Tracheostomy Incidence and Complications: A National Database Analysis.

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.

Clinical studies in COVID-related olfactory disorders: Review of an institutional experience.

Objective: To share a single institutional experience with clinical research on COVID-related olfactory dysfunction (OD). Data Source/Method: Narrative review of published original data and ongoing clinical trials on COVID-related OD at Washington University from 2020 to 2023. Results: There were three new diagnostic-/patient-reported outcome measures developed and tested. We report five clinical trials of interventions for COVID-related olfactory disorders: combined Visual-Olfactory Training (VOLT) with patient-preferred scents versus standard olfactory training (VOLT trial), oral gabapentin versus placebo (Gabapentin for the Relief of Acquired Chemosensory Experience trial), nasal theophylline irrigations versus placebo (Smell Changes and Efficacy of Nasal Theophylline trial), stellate ganglion block (single-arm), and mindfulness-based stress reduction (MBSR) versus lifestyle intervention (MBSR trial). Conclusions: Initial intervention trials for COVID-related OD have shown potential for improving subjective and objective olfactory outcomes. However, there remains no gold standard treatment that definitively outperforms placebo in controlled trials. Therefore, continued investigation of novel therapeutic strategies for COVID-related OD is necessary to maximize olfactory outcomes for affected patients.

Mandibular Advancement vs Combined Airway and Positional Therapy for Snoring: A Randomized Clinical Trial.

Importance: Approximately 150 million individuals in the US snore in the absence of obstructive sleep apnea (primary snoring), but few studies have examined the efficacy of treatments for snoring or evaluated the effect of snoring in sleeping partners. Objective: To evaluate the efficacy of 2 treatments for primary snoring. Design, Setting, and Participants: This pilot randomized clinical trial that included a convenience sample of people who snore without sleep apnea and their sleeping partner who underwent 4 weeks of snoring treatment was conducted at an academic medical center between October 3, 2022, and July 3, 2023. Interventions: Fifty couples were randomized to either use a mandibular advancement device (MAD) or receive combined airway and positional therapy (CAPT; external nasal dilator, nasal saline lavage with mometasone, mouth taping, and lateral positional therapy). Main Outcome and Measure: Percentage of sleeping partners who reported that their partner's snoring was either very much improved or much improved (responder) on the Clinical Global Impression of Improvement scale. Results: A total of 42 dyads completed the study; 23 (55%) were randomized to MAD and 19 (45%) to CAPT. Among people who snore, 26 (62%) were female, and the mean (SD) age was 48 (14) years. Of 23 dyads randomized to MAD, 21 people who snore (91%) were rated by the sleeping partner as a responder, while 11 of the 19 dyads (58%) randomized to CAPT were rated by the sleeping partner as responder, resulting in a difference of 33 percentage points (95% CI, 8-58) and a number needed to treat of 3. Of the 10 participants who were withdrawn, 4 were withdrawn due to adverse effects of the treatment that were evenly distributed between the MAD (n = 2) and CAPT (n = 2) groups. Conclusion and Relevance: The results of this randomized clinical trial showed that the MAD may be more effective than CAPT for treating primary snoring, while both treatment options were found to reduce primary snoring. Physicians should have a patient-centered discussion to determine which treatment is best for individual patients with primary snoring, weighing convenience, adverse effects, and cost as factors. Trial Registration: ClinicalTrials.gov Identifier: NCT05756647.

Use of Diagnostic Audiology and Cochlear Implantation in the US.

This study examined if cochlear implant (CI) use varies geographically within the US and if diagnostic audiology use correlates with CI usage.

Prognostic Factors for Survival Using a Clinical Severity Staging System Among Patients With Acute Invasive Fungal Sinusitis.

Importance: Despite the aggressive progression of fulminant acute invasive fungal sinusitis (AIFS), data on prognostic factors have been disparate, hindering the development of a staging system. A composite staging system may improve prognostication for patient counseling and conduct of clinical research. Objective: To identify prognostically important factors in AIFS and to incorporate the factors into a comprehensive Functional Severity Staging System and Clinical Severity Staging System. Design, Setting, and Participants: This retrospective cohort study included adult patients diagnosed with pathology-proven AIFS from June 1, 1992, to December 31, 2022, at Washington University Medical Center and Barnes-Jewish Hospital, a tertiary care center in St Louis, Missouri. Data were analyzed from April to July 2023. Main Outcome and Measures: Sequential sequestration and conjunctive consolidation was used to develop a composite staging system to predict 6-month overall survival. Results: Of 71 patients with pathology-proven AIFS over the 30-year period, the median (range) age of the cohort was 56 (19-63) years, and there were 47 (66%) male patients. The median (range) follow-up time was 2 (0-251) months. There were 28 patients alive within 6 months, for a 39% survival rate. Symptoms, comorbidity burden, and presence and duration of severe neutropenia were associated with 6-month survival and were consolidated into a 3-category Clinical Severity Staging System with 6-month survival of 75% for stage A (n = 16), 41% for stage B (n = 27), and 18% for stage C (n = 28). The discriminative power of the composite staging system was moderate (C statistic, 0.63). Conclusion and Relevance: This cohort study supports the clinical importance of symptomatology, comorbidity burden, and prolonged severe neutropenia at the time of AIFS presentation. The composite clinical staging system may be useful for clinicians when counseling patients with AIFS and conducting clinical research.

Smoking, Drinking, and Dietary Risk Factors for Head and Neck Cancer in Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial Participants.

Importance: There is a paucity of large-scale prospective studies evaluating the risk of developing head and neck cancer (HNC) associated with smoking, drinking, and dietary habits. Objective: To determine the association of smoking, drinking, and dietary habits with the risk of developing HNC. Design, Setting, and Participants: A nested cohort survival analysis of Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial participants was performed. Participants were between 55 and 74 years of age and recruited at 10 centers across the US from November 1993 to July 2001. Participants who developed HNC were matched with controls based on demographics and family history of HNC for analysis of smoking habits; for the analysis of drinking and dietary habits, matching was performed on smoking status and duration in addition to demographics and family history of HNC. Data analysis was performed from January to November 2023. Exposures: Smoking, drinking, and dietary habits. Main Outcome and Measure: Diagnosis of HNC. Results: In total, 139 926 participants (51% female; mean [SD] age, 62.6 [5.4] years) were included in the analysis of smoking habits with a median (IQR) follow-up time of 12.1 (10.3-13.6) years, 571 of whom developed HNC. HNC risk associated with smoking increased the closer the proximity of the head and neck subsite to the lungs, with the greatest risk associated with smoking observed in laryngeal cancer (current smoker hazard ratio [HR], 9.36; 95% CI, 5.78-15.15 compared to a nonsmoker). For analysis of drinking and dietary habits, 94 466 participants were included in the analysis of smoking habits with a median (IQR) follow-up time of 12.2 (10.5-13.6) years, 264 of whom developed HNC. HNC risk increased with heavy drinking (HR, 1.85; 95% CI, 1.44-2.38) and decreased with consumption of whole grains (HR, 0.78; 95% CI, 0.64-0.94/oz per day), whole fruits (HR, 0.90; 95% CI, 0.82-0.98/cup per day), and overall healthy eating, as scored by Healthy Eating Index 2015 (HR, 0.87; 95% CI, 0.78-0.98/10 points). Conclusions and Relevance: In this nested cohort study, the risk of HNC associated with smoking was higher for subsites that were closer to the lungs; heavy drinking was associated with greater HNC risk, while healthy eating was associated with a modest reduction in HNC risk.

Identifying Predictors of Treatment Response in Meniere's Disease: A Clinical Severity Staging System.

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.

Validation of Minimal Clinically Important Difference (MCID) for University of Pennsylvania Smell Identification Test (UPSIT).

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.

Stellate Ganglion Block for the Treatment of COVID-19-Induced Olfactory Dysfunction: A Prospective Pilot Study.

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.

Preexisting tumor-resident T cells with cytotoxic potential associate with response to neoadjuvant anti-PD-1 in head and neck cancer.

About 50% of patients with locally advanced head and neck squamous cell carcinoma (HNSCC) experience recurrences after definitive therapy. The presurgical administration of anti-programmed cell death protein 1 (PD-1) immunotherapy results in substantial pathologic tumor responses (pTR) within the tumor microenvironment (TME). However, the mechanisms underlying the dynamics of antitumor T cells upon neoadjuvant PD-1 blockade remain unresolved, and approaches to increase pathologic responses are lacking. In a phase 2 trial (NCT02296684), we observed that 45% of patients treated with two doses of neoadjuvant pembrolizumab experienced marked pTRs (≥50%). Single-cell analysis of 17,158 CD8+ T cells from 14 tumor biopsies, including 6 matched pre-post neoadjuvant treatment, revealed that responding tumors had clonally expanded putative tumor-specific exhausted CD8+ tumor-infiltrating lymphocytes (TILs) with a tissue-resident memory program, characterized by high cytotoxic potential (CTX+) and ZNF683 expression, within the baseline TME. Pathologic responses after 5 weeks of PD-1 blockade were consistent with activation of preexisting CTX+ZNF683+CD8+ TILs, paralleling loss of viable tumor and associated tumor antigens. Response was associated with high numbers of CD103+PD-1+CD8+ T cells infiltrating pretreatment lesions, whereas revival of nonexhausted persisting clones and clonal replacement were modest. By contrast, nonresponder baseline TME exhibited a relative absence of ZNF683+CTX+ TILs and subsequent accumulation of highly exhausted clones. In HNSCC, revival of preexisting ZNF683+CTX+ TILs is a major mechanism of response in the immediate postneoadjuvant setting.

Efficacy of Gabapentin For Post-COVID-19 Olfactory Dysfunction: The GRACE Randomized Clinical Trial.

Importance: The COVID-19 pandemic affected millions of people and has become a dominant etiology of olfactory dysfunction (OD). No interventions with definitive clinical utility exist. Gabapentin represents a potential therapy for COVID-19-induced OD. Objective: To evaluate the efficacy of oral gabapentin on olfactory function and olfaction-related quality of life in patients with COVID-19-induced OD. Design, Setting, and Participants: This pilot double-blinded, placebo-controlled randomized clinical trial (RCT) was conducted at Washington University School of Medicine in St Louis from January 7, 2022, to February 3, 2023. Adults with at least 3 months of OD after COVID-19 infection were eligible for inclusion. Participants with a history of other causes of OD or contraindications to gabapentin were excluded. Intervention: Patients were randomized 1:1 to oral gabapentin or placebo. All patients underwent titration to a maximum tolerable dose, which was maintained during an 8-week fixed-dose (FD) phase then tapered off. Participants were monitored for 4 weeks following cessation of study medication. Main Outcomes and Measures: Outcomes were assessed following the 8-week FD phase and 4 weeks after taper completion. The primary outcome measure was the response rate determined by subjective improvement in OD on the Clinical Global Impression of Improvement (CGI-I) after the FD phase. Other subjective and objective measures of olfactory function were also assessed as secondary outcome measures. Results: Sixty-eight participants were enrolled (34 randomized to each arm), a total of 44 participants completed the FD period and 20 (45.4%) reported response to treatment with at least slight improvement in olfaction from baseline. Of those randomized, 51 (75%) were women and 56 were White (82%) with a mean (SD) age of 43 (13.5) years. Baseline demographic features including age, sex, and race and ethnicity were not significantly different between the groups. Of the 18 participants in the gabapentin group, 8 (44%) were responders and of the 26 participants in the placebo group, 12 (46%) reported response to treatment (percent difference, 1.7%; 95% CI, -31.6% to 28.2%). Mixed-model analysis of all secondary outcome measures demonstrated no clinically meaningful or statistically significant difference between the gabapentin and placebo groups throughout the trial. There were no serious adverse events. Conclusions and Relevance: In this randomized clinical trial, gabapentin was not associated with statistically significant or clinically meaningful benefit over placebo and likely is not an efficacious therapy for COVID-19-induced OD. Trial Registration: ClinicalTrials.gov Identifier: NCT05184192.

Development and Validation of the Parosmia Olfactory Dysfunction Outcomes Rating (DisODOR).

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.

Acute Taste Dysfunction in Oropharyngeal Cancer Patients after Transoral Robotic Surgery.

OBJECTIVES: To compare taste changes after transoral robotic surgery (TORS) to taste changes in healthy controls. METHODS: Oropharyngeal cancer patients receiving TORS and healthy controls were recruited. Participants underwent posterolateral and whole-mouth psychophysical taste testing (identification, intensity, and hedonics) at baseline and at 2 weeks postoperatively (patients) or follow-up (controls). Surgeons reported suspension time and glossopharyngeal nerve injury (GNI) based on the identification and sacrifice of the nerve. A Clinical Global Impression (CGI) of taste symptoms was completed at each session ("My sense of taste bothers me" on a 5-point scale from Never [1] to Always [5]). A taste disorder (TD) was a CGI of 3 (Sometimes) or worse. Within-subject changes in CGI and psychophysical scores were computed. "Worsened taste" was a CGI increase by ≥1 point at follow-up. RESULTS: Of 69 participants, most (33/37 tumor, 31/32 controls) had normal baseline taste (CGI < 3). 14/33 (42%) TORS patients and no controls developed new TDs at follow-up. More smokers (7/9) had worsened taste than nonsmokers (19/60, difference = 46% [95% CI 16%-76%]). More patients without GNI (6/22) than with GNI (0/15) had postoperative phantogeusia (difference = 27% [95% CI 9-45%]). Tumor-ipsilateral taste identification (TI) decreased more in patients (-11.3%) than controls (0.8%, difference = 12.2% [95% CI 5.0-19.3%]). Suspension time was not associated with worsened taste symptoms or psychophysical changes. CONCLUSIONS: Patient-reported taste changes after TORS are frequent. Compared to healthy controls, TORS patients have decreased tumor-ipsilateral TI. Suspension time and GNI are unlikely to cause symptomatic TDs. Further investigations of the etiology and long-term symptom burden of TORS-associated TDs will aid in the management of oropharyngeal cancer patients. LEVEL OF EVIDENCE: 3 (non-randomized controlled cohort study) Laryngoscope, 133:3520-3528, 2023.

Anxiety and Depression Diagnoses and the Cough Severity Index: A Retrospective Study.

Background: As mental health comorbidities can impact patient perception of symptoms, understanding a potential association of anxiety and depression with patients' perception of their cough may provide insight into preferred treatment plans. Methods: A retrospective cohort study of patients presenting with chronic cough was completed. Demographics, anxiety and depression diagnoses, and patient-reported outcome measures were collected. Patient-reported outcomes between the four groups of patients-anxiety only, depression only, anxiety and depression, and none of these conditions-were compared using Kruskal-Wallis and Mann-Whitney U tests that were used for post-hoc analysis. Results: Cough Severity Index scores were higher in those with both anxiety and depression as compared to neither, with a median score of 26 (range: 5-39) versus 19 (range: 1-38), respectively (P = .041). These results were persistent also after controlling for sex and smoking status in the robust regression analysis. Conclusions: Patients with prior diagnoses of anxiety and depression self-reported more severe symptoms for chronic cough. Adequately understanding the association of mental health with perceived cough severity may help for more individualized, successful treatment plans.

Invasive fungal sinusitis risk factors among immunosuppressed hematopoietic stem cell transplant recipients.

KEY POINTS: Invasive fungal sinusitis (IFS) rate and risk factors in transplant recipients were explored IFS rate is higher in allogeneic recipients with prior transplants and worse comorbidity scores The at-risk timeframes for IFS development were identified.

Hearing Outcomes in a Deintensification Trial of Adjuvant Therapy for HPV-Related Oropharyngeal Squamous Cell Carcinoma.

OBJECTIVE: To explore whether deintensification of adjuvant therapy reduces ototoxicity among patients with human papillomavirus (HPV)-related oropharyngeal squamous cell carcinoma (OPSCC). STUDY DESIGN: Retrospective cohort study. SETTING: Single academic center. METHODS: The ototoxicity rate among adult patients with HPV-related OPSCC enrolled in the Minimalist Trial (MINT), a prospective phase 2 trial of surgery followed by risk-adjusted deintensified adjuvant therapy (42 Gy radiation given alone or with a single 100 mg/m2 dose of cisplatin), was compared to that among a historical cohort treated with standard adjuvant therapy (60-66 Gy radiation with up to three 100 mg/m2 doses of cisplatin). Ototoxicity was defined as Common Terminology Criteria for Adverse Events v5.0 ≥ Grade 2. Mixed model analysis was performed to investigate the association between deintensified adjuvant therapy and treatment-related hearing loss. RESULTS: A total of 29 patients (58 ears) were analyzed in the MINT cohort, and 27 patients (54 ears) in the historical cohort. The ototoxicity rate was 5% (n = 3/58 ears) in the MINT cohort and 46% (n = 25/54 ears) in the historical cohort (difference, 41%; 95% confidence interval [CI] = 27%-56%). Patients in the MINT cohort demonstrated a 95% decrease in risk of ototoxicity compared to those in the historical cohort (adjusted odds ratio: 0.05, 95% CI = 0.01-0.31). Differences in estimated marginal mean threshold shifts were statistically and clinically significant at frequencies ≥ 3 kHz. CONCLUSION: The deintensified adjuvant therapy given in MINT led to less ototoxicity than standard adjuvant therapy among patients with HPV-related OPSCC.

A Simple Guide to Effect Size Measures.

Importance: Effect size quantifies the magnitude of the difference or the strength of the association between variables. In clinical research it is important to calculate and report the effect size and the confidence interval (CI) because it is needed for sample size calculation, meaningful interpretation of results, and meta-analyses. Observations: There are many different effect size measures that can be organized into 2 families or groups-d family and r family. The d family includes measures that quantify the differences between groups. The r family includes measures that quantify the strength of the association. Effect sizes that are presented in the same units as the characteristic being measured and compared are known as nonstandardized or simple effect sizes. The nonstandardized effect sizes have the advantage of being more informative, easier to interpret, and easier to evaluate in the light of clinical significance or practical relevance. Standardized effect sizes are unit-less and are helpful for combining and comparing effects of different outcome measures or across different studies (ie, meta-analysis). Conclusions and Relevance: The choice of the correct effect size measure depends on the research question, study design, targeted audience, and the statistical assumptions being made. For a complete and meaningful interpretation of results from a clinical research study, the investigator should make clear the type of effect size being reported, its magnitude and direction, degree of uncertainty of the effect size estimate as presented by the CIs, and whether the results are compatible with a clinically meaningful effect.

Most-Cited Patient-Reported Outcome Measures Within Otolaryngology-Revisiting the Minimal Clinically Important Difference: A Review.

Importance: Patient-reported outcome measures (PROMs) allow clinicians and researchers to assess health-related information from a patient's perspective. These measures have been used more frequently over the last several decades, but an associated minimal clinically important difference (MCID) is needed to optimize their utility. This narrative review identified the top 100 most-cited otolaryngology-related PROM development and validation publications and assessed the presence and characteristics of the PROMs' associated MCID. Observations: In this narrative review, a literature search in Scopus and Web of Science was conducted on June 29, 2022, using keywords related to PROM development and validation studies in otolaryngology and reference lists. Studies that met the definition of a PROM and assessed an otolaryngologic disorder or study population were included for full-text review. After full-text review of 188 articles, the top 100 most-cited PROM development and validation publications, resulting in 106 total PROMs, were chosen for review. A total of 39 (37%) of the identified PROMs had an associated MCID. Of those reporting an MCID, 14 (35.9%) used an anchor-based method, 12 (30.8%) used a distribution-based method, 10 (25.6%) used both, and 3 (7.7%) did not specify or used neither method. Rhinology had the greatest number of PROMs with an associated MCID (16 of 24, 66%), and pediatrics had the fewest (1 of 13, 7.7%). The median number of citations of PROMs with an MCID was higher than those without an MCID. Conclusions and Relevance: The majority of the most-cited PROMs in otolaryngology lack an associated MCID. These data indicated that there are a multitude of PROMs that have been cited hundreds of times and used for decades without the ability to identify whether a particular change in score on the instrument is clinically meaningful. There is a need to determine and validate MCIDs for commonly used PROMs to aid clinical research and trial interpretation.