)

CINAHLS1

MH "Pneumonia, Aspiration/DI" OR MH "Deglutition Disorders/DI"

S2

MH "Endoscopy+"

S3

endoscop*

S4

S2 OR S3

S5

S1 AND S4

S6(((endoscopic OR fiberendoscopic) N2 (evaluation OR assessment)) N2 swallowing

S7

S5 OR S6

S8

"Observer Variation"

S9agreement* OR concordance

S10("intra-rater" OR intrarater OR "inter-rater" OR interrater)

S11

S8 OR S9 OR S10S12S7 AND S11― 128 ―

Cochrane Library#1[mh "Pneumonia, Aspiration"/DI] OR [mh "Deglutition Disorders"/DI]#2[mh Endoscopy] OR endoscop*:ti,ab,kw#3#1 and #2#4(((endoscopic OR fiberendoscopic) NEAR/2 (evaluation OR assessment)) NEAR/2 swallowing):ti,ab,kw#5#3 or #4

#6

[mh "Observer Variation"]#7(agreement* OR concordance):ti,ab,kw#8("intra-rater" OR intrarater OR "inter-rater" OR interrater):ti,ab,kw#9#6 or #7 or #8#10#5 and #9#11#5 and #9 in Cochrane Reviews, Cochrane Protocols#12#5 and #9 in Trials

Ichushi-Web#1

Pneumonia-aspirated/TH or aspiration pneumonia/AL or swallowed pneumonia/AL or attracted pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3

Swallowing/AL or Aspiration/AL (in Japanese)#4#1 or #2 or #3#5

Endoscopy/TH or Endoscopy/AL (in Japanese)#6

Consistency/AL or Degree of Consistency/AL or Inconsistency/AL or Inconsistent/AL or Inconsistent Not/AL (in Japanese)#7

Difference by observer/TH (in Japanese)#8

between examiners/AL or within examiners/AL or between raters/AL or within raters/AL or between raters/AL or within raters/AL or between
observers/AL or within observers/AL (in Japanese)#9#6 or #7 or #8#10#4 and #5 and #9

付録_hyo2-9.indd 1― 129 ―

（8）CQ 10①Database search formula
PubMed#1

Search "Pneumonia, Aspiration"[mh] OR "Deglutition Disorders"[mh]#2Search aspiration pneumonia*[tiab] OR deglutition disorder*[tiab] OR dysphagia[tiab]#3

Search aspirat*[tiab] OR residu*[tiab] OR deglutit*[tiab] OR swallow*[tiab]#4

Search #1 and #2 or #3#5

Search "Advanced Practice Nursing"[mh] OR "Nurse's Role"[mh] OR "Nurse Practitioners"[mh] OR "Nurse Specialists"[mh] OR "Education,
Nursing"[mh]#6Search trained nurse*[tiab]#7

Search speech-language*[tiab]#8

Search #5 or #6 or #7#9

Search endoscop*[tiab]#10

Search #8 and #9#11

Search "Endoscopy/nursing"[mh]#12

Search nurse endoscopist*[tiab] OR nurse-performed endoscop*[tiab] OR non-physician endoscop*[tiab] OR endoscopy nurs*[tiab]#13

Search #10 or #11 or #12#14

Search #4 and #13

EmbaseS1((EMB.EXACT.EXPLODE("aspiration pneumonia") OR EMB.EXACT.EXPLODE("dysphagia")))S2((TI,AB((aspiration N/2 pneumonia*) OR (deglutition N/2 disorder*) OR (swallowing N/2 disorder*) OR dysphagia*)))S3(TI,AB(aspirat* OR residu* OR deglutit* OR swallow*))

S4(S1 or S2 or S3)

S5(EMB.EXACT.EXPLODE("advanced practice nursing") OR EMB.EXACT.EXPLODE("nurse practitioner") OR EMB.EXACT.
EXPLODE("nursing education") OR EMB.EXACT.EXPLODE("nurse training") OR EMB.EXACT.EXPLODE("nurse specialist"))S6(TI,AB((trained N/2 nurse*) OR (speech P/1 language*)))S7(S5 or S6)

S8

TI,AB(endoscop*)

S9(S7 and S8)

S10(TI,AB((nurse* N/2 endoscopist*) OR ("nurse-performed" N/2 endoscop*) OR (("non-physician" OR nonphysician*) N/2 endoscop*) OR(endoscopy N/2 nurs*)))S11(S9 or S10)

S12

(S4 and S11)

CINAHLS1

MH "Pneumonia, Aspiration" OR MH "Deglutition Disorders"S2(aspiration N2 pneumonia*) OR (deglutition N2 disorder*) OR dysphagia*

S3

aspirat* OR residu* OR deglutit* OR swallow*

S4

S1 OR S2 OR S3

S5

MH "Advanced Practice Nursing" OR MH "Nurse's Role" OR MH "Nurse Practitioners" OR MH "Nurse Specialists" OR MH "Education,
Nursing"

S6(trained N2 nurse*) OR (speech W1 language*)

S7

S5 OR S6

S8

endoscop*

S9

S7 AND S8

S10(MH "Endoscopy+/NU")

S11(nurse N2 endoscopist*) OR ("nurse-performed" N2 endoscop*) OR (("non-physician" OR nonphysician*) N2 endoscop*) OR (endoscopy N2
nurs*)S12

S9 OR S10 OR S11

S13

S4 AND S12― 130 ―

Cochrane Library#1[mh "Pneumonia, Aspiration"] OR [mh "Deglutition Disorders"]#2((aspiration NEAR/2 pneumonia*) OR (deglutition NEAR/2 disorder*) OR dysphagia*):ti,ab,kw#3(aspirat* OR residu* OR deglutit* OR swallow*):ti,ab,kw#4#1 or #2 or #3#5[mh "Advanced Practice Nursing"] OR [mh "Nurse's Role"] OR [mh "Nurse Practitioners"] OR [mh "Nurse Specialists"] OR [mh "Education,
Nursing"]#6((trained NEAR/2 nurse*) OR (speech NEXT language*)):ti,ab,kw#7#5 or #6

#8

endoscop*:ti,ab,kw#9#7 and #8#10[mh Endoscopy/NU]#11((nurse NEAR/2 endoscopist*) OR ("nurse-performed" NEAR/2 endoscop*) OR (("non-physician" OR nonphysician*) NEAR/2 endoscop*)
OR (endoscopy NEAR/2 nurs*)):ti,ab,kw#12#9 or #10 or #11#13#4 and #12#14#4 and #12 in Cochrane Reviews, Cochrane Protocols#15#4 and #12 in Trials

Ichushi-Web#1

Pneumonia-aspirated/TH or aspiration pneumonia/AL or swallowed pneumonia/AL or attracted pneumonia/AL (in Japanese)#2@Dysphagia/TH or Dysphagia/AL (in Japanese)#3

Swallowing/AL or Aspiration/AL (in Japanese)#4#1 or #2 or #3#5

Advanced Professional Nursing Practice/TH or Nurse Practitioner/TH or Professional Nurse/TH or Nursing Education/TH or Role of the
Nursing Profession/TH (in Japanese)#6

Articulation Language/AL (in Japanese)#7#5 or #6

#8

Endoscopy/TH or Endoscopy/AL (in Japanese)#9#7 and #8#10(Endoscopy/TH) and (SH=Nursing) (in Japanese)#11

Endoscopy Nursing/AL (in Japanese)#12#9 or #10 or #11#13#4 and #12

付録_hyo2-10.indd 1― 131 ―

3．The Conﬂict of Interest Statuses of the Clinical Guideline Formulators

Name (Organization)
Supervisory
Committee
members

Economic COI

Junko Sugama (Fujita Health University)
Eiichi Saitoh (Fujita Health University)
Erika Ota (St. Luke’s International University)
Hiromi Sanada (The University of Tokyo)
Masako Yamada (St. Luke’s International University)
Miyuki Ishibashi (Chiba University)
Takeshi Nomura (Tokyo Women’s Medical University)
Takeo Nakayama (Kyoto University)

Yayoi Kamakura (Japanese Red Cross Toyota College ofNursing)
Guideline
Junko Sugama (Fujita Health University)
Development
Gojiro Nakagami (The University of Tokyo)
GroupErika Ota (St. Luke’s International University)
Junko Fukada (Aichi Prefectural University)
Naoko Sato (Chuo Partners Corporation Tokyo Hikari Nurse
Station)Seiko Shibata (Fujita Health University)
Takashi Hase (Noto General Hospital)
Tatsuto Miki (Fujita Health University Hospital)
Systematic Review Aya Kitamura (The University of Tokyo)
Team
Hiroshi Noguchi (Osaka City University)
Itoko Tobita (Jikei University of Health Care Sciences)
Kanae Mukai (Kanazawa University)
Masaru Matsumoto (The University of Tokyo)

Mikako Yoshida (Tohoku University)

Mikiko Arita (Osaka Shin-ai College)
Misako Dai (Fujita Health University)
Nao Tamai (The University of Tokyo)

Tamae Urai (Toyama Prefectural University)
Toshiaki Takahashi (The University of Tokyo)
Yohei Okawa (Tohoku University)
Yuka Miura (The University of Tokyo)

Yuko Mugita (The University of Tokyo)

None
None
None
None
None
None
None
None

Academic COI

None

None
None
None
None
None
None
None
Related clinical guideline preparation
members, : Japan Council for
Quality Health Care Minds Steering
Committee Chair, Japanese
Association of Medical Sciences
Association Medical Guideline
Review Committee, Japanese Societyof Neurology Guidelines Supervisor,
Japanese Society of Palliative
Medicine Guidelines Supervisor,
Japan Endoscopic Surgery Society
Guidelines Supervisor Committee
member
None

None
None
None
None
None

None
None
None
None
None

None
None
None
None
None
None
None
Endowed chairs (affiliations): From
April 2017 to the present : Social
cooperation course (Investor:
FUJIFILM Corporation )Endowed chairs (affiliations): From
April 2017 to March 2019 : Social
cooperation course (Investor:
FUJIFILM Corporation )
None
None
Endowed chairs (affiliations): From
April 2019 to the present : Social
cooperation course (Investor:
FUJIFILM Corporation )
None
None
None
Endowed chairs (affiliations): From
April 2019 to the present : Social
cooperation course (Investor:
FUJIFILM Corporation )
None

None
None
None
None
None
None
None
None

― 132 ―

None

None
None
None

None
None
None
None

None

Name (Organization)
Panel Members

Cooperating
members
External
Evaluation
Committee

Economic COI

Academic COI

Erika Ota (St. Luke’s International University)
Gojiro Nakagami (The University of Tokyo)
Junko Fukada (Aichi Prefectural University)
Junko Sugama (Fujita Health University)
Masako Kurachi (International University of Health andWelfare)

None
None
None
None
Other remuneration (100,000 JPY or
more)(2020.12.25): Toho University:
Writing Opinion

Naoko Sato (Chuo Partners Corporation Tokyo Hikari Nurse
Station)Seiko Shibata (Fujita Health University)
Takako Shirasaka (Day Service Torai Asu)
Takashi Hase (Noto General Hospital)
Tatsuto Miki (Fujita Health University Hospital)
Yukiko Yamane (Asahikawa Medical University)
Takaaki Suzuki (Nara Medical University Library)

None

None
None
None
None
Related clinical practice guideline
creation members: The Oto-RhinoLaryngological Society of Japan:
Clinical Practice Guidelines forthe Diagnosis and Management of
Dysphagia 2023
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lecture fees (500,000 JPY or more):
2019, Towa Pharmaceutical
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Eishu Nango (Japan Cochrane Center)
Itaru Takehara (The Japanese Society of Dysphagia
Rehabilitation)
Norio Watanabe (Japan Cochrane Center)
Ritsuko Yamada (Japan Academy of Gerontological Nursing)
Satoru Ebihara (The Japan Geriatrics Society)
Shingo Okada (Japanese Association for Home Care
Medicine)
Takumi Itagaki (Japan Rehabilitation Nursing Academy)
Yasuyo Tanaka (Japan Academy of Nursing for Home Care)― 133 ―

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Clinical practice guidelines for aspiration and pharyngeal residue assessment during eating and swallowing for nursing care: Japan edition
June 30, 2021 1st edition, 1st print
Supervisor: Japan Academy of Nursing Science (Public Interest Incorporated Association)
Edited by Supervisory Committee in Nursing Care Development/Standardization Committee
Published by Japan Academy of Nursing Science
Production: Nankodo Co. Ltd.
The Japanese Society of Nursing Science retains all copyrights, including the right to reproduce, translate,show, transfer, and publicly transmit the works contained in this publication, including the right to makea transmittable. Therefore, any act that infringes on the above rights without the permission of the Japanese Society of Nursing Science is prohibited.