European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2020
Establishing the minimal clinically important difference (MCID) of the Zurich Chronic Middle Ear Inventory (ZCMEI-21) in patients treated for chronic middle ear disease.
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Bächinger David, Mlynski Robert, Weiss Nora M
Аннотация
AIM: To determine the minimal clinically important difference (MCID) of the Zurich Chronic Middle Ear Inventory (ZCMEI-21), a questionnaire assessing health-related quality of life (HRQoL) in chronic otitis media (COM).
METHODS: In this longitudinal study, 103 patients completed the ZCMEI-21 before and after surgery for chronic otitis media. An anchor-based method including a global rating of change (GRC) was used to assess the MCID of the ZCMEI-21.
RESULTS: A total of 103 patients were included. The mean preoperative and postoperative ZCMEI-21 scores were 28.6 (SD 13.6), and 21.8 (SD 12.8), respectively. The mean change was 6.8 (SD 0.8; p < 0.0001). A significant correlation between the ZCMEI-21 scores and the GRC was found (r = - 0.5; p < 0.001). Using the anchor-based method, the MCID of the ZCMEI-21 was estimated at 5.3 (SD 12.0).
CONCLUSIONS: Knowledge of values indicating a clinically relevant change in patient-reported outcome measures is important when interpreting effects of different treatment modalities. This is the first study assessing the MCID of a questionnaire measuring HRQoL in COM, i.e. the ZCMEI-21. We recommend a MCID of 5 in COM patients undergoing surgical treatment. This information substantially increases the usefulness of the ZCMEI-21 as an outcome measure in COM as changes can be assessed with regard to their clinical meaningfulness.
METHODS: In this longitudinal study, 103 patients completed the ZCMEI-21 before and after surgery for chronic otitis media. An anchor-based method including a global rating of change (GRC) was used to assess the MCID of the ZCMEI-21.
RESULTS: A total of 103 patients were included. The mean preoperative and postoperative ZCMEI-21 scores were 28.6 (SD 13.6), and 21.8 (SD 12.8), respectively. The mean change was 6.8 (SD 0.8; p < 0.0001). A significant correlation between the ZCMEI-21 scores and the GRC was found (r = - 0.5; p < 0.001). Using the anchor-based method, the MCID of the ZCMEI-21 was estimated at 5.3 (SD 12.0).
CONCLUSIONS: Knowledge of values indicating a clinically relevant change in patient-reported outcome measures is important when interpreting effects of different treatment modalities. This is the first study assessing the MCID of a questionnaire measuring HRQoL in COM, i.e. the ZCMEI-21. We recommend a MCID of 5 in COM patients undergoing surgical treatment. This information substantially increases the usefulness of the ZCMEI-21 as an outcome measure in COM as changes can be assessed with regard to their clinical meaningfulness.