Lilly & Company, Lilly Corporate Center, Indianapolis, IN 46285, USA.
BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.
To fully assess the various dimensions affected by schizophrenia, clinical trials often include multiple scales measuring various symptom profiles, cognition, quality of life, subjective well-being, and functional impairment. In this exploratory study, we characterized the relationships among six clinical, functional, cognitive, and quality-of-life measures, identifying a parsimonious set of measurements.
We used baseline data from a randomized, multicenter study of patients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder who were experiencing an acute symptom exacerbation (n = 628) to examine the relationship among several outcome measures. These measures included the Positive and Negative Syndrome Scale (PANSS), Montgomery-Asberg Depression Rating Scale (MADRS), Brief Assessment of Cognition in Schizophrenia Symbol Coding Test, Subjective Well-being Under Neuroleptics Scale Short Form (SWN-K), Schizophrenia Objective Functioning Instrument (SOFI), and Quality of Life Scale (QLS). Three analytic approaches were used: 1) path analysis; 2) factor analysis; and 3) categorical latent variable analysis. In the optimal path model, the SWN-K was selected as the final outcome, while the SOFI mediated the effect of the exogenous variables (PANSS, MADRS) on the QLS.
The overall model explained 47% of variance in QLS and 17% of the variance in SOFI, but only 15% in SWN-K. Factor analysis suggested four factors: "Functioning," "Daily Living," "Depression," and "Psychopathology." A strong positive correlation was observed between the SOFI and QLS (r = 0.669), and both the QLS and SOFI loaded on the "Functioning" factor, suggesting redundancy between these scales. The measurement profiles from the categorical latent variable analysis showed significant variation in functioning and quality of life despite similar levels of psychopathology.
Researchers should consider collecting PANSS, SOFI, and SWN-K in their trials. This would allow a broad spectrum of assessments that would have the ability to capture a wide range of treatment outcomes and allow for a rich characterization of the subgroups involved. Additional research is needed to identify the critical cognitive measures.
Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in SchizophreniaClinicalTrials.gov identifier: NCT00337662; http://www.clinicaltrials.gov/
为了全面评估精神分裂症受影响的各个维度，临床试验通常包括多个量表，以测量各种症状特征、认知功能、生活质量、主观幸福感和功能障碍。在这项探索性研究中，我们对六种临床、功能、认知和生活质量测量指标进行了特征描述，确定了一套简洁的测量指标。
我们使用了一项随机、多中心研究的基线数据，该研究纳入了诊断为精神分裂症、分裂情感障碍或精神分裂样障碍且处于急性症状加重期的患者（n=628），以检查几种结局测量指标之间的关系。这些指标包括阳性和阴性症状量表（PANSS）、蒙哥马利-阿斯伯格抑郁评定量表（MADRS）、简明精神分裂症认知测验符号编码测验、神经安定剂下主观幸福感量表短式（SWN-K）、精神分裂症客观功能评定量表（SOFI）和生活质量量表（QLS）。我们使用了三种分析方法：1）路径分析；2）因子分析；3）类别潜在变量分析。在最优路径模型中，SWN-K 被选为最终结局，而 SOFI 则介导了外生变量（PANSS、MADRS）对 QLS 的影响。
总体模型解释了 QLS 变异的 47%和 SOFI 变异的 17%，但仅解释了 SWN-K 变异的 15%。因子分析提示存在四个因子：“功能”、“日常生活”、“抑郁”和“精神病理学”。SOFI 与 QLS 之间存在强烈的正相关（r=0.669），QLS 和 SOFI 均加载于“功能”因子上，表明这些量表之间存在冗余。类别潜在变量分析的测量特征显示，尽管精神病理学水平相似，但功能和生活质量存在显著差异。
研究人员在试验中应考虑同时收集 PANSS、SOFI 和 SWN-K。这将允许进行广泛的评估，能够捕捉到广泛的治疗结果，并对涉及的亚组进行丰富的特征描述。需要进一步的研究来确定关键的认知测量指标。
通过识别精神分裂症中抗精神病药物早期作用预测利培酮治疗反应
NCT00337662；http://www.clinicaltrials.gov/
