Biofeedback bij dysfagie
Uitgangsvraag
Wat is de meerwaarde van biofeedback (oppervlakte-EMG) in de behandeling van patiënten met dysfagie?
Aanbeveling
Bekijk of biofeedback in individuele gevallen de slikrevalidatie kan ondersteunen.
Gebruik biofeedback als adjuvans van reguliere sliktraining in goed overleg met patiënt en mantelzorger.
Overwegingen
Balans tussen gewenste en ongewenste effecten
Er is literatuuronderzoek verricht naar het effect van sliktraining met biofeedback in vergelijking met standaard sliktraining in patiënten met orofaryngeale dysfagie. Alleen in patiëntengroepen met een doorgemaakt cerebrovasculair accident (CVA), met hoofd-halskanker en met de ziekte van Parkinson is literatuur gevonden. In de analyse werden vijf studies geïncludeerd. Verschillende manieren van biofeedback werden gebruikt; oppervlakte-EMG van de suprahyoidale musculatuur en video-endoscopische feedback van het slikken van bolussen.
Voor de cruciale uitkomstmaat “functionele orale voedselinname” werden geen klinisch relevante verschillen gevonden voor de diverse patiëntengroepen.
Voor de cruciale uitkomstmaat “slik-gerelateerd kwaliteit van leven” werden ook geen klinisch relevante verschillen gevonden voor de diverse patiëntengroepen. In een studie van patiënten met de ziekte van Parkinson naderde het effect echter wel klinische relevantie in het voordeel van sliktraining met biofeedback.
Voor de belangrijke uitkomstmaat aspiratie werden geen klinisch relevante verschillen gevonden voor de diverse patiëntengroepen.
Voor de belangrijke uitkomstmaat “aantal of percentage van de patiënten dat terugkeert naar een normaal dieet” werd een klinisch relevant verschil gevonden in een studie met patiënten met een CVA in het voordeel van sliktraining met biofeedback na twee weken follow-up. Dit effect was echter niet meer klinisch relevant na een follow-up van 90 dagen. Dat zou impliceren dat het slikken sneller zou worden aangeleerd met biofeedback, maar dat het uiteindelijke resultaat op de langere termijn vergelijkbaar is. In een fMRI studie van Humbert (2012) werd al gezien dat visuele biofeedback tijdens het slikken tot een verhoogde frontale hersenactiviteit leidt. Dit impliceert dat er meer aandacht is voor de coördinatie en planning van motorische activiteiten door de visuele biofeedback en dat hiermee het leren mogelijk wordt versneld.
Onderstaande studies voldeden niet aan de opgestelde PICO, vanwege het type studie design (Acher, 2021) en omdat de verkeerde vergelijking werd opgesteld (Aoki, 2015). Ze geven echter wel aanvullend richting aan de aanbevelingen en daarom worden ze hieronder besproken.
Archer (2021) onderzocht in een pilot studie of de submentale spieractiviteit toenam na oppervlakte-EMG biofeedback tijdens ‘effortful swallow‘. Er werden 15 patiënten binnen 3 maanden na een doorgemaakt CVA en 85 gezonde patiënten (leeftijd 18-89 jaar) geïncludeerd. Voor de totale groep werd een significante verbetering gezien van de submentale spieractiviteit na oppervlakte-EMG met biofeedback ten opzichte van zonder. Tevens werd gekeken of leeftijd een negatief effect had op de effectiviteit van de ‘effortful swallow’ met oppervlakte-EMG biofeedback. Er werd geen significant verschil in de activiteit van de submentale spieren gezien op basis van leeftijd.
In een studie van Aoki (2015) werd een andere vorm van biofeedback gebruikt, namelijk tongkrachttraining middels een orale ballon. Er werden 31 patiënten met een doorgemaakte CVA geïncludeerd waarvan 17 patiënten tongkrachttraining met biofeedback kregen en 14 patiënten de standaard logopedische behandeling. Er werd geen klinisch relevant verschil gevonden na behandeling. Er werd in deze studie niet vergeleken in hoeverre tongkrachttraining met en zonder biofeedback effect hebben op de uitkomsten. In de systematische review (SR) van Benfield (2019) werden vijf studies met tongkrachttraining als biofeedback geïncludeerd. Echter, ook hier werd niet tongkrachttraining met en zonder biofeedback vergeleken.
Na de zoekactie van deze module, werd het SR van Toledo-Rodriguez (2025) gepubliceerd. In dit SR werden 5 RCT’s geïncludeerd (Benfield, 2023; Nordio, 2023; Alyanak, 2025; Huimin, 2015; McCullough, 2013) over de toegevoegde waarde van oppervlakte-EMG biofeedback naast conventionele therapie in patiënten met een doorgemaakt CVA. Het SR concludeerde dat biofeedback geassocieerd was met een toename van het verwijderen van het aantal voedingssondes en een iets betere kwaliteit van leven, maar er werd geen effect gezien op de slikfunctie. De kwaliteit van bewijs werd gegradeerd als laag (kwaliteit van leven), heel laag (voedingssonde, kwaliteit van leven) en hoog (slikfunctie). Het lage en heel lage kwaliteit van bewijs werd afgewaardeerd vanwege zeer ernstige imprecisie (zeer breed betrouwbaarheidsinterval).
Kwaliteit van bewijs
Over het algemeen is de kwaliteit van bewijs (zeer) laag. Dit betekent dat we (zeer) onzeker zijn over het gevonden geschatte effect van de cruciale uitkomstmaten.
Er is afgewaardeerd vanwege (zeer) ernstige:
- Risk of Bias: methodologische beperkingen binnen het randomisatieproces en de blindering.
- Imprecisie: onnauwkeurigheid, omdat het betrouwbaarheidsinterval de grens/grenzen van klinische relevantie overschrijdt en vanwege het niet bereiken van de optimale steekproefgrootte.
Waarden en voorkeuren van patiënten (en eventueel hun naasten/verzorgers)
De oppervlakte-EMG wordt veelal goed verdragen door patiënten. De video-endoscopische biofeedback is iets meer invasief door het gebruik van de flexibele laryngoscoop via de neus, maar wordt meestal ook goed verdragen. De toename van therapiebelasting voor de patiënt wordt ingeschat als beperkt. Het is weliswaar een toevoeging op reguliere behandeling, maar het kan ook leiden tot een efficiëntere leercurve om de te leren logopedische technieken juist toe te passen.
De bijwerkingen van oppervlakte-EMG biofeedback, zoals lokale huidirritatie door het gebruik van de plakkers, zijn beperkt. De bijwerkingen van video-endoscopische biofeedback, zoals lokale irritatie in neus en keelholte, zijn eveneens beperkt.
Indien de logopedist constateert dat de vooruitgang achterblijft bij de verwachting, is het advies om de behandeling in samenspraak met de patiënt te heroverwegen.
Kostenaspecten
De oppervlakte-EMG apparatuur moet eenmalig worden aangeschaft en het personeel moet eenmalig worden geschoold. Ook de kosten van de pleisters zijn relatief laag. Voor de video-endoscopische feedback dient de flexibele laryngoscoop aangeschaft te worden. Afhankelijk van de locatie van behandelen is deze mogelijk al voorhanden. Het gebruik van de flexibele laryngoscoop vergt enige training en ervaring. Daarnaast dienen de laryngoscopen gereinigd te worden na ieder gebruik, ofwel opnieuw aangeschaft bij disposable laryngoscopen. Gezien de lage kwaliteit van het wetenschappelijke bewijs is niet duidelijk te stellen of de mogelijke ziektewinst bij patiënten met slikklachten opweegt tegen de kosten die gemaakt worden.
Gelijkheid ((health) equity/equitable)
Biofeedback wordt niet standaard in ziekenhuizen of revalidatieklinieken aangeboden. Daarmee is de plek waar iemand is opgenomen of behandeld wordt, bepalend voor de toegankelijkheid tot biofeedback als aanvulling op reguliere logopedie. Gezien het beperkte wetenschappelijk bewijs voor biofeedback als adjuvans voor reguliere logopedische behandeling leidt dit slechts beperkt tot ongelijkheid van zorg.
Aanvaardbaarheid
Ethische aanvaardbaarheid
Sliktraining met biofeedback lijkt aanvaardbaar voor de betrokkenen. Er zijn geen ethische bezwaren.
Duurzaamheid
Bij sliktraining met biofeedback lijken de duurzaamheidsaspecten beperkt. Voor oppervlakte-EMG worden disposable plakkers gebruikt, echter, deze kunnen ook hergebruikt worden gedurende de volgende therapiesessies. Voor de video-endoscopische biofeedback dient rekening gehouden te worden met het reinigen van de flexibele endoscopen. Daarnaast zijn er ook disposable endoscopen beschikbaar.
Haalbaarheid
De apparatuur om sliktraining met biofeedback middels oppervlakte-EMG of video-endoscopie uit te voeren zijn commercieel verkrijgbaar. De oppervlakte-EMG is niet in elk ziekenhuis of revalidatiecentrum beschikbaar en de video-endoscopie in niet elk revalidatiecentrum en dus ook niet voor elke patiënt gemakkelijk beschikbaar. Daarnaast is met name voor video-endoscopie enige training en ervaring nodig.
Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies
De literatuur uit de literatuursamenvatting laat zien dat er onvoldoende wetenschappelijk bewijs is dat het toevoegen van biofeedback aan reguliere sliktraining bij patiënten met slikklachten door een CVA, hoofd-halskanker of bij patiënten met de ziekte van Parkinson een positief effect heeft op de slikfunctie en de kwaliteit van leven. Aanvullend wordt in een recente systematische review en meta-analyse van Toledo-Rodriguez (2025) eveneens geconcludeerd dat er onvoldoende wetenschappelijk bewijs hiervoor is. Het doel van biofeedback als adjuvans bij sliktraining dient een specifieke functieverbetering te beogen (bijvoorbeeld bij het aanleren en training van de Mendelsohn manoeuvre). Voor een selecte patiëntengroep kan de toevoeging van biofeedback mogelijk ondersteunen in het efficiënter bereiken van de gewenste behandeldoelen. Patiënten dienen hiervoor cognitief voldoende sterk te zijn en voldoende belastbaar om de extra inspanning te kunnen dragen en deze inspanning om te zetten naar een betere of efficiënter beoogde resultaat. Het gebruik van biofeedback als adjuvans van reguliere sliktraining dient derhalve in goed overleg met patiënt en mantelzorger te worden gemaakt en er moet bekeken worden of het in individuele gevallen de slikrevalidatie kan ondersteunen.
Eindoordeel:
Zwakke aanbeveling voor (doen).
Onderbouwing
Achtergrond
Biofeedback using surface electromyography (sEMG) is a therapeutic technique in which muscle activity is recorded through surface electrodes placed on the skin. This muscle activity is then converted into visual and/or auditory information (Huckabee, 1998). During swallowing rehabilitation, visual biofeedback via EMG recording can be beneficial. Muscles relevant to swallowing and accessible through surface EMG include the suprahyoid muscles. These muscles are among those targeted during the Mendelsohn maneuver, which aims to improve hyolaryngeal elevation during swallowing (Logemann, 1998). However, the added value of biofeedback in the treatment of patients with dysphagia remains inconclusive.
Conclusies / Summary of Findings
Summary of Findings
Stroke patients
PICO (1.1)
Population: stroke patients
Intervention: Swallowing training program with biofeedback
Comparator: Swallowing training programs without biofeedback (conventional therapy)
|
Outcome Timeframe |
Study results and measurements |
Absolute effect estimates |
Certainty of the evidence (Quality of evidence) |
Summary |
|
|
Conventional therapy |
Biofeedback |
||||
|
Functional oral intake of food experienced by the patient* |
Measured by: FOIS Scale: 1-7, higher is better Based on data from 27 patients in 1 study |
Difference (90 days): MD 0.4 higher (CI 95% 0.3 higher - 7.2 higher) |
Low Due to serious risk of bias, due to serious imprecision1 |
Swallowing training with biofeedback may result in little to no difference in functional oral intake of food experienced by the patient when compared with conventional therapy in stroke patients.
(Benfield, 2023) |
|
|
Measured by: FOIS Scale: 1-7, higher is better Based on data from 16 patients in 1 study |
MD 2 mo vs baseline: 2.02 (95% CI: 0.63 to 3.41) |
MD 2 mo vs baseline: 2.28 (95% CI: 1.59 to 2.97) |
Very low Due to serious risk of bias, due to very serious imprecision2 |
The evidence is very uncertain about the effect of swallowing training with biofeedback on functional oral intake of food experienced by the patient compared to conventional therapy in stroke patients.
(Nordio, 2022) |
|
|
Difference: MD 0.25 higher (CI 95% 1.15 lower - 1.67 higher)
|
|||||
|
Swallowing-related quality of life* |
Measured by: DHI Scale: 0-100, lower is better Based on data from 27 patients in 1 study |
Difference (90 days): MD 0.3 lower (CI 95% 21.2 lower - 20.7 higher) |
Very low Due to serious risk of bias, due to very serious imprecision3 |
The evidence is very uncertain about the effect of swallowing training with biofeedback on swallowing-related quality of life compared to conventional therapy in stroke patients.
(Benfield, 2023) |
|
|
Functional swallowing ability |
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on functional swallowing ability compared to conventional therapy in stroke patients. |
|
|
Number/percentage of patients who return to a normal diet**
|
Feeding route (oral diet – normal) Based on data from 27 patients in 1 study |
10/14 patients |
9/11 patients |
Low Due to serious risk of bias, due to serious imprecision4 |
Swallowing training with biofeedback may result in little to no difference in the number/percentage of patients who return to a normal diet when compared with conventional therapy in stroke patients.
(Benfield, 2023) |
|
Difference: RD 0.10 (10.5% higher) (CI 95% 0.222 lower to 0.432 higher) |
|||||
|
Aspiration*
|
Measured by: PAS (5 ml puree) Scale: 1-8, lower is better Based on data from 27 patients in 1 study |
Difference (2 weeks): MD 0.13 lower (CI 95% 1.75 lower – 0.92 higher) |
Very low Due to serious risk of bias, due to very serious imprecision5 |
The evidence is very uncertain about the effect of swallowing training with biofeedback on aspiration compared to conventional therapy in stroke patients.
(Benfield, 2023) |
|
|
Measured by: PAS (semi-solid) Scale: 1-8, lower is better Based on data from 16 patients in 1 study |
MD 2 mo vs baseline: -0.87 (95% CI: -2.71 to 0.97) |
MD 2 mo vs baseline: -0.99 (95% CI: -2.07 to 0.09) |
Very low Due to serious risk of bias, due to very serious imprecision6 |
The evidence is very uncertain about the effect of swallowing training with biofeedback on aspiration compared to conventional therapy in stroke patients.
(Nordio, 2022) |
|
|
Difference: MD 0.12 lower (CI 95% 2.26 lower - 2.02 higher) |
|||||
1. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel, Baseline imbalances
Imprecision: serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
2. Risk of bias: serious. Inadequate/lack of blinding of participants and personnel
Imprecision: very serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
3. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel, Baseline imbalances
Imprecision: very serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
4. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel, Baseline imbalances
Imprecision: serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
5. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel, Baseline imbalances
Imprecision: very serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
6. Risk of bias: serious. Inadequate/lack of blinding of participants and personnel
Imprecision: very serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
* The clinical relevance could not be determined for the study that only reported medians and interquartile ranges for specific outcomes (Alyanak (2025) – FOIS, DHI, PAS).
** The clinical relevance of the outcome ‘presence of enteral nutrition’ (Nordio, 2022) was not assessed, because absence of enteral nutrition is not necessarily equal to returning to a normal diet.
Patients with Parkinson’s Disease
PICO (1.2)
Population: patients with Parkinson’s Disease
Intervention: Swallowing training program with biofeedback
Comparator: Swallowing training programs without biofeedback (conventional therapy)
|
Outcome Timeframe |
Study results and measurements |
Absolute effect estimates |
Certainty of the evidence (Quality of evidence) |
Summary |
|||
|
Conventional therapy |
Biofeedback |
||||||
|
Functional oral intake of food experienced by the patient
|
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on functional oral intake of food experienced by the patient compared to conventional therapy in patients with Parkinson’s Disease. |
|||
|
Swallowing-related quality of life
|
Measured by: SDQ Scale: 0.5-44.5, lower is better Based on data from 42 participants in 1 study |
MD 1 mo vs baseline: 1.19 (95% CI: -3.44 to 5.82) |
MD 1 mo vs baseline: 5.60 (95% CI: 2.02 to 9.18) |
Low Due to serious risk of bias, due to serious imprecision1 |
Swallowing training with biofeedback may result in little to no difference in swallowing-related quality of life when compared with conventional therapy in patients with Parkinson’s Disease.
(Manor, 2013) |
||
|
Difference: MD 4.41 higher (CI 95% 1.44 lower – 10.26 higher) |
|||||||
|
Measured by: SWAL-CARE Scale: 0-100, higher is better Based on data from 42 participants in 1 study |
Mean: 22.34 ± 5.7 |
Mean: 26.26 ± 5.86 |
Low Due to serious risk of bias, due to serious imprecision2 |
Swallowing training with biofeedback may result in little to no difference in swallowing-related quality of life when compared with conventional therapy in patients with Parkinson’s Disease.
(Manor, 2013) |
|||
|
Difference: MD 3.92 higher (CI 95% 0.42 higher – 7.42 higher) |
|||||||
|
Functional swallowing ability |
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on functional swallowing ability compared to conventional therapy in patients with Parkinson’s Disease. |
|||
|
Number/percentage of patients who return to a normal diet
|
-
|
-
|
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on number/percentage of patients who return to a normal diet compared to conventional therapy in patients with Parkinson’s Disease. |
|||
|
Aspiration
|
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on aspiration compared to conventional therapy in patients with Parkinson’s Disease. |
|||
1. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel
Imprecision: serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
2. Risk of bias: serious. Inadequate concealment of allocation during randomization process, Inadequate/lack of blinding of participants and personnel
Imprecision: serious. Low number of patients (<100), Data from only one study
Head and neck cancer patients
PICO (1.3)
Population: Head and neck cancer patients
Intervention: Swallowing training program with biofeedback
Comparator: Swallowing training programs without biofeedback (conventional therapy)
|
Outcome Timeframe |
Study results and measurements |
Absolute effect estimates |
Certainty of the evidence (Quality of evidence) |
Summary |
|
|
Conventional therapy |
Biofeedback |
||||
|
Functional oral intake of food experienced by the patient
|
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on functional oral intake of food experienced by the patients compared to conventional therapy in head and neck cancer patients. |
|
|
Swallowing-related quality of life
|
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on swallowing-related quality of life compared to conventional therapy in head and neck cancer patients. |
|
|
Functional swallowing ability |
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on functional swallowing ability compared to conventional therapy in head and neck cancer patients. |
|
|
Number/percentage of patients who return to a normal diet
|
Restoration of exclusively oral nutrition Based on data from 33 patients in 1 study |
11/14 patients |
14/19 patients |
Very low Due to serious risk of bias, due to serious imprecision1 |
The evidence is very uncertain about the effect of swallowing training with biofeedback on the number/percentage of patients who return to a normal diet compared to conventional therapy in head and neck cancer patients.
(Denk, 1997) |
|
Difference: RD -0.049 (4.9% lower) (CI 95% 0.34 lower to 0.24 higher) |
|||||
|
Aspiration
|
- |
- |
No GRADE (no evidence was found) |
No evidence was found regarding the effect of swallowing training with biofeedback on aspiration compared to conventional therapy in head and neck cancer patients. |
|
1. Risk of Bias: very serious. Inadequate selection of participants, confounding, loss to follow up unclear
Imprecision: very serious. Low number of patients (<100), Data from only one study, Wide confidence intervals
Samenvatting literatuur
Description of studies
A total of five studies were included in the analysis of the literature. Findings were categorized according to disease type. Important study characteristics and results are summarized in table 2. The assessment of the risk of bias is summarized in the risk of bias tables (under the tab ‘Evidence tabellen’).
Stroke patients
Alyanak (2025) conducted a randomized controlled trial (RCT) to study the effects of game-based electromyography (EMG)-biofeedback therapy on swallowing functions and quality of life in patients with post-stroke dysphagia. Adult patients (>18y old) with a history of hemorrhagic or ischemic stroke lasting more than 3 months, with swallowing complaints after stroke, with a Mini-Mental State Examination (MMSE) score of at least 24, without serious systemic comorbidities, with a Functional Oral Intake Scale (FOIS) score of less than 6, with detection of pathology in the oropharyngeal phase of swallowing during videofluoroscopic evaluation and without treatment related to dysphagia in the last three months, were enrolled in the trial.
A total of 33 participants were randomized into two groups: an intervention group receiving game-based EMG-biofeedback (n=16), and a control group receiving only verbal feedback during clinical swallowing assessments (n=17). In total, the participants received 15 sessions of 30 minutes. The outcomes were the Functional Oral Intake Scale (FOIS), Penetration–Aspiration Scale (PAS), Dysphagia Outcome and Severity Scale (DOSS), and Dysphagia Handicap Index (DHI).
Benfield (2023) conducted a randomized controlled feasibility trial aimed at assessing the feasibility, safety, and preliminary efficacy of swallow strength and skill training using surface electromyographic (sEMG) biofeedback in acute stroke patients with dysphagia.
The study included 27 adult patients who were within 4 weeks post-stroke and had clinically confirmed dysphagia (FOIS<6). Exclusion criteria included a history of previous dysphagia and being medically unstable or having a poor medical prognosis.
Participants were randomly assigned to either usual care (n=15) or usual care plus sEMG-guided swallow training (n=12) delivered in up to 10 sessions over approximately two weeks.
Outcome measures included measures of dysphagia severity, quality of life, functional oral intake, swallow strength and skill, acceptability, tolerability and feasibility.
Nordio (2022) conducted an RCT to study the effect of sEMG biofeedback as an adjunctive treatment for post-stroke dysphagia. Seventeen patients diagnosed with dysphagia following stroke were enrolled. Inclusion criteria were first stroke, onset from stroke > 6 weeks, FOIS<6 and preserved comprehension. Exclusion criteria were hearing or visual impairments, severe concomitant medical conditions and other neurological diseases.
Participants were randomized into two groups: an intervention group receiving sEMG biofeedback therapy alongside standard treatment (n=9), and a control group receiving standard treatment alone (n=7). The program was 5 weeks in total, with 25 sessions of one hour (including recovery periods).
Outcome measures included the Functional Oral Intake Scale (FOIS) as the primary endpoint, and assessments of pharyngeal clearance and swallowing safety using fiberoptic endoscopic evaluation of swallowing (FEES).
Parkinson’s Disease patients
Manor (2013) conducted an RCT to investigate the effectiveness of video-assisted swallowing therapy (VAST) on swallowing function and quality of life in patients with Parkinson’s Disease. The study enrolled 42 non-demented patients with primary Parkinson’s Disease who experienced swallowing difficulties (confirmed via FEES). Exclusion criteria were a history of other uncontrolled neurological or medical disorders interfering with swallowing, brain surgery, dementia, or vision and hearing impairments.
Participants were randomly assigned to either an intervention group receiving VAST (n=21), which involved exposure to general and personalized video recordings of the swallowing process during therapy sessions, or a control group receiving conventional swallowing therapy without video assistance (n=21). Both groups underwent six therapy sessions conducted by the same speech and swallowing therapist.
Outcome measures included swallowing function assessed by FEES, quality of life measured through questionnaires, patient-reported quality of care, and enjoyment of eating evaluated with specific scales.
Head and neck cancer patients
Denk (1997) conducted an observational cohort study to evaluate the effect of videoendoscopic biofeedback on swallowing rehabilitation efficacy in patients after head and neck surgery. The study included 33 patients with prolonged postoperative aspiration following radical resections of malignant tumors of the oropharyngolaryngeal swallowing structures. Nineteen patients received videoendoscopic biofeedback as part of their swallowing therapy, while the 14 patients underwent standard swallowing rehabilitation without biofeedback. The therapy in both groups was 45 mins for 2-5 days/week, up to 6 months in total. Outcome measures were restoration of exclusively oral nutrition and tube status post therapy.
Table 2. Characteristics of included studies
|
Study |
Participants |
Comparison |
Follow-up |
Outcome measures |
Comments |
Risk of bias* |
|
Included in systematic review Battel, 2021 |
||||||
|
Manor, 2013
RCT |
Patients with Parkinson’s Disease
N at baseline Intervention: 21 Control: 21
Age (mean, SD) Intervention: 67.66, 8.26 Control: 69.86, 9.7
Sex (M/F) Total: 24/18 (not reported separately for the intervention and control group) |
Intervention: Video-assisted swallowing therapy (visual feedback) - video-assisted tool during each therapy session, for educating and assisting in understanding the structure of the swallowing mechanism and the way it functions.
Control: Conventional therapy (no visual cues)
Both groups were given 6 interventional sessions by the same speech and swallowing therapist, spread over a period of 6 weeks.
Exercises: swallowing exercises and compensatory therapy technique |
6 months |
Swallowing disturbances questionnaire (SDQ) – t=0, t=4 wks
Swallowing Quality of Life questionnaire (SWAL-QOL) – t=4 wks, t=6 months
Swallowing Quality of Care questionnaire (SWAL-CARE) – t=0 |
The authors report no competing interests. |
Some concerns (blinding and incomplete reporting of allocation concealment) |
|
Included in systematic review Benfield, 2019 |
||||||
|
Denk, 1997
observational cohort |
Head and neck cancer patients (after radical resection)
N at baseline Intervention: 19 Control: 14
Age (median (range)) Intervention: 54 (37-68) Control: 53 (37-79)
Sex (M/F) Intervention: 13/6 Control: 12/2
|
Intervention: Swallowing therapy with videoendoscopic biofeedback (visual and verbal feedback)
Control: Conventional swallowing therapy
45 mins, 2-5 days/week, up to 6 months (until full oral intake was achieved)
Exercises: Mendelsohn maneuver, effortful swallow, (super) supraglottic swallow |
6 months |
Restoration of exclusively oral nutrition
|
Not stated. |
High (selection, confounding, loss to follow up unclear) |
|
Individual studies |
||||||
|
Alyanak, 2025
RCT |
Stroke patients
N at baseline Intervention: 16 Control: 17
Age (mean, SD) Intervention: 63.36, 11.38 Control: 60.59 ± 12.54
Sex (M/F) Intervention: 11/5 Control: 11/6
|
Intervention: game-based EMG-biofeedback (visual and auditory feedback).
Control: conventional therapy (only verbal feedback).
Total of 15 sessions in both groups (5 days a week x 3 weeks) with equal duration.
Exercises: effortful swallow and Mendelsohn maneuver. |
3 weeks |
Functional Oral Intake Scale (FOIS)
Dysphagia Handicap Index (DHI)
Penetration-Aspiration Scale (PAS) |
The research was supported by the Scientific and Technological Research Council of Türkiye (TÜBİTAK) and by Kocaeli University Scientific Research Projects Coordination Unit.
The authors declare that they have no conflicts of interest. |
Some concerns (incomplete reporting of allocation concealment, limited sample size) |
|
Benfield, 2023
RCT |
Stroke patients
N at baseline Intervention: 12 Control: 15
Age (mean, SD) Intervention: 71.0, 10.4 Control: 75.1, 11.5
Sex (M/F) Intervention: 6/6 Control: 2/13
|
Intervention: sEMG biofeedback (visual and verbal feedback) in addition to usual care. Up to 10 sessions (up to 45 minutes) in 2 weeks.
Control: Usual care (swallow reviews, liaison with the multidisciplinary team, patient and family education and swallow therapy).
Exercises: Strength and skill training |
90 days |
Functional Oral Intake Scale (FOIS) – t=2 wks, t=90 days
Dysphagia Handicap Index (DHI) – t=2 wks, t=90 days
Penetration-Aspiration Scale (PAS) – t=2 wks
Feeding route – t=2 wks, t=90 days |
The research was funded by National Institute for Health Research (NIHR) and Collaboration for Leadership in Applied Health Research and Care (CLAHRC). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Conflict of interest: One of the authors is Stroke Association Professor of Medicine and Emeritus NIHR Senior Investigator; he has received honoraria from DiaMedica, Moleac, Phagenesis and Sanofi. |
Some concerns (incomplete reporting of allocation concealment, blinding, baseline imbalances) |
|
Nordio, 2022
pilot RCT |
Stroke patients
N at baseline Intervention: 9 Control: 7
Age (mean, SD) Intervention: 71, 9.8 Control: 69, 11.7
Sex (M/F) Intervention: 7/2 Control: 5/2
|
Intervention: Swallowing behavioral exercises with sEMG-biofeedback (visual feedback and verbal feedback)
Control: Swallowing behavioral exercises (only verbal feedback)
5 weekly sessions of 40 min (excluding pauses) in a 5-week program |
2 months |
Functional Oral Intake Scale (FOIS) – t=5 wks, t=2 months
Penetration-Aspiration Scale (PAS) – t=5 wks, t=2 months
Enteral nutrition – t=5 wks, t=2 months |
No funding was received for conducting this study.
The authors have no conflicts of interest to declare that are relevant to the content of the article. |
Some concerns (blinding, limited sample size) |
*For further details, see risk of bias table in the appendix
Results
Stroke patients
Three studies evaluated the impact of swallowing training with biofeedback on outcome measures in stroke patients (Alyanak, 2025; Benfield, 2023; Nordio, 2022).
Functional oral intake of food as experienced by the patient (crucial)
Three studies reported the outcome measure functional oral intake of food as experienced by the patient (Alyanak, 2025; Benfield, 2023; Nordio, 2022).
All studies reported this outcome measure with the use of the FOIS (Functional Oral Intake Scale, scale 1-7, higher is better). Results could not be pooled as two studies only reported medians and interquartile ranges.
Alyanak (2025) reported that in total 16 patients received swallowing training with biofeedback (game-based EMG), and 17 patients received conventional swallowing therapy. Baseline FOIS (median [IQR]) was 5.5 [3.5-6] in the biofeedback group versus 5 [5-6] in the control group. Post-intervention FOIS was 6 [5-6] in the biofeedback group versus 6 [5-6] in the control group. The median change was 0 [0-1] versus 0 [0-0]. No statistically significant differences in FOIS score change and post-treatment FOIS scores were reported. Clinical relevance could not be determined (Alyanak, 2025).
Benfield (2023) reported that in total 12 patients received swallowing training with biofeedback (sEMG), and 15 patients received conventional swallowing therapy. Baseline FOIS (median [IQR]) was 3 [1] in the biofeedback group versus 4 [1] in the control group. At 2-week follow-up, FOIS scores were 5 [3] in the biofeedback group versus 4 [2] in the control group. At 90-day follow-up, FOIS scores were 7 [1] versus 7 [2]. The unadjusted mean differences were 0.29 (95% CI: 0.1 to 1.2) at 2-week follow-up, and 0.4 (95% CI: 0.3 to 7.2) at 90-day follow-up, both in favor of biofeedback. These differences were not considered clinically relevant (Benfield, 2023).
Nordio (2022) reported that in total 9 patients received swallowing training with biofeedback (sEMG), and 7 patients received conventional swallowing therapy. Baseline FOIS was 4.14 ± 1.29 in the biofeedback group versus 4.06 ± 1.53 in the control group. At 5-week follow-up, FOIS scores were 5.71 ± 1.38 in the biofeedback group versus 5.56 ± 1.63 in the control group. At 2-month follow-up, FOIS scores were 6.42 ± 0.9 versus 6.08 ± 1.5. At 5-week follow-up, the mean difference was 1.57 (95% CI: 0.51 to 2.63) in the biofeedback group and 1.50 (95% CI: -0.01 to 3.01) in the control group. At 2-month follow-up, the mean difference was 2.28 (95% CI: 1.59 to 2.97) in the biofeedback group and 2.02 (95% CI: 0.63 to 3.41) in the control group.
The mean differences between groups were 0.07 (95% CI: -1.61 to 1.75) and 0.25 (95% CI: -1.15 to 1.67) for 5-weeks and 2-months, respectively, in favor of biofeedback. These differences were not considered clinically relevant (Nordio, 2022).
Swallowing-related quality of life (crucial)
Two studies reported the outcome measure swallowing-related quality of life (Alyanak, 2025; Benfield, 2023). Both studies reported the outcome swallowing-related quality of life with the use of the Dysphagia Handicap Index (DHI, scale 0-100, lower is better). Alyanak (2024) reported medians and interquartile ranges.
Alyanak (2025) reported that in total 16 patients received swallowing training with biofeedback (game-based EMG), and 17 patients received conventional swallowing therapy. Baseline DHI (median [IQR]) was 57 [48-65] in the biofeedback group versus 64 [50-75] in the control group. Post-intervention DHI was 41 [32-50] in the biofeedback group versus 60 [45-73] in the control group. The median change was -12 [-21.5 - -6) versus -4 [-6 - -2]. Statistically significant differences for both DHI score change and post-treatment DHI scores were reported, both in favor of biofeedback. Clinical relevance could not be determined (Alyanak, 2025).
Benfield (2023) reported that in total 12 patients received swallowing training with biofeedback (sEMG), and 15 patients received conventional swallowing therapy. Baseline DHI was 29.6 ± 20.1 in the biofeedback group versus 25.9 ± 16.7 in the control group. At 2-week follow-up, DHI scores were 27.2 ± 21.9 in the biofeedback group versus 18.9 ± 13.7 in the control group. At 90-day follow-up, DHI scores were 24.1 ± 27.4 versus 24.3 ± 25.4. The unadjusted mean differences were 0.23 (95% CI: -6.2 to 22.9) (in favor of control) at 2-week follow-up, and -0.3 (95% CI: -21.2 to 20.7) (in favor of biofeedback) at 90-day follow-up. These differences were not considered clinically relevant (Benfield, 2023).
Functional swallowing ability (important)
The outcome measure functional swallowing ability was not reported.
Number or percentage of patients who return to a normal diet (important)
Two studies reported the outcome measure number or percentage who return to a normal diet (Benfield, 2023; Nordio, 2022).
One study reported this outcome measure by the feeding route (oral diet – normal) (Benfield, 2023). In total, 12 patients received swallowing training with biofeedback (sEMG), and 15 patients received conventional swallowing therapy. After two weeks, 41.7% (5/12 patients) of the biofeedback group was on a normal oral diet, and 13.3% (2/15 patients) of the control group was on a normal oral diet. After 90 days, 81.9% (9/11 patients) of the biofeedback group was on a normal oral diet, and 71.4% (10/14 patients) of the control group was on a normal oral diet. The risk differences were 0.28 (95% CI: -0.043 to 0.611) and 0.10 (95% CI: -0.222 to 0.432), respectively, in favor of biofeedback. The difference after two weeks (28.4%) was considered clinically relevant. The difference after 90 days (10.5%) was not considered clinically relevant (Benfield, 2023).
One study reported this outcome measure by the presence of enteral nutrition (Nordio, 2022). In total, 9 patients received swallowing training with biofeedback (sEMG), and 7 patients received conventional swallowing therapy. After five weeks, 11.1% of the biofeedback group was on enteral nutrition, and 33.33% of the control group was on enteral nutrition. After two months, these percentages were 12.5% versus 20%, respectively. The clinical relevance of this outcome was not assessed, because absence of enteral nutrition is not necessarily equal to returning to a normal diet (Nordio, 2022).
Aspiration (important)
Three studies reported the outcome measure aspiration (Alyanak, 2025; Benfield, 2023; Nordio, 2022). As the studies did not report a total PAS score, the semi-solid PAS score was described (scale 1-8, lower is better). This represents a standardized texture commonly used in dysphagia management, while balancing the challenges of both liquids and solid foods. Results could not be pooled as one study only reported medians and interquartile ranges.
Alyanak (2025) reported that in total 16 patients received swallowing training with biofeedback (game-based EMG), and 17 patients received conventional swallowing therapy. The baseline semi-solid PAS score (median [IQR]) was 4 [2-5] in the biofeedback group versus 3 [2.5-4.5] in the control group. The post-intervention PAS was 2 [1-2] in the biofeedback group versus 2 [2-4] in the control group. The median change was -1.5 [-2.75-0.25] versus 0 [-1-0], which was reported as a statistically significant change. Clinical relevance could not be determined (Alyanak, 2025).
Benfield (2023) reported that in total 12 patients received swallowing training with biofeedback (sEMG), and 15 patients received conventional swallowing therapy. The baseline PAS score (5 ml puree) was 1.4 ± 1.2 in the biofeedback group versus 1.6 ± 0.9 in the control group. At 2-week follow-up, PAS scores were 1.6 ± 1.2 in the biofeedback group versus 2.0 ± 1.9 in the control group. The unadjusted mean difference was -0.13 (95% CI: -1.75 to 0.92) in favor of biofeedback (Benfield, 2023). This difference was not considered clinically relevant (Benfield, 2023).
Nordio (2022) reported that in total 9 patients received swallowing training with biofeedback (sEMG), and 7 patients received conventional swallowing therapy. (Nordio, 2022). Baseline PAS (semi-solid) was 2.07 ± 1.39 in the biofeedback group versus 2.25 ± 1.65 in the control group. At 5-week follow-up, PAS scores were 1.21 ± 0.8 in the biofeedback group versus 1.47 ± 1.25 in the control group. At 2-month follow-up, PAS scores were 1.08 ± 0.29 versus 1.38 ± 1.12. At 5-week follow-up, the mean difference was -0.86 (95% CI: -2.09 to 0.37) in the biofeedback group and -0.78 (95% CI: -2.69 to 1.13) in the control group. At 2-month follow-up, the mean difference was -0.99 (95% CI: -2.07 to 0.09) in the biofeedback group and -0.87 (95% CI: -2.71 to 0.97) in the control group.
The mean differences between groups were -0.08 (95% CI: -2.35 to 2.19) and -0.12 (95% CI: -2.26 to 2.02) for 5-weeks and 2-months, respectively, both in favor of biofeedback. These differences were not considered clinically relevant (Nordio, 2022).
Patients with Parkinson’s Disease
One study evaluated the impact of swallowing training with biofeedback on outcome measures in patients with Parkinson’s Disease (Manor, 2013).
Functional oral intake of food as experienced by the patient (crucial)
The study did not report the outcome measure functional oral intake of food as experienced by the patient (Manor, 2013).
Swallowing-related quality of life (crucial)
The study reported the outcome measure swallowing-related quality of life with the use of three questionnaires (Manor, 2013). In total 21 patients received swallowing training with biofeedback (video-assisted), and 21 patients received conventional swallowing therapy.
The SDQ (Swallowing Disturbances Questionnaire, scale 0.5-44.5, lower is better) was administered at baseline, immediately post-treatment and at 4-week follow-up. At baseline, the SDQ score was 14.65 ± 5.81 in the biofeedback group versus 14.27 ± 7.17 in the control group. Immediately post-treatment, the SDQ score was 12.73 ± 7.6 in the biofeedback group versus 13.43 ± 7.03 in the control group. At 1-month follow-up, the SDQ score was 9.05 ± 5.30 versus 13.08 ± 7.2. Immediately post-treatment, the mean difference was 1.92 (95% CI: -2.43 to 6.27) in the biofeedback group and 0.84 (-3.73 to 5.41) in the control group. At 1-month follow-up, the mean difference was 5.60 (95% CI: 2.02 to 9.18) versus 1.19 (95% CI: -3.44 to 5.82).
The mean differences between groups were 1.08 (95% CI: -5.23 to 7.39) and 4.41 (95% CI: -1.44 to 10.26) immediately post-treatment and at 1-month follow-up, respectively, both in favor of biofeedback. These differences were not considered clinically relevant. However, the between-group difference at 1-month approaches clinical relevance (Manor, 2013).
The SWAL-QOL (scale 0-100, higher is better) was administered at baseline, 4-week follow-up and 6-month follow-up. (Manor, 2013). No total scores for quality of life were reported. However, at 4-week follow-up, statistically significant differences on two of the nine domains (burden and symptoms frequency) were reported in favor of biofeedback. At 6-month follow-up, statistically significant differences on five domains (burden, eating desire, social functioning, mental health and symptoms frequency) were reported in favor of biofeedback. Clinical relevance could not be determined (Manor, 2013).
The SWAL-CARE (Swallowing Quality of Care questionnaire, scale 0-100, higher is better) was administered immediately post-treatment to assess the effectiveness of the advice of the speech and language pathologist. The SWAL-CARE score was 26.26 ± 5.86 in the biofeedback group, and 22.34 ± 5.7 in the control group. The mean difference was 3.92 points (95% CI: 0.42 to 7.42) in favor of biofeedback. This difference was not considered clinically relevant (Manor, 2013).
Functional swallowing ability (important)
The study did not report the outcome measure functional swallowing ability (Manor, 2013).
Number or percentage of patients who return to a normal diet (important)
The study did not report the outcome measure number or percentage who return to a normal diet (Manor, 2013).
Aspiration (important)
The study did not report the outcome measure aspiration (Manor, 2013).
Head and neck cancer patients
One study evaluated the impact of swallowing training with biofeedback on outcome measures in head and neck cancer patients (Denk, 1997).
Functional oral intake of food as experienced by the patient (crucial)
The study did not report the outcome measure functional oral intake of food as experienced by the patient (Denk, 1997).
Swallowing-related quality of life (crucial)
The study did not report the outcome measure swallowing-related quality of life (Denk, 1997).
Functional swallowing ability (important)
The study did not report the outcome measure functional swallowing ability (Denk, 1997).
Number or percentage of patients who return to a normal diet (important)
The study reported the outcome measure restoration of exclusively oral nutrition (with food of all consistencies without moderate or severe aspiration). In total 19 patients received swallowing training with biofeedback, and 14 patients received conventional swallowing therapy. Exclusively oral nutrition was restored in 73.7% of the biofeedback group (14/19 patients) and in 78.6% of the control group (11/14 patients). The risk difference was -0.049 (95% CI: -0.34 to 0.24) in favor of the control. The difference (-4.9%) was not considered clinically relevant (Denk, 1997).
Aspiration (important)
The study did not report the outcome measure aspiration (Denk, 1997).
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
What is the effectiveness of intensive swallowing training programs with or without biofeedback as treatment for patients with dysphagia?
Table 1. PICO
| Patients | Patients with oropharyngeal dysphagia |
| Intervention | Swallowing training program with biofeedback |
| Control | Swallowing training program without biofeedback (conventional therapy) |
| Outcomes |
|
| Other selection criteria | Study design: systematic reviews and meta-analyses, randomized controlled trials, observational comparative studies |
Relevant outcome measures
The guideline panel considered the functional oral intake of food as experienced by the patient and swallowing-related quality of life as a critical outcome measure for decision making; and functional swallowing ability, the number or percentage of patients who return to a normal diet and aspiration as an important outcome measure for decision making.
A priori, the guideline panel did not define the outcome measures listed above but used the definitions used in the studies.
The guideline panel used the GRADE standard limits of 25% (a relative risk (RR) of <0.80 and >1.25) for dichotomous outcomes and 10% for continuous outcomes as a minimal clinically (patient) important difference. For dichotomous outcomes with very few events, a risk difference of 25% was used as a minimal clinically (patient) important difference.
Search and select (Methods)
A systematic literature search was performed by a medical information specialist using the following bibliographic databases: Embase.com and Ovid/Medline. Both databases were searched from 2015 to April 3rd, 2025 for systematic reviews, RCTs and observational studies. Systematic searches were completed using a combination of controlled vocabulary/subject headings (e.g., Emtree-terms, MeSH) wherever they were available and natural language keywords. The overall search strategy was derived from four primary search concepts: (1) dysphagia; (2) biofeedback; (3) electromyography; and (4) modified barium swallow. Duplicates were removed using EndNote software. After deduplication a total of 2380 records were imported for title/abstract screening. Studies were selected based on the criteria described in Table 1. Titles and abstracts were screened using the ASReview software version 1.6.2. The settings TF-IDF and Naïve bayes were used. One study (Martin-Harris, 2015) was used as prior knowledge for inclusion and one study (Moghadam-Kia, 2017) was used as prior knowledge for exclusions.
The first 10% of hits were screened by the guideline development group and the guideline methodologist. The remaining articles were subsequently screened by the guideline methodologist, using the following stopping rule: stop after 200 subsequent exclusions.
Initially, 21 studies were selected based on title and abstract screening, and 292 studies were excluded. After reading the full-text articles, a total of five studies were included, and 16 studies were excluded (see the exclusion table under the tab ‘Evidence tabellen’).
Among these five studies were three RCTs (Alyanak, 2025; Benfield, 2023; Nordio, 2022) and two systematic reviews (SR) (Battel, 2021; Benfield, 2019). From the SR of Battel, one relevant study was included (Manor, 2013). From the SR of Benfield, one relevant study was included (Denk, 1997). The studies by Li (2016) and McCullough (2012 and 2013) from the latter SR were not included, as they did not have a control group in a comparative study design. Moreover, the study by Huimin (2015) from the SR by Benfield was not included, as no outcome measures relevant for this module were reported and the full-text of the article is in Chinese. This resulted in a total of five studies to be included in the analysis of the literature.
The included studies are described separately per disease category in the results section. These categories comprise stroke patients, patients with Parkinson’s Disease, and patients with head and neck cancer (HNC).
Referenties
- Alyanak B, İnanır M, Sade SI, Kablanoğlu S. Efficacy of Game-Based EMG-Biofeedback Therapy in Post-Stroke Dysphagia: A Randomized Controlled Trial. Dysphagia. 2025 Mar 5. doi: 10.1007/s00455-025-10819-1. Epub ahead of print. PMID: 40042633.
- Aoki, Y., Kabuto, S., Ozeki, Y., Tanaka, T., & Ota, K. (2015). The effect of tongue pressure strengthening exercise for dysphagic patients. Japanese Journal of Comprehensive Rehabilitation Science, 6, 129-136.
- Archer SK, Smith CH, Newham DJ. Surface Electromyographic Biofeedback and the Effortful Swallow Exercise for Stroke-Related Dysphagia and in Healthy Ageing. Dysphagia. 2021 Apr;36(2):281-292. doi: 10.1007/s00455-020-10129-8. Epub 2020 May 22. PMID: 32445060; PMCID: PMC8004490.
- Battel I, Calvo I, Walshe M. Interventions Involving Biofeedback to Improve Swallowing in People With Parkinson Disease and Dysphagia: A Systematic Review. Arch Phys Med Rehabil. 2021 Feb;102(2):314-322. doi: 10.1016/j.apmr.2020.06.033. Epub 2020 Aug 27. PMID: 32861667.
- Benfield JK, Everton LF, Bath PM, England TJ. Does Therapy With Biofeedback Improve Swallowing in Adults With Dysphagia? A Systematic Review and Meta-Analysis. Arch Phys Med Rehabil. 2019 Mar;100(3):551-561. doi: 10.1016/j.apmr.2018.04.031. Epub 2018 May 30. PMID: 29859178.
- Benfield JK, Hedstrom A, Everton LF, Bath PM, England TJ. Randomized controlled feasibility trial of swallow strength and skill training with surface electromyographic biofeedback in acute stroke patients with dysphagia. J Oral Rehabil. 2023 Jun;50(6):440-451. doi: 10.1111/joor.13437. Epub 2023 Mar 7. PMID: 36810785.
- Denk, D. M., & Kaider, A. (1997). Videoendoscopic biofeedback: a simple method to improve the efficacy of swallowing rehabilitation of patients after head and neck surgery. ORL, 59(2), 100-105.
- Huckabee, M. L., & Pelletier, C. A. (1998). Management of adult neurogenic dysphagia (pp. 93-145). San Diego, CA: Singular Publishing Group.
- Humbert IA, Joel S. Tactile, gustatory, and visual biofeedback stimuli modulate neural substrates of deglutition. Neuroimage. 2012 Jan 16;59(2):1485-90. doi: 10.1016/j.neuroimage.2011.08.022. Epub 2011 Aug 18. PMID: 21872665; PMCID: PMC3229638.
- Logemann, J. A. (1998). The evaluation and treatment of swallowing disorders. Current Opinion in Otolaryngology & Head and Neck Surgery, 6(6), 395-400.
- Manor Y, Mootanah R, Freud D, Giladi N, Cohen JT. Video-assisted swallowing therapy for patients with Parkinson's disease. Parkinsonism Relat Disord. 2013 Feb;19(2):207-11. doi: 10.1016/j.parkreldis.2012.10.004. Epub 2012 Nov 4. PMID: 23131836.
- Martin-Harris B, McFarland D, Hill EG, Strange CB, Focht KL, Wan Z, Blair J, McGrattan K. Respiratory-swallow training in patients with head and neck cancer. Arch Phys Med Rehabil. 2015 May;96(5):885-93. doi: 10.1016/j.apmr.2014.11.022. Epub 2014 Dec 11. PMID: 25498307; PMCID: PMC4410058.
- Moghadam-Kia S, Oddis CV, Sato S, Kuwana M, Aggarwal R. Antimelanoma Differentiation-associated Gene 5 Antibody: Expanding the Clinical Spectrum in North American Patients with Dermatomyositis. J Rheumatol. 2017 Mar;44(3):319-325. doi: 10.3899/jrheum.160682. Epub 2017 Jan 15. PMID: 28089977.
- Nordio S, Arcara G, Berta G, Dellai A, Brisotto C, Koch I, Cazzador D, Aspidistria M, Ventura L, Turolla A, D'Imperio D, Battel I. Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial. Dysphagia. 2022 Oct;37(5):1207-1216. doi: 10.1007/s00455-021-10385-2. Epub 2021 Nov 12. PMID: 34767083.
- Toledo-Rodríguez L, Casanova-Román M, Manzur H, Soto-Fernández P. Effects of Biofeedback on the Rehabilitation of People with Post-stroke Dysphagia: A Systematic Review and Meta-Analysis. Dysphagia. 2025 Oct 14. doi: 10.1007/s00455-025-10900-9. Epub ahead of print. PMID: 41085791.
Evidence tabellen
Risk of Bias table for intervention studies (randomized controlled trials; based on Cochrane risk of bias tool and suggestions by the CLARITY Group at McMaster University)
|
Study reference
|
Was the allocation sequence adequately generated?
Definitely yes Probably yes Probably no Definitely no |
Was the allocation adequately concealed?
Definitely yes Probably yes Probably no Definitely no |
Blinding: Was knowledge of the allocated interventions adequately prevented?
Were patients blinded?
Were healthcare providers blinded?
Were data collectors blinded?
Were outcome assessors blinded?
Were data analysts blinded?
Definitely yes Probably yes Probably no Definitely no |
Was loss to follow-up (missing outcome data) infrequent?
Definitely yes Probably yes Probably no Definitely no |
Are reports of the study free of selective outcome reporting?
Definitely yes Probably yes Probably no Definitely no |
Was the study apparently free of other problems that could put it at a risk of bias?
Definitely yes Probably yes Probably no Definitely no |
Overall risk of bias If applicable/necessary, per outcome measure
LOW Some concerns HIGH
|
|
Alyanak, 2025 |
Probably yes;
Reason: randomization by simple random method through a computer program |
Probably no;
Reason: no information on the concealment of the allocation |
Probably yes;
Reason: double-blind study, with all assessments conducted by a blinded evaluator |
Probably yes;
Reason: only one participant (intervention group) discontinued treatment |
Definitely yes;
Reason: all predefined outcomes were reported |
Probably yes;
Reason: limited sample size, short-term follow-up |
Some concerns
Reason: incomplete reporting of allocation concealment, limited sample size |
|
Benfield, 2023 |
Definitely yes;
Reason: computer generated randomization using minimization for age, swallow function and stroke severity with a 25% random element |
Probably no;
Reason: no information on the concealment of the allocation |
Probably no;
Reason: Clinicians and researchers conducting and analyzing videofluoroscopy and day 90 outcomes were blinded to treatment group; two-week outcome measures were not performed blinded to treatment group |
Probably yes;
Reason: high completion rate and no participants lost to follow-up. Failed sessions were reported |
Definitely yes;
Reason: all predefined outcomes were reported |
Probably no;
Reason: despite the use of minimization, randomization led to an imbalance in baseline stroke severity between groups, probably due to the large random factor of 25% in the small sample size |
Some concerns
Reason: incomplete reporting of allocation concealment, blinding, baseline imbalances |
|
Nordio, 2022 |
Probably yes;
Reason: simple computer-generated randomization with parallel assignment |
Probably yes;
Reason: order was concealed to the enrolling speech pathologists until group assignment |
Probably no;
Reason: single-blind study (participants blinded, therapists not). The otorhinolaryngologist and the speech therapist in charge for the assessments of dysphagia did not know about patients’ allocation |
Probably yes;
Reason: only one dropout (control group). Patients with missed evaluations at specific timepoints (n=3) were included in the analysis |
Definitely yes;
Reason: all predefined outcomes were reported |
Probably yes;
Reason: limited sample size |
Some concerns
Reason: blinding, limited sample size |
|
Manor, 2013 |
Probably no;
Reason: no information on the allocation methods |
Probably no;
Reason: no information on the concealment of the allocation |
Probably yes;
Reason: double blind study (evaluators and participants were unaware of the participants’ group assignment). Speech and language pathologist was not blinded to the type of therapy that each group received |
Probably yes;
Reason: no loss to follow-up reported |
Definitely yes;
Reason: all predefined outcomes were reported |
Probably yes;
Reason: limited sample size |
Some concerns
Reason: blinding and incomplete reporting of allocation concealment |
Risk of Bias table for intervention studies (cohort studies based on risk of bias tool by the CLARITY Group at McMaster University)
|
Author, year |
Selection of participants
Was selection of exposed and non-exposed cohorts drawn from the same population?
|
Exposure
Can we be confident in the assessment of exposure?
|
Outcome of interest
Can we be confident that the outcome of interest was not present at start of study?
|
Confounding-assessment
Can we be confident in the assessment of confounding factors?
|
Confounding-analysis
Did the study match exposed and unexposed for all variables that are associated with the outcome of interest or did the statistical analysis adjust for these confounding variables? |
Assessment of outcome
Can we be confident in the assessment of outcome?
|
Follow up
Was the follow up of cohorts adequate? In particular, was outcome data complete or imputed?
|
Co-interventions
Were co-interventions similar between groups?
|
Overall Risk of bias
|
|
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Definitely yes, probably yes, probably no, definitely no |
Low, Some concerns, High |
|
|
Denk, 1997 |
Probably no;
Reason: no information on the selection of cohorts |
Probably yes;
Reason: the swallowing rehabilitation was personalized according to guidelines |
Not relevant for the specified outcome measures |
Probably yes;
Reason: confounding factors were described (e.g. start of therapy and type of therapy) |
Probably no;
Reason: no adjustments for confounding were described |
Probably yes;
Reason: patients without success of therapy were censored with date of final therapy |
Probably no;
Reason: loss to follow up was not described. Patients without success of therapy were censored with date of final therapy |
Not described |
HIGH
Reason: selection, confounding, loss to follow up unclear |
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Albuquerque LCA, Pernambuco L, da Silva CM, Chateaubriand MM, da Silva HJ. Effects of electromyographic biofeedback as an adjunctive therapy in the treatment of swallowing disorders: a systematic review of the literature. Eur Arch Otorhinolaryngol. 2019 Apr;276(4):927-938. doi: 10.1007/s00405-019-05336-5. Epub 2019 Feb 15. PMID: 30771061. |
Study by Tang (2016) has a wrong comparison (combination therapy) |
|
Aoki, Y., Kabuto, S., Ozeki, Y., Tanaka, T., & Ota, K. (2015). The effect of tongue pressure strengthening exercise for dysphagic patients. Japanese Journal of Comprehensive Rehabilitation Science, 6, 129-136. |
Wrong comparison |
|
Archer SK, Smith CH, Newham DJ. Surface Electromyographic Biofeedback and the Effortful Swallow Exercise for Stroke-Related Dysphagia and in Healthy Ageing. Dysphagia. 2021 Apr;36(2):281-292. doi: 10.1007/s00455-020-10129-8. Epub 2020 May 22. PMID: 32445060; PMCID: PMC8004490. |
Wrong study design (phase 1 study, patients with dysphagia compared to healthy adults) |
|
Azola AM, Greene LR, Taylor-Kamara I, Macrae P, Anderson C, Humbert IA. The Relationship Between Submental Surface Electromyography and Hyo-Laryngeal Kinematic Measures of Mendelsohn Maneuver Duration. J Speech Lang Hear Res. 2015 Dec;58(6):1627-36. doi: 10.1044/2015_JSLHR-S-14-0203. PMID: 26426312; PMCID: PMC4987031. |
Does not meet PICO criteria (healthy adults as population) |
|
Azola AM, Sunday KL, Humbert IA. Kinematic Visual Biofeedback Improves Accuracy of Learning a Swallowing Maneuver and Accuracy of Clinician Cues During Training. Dysphagia. 2017 Feb;32(1):115-122. doi: 10.1007/s00455-016-9749-z. Epub 2016 Sep 28. PMID: 27677733; PMCID: PMC5303684. |
Does not meet PICO criteria (healthy adults as population, and other type of biofeedback as control group) |
|
Gandhi P, Steele CM. Effectiveness of Interventions for Dysphagia in Parkinson Disease: A Systematic Review. Am J Speech Lang Pathol. 2022 Jan 18;31(1):463-485. doi: 10.1044/2021_AJSLP-21-00145. Epub 2021 Dec 10. PMID: 34890260; PMCID: PMC9159671. |
One study included about biofeedback (Athukorala, 2014), but this study has no control group |
|
Hou M, Zhao Y, Zhao L, Yuan X, Liu Z, Li H. Efficacy of game training combined with surface electromyography biofeedback on post-stroke dysphagia. Geriatr Nurs. 2024 Jan-Feb;55:255-262. doi: 10.1016/j.gerinurse.2023.11.019. Epub 2023 Dec 12. PMID: 38091711. |
Wrong comparison (combination therapy) |
|
Huimin Z, Yongchao Y, Jiang R, Li L, Yao W, Weibo S et al. Effect of surface electromyographic biofeedback on the pharyngeal phase activities in patients with dysphagia after stroke. [Chinese]. Chinese Journal of Cerebrovascular Diseases 2015;12(11):572-6. |
Included in the review by Benfield (2019) |
|
Kwong E, Ng KK, Leung MT, Zheng YP. Application of Ultrasound Biofeedback to the Learning of the Mendelsohn Maneuver in Non-dysphagic Adults: A Pilot Study. Dysphagia. 2021 Aug;36(4):650-658. doi: 10.1007/s00455-020-10179-y. Epub 2020 Sep 5. PMID: 32889626. |
Does not meet PICO criteria (no population with dysphagia, and wrong comparison – two types of biofeedback) |
|
Li CM, Wang TG, Lee HY, Wang HP, Hsieh SH, Chou M, Jason Chen JJ. Swallowing Training Combined With Game-Based Biofeedback in Poststroke Dysphagia. PM R. 2016 Aug;8(8):773-9. doi: 10.1016/j.pmrj.2016.01.003. Epub 2016 Jan 11. PMID: 26791426. |
Included in the review by Benfield (2019) |
|
Martin-Harris B, McFarland D, Hill EG, Strange CB, Focht KL, Wan Z, Blair J, McGrattan K. Respiratory-swallow training in patients with head and neck cancer. Arch Phys Med Rehabil. 2015 May;96(5):885-93. doi: 10.1016/j.apmr.2014.11.022. Epub 2014 Dec 11. PMID: 25498307; PMCID: PMC4410058. |
No control group |
|
Meng QN, Zhu Y, Liu SW, Hu B, Chai DJ, Dong CX. Study on the treatment of dysphagia after stroke with electromyographic biofeedback intensive training. World J Clin Cases. 2024 Jul 6;12(19):3725-3733. doi: 10.12998/wjcc.v12.i19.3725. PMID: 38994319; PMCID: PMC11235442. |
Wrong study design |
|
Peng CH, Pauloski BR. Ultrasonography as Biofeedback to Increase Muscle Activation During the Mendelsohn Maneuver in Healthy Adults. Dysphagia. 2023 Aug;38(4):1156-1168. doi: 10.1007/s00455-022-10542-1. Epub 2022 Nov 23. PMID: 36418494. |
Does not meet PICO criteria (healthy adults as population) |
|
Şahin M, Ogut MF, Vardar R, Kirazli T, Engin EZ, Bor S. Novel esophageal speech therapy method in total laryngectomized patients: biofeedback by intraesophageal impedance. Dis Esophagus. 2016 Jan;29(1):41-7. doi: 10.1111/dote.12297. Epub 2014 Dec 17. PMID: 25515163. |
Wrong goal: improving speech instead of improving swallowing ability |
|
Tang Y, Lin X, Lin XJ, Zheng W, Zheng ZK, Lin ZM, Chen JH. Therapeutic efficacy of neuromuscular electrical stimulation and electromyographic biofeedback on Alzheimer's disease patients with dysphagia. Medicine (Baltimore). 2017 Sep;96(36):e8008. doi: 10.1097/MD.0000000000008008. PMID: 28885365; PMCID: PMC6392978. |
Wrong comparison (combination therapy) |
|
Vose AK, Marcus A, Humbert I. Kinematic Visual Biofeedback Improves Accuracy of Swallowing Maneuver Training and Accuracy of Clinician Cues During Training in Stroke Patients with Dysphagia. PM R. 2019 Nov;11(11):1159-1169. doi: 10.1002/pmrj.12093. Epub 2019 Apr 22. PMID: 30701691. |
One study included about biofeedback (Athukorala, 2014), but this study has no control group |
|
Wang, W., Jia, Y., Cai, H., Wang, W., & Sun, C. (2020). Functional patch combined with surface electromyographic biofeedback for post-stroke dysphagia. Chinese Journal of Tissue Engineering Research, 24(29), 4697. |
Wrong goal: improving speech instead of improving swallowing ability |
Verantwoording
Beoordelingsdatum en geldigheid
Publicatiedatum : 12-03-2026
Beoordeeld op geldigheid : 12-03-2026
Algemene gegevens
De ontwikkeling van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2023 een multidisciplinaire cluster ingesteld. Dit cluster bestaat uit vertegenwoordigers van alle relevante organisaties die betrekking hebben op de zorg voor patiënten met stem- en slikklachten.
Het cluster Laryngologie bestaat uit meerdere richtlijnen, zie hier voor de actuele clusterindeling. De stuurgroep bewaakt het proces van modulair onderhoud binnen het cluster. De expertisegroepsleden worden indien nodig gevraagd om hun expertise in te zetten voor een specifieke richtlijnmodule. Het cluster Laryngologie bestaat uit de volgende personen:
Clusterstuurgroep
- Dhr. dr. R.N.P.M. (Rico) Rinkel
- Mevr. drs. M.M.G.E.C. (Margaret) de Jong
- Mevr. dr. E.M.J.M. (Emke) van den Broek
- Dhr. dr. D.A. (Derrek) Heuveling
- Mevr. drs. M.J. (Marieke) Hazewinkel
Clusterexpertisegroep
- Dhr. dr. M.R.A. (Michel) van Hooren
- Mevr. drs. M. (Maya) Kemps
- Mevr. C. (Carine) Roos
- Mevr. Y.G.J. (Yvonne) Hendrick
- Mevr. drs. M.M. (Masja) van het Hoofd
- Mevr. P.S. (Petra) Verdouw
Met ondersteuning van
- Mevr. drs. B.L. (Babette) Gal-de Geest, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- Mevr. dr. A.C. (Anniek) van ‘t Veld, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- Mevr. E. (Esther) van der Bijl, informatiespecialist, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle clusterstuurgroepleden en actief betrokken expertisegroepsleden (fungerend als schrijver en/of meelezer bij tenminste één van de geprioriteerde richtlijnmodules) hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een richtlijnmodule worden wijzigingen in belangen aan de projectleider doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase. Een overzicht van de belangen van de clusterleden en betrokken expertisegroepsleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten.
Clusterstuurgroep
Tabel Gemelde (neven)functies en belangen stuurgroep
|
Clusterlid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Rico Rinkel (voorzitter) |
KNO-arts laryngoloog Amsterdam UMC |
Plv Regionaal Tuchtcollege |
Geen |
Geen restricties |
|
Emke van den Broek |
Laryngoloog UMC Utrecht |
Voorzitter kerngroep laryngologie, lid werkgroep chronische hoest, MAR larynxpapillomatose, bezoekend docent/KNO-arts opleiding logopedie Hogeschool Utrecht |
Geen |
Geen restricties |
|
Marieke Hazewinkel |
Radioloog bij MRON (Maatschap Radiologie Oost Nederland)
|
MRI trekker radioloog MST (Medisch Spectrum Twente) |
Geen |
Geen restricties |
|
Derrek Heuveling
|
KNO-arts Meander Medisch Centrum |
Lid Kerngroep Laryngologie Lid werkgroep Standpuntnota benigne speekselklierpathologie |
Geen |
Geen restricties |
|
Margaret de Jong
|
HumanCapitalCare arbodienst verlener
|
Lid klachtencommissie Sexuele Intimidatie en Geweld sociale werkvoorziening; onkostenvergoeding per zitting |
Geen |
Geen restricties |
Clusterexpertisegroep
Tabel Gemelde (neven)functies en belangen expertisegroep
|
Clusterlid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Michel van Hooren |
KNO-arts te Maasziekenhuis Pantein |
PhD candidate te UM: dysfonie en OD bij M. Parkinson |
Geen |
Geen restricties |
|
Maya Kemps
|
Klinisch geriater in Slingeland Ziekenhuis |
Geen |
Geen |
Geen restricties |
|
Carine Roos |
Logopedist slikteam, De Hoogstraat Revalidatie |
Axon docent slikproblematiek |
Geen |
Geen restricties |
|
Yvonne Hendrick |
Logopedist slikteam, De Hoogstraat Revalidatie |
Geen |
Geen |
Geen restricties |
|
Masja van het Hoofd |
Beleidsmedewerker Parkinson Vereniging |
Redacteur bij het parkinsonplatform in oprichting (informatieplatform vergelijkbaar met bijv ms.nl, diabetes.nl) |
Geen |
Geen restricties |
|
Petra Verdouw |
Patiëntenvereniging |
Geen |
Geen |
Geen restricties |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door deelname van relevante patiëntenorganisaties aan de need-for-update en/of prioritering. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijnmodule is tevens ter commentaar voorgelegd aan alle relevante patiëntenorganisaties in de stuur- en expertisegroep (zie ‘Samenstelling cluster’ onder ‘Verantwoording’). De eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijnmodule is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase).
| Module |
Uitkomst raming |
Toelichting |
|
Biofeedback bij dyfagie |
Geen financiële gevolgen |
Uitkomst 2 |
Werkwijze
AGREE
Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 3.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).
Need-for-update, prioritering en uitgangsvragen
Tijdens de need-for-update fase (november, 2023) inventariseerde het cluster de geldigheid van de richtlijnmodules binnen het cluster. Naast de partijen die deelnemen aan de stuur- en expertisegroep zijn hier ook andere stakeholders voor benaderd. Per richtlijnmodule is aangegeven of deze geldig is, herzien moet worden, kan vervallen of moet worden samengevoegd. Ook was er de mogelijkheid om nieuwe onderwerpen aan te dragen die aansluiten bij één (of meerdere) richtlijn(en) behorend tot het cluster. De richtlijnmodules waarbij door één of meerdere partijen werd aangegeven herzien te worden, werden doorgezet naar de prioriteringsronde. Ook suggesties voor nieuwe richtlijnmodules werden doorgezet naar de prioriteringsronde. Afgevaardigden vanuit de partijen in de stuur- en expertisegroep werden gevraagd om te prioriteren (zie ‘Samenstelling cluster’ onder ‘Verantwoording’). Hiervoor werd de RE-weighted Priority-Setting (REPS) – tool gebruikt. De uitkomsten (ranklijst) werd gebruikt als uitgangspunt voor de discussie. Voor de geprioriteerde richtlijnmodules zijn door de het cluster concept-uitgangsvragen herzien of opgesteld en definitief vastgesteld.
Uitkomstmaten
Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde het cluster welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. Het cluster waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde het cluster tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.
Methode literatuursamenvatting
Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur is te vinden onder ‘Zoeken en selecteren’. Indien mogelijk werd de data uit verschillende studies gepoold in een random-effects model. Review Manager 5.4 werd indien mogelijk gebruikt voor de statistische analyses. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.
Beoordelen van de kracht van het wetenschappelijke bewijs
De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding). GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).
Tabel Gradaties voor de kwaliteit van wetenschappelijk bewijs
|
GRADE |
Definitie |
|
Hoog |
|
|
Redelijk |
|
|
Laag |
|
|
Zeer laag |
|
Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in een richtlijnmodule volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).
Overwegingen (van bewijs naar aanbeveling)
Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE methodiek.
Formuleren van aanbevelingen
De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door het cluster wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. Het cluster heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.
In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.
Tabel Sterkte van de aanbevelingen
|
Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers |
||
|
|
Sterke aanbeveling |
Zwakke (conditionele) aanbeveling |
|
Voor patiënten |
De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet. |
Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. |
|
Voor behandelaars |
De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen. |
Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren. |
|
Voor beleidsmakers |
De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid. |
Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. |
Organisatie van zorg
Bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen. Meer algemene, overkoepelende, of bijkomende aspecten van de organisatie van zorg worden behandeld in de richtlijnmodule Organisatie van zorg.
Commentaar- en autorisatiefase
De conceptrichtlijnmodule werd voorgelegd aan alle partijen die benaderd zijn voor de need-for-update fase. De commentaren werden verzameld en besproken met het cluster. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door het cluster. De definitieve richtlijnmodule werd ter autorisatie of goedkeuring voorgelegd aan de partijen die beschreven staan bij ‘Initiatief en autorisatie’ onder ‘Verantwoording’.
Literatuur
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open. 2017 Nov 16;7(11):e018593. doi: 10.1136/bmjopen-2017-018593. PubMed PMID: 29150475; PubMed Central PMCID: PMC5701989.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016. doi: 10.1136/bmj.i2016. PubMed PMID: 27353417.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089. doi: 10.1136/bmj.i2089. PubMed PMID: 27365494.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42. doi: 10.1503/cmaj.090449. Epub 2010 Jul 5. Review. PubMed PMID: 20603348; PubMed Central PMCID: PMC3001530.
Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13. doi: 10.1016/j.jclinepi.2017.05.006. Epub 2017 May 18. PubMed PMID: 28529184; PubMed Central PMCID: PMC6542664.
Medisch Specialistische Richtlijnen 3.0 (2023). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html.
Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Zoekverantwoording
Algemene informatie
|
Cluster/richtlijn: Laryngologie - Module biofeedback |
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Uitgangsvraag/modules: Wat is de meerwaarde van biofeedback (oppervlakte-EMG) in de behandeling van patiënten met dysfagie? |
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Database(s): Embase.com, Ovid/Medline |
Datum: 3 april 2025 |
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Periode: vanaf 2015 |
Talen: geen restrictie |
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Literatuurspecialist: Esther van der Bijl |
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BMI-zoekblokken: voor verschillende opdrachten wordt (deels) gebruik gemaakt van de zoekblokken van BMI-Online https://blocks.bmi-online.nl/ Deduplication: voor het ontdubbelen is gebruik gemaakt van http://dedupendnote.nl/ |
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Toelichting:
Er werden geen sleutelartikelen aangeleverd voor deze search.
In overleg wordt het concept ‘modified barium swallow’ ook meegenomen in de search, omdat een indirecte vorm van biofeedback is.
Vanwege de grote opbrengst wordt de search in AS Review uitgevoerd. |
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Te gebruiken voor richtlijntekst: A systematic literature search was performed by a medical information specialist using the following bibliographic databases: Embase.com and Ovid/Medline. Both databases were searched from 2015 to the 3rd of April 2025 for systematic reviews, RCTs and observational studies. Systematic searches were completed using a combination of controlled vocabulary/subject headings (e.g., Emtree-terms, MeSH) wherever they were available and natural language keywords. The overall search strategy was derived from four primary search concepts: (1) dysphagia; (2) biofeedback; (3) electromyography; (4) modified barium swallow. Duplicates were removed using EndNote software. After deduplication a total of 2380 records were imported for title/abstract screening. |
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Zoekopbrengst - 3 april 2025
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EMBASE |
OVID/MEDLINE |
Ontdubbeld |
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SR |
229 |
139 |
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RCT |
520 |
315 |
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Observationele studies |
1254 |
1102 |
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Totaal |
2003 |
1556 |
2380* |
* voor AS Review
Zoekstrategie - 3 april 2025
Embase.com
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No. |
Query |
Results |
|
#1 |
'dysphagia'/exp OR 'oropharyngeal dysphagia'/exp OR 'oropharynx'/exp OR 'regurgitation'/exp OR 'swallowing'/exp OR 'cricopharyngeal dysfunction'/exp OR 'pharyngeal muscle'/exp OR (((deglutit* OR swallow*) NEAR/3 (disorder* OR problem* OR dysfunction* OR disturbanc* OR complication* OR disease* OR issue* OR condition)):ti,ab,kw) OR aphagopraxia:ti,ab,kw OR dysphag*:ti,ab,kw OR disphag*:ti,ab,kw OR dysfag*:ti,ab,kw OR disfag*:ti,ab,kw OR regurgitat*:ti,ab,kw OR oropharyn*:ti,ab,kw OR orofaryn*:ti,ab,kw OR cricopharyn*:ti,ab,kw OR cricofaryn*:ti,ab,kw OR pharyn*:ti,ab,kw OR faryn*:ti,ab,kw |
336689 |
|
#2 |
'biofeedback'/exp OR 'electromyography'/exp OR 'modified barium swallow'/exp OR 'videofluoroscopic swallowing study'/exp OR 'videofluoroscopic swallowing'/exp OR 'bio feed back*':ti,ab,kw OR 'bio feedback*':ti,ab,kw OR 'biofeed back*':ti,ab,kw OR 'biofeedback*':ti,ab,kw OR 'myobiofeedback*':ti,ab,kw OR 'myofeedback*':ti,ab,kw OR 'psychophysiological feedback*':ti,ab,kw OR 'electric* myograph*':ti,ab,kw OR 'electro* myograph*':ti,ab,kw OR electromyograph*:ti,ab,kw OR (((barium OR videofluoroscop* OR fluoroscop*) NEAR/3 swallow*):ti,ab,kw) OR vfss:ti,ab,kw |
153837 |
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#3 |
#1 AND #2 |
10886 |
|
#4 |
#3 AND [2015-2025]/py NOT ('conference abstract'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) |
3519 |
|
#5 |
'meta analysis'/exp OR 'systematic review'/exp OR 'scoping review'/exp OR 'rapid review'/exp OR 'umbrella review'/exp OR 'cochrane database of systematic reviews'/jt OR 'network meta-analysis'/exp OR 'networkmeta analy*':ti,ab,kw OR 'networkmetaanaly*':ti,ab,kw OR metaanaly*:ti,ab,kw OR 'meta analy*':ti,ab,kw OR metanaly*:ti,ab,kw OR prisma:ti,ab,kw OR prospero:ti,ab,kw OR metaanali*:ti,ab,kw OR 'meta anali*':ti,ab,kw OR metanali*:ti,ab,kw OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab,kw) OR (((structured OR systemic*) NEAR/3 (review* OR overview* OR synth*) NEAR/3 literature):ti,ab,kw) OR ((systemic* NEAR/1 review*):ti,ab,kw) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab,kw) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab,kw) OR (((literature NEAR/3 (review* OR overview*)):ti,ab,kw) AND (search*:ti,ab,kw OR database*:ti,ab,kw OR 'data base*':ti,ab,kw)) OR (('data extraction*':ti,ab,kw OR 'data source*':ti,ab,kw) AND ('study selection*':ti,ab,kw OR 'studies selection*':ti,ab,kw)) OR ('search strateg*':ti,ab,kw AND 'selection criteria*':ti,ab,kw) OR ('data source*':ti,ab,kw AND 'data synth*':ti,ab,kw) OR medline*:ti,ab,kw OR pubmed*:ti,ab,kw OR 'pub med*':ti,ab,kw OR embase:ti,ab,kw OR cochrane*:ti,ab,kw OR (((critical* OR rapid*) NEAR/2 (review* OR overview* OR synth*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synth*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynth*:ti,ab,kw OR 'meta synth*':ti,ab,kw OR 'review* of review*':ti,ab,kw |
1097022 |
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#6 |
'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti |
4244936 |
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#7 |
'major clinical study'/de OR 'clinical study'/de OR 'family study'/de OR 'longitudinal study'/de OR 'retrospective study'/de OR 'prospective study'/de OR 'cohort analysis'/de OR 'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR ((cohort NEAR/1 (study OR studies)):ab,ti) OR (('case control' NEAR/1 (study OR studies)):ab,ti) OR (('follow up' NEAR/1 (study OR studies)):ab,ti) OR (observational NEAR/1 (study OR studies)) OR ((epidemiologic NEAR/1 (study OR studies)):ab,ti) OR (('cross sectional' NEAR/1 (study OR studies)):ab,ti) OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab))) |
17970413 |
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#8 |
#4 AND #5 - SR |
229 |
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#9 |
#4 AND #6 NOT #8 - RCT |
520 |
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#10 |
#4 AND #7 NOT (#8 OR #9) - Observationeel |
1254 |
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#11 |
#8 OR #9 OR #10 - Totaal |
2003 |
Ovid/Medline
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# |
Searches |
Results |
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1 |
exp Deglutition Disorders/ or exp Deglutition/ or exp Oropharynx/ or deglutit*.ti,ab,kf. or swallow*.ti,ab,kf. or aphagopraxia.ti,ab,kf. or dysphag*.ti,ab,kf. or disphag*.ti,ab,kf. or dysfag*.ti,ab,kf. or disfag*.ti,ab,kf. or regurgitat*.ti,ab,kf. or oropharyn*.ti,ab,kf. or orofaryn*.ti,ab,kf. or cricopharyn*.ti,ab,kf. or cricofaryn*.ti,ab,kf. or pharyn*.ti,ab,kf. or faryn*.ti,ab,kf. |
242369 |
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2 |
exp Biofeedback, Psychology/ or exp Electromyography/ or bio feed back*.ti,ab,kf. or bio feedback*.ti,ab,kf. or biofeed back*.ti,ab,kf. or biofeedback*.ti,ab,kf. or myobiofeedback*.ti,ab,kf. or myofeedback*.ti,ab,kf. or psychophysiological feedback*.ti,ab,kf. or electric* myograph*.ti,ab,kf. or electro* myograph*.ti,ab,kf. or electromyograph*.ti,ab,kf. or ((barium or videofluoroscop* or fluoroscop*) adj3 swallow*).ti,ab,kf. or vfss.ti,ab,kf. |
126480 |
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3 |
1 and 2 |
7097 |
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4 |
limit 3 to yr="2015 -Current" |
2942 |
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5 |
4 not (comment/ or editorial/ or letter/) not ((exp animals/ or exp models, animal/) not humans/) |
2810 |
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6 |
exp Meta-Analysis/ or exp Network Meta-Analysis/ or exp Systematic Review/ or (networkmeta analy* or networkmetaanaly* or metaanaly* or meta analy* or metanaly* or prisma or prospero or metaanali* or meta anali* or metanali*).ti,ab,kf. or ((systemati* or scoping or umbrella or structured literature) adj3 (review* or overview*)).ti,ab,kf. or ((structured or systemic*) adj3 (review* or overview* or synth*) adj3 literature).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 (review* or overview*)) and (search* or database* or data base*)).ti,ab,kf. or ((data extraction* or data source*) and (study selection* or studies selection*)).ti,ab,kf. or (search strateg* and selection criteria*).ti,ab,kf. or (data source* and data synth*).ti,ab,kf. or (medline* or pubmed* or pub med* or embase or cochrane*).ti,ab,kf. or cochrane.jw. or ((critical* or rapid*) adj2 (review* or overview* or synth*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synth*)) and (search* or database* or data base*)).ab. or metasynth*.ti,ab,kf. or meta synth*.ti,ab,kf. |
816306 |
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7 |
exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw. |
2863803 |
|
8 |
Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or exp cohort studies/ or epidemiologic studies/ or ((multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.)) or Case control.tw. or cohort.tw. or Cohort analy$.tw. or (Follow up adj (study or studies)).tw. or (observational adj (study or studies)).tw. or Longitudinal.tw. or Retrospective*.tw. or prospective*.tw. or consecutive*.tw. or Cross sectional.tw. or Cross-sectional studies/ or historically controlled study/ or interrupted time series analysis/ |
7967387 |
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9 |
5 and 6 - SR |
139 |
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10 |
(5 and 7) not 9 - RCT |
315 |
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11 |
(5 and 8) not (9 or 10) - Observationeel |
1102 |
|
12 |
9 or 10 or 11 - Totaal |
1556 |