VIDEOFLUOROSCOPY

SWALLOWING STUDY
(VFSS)

HEALTH TECHNOLOGY ASSESSMENT SECTION

MEDICAL DEVELOPMENT DIVISION
MINISTRY OF HEALTH MALAYSIA
025/09
ii

DISCLAIMER
Technology review is a brief report, prepared on an urgent basis, which draws on
restricted reviews from analysis of pertinent literature, on expert opinion and / or
regulatory status where appropriate. It is not subjected to an external review process.
While effort has been made to do so, this document may not fully reflect all scientific
research available. Additionally, other relevant scientific findings may have been
reported since completion of this review.
Please contact: htamalaysia@moh.gov.my, if you would like further information.

Health Technology Assessment Section (MaHTAS),

Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya
Tel: 603 88831246
Fax: 603 8883 1230
Available at the following website: http://www.moh.gov.my

Prepared by:
Ms, Sin Lian Thye
Nursing Matron
Health Technology Assessment Section
Medical Development Division
Ministry of Health Malaysia

Reviewed by:
Datin Dr. Rugayah Bakri
Deputy Director
Health Technology Assessment Section
Medical Development Division
Ministry of Health Malaysia

DISCLOSURE
The author of this report has no competing interest in this subject and the preparation of
this report is totally funded by the Ministry of Health, Malaysia

ii

EXECUTIVE SUMMARY
Introduction
Dysphagia after stroke is common, and its detection is an important part of acute stroke
management. The literature suggests that swallowing difficulties can affect 22% to 65%
of patients, depending on methods of assessment used, and may persist in some patients
for many months. Dysphagia in acute stroke patients is a marker of poor prognosis,
increasing the risks of chest infection, malnutrition, persistent disability, prolonged
hospital stay, institutionalization on discharge and mortality.
Several instrumented and non-instrumented techniques for diagnosing oropharyngeal
dysphagia exist. The most frequently used swallowing assessment method is the clinical
bedside evaluation. Videofluoroscopy swallowing study (VFSS) also known as modified
barium swallow (MBS) and fiber-optic endoscopic evaluation of swallowing (FEES) are
the most common instrument evaluation tools for diagnosis and management of
dysphagia.
Objective/Aim
To assess the safety, effectiveness and cost implication of VFSS.
Result and Conclusion
There was fair level of evidence to show that VFSS is safe, with minimal adverse event
and minimal radiation exposure. There was fair level of evidence to show that VFSS was
effective in detecting the silent aspiration and hence, in the diagnosis of dysphagia.
However, when compared with FEES, the effectiveness of VFSS is equivalent to FEES.
There was evidence to suggest training using specific or standard criteria in order to
improve inter-rater reliability and propose clearly defined rating scale or group discussion
among assessors was necessary. No cost-effectiveness study was retrieved. However, the
cost of the equipment required for setting up the VFSS services was estimated at RM 1.9
Million.
Recommendation
Based on the above review, it is recommended that VFSS may be set up in the
Rehabilitation Centre for research purpose to obtain more evidence to support its
effectiveness and safety as it is costly to establish the service. In addition, the operator
must be well trained to obtain a satisfactory level of competency.
Methods
A literature search was performed using the following databases PUBMED, MEDLINE,
EBM Review-Cochrane database of systematic reviews via Ovid search engine, HTA
Databases, Australia and New Zealand Horizon Scanning Network (ANZHSN) FDA
website, MHRA website and general search engine - Google for published reports. In
addition, the reference list of the relevant articles was also scrutinized.

iii

1.

INTRODUCTION

Dysphagia after stroke is common, and its detection is an important part of acute stroke
management. The literature suggests that swallowing difficulties can affect 22% to 65%
of patients, depending on methods of assessment used,1;2;3;4;5;6;7 and may persist in some
patients for many months.8;9 Dysphagia in acute stroke patients is a marker of poor
prognosis, increasing the risks of chest infection, malnutrition, persistent disability,
prolonged hospital stay, institutionalization on discharge, and mortality.1;5;6;7;8;9;10
Aspiration (passage of material into the larynx below the true vocal cords) after
swallowing, especially fluids, is probably the most severe aspect of oropharyngeal
dysphagia with incidence between 22% and 52%.2;11;12 Nearly half of aspirations in
patients with stroke are silent 13 and they have been associated with increased morbidity
and mortality in many studies. 14 Moreover, the presence of oropharyngeal dysphagia in
patients recovering from stroke has often been associated with malnutrition, dehydration,
pulmonary infections, prolonged hospital stay, and death.15;16 Lower respiratory tract
infection is probably the most severe event related to dysphagia in the early period after
stroke, and it is more common in patients with oropharyngeal dysphagia and aspirations.
17

It is important to recognise and accurately diagnose dysphagia after stroke for at least
three reasons. Firstly, swallowing dysfunction is frustrating for patients who cannot eat
and drink what they would like, and may have to be fed by a tube. Secondly, it can cause
sudden death from choking, a more protracted hospitalisation (and even death) due to
aspiration pneumonia, dehydration or malnutrition, or long-term disability and
dissatisfaction from being unable to return to a normal diet,1;6;10 Thirdly, many of the
complications, such as aspiration pneumonia, should be preventable if they are
recognized early and managed appropriately.
Several instrumented and non-instrumented techniques for diagnosing oropharyngeal
dysphagia exist. The most frequently used swallowing assessment method is the clinical
bedside evaluation. It evaluates the structure and function of the oral stage of the
swallowing impairment, and allows formulation of a differential diagnosis of impairment
in pharyngeal, laryngeal and esophageal swallowing physiology. It combines elements of
history, cranial nerve assessment and swallow observation.18 This examination have been
traditionally designed and performed by speech language pathologists. However, the
clinical examination is reported to be less sensitive in the identification of dysphagia and
aspiration when compared to alternative instrumental assessment techniques. 19
Instrumental evaluation is supplement to the clinical evaluation. It permits collection of
detailed information regarding the structure and function of the oral , pharyngeal,
laryngeal as well as upper esophageal swallow complex. It also permit assessment of the
potential benefit of compensatory and treatment strategies.18 Instrumental examination
may be performed by a speech pathologist or an otolaryngologist. Radiographic study of
the pharynx and esophagus may include contrast or non-contrast x-rays and computed
tomography scan, traditional barium swallow, modified barium swallow, cookie swallow,
videoesophagogram, esophageal manometry, and 24-hour gastric pH monitoring. 20;21
1

Videofluoroscopy swallowing study (VFSS), also known as modified barium swallow

(MBS), and fiber-optic endoscopic evaluation of swallowing (FEES) are the most
common evaluation tools in diagnosis and management of dysphagia. Endoscopy enables
surface assessment and provides detailed images whilst fluoroscopy provides views of a
broader range of structures. Both provide a view of the bolus and provide information
regarding amplitude, speed, and timing of the structural movement.22
Once dysphagia is diagnosed, several treatment options are available: (i) noninvasive
therapies include diet, modification and swallow therapy, which many include postural
changes or specific exercise, and (ii) if these are not adequate or possible, minimally
invasive parenteral (intravenous) or naso-gastric (NG) feeding may be instituted
temporarily. These interventions are frequently carried out even before a formal diagnosis
of dysphagia has occurred. Invasive therapy may be necessary when dysphagia and
aspiration are serious enough to threaten health on a long-term basis; the most common
invasive therapy for neurogenic dysphagia is the percutaneous endoscopic gastrotomy
(PEG)18
This review evaluated the current evidence regarding VFSS upon the request from the
Deputy Director, of Medical Services Development Section, Medical Development
Division to purchase this technology for Rehabilitation Hospital in Cheras, Kuala
Lumpur.
2.

OBJECTIVES

To assess the safety, effectiveness and cost implication of VFSS.

3.

METHODOLOGY

3.1. Searching
A literature search was performed using the following databases PUBMED, MEDLINE,
EBM Review-Cochrane database of systematic reviews via Ovid search engine, HTA
Databases, Australia and New Zealand Horizon Scanning Network (ANZHSN) FDA
website, MHRA website and general search engine - Google for published reports. In
addition, the reference list of the relevant articles was also scrutinized. The search was
performed using the following keyword, free text word or MeSH term, either singly or in
various combinations: videofluoroscopy swallow studies, videofluoroscpic swallow study,
modified barium swallow study, aspiration, dysphagia, pneumonia, training, radiation,
diagnosis, assessment, evaluation, swallowing difficulty, diagnosis dysphagia after stroke.
3.2. Selection
All English published articles related to safety, effectiveness and cost effectiveness of
videofluoroscopy swallowing study were included. Critical appraisal of relevant literature
was performed and evidence graded according to NHS centre for Reviews and
Dissemination (CRD) University of York, Report Number 4 (2nd Edition) (Appendix 1)

4.

TECHNICAL FEATURES

VFSS is also known as a modified barium swallow study or an oral-pharyngeal motility

study or Cine-swallow study or Cookie swallow or a dynamic swallow study or
videofluoroscopic oropharyngeal swallowing study. The VFSS is recognized as the
reference standard for assessment of oropharyngeal swallowing although it has not been
shown to be a perfect gold standard.
This technique was originally developed for observation of the esophageal region. It was
later modified for assessment of the oropharyngeal component of swallowing23. The
VFSS is often carried out in a radiological suite. The VFSS is administered by a team
consisting of a radiologist to perform the fluoroscopy, a Speech Language Pathology
(SLP) to assess swallowing function and administer the therapy, and often a nurse or
paramedical attendant to assist the patient.
The VFSS is often administered to the patient in an upright seated position, although the
patient's typical eating position can also be used if it is different. The patient attempts to
swallow barium-impregnated boluses of different consistencies, progressing from solids
to pudding to thick liquids and ending with thin liquid (some practitioners reverse this
order). If aspiration is observed, patient maneuvers or various diet consistencies are tried
to see if aspiration can be eliminated or minimized. The examination is terminated if
unpreventable or dangerous aspiration is observed. The patient is observed from the front
and from the side, with the side view being the most useful. Due to limitations on
radiation exposure, the entire test usually is conducted within approximately 5 minutes.
This examination allows direct observation of not only aspiration and the time when it
occurrs, but also other structural and functional anomalies of the swallow. The dynamic
fluoroscopic images are captured on videotape and can be viewed repeatedly and in slow
motion following the examination.24 The images are then evaluated for abnormalities in
the swallowing mechanism by both the radiologist and the SLP. 25,
The following criteria are essential for a patient undergoing VFSS: 26
Must have good sitting balance. (Patients will be supported on three sides, but not
at the front. People who fall forward are at high risk of falling during the
procedure and are unsafe).
Must be alert and relatively aware of their surroundings.
Must be medically stable.
Must be relatively easy to transfer, such as from wheelchair to a chair is easiest.
Should have good head control. It is difficult to view the throat/mouth area on xray unless the person can hold their head up well.
Should not be very agitated or disruptive.
Should be aware of the procedure involved and why they are having it done (if
possible)

Younger females: If the patient is a young female the 'ten day rule' applies. (For
all young females undergoing the examination, the examination should be carried
out in the first ten days of their menstrual cycles).
VFSS are generally considered the most direct and comprehensive method for assessing
swallowing function. However, these examination are not without limitation. The most
common problems faced during the examination using VFSS methods are status of
dysphagic (being too mild or too severe), poor patient cooperation, transportation
difficulty, insufficient oral motor ability, combative patient, physician denial, payer
denial, and patient refusal. Some of these problems are the results of the healthcare
system, and are not inherent to examination itself. Some of the limitations when using
VFSS include inability to image soft tissue, observe dry swallows, observe a normal
meal throughout its full time course, and passive observation of bolus passage without the
ability for direct sensory testing in the absence of a bolus.27; 28; 29; 30

Figure 1: Videofluoroscopy swallowing study

Fibreoptic Endoscopy Evaluation Study (FEES)

Fibreoptic endoscopy evaluation study (FEES) is a more recent development instrumental
evaluation of dysphagia.27,30,31,32,33 This examination is administered by an
otolaryngologist and an SLP. It is performed with portable equipment at the patient's
bedside. A fiberoptic device attached to a video camera is inserted nasally so that the
pharynx and larynx can be observed from above. The image is observed on a small video
monitor and is recorded on videotape. Patients are first observed swallowing their own
secretions. Next, food and liquid of decreasing viscosity are swallowed. Various postural
positions can be tried. Barium is not necessary, but dye is often added to the food to
increase visibility (the image is in colour).

FEES cannot directly observe the oral region during swallowing. In the pharyngeal and
laryngeal regions, it is limited to observations immediately before
and after a swallow, because pharyngeal closure obscures the exact moment of
swallowing. However, aspiration can be clearly detected before the swallow, and
aspiration during the swallow is usually detectable by post swallow residue in the trachea
or by the act of coughing up aspirated material.
5.

RESULTS AND DISCUSSION

From the search strategy, 69 potentially relevant abstracts were identified of which 60
were retrieved. Of these retrieved articles, 34 were included.
5.1
Safety
In terms of safety, the radiation dosage involved in modern fluoroscopy is not considered
a major concern particularly for elderly patients 34, Level 3; 35; Level 3; 36,Level III. Agency for
Healthcare Research and Quality report found that there was no evidence on morbidity or
deaths caused by aspiration of barium compounds during oropharyngeal swallowing
studies.37, Level 1 However, Gray, Sivagolanathan and Simpkins revealed that two deaths
occurred due to accidental ingestion of barium contrast medium owing to disordered
swallowing in elderly women during the examination. 38, Level 3 Penington G et al.
reported that one case aspiration occurred in an 81 year-old woman who had persisting
severe dysphagia that lead to extreme risk of aspiration. However, patient was
discharged alive after a period of intensive respiratory care.39, Level 3 Allergic reactions to
barium sulfate appeared to be quite rare and had been estimated to occur at a rate less
than two per million. 40, Level 3
5.1.1 Safe Radiation dose
A study by Zammit-Maempel, Chappel and Leslie found that videofluoroscopy could be
performed using minimal radiation doses.41, Level 2 Chan, et al. study showed that the
scattered radiation dose received by the parents and staff during the examination was
within the acceptable level. The study was performed in adults and doses were very much
lower in children, which was expected to be miniscule.42, Level 2
5.1.2 Radiation exposure time and safe distance
Hayes et al. in their study on radiation safety for the speech language pathologist showed
that the mean fluoroscopic time for all examination was 165 s (2 min, 45 74 s). The
mean fluoroscopy time for examination of pharynx-only exams was 156 s (2 min, 36 70
s). The mean time for examination for pharynx or esophagus was 198 s (3 min, 18 78
s).43, Level 3 Wright, Boyd and Workman study including 23 patients showed that there was
a wide range of screening time used with an average time of 286 sec (32497 sec). This
wide range of screening time was attributed to the variability of the nature and severity of
the swallowing problems being assessed as well as the level of cooperation of the patients
undergoing the examination. 36, Level 3 Another study done by Zammit Maempel,
Chappel and Leslie on radiation dose in VFSS which included 230 patients found that
screening time depended on the complexity of the swallowing assessment and patient
compliance. A wide range of screening time was documented with a median time of 171
6

s (range = 18564 s). 41, Level 2 Hayes et al. in their study found that the distance of at least
5 ft from the source of primary radiation from the X-ray tube and the source of scattered
radiation from the patient, wearing lead gown and shielding will be able to reduce
radiation exposure to health-care personnel.43, Level 3
5.2

Effectiveness of VFSS

Splaingard et al. reported that only 42% of patients who manifested aspiration on VFSS
were diagnosed with abnormalities in the bedside test. This finding indicated that bedside
tests alone was insufficient for evaluating the frequency of aspiration.13, Level 2
A prospective study by Mann, Handkey and Cameron examined 128 patients with acute
first-ever stroke. They found that videofluroscopic detected 64% (95% CI=55-72%) of
swallowing disorder compared to clinical examination which detected only 51% (95%
CI=42-60%). The sensitivity and specificity for detecting aspiration by clinical
examination was 93% and 63% while, with the VFSS was 73% and 89% respectively.
The study also showed that the inter-observer agreement between the two speech
pathologist for diagnosis of swallowing disorder was (k: 0.82 0.09) and aspiration was
(k: 0.75, 0.09) which were good. However, the intra-observer agreement between a
speech pathologist and radiologist for the VFSS diagnosis of a swallowing disorder was
(k: 0.75 0.09) and for aspiration (k: 0.41 0.09) which was rated as good and fair
respectively.44, Level 3
Wu et al. conducted a study among 28 dysphagic patients using FEES and VFSS. For
each examination, a spoonful of pudding and dyed water were fed in sequence for three
times. The pharyngeal swallowing events were observed with fiberscope panoramically
and videotaped. Twenty eight chronic dysphagic patients underwent both VFSS and
FEES in a period of two weeks. Comparison of the results revealed that disagreements in
premature oral leakage to the pharynx, pharyngeal stasis, laryngeal penetration, aspiration,
effective cough reflex and velopharyngeal incompetence were 39.3%, 10.7%, 14.3%,
14.3%, 39.3% and 32.1% respectively. FEES was found to be more sensitive in detecting
these risky features of swallowing, except with respect to premature leakage. Thus it was
concluded that FEES is a safer, more efficient and sensitive method than VFSS in
evaluating swallowing safety.45, Level 2
A study was conducted to evaluate the clinical usefulness of flexible laryngoscope (FL)
which is similar to FEES compared with the VFSS for the evaluation of aspiration. Their
study concluded that FL can be used as a screening tool for the evaluation of dysphagia.
However, it cannot replace the VFSS to identify the presence and cause of aspiration. FL
can rule out up to 97% of aspiration with a detailed physical examination. When
aspiration was suspected in dysphagia patient, VFSS still remain the most valid and
reliable procedure to aid diagnosis of swallowing disorder. This can assist in formulating
plan for dysphagia therapy. 28, Level 2.

A study by Leder et al. assessed the aspiration status of 400 consecutive subjects with
risk of aspiration. It was reported 96% agreement between FEES and VFSS in revealing
the presence of silent aspiration. 46, Level 2
Leder et al. conducted another study in 2000, investigated 30 paediatric inpatients who
were randomly selected to VFSS and FEES or FEES alone. They found that there was
100% agreement between the VFSS and FEES group and FEES alone group.47, Level 2
Aviv et al. performed a prospective study on 126 dysphagic patients. They were
randomly evaluated using FEES or VFS to determine which was superior as diagnostic
test for detecting aspiration pneumonia. The incidence of aspiration pneumonia and the
pneumonia-free survival over a period of 2 years were used as measurement of outcome
for the study. They found that from 78 VFSS examinations performed in 76 patients, 14
patients (18.4%) developed pneumonia. From 61 FEES examinations performed in 50
patients, 6 patients (12.0%) developed pneumonia. These differences were not
statistically significant (x2 = 0.93, P=0.33). In the VFSS group, the median pneumoniafree interval was 47 days; in the FEES group, the median pneumonia free interval was 39
days. This differences were not statistically significant (z = 0.04, P = 0.96). The authors
concluded that whether dysphagic outpatients have their dietary and behavioral
management guided by the results of VFS or of FEES, their outcomes with respect to
pneumonia incidence and pneumonia-free interval are essentially the same. 48, level 2
A retrospective study by Tabaee et al. on a group of 54 dysphagic patients evaluated
using both methods (FEES and VFSS). The results of the FEES and VFSS using material
of similar consistency given to patients, were compared. The results found that there were
full agreement between the two methods in 18 patients (51.8%), minor disagreement in 7
patients (13.0%) and major disagreement in 19 patients (35.2%). The result showed fair
agreement between the two tests. 49, Level 3
5.3

Training

Legislation in the UK requires all those conducting radiological assessment to be trained

in radiation protection 50, Level 3
There is no stipulated level of training which would guarantee competency in the use of
videofluoroscoy or image interpretation. Several inter-rater reliability studies have
produced disappointing results and some authors had suggested the need for training
using specific or standard criteria in order to improve inter-rater reliability.51Level 1; 52 Level 3;
53 Level 3; 54 Level 3
Some authors have addressed this by proposing clearly defined rating
scale.55 Level 3; 56 Level 3 A study showed that the levels of agreement in ratings correlate
with assessors experience. 57 Level 3 The agreement improved with group discussion
among assessors.53 Level 3

5.4

Cost

The equipment required for setting up VFSS and the cost of the equipments are as shown
in table 1 below. Approximately a total of a total of RM 1.9 million is required for setting
up VFSS.
Table 1: List of equipments and the cost of equipments for setting up VFSS
No
1
2
3

5
6
7

6.

Name of Equipments
Siemens Digital Fluoroscopy
Hausted Chair
Commercial quality 4 track SVHS recorder
- Jog
- Shuttle
- Frame Lock
Video Monitor
Proper resolution for SVHS quality
Picture reduction control
Microphone
Time-date generator
Video printer
TOTAL

Price/unit (RM)
1 850 000.00
20 000.00
15 500.00

6 000.00

2 500.00
2 000.00
4 000.00
1 900 000.00

CONCLUSION

6.1
Safety
There was fair level of evidence to show that VFSS was safe, with minimal adverse event
and minimal radiation exposure.
6.2
Effectiveness
There was fair level of evidence to show that VFSS was effective in detecting the silent
aspiration and hence, in the diagnosis of dysphagia. However, when compared with
FEES, the effectiveness of VFSS is equivalent to FEES.
6.3
Training
There was evidence to suggest the need for training using specific or standard criteria in
order to improve inter-rater reliability or proposing clearly defined rating scale or group
discussion among assessors before using VFSS or FEES.
6.4
Cost
There was no cost-effectiveness study retrieved. However, the cost of the equipment
required for setting up the VFSS services is estimated at RM 1.9 Million.

7.

RECOMMENDATION

Based on the above review, it is recommended that VFSS may be set up in the
Rehabilitation Centre for research purpose to obtain more evidence to support its
effectiveness and safety as it is costly to establish the service. In addition, the operator
must be well trained to obtain a satisfactory level of competency.

10

8.

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