Computer Interview for Improving Human Rater Performance

描述（由申请人提供）：减少精神病学结果测量的可变性增强了统计能力，减少了临床试验的样本量要求，并降低了试验失败的可能性。协和评分系统（CRS）开发了一套基于计算机的评分工具，包括交互式计算机访谈（ICI）。这些患者自我报告工具的结果，利用一套专有算法来管理和评分青年躁狂症评定量表或其他措施，可用于监测人类临床评分者的表现。在第一阶段，我们评估了ICI的结构效度及其对少数民族人群、行业研究发起人和精神病患者的可接受性。我们还进行了一项试点研究，以评估ICI对评分者对症状敏感性的影响，获得评分者对其可接受性的反馈，并建立设计多中心II期临床试验所需的效应量估计。统计分析和市场研究表明，提高比率一致性的能力对进行精神病学临床试验的制药公司或临床研究组织是有价值的。CRS是一家将专业知识与互联网教育内容相结合的公司，在开发和实施这些创新技术方面处于有利地位。

DESCRIPTION (provided by applicant): Decreasing variability in psychiatric outcome measures augments statistical power, reduces sample size requirements for clinical trials, and reduces the likelihood of failed trials. Concordant Rater Systems (CRS) has developed a suite of computer-based rater tools, including Interactive Computer Interviews (ICI). Results from these patient self-report tools, which utilize a set of proprietary algorithms to administer and score the Young Mania Rating Scale or other measures, can be used to monitor the performance of human clinical raters. In Phase I, we assess the construct validity of the ICI as well as its acceptability to ethnic minority populations, industry study sponsors, and psychiatric patients. We also conduct a pilot study to assess the effect of the ICI on rater sensitivity to symptoms, obtain feedback from raters on its acceptability, and establish effect size estimates needed for design of multi-center clinical trials to be conducted in Phase II. Statistical analyses and market research suggest that the ability to improve rater concordance will be valuable to pharmaceutical companies or clinical research organizations that conduct clinical trials in psychiatry. As a company combining significant expertise in rater training with delivery of internet-based educational content, CRS is well positioned to develop and implement these innovative technologies.