Khashayar Dashtipour1, Zoltan Mari2, Joseph Jankovic3, Charles H Adler4, Marc Schwartz5, Mitchell F Brin6. 1. Loma Linda University School of Medicine, 11370 Anderson Street, Suite B-100, Loma Linda, CA, USA. Electronic address: kdashtipour@llu.edu. 2. Johns Hopkins Hospital, Meyer Bldg, Room 6-119, 600 N. Wolfe Street, Baltimore, MD, USA. Electronic address: mariz@ccf.org. 3. Baylor College of Medicine, Houston, TX, USA. Electronic address: josephj@bcm.edu. 4. Mayo Clinic, 13400 East Shea Boulevard, Scottsdale, AZ, USA. Electronic address: cadler@mayo.edu. 5. MedNet Solutions, Inc., 110 Cheshire Lane, Suite 300, Minnetonka, MN, USA. Electronic address: Marc@MSBiostats.com. 6. Allergan plc, 2525 Dupont Drive, Irvine, CA, USA; University of California, Irvine, CA, USA. Electronic address: Brin_Mitchell@allergan.com.
Abstract
OBJECTIVE: To determine the minimal clinically important change (MCIC) on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores using data from Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE), which captured real-world practices and outcomes. METHODS: Changes in the baseline TWSTRS scores (point and percentage changes) were compared to changes in the Patient and Clinician Global Impression of Change (PGIC and CGIC) ratings. Using logistic regression, the discrimination of the model was determined. RESULTS: Among the 479 patients who completed all TWSTRS assessments, the mean TWSTRS Total score significantly decreased from baseline (39.2) to the final visit (27.1) (P < .0001). TWSTRS Total score point changes that compared with PGIC assessments "very much improved," "much improved" or better, and "minimally improved" or better were -11, -9, and -8, respectively, and were similar to previously published changes (ie, a decrease of ≥10 points). TWSTRS Total score data met indicators of good cutoffs for discrimination of the model including ≥70% percentage of outcomes correctly classified when compared with PGIC ratings. The TWSTRS Total score mapped to PGIC and CGIC ratings better than any TWSTRS subscale score. CONCLUSIONS: The MCIC for improvement was ≥8 points based on mean TWSTRS Total scores in patients with cervical dystonia when compared against the patient-based evaluation of benefit (PGIC).
OBJECTIVE: To determine the minimal clinically important change (MCIC) on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores using data from Cervical DystoniaPatient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE), which captured real-world practices and outcomes. METHODS: Changes in the baseline TWSTRS scores (point and percentage changes) were compared to changes in the Patient and Clinician Global Impression of Change (PGIC and CGIC) ratings. Using logistic regression, the discrimination of the model was determined. RESULTS: Among the 479 patients who completed all TWSTRS assessments, the mean TWSTRS Total score significantly decreased from baseline (39.2) to the final visit (27.1) (P < .0001). TWSTRS Total score point changes that compared with PGIC assessments "very much improved," "much improved" or better, and "minimally improved" or better were -11, -9, and -8, respectively, and were similar to previously published changes (ie, a decrease of ≥10 points). TWSTRS Total score data met indicators of good cutoffs for discrimination of the model including ≥70% percentage of outcomes correctly classified when compared with PGIC ratings. The TWSTRS Total score mapped to PGIC and CGIC ratings better than any TWSTRS subscale score. CONCLUSIONS: The MCIC for improvement was ≥8 points based on mean TWSTRS Total scores in patients with cervical dystonia when compared against the patient-based evaluation of benefit (PGIC).
Authors: Pinky Agarwal; Richard Barbano; Henry Moore; Marc Schwartz; Aleksej Zuzek; Marjan Sadeghi; Atul Patel Journal: Front Neurol Date: 2022-06-30 Impact factor: 4.086
Authors: Jeanne P Vu; Elizabeth Cisneros; Ha Yeon Lee; Linh Le; Qiyu Chen; Xiaoyan A Guo; Ryin Rouzbehani; Joseph Jankovic; Stewart Factor; Christopher G Goetz; Richard L Barbano; Joel S Perlmutter; Hyder A Jinnah; Sarah Pirio Richardson; Glenn T Stebbins; Rodger Elble; Cynthia L Comella; David A Peterson Journal: J Neurol Sci Date: 2022-01-22 Impact factor: 4.553