Computer Interview for Improving Human Rater Performance

描述（由申请人提供）：降低精神病学结局指标的变异性可增强统计功效，降低临床试验的样本量要求，并降低试验失败的可能性。一致性评分系统（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）。来自这些患者自我报告工具的结果，其利用一组专有算法来管理和评分Young Mania评定量表或其他测量，可以用于监测人类临床评定者的表现。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、行业研究申办者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对评分者对症状的敏感性的影响，获得评分者对其可接受性的反馈，并建立在II期进行的多中心临床试验设计所需的效应量估计。统计分析和市场研究表明，提高评分者一致性的能力对制药公司或进行精神病学临床试验的临床研究组织是有价值的。作为一家将评分员培训方面的重要专业知识与基于互联网的教育内容交付相结合的公司，CRS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.