دورية أكاديمية

Determining the Minimal Clinically Important Difference (MCID) and Responsiveness of the Chinese Version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn): A Prospective Multicenter Study.

التفاصيل البيبلوغرافية
العنوان: Determining the Minimal Clinically Important Difference (MCID) and Responsiveness of the Chinese Version of Zurich Chronic Middle Ear Inventory (ZCMEI-21-Chn): A Prospective Multicenter Study.
المؤلفون: Yang R; Department of Otorhinolaryngology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China., Zhang Y; Department of Diseases Prevention and Control, Peking University Third Hospital, Beijing, China., Feng G; Department of Otorhinolaryngology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China., Han W; Department of Otorhinolaryngology Head and Neck Surgery, Chinese People's Liberation Army General Hospital, Beijing, China., Li Y; Department of Otorhinolaryngology, Tongren Hospital, Capital Medical University, Beijing, PR China., Li S; Department of Obstetrics and Gynecology, Peking University Third Hospital, Beijing, PR China., Pan T; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Ke J; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Zhang K; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Xin Y; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Song Y; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Zuo Q; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Zhao Y; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Zhou N; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Yao Z; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Röösli C; Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Huber AM; Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Bächinger D; Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Zurich, University of Zurich, Zurich, Switzerland., Ma F; Department of Otolaryngology-Head and Neck Surgery, Peking University Third Hospital, Beijing, PR China., Gao Z; Department of Otorhinolaryngology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
المصدر: Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology [Otol Neurotol] 2024 Aug 01; Vol. 45 (7), pp. e532-e540. Date of Electronic Publication: 2024 Jul 02.
نوع المنشور: Journal Article; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 100961504 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1537-4505 (Electronic) Linking ISSN: 15317129 NLM ISO Abbreviation: Otol Neurotol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Hagerstown, MD : Lippincott Williams & Wilkins, c2001-
مواضيع طبية MeSH: Quality of Life* , Minimal Clinically Important Difference* , Otitis Media*/surgery, Humans ; Male ; Female ; Middle Aged ; Adult ; Prospective Studies ; Chronic Disease ; Surveys and Questionnaires/standards ; Tympanoplasty/methods ; Aged ; China ; Reproducibility of Results ; Treatment Outcome
مستخلص: Objectives: 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).
Study Design: Prospective multicenter study.
Setting: Four Chinese tertiary referral centers admitting patients nationwide.
Patients: 230 adult patients with chronic otitis media (COM) undergoing tympanoplasty.
Intervention: 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.
Conclusion: 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.
Competing Interests: The authors disclose no conflicts of interest.
(Copyright © 2024, Otology & Neurotology, Inc.)
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تواريخ الأحداث: Date Created: 20240703 Date Completed: 20240712 Latest Revision: 20240716
رمز التحديث: 20240716
DOI: 10.1097/MAO.0000000000004237
PMID: 38956761
قاعدة البيانات: MEDLINE
الوصف
تدمد:1537-4505
DOI:10.1097/MAO.0000000000004237