FACTORS THAT IMPACT HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH TARDIVE DYSKINESIA- REGRESSION ANALYSES OF DATA FROM THE REAL-WORLD RE-KINECT STUDY
Author(s)
Caroff SM1, Cutler AJ2, Shalhoub H3, Lenderking WR4, Yeomans K5, Serbin M6, Anthony E6, Yonan C6
1Corporal Michael J. Crescenz Veterans Affairs Medical Center and the Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 2Meridien Research, Tampa, FL, USA, 3Evidera, Waltham, MA, USA, 4Evidera, Bethesda, MD, USA, 5Evidera, Montreal, QC, Canada, 6Neurocrine Biosciences, Inc., San Diego, CA, USA
OBJECTIVES: RE-KINECT, an ongoing study of tardive dyskinesia (TD) in antipsychotic-treated outpatients, includes 2 cohorts: patients with visible uncontrollable movements that are clinician-confirmed as possible TD (C2); and patients with no visible movements or with non-TD movements (C1). Data from the EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, administered before cohort assignment, were analyzed to assess health-related quality of life (HRQoL) in C2 vs. C1 and the effects of possible TD on HRQoL (C2 only). METHODS: To eliminate non-TD as a confounding factor, patients who presented with (or reported having) any uncontrollable movements not confirmed as TD were excluded from C1. A linear regression model (adjusted for confounding factors: age, gender, overall health, psychiatric severity, functional status, psychiatric diagnosis) was used to analyze the difference in EQ-5D-5L utility score (0=health state equivalent to death; 1=perfect health) between C2 (n=204) and C1 (n=450). Analyses were also conducted based on C2 patients who rated themselves as having “a lot” of overall TD severity (n=53) or “a lot” of TD impact on daily activities (n=41). In C2, the effects of TD severity (patient-rated, clinician-rated) and TD impact (patient-rated) on EQ-5D-5L utility were analyzed. RESULTS: The difference (±SE) between C2 and C1 was significant for EQ-5D-5L utility (-0.04±0.02, P<0.05). Larger significant differences were found when the model was limited to C2 patients with “a lot” of TD severity (-0.09±0.03; P<0.001) or TD impact (-0.15±0.03, P<0.001). EQ-5D-5L utility was most strongly associated with patient-rated TD impact (-0.021, P<0.001), followed by patient-rated TD severity (-0.028, P<0.05]). No significant association was found between EQ-5D-5L utility and clinician-rated TD severity (-0.007, P>0.05), which was significantly lower (less severe) than patient-rated severity (difference±SE: -0.28±0.12, P<0.05). CONCLUSIONS: TD is associated with measurably worse HRQoL, especially from the perspective of patients versus clinicians and particularly in patients who self-reported greater TD severity/TD impact.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PND84
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities, Patient-reported Outcomes & Quality of Life Outcomes
Disease
Neurological Disorders