Abstract：
OBJECTIVE: This study aimed to establish the minimal clinically important difference (MCID) and assess the responsiveness of the Chinese version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn).
METHODS: Prospective multicenter study.
METHODS: Four Chinese tertiary referral centers admitting patients nationwide.
METHODS: 230 adult patients with chronic otitis media (COM) undergoing tympanoplasty.
METHODS: Patients were required to complete the ZCMEI-21-Chn to measure health-related quality of life both preoperatively and postoperatively. An anchor-based method was used to determine the MCID of the derivative cohort by including the Global Rating of Change Questionnaire as an anchor. The generalizability and consistency with functional outcomes of the MCID estimates were externally examined in a validation cohort using a receiver operating characteristic curve analysis.
RESULTS: A total of 161 and 69 patients were included in the derivative and validation cohort. The mean preoperative and postoperative ZCMEI-21-Chn total scores were 28.4 (standard deviation [SD] 14.5) and 17.5 (SD 12.6). The mean change in ZCMEI-21-Chn score was 10.9 (SD 14.3, p < 0.001). The MCIDs of the ZCMEI-21-Chn for improvement and deterioration were estimated at 13 (SD 13.0) and -7 (SD 12.9), accordingly. For patients who have reported an improved health-related quality of life, a cutoff value of 15.6 dB HL for elevation of the air-conducted hearing threshold was noticed. However, change of clinical importance judged according to MCID and Japan Otological Society criteria disagreed with each other, notably with a Cohen\'s kappa ( κ ) of 0.14 ( p = 0.21) in the validation cohort.
CONCLUSIONS: This study is the first to establish the MCID of a COM-specific questionnaire in Chinese. For the COM population undergoing surgical intervention, MCID values of 13 for improvement and -7 for deterioration are recommended. The results were externally validated to be generalizable to nationwide usage, yet distinguishable from the audiological criteria. The availability of the MCID greatly adds to the clinical utility of the ZCMEI-21-Chn by enabling a clinically meaningful interpretation of its score changes.
METHODS: Prospective multicenter study.
METHODS: Four Chinese tertiary referral centers admitting patients nationwide.
METHODS: 230 adult patients with chronic otitis media (COM) undergoing tympanoplasty.
METHODS: Patients were required to complete the ZCMEI-21-Chn to measure health-related quality of life both preoperatively and postoperatively. An anchor-based method was used to determine the MCID of the derivative cohort by including the Global Rating of Change Questionnaire as an anchor. The generalizability and consistency with functional outcomes of the MCID estimates were externally examined in a validation cohort using a receiver operating characteristic curve analysis.
RESULTS: A total of 161 and 69 patients were included in the derivative and validation cohort. The mean preoperative and postoperative ZCMEI-21-Chn total scores were 28.4 (standard deviation [SD] 14.5) and 17.5 (SD 12.6). The mean change in ZCMEI-21-Chn score was 10.9 (SD 14.3, p < 0.001). The MCIDs of the ZCMEI-21-Chn for improvement and deterioration were estimated at 13 (SD 13.0) and -7 (SD 12.9), accordingly. For patients who have reported an improved health-related quality of life, a cutoff value of 15.6 dB HL for elevation of the air-conducted hearing threshold was noticed. However, change of clinical importance judged according to MCID and Japan Otological Society criteria disagreed with each other, notably with a Cohen\'s kappa ( κ ) of 0.14 ( p = 0.21) in the validation cohort.
CONCLUSIONS: This study is the first to establish the MCID of a COM-specific questionnaire in Chinese. For the COM population undergoing surgical intervention, MCID values of 13 for improvement and -7 for deterioration are recommended. The results were externally validated to be generalizable to nationwide usage, yet distinguishable from the audiological criteria. The availability of the MCID greatly adds to the clinical utility of the ZCMEI-21-Chn by enabling a clinically meaningful interpretation of its score changes.
摘要：
目的：本研究旨在建立最小临床重要差异（MCID）并评估苏黎世慢性中耳量表中文版（ZCMEI-21-Chn）的反应性。
方法：前瞻性多中心研究。
方法：全国有四个中国三级转诊中心接收患者。
方法：230例接受鼓室成形术的慢性中耳炎（COM）成人患者。
方法：患者需要完成ZCMEI-21-Chn以测量术前和术后与健康相关的生活质量。通过包括全球变化评级问卷作为锚点，使用基于锚点的方法来确定衍生队列的MCID。使用受试者工作特征曲线分析在验证队列中外部检查了MCID估计值的通用性和与功能结果的一致性。
结果：共有161名和69名患者被纳入衍生和验证队列。术前和术后ZCMEI-21-Chn的平均总分分别为28.4（标准差[SD]14.5）和17.5（SD12.6）。ZCMEI-21-Chn评分的平均变化为10.9(SD14.3,p<0.001)。用于改善和恶化的ZCMEI-21-Chn的MCID估计为13（SD13.0）和-7（SD12.9），因此。对于报告健康相关生活质量改善的患者，注意到空气传导听力阈值升高的临界值为15.6dBHL。然而,根据MCID和日本耳科学会标准判断的临床重要性变化不一致，特别是在验证队列中，科恩的κ(κ)为0.14(p=0.21)。
结论：本研究首次建立中文COM特异性问卷的MCID。对于接受手术干预的COM人群，建议MCID值为13用于改善，而-7用于恶化。结果经过外部验证，可推广到全国范围内使用，但与听力学标准有区别。MCID的可用性通过实现对其评分变化的临床有意义的解释而极大地增加了ZCMEI-21-Chn的临床效用。
方法：前瞻性多中心研究。
方法：全国有四个中国三级转诊中心接收患者。
方法：230例接受鼓室成形术的慢性中耳炎（COM）成人患者。
方法：患者需要完成ZCMEI-21-Chn以测量术前和术后与健康相关的生活质量。通过包括全球变化评级问卷作为锚点，使用基于锚点的方法来确定衍生队列的MCID。使用受试者工作特征曲线分析在验证队列中外部检查了MCID估计值的通用性和与功能结果的一致性。
结果：共有161名和69名患者被纳入衍生和验证队列。术前和术后ZCMEI-21-Chn的平均总分分别为28.4（标准差[SD]14.5）和17.5（SD12.6）。ZCMEI-21-Chn评分的平均变化为10.9(SD14.3,p<0.001)。用于改善和恶化的ZCMEI-21-Chn的MCID估计为13（SD13.0）和-7（SD12.9），因此。对于报告健康相关生活质量改善的患者，注意到空气传导听力阈值升高的临界值为15.6dBHL。然而,根据MCID和日本耳科学会标准判断的临床重要性变化不一致，特别是在验证队列中，科恩的κ(κ)为0.14(p=0.21)。
结论：本研究首次建立中文COM特异性问卷的MCID。对于接受手术干预的COM人群，建议MCID值为13用于改善，而-7用于恶化。结果经过外部验证，可推广到全国范围内使用，但与听力学标准有区别。MCID的可用性通过实现对其评分变化的临床有意义的解释而极大地增加了ZCMEI-21-Chn的临床效用。
