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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? 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 Evolution of the Profession Speed of medical technology change Discovery of causes of preventable diseases Our role has changed to include not only… Restoration of functions after disease and trauma, but also… Prevention of diseases that shorten lives 3 1 1/29/2009 Using Evidence in Practice Research consumerism à Clinicians are research consumers If not, they’d better be… 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 1. External Evidence: treatment, diagnosis à Controversial methods, common methods ES, DPNS, water protocols VFG vs. FEES diagnosis 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 6 2 1/29/2009 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? 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 9 3 1/29/2009 1. See A Patient Signs and Symptoms Medical Record, Interview Examination‐Collect Data Individual’s Characteristics Form a list of what is known, what issues need resolution 10 2. Ask a Question 1. Therapy à Best methods to achieve target outcome 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 1. Who is the Patient or what is the clinical Problem you are planning to treat? y p g 2. What Intervention are you considering? 3. What alternative or Comparison treatment is available? 4. What clinical Outcomes are you targeting? 12 4 1/29/2009 3. Seek the BEST evidence for the question 13 4. Appraise the evidence 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 a. Design b. Sample Size c. Internal Validity d. External Validity d External Validity Baker & Tickle‐Degnen, (2001). à An explicit scoring mechanism – multidimensional and unambiguous 15 5 1/29/2009 a. Design (Case-control study, cohort, case series) RCT, quasi‐experiment, cohort, pre‐post, SSD 16 b. Sample Size Persons per condition, observations (SSD) “More is always better.” True or false? 17 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 18 6 1/29/2009 c & d: internal and external validity Believability of research depends on how well authors controlled for sources of bias and error c. Internal Validity: à How well the study’s design controlled the for sources or error Efficacy: outcome under controlled conditions 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 20 Validity 1. Were all patients similar at start 1. Were all patients similar at start of trial? 2. Were patients 2. Were patients randomly randomly assigned to the treatment groups? à And was randomization list concealed And was randomization list concealed?? 3. Were clinician/judges blinded/subjects masked? 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 21 7 1/29/2009 Validity 5. Was follow 5. Was follow‐‐up up sufficiently sufficiently long and complete? 6. Were Were all all patients patients analyzed analyzed as as randomized? randomized? à Attrition, intention to treat 7. Was treatment effect hypothesized at start of trial? 8. Effects of maturation/recovery, test learning? 9. Conflicts of interest ??? 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 24 8 1/29/2009 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 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 27 9 1/29/2009 Electrical Stimulation Principles 28 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 30 10 1/29/2009 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. 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. 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. 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. Freed, M. L., Freed, L., Chatburn, R. L., & Christian, M. (2001). Electrical stimulation for swallowing disorders caused by stroke. Respiratory Care, 46, 466‐474. 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. 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. Leelamanit, V., Limsakul, C., & Geater, A. (2002). Synchronized electrical stimulation in treating pharyngeal dysphagia. Laryngoscope., 112, 2204‐2210. 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. 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. 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 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 33 11 1/29/2009 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 Heterogeneous cohort à Stroke not documented in all enrollees Selective assignment à based on “failed conventional treatment” Groups unequal at start of trial G l t t t f t i l à Distribution of comorbidity Attrition of 10% of subjects after assignment 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) 36 12 1/29/2009 Flaws #3 & 4: Unequal treatment, conflict of interest Some patients terminated when “insurance constraints” caused discharge P.I. owns patent to experimental product 37 Results 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. 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 Yet the method has been adopted by >10,000 SLP’s 39 13 1/29/2009 ES studies showing positive results 40 Studies showing + results Blumenfeld et al., 2006. Significant improvement in swallow function scores @ Crary et al., 2007. Good treatment outcomes without complications, good patient satisfaction @ Leelamanit et al., 2002. 20/23 (87%) patients improved RLED # à à à 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 , Chaudhuri et al., 2006. Significantly greater improvement in ES group @ 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 Ludlow et al., 2007. Improved PAS w/sensory stimulation only * 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 14 1/29/2009 Carnaby Mann meta‐analysis 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 Authors used a score of 4 or higher as cutoff for inclusion 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 45 15 1/29/2009 Ludlow et al., 2007. Depressed hyoid; increase asp risk * à Well designed small study Humbert et al., 2006. Significant reductions in pead HLE ith ES * HLE with ES * à Well designed small study Kiger et al., 2006. no difference between ES and traditional treatment # à Well designed study however used composite scale 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 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 Which method produces the “change”? 47 What seems to be the evidence consensus? Weak evidence that sensory stimulation may do something to some patients 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 May be counterproductive (reduces HLE, necessary for airway closure) à No adverse reactions have been published 48 16 1/29/2009 DPNS Evidence summary for “Deep Pharyngeal Neuromuscular Stimulation” 49 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” 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 “DPNS … specific stimulation techniques within the oral/pharyngeal areas”. *erroneous reference to innervation of hyolaryngeal elevators 51 17 1/29/2009 DPNS Evidence “DPNS study results indicate DPNS improves and/or restores oral/pharyngeal muscle strength, endurance, and pharyngeal reflex functions… “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/ 52 DPNS Evidence Developer has not authored any published research 53 54 18 1/29/2009 55 “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.” (Johnson & Jacobson, 2007; pg. 143) 56 “Free Water” Protocols Evidence Summary for using Free Water Protocols 57 19 1/29/2009 “Free Water” Protocol Principles The Frazier Rehab Institute Water Protocol à Kathy Panther, M.S., CCC, Louisville, Kentucky Safety of Water Hydration Compliance 58 “Free Water” Protocol Principles “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. “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 59 “Free Water” Protocol Principles According to its developers: Water is relatively safe to aspirate à Sterile, neutral pH, therefore safe to use in testing Hydration is increased using this method à “most patients”; should decrease IVF costs à Patients indicate they drink more water Compliance with interventions is higher à Patients complain less and comply more, with water à Burdon of thickening fluids is eliminated 60 20 1/29/2009 Free Water Protocols Evidence 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 Bronchoalveolar lavage Whelan et al. (2001) reduced fluid intake in patients prescribed thick liquids Numerous citations on dehydration in dysphagia Animal studies of water aspiration 62 “Free Water” Protocol Evidence 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 21 1/29/2009 Results Garon et al., 1997 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 Satisfaction: only one patient was satisfied with thick liquid (among all control subjects) Amount of water taken by experimental patients was considerably less than expected 64 “Free Water” Protocol Evidence 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 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. 66 22 1/29/2009 Free Water Protocols (#1) 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 Dependent Variables (all objective measures) à Pneumonia à Hydration à Fluid Intake Bronson‐Lowe, et al., 2008 67 Results 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 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 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 This needs to be replicated prospectively Bronson‐Lowe, et al., 2008 69 23 1/29/2009 Free Water Protocols (#2) Randomization to water protocol or prescribed dietary fluid (26 patients) 17 patients requiring feeding assistance à 8 assigned to control, 9 to treatment 9 independent feeding patients à 3 assigned to control, 6 to treatment All received oral care four times per day Becker, et al., 2008 70 Free Water Protocols (#2) 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) 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) 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 72 24 1/29/2009 Free Water Protocols (#2) Becker, et al., 2008 73 Free Water Protocols (#2) 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 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? 75 25 1/29/2009 1. Clinical Test Precision 76 Citation Martino R, Pron G, Diamant N, (2000). Screening for oropharyngeal dysphagia in stroke: insufficient evidence for guidelines. Dysphagia 15: 19‐30. a. How well do non‐instrumental tests predict aspiration? 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 Systematic Review with calculation of Predictive Value of each clinical sign End points/Outcomes à (a). Physiology: aspiration, residue detection à (b). Health: pneumonia, mortality, PEG 78 26 1/29/2009 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 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 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 50mL water swallow 81 27 1/29/2009 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 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 FEES and Videofluoroscopy 84 28 1/29/2009 Diagnosis: VFG vs. FEES 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: *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. *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. 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) Simultaneous FEES and VFG performed and recorded on 15 consecutive patients Video clips numbered and randomly ordered à 17 Judges viewed one liquid, one yogurt bolus à Judges blinded to diagnosis, corresponding FEES/VFG 2007: Penetration Aspiration Scale score 2006: Residue ratings Both studies: inter‐ and intra‐ rater reliability 87 29 1/29/2009 Results FEES PA scores significantly higher than VFG à p<.001 FEES residue scores significantly higher than VFG à p<.001 88 Results Reliability: Higher (not significantly) for VFG à Inter‐rater: .64 ‐ .67 (VFG, FEES) à Intra‐rater: .73 ‐ .79 (VFG, FEES) 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 FEESST à “laryngeal adductor reflex” à normal = <4 mm Hg à “Severe” deficit: absent response to >6 mm Hg. p g MBS à Typical protocol 92 Blinding Referring MD and patient unaware of assignment scheme PI not involved in assignment SLP screened and enrolled all patients PI blinded to results until analysis completed 93 31 1/29/2009 Blinding 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. FEESST (50) 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 [?] MBS (76) à Silent asp Æ PEG/NPO à Asp. not cleared Æ PEG/NPO 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 [?] FEESST patients received 11 extra tests? à 76 MBS patients, 50 FEESST patients Unequal treatment in favor of FEESST guided management. Aviv, 2000 98 Results: primary: no difference 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. No significant difference in pneumonia‐free interval 99 33 1/29/2009 Results‐ not reported “...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 Both endoscopic and MBS guided dysphagia management produce similar pneumonia outcomes Patients guided by FEESST were 11 times more likely to receive a PEG lik l t i PEG Dysphagic patients with PEG had 6.3% higher pneumonia risk 102 34 1/29/2009 So what about testing? 1. Good clinical techniques bear fair to good predictive value (combining them increases value) 2. Both FEES and VFG have advantages and disadvantages à As well as situations when one or the other is preferred, a better choice 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 Most frequent infectious cause of death* 63,000 deaths in 2003** à Incidence: 224** per 10,000 elderly adults p y 162*** per 10,000 persons over age 14 13%‐48% of all Nursing Home Infections 2nd most common nosocomial infection (UTI) in hospitals*** Marston, et al., 1997*; National Center for Health Statistics, 2003**; ***Niederman, et al., 2002 106 Pneumonia 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 Types à Nosocomial Pneumonias: Ventilator Associated, Nursing Home Acquired Pneumonia Pseudomonas aeruginosa, Proteus species, staph. Aureus 108 36 1/29/2009 Community Acquired Pneumonia Human Costs of Community Acquired Pneumonia 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 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 Community Acquired Pneumonia à Pathogen isolated à Patient’s residential environment à Lack of underlying source of dysphagia/aspiration 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 Human Costs of Community Acquired Pneumonia Pneumonia after stroke* à 26.9% mortality, vs. 4.4% in stroke w/o pneumonia Economic Costs of Community Acquired Pneumonia Cost of pneumonia: $8 billion/year (1998)** *Katzan, et al., 2003; ** Niederman, et al., 1998 111 37 1/29/2009 Aspiration Pneumonia (AP) Typically associated with Dysphagia à Can occur from other etiologies Can occur in a health care facility (HCF) à Nosocomial Aspiration Pneumonia Can occur outside of the HCF à Community Acquired Aspiration Pneumonia *Baine, et al., 2001 112 Aspiration Pneumonia Incidence 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 Human Costs of Aspiration Pneumonia à 115,000 cases per year AP admissions highest case‐fatality rate à 23.1% during hospitalization* 23 1% during hospitalization* Annual mortality (1998 numbers) à 115,000 x 23.1% fatality = 26,603 annual AP deaths *Baine et al, 2001; 115 Aspiration Pneumonia Economic Costs of Aspiration Pneumonia 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: 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 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? An inflammation of the alveoli… à Respiratory distress, failure must be treated …that is caused by infectious pathogens à Infection must be treated 118 What is Pneumonia? 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? 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? Phase 3: Gray hepatization phase O2 à RBC’s destroyed à Infection contained Bacteria absent O2 O2 à Infiltrates diminish CO2 O2 Phase 4: Resolution CO2 à Immunological “clean‐up” à Epithelium “heals”, surfactant restored O2 CO2 CO2 O2 O2 capillary 122 Aspiration Pneumonitis Acute Lung Injury caused by aspiration of caustic or particulate matter 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? Definition of Aspiration à Foreign matter enters the respiratory system Definition of Pneumonia à Infectious acute inflammation à Reaction to bacteria and byproducts Aspiration Pneumonia à Lung inflammation caused by pulmonary infection due to aspiration of colonized matter 125 What is Dysphagia‐ Related Aspiration Pneumonia (AP)? 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 Bacteria enter the area (seconds) Bacteria attach to underlying structures à Epithelium, prior biofilm, other surfaces à Seconds to minutes Bacteria grow and multiply (hours – days) An exopolymer forms and Biofilm is born Other bacteria attach to biofilm Todar's Online Textbook of Bacteriology 127 How Does AP Develop? Oral/Pharyngeal Colonization Risk Factors Medications*, Oral disease** inadequate oral hygiene Iatrogenic Risk Factors 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? Host Risk Factors (the patient) Underlying disease 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 Gastric Contents: Massive Acute Inflammation à Sterile, acidic Sterile acidic à Airways, respiratory membrane damage Opportunistic secondary infection à ARDS 131 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 IPF: 16/17 (94%) with abnormally low proximal or p p distal pH supine Normals: 4/8 (50%) Tobin et al., 1998 133 Distinguishing AP, Aspiration Pneumonitis, Other Pneumonias 134 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 Aspiration 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 Aspiration 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 Aspiration 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 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 Aspiration pneumonia à à à à à à à à Inflammation Cough – productive Bronchospasm Dyspnea Hypoxemia Purulent sputum Tachypnea Malaise 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 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 ***History à History of dysphagia‐producing disease à Position at onset of symptoms Infiltrates in dependent segments fl d d à Position at onset of symptoms Dependency for oral care/feeding, periodontal disease 143 AP, vs. Non‐AP 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. 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