Study reference

Study characteristics

Patient characteristics

Index test

(test of interest)

Reference test

Follow-up

Outcome measures and effect size

Comments

1a. Systematic reviews of bedside screening tests (direct observation)

Kertscher, 2014

Type of study:

Systematic review

A: Clavé, 2008

B: Martino, 2009

C: Suiter and Leder, 2008

D: Wakasugi, 2008

E: Mandysova, 2011

Conflict of interest: For this article no grants or other financial

support was received or supplied

Inclusion criteria:

(1) Comparison of bedside screening to a gold standard

(videofluoroscopic or fiberoptic endoscopic evaluation of

swallowing)

(2) Use of a cross-sectional design or (randomized) clinical trial

(3) Use of aspiration and/or penetration as end point

(4) Target group made up predominantly of adult patients with a neurological disorder

(5) The screening method must be noninvasive

(6) Paper written in either English, German or Dutch

(7) Publication date of the article falls between January 2008 and

December 2012

Exclusion criteria:

None mentioned

5 studies included

Diagnosis

A: Consecutive neurological patients with swallowing difficulties; 85 patients with dysphagia and 12 healthy subjects

B: Random subset of consecutive

stroke patients

C: Heterogeneous population (i.e.,

neurogenic patients, N = 1,064; medical, N = 492; pulmonary,

N = 451; other, N = 391; Cancer, N = 125)

D: Patients with clinical symptoms of dysphagia, i.e., coughing, difficulty eating, fever, pneumonia by aspiration, history of suffocation

E: acute and chronic stroke, MG, cranial nerve palsy, PD, amyotrophic lateral sclerosis (ALS), and other conditions that predispose patients to penetration or aspiration

Index test:

Bedside screening tests:

A: Volume-viscosity swallowing test (V-VST)

B: Toronto Bedside Swallowing

Screening Test (TOR-BSST)

C: 3-oz. water swallow test

D: Cough test

E: Brief Bedside Dysphagia Screening

Test

Reference test:

A: Videofluoroscopy (VFS)

B: VFS

C: Fiberoptic endoscopic evaluation of swallowing (FEES)

D: VFS or FEES

E: FEES

End-point of follow-up:

Follow-up period is not mentioned per study, but the period between the reference test and the index test in study A-D was short enough to be reasonably sure that the target condition did not change between the two tests, in study E this was not clear

Outcome measures and effect size (95%CI):

In all studies, aspiration is the endpoint. Study A also includes penetration as endpoint, study B includes psychological abnormality

Sensitivity; specificity:

A: 83.7% and 64.7% for bolus penetration into the larynx; 100% and 28.8% for aspiration; 69.2% and 80,6% for residue; 88.4% and 87,5% for piecemeal deglutition; 84.6% and 73,7% for identifying patients whose deglutition improved by enhancing bolus viscosity

B: 91% (72–99) and 67% (49–81) for all patients;

96% (72–100) and 64% (35–85) for acute patients;

80% (49-94) and 68% (48-83) for rehabilitation patients

C: 97% (95–98) and 49% (48–49) for coughing, choking, inability to drink

D: aspiration:

45% (36–54) and 87% (78–92)

E: - 87,1% and 30,4% in all patients; 95,2% and 27,5% in patients with neurological conditions;

60% and 42,9% in patients with ear, nose and throat conditions

Of the studies A,B,C,D, Kertscher described that methodological quality is sufficient. Of study E, methodological quality is doubtful. Studies that were included in the literature search of this review with insufficient methodological quality are left out

Daniels, 2012

Study design:

Systematic literature review

Literature search from 1985 up to March 2011

21A: McCullough, 2005

22B: Mann, 2001

23C: Lim, 2001

24D: Smithard, 1998

25E: Daniels, 1997

26F: Nishiwaki, 2005

27G: McCullough, 2001

28H: Smith Hammond, 2009

29I: Chong, 2003

31J: Kidd, 1993

32K: DePippo, 1992

Setting and Country:

America

Source of funding:

The project described was supported by Award Number

1I01RX000121 from the Rehabilitation Research & Development

Service of the VA Office of Research and Development.

Inclusion criteria English language, adults, articles should describe a homogeneous stroke population, comparison to

instrumental examination, clinical examination without equipment, outcome measures of dysphagia or aspiration, and

validity of screening items reported or able to be calculated.

Exclusion criteria SR: Review articles and non-peer-reviewed articles

11 studies included

Important patient characteristics at baseline: Six studies reported testing consecutive patients with

stroke (a-e, h). The remaining studied a subsample or particular type of patient with stroke

Items for screening

Bedside screening tests

A: 1. Cough, throat clear, voice change—3-oz WST

2. Cough, throat clear, voice change—10-mL WST

3. Cough, throat clear, voice change—5-mL WST

B: Impaired pharyngeal response (cough, voice

change—5, 10-mL WST)

C: Cough, voice change—50-mL WST

D: 1. Cough—5-mL WST

2. Weak, wet voice—5-mL WST

E: Cough, throat clear- 5-, 10-, 20-mL WST

F: Cough, voice change—30-mL WST

G: 1. Cough—5-mL various consistencies

2. Clinical estimate of aspiration—5-mL various

consistencies

H: Clinical sign of aspiration WST (cough, absent

swallow,2 secretion control)

I: Cough, voice change—WST (10 mL 5 trials)

J: Cough, voice change—WST (5 mL administered

10 times)

K: Cough, voice change—3-oz WST

Reference test:

Videofluoroscopy swallow study (VFSS) or videoendoscopic

evaluation of swallowing (VEES)

A: VFSS

B: VFSS

C: VEES

D: VFSS

E: VFSS

F: VFSS

G: VFSS

H: VFSS and VEES

I: VEES

J: VFSS

K: VFSS

End-point of follow-up:

Follow-up period is not mentioned per study, study B and E did not describe acceptable delay between clinical and instrumental test, whereas for study I, J, K this is unclear

Aspiration: Defined as pharyngeal penetration with residue

Effect measure: Sensitivity; specificity

A:

1. 0.4844; 0.9508

2. 0.3721; 0.9590

3. 0.4419; 0.9426

C: 0.8462; 0.7500

D: 1. 0.4000; 0.9324

2. 0.4500; 0.7432

F: 0.7222; 0.6744

G: 1. 0.6818; 0.8158

2. 0.7727; 0.6316

H: 0.5748; 0.8254

I: 0.7941; 0.6250

J: 0.8000; 0.8571

K: 0.8000; 0.5417

Risk of Aspiration: Defined as risk of pharyngeal penetration with residue

Effect measure: Sensitivity; specificity

E: 0.6538; 0.7879

Dysphagia: Defined as swallowing impairment

Effect measure: Sensitivity; specificity

B: 0.4512; 0.9565

Using logistic regression, unilateral jaw weakness, dysphonia, and global judgment of aspiration on the 3-oz WST were identified as the best combination of features to identify aspiration

Cervical auscultation and pulse oximetry were excluded due to questionable feasibility and contradictory validity findings for both

Patients without aspiration can still suffer from severe dysphagia. Most studies in this review are focusing on aspiration as outcome measure

Bours, 2009

Study design:

Systematic literature review

Literature search up to 26 June 2008

A: Leder and Espinosa, 2002

B: Logemann et al., 1999

C: Mann, 2002

D: Mari et al., 1997

E: Smith et al., 2000

F: Trapl et al., 2007

Setting and Country:

The Netherlands

Source of funding:

This research received no specific grant from any funding

agency in the public, commercial, or not-for-profit sectors

Inclusion criteria: English, Dutch and German language.

1. Screening compared with videofluoroscopic or fibreoptic

endoscopic evaluation of swallowing

2. Cross-sectional design or (randomized) clinical trial

3. Aspiration and/or penetration as endpoint

4. Predominant adult patients with neurological disorders

5. Non-invasive screening method

6. Written in English, German or Dutch

Exclusion criteria:

1. Invasive screening method

2. Screenings method only used to determine dysphagia in patients other than those with neurological disorders, such as patients with cancer or older patients with psychiatric conditions.

6 out of 35 articles in this review are included; 11 articles were excluded because of inclusion in Daniels (2012) and 18 articles because of insufficient methodological quality

Important patient characteristics at baseline:

N, mean age

A: 49, 70

B: 200, 65 years (14–97)

C: 228, Thirty

per cent were between 0 and

64 years; 39% between 65 and

74 years; 22% between 75 and

84 years; 9% ‡85 years

D: 93, 59Æ8 years (18–80)

E: 53,

F: 50, 69 years (51–90), Mean age group 1:74,6 (SE 2,4); mean age

group 2:76,8 (SE 1,85)

Diagnosis:

A: Acute stroke patients admitted

to a stroke unit

B: Patients referred for assessment

of potential dysphagia. Main

diagnoses was stroke, other

diagnoses were treatment for

head and neck cancer, spinal

cord and other aetiologies

C: Patients admitted to a hospital

with a first acute stroke

D: Patients (inpatients and outpatients) admitted to

a rehabilitation clinic with a neurological

disorder (acute stroke, Parkinson’s disease,

traumatic brain injury, multiple sclerosis,

amyotrophic lateral sclerosis, myotonic

dystrophy, abiotrophic disease

E: Patients with acute stroke admitted to a hospital.

F: Patients with first ever acute stroke

Index test:

Bedside screening tests:

A: 1. Clinical testing, determining

dysphonia, dysarthria, abnormal volitional

cough, abnormal gag reflex. 2. Water test

B: Screening procedure consisted of 28

items divided into five categories, each including multiple variables

C: Clinical assessment including oral-motor-sensory examination (voice, speech, and language function) and observation of swallowing saliva initially and subsequently 5 mL of water, 20 mL of water and a thickened fluid if

appropriate

D: Clinical assessment: a 25-item form and a 3 oz water swallow test

E: Bedside swallowing assessment and pulse oximetry

F: Gugging Swallowing Screen (GUSS) consisting of two parts: one indirect swallowing test consisting of a simple saliva test; two direct swallowing test consisting of three sequentially performed subsets, starting with semisolid, then liquid, and finally soli textures

Reference test: Videofluoroscopy (VFS) or fiberoptic endoscopic

evaluation of swallowing (FEES):

A: FEES

B: VF

C: VF

D: VF

E: VF

F: FEES

End-point of follow-up:

Not mentioned per study, but except for C, in all studies the period between reference test and index test was short enough to be reasonably sure that the target condition did not change between the two tests

Aspiration or penetration

Aspiration is defined as the entry of material below the level of the true vocal folds, while penetration is defined as the entry of material in the laryngeal vestibule but remaining above the levels of the vocal folds

Effect measure: Sensitivity (95% CI); specificity (95% CI)

A: ≥2 variables present: 86% (64–96); 30% (14–50)

B: : ≥5 unsafe ratings: 58% (48–67); 60% (50–70)

C: Dysphagia: 73% (62–82); 89% (76–96);

Aspiration: 93% (75–99); 63% (53–72)

D: Coughing: 51% (36–66); 86% (73–94)

E: Subjective assessment of aspiration: 80% (51–95); 68% (51–82)

F: Risk of aspiration on GUSS: 100% (84–100); 63% (41–82)

Conclusions:

1. A water test combined with pulse oximetry using

coughing, choking and voice alteration as the endpoints

is currently the best method to screen patients for dysphagia.

2. Single clinical features such as abnormal gag, volitional cough or medical history components are not useful to identify patients at risk of aspiration/penetration.

3. Further research is needed to determine the most effective procedure for administrating water tests and the value of pulse oximetry in addition to a trial swallow

Study reference

Study characteristics

Patient characteristics

Index test

(test of interest)

Reference test

Follow-up

Outcome measures and effect size

Comments

1b. Bedside screening tests (direct observation)

Edmiaston, 2014

Type of study: Observational study

Setting:

Between January 2009 and June 2010, the patients were prospectively enrolled

Country: USA

Conflicts of interest:

The authors have no conflict of interest to report

Inclusion criteria: clinical diagnosis of stroke (either

ischemic or haemorrhagic) and ≥ 18 years old

Exclusion criteria:

decreased level of alertness preventing participation in the VFSS (defined as a score of 2 on the

‘‘Alertness’’ component of the MASA), physical limitations preventing the ability to sit upright, confirmed or suspected pregnancy

N=225

Mean age: 63 ±15

Sex: 49,1% F

Caucasian: 56,6%

African American: 42,4%

NIHSS median: 5 (2-13)

Index test:

The Barnes-Jewish Hospital Stroke Dysphagia Screen (BJH-SDS), performed by a nurse at the bedside.

This test includes 5 items about the Glasgow Coma Scale, facial, tongue or palatal asymmetry/ weakness, and signs of aspiration during the 3 oz. water test

The screen result was recorded as ‘‘fail’’ if any 1 of the 5 items tested were abnormal or ‘‘pass’’ if all 5 items tested were normal. Pass means regular diet

Reference test:

Videofluoroscopic swallow study (VFSS): performed by a speech pathologist who was blinded to the results of the BJH-SDS.

The Dysphagia

Outcomes Severity Scale (DOSS) was used as the functional scale for identifying dysphagia on the VFSS

Endpoint of follow-up:

VFSS was performed within 8 hours of the BJH-SDS

Dysphagia

Defined as a well-recognized complication of both acute ischemic and haemorrhagic stroke

Sensitivity (95% CI):

94% (88%-98%)

Specificity (95% CI):

66% (57%-75%)

Aspiration

Not defined

Sensitivity (95% CI):

95% (86%-99%)

Specificity (95% CI):

50% (42%-58%)

Overall conclusion:

The BJH-SDS is a simple bedside screening tool that can be used by nursing staff to efficiently and sensitively identify swallowing impairments in the acute stroke population

225 patients are included in the study, based on a power analysis, to provide precise estimates of sensitivity and specificity within 10% of the true values. Because of severe oral dysfunction, two patients were excluded from the aspiration analysis

Shem, 2012

Type of study: Observational study

Setting: a county hospital with acute inpatient SCI unit

Country: USA

Conflicts of interest:

None. This manuscript has been funded by National Institute on Disability and Rehabilitation Research (NIDRR) Field Initiated

grant

Inclusion criteria:

individuals at least 18 years of age, any individual with

tetraplegia within 31 days of injury, individuals medically

stable to be able to participate in BSE initially and expected to

be able to participate in VFSS subsequently, and individuals who signed an informed consent and Health Insurance Portability

and Accountability Act (HIPAA) privacy document. Subjects with tracheostomies also were included

Exclusion criteria:

Individuals who were orally or nasally intubated; individuals with known preinjury swallowing

dysfunction; individuals with severe brain injury or any other significant cognitive deficits who could not follow

instructions during BSE or VFSS; or individuals with acute SCI requiring the use of a RotoRest bed

N= 39

Mean age ± SD: 41.6±16.63

Sex: n=30 M

Diagnosis:

Tetraplegia due to Spinal Cord Injury (SCI); Twenty-eight subjects had high cervical tetraplegia (C4 or higher) (72%), and 11 had lower cervical tetraplegia (28%)

A tracheostomy

was present in 22 subjects (56.4%), and 23 subjects

were on mechanical ventilators (59%), with 1 additional

subject being on noninvasive positive pressure ventilation

Index test:

Bedside Swallow Evaluation (BSE): a clinical swallowing examination that is

routinely conducted as the initial assessment of swallowing

function

Reference test:

Videofluoroscopic swallow study (VFSS)

Endpoint of follow-up:

VFSS was conducted within 72 hours of the BSE

Aspiration:

The entry of secretions or foreign material into the trachea and lungs past the true vocal cords

Sensitivity (95% CI): 100% (71.5%-

100%);

Specificity (95% CI):

93.3% (68.1%-99.8%)

Ramsey, 2006

Type of study: Observational study

Setting: Acute care hospitals

Country: UK

Conflicts of interest: None mentioned

Inclusion criteria:

Consecutive acute stroke patients >18

years of age admitted to 1 of 2 acute care hospitals. Stroke was defined according to World Health Organization criteria and

confirmed on computed tomography or magnetic resonance imaging brain scans

Exclusion criteria:

Stroke onset >5 days before

assessment, reduced consciousness level, intolerance of the contrast agent, disseminated malignancy, prior dysphagia, other neurological

diseases/local pathology affecting swallowing, or inability to obtain

consent, patients requiring continuous oxygen therapy and patients wearing nail varnish because of potential interference with pulse oximetry

Index test:

1. Pulse oximetry; Peripheral blood oxygen saturations were recorded automatically

during the modified BSA and stored for later analysis

2. Modified BSA (water replaced by radio-opaque contrast agent, followed by chest radiography to detect

aspiration)

Reference test:

Videofluoroscopy (VF), VF was undertaken in the remaining 54

(28.6%) patients by a speech and language therapist experienced in dysphagia management who was blinded to the modified BSA and

pulse oximetry results. The patient was seated in an upright position and consumed different consistencies of food/liquid impregnated

with barium while their swallow was imaged on a lateral projection from the teeth anteriorly to the posterior pharyngeal wall posteriorly

Endpoint of follow-up: VF was performed within 24 hours of BSA

Unsafe swallow:

Sensitivity; specificity:

Desaturation >2%:

31%; 72%

Desaturation >5%:

7%; 97%

- Desaturation >2% in either T1 or T2: 33%; 62%

- Desaturation >5% in either T1 or T2: 13%; 95%

- Failed BSA: 47%; 72%

- Failed BSA ± desaturation >2% in T1 or T2: 60%; 41%

- Failed BSA ± desaturation >5% in T1 or T2: 53%; 67%

This study shows that neither the widely used BSAs nor simple techniques such as pulse oximetry during swallowing have high enough sensitivity or specificity to be reliable and optimal methods of detecting aspiration risk in acute stroke patients

Somasundaram, 2014

Type of study: Prospective design

Setting: Neurological stroke unit

Country: Germany

Conflicts of interest: None mentioned, no specific sources of funding

Inclusion criteria:

Hospital admission within 72 h

after symptom onset, clinical and imaging evidence (computed tomography

or magnetic resonance imaging) of acute left-sided

MCA infarction

Exclusion criteria:

age younger than 18 years, imaging evidence of intracerebral haemorrhage or acute infarctions of other vascular territories, clinical course as a transitory

ischaemic attack, impaired level of consciousness, residual dysphagia after a previous stroke, history of other neurological or non-neurological disorders potentially causing swallowing disorders

(e.g. tumours of the mouth, pharynx or oesophagus, Parkinson’s

disease, multiple sclerosis, myasthenia gravis)

N= 67

Mean age ± SD:

68±13

Sex: 67% M

Diagnosis: patients with clinical and imaging evidence of acute (<72 h) left MCA stroke

Index test:

Clinical assessment: Dysphonia, dysarthria, abnormal volitional cough and abnormal gag reflex were assessed followed by a standardized

50-ml water-swallowing test determining the symptoms cough and voice change after swallow, starting with a 5-ml liquid bolus,

increasing up to 10- and 20-ml volumes while assessing the presence

of cough and voice change after swallow (by phonating ‘ah’). Voice change after swallow was judged for a wet/gurgly voice quality

after swallow

Reference test:

Fiberoptic

endoscopic evaluation of swallowing (FEES): performed by a neurologist and an SLP.

Endpoint of follow-up:

Clinical assessment was performed within 24 h after admission and instrumental

investigation (FEES) on average 4.4 h (±5.1) after clinical

evaluation

Outcome measure and effect size:

Sensitivity; specificity:

- Dysarthria (n=33): 70%; 50%

- Dysphonia (n=33): 31%; 65%

- Abnormal gag reflex (n=67): 32%; 92%

- Abnormal volition cough (n=67): 63%; 69%

- Cough after swallow (n=67): 61%; 81%

- Voice change after swallow (n=35): 8%; 95%

In left MCA stroke, the sensitivity and specificity of

common bedside dysphagia screening methods are low

Abnormal gag reflex, abnormal volitional cough and cough after swallow were significantly more frequent in dysphagic as compared to non-dysphagic patients, while dysphonia, dysarthria and voice change after swallow were not

Performing multivariable logistic regression including

significant predictors of dysphagia, no single independent predictor for dysphagia could be identified

2. Water swallowing tests

Hey, 2013

Type of study: Observational study

Country: Germany

Conflicts of interest:

Inclusion criteria:

Union international contre le cancer (UICC) stage II-IV, age 18 to 99 years and written informed consent

Exclusion criteria: neurological diseases (n=5) or pre-existing OD (n=8)

N=80 (out of 98 who met inclusion criteria and gave written consent)

Mean age ± SD: 60.96 ± 12,93

Sex: 58 M

Diagnosis: post-surgical Head and Neck Cancer

Index test:

Water Swallow Screening Test (WST), starting with 2 ml with a spoon, 5 ml via a cup, then 10 ml, and finally 20 ml. The first two volumes were offered twice, 10 ml and 20 ml were offered only once

Three criteria for failure: 1) wet voice before swallowing, 2)wet voice/voice chsnge after swallowing, 3) cough or throat clearing after swallowing

Reference test:

Fiberoptic

endoscopic evaluation of swallowing (FEES): performed by a phoniatrician who was blinded and independently of the speech and language pathologist

Endpoint of follow-up:

FEES was directly followed after the WST, maximum time frame was one hour

Sensitivity (95% CI); specificity (95% CI):

- Aspiration: defined by a level ≥6 on the penetration aspiration scale (PAS): 100% (91-100); 61% (44,5-75,8)

- Limitations in oral intake: defined by a level ≤4 on the Functional oral intake scale (FOIS): 97,8% (88,2-99,94); 68,6% (50,7-83,2)

- Oropharyngeal dysphagia in general: defined by PAS ≥4 or FOIS ≤4: 96,2% (86,8-99,5); 82,1% (63,1-93,9)

PAS: 6= material enters the airway, passes below the vocal folds and is ejected into the larynx or out of the airway

FOIS: 4= total oral diet of a single consistency

Osawa, 2013

Type of study: Observational study

Setting: Saitama Medical University International Medical Center

Country: Japan

Conflicts of interest: None

Inclusion criteria:

Not described

Exclusion criteria:

Not described

N= 111

Mean age ± SD: 65,6±13,4

Sex: n=65 M

Diagnosis:

cerebral infarction (n=64),

cerebral haemorrhage (n=26), subarachnoid haemorrhage (n=13), and other cerebrovascular disease (n=8)

The time from stroke onset to VF was 16.6 ± 10.3 days (range, 2–55)

Index test:

Water Swallowing Test (WST):

The WST was

performed under X-ray fluoroscopy using a liquid containing

barium sulfate that the subject drank while sitting at a 90° angle.

A speech therapist carried out assisted feeding and a clinical assessment

without looking at a VF image, and the amount of water was gradually increased from 3 ml (MWST) to 5, 10, 30, and 60 ml to determine if choking or gargling voice occurred or if oxygen

saturation (SpO 2) decreased

Reference test:

Videofluoroscopy (VF): In parallel with the WST, at least two physicians

assessed residual pharynx, penetration and aspiration in a

VF image. Clinical aspiration was suspected during swallowing if

speech therapists noted signs of choking or gargling voice or if SpO 2 decreased. Presence of actual aspiration was assessed by the physicians using VF image

Endpoint of follow-up:

WST and VF were performed on the same day

Aspiration:

Sensitivity; specificity:

- 5 ml: 52,9%; 90,4%

- 10 ml: 34,8%; 93,2%

- 30 ml: 51,4%; 78,9%

- 60 ml: 55,7%; 85,4%

- MWST: 55,3%; 80,8%

Patterson, 2011

Type of study:

Observational study

Setting: two university teaching hospitals in North East England

Country: UK

Conflicts of interest: None mentioned

Inclusion criteria: Referred for either radiotherapy or chemoradiotherapy

(CRT), with curative intent

Exclusion criteria:

Recurrent or residual disease or had pre-existing swallowing

difficulties.

N= 173: total study

N=110: study sample for the analysis of swallow performance over time

Mean age: 62 (42-87)

N=155: study sample for analysing the sensitivity and specificity of the WST

Sex: n=92 M

Diagnosis: cancer of

the larynx, hypopharynx, oropharynx, nasopharynx or unknown primary

Index test:

100 mL water swallow test (WST):

Swallowing assessments were conducted at four time points: pre-treatment, 3, 6 and 12 months

post-treatment

Patients were asked to drink 100 mL of water as quickly as is

comfortably possible. Two swallowing performance parameters

are derived from the 100 mL WST9 (1) swallow volume (mL swallowed

divided by number of swallows taken) and (2) swallow

capacity (mL swallowed divided by time taken)

Reference test:

Fibreoptic

endoscopic evaluation of swallowing (FEES): Patients were asked to swallow 10 mL of milk, which was dyed blue to maximize bolus visualization

in the laryngo-pharynx. Post swallow, the tip of the scope

was placed posterior to the epiglottis to record whether aspiration

occurred. In the event of significant aspiration, the patient was

asked to stop the task

Endpoint of follow-up: Fewer patients were assessed on FEES than the 100 mL WST mainly due to equipment and accommodation being unavailable or patient declining the examination

Aspiration:

Sensitivity; specificity:

- Pre- (n = 126): 80%; 76,7%

- 3 Months (n = 155): 77,1%; 46,7%

- 6 Months (n = 140): 93,8%; 46,3%

- 12 Months (n = 129): 66,7%’52,7%

Schultheiss, 2011

Type of study:

Prospective randomised blind study

Setting: ENT department, stroke unit or early rehabilitation clinic of an acute care hospital

Country: Germany

Conflicts of interest: None mentioned

Inclusion criteria: Patients were aged over 18 and had sufficient vigilance to ensure that they were able to take food and adequate situational understanding to be able to follow instructions

Exclusion criteria:

Patients who were pregnant, were fitted with a

non-deblockable tracheostomy tube, had limited vigilance,

inadequate situational understanding or clinical indications

of an acute infection

N= 62

Mean age: 64.68 (22–84)

Sex: 38 M

Diagnosis:

Patients with

oropharyngeal swallowing disorders of neurological (NEU)

and non-neurological (NNEU) origin were compared: 20 (32.3%) ENT patients with neoplastic diseases following treatment

(surgery or radiotherapy), 16 (25.8%) patients with a CVA, 8 (12.9%) patients with a cerebral haemorrhage,

4 (6.5%) with cerebral contusion following trauma and 2(3.2%) patients with tetraplegia

Index test:

Standardised saliva swallow test (SST), WST, BST, combinations of these tests; Spontaneous swallowing of saliva and swallowing frequency were assessed while preparing for the test and positioning the patient. The WST involved

testing two volumes each of 5, 10 and 20 ml water in

ascending order. The patient was instructed to drink each

volume of liquid in one go. The BST involved testing 1 g

(1/3 teaspoon), 2.5 g (1/2 teaspoon) and 5 g (1 teaspoon) of

jelly in ascending order. In order to monitor voice tone,

patients were asked to phonate an ‘ah’ sound after each

individual swallow attempt. A break of 1 min was allowed

between each swallow, during which the investigator

observed whether the patient was able to remove any residues

(check for coughing with or without follow-up

swallow)

Reference test:

Fibreoptic

endoscopic evaluation of swallowing (FEES): performed by an ENT specialist who was not

present during the clinical tests and was not aware of the

results of these tests

Endpoint of follow-up:

FEES was carried out within 24 h of the clinical swallow test

Sensitivity; specificity:

In all patients:

- WST: 70,7%; 95,2%

- WST_SST: 60,5%; 89,5%

- BST: 62,5%; 84,2%

- BST_SST: 89,6%; 72,7%

Neurological group:

- WST: 70,3%; 92,3%

- WST_SST: 62,1%; 81,8%

- BST: 64,3%; 80,8%

- BST_SST: 88,9%; 63,6%

Non-neurological group:

- WST: 71,4%; 100%

- WST_SST: 57,1%; 100%

- BST: 60%; 91.7%

- BST_SST: 90,9%; 90,9%

In a prospective, randomised, blind study, the results of a standardised saliva swallow test (SST), WST, BST, combinations of these tests and an endoscopic swallow test (FEES) in patients with oropharyngeal swallowing disorders of neurological (NEU) and non-neurological (NNEU) origin were compared

Conclusion: The results of this study show that the BST offers significant benefits for identifying aspiration for both the test population as a whole and for neurological and nonneurological sub-groups. As well as being highly sensitive and specific, a combination of BST and SST was found to be the only test with a statistically significant correlation with the endoscopic examination. The tests have adequate inter-rater reliability for everyday clinical use. A bolus swallow test should in future form an additional component during clinical diagnosis of dysphagia and dysphagia screening

Momosaki, 2013

Type of study: Observational study

Setting: consultation with a rehabilitation team was requested for swallowing evaluation

Country: Japan

Conflicts of interest: not mentioned

Inclusion criteria:

The subjects comprised 110 consecutive poststroke

patients who choked on water swallowing and had suspected

pharyngeal dysphagia, for whom consultation

with a rehabilitation team was requested for swallowing

evaluation

Exclusion criteria:

In several circumstances, the test was delayed for implementing until improvement was demonstrated:

altered consciousness (ie, inability to spontaneously

open the eyes), febrile state with body temperature

≥38  ̊C, significant hypoxia (arterial oxygen saturation

level ≤93%), poor oral hygiene, permanent tracheotomy,

and lack of comprehension of the test instructions. Such

patients whose condition did not improve were excluded

from the study (n=26)

N= 110

Mean age ± SD:

73±10

Sex: 53% M (n=48)

Diagnosis:

Consecutive poststroke patients, stroke was classified as intracerebral hemorrhage in 43 patients and cerebral infarction in 67 patients, and 62 patients had new-onset stroke

Index test:

Two-Step Thickened Water Test (TWTT) which comprises a bedside pretest (tongue protrusion, vocalization,

voluntary cough, and dry swallow) and a direct swallowing test using 4 mL of thickened water

Reference test:

Fiberoptic

endoscopic evaluation of swallowing (FEES), In this procedure, the patient was seated upright and an endoscope was inserted through the nasal cavity to directly visualize the oropharyngolarygeal area. The patient was then given 4 mL of paste food and instructed to swallow it. If possible, the patient was given more water and asked to swallow twice more, and the worst

swallowing activity was assessed. Any associated abnormalities,

including aspiration, were noted

Endpoint of follow-up:

FEES was performed within one hour after the TTWT

Sensitivity; specificity (95%)

Dysphagia for paste food: 93%; 88%

Dysphagia for normal water: 93%; 78,5%

Warnecke, 2008

Type of study: Observational study

Country: Germany

Conflicts of interest:

None mentioned

Inclusion criteria: ischaemic stroke and admittance

earlier than 24 hours after symptom onset, patients had to have either an NIH-SS >3 points and/or had to present with a facial palsy and/or dysarthria to be eligible for advanced dysphagia assessment

Exclusion criteria:

History of a preexisting dysphagia or disease

probably causing dysphagia, and a severely reduced

state of consciousness (ie, stupor or coma)

N= 100

Mean age ± SD: 71,43 ± 11,81

Sex: 54 M

Diagnosis:

Consecutive patients with first-ever stroke

The average of NIH-SS was 9.86 (SD 4.79) points

Index test: Simple 2-Step Swallowing Provocation Test (SPT)

A thin 4-charriere catheter was inserted through the nostril into the oropharynx with its tip being placed just beneath the velum. The swallowing reflex was induced by bolus injection of 0.4 ml (first step) and 2.0 ml (second step) of distilled water. The onset of swallowing was identified by visual observation and simultaneous

registration of the characteristic upward laryngeal movement by means of two of the examiner’s

fingers. The water bolus injection was administered near the end of expiration. The latent time from the beginning of water bolus injection to onset of swallowing (ie, laryngeal elevation) was measured with a stopwatch. Each of the two steps was classified as abnormal when the latent time was more than 3 seconds

Reference test:

Fiberoptic endoscopic

evaluation of swallowing (FEES), the patient

received teaspoon-wise three different food consistencies

dyed with blue food colouring for ease of

visualisation. The first food consistency introduced

was pureed food, followed by liquid and soft solid

food

Endpoint of follow-up:

In all subjects, SPT and FEES were performed immediately

one after another within 72 hours of stroke onset. In half of the patients, the SPT was performed first; the other half received FEES at the beginning

Aspiration risk:

1^st-step SPT:

sensitivity: 74,1%, specificity: 100%

2^nd-step SPT: sensitivity: 49,4%, specificity: 100%

In acute stroke patients with an impairment of the pharyngeal phase of swallowing, 1st-step SPT

reliably detects aspiration risk. In patients with a sole or

predominant impairment of the oral phase of swallowing

and a relatively intact pharyngeal phase, SPT fails to

detect aspiration risk sufficiently. In the latter group, FEES or additional clinical features more specifically indicating oral-phase pathology should be considered to accurately

judge the patient’s aspiration risk

Sampaio, 2014

Type of study: prospective, observational, and blind study

Setting: Neurosciences Outpatient Unit in a Federal University Hospital

Country: Brazil

Conflicts of interest: No Grants or other financial support was received or supplied. There are no financial relationships or conflicts of interest to disclose

Inclusion criteria:

(a) idiopathic Parkinson’s disease

(b) had undergone treatment with a dopaminergic agent

(c) had a minimum phonation time of 3s

(d) had a minimum vocal intensity of up to 50 dB

(e) were classified as having any Hoehn and Yahr (H&Y) disease stage

Exclusion criteria:

(a) had any other

neurological disease or movement disorders

(b) had a

documented history of a neoplastic disease

(c) had been

Tracheostomized

(d) were unable to undergo the FEES or understand verbal orders

N= 19

Mean age ± SD: 64.8 ± 10.3 years

Sex: 13 Male

Diagnosis: mean PD duration 7 ± 4 years

Index test:

Wet voice: Voice recording using five types of fluid

materials

1. saliva

2. water (20 ml)

3. yogurt drink (20 ml)

4. spoon-thick

Yogurt (10 ml)

5. spoon-thick

Yogurt (15 ml)

6. wafer cookie

Patients were asked to phonate an /e/ sound after swallowing

dyed secretions and each food material during the FEES

Reference test: Fiberoptic endoscopic evaluation of swallowing (FEES), penetration/aspiration of blue-dyed saliva only were evaluated. After examination and voice recordings using

dyed saliva, we conducted FEES with blue-dyed foods. Two binary endpoints

were selected for comparison with an index test: (1) presence/

absence of low penetration (LP; presence of material near or above the vocal folds) and (2) presence/absence of low penetration

and/or aspiration (LP/ASP; presence of material near/

above and/or beyond the vocal folds)

Endpoint of follow-up: not mentioned

Sensitivity (95% CI); specificity (95% CI)

Low penetration

1. 20.0 (3.3–71.2); 85.7 (57.2–97.8)

2. 25.0 (4.1–79.7); 80.0 (51.9–95.4)

3. 50.0 (8.3–91.7); 93.3 (68–98.9)

4. 33.3 (5.5–88.5); 81.3 (54.3–95.7)

5. 50.0 (8.3–91.7); 73.3 (44.9–92.1)

6. 100.0 (19.3–100.0); 76.5 (50.1–93.0)

Low penetration and/or aspiration

2. 33.3 (5.3–77.3); 84.6 (54.5–97.6)

3. 40.0 (6.5–84.6); 92.9 (66.1–98.8)

5. 40.0 (6.6–84.6); 71.4 (41.9–91.4)

6. 75.0 (20.3–95.9); 80.0 (51.9–95.4)

Twenty-eight patients were assessed by the FEES, but nine

were excluded from the study because their voice samples

did not meet the minimum conditions for reliable perceptual voice assessment (short phonation time and/or low voice intensity). Thus, nineteen patients with idiopathic Parkinson’s disease were included in the study and a total of 114 measurements

were performed

Wet voice was the least perceived vocal abnormality by the judges among the 114 voice samples (22.8 %), followed by hoarseness (59.6 %), while tremor was perceived in almost all samples (95.6 %)

                3. Bolus swallowing tests

Rofes, 2014

Type of study: stratified-sampling design

Setting: Gastrointestinal Physiology Lab of the Hospital de Matar

Country: Spain

No conflicts of interests are mentioned

Inclusion criteria:

Not clearly described

Exclusion criteria:

Not clearly described

N= 14 healthy subjects and 120 patients

Mean age ± SD

Healthy subjects:

30.5 ± 6.1

Patients: 74.4 ± 12.4

Sex

Healthy subjects: 57.1% male (n=8), patients: 54.2% male (n=65)

Diagnosis:

Patients with swallowing difficulties, of which 13 had a neuro-degenerative disease, 66 had had a stroke and 41 elderly people

Other important characteristics:

most patients included in the

study presented advanced age, polymorbidity,

high risk of malnutrition and polymedication

Index test:

1. Eating Assessment

Tool (EAT-10): a 10-item screening questionnaire, EAT-10 was administered to all patients and healthy volunteers.

Patients were instructed to complete the EAT-10 by themselves,

but could have guidance by relatives or caregivers if needed. The

EAT-10 consists of 10 questions about the severity of symptoms

of OD and its clinical and social impact, each question scoring from 0 (no problem) to 4 (severe problem) a score of ≥3 was abnormal

2. Volume-Viscosity Swallow Test (V-VST): an effort test that uses boluses of different volumes and

viscosities to identify clinical signs of impaired efficacy (impaired labial seal, piecemeal deglutition, and residue) and impaired safety of swallow (cough, voice

changes, and oxygen desaturation

≥3%)

Reference test: Videofluoroscopy (VFS), all patients were imaged for the videofluoroscopic

study while seated, in a lateral projection which included

the oral cavity, pharynx, larynx, and cervical esophagus

Endpoint of follow-up: The index tests and a VFS were performed on all subjects by a clinician blinded to the results of all clinical evaluations

Outcome measure and effect size:

Sensitivity (95% CI); specificity (95% CI)

Oropharyngeal dysphagia (OD)

1. 0.85 (0.77–0.91); 0.82 (0.57–0.96)

2. 0.94 (0.87–0.98) 0.88 (0.50–0.99)

Impaired efficacy

1. 0.88 (0.80–0.94) 0.59 (0.41–0.76)

2. 0.79 (0.62–0.90) 0.75 (0.45–0.92)

Impaired safety

1. 0.87 (0.79–0.93) 0.68 (0.46–0.85)

2. 0.87 (0.74–0.94) 0.81 (0.48–0.95)

Aspiration

1. 0.83 (0.61–0.95) 0.25 (0.17–0.34)

2. 0.91 (0.78–0.99) 0.28 (0.17–0.34)

Rofes, 2012

Type of study:

Observational study

Setting: Two university teaching hospitals in North East England

Country: UK

Conflicts of interest: None mentioned

Inclusion criteria: neurological diseases, neuromuscular degenerative diseases and patients with head and neck diseases including head and neck cancer, Zenker diverticulum and cricopharyngeal bars

Exclusion criteria:

Not described

N= 85

Diagnosis: patients with neurological disorders (stroke) and independently living older patients

Index test:

Volume-Viscosity Swallow Test (V-VST): an explorer offers the bolus to the patient who is sitting up straight, carefully with a syringe. The exploration can be recorded with a digital video camera for objective review. Starting with nectar viscosity and increasing volumes from 5- to 10- and 20-ml boluses in a progression of increasing difficulty (nectar, liquid, pudding)

Reference test:

Videofluoroscopy (VFS): not described in detail

Endpoint of follow-up: Not mentioned

Sensitivity; specificity (95%)

Dysphagia: 88,2%; 64,7%

The authors believe that V-VST is an excellent tool to screen patients for dysphagia. Patients with a positive test should undergo VFS for a full assessment of swallow function

Schultheiss, 2011

This study is described in detail under heading WST, Schultheiss, 2011

4. Questionnaires (EAT-10)

Rofes, 2014

This study is described in detail under heading WST, Rofes, 2014

5. Screening tests in children

Suiter, 2009

Type of study: Cross-sectional evaluation of a diagnostic test with a consecutive, referral-based sample

Setting: Urban, tertiary care, teaching hospital

Country: USA

Conflicts of interest:

Financial disclosure: Debra M. Suiter, none; Steven B. Leder, none; David E. Karas, speaker’s

bureau: Glaxo and Alcon; speaker’s bureau and funding for research: Arthrocare.

Inclusion criteria:

Not mentioned

Exclusion criteria:

Not mentioned

N= 56

Mean age ± SD: 13,4 ± 4,7 (2-18 years)

Sex: 33 M, 23 F

Diagnosis: Cardiothoracic surgery (n=2), head and neck surgery, (n=1), neurosurgery (n=10), general medical (n=8), pulmonary (n=2), cancer (n=2), left stroke (n=2),

right stroke (n=1), traumatic brain injury (n=10), progressive

neurological disorder (n=7), cervical spinal cord

injury (n=3), acute encephalopathy (n=3), seizure disorder (n=1), other neurological (n=4)

Index test:

The 3-ounce (90 cc) water swallow challenge

The base of the tongue, pharynx, and larynx was viewed and

swallowing was evaluated directly with six food boluses of

approximately 5 mL volume each. All patients were allowed to swallow spontaneously (i.e., without a verbal command to

swallow)

The first food challenge consisted of three boluses of puree consistency (yellow pudding) followed by three liquid boluses (white milk) because these colors have excellent

contrast with pharyngeal and laryngeal mucosa

Reference test: Fiberoptic

endoscopic evaluation of swallowing (FEES),

Endpoint of follow-up:

Outcome measures

Sensitivity (95% CI); specificity (95% CI):

Aspiration: defined as the entry of material into the airway below the level of the true vocal folds:

100% (75-100); 51% (35-67)

Diet:

100% (54-100); 51% (30-59)

Results corroborate recent findings with adults, that is, the 3-ounce water swallow challenge was sensitive for determining aspiration of thin liquids. This finding was confirmed by instrumental

assessment given that 100 percent of patients who aspirated on FEES also failed the water swallow challenge.

The 3-ounce water swallow challenge has been shown to be a clinically useful screening test for oropharyngeal

dysphagia in children

Study reference

(first author, year of publication)

 Was the spectrum of patients representative of the patients who will receive the test in practice?

yes/no/unclear

Is the reference standard likely to correctly classify the

target condition?

yes/no/unclear

Is the time period between reference standard and index test short enough to be reasonably sure that the target

condition did not change between the two tests?

yes/no/unclear

Did the whole sample or a random selection of the sample, receive verification using a reference standard?

yes/no/unclear

Did patients receive the same reference standard irrespective of the index test result?

yes/no/unclear

Was the reference standard independent of the index

test (i.e. the index test did not form part of the reference

standard)?

yes/no/unclear

Were the index test results interpreted without

knowledge of the results of the reference standard and vice versa?

yes/no/unclear

Were the same clinical data available when test results were interpreted as would be available when the test is used in practice?

yes/no/unclear

Were uninterpretable/ intermediate (unclear) test results reported?

yes/no/unclear

Were withdrawals from the study explained?

yes/no/unclear

Level of evidence

Edmiaston, 2014

Yes

Yes

Yes

Yes,

Yes

Yes

Yes

Unclear

No

No,

Low

Rofes, 2014

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

Unclear

No

Yes

Low

Sampaio, 2014

Yes

Unclear

Yes

Yes

Yes

Yes

Yes

Unclear

No

Yes

Low

Somasundaram, 2014

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

Unclear

Yes

No

Low

Hey, 2013

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

No

Yes

Low

Momosaki, 2013

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

Unclear

No

No

Low

Osawa 2013

Yes

Yes

Yes

Yes

Yes

Unclear

Yes

Unclear

No

No

Low

Rofes, 2012

Yes Also healthy elderly people were included

Yes

Unclear

Unclear

Yes

Yes

Unclear

Unclear

Unclear

Unclear

Low

Shem, 2012

Yes

Yes

Yes

Not the whole sample, but unclear if it was random

Yes

Yes

Yes

Unclear

No

Yes

Low

Patterson, 2011

Yes

Yes

Unclear

Not clear if it was random, not all patients received FEES

Yes

Yes

Yes

Unclear

No

Yes

Low

Schultheiss, 2011

Yes

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

No

Yes

Low Prospective randomised blind study

Suiter, 2009

Yes

Yes

Yes

Yes

Yes

Yes

Unclear

Unclear

No

No

Low

Cross-sectional evaluation of a diagnostic test with a consecutive, referral-based sample

Warnecke, 2008

Yes

Yes

Yes

Yes

Yes?

Yes

Yes

Unclear

No

No

Low

Ramsey, 2006

Yes

Yes

Yes

No

Yes

Yes

Yes

Unclear

Yes

Yes

Low

Study

First author, year

Appropriate and clearly focused question?¹

Yes/no/unclear

Comprehensive and systematic literature search?²

Yes/no/unclear

Description of included and excluded studies?³

Yes/no/unclear

Description of relevant characteristics of included studies?⁴

Yes/no/unclear

Appropriate adjustment for potential confounders in observational studies?⁵

Yes/no/unclear/ notapplicable

Assessment of scientific quality of included studies?⁶

Yes/no/unclear

Enough similarities between studies to make combining them reasonable?⁷

Yes/no/unclear

Potential risk of publication bias taken into account?⁸

Yes/no/unclear

Potential conflicts of interest reported?⁹

Yes/no/unclear

Kertscher, 2014

Yes

Yes

Yes

Yes

No

Yes

No

Unclear

No

Daniels, 2012

Yes

Yes

Yes

Yes

No

Yes

No

Unclear

No

Bours, 2009

Yes

Yes

Yes

Yes

No

Yes

No

Unclear

No