Objective: To understand the impact of tardive dyskinesia (TD) symptoms on patients, confirm the appropriateness of the Tardive Dyskinesia Impact Scale (TDIS) as a patient-reported outcome (PRO), and assess the correlation between the TDIS and clinician-reported outcomes (ClinROs).

Background: ClinROs such as the Abnormal Involuntary Movement Scale (AIMS) are often used to assess the onset or changes in TD, a persistent and potentially disabling movement disorder associated with prolonged exposure to dopamine receptor blocking agents. The TDIS, developed in 2015 to address the need for a TD-specific PRO that assesses the physical and social impacts of TD symptoms, was first used in a phase 3 study (KINECT 3) of valbenazine.

Method: A targeted PubMed review was conducted to identify studies that described the impacts of TD. Studies not related to the patient experience or not descriptive of signs/symptoms/impacts of TD were excluded. A Google search was used to identify patient blogs. Post hoc analyses of the TDIS were conducted using ClinRO data (AIMS, CGI-TD) and PRO data (PGIC) from the 6-week, double-blind, placebo-controlled period of KINECT 3. Spearman correlations were used to evaluate the relationships between TDIS and AIMS total score (sum of items 1-7), CGI-TD, PGIC.

Results: Of 73 articles, 12 (16%) were accepted for extraction; 13 patient blogs were identified. 30 TD signs/symptoms were identified, with orofacial movements and involuntary, repetitive movements being most commonly mentioned. 11 impacts were identified, including work, emotional aspects (e.g., embarrassment and isolation), and social life. A significant amount of overlap was found between these results and the TDIS conceptual framework. KINECT 3 included 225 intent-to-treat participants, ages 26-84 years; 53.8% were male and 56.9% were white/Caucasian. At Week 6, the correlation coefficients for TDIS/AIMS, TDIS/CGI-TD, and TDIS/PGIC were 0.34, 0.30, and 0.30, respectively.

Conclusion: TDIS appropriately captures patients’ experiences of the physical and social impacts of TD. The weak correlation between AIMS (ClinRO) and TDIS (TD-specific PRO) suggest that these instruments measure different aspects of TD. Used together, these scales may help clinicians gain important insights into patients’ daily experiences with TD and provide a more holistic assessment of this disorder.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impacts-of-tardive-dyskinesia-td-symptoms-on-patients-analysis-of-a-td-specific-patient-reported-outcome/