Comparison of Disease-Specific, Generic, and Hearing-Specific Instruments Assessing Health-Related Quality of Life in Patients Undergoing Middle Ear Surgery for Chronic Otitis Media: A Prospective Correlational Study.

OBJECTIVE: This study aimed to determine the responsiveness of three instruments (disease-specific, generic, and hearing-specific) assessing health-related quality of life (HRQoL) in adult patients undergoing surgery for chronic otitis media (COM). STUDY DESIGN: Prospective correlational study. SETTING: Two otology referral centers in England, United Kingdom. PATIENTS: Consecutive adult patients undergoing middle ear surgery for COM. MAIN OUTCOME MEASURES: HRQoL assessment and audiometry were performed preoperatively and 12 months after surgery. HRQoL was assessed using disease-specific (Chronic Otitis Media Questionnaire-12 [COMQ-12]), generic (Euro-Qol-5D-5L), and hearing-specific (Hearing Handicap Inventory for Adults [HHIA]) instruments. RESULTS: A total of 52 patients (mean [standard deviation {SD}] age, 47.3 [18.3] yr) were included, with 42 patients completing both preoperative and postoperative COMQ-12 forms. COMQ-12 and HHIA total scores significantly improved after surgery (COMQ-12: mean [SD], 28.3 [11.6] versus 14.8 [10.6]; p < 0.001; HHIA: 42.9 (28.4) versus 32.6 (27.5); p = 0.012). General HRQoL measured with the Euro-Qol-5D-5L was unaffected by surgery ( p > 0.05). The standardized response means for the COMQ-12 and HHIA total scores were 1.21 and 0.44, respectively. Postoperative air conduction thresholds were moderately correlated with the postoperative COMQ-12 ( r = 0.46, p = 0.005) and HHIA ( r = 0.41, p = 0.012) total scores. CONCLUSIONS: Middle ear surgery significantly improved both disease-specific and hearing-specific HRQoL, whereas general HRQoL did not change. Only the COMQ-12 is highly responsive to surgical intervention. This study supports the use of the COMQ-12 to monitor patient-reported outcomes in both research and routine clinical settings.

Presentation of dizziness in individuals with chronic otitis media: data from the multinational collaborative COMQ-12 study.

PURPOSE: In chronic otitis media (COM), disease chronicity and severity of middle ear inflammation may influence the development of inner ear deficits, increasing the risk of vestibular impairment. This secondary analysis of the multinational collaborative Chronic Otitis Media Questionnaire-12 (COMQ-12) dataset sought to determine the prevalence of vestibular symptoms in patients with COM and identify associated disease-related characteristics. METHODS: Adult patients with a diagnosis of COM in outpatient settings at nine otology referral centers across eight countries were included. We investigated the presence of vestibular symptoms (dizziness and/or disequilibrium) using participant responses to item 6 of a native version of the COMQ-12. Audiometric data and otoscopic assessment were also recorded. RESULTS: This analysis included 477 participants suffering from COM, with 56.2% (n = 268) reporting at least mild inconvenience related to dizziness or disequilibrium. There was a significant association between air conduction thresholds in the worse hearing ear and presence of dizziness [adjusted odds ratio (AOR), 1.01; 95% CI 1.00-1.02; p = 0.0177]. Study participants in European countries (AOR 1.53; 95% CI 1.03-2.28; p = 0.0344) and Colombia (AOR 2.48; 95% CI 1.25-4.92; p = 0.0096) were more likely to report dizziness than participants in Asian countries. However, ear discharge and cholesteatoma showed no association with dizziness in the adjusted analyses. CONCLUSION: Vestibular symptoms contribute to burden of disease in patients with COM and associates with hearing disability in the worse hearing ear. Geographical variation in presentation of dizziness may reflect financial barriers to treatment or cultural differences in how patients reflect on their health state.

Impact of Hearing Disability and Ear Discharge on Quality-of-Life in Patients with Chronic Otitis Media: Data from the Multinational Collaborative COMQ-12 Study.

OBJECTIVE: This study aimed to assess how two disease-related factors, hearing disability and ear discharge, affect health-related quality-of-life (HRQoL) in patients with chronic otitis media (COM). STUDY DESIGN: Multinational prospective cohort study. SETTING: Nine otology referral centers in eight countries. PATIENTS: Adult patients suffering from COM. MAIN OUTCOME MEASURES: Hearing disability and ear discharge were assessed by audiometry (Department of Health and Social Security formula) and otoscopy, respectively. Participants completed a native version of the Chronic Otitis Media Questionnaire-12 (COMQ-12). We determined how the two disease-related factors affect HRQoL by performing two separate analyses: (1) using a 6-item score combining responses to COMQ-12 items independent of hearing loss and ear discharge and (2) using item 12 alone as a proxy for global HRQoL. RESULTS: This study included 478 participants suffering from COM. There was a significant association between HRQoL and hearing disability in the adjusted analysis. For every unit increase in the Department of Health and Social Security average hearing threshold (1) there was an increase of 0.06 (95% CI [0.007, 0.121], p = 0.0282) in the 6-item score and (2) the adjusted odds of having a higher item 12 score was 1.03 (95% CI [1.01, 1.04], p = 0.0004). There was no association between the presence of ear discharge and HRQoL in both COMQ-12 score analyses. CONCLUSIONS: Knowledge of disease-related factors that influence HRQoL will aid interpretation of patient-reported measures for COM. Patients with a greater degree of hearing impairment appear to have poorer HRQoL, which is not exacerbated by the presence of ear discharge. The magnitude of postoperative hearing improvement rather than the attainment of a dry ear may be a better indicator of surgical success from the patient's perspective.

Secondary Obliteration Surgery for Troublesome Mastoid Cavities: A Prospective Series of 228 Pediatric and Adult Cases.

OBJECTIVE: To present the results of a 15-year longitudinal study in a pediatric and adult population with secondary obliteration of troublesome mastoid cavities. STUDY DESIGN: Prospective longitudinal study. PATIENTS: Children (≤16 yrs) and adults who had obliteration surgery (228 ears) between 2000 and 2017. INTERVENTIONS: Therapeutic. SETTING: Tertiary referral center. MAIN OUTCOME MEASURES: 1) Incidence of recurrent or residual cholesteatoma; 2) creation of a dry ear at 5 years postsurgery; 3) postoperative complications; 4) waterproof status of ear; 5) number of subsequent ear surgery required. RESULTS: Thirty-one pediatric and 197 adult cases contributed to the study. At 5 years 11 of 98 (10.8%) had been lost to follow-up. Using Kaplan-Meier survival analysis, the residual rate after 5 years was 4.2% (95% CI: 0.3%-8.2%) and the recurrence rate was 1% (95% CI: 0.0%-3.0%). Of the 223 ears available for assessment, 209 (93.7%) achieved a dry state, 6 (2.7%) had intermittent discharge, 6 (2.7%) had flap necrosis requiring flap trimming, and 1 (0.4%) developed meatal stenosis. Using a cross-sectional analysis at 12 months of follow-up, the otorrhea risk was 19.2% and the risk of definitive waterproofing was 10.9%. There was a reoperation risk of 10% within 5 years which included second-stage ossiculoplasty. CONCLUSIONS: Secondary mastoid obliteration is a safe and useful technique in treating the troublesome mastoid cavity in both children and adults. It is associated with a low cholesteatoma recidivism rate and high rate of a trouble-free ear in the long term.

Multinational Appraisal of the Chronic Otitis Media Questionnaire 12 (COMQ-12).

OBJECTIVES: The Chronic Otitis Media Questionnaire-12 (COMQ-12) assesses patient-reported health-related quality of life. A multinational collaborative project was performed to translate and appraise the psychometric properties of the COMQ-12 across Europe, Asia, and South America. METHODS: Eight otology units from seven countries (China, Colombia, France, Italy, Japan, Korea, Turkey) created native versions of the COMQ-12 by the process of translation and back-translation. Questionnaire reliability was assessed on the basis of internal consistency by calculating Cronbach's coefficient alpha. Exploratory factor analysis was performed to identify underlying correlations between individual questionnaire items. RESULTS: This study included 478 participants from 8 countries. Calculated values for Cronbach's coefficient alpha were between 0.71 and 0.90. Exploratory factor analysis allowed the identification of three dominant factors, the primary factor (related to hearing problems) explaining 42% of the total variance, the secondary factor (related to daily activities) explaining 30% of the variance, and the third factor (related to acute disease activity) explaining 28% of the variance. CONCLUSIONS: This is a large study of patients with chronic otitis media, from centers from within many different countries spanning Europe, Asia, and South America. This study supports the use of the COMQ-12 within the individual countries where it was tested.

Validation of a Portuguese version of the health-related quality of life measure for active chronic otitis media (COMQ-12) / Validation of a Portuguese version of the health-related quality of life measure for active chronic otitis media (COMQ-12)

Abstract Introduction: Measuring the impact on quality of life, especially after the beginning of the treatment, is becoming increasingly important in healthcare. Objective: The aim of this study was to translate the Chronic Otitis Media Questionnaire-12 (COMQ-12) into Portuguese language and validate this version in a group of patients with chronic otitis media. Methods: The Portuguese version of COMQ-12 was obtained by translation and back translation. Portuguese speaking patients with a history of active chronic otitis media were asked to complete the COMQ-12 Portuguese version. Cronbach's α coefficient was calculated for an estimation of the internal consistency of the questionnaire. Results: A total of 100 patients were included in the study; 49 women and 51 men, with a mean age of 39 years (range 12-77 years, median 40 years). The average COMQ-12 score was 29, out of a maximum score of 60. Cronbach's α result for the Portuguese version of the COMQ-12 was 0.85, indicating a high internal consistency. The participants presented with different forms of chronic otitis media, and almost all domains of the COMQ-12 questionnaire were able to differentiate between patients with healed chronic otitis media and patients with cholesteatoma or wet tympanic membrane perforation. Showing that patients with healed chronic otitis media have a better quality of life, measured by the COMQ-12, is a first step to guarantee the questionnaire's validity. The next step will consist on routinely using the questionnaire in patients undergoing surgery for chronic otitis media in order to evaluate their quality of life after treatment. Conclusion: The COMQ-12 Portuguese version showed high reliability, and may be used as an assessment of quality of life in patients with chronic otitis media

Resumo: Introdução: Medir o impacto na qualidade de vida, especialmente após o início do tratamento dos pacientes, está se tornando cada vez mais importante nos cuidados da saúde. Objetivo: O objetivo deste estudo foi traduzir o Questionário de Otite Média Crônica-12 (COMQ-12) para a língua portuguesa e validar essa versão em um grupo de pacientes com Otite Média Crônica. Método: A versão em Língua Portuguesa do COMQ-12 foi obtida através de tradução e posterior retrotradução. Pacientes nativos da língua portuguesa com histórico de OMC ativa foram convidados a completar o COMQ-12 em Português. O coeficiente α de Cronbach foi calculado para estimar a consistência interna do questionário. Resultados: Um total de 100 pacientes foram incluídos no estudo; 49 eram mulheres e 51 eram homens, com média de idade de 39 anos (variação: 12 a 77 anos, mediana de 40 anos). O escore médio do COMQ-12 foi 29, de um escore máximo de 60. O resultado do coeficiente α de Cronbach para a versão em português do COMQ-12 foi de 0,85, indicando que sua consistência interna era alta. Os participantes apresentavam diferentes formas de otite média crônica e quase todos os domínios do questionário COMQ-12 foram capazes de diferenciar entre pacientes com otite média crônica curada e pacientes com colesteatoma ou perfuração úmida de membrana timpânica. Demonstrar que pacientes com otite média crônica curada apresentam uma melhor qualidade de vida, medida pelo COMQ-12 é o primeiro passo para garantir a validade do questionário. O próximo passo será utilizá-lo rotineiramente em pacientes submetidos à cirurgia para otite média crônica e avaliar a qualidade de vida após o tratamento. Conclusão: A versão em português do questionário COMQ-12 mostrou alta confiabilidade e pode ser utilizada como questionário de medida de qualidade de vida em pacientes com otite média crônica.

Validation of a Portuguese version of the health-related quality of life measure for active chronic otitis media (COMQ-12).

INTRODUCTION: Measuring the impact on quality of life, especially after the beginning of the treatment, is becoming increasingly important in healthcare. OBJECTIVE: The aim of this study was to translate the Chronic Otitis Media Questionnaire-12 (COMQ-12) into Portuguese language and validate this version in a group of patients with chronic otitis media. METHODS: The Portuguese version of COMQ-12 was obtained by translation and back translation. Portuguese speaking patients with a history of active chronic otitis media were asked to complete the COMQ-12 Portuguese version. Cronbach's α coefficient was calculated for an estimation of the internal consistency of the questionnaire. RESULTS: A total of 100 patients were included in the study; 49 women and 51 men, with a mean age of 39 years (range 12-77 years, median 40 years). The average COMQ-12 score was 29, out of a maximum score of 60. Cronbach's α result for the Portuguese version of the COMQ-12 was 0.85, indicating a high internal consistency. The participants presented with different forms of chronic otitis media, and almost all domains of the COMQ-12 questionnaire were able to differentiate between patients with healed chronic otitis media and patients with cholesteatoma or wet tympanic membrane perforation. Showing that patients with healed chronic otitis media have a better quality of life, measured by the COMQ-12, is a first step to guarantee the questionnaire's validity. The next step will consist on routinely using the questionnaire in patients undergoing surgery for chronic otitis media in order to evaluate their quality of life after treatment. CONCLUSION: The COMQ-12 Portuguese version showed high reliability, and may be used as an assessment of quality of life in patients with chronic otitis media.

A systematic review of patient-reported outcome measures for chronic suppurative otitis media.

OBJECTIVE: The purpose of this review was to systematically appraise the world literature to identify existing patient-reported outcome measures (PROMs) for the assessment of outcomes in patients with chronic suppurative otitis media, to verify the diversity of the individual questionnaire items, to report the methods employed to evaluate the questionnaires, and to identify areas for development in the future. DATA SOURCES: Embase (January 1980-November 2014), MEDLINE (January 1946-November 2014), Cumulative Index to Nursing and Allied Health Literature (January 1981-November 2014), and PsycINFO (January 1806-November 2014). REVIEW METHODS: A systematic literature search was independently undertaken by the two authors according to predefined inclusion and exclusion criteria. RESULTS: Nine original articles were identified, which overall outlined the evaluation of four different questionnaires. CONCLUSIONS: This systematic appraisal of the world literature has identified four PROM questionnaires for use in patients with chronic suppurative otitis media. All four questionnaires evaluate reliability and validity using different psychometric methods. The Chronic Ear Survey questionnaire has been most broadly evaluated and disseminated. All four questionnaires assess static health status. There are many advantages to developing a dynamic one-hit questionnaire to assess the health status of patients having undergone an intervention for chronic suppurative otitis media. LEVEL OF EVIDENCE: NA Laryngoscope, 126:1458-1463, 2016.

Pediatric cholesteatoma surgery using a single-staged canal wall down approach: results of a 5-year longitudinal study.

OBJECTIVE: To present the results of a 5-year longitudinal study in a pediatric population undergoing surgery for extensive cholesteatoma using a canal wall down (CWD) approach with obliteration. STUDY DESIGN: Prospective longitudinal study. PATIENTS: Children (<16 years) undergoing surgery for cholesteatoma (58 ears) between 1999 and 2013. INTERVENTIONS: Therapeutic. SETTING: District general hospital. MAIN OUTCOME MEASURES: (1) Residual, recurrence, and recidivist cholesteatoma rates at 5 years post-surgery; (2) postoperative hearing; (3) postoperative waterproofing of the ear; (4) number of subsequent ear surgery required. RESULTS: Fifty-five children (58 ears) contributed to the study. At 5 years, 16 of 58 (27.6%) had been lost to follow-up. Using Kaplan-Meier survival analysis, the residual rate after 5 years was 9.9% (95% CI: 3.8-24.4%), representing four residual cholesteatomas, and there were no recurrences detected. Using a cross-sectional analysis at 12 months of follow-up, the otorrhea risk was 0% and the risk of definitive waterproofing was 94.8%. There was a re-operation risk of 17.2% within 5 years which included second-stage ossiculoplasty. Regarding hearing, of the data available (n = 16), 10 children (62.5%) maintained their hearing (change between -10 and =10 dB), 2 (12.5%) had hearing gain (>10 dB), and 4 children (25%) had hearing reduction at 12 months postoperation. Four of 16 children (25%) had a postoperative hearing level of 30 dB or lower. CONCLUSION: The use of a CWD approach with obliteration of the mastoid cavity to surgically treat extensive cholesteatoma in children results in a low recurrence rate and high rate of a trouble-free ear in the long term.

Neurofibroma of the pinna.

Neurofibromas are relatively common lesions of the nervous system, but only a few cases involving the pinna have been reported. The emphasis in most of these reports was on the cosmetic deformity; functional impairment in the form of hearing loss has been mentioned in only a few reports. We report a case of pinnal neurofibroma in which the primary complaint was otitis externa; hearing loss and cosmetic deformity were also present. Surgical excision resulted in an excellent functional and cosmetic outcome. This case demonstrates that neurofibroma of the pinna in the area of the external meatus can produce functional as well as cosmetic impairment, and surgery can produce a very satisfactory result.

The Yung percutaneous mastoid vent: results of a multicenter trial.

OBJECTIVE: The primary goal of the study was to find out whether the Yung vent would remain patent long-term. The secondary goal was to find out whether mastoid ventilation could overcome permanent ventilation disorder within the middle ear. STUDY DESIGN: The study was an open prospective investigation. SETTING: The study was a multicenter study involving three tertiary referral centers. PATIENTS: Twenty-three subjects older than 12 years were included. The inclusion criteria were complete atelectasis, failed tympanoplasty because of persistent eustachian tube dysfunction, and persistent otitis media with effusion in spite of repeated ventilation tube insertion. INTERVENTION: Tympanoplasty with insertion of the Yung percutaneous mastoid vent. MAIN OUTCOME MEASURES: Patency of the vent, adverse effects, patient acceptance, hearing results, and appearance of the tympanic membrane were assessed every 3 months up to 18 months postoperatively. RESULTS: : At 18 months, 20 of 23 vents were still patent. Overall, there had been no unacceptable adverse effect on any patient. Eighteen of 23 ears had improved hearing. The tympanic membrane had returned from a collapsed state to near normal in 13 of 17 completely atelectatic ears. There were five patients who had no benefit from the vent because of blockage within the epitympanum or middle ear effusion. CONCLUSION: The Yung percutaneous mastoid vent can maintain long-term patency. It is effective in the treatment of complete atelectasis as an adjunct to tympanoplasty.

Concomitant nasal procedures in endoscopic dacryocystorhinostomy.

Dacryocystorhinostomy (DCR) is the preferred treatment for lacrimal duct blockage. Endoscopic DCR has been practised increasingly in recent years as it avoids a facial scar and can be performed as a day procedure. Recent improvements in endonasal surgical technique led to success rates of up to 90 per cent. However, the endonasal approach often requires septal or turbinate surgery to optimze access to the lacrimal area. The incidence of concomitant procedures was investigated in 256 patients undergoing endonasal nonlaser DCR. In this study 55 out of 256 patients (21.5 per cent) required additional endonasal procedures to improve access to the lacrimal area. It is therefore advisable that otolaryngologists are involved in this procedure.

Sphenoid sinus mucocele: late complication of Sphenoidotomy.

Sphenoid sinus mucocele is an infrequent but well-recognized entity in sinus pathology. The symptoms produced by it are related to the anatomical surroundings of the sphenoid sinus. We describe a case of sphenoid sinus mucocele presenting with ipsilateral oculomotor nerve palsy 10 years after endoscopic sphenoidotomy. The patient underwent emergency endoscopic decompression of the sphenoid sinus with marsupialization of the mucocele, resulting in immediate remission of his symptoms. We conclude that the otorhinolaryngologist should be aware of such a potential complication when counselling the patient prior to endoscopic sinus surgery.

Nasal polyposis in children with cystic fibrosis: a long-term follow-up study.

The incidence of nasal polyposis among children 5 to 18 years of age with cystic fibrosis (CF) was investigated with a systematic examination of all children on the local CF register. Out of 23 children with CF, 13 had endoscopic evidence of nasal polyposis. Four children had grade 2 polyposis, and 9 children had grade 3 polyposis. Complete opacity of the maxillary sinus was identified on a computed tomographic sinus scan in all but 2 of the children. Only 1 child had a developed frontal sinus. Between 1989 and 2000, 12 children underwent radical endoscopic sinus surgery for their nasal polyposis. There was good postoperative improvement in all of the children; however, 7 eventually required revision surgery because of recurrence of the nasal polyps. The median interval between repeated sinus surgeries was 4 years (range, 18 months to more than 6 years). This information can help in the counseling of parents when sinus surgery is considered for children with CF.