Cohort-based Screening of Tardive Dyskinesia

Patients were assigned to 1 of 2 cohorts based on clinician assessment (Fig. 1). Training for TD screening (via videos) was provided to all clinical site personnel to promote inter-rater reliability. Cohort 1 was defined in the study protocol as patients who had no abnormal involuntary movements or whose movements were not consistent with possible TD based on clinician assessment. To avoid any potential overlap with patients with possible TD (as described below), this analysis focused on a modified Cohort 1 (no abnormal involuntary movements), which excluded patients with non-TD involuntary movements such as tremor.Fig. 1

Overview of possible TD symptom screen and cohort assignment. EQ-5D-5L, EuroQoL 5-dimension 5-level questionnaire; SDS, Sheehan Disability Scale; TD, tardive dyskinesia

Cohort 2 was defined in the study protocol as patients who had abnormal involuntary movements that were confirmed by their clinician as possible TD. All patients in Cohort 2 had a clinician-rated severity of possible TD as “some” or “a lot” in at least 1 of the following body regions: head/face, neck/trunk, upper extremities, and/or lower extremities. For this analysis, Cohort 2A (“aware”) was defined as patients with clinician-confirmed possible TD who also self-reported having abnormal involuntary movements within the past 4 weeks and had a self-rated severity of “some” or “a lot” in at least 1 of the 4 body regions. Data from Cohort 2NA (“not aware”), defined as patients with possible TD who self-reported having no abnormal involuntary movements in the past 4 weeks, were analyzed to provide supplementary information about the potential effects of patient awareness on HRQoL.