What constitutes a clinically important change in Mayo Elbow Performance Index and range of movement after open elbow arthrolysis?

Ziyang Sun, Juehong Li, Gang Luo, Feiyan Wang, Yuehao Hu, Cunyi Fan, Ziyang Sun, Juehong Li, Gang Luo, Feiyan Wang, Yuehao Hu, Cunyi Fan

Abstract

Aims: This study aimed to determine the minimal detectable change (MDC), minimal clinically important difference (MCID), and substantial clinical benefit (SCB) under distribution- and anchor-based methods for the Mayo Elbow Performance Index (MEPI) and range of movement (ROM) after open elbow arthrolysis (OEA). We also assessed the proportion of patients who achieved MCID and SCB; and identified the factors associated with achieving MCID.

Methods: A cohort of 265 patients treated by OEA were included. The MEPI and ROM were evaluated at baseline and at two-year follow-up. Distribution-based MDC was calculated with confidence intervals (CIs) reflecting 80% (MDC 80), 90% (MDC 90), and 95% (MDC 95) certainty, and MCID with changes from baseline to follow-up. Anchor-based MCID (anchored to somewhat satisfied) and SCB (very satisfied) were calculated using a five-level Likert satisfaction scale. Multivariate logistic regression of factors affecting MCID achievement was performed.

Results: The MDC increased substantially based on selected CIs (MDC 80, MDC 90, and MDC 95), ranging from 5.0 to 7.6 points for the MEPI, and from 8.2° to 12.5° for ROM. The MCID of the MEPI were 8.3 points under distribution-based and 12.2 points under anchor-based methods; distribution- and anchor-based MCID of ROM were 14.1° and 25.0°. The SCB of the MEPI and ROM were 17.3 points and 43.4°, respectively. The proportion of the patients who attained anchor-based MCID for the MEPI and ROM were 74.0% and 94.7%, respectively; furthermore, 64.2% and 86.8% attained SCB. Non-dominant arm (p = 0.022), higher preoperative MEPI rating (p < 0.001), and postoperative visual analogue scale pain score (p < 0.001) were independent predictors of not achieving MCID for the MEPI, while atraumatic causes (p = 0.040) and higher preoperative ROM (p = 0.005) were independent risk factors for ROM.

Conclusion: In patients undergoing OEA, the MCID for the increased MEPI is 12.2 points and 25° increased ROM. The SCB is 17.3 points and 43.3°, respectively. Future studies using the MEPI and ROM to assess OEA outcomes should report not only statistical significance but also clinical importance. Cite this article: Bone Joint J 2021;103-B(2):366-372.

Keywords: Elbow stiffness; Heterotopic ossification; Mayo Elbow Performance Index; Minimal clinically important difference; Minimal detectable change; Range of movement; Substantial clinical benefit.

Figures

Fig. 1
Fig. 1
The anchor-based MCID and SCB calculations of the MEPI, extension, flexion, and ROM for open elbow arthrolysis. For example, for MEPI: no significant difference (p = 0.685) was found among preoperative MEPI for the S (67.4 points), M (65.4 points), and N (66.5 points) groups. The mean changes (△) of the MEPI from preoperative to two-year follow-up were 27.9 points, 22.8 points, and 10.6 points for S, M and N groups, respectively. Therefore, anchor-based MCID and SCB of the MEPI were 12.2 points (M minus N) and 17.3 points (S minus N). M, minimum improvement group; MCID, minimal clinically important difference; MEPI, Mayo Elbow Performance Index; N, no change group; ROM, range of movement; S, substantial improvement group.

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