REAL-WORLD EVALUATION SCREENING STUDY AND REGISTRY OF DYSKINESIA IN PATIENTS TAKING ANTIPSYCHOTIC AGENTS: THE RE-KINECT STUDY

• Published in: Value in health Vol. 20; no. 5; p. A311
• Main Authors: Yeomans, K, Lenderking, WR, Ross, L, Shalhoub, H, Yonan, C
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01-05-2017
• Subjects: Adults; Antipsychotics; Caregivers; Chart reviews; Clinical assessment; Disability; Drug therapy; Functioning; Health status; Involuntary; Limbs; Lower limbs; Medical screening; Mental disorders; Movement disorders; Neck; Neurological disorders; Outpatients; Patients; Psychiatric symptoms; Psychiatry; Quality of life; Questionnaires; Recruitment; Symptoms; Tardive dyskinesia
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.05.005

OBJECTIVES: Tardive dyskinesia (TD) is an involuntary movement disorder that is associated with exposure to antipsychotic medications. Scant evidence exists regarding the burden of TD symptoms and even less has been published, recently, regarding the role of TD in the overall health status of patients. A prospective registry study, RE-KINECT, was designed to document the presence and impact of abnormal, involuntary movements (possible TD) in a real-world cohort of outpatients taking antipsychotics. METHODS: Approximately 1000 adults from 70 outpatient US psychiatry practices will be included. Patients with ≥3 months lifetime exposure to antipsychotic(s) and ≥ 1 psychiatric disorder will be eligible for screening. TD symptom estimation involves a two-tiered approach: (1) visual observation of involuntary movements by an intake staff member (2) independent clinician assessment and confirmation of possible TD symptoms in general body regions (head/face, neck/trunk, upper/lower limbs). Assignment to Cohort 1 or 2 (without or with visible signs of involuntary movements, respectively) is based on clinician assessment. To measure the possible impact of psychiatric illness (both Cohorts), baseline data include: clinician assessment, patient HRQOL and burden/ disability questionnaires; and 12-month retrospective chart review (medical and treatment history). Cohort 2 will participate in a 12-month longitudinal evaluation period with baseline caregiver questionnaire (optional); clinician assessments of significant recent changes in TD symptoms or psychiatric condition and patient-reported outcomes (e.g., overall health status, awareness of involuntary movements, disease burden, health related quality of life [EQ5D], functional impact/ disability [Sheehan Disability Scale]) at each visit; and final retrospective chart review. RESULTS: Recruitment is ongoing; interim baseline data will be presented at meeting. CONCLUSIONS: This novel registry aims to evaluate the real world potential impact/burden of TD compared to similar patients (with psychiatric illness) without TD. Prevalence of possible TD based on non-clinician and clinician screening and functional impacts of the condition will be described.