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1/29/2009
DIAGNOSIS AND MANAGEMENT OF DYSPHAGIA AND ITS ADVERSE OUTCOMES
Evidence Based Decision Making by SLP’s March 07, 2009
Ohio Speech Language and Hearing Association Convention
Columbus, OH
James L. Coyle, Ph.D., CCC‐SLP, BRS‐S
Department of Communication Science and Disorders
University of Pittsburgh
1
Why “Medical” SLP?
ƒ Our profession’s history
à Communication science: anatomy, physiology
à Psychological/social communicative mechanisms à Transmission of sound
T
i i f d
à Conditions impairing use of communication
à Environmental factors affecting communication
à Effects of communication and swallowing function on individuals and society
Johnson & Jacobson, 2007.
2
Medical Speech Language Pathology
ƒ Evolution of the Profession
ƒ Speed of medical technology change
ƒ Discovery of causes of preventable diseases
Our role has changed to include not only…
ƒ Restoration of functions after disease and trauma, but also…
ƒ Prevention of diseases that shorten lives
3
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Using Evidence in Practice
ƒ Research consumerism
à Clinicians are research consumers
‚ If not, they’d better be…
ƒ Evidence is essential
E id
i ti l
à Buying a product Æ offering a clinical service
à Choosing a physician Æ offering competent service
à Agreeing to a treatment Æ choosing the best treatment for our patient
4
Topics
ƒ 1. External Evidence: treatment, diagnosis
à Controversial methods, common methods
‚ ES, DPNS, water protocols
‚ VFG vs. FEES diagnosis
ƒ 2. Pulmonary Issues: Aspiration Pneumonia
à Using evidence to differentiate among similar syndromes
à What is and what is not aspiration pneumonia
5
Evidence. What is Evidence?
Smith et al., 2003
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A Little Data Can Be a Dangerous Thing…
p<0.05!!!
“… significant inverse relationship between pirates and global temperature.” 7
What is Evidence‐Based Practice?
8
What is Evidence‐Based Practice?
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
1. See a patient
2. Ask a question
3. Seek the best evidence for that question
4. Appraise that evidence
5. Apply the evidence
6. Monitor the change
7. Continuously re‐evaluate ourselves
University of Oxford
Centre for Evidence Based Medicine
http://www.jr2.ox.ac.uk/bandolier
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1. See A Patient
ƒ Signs and Symptoms ƒ Medical Record, Interview
ƒ Examination‐Collect Data
ƒ Individual’s Characteristics
ƒ Form a list of what is known, what issues need resolution
10
2. Ask a Question
ƒ 1. Therapy
à Best methods to achieve target outcome
ƒ 2. Screening/Diagnostic tests à Predicting instrumental test results
à Predict long term consequences
11
2. Ask a Question
The “Answerable” Clinical Question has 4‐Parts PICO
ƒ 1. Who is the Patient or what is the clinical Problem you are planning to treat?
y
p
g
ƒ 2. What Intervention are you considering?
ƒ 3. What alternative or Comparison treatment is available? ƒ 4. What clinical Outcomes are you targeting?
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3. Seek the BEST evidence for the question
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4. Appraise the evidence
ƒ Read the article(s), evaluate them!
à Characteristics of good and not‐so‐good published research…
à Some “types” of articles are stronger than S
“
” f i l h others.
‚ Which article “types” are stronger?
‚ Which have better quality?
‚ Which are more valid?
14
4 Characteristics to Evaluate ƒ a. Design
ƒ b. Sample Size
ƒ c. Internal Validity
ƒ d. External Validity
d External Validity
ƒ Baker & Tickle‐Degnen, (2001).
à
An explicit scoring mechanism – multidimensional and unambiguous
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a. Design
(Case-control study, cohort, case series)
RCT, quasi‐experiment, cohort, pre‐post, SSD
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b. Sample Size
ƒ Persons per condition, observations (SSD)
ƒ “More is always better.” True or false?
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Synthesis
•Average 1‐2 per day drinker has 1.19 times greater odds of outscoring teetotalers
•Average 1‐2 per day drinker scored 0.28 SD higher on MMSE than average teetotaler
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c & d: internal and external validity
ƒ Believability of research depends on how well authors controlled for sources of bias and error
ƒ c. Internal Validity:
à How well the study’s design controlled the for sources or error
‚ Efficacy: outcome under controlled conditions
ƒ d. External Validity:
à How well the study matches reality
‚ Effectiveness: outcome in typical practice
19
Therapy Studies–
judging validity
Patients/
Subjects Control
Group
Experimental (Tx) Group
Control Effects
Treatment Effects
Subjects Analyzed
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Validity
ƒ 1. Were all patients similar at start
1. Were all patients similar at start of trial?
ƒ 2. Were patients 2. Were patients randomly
randomly assigned to the treatment groups? à And was randomization list concealed
And was randomization list concealed??
ƒ 3. Were clinician/judges blinded/subjects masked?
ƒ 4. Were all patients were treated 4. Were all patients were treated equally?
equally?
à except for the experimental method
except for the experimental method
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Validity
ƒ 5. Was follow
5. Was follow‐‐up up sufficiently
sufficiently long and complete?
ƒ 6. Were Were all all patients patients analyzed
analyzed as as randomized?
randomized?
à Attrition, intention to treat
ƒ 7. Was treatment effect hypothesized at start of trial?
ƒ 8. Effects of maturation/recovery, test learning?
ƒ 9. Conflicts of interest ???
ƒ 10. Is the treatment feasible?
22
Effects of Randomization
http://www.jr2.ox.ac.uk/bandolier
23
Effects of Blinding
http://www.jr2.ox.ac.uk/bandolier
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Evidence for common and controversial therapeutic interventions
Electrical Stimulation
Physiologic Principles
DPNS
“DPNS”
Evidence Summary
“Free Water Protocols”
Comments on Clinical Use
25
Electrical Stimulation
Evidence Summary for Electrical Stimulation for Oropharyngeal Dysphagia
26
Electrical Stimulation Principles
ƒ Facilitate laryngeal elevation
à 1. Necessary for airway closure
à 2. Essential to UES opening
2 Essential to UES opening
à 3. Contributes to bolus clearance
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Electrical Stimulation Principles
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sternohyoid
thyrohyoid
geniohyoid
g
y
ant. digastric
mylohyoid
platysma
Images from Visible Human Project: http://www.nlm.nih.gov/research/visible/visible_human.html 29
Evidence for Electrical Stimulation
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ƒ
Blumenfeld, L., Hahn, Y., LePage, A., Leonard, R., & Belafsky, P. C. (2006). Transcutaneous electrical stimulation versus traditional dysphagia therapy: a nonconcurrent cohort study. Otolaryngology ‐ Head & Neck Surgery.135(5):754‐7.
ƒ
Burnett, T. A., Mann, E. A., Cornell, S. A., & Ludlow, C. L. (2003). Laryngeal elevation achieved by neuromuscular stimulation at rest. Journal of Applied Physiology., 94, 128‐134.
ƒ
Carnaby‐Mann, G. D. & Crary, M. A. (2007). Examining the evidence on neuromuscular electrical stimulation for swallowing: A meta‐analysis. Archives of Otolaryngology‐‐Head & Neck Surgery, 133, 564‐571.
ƒ
Crary, M. A., Carnaby‐Mann, G. D., & Faunce, A. (2007). Electrical stimulation therapy for dysphagia: descriptive results of two surveys. Dysphagia.22(3):165‐73.
ƒ
Freed, M. L., Freed, L., Chatburn, R. L., & Christian, M. (2001). Electrical stimulation for swallowing disorders caused by stroke. Respiratory Care, 46, 466‐474.
ƒ
Humbert, I. A., Poletto, C. J., Saxon, K. G., Kearney, P. R., Crujido, L., Wright‐Harp, W. et al. (2006). The effect of surface electrical stimulation on hyolaryngeal movement in normal individuals at rest and during swallowing. Journal of Applied Physiology, 101, 1657‐1663.
ƒ
Kiger, M., Brown, C. S., & Watkins, L. (2006). Dysphagia management: an analysis of patient outcomes using VitalStim therapy compared to traditional swallow therapy. Dysphagia, 21, 243‐253.
ƒ
Leelamanit, V., Limsakul, C., & Geater, A. (2002). Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope., 112, 2204‐2210.
ƒ
Ludlow, C. L., Humbert, I., Saxon, K., Poletto, C. J., Sonies, B., & Crujido, L. (2007). Effects of surface electrical stimulation both at rest and during swallowing in chronic pharyngeal dysphagia. Dysphagia, 22, 1‐
10.
ƒ
Shaw, G. Y., Sechtem, P. R., Searl, J., Keller, K., Rawi, T. A., & Dowdy, E. (2007). Transcutaneous
neuromuscular electrical stimulation (VitalStim) curative therapy for severe dysphagia: myth or reality? Annals of Otology, Rhinology & Laryngology, 116, 36‐44.
ƒ
Suiter, D. M., Leder, S. B., & Ruark, J. (2006). Effects of neuromuscular electrical stimulation on submental
muscle activity. Dysphagia, 21, 56‐60.
31
Article Citation
ƒ 1. Freed, M.L., Freed, L., Chatburn, R.L., and Christian, M., (2001). Electrical stimulation
for swallowing disorders caused by stroke. Respiratory Care 46(5), 466‐74.
46(5) 466 74
32
Research Design
Recall…
Homogeneous Cohort Of Subjects Random Assignment
Control
Group
Treatment Effects
Equal
Treatment
Experimental Group
Blind judgment,
comparison
Treatment Effects
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Freed et al.
SLP (MLF) screens 125 CVA “with possible
swallow disorder”
3
Unknown
Reasons
11 “dropped out” during
study
(? Group)
110 consent, enrolled by SLP (MLF)
MBS; SLP (MLF) assigns SFS
TS 36
9
8
99 completed study
6
Drug
Toxicity
2
Transferred
ES group 63
3
6
Stroke Not
Documented
“most of these patients had already failed conventional therapy which is why they were referred for the study” Pg. 472
Comorbid
“cancer” 34
Flaws #1: Assignment
ƒ Heterogeneous cohort
à Stroke not documented in all enrollees
ƒ Selective assignment
à based on “failed conventional treatment”
ƒ Groups unequal at start of trial
G
l t t t f t i l
à Distribution of comorbidity
ƒ Attrition of 10% of subjects after assignment
ƒ Judge not blinded to patient assignment
35
Flaws #2: Blinding Radiologist Reads MBS
Dictates Report, Sends
Report to SLP (MLF)
SLP* reads radiologist report
SLP* assigns Swallow Function Score**
SLP* Assesses
Aspiration Daily Using
Bronchial Auscultation
SLP* Treats
ES and TS
Patients
SLP* assigns Patients to Treatment Groups
Inpatients: 1 hour/Daily
Until SFS Score >5
Or Discharged
Outpatients: 1 hour/TIW
Until SFS Score >6 Or “No More Progress Would be Made”
* First author
** “type of liquid that could be safely swallowed” (p. 468)
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Flaws #3 & 4: Unequal treatment, conflict of interest
ƒ Some patients terminated when “insurance constraints” caused discharge
ƒ P.I. owns patent to experimental product
37
Results
ƒ Both groups improved significantly from their own baselines
à ES: p<0.0001; TS: p<0.005
Table 1. Raw Data and Significance (p) of Comparisons
n
Mean + SD
(pre‐
treatment)
Mean + SD
(post‐
treatment)
p*
ES (treatment)
63
0.76 +1.04
4.52 +1.69
<0.0001*
TS (control)
36
0.75 +1.20
1.39 + 1.13
0.0048*
Swallow Function Score
Between Group Difference (post‐treatment scores)
<0.0001*
*as reported by authors
38
Conclusion: Freed et al.
ƒ Treatment effect sizes are high, BUT...
à Flawed methods, investigator bias (blinding), attrition without accounting, poor theoretical support for methods, selective assignment, support for methods
selective assignment unequal treatment, dissimilarity of groups at start of trial, conflict of interest...
à ...invalidate the results of this study ƒ Yet the method has been adopted by >10,000 SLP’s
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ES studies showing positive results
40
Studies showing + results
ƒ
Blumenfeld et al., 2006. Significant improvement in swallow function scores @
ƒ
Crary et al., 2007. Good treatment outcomes without complications, good patient satisfaction @
ƒ
Leelamanit et al., 2002. 20/23 (87%) patients improved RLED #
à
à
à
ƒ
Used Freed’s unsubstantiated SFS, unblinded, selective assignment, conflict of interest
Opinion survey of SLP’s that use and do not use ES, Funded by Chattanooga
Heterogeneous patients, 4 hrs/day treatment, subjective judgment, unblinded
Shaw et al., 2007. 11/18 (61) patients improved @
à
? Duration post onset, ? Judges, subjective
p
,
g ,
j
scoring methods, retrospective, unblinded
g
,
p
,
ƒ
Chaudhuri et al., 2006. Significantly greater improvement in ES group @
ƒ
Burnett et al., 2003. Hyoid elevation achieved with ES *
à
à
Outcome = ASHA NOMS scored by treating SLP? (no objective measures), unblinded
HLE with intramuscular stim at rest, good design
ƒ
Ludlow et al., 2007. Improved PAS w/sensory stimulation only *
ƒ
Carnaby‐Mann & Crary, 2007. Small, but significant treatment effect for NMES #
à
à
à
à
Very small sample; (see neg results next)
Included above studies that are flawed (authors mention this weakness in article)
Funded by manufacturer of product
Used very low cutoff for quality (4/13 on Pedro)
* = good design; # = fair design; @ = poor design
41
Shaw – subjective measures
42
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Carnaby Mann meta‐analysis
ƒ Meta‐analysis
à Determine construct of interest
à Establish research question
à Seek literature à Rate literature
à Discard poor quality studies
à Calculate indiv. effect sizes
à Calculate combined effect size
à Determine homogeneity of studies
43
Carnaby Mann meta‐analysis
ƒ Authors used a score of 4 or higher as cutoff for inclusion
ƒ Potential eligible study *
à Nonrandom, unconcealed à
à
à
à
à
à
assignment
Unblinded judges/ clinicians, Up to 15% attrition
Dissimilar subjects
One “key” outcome, subjective or objective
Not analyzed as randomized
No between groups results
*
*
*
*
44
ES studies showing negative results
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ƒ Ludlow et al., 2007. Depressed hyoid; increase asp risk *
à Well designed small study
ƒ Humbert et al., 2006. Significant reductions in pead
HLE ith ES *
HLE with ES *
à Well designed small study
ƒ Kiger et al., 2006. no difference between ES and traditional treatment #
à Well designed study however used composite scale
ƒ Suiter et al., 2008. No difference in submental
myelectric activity after 10 treatments *
à Well designed, small study, investigated normals not patients
* = good design; # = fair design; @ = poor design
46
ƒ Kiger et al., 2006, (pg. 250).
à A potential factor contributing to the negative outcome is the fact that ‚ “…when Vital Stim
when Vital Stim results produce no improvement as documented by a follow‐up VFSS or FEES, the Vital Stim protocol recommends referring patients to an otolaryngologist or gastroenterologist for cricopharyngeal dilatation.”
à Patients did NOT undergo dilatation
ƒ Which method produces the “change”?
47
What seems to be the evidence consensus?
ƒ Weak evidence that sensory stimulation may do something to some patients
ƒ But the notion that this method improves myoelectric
l t i activity is not supported
ti it i t t d
à Depth of musculature to stimulate too deep for low level stimulation to reach
ƒ May be counterproductive (reduces HLE, necessary for airway closure)
à No adverse reactions have been published
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DPNS
Evidence summary for “Deep Pharyngeal Neuromuscular Stimulation”
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DPNS Principles
“…developed at a major hospital system in Florida during the period 11/91 through 11/93. “
g
y p g
q
“after finding ‘traditional’ … dysphagia techniques to be largely ineffective…”
Retrieved 01/23/09 from http://www.speechteam.com
50
Principles of “DPNS”
ƒ Assumptions
à Pharyngeal phase is reflexive
à Mouth and tongue receptors “elicit” swallow “reflex”
à Stimulating posterior receptors produces reflexes
‚ Hypothesized
à Food in pharynx may occasionally trigger a swallow
à CN IX, X, and XII* mediate pharyngeal motor functions
à Pharyngeal reflexes input to brainstem
à Swallow is impaired when these reflexes are diminished
ƒ “DPNS … specific stimulation techniques within the oral/pharyngeal areas”.
*erroneous reference to innervation of hyolaryngeal elevators
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DPNS Evidence
ƒ “DPNS study results indicate DPNS improves and/or restores oral/pharyngeal muscle strength, endurance, and pharyngeal reflex functions… ƒ “The ongoing study of the results of DPNS strongly indicate a high efficacy rate for patients with varying neurological etiologies.”
Retrieved 01/23/09 from http://www.speechteam.com/
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DPNS Evidence
Developer has not authored any published research
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ƒ “In swallowing there are currently several procedures being advocated for which there is no published evidence in peer‐reviewed journals: deep pharyngeal neuromuscular stimulation (DPNS), electrical stimulation (E‐
Stim), to the surface of the neck, and myofascial release.”
ƒ
(Johnson & Jacobson, 2007; pg. 143)
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“Free Water” Protocols
Evidence Summary for using Free Water Protocols
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“Free Water” Protocol Principles
ƒ The Frazier Rehab Institute Water Protocol
à Kathy Panther, M.S., CCC, Louisville, Kentucky ƒ Safety of Water
ƒ Hydration
ƒ Compliance
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“Free Water” Protocol Principles
ƒ “Concern over patient and family non‐
compliance with thin liquid restrictions both within the facility and after discharge led us to alter our protocol in 1984. ƒ “Previously prohibited, oral intake of water became a major feature in both treatment and day to day hydration.”
Retrieved 01/20/09 from http://www.speech‐languagepathologist.org/archives/chat/SLP/April212003.html
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“Free Water” Protocol Principles
According to its developers:
ƒ Water is relatively safe to aspirate
à Sterile, neutral pH, therefore safe to use in testing
ƒ Hydration is increased using this method
à “most patients”; should decrease IVF costs
à Patients indicate they drink more water
ƒ Compliance with interventions is higher
à Patients complain less and comply more, with water
à Burdon of thickening fluids is eliminated
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Free Water Protocols Evidence
ƒ Literature search
à “Free Water”, + Deglutition Disorders
à Panther, K.
‚ One citation on semantic relations in the Journal of p
g
, 9 3
Speech & Hearing Disorders, 1983
‚ Perspectives article in 03/05 describing protocol
 “Currently there is no published evidence that will give dysphagia clinicians a definitive scientific basis for the safe delivery of water to patients with dysphagia”
‚ ASHA journal (pre “Leader”) piece in 1998
Leonard, L. B., Steckol, K. F., & Panther, K. M. (1983). Returning meaning to semantic relations: some clinical applications. Journal of Speech and Hearing Disorders, 48, 25‐36.
61
Free Water Protocols Evidence
ƒ Bronchoalveolar lavage
ƒ Whelan et al. (2001) reduced fluid intake in patients prescribed thick liquids
ƒ Numerous citations on dehydration in dysphagia
ƒ Animal studies of water aspiration 62
“Free Water” Protocol Evidence
ƒ Garon et al., 1997
à 10 aspiration‐documented patients randomized to
‚ Thick liquids only at all times
‚ Thick liquids for diet, AND free access to water under specified rules
d ifi d l
à No patient in either group developed pneumonia, dehydration, complications (30 day follow‐up) 63
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Results Garon et al., 1997
ƒ Fluid intake
à Control (thick liquids): 1210mL/day
à Experimental (free water): 1318mL per day
‚ 855mL, 463mL water thick liquid
8
L 6 L t thi k li id
ƒ Satisfaction: only one patient was satisfied with thick liquid (among all control subjects)
ƒ Amount of water taken by experimental patients was considerably less than expected
64
“Free Water” Protocol Evidence
ƒ Robbins et al. 2008. Protocol 201
à Thin liquids/chin‐down posture: 10% pneumonia
à Thick liquids: 11% pneumonia
‚ Nectar: 8%, Honey: 15%
à Dehydration
‚ Thin: 2%, Thick: 6%
à UTI
‚ Thin: 3%, Thick: 6%
à 3 times longer hospital stay in honey‐thick who developed pneumonia
65
“Free Water” Protocol Evidence
ƒ Two more recent studies
à One presented at ASHA 2008
‚ Bronson‐Lowe, et al., 2008. Effects of a free water protocol for patients with dysphagia
protocol for patients with dysphagia.
à One in press and presented at ASHA 2008
‚ Becker et al., 2008. An oral water protocol in rehabilitation patients with dysphagia for liquids.
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Free Water Protocols (#1)
ƒ Retrospective study comparing patients with historical controls (via chart review)
à 30 patients using the water protocol (experimental)
à 46 eligible but not treated patients (historical control)
à 25 eligible concurrent untreated patients
ƒ Dependent Variables (all objective measures)
à Pneumonia
à Hydration
à Fluid Intake
Bronson‐Lowe, et al., 2008
67
Results
ƒ Water (treatment) vs. Historical Control
à Significant differences (favoring treatment)
‚ Avg. daily fluid intake (p=.03)
à No significant differences between groups:
‚ Pneumonia, Dehydration
,
y
ƒ Water vs. concurrent control
à Significant differences (favoring treatment)
‚ Pneumonia (p=.02), Fluid intake (p<.01)
à No significant differences
‚ Dehydration
Bronson‐Lowe, et al., 2008
68
Authors’ discussion
ƒ Authors could not determine whether results were influenced by
à Increased oral hygiene in the treatment group
à Increased oral hydration in the treatment group
à More compliance with aspiration precautions in treated patients
à Hydration not affected by treatment/control assignment
ƒ This needs to be replicated prospectively
Bronson‐Lowe, et al., 2008
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Free Water Protocols (#2)
ƒ Randomization to water protocol or prescribed dietary fluid (26 patients)
ƒ 17 patients requiring feeding assistance
à 8 assigned to control, 9 to treatment
ƒ 9 independent feeding patients
à 3 assigned to control, 6 to treatment ƒ All received oral care four times per day
Becker, et al., 2008
70
Free Water Protocols (#2)
ƒ Dependent Variables
à Adverse events (pneumonia, UTI, death) ‚ Objective measures
à FIM
FIM, FCM scores FCM ‚ Subjective measures, not blinded
à Length of stay
‚?
Becker, et al., 2008
71
Free Water Protocols (#2)
ƒ Results
à No differences
‚ Pneumonia: 1 patient in each group
‚ UTI: 2 patients in each group
‚ FIM, FCM: no significant differences
à Differences
Diff
‚ Death: 2 treatment deaths, no control deaths
‚ Length of stay*: 29.1 days (control) vs. 15.8 (tx)
ƒ Other findings:
à Independent‐feeding patients consumed significantly less fluid than dependent patients (p<.01), regardless of group
‚ (opposite finding from study #1)
Becker, et al., 2008
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Free Water Protocols (#2)
Becker, et al., 2008
73
Free Water Protocols (#2)
ƒ Discussion
à The presence of two deaths in the treatment group cannot be ignored
‚ …and may underscore the importance of clinical and may underscore the importance of clinical judgment in applying this and other treatments
 Both patients that died had chronic pulmonary conditions
à Dependent patients drank more
‚ Staff/caregiver influences?
Becker, et al., 2008
End treatment
74
Diagnostic Methods
ƒ Research consumers have 2 questions:
à 1. Clinical test precision ‚ Which clinical testing method best predicts what an accepted instrumental test will find?
à 2. Which instrumental test is superior?
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1. Clinical Test Precision
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Citation
ƒ Martino R, Pron G, Diamant N, (2000). Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines. Dysphagia 15: 19‐30.
ƒ a. How well do non‐instrumental tests predict aspiration?
ƒ b. How well do non‐instrumental tests predict health outcomes in dysphagics?
à Does screening affect length of stay, mortality, pneumonia incidence, etc.?
77
Methods
ƒ Systematic Review with calculation of Predictive Value of each clinical sign
ƒ End points/Outcomes
à (a). Physiology: aspiration, residue detection à (b). Health: pneumonia, mortality, PEG
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154 articles accepted
89 Accepted
n=24: (a) clinical exam and VFG
58 ineligible
14 eliminated
65 Rejected
10 reviewed
5: specific CVA types
3 reviewed
n=7: (b) clinical exam and outcomes
4 eliminated
5: generalizable to “stroke”
a. Do clinical tests predict aspiration or physiologic deficits?
b. Do clinical tests predict health outcomes?
79
Clinical Test precision
ƒ 39 clinical signs predicted VFG findings
à 5 of them, when present, were 2‐5 times more likely than a coin toss, to predict aspiration.
‚
‚
‚
‚
‚
Failed water swallow test (30mL)
Failed water swallow test (50mL)
Cranial nerve IX sensory abnormality
Abnormal pharyngeal sensation
Facial weakness
80
Clinical Test precision
ƒ 10 clinical examinations reveal signs that predict pneumonia, mortality, future PEG placement
à Only one had a weak (but clean) predictive value
O l h d k (b t l ) di ti l
ƒ 50mL water swallow
81
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Clinical Test precision
50mL H2O swallow
Pneumonia
“Acute Stroke Pathway”
2 years
Aspiration
pneumonia
Mortality
PEG tube
inserted
“Acute Stroke Pathway” ‐ 1 year
Aspiration
pneumonia
PEG tube
inserted
ARR
0.13
0.07
0.06
0.02
0.03
0.01
RRR
81.2%
85.1%
70%
18%
38.8%
6.7%
NNT
7.69 (8)
50
33.3 (34)
100
14.3 (15) 16.7 (17)
82
Clinical Test precision
ƒ Clinical exams should include:
à Signs with strong predictive value for dysphagia
‚ Failed water swallow test
‚ Cranial nerve sensory/motor abnormalities
‚ Facial Weakness
à These have weak predictive value; do not use solely:
‚ Weak voluntary cough
‚ Dysphonia
‚ Abnormal motor exam (extremities)
83
2. Comparing Instrumental Tests
ƒ FEES and Videofluoroscopy
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Diagnosis: VFG vs. FEES
ƒ Characteristics of good diagnosis research
à New test compared to accepted gold standard
‚ Simultaneous events using both test methods
‚ Gold standard applied despite outcome
à Independent judges score the two tests I d
d t j d th t t t ‚ Blinded to one another’s judgments
à Appropriate spectrum of patients tested
à Can be replicated, large enough “N”, no conflict of interest
à New method is feasible
85
Three studies:
ƒ *Kelly, A. M., Drinnan, M. J., & Leslie, P. (2007). Assessing penetration and aspiration: how do videofluoroscopy and fiberoptic endoscopic evaluation of swallowing compare? Laryngoscope, 117, 1723‐1727.
ƒ *Kelly, A. M., Leslie, P., Beale, T., Payten, C., & Drinnan, M. J. (2006). Fibreoptic endoscopic evaluation of swallowing and videofluoroscopy: yp
p
p
p y g
does examination type influence perception of pharyngeal residue severity? Clinical Otolaryngology, 31, 425‐432.
ƒ Aviv, J.E., (2000). Prospective, randomized outcome study of endoscopy versus modified barium swallow in patients with dysphagia. Laryngoscope, 110(4):563‐74.
* Same patients generated both data sets
86
Kelly, et al. (2006,2007)
ƒ Simultaneous FEES and VFG performed and recorded on 15 consecutive patients
ƒ Video clips numbered and randomly ordered
à 17 Judges viewed one liquid, one yogurt bolus
à Judges blinded to diagnosis, corresponding FEES/VFG
ƒ 2007: Penetration Aspiration Scale score
ƒ 2006: Residue ratings
ƒ Both studies: inter‐ and intra‐ rater reliability 87
29
1/29/2009
Results
ƒ FEES PA scores significantly higher than VFG
à p<.001
ƒ FEES residue scores significantly higher than VFG à p<.001
88
Results
ƒ Reliability: Higher (not significantly) for VFG
à Inter‐rater: .64 ‐ .67 (VFG, FEES)
à Intra‐rater: .73 ‐ .79 (VFG, FEES)
ƒ Overall: FEES scores more severe impairments, VFG reliability slightly higher
89
Aviv, 2000.
“Prospective, randomized outcome study...”
Outpatients with Dysphagia
FEES(ST)
pneumonia
No
pneumonia
MBS
pneumonia
No
pneumonia
Dependent Variable: Pneumonia
90
30
1/29/2009
Assignment to Test Method
126 Outpatients with Dysphagia
Monday, Thursday
Tuesday, Wednesday, Friday
FEES(ST)
n=50
MBS
n=76
“Patients whose consults were requested on Tuesday, Wednesday, or Friday were randomly assigned to MBS...”
91
Methods
ƒ FEESST
à “laryngeal adductor reflex”
à normal = <4 mm Hg à “Severe” deficit: absent response to >6 mm Hg. p
g
ƒ MBS
à Typical protocol
92
Blinding
ƒ Referring MD and patient unaware of assignment scheme
ƒ PI not involved in assignment
ƒ SLP screened and enrolled all patients
ƒ PI blinded to results until analysis completed
93
31
1/29/2009
Blinding
ƒ Blinding is not clear
à Same team of SLP’s carried out all testing in conjunction with the PI (Clinical, FEESST)
‚ But PI was “blinded to results until study ended”??
à SLP performed MBS
f
d
à Same MD examined all patients in each diagnostic group
94
Groups similar at start of trial?
Mon., Thu.
Tue., Wed., Fri.
ƒ FEESST (50)
ƒ MBS (76)
à 6/50 (12%) chronic neurogenic
à 5
50 patients underwent p
61 FEESST tests
‚ Repeated exams are not described
à ? Stroke patients
à 30/76 (39%) chronic neurogenic
‚ Significantly more (X2 = 11.2, p<0.001)
à 76 patients underwent 78 MBS tests
à ? Stroke patients
95
Equal treatment?
<4mm 4‐6mm
>6mm
>6mm
96
32
1/29/2009
Equal treatment [?]
ƒ MBS (76)
à Silent asp Æ PEG/NPO
à Asp. not cleared Æ
PEG/NPO
ƒ FEESST (50)
à Pt. with normal, moderate, or unilateral severe sens. impairment
‚ Treated like MBS patients
à Any patient with bilateral à All others: conservative management (diet + maneuvers)
severe sensory impairment and laryngeal penetration Æ PEG/NPO
à All others: conservative management (diet + maneuvers)
97
Equal treatment [?]
ƒ FEESST patients received 11 extra tests?
à 76 MBS patients, 50 FEESST patients
ƒ Unequal treatment in favor of FEESST guided management.
Aviv, 2000
98
Results: primary: no difference
ƒ Results: no significant difference in incidence of pneumonia;
à MBS: 14/76 (18.4%); FEESST: 6/50 (12%) (NS) ‚ Unfortunately since groups were unequal we don’t know whether the higher pneumonia in MBS group is associated with diagnosis.
ƒ No significant difference in pneumonia‐free interval
99
33
1/29/2009
Results‐ not reported
ƒ “...the recommendations for placing a PEG in the MBS group were too few to draw conclusions regarding differences in pneumonia outcome between patients who had a PEG placed or continued versus those who did not... However in the FEESST group, enough PEG recommendations were made to conduct analysis.” pg. 571
Caveat emptor
100
Do‐it‐yourself analysis…
MBS
FEESST
Pneumonia
14
6
No Pneumonia
62
44
% i % pneumonia (NS)
8 % 18.4% % 12% 2/76 (<3%) 16/50 (32%) Received PEG
Results
6.3% higher risk of 11X increased risk of PEG pneumonia with PEG
with FEESST
101
Bottom Line
ƒ Both endoscopic and MBS guided dysphagia management produce similar pneumonia outcomes
ƒ Patients guided by FEESST were 11 times more likely to receive a PEG
lik l t i PEG
ƒ Dysphagic patients with PEG had 6.3% higher pneumonia risk
102
34
1/29/2009
So what about testing?
ƒ 1. Good clinical techniques bear fair to good predictive value (combining them increases value)
ƒ 2. Both FEES and VFG have advantages and disadvantages
à As well as situations when one or the other is preferred, a better choice
ƒ 3. Select your methods based on the clinical questions
à VFG: excellent evaluation; FEES is excellent at monitoring progress, biofeedback, adjusting plan, etc.
End diagnosis
103
Differential Diagnosis of Aspiration and other Pneumonias
104
Dysphagia is Not a Disease
Disease,
Condition:
Disease,
Condition:
D h i
Dysphagia
Neurologic
Traumatic
Neoplastic
Structural
Iatrogenic
“Deconditioning”
Pulmonary
Others
Pulmonary
Nutritional
Community -Acquired
Social
Psychological
Others
105
35
1/29/2009
Pneumonia
ƒ Most frequent infectious cause of death*
ƒ 63,000 deaths in 2003**
à Incidence: ‚ 224** per 10,000 elderly adults
p
y
‚ 162*** per 10,000 persons over age 14
ƒ 13%‐48% of all Nursing Home Infections
ƒ 2nd most common nosocomial infection (UTI) in hospitals***
Marston, et al., 1997*; National Center for Health Statistics, 2003**; ***Niederman, et al., 2002
106
Pneumonia
ƒ Types
à Community Acquired Pneumonia (CAP)
‚ Pneumonia not acquired in a health care facility
‚ 5.6 million cases per year*
5 6 million cases per year*
‚ Typical: Streptococcus, Klebsciella
pneumoniae
‚ Atypical **: H. influenzae, RSV, Legionella, E. coli, Staph. aureus, others
*Niederman, 2002; **El Solh, et al., 2001; ***CDC guidelines
107
Pneumonia
ƒ Types
à Nosocomial Pneumonias: Ventilator Associated, Nursing Home Acquired Pneumonia
‚ Pseudomonas aeruginosa, Proteus species, staph. Aureus
108
36
1/29/2009
Community Acquired Pneumonia
ƒ Human Costs of Community Acquired Pneumonia
ƒ Pneumonia admissions: 743,000*
à Pneumonia in a 5% Medicare admissions sample* ‚ 30,000 30 000 – 37,000 per year x 20 = 600,000 37 000 per year x 20 = 600 000 – 740,000/year
740 000/year
ƒ Case fatality rate
‚ 55% (elderly)
‚ Leading cause of mortality in children under 5***
*Baine, et al., 2001; ** Niederman, et al., 2001; ***Almirall, et al., 2000
109
Other pneumonias
ƒ Community Acquired Pneumonia
à Pathogen isolated
à Patient’s residential environment
à Lack of underlying source of dysphagia/aspiration
ƒ Ventilator Associated Pneumonia
V il
A
i d P
i
à Exposure to mechanical ventilation
à Absence of oral intake at onset
à Gastroesophageal reflux common in Ventilation
110
Community Acquired Pneumonia
ƒ Human Costs of Community Acquired Pneumonia
ƒ Pneumonia after stroke*
à 26.9% mortality, vs. 4.4% in stroke w/o pneumonia
ƒ Economic Costs of Community Acquired Pneumonia
ƒ Cost of pneumonia: $8 billion/year (1998)**
*Katzan, et al., 2003; ** Niederman, et al., 1998
111
37
1/29/2009
Aspiration Pneumonia (AP)
ƒ Typically associated with Dysphagia
à Can occur from other etiologies
ƒ Can occur in a health care facility (HCF)
à Nosocomial Aspiration Pneumonia
ƒ Can occur outside of the HCF
à Community Acquired Aspiration Pneumonia
*Baine, et al., 2001
112
Aspiration Pneumonia Incidence
ƒ 15.5% of 1998 pneumonia admissions = AP*
Baine, et al., 2001
113
Aspiration Pneumonia
Pneumonia
40000
35000
AP
6000
+22.6
5000
30000
4000
25000
20000
15000
3000
+93.5%
2000
10000
1000
5000
0
0
91
92
93
Pneumonia
94
95
96
97
98
Aspiration Pneumonia
Baine, et al., 2001
114
38
1/29/2009
Aspiration Pneumonia
ƒ Human Costs of Aspiration Pneumonia
à 115,000 cases per year
ƒ AP admissions highest case‐fatality rate
à 23.1% during hospitalization*
23 1% during hospitalization*
ƒ Annual mortality (1998 numbers)
à 115,000 x 23.1% fatality = 26,603 annual AP deaths
*Baine et al, 2001; 115
Aspiration Pneumonia
ƒ Economic Costs of Aspiration Pneumonia
ƒ Cost of pneumonia: $8 billion (1998)*
à AP: 15.5% of all CAP**
à $8 billion x 15.5% = $1.3 billion (1998 dollars)
*Niederman, et al, 2001; **Baine et al., 2001.
116
Importance:
ƒ If we reduce the incidence of AP by a modest 20%
à 23,000 fewer cases each year
à 4,000‐5,000 saved lives each year
d li h ƒ If we reduce the admissions or length of stay for AP by a modest 10%
à $130 million saved (1998 dollars)
117
39
1/29/2009
What is Pneumonia?
ƒ An inflammation of the alveoli…
à Respiratory distress, failure must be treated
ƒ …that is caused by infectious pathogens
à Infection must be treated
118
What is Pneumonia?
ƒ Phase 1: Edema à Pathogen infiltrates, infects alveoli
O2
‚ Draws nourishment from p
alveolar epithelium
 Damaging alveolar epithelium
O2
CO2
‚ Producing metabolic byproducts (toxins)
CO2
O2
 Irritants to alveoli
O2
CO2
O2
CO2
Mandell & Wunderink, 2007
O2
Capillary – RBC, WBC
O2
119
What is Pneumonia?
ƒ Phase 2: Red O2
hepatization phase.
à Alveoli become excessively permeable
O2
‚ Red blood cells “leak” from capillaries
CO2
O2
O2
à Immunological CO2
response
‚ Inflammation of the lung = Pneumonitis
O2
O2
O2
CO2
CO2
Capillary – RBC, WBC
120
40
1/29/2009
What is Pneumonia?
à Alveoli fill with RBC, WBC, O2
serum, infectious debris
à Respiratory surface area is reduced by infiltrate
CO2
‚ Dyspnea, hypoxemia
O2
O2
O2
O2
à Epithelium thickens
à Surfactant production is diminished
‚ Reduces compliance of lung
‚ …further source of dyspnea
à Can spread with cough
CO2
O2
CO2
O2
CO2
capillary
121
What is Pneumonia?
ƒ Phase 3: Gray hepatization phase
O2
à RBC’s destroyed
à Infection contained
‚ Bacteria absent
O2
O2
à Infiltrates diminish
CO2
O2
ƒ Phase 4: Resolution
CO2
à Immunological “clean‐up”
à Epithelium “heals”, surfactant restored
O2
CO2
CO2
O2
O2
capillary
122
Aspiration Pneumonitis
ƒ Acute Lung Injury caused by aspiration of caustic or particulate matter
ƒ Inflammation of alveoli by effects of irritants
à No infection (sterile/non‐pathogenic material)
à Inflammatory response (edema) reduces surface area (as shown earlier)
‚ No infectious spread from site of origin
‚ May spread as volume increases
123
41
1/29/2009
O2
No Infectious agent
Chemical irritant
CO2
O2
O2
O2
O2
O2
CO2
CO2
O2
O2
O2
O2
CO2
O2
O2
CO2
O2
CO2
CO2
O2
O2
CO2
CO2
CO2
capillary
124
What is Aspiration Pneumonia?
ƒ Definition of Aspiration
à Foreign matter enters the respiratory system
ƒ Definition of Pneumonia
à Infectious acute inflammation
à Reaction to bacteria and byproducts
ƒ Aspiration Pneumonia
à Lung inflammation caused by pulmonary infection
due to aspiration of colonized matter
125
What is Dysphagia‐
Related Aspiration Pneumonia (AP)?
ƒ Aspirated Pathogens are Different
à O
Oral pharyngeal flora
l h
l fl
‚ Eruption of teeth
à * pathogens Æ
à Others found in flora
à Opportunistic infection
Staphylococcus epidermidis
Staphylococcus aureus*
Streptococcus salivarius
Streptococcus mutans*
Enterococcus faecalis*
Streptococcus pneumoniae*
Streptococcus pyogenes*
Neisseria sp.
Neisseria meningitidis*
g
Enterobacteriaceae* (E. coli)
Proteus sp.
Pseudomonas aeruginosa* Haemophilus influenzae*
Lactobacillus sp. Clostridium sp.* Corynebacteria
Spirochetes Mycoplasmas
Todar's Online Textbook of Bacteriology
126
42
1/29/2009
Oral biofilm development
ƒ Bacteria enter the area (seconds)
ƒ Bacteria attach to underlying structures
à Epithelium, prior biofilm, other surfaces
à Seconds to minutes
ƒ Bacteria grow and multiply (hours – days)
ƒ An exopolymer forms and Biofilm is born
ƒ Other bacteria attach to biofilm
Todar's Online Textbook of Bacteriology
127
How Does AP Develop?
ƒ
Oral/Pharyngeal Colonization Risk Factors
ƒ
ƒ
ƒ
Medications*, Oral disease**
inadequate oral hygiene
Iatrogenic Risk Factors
ƒ
ƒ
ƒ
ƒ
Recent Extubation*
Tracheostomy***
Medication side effects*
Postoperative sensorimotor
impairment*
* CDC/MMWR 46, RR‐1, (1997); **Langmore et al, (1998);***Eibling and Gross, 1996; Gross et al, (2003).
128
How Does AP Develop?
ƒ
Host Risk Factors (the patient) ƒ
Underlying disease
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
ƒ
Immunocompromise* (infection)
Impaired mucociliary clearance** (resistance)
Pulmonary disease (resistance)
Sensorimotor impairments (dysphagia)
Obesity, neck malignancy * (dysphagia)
Impaired Mental Status (up to 70%)* (dysphagia)
Dementia* (dysphagia, feeding dependence)
* CDC/MMWR 46, RR‐1, (1997); **Langmore et al, (1998);***Eibling and Gross, 1996; Gross et al, (2003).
129
43
1/29/2009
Source of Colonization + Prandial Aspiration + Poor Host Resistance… Aspiration Pneumonia
130
Aspiration Pneumonitis
ƒ Gastric Contents: Massive Acute Inflammation
à Sterile, acidic Sterile acidic à Airways, respiratory membrane damage
‚ Opportunistic secondary infection
à ARDS
131
ƒ Aggressive acid suppression may create conditions favoring pathogenesis of pneumonia*
à PPI: O.R. = 1.94 –
PPI O R 2.28 (over control)**
8 (
t l)**
à H2 receptor antagonist: O.R. = 1.36 – 1.64**
*Marik, 2001; Marik and Zaloga, 2002; **Laheij, et al., 2004
132
44
1/29/2009
Aspiration and Lung Damage
Idiopathic Pulmonary Fibrosis
ƒ IPF: 16/17 (94%) with abnormally low proximal or p
p
distal pH supine
ƒ Normals: 4/8 (50%) Tobin et al., 1998
133
Distinguishing AP, Aspiration Pneumonitis, Other Pneumonias
134
ƒ The Medical Record contains important clues
à HISTORY OF ONSET
à The course and progression of the disease
à Presence/absence of underlying source/cause of P
/ b
f d l i /
f aspiration
à Results of lab, radiographic tests
135
45
1/29/2009
Differential Diagnosis‐
history
ƒ Aspiration ƒ Aspiration pneumonia
pneumonitis
à History: ‚ predisposing disease
‚ Dysphagia
‚ esophageal dysmotility/paresis
‚ witnessed choking at meal; may be unwitnessed.
à History: ‚ depressed LOC (anesthesia, sedation, coma)
‚ may be witnessed (as in post‐operative)
‚ Onset not at mealtime
‚ Emesis preceded dyspnea
136
Differential Diagnosis
Radiographic Signs
ƒ Aspiration ƒ Aspiration pneumonia
pneumonitis
à Radiographic à Radiographic evidence of infiltrates in dependent lobes or segments
‚ (position when aspirating…)
=
evidence of infiltrates in dependent lobes or segments
‚ (position…)
137
Differential Diagnosis
Clinical, laboratory signs
ƒ Aspiration ƒ Aspiration pneumonia
pneumonitis
à Fever (+1C x 24h)
à Afebrile or short à Pathogen identified duration fever (“spike”)
à Sterile bacteriology
via protected culture
‚ Oral, nosocomial
pathogen
à persistent leukocytosis
‚ Normal oral flora
‚ Opportunistic secondary infection
à brief leukocytosis
138
46
1/29/2009
Differential Diagnosis
Clinical, laboratory signs
ƒ Laboratory Values
à WBC: current overall immune activity (x1000/ml)
‚ 4.5 – 10.5 k cells/microliter
à Neutrophils: immunocompromise?
à If Neutropenic: WBC elevation absent/reduced
in infection
Wallach JW (2000). Interpretation of Diagnostic
Tests. Philadelphia, Lippincott Williams & Wilkins.
The Medical Record
139
Differential Diagnosis‐
clinical, laboratory signs
ƒ Aspiration pneumonia
à
à
à
à
à
à
à
à
Inflammation
Cough – productive
Bronchospasm Dyspnea
Hypoxemia Purulent sputum Tachypnea Malaise
ƒ Aspiration pneumonitis
à
à
à
à
à
à
à
à
Inflammation
Cough ‐ not productive
Bronchospasm Dyspnea Hypoxemia Frothy or bloody sputum
Tachypnea
Respiratory distress
minutes to hours after aspiration; may persist
140
Radiographic evidence
ƒ Chest x‐ray
à Infiltrates cause radiographic “shadows” at sites of infection‐induced inflammation
‚ Advanced pneumonia may involve entire lobes
 Infection can spread
 Aspiration Pneumonitis ‐ Does not spread…
141
47
1/29/2009
Aspiration Related Infiltrates
(R) Basilar infiltrates
(R) Upper lobe infiltrates
Aspiration produces pneumonitis or pneumonia in gravity dependent portions of lung(s).
“Dependence” depends on posture when aspiration occurs,
occurs density & volume aspirated.
142
AP, vs. Non‐AP
ƒ ***History
à History of dysphagia‐producing disease
à Position at onset of symptoms
ƒ Infiltrates in dependent segments
fl
d
d
à Position at onset of symptoms
ƒ Dependency for oral care/feeding, periodontal disease
143
AP, vs. Non‐AP
ƒ Bacteriology
à Non‐AP
‚ Typical: Streptococcus, Klebsciella pneumoniae
‚ Atypical **: H. influenzae, RSV, Legionella, E. coli, Staph aureus others
Staph. aureus, others
à AP
‚ Oral pathogens
à Nosocomial (VAP, etc.)
‚ Pseudomonas aeruginosa, Proteus species, staph. Aureus
144
48
1/29/2009
Summary
ƒ Determination of the etiology of respiratory disease, presumed to be aspiration related, is essential in mitigation of recurrence.
à Aspiration may not be related to a swallowing
disorder, but can result from a number of other sources.
à Aspiration is only one potential source of pneumonia
à All respiratory illnesses are NOT pneumonia
à ALL PNEUMONIAS ARE NOT ASPIRATION RELATED
145
Summary
ƒ A medical diagnosis of “aspiration pneumonia” should not lead the SLP to assume dysphagia is present
ƒ The SLP must use all available patient information and examination data, to determine the likelihood that dysphagia poses a risk to the patient
146
Thank you.
147
49
James L. Coyle, Ph.D.
OSLHA Convention, 03/07/09
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James L. Coyle, Ph.D.
OSLHA Convention, 03/07/09
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James L. Coyle, Ph.D.
OSLHA Convention, 03/07/09
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