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Articles

Behavioural intervention for dysphagia in acute stroke:


a randomised controlled trial
Giselle Carnaby, Graeme J Hankey, Julia Pizzi

Summary
Background Swallowing dysfunction after stroke is common, but there is little reliable evidence for how the disorder Lancet Neurol 2006; 5: 3137
should be managed. This study compared standard low-intensity and high-intensity behavioural interventions with Published online
usual care for dysphagia. November 30, 2005
DOI:10.1016/S1474-4422(05)
70252-0
Methods 306 patients with clinical dysphagia admitted to hospital with acute stroke were randomly assigned to
Department of Psychiatry,
receive usual care (n=102), prescribed by the attending physician; standard low-intensity intervention (n=102), University of Florida, Florida,
comprising swallowing compensation strategies and diet prescription three times weekly for up to a month; or USA (G Carnaby PhD);
standard high-intensity intervention and dietary prescription (n=102), at least daily for up to a month. The primary Stroke Unit, Department of
Neurology, Royal Perth
outcome measure was survival free of an abnormal diet at 6 months. Analysis was done by intention to treat. This
Hospital, WA, Australia
study is registered with ClinicalTrials.gov, number NCT00257764. (G Hankey FRACP, J Pizzi BSc);
and School of Medicine and
Findings 60 patients died and three patients were lost to follow up before the 6-month analysis. Of patients randomly Pharmacology, University of
Western Australia, WA,
allocated usual care, 56% (57/102) survived at 6 months free of an abnormal diet compared with 67% (136/204)
Australia (G Hankey FRACP)
allocated standard swallowing therapy (relative risk 119, 95% CI 098145). Standard swallowing therapy was
Correspondence to:
associated with a non-signicant trend toward a reduction in death (080, 0513), institutionalisation (069, Giselle Carnaby (ne Mann)
0411), and dependency (105, 0813); a signicant reduction in swallowing-related medical complications gmann@pyschiatry.u.edu
(073, 0609), chest infection (056, 0408), and death or institutionalisation (073, 055097); and a
signicant rise in the proportion of patients regaining swallowing function (141, 103194) by 6 months.
Compared with usual care and low-intensity therapy, high-intensity therapy was associated with an increased
proportion of patients who returned to a normal diet (p=004) and recovered swallowing (p=002) by 6 months.

Interpretation These data show a consistent trend towards more favourable outcomes in dysphagic stroke patients
who are assigned a standard programme of early behavioural swallowing intervention, including active therapeutic
approaches and dietary modication.

Introduction inclusion of unmatched comparison groups with mixed


Swallowing disorders (dysphagia with or without causes, the authors concluded that swallowing therapy
aspiration) are present in about 2750% of patients with was efcacious. Rosenbek and co-workers15 undertook a
acute stroke,15 and are associated with an increased risk controlled, multiple crossover design assessment of the
of complications, such as aspiration pneumonia, effect of thermal stimulation of the fauces on
dehydration, and malnutrition, in a fth to a third swallowing in seven patients with multiple previous
of patients.1,6,7 These complications are theoretically strokes. They identied initial change in duration and
preventable by prompt and accurate diagnosis of the descriptive measures of swallowing; however, these
swallowing disorder and appropriate intervention. The changes were not maintained a month after treatment.
possible interventions include indirect behavioural From a different focus, Sukthankar and colleagues16 did
strategies (eg, modication of food consistency),8 direct a randomised controlled trial of nine patients with
behavioural strategies (eg, stimulation of oral and dysphagia secondary to stroke or head injury. Patients
pharyngeal structures),9 and enteral feeding by means of were randomised to receive treatment with oral
a nasogastric tube or by percutaneous endoscopic exercises or oral exercises with visual and audio
gastrostomy.1013 biofeedback. These authors concluded that oral exercises
Feeding by percutaneous endoscopic gastrostomy is combined with biofeedback methods improved
associated with an increased rate of death or a poor swallowing recovery, despite including only lip and
outcome compared with feeding by nasogastric tube.11,12 tongue force measures as outcomes. DePippo and
The effectiveness of behavioural interventions for co-workers17 studied 115 orally fed patients with sub-
swallowing disorders after stroke, however, is uncertain. acute stroke, mild dysphagia, and absent or minimum
Kasprisin and colleagues14 did a non-randomised, aspiration on videouoroscopy. Patients were randomly
uncontrolled study of swallowing therapy in patients assigned to one of three graded levels of treatment,
with stroke and mixed neurogenic causes (n=69). The including dietary modication and swallowing therapy.
main outcome of this study was pneumonia However, the study did not include a non-treatment
development as reported from chart review. Despite the control group. Outcome measures included pneumonia,

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dehydration, calorie-nitrogen decit, and death. The (PHAD score) and the type and method of oral intake
authors concluded that outcome did not differ among were also reported. An instrumental assessment of
the three groups. Furthermore, only 15% of patients swallowing function, by means of videouoroscopy, was
reached one or more of these endpoints within the done routinely in patients assigned to the high-intensity
12-month study period. and low-intensity treatment groups; patients allocated
Taken together these studies suggest positive usual care were managed at the discretion of the
outcomes from behavioural interventions for dysphagia. attending clinician.
However, signicant design issues make it impossible The study protocol was approved by the ethics
to conclude efcacy for this form of intervention; committee and institutional review board of Royal Perth
specically, small sample sizes,1417 restriction to patients Hospital.
with a narrow spectrum17 or multiple causes of
dysphagia,14,16 and limitation by delayed intervention15 or Procedures
lack of a control group.15,17 Randomisation was undertaken by use of a block
The primary aim of this study was to ascertain whether randomisation technique. The treatment allocation was
a standard behavioural intervention for swallowing based on a computer-generated random numbers list
dysfunction after stroke, given by a speech pathologist generated with the SPSS statistical package (version
for up to a month after stroke, could improve swallowing 9.0). The randomisation schedule was held in the trial
function, as measured by the proportion of patients ofce, remote from the study environment. After clinical
returning to a normal (prestroke) diet by 6 months after assessment by the study speech pathologist (JP), eligible
stroke, compared with usual care in hospital. Secondary patients were informed about the trial and, after
aims were to determine a) whether the intervention providing informed consent, were randomly assigned to
could increase the proportion of patients who recovered one of three treatment options by means of a telephone
swallowing function and reduce the proportion who call to the trial ofce by the study speech pathologist.
developed dysphagic-related complications, died, were The three treatment groups were usual care, standard
institutionalised, or dependent in activities of daily living low-intensity treatment, and standard high-intensity
by 6 months after stroke; and b) whether there was treatment. Usual care (control) consisted of patient
a dose-dependent effect associated with high-intensity management by the attending physicians as per usual
and low-intensity standard behavioural interventions. practice. Physicians referred their patients to the
existing hospital speech pathology service if they
Methods considered it to be appropriate. Treatment, if offered,
Patients consisted mainly of supervision for feeding and
The study was undertaken in a university teaching precautions for safe swallowing (eg, positioning, slowed
hospital, the Royal Perth Hospital, which provides rate of feeding). Videouoroscopic assessment of
medical services for the eastern suburban region of swallowing function was undertaken only if prescribed
Perth, Western Australia. All patients presenting to the by the attending physician.
Royal Perth Hospital over a 3-year period were screened Standard low-intensity swallowing therapy was
for inclusion in the study. Patients were included if a composed of swallowing compensation strategies,
clinical diagnosis of stroke was conrmed by the mainly environmental modications (eg, upright
attending clinician (GJH), according to the WHO positioning for feeding); safe swallowing advice (eg,
denition of stroke;18 if the onset of stroke was within the reduced rate of eating); and appropriate dietary
previous 7 days; if the study speech pathologist (JP) modication, under the direction of the study speech
made a clinical diagnosis of swallowing difculty pathologist, three times per week for a month, or for the
(dysphagia), as measured by a score of less than 85 on duration of the hospital stay (if less than a month). The
the Paramatta Hospitals assessment of dysphagia;1921 if choice of specic swallowing compensation strategies
the patient had no history of swallowing treatment or was directed by the ndings of the clinical swallowing
surgery of the head or neck; and if the patient gave examination and videouoroscopy (at baseline and at
written informed consent to participate in the trial and follow up, if necessary).
be followed up for the next 6 months. Patients for whom Standard high-intensity swallowing therapy consisted
consent could not be gathered were placed on a waiting of direct swallowing exercises (eg, effortful swallowing,
list, reassessed daily, and included if they met the entry supraglottic swallow technique) and appropriate dietary
criteria and consented within 7 days of stroke onset. modication, under the direction of the study speech
Eligible patients underwent a baseline assessment of pathologist, every working day for a month or daily for
demography, comorbidity, premorbid function, clinical the duration of the hospital stay (if less than a month).
stroke syndrome, stroke pathology, stroke subtype, and The choice of specic swallowing exercises was
results of CT and MRI brain scans. Stroke severity was established by the ndings of the clinical examination
measured according to the modied Rankin score22 and and videouoroscopy (at baseline and at follow up, if
the modied Barthel index,23 and swallowing function necessary).

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All people involved in the study were unaware of the


treatment allocation, apart from the patients and the
3227 suspected clinical strokes
study speech pathologist who treated the patients
assigned to the high-intensity and low-intensity groups.
2356 ineligible
The study speech pathologist, who assessed all stroke
460 not notified of study
admissions for eligibility in the trial, worked 92 discharged/outside window
independently of the hospital speech pathology service 595 not dysphagic
1041 non-stroke diagnosis
and did not share any trial information with the hospital 90 died before assessment
therapists. The hospital speech pathology service 78 inappropriate 871 eligible
continued to receive sporadic referrals from the hospital
physicians, as per usual practice, and some of these
565 not randomised
patients had been enrolled in the trial and assigned usual 136 refused consent
care. The physicians were not informed if their patients 61 died before randomised
71 discharged before randomised
had been randomly assigned to usual care in the trial.
53 not notified
Clinical neurological assessments and grading of CT 244 enrolled in other trials 306 randomised
and MRI brains scans were done by the study neurologist
(GJH) before randomisation. All patients were cared for
in the stroke unit, the general neurology ward, or the
general medical wards.
Outcome was assessed by an independent speech
102 assigned high-intensity 102 assigned low-intensity 102 assigned usual care
pathologist (GC), who was unaware of the treatment treatment (1 non-stroke) treatment (2 non-stroke) (1 non-stroke)
allocation, every month for 6 months after randomisation.
Inpatient progress and the occurrence of any possible
complications were sought from multiple overlapping
sources, such as asking patients, relatives, and staff at 17 died at 6 months 20 died at 6 months 23 died at 6 months
each monthly assessment. Information about treatment 2 lost to follow up 1 lost to follow up

was not requested and treatment records were not


reviewed to maintain masking. Outcome after hospital
discharge was recorded by the patient or caregiver in a
Analysed for endpoints: Analysed for endpoints: Analysed for endpoints:
dedicated diary, and veried, if necessary, by the patients 94 at 1 month 94 at 1 month 92 at 1 month
community doctor and reviewed at each monthly contact. 83 at 6 months 81 at 6 months 79 at 6 months
The primary outcome measure was the proportion of
patients who returned to their normal prestroke diet
within 6 months after randomisation. Secondary outcome Figure 1: Trial prole
measures included the time to return to a normal diet; the
proportion of patients who had recovered functional High intensity Low intensity Usual care
swallowing or developed one or more dysphagia-related (n=102) (n=102) (n=102)
medical complications (such as chest infection, Demographics
dehydration, calorie-nitrogen decit); and the proportion Age, years 698 (125) 72 (124) 714 (127)
of patients who had died, were institutionalised, or Sex, male 60 (59%) 59 (58%) 59 (58%)
Clinical syndrome
dependent in activities of daily living by 6 months after
Total anterior circulation syndrome 36 (35%) 30 (29%) 42 (41%)
stroke. Partial anterior circulation syndrome 34 (33%) 35 (34%) 30 (29%)
Abnormal diet was dened as dietary intake (oral or Lacunar syndrome 23 (23%) 25 (25%) 19 (19%)
non-oral) needing a restricted consistency or special Posterior circulation syndrome 8 (8%) 10 (10%) 10 (10%)
Unknown/non-stroke 1 (1%) 2 (2%) 1 (1%)
preparation before it could be consumed safely. Pathology
Functional swallowing was dened as a return to Cerebral infarction 93 (91%) 90 (88%) 90 (88%)
prestroke diet without swallowing complications. Chest Cerebral haemorrhage 8 (8%) 10 (10%) 11 (11%)
infection was dened as at least three of: fever more Unknown 1 (1%) 2 (2%) 1 (1%)
Stroke severity
than 38C; productive cough; abnormal respiratory Barthel index 15 80 (78%) 80 (78%) 81 (79%)
examination (tachypnoea 22 breaths per min, Barthel index 15 22 (22%) 22 (22%) 21 (21%)
tachycardia, inspiratory crackles, bronchial breathing); Stroke handicap
arterial hypoxaemia (PaO293kPa); culture of a relevant Rankin score 3 15 (15%) 21 (21%) 17 (17%)
Rankin score 3 87 (85%) 81 (79%) 85 (83%)
pathogen; and positive chest radiograph in a patient with Length of hospital stay, days 191 (105) 192 (133) 214 (124)
suspected chest infection. Dehydration was dened as
loss of total bodyweight (10%), postural hypotension Data are number (%) or mean (SD).

(30 mm Hg), urea to creatinine ratio greater than Table 1: Baseline characteristics
123 mmol/L, or serum sodium more than 145 mmol/L

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improve this rate by 20% in absolute terms to 90% at


High intensity Low intensity Usual care ANOVA p
6 months. In order to have 80% power at the 5% (two
Videouoroscopic swallowing assessment 81 (79%) 88 (86%) 28 (27%)
Swallowing treatment sessions 116 (63) 78 (38) 48 (39) 51 00001
tailed) signicance level to reliably identify this treatment
Duration of treatment per session, min 242 (76) 248 (67) 160 (92) 389 00001 effect or larger, the sample size needed was estimated to
Days treatment provided* 114 (65) 167 (79) 179 (87) 20 0001 be 300 (100 in each group).
Analyses were by intention to treat. Therefore, all
Data are number (%) or mean (SD). *Data are for patients who received treatment and do not include those who received none.
306 patients who were randomised were included in the
Table 2: Swallowing intervention, by treatment group analysis, including the four patients who were subse-
quently deemed to have not had a stroke.
Parametric statistical tests (eg, t tests) were undertaken
Usual care Standard swallowing Relative risk (95% CI)
(n=102) therapy (n=204)
for normally distributed variables, and non-parametric
tests (eg, Mann Whitney U tests) were done for skewed
Primary outcome at 6 months
Normal diet 57 136 119 (098145) variables. Odds ratios and their 95% CIs were derived for
Secondary outcomes at 6 months all primary and secondary outcomes. Logistic regression
Functional swallowing 33 93 141 (103194) models were tted to each of the main binary endpoints.
Any complication 64 94 073 (060092)
Rank data and other continuous endpoints were reviewed
Chest infection 48 54 056 (041076)
Death 23 37 080 (04913) by ANOVA. The 2 test was used for discrete counts of
Institutionalisation 26 36 069 (04311) patients with particular categories of adverse and dietary
Dependency (Rankin3) 49 103 105 (08213) events. In our protocol the primary comparison of interest
Death or institutionalisation 49 72 073 (055097)
was that between the standard treatment and usual care
Death or dependency 72 140 097 (08311)
groups; a trend analysis was also done using 2 for linear
Data are number of patients. trend in proportion for all three groups. Differences in the
Table 3: Comparison of organised swallowing therapy (high-intensity and low-intensity groups
Kaplan-Meier curves were analysed with log rank tests.
combined) versus usual care This study is registered with ClinicalTrials.gov, number
NCT00257764.

not due to renal insufciency or use of diuretics. Calorie- Role of the funding source
nitrogen decit was dened as serum albumin less The sponsor of the study had no role in study design,
than 25 g/L or sustained ketonuria without glycosuria. data collection, data analysis, data interpretation, or
Dependency was dened as a modied Rankin scale score writing of the report. The corresponding author had full
of 3 or more or a Barthel index score of 15/20 or less. access to all the data in the study and had nal
responsibility for the decision to submit for publication.
Statistical analysis
The study sample size calculations were based on our Results
earlier nding that 87% of patients with dysphagia after A total of 3227 patients with suspected strokes were
rst-ever acute stroke returned to a normal diet by referred to the study team between May 1, 1996, and
6 months.7 Because many of these patients with mild May 31, 1999, of whom 27% were eligible for inclusion
stroke had been treated with standard behavioural in the study (gure 1). Written informed consent was
swallowing therapies, we postulated that about 70% of obtained from 306 (35%) of the 871 eligible patients.
patients assigned usual care in this study would have a Ineligible patients did not differ signicantly from
6-month survival period free of an abnormal diet and that enrolled patients in severity of stroke or dysphagia.
assignment to standard swallowing therapy would Table 1 shows the baseline characteristics of the patients.
The mean time to admission was 8 h after stroke onset
Usual care Low intensity High intensity p and to randomisation was 27 days after stroke onset for
Primary outcome at 6 months all treatment groups. The mean duration of hospital stay
Normal diet 57 65 71 004 did not differ between the three groups.
Secondary outcomes at 6 months The number of swallowing therapy sessions and the
Functional swallowing 33 44 49 002
Chest infection 48 26 28 0003
duration of sessions for patients assigned to the
Any complication 64 44 50 005 standard treatment groups were signicantly greater
Death 23 20 17 029 than for those assigned to the usual care group (table 2).
Institutionalisation 26 17 19 022 The number of days over which patients received
Dependency (Rankin3) 72 68 69 065
Death or institutionalisation 49 36 36 006
swallowing therapy was signicantly less in the standard
Death or dependency 72 69 72 087 treatment groups than in the usual care group.
Follow up at 6 months was complete for 243 (99%) of
Data are number of patients.
the 246 survivors. Data for the 60 patients who died and
Table 4: Comparison of high-intensity versus low-intensity speech therapy versus usual care three patients lost to follow up at 56 days, 110 days,
and 163 days after randomisation, respectively, were

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censored for time spent in the study and included in the Discussion
intention-to-treat analysis (gure 1). The results of this study do not lend support to the
Of the 102 patients randomly allocated usual care, 56% primary study hypothesis that a standard programme of
survived free of an abnormal diet at 6 months after swallowing therapy given early to patients with acute
stroke compared with 67% of the 204 patients allocated stroke and maintained as required, is associated with a
standard swallowing treatment (table 3). Of patients signicant increase in the proportion of patients who
allocated high-intensity swallowing treatment, 70% survive free of an abnormal diet by 6 months after
survived free of an abnormal diet at 6 months after stroke. Furthermore, there was no signicant effect of
stroke, compared with 64% of patients allocated low- swallowing therapy on death, institutionalisation, and
intensity swallowing treatment and 56% of patients dependency at 6 months after stroke. However, the study
assigned usual care (table 4). The time to return to a did show a consistent, albeit non-signicant, trend in
normal diet was signicantly shorter for patients favour of swallowing therapy versus usual care for these
assigned usual care compared with standard swallowing outcomes, and a signicant rise in the proportion of
treatment (F=34, p003). Kaplan-Meier survival patients who achieved functional swallowing and a
curves for the three groups, however, were not decrease in the proportion of patients who had a
signicantly different (gure 2). dysphagia-related medical complication (especially
Of patients allocated standard swallowing therapy, aspiration pneumonia) and died or needed
46% achieved prestroke swallowing function at institutionalisation (as a combined outcome) by
6 months compared with 32% of patients allocated usual 6 months after stroke. A doseresponse relation was also
care (table 3). Among patients allocated the high- apparent with a signicant trend toward improved
intensity swallowing intervention, 48% achieved recovery of swallowing function and less chest infection
prestroke swallowing function at 6 months compared in patients randomly allocated intensive standard
with 43% of patients allocated the low-intensity swallowing therapy than in those allocated less intensive
swallowing intervention and 32% of patients assigned therapy and usual care.
usual care (table 4). The strengths of this study are the reduced systematic
Among patients allocated standard swallowing bias in treatment allocation by randomisation, reduced
therapy, 46% experienced a swallowing-related medical observer bias in outcome assessment by the masking of
complication within the rst 6 months after stroke the outcome assessor to the treatment allocation, and the
compared with 63% of patients allocated usual care minimisation of random error by the relatively large
(table 3). Most complications avoided by swallowing number of patients and outcomes studied.
therapy were chest infection due to aspiration (47% There are several weaknesses of this study. The rst is
usual care vs 26% organised care). Signicantly fewer that the patient and the treating therapist were aware of
patients allocated standard swallowing therapy (36%) the treatment allocation, which introduces the
than usual care (48%) were dead or institutionalised at possibility of bias in the way treatment was delivered to
6 months. certain patients and the way patients reported subjective
outcomes. The most likely systematic error was that
patients assigned usual care could have been treated
10 with a more standard approach by hospital therapists
because they may have indirectly learnt about the
08
ongoing trial and observed how other enrolled patients
were being treated, thus biasing the results toward the
null hypothesis. We believe that the patients awareness
Cumulative survival

06
of treatment allocation was unlikely to have biased the
results because 59% of patients discharged from
High intensity
04
Low intensity
hospital were unable to identify the nature of the
Usual care swallowing treatment they received. Furthermore,
02
patient outcome recording bias is unlikely to have
affected rates of objective outcomes, such as medical
Log rank test p=046 complications (eg, chest infection), death, and
00 institutionalisation. Finally, the independent outcome
0 50 100 150 assessor, who recorded patient diet progress and
Days follow up after randomisation swallowing function, was able to predict the treatment
Numbers at risk
allocation correctly in only 29% of patients (Kappa 032).
High intensity 102 42 23 14
Low intensity 102 44 32 22 Another potential weakness is that, despite this being
Usual care 102 40 19 8 the largest randomised trial of any behavioural
swallowing intervention in acute stroke, the numbers of
Figure 2: Time to survival free of an abnormal diet patients and outcome events were still rather small. As a

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result, our estimates are imprecise with wide 95% CIs, outcomes in 115 dysphagic stroke patients admitted to a
introducing the possibility that our results could be due subacute rehabilitation centre.17 However, this study did
to chance. However, the qualitative consistency of the not include a control group, patients were assessed a
results across several outcome events (ie, all favouring mean of 45 weeks after their stroke, and the number of
standard treatment) is suggestive of a true positive outcome events was very small.17
treatment effect, but the size of the treatment effect The results of our study provide reasonably reliable
remains imprecise. data, which lend support to the potential value of
A nal limitation of our study is that it was undertaken behavioural swallowing intervention after acute stroke to
in a single centre with hospital-referred patients with help with the return to prestroke swallowing function
moderate to severe stroke. The generalisability (external and minimisation of dysphagia-related adverse
validity) of the results to other therapists and patients outcomes. These encouraging results might be
therefore remains uncertain. However, our intervention attributed to the quality and quantity of the intervention;
is clearly described and our patients are typical of patients assigned to the standardised swallowing care
those who have swallowing dysfunction after stroke. groups were treated more frequently and for longer
Additionally, our study yielded a mean age of patients durations (ie, more intensively) over a shorter period of
with stroke (71 years) that is younger than the currently time than were those assigned usual care. If these
reported mean age for stroke in the USA (77 years). We results can be replicated in other settings, they would
believe, however, that our mean age and range are suggest that the management of patients with acute
representative of the Australian population. Australia is stroke should include a dedicated, standard programme
a large country with many diverse population groups. of early behavioural swallowing intervention, composed
The age and sex distribution, together with ethnic of active therapeutic approaches as well as dietary
mix and lifestyle factors, affects our ndings. In our modication.
study, 5% of the study sample was from pan-Asian Acknowledgments
background. Recent Asian stroke studies have also This study was supported by an educational grant from the Royal Perth
identied a lower mean age for stroke.24 Moreover, a Hospital Medical Research Foundation.
review of the mean stroke age from studies that used Authors contributions
analogous Australian samples shows comparable GC participated in the development and design of the study, conducted
and supervised assessments and procedures within the study, reviewed
results.2527 and interpreted data, and participated in the development of the
The faster time to return to a normal diet among manuscript. GJH participated in the design of the study, conducted and
patients allocated usual care could be due to the fact that supervised neurological assessments and procedures, reviewed and
52 of the 102 patients assigned usual care were interpreted data, and participated in the development of the manuscript.
JP participated in the management of the study, conducted speech-
immediately prescribed a normal diet on admission by language pathology treatments and procedures, reviewed and interpreted
ward staff, without waiting for an assessment of data included in the study, and participated in development of the
swallowing function by a speech and swallowing manuscript.
therapist. This was a common observation in our Conicts of interest
previous studies5,7 and was one of the reasons for our We have no conicts of interest.
study hypothesis that usual care would be associated References
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