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    Abnormal Involuntary Movement Scale in Tardive Dyskinesia:Minimal Clinically Important Difference

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    Author
    Stacy, Mark; Sajatovic, Martha; Kane, John M.; Cutler, Andrew J.; Liang, Grace S.; O’Brien, Christopher F.; Correll, Christoph U.
    Abstract
    Background A minimal clinically important difference has not been established for the Abnormal Involuntary Movement Scale in patients with tardive dyskinesia. Valbenazine is a vesicular monoamine transporter 2 inhibitor approved for the treatment of tardive dyskinesia in adults. Efficacy in randomized, double‐blind, placebo‐controlled trials was defined as the change from baseline in Abnormal Involuntary Movement Scale total score (sum of items 1‐7). Objectives To estimate an minimal clinically important difference for the Abnormal Involuntary Movement Scale using valbenazine trial data and an anchor‐based method. Methods Data were pooled from three 6‐week double‐blind, placebo‐controlled trials: KINECT (NCT01688037), KINECT 2 (NCT01733121), and KINECT 3 (NCT02274558). Valbenazine doses were pooled for analyses as follows: “low dose,” which includes 40 or 50 mg/day; and “high dose,” which includes 75 or 80 mg/day. Mean changes from baseline in Abnormal Involuntary Movement Scale total score were analyzed in all participants (valbenazine‐ and placebo‐treated) with a Clinical Global Impression of Change‐Tardive Dyskinesia or Patient Global Impression of Change score of 1 (very much improved) to 3 (minimally improved). Results The least squares mean improvement from baseline to week 6 in Abnormal Involuntary Movement Scale total score was significantly greater with valbenazine (low dose: –2.4; high dose: –3.2; both, P < 0.001) versus placebo (–0.7). An minimal clinically important difference of 2 points was estimated based on least squares mean changes in Abnormal Involuntary Movement Scale total score in participants with a Clinical Global Impression of Change‐Tardive Dyskinesia score ≤3 at week 6 (mean change: –2.2; median change: –2) or Patient Global Impression of Change score ≤3 at week 6 (mean change: –2.0; median change: –2). Conclusions Results from an anchor‐based method indicate that a 2‐point decrease in Abnormal Involuntary Movement Scale total score may be considered clinically important. © 2019 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.
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    http://hdl.handle.net/10342/7846
    Date
    2019-05-27
    Citation:
    APA:
    Stacy, Mark, & Sajatovic, Martha, & Kane, John M., & Cutler, Andrew J., & Liang, Grace S., & O’Brien, Christopher F., & Correll, Christoph U.. (May 2019). Abnormal Involuntary Movement Scale in Tardive Dyskinesia:Minimal Clinically Important Difference. Movement Disorders, (34:8), p.1203-1209. Retrieved from http://hdl.handle.net/10342/7846

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    MLA:
    Stacy, Mark, and Sajatovic, Martha, and Kane, John M., and Cutler, Andrew J., and Liang, Grace S., and O’Brien, Christopher F., and Correll, Christoph U.. "Abnormal Involuntary Movement Scale in Tardive Dyskinesia:Minimal Clinically Important Difference". Movement Disorders. 34:8. (1203-1209.), May 2019. April 18, 2021. http://hdl.handle.net/10342/7846.
    Chicago:
    Stacy, Mark and Sajatovic, Martha and Kane, John M. and Cutler, Andrew J. and Liang, Grace S. and O’Brien, Christopher F. and Correll, Christoph U., "Abnormal Involuntary Movement Scale in Tardive Dyskinesia:Minimal Clinically Important Difference," Movement Disorders 34, no. 8 (May 2019), http://hdl.handle.net/10342/7846 (accessed April 18, 2021).
    AMA:
    Stacy, Mark, Sajatovic, Martha, Kane, John M., Cutler, Andrew J., Liang, Grace S., O’Brien, Christopher F., Correll, Christoph U.. Abnormal Involuntary Movement Scale in Tardive Dyskinesia:Minimal Clinically Important Difference. Movement Disorders. May 2019; 34(8) 1203-1209. http://hdl.handle.net/10342/7846. Accessed April 18, 2021.
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