Quality of Life Outcomes After Pediatric Otitis Media Surgery: A Systematic Review and Meta-Analysis.

OBJECTIVES: Systematically review of literature characterizing health-related quality of life (HRQoL) impact of surgery in pediatric otitis media (OM) patients, and meta-analysis of studies using the OM-6 questionnaire. DATA SOURCES: Pubmed, EMBASE, Cochrane Library, Scopus. REVIEW METHODS: A systematic review of literature of studies evaluating HRQoL outcomes for OM patients managed by surgery. Two investigators independently reviewed abstracts and full-length articles. Risk of bias was assessed using the MINORS criteria and Cochrane Risk of Bias 2 tool. RESULTS: The search yielded 1272 studies, 50 underwent full-text review and 23 met inclusion criteria. Non-randomized studies were of moderate to good quality, while randomized trials had a high risk of bias. Age ranged from 6 months to 15 years. Race and socioeconomic factors were inconsistently reported. There were 11 HRQoL outcome measure instruments of which four were disease-specific. Eleven studies used OM-6 and nine were included in the meta-analysis. Pooled analysis of five studies showed a mean OM-6 change of 1.79 (95% CI: 1.53-2.06; 95% PI: 0.92-2.67; I2 = 68%) 4-6 weeks after surgery; a mean change of 1.87 (95% CI: 1.15-2.58; 98%) after 6 months across two studies; and a mean change of 1.64 (1.02 to 2.27; -6.35 to 9.64; 98%) after 9-13 months across three studies. CONCLUSIONS: There is no consistency in HRQoL instruments used to evaluate pediatric OM surgery outcomes in current literature with few RCTs. Meta-analysis showed a clinically significant large improvement in HRQoL 4-6 weeks after tympanostomy tube placement. LEVEL OF EVIDENCE: N/A Laryngoscope, 134:4176-4185, 2024.

Symptoms of depression, anxiety and stress in patients with chronic otitis media.

PURPOSE: Persistent symptoms of chronic otitis media cause limitations in daily routine and social interactions, influencing significantly patients' quality of life and mental health. The purpose of the study was to assess the intensity depression, anxiety and stress symptoms in patients with chronic otitis media and to examine if patient demographic data, characteristics and reported symptoms of otitis influence reported depression, anxiety and stress symptoms. MATERIAL AND METHODS: The study included 316 adult patients diagnosed with unilateral or bilateral chronic otitis media with or without cholesteatoma. Patients underwent a complete otological, audiological and radiological assessment. Chronic otitis media questionnaire 12 (COMQ-12) was used to assess the impact of COM and Depression Anxiety Stress Scale 21 (DASS-21) was used for depression, anxiety and stress assessment. RESULTS: Some level of anxiety and stress were detected in 70.57% 49.37% of the patients, respectively. 13.29% of the patients had scores indicating depression disorder. The mean value of the COMQ-12 questionnaire for this group of patients was 26.24 (SD±11.47) More intense symptoms of COM were significantly associated (p<0.05) with higher scores on DASS-21 subscales. Multivariate logistic regression analysis indicated that significant positive predictors of higher anxiety scores were pure tone average (PTA) on better and worse hearing ear (p<0.05). Drainage from the ear, hearing problems at home and tinnitus were significant positive predictors of a higher DASS-depression score. (p<0.05). CONCLUSION: The study confirmed positive correlation between reported level of anxiety, depression and stress, severity of COM symptoms and quality of life. Level of hearing on the better and worse hearing ear were significant positive predictors of anxiety and stress in patients with COM.

Measuring health-related quality of life in chronic otitis media in a Chinese population: cultural adaption and validation of the Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn).

BACKGROUND: The demand for assessing health-related quality of life (HRQoL) in chronic otitis media (COM) is increasing globally. The currently available Chinese-language patient-reported outcome measurement (PROM) specific for COM includes merely a limited range of related symptoms and dimensions. Hence, in this study, we aim to translate, culturally adapt, and validate the Zurich Chronic Middle Ear Inventory (ZCMEI-21) in Chinese, to enable a comprehensive evaluation of the patients' subjective health outcome in COM. METHODS: We sampled and surveyed 223 COM patients at three tertiary referral centers in China, using the Chinese translation of ZCMEI-21 (ZCMEI-21-Chn) and the EQ-5D questionnaire, a generic measure of HRQoL. Confirmatory factor analysis (CFA) was performed to investigate the structural model fit to the dataset. Cronbach's α and test-retest reliability coefficient were calculated to establish reliability, and correlation was tested between ZCMEI-Chn scores and EQ-5D scores for convergent validity. RESULTS: A total of 208 adult patients with COM were included, with a mean age of 46 years (SD 14 years) and a male proportion of 41% (85/208). A modified bifactor model with ωH of 0.65 and ECV of 0.47 was found to fit the scale scores, indicating fair general factor saturation and multidimensionality of the instrument. ZCMEI-21-Chn demonstrated good reliability (Cronbach's α = 0.88, test-retest reliability = 0.88). The total scores of ZCMEI-21-Chn had a moderate correlation with a question directly addressing HRQoL (r = 0.40, p < 0.001), EQ-5D descriptive system score (r = 0.57, p < 0.001), and EQ-5D visual analogous scale (r = 0.30, p < 0.001). CONCLUSIONS: The ZCMEI-21-Chn is valid, reliable and culturally adapted to Chinese adult patients with COM. This study offers clinicians an efficient and comprehensive instrument to quantify COM patients' self-reported health outcomes, which could facilitate the standardization of HRQoL data aggregation in COM on a global scale.

Health Related Quality of Life after the Bony Obliteration Tympanoplasty for COM with Cholesteatoma using the COMQ12 - A Disease Specific PROM.

OBJECTIVES: This study aimed to investigate the effect of canal wall up with bony obliteration tympanoplasty (CWU-BOT) on the health-related quality of life (HRQOL) in patients with chronic otitis media with cholesteatoma by using the chronic otitis media questionnaire 12 (COMQ-12). MATERIALS AND METHODS: This study is a retrospective analysis of the COMQ-12 of 26 patients who completed the COMQ-12 before and after a CWU-BOT with eradication of cholesteatoma followed by obliteration of the mastoid and paratympanic space with bone chips and bone pâté and reconstruction of the tympanic membrane and ossicular chain. RESULTS: All patients were operated upon in our institute between 2014 and 2017. The median score of the 12 questions was preoperatively and postoperatively calculated, and then compared. A large effect was observed in the total score and the questions about running ear, discharge, and visits to the general practitioner. A medium positive size effect was observed in the questions about hearing in noisy surroundings, discomfort, dizziness, tinnitus, medication use, and the mental aspect of the patient. In the questions about the hearing at home and quality of life and impact on work, we noted a small positive size effect. In 50% of patients, the HRQOL became normal; the remaining 50% improved to a level very close to normal. CONCLUSION: Canal wall up with bony obliteration tympanoplasty (CWU-BOT) showed a clear decrease in the severity of the symptoms, life and work impact, and health care after surgery.

Cross-cultural adaption and validation of the Chronic Otitis Media Questionnaire 12 (COMQ-12) in the Italian language.

PURPOSE: The evaluation of Health-Related Quality of Life (HRQoL) in patients with chronic otitis media COM has gained attention over the past years and several questionnaires have been developed to evaluate it in affected patients. The Chronic Otitis Media Questionnaire 12 (COMQ-12) is a widely used disease-specific tool that evaluates the severity of symptoms, the specific impact on work and lifestyle, the effects on the health service, and general impact of the disease in patients with COM. The COMQ-12 questionnaire has been translated and validated into different languages; however, an Italian version is not yet available. The aim of this original study was to translate the COMQ-12 questionnaire into the Italian language and validate this new Italian language version in Italian-speaking patients with COM. METHODS: The COMQ-12 was translated into Italian (COMQ-12-It) following international guidelines. Validation was performed comparing and correlating COMQ-12-It with (1) a question that addresses HRQoL, and (2) the results of a generic questionnaire assessing HRQoL, namely the EQ-5D-5L questionnaire. RESULTS: Forty-eight patients with COM were included in the study. Cronbach's alpha was 0.80 indicating a high reliability. There was a strong positive correlation between the question that directly addressed HRQoL and total score (correlation coefficient = 0.62), while the regression analysis between total score of COMQ-12-It and EQ-5D-5L showed a positive relation but only a weak positive correlation (correlation coefficient 0.36). CONCLUSIONS: Our study showed evidence that the Italian version of the COMQ-12 questionnaire is a valid and reliable tool to evaluate HRQoL in Italian-speaking patients with COM.

Validity and Test-Retest Reliability of the Dutch Version of the Chronic Otitis Media Benefit Inventory.

OBJECTIVES: We aimed to test the validity and test-retest reliability of the Dutch translation of the Chronic Otitis Media Benefit Inventory (COMBI) questionnaire. MATERIALS AND METHODS: In total, 30 chronic otitis media (COM) patients with a previous ear surgery completed the questionnaire; 30 patients with a negative medical history of COM complaints and with previous non-otologic surgery as the control group completed the questionnaire. For estimating the test-retest reliability, patients of the COM group completed the questionnaire twice; the scores were compared to those of the control group to test the validity. RESULTS: The overall COMBI score ranged as 32-60 in the patient test group, 32-60 in the patient retest group, and 35-40 in the control group. A mean (standard deviation) score of 43.87 (6.81) in the patient test group, 44.4 (6.83) in the patient retest group, and 36.7 (1.29) in the control group was noted. Post-intervention, the COM patients had a significantly higher absolute COMBI score compared to the control group. The diagnostic accuracy was investigated, and a cut-off score of 38.5 was found to have a high sensitivity and specificity in distinguishing a significant positive change from an insignificant change after the intervention. The average-measures intra-class correlation coefficient for absolute agreement (ICCAA) was 0.985 (95% confidence interval: 0.969-0.993), indicating an excellent test-retest reliability in the control group. CONCLUSION: The Dutch version of the COMBI questionnaire has a good validity, diagnostic accuracy, and test-retest reliability.

English translation and validation of the Zurich chronic middle ear inventory (ZCMEI-21-E) assessing quality of life in chronic otitis media: A prospective international multicentre study.

OBJECTIVES: To translate and validate the Zurich Chronic Middle Ear Inventory (ZCMEI-21) for the English language in order to provide an English instrument to assess health-related quality of life in chronic otitis media (COM). DESIGN: Pilot translation study including cognitive debriefings, prospective multicentre cross-sectional psychometric validation study. SETTING: Four tertiary referral centres in three different English-speaking countries (UK, USA and Australia). PARTICIPANTS: Adult patients suffering from COM. MAIN OUTCOME MEASURES: The English translation of the ZCMEI-21 (ZCMEI-21-E) and the five-level version of the EQ-5D questionnaire. The EQ-5D, which constitutes a generic measure of health-related quality of life, consists of a descriptive system score and a visual analogue scale. Statistical outcomes included single-item descriptive statistics, internal consistency (Cronbach's α) as an indicator of reliability, as well as construct validity. RESULTS: A total of 124 patients suffering from COM were included. The mean age was 50.1 years (SD 16.9 years), and 72 (58.1%) were males. The Cronbach's α of the ZCMEI-21-E was 0.91, suggesting an excellent internal consistency. The Spearman's correlation coefficient of the ZCMEI-21-E total score was 0.55 (P < 0.0001) for convergent construct validity with EQ-5D descriptive system score and 0.57 (P < 0.0001) with the EQ-5D visual analogue scale. CONCLUSIONS: The ZCMEI-21-E is a new validated questionnaire that provides clinicians with a short, comprehensive and reliable instrument to quantify health-related quality of life in patients suffering from COM. The ZCMEI-21-E may be of use in clinical routine as well as in outcome research and monitoring.

Japanese translation, cross-cultural adaption and multicentre validation of the Zurich chronic middle ear inventory (ZCMEI-21-Jap).

OBJECTIVE: In the assessment of chronic otitis media (COM) and its treatment, patient-reported outcomes are becoming increasingly important. The aim of the present study was to translate and validate the Zurich chronic middle ear inventory (ZCMEI-21) in Japanese in order to provide the first Japanese-language instrument for measuring health-related quality of life (HRQoL) in COM. METHODS: The ZCMEI-21 was translated into Japanese according to published guidelines. In order to assess validity, the ZCMEI-21-Jap total score was compared to a question directly addressing HRQoL as well as the five-level version of the EQ-5D questionnaire, a generic measure of HRQoL. RESULTS: Demographic data and validity were assessed in a total of 91 COM patients. The ZCMEI-21-Jap total and subscale scores were well comparable to those of the original validation study. Cronbach's α of the ZCMEI-21-Jap was 0.85, indicating an excellent internal consistency. The ZCMEI-21-Jap total score showed a strong correlation (r=0.68, p<0.0001) to the question directly addressing HRQoL and, as expected, only a moderate correlation to the EQ-5D scores (r=0.49, p<0.0001 for descriptive system score and r=0.44, p<0.0001 for VAS score). CONCLUSION: We successfully translated the ZCMEI-21 into Japanese and were able to obtain sufficient information during the validation process for the use of the ZCMEI-21-Jap to quantify HRQoL in patients with COM. With the current study, we aim to take a step forward towards an international standardization of reporting HRQoL in COM.

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.

Effects of cavity reconstruction on morbidity and quality of life after canal wall down tympanomastoidectomy / Efeitos da reconstrução da cavidade da timpanomastoidectomia com técnica aberta na morbidade e qualidade de vida

Abstract Introduction: Canal wall down tympanomastoidectomy is commonly used to treat advanced chronic otitis media or cholesteatoma. The advantages of canal wall down mastoidectomy are excellent exposure for disease eradication and postoperative control of residual disease; its disadvantages include the accumulation of debris requiring life-long otological maintenance and cleaning, continuous ear drainage, fungal cavity infections, and the occurrence of dizziness and vertigo by changing temperature or pressure. Objective: To evaluate whether cavity-induced problems can be eliminated and patient comfort can be increased with mastoid cavity reconstruction. Methods: In total, 11 patients who underwent mastoid cavity reconstruction between March 2013 and June 2013 comprised the study group, and 11 patients who had dry, epithelialized CWD cavities were recruited as the control group. The study examined three parameters: epithelial migration, air caloric testing, and the Glasgow Benefit Inventory. Epithelial migration, air caloric testing, and the Glasgow Benefit Inventory were evaluated in the study and control groups. Results: The epithelial migration rate was significantly faster in study group (1.63 ± 0.5 mm/week) than control group (0.94 ± 0.37 mm/week) (p = 0.003, p < 0.05). The mean slow component velocity of nystagmus of the study group (13.33 ± 5.36°/s) was significantly lower when compared to control group (32.11 ± 9.12°/s) (p = 0.018). The overall the Glasgow Benefit Inventory score was −7.21, and the general subscale, physical and social health scores were −9.71, −21.09, and +20.35, respectively in the control group. These were +33.93, +35.59, +33.31, and +29.61, respectively in the study group. All but the social health score improved significantly (0.007, 0.008, 0.018, and 0.181, respectively). Conclusions: Cavity reconstruction improves epithelial migration, normalizes caloric responses and increases the quality of life. Thus, cavity rehabilitation eliminates open-cavity-induced problems by restoring the functional anatomy of the ear.

Resumo Introdução: A timpanomastoidectomia com a técnica Canal Wall Down, ou técnica aberta, é comumente utilizada para tratar otite média crônica avançada ou colesteatoma. As vantagens da mastoidectomia pela técnica aberta são uma excelente exposição para a erradicação da doença e controle pós-operatório da doença residual; suas desvantagens incluem o acúmulo de detritos que requerem manutenção e limpeza otológica ao longo da vida, drenagem contínua da orelha, infecções fúngicas na cavidade e a ocorrência de tonturas e vertigem com alterações de temperatura ou pressão. Objetivo: Avaliar se os problemas induzidos pela cavidade podem ser eliminados e o conforto do paciente aumentado com a reconstrução da cavidade mastoide. Método: No total, 11 pacientes submetidos à reconstrução da cavidade mastoide entre março de 2013 e junho de 2013 constituíram o grupo de estudo, e 11 pacientes com cavidades secas e epitelizadas, operadas pela técnica aberta, foram recrutados como grupo controle. O estudo analisou três parâmetros: migração epitelial, prova calórica com estimulação a ar e o questionário Glasgow Benefit Inventory. A migração epitelial, a prova calórica e o Glasgow Benefit Inventory foram avaliados nos grupos de estudo e controle. Resultados: A taxa de migração epitelial foi significativamente mais rápida no grupo de estudo (1,63 ± 0,5 mm/semana) do que no grupo controle (0,94 ± 0,37 mm/semana) (p = 0,003, p < 0,05). A velocidade média do componente lento do nistagmo no grupo de estudo (13,33 ± 5,36°/s) foi significativamente menor se comparada ao grupo controle (32,11 ± 9,12°/s) (p = 0,018). O escore global do Glasgow Benefit Inventory foi de -7,21 e os escores da subescala geral, saúde física e social foram -9,71, -21,09 e +20,35, respectivamente, no grupo controle. Esses escores foram +33,93, +35,59, +33,31 e +29,61, respectivamente, no grupo de estudo. Todos, exceto o escore de saúde social, melhoraram significativamente (0,007, 0,008, 0,018 e 0,181, respectivamente). Conclusões: A reconstrução da cavidade melhora a migração epitelial, normaliza as respostas da prova calórica e aumenta a qualidade de vida. Assim, a reabilitação da cavidade elimina os problemas induzidos por cavidades abertas ao restaurar a anatomia funcional da orelha.

Validations of the OM-6 Parent-Proxy Survey for Infants/Toddlers with Otitis Media.

Objective To validate the Otitis Media-6 (OM-6), a parent-proxy quality-of-life (QOL) questionnaire for infants/young children with OM, against other previously validated generic QOL questionnaires. Study Design Multi-institutional cross-sectional study. Setting Twenty-three otolaryngology, pediatric, and family practices across the United States. Subjects and Methods Caregivers of 6- to 24-month-old children with a history of OM completed the OM-6, OM History Form, and Pediatric Quality of Life (PedsQL) Infant Scales survey. Principal components analysis (PCA) examined the underlying factor structure of items on the OM-6, and Cronbach's α measured the internal consistency of items on each factor. Discriminant validity was assessed with receiver operating curves (ROCs). Results Surveys from 1045 patients were analyzed. The overall OM-6 was strongly to moderately correlated with the PedsQL Infant Scales scores (Pearson r = -0.649 for ages 6-12 months and -0.566 for ages 13-24 months). Two underlying constructs, "Behavior and Symptoms" and "Hearing and Speech," emerged from the PCA. Each factor and the overall OM-6 showed excellent internal consistency reliability (each Cronbach's α >0.75). The areas under the curve on the ROC analyses were <0.65 for recurrent and chronic OM using a variety of frequency and chronicity cut-points and definitions. Conclusion The OM-6 measures 2 underlying QOL constructs, Behavior and Symptoms and Hearing/Speech. The overall OM-6 showed acceptably high internal consistency reliability and good construct validity. However, the ability of the OM-6 to identify children who have more severe clinical recurrent or chronic OM vs milder disease was not supported by our analysis.

Effects of cavity reconstruction on morbidity and quality of life after canal wall down tympanomastoidectomy.

INTRODUCTION: Canal wall down tympanomastoidectomy is commonly used to treat advanced chronic otitis media or cholesteatoma. The advantages of canal wall down mastoidectomy are excellent exposure for disease eradication and postoperative control of residual disease; its disadvantages include the accumulation of debris requiring life-long otological maintenance and cleaning, continuous ear drainage, fungal cavity infections, and the occurrence of dizziness and vertigo by changing temperature or pressure. OBJECTIVE: To evaluate whether cavity-induced problems can be eliminated and patient comfort can be increased with mastoid cavity reconstruction. METHODS: In total, 11 patients who underwent mastoid cavity reconstruction between March 2013 and June 2013 comprised the study group, and 11 patients who had dry, epithelialized CWD cavities were recruited as the control group. The study examined three parameters: epithelial migration, air caloric testing, and the Glasgow Benefit Inventory. Epithelial migration, air caloric testing, and the Glasgow Benefit Inventory were evaluated in the study and control groups. RESULTS: The epithelial migration rate was significantly faster in study group (1.63±0.5mm/week) than control group (0.94±0.37mm/week) (p=0.003, p<0.05). The mean slow component velocity of nystagmus of the study group (13.33±5.36°/s) was significantly lower when compared to control group (32.11±9.12°/s) (p=0.018). The overall the Glasgow Benefit Inventory score was -7.21, and the general subscale, physical and social health scores were -9.71, -21.09, and +20.35, respectively in the control group. These were +33.93, +35.59, +33.31, and +29.61, respectively in the study group. All but the social health score improved significantly (0.007, 0.008, 0.018, and 0.181, respectively). CONCLUSIONS: Cavity reconstruction improves epithelial migration, normalizes caloric responses and increases the quality of life. Thus, cavity rehabilitation eliminates open-cavity-induced problems by restoring the functional anatomy of the ear.

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 prospective observational cohort study to assess the incidence of acute otitis media among children 0-5 years of age in Southern Brazil

Abstract Objectives: To estimate acute otitis media incidence among young children and impact on quality of life of parents/caregivers in a southern Brazilian city. Methods: Prospective cohort study including children 0-5 years of age registered at a private pediatric practice. Acute otitis media episodes diagnosed by a pediatrician and impact on quality of life of parents/caregivers were assessed during a 12-month follow-up. Results: During September 2008-March 2010, of 1,136 children enrolled in the study, 1074 (95%) were followed: 55.0% were ≤2 years of age, 52.3% males, 94.7% white, and 69.2% had previously received pneumococcal vaccine in private clinics. Acute otitis media incidence per 1000 person-years was 95.7 (95% confidence interval: 77.2-117.4) overall, 105.5 (95% confidence interval: 78.3-139.0) in children ≤2 years of age and 63.6 (95% confidence interval: 43.2-90.3) in children 3-5 years of age. Acute otitis media incidence per 1000 person-years was 86.3 (95% confidence interval: 65.5-111.5) and 117.1 (95% confidence interval: 80.1-165.3) among vaccinated and unvaccinated children, respectively. Nearly 68.9% of parents reported worsening of their overall quality of life. Conclusion: Acute otitis media incidence among unvaccinated children in our study may be useful as baseline data to assess impact of pneumococcal vaccine introduction in the Brazilian National Immunization Program in April 2010.

Quality of life of young patients with recurrent respiratory papillomatosis.

OBJECTIVE: To assess quality of life of children and teenagers with recurrent respiratory papillomatosis, according to the evidence of infection by human papillomavirus types 6 and 11, compared with healthy volunteers and patients with chronic otitis media. METHOD: Participants and their parents completed the Pediatric Quality of Life Inventory 4.0. RESULTS: Patients with recurrent respiratory papillomatosis and their parents reported lower quality of life than healthy subjects (p < 0.01), but similar quality of life to patients with chronic otitis media. Those with human papillomavirus type 11 showed the lowest scores among all participants (p < 0.05). CONCLUSION: Young Mexican patients with recurrent respiratory papillomatosis and their parents perceive a poor quality of life, and they may experience limitations in interactions with their peers. Infection by human papillomavirus type 11 may increase the impact of the disease on quality of life.

The Chronic Otitis Media Benefit Inventory (COMBI): Development and Validation of a Dynamic Quality of Life Questionnaire for Chronic Ear Disease.

OBJECTIVE: This study introduces a change-oriented short-form health-related quality of life questionnaire suited to symptoms of adult chronic middle ear disease and its consequences, and describes its properties. STUDY DESIGN: Two-centre prospective correlational study primarily for instrument development. SETTING: Two otology secondary care centers in England. PATIENTS: Fifty-two consecutive adult patients with active chronic otitis media undergoing surgery. METHODS: The 12 items for the chronic otitis media benefit inventory (COMBI) were appraised chiefly for internal consistency of resulting score and for factor structure (exploratory factor analysis). RESULTS: The internal consistency of the COMBI was high within our cohort of patients, with a Cronbach's alpha value of 0.907. The three-factor solution from factor analysis explaining 73.6% of the variance was readily interpretable in terms of the intended item content: changes in hearing, ear symptoms, and daily activities plus healthcare uptake. CONCLUSIONS: The COMBI has suitable properties for the dynamic assessment of active chronic otitis media. Initial psychometric appraisal confirms its suitability for early adoption to acquire more comprehensive large-sample information with it and on it, for future refinement and application.

Associations between otitis media and child behavioural and learning difficulties: Results from a Danish cohort.

OBJECTIVES: Findings from studies investigating early childhood episodes of otitis media (OM) and developmental outcomes are inconclusive. This may in part be because large-scale prospective studies controlling for relevant confounding factors are sparse. The present study investigates associations between OM in early childhood and later behavioural and learning difficulties controlling for relevant confounding factors. METHODS: The study applied data from the Aarhus Birth Cohort's 10-12-year-old follow-up (N=7578). Associations between retrospective parent-reported OM (no OM; 1-3 episodes of OM with/without tympanostomy tubes; 4+ OM episodes without tympanostomy tubes and; 4+ OM episodes with tympanostomy tubes) one the one hand, and parent- and teacher-reported scores on the Strengths and Difficulties Questionnaire (SDQ) and parent-reported academic difficulties on the other hand, were investigated. The following variables were controlled for: parental educational level, maternal and paternal school problems, parental post-natal smoking, breastfeeding, and age at which the child started walking. All analyses were stratified by gender. RESULTS: Large differences in background characteristics were observed for the group of children with 4+ OM episodes with tympanostomy tubes compared to the no OM group. After controlling for relevant confounders, negative associations were consistently observed for the group of children with 4+ episodes of OM with tympanostomy tubes compared to the group of children without OM. This was particularly so for girls. CONCLUSION: The findings suggest an association between 4+ episodes of early OM with tympanostomy tubes and behavioural and learning difficulties later in childhood. The large inter-group differences, i.e. impact of residual and unmeasured confounding factors, may in part explain the observed associations and underline the need to include these in future studies.

Development and validation of the Zurich chronic middle ear inventory (ZCMEI-21): an electronic questionnaire for assessing quality of life in patients with chronic otitis media.

Because existing patient-reported outcome measures (PROMs) specific for chronic otitis media (COM) are lacking certain relevant symptoms and dimensions of health-related quality of life (HRQoL), we aimed to develop and validate a new questionnaire for comprehensively measuring HRQoL in adult patients with COM. An expert panel and patients were involved in developing the first version of the Zurich chronic middle ear inventory, containing 33 items (ZCMEI-33). An electronic application was chosen not only to provide maximal data quality, but also to facilitate and accelerate data analysis. Item reduction was performed by testing the questionnaire in a first cohort (n = 85). Using sequential statistical analysis, the ZCMEI-33 was reduced to 21 items (ZCMEI-21). Subsequently, the ZCMEI-21 was validated in a second cohort (n = 76). Validation revealed a Cronbach's α of 0.91, indicating excellent internal consistency. Moreover, the ZCMEI-21 was able to discriminate between patients with COM and healthy participants (p < 0.0001), thus possessing good discrimination validity. Assessing criterion validity, the ZCMEI-21 total score was compared to a question directly addressing HRQoL and the EQ-5D descriptive system score, a generic measure of HRQoL. Whereas the ZCMEI-21 total score and the EQ-5D descriptive system score were only moderately correlated (r = 0.60, p < 0.0001), the ZCMEI-21 total score and the question directly addressing HRQoL showed a strong correlation (r = 0.74, p < 0.0001). In conclusion, sufficient information on reliability and validity was obtained to propagate the application of the ZCMEI-21 to quantify HRQoL in patients with COM.

Otitis Media and Caregiver Quality of Life: Psychometric Properties of the Modified Danish Version of the Caregiver Impact Questionnaire.

OBJECTIVE: Otitis media in children may have a considerable impact on caregiver quality of life. The disease-specific Caregiver Impact Questionnaire is designed to assess caregiver quality of life in relation to child otitis media. Assessment of the psychometric properties of this instrument is limited. This study assesses the psychometric properties of this instrument including validity, reproducibility, responsiveness, and interpretability. STUDY DESIGN: Longitudinal validation study. SETTING: Secondary care units. METHODS: Analyses were based on data from 435 families. Validity was assessed using confirmatory factor analysis, internal consistency, and hypothesis testing. Test-retest reliability and measures of smallest detectable change were investigated in the assessment of reproducibility. Responsiveness was investigated by means of hypothesis testing and receiver operating characteristic analysis. An anchor-based distribution method was applied for determining minimal important change as perceived by the respondent. RESULTS: Factor analysis confirmed the hypothesized 1-factor structure with an acceptable fit. Cronbach's alpha was .90. In the analysis of construct validity, 88.9% of the hypothesized correlations were correctly predicted. Intraclass correlation coefficient was 0.87 and smallest detectable change corresponded to approximately one-fourth of the scale. Responsiveness was found to be good and a change score of 13.8 represented minimal important change. CONCLUSION: The modified Danish version of the Caregiver Impact Questionnaire is a valid and reproducible measurement tool that is also sensitive to measuring change in the current setting. A change score representing minimal important change as perceived by the respondent is proposed. Results of this study support the use of this instrument.

Caregiver Quality of Life Is Related to Severity of Otitis Media in Children.

OBJECTIVE: Otitis media (OM) in children is the most frequent reason for physician visits in developed countries and burdens caregivers, society, and the child. Our objective was to describe the impact of OM severity on parent/caregiver quality of life (QoL). STUDY DESIGN: Multi-institutional prospective cross-sectional study. SETTING: Otolaryngology, family, and pediatric practices. SUBJECTS AND METHODS: Children 6 to 24 months old with and without a primary diagnosis of recurrent OM and their caregivers. Physicians provided patient history, and parents/caregivers completed a Family Information Form, the PedsQL Family Impact survey, the Patient Reported Outcomes Measurement Information System (PROMIS) survey, and the OM 6-item severity survey (OM-6). RESULTS: A total of 2413 subjects were enrolled and data from 1208 patients and physician were analyzed. The average child age was 16 months, and 54% were male. The mean OM-6 score was 3.2. The mean PedsQL Family Impact score for parents was 66.9 from otolaryngology sites and 78.8 from pediatrics/family practice sites (P < .001). Higher (worse) OM-6 scores correlated significantly with worse PedsQL Family Impact scores (Pearson r = -0.512, P < .01). Similarly, increasing OM-6 scores strongly correlated with increased parental anxiety, depression, and fatigue, as well as decreased satisfaction (all P < .01). CONCLUSIONS: Worse PedsQL Family Impact and PROMIS scores were highly correlated with elevated OM-6 scores, suggesting that severity of childhood OM significantly affects parent/caregiver QoL. Understanding the impact of a child's illness on parent/caregiver QoL can help physicians counsel patients and families and provide better family-centered, compassionate care.