Tulliez Sebastien, Karantzoulis Stella, Marcus James C, Casamayor Montserrat, Blanchard Cassie, Goenjian Haig, Kantrowitz Joshua T, Shirikjian Lara, Sonnenberg John, Reuteman-Fowler Corey, Harvey Philip D, Keefe Richard S E
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.
IQVIA, New York, NY, USA.
Schizophrenia (Heidelb). 2025 Apr 28;11(1):71. doi: 10.1038/s41537-025-00619-9.
Cognitive impairment is a core feature of schizophrenia, profoundly impacting patients' functional abilities. As such, evaluating cognition-related functional activity/impairment is essential for identifying effective treatments. This study presents findings from a non-interventional quantitative study to assess the inter-rater reliability (IRR) of the Schizophrenia Cognition Rating Scale (SCoRS) with a sample representative of clinical trial populations.
Structured, one-to-one, 10-15-minute live interviews with patients with schizophrenia were conducted by trained SCoRS interviewers (raters), and a separate interview was then conducted with the patient's study partner (informant). Both interviews were recorded so that each interview was assessed by three different SCoRS raters in total (one live, two via recording). IRR was assessed using interclass correlation (ICC) and categorized as low (<0.70), good (0.70-0.90), or excellent (>0.90).
A total of 44 patients with schizophrenia were evaluated by 12 raters (overall). The SCoRS Total Score (mean [SD]: 41.4 [10.2]) indicated moderate-to-moderately-severe impairment of cognition-related functioning, with high inter-patient variability. The SCoRS Total Score demonstrated excellent IRR, with an ICC of 0.91 (95% CI 0.88-0.95).
The 20-item SCoRS Total Score demonstrated excellent IRR in assessing cognition-related functional capacity in patients with schizophrenia, supporting its use as an endpoint in clinical studies.
认知障碍是精神分裂症的核心特征,对患者的功能能力有深远影响。因此,评估与认知相关的功能活动/障碍对于确定有效治疗方法至关重要。本研究展示了一项非干预性定量研究的结果,以评估精神分裂症认知评定量表(SCoRS)在具有临床试验人群代表性样本中的评分者间信度(IRR)。
由经过培训的SCoRS访谈者(评分者)对精神分裂症患者进行结构化、一对一、10 - 15分钟的现场访谈,然后与患者的研究伙伴(信息提供者)进行单独访谈。两次访谈均进行录音,以便每个访谈总共由三名不同的SCoRS评分者进行评估(一名现场评分,两名通过录音评分)。使用组内相关系数(ICC)评估IRR,并分为低(<0.70)、良好(0.70 - 0.90)或优秀(>0.90)。
共有44名精神分裂症患者接受了12名评分者(总计)的评估。SCoRS总分(均值[标准差]:41.4 [10.2])表明与认知相关功能存在中度至中度严重损害,患者间差异较大。SCoRS总分显示出优秀的IRR,ICC为0.91(95%可信区间0.88 - 0.95)。
20项SCoRS总分在评估精神分裂症患者与认知相关的功能能力方面显示出优秀的IRR,支持其作为临床研究的终点指标使用。