Department of Otolaryngology - Head and Neck Surgery, Peking University Third Hospital, Beijing, 100191, PR China.
Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, PR China.
Health Qual Life Outcomes. 2020 Jul 8;18(1):218. doi: 10.1186/s12955-020-01461-6.
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.
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.
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 ω 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).
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.
全球范围内对评估慢性中耳炎（COM）患者健康相关生活质量（HRQoL）的需求不断增加。目前可用的针对 COM 的中文患者报告结局测量（PROM）仅包含有限的相关症状和维度。因此，本研究旨在翻译、文化调适并验证 Zurich Chronic Middle Ear Inventory（ZCMEI-21）的中文版（ZCMEI-21-Chn），以全面评估 COM 患者的主观健康结局。
我们在中国的三家三级转诊中心采集并调查了 223 名 COM 患者，使用 ZCMEI-21 的中文翻译（ZCMEI-21-Chn）和通用 HRQoL 测量工具 EQ-5D 问卷。采用验证性因子分析（CFA）对数据进行结构模型拟合。计算 Cronbach's α 和重测信度系数以建立可靠性，测试 ZCMEI-Chn 评分与 EQ-5D 评分之间的相关性以验证其聚合效度。
共纳入 208 例成年 COM 患者，平均年龄 46 岁（SD 14 岁），男性占 41%（85/208）。一个修正的双因子模型（ω=0.65，ECV=0.47）被发现拟合该量表评分，表明量表具有较好的一般因子饱和度和多维性。ZCMEI-21-Chn 具有良好的信度（Cronbach's α=0.88，重测信度=0.88）。ZCMEI-21-Chn 的总分与直接反映 HRQoL 的问题（r=0.40，p<0.001）、EQ-5D 描述性系统评分（r=0.57，p<0.001）和 EQ-5D 视觉模拟量表（r=0.30，p<0.001）均呈中度相关。
ZCMEI-21-Chn 在中国成人 COM 患者中具有有效性、可靠性和文化适应性。本研究为临床医生提供了一种高效、全面的工具，用于量化 COM 患者的自我报告健康结局，这有助于在全球范围内对 COM 的 HRQoL 数据进行标准化汇总。
