Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
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.
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).
(30 mm Hg), urea to creatinine ratio greater than Table 1: Baseline characteristics
123 mmol/L, or serum sodium more than 145 mmol/L
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
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
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
with a failure to diagnose unobvious swallowing 1 Gordon C, Hewer RL, Wade DT. Dysphagia in acute stroke. BMJ
1987; 295: 41114.
dysfunction in some patients and predispose such 2 Wolfe C, Taub N, Woodrow J, Richardson E, Warburton F,
patients to a high risk of aspiration pneumonia. Burney P. Patterns of acute stroke care in three districts in
Differences in time to achieve certain diet levels might southern England. J Epidemiol Commun Health 1993; 47: 14448.
also be strongly affected by care practices (eg, 3 Odderson IR, Keaton JC, McKenna BS. Swallow management in
patients on an acute stroke pathway: quality is cost effective.
perceptions of the staff or involvement of a swallowing Arch Phys Med Rehab 1995; 76: 113033.
clinician, rather than the patients functional feeding 4 Smithard D, ONeill P, Park C, et al. Complications and outcome
ability alone). after acute stroke: does dysphagia matter? Stroke 1996: 27: 120004.
5 Mann G, Hankey GJ, Cameron D. Swallowing disorders after acute
Our trial was not powered to reliably identify or stroke: prevalence and diagnostic accuracy. Cerebrovasc Dis 2000;
exclude a doseresponse relation between intensity of 10: 38086.
swallowing therapy and outcome. Because the results of 6 Smithard DG, ONeill PA, England RE, et al. The natural history of
dysphagia following a stroke. Dysphagia 1997; 12: 18893.
the low-intensity and high-intensity groups were not
7 Mann G, Hankey GJ, Cameron D. Swallowing dysfunction after
strikingly different from one another, it is not possible to acute stroke: prognosis and prognostic factors at 6 months. Stroke
determine whether there is a differential treatment 1999; 30: 74448.
effect and whether low-intensity treatment could be as 8 Logemann J. Approaches to management of disordered
swallowing. Clin Gastroenterol 1991; 5: 26980.
effective as high-intensity treatment. 9 Lazarra G, Lazarus C, Logemann J. Impact of thermal stimulation
The only other truly randomised trial of behavioural on the triggering on the swallow reex. Dysphagia 1986; 1: 7377.
swallowing therapy after stroke reported no signicant 10 Finestone HM. Safe feeding methods in stroke patients. Lancet
effect of graded levels of instruction regarding types of 2000; 355: 166263.
11 FOOD Trial Collaboration. Effect of timing and method of enteral
food and the manner of intake on swallowing-related
tube feeding for dysphagic stroke patients (FOOD): a multicentre 19 Warms T, Champion R, Mortensen L. The Paramatta hospitals
randomised controlled trial. Lancet 2005; 365: 76472. assessment of dysphagia. Aust Commun Q 1990; 11: 2526.
12 Bath PMW, Bath FJ, Smithard DG. Interventions for dysphagia in 20 Warms T. The Paramatta hospitals assessment of dysphagia,
acute stroke. Cochrane Database Syst Rev 2004; 4: CD 000323. 3rd edn. Sydney, Australia: Westmead Hospital and Community
13 Norton B, Homer-Ward M, Donnelly MT, Long RG, Homes GKT. Health Services, 1998.
A randomised prospective comparison of percutaneous endoscopic 21 Morgan A, Ward E, Murdoch B. Clinical progression and outcome
gastrostomy and nasogastric tube feeding after acute dysphagic of dysphagia following paediatric traumatic brain injury:
stroke. BMJ 1996; 312: 1316. a prospective study. Brain Inj 2004; 18: 35976.
14 Kasprisin AT, Clumeck H, Nino-Murcia, M. The efcacy of 22 Burn JP. Reliability of the modied Rankin scale. Stroke 1992;
rehabilitative management of dysphagia. Dysphagia 1989; 4: 4852. 23: 438.
15 Rosenbek JC, Robbins J, Fishback B, Levine RL. Effects of thermal 23 Collin C, Wade DT, Davis S, Horne V. The Barthel ADL index:
application on dysphagia after stroke. J Speech Hear Res 1991; 34: a reliability study. Int Disabil Stud 1988; 10: 6163.
125768. 24 Basri H, Asman R. Predictors of in-hospital mortality after an acute
16 Sukthankar SM, Reddy NP, Canilang EP, Stephenson L, ischaemic stroke. Neurol J Southeast Asia 2003; 8: 58.
Thomas R. Design and development of portable biofeedback 25 Lee AH, Somerford PJ, Yau KKW. Factors inuencing survival
systems for use in oral dysphagia rehabilitation. Med Eng Phys after stroke in Western Australia. Med J Aust 2003; 179: 28993.
1994; 16: 43035. 26 Thrift AG, Dewey HM, Macdonell RA, McNeil JJ, Donnan GA.
17 DePippo KL, Holas MA, Reding MJ, Mandel FS, Lesser ML. Stroke incidence on the east coast of Australia: the North East
Dysphagia therapy following stroke: a controlled trial. Neurology Melbourne Stroke Incidence Study (NEMESIS). Stroke 2000;
1994; 44: 165560. 31: 208792.
18 Anon. Recommendations on stroke prevention, diagnosis, and 27 Ng WK, Goh KJ, Geiroge J, et al. A comparative study of stroke
therapy. Report of the WHO Task Force on Stroke and other subtype between Asian and Causcasians in two hospital based
Cerebrovascular Disorders. Stroke 1989; 20: 140731. stroke registries. Neurol J Southeast Asia 1988; 3: 1926.