Duncan et al.

Systematic Reviews (2019) 8:283

https://doi.org/10.1186/s13643-019-1196-0

PROTOCOL Open Access

Interventions for oropharyngeal dysphagia

in acute and critical care: a protocol for a
systematic review and meta-analysis
Sallyanne Duncan1* , Jennifer Mc Gaughey2, Richard Fallis3, Daniel F. McAuley1, Margaret Walshe4 and
Bronagh Blackwood1

Abstract
Background: Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care,
affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill
patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia
include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-
admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke
populations. While intervention studies in critical care have been emerging since 2015, they are limited and so
there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future
clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between
dysphagia interventions and clinically important patient outcomes in acute and critical care settings.
Methods: We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from
inception to the present. We will include studies conducted with adults in acute care settings such as acute
hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised
controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or
another intervention. The main outcomes that will be collected include length of time taken to return to oral
intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of
life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated
with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess
articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate.
Discussion: No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia
interventions in acute and critical care. Results of the proposed systematic review will inform practice and the
design of future clinical trials.
Systematic review registration: PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/)
Keywords: Dysphagia, Deglutition disorders, Acute care, Acute hospital, Critical care, Intensive care, Swallow
interventions, Swallow therapy

* Correspondence: sduncan10@qub.ac.uk
1
Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine,
Dentistry and Biomedical Sciences, Queen’s University, Belfast, 97 Lisburn
Road, Belfast BT9 7BL, UK
Full list of author information is available at the end of the article

© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Duncan et al. Systematic Reviews (2019) 8:283 Page 2 of 8

Background direct rehabilitative methods include peripheral sensory

Description of the condition stimulation such as thermal tactile stimulation, electro-
In acute and critical care settings, a patient’s medical, therapies and non-invasive brain stimulation.
neurological, respiratory and cognitive status can alter To date, the evidence base for such dysphagia inter-
from day to day thus impacting on swallow function. ventions in acute care settings has tended to focus pre-
This provides a challenge for professionals seeking to in- dominantly on acute stroke patients but some studies
tensively remediate swallowing difficulties. Following also target brain injury, head and neck cancer and frail
acute stroke, dysphagia is in part caused by a loss of elderly populations [12–15]. Acute stroke populations
functional connectivity within the neural swallowing net- also dominate the evidence base for dysphagia treatment
work. However, neuroplasticity results in the undamaged in intensive care. Pharyngeal electrical stimulation has
hemisphere compensating for lost functions from lesions been tested in this population while tracheostomised, by
in the affected hemisphere, with more than half of these placing a small catheter that contains electrodes in the
patients recovering swallow function in the first 3 weeks pharynx to allow stimulation of nearby structures. Posi-
post-stroke [1]. Other individuals with dysphagia who tive outcomes for length of time to decannulation were
may present in these settings include patients with trau- reported but no differences noted in outcomes address-
matic injuries to brain or cervical spine, patients with ing length of stay or return to oral intake [16]. These pa-
progressive symptoms in line with their neurodegenera- tients present with complex swallowing difficulties; the
tive or neuromuscular condition necessitating an inten- central swallowing network is disrupted due to the brain
sive care or acute care stay and frail elderly patients lesion, but as a result of intensive care treatment and its
hospitalised for acute illness and presenting with sarco- complications, damage to different peripheral structures
penia, a loss of skeletal muscle mass and function due to is also possible.
aging [2–4]. Dysphagia is the consequence of such loss Moreover, any evidence for the efficacy and effective-
of function in the skeletal muscles of swallowing. ness of dysphagia interventions in non-stroke intensive
Within critical care settings, skeletal muscle dysfunc- care populations is limited at present. Electrotherapies
tion is common particularly with patients who have been are the mainstay treatment being used in research. How-
intubated and mechanically ventilated for prolonged pe- ever, the high cost associated with some of these therap-
riods, have a tracheostomy or have intensive care ac- ies preclude them from use in routine clinical practice.
quired weakness. During intubation, the oral, pharyngeal An unpublished 2018 clinical trial in an acute respiratory
and laryngeal muscles of swallowing are immobilised. distress syndrome population enrolled patients that were
This has been shown to alter the mechanoreceptors and predicted to require more than 4 days intubation [17].
chemoreceptors of pharyngeal and laryngeal mucosae, They commenced neuromuscular electrical stimulation
while also causing muscle atrophy and loss of proprio- shortly after being intubated, and treatment continued
ception [5, 6]. Reduced pharyngeal and laryngeal sensa- until patients were extubated. The findings from this
tion places patients at higher risk of silently aspirating trial are forthcoming. Given that critically ill patients are
food and fluids into the upper airway (i.e. no cough weak with vulnerable respiratory systems, a passive treat-
response when aspiration occurs). These patients present ment like electrotherapy has been found to be both de-
with tongue weakness and take longer to swallow when liverable and safe in this setting. However, there are
compared with age matched controls, suggesting other interventions that could plausibly be tested in in-
swallow-related muscle weakness [7, 8]. Recent studies tensive care.
have found skeletal muscle wasting and weakness occur One such intervention is respiratory muscle strength
early and frequently during mechanical ventilation and training. Mechanical ventilation rapidly causes atrophy
after the onset of critical illness [9–11]. of the diaphragm muscles, increasing the risk of weaning
failure. Strength training the inspiratory muscles has
Description of the intervention emerged as a possible treatment for these patients, with
Dysphagia interventions involve approaches that may be studies reporting improved maximal inspiratory pressure
compensatory or rehabilitative in nature. Compensatory and improved weaning outcomes post-treatment [18,
approaches aim to alter the flow of a food or liquid bolus 19]. The expiratory muscles, including the submental
by modifying their consistency or by repositioning the muscles used during swallowing, also atrophy during in-
head, neck or body before the onset of swallowing, a tubation and mechanical ventilation. Strength training
temporary measure to facilitate safer eating and drink- these muscles was primarily done by physiotherapy to
ing. Direct swallowing rehabilitation involves swallowing improve cough strength in respiratory patients. How-
exercises that focus on muscle strength, resistance train- ever, the last decade has seen this training technique
ing or skill training such as tongue or respiratory muscle being used as a dysphagia intervention for patients with
strength training and swallowing manouevres. Other Parkinson’s disease or stroke [20, 21]. Increased
Duncan et al. Systematic Reviews (2019) 8:283 Page 3 of 8

musculature force activation in the expiratory muscles inform future clinical trials of dysphagia
results in improvements in swallow biomechanics, cough interventions in intensive care.
strength and aspiration rates.
Methods
How the intervention might work Types of studies
Swallowing difficulties can arise from both disruptions We will consider intervention studies using randomised
to the central neural swallowing network, as seen in and quasi-randomised clinical trial methodology only.
acute stroke patients, or due to other mechanisms in in- All clinical trials published from inception in any lan-
tensive care causing sensory and motor impairments, guage will be included in this review. Relevant rando-
such as critical illness polyneuropathy. The principle of mised controlled trials are classified as all trials that
neuroplasticity indicates that if a neural substrate is not involve at least one group receiving a specific dysphagia
biologically active, its function can degrade. In swallow- intervention aimed at improving or eliminating dysphagia
ing, disuse of this mechanism may diminish its cortical and one group receiving a traditional dysphagia interven-
representation and pose a threat to functional recovery tion, a placebo or usual care. Treatments administered
in the long term [22]. The aim of direct swallowing re- had to be allocated by a random process. We will classify
habilitation is to accelerate this process of plasticity. as quasi-randomised clinical trials all trials of similar de-
Studies have shown that pushing any muscular system sign where the method of allocation to the treatment
in an intense and persistent way will bring about group is known but is not considered strictly random (i.e.
changes in neural innervation and patterns of movement alternate allocation by day or date of birth or medical rec-
[23]. It is also thought that some dysphagia interventions ord number). We will only include cross-over trials in the
may improve swallowing by enhancing the sensory drive review if the data from the first intervention period were
to the brain and causing increased activity in motor reported and we will only use this data.
swallowing areas [24].
Types of participants
We will include only studies conducted in acute care
Why it is important to do this review? settings (i.e. studies carried out in any acute hospital
The management options for patients with dysphagia in ward or unit including acute medical, respiratory, surgi-
acute care and critical care are limited. This is due his- cal, neurological or critical care/intensive care units
torically to an under recognition of dysphagia and its as- within an acute hospital or tertiary hospital setting).
sociation with increased morbidity and mortality in Adult participants, 18 years or older of any sex, ethni-
these settings. Studies are now emerging in these set- city, stage of illness and degree of medical, respiratory,
tings but are limited, with small sample sizes used and neurological or surgical severity will be included. We
variable results when similar outcomes are addressed will impose no limitations regarding the length of intub-
[13–18, 25]. There is still a lot to learn about interven- ation and ventilation time or the presence of a tracheos-
tion type, mode of delivery and optimal treatment inten- tomy tube in critical care study participants.
sity and timing to ensure effectiveness in intensive care
settings. Often, limited information is provided in stud- Exclusion criteria
ies on protocol adherence and how acceptable an inter- We will exclude cluster-randomised controlled trials as we
vention is for participants and trainers, and so, it is are not considering the group effect of a dysphagia inter-
difficult to know if interventions are genuinely ineffect- vention. We will exclude treatment studies carried out in
ive or have failed to be fully implemented. To date, no outpatient settings, rehabilitation units, residential care
systematic review has looked at both the effectiveness of homes (i.e. nursing homes) or long-term care facilities.
dysphagia interventions in acute and critical care or de-
scribed in detail the key components of interventions Types of interventions
tested in these settings to inform future clinical trials in Interventions
intensive care. We will consider any dysphagia intervention delivered
alone or in combination with a traditional swallowing re-
Objectives habilitation programme (usual care) in included studies.
Such interventions may include:
1. To determine the effectiveness of dysphagia
interventions in improving oral intake and reducing  Electrotherapeutic interventions
aspiration for adults in acute and critical care.  Respiratory muscle training
2. To identify key intervention components such as  Sensory-motor interventions such as thermal-tactile
delivery, dose, intensity, timing and fidelity to stimulation
Duncan et al. Systematic Reviews (2019) 8:283 Page 4 of 8

 Lingual strength training function or physiological parameter as per

 Swallow skill training using biofeedback instrumental assessment.
 Non-invasive brain stimulation 5. Incidence of pneumonia as measured by the
 An isolated swallowing manouevre or swallowing presence of a new or worsening chest X-ray or
exercise computed tomography (CT) change consistent with
pneumonia in the context of at least two of the fol-
Comparisons lowing: temperature < 35 °C or > 38 °C; a white cell
The comparison group in these studies will receive a count of < 4 × 109/L or > 11 × 109/L; or purulent
traditional swallowing rehabilitation programme (some- tracheal secretions.
times termed ‘usual care’ in studies) or placebo interven- 6. Economic and resource costs as measured by
tion. Traditional rehabilitation or usual care in duration of hospital stay, number of staff and staff
dysphagia management can vary widely across studies, training cost required to deliver the intervention.
ranging from diet/fluid modification alone to a combin- 7. Quality of life as measured by validated dysphagia
ation of this approach with swallowing manouevres, scales (e.g. Swallowing Quality of Life Scale [31] or
swallowing exercises, head and neck postures or envir- Dysphagia Handicap Index [32]) at relevant short-
onmental modifications. A placebo in dysphagia studies and long-term time points as reported by the
generally refers to sham stimulation in neurostimulation authors.
studies or use of a sham training device in respiratory
muscle strength training studies. Search strategy
Electronic searches
We will search the following databases for relevant stud-
Types of outcome measures ies from inception onwards with no language restric-
Primary outcomes tions: CENTRAL, MEDLINE, EMBASE, Web of Science
and CINAHL. We will also search the following trial
1. Time taken in days from onset of dysphagia registers: ClinicalTrials.gov (www.clinicaltrials.gov) and
intervention for participants to return to a the World Health Organisation International Clinical
functional oral diet as determined by an appropriate Trials Registry Platform (www.who.int/ictrp/en/). If we
decision tool such as the Functional Oral Intake fail to retrieve any relevant trials from either of these
Scale [26] or similar rating scale. registries, we will search additional registries [i.e.
2. Change in incidence of aspiration as rated by ISRCTN and UKCTG registries]. We will not impose lan-
videofluoroscopy or endoscopic evaluation of guage or other restrictions. Any non-English publications
swallowing using Penetration Aspiration Scale [27] will be translated by accessing translation services avail-
at relevant short- and long-term time points, as re- able from Queen’s University Belfast Medical Library or
ported by the authors. accessing staff or doctoral/postdoctoral research students
who are native speakers in the School of Medicine, Den-
Secondary outcomes tistry and Biomedical Sciences at Queen’s University.
Key search terms (both MESH and keyword terms)
1. Change in secretion severity as rated by endoscopic will include the following: dysphagia, deglutition disor-
evaluation using a validated scale such as the New ders, acute care, acute hospital, critical care, critical ill-
Zealand Secretion Scale [28] at relevant short- and ness, swallowing rehabilitation, swallowing therapy. Our
long-term time points, as reported by the authors. MEDLINE search strategy (Additional file 1) will be
2. Change in residue severity as rated by adapted for searches in the other databases to be in-
videofluoroscopy or endoscopy using a validated cluded in this review.
scale such as the Yale Residue Scale [29] at relevant
short- and long-term time points, as reported by Data collection and analysis
the authors. Selection of studies
3. Nutritional status as measured by a validated Citations will be stored using the Covidence software
nutritional screening tool such as the Malnutrition (www.covidence.org) and duplicates removed. Studies
Universal Screening Tool [30] or similar as will be screened initially according to the title and ab-
described by authors, to assess potential negative stract by two authors independently, and those not
consequences of dysphagia (i.e. malnutrition, meeting the criteria will be discarded. Disagreement will
dehydration, weight loss). be resolved by discussion and referral to a third author if
4. Adverse events associated with intervention such as necessary. After this initial stage, the full text of all
patient discomfort, deterioration in swallow remaining studies will be reviewed by two authors
Duncan et al. Systematic Reviews (2019) 8:283 Page 5 of 8

independently for inclusion or exclusion in the final Any disagreements will be resolved by involving a
study. As before, disagreements will be resolved by dis- third reviewer. We will construct a ‘risk of bias’ table to
cussion and referral to a third author if necessary. present the results within and across studies. We will
use the assessment of risk of bias to perform sensitivity
analyses based on methodological quality as necessary.
Data extraction and management
We will record general study information along with
type of study, the context and organisation of the study Data synthesis and analysis
setting, recruitment information, sample size and patient If sufficient trials are available and their populations and
characteristics (including sex, age, primary diagnosis, co- outcome measures are clinically similar, we will carry
morbidities and severity of dysphagia at baseline). Pri- out meta-analyses of primary and secondary outcomes.
mary and secondary outcomes will be recorded includ- The following measures of treatment effect will be used:
ing the specific measurement, analysis metric, method of risk ratio (RR) and 95% confidence interval (CI) for the
aggregation and time point for each outcome, as per analysis of dichotomous outcomes, mean difference
SPIRIT 2013 statement [33]. A full description of the (MD) or standardised mean differences (SMD) and 95%
intervention including mode of delivery, dose, intensity, CI for continuous outcomes. Individual participants in
timing and fidelity will be extracted using the TIDieR each trial arm will comprise the unit of analysis. We will
checklist [34]. After piloting, this data will be extracted only use data reported from the first intervention time
independently by two authors using a data extraction period in any cross-over trials included in this review.
form (Additional file 2). Any discrepancies will be re- The comparison group will receive either a placebo such
solved by involving a third review author. as sham stimulation or standard care such as traditional
swallowing exercises and/or diet modification.
Assessment of risk of bias If two or more randomised controlled trials contribute
A bias in the conduct of a trial may distort the design, data for an outcome, the data will be combined in a
execution, analysis or interpretation of the research [35]. meta-analysis using Review Manager 5.3 on an intention
In this review, the risk of bias in included studies will be to treat basis if appropriate to do so [37]. We plan to
independently assessed by two review authors using the pool results using RevMan software with a fixed-effect
domain-based evaluation recommended by the Cochrane model and assess the results for heterogeneity. If there is
Collaboration [36]. For each domain, we will assign a substantial heterogeneity, we will repeat the meta-
judgement regarding the risk of bias as ‘high’, ‘low’ or analysis using a random-effects model. Where there are
‘unclear’. The domains include: data from only one study for an outcome, the results will
be reported narratively.
1. Random sequence generation (low risk includes
random methods such as random number table, Assessment of heterogeneity
computer random number generator or coin toss) If the presence of statistical heterogeneity is indicated by
2. Allocation concealment (low risk includes central poor overlap between confidence intervals across stud-
allocation or serially numbered, or sealed, opaque ies, the χ2 (chi-squared) test will be used to measure this
envelopes) statistic. The impact of such heterogeneity on the meta-
3. Blinding of participants and personnel (considered analysis will be evaluated using the I2 statistic. This will
low risk if authors mentioned that participants and describe the percentage of the variability in effect esti-
personnel were blinded to the intervention) mates that is due to differences between trials rather
4. Blinding of outcome assessment (considered low than sampling error (chance). A value of > 50% implies
risk if trial authors mentioned that outcome substantial heterogeneity [38]. We will qualitatively as-
assessors were blinded to group allocation) sess clinical heterogeneity by examining potential
5. Incomplete outcome data (considered low risk if sources, such as the type of intervention in each trial
outcome data were completely addressed) and the type of participants enrolled. Quantitative ex-
6. Selective outcome reporting (considered low risk if ploration of any substantial heterogeneity will also be
a protocol was available and pre-specified outcomes done via subgroup analysis.
were reported accordingly, or in the absence of a
protocol, if all expected outcomes were reported)
7. Other biases such as trial not being registered, Dealing with missing data
interventions being insufficiently well delivered or In the event that data are missing from reported trials,
conflicts of interest such as inappropriate funder we will, where possible, contact trial authors to request
influence access to this data for trials published in the last 5 years.
Duncan et al. Systematic Reviews (2019) 8:283 Page 6 of 8

Assessment of reporting biases Discussion

We will identify reporting biases (publication bias, time Oropharyngeal dysphagia is common in acute and crit-
lag bias, duplicate publication bias, citation bias, lan- ical care, affecting 47% of frail elderly, 50% of acute
guage bias or outcome-reporting bias) and minimise stroke and 62% of critically ill patients. Most clinical tri-
reporting biases through a comprehensive search for als testing dysphagia interventions in these settings have
studies, inclusion of unpublished studies and use of trial been with stroke populations, including a small number
registries. If a sufficient number of studies is identified completed in neurological intensive care with tracheos-
(n > 10), we will evaluate biases using funnel plot asym- tomised stroke patients. There still remains much to
metry testing. For continuous outcomes with interven- learn about the type and appropriate intensity of treat-
tion effects measured as mean differences, a test ments for other intensive care populations (e.g. respira-
proposed by Egger et al. [39] may be used to test for tory, cardiac, spinal and trauma).
funnel plot asymmetry: linear regression of intervention Swallowing difficulties in intensive care can arise from
effect estimate against its standard error, weighted by both central neural impairments, such as stroke and per-
the inverse of the variance of the intervention effect ipheral neural impairments such as critical illness poly-
estimate. neuropathy. During periods of intubation and
mechanical ventilation, the muscles involved in swallow-
‘Summary of findings’ table ing are largely immobilised. Such disuse of the swallow-
A summary of findings table will be included in the re- ing mechanism may diminish its cortical representation
view as per the Cochrane Handbook guidelines [36]. and delay functional recovery in the long term [22]. Dir-
This will include results for one population group; de- ect swallowing rehabilitation aims to accelerate the
scriptions of the intervention and comparison interven- process of neural plasticity, with studies showing that in-
tion; description of all patient important outcomes, both tense and persistent muscle training will bring about
desirable and undesirable; the number of participants changes in neural innervation and patterns of movement
and studies for each outcome; a measure of the typical [23].
burden of these outcomes; summary of the intervention This review will provide an overview of such dysphagia
effect; and a measure of the quality of evidence, using interventions in acute and critical care, informing clin-
the GRADE system [40]. ical practitioners of current evidence base and providing
The five GRADE considerations that will be used are important information for future trial design in intensive
study limitations, consistency of effect, imprecision, in- care. Novel to this review is the detailed analysis of key
directness and publication bias. This approach will as- intervention components using the TIDieR checklist.
sign one of four grades to the quality of the evidence: This will yield valuable information about intervention de-
high, moderate, low or very low. livery, intensity, timing and fidelity in studies, allowing re-
searchers to replicate and build on research findings. Such
information may also have implications for clinical guide-
Sensitivity analysis
lines and service delivery in these settings. This review will
If appropriate, we will investigate the influence of bias on
also comprehensively analyse and summarise outcomes.
results by undertaking a sensitivity analysis of the primary
The use and variability of outcomes across studies will
outcomes excluding studies with a high risk of bias.
provide important information for future trial design and
the potential development of a core outcome set for dys-
Subgroup analysis phagia intervention studies in intensive care.
If sufficient studies are available, we will undertake sub-
group analysis to explore reasons behind heterogeneity Supplementary information
that may be related to the following groups: acute care Supplementary information accompanies this paper at https://doi.org/10.
versus critical care populations, younger age groups (i.e. 1186/s13643-019-1196-0.
< 65 years) versus older age groups (>65 years) and types
of dysphagia interventions. Additional file 1. Medline search strategy.
Additional file 2. Data extraction form.
Additional file 3. PRISMA-P checklist.
Standards
Reporting will conform to the Preferred Reporting Items
Abbreviations
for Systematic Reviews and Meta-Analyses (PRISMA) CENTRAL: Cochrane Central Register of Controlled Trials; CINAHL: Cumulative
standards [41] (Additional file 3). This systematic review Index of Nursing and Allied Health Literature; EMBASE: Excerpta medica
has been registered with PROSPERO, an international database; GRADE: Grading of Recommendations, Assessment, Development
and Evaluation; ISRCTN: International Standard Randomized Controlled Trials
prospective register of systematic reviews (http://www. Number; PRISMA: Preferred Reporting Items for Systematic Reviews and
crd.york.ac.uk/PROSPERO/). Meta-analysis Standards SPIRITStandard Protocol Items: Recommendations
Duncan et al. Systematic Reviews (2019) 8:283 Page 7 of 8

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