Complete Genome Sequence of Candida mucifera from an Otitis Media Patient.

We describe for the first time, a high-quality genome for a rare human yeast pathogen Candida mucifera, from a patient with chronic suppurative otitis media. This pathogen exhibited reduced azole susceptibility, similar to its close relatives within the Trichomonascus ciferrii species complex.

Efficacy of Biologic Therapies for Eosinophilic Otitis Media: A Systematic Review and Meta-analysis.

Eosinophilic otitis media, first reported in Japan, is a viscous, intractable otitis media often linked to bronchial asthma and chronic rhinosinusitis, characterized by highly viscous middle ear effusion. Its pathological mechanism remains unclear and the condition occasionally does not respond to steroids. It is now recognized as a rare type 2 inflammatory disease and should be treated specifically to enhance quality of life. This systematic review and meta-analysis evaluated the efficacies of biologic treatments. We searched PubMed, SCOPUS, Embase, Web of Science, and Cochrane databases up to September 2023. We retrieved ear examination findings, otitis media-related and symptom scores, air-bone gaps and hearing thresholds, serum eosinophil, and immunoglobulin E (IgE) levels before and after biologic treatments. Biologics treatment significantly improved subjective otitis media-related scores, compared with control group (standard mean difference (SMD) -1.62; 95% confidence interval (CI) [-2.24; -1.01], I2=54%). Additionally, the serum eosinophil counts and IgE levels significantly decreased (SMD -1.40; 95% CI [-1.99; -0.81], I 2=0%) after 6-12 months of biologic treatments, but the hearing thresholds did not significantly change. There were no significant differences between groups treated with dupilumab and groups treated with other biologics. Biologics treatment for eosinophilic otitis media significantly improved subjective otitis media-related scores and decreased serum eosinophil and IgE levels, but no significant changes in hearing threshold. More randomized cohort studies are needed to confirm the efficacies of biologics in patients with refractory eosinophilic otitis media.

Subdural empyema-a rare complication of chronic otitis media: a case report.

BACKGROUND: Subdural empyema is an extremely rare and fatal intracranial complication of chronic otitis media. Due to its rarity and vague symptoms, it is often diagnosed late if not completely missed; specially in developing countries where the diagnostic modalities are hardly available or accessible. To the best knowledge of the authors, this is a preliminary reported case of subdural empyema as a complication of chronic otitis media in Eritrea. It aims to provide vital information on the clinical presentation, preferred diagnostic modalities, and the proper management of such cases. CASE REPORT: An 8 years old female patient from the Rashaida ethnic group presented with fever, right ear purulent discharge, right post-auricular swelling, and altered mental status. Prior to her admission, she had history of recurrent purulent discharge from her right ear for almost 2 years, and had been diagnosed with chronic otitis media. Upon admission her GCS was 13/15 which later on deteriorated to be 3/15 on day 3. MRI was done and showed a right fronto-tempo-parietal subdural empyema with mass effect, shifting the midline to the left. She was immediately started on empirical broad-spectrum antibiotics. After the diagnosis was made, craniotomy was done, and 30 ml of pus was removed from the subdural space. Culture and sensitivity of the pus obtained intraoperatively was done but produced no yield. Hence, she was continued on the empirically started antibiotics. The patient's condition was well improved by post-operative day 4. CONCLUSION: It is important to have a high index of suspicion of intracranial complications in patients with history of chronic otitis media or other otologic complaints, who present with neurologic manifestations. Subdural empyema still being uncommon even among the intracranial complications of COM, it is often missed. Hence, timely diagnosis with MRI, immediate surgical evacuation of the empyema along with the prolonged administration of broad-spectrum antibiotics is highly recommended.

A 3D and Explainable Artificial Intelligence Model for Evaluation of Chronic Otitis Media Based on Temporal Bone Computed Tomography: Model Development, Validation, and Clinical Application.

BACKGROUND: Temporal bone computed tomography (CT) helps diagnose chronic otitis media (COM). However, its interpretation requires training and expertise. Artificial intelligence (AI) can help clinicians evaluate COM through CT scans, but existing models lack transparency and may not fully leverage multidimensional diagnostic information. OBJECTIVE: We aimed to develop an explainable AI system based on 3D convolutional neural networks (CNNs) for automatic CT-based evaluation of COM. METHODS: Temporal bone CT scans were retrospectively obtained from patients operated for COM between December 2015 and July 2021 at 2 independent institutes. A region of interest encompassing the middle ear was automatically segmented, and 3D CNNs were subsequently trained to identify pathological ears and cholesteatoma. An ablation study was performed to refine model architecture. Benchmark tests were conducted against a baseline 2D model and 7 clinical experts. Model performance was measured through cross-validation and external validation. Heat maps, generated using Gradient-Weighted Class Activation Mapping, were used to highlight critical decision-making regions. Finally, the AI system was assessed with a prospective cohort to aid clinicians in preoperative COM assessment. RESULTS: Internal and external data sets contained 1661 and 108 patients (3153 and 211 eligible ears), respectively. The 3D model exhibited decent performance with mean areas under the receiver operating characteristic curves of 0.96 (SD 0.01) and 0.93 (SD 0.01), and mean accuracies of 0.878 (SD 0.017) and 0.843 (SD 0.015), respectively, for detecting pathological ears on the 2 data sets. Similar outcomes were observed for cholesteatoma identification (mean area under the receiver operating characteristic curve 0.85, SD 0.03 and 0.83, SD 0.05; mean accuracies 0.783, SD 0.04 and 0.813, SD 0.033, respectively). The proposed 3D model achieved a commendable balance between performance and network size relative to alternative models. It significantly outperformed the 2D approach in detecting COM (P≤.05) and exhibited a substantial gain in identifying cholesteatoma (P<.001). The model also demonstrated superior diagnostic capabilities over resident fellows and the attending otologist (P<.05), rivaling all senior clinicians in both tasks. The generated heat maps properly highlighted the middle ear and mastoid regions, aligning with human knowledge in interpreting temporal bone CT. The resulting AI system achieved an accuracy of 81.8% in generating preoperative diagnoses for 121 patients and contributed to clinical decision-making in 90.1% cases. CONCLUSIONS: We present a 3D CNN model trained to detect pathological changes and identify cholesteatoma via temporal bone CT scans. In both tasks, this model significantly outperforms the baseline 2D approach, achieving levels comparable with or surpassing those of human experts. The model also exhibits decent generalizability and enhanced comprehensibility. This AI system facilitates automatic COM assessment and shows promising viability in real-world clinical settings. These findings underscore AI's potential as a valuable aid for clinicians in COM evaluation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000036300; https://www.chictr.org.cn/showprojEN.html?proj=58685.

Genome-wide association study indicates novel associations of annexin A13 to secretory and GAS2L2 with mucous otitis media.

To evaluate the genetics of chronic nonsuppurative otitis media (OM). We performed a genome-wide association study of 429,599 individuals included in the FinnGen study using three different case definitions: combined chronic nonsuppurative OM (7034 cases) (included serous and mucous chronic OM), mucous chronic OM (5953 cases), and secretory chronic OM (1689 cases). Individuals without otitis media were used as controls (417,745 controls). We used immunohistochemistry (IHC) of the murine middle ear to evaluate the expression of annexin A13. Four loci were significantly associated (p < 1.7 × 10-8) with nonsuppurative OM. Three out of the four association signals included missense variants in genes that may play a role in otitis media pathobiology. According to our subtype-specific analyses, one novel locus, located near ANXA13, was associated with secretory OM. Three loci (near TNFRSF13B, GAS2L2, and TBX1) were associated with mucous OM. Immunohistochemistry of murine middle ear samples revealed annexin A13 expression at the apical pole of the Eustachian tube epithelium as well as variable intensity of the secretory cells of the glandular structure in proximity to the Eustachian tube. We demonstrated that secretory and mucous OM have distinct and shared genetic associations. The association of GAS2L2 with ciliary epithelium function and the pathogenesis of dysfunctional mucosa in mucous OM is suggested. The abundant expression of annexin A13 in the Eustachian tube epithelium, along with its role in apical transport for the binding and transfer of phospholipids, indicates the role of annexin A13 and phospholipids in Eustachian tube dysfunction.

Comparison of the Impacts of Different Middle Ear Mucosal Conditions on Type I Tympanoplasty Outcomes.

BACKGROUND: This study aimed to explore the impacts of different middle-ear mucosal conditions on the outcomes of type I tympanoplasty. METHODS: A retrospective analysis of 164 patients with chronic otitis media was carried out. The patients were divided into 4 groups according to their mucosal condition. Preoperative hearing levels and air-bone gap (ABG) before and after surgery were compared via the Kruskal‒Wallis H test. The chi-squared test and Fisher's exact test were used to assess the postoperative complications and impact factors of functional success. RESULTS: Preoperatively, neither the air conduction nor bone conduction values differed significantly among groups with different mucosal conditions. All of the ABG closed dramatically after type I tympanoplasty (P < .05) regardless of the mucosal conditions. The functional success rates were lower when the intratympanic mucosa was moderately or severely edematous compared with mildly edematous or normal (P < .05). The disease course, perforation site, and perforation size, as well as the status of the opposite ear, were not related to the auditory functional outcome. The differences in postoperative reotorrhea and reperforation among the 4 groups were not statistically significant. CONCLUSION: Preoperative hearing levels were not affected by middle-ear mucosal conditions. The functional success rate was influenced by mucosal conditions, but hearing levels were significantly enhanced after surgical intervention regardless of the mucosal status. Postoperative complications were not related to the mucosal conditions. Thus, type I tympanoplasty is adoptable for mucosal abnormalities when pharmacotherapy cannot result in a healthy tympanum.

Otitis media sequelae and hearing in adolescence after administration of an 11-valent conjugate pneumococcal vaccine in infancy: a prospective cohort study with long-term follow-up of the ARIVAC trial.

BACKGROUND: Pneumococcal conjugate vaccines (PCVs) have been shown in randomised controlled trials and epidemiological studies to prevent acute otitis media caused by vaccine serotype pneumococci, although their role in preventing complications of acute otitis media is less clear. We hypothesised that the 11-valent PCV would reduce the long-term sequelae of acute otitis media, including moderate-to-severe ear disease and hearing loss. METHODS: This prospective cohort study, referred to as 11PCV study, included follow-up after 16-20 years of children previously enrolled in 2000-04, at age 6 weeks to 6 months, in the randomised, placebo-controlled, ARIVAC trial of 11-valent PCV for the prevention of radiographical pneumonia. The ARIVAC trial and this 11PCV study were conducted at six study centres in Bohol, Philippines. Ear disease was classified using video-otoscopy review and observations derived from the ear exam. The final classification of the worst ear disease was mild (ie, acute otitis media, otitis media with effusion, healed perforation, or tympanosclerosis), moderate (ie, dry perforation or adhesive otitis media), or severe (chronic suppurative otitis media). Hearing loss was assessed following a standard schema and classified according to the worst ear as mild (>15 to 30 dB puretone average) or moderate-to-profound (>30 dB pure tone average). We calculated the relative and absolute risk reduction in the primary outcome of moderate-to-severe ear disease and the secondary outcomes of mild or moderate-to-profound hearing loss in adolescents who previously received the 11-valent PCV compared with those who received placebo during infancy in ARIVAC. FINDINGS: Of the 15 593 children assessed for eligibility in ARIVAC, 12 194 were randomly assigned and 8926 were alive and could be located for enrolment in this 11PCV study between Sept 19, 2016, and Dec 13, 2019. 8321 (4188 in the vaccine group and 4133 in the placebo group) completed follow-up of the 11PCV study by March 30, 2020, and had sufficient data to classify ear disease and be included in the primary outcome analysis. The primary outcome of the absolute risk reduction in moderate-to-severe ear disease in the vaccine group (310 [7·4%] of 4188) versus those in the placebo group (356 [8·6%] of 4133) was 1·2% (95% CI 0·0-2·4; p=0·046) and the relative risk reduction was 14·1% (0·0 to 26·0). There were no differences in secondary outcomes of mild hearing loss or moderate-to-profound hearing loss between the vaccine and placebo groups. INTERPRETATION: The absolute risk reduction for moderate-to-severe ear disease in adolescence of 1·2% (12 per 1000 children) was almost three times higher than the 0·45% reduction (4·5 per 1000 children) in radiographical pneumonia in the first 2 years of life shown in ARIVAC. Administration of 11-valent PCV in infancy was associated with absolute and relative risk reductions in the sequelae of acute otitis media 16-20 years after the original ARIVAC trial. FUNDING: Bill & Melinda Gates Foundation.

Relationship between sleep position and otitis media in infants: The Japan environment and children's study.

OBJECTIVE: Otitis media is a disease that commonly occurs in infants. Various risk factors have been reported. Sleep position has been reported to be associated with various diseases. There is no report on the relationship between otitis media and sleep position. We examined the incidence of otitis media and sleep position in infants. METHODS: We used data from the Japan Environment Children's Study. We used multivariate logistic analysis to examine the relationship between sleep position and the incidence of otitis media in infants aged up to 6 months. In addition, we conducted a stratified analysis based on whether the child was able to turn over in bed at 6 months of age. RESULTS: The study population comprised 85,731 participants. The incidence of otitis media by sleep position was significantly higher when the infant was in the prone position compared to any other position (adjusted odds ratio, 1.206; 95 %CI, 1.038-1.401). Stratified analysis of turning showed that otitis media was more common in the prone position in all groups. CONCLUSION: In the current study, infants aged 6 months or younger who slept in the prone position were more likely to have otitis media. Sleep position interview and guidance on changing sleep position may be useful for the prevention of otitis media.

Children with previous COVID-19 infection are more likely to present with recurrent acute otitis media or tube otorrhea.

OBJECTIVE: Since December 2021, the number of children with COVID-19 infections has increased. Sequelae in children have not been well-described. Our goal was to determine if children with a history of COVID-19 infection (C19 group) were more likely to present with recurrent acute otitis media (rAOM) or post-ventilation tube otorrhea (VTO) than children who had no history of COVID-19 infection (NoC19 group). METHODS: Charts of consecutive children presenting at a pediatric otolaryngology clinic from March-May 2022 were reviewed. Demographics, COVID-19 test history, comorbidities, ultimate diagnosis, physical exam findings, and management plan were included. No children had a known COVID-19 infection at the time of visit. RESULTS: 524 children were included, 228 (43.5 %) girls and 296 (56.5 %) boys. Mean age was 5 years (95 % CI 4.6-5.4). 115 (21.9 %) had a history of COVID-19 infection. 104 (19.8 %) had a diagnosis of rAOM or VTO, 26.1 % (30/115) children in C19 and 18.1 % (74/409) children in NoC19 (Fisher's Exact p = .04, OR = 1.6). For children without ventilation tubes in place, 23.5 % (27/115) in C19 had rAOM versus 15.2 % (62/409) in NoC19 (p = .03, OR = 1.7). 18.3 % (21/115) of the C19 group had nasal congestion compared to 6.6 % (27/409) of the NoC19 group (p < .001, OR = 3.2). There was no difference in incidence of otitis media with effusion, tonsil/adenoid hypertrophy, sleep-disordered breathing, or epistaxis between the groups. CONCLUSION: Infection with COVID-19 may be associated with an increased risk of rAOM and VTO in children. This may affect healthcare utilization by increasing the need for pediatric and otolaryngologic care.

Assessing Chronic Ear Symptoms in Bone-Conduction Hearing Implant (BCHI) Patients Using the Chronic Otitis Media Benefit Inventory (COMBI) Score.

OBJECTIVE: This study aimed to determine improvement in health-related quality of life (HRQoL) using a validated disease-specific patient-reported outcome measure (PROM) questionnaire in patients undergoing bone-conduction hearing implant (BCHI) insertion. STUDY DESIGN: A mixed retrospective and prospective correlational study. SETTING: Single tertiary referral center in the United Kingdom. PATIENTS: All adult patients undergoing their first BCHI over 6 years (April 1, 2017, to March 3, 2023). MAIN OUTCOME MEASURES: The Chronic Otitis Media Benefit Inventory (COMBI) score (postintervention) and the Glasgow Health Status Inventory (GHSI) (pre-and post-BCHI questionnaire). RESULTS: Improvements were seen across all COMBI domains. The mean total COMBI score was 46.3 (standard deviation = 5.3). Although expected significant improvements were seen in hearing and social domains, there were also notable gains in ear symptoms and reduced medical intervention post-BCHI. There was a statistically significant improvement in all GHSI scores post-BCHI (median total difference 67.1, p < 0.0001). CONCLUSIONS: This study reports very favorable outcomes for BCHI patients using two different PROMs: COMBI and GHSI. Although these PROMs complement each other, they also offer different perspectives on the same cohort of patients, with COMBI providing a unique insight into specific ear symptoms. This is the first reported study using this complement of PROMS in BCHI patients and offers further evidence for the wide-reaching improvements BCHI can have for patients.

Paediatric post-grommets surgery review: Audiology-led clinic.

BACKGROUND: Otitis media (OM) has a high prevalence in childhood, and grommet insertion is the most common surgical treatment for OM. The public health system in Australia faces considerable strains, including high demand for Ear, Nose and Throat (ENT) specialists. Extending the scope of practice for audiologists to manage post-operative care for children receiving grommets has the potential to alleviate this burden. METHODS: This non-randomised, cross-sectional study investigated the efficacy and feasibility of an audiology-led clinic for managing paediatric patients after grommet insertion at a tertiary teaching hospital in Western Australia. Senior audiologists reviewed children at 6 weeks and 10 months post-operatively, escalating care to an ENT specialist if abnormalities were observed. Children with normal hearing and patent grommets were reviewed and discharged by the audiologist. RESULTS: A total of 93 children were included (mean age 5.18 ± 2.25 years, range 1.59-11.46 years). At the 6-week review, 72/93 (77 %) presented with in-situ grommets and normal hearing, while 21/93 (22 %) were escalated for immediate ENT care. At the 10-month review, 54/72 (75 %) were discharged without further ENT intervention, and 18/72 (25 %) required additional ENT investigation. CONCLUSION: This study demonstrated that an audiology-led follow-up clinic for post-grommet insertion is a viable option, providing efficient, high-quality care. Two-thirds of paediatric patients did not require ENT input or review post-operatively. The results support interdisciplinary models of care, which could help address challenges faced by overburdened ENT services.

Sigmoid sinus diverticulum without pulsatile tinnitus occurring concurrently with chronic otitis media mucosal type.

Sigmoid sinus diverticulum is a rare vascular anomaly often associated with pulsatile tinnitus. It can occur in cases of chronic otitis media squamous type (unsafe type) due to dehiscence of the sigmoid sinus plate caused by cholesteatoma. The presentation of which is that of pulsatile tinnitus. However, we present an unusual case of sigmoid sinus diverticulum occurring concurrently with chronic otitis media mucosal type (safe type) but in the absence of pulsatile tinnitus. This case report highlights the diagnostic challenges and management of this rare clinical scenario.

Artificial Intelligence and Pediatric Otolaryngology.

Artificial intelligence (AI) studies show how to program computers to simulate human intelligence and perform data interpretation, learning, and adaptive decision-making. Within pediatric otolaryngology, there is a growing body of evidence for the role of AI in diagnosis and triaging of acute otitis media and middle ear effusion, pediatric sleep disorders, and syndromic craniofacial anomalies. The use of automated machine learning with robotic devices intraoperatively is an evolving field of study, particularly in the realms of pediatric otologic surgery and computer-aided planning for maxillofacial reconstruction, and we will likely continue seeing novel applications of machine learning in otolaryngologic surgery.

Bezold's abscess, an uncommon complication of otitis media and cholesteatoma: a case report.

BACKGROUND: Mastoiditis frequently occurs in children as they are more susceptible to middle ear infections, but infrequently occurs in adults. A rare complication that results from mastoiditis and an obstructing cholesteatoma is a Bezold's abscess, of which there are less than 100 reported cases in literature to date. CASE PRESENTATION: Here, we present a case of a 72-year-old Caucasian man who has had no history of prior ear infections and was found to have a cholesteatoma and advanced acute coalescent mastoiditis complicated by a Bezold's abscess. CONCLUSIONS: Bezold's abscess is a rare entity infrequently encountered in the modern era, likely owing to more prompt treatment of otitis media. Cholesteatoma poses a great risk for both the development of otitis media and further progression to mastoiditis and its associated complications, such as Bezold's abscess. Knowledge of said abscess is crucial; without prompt recognition, further spread of infection can occur with vascular or mediastinal involvement.

Anti-inflammatory response to 1,8-Cineol and associated microbial communities in Otitis media patients.

Chronic Otitis Media (COM) is defined as long term inflammation and colonization with pathogenic bacteria due to a defect or retraction of the tympanic membrane. Surgical interventions are often augmented by antibiotic resistance development and therefore, off-label treatment using the natural drug 1,8-Cineol was carried out. All COM patients underwent antibiotic therapy and middle ear surgery and developed antibiotic resistances. Microbiological investigations from the auditory canal and stool samples were performed in correlation with the clinical course. Therapy of COM patients with 1,8-Cineol revealed a clear reduction of inflammatory microbes P. aeruginosa and Proteus mirabilis in ear samples as well as intestinal Prevotella copri, which was associated with an improved clinical outcome in certain individuals. The present off-label study revealed manifold anti-inflammatory effects of the natural monoterpene 1,8-Cineol in Otitis media patients. A better understanding of the underlying mechanisms will improve the current treatment options and possible forms of application of this natural drug.

Endoscopic and Microscopic Tympanoplasty for Adhesive Otitis Media: A Comparative Prospective Analysis.

BACKGROUND This prospective study aimed to compare outcomes and hearing improvement in 51 patients with adhesive otitis media following endoscopic and microscopic tympanoplasty. MATERIAL AND METHODS Between April 2021 and April 2022, 51 patients diagnosed with pars tensa retraction and hearing loss who underwent endoscopic and microscopic cartilage tympanoplasty were included in the study (endoscopic tympanoplasty group: 26 patients, microscopic tympanoplasty group: 25 patients). Pure-tone audiometric data (0.5, 1, 2, and 4 kHz), air-bone gap (ABG), and postoperative graft intake were compared. RESULTS Hearing gain in the ABG was significant in both groups (p<0.05). When the groups were compared for mean hearing gain in the ABG, the difference was significant (p<0.05). The postoperative ABG in the endoscopic group was significantly smaller than that in the microscopic group. When the postoperative air conduction threshold was evaluated, there was no significant difference between the 2 groups at 4 kHz, whereas a significant difference was observed in the endoscopic tympanoplasty group at 0.5, 1, and 2 kHz. Postoperative graft failure and otorrhea were not observed in any of the patients. CONCLUSIONS Pars tensa retractions and adhesive otitis media show comparable outcomes with both endoscopic and microscopic techniques. In endoscopic tympanoplasty, better visualization allows for better hearing outcomes. The endoscopic method, characterized by a wide field of view and a less invasive approach, enhances access to retraction limits.

Otology: Ear Infections.

Acute otitis media (AOM) is a common diagnosis in children who present with symptoms of otalgia, fever, or irritability and is confirmed by a bulging tympanic membrane or otorrhea on physical examination. It often is preceded by a viral infection, but the bacterial pathogens isolated most commonly are Streptococcus pneumonia, Haemophilus influenzae, and Moraxella catarrhalis. Watchful waiting may be appropriate in children 6 months or older with uncomplicated unilateral AOM. When antibiotics are indicated, amoxicillin is the first-line treatment in those without recent treatment with or allergy to this drug. Otitis media with effusion (OME) is fluid in the middle ear without symptoms of AOM and typically resolves within 3 months. Tympanostomy tube placement is the most common ambulatory surgery for children in the United States. It is used to ventilate the middle ear space and may be performed to treat recurrent AOM, persistent AOM, or chronic OME. Acute otitis externa is inflammation of the external ear canal, often due to infection. On examination, the ear canal is red and inflamed, with patients typically experiencing discomfort with manipulation of the affected ear. It is treated with a topical antibiotic with or without topical corticosteroid.

Testing the homogeneity of odds ratio across strata for combined bilateral and unilateral data.

Bilateral and unilateral combined data are commonly involved in clinical trials or observational studies designed to test the treatment effectiveness on paired organs or bodily parts within individual subjects. It is essential to examine if the treatment effect is consistent across different subgroups such as age, gender, or disease severity for understanding how the treatment works for various patient populations. In this paper, we propose three large-sample homogeneity tests of odds ratio in the stratified randomization setting using correlated combined data. Our simulation results show that the score test exhibits robust empirical type I error control and demonstrates strong power characteristics compared to other methods proposed. We apply the proposed tests to real-world datasets of acute otitis media and myopia to illustrate their practical application and utility.

Determining the Minimal Clinically Important Difference (MCID) and Responsiveness of the Chinese Version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn): A Prospective Multicenter Study.

OBJECTIVES: This study aimed to establish the minimal clinically important difference (MCID) and assess the responsiveness of the Chinese version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn). STUDY DESIGN: Prospective multicenter study. SETTING: Four Chinese tertiary referral centers admitting patients nationwide. PATIENTS: 230 adult patients with chronic otitis media (COM) undergoing tympanoplasty. INTERVENTION: Patients were required to complete the ZCMEI-21-Chn to measure health-related quality of life both preoperatively and postoperatively. An anchor-based method was used to determine the MCID of the derivative cohort by including the Global Rating of Change Questionnaire as an anchor. The generalizability and consistency with functional outcomes of the MCID estimates were externally examined in a validation cohort using a receiver operating characteristic curve analysis. RESULTS: A total of 161 and 69 patients were included in the derivative and validation cohort. The mean preoperative and postoperative ZCMEI-21-Chn total scores were 28.4 (standard deviation [SD] 14.5) and 17.5 (SD 12.6). The mean change in ZCMEI-21-Chn score was 10.9 (SD 14.3, p < 0.001). The MCIDs of the ZCMEI-21-Chn for improvement and deterioration were estimated at 13 (SD 13.0) and -7 (SD 12.9), accordingly. For patients who have reported an improved health-related quality of life, a cutoff value of 15.6 dB HL for elevation of the air-conducted hearing threshold was noticed. However, change of clinical importance judged according to MCID and Japan Otological Society criteria disagreed with each other, notably with a Cohen's kappa ( κ ) of 0.14 ( p = 0.21) in the validation cohort. CONCLUSION: This study is the first to establish the MCID of a COM-specific questionnaire in Chinese. For the COM population undergoing surgical intervention, MCID values of 13 for improvement and -7 for deterioration are recommended. The results were externally validated to be generalizable to nationwide usage, yet distinguishable from the audiological criteria. The availability of the MCID greatly adds to the clinical utility of the ZCMEI-21-Chn by enabling a clinically meaningful interpretation of its score changes.