Auteur, jaartal

Inclusie/Exclusie

Reden van exclusie

Syst. review

Miller, 2014

Exclusie

Zoekstrategie niet beschikbaar; geen in- en exclusie criteria geformuleerd; evidencetabel niet beschikbaar

Tan, 2014

Exclusie

Systematisch gezocht tot december 2011; zoekstrategie niet beschikbaar; valt wel binnen de PICO, alleen gevonden RCTs zijn met deze zoekactie ook gevonden

Miller, 2013

Exclusie

Gezocht in 1 database; zoekstrategie niet beschikbaar

Beavan, 2013

Exclusie

Narratieve review (niet systematisch gezocht);

Geeganage, 2012

Exclusie

Systematisch gezocht tot juli 2011; 1 trial geincludeerd NMES (Lim 2009) en 1 trial geincludeerd pharyngeal electrical stimulation (Jayasekeran,2010) beiden ook gevonden met deze zoekactie

Burns, 2011

Exclusie

Zoekstrategie of evidence tabellen niet beschikbaar; geselecteeerde RCT zijn ook gevonden met deze zoekactie

Clark, 2009

Exclusie

Systematisch gezocht in 2007; zoekstrategie is niet beschikbaar

Huckabee, 2007

Exclusie

Sytematisch gezocht in 2007; beperkte zoekstrategie beschikbaar; evidence tabellen niet beschikbaar

Carnaby – Mann, 2007

Exclusie

Systematisch gezocht in augustus 2006; zoekstrategie niet beschikbaar; geen RCTs geïncludeerd

RCT

Terre, 2015

Inclusie

Li, 2015

Exclusie

Het meten van een aspiration-penetration scale wordt in de methode sectie genoemd, maar niet gerapporteerd; verdere geen relevante uitkomstmaten gerapporteerd

Michou, 2014

Exclusie

Vergelijking tussen verschillende elektrostimulatie technieken

Lee, 2014

Inclusie

Huang, 2014

Inclusie

Sun, 2013

Exclusie

Niet vergeleken met een controle groep

Rofes, 2013

Exclusie

Vergelijking tussen twee methoden van elektrostimulatie

Restivo, 2013

Exclusie

Patiënten kregen geen therapie tijdens de trial

Nam, 2013

Exclusie

Vergelijking tussen twee methoden van elektrostimulatie

Moon, 2013

Exclusie

Gezonde vrijwilligers; vergelijking tussen jong en oud

Long, 2013

Exclusie

Interventiegroep kreeg naast NMES ook balloon dilatatie, de controle groep kreeg geen balloon dilatatie

Kushner, 2013

Exclusie

Case-control studie

Baijens, 2013

Exclusie

Zelfde studiepopulatie als Heijnen, 2012

Park, 2012

Exclusie

Niet NMES bovenop rehabilitatie, maar bovenop ‘effortful’ slikken

Heijnen, 2012

Exclusie

Onduidelijk hoeveel patiënten zijn geïncludeerd en gevolgd

Baijens, 2012

Exclusie

Matched case-control studie

Xia, 2011

Inclusie

Verin, 2011

Exclusie

Geen controle groep

Lin, 2011

Exclusie

Elektrostimulatie zonder therapie vergeleken met therapie

Christiaanse, 2011

Exclusie

Kinderen; cohort studie

Pattani, 2010

Exclusie

Pilot studie van vijf patiënten; alle patiënten ontvingen behandeling

Ludlow, 2010

Exclusie

Narratieve review

Jayesekeran, 2010

Exclusie

Onduidelijk of patiënten rehabilitatie therapie ontvingen

Ryu, 2009

Inclusie

Permsirivanich, 2009

Exclusie

Vergelijking tussen NMES en conventionele therapie. NMES kregen geen conventionele therapie erbij.

Park, 2009

Exclusie

Gezonde vrijwilligers

Lim, 2009

Exclusie

Niet gerandomiseerd

Bogaardt, 2009

Exclusie

Geen vergelijkende groep

Carnaby- Mann, 2008

Exclusie

Case series

Bulow, 2008

Exclusie

Vergelijking tussen NMES en therapie

Shaw, 2007

Exclusie

Alle patiënten hebben elektrostimulatie therapie gekregen; geen vergelijkende groep

Crary, 2007

Exclusie

Betreft vragenlijsten naar behandelaars

Suiter, 2006

Exclusie

Geen vergelijkende groep; alle patiënten ontvingen NMES

Blumenfeld, 2006

Exclusie

Cohort studie; vergelijking tussen elektrostimulatie en ‘normale’ therapie

Leelamanit, 2002

Exclusie

Alle patiënten ontvingen elektrostimulatie; geen vergelijkende groep

Freed, 2001

Exclusie

Vergelijking tussen elektrostimulatie en thermal-tactile stimulatie

Study reference

Study characteristics

Patient characteristics ²

Intervention (I)

Comparison / control (C) ³

Follow-up

Outcome measures and effect size ⁴

Comments

Terré, 2015

Type of study:

Randomized controlled trial

Setting: Patients with subacute oropharyngeal dysphagia secondary to acquired brain injury

Country: Unclear

Source of funding: Non-commercial

Inclusion criteria:

• Patients with acquired brain injury (stroke, TBI) able to understand and follow necessary verbal instructions to collaborate in the treatment
• TBI patients with a Rancho Los Amigos level of cognitive functioning scale >4
• Stroke patients with a Barcelona (comprehension) test score >15
• Video-fluoroscopic demonstration of tracheal aspiration
• Patients over the age of 18
• Medically stable with follow-up <6 months since insult

Exclusion criteria:

• Previous stroke or TBI
• Previous dysphagia secondary to any other etiology
• No other metabolic or neurological diseases

N total at baseline:

Intervention: 10

Control: 10

Important prognostic factors²:

For example

Mean age (range):

I: 46 (28-60)

C: 51 (22-69)

Sex:

I: 60% M

C: 60% M

Groups comparable at baseline?

Neuromuscular electrical stimulation (NMES) using the Vital-Stim Therapy system and conventional swallowing therapy

Each patient underwent a total of 20 sessions (five per week), with each session lasting 60 min.

Sham electrical stimulation (SES) and conventional swallowing therapy

Length of follow-up:

3 months

Loss-to-follow-up:

Not described

Incomplete outcome data:

Not described

1. Functional oral intake score

Displayed as mean (range)

Baseline

I: 1.9 (1-4)

C: 2.1 (1-4)

p>0.05

1 month

I: 4.5 (1-7)

C: 3.1 (1-7)

p=0.005

3 months

I: 5.3 (1-7)

C: 4.6 (1-7)

p>0.05

2. Swal-Qol/MDADI

Not measured

3. Airway aspiration

Defined as food crossing the vocal cords and entering the airway, n (%)

Baseline

I: 10 (100)

C: 10 (100)

1 month

I: 8 (80)

C: 9 (90)

3 months

I: 6 (60)

C: 6 (60)

No statistical test was performed

4. Feeding: tube to oral

Data cannot be extracted

Authors’ conclusions: Neuromuscular electrical stimulation significantly accelerated swallowing function improvement in patients with oropharyngeal dysphagia secondary to acquired brain injury.

According to the videofluoroscopic evaluation, changes in diet (increased viscosity and decreased bolus size) and active maneuvering (supraglottic deglutition for better airway closure) were individually prescribed together with motor control exercises aimed at improving motor control of swallowing structures in the oral and pharyngeal phase (anterior and posterior lingual exercises, velar exercises, Mendelsohn Maneuver). These kinds of conventional therapy were the same for both groups.

Lee,

2014

Type of study: Randomized trial

Setting: Stroke patients with dysphagia

Country: Not stated

Source of funding: Not stated

Inclusion criteria:

• Age between 18 and 80 years
• Supratentorial ischemic stroke
• Primary diagnosis of stroke confirmed by computed tomography or magnetic resonance imaging
• FOIS of 5 or less
• Korean Mini-Mental State Examination (K-MMSE) score of 21 or higher
• Stable underlying disease process

Exclusion criteria:

• Presence of dysphagia before stroke
• Previous stroke history
• Unstable cardiopulmonary status, serious psychological disorder or epilepsy
• Tumor or radiotherapy of the head and neck region
• Underwent swallowing therapy before participation in the present study
• Unstable medical conditions that may interfere with video-fluoroscopy

N total at baseline:

Intervention: 31

Control: 26

Important prognostic factors²:

Mean age ± SD:

I: 63 (11)

C: 66 (9)

Sex:

I: 71% M

C: 77% M

Groups comparable at baseline? Yes

NMES/TDT

NMES therapy was applied simultaneously with TDT during the first 30 minutes. Each session was 30 minutes per day, 5 times a week for a total of 3 weeks.

Traditional dysphagia therapy, including thermal-tactile stimulation with any combination of lingual-strengthening exercises, laryngeal adduction-elevation exercises, effortful swallowing, Mendelsohn maneuver, Masako maneuver, and Shaker exercises by one speech therapist every day.

TDT

Length of follow-up: 12 weeks

Loss-to-follow-up:

Not stated

Incomplete outcome data:

Not stated

1. Functional oral intake score

Displayed as mean change (SD)

Baseline

I: 2.0 (1.3)

C: 2.2 (1.5)

P=0.49

3 weeks

I: 1.4 (1.0)

C: 0.5 (0.7)

P<0.001

6 weeks

I: 2.4 (1.3)

C: 1.1 (0.9)

P<0.001

12 weeks

I: 3.1 (1.4)

C: 1.7 (0.9)

P<0.001

2. Swal-Qol/MDADI

Not measured

1. Airway aspiration

Data was not reported

4. Feeding: transition from tube to oral

Defined as changes in feeding materials, n (%)

Non-oral (tubal feeding)

Baseline

I: 25 (81)

C: 22 (85)

3 weeks

I: 12 (39)

C: 16 (61)

6 weeks

I: 5 (16)

C: 4 (15)

12 weeks

I: 2 (7)

C: 3 (12)

No statistical test was performed

Authors’ conclusions: An early application of NMES combined with TDT showed a positive effect in acute/subacute ischemic stroke patients with dysphagia. These results indicated that the early application of NMES could be used as a supplementary treatment of TFT to help rehabilitate acute/subacute dysphagia stroke patients by improving their swallowing coordination.

Huang, 2014

Type of study:

Randomized trial

Setting: Acute stroke patients admitted to a rehabilitation unit

Country: Taiwan

Source of funding: Non-commercial

Inclusion criteria:

• Recent cerebral hemispheric stroke with swallowing difficulty
• FIOS equal to or less than level 4

Exclusion criteria:

• Impaired communication ability due to cognitive deficit, aphasia, or serious psychologic disorders
• Other systemic neurologic disorders leading to swallowing difficulty
• Swallowing disorders caused by structural lesions
• Use of an electrically sensitive biomedical device
• Pneumonia or acute medical conditions

N total at baseline:

Intervention: 10

Control: 11

Important prognostic factors²:

Median age IQR:

I: 68 (10)

C: 67 (10)

Sex:

I: 90% M

C: 55% M

Groups comparable at baseline? Yes, except sex

NMES and TS with VitalStim therapeutic device

Patients were treated 3 times per week (60 minutes per session), and 10 sessions of NMES were performed per patient.

TS: therapies included oral exercise, compensatory technique, faucial thermal-tactile stimulation, and swallowing therapeutic maneuvers

TS therapy

Patients were treated 3 times per week (60 minutes per session), and 10 sessions of TS were performed per patient.

Length of follow-up: Not stated

Loss-to-follow-up:

Not stated

Incomplete outcome data:

Not stated

1. Functional oral intake score

Displayed as median change from baseline (IQR)

Before treatment

I: 1.8 (1.1)

C: 1.6 (0.8)

Change after treatment

I: 3.0 (1.4)

C: 3.7 (1.6)

2. Swal-Qol/MDADI

Not measured

1. Airway aspiration

Measured with the 8-point penetration-aspiration scale, median (IQR)

Before treatment

I: 3.5 (2.5)

C: 3.8 (2.6)

Change after treatment

I: -1.5 (2.0)

C: -1.0 (1.6)

1. Feeding: transition from tube to oral

Cannot be extracted

Authors’ conclusions: TS therapy and combined therapy both have therapeutic effects on improving the swallowing function based on the clinical FOIS in acute stroke patients with dysphagia.

Xia, 2011

Type of study:

Randomized trial

Setting: Post-stroke dysphagia patients

Country: China

Source of funding:

Non-commercial

Inclusion criteria:

• Fulfilling the diagnostic criteria for various cerebrovascular diseases
• Being finally diagnosed as having cerebral infarction or cerebral haemorrhage by CT or MRI
• Having swallowing disorder as confirmed by water drinking test
• No pulmonary diseases
• Being 40-80 years old
• Possessing clear consciousness and being able to cooperate
• Being willing to provide written consent

N total at baseline:

Intervention: 40

Control: 40

Important prognostic factors²:

Mean age SD:

I: 65 (15)

C: 65 (14)

Sex:

I: 70% M

C: 63% M

Groups comparable at baseline? Yes

VitalStim therapy and conventional swallowing training

Administered twice a day, lasting 30 min each time, 5 days a week, for 4 successive weeks.

Conventional swallowing therapy

Included basic training and direct food intake training.

Length of follow-up: Not stated

Loss-to-follow-up:

Not stated

Incomplete outcome data:

Not stated

1. Functional oral intake score

Not measured

2. Swal-Qol/MDADI

Swal-QoL, mean (SD)

Prior to treatment:

I: 885 (60)

C: 863 (83)

After treatment

I: 458 (35)

C: 624 (45)

3. Airway aspiration

Not measured

4. Feeding: transition from tube to oral

Not measured

Authors’ conclusions:

VitalStim therapy coupled with conventional swallowing training was conducive to recovery of post-stroke dysphagia.

Ryu, 2009

Type of study:

Randomized controlled trial

Setting: Patients undergone surgical or radiation treatment for head and neck cancer with dysphagia

Country: Korea

Source of funding: Non-commercial

Inclusion criteria:

• Undergone surgical or radiation treatment for head and neck cancer
• Suffering from dysphagia as a treatment complication
• Confirmed on a ideofluoroscopic swallowing study
• Currently on a restricted diet
• Stable vital signs
• Able to participate in the treatment program

Exclusion criteria:

• Cognitive impairment
• History of cerebrovascular disease
• Serious psychologic disorder
• Cardiac pacemaker
• Aged less than 20 years
• Unable to tolerate electrical stimulation

N total at baseline:

Intervention: 21 randomized; 14 included

Control: 25 randomized; 12 included

Important prognostic factors²:

Mean age SD:

I: 63 (7)

C: 60 (12)

Sex:

I: 100% M

C: 92% M

Groups comparable at baseline? Yes

NMES followed by conventional rehabilitation treatment

Administered once a day with NMES for 30 min followed by conventional rehabilitation treatment for 30 min for 5 days per week for 2 weeks.

Sham stimulation followed by conventional rehabilitation treatment

Length of follow-up: Not stated

Loss-to-follow-up:

I: 7 (33%)

Reasons: 1 orocervical fistula, 3 early discharge and traffic problems, 3 unwillingness to participate in the experimental group

C: 13 (52%)

Reasons: 1 deep neck infection; 7 early discharge and traffic problems; 1 incorrect pathology diagnosed as inflammation; 4 unwillingness to participate

Incomplete outcome data:

I: 7 (33%)

Reasons: 1 orocervical fistula, 3 early discharge and traffic problems, 3 unwillingness to participate in the experimental group

C: 13 (52%)

Reasons: 1 deep neck infection; 7 early discharge and traffic problems; 1 incorrect pathology diagnosed as inflammation; 4 unwillingness to participate

1. Functional oral intake score

Measured with the functional dysphagia scale, not stated whether mean or median

Pre-treatment

I: 33.9 (13.2)

C: 38.6 (15.9)

Post-treatment

I: 22.4 (13.4)

C: 35.3 (17.7)

2. Swal-Qol/MDADI

Measured with MDADI, not stated whether mean or median*

Pre-treatment

I: 48.2 (9.8)

C: 53.1 (10.2)

Post-treatment

I: 53.4 (11.0)

C: 55.9 (11.2)

3. Airway aspiration

Not measured

4. Feeding: transition from tube to oral

Not measured

Authors’ conclusions:

The results of this study suggest that the combination of electrical stimulation and conventional rehabilitation treatment is superior to conventional rehabilitation treatment alone in patients suffering from dysphagia following treatment for head and neck cancer.

Study reference

(first author, publication year)

Describe method of randomisation¹

Bias due to inadequate concealment of allocation?²

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?³

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?³

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?⁴

(unlikely/likely/unclear)

Bias due to loss to follow-up?⁵

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?⁶

(unlikely/likely/unclear)

Terre, 2015

“using a random computerized system”

Unclear

Unlikely

Unlikely

Unlikely

Unlikely

Unclear

Unclear

Lee, 2014

“Patients were randomly allocated by a computer generated block randomization sequence into two groups, assigning patients to NMES/TDT group or TDT group with a chance of 50% to be assigned to therapy”

Unclear

Likely

Unclear

Unclear

Unlikely

Unclear

Unclear

Huang, 2014

“We randomly divided the patients into 3 groups”

Unclear

Likely

Unlikely

Unlikely

Unlikely

Unclear

Unclear

Xia, 2011

“The patients were randomly and evenly divided into three groups”

Unclear

Likely

Unlikely

Unlikely

Likely

Unclear

Unclear

Ryu, 2009

“The trial statistician randomly allocated each patient to either the experimental or the control group”

Unclear

Unlikely

Unclear

Unlikely

Unlikely

Likely

Unclear