Prophylactic Swallowing Therapy During Head-and-Neck Cancer Radiotherapy: Effect of Service-Delivery Mode and Overall Adherence Level on Swallowing Function and Muscle Strength-the PRESTO Trial.

Prophylactic swallowing exercises (PSE) during head-and-neck cancer (HNC) (chemo)radiotherapy (CRT) have a positive effect on swallowing function and muscle strength. Adherence rates to PSE are, however, moderate to low, undermining these effects. PRESTO already showed that the service-delivery mode (SDM), the way the exercises are offered, can influence adherence. The aim of this study was to investigate the effect of SDM on swallowing function and muscle strength during and post-CRT. In addition, the effect of overall adherence (OA), independent of SDM, was also investigated. A total of 148 HNC patients, treated with CRT, were randomly assigned to one of the three SDM's (paper-supported, app-supported, or therapist-supported PSE) and performed a 4-week PSE program. OA was calculated based on the percentage of completed exercises. Patients were divided into OA levels: the OA75+ and OA75- group performed respectively ≥ 75 and < 75% of the exercises. Swallowing function based on Mann Assessment of Swallowing Ability-Cancer (MASA-C), tongue and suprahyoid muscle strength during and up to 3 months after CRT were compared between the SDM's and OA levels. Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni-Holm correction was used. No significant differences were found between the three SDMs. Significant time effects were found: MASA-C scores decreased and muscle strength increased significantly during CRT. By the end of CRT, the OA75+ showed significantly better swallowing function compared to OA75-. Muscle strength gain was significantly higher in the OA75+ group. SDM had no impact on swallowing function and muscle strength; however, significant effects were shown for OA level. Performing a high level of exercise repetitions is essential to benefit from PSE.Trial registration ISRCTN, ISRCTN98243550. Registered December 21, 2018-retrospectively registered, https://www.isrctn.com/ISRCTN98243550?q=gwen%20van%20nuffelen&filters=&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search.

Increasing Adherence to Prophylactic Swallowing Exercises During Head and Neck Radiotherapy: The Multicenter, Randomized Controlled PRESTO-Trial.

BACKGROUND: Prophylactic swallowing exercises (PSE) during radiotherapy can significantly reduce dysphagia after radiotherapy in head and neck cancer (HNC). However, its positive effects are hampered by low adherence rates during the burdensome therapy period. Hence, the main goal of this multicenter randomized controlled trial (RCT) was to investigate the effect of 3 different service-delivery modes on actual patients' adherence. METHODS: A total of 148 oropharyngeal cancer patients treated with primary (chemo)radiotherapy were randomly assigned to a 4 weeks PSE program, either diary-supported (paper group; n = 49), app-supported (app group; n = 49) or therapist-supported (therapist group; n = 50). Participants practiced 5 days/week, daily alternating tongue strengthening exercises with chin tuck against resistance exercises. Adherence was measured as the percentage of completed exercise repetitions per week (%reps). Statistical analysis was performed by means of SPSSv27, using Linear Mixed-effects Models with post hoc pairwise testing and Bonferroni-Holm correction. RESULTS: Adherence and evolution of adherence over time was significantly different between the three groups (p < .001). Adherence rates decreased in all three groups during the 4 training weeks (p < .001). During all 4 weeks, the therapist group achieved the highest adherence rates, whilst the app group showed the lowest adherence rates. CONCLUSIONS: PSE adherence decreased during the first 4 radiotherapy weeks regardless of group, but with a significant difference between groups. The therapist group achieved the highest adherence rates with a rather limited decline, therefore, increasing the face-to-face contact with a speech-language therapist can overcome the well-known problem of low adherence to PSE in this population. TRIAL REGISTRATION: Trial registration: ISRCTN, ISRCTN98243550. Registered December 21, 2018 - retrospectively registered, https://www.isrctn.com/ISRCTN98243550?q=gwen%20van%20nuffelen&filters=&sort=&offset=1&totalResults=2&page=1&pageSize=10&searchType=basic-search .

Home-based intensive treatment of chronic radiation-associated dysphagia in head and neck cancer survivors (HIT-CRAD trial).

BACKGROUND: Chronic radiation-associated dysphagia (C-RAD) is considered to be one of the most severe functional impairments in head and neck cancer survivors treated with radiation (RT) or chemoradiation (CRT). Given the major impact of these late toxicities on patients' health and quality of life, there is a strong need for evidence-based dysphagia management. Although studies report the benefit of strengthening exercises, transference of changes in muscle strength to changes in swallowing function often remains limited. Therefore, combining isolated strengthening exercises with functional training in patients with C-RAD may lead to greater functional gains. METHODS: This 3-arm multicenter randomized trial aims to compare the efficacy and possible detraining effects of mere strengthening exercises (group 1) with a combination of strengthening exercises and functional swallowing therapy (group 2) and non-invasive brain stimulation added to that combination (group 3) in 105 patients with C-RAD. Patients will be evaluated before and during therapy and 4 weeks after the last therapy session by means of swallowing-related and strength measures and quality of life questionnaires. DISCUSSION: Overall, this innovative RCT is expected to provide new insights into the rehabilitation of C-RAD to optimize post-treatment swallowing function. TRIAL REGISTRATION: International Standard Randomized Controlled Trials Number (ISRCTN) registry ID ISRCTN57028065. Registration was accepted on 15 July 2021.

Accuracy of High-Resolution Pharyngeal Manometry Metrics for Predicting Aspiration and Residue in Oropharyngeal Dysphagia Patients with Poor Pharyngeal Contractility.

Several physiological metrics can be derived from pharyngeal high-resolution impedance manometry (HRPM), but their clinical relevance has not been well established. We investigated the diagnostic performance of these metrics in relation to videofluoroscopic (VFS) assessment of aspiration and residue in patients with oropharyngeal dysphagia. We analyzed 263 swallows from 72 adult patients (22-91 years) with diverse medical conditions. Metrics of contractility, upper esophageal sphincter (UES) opening and relaxation, flow timing, intrabolus distension pressure, and a global Swallow Risk Index (SRI) were derived from pressure-impedance recordings using pressure-flow analysis. VFS data were independently scored for airway invasion and pharyngeal residue using the Penetration-Aspiration Scale and the Normalized Residue Ratio Scale, respectively. We performed multivariate logistic regression analyses to determine the relationship of HRPM metrics with radiological outcomes and receiver-operating characteristic (ROC) analysis to evaluate their diagnostic accuracy. We identified aspiration in 25% and pharyngeal residue in 84% of the swallows. Aspiration was independently associated with hypopharyngeal peak pressure < 65 mmHg (HypoPeakP) [adjusted odds ratio (OR) 5.27; 95% Confidence Interval (CI) (0.99-28.1); p = 0.051], SRI > 15 [OR 4.37; 95% CI (1.87-10.2); p < 0.001] and proximal esophageal contractile integral (PCI) < 55 mmHg·cm·s [OR 2.30; 95% CI (1.07-4.96); p = 0.034]. Pyriform sinus residue was independently predicted by HypoPeakP < 65 mmHg [OR 7.32; 95% CI (1.93-27.7); p = 0.003], UES integrated relaxation pressure (UES-IRP) > 3 mmHg [OR 2.96; 95% CI (1.49-5.88); p = 0.002], and SRI > 15 [OR 2.17; 95% CI (1.04-4.51); p = 0.039]. Area under ROC curve (AUC) values for individual HRPM metrics ranged from 0.59 to 0.74. Optimal cut-off values were identified. This study demonstrates the diagnostic value of certain proposed and adjunct HRPM metrics for identifying signs of unsafe and inefficient bolus transport in patients with oropharyngeal dysphagia.

Transoral robotic surgery (TORS) using the da Vinci Xi: prospective analysis of feasibility, safety, and outcomes.

BACKGROUND: The da Vinci Xi system is not Food and Drug Administration approved for transoral robotic surgery (TORS), resulting in limited data. METHODS: This prospective study evaluates the feasibility, safety, and outcomes of Xi-TORS in an oncological setting. RESULTS: Sixty-one patients with head and neck cancer were consecutively included for Xi-TORS. Adequate exposure and macroscopically complete resection were achieved in 59 patients (success rate = 96.7%). Intraoperative difficulties and complications were encountered in 47.5% and 20.3% of patients, respectively. Postoperative hemorrhage occurred in 11.9%; no treatment-related deaths were encountered. Two-year overall survival and disease-specific survival were 90.5% and 95.6%, respectively. No long-term (>1 month) tracheotomies were necessary, and only two patients remained tube-feeding dependent. The functional baseline level was regained at 12 months for the MD Anderson Dysphagia Inventory and at 24 months for the Swallowing quality-of-life questionnaire. QLQ-H&N35-assessed QOL returned to baseline 6 months postoperatively. CONCLUSIONS: Xi-TORS is safe, feasible, and with high oncological and functional effectiveness.

Training for Caregivers and Compliance with Dysphagia Recommendations in a Tertiary Multiple Sclerosis Rehabilitation Center.

BACKGROUND: Dysphagia is common in persons with multiple sclerosis (MS). Speech and language therapists give dysphagia recommendations to persons with MS and caregivers. Nonadherence to these recommendations can increase the risk of aspiration. We investigated current compliance with dysphagia recommendations among caregivers and kitchen staff and assessed improvement in compliance by increasing knowledge through tailored training. METHODS: An observational cohort study was conducted over 4 weeks during which the compliance of the caregivers and kitchen staff in a rehabilitation center was monitored. A questionnaire was used to assess reasons for noncompliance. A 2-hour training session was provided for all caregivers and kitchen staff to improve their knowledge and skills. The compliance rate was observed again 1 and 6 months after the training. Compliance was defined by whether recommendations were followed. RESULTS: Results showed a significant improvement after training for overall compliance by caregivers (from 58% to >81%, P < .001). This improvement was still observed 6 months later (80%). After training, significant differences were found in compliance with the following recommendations (P ≤ .001): consistency of soup, consistency of liquids, food preparation, alertness, speed, amount, posture, and supervision. Recommendation for utensils did not improve (P = .44). Compliance with diet modifications made by the kitchen staff improved significantly (from 74% to >86%, P = .002), and even more during follow-up (to >95%, P = .009). CONCLUSIONS: Dysphagia training tailored to the needs of caregivers to improve knowledge significantly improves compliance with dysphagia recommendations and the quality of care.

Impact of COVID-19: urging a need for multi-domain assessment of COVID-19 inpatients.

OBJECTIVE: To retrospectively analyse data obtained from the multi-domain assessment of hospitalized COVID-19 patients, to describe their health status at discharge, and to investigate whether subgroups of patients, more specific ICU patients and older adults (> 70 years), had more (or less) risk to experience specific impairments. METHODS: Retrospective case series in the University Hospitals Leuven, Belgium of confirmed COVID-19 patients 'after surviving an ICU-stay', 'aged ≥ 70 years', or 'aged < 70 years with a length of hospitalization > 7 days'. Exclusion criteria were 'unwilling to cooperate', 'medically unstable', or 'palliative care policy'. Following tests were used: 'Five Times Sit To Stand Test', 'hand grip dynamometry', 'Barthel index', 'Swallowing screening', 'Montreal Cognitive Assessment', 'Hospital Anxiety and Depression Scale', and 'Nutritional Risk Screening 2002'. RESULTS: One or more tests were obtained in 135/163 patients (83.3%). Physical impairments were present in 43.2-82.8% of the patients. Median BI was 10/20 indicating limited self-dependency. Swallow impairments were present in 3/53 (5.7%) and 24/76 (31.6%) had risk of malnutrition. Impaired memory was seen in 26/43 (60.5%) and 22/47 (46.8%) had elevated anxiety/depression scores. Older adults had more physical, functional, and cognitive impairments. ICU patients had a lower hand grip force. CONCLUSION(S): The high prevalence of physical, cognitive, psychological, and functional impairments in hospitalized COVID-19 patients, both ICU and non-ICU patients, indicates that assessment of impairments is imperative. These results imply that rehabilitation and follow-up is essential for these patients. This paper proposes a short, workable assessment composed with known outcome measures to assess different domains of COVID-19 patients.

Functional Outcomes and Complications After Salvage Total Laryngectomy for Residual, Recurrent, and Second Primary Squamous Cell Carcinoma of the Larynx and Hypopharynx: A Multicenter Retrospective Cohort Study.

Background/Purpose: We analyzed complications and functional outcomes and aimed at identifying prognostic factors for functional outcomes and complications in patients who underwent salvage total laryngectomy (STL) for residual, recurrent, and second primary squamous cell carcinoma (SCC) of the larynx and hypopharynx after initial (chemo)radiation. Methods: Retrospective cohort study of patients who underwent STL in four major Belgian reference hospitals between 2002 and 2018. Prognostic factors for functional outcomes and complications were identified with uni- and multivariable analysis. Results: A total of 405 patients were included in the final analysis. STL was performed for residual tumor (40.2%), local recurrence (40.5%), or second primary laryngeal or hypopharyngeal SCC (19.4%). Early postoperative complications were experienced by 34.2% of patients: postoperative hemorrhage occurred in 5.4%, wound infection in 16.2%, and clinical pharyngocutaneous fistula (PCF) in 25.5% of patients. Early readmission proved necessary in 15.1% of cases, most often due to late PCF development (72.2%). Patients achieved total peroral intake in 94.2% of cases. However, subjective dysphagia was reported by 31.3% of patients during follow-up. Functional speech, defined as functional communication by speech without additional aids, was reported in 86.7% of cases and was most often achieved by tracheo-esophageal puncture (TEP) (94.1%). In a multivariable model, lower preoperative hemoglobin (<12.5 g/dl) was identified as an independent prognostic factor for higher overall complication rate. No risk factors were found significant for clinical fistula formation. Vascularized tissue augmentation did not significantly prevent clinical PCF. Patients with positive section margins, patients initially treated with surgery combined with adjuvant RT (vs. radiotherapy alone), and those developing PCF after STL were less likely to achieve total peroral intake. Postoperative dysphagia proved more likely in patients who developed a PCF postoperatively, and less likely in patients who underwent STL without partial pharyngectomy and in patients with myocutaneous pectoralis major (PM) flap reconstruction, compared to muscle onlay PM flap. Achieving postoperative functional speech proved most likely in patients with smaller tumors (lower pT classification) and free section margins. Conclusion: Substantial complication rates and favorable functional outcomes are reported after STL.

Study protocol for a randomized controlled trial: prophylactic swallowing exercises in head-and-neck cancer patients treated with (chemo)radiotherapy (PRESTO trial).

BACKGROUND: Dysphagia is a common and serious complication after (chemo)radiotherapy (CRT) for head-and-neck cancer (HNC) patients. Prophylactic swallowing exercises (PSE) can have a significantly positive effect on post-treatment swallowing function. However, low adherence rates are a key issue in undermining this positive effect. This current randomized trial will investigate the effect of adherence-improving measures on patients' swallowing function, adherence and quality of life (QOL). METHODS: This ongoing trial will explore the difference in adherence and swallowing-related outcome variables during and after PSE in HNC patients performing the same therapy schedule, receiving different delivery methods. One hundred and fifty patients treated in various hospitals will be divided into three groups. Group 1 performs PSE at home, group 2 practices at home with continuous counseling through an app and group 3 receives face-to-face therapy by a speech and language pathologist. The exercises consist of tongue-strengthening exercises and chin-tuck against resistance with effortful swallow. The Iowa Oral Performance Instrument and the Swallowing Exercise Aid are used for practicing. Patients are evaluated before, during and after treatment by means of strength measurements, swallowing and QOL questionnaires. DISCUSSION: Since low adherence rates undermine the positive impact of PSE on post-treatment swallowing function, there is need to develop an efficient PSE protocol maximizing adherence rates. TRIAL REGISTRATION: ISRCTN, ID: ISRCTN98243550. Registered retrospectively on 21 December 2018.

Clinical factors impacting on late dysphagia following radiotherapy in patients with head and neck cancer.

OBJECTIVE: Patient and treatment characteristics of patients with head and neck cancer (HNSCC) were correlated with dysphagia scored on swallowing-videofluoroscopy (VFS) and with patient- and physician-scored dysphagia. METHODS: 63 HNSCC patients treated with radiotherapy (RT) were evaluated at baseline, and 6 and 12 months post-RT. VFS was scored with Penetration Aspiration Scale (PAS) and Swallowing Performance Scale (SPS). Physician- and patient-scored dysphagia were prospectively recorded according to Common Terminology Criteria for Adverse Events scoring system, Radiation Therapy Oncology Group/EORTC scoring system and European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ H&N35). RESULTS: Univariable analysis revealed a significant association between tumour-subsite and higher SPS (p = 0.02) and patient-scored dysphagia (p = 0.02) at baseline. At 12 months, tumour-subsite was significantly associated with higher PAS and SPS. Multivariable analysis and pairwise comparison showed that hypopharyngeal cancer and carcinoma of unknown primary  were associated with higher SPS at baseline and at 12 months, respectively (p = 0.03 and p = 0.01). Upfront neck dissection (UFND) was significantly associated with higher SPS and physician-scored dysphagia in univariable analysis at all timepoints. At 12 months, there was also a significant association with higher PAS (p < 0.01) and patient-scored dysphagia (p < 0.01). After multivariable analysis, the association between UFND and higher PAS (p < 0.01) and SPS (p < 0.01) remained significant at 12 months. CONCLUSION: Hypopharyngeal tumours and carcinoma of unknown primary were related to more dysphagia at baseline and at 12 months, respectively. Furthermore, UFND was associated with more severe dysphagia scored by physicians and patients and on VFS at 12 months. Advances in knowledge: This is the first paper reporting a significant link between UFND and late dysphagia scored with VFS. We advocate abandoning UFND and preserving neck dissection as a salvage option post-RT.

Does the total dysphagia risk score correlate with swallowing function examined by videofluoroscopy?

OBJECTIVE: The purpose of this study was to correlate the total dysphagia risk score (TDRS) with swallowing function as measured by videofluoroscopy of swallowing using the swallowing performance scale (SPS) and the penetration aspiration scale (PAS). METHODS: 63 patients from two different centres treated with radiotherapy for head and neck cancer were evaluated in the current study. Swallowing videofluoroscopies at baseline, 6 and 12 months following radiotherapy were evaluated by two observers. The TDRS of all patients was calculated and correlated with the consensus PAS and SPS scores of the two observers. RESULTS: Regarding the PAS scale, we did not observe a significant correlation with the TDRS. Regarding SPS, we found a significant correlation at 6 months (p = 0.01) and a borderline significant correlation at 12 months (p = 0.05). We observed statistically lower SPS scores for patients in the intermediate-risk category when compared to the high-risk category. When we compared low vs high TDRS risk patients, we did not observe a significant difference regarding SPS scores. When comparing low- vs intermediate-risk patients, we observed higher SPS scores in the low-risk group (p = 0.01). When the low- and intermediate-risk patients were grouped together, we observed less swallowing problems as measured by SPS in the low and intermediate group when compared to the high-risk group (p = 0.05) at 6 months. CONCLUSION: Patients with high-risk TDRS scores have higher SPS scores when compared to the intermediate group and the intermediate- and low-risk group together. However, low-risk patients in our patient cohort could not be distinguished from high or intermediate-risk patients. Advances in knowledge: TDRS was never correlated with videofluoroscopies in past studies. The hypothesis of this paper was to see if the TDRS could guide us to see which patients are at risk for high scores on SPS and PAS and might need a videofluoroscopic examination in the follow up. Given the poor correlations in our study, however, we cannot recommend the use of the TDRS to select patients who might benefit from the additional information provided by videofluoroscopies.

Language processing in bilingual aphasia: a new insight into the problem.

There is increasing evidence that a bilingual person should not be considered as two monolinguals in a single body, a view that has gradually been adopted in the diagnosis and treatment of bilingual aphasia. However, its investigation is complicated due to the large variety in possible language combinations, pre- and postmorbid language proficiencies, and age of second language acquisition. Furthermore, the tests and tasks used to assess linguistic capabilities differ in almost every study, hindering a direct comparison of their outcomes. Behavioral, electrophysiological, and neuroimaging data from healthy population show that the processing of second language domains (semantics, syntax, morphology) depends on factors such as age and method of acquisition, proficiency level and environment in which the second language was acquired. A number of single and multiple case reports that rely on behavioral testing of bilingual aphasics replicate these results. Additionally, they show that the patient's performance depends on the size and location of the lesion, as well as language typology and morphological characteristics. Furthermore, the impairment and recovery patterns and recovery generalization from treated to untreated language depend on the lexical and orthographic distances between the two languages. For healthy bilinguals, language processing is usually studied in comparison to monolinguals. We advocate that a good starting point for identifying patterns specific for bilingual aphasia is to compare patient studies of bilinguals and monolinguals.

Sentence Context Prevails Over Word Association in Aphasia Patients with Spared Comprehension: Evidence from N400 Event-Related Potential.

Behavioral and event-related potential (ERP) studies on aphasia patients showed that lexical information is not lost but rather its integration into the working context is hampered. Studies have been conducted on the processing of sentence-level information (meaningful versus meaningless) and of word-level information (related versus unrelated) in aphasia patients, but we are not aware of any study that assesses the relationship between the two. In healthy subjects the processing of a single word in a sentence context has been studied using the N400 ERP. It was shown that, even when there is only a weak expectation of a final word in a sentence, this expectation will dominate word relatedness. In order to study the effect of semantic relatedness between words in sentence processing in aphasia patients, we conducted a crossed-design ERP study, crossing the factors of word relatedness and sentence congruity. We tested aphasia patients with mild to minimum comprehension deficit and healthy young and older (age-matched with our patients) controls on a semantic anomaly judgment task when simultaneously recording EEG. Our results show that our aphasia patient's N400 amplitudes in response to the sentences of our crossed-design study were similar to those of our age-matched healthy subjects. However, we detected an increase in the N400 ERP latency in those patients, indicating a delay in the integration of the new word into the working context. Additionally, we observed a positive correlation between comprehension level of those patients and N400 effect in response to meaningful sentences without word relatedness contrasted to meaningless sentences without word relatedness.

The effect of orofacial myofunctional treatment in children with anterior open bite and tongue dysfunction: a pilot study.

OBJECTIVES: Insufficient attention is given in the literature to the early treatment of anterior open bite (AOB) subjects receiving orofacial myofunctional therapy (OMT), which aims to harmonize the orofacial functions. This prospective pilot study investigates the effects of OMT on tongue behaviour in children with AOB and a visceral swallowing pattern. MATERIALS AND METHODS: The study comprised of 22 children (11 boys, 11 girls; age range: 7.1-10.6 years). They were randomly assigned into OMT and non-OMT subjects. The randomization was stratified on the presence of a transversal crossbite. At baseline (T0), at the end of treatment (T1) and at 6 months after T1 (T2) maximum tongue elevation strength was measured with the IOPI system (IOPI MEDICAL LLC, Redmond, Washington, USA). Functional characteristics such as tongue posture at rest, swallowing pattern and articulation and the presence of an AOB were observed. RESULTS: OMT did significantly change tongue elevation strength, tongue posture at rest, and tongue position during swallowing of solid food. At T2 more OMT subjects had contact between the lower central incisors and their antagonists or palate (P = 0.036). More OMT subjects performed a physiological pattern of water swallowing than non-OMT children at T1 and T2, although the differences were not significant. Articulation of /s,l,n,d,t/ was not improved by OMT. No interaction between OMT and expansion was found for any of the parameters. CONCLUSION: OMT can positively influence tongue behaviour. However, further research is recommended to clarify the success of OMT as an adjunct to orthodontic treatment and to identify possible factors influencing the outcome.

Bolus Residue Scale: An Easy-to-Use and Reliable Videofluoroscopic Analysis Tool to Score Bolus Residue in Patients with Dysphagia.

Background. We aimed to validate an easy-to-use videofluoroscopic analysis tool, the bolus residue scale (BRS), for detection and classification of pharyngeal retention in the valleculae, piriform sinuses, and/or the posterior pharyngeal wall. Methods. 50 randomly selected videofluoroscopic images of 10 mL swallows (recorded in 18 dysphagia patients and 8 controls) were analyzed by 4 experts and 6 nonexpert observers. A score from 1 to 6 was assigned according to the number of structures affected by residue. Inter- and intrarater reliabilities were assessed by calculation of intraclass correlation coefficients (ICCs) for expert and nonexpert observers. Sensitivity, specificity, and interrater agreement were analyzed for different BRS levels. Results. Intrarater reproducibility was almost perfect for experts (mean ICC 0.972) and ranged from substantial to almost perfect for nonexperts (mean ICC 0.835). Interjudge agreement of the experts ranged from substantial to almost perfect (mean ICC 0.780), but interrater reliability of nonexperts ranged from substantial to good (mean 0.719). BRS shows for experts a high specificity and sensitivity and for nonexperts a low sensitivity and high specificity. Conclusions. The BRS is a simple, easy-to-carry-out, and accessible rating scale to locate pharyngeal retention on videofluoroscopic images with a good specificity and reproducibility for observers of different expertise levels.

A comparison of two spelling Brain-Computer Interfaces based on visual P3 and SSVEP in Locked-In Syndrome.

OBJECTIVES: We study the applicability of a visual P3-based and a Steady State Visually Evoked Potentials (SSVEP)-based Brain-Computer Interfaces (BCIs) for mental text spelling on a cohort of patients with incomplete Locked-In Syndrome (LIS). METHODS: Seven patients performed repeated sessions with each BCI. We assessed BCI performance, mental workload and overall satisfaction for both systems. We also investigated the effect of the quality of life and level of motor impairment on the performance. RESULTS: All seven patients were able to achieve an accuracy of 70% or more with the SSVEP-based BCI, compared to 3 patients with the P3-based BCI, showing a better performance with the SSVEP BCI than with the P3 BCI in the studied cohort. Moreover, the better performance of the SSVEP-based BCI was accompanied by a lower mental workload and a higher overall satisfaction. No relationship was found between BCI performance and level of motor impairment or quality of life. CONCLUSION: Our results show a better usability of the SSVEP-based BCI than the P3-based one for the sessions performed by the tested population of locked-in patients with respect to all the criteria considered. The study shows the advantage of developing alternative BCIs with respect to the traditional matrix-based P3 speller using different designs and signal modalities such as SSVEPs to build a faster, more accurate, less mentally demanding and more satisfying BCI by testing both types of BCIs on a convenience sample of LIS patients.

Reproducibility and agreement of pharyngeal automated impedance manometry with videofluoroscopy.

BACKGROUND & AIMS: Automated impedance manometry analysis (AIM) measures swallow function variables that define bolus timing, intrabolus pressure, contractile vigor, and bolus presence; these are combined to derive a swallow risk index (SRI) that is correlated with pharyngeal dysfunction and aspiration. We assessed intra-rater and inter-rater reproducibility of AIM analysis-derived variables; the diagnostic accuracy of AIM-based criteria for detecting aspiration was determined by using expertly scored videofluoroscopy as the standard. METHODS: Data on 50 bolus swallows of 10 mL each were randomly selected from a database of swallows that were simultaneously recorded with impedance, manometry, and videofluoroscopy. Data were divided into 5 subgroups of 10 swallows for analysis: 10 dysphagic liquid, 10 dysphagic liquid with aspiration, 10 dysphagic semisolid, 10 control liquid, and 10 control semisolid. Repeat analyses were performed by 10 observers with varying levels of expertise in manometry by using purpose-designed software (AIMplot). Swallow videos were scored by 4 experts by using the penetration-aspiration scale (PAS) score. Reproducibility of calculation of swallow function variables and the SRI and PAS was assessed by using intraclass correlation coefficient (ICC). The majority consensus of expert PAS scores was used to dichotomously define aspiration (consensus PAS >3). Observer analyses were compared by Cohen κ statistical analysis. RESULTS: The intra-rater and inter-rater reproducibility of swallow function variables was high (SRI mean intra-rater ICC, 0.97 and mean inter-rater ICC, 0.91). SRI >15-20 was optimal for detecting the presence of aspiration during liquid bolus swallows with an almost perfect agreement with expert scoring of videofluoroscopy (κ > 0.8). CONCLUSIONS: AIM analysis has high intra-rater and inter-rater reproducibility, and among observers of varying expertise, SRI predicts the presence of aspiration.

A novel method for the nonradiological assessment of ineffective swallowing.

OBJECTIVES: This validation study evaluates a new manometry impedance-based approach for the objective assessment of pharyngeal function relevant to postswallow bolus residue. METHODS: We studied 23 adult and pediatric dysphagic patients who were all referred for a videofluoroscopy, and compared these patients with 10 adult controls. The pharyngeal phase of swallowing of semisolid boluses was recorded with manometry and impedance. Fluoroscopic evidence of postswallow bolus residue was scored. Pharyngeal pressure impedance profiles were analyzed. Computational algorithms measured peak pressure (Peak P), pressure at nadir impedance (PNadImp), time from nadir impedance to PeakP (PNadImp-PeakP), the duration of impedance drop in the distal pharynx (flow interval), upper esophaghageal sphincter (UES) relaxation interval (UES-RI), nadir UES pressure (NadUESP), UES intrabolus pressure (UES-IBP), and UES resistance. A swallow risk index (SRI) was derived by the formula: SRI=(FI × PNadImp)/(PeakP × (TNadImp-PeakP+1)) × 100. RESULTS: In all, 76 patient swallows (35 with residue) and 39 control swallows (12 with residue) were analyzed. Different functional variables were found to be altered in relation to residue. In both controls and patients, flow interval was longer in relation to residue. In controls, but not patients, residue was associated with an increased PNadImp (suggestive of increased pharyngeal IBP). Controls with residue had increased UES-IBP, NadUESP, and UES resistance compared with patients with residue. Residue in patients was related to a prolonged UES-RI. The SRI was elevated in relation to residue in both controls and patients and an average SRI of 9 was optimally predictive of residue (sensitivity 75% and specificity 80%). CONCLUSIONS: We present novel findings in control subjects and dysphagic patients showing that combined manometry and impedance recordings can be objectively analyzed to derive pressure-flow variables that are altered in relation to the bolus residual and can be combined to predict ineffective pharyngeal swallowing.

A method to objectively assess swallow function in adults with suspected aspiration.

BACKGROUND & AIMS: Pharyngeal manometry and impedance provide information on swallow function. We developed a new analysis approach for assessment of aspiration risk. METHODS: We studied 20 patients (30-95 years old) with suspected aspiration who were referred for videofluoroscopy, along with controls (ages 24-47 years). The pharyngeal phase of liquid bolus swallowing was recorded with manometry and impedance. Data from the first swallow of a bolus and subsequent clearing swallows were analyzed. We scored fluoroscopic evidence of aspiration and investigated a range of computationally derived functional variables. Of these, 4 stood out as having high diagnostic value: peak pressure (PeakP), pressure at nadir impedance (PNadImp), time from nadir impedance to peak pressure (TNadImp-PeakP), and the interval of impedance drop in the distal pharynx (flow interval). RESULTS: During 54 liquid, first swallows and 40 clearing swallows, aspiration was observed in 35 (13 patients). Compared to those of controls, patient swallows were characterized by a lower PeakP, higher PNadImp, longer flow interval, and shorter TNadImp-PeakP. A Swallow Risk Index (SRI), designed to identify dysfunctions associated with aspiration, was developed from iterative evaluations of variables. The average first swallow SRI correlated with the average aspiration score (r = 0.846, P < .00001 for Spearman Rank Correlation). An average SRI of 15, when used as a cutoff, predicted aspiration during fluoroscopy for this cohort (κ = 1.0). CONCLUSIONS: Pressure-flow variables derived from automated analysis of combined manometric/impedance measurements provide valuable diagnostic information. When combined into an SRI, these measurements are a robust predictor of aspiration.

Organ preservation surgery for advanced unilateral glottic and subglottic cancer.

OBJECTIVES: Functional surgery of unilateral T(2b) to T3 glottic cancer and cricoid chondrosarcoma is possible using the technique of tracheal autotransplantation. The objective of this paper is to report the functional and oncologic outcome of 24 consecutive patients treated with this technique between 2001 and 2007. METHODS: Seventeen patients, of whom nine were previously irradiated, had unilateral glottic cancer with impaired mobility of the vocal fold. Clinical staging was T(2b) to (3)N(0). Seven patients had a chondrosarcoma of the cricoid cartilage. In a first operation, an extended hemilaryngectomy was performed, and a radial forearm flap, comprising a distal fascial and a proximal skin component, was transferred to the neck. The fascial paddle was wrapped around the upper 4-cm segment of cervical trachea, and the skin paddle was used for temporary closure of the extended hemilaryngectomy defect. The definitive reconstruction was performed after 2 to 3 months and consisted of removal of the skin paddle from the laryngeal defect and a transplantation of a patch of revascularized cervical trachea to reconstruct the laryngeal defect. RESULTS: Swallowing and speech were restored after the first operation. The glottic and subglottic airway lumen was restored during the second operation. The tracheostomy could be closed in 20 patients. After a median follow-up period of 33 (range, 1-66) months or almost 3 years, 23 patients remained free of tumor recurrence. CONCLUSIONS: Tracheal autotransplantation can be recommended as a functional treatment for selected T(2b) to T(3) glottic cancers and for unilateral chondrosarcomas of the cricoid cartilage. The technique is oncologically robust while resulting in good postoperative function.