OBJECTIVE: Evaluating the current health state in chronic otitis media (COM), audiologic results are complemented by subjective outcomes, such as health-related quality of life (HRQoL). Two disease-specific instruments assessing HRQoL in COM in German-speaking patients exist, i.e., the chronic otitis media outcome test (COMOT-15) and the Zurich chronic middle ear inventory (ZCMEI-21). Since the psychometric properties of these questionnaires in a concurrent application are unknown, the aim of this study was to compare the COMOT-15 and the ZCMEI-21.
METHODS: HRQoL was assessed in adult COM patients using the COMOT-15 and the ZCMEI-21. Psychometric properties were determined, including response distribution, concurrent validity, internal consistency, correlation to hearing and gender differences.
RESULTS: In 173 patients (mean age 51.5 years), both questionnaires showed normally distributed scores without strong floor and ceiling effects. The total scores and subscores of both questionnaires exhibited satisfactory internal consistency (Cronbach\'s α 0.7-0.9) with the exception of the COMOT-15 hearing subscore (α = 0.94) and the ZCMEI-21 medical resource subscore (α = 0.66). Fair correlations between the air conduction pure-tone average and the total scores were found (COMOT-15: r = 0.36, p < 0.0001; ZCMEI-21: r = 0.34, p < 0.0001).
CONCLUSIONS: In the first study comparing the COMOT-15 and the ZCMEI-21, both questionnaires exhibited satisfactory psychometric properties with several subtle differences. The COMOT-15 has a strong focus on hearing with a probably redundant content of the hearing subscore and may be suited for hearing-focused research questions. The ZCMEI-21 provides a comprehensive assessment of the COM symptom complex and may therefore also be used in research settings, where ear discharge, vertigo or pain should be covered.

OBJECTIVE: Different types of chronic middle ear disease (CMED) present with differing severity of single symptoms, such as discharge, vertigo or hearing loss, which impair health-related quality of life (HRQoL). Here, we aimed to (i) investigate characteristics of HRQoL and (ii) evaluate the association between HRQoL and hearing among different types of CMED.
METHODS: In this prospective longitudinal cohort study, we included adult patients undergoing surgical treatment for CMED. Primary outcomes included HRQoL assessed by the Zurich Chronic Middle Ear Inventory (ZCMEI-21) and hearing assessed by pure-tone audiometry.
RESULTS: In the included 108 patients (51% females), CMED were chronic otitis media (COM) with (n = 46) or without (n = 22) cholesteatoma, persistent mastoid cavity (with [n = 15] or without [n = 10] recurrent cholesteatoma), revision ossiculoplasty for hearing restoration (n = 14), and postinflammatory meatal fibrosis (n = 1). Preoperatively, the mean ZCMEI-21 score showed statistically significant differences among different types of CMED (p = 0.007) with persistent mastoid cavity without cholesteatoma exhibiting the highest score (34.1, SD 7.7) indicating poor HRQoL. At a mean follow-up period of 183 days, no statistically significant differences in the ZCMEI-21 scores among different types of CMED were observed (p = 0.67).
CONCLUSIONS: This study objectifies differences in HRQoL among different types of CMED. In patients with indication for functional surgery only, e.g., persistent mastoid cavity without cholesteatoma, the worst HRQoL was observed. Yet, in these types of CMED, HRQoL guides decision for treatment. Moreover, differences in HRQoL among different types of CMED were not closely associated with hearing, but largely depended on other symptoms, such as discharge or vertigo.

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.

The Zurich Chronic Middle Ear Questionnaire (ZCMEI-21) is a newly-developed German-language questionnaire. The purpose of this study was to analyze the quality of life (QoL) of chronic otitis media (COM) patients and translate, transculturally adapt, and validate the ZCMEI-21 into Turkish.
Based on internationally accepted guidelines, the ZCMEI-21 was translated into Turkish. To assess its validity, the total score of the ZCMEI-21-Tur was compared to the scores taken from the original validation study and a question that was directly related to the health-related QoL (HRQoL), as well as the general criterion EQ-5D-5L. Questionnaires were completed by healthy volunteers and the results were evaluated statistically.
A total of 80 COM patients and 40 healthy volunteers were prospectively enrolled in this study. Regarding internal consistency, the questionnaire showed a Cronbach α of 0.94, which indicated high internal consistency. Moreover, internal consistency was also determined to be excellent for the Cronbach α of the individual subscales, as follows: ear sign symptoms, 0.79; hearing, 0.83; psychosocial impact, 0.91, and medical resources, 0.84.
The ZCMEI-21 was translated into Turkish and validated. Therefore, the ZCMEI-21-Tur was suitable for use in assessing HRQoL in adult patients with COM.

OBJECTIVE: To investigate the association between the \"ChOLE\" classification, hearing outcomes and disease-specific health-related quality of life (HRQoL).
METHODS: In two tertiary referral centers, patients requiring primary or revision surgery for cholesteatoma were assessed for eligibility. Audiometric assessment was performed pre- and postoperatively. The ChOLE classification was determined intraoperatively and via the preoperative CT scan. HRQoL was assessed pre- and postoperatively using the Zurich Chronic Middle Ear Inventory (ZCMEI-21).
RESULTS: A total of 87 patients (mean age 45.2 years, SD 16.2) were included in this study. ChOLE stage I cholesteatoma was found in 8 (9%), stage II cholesteatoma was found in 65 (75%), and stage III cholesteatoma was found in 14 (16%) patients. Postoperatively, the mean air-bone gap (0.5, 1, 2, 3 kHz) was significantly smaller than before surgery (14.3 dB vs. 23.0 dB; p = 0.0007). The mean ZCMEI-21 total score significantly decreased after surgery (26.8 vs. 20.7, p = 0.004). No correlation between the ZCMEI-21 total score and both the ChOLE stage and the extent of the cholesteatoma (ChOLE subdivision \"Ch\") was found. A trend towards worse HRQoL associated with a poorer status of the ossicular chain (ChOLE subdivision \"O\") was observed. The audiometric outcomes were not associated with the extent of the cholesteatoma. The ChOLE subdivision describing the ossicular status showed a strong association with the pre- and postoperative air conduction (AC) thresholds. Further, the ZCMEI-21 total score and its hearing subscore correlated with the AC thresholds.
CONCLUSIONS: The ChOLE classification does not show a clear association with HRQoL measured by the ZCMEI-21. The HRQoL neither seems to be associated with the extent of the disease nor with the ossicular chain status. Yet, surgical therapy significantly improved HRQoL by means of reduced ZCMEI-21 total scores, which were strongly associated with the AC thresholds. Intraoperative assessment of a cholesteatoma using the ChOLE classification and HRQoL complement each other and provide useful information.

OBJECTIVE: To assess the change in health-related quality of life (HRQoL) in patients undergoing mastoid cavity obliteration.
METHODS: Patients who had undergone canal wall-down mastoidectomy for chronic otitis media with creation of a persistent mastoid cavity and underwent revision tympanomastoid surgery including mastoid cavity obliteration using autologous material were included. Audiological measurements including air conduction (AC) and bone conduction (BC) pure-tone averages (PTA) and the air-bone gap (ABG) were assessed. Health-related Quality of Life (HRQoL) was assessed by the Zurich Chronic Middle Ear Inventory (ZCMEI-21) pre- and postoperatively.
RESULTS: A total of 25 patients (16 females and 9 males; mean age 51.6 years, 14 right and 11 left ears) were included. Patients were reexamined after a mean follow-up period of 9.2 months (SD = 6.5) after obliteration of the mastoid cavity. Compared to the preoperative visit, patients showed a significantly reduced AC PTA at the postoperative visit (mean difference: - 4.1; SD = 10.4, p = 0.045). The mean ZCMEI-21 score changed from 31.7 (SD = 14.5) preoperatively to 17.4 (SD = 15.1) postoperatively (mean difference: - 14.3; SD = 19.1; p = 0.0002). The mean ZCMEI-21 score changes were neither correlated to the AC PTA shift (p = 0.60) nor to the ABG shift (p = 0.66).
CONCLUSIONS: This is the first study reporting a highly significant and clinically important improvement in HRQoL after mastoid cavity obliteration in a prospective setting. The improvement in HRQoL was not correlated to the hearing improvement. As a clinical implication, we provide evidence for a substantial subjective benefit of the surgical obliteration of a symptomatic mastoid cavity and, therefore, encourage this surgical procedure.

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).
Pilot translation study including cognitive debriefings, prospective multicentre cross-sectional psychometric validation study.
Four tertiary referral centres in three different English-speaking countries (UK, USA and Australia).
Adult patients suffering from COM.
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.
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.
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.

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).
CONCLUSIONS: 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.