Validation of a Novel Allergy-Specific Domain for the 22-Item Sino-Nasal Outcomes Test.

OBJECTIVES: To develop and assess the validity of a novel allergy-specific domain for the 22-item sino-nasal outcomes test (SNOT-22), to provide a new tool that efficiently quantifies the impact of allergic rhinitis (AR) concurrent with chronic rhinosinusitis. STUDY DESIGN: Prospective validation study. SETTING: Tertiary care hospital and community-based clinic. METHODS: Proposed items were developed based on clinician and patient input, and further assessed via factor analysis and for internal consistency (n = 1987). Items were then additionally assessed for convergent and discriminant validity (n = 415), applying data from concurrent completions of the Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE), Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire (MiniRQLQ), and validated global health assessments. Assessments of intra-rater reliability, responsiveness to change, and qualitative input were also performed. RESULTS: Factor analysis demonstrated that proposed allergy items mapped to a single domain. Items were internally consistent (Cronbach α: 0.80 within domain, 0.91 within all SNOT). In assessments of convergent validity, domain scores were associated with MiniRQLQ (Spearman's ρ: 0.46, 95% confidence interval [CI]: 0.30-0.59) and NOSE scores (0.36, 95% CI: 0.27-0.44). The novel items also discriminated among clinical states: a 1-point increase in domain score was associated with an 8.32 (95% CI: 5.43-12.75) increase in the odds of prompting a visit for allergy-related symptoms and a 1.52 (95% CI: 1.13-2.05) increase in the odds of positive allergy testing. Intra-rater reliability was substantial (Cohen's κ: 0.8, 95% CI: 0.8-0.9), and responsiveness to change was demonstrated (mean difference: -0.6, 95% CI: -0.8 to -0.4). CONCLUSIONS: This novel domain is a valid, efficient measure of AR alongside rhinosinusitis.

Psychological Status as an Effect Modifier of the Association Between Allergy Symptoms and Allergy Testing.

OBJECTIVE: Patient-reported outcome measures, while valuable, may not correlate with diagnostic test results. To better understand this potential discrepancy, our objective was to determine whether psychological health is an effect modifier of the association between patient-reported allergy outcome scores and allergy test results. STUDY DESIGN: Prospective outcomes study. SETTING: Tertiary care hospital and community-based clinic. METHODS: This study included 600 patients at least 18 years of age who presented for symptoms related to allergic rhinitis and completed the related sinonasal outcome test (SNOT), which includes validated nasal, allergy, and psychological domains. Stratified analyses of odds ratios and Spearman correlation coefficients were utilized to assess for effect modification by psychological status. RESULTS: Worse patient-reported allergic rhinitis symptoms were significantly associated with positive allergy test results (odds ratio [OR] 1.69, 95% confidence interval [CI] 1.22-2.34, P = .002) in patients with better psychological health. In contrast, there was no association in patients with worse psychological health (OR 1.06, 95% CI 0.36-3.10, P = .92). These findings were corroborated by assessments of correlation: allergy domain scores were positively correlated with allergy testing scores (Spearman rho 0.18, 95% CI 0.10-0.25, P < .001) in patients with better psychological health, while there was no correlation in patients with worse psychological health (-0.02, 95% CI -0.16-0.12, P = .77). CONCLUSIONS: Psychological status was an effect modifier of the association between allergy domain and allergy testing data. When assessing the relationship between subjective measures, such as sinonasal validated instruments, and objective measures, such as allergy test results, accounting for effect modifiers such as psychological state can provide clinical and research-related insights.

Mitigation of Effect Modification by Psychological Status in Patients With Hearing Loss.

Importance: Although patient-reported outcomes provide valuable insights, these subjective data may not align with objective test results. Hearing loss is a pervasive problem, such that concordance between subjective perceptions of hearing ability and objective audiogram assessments would be beneficial. Objectives: To determine (1) whether psychological status is an effect modifier of the association between subjective patient reports of hearing ability and objective audiometry results, and (2) whether any effect modification observed in standard static questionnaires would be either mitigated or exacerbated by adaptive testing based on Item Response Theory analyses. Design, Setting, and Participants: This diagnostic study at a tertiary care center and community-based practice included consecutive adults who presented with queries related to hearing loss. Participants were recruited and enrolled and data analyses occurred from 2022 to 2024. Exposures: Participants prospectively reported their hearing-specific abilities through either a standard static or adaptive version of the Inner Effectiveness of Auditory Rehabilitation (EAR) scale, alongside validated measures of their mental health and audiometry. Word recognition scores (WRS) and pure tone averages (PTA) were used to analyze audiometric testing. Main Outcomes and Measures: The association between subjective Inner EAR results and audiometry was evaluated. Stratified analyses were used to assess for effect modification by psychological status. The results of standard static and adaptive testing were compared. Results: In this study of 395 patients (mean [range] age, 55.9 [18-89] years; 210 [53.2%] female), standard static Inner EAR mean scores were appropriately higher in patients with higher (better) WRS (50.7, 95% CI, 46.4-54.9), compared with patients with lower (worse) WRS (34.7, 95% CI, 24.3-45.1). However, among patients with worse mental health, there was no association between standard static Inner EAR scores and WRS. In contrast, adaptive Inner EAR mean scores were significantly higher for those with better WRS, regardless of mental health status. Thus, effect modification was observed in standard static assessments, whereas adaptive testing remained durably associated with audiometry, regardless of mental health. Conclusions and Relevance: Psychological status was an effect modifier of the association between standard Inner EAR scale scores and audiometry, with a positive association observed only in those with better mental health. Adaptive testing scores, however, remained significantly associated with audiometry, even when mental status was worse. Adaptive testing may stabilize the association between subjective and objective hearing outcomes.

The Impact of Sinonasal Symptoms in Relation to Potentially Life-Threatening Comorbidities.

OBJECTIVE: While general health may be influenced by sinonasal symptoms, their effects may be overshadowed by comorbid states which may be more serious. To assess the validity of this postulate, we measured the extent to which sinonasal symptoms and concurrent conditions influenced general health. STUDY DESIGN: Observational outcomes study. SETTING: Academic medical center, community care sites. METHODS: Adults with sinonasal symptoms completed the 22-item Sinonasal Outcome Test, along with the Patient-Reported Outcomes Measurement Information System global health short form. Comorbidities were categorized with the Deyo modification of the Charlson comorbidity index. Multivariate regression analyses were utilized to determine the relative impact of sinonasal symptoms and concurrent comorbid conditions on general health. RESULTS: Data from 219 consecutive patients demonstrated that sinonasal symptoms were associated with significantly diminished general physical (ß = -1.431, p < .001), mental (ß = -1.000, p < .001), overall (ß = -1.026, p < .001), and social health (ß = -0.872, p = .003), regardless of the presence of potentially life-threatening comorbid conditions. Comorbid conditions included cardiovascular disease, chronic obstructive pulmonary disease, connective tissue disease, peptic ulcer, diabetes mellitus, and hepatic disease. The effect of sinonasal symptoms was neither subsumed nor overshadowed by the effects of comorbid states. Nasal, ear, sleep, and psychological domain scores were also associated with general physical, mental, and global health while adjusting for the impact of comorbidities. CONCLUSION: Sinonasal symptoms have a substantial effect on general health which is not subsumed by the presence of potentially life-threatening concurrent comorbidities. These data may help support the importance of funding and resource allocation for conditions causing sinonasal symptoms.

Association of Outpatient Oral Macrolide Use With Sensorineural Hearing Loss in Children, Adolescents, and Young Adults.

Importance: Prior publications have reported the sporadic development of sensorineural hearing loss (SNHL) after intravenous or high-dose macrolide therapy for adults with comorbid conditions, but investigations of the auditory effect of oral outpatient dosing for children, adolescents, and young adults have been limited. Objective: To determine whether broad-based outpatient use of oral macrolide therapy is associated with increased risk of pediatric SNHL through nationally representative analyses. Design, Setting, and Participants: A retrospective case-control study of 875 matched pairs of children, adolescents, and young adults was performed, matching on age, sex, and the time elapsed since prescription date. All eligible pediatric patients were included, with matched control participants from the TRICARE US military health insurance system who were evaluated between October 1, 2009, and September 30, 2014. Exposures: Oral outpatient macrolide treatment compared with penicillin use among pediatric patients. Main Outcomes and Measures: The clinical outcome of interest was SNHL in children, adolescents, and young adults. Multivariable conditional logistic regression was used to compare the risk of prior macrolide exposure with penicillin exposure, adjusted for other risk factors and potential confounders. Four time frames between exposure and diagnosis were additionally assessed. Results: There were 875 eligible matched pairs of children, adolescents, and young adults included. The mean (SD) age of the participants was 5.7 (4.9) years; 1082 participants were male (62%), 58 were Asian (3%), 254 were Black (15%), 1152 were White (66%), and 286 were of Native American and other (no further breakdown was available in the TRICARE database) race and ethnicity (16%). In multivariable analysis, participants who had SNHL had increased odds of having received a macrolide prescription compared with a penicillin prescription when all time frames from exposure were included (adjusted odds ratio, 1.31; 95% CI, 1.05-1.64). There were significantly higher odds of macrolide exposure than penicillin exposure when diagnosis and testing occurred more than 180 days after antibiotic exposure (adjusted odds ratio, 1.79; 95% CI, 1.23-2.60). Conclusions and Relevance: In this case-control study of a nationally representative patient population, findings suggest that children, adolescents, and young adults with SNHL had increased odds of outpatient oral macrolide use compared with penicillin use, particularly when having received a diagnosis more than 180 days after exposure. Further study of the association of macrolides with SNHL in children, adolescents, and young adults is warranted.

The Sinonasal Outcome Test-22 or European Position Paper: Which Is More Indicative of Imaging Results?

OBJECTIVE: The 22-item Sinonasal Outcome Test (SNOT-22) is a trusted measure of symptom severity in chronic rhinosinusitis. The European Position Paper on Rhinosinusitis (EPOS) provides widely accepted diagnostic criteria, which include sinonasal symptoms, their duration, and imaging results. Our objective was to compare these approaches to assessing symptoms to determine if either was more indicative of radiologic findings, to support decisions in telehealth. STUDY DESIGN: Observational outcomes study. SETTING: Tertiary care center. METHODS: In total, 162 consecutive patients provided a structured sinonasal history, completed the SNOT-22, and underwent sinus computed tomography (CT) within 1 month. SNOT-22 scores, EPOS-defined symptom sets, and Lund-Mackay results were assessed. To facilitate direct comparisons, we performed stepwise evaluations of sinonasal symptoms alone and combined with duration. The discriminatory capacity for imaging results was determined through areas under the receiver operating characteristic curves (ROC-AUC) for dichotomous outcomes and ordinal regression for multilevel outcomes. RESULTS: In ROC-AUC analyses, SNOT-22 and EPOS-defined symptoms had similar discriminatory capacity for Lund-Mackay scores, regardless of duration. Within ordinal regression analyses, SNOT-22 nasal scores were significantly associated with Lund-Mackay scores, while EPOS-defined nasal symptoms were not statistically significantly related. CONCLUSIONS: SNOT-22 nasal scores and EPOS-defined nasal symptoms may have similar associations with imaging results when assessed via ROC-AUC, while SNOT-22 may have more association within ordinal data. Understanding the implications of discrete patterns of symptoms may confer benefit, particularly when in-person and fiberoptic exams are limited.

Sinonasal Outcome Scores and Imaging: A Concurrent Assessment of Factors Influencing Their Association.

OBJECTIVE: The overall discriminatory ability of validated instrument scores for computed tomography (CT) findings of chronic rhinosinusitis has limitations and may be modified by multiple factors. To support optimal methods for assessment, we studied which factors could influence this relationship, including the concurrent impact of multiple discrete CT scoring mechanisms, colocalized imaging findings, and nasal comorbid conditions. STUDY DESIGN: Observational outcomes study. SETTING: Academic medical center. METHODS: Patients with sinonasal complaints who completed the 22-item Sinonasal Outcome Test (SNOT-22) and underwent CT were included. Multivariate ordinal regression was utilized to assess associations. CT data were quantified with the Lund-Mackay system, Zinreich system, and a direct measure of maximal mucosal thickness. The impact of incidental findings (mucous retention cysts, periapical dental disease) and nasal comorbid conditions was also assessed. RESULTS: A total of 233 patients were included. SNOT-22 nasal scores were significantly associated with CT results when those with incidental findings were excluded, regardless of the radiologic scoring mechanism utilized: Lund-Mackay regression coefficient, 0.321 (P = .046); Zinreich, 0.340 (P = .033); and maximum mucosal thickness, 0.316 (P = .040). This relationship subsided when incidental findings were present. SNOT-22 overall scores, sleep scores, and psychological domain scores had no significant association with imaging results, regardless of radiologic scoring system utilized. Nasal comorbid conditions had inconsistent associations. CONCLUSIONS: SNOT-22 nasal domain scores were associated with all 3 radiologic scoring systems when incidental findings were absent but not when they were present. Delineating the presence or absence of these colocalized findings affected the relationship between SNOT-22 scores and radiological results, beyond other concurrent factors.

Psychological Status as an Effect Modifier of the Association Between Sinonasal Instrument and Imaging Results.

OBJECTIVE: To determine whether psychological status is an effect modifier of the previously observed low discriminatory capacity of Sinonasal Outcome Test-22 (SNOT-22) scores for Lund-Mackay computed tomography (CT) results. STUDY DESIGN: Observational outcomes study. SETTING: Tertiary care center. SUBJECTS AND METHODS: We assessed patients presenting with chronic sinonasal complaints who underwent CT of the sinuses within 1 month of completing the SNOT-22 instrument. SNOT-22 overall and domain scores were calculated, as were Lund-Mackay CT scores. The discriminatory capacity of SNOT-22 scores for CT results was determined using the receiver-operator characteristic area under the curve (ROC-AUC). Patient-Reported Outcome Measurement Information System (PROMIS) mental health T-scores were assessed, and stratified analyses were used to test for effect modification by psychological status. RESULTS: In stratified analyses, patients with better PROMIS mental health scores had SNOT-22 overall (ROC-AUC 0.96) and nasal domain scores (ROC-AUC 0.97-0.98) that were highly discriminatory for Lund-Mackay scores, while those with worse mental health scores did not (ROC-AUC 0.42-0.55, P < .007). Patients with better SNOT-22 psychological domain scores also had nasal scores that discriminated among CT results significantly better than those with worse psychological domain scores (ROC-AUC 0.65-0.69 and 0.34-0.35, respectively, P < .013). CONCLUSIONS: Psychological status is an effect modifier of the relationship between SNOT-22 and Lund-Mackay scores. SNOT-22 scores were discriminatory for Lund-Mackay CT results in patients with better psychological status, while they were nondiscriminatory in those with worse psychological status. When assessing the relationship between subjective and objective measures of chronic rhinosinusitis, accounting for effect modification may have practical utility.

The Utility and Feasibility of Extending Beyond Traditional Patient Descriptions in Daily Practice.

OBJECTIVES/HYPOTHESIS: Institutional and national programs have endorsed the use of validated instruments in daily practice, but their utility for frontline clinicians is unknown. Our first objective was thus to determine if routinely obtained patient descriptions accurately predict disease-specific validated instrument results. Our second objective was to assess the feasibility of deploying an electronic system to obtain and document patient-reported descriptions of health status. STUDY DESIGN: Prospective assessment of consecutive eligible ambulatory care patients. METHODS: For the first objective, patients presenting with the same chief complaint at consecutive visits provided concurrent routine symptom descriptions and validated instrument responses. To determine whether patients' routine descriptions predicted scores from disease-specific instruments, receiver operator characteristic (ROC) curves, sensitivity/specificity, Spearman ρ correlation, and regression models were utilized. For the second objective, feasibility assessment focused on percent with successful response capture, time to questionnaire completion, and impact on physician time needed to obtain and document patient histories. RESULTS: For the first objective, among patients with hearing loss, eustachian tube dysfunction, nasal obstruction, and chronic rhinosinusitis, the areas under the ROC curves were 0.38 to 0.83. Spearman ρ coefficients were 0.25 to 0.46. Sensitivity and specificity ranged from 15.9% to 87.8%, with correct classification in 42.3% to 55.2% of cases. For the second objective, there was a 91% completion rate. Completion times were 7:18 to 12:37 for new patients and 3:23 to 6:41 for established patients. Physician time savings were estimated at 11 minutes per patient. CONCLUSIONS: Using validated instruments and electronic data collection systems in daily practice has practical and clinical implications. These topics warrant further study. LEVEL OF EVIDENCE: 2c Laryngoscope, 130:S1-S13, 2020.

Macrolide-associated sensorineural hearing loss: A systematic review.

OBJECTIVES: To investigate the potential association of macrolide antibiotics with sensorineural hearing loss (SNHL) and which agents and dosage may be related. To evaluate whether an optimal treatment exists for reversing SNHL that occurs after macrolide therapy. STUDY DESIGN: Systematic review of the literature. METHODS: Computerized (PubMed, EMBASE, Cochrane Library) and manual searches were performed to identify human studies of all ages (patients) who received macrolides (intervention, with or without control) and documented SNHL (outcome). All study designs were assessed. Extracted data included macrolide regimen details, as well as the timing, severity, and reversibility of SNHL with drug cessation alone or with additional medical intervention. Study designs and the associated risk of bias were assessed. RESULTS: The 44 publications (3 prospective, 41 retrospective) that met these criteria described 78 cases of audiometrically confirmed SNHL. SNHL was associated with oral and intravenous macrolide administration at standard and elevated doses. SNHL was irreversible in six cases, despite macrolide cessation (n = 5) and oral steroid treatment (n = 1). Irreversible SNHL was observed following 2 to 3 days of exposure. SNHL was reversible with macrolide cessation alone in 70 cases. In two cases, macrolide cessation coupled with oral steroid administration restored hearing. Reversible cases improved within hours to days. Nine studies also described 42 cases of subjective patient-reported hearing loss. Limitations in the data arose from study design, related comorbidities, and concomitant drug administration. CONCLUSION: SNHL may follow macrolide exposure, even at standard oral doses. Further research is needed to understand the incidence, prevalence, and biological mechanism of its ototoxicity. Laryngoscope, 128:228-236, 2018.

Antihistamine Use for Otitis Media with Effusion: Ongoing Opportunities for Quality Improvement.

OBJECTIVES: The otitis media with effusion (OME) clinical practice guideline endorsed by the American Academy of Otolaryngology-Head and Neck Surgery Foundation, the American Academy of Pediatrics, and the American Academy of Family Physicians recommends against using antihistamines. Avoiding antihistamines was previously endorsed as a performance measure by the National Quality Foundation, but data regarding current practice patterns are lacking. Thus, our objectives were to evaluate (1) antihistamine usage in association with OME, (2) whether practice varies according to visit setting, and (3) if usage patterns are such that a future change would be measurable. STUDY DESIGN: Cross-sectional analysis. SETTING: Ambulatory visits in the United States. SUBJECTS AND METHODS: National Ambulatory Medical Care Surveys and National Hospital Ambulatory Medical Care Surveys, 2005-2010; univariate, multivariate, and stratified analyses of antihistamine usage were performed. RESULTS: A total of 133,968 observations representing 1.49 × 10(9) pediatric visits met inclusion criteria. Antihistamines were used in 9.5% of OME visits, as opposed to 5.5% of visits without OME (univariate odds ratio, 1.83; 95% confidence interval, 1.02-3.29; P = .042). Multivariate analysis confirmed that OME was associated with a significant increase in nonsedating antihistamine usage (odds ratio, 3.53; 95% confidence interval, 1.62-7.71; P = .002), when adjusted for age, sex, race/ethnicity, allergic conditions and nasal inflammatory diagnoses. CONCLUSIONS: Oral antihistamines are significantly more likely to be administered when OME is diagnosed. Although antihistamine use for OME is proportionally low, the high prevalence of OME creates an opportunity for quality improvement. Future changes in clinician behavior in response to an updated guideline or related performance metric could be monitored.

Prevalence of biofilm-forming bacteria in chronic rhinosinusitis.

BACKGROUND: Recently, biofilms have been implicated in the pathogenesis of recalcitrant chronic rhinosinusitis (CRS). We sought to determine the prevalence of biofilm-forming cultures obtained from patients with CRS and clinical factors that may contribute to biofilm formation. METHODS: Endoscopically guided sinonasal cultures were obtained in duplicate from CRS patients with evidence of mucopurulence. Bacterial swabs were sent for microbiological characterization and were simultaneously evaluated for biofilm-forming capacity by a modified Calgary Biofilm Detection Assay. Biofilm formation was based on concomitant values of biofilm-forming Pseudomonas aeruginosa O1 (PAO1) (positive control) and non-biofilm-forming mutants sad-31 (type IV pili) and sad-36 (flagella K; negative control). Samples, with growth greater than the sad-31 mutant, were designated as biofilm formers. RESULTS: Sinonasal cultures were obtained from 157 consecutive patients (83 female patients) over a 4-month period. Forty-five samples (28.6%) showed biofilm formation. Among patients with a prior history of functional endoscopic sinus surgery (FESS), 30.7% (n = 42) showed biofilm growth. For patients naive to surgical intervention (n = 20), only 15% showed biofilm formation. A positive, statistically significant correlation existed between biofilm formation and number of prior FESS procedures. Polymicrobial cultures, Pseudomonas aeruginosa, and/or Staphylococcus aureus comprised 71% of samples. Chi-squared analysis showed an association with prior infections, but not with any pharmacologic therapy or comorbidies. CONCLUSION: We show a high percentage of CRS patients (28.6%) whose sinonasal mucopurulence has biofilm-forming capacity. Postsurgical patients had a high prevalence of biofilm-forming bacteria, a possible reflection of the severe nature of their disease. Additional studies are warranted.