Silk-Hyaluronic Acid for Vocal Fold Augmentation: Safety Profile and Long-Term Voice Outcomes.

OBJECTIVES: Silk-hyaluronic acid (silk-HA) is a novel vocal fold augmentation material used in humans since July 2020. We aim to describe indications, voice outcomes, and longevity data for silk-HA injectable when used for vocal fold injection (VFI) augmentation in a large cohort of patients with longer-term follow-up than preliminary clinical studies. METHODS: Retrospective chart review of Silk-HA injections for glottic insufficiency (GI) and follow-up between July 2020 and November 2023. Subject demographics, diagnoses, volume of material injected, VHI-10 data, time from injection, need for reinjection, and complications were collected. Blinded perceptual voice analysis of randomly selected pre- and post-intervention voice samples for unilateral vocal fold paralysis patients was performed by three voice-specialized speech-language pathologists, and changes in VHI-10 determined at various time intervals up to 1year and beyond. RESULTS: A total of 160 silk-HA injection procedures were performed: 59% female, with a mean age of 66± 13 (range 21-90) years. Ninety-four subjects had unilateral paralysis (58.4%); the remainder had scar, atrophy, paresis, or a combination thereof. Mean volume of silk-HA injected was 0.24± 0.14 cc. Major complications were rare, most notable for laryngoscopic evidence of hemilaryngeal edema (n = 6, 3.8%), with a readmission rate to hospital of 1.3% (n = 2). There was a statistically significant decrease in paired ΔVHI-10 and CAPE-V ratings for each of the postoperative follow-up intervals. A total of 24 (27.2%) repeat medialization procedures were recommended following silk-HA injection for unilateral paralysis. CONCLUSIONS: This study demonstrates that silk-HA is a safe product for VFI augmentation, and effective injectable for the treatment of GI due to unilateral vocal fold paralysis. Based on the current data, it is reasonable to counsel patients that they should expect benefit for several months following the injection. If patients reach 1year from their injection with a stable and satisfactory outcome, the majority experience ongoing benefit without need for additional procedures, however, the final duration of clinical effect appears to be years, but it is yet to be determined.

Training for Awake, Office-Based Laryngeal Procedures-The Laryngology Fellow's Perspective.

OBJECTIVE: The aim was to explore recent laryngology graduates' perspectives on their experience, competency, and challenges learning office-based procedures during fellowship training in the United States and Canada. METHODS: Anonymous 22-item questionnaire survey was distributed electronically to fellowship-trained laryngologists having completed fellowship within past 5 years. RESULTS: Ninety fellowship-trained laryngologists between 2018 and 2022 were surveyed. Response rate was 48.9% (n = 44), 1 declined participation, with 20 different fellowship programs represented. Fellows were frequently provided the opportunity to act as primary surgeon for most procedures, except for laryngeal botulinum toxin injection, diagnostic laryngeal electromyography, trans-nasal esophagoscopy, secondary tracheoesophageal puncture, and high-resolution pharyngeal manometry. A majority reported high (n = 27, 62.8%) or moderate (n = 12, 27.9%) confidence with vocal fold injection augmentation. Various techniques were taught: transoral (74.4%), cricothyroid (74.4%), thyrohyoid (69.8%), transcartilagenous (14.0%), and catheter-needle (25.6%). Numerous statistically significant associations with independent procedure involvement and competence were identified. Laryngeal botulinum toxin injection was a procedure performed with high frequency but low volume of independent fellow involvement, and the procedure with which fellows reported wanting more practice learning. Most common training barriers included patient being awake, patient consenting to trainee performing the procedure, and the technical challenge/complexity of the procedure. Teaching methods/tools largely focused on informal debriefing (97.3%) and case by case troubleshooting (81.1%). CONCLUSIONS: Laryngology fellows are well trained with favorable perceived levels of competence for numerous office-based procedures, particularly vocal fold injection augmentation. Procedures for which fellows reported a low level of independent participation trended towards lower perceived competency. LEVEL OF EVIDENCE: 5 Laryngoscope, 134:873-881, 2024.

A Cognitive Occupation-Based programme for people with MS: acceptability, feasibility, and experiences of people with multiple sclerosis.

PURPOSE: COB-MS is an eight-session, Cognitive Occupation-Based programme for people with both MS and cognitive difficulty - designed to enhance cognition and daily functioning, through a combination of goal-setting, cognitive strategy engagement, group activities, home-practice activities and one-on-one sessions. This research aims to investigate the acceptability of COB-MS from the perspective of people living with MS, as well as the occupational therapists who facilitated the programme. MATERIALS AND METHODS: Two content analyses were conducted on interview data from (n = 11) COB-MS participants and (n = 8) COB-MS facilitators. Thematic analysis was also conducted on the participant interview data. RESULTS: Through a, primary, content analysis, participants reported that the COB-MS provided both a positive experience and quality resources. Qualitative improvement and utilisation of their learning beyond completion of the intervention were also identified. Four themes were identified via, secondary, thematic analysis: (1) Group interaction within COB-MS was vital; (2) Online COB-MS had positive and negative effects on participation; (3) COB-MS as a provider of clarity; and (4) Using learned strategies after the completion of COB-MS. Recommendations for future administration are provided. CONCLUSIONS: Findings suggest COB-MS acceptability, as well as appropriateness and feasibility, indicative of progression to a definitive trial in future research. TRIAL REGISTRATION: ISRCTN: ISRCTN11462710. Registered on 9 September 2019.

Cognitive difficulties associated with multiple sclerosis (MS) impact on daily life activities and are considered invisible MS symptoms. This invisibility and the lack of acknowledgement of such symptoms often adds to the distress experienced by people with MS.Occupational therapists are well-placed to address the daily-life impacts of cognitive difficulties in MS.The COB-MS is an occupation-focused intervention that aims to enhance daily function.The intervention was found to be well-accepted well by people with MS and occupational therapists and can feasibly be delivered in clinical practice.

An Evaluative Review of Barriers to Critical Thinking in Educational and Real-World Settings.

Though a wide array of definitions and conceptualisations of critical thinking have been offered in the past, further elaboration on some concepts is required, particularly with respect to various factors that may impede an individual's application of critical thinking, such as in the case of reflective judgment. These barriers include varying levels of epistemological engagement or understanding, issues pertaining to heuristic-based thinking and intuitive judgment, as well as emotional and biased thinking. The aim of this review is to discuss such barriers and evaluate their impact on critical thinking in light of perspectives from research in an effort to reinforce the 'completeness' of extant critical thinking frameworks and to enhance the potential benefits of implementation in real-world settings. Recommendations and implications for overcoming such barriers are also discussed and evaluated.

Comparison of Outcome Measures (Subjective, Objective, and Patient-Based) in Laryngeal Dystonia Treatment With Botulinum Toxin A Injection.

BACKGROUND: Outcome assessment in laryngeal dystonia is hindered by lack of consensus on a core set of outcome measures to quantify treatment effect and disease severity on quality of life. Potential outcome measure domains include objective voice, clinician reported, and patient reported outcome measures (PROMs) for determining treatment success and longitudinal disease tracking. We aim to determine correlations between a selections of outcome measure tools following Botulinum toxin injection. METHODS: A selection of instruments were administered to assess adductor laryngeal dystonia patient outcomes before and after Botulinum toxin injection. Voice samples recorded using a cellular telephone application were used for objective acoustic measures (CPPS, acoustic voice quality index) and speech language pathologist perceptual analysis (CAPE-V). Additionally, patients completed a PROMs battery consisting of the Voice Handicap Index-10, Communicative Participation Item Bank-10, OMNI-Vocal Effort Scale, 3 visual analog scale (VAS) questions. Changes in these outcome measures pre-post treatment were compared between each other and with a global rating of change questionnaire (GRCQ) using Spearman's rank correlation coefficients. RESULTS: Twenty six patients (20 female, mean age 57.7 years) participated. Using an anchor based GRCQ, patients reported Botox efficacy was the only outcome measure found to have significant correlation (r = 0.54, P = 0.022); all other outcome measures did not meet statistically significant correlation. Amongst the selected outcome tools, several moderate-strong correlations were identified, largely for outcome measures within the same domain. Most notable were correlations between the patient reported OMNI-VES and VAS questions (r > 0.68, P < 0.05), clinician CAPE-V strain and overall severity (r = 0.900, P < 0.001), and acoustic voice quality index with sustained vowel CPPs (r = -0.797, P = 0.002). CONCLUSION: Correlation between outcome measures instruments used for patients with adductor laryngeal dystonia requires further attention. Weak correlations with an anchor based GRCQ were found for this study's selected outcome instruments. A select number of correlations were found between outcome instruments within each of the individual outcome measure domains (patient perception, clinical perception, objective acoustics), but there was largely a lack of correlation found for instruments between these three separate domains.

Gender-Affirming Voice Surgery: Considerations for Surgical Intervention.

The purpose of this article is to provide an overview of the current state and available evidence surrounding surgical voice care for the transgender and/or gender expansive population. The term "gender expansive" has been proposed as an inclusive term to classify those who do not identify with traditional gender roles but are otherwise not confined to one gender narrative or experience. We aim to review indications and candidacy for surgery, surgical procedure options for altering vocal pitch, and typical postoperative expectations. The role of voice therapy and considerations for perioperative care will also be discussed.

Evaluating the feasibility and preliminary efficacy of a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): an update to the protocol for a feasibility cluster-randomised controlled trial.

BACKGROUND: Cognitive difficulties experienced by people with multiple sclerosis (MS) impact on quality of life and daily functioning, from childcare and work to social and self-care activities. The Cognitive Occupation-Based programme for people with MS (COB-MS) was developed as a holistic, individualised cognitive rehabilitation intervention to address the wide-ranging symptoms and functional difficulties that present in MS, including the ability to maintain employment, social activities, home management and self-care. The aim of the research is to evaluate the feasibility and preliminary efficacy of COB-MS for people with MS. METHODS: Due to the impacts of COVID-19, trial activities that were planned for in-person delivery were completed remotely. One hundred and twenty people with MS will be assigned to participate in either the COB-MS programme or a treatment-as-usual, wait-list control group as part of this single-blind, cluster-randomised controlled feasibility and preliminary efficacy trial of the COB-MS programme. The COB-MS group will participate in an eight-session occupational-based cognitive rehabilitation programme over 9 weeks. The COB-MS intervention was planned for in-person delivery but was delivered online by occupational therapists to small groups of people with MS. The primary outcome measure is the Goal Attainment Scaling at 12 weeks. Participants will be assessed pre-intervention, post-intervention, 12 weeks post-intervention and 6 months post-intervention. Qualitative evaluations of participants' perspectives will also be examined as part of the feasibility study. Data, due to be collected in-person, was collected online or by post. The original study design, including the statistical analysis plan, remains unchanged despite the shift to a remote trial conduct. DISCUSSION: Results will provide recommendations for a future definitive trial of COB-MS, with respect to both feasibility and preliminary, clinical efficacy. TRIAL REGISTRATION: ISRCTN ISRCTN11462710 . Registered on 9 September 2019 and updated on 23 September 2020 to account for changes outlined here.

Remote administration of BICAMS measures and the Trail-Making Test to assess cognitive impairment in multiple sclerosis.

Reliable remote cognitive testing could provide a safer assessment of cognitive impairment in multiple sclerosis (MS) during the COVID-19 pandemic and thereafter. Here we aimed to investigate the reliability and feasibility of administering Brief International Cognitive Assessment for MS (BICAMS) and the Trail-Making Test (TMT) to people with MS online. Between-group differences on BICAMS and the TMT were examined in a sample of 68 participants. Group 1 (N = 34) was tested in-person pre-pandemic. Group 2 was tested remotely. Within-group differences for in-person and virtual administrations were examined for Group 1. No significant differences between virtual and in-person administrations of the CVLT-II and SDMT were detected. BVMT-R scores were significantly higher for virtual administrations (M = 20.59, SD = 6.65) compared to in-person administrations (M = 16.35, SD = 6.05), possibly indicating inter-rater differences. Strong positive correlations were found for in-person and virtual scores within Group 1 on the CVLT-II (r = .84), SDMT (r = .85), TMT-A (r = .88), TMT-B (r = .76) and BVMT-R (r = .72). No significant differences between in-person and remote administrations of CVLT-II and SDMT in people living with MS were detected. Recommendations for future studies employing the TMT and BVMT-R online are provided.

A qualitative investigation of reasoning behind decisions to decline participation in a research intervention: A study-within-a-trial.

The current study-within-a-trial explored individuals' decisions to decline participation in research trialling a chronic illness-focused therapy (i.e. multiple sclerosis). Four themes were identified from seven semi-structured interviews with participation decliners and were confirmed by the host trial's Patient & Public Involvement (PPI) panel: acknowledgement of the value of research; 'fit' of the study; misinterpretation of participant information; and 'ignorance is bliss' - discussed in light of theory and research. This study-within-a-trial extends research on trial recruitment and participation decline; while also suggesting that PPI can be utilised in both a practical and impactful manner.

Exploring Patient's Preference of Patient-Reported Outcome Measures in Laryngeal Movement Disorders.

BACKGROUND: Despite many available patient-reported outcome measures (PROMs) for laryngeal movement disorders, there is a lack of patient input regarding which PROM most accurately and conveniently captures aspects related to their vocal disease. This study aimed to assess patients' preferences among a selection of voice-related PROMs (Voice Handicap Index-10 [VHI-10], OMNI-Vocal Effort Scale [OMNI-VES], Communicative Participation Item Bank-General Short Form [CPIB-10], and Visual Analog Scales [VAS]) within the laryngeal movement disorder population and investigate associations between selected instruments. METHODS: Prior to botulinum toxin A injection, patients with laryngeal dystonia and/or essential tremor of the vocal tract were administered the VHI-10, OMNI-VES, CPIB-10, and three novel VAS questions in a randomized order. Patients rank ordered the four PROMs based on the PROMs' reflection of their voice problems. Pearson's correlation coefficients evaluated pairwise associations among PROM scores. Fisher's exact test compared the preferred PROM rankings. RESULTS: Seventy patients (53 female, mean age = 60.7 years) participated. The VHI-10 and CPIB-10 were most preferred at 33.9% and 27.4% respectively. The OMNI-VES and VAS scales were less favored (19.4%, each). When analyzed by age ≥60 years, the CPIB-10 was most favored (33.3%), but for age <60 years, VHI-10 was most preferred (42.3%). There was a strong correlation between scores of all administered PROMs (strongest correlation between OMNI-VES and VAS, r = 0.8, p < 0.001; the weakest correlation between OMNI-VES and VHI-10, r = 0.6, p < 0.001). CONCLUSIONS: With an increasing trend in PROMs usage and a strong correlation between all evaluated outcome instruments, insight regarding patients' PROM preferences is an area for further consideration. LEVEL OF EVIDENCE: NA Laryngoscope, 133:1448-1454, 2023.

Preliminary Results on the Safety and Efficacy of Silk-Hyaluronic Acid for Treatment of Glottic Insufficiency.

OBJECTIVES: Silk-Hyaluronic Acid (Silk-HA) is a novel vocal fold augmentation material that has been used in humans since July 2020. There is a paucity of published data on Silk-HA and its longevity remains a question. This study aimed to evaluate a single surgeon's initial experience performing Silk-HA injection laryngoplasty for the treatment of glottic insufficiency. METHODS: Retrospective chart review of Silk-HA injections between July 2020 and December 2021. Subject demographics, diagnoses, volume of material injected, VHI-10 data, and complications were collected. A blinded perceptual voice analysis of voice samples was performed by two voice-specialized speech-language pathologists (SLP) for a subset of unilateral vocal fold paralysis patients before and 3-months following silk-HA injection. Univariate assessment of the change in VHI-10 and perceptual voice analyses at 3-month follow up was determined. RESULTS: 58 patients (43.1% female) underwent Silk-HA injection with a mean age of 64 (range 21-88). 38 subjects had unilateral paralysis (65.6%), and the remaining had scar, atrophy, paresis or a combination thereof. 49 injections were unilateral (84.5%). Mean volume of silk injected was 0.26 mL. Complications were rare, most notable though for 2 admissions for dyspnea and laryngoscopic evidence of hemi-laryngeal edema (3.4%). Mean change in CAPE-V overall severity rating was -32.9 (P<0.0001), and VHI-10 was -14.6 ± 10 (P=0.0013). 14 patients underwent a repeat silk-HA injection for ongoing glottic insufficiency (loss of augmentation vs under-augmentation). CONCLUSIONS: Preliminary results for Silk-HA show potential for ongoing improvement of glottic insufficiency at 3 months from date of augmentation. Clinician and patient perception of voice outcomes showed overall improvement at three months, though longevity remains to be determined. While overall well tolerated and without serious complications in 96% of the cohort, patients should be counseled on the potential for airway edema and symptomatic dyspnea requiring steroid management and observation.

Assessment and Management of Cognitive and Psychosocial Difficulties for People with Multiple Sclerosis in Ireland: A National Survey of Clinical Practice.

Background: A recent survey of 109 healthcare professionals explored how UK healthcare professionals typically assess and treat multiple sclerosis (MS)-related cognitive impairment. Little is currently known about what constitutes usual care for cognitive impairment and psychosocial care for people with MS in Ireland. Aim: The aim of the current research was to survey healthcare professionals (HCPs) who work with people with MS, to understand current assessment and management of cognition and psychosocial care in people with MS in the Republic of Ireland. Methods: A cross-sectional survey design was used. Data were collected online through Microsoft forms and through postal responses. The original UK questionnaire was adapted, piloted, and distributed to Irish HCPs. Participants were qualified HCPs who work clinically with people with MS in the Republic of Ireland. Results: Ninety-eight HCPs completed the survey. Only 34% of those surveyed reported routine screening of cognition for people with MS within their services; approximately, 36% HCPs reported that they did not provide information or services in relation to cognition to people with MS and 39% reported not referring elsewhere when cognitive difficulties were suspected. Out of the 98 HCPs, 47% reported assessing mood difficulties as part of their services, with 14% unsure. In total, 70% of participants reported onward referral took place if mood difficulties were identified. The Montreal Cognitive Assessment was the most commonly administrated cognitive assessment. Cognitive intervention choices were found to be guided by clinical judgement in 75.5% of cases. Discussion. Despite the high importance placed on cognitive and psychosocial care, there is very little consistency in treatment and assessment across services for people with MS in Ireland.

Obstructive Sleep Apnea Is Associated with Serious Complications But Not Increased Mortality Following Elective Bariatric Surgery: a Retrospective Cohort Study of 751,952 Patients.

BACKGROUND: The aim of the study was to characterize the prevalence of obstructive sleep apnea (OSA) in elective bariatric surgery patients and to determine if OSA is an independent predictor of 30-day serious complications and 30-day mortality among bariatric surgery patients. METHODS: An analysis of the MBSAQIP database from 2015 to 2019 was conducted, and patients were stratified by OSA diagnosis. Data was extracted on patient age, sex, race, and comorbidities. A multivariate logistic regression model was created to evaluate the impact of OSA on 30-day serious complications and 30-day mortality. RESULTS: Of 751,952 patients, 287,180 (38.2%) were identified as having OSA. OSA patients were older (48.0 ± 11.4 vs. 42.2 ± 11.9 years; p < 0.0001) and were of increased BMI (46.5 ± 8.5 kg/m2 vs. 44.6 ± 7.3 kg/m2; p < 0.0001). OSA was not associated with 30-day mortality in the multivariable logistic regression model (OR 0.98, 95% CI 0.83-1.16; p = 0.829). OSA was associated with increased odds of 30-day serious complications (OR 1.33, 95% CI 1.30-1.36; p < 0.0001). In addition, dialysis (OR 3.07, 95% CI 2.68-3.52; p < 0.0001), positive venous thromboembolism history (OR 2.46, 95% CI 2.32-2.60; p < 0.0001), and oxygen dependence (OR 2.42, 95% CI 2.18-2.68; p < 0.0001) were all identified as major predictors of serious complications. CONCLUSION: We identified OSA as a modifiable factor predictive of serious complications following elective bariatric surgery. OSA is highly prevalent in this patient population, and it appears to be an important risk factor that deserves further attention in terms of peri-operative optimization strategies.

Comparing the effects of a patient-designed-and-informed participant information leaflet in comparison with a standard, researcher-designed information leaflet on recruitment, retention and understanding: A study-within-a-trial.

Background and aim: The process of trial recruitment is vital, given its impact on resources, statistical power and the validity of findings. A participant information leaflet (PIL) is often the initial and primary source of information engaged by potential participants during recruitment. Research suggests that a variety of manipulations to a PIL can be made during its development to enhance understanding, readability and accessibility. In light of this, PIL-design led by Public and Patient Involvement (PPI) may also yield positive effects in this respect, as well as consent and retention. This study-within-a-trial (SWAT) compared the effects of a PPI-developed PIL with a standard, researcher-developed PIL on rates of consent, retention, decision certainty, understanding, readability, accessibility, likeability and decision to consent. Method: This SWAT used a double-blind, two-armed randomised design. The SWAT was conducted within a host trial of cognitive rehabilitation in multiple sclerosis. Results: A total of 234 people expressed interest in the trial, of which 94 were retained at 6-month follow up. Results revealed no effects on levels of consent and retention between the two PIL groups. Conclusions: These null effects provide interesting points of discussion and important implications for not only future research on PILs, but also for future research that involves recruitment to health-related interventions.

Creation and Implementation of the UCSF Laryngeal Symptom Diary for Trial Vocal Fold Injection.

OBJECTIVES: Patient recollection of their trial vocal fold injection outcomes is crucial in determining future treatment. This study aims to assess a new clinical tool, the UCSF Laryngeal Symptom Diary, for its ease of use, clinical value in patient symptom tracking, and utility for long-term decision-making following trial vocal fold injection. MATERIALS AND METHODS: In this prospective cohort study, consecutive patients undergoing trial vocal fold injection between June 2019 and January 2020 completed the UCSF Laryngeal Symptom Diary. Patients rated standardized and customized laryngeal symptoms weekly. Upon follow-up, a survey pertaining to the diary was completed by both the patient and treating laryngologist. RESULTS: A total of 29 patients opted to participate and were provided with the UCSF Laryngeal Symptom Diary. The diary was returned by 82.3% (n = 24/29) of patients. Mean time to follow up was 5.98 weeks. Survey participation rate was 93.1% (n = 27/29). From the patients' perspective, 66.7% (n = 18/27) found the diary useful in following their symptom evolution. Treating laryngeal surgeon noted excellent concordance between diary entries and patient's overall injection benefit (91.7%, n = 22/24). The diary was useful in clinician-recommendation of subsequent treatment options in 70.8% (n = 17/24) of patients. CONCLUSION: The UCSF Laryngeal Symptom Diary is a patient friendly clinical tool for trial vocal fold injection that facilitates patient tracking of symptom evolution and helps guide treating clinicians in subsequent treatment planning.

Implementation of Telemedicine in a Laryngology Practice During the COVID-19 Pandemic: Lessons Learned, Experiences Shared.

OBJECTIVES: The novel coronavirus disease 2019 has posed significant limitations and barriers to providing in-person healthcare. We aim to provide a summary of learned experiences and important considerations for implementing and offering telehealth to provide laryngology subspecialty care during the COVID-19 pandemic and thereafter. MATERIALS AND METHODS: Four laryngologists and a voice-specialized speech-language pathologist from a tertiary-care academic Voice and Swallowing Center were engaged in a structured group consensus conference. Participants shared input, experiences, and practice patterns employed via telemedicine (via telephone or video-communication) during the early COVID-19 era. RESULTS: Key identified areas of consideration when offering telemedicine included (1) how to set up and structure a telemedicine visit and maintain patient confidentiality, (2) patient examination and treatment initiation, (3) optimization of the tele-visit, (4) limitations and recognition of when a tele-visit is insufficient for patient care needs, (5) billing/reimbursement considerations. Group consensus for the aforementioned topics is summarized and discussed. CONCLUSION: During the COVID-19 pandemic, a telemedicine model can be effectively employed to improve patient access to subspecialty laryngology care, including a multidisciplinary care approach, with initiation of various therapeutic interventions. A major limitation given the preclusion of in-person assessment is the lack of access to laryngoscopy, which can likely be delayed safely in the majority of individuals.

Aesthesiometer-Based Testing for Laryngopharyngeal Hyposensitivity.

OBJECTIVES/HYPOTHESIS: To develop a method for threshold estimation of the laryngeal adductor reflex (LAR) response using Cheung-Bearelly monofilaments. STUDY DESIGN: Cross-sectional. METHODS: Twenty-two healthy adults (12 men, 10 women) were tested for LAR response outcome using 30 mm 5-0 and 4-0 nylon monofilaments. Tactile stimuli were delivered to the aryepiglottic (AE) fold and medial pyriform sinus (MPS). Dichotomous classifier features and performance (area under the curve (AUC)), the LAR response outcome agreement and disagreement matrix, and test-retest reliability were examined. From those data, a test protocol that would minimize patient burden to estimate the LAR triggering threshold was formulated. RESULTS: Classifier performance of 5-0 monofilament stimulation of the AE fold (sensitivity = 0.63, specificity = 0.63, PPV = 0.74, NPV = 0.25) and MPS (sensitivity = 0.45, specificity = 0.77, PPV = 0.74, NPV = 0.23,) was slightly below that of 4-0 monofilament stimulation of the AE fold (sensitivity = 0.82, specificity = 0.50, PPV = 0.82, NPV = 0.50) and MPS (sensitivity = 0.84, specificity = 0.64, PPV = 0.90, NPV = 0.56), based on AUC. LAR response outcome agreement for 5-0 and 4-0 stimulations was high (93%) for 5-0 positive response, but low (29%) for 5-0 negative response. Aesthesiometer test-retest reliability for LAR response outcome was excellent (Cronbach's alpha = 0.97). CONCLUSIONS: Threshold estimation of the LAR response may be operationalized by adopting a decision tree protocol. For negative LAR response to initial 5-0 monofilament stimulation and positive response to subsequent 4-0 monofilament stimulation, the higher threshold is confirmed. Positive LAR response to 5-0 or 4-0 monofilament stimulation is expected in over 90% of asymptomatic adults. Negative LAR response to 4-0 monofilament stimulation identifies patients at risk for laryngopharyngeal hyposensitivity. LEVEL OF EVIDENCE: 3b Laryngoscope, 132:163-168, 2022.

Laryngeal Adductor Reflex Movement Latency Following Tactile Stimulation.

OBJECTIVE: To measure the latency of laryngeal adductor reflex (LAR) motion onset at 2 laryngopharyngeal subsites using calibrated aesthesiometers. STUDY DESIGN: Cross-sectional. SETTING: Academic institution. METHODS: Twenty-one asymptomatic, healthy subjects (11 male, 10 female) underwent laryngopharyngeal sensory testing with tactile stimuli delivered to the aryepiglottic fold and medial pyriform sinus using 30-mm Cheung-Bearelly monofilaments (4-0 and 5-0 nylon sutures) via channeled flexible laryngoscope. The LAR onset latency, defined as the first visual detection of ipsilateral vocal fold adduction following tactile stimulation, was measured with frame-by-frame analysis of video recordings. RESULTS: The overall mean LAR latency across both subsites and stimulation forces was 176.6 (95% CI, 170.3-183.0) ms, without significant difference between subsites or forces. The critical value for LAR response latency prolongation at the .01 significance level was 244 ms. At 30 frames/s video capture resolution, LAR response latency ≥8 frame intervals would indicate abnormal prolongation. CONCLUSION: Aesthesiometer-triggered LAR latency appears to be invariant over an 8.7-dB force range and between the aryepiglottic fold and medial pyriform sinus subsites in controls. Laryngeal adductor reflex latency incongruences between stimulation forces or laryngopharyngeal subsites may serve as pathophysiological features to dissect mechanisms of upper aerodigestive tract disorders. LEVEL OF EVIDENCE: Level 3B.

Exploring the impact of ineligibility on individuals expressing interest in a trial aimed at improving daily functioning regarding perceptions of self, research and likelihood of future participation.

BACKGROUND: Eligibility guidelines in research trials are necessary to minimise confounds and reduce bias in the interpretation of potential treatment effects. There is limited extant research investigating how being deemed ineligible for such trials might impact patients' perceptions of themselves and of research. Better understanding of the impact of patient ineligibility could enhance design and implementation of future research studies. METHODS: Eight semi-structured telephone interviews were conducted to explore the impact of ineligibility on self-perceptions; perceptions regarding the nature of research; and the likelihood of expressing interest in future research. Data were collected and analysed thematically through inductive, interpretive phenomenological analysis (IPA). RESULTS: Five themes emerged regarding the experience of being deemed ineligible: (1) Being deemed ineligible is emotion and reaction evoking; (2) 'Doing your bit': Helping others and increasing the value of research; (3) Communication of ineligibility; (4) Appreciation for those who express interest; and (5) Subsequent perceptions and attitudes towards research. CONCLUSIONS: The results suggest that being deemed ineligible can elicit negative emotional outcomes but is not likely to change perceptions of or attitudes towards research, possibly due to a desire to help similar others. Ineligibility can impact future participation in some cases, thus reducing the recruitment pool for subsequent research studies. Recommendations are provided to help minimise this risk. Advising of ineligibility in a personal way is recommended: with enhanced clarity regarding the reasoning behind the decision; providing opportunities to ask questions; and ensuring that appreciation for the patient's time and interest are communicated.