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# Comparison of 2 Interventions for Liquid Aspiration on Pneumonia Incidence A Randomized Trial

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Aspiration pneumonia is common among frail elderly persons with dysphagia. Although interventions to prevent aspiration are routinely used in these patients, little is known about the effectiveness of those interventions. To compare the effectiveness of chin-down posture and 2 consistencies (nectar or honey) of thickened liquids on the 3-month cumulative incidence of pneumonia in patients with dementia or Parkinson disease. Randomized, controlled, parallel-design trial in which patients were enrolled for 3-month periods from 9 June 1998 to 19 September 2005. 47 hospitals and 79 subacute care facilities. 515 patients age 50 years or older with dementia or Parkinson disease who aspirated thin liquids (demonstrated videofluoroscopically). Of these, 504 were followed until death or for 3 months. Participants were randomly assigned to drink all liquids in a chin-down posture (n = 259) or to drink nectar-thick (n = 133) or honey-thick (n = 123) liquids in a head-neutral position. The primary outcome was pneumonia diagnosed by chest radiography or by the presence of 3 respiratory indicators. 52 participants had pneumonia, yielding an overall estimated 3-month cumulative incidence of 11%. The 3-month cumulative incidence of pneumonia was 0.098 and 0.116 in the chin-down posture and thickened-liquid groups, respectively (hazard ratio, 0.84 [95% CI, 0.49 to 1.45]; P = 0.53). The 3-month cumulative incidence of pneumonia was 0.084 in the nectar-thick liquid group compared with 0.150 in the honey-thick liquid group (hazard ratio, 0.50 [CI, 0.23 to 1.09]; P = 0.083). More patients assigned to thickened liquids than those assigned to the chin-down posture intervention had dehydration (6% vs. 2%), urinary tract infection (6% vs. 3%), and fever (4% vs. 2%). A no-treatment control group was not included. Follow-up was limited to 3 months. Care providers were not blinded, and differences in cumulative pneumonia incidence between interventions had wide CIs. No definitive conclusions about the superiority of any of the tested interventions can be made. The 3-month cumulative incidence of pneumonia was much lower than expected in this frail elderly population. Future investigation of chin-down posture combined with nectar-thick liquid may be warranted to determine whether this combination better prevents pneumonia than either intervention independently.
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Comparison of 2 Interventions for Liquid Aspiration on
Pneumonia Incidence A Randomized Trial
JoAnne Robbins, PhD, Gary Gensler, MS, Jacqueline Hind, MS, Jeri A. Logemann, PhD, Anne
S. Lindblad, PhD, Diane Brand, BS, Herbert Baum, PhD, David Lilienfeld, MD, PhD, Steven
Kosek, MS, Donna Lundy, PhD, Karen Dikeman, MA, Marta Kazandjian, MA, Gary D.
Gramigna, MS, Susan McGarvey-Toler, MS, and Patricia J. Miller Gardner, JD
Abstract
Background—Aspiration pneumonia is common among frail elderly persons with dysphagia.
Although interventions to prevent aspiration in these patients are routinely used in these patients,
little is known about the effectiveness of those interventions.
Objective—To compare the effectiveness of chin-down posture and 2 consistencies (nectar or
honey) of thickened liquids on the 3-month cumulative incidence of pneumonia in participants with
dementia or Parkinson disease.
Design—Randomized, controlled, parallel-design trial in which patients were enrolled from 9 June
1998 to 19 September 2005.
Setting—47 hospitals and 79 subacute facilities.
Patients—515 patients age 50 years or older with dementia or Parkinson disease who aspirated thin
liquids (demonstrated videofluoroscopically). Of these, 504 were followed until death or 3 months.
Interventions—Participants were randomly assigned to drink all liquids in a chin-down posture (n
= 259) or to drink nectar-thick (n = 133) or honey-thick (n = 123) liquids in a head-neutral position.
Measurements—The primary outcome was pneumonia diagnosed by chest radiography or by the
presence of 3 respiratory indicators.
Results—52 participants had pneumonia, yielding an overall estimated 3-month cumulative
incidence of 11%. The 3-month cumulative incidence of pneumonia was 0.098 and 0.116 in the chin-
down posture and thickened-liquid groups, respectively (hazard ratio [HR], 0.84 [95% CI, 0.49 to
1.45]; P = 0.53). The 3-month cumulative incidence of pneumonia was 0.084 in the nectar-thick
liquid group compared with 0.150 in the honey-thick liquid group (HR, 0.50 [CI, 0.23 to 1.09]; P =
0.083). More patients assigned to thickened liquids than those assigned to the chin-down posture
intervention had dehydration (6% vs. 2%), urinary tract infection (6% vs. 3%), and fever (4% vs.
2%).
Limitations—A no-treatment control group was not included. Follow-up was limited to 3 months.
Care providers were not blinded, and differences in cumulative pneumonia incidence between
Conclusion—No definitive conclusions about the superiority of any of the tested interventions can
be made. The 3-month cumulative incidence of pneumonia was much lower than expected in this
frail elderly population. Future investigation of chin-down posture combined with nectar-thick liquid
may be warranted to determine whether this combination better prevents pneumonia than either
intervention independently.
Trial Registration—Clinical Trials.gov registration number: NCT00000362
Swallowing disorders are associated with increased morbidity and mortality. An estimated 18
million adults will require care for dysphagia-related malnutrition, dehydration, pneumonia,
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and reductions in quality of life by 2010 (1-3). Patients with dysphasia have an increased
incidence of aspiration pneumonia because the aspirated material is heavily colonized with
bacteria. Pneumonia is the most common cause of infectious death in the United States among
persons age 65 years or older and the third leading cause of death for persons age 85 years or
older (4). One hospital admission for pneumonia is estimated to cost $7166 (5). Rates of hospital discharge for Medicare beneficiaries with pneumonia as a primary diagnosis have increased by 93.5% in the past decade (6), along with length of stay and death rates (4). Liquid aspiration is the most common type of aspiration in elderly persons (1). Relative risk for pneumonia is highest in patients with dementia, followed by those who are institutionalized (7). As many as 50% of patients with parkinsonism are estimated to have dysphagia (8), and one third aspirate silently---that is, with no external sign (such as coughing) to eject material or alert caregivers (9). Many short- and long-term care facilities use thickened liquid diets to treat of aspiration (10). In these diets, thin liquids (for example, water, tea, coffee) are eliminated, even in the absence of efficacy data, at a substantial cost in financial and quality-of-life terms. It costs approximately$200 per month for an individual to drink thickened liquids (11,12). A common
alternative to thickened liquids is use of a chin-down posture (13-17). Welch and coworkers
(13) noted that posterior shift of anterior pharyngeal structures with the chin-down posture
improved airway protection. Whereas previous studies have provided a basis for the
widespread clinical use of chin-down posture, none has provided long-term health outcome
data.
Results from a previously reported portion of this study demonstrated short-term elimination
of aspiration during the videofluorographic swallowing evaluation most often with honey-thick
liquids, followed by nectar-thick liquids, and finally chin-down position (18). We sought to
compare the effectiveness of chin-down posture and thickened liquids (nectar thick and honey
thick) on the incidence of pneumonia in participants with dementia or Parkinson disease during
3 months of treatment.
Methods
Design
The study design and methods are described in detail elsewhere (19). In brief, between
enrollment initiation on 9 June 1998 and closure on 16 September 2005, 47 acute-care hospitals
and 79 subacute residential facilities combined their patients to enroll 515 participants, a total
that was 65 participants short of the recruitment goal. Follow-up was completed on 9 December
2005. The Data and Safety Monitoring Committee recommended discontinuing enrollment,
on the basis of a futility analysis suggesting that enrolling additional participants would not
change the findings.
Participants were enrolled in this 3-month follow-up study if they were observed to aspirate
when swallowing 3 mL of thin liquids from a spoon or when drinking from a cup without an
intervention during videofluoroscopy or swallowing. Aspiration was defined as barium
observed below the vocal folds. Participants who qualified were then given boluses to perform
3 conditions in random order: thin liquid (15 centipoise) swallowed in a chin-down posture,
nectar-thick liquid (300 centipoise) swallowed in a head-neutral position, and honey-thick
liquid (3000 centipoise) swallowed in a head-neutral position. Participants who did equally
well (all conditions eliminated aspiration) or equally poor (no conditions eliminated aspiration)
but wished to continue oral intake, despite being warned about risk for pneumonia, were
randomly assigned to 1 of the conditions as an intervention and followed for 3 months.
Participants who aspirated during 1 or 2 of the conditions were not randomly assigned. On-
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site speech-language pathologists, nurses, and direct care and dietary staff who completed
rigorous training about facilitation of the chin-down posture and proper techniques to thicken
liquids supervised administration of the interventions. The number of participants under
supervision by a speech-language pathologist ranged from 1 to 93 (median, 4 participants).
Clinicians were instructed to refrain from using concomitant active or compensatory
interventions with participants during the study period. Research staff made monthly site visits
to monitor protocol adherence. All participants or their representatives provided written
informed consent. Each facility’s institutional review board of record, as approved by the
Office for Human Research Protections, Department of Health and Human Services, approved
the study.
Setting and Participants
Inclusion criteria were a physician-identified diagnosis of dementia (Alzheimer type, single or
multistroke type, or other nonresolving types) or Parkinson disease and patient age (50 to 95
years). Exclusion criteria were tobacco use in the past year, current alcohol abuse, history of
head or neck cancer, insulin-dependent diabetes for 20 years or more, nasogastric tube, other
progressive or infectious neurologic diseases, or pneumonia within 6 weeks of enrollment.
Outpatients and inpatients from participating acute and subacute care facilities who were
suspected of aspirating liquids by their physicians and speech-language pathologists during
standard clinical care were referred for a videofluoroscopic swallowing study at a participating
acute-care facility. The informed consent process was completed with the patient and care
provider by the speech-language pathologist or research personnel before the swallowing
study. After the swallowing study, participants returned to their living situation (acute care,
subacute care, or home) while the videofluoroscopic images were analyzed. Participants were
randomly assigned to an intervention group within 24 hours.
Randomization and Interventions
The primary interventions were chin-down posture while consuming thin liquids versus
consuming thickened liquids (nectar thick or honey thick [Resource ThickenUp, Nestlé
HealthCare Nutrition [formerly Novartis Medical Nutrition], Minneapolis, Minnesota]) in a
head-neutral position. The thin, nectar-thick, and honey-thick barium solutions (Varibar, E-Z-
EM, Lake Success, New York) were manufactured in a standardized formulation for this study.
Standardized recipes matching the viscosities of the barium products were developed for a
wide variety of thickened beverages.
Participants were randomly assigned centrally by a telephone system controlled by the
Statistical and Data Center at the EMMES Corporation (Rockville, Maryland). A study speech-
language pathologist called a central telephone number and entered participant criteria when
prompted to by using the telephone keys. If the patient was eligible, an intervention was
assigned and a summary page that included intervention assignment and meal-monitoring was
faxed to the speech-language pathologist. Randomization sequences for primary assignment
(chin-down posture vs. thickened liquids) were developed by a statistician at the Statistical and
Data Center. The sequences were stratified by participant age (50 to 79 years or 80 to 95 years)
and diagnosis (Parkinson disease with or without dementia, or dementia only) and included
randomly assigned block sizes of 32, 40, or 48 within each of the 4 strata. If a participant was
assigned to thickened liquids, a second randomization was done to assign the participant to
nectar-thick liquids or honey-thick liquids with equal probability. Neither the participants nor
direct caregivers were blinded to intervention assignment, but neither group made outcome
judgments. We expected that all liquids, regardless of amount or frequency of administration,
would be provided to participants consistent with the intervention to which the participant was
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randomly assigned. All participants continued nonliquid nutritional intake in the same manner
as before enrollment. Eight percent received nutrition by means of a gastrostomy tube.
Measurements and Outcomes
Primary Outcome
The primary outcome for the study was definite pneumonia. Definite pneumonia was defined
as evidence of pneumonia on chest radiography or 3 or more of the following: sustained fever
(temperature >100 °F [38 °C]), rales or rhonchi on chest auscultation, sputum Gram stain
showing substantial leukocytes, or sputum culture showing a respiratory pathogen.
Suspected pneumonia was defined as at least 2 of the 4 features of definite pneumonia (except
evidence of pneumonia on a chest radiograph). The primary care physician determined the
need for chest radiography or sputum culture as part of standard clinical care. Chest radiography
was done in all 52 patients with pneumonia; 2 of these patients did not have evidence of
pneumonia on chest radiography, but had 3 or 4 of the features of definite pneumonia.
Secondary Outcomes and Comparisons
A secondary outcome of interest was definite pneumonia or death. Secondary comparisons of
interest were relative effectiveness of the 2 degrees of thickening (honey thick vs. nectar thick)
and the effect of aspiration status at study entry (having aspirated all intervention liquids or
none of the intervention liquids during the swallowing study). A future manuscript will address
other secondary outcomes and comparisons.
Follow-up Procedures
Initially, all participants were monitored at all meals by caregivers and study staff for adherence
with the assigned intervention (“meal-monitoring”). In 1999, to lessen the burden on care
providers, meal-monitoring was reduced to randomized sets of 3 meals per week. Ultimately,
a goal of meal-monitoring for 300 participants, distributed evenly across the 3 interventions,
was selected, which provided CI widths of about 10 percentage points when compliance of
50% was assumed. Because the study was terminated early, 268 participants (96 in the chin-
down posture group, 90 in the nectar-thick liquid group, and 82 in the honey-thick liquid group)
were monitored for compliance with the assigned intervention. Participant characteristics did
not vary by more than 4 percentage points between the meal-monitored group and the group
that was not meal-monitored.
Exit forms were completed for participants at the end of the study or if participants discontinued
the intervention before the end of 3-month follow-up. Regardless of when participants exited
the intervention, their health outcomes were followed for 3 months. However, if participants
had pneumonia, their use of the intervention stopped and they were referred to their speech-
language pathologist for dysphagia management. Postintervention therapies were recorded
starting in 2001, although whether the therapy was administered in a manner consistent with
the study specifications was not specifically documented.
Clinicians assessed adverse events, which were defined as any clinically significant event
possibly related to the assigned intervention (for example, dehydration). Clinicians were
instructed not to report events expected as part of the participant’s disease progression or aging
process (for example, worsening of Parkinson disease symptoms). Clinicians rated all adverse
events as mild, moderate, severe, or life-threatening.
The Data and Safety Monitoring Committee met 16 times, either by phone or face-to-face. The
composition of the committee represented various disciplines included in the project. The
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committee discussed progress in patient accrual, study outcomes, and participant safety.
Quality site monitoring was conducted by the statistical and data center through extensive data
editing, queries, and site visits to selected facilities. Any problems identified by these quality-
control staff members were discussed with study personnel and corrected.
Statistical Analysis
Available literature at the time of study design suggested a 20% rate of cumulative pneumonia
incidence in the study population at 3 months (20-22). A sample size of 290 participants was
needed in each group (580 total) to provide a minimum of 90% power to detect a decrease in
cumulative pneumonia incidence of 10 percentage points in the chin-down posture group if
the cumulative pneumonia incidence in the thickened-liquids group was 20% (a 50% reduction
in pneumonia incidence). A monitoring plan defined before study initiation provided control
of α spending during interim safety analyses throughout the course of the study (23). The study
conducted interim analyses for 8 Data and Safety Monitoring Committee meetings scheduled
from July 2000 to August 2005. Each interim analysis evaluated a z statistic comparing rates
of pneumonia or death between primary interventions by using an O’Brien-Fleming lower
bound (24) with an α value of 0.025 and a Pocock (25) upper bound with an α value of 0.025.
Neither the upper nor the lower boundary was crossed in an interim analysis. In addition, an
unplanned conditional power calculation (26) was conducted at each interim analysis to
determine the likelihood of rejecting the null hypothesis at upcoming interim analyses, given
the study assumptions of a pneumonia or death rate of 0.10 with chin-down posture versus a
pneumonia or death rate of 0.20 with thickened liquids. At the first interim analysis, the
conditional power was greater than 0.5. By the final interim analysis, the conditional power
was less than 0.001, which provided clear evidence to terminate recruitment before reaching
the enrollment goal. Cumulative incidence rates for the outcomes of pneumonia and pneumonia
or death overall were calculated by using the Kaplan-Meier life table method. A Cox model
approach was used to assess primary intervention effect (chin-down posture vs. thickened
liquids) and secondary intervention effect (nectar thick vs. honey thick liquids) after controlling
for the 2 enrollment strata: age and diagnosis. Fisher exact tests (27) were used to compare
adverse event rates. All tests of hypotheses were 2-sided. P values are presented without
adjustment for testing of multiple end points. Missing data were limited to outcomes for
participants lost to follow-up without a known death or pneumonia event during 12 weeks of
follow-up. For these participants, follow-up time was censored at the time of study
discontinuation. All randomly assigned participants were included in the analyses to the extent
that information was available according to the intention-to-treat principle. All statistical
analyses were done by using SAS software, version 8.2 (SAS Institute, Cary, North Carolina).
Role of the Funding Source
The National Institutes of Health, through the Committee and Project Officer, had a role in the
design and conduct of the study, interpretation of the data, and review or approval of the
manuscript; however, they did not have a role in the collection, management, and analysis of
data or preparation of the manuscript.
Results
Study Flow
Figure 1 describes the study population. Seven hundred forty-two persons participated in the
short-term swallowing study (18), of whom 515 were eligible and randomly assigned in our
follow-up study. Two hundred fifty-nine participants were assigned to the chin-down posture
group, and 256 participants were assigned to thickened-liquids group. Of the 515 randomly
assigned participants, 413 completed 3 months of follow-up with no incidence of pneumonia,
39 without previous incidence of pneumonia were followed until death, 52 developed
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pneumonia (of whom 21 subsequently died), and 11 without previous incidence of pneumonia
had incomplete follow-up (ranging from <1 week to 2 months).
Demographic Characteristics
Table 1 shows participant characteristics by intervention group. Seventy percent were men,
59% were age 80 years or older (median age, 81), and 16% were of minority ethnicity. Fifty
disease with dementia. About two thirds of participants qualified for enrollment in the study
by aspirating with all interventions in the swallowing study.
Cumulative Incidence Rates within Intervention and Participant Subgroups
Pneumonia Outcome
Figure 2 shows the Kaplan-Meier estimate (28) of pneumonia by main intervention group. The
3-month Kaplan-Meier estimates of pneumonia in the chin-down posture and thickened-liquid
groups were 0.098 (24 events) and 0.116 (28 events), respectively (hazard ratio [HR], 0.84
[95% CI, 0.49 to 1.45]; P = 0.53). When participants were stratified by short-term aspiration
status, the 3-month Kaplan-Meier estimates of pneumonia in the chin-down posture and
thickened-liquid groups were 0.082 (6 events) and 0.0436 (4 events), respectively (HR, 1.91
[CI, 0.54 to 6.78]; P = 0.32) for participants who aspirated during none of the interventions
and 0.105 (18 events) and 0.161 (24 events), respectively (HR, 0.64 [CI, 0.35 to 1.18]; P =
0.153), for participants who aspirated during all 3 interventions.
The 3-month Kaplan-Meier estimates of pneumonia in the nectar-thick and honey-thick liquid
groups were 0.084 (10 events) and 0.150 (18 events), respectively (HR, 0.50 [CI, 0.23 to 1.09];
P = 0.083). When participants were stratified by short-term aspiration status, the 3-month
Kaplan-Meier estimates of pneumonia in the nectar-thick and honey-thick liquid groups were
0.000 (0 events) and 0.084 (4 events), respectively (P = 0.051, log-rank test) for participants
who aspirated during none of the interventions and 0.130 (10 events) and 0.195 (14 events),
respectively (HR, 0.58 [CI, 0.26 to 1.31; P = 0.193), for participants who aspirated during on
all 3 interventions. Figure 3 shows that the 95% CIs for the estimated effect of intervention
within subgroups for pneumonia generally overlapped, and all contained the estimated HR for
all participants. No diagnosis--intervention interaction effect was observed (P = 0.117). Using
suspected pneumonia as an outcome did not materially alter the intervention effect estimates.
Pneumonia or Death
The 3-month Kaplan-Meier estimates of pneumonia or death in the chin-down posture and
thickened-liquid groups were 0.180 (46 events) and 0.183 (46 events), respectively (HR, 0.98
[CI, 0.65 to 1.48]; P = 0.94). The 3-month Kaplan-Meier estimates of pneumonia or death in
the nectar-thick and honey-thick liquid groups were 0.163 (21 events) and 0.205 (25 events),
respectively (HR, 0.76 [CI, 0.43 to 1.36]; P = 0.36).
Figure 3 shows that the 95% CIs for the estimated effect of intervention within subgroups for
pneumonia or death generally overlapped, and all contained the estimated HR for all
participants.
Table 2 summarizes adverse events, hospitalizations, and mortality by intervention. Fourteen
participants withdrew from the interventions because of an adverse event or hospitalization.
One hundred nineteen participants (23%) had at least 1 adverse event during the study. The
combined outcome of at least 1 dehydration, urinary tract infection, or fever event (all defined
by the primary physician) was more frequent in the thickened-liquid groups than the chin-down
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posture group (23 patients vs. 12 patients [9% vs. 5%]; difference, 4 percentage points [CI, 0.3
to 9 percentage points]; P = 0.055). Withdrawals due to adverse experiences or hospitalizations
were also more common in the thickened-liquid groups than the chin-down posture group (10
patients vs. 4 patients [4% vs. 2%]; difference, 2 percentage points [CI, -0.4 to 5 percentage
points]; P = 0.112). Increased breathing difficulty was more frequent in the chin-down posture
group (4 [2%] vs. 0; P = 0.124). Among participants assigned to thickened liquids, diarrhea
was more frequent in the nectar-thick liquid group than in the honey-thick liquid group (5
patients vs. 0 patients [2% vs. 0%]; P = 0.061). Occurrence of a serious adverse event (life-
threatening adverse event, hospitalization, or death) was balanced across primary and
secondary intervention groups. Median length of hospital stay because of pneumonia for
participants in the honey-thick liquid group was 18 days (6 events) compared with 6 days for
the chin-down posture group (13 events) and 4 days for the nectar-thick liquid group (9 events).
Adherence was measured weekly across assessed meals and classified on a monthly basis as
0% to 25%, 26% to 50%, 51% to 75%, or 76% to 100% (Appendix Table, available at
www.annals.org). Data on 31 of the 268 participants monitored for intervention adherence
were too sparse to analyze, and compliance was not rated across 3 months of follow-up for an
additional 74 participants. In the chin-down posture group, a higher proportion of participants
with Parkinson disease had adherence greater than 50% compared with participants with
dementia or Parkinson disease with dementia (91% vs. 57% to 58%). Adherence greater than
50% to the nectar-thick intervention across 3 months of follow-up was fairly even across
diagnoses (67% to 73%). Adherence greater than 50% to the honey-thick intervention across
3 months of follow-up was highest among participants with dementia (91%), followed by
participants with Parkinson disease (75%) and then by participants with Parkinson disease with
dementia (56%). Cumulative pneumonia incidence in each intervention was similar among
participants with adherence greater than 50% compared with the entire cohort. Among 340
participants for whom data are available about changes in therapy, 15 (4%) switched to a
different therapy before the end of follow-up.
Discussion
We compared 2 common but untested interventions to prevent pneumonia---chin-down posture
and thickened liquids---in persons with dementia or Parkinson disease who had a known
tendency to aspirate liquid. By performing a systematic search of PubMed from January 1990
to December 2007 using the terms dysphagia, pneumonia, Parkinson’s disease and
dementia, we identified no other studies that compared outcomes of such treatments in these
populations.
We found a 3-month cumulative incidence of pneumonia of 11% across all enrolled
participants. This rate was much lower than the rate assumed at study initiation and lower than
a 3-month cumulative pneumonia incidence of 20% to 40% reported in elderly patients with
stroke, dementia, or Parkinson disease or residing in nursing homes (20-22,29-32). We cannot
determine whether the lower rate in our sample represents an effect of intervention or changes
over time in other health care delivery because we did not include a control group for no
treatment.
Our study failed to reject the null hypothesis of no difference between the chin-down-posture
and thickened-liquid interventions. Our results are consistent with differences as large as a
51% decrease in the HR for pneumonia and a 45% increase in the HR for pneumonia associated
with the chin-down posture (HR, 0.84 [CI, 0.49 to 1.45]; P = 0.53). Our secondary results found
that participants drinking nectar-thick liquids had a lower incidence of pneumonia than those
drinking honey-thick liquids (HR, 0.50 [CI, 0.23 to 1.09]; P = 0.083), although the results do
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not exclude an increase in the HR for pneumonia of 9% associated with nectar-thick liquids
compared with honey-thick liquids. Although only 10 cases of pneumonia occurred in the 170
participants for whom all of the conditions in the short-term trial worked equally well, no cases
were reported in those randomly assigned to drink nectar-thick liquids for 3 months. These
intriguing findings warrant further study. Nectar-thick liquids may be easier to clear from the
airway than more viscous liquids, as indicated by the longer median length of hospital stay for
participants randomly assigned to honey-thick liquid who developed pneumonia.
The common clinical assumption that “the thicker the liquid, the safer the swallow,” is largely
based on short-term response and either bedside or videofluoroscopic evaluation (18). Our
findings temper support for 3000-centipoise honey-thick liquid as an intervention in patients
with dementia or Parkinson disease who aspirate thin liquid. Of note, however, we studied only
participants who did not benefit preferentially from an intervention. It remains to be discovered
whether participants for whom honey-thick fluid reduces aspiration preferentially in the
fluoroscopy suite, and are then treated with honey-thick liquids, remain in better respiratory
health with fewer or less severe adverse outcomes (for example, hospital length of stay if
pneumonia occurred).
The outcomes of our study focus on important issues of clinical significance. The lower-than-
expected pneumonia incidence in our sample changes the threshold at which clinicians,
patients, or caregivers balance the risks and benefits of the available interventions. If one
chooses to use an intervention with no proven effect on risk for aspiration and pneumonia, the
chin-down posture, which allows the person to enjoy the taste and texture of thin liquids, is an
option. Alternatively, choosing nectar-thick liquids, which require less training and oversight
during the swallowing process, is also a reasonable choice. Moreover, in the neurodegenerative,
often depressed critical care patients, choices as basic as drinking a cold glass of water or a hot
cup of tea ultimately depend on the desires and judgments of the patients and their caregivers.
Our study has limitations. We did not include a no-treatment group because “no treatment” is
unethical in the context of standard clinical care. The nature of the interventions did not allow
blinding of direct care providers, although these individuals were not responsible for
determining the primary outcome of pneumonia diagnosis. The 3-month follow-up period was
short, but it was chosen to balance concern over attrition in a frail elderly population with
sensitivity to develop detectible pneumonia. Adherence to prescribed interventions was, as
expected, a problem. An “efficacy” study conducted in circumstances with intensive or optimal
staffing that ensured adherence to interventions might show benefits of 1 therapy over another.
However, staffing shortages and care provider “burnout” are known limitations that exist
widely across institutional and even noninstitutional settings: findings from an “efficacy” study
conducted in an unrealistic setting would not be generalizable.
In the end, given the lower-than-expected overall pneumonia incidence and the point estimates
of pneumonia incidence for each intervention, it is difficult to argue that further study is needed
to better quantify potential differences between chin-down posture and thickened liquids.
Future investigation of chin-down posture combined with nectar-thick liquid may be warranted
to determine whether use of both interventions simultaneously significantly decreases the
pneumonia rate compared with use of either intervention alone. Our findings should prompt
clinicians to question the practice of recommending very thick liquids (in this case, 3000
centipoise) without first evaluating all possible intervention options and considering of the
relative cost burden to the patient and care providers, not just in terms of dollars but also quality
of life.
From William S. Middleton Memorial Veterans Hospital, Geriatric Research Education and
Clinical Center (GRECC), Madison, Wisconsin; The EMMES Corporation, Rockville,
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Maryland; University of Wisconsin, Madison, Wisconsin; Northwestern University, Evanston,
Illinois; ORC Macro, Calverton, Maryland; Stanford University School of Medicine, Palo Alto,
California; Minneapolis Veterans Affairs Medical Center, Minneapolis, Minnesota; University
of Miami Hospital and Clinics, Miami, Florida; New York Hospital Medical Center-Queens,
Flushing, New York; Veterans Affairs Boston Healthcare System, West Roxbury,
Massachusetts; Richard L. Roudebush Veterans Affairs Medical Center, Indianapolis, Indiana;
and American Speech-Language-Hearing Association, Rockville, Maryland.
Acknowledgment
The authors thank Susi Nehls, BS, for editing expertise; Abby Duane, BS, for preparing the manuscript; E. Kenneth
Sullivan, PhD, for study design and statistical analysis; Carol Caperton Wenck, MS, CCRA, for coordination of the
project; and Jeffrey Glassroth, MD, and Jeffrey Grossman, MD, for sharing their perspectives on critical care of patients
with pneumonia.
Grant Support: By the National Institute on Deafness and Other Communication Disorders, National Institutes of
Health (DC03206). Additional support for the grant was provided by Novartis and E-Z-EM to the American Speech-
Language-Hearing Association, Communication Sciences and Disorders Clinical Trials Research Group. This is
GRECC Manuscript #2006-03.
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Figure 1.
Study flow diagram.
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Figure 2.
Cumulative incidence of pneumonia in the chin down posture and thickened liquid groups
(P = 0.53, log-rank test).
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Figure 3.
A.Forest plot showing primary intervention effect for pneumonia in subgroups.
B. Forest plot showing primary intervention effect for pneumonia or death in subgroups.
Robbins et al. Page 14
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Robbins et al. Page 15
Table 1
Participant Characteristics at Enrollment
*
Interventions Thickened Liquids
Chin Down Thickened Liquids Nectar-Thick Honey-Thick
N % N % N % N %
N 259 100 256 100 133 100 123 100
Gender
Male 178 69 181 71 93 70 88 72
Female 81 31 75 29 40 30 35 28
Age
50-59
2 1 4 2 2 2 2 2
60-69 16 6 21 8 16 12 5 4
70-79 88 34 78 30 37 28 41 33
80-89 127 49 125 49 66 50 59 48
90-95 26 10 28 11 12 9 16 13
Age: Mean (median) 81 (81) 80 (81) 80 (81) 81 (81)
Race
White 217 84 214 84 111 84 103 84
Black 22 8 18 7 7 5 11 9
Hispanic 10 4 7 3 3 2 4 3
Asian or Pacific Islander 9 3 16 6 12 9 4 3
Other 1 <1 1 <1 0 0 1 1
Educational level
No formal education 1 <1 2 1 1 1 1 1
Some grammar school 51 20 36 14 18 14 18 15
Some high school 42 16 42 16 26 20 16 13
High school graduate 76 29 80 31 37 28 43 35
1+ years of college 55 21 66 26 36 27 30 24
1+ years of graduate school 20 8 24 9 13 10 11 9
Not reported 14 5 6 2 2 2 4 3
Diagnosis
Dementia - Alzheimer’s 42 16 46 18 20 15 26 21
Dementia - Single or multi stroke 40 15 35 14 17 13 18 15
Dementia - Other 49 19 48 19 29 22 19 15
Idiopathic PD
- No Dementia
83 32 71 28 39 29 32 26
Idiopathic PD
- Dementia
45 17 56 22 28 21 28 23
Aspiration during Immediate (short-term) study
None of the interventions 76 30 94 37 46 35 48 39
All of the interventions 183 70 162 63 87 65 75 61
*
PD: Parkinson’s disease
Includes one participant enrolled 2 weeks short of turning 50 years o
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Table 2
Adverse Experiences, Hospitalizations, or Death, by Intervention
N (%)
Condition Chin Down (n=259) Thickened Liquids (n=256) Nectar-
Thick (n=133)
Honey-
Thick (n=123)
Participants with at least one
*
51 (20%) 68 (27%) 38 (29%) 30 (24%)
Dehydration 6 (2%) 15 (6%) 7 (5%) 8 (7%)
Urinary tract infection (UTI) 8 (3%) 16 (6%) 11 (8%) 5 (4%)
Fever 4 (2%) 10 (4%) 7 (5%) 3 (2%)
Weight loss 4 (2%) 6 (2%) 3 (2%) 3 (2%)
Fatigue/weakness 4 (2%) 6 (2%) 3 (2%) 3 (2%)
Vomiting 3 (1%) 7 (3%) 5 (4%) 2 (2%)
Diarrhea 1 (<1%) 5 (2%) 5 (4%) 0 (0%)
Increased breathing difficulty 4 (2%) 0 (0%) 0 (0%) 0 (0%)
At least one dehydration, UTI, or
fever event
12 (5%) 23 (9%) 14 (11%) 9 (7%)
At least one weight loss or
fatigue event
7 (3%) 8 (3%) 4 (3%) 4 (3%)
Participants hospitalized at least
once
52 (20%) 51 (20%) 28 (21%) 23 (19%)
Withdrawals from interventions
hospitalization
4 (2%) 10 (4%) 5 (4%) 5 (4%)
Death 32 (12%) 29 (11%) 15 (11%) 14 (11%)
*
71 (27%) 66 (26%) 34 (26%) 32 (26%)
*
Adverse events occurring in 10 or more participants or those clinically meaningful are listed.
An outcome of life-threatening adverse experience, hospitalization, or death.
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Electronic-only Table
Compliance of >50% at each month, by intervention and diagnosis
*
Intervention
Chin Down Nectar-thick Honey-thick
Diagnosis
M1
M2
M3
§
M1 M2 M3 M1 M2 M3
Parkinson’s Disease (# with >50% compliance / # available) 21/25 21/24 20/22 23/28 17/23 14/21 15/19 12/16 12/16
>50% compliant (%) 84% 88% 91% 82% 74% 67% 79% 75% 75%
Dementia (# with >50% compliance / # available) 20/32 16/26 13/23 26/32 18/25 16/22 33/35 24/27 21/23
>50% compliant (%) 63% 62% 57% 81% 72% 73% 94% 89% 91%
PD with Dementia (# with >50% compliance / # available) 12/17 7/12 7/12 15/18 13/17 11/15 9/14 8/10 5/9
>50% compliant (%) 71% 58% 58% 83% 76% 73% 64% 80% 56%
TOTAL (# with >50% compliance / # available) 53/74 44/62 40/57 64/78 48/65 41/58 57/68 42/53 38/48
>50% compliant (%) 72% 71% 70% 82% 74% 71% 84% 79% 79%
*
M1 = Month 1; M2 = Month 2; M3 = Month 3; PD = Parkinson’s disease
Numbers in M1 columns reflect participants whose compliance through the first month was > 50%.
Numbers in M2 columns reflect participants whose compliance was > 50% for both month 1 and month 2.
§
Numbers in M3 columns reflect participants whose compliance was >50% for all three months.
Ann Intern Med. Author manuscript; available in PMC 2008 October 1.
... It is recommended to involve clients and give information about the various options for managing OD and let them have the possibility to consider the pros and cons in the context of one's own goals and preferences. This will allow clients to decide by themselves, which should then be respected [1,7]. As in our previous systematic review [3] we did not identify any studies using TMD with a control group receiving standard care. ...
... Compared to Beck et al. [3] in which the Cochrane risk of bias tool 1 (RoB1) was applied, we used the RoB2 [4] in the current work. This resulted in an up-grading of the evidence for the two previous included studies [7,8]. This finding might be because RoB2 contains signaling questions and pathways, which might have assisted us to address more aspects within each risk of bias domain compared to RoB1 that do not provide such guidance. ...
... This finding might be because RoB2 contains signaling questions and pathways, which might have assisted us to address more aspects within each risk of bias domain compared to RoB1 that do not provide such guidance. However, the strength of our guideline recommendations might be questioned as the data from Robbins et al. [7] and Logemann et al. [8] originates from the same study population and the study by Sezgin et al. [6] was low quality graded. Additionally, in the study by Robbins et al. [7], recruitment was terminated before reaching the estimated sample size. ...
Article
Background & Aims It is well known that oropharyngeal dysphagia (OD) challenges eating, drinking, and swallowing by penetration to the airway. In clinical practice, thickening agents in liquid and texture modified diets are used to reduce pneumonia and secure nutritional status. The scientific evidence on this OD management is, however, limited. In 2016 we updated an original clinical guideline on OD in adults. Based on the strength of the evidence of two randomized control trials (RCTs), we provided a weak clinical recommendation against the use of thickening agents for liquid and none for diet. In the hope of finding new scientific evidence, we aimed to update the clinical guideline by examining the evidence if thickening of liquid and diet 1) improve survival and quality of life, 2) reduce the occurrence of aspiration risk and pneumonia, 3) improve dehydration, nutritional status, and mealtime performance, and 4) relate to patient preferences and intervention adherence. Methods We performed a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist. We first searched systematic reviews and meta-analyses, and secondly, the primary literature of RCTs. We undertook the search in PubMed, Embase, CINAHL, Cochrane Database of Systematic Reviews, and Cochrane Central Register of Controlled Trials from January 1, 2015, to May 19, 2021. The quality of the evidence was evaluated using the revised Cochrane risk-of-bias tool and the GRADE (Grading of Recommendations: Assessment, Development and Evaluation) approach. Results One new study was included, resulting in a total of three RCTs, of which two were already included in our former guideline. The three studies focused on the thickening of liquid, but no change of the former weak recommendation against the thickening of liquid could be made due to the quality of evidence evaluation. Conclusion There is no convincing evidence that thickened liquid or texture modified diet prevents death or pneumonia nor improves the quality of life, nutritional status, or oral intake in individuals with OD. There is a need for future studies to examine the effect and discuss outcome measures in OD management with thickening agents.
... Thickened liquids, for example, might reduce, but not eliminate, the volume of aspirate for some but have not been shown to date to reduce the risk of pneumonia [14]. Indeed, the only large randomised clinical trial suggested that very thick fluids may increase the risk and severity of pneumonia [54]. If modified texture diets are proposed, patients need to know of this uncertainty in the evidence to make their own informed choice ( Table 1). ...
... Increased residue and reduced cilial clearance with TL might mean more risk of pneumonia There is no evidence to suggest TL reduce pneumonia [50]. There is some limited evidence that very thick liquids lead to more and to more severe pneumonia [54]. Animal studies suggest that aspiration of TL causes more lung inflammation than aspiration of thin liquids [56] Easier to control swallowing with TL may mean less distress and coughing when drinking TL are less thirst quenching and pleasant to drink [57] The balance of evidence is that TL have an adverse impact on QOL, and many people will not accept them as a result [58] Reduced fluid intake and greater risk of dehydration and renal impairment ...
Article
Background Use of modified texture diets-thickening of liquids and modifying the texture of foods-in the hope of preventing aspiration, pneumonia and choking, has become central to the current management of dysphagia. The effectiveness of this intervention has been questioned. We examine requirements for a valid informed consent process for this approach and whether the need for informed consent for this treatment is always understood or applied by practitioners. Main text Valid informed consent requires provision of accurate and balanced information, and that agreement is given freely by someone who knows they have a choice. Current evidence, including surveys of practitioners and patients in different settings, suggests that practice in this area is often inadequate. This may be due to patients' communication difficulties but also poor communication-and no real attempt to obtain consent-by practitioners before people are 'put on' modified texture diets. Even where discussion occurs, recommendations may be influenced by professional misconceptions about the efficacy of this treatment, which in turn may poison the well for the informed consent process. Patients cannot make appropriate decisions for themselves if the information provided is flawed and unbalanced. The voluntariness of patients' decisions is also questionable if they are told 'you must' , when 'you might consider' is more appropriate. Where the decision-making capacity of patients is in question, inappropriate judgements and recommendations may be made by substitute decision makers and courts unless based on accurate information. Conclusion Research is required to examine the informed consent processes in different settings, but there is ample reason to suggest that current practice in this area is suboptimal. Staff need to reflect on their current practice regarding use of modified texture diets with an awareness of the current evidence and through the 'lens' of informed consent. Education is required for staff to clarify the importance of, and requirements for, valid informed consent and for decision making that reflects people's preferences and values.
... Thickened liquids, for example, might reduce, but not eliminate, the volume of aspirate for some but have not been shown to date to reduce the risk of pneumonia [14]. Indeed, the only large randomised clinical trial suggested that very thick fluids may increase the risk and severity of pneumonia [54]. If modified texture diets are proposed, patients need to know of this uncertainty in the evidence to make their own informed choice ( Table 1). ...
... Increased residue and reduced cilial clearance with TL might mean more risk of pneumonia There is no evidence to suggest TL reduce pneumonia [50]. There is some limited evidence that very thick liquids lead to more and to more severe pneumonia [54]. Animal studies suggest that aspiration of TL causes more lung inflammation than aspiration of thin liquids [56] Easier to control swallowing with TL may mean less distress and coughing when drinking TL are less thirst quenching and pleasant to drink [57] The balance of evidence is that TL have an adverse impact on QOL, and many people will not accept them as a result [58] Reduced fluid intake and greater risk of dehydration and renal impairment ...
Article
Full-text available
Background Use of modified texture diets—thickening of liquids and modifying the texture of foods—in the hope of preventing aspiration, pneumonia and choking, has become central to the current management of dysphagia. The effectiveness of this intervention has been questioned. We examine requirements for a valid informed consent process for this approach and whether the need for informed consent for this treatment is always understood or applied by practitioners. Main text Valid informed consent requires provision of accurate and balanced information, and that agreement is given freely by someone who knows they have a choice. Current evidence, including surveys of practitioners and patients in different settings, suggests that practice in this area is often inadequate. This may be due to patients’ communication difficulties but also poor communication—and no real attempt to obtain consent—by practitioners before people are ‘put on’ modified texture diets. Even where discussion occurs, recommendations may be influenced by professional misconceptions about the efficacy of this treatment, which in turn may poison the well for the informed consent process. Patients cannot make appropriate decisions for themselves if the information provided is flawed and unbalanced. The voluntariness of patients’ decisions is also questionable if they are told ‘you must’, when ‘you might consider’ is more appropriate. Where the decision-making capacity of patients is in question, inappropriate judgements and recommendations may be made by substitute decision makers and courts unless based on accurate information. Conclusion Research is required to examine the informed consent processes in different settings, but there is ample reason to suggest that current practice in this area is suboptimal. Staff need to reflect on their current practice regarding use of modified texture diets with an awareness of the current evidence and through the ‘lens’ of informed consent. Education is required for staff to clarify the importance of, and requirements for, valid informed consent and for decision making that reflects people’s preferences and values.
... However, there is a lack of evidence about interventions or negative results in the few trials performed [14]. In a randomized clinical trial comparing the incidence of pneumonia among 515 patients with dementia and PD who were randomized to either chin-down posture technique or two types of thickened fluids (nectar-and honey-thick consistencies) over a 3 month follow up period, at least one hospital admission was observed in 20% of each intervention arms [40]. Considering the complexity of managing PD, it is likely that a multimodal approach which addresses motor and non-motor complications, as well as palliatives aspects in end-stage disease, may be more effective compared to a single intervention approach [14,41,42]. ...
Article
Full-text available
Background: There is a need for identifying risk factors for hospitalization in Parkinson's disease (PD) and also interventions to reduce acute hospital admission. Objective: To analyze the frequency, causes, and predictors of acute hospitalization (AH) in PD patients from a Spanish cohort. Methods: PD patients recruited from 35 centers of Spain from the COPPADIS-2015 (COhort of Patients with PArkinson's DIsease in Spain, 2015) cohort from January 2016 to November 2017, were included in the study. In order to identify predictors of AH, Kaplan-Meier estimates of factors considered as potential predictors were obtained and Cox regression performed on time to hospital encounter 1-year after the baseline visit. Results: Thirty-five out of 605 (5.8%) PD patients (62.5 ± 8.9 years old; 59.8% males) presented an AH during the 1-year follow-up after the baseline visit. Traumatic falls represented the most frequent cause of admission, being 23.7% of all acute hospitalizations. To suffer from motor fluctuations (HR [hazard ratio] 2.461; 95% CI, 1.065-5.678; p = 0.035), a very severe non-motor symptoms burden (HR [hazard ratio] 2.828; 95% CI, 1.319-6.063; p = 0.008), falls (HR 3.966; 95% CI 1.757-8.470; p = 0.001), and dysphagia (HR 2.356; 95% CI 1.124-4.941; p = 0.023) was associated with AH after adjustment to age, gender, disease duration, levodopa equivalent daily dose, total number of non-antiparkinsonian drugs, and UPDRS-III-OFF. Of the previous variables, only falls (HR 2.998; 95% CI 1.080-8.322; p = 0.035) was an independent predictor of AH. Conclusion: Falls is an independent predictor of AH in PD patients.
... [42] Thickening of liquid feed reduces aspiration in patients of OD but carries the risk of dehydration and urinary tract infection. [43,44] Certain postural adjustments can be taught to patients and caregivers, which are compensatory interventions that are helpful in a range of specific clinical conditions. Chin-up widens the oropharynx and helps the movement of the bolus from the mouth into the pharynx, which is useful in patients with the oral or lingual defects. ...
Article
Full-text available
The process of eating and swallowing is a complex physiologic process requiring volitional as well as reflexive activities and involving multiple structural and functional elements. Dysphagia is a geriatric syndrome resulting in multiple negative health consequences. Dysphagia can have profound adverse influences, including malnutrition, dehydration, aspiration pneumonia, and depression poor quality of life in the elderly. With the aging of the population across the globe, health‑care providers are encountering older patients with dysphagia either due to oropharyngeal or esophageal disease. Barium swallow remains a low‑cost initial alternative for luminal and esophageal motility assessment. A variety of emerging modalities can help detect anatomical and functional deficits. These include fiberoptic endoscopic evaluation of swallowing, videofluoroscopic swallow study, high‑resolution pharyngeal manometry, and esophagogastroduodenoscopy. This review provides a comprehensive review of diagnostic modalities and addresses several issues regarding the collaborative management of elderly persons with dysphagia, including a brief discussion on how swallowing mechanisms are affected by the aging process.
... No reminders were sent to non-responders. There were no adequate validated questionnaires for this purpose, so an original questionnaire was made based on a literature review [14,15] and discussion between researchers. The following items were included in the questionnaire, distributed after hospital discharge: age, sex, height, and weight, whether the patient was alive or dead (with the cause of mortality), times of subsequent hospital admissions (yes/no, and the dates of any hospitalizations), state of consciousness, food consistency, frequency of aspiration, physical activity status, a urinary catheter (yes/no), and percutaneous endoscopic gastrostomy (PEG) tube feeding (yes/no). ...
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Aspiration pneumonia (AP) is the leading cause of death among the elderly in Japan. The factors associated with the survival of elderly patients with AP are investigated in this retrospective observational study. Patients with AP over the age of 60 who were assessed for swallowing function in our hospital between April 2015 and March 2016 were eligible. Data on patients' body mass index (BMI), food consistency, and Karnofsky performance status were collected from medical records in hospital and again after recovery. Following hospital discharge, eligible patients were sent questionnaires containing information about their physical conditions, such as body weight and the Japanese version of the functional independence measure. Respondents were divided into two groups: those who died and those who survived, and the factors associated with patient mortality were investigated. There were 19 responses from 50 eligible patients, and seven patients died. The participants' average age was 81 years (SD 9.32). There were ten male participants (52.6%, p=1.00), and there were no significant differences in the mortality and survival groups. The most significant finding was that BMI was significantly lower in the patients who died (p=0.037, Cohen’s d=1.10). Fisher's exact tests clearly demonstrated that patients with a BMI <19.9 had a higher mortality rate (p=0.017). Lower BMI may be associated with increased mortality in elderly patients with a history of AP. In general practice, BMI is simple to measure and may allow for an easy assessment of the risk of AP-related mortality.
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Background: The progression of Parkinson's disease is associated with complications, most of them preventable. Aim: To analyze hospitalizations with a diagnosis of Parkinson's disease in Chile, comparing the different health subsystems. Material and methods: Analysis of hospital discharge database available at the website of the Chilean Ministry of Health. Discharges that incorporated the diagnosis of Parkinson's disease (ICD 10 code G20), between the years 2001 and 2018 were analyzed. Results: The rate of discharges with the diagnosis of Parkinson's disease was 34.5 per 100,000 hospitalizations. The figures were 55.2 and 29.8 discharges per 100,000 in 2001 and 2018, respectively. Sixty seven percent of hospital admissions for Parkinson's occurred in the public sector and corresponded to beneficiaries of the public health insurance system (FONASA). Beneficiaries of private insurance systems accounted for 12% of hospital admissions. The mean hospital stay was 13.4 days. Conclusions: There is a decrease over time in the rate of hospitalizations with Parkinson's disease. This trend may be related with the incorporation of this disease in a special governmental program that guarantees a timely access to diagnosis and treatment.
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