Search

PurposePembrolizumab improved survival in patients with recurrent or metastatic head and neck squamous-cell carcinoma (HNSCC). The aims of this study were to determine if pembrolizumab would be safe, result in pathologic tumor response (pTR), and lower the relapse rate in patients with resectable human papillomavirus (HPV)-unrelated HNSCC.Patients and methodsNeoadjuvant pembrolizumab (200 mg) was administered and followed 2 to 3 weeks later by surgical tumor ablation. Postoperative (chemo)radiation was planned. Patients with high-risk pathology (positive margins and/or extranodal extension) received adjuvant pembrolizumab. pTR was quantified as the proportion of the resection bed with tumor necrosis, keratinous debris, and giant cells/histiocytes: pTR-0 (

Objective: To describe the incidence of tracheostomy‐related complications and identify prognostic risk factors. Study Design: Administrative database analysis. Setting: Outpatient and inpatient insurance claims records obtained from a national database. Methods: PearlDiver, a private analytics database of insurance claims from Medicare, Medicaid, and commercial insurance companies, was used to identify patients who underwent tracheostomies and associated complications between January 2010 and October 2021 by CPT and ICD‐9/ICD‐10 codes. Results: A total of 198,143 tracheostomies were identified from PearlDiver, and at least 1 tracheostomy‐related complication occurred within 90 days of the procedure in 22,802 (10.3%) of these cases. The proportion of tracheostomy‐related complications was 2.3 times higher in 2019 compared to 2010 (95% confidence interval [CI]: 2.18‐2.52). The risk of developing tracheostomy‐complications was associated with the hospital region (highest in the Midwest as compared to the West [odds ratio [OR] = 1.32; 95% CI: 1.25‐1.39]), provider specialty (highest for otolaryngologists as compared to nonsurgical physicians [OR = 2.22; 95% CI: 2.10‐2.34]), insurance plan type (lowest for cash payment compared to Medicaid [OR = 0.70, 95% CI: 0.50‐0.94]), and Elixhauser Comorbidity Index (ECI) (highest in patients with ECI of 7+ compared to 0‐1 [OR = 2.96; 95% CI: 2.17‐3.24]), but was not significantly associated with patient age (OR = 0.99; 95% CI: 0.99‐0.99), or gender (OR = 1.04; 95% CI: 1.01‐1.07). Conclusions: Complications after tracheostomy are common and sicker patients are at higher risk for complications. Identifying factors associated with increased risk for complications could help to improve patient and family counseling, guide quality improvement initiatives, and inform future studies on tracheostomy outcomes. [ABSTRACT FROM AUTHOR]

Background: The University of Pennsylvania Smell Identification Test is widely used to measure change in olfactory function, but a minimal clinically important difference (MCID) has not been well-established. A study published in 1997 regarding patients with head trauma reported an MCID of 4 but did not detail the methods used in the calculation. Objective: To validate the MCID for UPSIT in patients with postviral, sinusitis, and procedure-associated olfactory loss. Methods: This was a secondary analysis of prospectively collected data from 5 clinical research studies related to olfactory function. Three studies included subjects with COVID-19-related olfactory dysfunction, one with chronic sinusitis subjects, and one with subjects undergoing transsphenoidal surgery. All subjects had completed a baseline and follow-up UPSIT, baseline and follow-up Clinical Global Impression-Severity (CGI-Severity), and a follow-up CGI-Improvement. Both distribution- and anchor-based methods were used to determine the MCID of UPSIT. Distribution-based method calculated MCID using half standard deviation of baseline UPSIT and delta UPSIT scores. Clinical-anchor method determined MCID by comparing delta UPSIT scores between consecutive CGI-I clinical categories ranging from very much better to very much worse. Results: The study population comprised 295 subjects. Subjects had a mean (SD) baseline UPSIT score of 27 (7.5), and follow-up score of 28 (7.9), and a mean UPSIT change of 0.6 (5.8). Half the baseline UPSIT SD was 3.75 and half the delta UPSIT SD was 2.9. With the anchor-based approach, an MCID of 4 was defined as clinically meaningful by exploring the relationship between delta UPSIT and CGI-Improvement. Using a more conservative approach based on the MCID values identified from both methods, we determined that a change of 4 or greater is the appropriate MCID for UPSIT. Conclusion: Investigators in the future should use 4 as MCID for UPSIT and report the percentage of study subjects who achieve a clinically meaningful difference. Level of Evidence: III. [ABSTRACT FROM AUTHOR]

This article discusses the development and validation of a decision aid (DA) for patients newly diagnosed with vestibular schwannoma (VS). The lack of information is identified as a major barrier for patients facing treatment decisions for VS. The study involved the use of virtual focus groups, discussions with treating physicians, and a literature review to identify the 15 items included in the DA. Participants were randomized into groups, with one group receiving the DA and a fact sheet, and the other group receiving only the fact sheet. The primary outcome measure was the difference in Decisional Conflict Scale (DCS) between two time points. The results showed that the use of the DA reduced decisional conflict and increased patient satisfaction with their decision. This study is significant because it is the first randomized control trial (RCT) of a DA for VS patients. [Extracted from the article]

Objective: The objective of this study was to explore the safety and feasibility of stellate ganglion blocks (SGBs) to treat persistent COVID‐19‐induced olfactory dysfunction (OD). Secondarily, the goal was to determine effect sizes to plan a future randomized clinical trial. Study Design: Prospective case series. Setting: Quaternary Care Academic Medical Center. Methods: In this single‐arm pilot trial, adult participants with a COVID‐19 diagnosis ≥ 12 months prior to enrollment with OD underwent bilateral SGBs. Subjects were followed for 1 month after completion of SGB. The primary outcome measure was the change in the Clinical Global Impression‐Improvement Scale for smell loss. Secondary outcome measures included changes in the University of Pennsylvania Smell Identification Test (UPSIT) and Olfactory Dysfunction Outcomes Rating (ODOR). Results: Twenty participants were enrolled with a mean (SD) age of 46 (11) years and a mean (SD) duration of OD of 21 (5) months. At 1 month, 10 (50%) participants experienced at least slight subjective improvement in their OD, 11 (55%) attained a clinically meaningful improvement in smell identification using the UPSIT, and 7 (35%) achieved a clinically meaningful improvement in olfactory‐specific quality of life (QoL) measured by the ODOR. The median difference between UPSIT scores at baseline and 1 month was 6 (95% confidence interval: 3‐11), exceeding the minimal clinically important difference of 4. There were no serious adverse events. Conclusion: Sequential SGBs for COVID‐19‐associated OD were safe and associated with modest improvements in subjective olfaction, odor identification, and olfactory‐specific QoL. A placebo‐controlled trial is warranted to determine the efficacy of SGBs for COVID‐19‐associated OD. [ABSTRACT FROM AUTHOR]

Objective: Identify clinically important factors associated with conservative treatment response in Meniere's disease and incorporate these factors into a composite clinical severity staging system. Study Design: Retrospective cohort. Setting: Tertiary academic medical center. Methods: Adult patients newly diagnosed with Meniere's disease between January 1, 2016 and December 31, 2019 were eligible. Patients with previous treatment for Meniere's disease, prior otologic surgery, or a lack of follow‐up data were excluded. Treatment‐responsive patients were managed with only conservative therapies (eg, dietary modifications, diuretics) and unresponsive patients underwent more intensive therapies (eg, intratympanic procedures, surgical interventions). Results: Of 78 patients included in the study, 49 (63%) were responsive to conservative therapies and 29 (37%) were not. Responsive patients had higher proportions of no or mild vertigo (24%, 95% confidence interval [CI]: 3.1%–45.8%) and none or mild comorbidity (27%, 95% CI: 9.2%–44.7%) and a lower proportion of hearing loss (19%, 95% CI: 5.6%–32.4%) compared to unresponsive patients. Conjunctive consolidation of these 3 factors was performed to develop a three‐stage system with a treatment response gradient ranging from 100% to 64% to 18% for stage 1 (n = 11), stage 2 (n = 56), and stage 3 (n = 11), respectively. Conclusions: This study identified decreased vertigo severity, reduced comorbidity burden, and absence of hearing loss as factors associated with conservative treatment response in Meniere's disease. A composite clinical severity staging system including these 3 factors can be used to optimize treatment selection and promote patient‐centered management of Meniere's disease. [ABSTRACT FROM AUTHOR]

Objective: Develop and validate a quality‐of‐life (QoL) outcome measure for patients with dysosmia. Study Design: Cross‐sectional survey study. Setting: Otolaryngology clinics, research registries, and Facebook support groups. Methods: A 59‐item pilot survey with questions addressing parosmia concerns was developed using input from subjects with parosmia and clinical expertise from Otolaryngologists. After item reduction, the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR) was reduced to its final 29 items. DisODOR maximum score is 116 (each item score 0‐4) with higher scores indicating a higher degree of dysfunction from smell distortion. DisODOR was validated using participants with parosmia persisting >3 months after severe acute respiratory syndrome coronavirus 2 (cases) and healthy controls. Reliability, face and content validity, internal consistency, convergent validity, discriminative validity, sensitivity to change, and the minimal clinically important difference (MCID) were assessed. Results: A total of 134 cases and 20 controls completed DisODOR. The mean (SD) age was 45.9 (12.2) for cases and 29.6 (8.9) for controls. The mean score difference between cases and controls was 45.0 (95% confidence interval, 40.5‐49.5) displaying good discriminative validity. DisODOR showed strong test–retest reliability (r =.942) with high internal consistency (Cronbach's α =.971). DisODOR had a moderate correlation with SNOT‐22 scores (r =.619) indicating good convergent validity. There is an excellent association with the global impression of severity categories (η2 = 0.447). Based on the distribution method, the MCID is 15. Conclusion: DisODOR is a valid, reliable QoL instrument for parosmia that can be used to measure the functional impact and QoL impairment for parosmia patients. DisODOR is sensitive to change and thus can be used in studies investigating treatments for parosmia. [ABSTRACT FROM AUTHOR]

Objectives: To examine long‐term speech and cognition outcomes in older adult cochlear implant (CI) recipients. First, by evaluating if CI performance was maintained over an extended follow‐up period regardless of preoperative cognitive status. Secondly, by evaluating if there was a difference in the rate of cognitive decline between preoperative mild and normal cognition following CI over an extended period of time. Study Design and Setting: Retrospective cohort study. Methods: CI recipients ≥65 years of age implanted between 2009 and 2014 with 4+ years follow up. Pre‐ and postoperative audiometric and speech outcome assessments were collected. Cognitive status was measured using the mini mental status examination (MMSE) at numerous time points. Results: Fifty‐three patients met inclusion. Patients were divided into two groups based on preoperative MMSE with scores considered normal (28–30) and those with mildly impaired cognition (MIC, scores 25–27). Audiometric and speech performance improved significantly at one‐year post implantation and this was maintained without significant change at 4+ years, regardless of cognitive status. Mixed modeling analysis controlling for age demonstrated no significant difference in the rate of cognitive decline at 4+ years post implantation between the normal cognition cohort (1.74; 95%CI 0.89–2.6) and MIC (2.9; 95%1.91–3.88). Conclusion: Speech performance was significantly improved and sustained after CI in both normal cognition and MIC patients. The rate of cognitive decline in older adult CI patients appears to be similar regardless of preoperative cognitive status. Although results demonstrate rates of cognitive decline following CI did not differ between cognition groups over 4+ years, future studies will need to further investigate this over extended time periods with a more comprehensive cognitive testing battery. Level of Evidence: 4 Laryngoscope, 133:2379–2387, 2023 [ABSTRACT FROM AUTHOR]