Implementing Dysphagia Outcome Assessments into Clinical Settings: Leveraging Principles of Implementation, Dissemination, and Psychometrics.

PURPOSE: Myriad dysphagia assessment tools have been designed, but their application is variable. This is partly due to a lack of implementation and dissemination strategy as well as to limited guidance regarding which instruments are optimally designed and best used for clinical and research applications. METHOD: This tutorial provides a high-level overview of implementation and dissemination, their interaction with psychometrics and knowledge coproduction, and how these concepts relate to proper development and widespread application of contextually relevant, psychometrically optimized, evidence-based dysphagia assessment instruments. RESULTS: A review of the literature identified two dysphagia assessment instruments that purposefully integrated implementation and dissemination processes after measurement development. Application of knowledge coproduction was not identified in any papers reporting development and testing of dysphagia assessment instruments. A better understanding of coproduction and psychometrics when developing measures, while simultaneously applying implementation science and dissemination strategies, can result in the development of optimal dysphagia assessment tools that are more consistently adopted into clinical practice. CONCLUSIONS: Clinicians and researchers should promote the development of psychometrically sound measures, and employ principles of implementation science and effective dissemination strategies to advocate for, and promote the use of, well-designed instruments within their appropriate clinical contexts. Support from governing bodies and funding agencies could enhance future efforts to develop, and encourage widespread uptake of, optimally developed dysphagia assessment tools.

Confidence, Accuracy, and Reliability of Penetration-Aspiration Scale Ratings on Flexible Endoscopic Evaluations of Swallowing by Speech Pathologists.

This study investigated rater confidence when rating airway invasion with the penetration-aspiration scale (PAS) on flexible endoscopic evaluations of swallowing (FEES), raters' accuracy against a referent-standard, inter-rater reliability, and potential associations between clinician confidence, experience, and accuracy. Thirty-one clinicians who use FEES in their daily practice were asked to judge airway invasion with the PAS and to rate their confidence that their score was correct (0-100) for 40 video clips, five in each of the 8 PAS categories. We found that raters were most confident in rating PAS 1, 7, and 8. The average confidence score across all videos was 76/100. Confidence did not have a significant relationship with accuracy against the referent-standard. Accuracy was highest for PAS 1 (92%), followed by PAS 8 (80%), PAS 7 (77%), and PAS 4 (72%). Accuracy was below 60% for PAS 2, 3, 5, and 6, the lowest being for PAS 3 (49%). Mean accuracy for all ratings, compared to referent-standard ratings, was highest for the intermediate group (71%), followed by expert (68%) and novice (65%). In general, we found that certain PAS scores tend to be rated more accurately, and that participating SLPs had varied confidence in PAS ratings on FEES. Potential reasons for these findings as well as suggested next steps are discussed.

A systematic review and meta-analysis of neuromodulators to treat chronic airway hypersensitivity.

OBJECTIVES: Chronic laryngitis can present with numerous symptoms, including chronic cough. Patients who do not respond to standard treatment are sometimes diagnosed with chronic airway hypersensitivity (CAH). In many centers, neuromodulators are prescribed off-label despite limited evidence of efficacy. A previous meta-analysis suggested neuromodulator therapy improved cough-related quality-of-life (QoL). This current updated and expanded meta-analysis examined whether neuromodulators reduced cough frequency, reduced cough severity, and/or improved QoL in CAH patients. DATA SOURCES: PubMed, Embase, Medline, Cochrane Review, and publication bibliographies were searched from 01/01/2000 to 07/31/2021 using MESH terms. REVIEW METHODS: PRISMA guidelines were followed. 999 abstracts were identified/screened, 28 studies were fully reviewed, and 3 met inclusion criteria. Only randomized controlled trials (RCT) investigating CAH patients with comparable cough-related outcomes were included. Three authors reviewed potentially eligible papers. Fixed-effect models and calculated pooled estimates using the Inverse-Variance method were used. RESULTS: The estimated difference in change in log coughs per hour (from baseline to intervention end) between treatment and control groups was -0.46, 95%CI [-0.97; 0.05]. Estimated change-from-baseline in VAS scores was -12.24, 95 % CI [-17.84; -6.65] lower for patients who received treatment vs placebo. Estimated change-from-baseline for LCQ scores was 2.15, 95 % CI [1.49-2.80] higher for patients who receive treatment vs placebo. Only change in LCQ score was clinically significant. CONCLUSIONS: This study tentatively suggests that neuromodulators have the potential to reduce cough symptoms associated with CAH. However, high-quality evidence is lacking. This could be due to limited treatment effect or significant limitations in the design and comparability of existing trials. A well-designed and properly powered RCT is needed to authoritatively test the efficacy of neuromodulators for the treatment of CAH. LEVEL OF EVIDENCE: Level I, evidence from a systematic review or meta-analysis of all relevant RCTs (randomized controlled trial) or evidence-based clinical practice guidelines based on systematic reviews of RCTs or three or more RCTs of good quality that have similar results.

Development of Two Patient Self-Reported Measures on Functional Health Status (FOD) and Health-Related Quality of Life (QOD) in Adults with Oropharyngeal Dysphagia Using the Delphi Technique.

Introduction. Patient self-evaluation is an important aspect in the assessment of dysphagia and comprises both Functional Health Status (FHS) and Health-Related Quality of Life (HR-QoL). As many measures combine both FHS and HR-QoL, disease-related functioning cannot be distinguished from disease-related quality of life as experienced by the patient. Moreover, current patient self-reported measures are limited by poor and incomplete data on psychometric properties. Objective. This study aimed to establish content validity for the development of two new self-reported measures on FHS and HR-QoL in adults with oropharyngeal dysphagia (OD), in line with the psychometric taxonomy and guidelines from the COSMIN group (COnsensus-based Standards for the selection of health Measurement INstruments). Methods. Using the Delphi technique, international expert consensus was achieved; participants and patients with dysphagia evaluated relevance, comprehensiveness, and comprehensibility of definitions of relevant constructs (i.e., dysphagia, FHS and HR-QoL) and potential items. Results. A total of 66 Delphi participants from 45 countries achieved consensus across two rounds. The Delphi study resulted in two prototype measures, the Functional health status measure of Oropharyngeal Dysphagia (FOD) and the health-related Quality of life measure of Oropharyngeal Dysphagia (QOD), consisting of 37 and 25 items, respectively. Minimal revisions were required based on feedback by patients. Conclusions. This study provides evidence of good content validity for both newly developed prototype measures FOD and QOD. Future studies will continue the process of refining the measures, and evaluate the remaining psychometric properties using both Classic Test Theory (CTT) and Item Response Theory (IRT) models.

Correlating muscle resection with functional swallow outcomes: An anatomic framework informed systematic review of the literature.

OBJECTIVE: To perform a systematic review of studies reporting swallow-associated outcomes in patients who received surgery for head and neck cancer (HNC), informed by an anatomic and physiologic framework of pharyngeal phase of swallowing (Pearson's dual-sling model). METHODS: PUBMED and Google Scholar databases were searched for peer-reviewed papers published between 1990 and 2019 using relevant MeSH terms. Exclusion criteria were 1) discussions comparing reconstruction techniques, 2) case-report/series (n < 10), 3) perspective articles, 4) papers comparing objective instrumental methods of swallowing evaluation, 5) animal/cadaver studies, 6) no instrumental or validated swallow assessment tools used, 7) papers that discuss/include radiotherapy treatment, 8) systematic reviews, 9) papers that discuss swallow training or rehabilitation methods. Two investigators reviewed papers meeting inclusion/exclusions criteria. Muscles resected, anatomic resection site, swallow outcomes, and patient treatment variables were collected. RESULTS: A total of 115,020 peer-reviewed papers were identified. 74 papers were relevant to this review, 18 met inclusion and exclusion criteria, and none discussed surgical impact on the pharyngeal phase of swallowing using Pearson's dual-sling model. Most papers discussed the effect of tongue-base, supraglottic, or regional anatomic resection. Post-surgical resection Follow-up times ranged from 1 to 13 months. 67% of studies used objective instrumental swallow studies; 22% used patient reported outcome measures. Follow up time since surgical resection, time to feeding tube removal, feeding tube present/absent, aspiration severity were used to define dysphagia endpoints. CONCLUSIONS: To date, no surgical HNC studies have used the dual-sling mechanism to guide study design, and dysphagia assessment has been inconsistent. To counsel patients on the effects of surgery on pharyngeal phase of swallow function, specialists need physiologically grounded research that correlates muscles resected with consistent measures of swallow function.

Buteyko Breathing Technique for Exertion-Induced Paradoxical Vocal Fold Motion (EI-PVFM).

PURPOSE: The primary purpose of the current study was to determine the usefulness of Buteyko breathing technique (BBT) in reducing dyspnea in patients with one form of Paradoxical Vocal Fold Motion (PVFM), exertion-induced PVFM (EI-PVFM), concomitant with hyperventilation. The secondary purpose was to determine whether BBT had an effect on physiological markers of hyperventilation, as speculated by BBT theory: respiratory tidal minute volume (RTMV), end-tidal carbon dioxide (ETCO2), and resting heart rate (HR). METHODS: Using a within-subjects, repeated measures group design, 12 participants with EI-PVFM and hyperventilation underwent 12 weeks of BBT, following an initial no-treatment control condition. Outcome measures of PVFM-dyspnea frequency and severity-and of hyperventilation-HR, RTMV, and ETCO2-were acquired pre- and post-treatment. RESULTS: Results showed post-treatment decreases in dyspnea severity, HR, and RTMV, as well as increases in ETCO2. Decreases in dyspnea and RTMV measures remained after correction for alpha inflation. CONCLUSIONS: Findings suggest BBT may be useful for some individuals with EI-PVFM and hyperventilation. The high prevalence of hyperventilation in EI-PVFM found in the current study warrants further investigation.

Abnormalities of Aspiration and Swallowing Function in Survivors of Acute Respiratory Failure.

The mechanisms responsible for aspiration are relatively unknown in patients recovering from acute respiratory failure (ARF) who required mechanical ventilation. Though many conditions may contribute to swallowing dysfunction, alterations in laryngeal structure and swallowing function likely play a role in the development of aspiration. At four university-based tertiary medical centers, we conducted a prospective cohort study of ARF patients who required intensive care and mechanical ventilation for at least 48 h. Within 72 h after extubation, a Fiberoptic Flexible Endoscopic Evaluation of Swallowing (FEES) examination was performed. Univariate and multivariable analyses examined the relationship between laryngeal structure and swallowing function abnormalities. Aspiration was the primary outcome, defined as a Penetration- Aspiration Scale (PAS) score of 6 or greater. Two other salient signs of dysphagia-spillage and residue-were secondary outcomes. A total of 213 patients were included in the final analysis. Aspiration was detected in 70 patients (33%) on at least one bolus. The most commonly aspirated consistency was thin liquids (27%). In univariate analyses, several abnormalities in laryngeal anatomy and structural movement were significantly associated with aspiration, spillage, and residue. In a multivariable analysis, the only variables that remained significant with aspiration were pharyngeal weakness (Odds ratio = 2.57, 95%CI = 1.16-5.84, p = 0.019) and upper airway edema (Odds ratio = 3.24, 95%CI = 1.44-7.66, p = 0.004). These results demonstrated that dysphagia in ARF survivors is multifactorial and characterized by both anatomic and physiologic abnormalities. These findings may have important implications for the development of novel interventions to treat dysphagia in ARF survivors.Clinical Trials Registration ClinicalTrials.gov Identifier: NCT02363686, Aspiration in Acute Respiratory Failure Survivors.

The Association Between Endotracheal Tube Size and Aspiration (During Flexible Endoscopic Evaluation of Swallowing) in Acute Respiratory Failure Survivors.

OBJECTIVES: To determine whether a modifiable risk factor, endotracheal tube size, is associated with the diagnosis of postextubation aspiration in survivors of acute respiratory failure. DESIGN: Prospective cohort study. SETTING: ICUs at four academic tertiary care medical centers. PATIENTS: Two hundred ten patients who were at least 18 years old, admitted to an ICU, and mechanically ventilated with an endotracheal tube for longer than 48 hours were enrolled. INTERVENTIONS: Within 72 hours of extubation, all patients received a flexible endoscopic evaluation of swallowing examination that entailed administration of ice, thin liquid, thick liquid, puree, and cracker boluses. Patient demographics, treatment variables, and hospital outcomes were abstracted from the patient's medical records. Endotracheal tube size was independently selected by the patient's treating physicians. MEASUREMENTS AND MAIN RESULTS: For each flexible endoscopic evaluation of swallowing examination, laryngeal pathology was evaluated, and for each bolus, a Penetration Aspiration Scale score was assigned. Aspiration (Penetration Aspiration Scale score ≥ 6) was further categorized into nonsilent aspiration (Penetration Aspiration Scale score = 6 or 7) and silent aspiration (Penetration Aspiration Scale score = 8). One third of patients (n = 68) aspirated (Penetration Aspiration Scale score ≥ 6) on at least one bolus, 13.6% (n = 29) exhibited silent aspiration, and 23.8% (n = 50) exhibited nonsilent aspiration. In a multivariable analysis, endotracheal tube size (≤ 7.5 vs ≥ 8.0) was significantly associated with patients exhibiting any aspiration (Penetration Aspiration Scale score ≥ 6) (p = 0.016; odds ratio = 2.17; 95% CI 1.14-4.13) and with risk of developing laryngeal granulation tissue (p = 0.02). CONCLUSIONS: Larger endotracheal tube size was associated with increased risk of aspiration and laryngeal granulation tissue. Using smaller endotracheal tubes may reduce the risk of postextubation aspiration.

Development of an Accurate Bedside Swallowing Evaluation Decision Tree Algorithm for Detecting Aspiration in Acute Respiratory Failure Survivors.

BACKGROUND: The bedside swallowing evaluation (BSE) is an assessment of swallowing function and airway safety during swallowing. After extubation, the BSE often is used to identify the risk of aspiration in acute respiratory failure (ARF) survivors. RESEARCH QUESTION: We conducted a multicenter prospective study of ARF survivors to determine the accuracy of the BSE and to develop a decision tree algorithm to identify aspiration risk. STUDY DESIGN AND METHODS: Patients extubated after ≥ 48 hours of mechanical ventilation were eligible. Study procedures included the BSE followed by a gold standard evaluation, the flexible endoscopic evaluation of swallowing (FEES). RESULTS: Overall, 213 patients were included in the final analysis. Median time from extubation to BSE was 25 hours (interquartile range, 21-45 hours). The FEES was completed 1 hour after the BSE (interquartile range, 0.5-2 hours). A total of 33% (70/213; 95% CI, 26.6%-39.2%) of patients aspirated on at least one FEES bolus consistency test. Thin liquids were the most commonly aspirated consistency: 27% (54/197; 95% CI, 21%-34%). The BSE detected any aspiration with an accuracy of 52% (95% CI, 45%-58%), a sensitivity of 83% (95% CI, 74%-92%), and negative predictive value (NPV) of 81% (95% CI, 72%-91%). Using recursive partitioning analyses, a five-variable BSE-based decision tree algorithm was developed that improved the detection of aspiration with an accuracy of 81% (95% CI, 75%-87%), sensitivity of 95% (95% CI, 90%-98%), and NPV of 97% (95% CI, 95%-99%). INTERPRETATION: The BSE demonstrates variable accuracy to identify patients at high risk for aspiration. Our decision tree algorithm may enhance the BSE and may be used to identify patients at high risk for aspiration, yet requires further validation. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02363686; URL: www.clinicaltrials.gov.

Association of Neck Range of Motion and Skin Caliper Measures on Dysphagia Outcomes in Head and Neck Cancer and Effects of Neck Stretches and Swallowing Exercises.

To date, there is a paucity of information in the literature regarding the association between cervical range of motion (CROM) and skin caliper measures (SCM) and swallowing outcomes in post-RT individuals with head and neck cancer. Also lacking in the literature are reports of the effect of swallowing exercises and neck stretches on changes in CROM and SCM and their associations with swallowing outcomes. The aim of this study was to assess the associations between CROM and SCM before initiation of a neck stretching and swallowing exercise program and to determine if 12 weeks of twice daily practice changes in CROM and SCM were associated with changes in swallowing outcomes in a cohort of 119 head and neck cancer survivors. Primary results revealed that at baseline, greater right and left CROM were associated with lower penetration aspiration scale (PAS) scores (r = - 0.321, p = < 0.001; r = - 0.203, p = 0.026, respectively). Improved skin pliability revealed lower PAS scores (r = - 0.210, p = 0.022). After 12 weeks, there were no significant correlations between changes in CROM and SCM and PAS scores. Changes in left CROM and CROM extension had positive associations with the Head and Neck Cancer Inventory eating score (r = 0.210, p = 0.026; r = 0.245, p = 0.009, respectively). Findings appear to indicate that any improvement was not associated with changes in swallowing outcomes. Head and neck cancer survivors may perceive improved diet and swallowing skills through exercise, with respect to improved CROM extension.

Application of Manual Therapy for Dysphagia in Head and Neck Cancer Patients: A Preliminary National Survey of Treatment Trends and Adverse Events.

BACKGROUND: Radiation-associated dysphagia is a common and debilitating consequence of treatment for head and neck cancer (HNC). Since commonly employed dysphagia therapy programs for HNC patients still lack authoritative efficacy, some speech-language pathologists (SLPs) have started employing manual therapy (MT) techniques in an attempt to prevent or rehabilitate dysphagia in this patient population. However, exceptionally little is known about the use of MT in this patient population. OBJECTIVES: The purpose of this study was to describe practice patterns as well as the rate, type, and severity of adverse events associated with SLP provision of MT to HNC patients. METHODS: An Internet-based questionnaire geared toward SLPs who practice MT was developed and sent to SLPs practicing in the United States, 3 times, through 3 national listservs (American Speech Language Hearing Association [ASHA] Special Interest Division 13, ASHA Special Interest Division 3, and University of Iowa Voiceserv), over the course of 4 weeks. RESULTS: Of the 255 respondents, 116 (45.5%) performed MT on HNC patients. Of these 116 SLPs, 27.6% provided proactive MT during radiation, 62.1% provided 1 to 2 sessions per week, and 94.8% prescribed a MT home program. The rate, type, and severity of reported adverse events were similar between HNC and non-HNC patients. CONCLUSION: This preliminary survey demonstrated that SLPs provide MT to HNC patients during and after cancer treatment, and that reported adverse events paralleled those experienced by noncancer patients. However, these results should be taken with caution, and a well-designed prospective study is needed to formally establish the safety and the preliminary efficacy of this novel clinical intervention.

Relationship Between Laryngeal Sensation, Length of Intubation, and Aspiration in Patients with Acute Respiratory Failure.

Dysphagia is common in hospitalized patients post-extubation and associated with poor outcomes. Laryngeal sensation is critical for airway protection and safe swallowing. However, current understanding of the relationship between laryngeal sensation and aspiration in post-extubation populations is limited. Acute respiratory failure patients requiring intensive care unit admission and mechanical ventilation received a Flexible Endoscopic Evaluation of Swallowing (FEES) within 72 h of extubation. Univariate and multivariable analyses were performed to examine the relationship between laryngeal sensation, length of intubation, and aspiration. Secondary outcomes included pharyngolaryngeal secretions, pneumonia, and diet recommendations. One-hundred and three patients met inclusion criteria. Fifty-one patients demonstrated an absent laryngeal adductor reflex (LAR). Altered laryngeal sensation correlated with the presence of secretions (p = 0.004). There was a significant interaction between the LAR, aspiration, and duration of mechanical ventilation. Altered laryngeal sensation was significantly associated with aspiration on FEES only in patients with a shorter length of intubation (p = 0.008). Patients with altered laryngeal sensation were prescribed significantly more restricted liquid (p = 0.03) and solid (p = 0.001) diets. No relationship was found between laryngeal sensation and pneumonia. There is a high prevalence of laryngeal sensory deficits in mechanically ventilated patients post-extubation. Altered laryngeal sensation was associated with secretions, aspiration, and modified diet recommendations especially in those patients with a shorter length of mechanical ventilation. These results demonstrate that laryngeal sensory abnormalities impact the development of post-extubation dysphagia.

The impact of time after radiation treatment on dysphagia in patients with head and neck cancer enrolled in a swallowing therapy program.

BACKGROUND: Swallowing dysfunction after radiotherapy (RT) for head and neck cancer can be devastating. A randomized control trial compared swallow exercises versus exercise plus neuromuscular electrical stimulation therapy and found no overall difference in outcomes. METHODS: Quality of life (QOL), diet, and swallowing variables collected at discrete intervals on 117 patients were reanalyzed to test the hypothesis that shorter time between the completion of radiotherapy and beginning of the swallowing therapy program yielded improved outcomes. RESULTS: At baseline, subjects < 1 year post radiation had significantly better function than subjects >2 years post RT in several measures. Over the therapy program, the early group showed significant improvement in diet and QOL. Swallowing physiologic variables showed no difference between groups. CONCLUSION: Beginning a swallowing therapy program within 1 year of completion of radiotherapy demonstrates more consistent improvement in QOL and diet performance compared to later periods.

Oral Care Clinical Trial to Reduce Non-Intensive Care Unit, Hospital-Acquired Pneumonia: Lessons for Future Research.

Hospital-acquired pneumonia (HAP) contributes greatly to patient mortality and healthcare costs. Studies have shown that aggressive oral care in intensive care units (ICUs) can significantly reduce pneumonia rates, and hospitals have implemented stringent protocols in this setting. However, little is known about the effectiveness of aggressive oral care in reducing HAP in non-intensive care wards, prompting us to conduct a nonrandomized controlled clinical trial. A structured toothbrushing program was provided to an experimental cohort of patients. A control group received usual care. Patient demographics, toothbrushing frequency, and pneumonia diagnosis were recorded over a 3.5-month period. Difference in pneumonia rates was computed using unadjusted and multivariate logistic regression analyses. No significant difference in pneumonia rates between control and experimental groups was found (1.7% versus 1.8%). Toothbrushing rates increased significantly in the experimental group (p = .002) but fell short of protocol frequency. It became apparent that aggressive toothbrushing program implementation requires nursing-led interdisciplinary involvement, more intensive training, a streamlined documentation system, and efficient compliance tracking. Lessons from this study should be used for future large-scale research. A secondary analysis of these data did, however, suggests that increasing toothbrushing rates may have the potential to reduce pneumonia in the non-ICU acute care setting.

Emergency Airway Response Team (EART) Documentation: Criteria, Feasibility, and Usability.

Patients in an acute care hospital who experience a difficult airway event outside the operating room need a specialized emergency airway response team (EART) immediately. This designated team manages catastrophic airway events using advanced airway techniques as well as surgical intervention. Nurses respond as part of this team. There are no identified difficult airway team documentation instruments in the literature, and the lack of metrics limits the quality review of the team response. This study identified EART documentation criteria and incorporated them into a nursing documentation instrument to be completed by a nurse scribe during the event. The EART instrument was tested by nurses for usability, feasibility, and completeness. Twenty-one critical care nurses participated in this study. The results confirmed good usability, positive feasibility, and 79% documentation completeness using this tool. These criteria and this instrument can be important in documenting the EART and in evaluating the quality of the team performance.

Emergency Airway Response Team Simulation Training: A Nursing Perspective.

BACKGROUND: Simulation-based education is an important tool in the training of professionals in the medical field, especially for low-frequency, high-risk events. An interprofessional simulation-based training program was developed to enhance Emergency Airway Response Team (EART) knowledge, team dynamics, and personnel confidence. This quality improvement study evaluated the EART simulation training results of nurse participants. METHOD: Twenty-four simulation-based classes of 4-hour sessions were conducted during a 12-week period. Sixty-three nurses from the emergency department (ED) and the intensive care units (ICUs) completed the simulation. Participants were evaluated before and after the simulation program with a knowledge-based test and a team dynamics and confidence questionnaire. Additional comparisons were made between ED and ICU nurses and between nurses with previous EART experience and those without previous EART experience. RESULTS: Comparison of presimulation (presim) and postsimulation (postsim) results indicated a statistically significant gain in both team dynamics and confidence and Knowledge Test scores (P < .01). There were no differences in scores between ED and ICU groups in presim or postsim scores; nurses with previous EART experience demonstrated significantly higher presim scores than nurses without EART experience, but there were no differences between these nurse groups at postsim. CONCLUSIONS: This project supports the use of simulation training to increase nurses' knowledge, confidence, and team dynamics in an EART response. Importantly, nurses with no previous experience achieved outcome scores similar to nurses who had experience, suggesting that emergency airway simulation is an effective way to train both new and experienced nurses.

The color of cancer: Margin guidance for oral cancer resection using elastic scattering spectroscopy.

OBJECTIVES/HYPOTHESIS: To evaluate the usefulness of elastic scattering spectroscopy (ESS) as a diagnostic adjunct to frozen section analysis in patients with diagnosed squamous cell carcinoma of the oral cavity. STUDY DESIGN: Prospective analytic study. METHODS: Subjects for this single institution, institutional review board-approved study were recruited from among patients undergoing surgical resection for squamous cell cancer of the oral cavity. A portable ESS device with a contact fiberoptic probe was used to obtain spectral signals. Four to 10 spectral readings were obtained on each subject from various sites including gross tumor and normal-appearing mucosa in the surgical margin. Each reading was correlated with the histopathologic findings of biopsies taken from the exact location of the spectral readings. A diagnostic algorithm based on multidimensional pattern recognition/machine learning was developed. Sensitivity and specificity, error rate, and area under the curve were used as performance metrics for tests involving classification between disease and nondisease classes. RESULTS: Thirty-four (34) subjects were enrolled in the study. One hundred seventy-six spectral data point/biopsy specimen pairs were available for analysis. ESS distinguished normal from abnormal tissue, with a sensitivity ranging from 84% to 100% and specificity ranging from 71% to 89%, depending on how the cutoff between normal and abnormal tissue was defined (i.e., mild, moderate, or severe dysplasia). There were statistically significant differences in malignancy scores between histologically normal tissue and invasive cancer and between noninflamed tissue and inflamed tissue. CONCLUSIONS: This is the first study to evaluate the effectiveness of ESS in guiding mucosal resection margins in oral cavity cancer. ESS provides fast, real-time assessment of tissue without the need for pathology expertise. ESS appears to be effective in distinguishing between normal mucosa and invasive cancer and between "normal" tissue (histologically normal and mild dysplasia) and "abnormal" tissue (severe dysplasia and carcinoma in situ) that might require further margin resection. Further studies, however, are needed with a larger sample size to validate these findings and to determine the effectiveness of ESS in distinguishing visibly and histologically normal tissue from visibly normal but histologically abnormal tissue. LEVEL OF EVIDENCE: NA Laryngoscope, 127:S1-S9, 2017.

Variability of the Pressure Measurements Exerted by the Tip of Laryngoscope During Laryngeal Sensory Testing: A Clinical Demonstration.

PURPOSE: Clinicians often test laryngeal sensation by touching the laryngeal mucosa with the tip of a flexible laryngoscope. However, the pressure applied to the larynx by using this touch method is unknown, and the expected responses elicited by this method are uncertain. The variability in pressure delivered by clinicians using the touch method was investigated, and the subject responses to the touches were also reported. METHODS: A fiberoptic pressure sensor passed through the working channel of a laryngoscope, with its tip positioned at the distal port of the channel. Two examiners each tested 8 healthy adults. Each examiner touched the mucosa covering the left arytenoid 3 times. The sensor recorded the pressure exerted by each touch. An investigator noted subject responses to the touches. From the recorded videos, the absence or presence of the laryngeal adductor reflex in response to touch was judged. RESULTS: Pressure values obtained for 46 of the 48 possible samples ranged from 17.9 mmHg to the measurement ceiling of 350.0 mmHg. The most frequently observed response was positive subject report followed by the laryngeal adductor reflex. CONCLUSION: Pressure applied to the larynx by using the touch method was highly variable, indicating potential diagnostic inaccuracy in determining laryngeal sensory function.

Comparing dysphagia therapy in head and neck cancer patients in Australia with international healthcare systems.

PURPOSE: The Australian healthcare system has invested heavily in multidisciplinary cancer care teams. Despite such investments, guidelines that clearly delineate standard of care dysphagia treatment are lacking and services provided to Head and Neck Cancer (HNC) patients are not always consistent. There is little consensus regarding the frequency and intensity of dysphagia therapy. This is largely due to a lack of well-designed clinical trials that establish the efficacy of any dysphagia therapy in this patient population. The aim of this study was to evaluate HNC dysphagia therapy patterns among Australian speech-language pathologists (SLPs). METHOD: A 22 question internet-based survey was administered to a web-based professional interest group. Results were analysed by institution type and individual clinical experience. RESULT: A response rate of 46% was achieved (67 out of 144 surveyed). This survey identified several aspects of dysphagia management that were provided uniformly in addition to many aspects of care that showed a lack of consensus. CONCLUSION: By comparing the results of this survey with existing international best-evidence treatment guidelines, the development of uniform Australian guidelines may be facilitated. However, more authoritative data on dysphagia treatment efficacy is needed to provide uniform evidence-based HNC dysphagia treatment guidelines.