:Study Objective:Tardive dyskinesia (TD) is a persistent and potentially disabling movement disorder associated with prolonged antipsychotic use. RE KINECT, a real-world screening study of antipsychotic-treated outpatients, included patients with movements that were clinician-confirmed as possible TD (Cohort 2) and patients with no involuntary movements (Cohort 1). Baseline data from the patient rated EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and Sheehan Disability Scale (SDS) were analyzed to evaluate health related quality of life (Cohort 2 vs. Cohort 1) and the effects of possible TD on quality of life (Cohort 2).Methods:Assessments included EQ-5D-5L utility score (0=equivalent to death to 1=perfect health); SDS total score (0=no impact to 30=highest impact); patient- and clinician-rated severity of possible TD in 4 body regions (0=none, 1=some, and 2=a lot; summary score, 0 to 8); and patient-rated impact of possible TD in 7 daily activities (0=none, 1=some, and 2=a lot; summary score, 0 to 14). Populations included Cohort 1 (N=450); full Cohort 2 (N=204); and limited Cohort 2 (N=111, patients who self-reported “some” or “a lot” of TD severity in ≥1 body region). Mean differences between Cohort 2 and Cohort 1 in EQ-5D-5L utility and SDS total scores were analyzed using a generalized linear regression model that was adjusted for potentially confounding factors (e.g., age, sex, psychiatric diagnosis). Associations between TD summary scores (severity, impact) and quality of life (EQ-5D-5L utility, SDS total) were analyzed using a regression model.Results:The mean score difference between full Cohort 2 (N=204) and Cohort 1 (N=450) was significant for EQ-5D-5L utility (-0.037; P<0.05 [adjusted analysis]) but not SDS total (0.267; P>0.05). However, when limited to Cohort 2 patients who self-reported “a lot” of TD severity (n=53) or impact (n=33), both EQ 5D 5L utility and SDS total scores were significantly worse than in Cohort 1 (P<0.05). Regression coefficients indicated significant associations between patient-rated impact and EQ 5D-5L utility in the full Cohort 2 (-0.021, P<0.001) and limited Cohort 2 (-0.024, P<0.001). A significant association was also found with patient rated severity in limited Cohort 2 (P<0.05), but not with clinician-rated severity. Similar results were found for SDS total score.Conclusions:RE-KINECT patients were consistent in evaluating the severity and impact of TD, whether based on subjective assessments or standardized patient-reported instruments (EQ-5D-5L, SDS). Clinician-rated severity of TD may not always correlate with patient perceptions of the significance of TD. Patient self-assessments (focused on symptom impact) can be clinically relevant; incorporating such measures into everyday practice may provide a more comprehensive approach to TD assessment and management.Funding Acknowledgements:Supported by Neurocrine Biosciences, Inc.

中文翻译：

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105 基于患者和临床医生评估的可能迟发性运动障碍患者的健康相关生活质量

: 研究目的：迟发性运动障碍 (TD) 是一种与长期使用抗精神病药物相关的持续性和潜在致残性运动障碍。RE KINECT 是一项针对接受抗精神病药物治疗的门诊患者的真实世界筛查研究，包括经临床医生确认为可能 TD 的患者（队列 2）和无不自主运动的患者（队列 1）。对来自患者评定的 EuroQoL 5 维 5 级问卷 (EQ-5D-5L) 和 Sheehan 残疾量表 (SDS) 的基线数据进行分析，以评估与健康相关的生活质量（队列 2 与队列 1）和可能的影响TD 生活质量（队列 2）。方法：评估包括 EQ-5D-5L 效用评分（0=相当于死亡到 1=完美健康）；SDS 总分（0=没有影响到 30=最高影响）；患者和临床医生评定的 4 个身体区域可能的 TD 严重程度（0=无，1=一些，2=很多；总分，0 到 8）；以及 7 项日常活动中可能的 TD 对患者的影响（0=无，1=一些，2=很多；总分，0 到 14）。人群包括队列 1（N=450）；完整的队列 2 (N=204)；和有限的队列 2（N=111，自我报告 ≥1 个身体区域 TD 严重程度“一些”或“很多”的患者）。队列 2 和队列 1 在 EQ-5D-5L 效用和 SDS 总分方面的平均差异使用针对潜在混杂因素（例如年龄、性别、精神病诊断）进行调整的广义线性回归模型进行分析。使用回归模型分析 TD 总分（严重性、影响）和生活质量（EQ-5D-5L 效用、SDS 总分）之间的关联。 结果：完整队列 2 (N=204) 和队列 1 (N=450) 之间的平均得分差异对于 EQ-5D-5L 效用是显着的 (-0.037; P<0.05 [调整分析])，但不是 SDS 总分 (0.267; P >0.05)。然而，当仅限于自我报告“很多”TD严重程度（n = 53）或影响（n = 33）的队列 2 患者时，EQ 5D 5L 效用和 SDS 总分均明显低于队列 1（P <0.05)。回归系数表明，在完整队列 2（-0.021，P<0.001）和有限队列 2（-0.024，P<0.001）中，患者评定的影响与 EQ 5D-5L 效用之间存在显着关联。在有限的队列 2 中，患者评定的严重程度也有显着相关性（P<0.05），但与临床医生评定的严重程度无关。SDS总分也发现了类似的结果。结论：无论是基于主观评估还是标准化的患者报告工具（EQ-5D-5L，SDS），RE-KINECT 患者在评估 TD 的严重程度和影响方面都是一致的。临床医生评定的 TD 严重程度可能并不总是与患者对 TD 重要性的看法相关。患者自我评估（侧重于症状影响）可能具有临床相关性；将这些措施纳入日常实践可能会为 TD 评估和管理提供更全面的方法。资金致谢：由 Neurocrine Biosciences, Inc. 提供支持。患者自我评估（侧重于症状影响）可能具有临床相关性；将这些措施纳入日常实践可能会为 TD 评估和管理提供更全面的方法。资金致谢：由 Neurocrine Biosciences, Inc. 提供支持。患者自我评估（侧重于症状影响）可能具有临床相关性；将这些措施纳入日常实践可能会为 TD 评估和管理提供更全面的方法。资金致谢：由 Neurocrine Biosciences, Inc. 提供支持。