Abstract
AimTo 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).MethodsIn 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.ResultsA 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).ConclusionsKnowledge 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.
Highlights
Health-related quality of life (HRQoL) assessment has become an important outcome in clinical trials as well as in clinical practice [1,2,3]
Chatzimichalis et al reported a mean ZCMEI-21-E total score difference of 8.7 (SD 3.3, p < 0.01) between unilateral and bilateral chronic otitis media (COM). Even though this interpretation is hindered by the fact that these data do not originate from the same patients, the results indicate that the difference in HRQoL is clinically important
Further analyses could focus on identifying patient subgroups by taken further contributors to the minimal clinically important difference (MCID) into account, such as gender differences or the severity of the disease [9]. We consider these contributors as minor in our cohort, as we found no significant differences in the ZCMEI-21 total score changes between male and female patients
Summary
Health-related quality of life (HRQoL) assessment has become an important outcome in clinical trials as well as in clinical practice [1,2,3]. HRQoL outcome measures used to determine differences in symptoms over time need to be responsive to the change, e.g. to evaluate the effectiveness of therapies. Even though questionnaire score differences “Otto Körner”, University Medical Center, Doberaner Strasse 137‐139, 18057 Rostock, Germany may exhibit statistical significance, this may not necessarily reflect a meaningful difference in HRQoL, i.e. a clinically important difference. It is important to translate questionnaire score changes into clinically relevant concepts. For this reason, the minimal clinically important difference (MCID) has been introduced [6]. The MCID can be determined using different methods, of which anchor-based methods have been described being superior to other methods [8, 9]
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