Chronic Otitis Media Questionnaire-12 Research Articles

Translation and validation of the Indonesian version of the chronic otitis media questionnaire-12

Chronic suppurative otitis media (CSOM) is a pathological disorder affecting the ear, characterized by a persistent and long-lasting middle ear infection accompanied by the absence of an intact tympanic membrane. Multiple measures can be employed to evaluate the quality of life among patients with CSOM. One such instrument is the chronic otitis media questionnaire-12 (COMQ-12), which has demonstrated satisfactory levels of validity and reliability. The utilization of the COMQ-12 questionnaire has the potential to improve the quality of life experienced by CSOM patients. This study aimed to evaluate the validity and reliability of the Indonesian adaptation instrument of the COMQ-12 in patients with CSOM in the Otorhinolaryngology department of multiple hospitals in Yogyakarta. The study was conducted from February to July 2023. The study comprised 48 participants, consisting of 16 males and 32 females. The adapted Indonesian version of the COMQ-12 instrument demonstrates validity and reliability in assessing patients' quality of life with CSOM, as evidenced by a statistically significant r-value of 0.2353. The internal consistency analysis reveals that Cronbach's α coefficient is 0.868. The Indonesian adaptation of the COMQ-12 demonstrates validity and reliability as an assessment tool for measuring the health-related quality of life in patients diagnosed with CSOM.

Effect of type 1 tympanoplasty on health-related Quality of Life assessed by Chronic Otitis Media Questionnaire 12.

The aim of the study was to evaluate the changes in the quality of life of patients who underwent Type 1 tympanoplasty using the Chronic Otitis Media Questionnaire 12 (COMQ-12). Prospectively collected data of patients aged between 18-65 years, who had undergone type 1 tympanoplasty between January 2018 to January 2019 were included in the study. The Turkish version of COMQ-12 was completed by all of the patients preoperatively as well as 12 months postoperatively. Preoperative and postoperative graft uptake outcomes, hearing assessment results, and scores of COMQ-12 were evaluated. Shapiro-Wilk test, Mann-Whitney U test, and Wilcoxon test were used. A total of 98 patients were included. Noticeable improvement in the severity of symptoms, negative effect on daily life and work routine, health care, and general well-being was detected by subjective scores of the questionnaire. The COMQ-12 preoperative and postoperative overall average score was 25 and 7, respectively (p<0.001). Graft uptake success was found to be 85%. Hearing assessment evaluation showed a mean change in air conduction values of 8.78 (SD 1.17), and a mean change in air-bone gap values of 7 (SD 0.8), both showing statistical significance (p<0.001). According to the COMQ-12 questionnaire data after surgery, symptom severity, lifestyle and work impact, health service impact, and general discomfort were significantly reduced.

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

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). Prospective correlational study. Two otology referral centers in England, United Kingdom. Consecutive adult patients undergoing middle ear surgery for COM. 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. 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. 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.

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

PurposePersistent 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 methodsThe 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.ResultsSome 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)ConclusionThe 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.

Health Related Quality of Life after Canal Wall Down Mastoidectomy with tympanoplasty using the chronic otitis media questionnaire-12 (COMQ12)

Background and objectives: To assess quality of life after canal wall down mastoidectomy in patients operated for chronic otitis media both mucosal and squamosal type. Methods: Quasi-experimental study design, conducted on fifty patients who were candidates for canal wall down mastoidectomy, between (September, 2016 to September, 2019). All patients were questioned before the operation and one year after the operation using Quality of life questioner for chronic otitis media (COMQ12). Results: fifty patients, mean age ± SD was 36.52 ± 10.85, The highest proportion (40%) of the sample aged 35-44 years and around half (52%) were male. Mean total score of the COMQ12 before the operation was 25.94, which was decreases to 10.56 after the operation. There was significant improvement in ear symptoms regarding discharging ear and offensive odor post operatively, and also reduction in doctors visit for taking medications and fear from showering, there was non-significant change in questions regarding dizziness, tinnitus and discomfort around the ear, post operatively regarding questions related to the hearing there was significant deterioration post operatively. Conclusions: Canal wall down with type III tympanoplasty showed a clear decrease in the severity of the ear symptoms, impact on life and work, and health care after surgery. Hearing was the only disabling factor that negatively affect outcome in post-operative quality of life.

Quality of life after cholesteatoma surgery: comparison between surgical techniques.

SUMMARYObjectiveTo evaluate the long-term quality of life (QoL) in patients operated for cholesteatoma by canal wall-up tympanoplasty (CWUT) or canal wall-down tympanoplasty (CWDT) with mastoid obliteration.MethodsQoL was evaluated by the Chronic Otitis Media Questionnaire - 12 (COMQ-12). For each patient, the total score and three partial subscores, concerning disease activity, functional impairment and general impact on the patient’s life were calculated. These scores were correlated with the surgical technique, as well as anatomical and functional results.Results68 procedures were classified as CWUT and 78 as CWDT with obliteration. The mean follow-up was 65 months. Total and partial COMQ-12 scores did not show any significant difference between the two groups. Correlation analysis showed a significant direct association between the postoperative Air-Bone Gap (ABG) and both the COMQ-12 total score and functional subscore in the CWUT group.ConclusionsThis is the first study comparing CWUT and CWDT with obliteration with the COMQ-12, thus confirming the overlapping results in terms of QoL. These findings, together with the evidence of the significantly lower rates of recidivism, show that CWDT with obliteration should be considered as a good alternative to CWUT.

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.

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). Multinational prospective cohort study. Nine otology referral centers in eight countries. Adult patients suffering from COM. 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. 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. 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.

Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial.

PurposeTo determine the efficacy of autologous platelet- and extracellular vesicle-rich plasma (PVRP) to treat chronic postoperative temporal bone cavity inflammation (CPTBCI) after exhausting surgical and standard conservative therapies.Materials and MethodsPatients were randomly allocated to treatment with PVRP (PVRP group) or standard conservative methods (control group) in a setting of four once-monthly checkups and subsequent follow-up. The treatment outcome was measured with the Chronic Otitis Media Questionnaire-12 (COMQ-12), CPTBCI focus surface area, and CPTBCI symptom-free time after the fourth checkup.ResultsEleven patients from each group completed the trial; 95% of patients suffered from chronically discharging mastoid cavity (the type of CPTBCI). Within four checkups, the COMQ-12 score decreased statistically significantly in the PVRP group (p < 0.001) but not in the control group (p = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (p < 0.0005) but not between other checkups (p > 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (p = 0.152). Nine patients from the PVRP group and three patients from the control group were CPTBCI symptom-free at the fourth checkup. The median symptom-free time was 9.2 months (95% CI [7.4, 11.9]) in the PVRP group. Cumulatively, 49% of patients in the PVRP group remained CPTBCI symptom-free for 12.7 months after the fourth checkup.ConclusionAutologous PVRP represents a novel additional and successful treatment modality for a chronically discharging radical mastoid cavity when the surgical and standard conservative treatment methods have been exhausted.Trial Numberhttps://clinicaltrials.gov (NCT04281901).

Arabic Cross-Cultural Adaptation and Validation of Health-Related Quality of Life Measures for Chronic Otitis Media (COMQ-12)

Our study aimed to translate the chronic otitis media questionnaire-12 (COMQ-12) into the Arabic language, evaluate the internal consistency of the test and test-retest reliability, and validate the adaptation for further use in Arabic studies. A prospective observation monocenter cohort study. This study was done at Kafrelsheikh University Hospital, Egypt. One hundred twenty five ear pathology-free patients were asked to complete the questionnaire forming group A. One hundred twenty five patients with different forms of COM completed the questionnaire 2 weeks before the planned ear surgery and the same day of the operation, forming group B. Those patients who underwent the ear surgery, completed the questionnaire again 6 months after the operation forming group C. We did an Arabic forward and backward translation of the original COMQ-12. The patients in group B underwent ear surgery (tympanoplasty with or without mastoidectomy). After fulfilling the questionnaire in different groups, we assessed the psychometric properties of the Arabic version of COMQ-12: internal consistency, reliability, reproducibility, validity, and responsiveness. Cronbach's α was 0.973. The Spearman's rank correlation coefficient was 0.981, while the Intraclass correlation coefficient was 0.973. A statistically significant difference was present between group A (average total score 2.38 ± 1.543) and group B (average total score 35.86 ± 5.98). Also, there was a statistically significant difference between group B and group C (average total score 7.46 ± 8.294). The calculated cut-off point of the total score was more than or equal to eight. The cross-culturally Arabic adaptation of COMQ-12 was reliable, valid with strong internal consistency and responsiveness. It can detect the significant effect of COM on the quality of life of Arabic patients. This effect would be improved obviously after surgical management that markedly enhanced the preoperative hearing problem.

The Romanian Version of Health-Related Quality of Life Questionnaire 12 for Chronic Otitis Media. The Socio-Economic Status Impact Significance

Objective: Our primary objective was to translate and validate Chronic Otitis Media (COM) Questionnaire-12 (COMQ-12) in Romanian. The secondary objective was to investigate the effect of the socioeconomic status on the preoperative COMQ-12 scores in individuals with a similar stage of disease. Methods: This was a cross-sectional study. Patients diagnosed with different stages of (COM) with cholesteatoma, scheduled for the first surgery, filled in the Romanian translated version of the COMQ-12. The patients were divided according to the stage of the disease and the environment of origin: rural versus urban areas. Results: The internal consistency of the Romanian COMQ-12 proved excellent, with a Cronbach’s alpha equal to 0.959. The correlation of the 24 randomly split-half reliability analysis varied from 0.904 to 0.917, with a mean of 0.908. Significantly higher COMQ-12 scores are obtained by patients from urban (mean = 42.14, SD =9.04) as compared to those from rural (mean = 30.44, SD = 5.88) only for those with stage III disease (P-value=0.0292). Conclusions: Romanian version of COMQ-12 proved to be a valid instrument that can be use in clinical practice to provide suitable information in COM patients, which contributes to the development of an international common otology dataset. Patients from rural areas tend to disregard their symptoms, being more predisposed to potential complications related to COM rather than urban patients at the same stage of the disease.

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

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. 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. 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. 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 Spanish version of the health-related quality of life (HRQoL) measure for Chronic Otitis Media (COMQ-12)

BackgroundEvaluation of health-related quality of life (HRQoL) is considered an important aspect of clinical assessment and health research. Chronic Otitis Media (COM) is related to the quality of life deterioration subsequent to COM symptoms, social communication impairments, and lower work performance. However, there is no reliable information regarding the impact of this disease on health and quality of life in many resource-poor countries. Therefore, we translated into Spanish the Chronic Otitis Media Questionnaire-12 (COMQ-12) for the evaluation of HRQoL of Chronic Otitis Media (COM) in adult patients. Also, we assessed the psychometric properties of the Spanish version of the questionnaire.MethodsTwo otology referral centers in Bogotá, Colombia were included. The Spanish version of COMQ-12 was applied twice to 200 adult patients with confirmed COM diagnosis and 31 healthy controls to perform the validation process and assess the internal consistency of this questionnaire. Psychometric characteristics (internal consistency, test–retest reliability, and construct validity) of the COMQ-12 were assessed. Exploratory Factor Analysis and Confirmatory Factor Analysis were conducted via structural equation modeling to test the questionnaire’s structure.ResultsThe Spanish version of the COMQ-12 showed good internal consistency (Cronbach’s Alpha: 0.86, McDonald’s Omega: 0.89). Coefficients corresponding to Lin’s Concordance test and test–retest reliability were 0.95 and 0.83 respectively. Correlation between the Visual Analogue Scale (VAS) and the COMQ-12 was 0.68 (95% CI 0.59–0.75, p value < 0.001). Factor analysis of the Spanish version of the COMQ-12 indicated a questionnaire structure with three domains: smelly discharge related symptoms; hearing loss related symptoms; and impact on work, lifestyle, and health services.ConclusionThis Spanish version of the COMQ-12 showed high reliability and high internal consistency. This questionnaire can be used as an objective clinical tool to assess the HRQoL of patients who have a COM diagnosis.Trial registrationHospital Universitario Fundación Santa Fe, Ethical Committee Registration ID: CCEI-8807-2018. Hospital de San José, Ethical Committee: Record number 500, DI-I-0632-18.

Slovenian Cross-Cultural Adaptation and Validation of Health-Related Quality of Life Measures for Chronic Otitis Media (COMQ-12), Vertigo (DHI, NVI) and TINNITUS (THI).

PurposeTo provide physicians and patients with the tools needed to evaluate patients’ problems and health-related quality of life by cross-culturally adapting and validating the Chronic Otitis Media Questionnaire 12 (COMQ-12), the Dizziness Handicap Inventory (DHI), the Neuropsychological Vertigo Inventory (NVI) and the Tinnitus Handicap Inventory (THI).Materials and methodsCOMQ-12, DHI, NVI and THI were translated into the Slovenian language and completed by patients treated at our department for chronic otitis media, vertigo or tinnitus. The control group for each questionnaire consisted of healthy volunteers. Internal consistency, test-retest reliability, discriminant validity, diagnostic accuracy and cut-off value were determined for each questionnaire.ResultsTest-retest reliability was excellent for DHI (ICC A=0.946) and NVI (p=0.315, ICC A=0.975), good to excellent for COMQ-12 (p=0.680, ICC A=0.858) and satisfactory for THI (p=0.120). Discriminant validity was confirmed for each questionnaire (p>0.05) using the Mann-Whitney U test (COMQ-12, DHI, THI) or the Welch t-test (NVI). COMQ-12 had acceptable (α=0.796) and DHI (α=0.910), NVI (α=0.950) and THI (α=0.924) perfect internal consistency. COMQ-12 and DHI had excellent, NVI acceptable and THI perfect diagnostic accuracy (AUC=0.987, AUC=0.999, AUC=0.781 and AUC=1.000 respectively). Cut-off values determined by Youden’s index were 7, 7, 9 and 56 for COMQ-12, THI, DHI and NVI, respectively.ConclusionSlovenian COMQ-12, DHI, NVI and THI are a valid and accurate tool for the diagnosis and measurement of health-related quality of life in patients with chronic otitis media, vertigo and tinnitus. They could aid general practitioners, occupational health specialists, neurologists and otorhinolaryngologists.

The utilization of Chronic Otitis Media Questionnaire-12 in chronic otitis media with or without cholesteatoma.

This study aimed to compare patients who had chronic otitis media with and without cholesteatoma in terms of the quality of life related to health. The Turkish version of the Chronic Otitis Media Questionnaire-12 (COMQ-12) was completed by totally 100 healthy subjects and 100 patients who had chronic otitis media (COM). The COM group was divided into cholesteatoma and without cholesteatoma [dry tympanic membrane perforation (TMP) and draining ear] groups. COMQ-12 score = 3.6 for healthy people. The average scores of dry TMP, draining ear, and cholesteatoma groups were 32.90, 27.34, and 45.95, respectively. A significant difference was between the cholesteatoma and without cholesteatoma groups in total scores (p = 0.001). No difference was found between the groups in age (p = 0.518) and gender (p = 0.975). The COMQ-12 could be a useful tool to differentiate chronic otitis media with or without cholesteatoma.

Validity and Reliability of Turkish Version of Chronic Otitis Media Questionaire-12.

Disease-specific quality of life scales have garnered prominence in recent years. Chronic Otitis Media Questionnaire-12 (COMQ-12) is a new scale developed for evaluating health-related quality of life in patients with chronic otitis media (COM). This study aimed to investigate the validity and reliability of the Turkish version of COMQ-12. The COMQ-12 was translated into Turkish. The Turkish version was administered to four groups consisting of 35 individuals to assess its validity. Group 1 consisted of healthy individuals, group 2 had patients with inactive COM, group 3 had patients with healed COM and group 4 had patients with active COM. The questionnaire was administered to healthy participants twice to estimate test-retest reliability. The scores of the control group were compared with the others to test the validity of the questionnaire. The test and retest Cronbach's alpha values of the Turkish version of COMQ-12 were 0.918 and 0.917, respectively, which indicates excellent internal consistency. The total and each item scores of the active COM group were significantly higher than the control group (p < 0.001). The single measures intraclass correlation coefficient was 0.824 (with a 95% confidence interval from 0.678 to 0.907). The Turkish version of COMQ-12 was determined to be highly valid and reliable. It is thought that the effect of COM on the quality of life can be monitored more objectively by using this questionnaire.

Adaptation and validation of the chronic otitis media questionnaire 12 (COMQ-12) in the Mexican Spanish language (COMQ-12-Mx)

Background: Chronic otitis media (COM) questionnaire 12 (COMQ-12) is a specific-disease tool that evaluates COM patients.Objective: To validate COMQ-12 in the Mexican Spanish language (COMQ-12-Mx).Materials and methods: Mexican Spanish-speaking healthy volunteers and COM patients who attended a Secondary Care Center from May 2019 to October 2019. The COMQ-12 in Mexican Spanish was obtained by translation and back translation from an English-Spanish translator. All participants completed the COMQ-12-Mx questionnaire. COM patients were included regardless of their COM status. Control group completed the questionnaire twice. Participants were categorized into three groups: group 1 (COM), group 2 (volunteers first test) and group 3 (volunteers retest). Cronbach’s alpha was used for internal consistency, Spearman’s rank correlation coefficient was used for test-retest reliability and Mann–Whitney U test compared groups.Results: We included 78 Mexican Spanish-speaking participants (COM n = 37, healthy volunteers n = 41), 51 females and 27 males, mean age was 39.67 years (SD ± 18.32). Group 1 COMQ-12-Mx score was 22.108 ± 11.79, group 2 score was 3.561 ± 4.399 (p ≤ .001) and group 3 score was 3.683 ± 4.435. Cronbach’s alpha was 0.828 and test-retest reliability achieved a 0.928 outcome.Conclusions: COMQ-12-Mx is a valid and reliable tool to evaluate quality life in Mexican Spanish-speaking patients with COM.

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

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). 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. 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. 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

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. 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. 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). 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.

Turkish Translation and Validation of Chronic Otitis Media Questionnaire-12.

The aim of this study was to translate the Chronic Otitis Media Questionnaire-12 (COMQ-12) into Turkish, evaluate the internal consistency of the test and test-retest reliability, and validate the adaptation for further use in Turkish studies. A total of 50 healthy subjects and 50 patients with chronic otitis media (COM) have completed a translated Turkish version of the COMQ-12. Healthy subjects were asked to complete the test twice. A statistical analysis was performed to evaluate the validity and test-retest reliability of the questionnaire. Patients were divided into three groups. Group 1 were patients with COM; Group 2 represented the first test of the control group; and Group 3 represented the second test of the control group. Cronbach's test was performed to test internal consistency, and Spearman's test was performed to evaluate test-retest validity. The average score was 30.64 for Group 1, 3.60 for Group 2, and 3.66 for Group 3. The COMQ-12 score of the patient group was significantly higher than the score of the control group (p<0.001). The area under the receiver operating characteristics curve value was calculated as 0.992, which showed a strong diagnostic accuracy, and the cut-off point was defined as 9. A Cronbach's alpha value of 0.810 was found. Spearman's rank correlation coefficient value (Spearman's rho) was calculated as 0.920. The Turkish adaptation of the COMQ-12 is a consistent and valid test with high sensitivity and specificity that can be used in Turkish for further studies instead of the original questionnaire.

Psychometric characteristics of the chronic Otitis media questionnaire 12 (COMQ \u2013 12): stability of factor structure and replicability shown by the Serbian version

BackgroundRecently, demand for and supply of short-form patient-reported outcome measures (PROMs) have risen throughout the world of healthcare. Our contribution to meeting that demand has been translating and culturally adapting the Chronic Otitis Media Questionnaire-12 (COMQ-12) for adults into Serbian and enhancing its psychometric base on the relatively large Serbian COM caseload. Chronic otitis media can seriously affect quality of life progressively and in long-term, and it remains the major source of hearing problems in the developing world.MethodsThe translated questionnaire was given twice to 60 adult patients with chronic otitis media of three types (inactive, active mucosal and active squamous disease) and to 60 healthy volunteers. Both patients and volunteers also filled the generic Short-Form 36 questionnaire (SF-36). Conventional statistical procedures were used in strategically driven development of scoring. Additionally, item responses were scaled by linear mapping against the provisional total score. Generalizability, detailed factor interpretation and supportability of scores were criteria, for the best compromise factor solution.ResultsTest-retest reliability was very high (0.924 to 0.989, depending on score). The a priori content dimensions of the questionnaire were strongly supported by 3-factor exploratory and confirmatory factor analyses for content validity, separating (i) ear symptoms from (ii) hearing problems, from (iii) daily activity restriction plus healthcare uptake. The 3-factor structure was furthermore highly stable on replication. The very large effect sizes when contrasting patients with healthy volunteers, and active with inactive disease established construct validity for the total score. A strong association with disease activity and a moderate one with generic health-related quality of life (HRQoL), the SF-36, supported construct validity for two of three factors extracted (ear symptoms, and impact on daily activities plus healthcare uptake).ConclusionsGiven the minimal psychometric work to date on COMQ-12, this interim sample with 120 data points adds materially to knowledge of its reliability, several forms of validity and the feasibility of profile sub-scores to supplement total scores. The good psychometric properties shown for COMQ-12 justify both its routine clinical use and acquisition of the necessarily larger sample for generality, score optimisation and the evaluation of responsiveness.