OBJECTIVE: The current investigation aimed to establish preliminary normative data for endoscopic swallow studies (FEES). The investigators collected data for three timing measures (time to whiteout, duration of whiteout, and total swallow time), three swallowing outcomes (safety, efficiency, and number of swallows per bolus), and one physiologic event (glottal response), for both healthy young and older adults using two liquid volumes, one pureed bolus and a solid bolus.
METHODS: Blinded raters retrospectively analyzed 65 randomly selected, deidentified videos of endoscopic swallowing examinations from a pool of 163 young and older adults with typical swallowing abilities. Timing measures and analysis of airway invasion, amount of residue, number of swallows, and glottal response were obtained.
RESULTS: Preliminary means and quartiles were established for healthy adults in two age groups (young and old), for time to whiteout (WO), number of swallows per bolus, glottal response, Yale Residue Rating Scale Scores, Penetration-Aspiration Scale scores, duration of WO, and total swallow duration. Differences were found between the older and younger groups.
CONCLUSIONS: The current study represents a preliminary attempt to provide quantitative and normative values for FEES. These data represent reference values to which other bolus presentations and populations can be compared. The data represents proof of concept and merits additional investigation.
UNASSIGNED: 1756246-2: Approved 2022/06/06.
BACKGROUND: Study does not meet criteria. DATA REPOSITORY: https://doi.org/10.6084/m9.figshare.25800025 .

While functional endoscopic evaluation of swallowing (FEES) is the most useful diagnostic test for the evaluation of dysphagia, it cannot evaluate the esophageal phase of swallowing. To evaluate if a modification for the FEES exam by swallowing an empty capsule and screening of the upper esophagus could be used for early detection of esophageal dysphagia. A prospective, single-center, pilot study. At the end of a standard FEES exam, the patients were asked to swallow an empty capsule. Fifteen seconds later, the endoscope was inserted into the upper esophagus. A pathological capsule test was defined when the capsule was seen in the esophagus. In such cases, the patient was advised to undergo a gastroscopy, MBS, or esophageal manometry, which were compared to the results of the capsule test. The capsule test was utilized in 109 patients. A pathological capsule test was found in 55 patients (57.8%). In 48 patients (87.3%), an isolated or combined esophageal dysphagia was seen. The accuracy value of the capsule test compared to gastroenterology tests was 83.3%, sensitivity 88.46%, specificity 75%, PPV 85%, and NPV 80%. A modification of the standard FEES exam by including an empty capsule swallow test with an upper esophagus examination may provide a useful screening tool for esophageal dysphagia.

BACKGROUND: Dysphagia, with its negative impact on life expectancy and quality of life, is a major side effect of head and neck squamous cell carcinoma (HNSCC). In a typical Head and Neck Cancer Center, more than half of patients are affected. Improving treatment, and ideally prevention respectively prehabilitation, therefore seems more than desirable.
METHODS: The study is planned as a monocentric, prospective, outcome-blinded, randomized interventional study comparing an advanced phoniatric-logopedic prehabilitation with a control (standard of care). Seventy patients (30 control group, 30 intervention group, 10 drop-out rate of 15%) with an initial diagnosis of invasive HNSCC and curative treatment intention will be included over a period of 17 months. In addition to the previous standard, both groups will undergo both detailed subjective assessment of swallowing function and quality of life by means of various questionnaires and objective analyses by bioelectrical impedance measurements and phoniatric endoscopic swallowing examinations. In the intervention group, risk-related nutritional counseling (face-to-face) and phoniatric-logopedic prehabilitation are provided: detailed counseling with video demonstration and exercises to strengthen and improve the range of motion of the oral, pharyngeal, and laryngeal muscles (guided by exercise diary). Controls are performed at 6 weeks, 3 and 6 months, and 9 or 12 months after the end of therapy during the regular tumor follow-up. Primary study endpoints are swallowing function and emotional distress at 6 weeks of control visit.
CONCLUSIONS: Prehabilitation measures have already proven successful in other patient groups, e.g., transplant patients. In the field of head and neck oncology, interest in such concepts has increased significantly in recent years. However, usually, only subgroups, e.g., patients with swallowing problems after radiochemotherapy alone, are in focus. Our study aims to investigate the general benefit of prehabilitation with regard to swallowing function, which is so important for protection of aspiration and quality of life.
BACKGROUND: German Clinical Trials Register DRKS00029676 . International Clinical Trials Registry Platform DRKS00029676 . Registered on 19 July 2022.

BACKGROUND: Abroad medical electives are recognized as high-impact practice and considered a necessity to provide global health training. As of recently, the COVID-19 pandemic and its related travel restrictions prohibited most international elective activities. Another important barrier to abroad electives that received comparably little attention is elective and application fees, which - combined - may be as high as $5000 per month, and may prevent students with limited financial resources from applying for an international elective. Elective fees have never been systematically analyzed and trends in teaching and application fees have rarely been subject to dedicated scientific investigations.
METHODS: Using data from two large elective reports databases, the authors addressed this gap in the literature. The authors analyzed trends in abroad elective fees within the last 15 years in some of the most popular Anglo-American elective destinations among students from Germany, including the United States of America, Australia, New Zealand, the Republic of South Africa, Ireland and the United Kingdom.
RESULTS: The authors identified n = 726 overseas elective reports that were uploaded between 2006 and 2020, of which n = 438 testimonies met the inclusion criteria. The United Kingdom and Australia were the most popular elective destinations (n = 123 and n = 113, respectively), followed by the Republic of South Africa (n = 104) and the United States of America (n = 44). Elective fees differed substantially-depending on the elective destinations and time point. Median elective fees were highest in the United States of America (€ 1875 for a 4-week elective between 2018-2020), followed by the Republic of South Africa (€ 400) and Australia (€ 378). The data also suggests an increasing trend for elective fees, particularly in the United States.
CONCLUSIONS: Rising fees warrant consideration and a discussion about the feasibility of reciprocity and the bidirectional flow of students in bidirectional exchange programs.

Late-stage progressive decline of swallowing function after radiotherapy for head and neck cancer (HNC) is often difficult to monitor. This study examined the feasibility and clinical outcomes of speech-language pathology implementing flexible endoscopic evaluation of swallow (FEES) screening during annual cancer surveillance visits to monitor late-stage swallowing function.
Patients >2 years post treatment who attended routine oncological visits underwent FEES screening. Feasibility (service data, stakeholder survey) and swallowing outcomes (oral intake, secretions, internal lymphedema, penetration-aspiration, and residue) were collected.
Screening was completed with 70% (50/71) of eligible patients. Medical staff and speech-language pathologists indicated the protocol was worthwhile and achievable to incorporate into practice. Almost all patients were willing to complete the protocol annually. FEES outcomes identified 84% with dysphagia versus only 26% self-reported dysphagia.
Findings indicate FEES screening incorporated into annual oncological reviews is feasible and effective at monitoring late-stage swallowing function following HNC.

OBJECTIVE: Topic treatment can be useful to improve short and long-term nasal outcomes after nasal surgery, reducing discomfort and risk of synechia. This study aimed at evaluating the effect on clinical outcomes of nasal packaging using Fitostimoline® gauze in FESS and septoplasty.
METHODS: A case-control study on hospitalized patients was performed in a tertiary referral center. The control group included 20 patients treated with the standard surgical protocol for septoplasty and standard nasal packaging; treatment group included 21 patients underwent same surgical procedure but in whom the nasal tampon was wrapped with a gauze containing Fitostimoline® before being placed into the nose.
RESULTS: Patients in treatment group had better outcomes than control; nasal mucosa showed better healing - recovery of normal color- in those patients in whom we applied the Fitostimoline® gauze around tampons. Moreover, 100 % patients in the treatment group did not refer discomfort during at tampon removal versus 60 % subjects in the control group who referred pain, tension or tearing during the same action.
CONCLUSIONS: Our results, although preliminary because of the small cohort of subjects included, suggest that the apposition of a gauze with Fitostimoline® after nasal surgery might improve the mucosal healing with consequent reduction of patients discomfort during the post-surgical period.

UNASSIGNED: The spread of airborne diseases, including coronaviruses, remains a widespread public health concern. Published studies outline the use of protective barriers to limit the spread of pathogenic particles and droplets resulting from coughing, sneezing, and talking. The findings suggest a role for these barriers during aerosol-generating procedures, such as flexible endoscopic evaluation of swallowing (FEES). However, the question remains of whether doffing a protective barrier will create a concentrated cloud of particles that will increase health professionals\' exposure.
UNASSIGNED: We simulated four clinical scenarios of coughing and sneezing, talking, eating and drinking, and delivering supplemental oxygen to test whether doffing the FEES Box protective barrier would result in a particle cloud.
UNASSIGNED: For all scenarios simulated, doffing the FEES Box did not result in a significant increase in mean particle count. Further, the manner of FEES Box removal did not significantly influence mean particle counts on a consistent basis.
UNASSIGNED: These results suggest that doffing the FEES Box does not increase exposure to airborne particles. Although more research is needed to confirm these findings, FEES Box usage should be considered during aerosol-generating procedures, to protect and reassure healthcare professionals who work with patients with COVID-19 or other airborne diseases.

Visuoperceptual evaluation of fiberoptic endoscopic evaluation of swallowing (FEES) is a commonly used assessment in dysphagia or swallowing disorders. Currently, no international consensus exists regarding which visuoperceptual measures to use for the analysis of FEES recordings. Moreover, existing visuoperceptual FEES measures are limited by poor and incomplete psychometric data, identifying an urgent need for developing a visuoperceptual measure to interpret FEES recordings. Following the COSMIN group\'s (COnsensus-based Standards for the selection of health Measurement INstruments) psychometric taxonomy and guidelines, this study aimed to establish the content validity of a new visuoperceptual FEES (V-FEES) measure in adults with oropharyngeal dysphagia. Using the Delphi technique, international consensus was achieved among dysphagia experts across 21 countries, resulting in a new prototype measure for V-FEES, comprising 30 items, 8 function testing items (i.e., specific tasks performed by patients while observing and rating items), and 36 unique operationalisations (i.e., defining items into measurable factors that could be measured empirically using visuoperceptual observation). This study supports good content validity for V-FEES, including participants\' feedback on the relevance, comprehensiveness, and comprehensibility of the included items. Future studies will continue the instrument development process and determine the remaining psychometric properties using both the classic test theory (CTT) and item response theory (IRT) models.

Research pharmacy effort required to safely and compliantly manage investigational products (IP) varies between studies. No validated tool exists in the United States to evaluate these differences in effort. The Vizient Pharmacy Research Committee Investigational Drug Services (IDS) Subcommittee previously developed a systematic complexity scoring tool (CST) through expert consensus to assign a complexity score for pharmacy effort. This project seeks to develop and validate complexity categories based on CST scores.
Vizient member institutions in IDS assigned a CST complexity score and a perceived complexity category (low, medium, or high) for study initiation and maintenance. Receiver operating characteristic (ROC) curve analysis defined the best CST score cutoff points for each complexity category. Comparing the CST-assigned to the user-perceived complexity category determined whether the CST-assigned complexity category aligned with practitioner assignment.
A total of 322 responses were used to determine complexity score categories. The AUC values for study initiation and maintenance were 0.79 (P < 0.001) for the low/medium boundary and 0.80 (P < 0.001) for the medium/high boundary, suggesting the performance of the CST is good. The agreement between CST-assigned and user-perceived complexity categories was 60% for study initiation and 58% for maintenance. The Kendall rank correlation coefficient between the raters and ROC categories was strong, with a value of 0.48 for study initiation and 0.47 for maintenance.
Development of the CST allows IDS pharmacies to objectively measure the complexity of clinical trials, which is a significant step towards assessing workload and guiding resource allocation.

BACKGROUND: Placement of a tracheostomy for patients requiring prolonged mechanical ventilation (PMV) improves patients\' comfort, decreases dead space ventilation, allows superior airway hygiene, and reduces the incidence of ventilator-associated pneumonia. Controversy still exists regarding the role of standard tracheostomy (ST) as opposed to the less frequently done Björk flap tracheostomy (BFT). This study compares the functional outcomes of these two techniques.
METHODS: Seventy-nine patients receiving tracheostomy in a 12-month period: 38 BFT vs. 41 ST. Data included demographics, indications for PMV, ventilator days before tracheostomy, time to and a number of patients who passed the fiberoptic endoscopic evaluation of swallowing (FEES), time to and a number of patients decannulated.
RESULTS: Indications in both groups were PMV from trauma (18/38 vs 15/41), pneumonia (13/38 vs 13/41), and ARDS (7/38 vs 11/4), respectively (p > 0.05). Patients in both groups did not differ with regard to age, sex, GCS, duration of PMV before tracheostomy, the time to and a number of patients who passed the 1st FEES. However, the number of days and the number of FEES required before the next successful FEES in the 20 BFT and 21 ST patients who failed the 1st was 9 (4) vs. 16 (5), and 2 (1) vs. 4 (1), respectively (p < 0.05). Additionally, the number of intraoperative complications in aggregate were 0/38 in the BFT as opposed to 6/41 in the ST group (p < 0.05).
CONCLUSIONS: We conclude that BFT may be associated with an overall shorter time to restoration of normal swallowing when compared to ST.